Smoking cessation interventions and strategies. Technical report

Transcription

1 Volume 4 Issue ISSN Smoking cessation interventions and strategies Technical report Craig Lockwood Amanda O Connell Phillip Thomas

2 JBI Best Practice Technical Reports Joanna Briggs Institute Evidence Based Publications The Joanna Briggs Institute is involved in the development and dissemination of a number of publications that inform health professionals about clinical practice and specifically what constitutes best practice in health care. These serials include the International Journal of Evidence Based Healthcare (formerly JBI Reports) published by Blackwell Publishing and available online at Systematic reviews conducted by Collaborating Centres of the Joanna Briggs Institute are published in the International Journal of Evidence Based Healthcare. These systematic review reports are further abstracted and published by Blackwell Publishing as the series Best Practice Information Sheets for Health Professionals. All Best Practice Information Sheets are derived from systematic reviews of health care research literature either conducted by the Joanna Briggs Institute Collaborating Centres or in some cases by an external source. Aims and scope of the Technical Report The conduct of systematic reviews and the development of Best Practice Information Sheets involve rigorous, standardised methods to ensure that all information provided to health professionals is of the highest standard and constitutes best practice. The conduct of a systematic review and development of the corresponding Best Practice issue are two parts of a staged process. All aspects of the conduct of the systematic review and the development of the accompanying Best Practice issue are documented so that these methods may be scrutinised. The processes involved in conducting Joanna Briggs Institute systematic reviews, including review methods are documented within the systematic review report. The format of Best Practice precludes it from including detailed information regarding the abstraction of evidence and development of recommendations embodied in the publication. For this reason JBI Best Practice Technical Reports are provided as a complementary publication to document all aspects of the development of Best Practice Information Sheets. In determining the quality of the Joanna Briggs Institute Best Practice Information Sheets the information provided in the Technical Report and the Systematic Review Report should also be considered. Contact details The Joanna Briggs Institute, Royal Adelaide Hospital, North Terrace Adelaide, South Australia, 5000, Australia jbi@adelaide.edu.au Telephone: Facsimile: Disclaimer The procedures described in Best Practice must only be used by people who have appropriate expertise in the field to which the procedure relates. The applicability of any information must be established before relying on it. While care has been taken to ensure that this edition of Best Practice summarises available research and expert consensus, any loss, damage, cost, expense or liability suffered or incurred as a result of reliance on these procedures (whether arising in contract, negligence or otherwise) is, to the extent permitted by law, excluded. Publisher The Joanna Briggs Institute Adelaide The Joanna Briggs Institute 2008 ISSN Technical Report Smoking cessation interventions and strategies page ii

3 Contents Introduction 91 Best Practice Information Sheets development methods 91 Acknowledgements 91 Identification and synthesis of the evidence 92 Executive summary 93 Abstraction of the evidence and development of practice recommendations 104 Appendix 1 Grades of Recommendation and Implications for Practice 105 Appendix 2 Included studies 106 Appendix 3 References 145 Technical Report Smoking cessation interventions and strategies page iii

4 Smoking cessation interventions and strategies Technical Report Craig Lockwood, RN MSc Amanda O Connell, RN CardiacCareCert GDipCardiacNsg Phillip Thomas, BA MA GradDipInfStud Correspondence: The Joanna Briggs Institute Royal Adelaide Hospital North Terrace Adelaide SA jbi@adelaide.edu.au Introduction The aim of Joanna Briggs Institute evidence publications is to provide the best available evidence relating to clinical questions that are important to health professionals and consumers. Although the publications relate to the same clinical question/s and are therefore complementary they serve different purposes and so are of a different scope and format. The Best Practice Information Sheets are targeted to base level health professionals and are restricted to a six-page format, recognising the time constraints on today s clinicians. This prevents details of the development process being presented in the Best Practice Information Sheets. The Best Practice Information Sheet Technical Report provides this detail to allow scrutiny of the development process. The development of these