Psychosocial interventions for smoking cessation in patients with coronary heart disease

Abstract

Background

This is an update of a Cochrane review previously published in 2008. Smoking increases the risk of developing atherosclerosis but also acute thrombotic events. Quitting smoking is potentially the most effective secondary prevention measure and improves prognosis after a cardiac event, but more than half of the patients continue to smoke, and improved cessation aids are urgently required.

Objectives

This review aimed to examine the efficacy of psychosocial interventions for smoking cessation in patients with coronary heart disease in short‐term (6 to 12 month follow‐up) and long‐term (more than 12 months). Moderators of treatment effects (i.e. intervention types, treatment dose, methodological criteria) were used for stratification.

Search methods

The Cochrane Central Register of Controlled Trials (Issue 12, 2012), MEDLINE, EMBASE, PsycINFO and PSYNDEX were searched from the start of the database to January 2013. This is an update of the initial search in 2003. Results were supplemented by cross‐checking references, and handsearches in selected journals and systematic reviews. No language restrictions were applied.

Selection criteria

Randomised controlled trials (RCTs) in patients with CHD with a minimum follow‐up of 6 months.

Data collection and analysis

Two authors independently assessed trial eligibility and risk of bias. Abstinence rates were computed according to an intention to treat analysis if possible, or if not according to completer analysis results only. Subgroups of specific intervention strategies were analysed separately. The impact of study quality on efficacy was studied in a moderator analysis. Risk ratios (RR) were pooled using the Mantel‐Haenszel and random‐effects model with 95% confidence intervals (CI).

Main results

We found 40 RCTs meeting inclusion criteria in total (21 trials were new in this update, 5 new trials contributed to long‐term results (more than 12 months)). Interventions consist of behavioural therapeutic approaches, telephone support and self‐help material and were either focused on smoking cessation alone or addressed several risk factors (eg. obesity, inactivity and smoking). The trials mostly included older male patients with CHD, predominantly myocardial infarction (MI). After an initial selection of studies three trials with implausible large effects of RR > 5 which contributed to substantial heterogeneity were excluded. Overall there was a positive effect of interventions on abstinence after 6 to 12 months (risk ratio (RR) 1.22, 95% confidence interval (CI) 1.13 to 1.32, I² 54%; abstinence rate treatment group = 46%, abstinence rate control group 37.4%), but heterogeneity between trials was substantial. Studies with validated assessment of smoking status at follow‐up had similar efficacy (RR 1.22, 95% CI 1.07 to 1.39) to non‐validated trials (RR 1.23, 95% CI 1.12 to 1.35). Studies were stratified by intervention strategy and intensity of the intervention. Clustering reduced heterogeneity, although many trials used more than one type of intervention. The RRs for different strategies were similar (behavioural therapies RR 1.23, 95% CI 1.12 to 1.34, I² 40%; telephone support RR 1.21, 95% CI 1.12 to 1.30, I² 44%; self‐help RR 1.22, 95% CI 1.12 to 1.33, I² 40%). More intense interventions (any initial contact plus follow‐up over one month) showed increased quit rates (RR 1.28, 95% CI 1.17 to 1.40, I² 58%) whereas brief interventions (either one single initial contact lasting less than an hour with no follow‐up, one or more contacts in total over an hour with no follow‐up or any initial contact plus follow‐up of less than one months) did not appear effective (RR 1.01, 95% CI 0.91 to 1.12, I² 0%). Seven trials had long‐term follow‐up (over 12 months), and did not show any benefits. Adverse side effects were not reported in any trial. These findings are based on studies with rather low risk of selection bias but high risk of detection bias (namely unblinded or non validated assessment of smoking status).

Authors' conclusions

Psychosocial smoking cessation interventions are effective in promoting abstinence up to 1 year, provided they are of sufficient duration. After one year, the studies showed favourable effects of smoking cessation intervention, but more studies including cost‐effectiveness analyses are needed. Further studies should also analyse the additional benefit of a psychosocial intervention strategy to pharmacological therapy (e.g. nicotine replacement therapy) compared with pharmacological treatment alone and investigate economic outcomes.

Plain language summary

Psychosocial smoking cessation interventions help patients with heart attacks to quit.

Smoking is a risk factor for heart attacks and stopping smoking is recommended for patients after a heart attack. Psychosocial smoking cessation interventions like counseling can help such patients to stop smoking, if they are provided for over one month. Psychosocial interventions can help such patients to quit within 6 months but studies about the long term effects did not support the beneficial short‐term findings. Most trials used a mixture of different intervention strategies, therefore no single strategy showed superior efficacy.

Background

Description of the condition

Smoking is a major, and independent risk factor for coronary heart disease (CHD). Compared to non‐smokers the odds ratio (OR) for myocardial infarction is about 2.5, and for cardiovascular diseases overall the OR is about 2 (Cook 1986; Jacobs 1999; Kawachi 1993; Kawachi 1994; Keil 1998; Njolstad 1996; Nyboe 1991; Prescott 1998; Shaper 1985; Tunstall‐Pedoe 1997; Willett 1987; Woodward 1999). Furthermore, after a cardiac event smokers are twice as likely to get restenosis or to die from a cardiovascular disease (Cullen 1997; Fulton 1997; Kawachi 1993; Kawachi 1994; Kuller 1991; Luoto 1998; Tverdal 1993; Willett 1987). A systematic review in patients with CHD estimated a reduction in mortality risk of 36% in 3‐5 years after quitting smoking (Critchley 2003). Non‐fatal myocardial infarction (MI) also occurs less often in smokers who quit after their first cardiac event (OR 0.62, 95% CI 0.46 to 0.83) (Barth 2007). Compared to persistent smokers, quitters after an acute coronary syndrome have at 6 months a lower risk ratio (RR) of 0.74 for MI/stroke/death (95% CI 0.53 to 1.02; P=0.0698) (Chow 2010). However, many smokers do not quit even after a CHD diagnosis (Critchley 2003) , or resume smoking after the initial "smoking‐free" acute cardiac event hospitalisation and it is critical to summarise available evidence on the effectiveness of different intervention strategies for smoking cessation in this patient group.

Available interventions for smoking cessation

Several intervention strategies in healthy people have shown encouraging results in systematic reviews. For self‐help interventions tailored materials were more efficacious than no intervention (RR 1.31, 95% CI 1.20 to 1.42) but "standard materials" were also efficacious (RR 1.21, 95% CI 1.05 to 1.39). Tailored materials are adapted to the situation of the client and to the specific support needs. Tailored materials might potentially be more effective due to additional patient contact whilst assessing individual patient needs (Noar 2007). Other reviews of smoking cessation using telephone support have suggested that continuous personal contact might improve cessation rate. Continuous telephone counselling was more effective than less intense interventions such as educational self‐help materials only (Stead 2013a). Self‐help interventions as "add‐ons" to counselling was shown to be not efficacious (Lancaster 2009). Telephone support as a single intervention increased quit rates by 37% (RR 1.37, CI 1.26 to 1.50). (Stead 2013a)

Different treatment providers also showed beneficial effects in smoking cessation counselling. Brief advice from a physician was effective for quitting (RR 1.66, 95% CI 1.42 to 1.94) with somewhat larger efficacy in more intense interventions (RR 1.84, 95% CI 1.60 to 2.13) (Stead 2013b). Counseling by nurses was less effective but still showed positive results (RR 1.29, 95%CI 1.20 to 1.39) (Rice 2013).

Rigotti has demonstrated the efficacy of smoking cessation interventions for hospitalised patients (RR 1.37, 95% CI 1.27 to 1.48) and stressed the importance of at least one follow‐up contact to maintain abstinence (Rigotti 2012). This finding is in line with the review on nursing interventions, which pointed out the need for follow up contacts as well (Rice 2013). The incorporated treatment strategies in these reviews can be summarised as psychosocial interventions and can be differentiated from psychopharmacological or substance replacement treatment strategies (e.g. antidepressants, nicotine replacement). For cardiac patients, such psychosocial interventions to quit smoking are recommended along with nicotine replacement therapies and bupropion (ACC/AHA 2002; ACC/AHA 2004; DeBacker 2003; Ockene 1997).The most recent European guidelines (ESC 2012; ESC 2013; ESC/EACPR 2012) underline the importance of assessing smoking status and offering adequate interventions for quitting smoking in cardiac patients.

Pharmacological interventions (e.g. NRTs and medication such as bupropion) are also established medical treatment for smoking cessation, which may be used in isolation or in conjunction with a psychosocial intervention. Nicotine replacement therapy (NRT) and medication (especially Bupropion and Varenicline) are also established medical treatments for smoking cessation. NRT and Bupropion showed similar efficacy compared to placebo with an OR of 1.84 (95% CI 1.71 to 1.99) and an OR of 1.82 (95% CI 1.60 to 2.06) respectively (Cahill 2013). Varenicline improved cessation rates as well with an OR of 1.57 (95% CI 1.29 to 1.91) (Cahill 2013). No increase in adverse cardiac events for Bupropion was found (Stead 2012) but concerns about adverse cardiac events caused by Varenicline were raised (Singh 2011).

Why is it important to do this review

Our initial meta‐analysis of psychosocial smoking cessation interventions in CHD patients showed that they were effective in increasing abstinence at 6‐12 months provided the interventions were of sufficient intensity . However, studies with long‐term follow up were scarce and study quality of early studies was very limited. In an updated systematic review we incorporated more recent trials in order to increase the study pool and the robustness of our findings.

Objectives

This review aimed to evaluate psychosocial intervention strategies for smoking cessation in patients with CHD, with four specific objectives.

1. To examine the efficacy of psychosocial interventions for smoking cessation in patients with coronary heart disease in short‐term (6 to 12 month follow‐up) and long‐term (more than 12 months).
 2. To examine the efficacy of different psychosocial intervention types (e.g. telephone support) to stop smoking in patients with coronary heart disease.
 3. To investigate the dose‐response relationship: Are brief interventions as effective as more intense interventions?
 4. To examine methodological criteria which may moderate the efficacy of smoking cessation interventions in patients with coronary heart disease (for example validation versus self‐report of abstinence).

Methods

Criteria for considering studies for this review

Types of studies

We included randomised controlled trials studying the efficacy of psychosocial interventions for smoking cessation in CHD patients with an assessment of smoking status at least 6 months after baseline assessment of smoking status.

In the control condition usual care or no specific intervention was delivered.

Types of participants

Patients with CHD ‐ myocardial infarction, coronary artery bypass surgery, percutaneous transluminal coronary angioplasty (International Classification of Diseases 9 codes 410‐414). Studies including patients with other diseases were accepted if at least 80% of patients in the sample suffered from CHD. CHD patients with any co‐morbidities were included. Patients had to be smokers at baseline. Initial smoking status was assessed either by self‐report or by a validated measure. Studies on hospital populations with mixed somatic diagnosis (for example cancer and CHD) were excluded. Trials were also excluded if there was not sufficient information available about the patient's somatic diagnoses.

Types of interventions

The psychosocial intervention could be provided in two ways; either as a separate psychosocial intervention with a main focus on smoking cessation or as a part of a more comprehensive cardiac rehabilitation programme targeting also other risk factors (e.g. obesity, inactivity). Any psychosocial intervention with the goal to change smoking behaviour in CHD patients was of interest. Psychosocial interventions use counselling, motivational support and advice, with or without provision of written educational materials about strategies for smoking cessation. We excluded studies, that used only a pharmacological treatment or nicotine replacement therapy. Other non pharmacological interventions like exercise or physiotherapy were not considered as psychosocial interventions due to the missing psychological ingredient of such interventions. Interventions could be delivered initially during hospital admission or after hospital admission to non acute patients during rehabilitation. The interventions could be provided in group or individual settings.

The psychosocial interventions were categorised according to their ingredients into five non exclusive categories (behavioural therapy, phone support, self‐help, multirisk, specific intervention). Behavioural therapy is based on learning theory and applies strategies like coping with risky situations for smoking, incentives for abstinence and motivational issues (i.e. motivational interviewing). Phone support provide encouraging support via the telephone. Self‐help provides information on how to withdraw from smoking. These three intervention strategies are often used as combination. We additionally coded if the intervention focus on smoking (specific intervention) or if other risk factors were also adressed by the intervention (multirisk intervention). These two strategies are mutually exclusive.

The control conditions were either usual care (patients were allowed to seek support for smoking cessation but a structured referal was not done) or control conditions with unspecific interventions (such as educational material on health issues).

Types of outcome measures

Abstinence by self‐report or validated (e.g. carbon monoxide) measurement at a minimum of 6 months. The outcome is dichotomous (non smoker versus smoker). We did not extract data on the number of cigarettes smoked per day, as there is little evidence that smoking reduction alters the risk of future cardiac events or mortality.

Search methods for identification of studies

Electronic searches

We searched the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 12, 2012) on The Cochrane Library, MEDLINE (OVID, 1950 to January week 1 2013), EMBASE (OVID, 1980 to 2013 week 1), PsycINFO (OVID, 1806 to January week 2 2013), Conference Proceedings Citation Index ‐ Science (CPCI‐S, 1990 to 11 January 2013) on Web of Science (Thomson Reuters) and PSYNDEX (1977 to June 2003). This is an updated search (see Appendix 1) of the initial search which was done in 2003 (see Appendix 2). The sensitivity maximising Cochrane RCT filter has been applied to the MEDLINE search and adaptations of it to EMBASE, PsycINFO and Web of Science (Lefebvre 2011).

Additionally we searched in The Cochrane Library for reviews on smoking cessation for primary studies (Issue 4, 2012).

Searching other resources

We searched for trials included in other reviews (Lancaster 2005; Rigotti 2007; Stead 2005; Stead 2006; Wiggers 2003) and hand‐searched relevant journals from 1998 to 2003 (Annals of Internal Medicine, Archives of Internal Medicine, British Medical Journal, Psychology and Health, Health Psychology, Tobacco Control) for the initial selection of trials for the first version of this review.

Data collection and analysis

Data extraction and coding 
 Data were independently extracted by two people (initially: JB and Corina Güthlin; update: TJ and ID). In case of differences between codings in the updated dataset a consensus was reached with a third rater (JB).

Assessment of risk of bias in included studies

We coded four quality indicators according to the risk of bias tool from each study (see Cochrane Handbook). Two reviewers independently assessed risk of bias (JB, TJ): Allocation concealment, sequence generation, completeness of outcome data, and validation of smoking status. Allocation concealment and sequence generation was coded according to the guidelines of the Cochrane Collaboration (see Cochrane Handbook). We extracted data on both an intention‐to‐treat (ITT) analysis and a completer analysis. In the first model we classified persons without information about smoking status at follow‐up as smokers (ITT analysis) (attrition bias). In the second model we included only participants with follow‐up information on smoking status (completer analysis) as presented by the authors. In ambiguous studies we classified the outcome data as completer analysis. If an ITT analysis from the study report was possible, we extracted the data from this information.