publications is essentially a stepped process involving first the identification and synthesis of the evidence (Systematic Review) and then the abstraction of the evidence and development of recommendations for practice (Best Practice Information Sheets). In examining the methods and processes that ultimately produce practice recommendations the reader should consider the information available in the both the Systematic Review Report and the Best Practice Information Sheet Technical Report for a given information sheet. This technical report details the development process for the following Best Practice Information sheet. Joanna Briggs Institute (2008). Smoking cessation interventions and strategies. Best Practice Evidence Based Information Sheets for Health Professionals, 12(8), 1-4. Best Practice Information Sheets development methods All Joanna Briggs Best Practice Information Sheets are developed by staff of the Joanna Briggs Institute in collaboration with staff from one of the Joanna Briggs Collaborating Centres with the assistance of an advisory panel of clinicians and other experts. Acknowledgements Best Practice Information Sheet developers Craig Lockwood, Associate Director, The Joanna Briggs Institute Amanda O Connell, Manager Collaboration Support Unit, The Joanna Briggs Institute Phillip Thomas, Research Fellow, Collaboration Support Unit, The Joanna Briggs Institute Advisory Panel Dr. Suzi Robertson-Malt, National & Gulf Centre for Evidence Based Medicine, Riyadh, Kingdom of Saudi Arabia Technical Report Smoking cessation interventions and strategies page 91

5 Maggie Roberts, School of Nursing, Nottingham University, Nottingham, United Kingdom Dr. Bridie Kent, School of Nursing, Faculty of Medical and Health Sciences, Unverity of Auckland, New Zealand Identification and synthesis of the evidence All Best Practice Information Sheets are derived from systematic reviews of the best available evidence. The 14 reviews upon which the information sheet is based are: Barth J, Critchley J, Bengel J. Efficacy of Psychosocial interventions for smoking cessation in patients with Coronary Heart Disease: a systematic review. Annals of Behavioural Medicine. 2006; 32(1): David S, Lancaster T, Stead LF, Evins AE. Opioid antagonists for smoking cessation. Cochrane Database of Systematic Reviews. 2006; Issue 6. Gourlay SG, Stead LF, Benowitz NL. Clonidine for smoking cessation. Cochrane Database of Systematic Reviews. 2004; Issue 3. Hajek P, Stead LF. Aversive smoking for smoking cessation. Cochrane Database of Systematic Reviews. 2001; Issue 3. Hughes JR, Stead LF, Lancaster T. Antidepressants for smoking cessation. Cochrane Database of Systematic Reviews. 2007; Issue 1. Lancaster T, Stead LF. Individual behavioural counselling for smoking cessation. Cochrane Database of Systematic Reviews. 2005; Issue 3. Lancaster T, Stead LF. Self-help interventions for smoking cessation. Cochrane Database of Systematic Reviews. 2005; Issue 3. Møller A, Villebro N. Interventions for preoperative smoking cessation. Cochrane Database of Systematic Reviews. 2005; Issue 3. Rice VH, Stead LF. Nursing interventions for smoking cessation. Cochrane Database of Systematic Reviews. 1999; Issue 3. Rigotti NA, Munafo MR, Stead LF. Interventions for smoking cessation in hospitalised patients. Cochrane Database of Systematic Reviews. 2007; Issue 3. Technical Report Smoking cessation interventions and strategies page 92

6 Silagy C, Lancaster T, Stead LF, Mant D, Fowler G. Nicotine replacement therapy for smoking cessation. Cochrane Database of Systematic Reviews. 2004; Issue 3. CD updated review at: Stead LF, Hughes J. Lobeline for smoking cessation. Cochrane Database of Systematic Reviews. 1997; Issue 3. Stead LF, Lancaster T. Group behaviour therapy programmes for smoking cessation. Cochrane Database of Systematic Reviews. 2005; Issue 2. White A, Rampes H, Campbell JL. Acupuncture and related interventions for smoking cessation. Cochrane Database of Systematic Reviews. 2006; Issue 1. Executive summary Background The evidence concerning smoking cessation has increased markedly since the late 1990s and there are various forms of interventions. Nicotine replacement therapy (NRT) forms the mainstay of many smoking cessation strategies, but there is now a comprehensive body of evidence concerning a wide range of other interventions. These range from behaviour therapy, group or individual counselling, self-help strategies, pharmacotherapeutic interventions, to strategies that involve specific populations of patients and/or specific conditions, such as coronary heart disease (CHD). Self-help is a form of therapy where the individual manages his/her own smoking cessation program and consequently, self-help is low cost but its cost effectiveness is low when compared to other therapies. There are behavioural interventions to stop smoking and these include social skills training, coping skills, contingency management, self-control, and cognitive-behavioural interventions. Group therapy lies between intensive individual counselling and self-help with minimal support by a therapist, and this makes it a less resource-consuming option that intensive one-to-one counselling. It offers equivalent cessation rates in a more economically viable model. Anecdotal evidence has shown that smoking is more likely to occur in people who have a history of depression, and that smoking cessation will itself lead to depressive episodes. Furthermore, people may prefer a non-nicotine form of pharmacotherapy when they consider quitting smoking. Antidepressants may therefore serve a dual purpose as a smoking cessation strategy and several antidepressants have been the subject of extensive trials. NRT and antidepressants continue to be the most viable pharmaceutical options, but alternative therapies such as hypnotherapy and acupuncture have been systematically reviewed. Specific patient groups for specific interventions have been investigated as to their willingness to quit smoking. Patients, including those preparing for surgery, those with depression, or CHD, or admitted to hospital, have been the subject of research. Objectives The objectives of the fourteen systematic reviews included in this information sheet were as follows. Barth, Critchley and Bengel (2005) set out to conduct a systematic review on the efficacy of psychosocial interventions to quit smoking in patients with Coronary Heart Disease. David, Lancaster Stead and Evins (2006) evaluated the efficacy fo opioid antagonists in promoting long-term smoking cessation. The drugs included naloxone and the longer-acting opioid antagonist naltrexone. Technical Report Smoking cessation interventions and strategies page 93

7 Gourlay, Stead and Benowitz (2007) had the objective of determining clonidine s effectiveness in helping smokers to quit. Hajek and Stead (2001) had two aims: firstly, to determine the efficacy of rapid smoking and other aversive methods in helping smokers to stop smoking; secondly, to determine whether there is a dose-response effect on smoking cessation at different levels of aversive stimulation. Hughes, Stead and Lancaster (2007) assessed the effect of anti-depressant medications in assisting long-term smoking cessation. Medications included bupropion, doxepin, fluoxetine, imipramine, moclobemide, nortriptyline, parotexine, sertraline, tryptophan and venlafaxine. Lancaster and Stead (2005) investigated the effects of individual counselling on smoking cessation. The review addresses the following hypotheses: 1. Individual counselling is more effective than no treatment or brief advice in promoting smoking cessation. 2. Individual counselling is more effective than self-help materials in promoting smoking cessation. 3. A more intensive counselling intervention is more effective than a less intensive intervention. Lancaster and Stead (2005) evaluated the effectiveness of different forms of: self-help materials, compared with no treatment and with other minimal contact strategies; effectiveness of adjuncts to self-help, such as computer-generated feedback, telephone hotlines and pharmacotherapy; and the effectiveness of approaches tailored to the individual compared with non-tailored materials. Møller and Villebro (2005) examined the effectiveness of preoperative smoking intervention on smoking cessation in the post-operative period and longer term. The effect of smoking cessation on the incidence of post-operative complications was also an objective. Rice and Stead (2004) looked at the effectiveness of nursing-delivered smoking cessation interventions. This review did not address the incremental effects of providing nicotine replacement therapy (NRT) by nurses. Rigotti, Munafo and Stead (2007) examined the effectiveness of interventions for smoking cessation that are initiated for hospitalised patients. A secondary objective was to explore the possibility that the efficacy of interventions differed for patients with different diagnoses. This was done using subgroup analysis of trials that recruited patients from more than one specialty, and by indirect comparison of trials that recruited patients from within one disease category. Silagy, Lancaster, Stead, Mant and Fowler (2004) in their reviewed had the following objectives: determining the effectiveness of different types of NRT (chewing gum, transdermal patches, nasal spray, inhalers, tablets) in achieving abstinence from cigarettes, or sustained reduction in smoking; determining whether the effect is influenced by the clinical setting in which the smoker is recruited and treated, the dosage and form of NRT used, or intensity of additional advice and support offered to the smoker; determining whether combinations of NRT are more effective than one type alone; determining its effectiveness compared to other pharmacotherapies. Stead and Hughes (1997) assessed the effects of lobeline on long-term smoking cessation. Their hypothesis was that lobeline was more effective than placebo, or an alternative treatment, in achieving long-term smoking cessation. Stead and Lancaster (2005) aimed to determine the effects of smoking cessation programmes delivered in a group format compared to self-help materials, or to no intervention. They also compared the effectiveness of group therapy and individual counselling and determined the effect of Technical Report Smoking cessation interventions and strategies page 94