We coded biochemical validation of smoking status. If trials used cotinine levels in urine or other standardised procedures to assess smoking status we coded this as validated outcome assessment. In studies with self‐report or peer‐report outcome assessment we classified this as non‐validated outcome assessment.

Three quality indicators were not separately coded for each study. Blinding of treatment providers and patients is not possible in psychosocial interventions (performance bias). The assessment of study outcomes (i.e. validation) was used to rate the validity of smoking status (detection bias). However, an overall rating of blinding comprising both facets was not done. We were not able to rate the selective outcome reporting, since the majority of studies did not specify any primary or secondary outcomes in the publications or protocols. Therefore the category "unclear" reflects the available information.

Data about sample and intervention 
 Data on setting, CHD diagnosis or procedure, number of subjects, sex, age, and length of follow up were extracted. Four types of intervention strategies were coded; behavioural therapeutic approaches ; phone support ; additional self‐help intervention ; multi‐risk factor interventions vs. specific interventions for smoking cessation (see Characteristics of included studies table). The number of patients is indicated by a small n and the number of trials for a specific analysis is indicated with a capitalised N. 
 Data about treatment duration 
 We assessed duration of treatment as in another review (Rigotti 2012) and coded this as follows:

1) Single initial contact lasting <= 1 hour, no follow‐up support;
 2) One or more contacts in total > 1 hour, no follow‐up support;
 3) Any initial contact plus follow‐up <=1 month;
 4) Any initial contact plus follow‐up > 1 month and <= 6 month; and
 5) Any initial contact plus follow‐up > 6 month.

A cut off of 3 was used to classify interventions as brief (categories 1 to 3) or as intense (4 and 5).

Measures of treatment effect

Risk ratios (RR) were calculated from abstinence rates after the intervention comparing the intervention group with the control group. A RR > 1 indicates superiority of the intervention group over the control group and vice versa.

Dealing with missing data

We used data from the conservative analysis (ITT) in preference, and only used data from the completer analysis if data from the ITT analysis was not available. As a sensitivity analysis, we performed a meta‐analysis with studies with ITT data only.

Data synthesis 
 Risk ratios with 95% confidence intervals were calculated for the pooled estimates. A random‐effects model for pooling the studies was employed because of expected heterogeneity in the primary studies (DerSimonian and Laird method) (Deeks 1999). A forest plot presents the results of the overall analysis with all studies.

Assessment of heterogeneity

Heterogeneity was assessed by examining forest plots of trials, by calculating chi squared heterogeneity test, and I² statistics. The chi squared value tests for statistically significant heterogeneity between trials; higher I² values indicate greater variability between trials than would be expected by chance alone (range 0‐100%) (Higgins 2003).

Subgroup analysis and investigation of heterogeneity

We performed four sub‐group analyses according to risk of bias indicators:

• Trials with adequate sequence generation were compared to trials with inadequate or unclear sequence generation

• Trials with adequate allocation concealment were compared to trials with inadequate or unclear allocation concealment

• Trials with validated smoking status were compared to non‐validated trials

• Trials were grouped according to their procedure to deal with incomplete outcome data. As described above ITT analysis (adequate) and completer analysis (inadequate) were coded.

In addition to that we conducted sub‐group analysis according to intervention characteristics and length of follow‐up

• Trials were grouped by type of intervention (i.e. behavioural therapy, phone support, self‐help, multirisk, specific intervention).

• Trials with a treatment duration of less than 1 month (brief intervention) versus studies with an intervention of 1 month or more (intense intervention).

• Intervention effects were measured in short‐term (6 to 12 months) and long‐term (more than 12 months).

Results

Description of studies

The combination of the electronic database searches and additional citations found by scanning references in relevant Cochrane Reviews, other meta‐analyses, and journals in 2006, 2009 and 2013 resulted in 2761 records (Appendix 4; see flowchart in Figure 1). After exclusions on the basis of title and abstract, 364 full‐text articles were assessed for inclusion. Of these a further 321 full‐text articles were excluded for reasons detailed in the characteristics of excluded studies table (Characteristics of excluded studies) and under http://www.juergen‐barth.de/en/wp‐content/uploads/2013/09/Reasons%20for%20excluded%20studies%20Initial%20Review%202006.pdf . Four papers are awaiting assessment as we could not access the papers and authors did not respond to PDF requests (Becker 2003; Boulay 2001; Enriquez‐Puga 2001; Puente‐Silva 1989).

1.

Flow chart of study selection

Forty trials (with short‐term and long‐term results) were included in the review (Allen 1996; Benner 2008; Blasco 2012; Bolman 2002a; Burt 1974; Carlsson 1997; CASIS 1992; Chan 2012; Cossette 2011; Costa e Silva 2008; DeBusk 1994; Dornelas 2000; Froelicher 2004; Gao 2011; Hajek 2002; Han 2011; Hanssen 2007; Hanssen 2009; Heller 1993; Holmes‐Rovner 2008; Jiang 2007; Kubilius 2012; Mildestvedt 2007; Mosca 2010; Naser 2008; Neubeck 2011; Ortigosa 2000; Otterstad 2003; Pedersen 2005; Quist‐Paulsen 2003; Quist‐Paulsen 2005; Quist‐Paulsen 2006a; Reid 2003; Rigotti 1994; Sivarajan 1983; Smith 2009; Taylor 1990; van Elderen (group); van Elderen (phone); Zwisler 2008). Of those 40 trials 33 reported on short‐term results, 4 trials reported both short‐ and long‐term results and 3 trials reported on long‐term results only. In summary seven trials provided data on a long‐term follow up after 12 months (CASIS 1992; Froelicher 2004; Hanssen 2009; Mildestvedt 2007; Naser 2008; Otterstad 2003; Rigotti 1994). As a result of this update we identified 21 new trials, which contributed to this review. Five new trials contributed to long‐term results.

From the studies with short‐term findings (N = 37), sixteen studies were carried out in Europe (1 Sweden, 2 United Kingdom, 3 Netherlands, 5 Norway, 2 Spain, 1 Lithuania, 2 Denmark), ten were from the USA, two from Australia, three from Canada, four from China, one from Brazil and one was a multinational study. The papers were mainly published in English, one was written in Spanish (Ortigosa 2000), one in French (Cossette 2011) and one in Danish (Pedersen 2005). All trials compared a specific smoking cessation intervention with a usual care condition, had comparable groups at study entry, had lower than 50% drop out rates and assessed smoking status before a cardiac event or procedure. 3830 patients were randomised to the usual care group and 3852 received a special psychosocial intervention. As expected, 70 to 90% of the patients were male, mean age was relatively young, 50 to 60 years.The patients suffered predominantly from myocardial infarction or had invasive interventions (bypass surgery, stent). The intervention strategies employed were behavioural therapeutic interventions (20 studies), and self‐help programmes (18 studies). Additional phone support was provided in 26 trials. Seventeen studies reported interventions aimed specifically at smoking cessation, 20 studies employed multi‐risk strategies. Behavioural therapeutic interventions were either provided in a group setting or as individual counselling. The aim was to identify cues related to smoking, or more generally stress reduction and relaxation techniques. Other components included preparation for relapse or specific motivational techniques based on the transtheoretical model (Prochaska 1986) or the strategy of motivational interviewing (Rollnick 1997). Self‐help interventions consisted of information booklets, audio‐ or videotapes. Information booklets which simply described risk factors were not considered self‐help interventions. No studies were available for the comparison of different psychosocial interventions or of psychosocial intervention with different intensity.

In an initial pooling of the short‐term results from 40 included trials we found a RR of 1.24 (95% CI 1.14 to 1.35, n = 7928, N = 40) indicating the efficacy of psychosocial smoking cessation interventions in CHD patients (Analysis 1.1). However, a funnel plot showed outliers with very large effect sizes (Figure 2). These outliers contributed to a large amount of heterogeneity, since we found in the initial analysis an I² of 61%. Therefore a further three studies were excluded using the post hoc exclusion criteria of an unrealistic treatment effect of an RR larger than 5. Feeney 2001 reported a RR of 32.94. Lisspers 1999 reported a RR of 8.25. Mitsibounas 1992 found an effect of RR = 6.00. These trials all had also very substantial methodological flaws. Excluding these three studies had only a small effect on the overall effectiveness of the intervention (RR 1.22, 95% CI 1.13 to 1.32, n = 7682, N = 37) but achieved a more balanced funnel plot (Figure 3).

1.1. Analysis.

Comparison 1 Initial analysis: Efficacy of psychosocial interventions on abstinence all trials, Outcome 1 Abstinence 6 to 12 months (ITT preferred over completer).

2.

Funnel plot of comparison: 1 Initial analysis: Efficacy of psychosocial interventions on abstinence (6 to 12 months; all trials), outcome: 1.1 Abstinence 6 to 12 months (ITT preferred over completer).

3.

Funnel plot of comparison: 2 Efficacy of psychosocial interventions on abstinence (6 to 12 months; all trials), outcome: 2.1 Abstinence 6 to 12 months (ITT preferred over completer).

Risk of bias in included studies

Out of 37 studies, 18 reported an adequate method for random sequence generation (Allen 1996; Benner 2008; Blasco 2012; Chan 2012; Cossette 2011; Costa e Silva 2008; DeBusk 1994; Dornelas 2000; Froelicher 2004; Hajek 2002; Hanssen 2007; Jiang 2007; Mosca 2010; Neubeck 2011; Reid 2003; Smith 2009; Taylor 1990; Zwisler 2008). Seventeen studies had unclear information concerning sequence generation (Bolman 2002a; Carlsson 1997; CASIS 1992; Gao 2011; Han 2011; Holmes‐Rovner 2008; Kubilius 2012; Ortigosa 2000; Otterstad 2003; Pedersen 2005; Quist‐Paulsen 2003; Quist‐Paulsen 2005; Quist‐Paulsen 2006a; Rigotti 1994; Sivarajan 1983; van Elderen (group); van Elderen (phone)) and only Burt 1974 and Heller 1993 reported an inadequate method. Only 13 studies reported adequate allocation concealment (Benner 2008; Chan 2012; Cossette 2011; DeBusk 1994; Froelicher 2004; Hajek 2002; Hanssen 2007; Otterstad 2003; Pedersen 2005; Quist‐Paulsen 2005; Quist‐Paulsen 2006a; Reid 2003; Zwisler 2008). Sixteen studies reported unclear information (Allen 1996; Blasco 2012; Bolman 2002a; Carlsson 1997; CASIS 1992; Gao 2011; Han 2011; Jiang 2007; Kubilius 2012; Mosca 2010; Ortigosa 2000; Otterstad 2003; Rigotti 1994; Sivarajan 1983; van Elderen (group); van Elderen (phone)) and eight studies were inadequate concerning allocation concealment (Burt 1974; Costa e Silva 2008; Dornelas 2000; Heller 1993; Holmes‐Rovner 2008; Neubeck 2011; Smith 2009; Taylor 1990). Blinding was inadequate in all studies, except in Bolman 2002a where it was adequate since the personnel were not blinded but this was unlikely to introduce bias because the whole hospital was randomised with significant difference between the two groups at the process evaluation. Concerning incomplete outcome data, 26 studies reported adequate information (Blasco 2012; Bolman 2002a; CASIS 1992; Chan 2012; Cossette 2011; Costa e Silva 2008; DeBusk 1994; Dornelas 2000; Froelicher 2004; Hajek 2002; Hanssen 2007; Holmes‐Rovner 2008; Jiang 2007; Mosca 2010; Ortigosa 2000; Otterstad 2003; Quist‐Paulsen 2003; Quist‐Paulsen 2005; Quist‐Paulsen 2006a; Reid 2003; Rigotti 1994; Sivarajan 1983; Smith 2009; Taylor 1990; van Elderen (group); Zwisler 2008). Eleven studies were either unclear or reported inadequate information about incomplete outcome data (Allen 1996; Benner 2008; Burt 1974; Carlsson 1997; Gao 2011; Han 2011; Heller 1993; Kubilius 2012; Neubeck 2011; Pedersen 2005; van Elderen (phone)). In 24 studies, smoking cessation was self‐reported and 13 studies validated self‐reported smoking cessation with measurements of cotinine in urine or saliva. Summary of risk of bias are found in Figure 4; Figure 5.

4.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

5.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Effects of interventions

Psychosocial smoking cessation interventions were effective in achieving smoking abstinence in CHD patients (number of patients = 3852), compared with usual care (number of patients = 3830) (see Table 1). In all trials, patients receiving the specific psychosocial intervention had more than a 20% higher chance of quitting (RR 1.22, 95% CI 1.13 to 1.32, n = 7682, N = 37). There was moderate heterogeneity between studies (chi² 77.98; df 36, P < 0.0001, I² 54%) (Analysis 2.1). Therefore the overall result should be interpreted with some caution. There were considerable differences between trials in the proportion of abstinent patients after the intervention: Kubilius 2012 achieved 100% abstinence in the intervention group, but Chan 2012 reports the lowest abstinence rate with 26.5%. These differences between trials in quit rates might also be responsible for some of the heterogeneity in findings. The pooled RR suggests that psychosocial interventions can increase the chance of quitting compared with usual care, but the heterogeneity in the results need further exploration. The quality of the trials may partly explain this heterogeneity and therefore a subgroup analysis according to risk of bias indicators was used.

1. Summary of findings short term.

Analysis	Studies	Participants	Risk Ratio	Confidence Interval 95%	Heterogeneity I square
Overall analyses
All studies (with outliers)	40	7928	1.24	1.14‐1.35	61%
All studies (without outliers)	37	7682	1.22	1.13‐1.32	54%
Stratified analyses by risk of bias indicators
Sequence generation
Adequate	18	5046	1.21	1.07‐1.36	61%
Inadequate	19	2636	1.24	1.12‐1.37	53%
Allocation concealment
Adequate	13	4784	1.21	1.09‐1.34	39%
Inadequate	24	2898	1.24	1.11‐1.38	65%
Handling of incomplete outcome data
Adequate	26	6436	1.18	1.09‐1.28	46%
Inadequate	11	1246	1.36	1.12‐1.65	72%
Validation of outcome
Validated outcome measure	13	2803	1.22	1.07‐1.39	60%
Non‐validated outcome measure	24	4879	1.23	1.12‐1.35	52%

2.1. Analysis.

Comparison 2 Efficacy of psychosocial interventions on abstinence without outliers, Outcome 1 Abstinence 6 to 12 months (ITT preferred over completer).