8 adding group therapy to advice from a health professional or to nicotine replacement. Whether specific components increased the effectiveness of group therapy was also examined. The authors looked at the rate at which offers of group therapy are accepted. White, Rampes and Campbell (2006) determined the effectiveness of acupuncture and the related interventions of acupressure, laser therapy and electrostimulation, in smoking cessation in comparison with no intervention, sham treatment, or other interventions. Search strategy Barth, Critchley and (2005) searched the following electronic databases for relevant studies (no restriction on language or publication type): MEDLINE and PreMEDLINE and BIOSIS (1966-July, 2003), EMBASE (until 1998), Cochrane Controlled Trials Register (Issue 2, 2003), PyscINFO ( August 2003). MESH terms and free text searching were used. David, Lancaster, Stead and Evins (2006) searched the Cochrane Tobacco Addiction Group for trials of naloxone, naltrexone and other opiod antagonists. MEDLINE was searched using Narcotic antagonists and smoking terms in March The authors contacted investigators where possible for information concerning unpublished studies. Gourlay, Stead and Benowitz (2004) searched the Cochrane Tobacco Addiction Group trials register for clonidine studies. MEDLINE and PsycLIT searches combining the MeSH terms 'clonidine' and 'smoking' were performed as was a search of clinical trials registered on Information on unpublished studies was requested through the newsgroup of the Society for Research on Nicotine and Tobacco. Hajek and Stead (2001) searched the Cochrane Tobacco Addiction Group specialised register for studies evaluating any technique of aversive smoking. MEDLINE and PsycINFO searches combining the MeSH terms 'clonidine' and 'smoking' were performed as was a search of clinical trials registered on Information on unpublished studies was requested through the newsgroup of the Society for Research on Nicotine and Tobacco. The following behavioural science journals were covered: Behaviour Research and Therapy to 1979, Behavior Therapy to 1996, Journal of Consulting and Clinical Psychology and Journal of Behavioural Medicine No attempt was made to obtain unpublished theses, dissertations and conference presentations, since these are among the 'grey literature' routinely searched for the Tobacco Addiction Group's specialised register. Hughes, Stead and Lancaster (2007) searched the Cochrane Tobacco Addiction Group trials register, which includes trials indexed in MEDLINE, EMBASE, SciSearch and PsycINFO, and other reviews and meeting abstracts. All trials using pharmacotherapy other than nicotine, clonidine or lobeline for smoking cessation were found, and those using medications generally classified as having an antidepressant effect were selected for inclusion in this review. The authors checked the citation lists of these studies, recent reviews of non-nicotine pharmacotherapy and abstracts from the meetings of the Society for Research on Nicotine and Tobacco. Several studies were located by contacting investigators in the area and authors checked all records of trials of bupropion held on the GlaxoSmithKline Clinical Trials Register for unpublished studies. Lancaster and Stead (2005) checked the Cochrane Tobacco Addiction Group specialised register for studies with counsel* in any field. Authors also checked previous reviews and meta-analyses for relevant studies, including all studies in the US guidelines (AHCPR 1996; AHRQ 2000). Lancaster and Stead (2005) checked the Cochrane Tobacco Addiction Group specialised register for studies with self-help, manual or booklet. Møller and Villebro (2005) searched the specialized register of the Cochrane Tobacco Addiction Group using the free text and keywords (surgery) OR (operation) OR (anaesthesia) or (anesthesia). MEDLINE, EMBASE and CINAHL were also searched, combining tobacco- and surgery-related terms. Technical Report Smoking cessation interventions and strategies page 95

9 Rice and Stead (2004) searched the Cochrane Tobacco Addiction Group specialised register and CINAHL in June Rigotti, Munafo and Stead (2007) searched the Cochrane Tobacco Addiction Group register for papers identified from CENTRAL, MEDLINE, EMBASE, PsycINFO and CINAHL that dealt with interventions for smoking cessation in hospitalised patients, using terms including (hospital and patient*) or hospitali* or inpatient* or admission* or admitted. Authors also handsearched conference abstracts. Searches for the register cover smoking cessation, nicotine dependence, nicotine addiction and tobacco use. Furthermore the authors searched the Centers for Disease Control Smoking and Health database for the original review and asked experts in smoking cessation for details of conference abstracts and studies in press. Silagy, Lancaster, Stead, Mant and Fowler (2004) searched the Cochrane Tobacco Addiction Group trials register. Stead and Hughes (1997) searched the Cochrane Tobacco Addiction Group trials register, MEDLINE and review bibliographies. Stead and Lancaster (2005) searched the Cochrane Tobacco Addiction Group trials register, MEDLINE and PsycINFO, including the terms behavior therapy, cognitive therapy, psychotherapy or group therapy. Handsearching of the following journals was undertaken: Behavioural Sciences; Behaviour Research and Therapy; Journal of Consulting and Clinical Psychology; Behaviour Therapy; and Journal of Behavioural Medicine. The authors also checked the US Public Health Service Clinical Practice Guidelines on smoking cessation (Fiore 1996; Fiore 2000) for trials used in meta-analyses assessing the efficacy of different treatment formats and the components of effective interventions. White, Rampes and Campbell (2006) searched the Cochrane Tobacco Addiction Group specialised register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, BIOSIS Previews, PsycINFO, Science and Social Sciences Citation Index, AMED, CISCOM, and Medical Acupuncture Research Foundation Acubriefs website. In addition to these searches the authors obtained relevant references from published reviews, clinical trials and conference abstracts. Selection criteria Barth, Critchley and (2005) assessed the eligibility of the retrieved articles for inclusion using an eligibility form and the most important criterion was that of being a randomised controlled trial. Smoking cessation had to be reported or study was excluded. David, Lancaster, Stead and Evins (2006) used randomized controlled trials of opioid antagonists that reported smoking status at least 6 months after intervention to assess the efficacy for long-term cessation. They also considered randomized controlled trials of opioid antagonists with short-term follow-up that reported the outcomes of withdrawal, reinforcing properties of smoking, or ad libitum smoking. Studies had to comprise adult smokers types of intervention had to be: naltrexone, naloxone, buprenorphine or other opioid antagonists, with or without concurrent nicotine replacement therapy. Gourlay, Stead and Benowitz (2004) considered randomised controlled trials of clonidine versus placebo with a smoking cessation endpoint assessed at least 12 weeks following end of treatment. Hajek and Stead (2001) selected randomised trials comparing aversion treatments with inactive procedures or which compared aversion treatments of different intensity for smoking cessation. Trials had to report follow-up of at least 6 months from beginning of treatment. Hughes, Stead and Lancaster (2007) considered randomized trials comparing antidepressant with placebo or with an alternative therapeutic control, or comparing different dosages of an antidepressant that reported six-month or longer follow-ups. The participants were current smokers, Technical Report Smoking cessation interventions and strategies page 96

10 or recent quitters (for trials of relapse prevention). Types of intervention consisted of: treatment with any medication with antidepressant properties to aid a smoking cessation attempt or to prevent relapse, or in the case of trials for harm reduction, to reduce the number of cigarettes smoked and aid subsequent cessation. Outcome measures were efficacy: measured via a) abstinence from smoking, assessed at follow up at least six months from start of treatment; or b) for trials of harm reduction, incidence of reducing cigarette consumption to 50% or less of baseline, and abstinence. Lancaster and Stead (2005) selected randomised or quasi-randomised controlled trials with a minimum follow-up of 6 months, where at least one treatment arm consisted of an unconfounded intervention from a counsellor. The participants had to be any adult smokers, except pregnant women. The authors defined individual counselling as a face-to-face encounter between a smoking patient and a counsellor trained in assisting smoking cessation. The authors used sustained abstinence, or multiple point prevalence, where available and included studies using self-report with or without biochemically validated cessation, and performed sensitivity analyses to determine whether the estimates differed significantly in studies without verification. Lancaster and Stead (2005) included randomised controlled trials with a minimum follow-up of 6 months, where at least one arm consisted of a self-help intervention without repeated