Sub‐group analyses according to risk of bias indicators:

None of the quality indicators affected the effect estimates (all p values > 0.20). Trials with adequate sequence generation showed similar effects compared to trials with inadequate or unclear sequence generation. Trials with adequate sequence generation had a pooled RR of 1.21 (95% CI 1.07 to 1.36, n = 5046, N = 18); trials with inadequate or unclear sequence generation had a pooled RR of 1.24 (95% CI 1.12 to 1.37, n = 2636, N = 19) (Analysis 3.1). No reduction in heterogeneity was achieved by this stratification.

3.1. Analysis.

Comparison 3 Forest plot: Stratified analysis by risk of bias indicators, Outcome 1 Abstinence 6 to 12 months.

We have a similar picture when we compared trials with adequate allocation concealment versus inadequate or unclear allocation concealment. The RR was 1.24 (95% CI 1.11 to 1.38, n = 2898, N = 24) for trials with inadequate or unclear allocation concealment, and 1.21 (95% CI 1.09 to 1.34, n = 4784, N = 13) for trials with adequate allocation concealment (Analysis 3.2). Heterogeneity in the subgroup of studies with adequate allocation concealment was considerably reduced (I² 39% compared to the initial analysis with an I² of 54%)

3.2. Analysis.

Comparison 3 Forest plot: Stratified analysis by risk of bias indicators, Outcome 2 Abstinence 6 to 12 months.

Trials with an adequate method to analyse incomplete outcome data (ITT) appeared less efficacious compared to trials with inadequate or unclear methods to analyse incomplete outcome data (completer analysis), but this difference was not statistically significant. Trials with completer analysis had a larger effect with a RR of 1.36 (95% CI 1.12 to 1.65, n = 1246, N = 11) (Analysis 3.3). Trials with ITT analysis found a reduced effect of 1.18 (95% CI 1.09 to 1.28, n = 6436, N = 26). Heterogeneity in the subgroup of studies with ITT analysis was slightly reduced (I² 46% compared to the initial analysis with an I² of 54%).

3.3. Analysis.

Comparison 3 Forest plot: Stratified analysis by risk of bias indicators, Outcome 3 Abstinence 6 to 12 months.

Trials which validated self‐reported smoking status showed similar efficacy to trials with non validated outcome assessment. Trials with validated abstinence reported a RR of 1.22 (95% CI 1.07 to 1.39, n = 2803, N = 13); non‐validated trials had a similar effect with a RR of 1.23 (95% CI 1.12 to 1.35, n = 4879, N = 24) (Analysis 3.4). Heterogeneity was not reduced.

3.4. Analysis.

Comparison 3 Forest plot: Stratified analysis by risk of bias indicators, Outcome 4 Abstinence at 6 to 12 months.

Types of intervention 
 We found no clear evidence that any treatment strategy was more efficacious than others, but heterogeneity was reduced slightly within the intervention cluster. Behavioral therapeutic interventions showed a significant effect on abstinence (RR 1.23, 95% CI 1.12 to 1.34, n = 5170, N = 20) with lower heterogeneity (I² 40%) (Analysis 4.1). Telephone support was also effective (RR 1.21, 95% CI 1.12 to 1.30, n = 5807, N = 26) and trials more consistent (I² 44%) (Analysis 4.2). However, as most behavioural therapy trials also used telephone support as an intervention strategy, it is difficult to separate the effects of these two types of interventions. Five trials used solely a behavioural therapeutic approach without additional phone contacts (Bolman 2002a; Otterstad 2003; Sivarajan 1983; van Elderen (group); Zwisler 2008). Nine trials used telephone support without behavioural therapeutic techniques (Benner 2008; Blasco 2012; Gao 2011; Han 2011; Hanssen 2007; Jiang 2007; Neubeck 2011; Ortigosa 2000; Quist‐Paulsen 2005). Interventions using self‐help materials showed comparable effectiveness (RR 1.22, 95% CI 1.12 to 1.33m n = 3789, N = 18) (Analysis 4.3). Stratification of trials using self‐help materials reduced heterogeneity (I² 40%). We also considered the specificity of the intervention (smoking cessation alone compared with a multi‐risk factor intervention). No meaningful difference was found between multi‐risk factor interventions (RR 1.19, 95% CI 1.08 to 1.32, n = 2337, N = 20) and specific cessation intervention (RR 1.26, 95% CI 1.11 to 1.42, n = 5345, N = 17) (Analysis 4.4). Specific intervention showed highly heterogenous effects (I² 61%); likewise multi‐risk factor intervention effects differed substantially between trials (I² 52%).
 
 Duration of the intervention 
 We found clear evidence that brief interventions (i.e. no follow‐up contact or within 4 weeks after initial intervention) were not effective (Chan 2012; Hajek 2002; Heller 1993; Ortigosa 2000; Rigotti 1994) (RR 1.01, 95% CI 0.91 to 1.12, I² 0%, n = 2693, N = 5) (Analysis 5.1). When CHD patients were treated with interventions including follow‐up contacts after the initial period of 1 month, the chance of quitting increased substantially (RR 1.28, 95% CI 1.17 to 1.40, I² 58%, n = 4968, N = 31) (Analysis 5.1). One study did not report on the duration of the intervention (Gao 2011).
 
 Long‐term follow‐up 
 We found preliminary evidence from seven trials for the efficacy of smoking cessation interventions in the long‐term (number of patients in the intervention group = 382; number of patients with usual care = 359) (see Table 2). Due to high drop‐out rates after 12 months, separate meta‐analyses for completer and ITT effects were done. In the completer analysis smoking cessation interventions were effective (RR 1.16, 95% CI 1.02 to 1.31, n = 741, N = 7) however, this initial finding was not confirmed in the ITT analysis (RR 1.08, 95% CI 0.92 to 1.28, n = 854, N = 5) (Analysis 6.1 and Analysis 6.2, respectively).

4.1. Analysis.

Comparison 4 Forest plot: Stratified analysis by type of intervention (6 to 12 months), Outcome 1 Abstinence 6 to 12 months BEHAVIORAL THERAPY.

4.2. Analysis.

Comparison 4 Forest plot: Stratified analysis by type of intervention (6 to 12 months), Outcome 2 Abstinence 6 to 12 months TELEPHONE SUPPORT.

4.3. Analysis.

Comparison 4 Forest plot: Stratified analysis by type of intervention (6 to 12 months), Outcome 3 Abstinence 6 to 12 months SELF HELP MATERIALS.

4.4. Analysis.

Comparison 4 Forest plot: Stratified analysis by type of intervention (6 to 12 months), Outcome 4 Abstinence 6 to 12 months Specific vs. Multi‐Risk‐Factor Intervention.

5.1. Analysis.

Comparison 5 Sensitivity analysis brief / intense intervention (6 to 12 months), Outcome 1 Abstinence 6 to 12 months all studies.

2. Summary of finding long term.

Analysis	Studies	Participants	Risk Ratio	95% Confidence Interval	Heterogeneity I square
Overall analysis
All studies (completer data)	7	741	1.16	1.02‐1.31	6%
Sensitivity analysis
Studies with ITT analysis	5	854	1.08	0.92‐1.28	0%

6.1. Analysis.

Comparison 6 Forest plot: Efficacy of psychosocial interventions on long‐term abstinence, Outcome 1 Abstinence more than 12 months (completer only).

6.2. Analysis.

Comparison 6 Forest plot: Efficacy of psychosocial interventions on long‐term abstinence, Outcome 2 Abstinence more than 12 months (ITT only).

Out of seven studies, three reported an adequate method for random sequence generation (Froelicher 2004; Hanssen 2009; Naser 2008) and four had unclear information (CASIS 1992; Mildestvedt 2007; Otterstad 2003; Rigotti 1994). Only three studies reported adequate allocation concealment (Froelicher 2004; Hanssen 2009; Otterstad 2003) and four contained unclear information (CASIS 1992; Mildestvedt 2007; Naser 2008; Rigotti 1994). Blinding was coded as inadequate in all studies, however, blinding of treatment providers is not possible in psychosocial interventions. Concerning incomplete outcome data, five studies reported adequate information (CASIS 1992; Froelicher 2004; Hanssen 2009; Mildestvedt 2007; Naser 2008) and only two were inadequate (Otterstad 2003; Rigotti 1994).

A potential problem with all systematic reviews is publication bias. Our literature search was comprehensive, prepared and partly carried out by the Cochrane Heart Group (UK). Additionally, we investigated publication bias using a funnel plot. The results appear reasonably symmetric which is an indicator of a publication of the studies independent of the study result (Figure 5). There may be a slight tendency for larger trials to show smaller benefits; but larger studies may have interventions with shorter duration and hence smaller effect sizes.

Discussion

Summary of main results

We found support for the efficacy of smoking cessation interventions with more than 1 month duration, but brief interventions of less than 1 month without supporting contact over time were not effective. We were unable to determine the minimum number of contacts needed. There was no evidence for the efficacy in long‐term follow up studies (over 12 months) with high study quality. Only long‐term studies with completer analysis showed a beneficial effect of psychosocial smoking interventions.

Overall completeness and applicability of evidence 

Detailed conclusions about effective intervention strategies are obscured by the fact that a mixture of different interventions was included in many trials. Interventions using telephone support, behavioural therapies, and self‐help were all effective. Some interventions focused only on smoking cessation, but others addressed smoking as part of a multiple risk factor intervention programme (generally a 'cardiac rehabilitation programme'). There was no difference in the chance of quitting for multiple risk factor cardiac rehabilitation programmes, compared with interventions focusing on smoking cessation only. 'Cardiac rehabilitation' programmes may vary in their components, but generally include a graded exercise programme and may also include advice and support from a range of health professionals (such as dieticians, behavioural change specialists etc.). It is difficult to distinguish between the effects of the smoking cessation component of these programmes, and the general support and encouragement of a lifestyle change. Some trials employ nicotine replacement therapy (NRT) as additional cessation strategies, which we could not control for. In one trial, more patients in the psychosocial intervention group received NRT compared to the usual care group (DeBusk 1994) which might bias findings. Other trials did not report use of NRT or other medications to assist with quitting such as bupropion.

Agreements and disagreements with other studies or reviews

Our findings confirm the magnitude of the effect of a smoking cessation intervention of about 30% as shown in other studies. However, the effect is much lower compared to an advice from a physician (about 70% increase in quit rates). This difference can be explained by the high quit rates in the control condition. In GP practices among predominantly healthy patients only about 1% of the population quit smoking without any specific intervention. The situation is completely different in patients with an acute or chronic medical condition. In the included studies of this review about two thirds of the studies reported an abstinence rate of more than 30% without any specific intervention and about half of the studies reported an abstinence rate of more than 50% in the control condition. Therefore, the number to treat statistics should be reported from psychosocial smoking cessation studies to allow health policy makers an appropriate evaluation of the effect of the intervention beyond statistical significance.

Interventions on an individual level should be accompanied by policy measures like smoke free legislation. Non‐smoking environment policy interventions were found to be associated with lower rates of myocardial infarction (Lin 2013). Web‐based interventions for smoking cessation have the advantage of good accessibility. Such interventions were also found to improve quit rates substantially in adult populations (Myung 2009; Civljak 2013) and randomised studies in cardiac patients should be done. The older age of CHD patients might limit the feasibility of web‐based interventions due to impaired vision, cognition and physical skills (Becker 2004).

Quality of the evidence

One possible threat to our results might be methodological flaws in the included primary studies which might overestimate the effectiveness of psychosocial smoking interventions in CHD patients. In the stratified analyses according to quality criteria no significant differences were found. However, the pattern showed larger effects in studies with methodological weaknesses. In particular, studies with an ITT analysis showed smaller effects compared to a "completer analysis". RCTs of smoking cessation should not be published without an ITT analysis as the primary outcome. Trial procedures and quality should be described in more detail, according to CONSORT guidelines (Schulz 2010). The overall reporting quality was very poor and the risk of bias was difficult to assess since no information was available in many cases. This leads to conclusions that many trials had a high risk of bias but this may be reflecting the limited quality of reporting rather than the intervention delivery. The validation of smoking status was not a standard procedure in the trials as only 14 out of 37 (38%) described using any measure of biochemical validation. However, there were no differences between trials with validated or self‐reported smoking status in this review. Some studies provide data to apply post hoc ITT analysis in addition to reported completer results. Since we used such an approach the number of trials with ITT data (26 of 37, 70%) is an overestimation of the quality in publications.

Authors' conclusions

Implications for practice.

After a cardiac event about 30% to 50% of smokers with CHD quit without professional help. Additional psychosocial interventions show a superior quitting rate compared to usual care in the short‐term. Long‐term follow‐up showed an attenuation in the benefit of psychosocial interventions for smoking cessation but psychosocial smoking cessation intervention are still a promising strategy. Interventions for smoking cessation in CHD patients should last for more than 1 month. Brief interventions were not effective. The overall effect of psychosocial smoking cessation interventions in CHD patients can be expressed by the number needed to treat statistics with a figure of twelve if a spontanous quitting rate of 30% is assumed. This means that about fifteen patients had to be treated for one person to be abstinent from tobacco after 1 year (NNT = 14.9, CI 11.1 to 24.3). For intense intervention the NNT is somewhat lower (NNT = 11.9, CI 9.6 to 16.7).

Implications for research.

We found that the intensity of psychosocial interventions is of crucial importance for their efficacy. Approaches with very low intensity were not promising. Also the most recent large study (published in 2012) with a brief intervention did not find a significant effect. Future trials should also compare the additional benefits of combining NRT (or other pharmacological interventions such as bupropion) and psychosocial interventions, compared with NRT or psychosocial interventions alone in CHD patients. This would allow a comprehensive evaluation, since psychosocial interventions might increase abstinence per se but might also increase the efficacy of NRT itself by an increase of motivation for treatment (Heckman 2010).

In general more details on the intensity of the intervention (total duration, number of sessions, numbers of pages in leaflets etc) and the underlying theoretical approach are needed. We did not find any difference in the efficacy of different psychosocial approaches. Treatment differences might be blurred by difficulties in classifying studies due to limited reporting of the interventions. However, this result is in line with other studies of non‐pharmacological intervention namely in psychotherapy outcome research, where different interventions strategies showed no differences in their efficacy beyond chance in a various disorders (Wampold 1997), which was also supported in a recent network meta‐analysis on depression (Barth 2013). It is impossible to decide which type of intervention is most promising since direct comparison studies of different interventions are generally unavailable and the intervention itself can often not be classified adequately.

We had not been able to incorporate studies on economic outcomes since studies did not report on that. Any future trials should include such cost‐effectiveness analyses to help decision making for health care professionals also according to this outcome.