face-to-face therapist contact. The authors also included trials where allocation to treatment was by a quasirandomised method. Participants consisted of adult smokers except pregnant smokers and adolescent smokers. Møller and Villebro (2005) considered randomised trials in which recruited smokers prior to surgery, were offered a smoking cessation intervention, and measured abstinence from smoking in the preoperative and post-operative periods. The authors also considered randomised trials of the effect of smoking cessation on the incidence of intra- and post-operative complications. Rice and Stead (2004) included studies with at least two treatment groups, and participants had to be adult smokers of either gender and recruited in any type of healthcare setting. The only exceptions were studies that had exclusively recruited pregnant women. Trials in which 'recent quitters' were classified as smokers were included. Nursing intervention was defined as the provision of advice, counselling, and/or strategies to help patients quit smoking. The major outcome was smoking cessation rather than a reduction in withdrawal symptoms, or reduction in number of cigarettes smoked. Trials had to report follow-up of at least 6 months for inclusion in the review. Rigotti, Munafo and Stead (2007) selected randomised and quasi-randomised trials of behavioural, pharmacological or multi-component interventions to help patients stop smoking, conducted with hospitalised patients who were current smokers or recent quitters (defined as having quit more than one month before hospital admission). The intervention had to start in the hospital but could continue after hospital discharge. The authors excluded studies of patients admitted for psychiatric disorders or substance abuse, studies that did not report abstinence rates and studies with follow-up of less than 6 months. Silagy, Lancaster, Stead, Mant and Fowler (2004) incorporated randomised trials in which NRT was compared to placebo or to no treatment, or where different doses of NRT were compared. Trials that did not report cessation rates or only follow-up of less than 6 months were excluded. Stead and Hughes (1997) looked for randomised studies using a placebo or an alternative therapeutic control. Types of participants included any smokers and interventions consisted of treatment with any form of lobeline. The outcome measures were smoking cessation, assessment at follow-up at least 6 months from start of treatment. Stead and Lancaster (2005) considered randomised trials that compared group therapy with self-help, individual counselling, another intervention or no intervention (including usual care or a waiting list control). They also considered trials that compared more than one group programme, including those trials with a minimum of two group meetings, and follow-up of smoking status at least 6 months after the programme began. Technical Report Smoking cessation interventions and strategies page 97

11 White, Rampes and Campbell (2006) included all randomised controlled trials comparing acupuncture, acupressure, laser therapy or electrostimulation with either no intervention, or a sham form of the intervention, or another intervention, for smoking cessation. The participants were smokers of any age who wished to stop smoking. Interventions consisted of non-pharmacological stimulation interventions involving needle puncture or finger pressure or laser therapy in areas of the body, or the related intervention of electrostimulation to the head region, either through surface electrodes or through needles. Types of outcome measures: complete abstinence from smoking. Data collection and analysis In Barth, Critchley and Bengel (2006) data management and analysis were carried out using Review Manager 4.2. Heterogeneity was assessed by examining forest plots of trials, by calculating chisquare heterogeneity test, and I2 statistics. The Chi-square 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%)(40). A random effects model for pooling the studies was employed due to expected heterogeneity in the primary studies. David, Lancaster, Stead and Evins (2006) extracted data in duplicate on the type of study population, nature of the drug therapy, outcome measures, method of randomisation, and completeness of followup. The main outcome measure was cotinine- or carbon monoxide-verified abstinence from smoking after at least 6 months follow-up in patients smoking at baseline. Where appropriate the authors performed a meta-analysis using a fixed-effect model (Mantel-Haenszel odds ratios). Gourlay, Stead and Benowitz (2004) extracted data in duplicate on the type of subjects, the dose and duration of clonidine therapy, outcome measures, method of randomization, and completeness of follow-up. The main outcome measure was abstinence from smoking after at least 12 weeks follow up in patients smoking at baseline. They used the most rigorous definition of abstinence