What's new

Date	Event	Description
2 July 2015	New citation required but conclusions have not changed	The addition of 21 trials did not change the short‐term findings. Psychosocial interventions for smoking cessation might also be effective in long‐term, but evidence is weak.
24 October 2013	New search has been performed	Updated search in January 2013.

History

Review first published: Issue 1, 2008

Date	Event	Description
9 September 2008	Amended	Converted to new review format.
3 October 2007	New citation required and conclusions have changed	Substantive amendment

Notes

Used abbreviations 
 AMI: acute myocardial infarction
 AP: angina pectoris

BT: behavioral therapeutic intervention
 BIOSIS: database on life science and biomedical research (www.biosis.org)
 CABG: coronary artery bypass graft
 CHD: coronary heart disease
 CI: confidence interval

CONSORT: Consolidated Standards of Reporting Trials
 EMBASE: database with biomedical and pharmacological information (www.embase.com)
 ICD: International Classification of Diseases
 ITT: intention to treat analysis

I²: I square, heterogeneity from 0 to 100.
 Medline: database of the U.S. National Library of Medicine
 MI: myocardial infarction
 MeSH; medical subject heading

MR: multi‐risk factor intervention
 N: number of studies
 n: number of patients

NRT: nicotine replacement therapy
 OR: odds ratio

Ph: support by phone
 PsycINFO: database of the American Psychological Association
 PSYNDEX: database of the Center for Psychological Information and Documentation at the University of Trier, Germany
 PTCA: percutaneous transluminal coronary angioplasty

RR: relative risk

SH: self‐help intervention

UK: United Kingdom

Appendices

Appendix 1. Search strategy 2013

CENTRAL

#1 MeSH descriptor Heart Diseases explode all trees
 #2 MeSH descriptor Coronary Artery Bypass explode all trees
 #3 angina*
 #4 cabg
 #5 coronary near bypass*
 #6 (coronary near disease*) or chd
 #7 (myocard* near infarct*) or (heart near infarct*)
 #8 (cardiac next disease*) or (heart next disease*)
 #9 acs
 #10 ami
 #11 cardiac near/2 inpatient*
 #12 cardiac near/2 in‐patient*
 #13 cardiac near/2 patient*
 #14 heart near/2 patient*
 #15 heart near/2 inpatient*
 #16 heart near/2 in‐patient*
 #17 (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16)
 #18 MeSH descriptor Smoking Cessation, this term only
 #19 smok* near cessation
 #20 smok* near cease*
 #21 smok* near quit*
 #22 antismoking
 #23 anti‐smoking
 #24 smok* near giv*
 #25 smok* near stop*
 #26 (#18 OR #19 OR #20 OR #21 OR #22 OR #23 OR #24 OR #25)
 #27 (#17 AND #26)

MEDLINE OVID

1. exp Heart Diseases/
 2. exp Coronary Artery Bypass/
 3. angina*.tw.
 4. cabg.tw.
 5. (coronary adj6 bypass*).tw.
 6. (coronary adj6 disease*).tw.
 7. (myocard* adj6 infarct*).tw.
 8. (heart adj6 infarct*).tw.
 9. chd.tw.
 10. (heart adj disease*).tw.
 11. (cardiac adj disease*).tw.
 12. acs.tw.
 13. ami.tw.
 14. (cardiac adj2 inpatient*).tw.
 15. (cardiac adj2 in‐patient*).tw.
 16. (cardiac adj2 patient*).tw.
 17. (heart adj2 patient*).tw.
 18. (heart adj2 inpatient*).tw.
 19. (heart adj2 in‐patient*).tw.
 20. or/1‐19
 21. Smoking Cessation/
 22. (smok* adj6 cessation).tw.
 23. (smok* adj6 cease*).tw.
 24. (smok* adj6 quit*).tw.
 25. antismoking.tw.
 26. anti‐smoking.tw.
 27. (smok* adj6 giv*).tw.
 28. (smok* adj6 stop*).tw.
 29. or/21‐28
 30. 20 and 29
 31. randomized controlled trial.pt.
 32. controlled clinical trial.pt.
 33. randomized.ab.
 34. placebo.ab.
 35. drug therapy.fs.
 36. randomly.ab.
 37. trial.ab.
 38. groups.ab.
 39. 31 or 32 or 33 or 34 or 35 or 36 or 37 or 38
 40. exp animals/ not humans.sh.
 41. 39 not 40
 42. 30 and 41
 43. (20* not (2000* or 2001* or 2002*)).ed.
 4. 42 and 43

EMBASE OVID

1. heart disease/
 2. coronary artery bypass graft/
 3. angina*.tw.
 4. cabg.tw.
 5. (coronary adj6 bypass*).tw.
 6. (coronary adj6 disease*).tw.
 7. (myocard* adj6 infarct*).tw.
 8. (heart adj6 infarct*).tw.
 9. chd.tw.
 10. (heart adj disease*).tw.
 11. (cardiac adj disease*).tw.
 12. acs.tw.
 13. ami.tw.
 14. (cardiac adj2 inpatient*).tw.
 15. (cardiac adj2 patient*).tw.
 16. (heart adj2 patient*).tw.
 17. (heart adj2 inpatient*).tw.
 18. (heart adj2 in‐patient*).tw.
 19. (cardiac adj2 in‐patient*).tw.
 20. or/1‐19
 21. smoking cessation/
 22. (smok* adj6 cessation).tw.
 23. (smok* adj6 cease*).tw.
 24. (smok* adj6 quit*).tw.
 25. antismoking.tw.
 26. anti‐smoking.tw.
 27. (smok* adj6 giv*).tw.
 28. (smok* adj6 stop*).tw.
 29. or/21‐28
 30. 20 and 29
 31. random$.tw.
 32. factorial$.tw.
 33. crossover$.tw.
 34. cross over$.tw.
 35. cross‐over$.tw.
 36. placebo$.tw.
 37. (doubl$ adj blind$).tw.
 38. (singl$ adj blind$).tw.
 39. assign$.tw.
 40. allocat$.tw.
 41. volunteer$.tw.
 42. crossover procedure/
 43. double blind procedure/
 44. randomized controlled trial/
 45. single blind procedure/
 46. 31 or 32 or 33 or 34 or 35 or 36 or 37 or 38 or 39 or 40 or 41 or 42 or 43 or 44 or 45
 47. (animal/ or nonhuman/) not human/
 48. 46 not 47
 49. 30 and 48
 50. (20* not (2000* or 2001* or 2002*)).em.
 51. 49 and 50

PsycINFO

1. exp heart disorders/
 2. angina*.tw.
 3. cabg.tw.
 4. (coronary adj6 bypass*).tw.
 5. (coronary adj6 disease*).tw.
 6. (myocard* adj6 infarct*).tw.
 7. (heart adj6 infarct*).tw.
 8. chd.tw.
 9. (heart adj disease*).tw.
 10. (cardiac adj disease*).tw.
 11. acs.tw.
 12. ami.tw.
 13. (cardiac adj2 inpatient*).tw.
 14. (cardiac adj2 in‐patient*).tw.
 15. (cardiac adj2 patient*).tw.
 16. (heart adj2 patient*).tw.
 17. (heart adj2 inpatient*).tw.
 18. (heart adj2 in‐patient*).tw.
 19. or/1‐18
 20. smoking cessation/
 21. (smok* adj6 cessation).tw.
 22. (smok* adj6 cease*).tw.
 23. (smok* adj6 quit*).tw.
 24. antismoking.tw.
 25. anti‐smoking.tw.
 26. (smok* adj6 giv*).tw.
 27. (smok* adj6 stop*).tw.
 28. or/20‐27
 29. 19 and 28
 30. random$.tw.
 31. factorial$.tw.
 32. crossover$.tw.
 33. cross‐over$.tw.
 34. placebo$.tw.
 35. (doubl$ adj blind$).tw.
 36. (singl$ adj blind$).tw.
 37. assign$.tw.
 38. allocat$.tw.
 39. volunteer$.tw.
 40. control*.tw.
 41. "2000".md.
 42. or/30‐41
 43. 29 and 42
 44. (20* not (2000* or 2001* or 2002*)).up.
 45. 43 and 44

Conference Proceedings Citation Index‐ Science (CPCI‐S) on Web of Science

#29 #28 AND #27
 #28 TS=(random* or blind* or allocat* or assign* or trial* or placebo* or crossover* or cross‐over*)
 #27 #26 AND #18
 #26 #19 or #20 or #21 or #22 or #23 or #24 or #25
 #25 TS=(smok* SAME stop*)
 #24 TS=(smok* SAME giv*)
 #23 TS=anti‐smoking
 #22 TS=antismoking
 #21 TS=(smok* SAME quit*)
 #20 TS=(smok* SAME cease*)
 #19 TS=(smok* SAME cessation)
 #18 #1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9 or #10 or #11 or #12 or #13 or #14 or #15 or #16 or #17
 #17 TS=(heart SAME in‐patient*)
 #16 TS=(heart SAME inpatient*)
 #15 TS=(heart SAME patient*)
 #14 TS= (cardiac SAME patient*)
 #13 TS=(cardiac SAME in‐patient*)
 #12 TS=(cardiac SAME inpatient*)
 #11 TS=ami
 #10 TS=acs
 #9 TS="heart disease*"
 #8 TS="cardiac disease*"
 #7 TS=chd
 #6 TS=(heart SAME infarct*)
 #5 TS=(myocard* SAME infarct*)
 #4 TS=(coronary SAME disease*)
 #3 TS=(coronary SAME bypass*)
 #2 TS=cabg
 #1 TS=angina*

Appendix 2. Search strategy 2003

CENTRAL

#1 HEART DISEASES (exp MeSH)
 #2 CORONARY ARTERY BYPASS (exp MeSH)
 #3 angina*
 #4 cabg
 #5 (coronary near bypass*)
 #6 (coronary near disease*)
 #7 MYOCARDIAL INFARCTION (exp MeSH)
 #8 (myocard* near infarct*)
 #9 (heart near infarct*)
 #10 chd
 #11 (heart next disease*)
 #12 (cardiac next disease*)
 #13 acs
 #14 ami
 #15 (cardiac next inpatient*)
 #16 (cardiac next patient*)
 #17 (heart next patient*)
 #18 (heart next inpatient*)
 #19 (#1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9)
 #20 (#10 or #11 or #12 or #13 or #14 or #15 or #16 or #17 or #18)
 #21 (#19 or #20)
 #22 SMOKING CESSATION (exp MeSH)
 #23 (smoking near cessation)
 #24 (smoking near cease*)
 #25 (smoking near quit*)
 #26 antismoking
 #27 (anti next smoking)
 #28 (smoking near giv*)
 #29 (smoking near stop*)
 #30 (#22 or #23 or #24 or #25 or #26 or #27 or #28 or #29)
 #31 (#21 and #30)

MEDLINE, Pre‐MEDLINE, BIOSIS and Journals@Ovid

#1 (HEART DISEASES ) in KW,MESH,PS
 #2 (coronary artery bypass) in KW,MESH,PS
 #3 angina*
 #4 cabg
 #5 coronary near bypass
 #6 coronary near disease
 #7 (myocardial infarction) in KW,MESH,PS
 #8 myocard* near infarct*
 #9 heart near infarct*
 #10 chd
 #11 heart next disease*
 #12 acs
 #13 ami
 #14 cardiac next inpatient*
 #15 cardiac next patient*
 #16 heart next patient*
 #17 heart next inpatient*
 #18 #1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9 or #10 or #11 or #12 or #13 or #14 or #15 or #16 or #17
 #19 (smoking cessation) in KW,MESH,PS
 #20 smoking near cease*
 #21 smoking near cessation
 #22 smoking near quit
 #23 antismoking
 #24 anti next smoking
 #25 smoking near giv*
 #26 smoking near stop*
 #27 #19 or #20 or #21 or #22 or #23 or #24 or #25 or #26
 #28 #18 and #27

EMBASE

#1 HEART DISEASES (exp MeSH)
 #2 CORONARY ARTERY BYPASS (exp MeSH)
 #3 angina*
 #4 cabg
 #5 (coronary near bypass*)
 #6 (coronary near disease*)
 #7 MYOCARDIAL INFARCTION (exp MeSH)
 #8 (myocard* near infarct*)
 #9 (heart near infarct*)
 #10 chd
 #11 (heart next disease*)
 #12 (cardiac next disease*)
 #13 acs
 #14 ami
 #15 (cardiac next inpatient*)
 #16 (cardiac next patient*)
 #17 (heart next patient*)
 #18 (heart next inpatient*)
 #19 (#1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9)
 #20 (#10 or #11 or #12 or #13 or #14 or #15 or #16 or #17 or #18)
 #21 (#19 or #20)
 #22 SMOKING CESSATION (exp MeSH)
 #23 (smoking near cessation)
 #24 (smoking near cease*)
 #25 (smoking near quit*)
 #26 antismoking
 #27 (anti next smoking)
 #28 (smoking near giv*)
 #29 (smoking near stop*)
 #30 (#22 or #23 or #24 or #25 or #26 or #27 or #28 or #29)
 #31 (#21 and #30)

PsycINFO

#1 TI coronary artery bypass Or AB coronary artery bypass Or MJ coronary artery bypass
 #2 TI angina Or AB angina OrMJ angina
 #3 TI cabg Or AB cabg Or MJ cabg
 #4 TI coronary Or AB coronary Or MJ coronary
 #5 TI bypass Or AB bypass Or MJ bypass
 #6 TI myocard Or AB myocard Or MJ myocard
 #7 TI myocard Or AB myocard Or MJ myocard
 #8 TI diseas* Or AB diseas*Or MJ diseas*
 #9 TI heart* Or AB heart* Or MJ heart*
 #10 TI chd Or AB chd OrMJ chd
 #11 TI acs Or AB acs Or MJ acs
 #12 TI ami Or AB ami Or MJ ami
 #13 TI cardiac Or AB cardiac Or MJ cardiac
 #14 TI patient* Or AB patient* OrMJ patient*
 #15 TI inpatient* Or AB inpatient* Or MJ inpatient*
 #16 TI smok* Or AB smok* Or MJ smok*
 #17 TI cessation Or AB cessation Or MJ cessation
 #18 TI cease* Or AB cease* Or MJ cease*
 #19 TI quit Or AB quit Or MJ quit*
 #20 TI anti Or AB anti Or MJ anti
 #21 TI giv* Or AB giv* Or MJ giv*
 #22 TI stop* Or AB stop* OrMJ stop*
 #23 (S5 And S4)
 #24 (S8And S4)
 #25 (S7 And S6)
 #26 (S9And S7
 #27 (S14 And S13)
 #28 (S15 And S13)
 #29 (S14 And S9)
 #30 (S15 And S9)
 #31 (S30 Or S29 Or S28 Or S27 Or S26 Or S25 Or S24 Or S23 Or S15 Or S14 Or S13 Or S12 Or S11 Or S10 Or S9 Or S8 Or S7
 Or S6 Or S5 Or S4 Or S3 Or S2 Or S1)
 #32 (S17 And S16)
 #33 (S18 And S16)
 #34 (S19 And S16)
 #35 (S20 And S16)
 #36 (S21 And S16)
 #37 (S22 And S16)
 #38 (S37 Or S36 Or S35 Or S34 Or S33 Or S32 Or S22 Or S21 Or S20 Or S19 Or S18 Or S17 Or S16)
 #39 (S37 Or S36 Or S35 Or S34 Or S33 Or S32)
 #40 (S13 Or S12 Or S11 Or S10 Or S9 Or S8 Or S7 Or S6 Or S5 Or S4 Or S3 Or S2 Or S1)
 #41 (S39 and S40)

PSYNDEXplus

#1 HEART DISEASES
 #2 CORONARY ARTERY BYPASS
 #3 angina*
 #5 coronary near bypass*
 #6 coronary near disease*
 #7 MYOCARDIAL INFARCTION
 #8 myocard* near infarct*
 #9 heart near infarct*
 #10 chd
 #11 heart next disease*
 #12 cardiac next disease*
 #13 acs
 #14 ami
 #15 cardiac next inpatient*
 #16 cardiac next patient*
 #17 heart next patient*
 #18 heart next inpatient*
 #19 #1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9 or #10 or #11 or #12 or #13 or #14 or #15 or #16 or #17 or #18
 #20 SMOKING CESSATION
 #21 smoking near cessation
 #22 smoking near cease*
 #23 smoking near quit*
 #24 antismoking
 #25 anti next smoking
 #26 smoking near giv*
 #27 smoking near stop*
 #28 #20 or #21 or #22 or #23 or #24 or #25 or #26 or #27
 #29 herz
 #30 herzinfarkt
 #31 kardiovaskulaer*
 #32 KHK
 #33 myokard*
 #34 koronar*
 #35 bypass
 #36 #29 or #30 or #31 or #32 or #33 or #34 or #35
 #37 raucherentwoehnung
 #38 tabakabstinenz
 #39 tabak near abstinenz
 #4 cabg
 #40 rauchen near abstinenz
 #41 rauchen near aufhoeren
 #42 #37 or #38 or #39 or #40 or #41
 #43 #19 or #36
 #44 #28 or #42
 #45 #43 and #44

Data and analyses

Comparison 1. Initial analysis: Efficacy of psychosocial interventions on abstinence all trials.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Abstinence 6 to 12 months (ITT preferred over completer)	40	7928	Risk Ratio (M‐H, Random, 95% CI)	1.24 [1.14, 1.35]

Comparison 2. Efficacy of psychosocial interventions on abstinence without outliers.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Abstinence 6 to 12 months (ITT preferred over completer)	37	7682	Risk Ratio (M‐H, Random, 95% CI)	1.22 [1.13, 1.32]

Comparison 3. Forest plot: Stratified analysis by risk of bias indicators.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Abstinence 6 to 12 months	37	7682	Risk Ratio (M‐H, Random, 95% CI)	1.22 [1.13, 1.32]
1.1 adequate sequence generation	18	5046	Risk Ratio (M‐H, Random, 95% CI)	1.21 [1.07, 1.36]
1.2 inadequate sequence generation	19	2636	Risk Ratio (M‐H, Random, 95% CI)	1.24 [1.12, 1.37]
2 Abstinence 6 to 12 months	37	7682	Risk Ratio (M‐H, Random, 95% CI)	1.22 [1.13, 1.32]
2.1 adequate allocation concealment	13	4784	Risk Ratio (M‐H, Random, 95% CI)	1.21 [1.09, 1.34]
2.2 inadequate allocation concealment	24	2898	Risk Ratio (M‐H, Random, 95% CI)	1.24 [1.11, 1.38]
3 Abstinence 6 to 12 months	37	7682	Risk Ratio (M‐H, Random, 95% CI)	1.22 [1.13, 1.32]
3.1 adequate incomplete outcome data	26	6436	Risk Ratio (M‐H, Random, 95% CI)	1.18 [1.09, 1.28]
3.2 inadequate incomplete outcome data	11	1246	Risk Ratio (M‐H, Random, 95% CI)	1.36 [1.12, 1.65]
4 Abstinence at 6 to 12 months	37	7682	Risk Ratio (M‐H, Random, 95% CI)	1.22 [1.13, 1.32]
4.1 validated outcome measures	13	2803	Risk Ratio (M‐H, Random, 95% CI)	1.22 [1.07, 1.39]
4.2 non‐validated outcome measures	24	4879	Risk Ratio (M‐H, Random, 95% CI)	1.23 [1.12, 1.35]

Comparison 4. Forest plot: Stratified analysis by type of intervention (6 to 12 months).

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Abstinence 6 to 12 months BEHAVIORAL THERAPY	37	7682	Risk Ratio (M‐H, Random, 95% CI)	1.22 [1.13, 1.32]
1.1 Behavioral therapeutic approach	20	5170	Risk Ratio (M‐H, Random, 95% CI)	1.23 [1.12, 1.34]
1.2 No behavioral therapeutic approach	17	2512	Risk Ratio (M‐H, Random, 95% CI)	1.22 [1.07, 1.39]
2 Abstinence 6 to 12 months TELEPHONE SUPPORT	37	7682	Risk Ratio (M‐H, Random, 95% CI)	1.22 [1.13, 1.32]
2.1 Telephone support	26	5807	Risk Ratio (M‐H, Random, 95% CI)	1.21 [1.12, 1.30]
2.2 No telephone support	11	1875	Risk Ratio (M‐H, Random, 95% CI)	1.27 [1.04, 1.54]
3 Abstinence 6 to 12 months SELF HELP MATERIALS	37	7682	Risk Ratio (M‐H, Random, 95% CI)	1.23 [1.14, 1.34]
3.1 SELF HELP MATERIALS provided	18	3789	Risk Ratio (M‐H, Random, 95% CI)	1.22 [1.12, 1.33]
3.2 No self help materials	19	3893	Risk Ratio (M‐H, Random, 95% CI)	1.26 [1.09, 1.46]
4 Abstinence 6 to 12 months Specific vs. Multi‐Risk‐Factor Intervention	37	7682	Risk Ratio (M‐H, Random, 95% CI)	1.22 [1.13, 1.32]
4.1 Specific smoking cessation intervention	17	5345	Risk Ratio (M‐H, Random, 95% CI)	1.26 [1.11, 1.42]
4.2 Multi risk factor intervention	20	2337	Risk Ratio (M‐H, Random, 95% CI)	1.19 [1.08, 1.32]

Comparison 5. Sensitivity analysis brief / intense intervention (6 to 12 months).

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Abstinence 6 to 12 months all studies	36	7661	Risk Ratio (M‐H, Random, 95% CI)	1.22 [1.13, 1.32]
1.1 brief intervention	5	2693	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.91, 1.12]
1.2 high intensity intervention	31	4968	Risk Ratio (M‐H, Random, 95% CI)	1.28 [1.17, 1.40]

Comparison 6. Forest plot: Efficacy of psychosocial interventions on long‐term abstinence.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Abstinence more than 12 months (completer only)	7	741	Risk Ratio (M‐H, Random, 95% CI)	1.16 [1.02, 1.31]
2 Abstinence more than 12 months (ITT only)	5	854	Risk Ratio (M‐H, Random, 95% CI)	1.08 [0.92, 1.28]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Allen 1996.

Methods	Completer Analysis
Participants	138 women who underwent first‐time CABG at a hospital. IG: 14 smokers CG: 11 smokers
Interventions	Usual care: patient education and instructions for exercise. Psychosocial intervention: nurse‐directed multimodal behavioural program based on social cognitive theory (videotape, workbook, counselling). Started with discharge from hospital, two updates 1 and 2 months later (BT, Ph, SH, MR, Intensity 4)
Outcomes	Follow‐up at 12 months (abstinence self report)
Notes	IG: Completer = 64.3% CG: Completer = 54.5%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computerized schema that achieved a balanced allocation
Allocation concealment (selection bias)	Unclear risk	No information available
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Unclear information available
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Benner 2008.

Methods	Completer Analysis
Participants	patients with an increased cardiovascular risk, not necessarily CHD in all cases. IG: 273 smokers CG: 257 smokers
Interventions	Usual care: predicted Framingham 10‐year risk of CHD was calculated but was not communicated to either the physician or the patient until the final visit Psychosocial intervention: patients were advised according to a CHD risk evaluation and communication programme. They received a Heart Health Report and had three follow‐up phone calls by a physician or study nurse and the patients completed a "Knowledge, Attitudes and Behavior" (KAB) questionnaire. (Ph, MR, Intensity 4)
Outcomes	Follow‐up at 6 month (abstinence self‐report)
Notes	IG: Completer = 56.4% CG: Completer = 38.5%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐based algorithm
Allocation concealment (selection bias)	Low risk	Random permutation of 100 numbers
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	High risk	No data on ITT available
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Blasco 2012.

Methods	ITT
Participants	203 acute coronary syndrome patients IG: 78 smokers CG: 75 smokers
Interventions	Usual care: written recommendations and verbal information about CVD prevention only Psychosocial intervention: written recommendations and verbal information about CVD prevention. Patients received an automatic sphygmomanometer, a glucose and lipid meter and a cellular phone. Results were sent through their mobile phones and a cardiologist then sent individualised short messages with recommendations to the patients during the 12‐month follow‐up period. (Ph, MR, Intensity 5)
Outcomes	Follow‐up at 12 month (validation by 1‐step cotinine immunoassay in urine)
Notes	IG: ITT = 80.8% CG: ITT = 81.3%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Two different randomisation lists
Allocation concealment (selection bias)	Unclear risk	No information available
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Bolman 2002a.

Methods	Completer Analysis, ITT
Participants	Hospitalised smokers with multiple coronary disorders IG: 132 smokers CG: 211 smokers
Interventions	Usual care: no systematic attention was given to smoking Psychosocial intervention: C‐Mis which consisted of stop‐smoking advice by the cardiologist followed by 15‐30min of standardised individual counselling and the provision of self‐help material by the ward nurse and aftercare by the cardiologist. After that more in‐depth counselling, which was attuned to the patient's stage of change. (BT, SH, Specific, Intensity 4)
Outcomes	Follow‐up at 3 and 12 months (abstinence self‐report)
Notes	IG: Completer = 58.0% ITT = 38.6% CG: Completer = 45.4% ITT = 77.3%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information available
Allocation concealment (selection bias)	Unclear risk	No information available
Blinding (performance bias and detection bias) All outcomes	Low risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	Low risk	The whole hospital was randomised with significant difference between the two groups at the process evaluation
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	High risk	No data on ITT available
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Burt 1974.

Methods	Completer Analysis
Participants	280 men in a coronary care unit with AMI IG: 125 smokers CG: 98 smokers
Interventions	Usual care: conventional advice to stop smoking by physician. Psychosocial intervention: information about the effects of smoking by physician and nurse, reinforced by a booklet about coronary‐risk factors. Continued in follow‐up clinic and through a community nurse. (Specific, Intensity 5)
Outcomes	Follow‐up at 12 months (abstinence self‐report)
Notes	IG: Completer = 63.2% CG: Completer = 27.5%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Randomisation according to the day of admission
Allocation concealment (selection bias)	High risk	The group allocation can be foreseen from the day of admission
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	High risk	No data on ITT available
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Carlsson 1997.

Methods	Completer
Participants	168 patients with AMI admitted to the coronary care unit at Malmö General Hospital IG: 32 smokers CG: 35 smokers
Interventions	Usual care: two visits to general practitioner. Psychosocial intervention: nurse‐directed secondary prevention unit after the usual follow‐up schedule: education and counselling (individual and group sessions) about smoking, exercise, nutrition for about 9 hours and exercise training 2‐3 times per week. Visits to cardiologist after 2, 3, 6 months and to nurse after 3, 5, 6, 9, 12 months. (MR, Intensity 5)
Outcomes	Follow‐up at 12 months (abstinence self‐report)
Notes	IG: Completer = 50% CG: Completer = 25.7%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information available
Allocation concealment (selection bias)	Unclear risk	No information available
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	High risk	No data on ITT available
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

CASIS 1992.

Methods	Completer, ITT
Participants	267 smokers with CAD of 3 hospitals who scheduled for coronary arteriography IG: 135 smokers CG: 132 smokers
Interventions	Usual care: brief advice from physician to stop smoking. Psychosocial intervention: intervention provided by trained behaviorally oriented health educators: inpatient counselling session (30 min), outpatient counselling visits and telephone calls (at 1and 3 weeks, abstinent smokers at 3 months, relapsed smokers at 2 and 4 months), outpatient group program, self‐help materials. (BT, Ph, SH, Specific, Intensity 4)
Outcomes	Follow‐up at 6, 12 and 60 months (validation by saliva samples)
Notes	IG: Completer = 57.3% ITT = 34.8% CG: Completer = 47.4% ITT = 28%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information available
Allocation concealment (selection bias)	Unclear risk	No information available
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Chan 2012.

Methods	ITT
Participants	1860 Chinese cigarette smokers who attended the cardiac out‐patient clinic of 10 major hospitals in Hong Kong for routine follow‐up visits. More than 50% of the patients suffered from CHD. IG: 938 smokers CG: 922 smokers
Interventions	Usual care: a 15‐minute face‐to‐face counselling on healthy diet by the nurse counsellor at baseline visit and a one‐page A4‐sized leaflet which highlighted the importance of a healthy diet for cardiac patients. No telephone counselling. Psychosocial intervention: 30‐minute individualised face‐to‐face smoking cessation counselling matched with their stage of readiness to quit at baseline visit. The individualised stage‐matched smoking cessation counselling was developed based on the Transtheoretical Model of Change. They also received telephone calls from the nurse counsellor at 1 week and 1 month after the baseline visit. (BT, Ph, Specific, Intenstity 4)
Outcomes	Follow up at 3, 6 and 12 months (abstinence self‐report)
Notes	IG: ITT = 26.5% CG: ITT = 25.4%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Simple random sampling procedure (without replacement) using MS Excel
Allocation concealment (selection bias)	Low risk	Sequentially numbered, sealed and opaque envelopes
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Cossette 2011.