for each trial, and biochemically validated rates if available and performed a meta-analysis using a fixed effect model. Hajek and Stead (2001) extracted data in duplicate on the study population, type of aversion treatment, outcome measure, method of randomisation and completeness of follow-up. The outcome measure was abstinence from smoking at maximum follow-up, using the strictest measure reported by the authors. Subjects lost to follow-up were regarded as smokers. Authors performed a metaanalysis using a fixed effect model. Hughes, Stead and Lancaster (2007) extracted data in duplicate on the type of study population, nature of the pharmacotherapy, outcome measures, method of randomisation, and completeness of follow-up. The main outcome measure was abstinence from smoking after at least 6 months follow-up in patients smoking at baseline, expressed as an odds ratio (OR). The authors used the most rigorous definition of abstinence available in each trial, and biochemically validated rates if available, and performed a meta-analysis using a fixed-effect model. Lancaster and Stead (2005) both extracted the data. The principal outcome was cessation rates and the information extracted included descriptive information (the population and intervention studied), method of randomisation and allocation concealment, completeness of follow-up, and whether selfreported cessation was validated. Participants lost to follow-up were assumed to be continuing smokers. The authors summarized individual study results as an odds ratio, calculated as: (number of quitters in intervention group/ number of continuing smokers in intervention group) / (number of quitters in control group/ number of continuing smokers in control group). Where appropriate a metaanalysis was done using a Mantel-Haenszel fixed-effect method to estimate a pooled odds ratio with 95% confidence intervals. Lancaster and Stead (2005) extracted data in duplicate on the participants, nature of the self-help materials, amount of face-to-face contact given to intervention and to control conditions, outcome measures, method of randomisation, and completeness of follow-up. The main outcome measure was abstinence from smoking after at least 6 months follow-up in people smoking at baseline. The authors Technical Report Smoking cessation interventions and strategies page 98

12 used the most rigorous definition of abstinence in each trial, and biochemically validated rates when available and performed a meta-analysis using a fixed-effect model where appropriate. Møller and Villebro (2005) independently assessed studies to determine eligibility. The results were discussed between the authors. Two tests for heterogeneity were used: the Chi squared test for heterogeneity, with P < 0.1 considered significant, and the I 2 statistic, with values above 75% interpreted as as high heterogeneity. It can be interpreted as the proportion of total variation observed between the studies attributable to differences between studies rather than to sampling error (chance). Where it was appropriate to pool studies, we used the Mantel-Haenszel fixed-effect method for pooling ORs, with 95% confidence intervals. Rice and Stead (2004) extracted the data independently. The main outcome measure was abstinence from smoking after at least 6 months of follow-up. The most rigorous definition of abstinence for each trial, and biochemically validated rates if available were used. Where statistically and clinically appropriate, the authors pooled studies using a Mantel-Haenszel fixed effect model and reported the outcome as a risk ratio (RR) with 95% confidence interval (CI). Rigotti, Munafo and Stead (2007) checked studies identified for relevance and two authors extracted data independently. Disagreements were resolved by consensus. If necessary the original authors were contacted for clarification of data. Data collection included information on country, reasons for hospitalisation, recruitment criteria, method of randomisation, smoking behaviour, therapist types, description of experimental and control interventions. Studies were assessed regarding the reporting of validation of self-reported smoking cessation, and how they handled patients lost to follow up. The authors used statistical methods for pooling using a Mantel-Haenszel fixed-effect method, with 95% confidence intervals. Silagy, Lancaster, Stead, Mant and Fowler (2004) extracted data in duplicate on the type of participants, dose, duration and form of nicotine therapy, outcome measures, method of randomisation, and completeness of follow-up. The main outcome measure was abstinence from smoking after at least 6 months of follow-up. Authors used the most rigorous definition of abstinence for each trial, and biochemically validated rates if available, and then calculated the risk ratio (RR) for each study. Where appropriate, a meta-analysis using a Mantel-Haenszel fixed-effect model was performed. Stead and