Methods	Completer Analysis, ITT
Participants	Hospitalised smokers in a centre for cardiovascular care (CHA) with multiple coronary disorders. IG: 20 smokers CG: 20 smokers
Interventions	Usual care: phone support via "J'arrête" or CAT (= Centre d'abandon du tabagisme = Center for smoking cessation) Psychosocial intervention: Intervention by ISCT (= infirmière spécialisée en cessation tabagique = specialised nurse for smoking cessation). Information about why it is important to stop smoking according to the Stages of Change model from Prochaska and DiClimente. Motivational letters were sent to the patients until 6 months after hospitalisation. (BT, Ph, Specific, Intensity 4)
Outcomes	Follow‐up at 6 months (abstinence self‐report)
Notes	IG: Completer = 38.5% ITT = 25% CG: Completer = 60% ITT = 30%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Preparation of random list by independent coordinating center
Allocation concealment (selection bias)	Low risk	Sequentially numbered, sealed and opaque envelopes
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Costa e Silva 2008.

Methods	ITT
Participants	153 patients that were hospitalised because of their first acute myocardial infarction IG: 35 smokers CG: 24 smokers
Interventions	Usual care: conventional outpatient clinic for hear care at the Institute of Cardiology/University Foundation of Cardiology, where the patiens were seen only by the appointed cardiologist Psychosocial intervention: transciplinary care was provided at the outpatient clinic for secondary prevention of CAD by a cardiologist, endocrinologist, nurse and dietitian (MR, Intensity 4)
Outcomes	Follow‐up at 3 and 6 months (abstinence self‐report)
Notes	IG: ITT = 45.7% CG: ITT = 45.8%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation Software (Random, PEPI 4.0)
Allocation concealment (selection bias)	High risk	"The patients and health professionals involved in outpatient treatment were not blinded as to their allocation." (Costa e Silva 2008, page 490)
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

DeBusk 1994.

Methods	Completer Analysis
Participants	585 patients with AMI in five medical centres IG: 131 smokers CG: 120 smokers
Interventions	Usual care: counselling on dietary change, lipid lowering therapy, and on demand smoking cessation interventions. Psychosocial intervention: physician‐directed, nurse‐managed, home‐based case‐management system (behavioural intervention, telephone and mail contact) in addition to the usual care. Started in the hospital and finished 12 months later. (BT, Ph, SH, MR, Intensity 5)
Outcomes	Follow‐up at 6 and 12 months (abstinence validated)
Notes	IG: Completer = 70.2% ITT = 59.5% CG: Completer = 53.3% ITT = 47.1%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer program that achieved a balanced allocation
Allocation concealment (selection bias)	Low risk	Central allocation
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Dornelas 2000.

Methods	Completer Analysis, ITT
Participants	100 smokers with AMI admitted to hospital IG: 54 smokers CG: 46 smokers
Interventions	Usual care: verbal and written recommendation to watch education video of AHA. Psychosocial intervention: bedside cessation counselling (motivation for cessation, relapse prevention) delivered by a psychologist based on the transtheoretical model. Seven telephone calls at 1, 4, 8, 12, 16, 20, 26 weeks (BT, Ph, Specific, Intensity 4)
Outcomes	Follow‐up at 6 and 12 months (validation by a significant other)
Notes	IG: Completer = 70% ITT = 51.8% CG: Completer = 40% ITT = 34.8%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Drawing from random numbers
Allocation concealment (selection bias)	High risk	Random assignment by drawing from random numbers from an envelope, but no information if sequentially numbered, opaque or sealed
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Feeney 2001.

Methods	Completer Analysis, ITT
Participants	198 patients sequentially admitted to the coronary care unit (CCU) all having suffered from AMI. IG: 96 smokers CG: 102 smokers
Interventions	Usual care: Verbal and printed advice about tobacco cessation (primarily didactic). Patients watched an educational video during their stay and were reviewed by a nurse. Outpatients supportive counselling and follow‐up at 3, 6 and 12 months. All patients were advised by the attending cardiologist to stop smoking. Psychosocial intervention: Standford Heart Attack Staying Free programme: behavioral components, 2 audiotapes for home use with the programme's principal points. On hospital discharge the patients received telephone contact weekly for 4 weeks and at 2, 3, 6 and 12 months including inquiries about relapse. Additional support and advice were given if considered necessary. (BT, Ph, SH, specific, Intensity 5)
Outcomes	Follow‐up at 1, 3 and 12 months (validated)
Notes	IG: Completer = 66% ITT = 32.3% CG: Completer = 4.8% ITT = 0.9%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random list of odd and even numbers
Allocation concealment (selection bias)	Unclear risk	No information available
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	High risk	No data on ITT available
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Froelicher 2004.

Methods	Completer Analysis, ITT
Participants	277 women hospitalised with a diagnosis of CVD or peripheral vascular disease IG: 142 smokers CG: 135 smokers
Interventions	Usual care: brief counselling from a physician regarding the need for and benefits of smoking cessation, a copy of the pamphlet "Calling it quits" and a list of local smoking cessation classes and programs in the communities Psychosocial intervention: nurse‐managed smoking cessation and relapse prevention intervention. Usual care plus 30 to 45min individualised counselling session with multimedia aids that study participants were given before their discharge. During the session: videotape from the American Heart Association (AHA) together with a videotape on smoking cessation. After discharge up to 5 structured telephone calls to continue the intervention (BT, Ph, SH, Specific, Intensity 4)
Outcomes	Follow‐up at 6, 12, 24 and 30 months (validation by saliva sample)
Notes	IG: Completer = 56.2% ITT = 47.9% Long‐term IG: Completer = 65.1% ITT = 50% CG: Completer = 44.8% ITT = 41.5% Long‐term CG: Completer = 63.6% ITT = 50.4%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random permutated blocks
Allocation concealment (selection bias)	Low risk	Equal chance of assignment to CG or IG
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Gao 2011.

Methods	Completer Analysis
Participants	A consecutive series of patients who accepted the PCI were recruited from a metropolitan hospital in Taiyuan IG: 10 smokers CG: 11 smokers
Interventions	Usual care: ordinary health education including discharge guidance and distribution of health education materials Psychosocial intervention: comprehensive health educating program including centralised training and telephone follow‐up. Comprehensive health education consisted of basic medical knowledge about CHD including secondary prevention of post‐PCI, information about healthy diet, correct pos‐operation rehabilitation exercise and doctors and nurses tutored patients on how to quit smoking and refrain from drinking (Ph, MR, Intensity 9)
Outcomes	Follow‐up at 6 and 12 months (abstinence self‐report)
Notes	IG: Completer = 90% CG: Completer = 72.7%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information available
Allocation concealment (selection bias)	Unclear risk	No information available
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	High risk	No data on ITT available
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Hajek 2002.

Methods	Completer Analysis, ITT
Participants	540 patients in hospitals in UK with MI and CABG IG: 274 CG: 266
Interventions	Usual care: verbal advice to stop smoking and booklet "Smoking and your heart". Psychosocial intervention: in 17 hospitals patients motivated to stop smoking received intervention. Education with booklet (Smoking and your Heart) from the British Heart Foundation. Short quiz on contents of the booklet; support of other cardiac patient is arranged by nurse Duration about 34min (SH, Specific, Intensity 1)
Outcomes	Follow‐up at 6 weeks and 12 months (validated)
Notes	IG: Completer = 39% ITT = 36% CG: Completer = 43% ITT = 41%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	In batches of 20 with envelopes provided to each nurse
Allocation concealment (selection bias)	Low risk	Serially numbered, opaque and sealed envelopes
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Han 2011.

Methods	Completer Analysis
Participants	Patients with acute coronary syndrome and PCI IG: 51 smokers CG: 56 smokers
Interventions	Usual care: only received 2 follow‐ups Psychosocial intervention: exercise, body weight measurement, how to relax. For smokers: follow‐up, time since last cigarette (Ph, MR, Intensity 4)
Outcomes	Follow‐up at 6 and 12 months (not validated)
Notes	IG: Completer = 94.1% CG: Completer = 80.8%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information available
Allocation concealment (selection bias)	Unclear risk	No information available
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	High risk	No data on ITT available
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Hanssen 2007.

Methods	Completer Analysis, ITT
Participants	413 patients with AMI admitted to the Department of Heart Disease IG: 77 smokers CG: 61 smokers
Interventions	Usual care: one visit to a physician at the outpatient clinic 6‐8 weeks after discharge and subsequent visits to the patient's general practitioner Psychosocial intervention: telephone follow‐up and an open telephone line providing patients with information, education and support on the basis of individual needs. Also provided patients with information about what are common questions after AMI and encourage further elaboration on the issues if desired (Ph, MR, Intensity 4)
Outcomes	Follow‐up at 3 and 6 months (abstinence self‐report)
Notes	IG: Completer = 60% ITT = 46.8% CG: Completer = 40.8% ITT = 32.8%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated list of random numbers
Allocation concealment (selection bias)	Low risk	Sealed, opaque envelopes
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Hanssen 2009.

Methods	Completer Analysis, ITT
Participants	413 patients with AMI admitted to the Department of Heart Disease IG: 77 smokers CG: 61 smokers
Interventions	Usual care: one visit to a physician at the outpatient clinic 6‐8 weeks after discharge and subsequent visits to the patient's general practitioner Psychosocial intervention: telephone follow‐up and an open telephone line providing patients with information, education and support on the basis of individual needs. Also provided patients with information about what are common questions after AMI and encourage further elaboration on the issues if desired (Ph, MR, Intensity 5)
Outcomes	Follow‐up at 12 and 18 months (abstinence self‐report)
Notes	IG: Completer = 54.6% ITT = 39.0% CG: Completer = 53.5% ITT = 37.7%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated list of random numbers
Allocation concealment (selection bias)	Low risk	Sealed, opaque envelopes
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Heller 1993.

Methods	Completer Analysis
Participants	450 patients with AMI discharged from the hospital IG: 66 smokers CG: 73 smokers
Interventions	Usual care: no specific information given Psychosocial intervention: letter to the subjects' GP, three mail‐out packages for the subjects (information about nutrition, smoking, walking programme) and monthly newsletters. (SH, MR, Intensity 1)
Outcomes	Follow‐up at 6 months (abstinence self‐report)
Notes	IG: Completer = 65% CG: Completer = 53%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Allocation to an intervention or usual care group according to the name of the usual general practitioner
Allocation concealment (selection bias)	High risk	The group allocation can be foreseen by the name of the usual general practitioner
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Unclear information available
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Holmes‐Rovner 2008.

Methods	ITT
Participants	719 participants with a diagnosis of ACS and a documented serum troponin I level greater than the upper limits of normal were recruited from hospitals that participated in the American College of Cardiology Guidlines Applied to Practice (GAP) QI program IG: 82 smokers CG: 70 smokers
Interventions	Usual care: GAP QI‐only: written discharge contract listing recommended outpatient medications, cardiac rehabilitation recommendations and health behaviour changes, as well as numerical values for ejection fraction and cholesterol Psychosocial intervention: HARP QI‐Plus telephone coaching: Six‐session health behaviour change telephone counselling program during the first three months after discharge. Primary behaviour goals included: reduction or elimination of smoking, increasing physical activity and eating a healthier diet. Behaviour change strategies included behavioral staging, motivational interviewing, goal setting, relapse prevention and obtaining social support. Each patient received an information booklet and goal worksheets (BT, Ph, SH, MR, Intensity 4)
Outcomes	Follow‐up at 3 and 8 months (abstinence self‐report)
Notes	IG: ITT = 92.7% CG: ITT = 85.7%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information available
Allocation concealment (selection bias)	Unclear risk	No information available
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Jiang 2007.

Methods	ITT
Participants	167 (83+84) patients with CHD (angina pectoris or myocardial infarction) in Chengdu, China IG: 33 smokers CG: 38 smokers
Interventions	Usual care: routine care Psychosocial intervention: 12‐week home‐based multifaceted cardiac rehabilitation intervention with two phases: (1) hospital‐based patient/family education, (2) home‐based rehabilitation care (Ph, MR, Intensity 4)
Outcomes	Follow‐up at 3 and 6 months (abstinence self‐report)
Notes	IG: ITT = 51.5% CG: ITT = 39.5%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generalized random table
Allocation concealment (selection bias)	Unclear risk	No information available
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Kubilius 2012.

Methods	Completer Analysis
Participants	140 patients with angiographically confirmed coronary heart disease and NYHA functional class II‐IV ischemic heart failure IG: 10 smokers CG: 8 smokers
Interventions	Usual care: drug treatment only without any rehabilitation program Psychosocial intervention: 3‐stage rehabilitation: (1) bed and floor exercises and motivation for risk factor correction. (2) 5 lectures, individual aerobic exercise training and recommendations for dietary changes and smoking cessation. 5 lectures comprising cardiovascular anatomy and pathophysiology, risk factors for ischemic heart disease and their management. Recommendations for smoking cessation included the period of smoking cessation and NRT for 3 months. (3) Indivudal programs at home. Patients were asked to exercise 30min per day and to follow dietary and smoking cessation recommendations (5 months). Healthy lifestyle counselling was performed once a month and the patients were suggested to use symptomatic and cardioprotective drugs every day (MR, Intensity 4)
Outcomes	Follow‐up at 3 and 6 months (abstinence self‐report)
Notes	IG: Completer = 100% CG: Completer = 100%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information available
Allocation concealment (selection bias)	Unclear risk	No information available
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Unclear information available
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Lisspers 1999.

Methods	Completer Analysis
Participants	93 patients recruited among referrals to the Department of Cardiology, Karolinska Hospital, for PTCA. IG: 7 smokers CG: 5 smokers
Interventions	Usual care: Patients were asked to keep contact with their own physician. they were neither encouraged nor discouraged to undertake any further rehabilitative efforts. Psychosocial intervention: Health education and behavior‐change activities, including lectures and discussions but focusing mainly on practical skills training and habit rehearsal directed toward stress management and diet, exercise and smoking habits. (BT, MR, Intensity 5)
Outcomes	Follow‐up at 12 months (abstinence self‐report)
Notes	IG: Completer = 71% CG: Completer = 0%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information available
Allocation concealment (selection bias)	Unclear risk	No information available
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	High risk	No data on ITT available
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Mildestvedt 2007.

Methods	Completer Analysis
Participants	266 patients attending a four‐week CR programme at Krokeide Rehabilitation Centre IG: 16 smokers CG: 15 smokers
Interventions	Usual care: standard rehabilitation treatment which included dietary and smoking cessation counselling in a group setting Psychosocial intervention: standard treatment plus additional individualised self‐efficacy and autonomy‐supportive intervention. Key features of the intervention: goal setting and selecting personalised strategies to overcome barriers. Two individual sessions during the rehabilitation stay and two follow‐up telephone calls at 6 and 24 months focusing on the personally selected goals. Cognitive intervention. Counselling aimed at strengthening the motivational adherence to these lifestyle changes through autonomy‐supportive dialogues (BT, Ph, MR, Intensity 5)
Outcomes	Follow‐up at 6 and 24 months (abstinence self‐report)
Notes	IG: Completer = 37.5% CG: Completer = 20.0%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information available
Allocation concealment (selection bias)	Unclear risk	No information available
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Mitsibounas 1992.

Methods	Completer Analysis, ITT
Participants	43 Athenian residents with acute myocardial infarction and no further complications. IG: 18 smokers CG: 18 smokers
Interventions	Usual care: The patients had a clinical follow‐up and electrocardiogram once a month, a treadmill exercise test and 24‐hour Holter monitoring twice a year, and a coronary arteriography once a year. Psychosocial intervention: Patients attended group meetings. The aim of these group meetings was to help patients realise that at least one of the alternative solutions to their conflict was socially (by the group) acceptable. Besides group meetings, the patients had a clinical follow‐up and electrocardiogram test every 2 weeks. Within 1 year, a treadmill exercise test and a 24‐hour Holter monitoring were performed twice, and a coronary arteriogram once. (MR, Intensity 5)
Outcomes	Follow‐up at 3, 6 and 12 months (not validated)
Notes	IG: Completer = 72% ITT = 67% CG: Completer = 11% ITT = 10%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information available
Allocation concealment (selection bias)	Unclear risk	No information available
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Mosca 2010.

Methods	ITT
Participants	304 women with CHD admitted to the New York‐Presbyterian Hospital (Columbia and Weill Cornell Campuses) or the University of North Carolina Health System IG: 32 smokers CG: 22 smokers
Interventions	Usual care: encouraged to attend cardiac rehabilitation and to exercise a minimum of 3‐5 days/week Psychosocial intervention: education and counselling by a prevention facilitator/educator during hospitalisation and during phone visits at 2, 4 and 12 weeks and at 6 weeks postdischarge. 1 hour of structured counselling before discharge that reviewed smoking, exercise, nutrition, weight and blood pressure and cholesterol goals for secondary prevention. Advised on recommendations for behavior change personalised to their specific needs (BT, Ph, MR, Intensity 4)
Outcomes	Follow‐up at 6 weeks and 6 months (abstinence self‐report)
Notes	IG: ITT = 46.9% CG: ITT = 68.2%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Blocked design using a central dial‐in web‐based system
Allocation concealment (selection bias)	Unclear risk	No information available
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Naser 2008.

Methods	Completer Analysis
Participants	Patients after first MI in Iran. IG: 15 smokers CG: 5 smokers
Interventions	Usual care: did not receive any kind of intervention Psychosocial intervention: intensive multi‐factorial lifestyle modification (IMLM): 30min hospital based consultation along with written guidelines for prevention of common established risk factors. Patients were then scheduled for a two year post‐hospital intervention program consisting of CRP exercise sessions, lifestyle counselling and telephone follow‐ups (BT, Ph, MR, Intensity 5)
Outcomes	Follow‐up at 12 and 24 months (abstinence self‐report)
Notes	IG: Completer = 90% CG: Completer = 70%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated variable block program
Allocation concealment (selection bias)	Unclear risk	No information available
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Neubeck 2011.

Methods	Completer Analysis
Participants	Acute coronary syndrome patients IG: 6 smokers CG: 11 smokers
Interventions	Usual care: ongoing conventional health care, managing their cardiovascular health in consultation with their GP and cardiologist Psychosocial intervention: CHOICE (= Choice of Health Options In prevention of Cardiovascular Events): ongoing conventional health care and a 3‐months modular patient‐centered program. The CHOICE‐program included a 1h initial consultation and multiple telephone calls over 3 months. The program was designed to have an individualised, structured case management approach and is conducted in consultation with the patient's GP. (Ph, MR, Intensity 4)
Outcomes	Follow‐up at 48 months (validated)
Notes	IG: Completer = 66.7% CG: Completer = 18.2%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated
Allocation concealment (selection bias)	High risk	Consecutive numbered envelopes, but no information if sealed or opaque
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	High risk	No data on ITT available
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Ortigosa 2000.

Methods	Completer Analysis, ITT
Participants	90 patients with myocardial infarction in hospital in Spain IG: 43 smokers CG: 47 smokers
Interventions	Usual care: advice only. Psychosocial intervention: advice by doctor immediately after admission to hospital (10 minutes). Additional enhancement of motivation by nurses and phone contacts (after 2, 3, 4 weeks). (Ph, Specific, Intensity 3)
Outcomes	Follow‐up at 1, 3 and 12 months (validated)
Notes	IG: Completer = 62% ITT = 61% CG: Completer = 69% ITT = 66%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information available
Allocation concealment (selection bias)	Unclear risk	No information available
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Otterstad 2003.

Methods	Completer Analysis, ITT
Participants	197 patients after an acute myocardial infarction, hospitalisation for unstable angina pectoris, percutaneous coronary intervention or coronary artery bypass grafting IG: 49 smokers CG: 42 smokers
Interventions	Usual care: standardised, nurse‐based information on CHG in general and lifestyle measures Psychosocial intervention: lifestyle intervention: 6‐week period of "heart school"‐ Physical exercise plus group meetings. Dietary advice, smoking cessation, physical activity counselling, risk factor management, psychosocial management and health education related to cardiovascular disease, medication, reduction of mental stress, relaxation and psychosocial factors (BT, MR, Intensity 5)
Outcomes	Follow‐up at 6 and 24 months (abstinence self‐report)
Notes	IG: Completer = 56.8% ITT = 42.9% Long‐term IG: Completer = 48.7% ITT = 36.7% CG: Completer = 39.4% ITT = 31.0% Long‐term CG: Completer = 24.2% ITT = 19.1%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information available
Allocation concealment (selection bias)	Low risk	Pre‐prepared sealed opaque envelopes
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	High risk	No data on ITT available
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Pedersen 2005.

Methods	Completer Analysis
Participants	Patients with multiple cardiovascular disorders IG: 54 smokers CG: 51 smokers
Interventions	Usual care Psychosocial intervention: According to STOP concept including information on impact of smoking on heart disease as well as on nicotine replacement alternatives, nicotine dependence test and 5x30min individual consultation (personal or via phone) in first 5 weeks. (SH, Specific, Intensity 4)
Outcomes	Follow‐up at 12 months (abstinence self‐report)
Notes	IG: Completer = 51.1% CG: Completer = 39.6%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information available
Allocation concealment (selection bias)	Low risk	Patients selected an envelope with the treatment condition from a pool of envelopes
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	High risk	No data on ITT available
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Quist‐Paulsen 2003.

Methods	Completer Analysis, ITT
Participants	Patients in hospital (reasons myocardial infarction, angina pectoris, coronary artery bypass surgery) IG: 118 smokers CG: 122 smokers
Interventions	Usual care: no specific intervention. Psychosocial intervention: group intervention with nurses (twice a week). Booklet with emphasis on health benefits from smoking cessation. Also fear arousing message about death rates of persistent smokers. Advice not to smoke during hospital stay and motivation for NRT if needed additional phone contacts (5 times) in 5 months after hospital stay. (BT, Ph, SH, Specific, Intensity 4)
Outcomes	Follow‐up 12 months (validated)
Notes	IG: Completer = 57% ITT = 48% CG: Completer = 37% ITT = 36%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information available
Allocation concealment (selection bias)	Unclear risk	No information available
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Quist‐Paulsen 2005.

Methods	Completer Analysis, ITT
Participants	240 patients 2 to 4 days after admission for coronary heart disease (acute myocardial infarction, unstable angina or recent coronary bypass) IG: 118 smokers CG: 122 smokers
Interventions	Usual care: patients were offered group sessions in the ward twice a week, where the importance of smoking cessation was mentioned. During these sessions a video was shown and a booklet handed out that contained general information on coronary heart disease and advice on quitting smoking. They received no further specific instructions on how to stop smoking Psychosocial intervention: after discharge nurses contacted participants by telephone at 2 days, 1 week, 3 weeks, 3 months and 5 months. Those with special needs were telephoned monthly thereafter. The intervention was based on a 17‐page booklet which emphasised the health benefits of quitting smoking after a coronary event. The booklet also contained information on how to prevent relapse, how to stop smoking and how to use nicotine replacements. How to identify and cope with high‐risk situations for relapse was also explained. Spouses who smoked were also asked to give up (Ph, Sh, Specific, Intensity 4)
Outcomes	Follow‐up at 12 months (nicotine‐validated)
Notes	IG: Completer = 57% ITT = 48.3% CG: Completer = 37.3% ITT = 36.1%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information available
Allocation concealment (selection bias)	Low risk	Doctor’s not involved = concealed
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Quist‐Paulsen 2006a.

Methods	Completer Analysis, ITT
Participants	240 daily smokers, motivate to quit smoking and admitted for acute myocardial infarction, unstable angina or recent coronary bypass IG: 118 smokers CG: 112 smokers
Interventions	Usual care: firm and unequivocal advice to stop smoking, but no further instructions on how to stop smoking Psychosocial intervention: smoking cessation program initiated at the hospital and delivered by cardiac nurses. It was based on a booklet produced for the study and focuses on fear arousal and prevention of relapse. The patients were contacted regularly for several months after discharge (BT, Ph, SH, Specific, Intensity 4)
Outcomes	Follow‐up at 12 months (validated)
Notes	IG: Completer = 57% ITT = 48.3% CG: Completer = 37.3% ITT = 36.1%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information available
Allocation concealment (selection bias)	Low risk	Nurses were given a serially numbered sealed envelope from a secretary who was otherwise uninvolved in the study. No information about opaque, but unnecessary since nurse was not involved
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	High risk	No data on ITT available
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Reid 2003.

Methods	ITT
Participants	Patients in hospital in Canada (reasons: angiography, PTCA, Myocardial infarction, coronary artery bypass surgery. IG: 126 smokers CG: 128 smokers
Interventions	Usual care: no additional intervention after discharge. Psychosocial intervention: assessment of smoking status after 4 weeks. Abstinent patients were reinforced. Those still smoking were offered support by nurse (3 sessions with 20minutes in 8 weeks) and additionally nicotine patch therapy (BT, Ph, SH, Specific, Intensity 4)
Outcomes	Follow‐up at 3 and 12 months (not validated self‐report)
Notes	IG: ITT = 39% CG: ITT = 36%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated randomisation list
Allocation concealment (selection bias)	Low risk	Blocks of six, research staff was unaware of treatment allocation
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Unclear information available
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Rigotti 1994.

Methods	ITT
Participants	93 patients (smokers) scheduled for CABS in the postoperative cardiac surgery unit at Massachusetts General Hospital IG: 44 smokers CG: 43 smokers
Interventions	Usual care: Brief advice not to smoke within a group session. Psychosocial intervention: Nurse‐based smoking cessation and relapse prevention programme adapted from the American Lung Association's "In Control" programme: three‐counselling sessions, videotape, family members were included. Phone call 1 week after discharge by nurse. (BT, Ph, SH, Specific, Intensity 3)
Outcomes	Follow‐up at 2, 4, 8, 12 months and 5 years (validation by saliva cotinine)
Notes	IG: ITT = 43% CG: ITT = 44%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information available
Allocation concealment (selection bias)	Unclear risk	No information available
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	High risk	No data on ITT available
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Sivarajan 1983.

Methods	Completer Analysis, ITT
Participants	258 patients hospitalised with AMI IG1: 43 smokers IG2: 39 smokers CG: 37 smokers
Interventions	Usual care: conventional medical and nursing management. Psychosocial intervention: two intervention groups ‐ EG1: exercise only (for 12 weeks, weekly clinic visits); EG2: exercise, teaching and counselling ( 8 group sessions about risk factors, diet, exercise, stress management etc, individual counselling if needed). Data only of EG 2 used for analysis. (BT, SH, MR, Intensity 4)
Outcomes	Follow‐up at 3 and 6 months (abstinence self‐report)
Notes	IG: Completer = 48% ITT = 33% CG: Completer = 58% ITT = 37%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information available
Allocation concealment (selection bias)	Unclear risk	No information available
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Unclear information available
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Smith 2009.

Methods	Completer Analysis, ITT
Participants	CHD patients after myocardial infarction. All received bypass surgery. Canada. IG: 137 smokers CG: 139 smokers
Interventions	Usual care: minimal intervention: research nurses advised patients to quit smoking by personalizing messages to each patient's medical conditions. The nurse reviewed 2 pamphlets (how to quit and where to find help quitting) with the patient and she put a note in each patient's chart to ask the attending physician to deliver a scripted nonsmoking message at the bedside during the patient's hospital stay. Pharmacotherapy was introduced as an aid to cessation was available Psychosocial intervention: intensive intervention: minimal intervention plus 45‐60min of bedside education and counselling, take‐home materials (video, workbook, audiotape) and 7 telephone counselling sessions initiated by the research nurse (2, 7, 14, 21, 30, 45 and 60 days after discharge) (BT, Ph, SH, Specific, Intensity 4)
Outcomes	Follow‐up at 3, 6 and 12 months (abstinence self‐report)
Notes	IG: Completer = 59.4% ITT = 53.3% CG: Completer = 38.7% ITT = 34.5%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer random number generator
Allocation concealment (selection bias)	High risk	The research nurse opened the randomisation envelopes and informed the patients of intervention assignment, but no information if envelopes were sequentially numbered, sealed and opaque
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Taylor 1990.

Methods	Completer Analysis, ITT
Participants	173 patients (smokers) admitted to hospital with AMI IG: 72 smokers CG: 58 smokers
Interventions	Usual care: no specific instruction to stop smoking. 10% participated in non smoking classes. Psychosocial intervention: nurse‐managed intervention based on social learning theory: manual "Staying Free", 2 audio tapes for relaxation. Telephone contact after discharge (6 times), counselling after relapse. (BT, Ph, SH, Specific, Intensity 4)
Outcomes	Follow‐up at 6 and 12 months (biochemical validation)
Notes	IG: Completer = 70% ITT = 59% CG: Completer = 44% ITT = 30%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random list of odd and even numbers
Allocation concealment (selection bias)	High risk	A sequence of numbers sealed in envelopes was created, but no information if envelopes were sequentially numbered and opaque
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

van Elderen (group).

Methods	Completer Analysis, ITT
Participants	Of 477 patients with CHD after discharge from hospital 258 were included. Diagnosis: MI (144), CABS (42), PTCA (10), other (21) IG: 66 smokers CG: 70 smokers
Interventions	Usual care: standard rehabilitation with medical care and physical training. Psychosocial intervention: health education programme "Heart and Health" based on Ellis' Rational Emotive Therapy (ABCDE model): information about heart disease, risks, diet, exercise, identification and modification of irrational beliefs. 8 weekly group sessions (2h) for the patients and their partners, one follow‐up session at 2 months. (BT, MR, Intensity 4)
Outcomes	Follow‐up at 3 and 12 months (abstinence self‐report)
Notes	IG: Completer = 72% ITT = 69% CG: Completer = 50% ITT = 46%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information available
Allocation concealment (selection bias)	Unclear risk	No information available
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis possible
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

van Elderen (phone).

Methods	Completer Analysis
Participants	60 patients admitted to hospital with AMI IG: 15 smokers CG: 16 smokers
Interventions	Usual care: standard medical care. Psychosocial intervention: health education and counselling programme: two nurse‐based counselling sessions, two group health education sessions (medication, aetiology of MI, risk factors, anxiety, depression etc). Weekly telephone contacts by nurse after discharge for 6 weeks. (Ph, SH, MR, Intensity 4)
Outcomes	Follow‐up after intervention, at 8 weeks and 1 year (abstinence self‐report)
Notes	IG: Completer = 60% CG: Completer = 37%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information available
Allocation concealment (selection bias)	Unclear risk	No information available
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	High risk	No biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Unclear information available
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

Zwisler 2008.

Methods	Completer Analysis, ITT
Participants	Patients with CHF, IHD or HR who were admitted to the Department of Cardiology of Bispebjerg Hospital IG: 110 smokers CG: 117 smokers
Interventions	Usual care: the discharging physician in the outpatient clinic or a general practitioner offered the UC patients follow‐up. The UC patients were informed that they would be contacted after 12 months to assess outcomes. Psychosocial intervention: hospital‐based CCR: standardised cardiac rehabilitation program. 6 week intensive CCR‐program with patient education, 12 exercise training sessions, dietary counselling, smoking cessation, psychosocial support, risk factor management and clinical assessment. Follow‐up visits at 3, 6 and 12 months. (BT, MR, Intensity 4)
Outcomes	Follow‐up at 12 months (validated)
Notes	IG: Completer = 51% ITT = 44.5% CG: Completer = 37.6% ITT = 29.9%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated, random‐permutated multiblock within‐stratum method
Allocation concealment (selection bias)	Low risk	Within each risk stratum the block size, unknown to the investigators, alternated between 6 and 8 patients (see secondary literature: Zwisler 2005)
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding in general not possible in psychosocial interventions
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Biochemically validated outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis
Selective reporting (reporting bias)	Unclear risk	Always rated as unclear, since no protocol information was available in any study

ITT = intention to treat analysis; CABG = coronary artery bypass surgery; CAD = coronary artery disease; AMI = acute myocardial infarction; CG = control group; IG = experimental intervention group; GP = general practitioner
 Duration of treatment is coded as follows (intensity):
 coding 1: single initial contact lasting <= 1 hour, no follow‐up support
 coding 2: one or more contacts in total > 1 hour, no follow‐up support
 coding 3: any initial contact plus follow‐up <=1 month
 coding 4: any initial contact plus follow‐up > 1 month and <= 6 month
 coding 5: any initial contact plus follow‐up > 6 month.

Number in notes section show abstinence rates in percent

Characteristics of excluded studies [ordered by study ID]

Study	Reason for exclusion
Albu 2006	Smoking cessation was not the aim of the study
Andersen 2002	Patients with other disease, or healthy subjects
Andersson 2010	No data reported for smoking cessation as outcome
Anonymous 2003	Review
Anonymous 2006	No empirical study
Armstrong 2011	No paper
Avanzini 2011	Not randomized
Bastian 2011	No extra results for CHD
Baughman 1982	No intervention specified or no specific smoking cessation intervention
Belson 2002	Heterogeneity in diagnosis included / no assessment of smoking status
Bock 2008	No CVD population
Bolman 2002b	Follow up too short
Brenner 1989	No intervention specified or no specific smoking cessation intervention / no assessment of smoking status
Brown 2004	Summary of Quist‐Paulsen
Byfield 2001	Patients with other disease, or healthy subjects / no assessment of smoking status
Campbell 1996	Heterogeneity in diagnosis included
Campbell 1998a	No clear diagnosis of CHD
Campbell 1998b	No clear diagnosis of CHD
Campbell 2004	No empirical study
Chan 2005	No RCT / conference paper
Cho 2012	No data on abstinence
Chow 2010	No intervention specified or no specific smoking cessation intervention
Circo 1985	Follow up too short
Connett 1984	No information about diagnosis included
Cook 1989	No data reported
Cupples 1999	Patients with other heart disease
Davidoff 2001	No psycosocial intervention
Eaker 1982	Patients with other disease, or healthy subjects
Einecke 2004	No psychosocial intervention
Ellingsen 2003	Only data analysis / no primary study / outcome mortality
Engblom 1992	No intervention specified or no specific smoking cessation intervention
Erdman 1983	No intervention specified or no specific smoking cessation intervention
Espinosa 2004	No RCT / only data analysis / wrong population
Finnegan 1985	Cross sectional analysis, not sufficient data / no intervention specified or no specific smoking cessation intervention
Fletcher 1987	No intervention specified or no specific smoking cessation intervention / no comparison of smoking status feasible
Fonarow 2007	No RCT / Comparison of medication
Fortmann 1994	No intervention specified or no specific smoking cessation intervention / no comparison of usual care and specific psychosocial intervention
Fox 2002	Not randomized
Frasure‐Smith 1997	No comparison of smoking status feasible
Fredrickson 1995	Patients with other disease, or healthy subjects / no intervention specified or no specific smoking cessation intervention / follow up too short
Giallauria 2005	No RCT / retrospective study
Gohlke 2004	Review, no study
Goldenberg 2003	No RCT / no intervention study / retrospective analysis of previous data
Guthrie 2001	No intervention specified or no specific smoking cessation intervention
Hajek 2010	No smoking cessation reported
Hall 1983	Heterogeneity in diagnosis included
Haskell 1994	No possibility to include data in meta‐analysis
Hilleman 2004	No RCT
Hjermann 1986	Heterogeneity in diagnosis included
Holme 2006	Smoking intervention not an outcome of interest
Horlick 1984	No comparison of smoking status feasible
Hosokawa 2008	Smoking intervention not an outcome of interest
Houston 2005	No RCT / observational study / outcome mortality
Houston‐Miller 1997	Heterogeneity in diagnosis included
Jacobsen 2008	No empirical study / no RCT
Jain 2003	No RCT
Jami 2007	Retrospective medical chart review
Jatuporn 2003	Medication vs. lifestyle modification / Smoking is not an outcome of interest
Jolly 2003	Target group consists of mixed patients (smokers / nonsmokers) / study protocol
Jones 1996	No intervention specified or no specific smoking cessation intervention / no assessment of smoking status
Joseph 1996	No intervention specified or no specific smoking cessation intervention
Joseph 2005	No abstinence rates
Kallio 1981	Follow up too short
Knutsen 1991	Patients with other disease, or healthy subjects
Kornitzer 1980	Patients with other disease, or healthy subjects
Kornitzer 1989	Patients with other disease, or healthy subjects / no comparison of smoking status feasible
Kotowycz 2010	Follow up too short
Kristeller 1993	No comparison of smoking status feasible
Kuller 1991	Heterogeneity in diagnosis included / no intervention specified or no specific smoking cessation intervention
La Rosa 2006	Smoking cessation not goal of intervention / comparison of medication
Lancaster 1999	Patients with other disease, or healthy subjects
Lear 2002	Only 5 smokers and no results
Leung 2008	No RCT / no intervention
Maddison 2011	Study protocol
Marra 1985	No intervention specified or no specific smoking cessation intervention
Matsui 2005	Only text for methods
Mayou 2002	No intervention specified or no specific smoking cessation intervention / no comparison of smoking status feasible
McGee 2006	No psychosocial intervention
McHugh 2001	No assessment of smoking status
Meland 1999	Cross sectional analysis, not sufficient data
Murchie 2003	No clear diagnosis of CHD
Murray 2007	Smoking is not an outcome of interest
Muscari 2005	Smoking cessation not goal of intervention
Nisbeth 2000	Patients with other disease, or healthy subjects / no results for CG and smoking
O'Malley 2003	No psychosocial intervention
O'Neil 2011	Study protocol
Oldridge 1997	No RCT/ only cost effectiveness
Ong 2005	No RCT/ no comparison of CG and IG
Ornish 1990	No comparison of smoking status feasible / no assessment of smoking status
Patel 1985	No information about diagnosis included / no comparison of smoking status feasible
Perk 2000	No RCT
Piestrzeniewicz 2004	Study not available
Plans‐Rubio 2004	No RCT / only data analysis / no comparison with CG
Powers 2011	Follow up too short
Prieme 1998	Patients with other disease, or healthy subjects / cross sectional analysis, not sufficient data /no intervention specified or no specific smoking cessation intervention / no assessment of smoking status
Puura 2003	No CVD / wrong outcome
Quist‐Paulsen 2006b	Cost effectiveness
Redfern 2009	Relative Risk is larger than 5, RR = 20.09
Reid 2005	Smoking is not an outcome / unclear if smoking cessation is part of the intervention
Reid 2007	No psychosocial intervention / NRT vs. NRT + phone
Rice 1994	Heterogeneity in diagnosis included
Rigotti 2006	Comparison of medication / no psychosocial intervention
Rigotti 2011	Follow up too short
Risser 1990	Patients with other disease, or healthy subjects
Rollins 2004	Outcome guideline compliance
Rose 1978	Patients with other disease, or healthy subjects
Rose 1982	Patients with other disease, or healthy subjects
Rose 1992	Patients with other disease, or healthy subjects
Sanders 1989	No information about diagnosis included
Scherr 2010	Not randomized
Schimmer 2006	No smoking cessation / no random allocation
Schmitz 1999	No comparison of usual care and specific psychosocial intervention
Schoenenberger 2010	No psychosocial intervention
Schumacher 2006	Smoking is not an outcome of the study
Simon 2003	Heterogeneity in diagnosis included
Sippel 1999	Heterogeneity in diagnosis included
Smith 1998	No study
Sondergaard 2006	Mixed population
Steptoe 1999	Other heart diseases / patients with other disease, or healthy subjects
Steptoe 2001	Other heart diseases / patients with other disease, or healthy subjects
Stewart 1999	Other heart diseases / no intervention specified or no specific smoking cessation intervention
Strandberg 2001	Target group consists of mixed patients (smokers / nonsmokers) / no cessation data from the control group
Suurkula 1996	Heterogeneity in diagnosis included
Taylor 1988	No intervention specified or no specific smoking cessation intervention
Taylor 1997	No assessment of smoking status
Thomas 2007	No RCT / no empirical study
Thompson 2009	Summary of Jolly (2003)
Tiffany 1986	Patients with other disease, or healthy subjects
Tonnesen 1999	Other heart diseases
Tonstad 2003	Heterogeneity in diagnosis included / no intervention specified or no specific smoking cessation intervention
Toobert 1998	No comparison of smoking status feasible
Toobert 2000	No comparison of smoking status feasible
Trockel 2008	No psychosocial intervention aiming at smoking cessation
Tzivoni 1998	Cross sectional analysis, not sufficient data /no intervention specified or no specific smoking cessation intervention
Uysal 2012	Follow up too short
Vasiliauskas 2009	Unclear information / translation not available
Vedin 1976	No intervention specified or no specific smoking cessation intervention
Wallner 1999	No intervention specified or no specific smoking cessation intervention / no assessment of smoking status
Waters 1996	No intervention specified or no specific smoking cessation intervention
Wewers 1994	Heterogeneity in diagnosis included
Whitlock 1997	Heterogeneity in diagnosis included / no information about diagnosis included
Wiggers 2006	Pharmacological criteria as comparator
Wister 2007	Target group consists of mixed patients (smokers / nonsmokers)
Woollard 2003	Smoking is not an outcome of interest
Xian 2010	No RCT / comparison of hospitals
Yorio 2008	Smoking is not an outcome of the study
Zwisler 2005	Smoking is not an outcome of the study

Characteristics of studies awaiting assessment [ordered by study ID]

Becker 2003.

Methods	Was not extracted since we could not access the paper and authors did not respond to PDF requests
Participants	Was not extracted since we could not access the paper and authors did not respond to PDF requests
Interventions	Was not extracted since we could not access the paper and authors did not respond to PDF requests
Outcomes	Was not extracted since we could not access the paper and authors did not respond to PDF requests
Notes	Was not extracted since we could not access the paper and authors did not respond to PDF requests

Boulay 2001.

Methods	Was not extracted since we could not access the paper and authors did not respond to PDF requests
Participants	Was not extracted since we could not access the paper and authors did not respond to PDF requests
Interventions	Was not extracted since we could not access the paper and authors did not respond to PDF requests
Outcomes	Was not extracted since we could not access the paper and authors did not respond to PDF requests
Notes	Was not extracted since we could not access the paper and authors did not respond to PDF requests

Enriquez‐Puga 2001.

Methods	Was not extracted since we could not access the paper and authors did not respond to PDF requests
Participants	Was not extracted since we could not access the paper and authors did not respond to PDF requests
Interventions	Was not extracted since we could not access the paper and authors did not respond to PDF requests
Outcomes	Was not extracted since we could not access the paper and authors did not respond to PDF requests
Notes	Was not extracted since we could not access the paper and authors did not respond to PDF requests

Puente‐Silva 1989.

Methods	Was not extracted since we could not access the paper and authors did not respond to PDF requests
Participants	Was not extracted since we could not access the paper and authors did not respond to PDF requests
Interventions	Was not extracted since we could not access the paper and authors did not respond to PDF requests
Outcomes	Was not extracted since we could not access the paper and authors did not respond to PDF requests
Notes	Was not extracted since we could not access the paper and authors did not respond to PDF requests

Contributions of authors

JB performed initial searches for studies, assessed studies for inclusion, carried out data extraction. He wrote the initial draft, supervised the entire project and edited the review.
 TJ assessed studies for inclusion, extracted data, analysed data, and edited the review. ID extracted data and edited the review. JC gave advice on statistical procedures, and edited the review.

Sources of support

Internal sources

• Department of Rehabilitation Psychology, Germany.

• Wissenschaftliche Gesellschaft University of Freiburg, Germany.

External sources

• No sources of support supplied

Declarations of interest

None known.

New search for studies and content updated (no change to conclusions)