Hughes (1997) ensured that the strictest available criteria to define cessation would be used, with figures for sustained abstinence extracted in preference to point prevalence where both were presented. In studies using biochemical validation of cessation, only those subjects meeting the criteria for biochemically confirmed abstinence would be regarded as having stopped smoking. Subjects in either group lost to follow-up would be regarded as being continuing smokers. Two reviewers would extract data independently. Statistical meta-analysis would be used to derive a typical Odds Ratio and its associated confidence intervals, using a fixed-effects model. Stead and Lancaster (2005) extracted data in duplicate on the participants, interventions provided to the groups and the controls, including programme length, intensity and main components, outcome measures, method of randomisation, and completeness of follow-up. The main outcome measure was abstinence from smoking after at least 6 months follow-up in patients smoking at baseline. Authors used the most rigorous definition of abstinence in each trial, and biochemically validated rates where available. Subjects lost to follow-up were analysed as continuing smokers. Where possible, a metaanalysis was performed using a fixed-effects (Mantel-Haenszel) model. White, Rampes and Campbell (2006) extracted data in duplicate on the type of smokers recruited, nature of the acupuncture and control procedures, outcome measures, method of randomisation, and completeness of follow-up. The authors assessed abstinence from smoking at the earliest time-point (before 6 weeks), and at the last measurement point between 6 months and 1 year. They used the most rigorous definition of abstinence for each trial, and biochemically validated rates if available. Those lost to follow-up were counted as continuing smokers. Where appropriate the authors performed a meta-analysis using a fixed-effect model. Technical Report Smoking cessation interventions and strategies page 99

13 Main results Barth, Critchley and Bengel (2006) found 19 RCTs, comparing a specific psychosocial intervention with usual care with a minimum of 6-month follow-up. The trials mostly included older male patients with CHD, predominantly myocardial infarction. Results found a positive effect of interventions on abstinence after 6 to 12 months (OR = 1.66, 95% CI = ), but substantial heterogeneity between trials. Clustering the trials by type of intervention reduced heterogeneity, although many trials used more than one type of intervention. Trials involving behavioral therapies or telephone contact were little different from self-help techniques (OR = 1.65, 95% CI = for behavioral therapies; OR = 1.58, 95% CI = for telephone sup support; OR = 1.47, 95% CI = for self-help). More intense interventions showed increased quit rates (OR = 1.95, 95% CI = ) whereas interventions of low intensity did not appear effective (OR = 0.92, 95% CI = ). Studies with validated assessment of smoking status at follow-up had lower efficacy than nonvalidated trials. David, Lancaster, Stead and Evins (2006) found that 4 trials of naltrexone met inclusion criteria for meta-analyses for long-term cessation. All four trials failed to detect a significant difference in quit rates between naltrexone and placebo. In a pooled analysis no significant effect of naltrexone on long-term abstinence emerged, and confidence intervals were wide (odds ratio 1.26, 95% confidence interval 0.80 to 2.01). No trials of naloxone or buprenorphine reported long-term follow-up. Gourlay, Stead and Benowitz (2004) found that of all the 6 trials there was a statistically significant effect of clonidine in one. The pooled odds ratio for success with clonidine versus placebo was 1.89 (95% confidence interval 1.30 to 2.74). There was a high incidence of dose-dependent side effects, particularly dry mouth and sedation. Hajek and Stead (2001) found that the odds ratio (OR) for abstinence following rapid smoking compared to control was 2.01 (95% confidence intervals (CI): 1.36 to 2.95). Several factors suggest that this finding should be interpreted cautiously. A funnel plot of included studies was asymmetric, due to the relative absence of small studies with negative results. Most trials had serious methodological problems likely to lead to spurious positive results. The only trial using biochemical validation of all self-reported cessation provided a non-significant result. Other aversion methods were not shown to be effective (OR 1.15, 95% CI 0.73 to 1.82). There was a borderline dose-response to the level of aversive stimulation (OR 1.67, 95% CI 0.99 to 2.81). Hughes, Stead and Lancaster (2007) in their updated study found 40 trials of bupropion and eight trials of nortriptyline. When used as the sole pharmacotherapy, bupropion (31 trials, odds ratio [OR] 1.94, 95% confidence interval [CI] 1.72 to 2.19) and nortriptyline (four trials, OR 2.34, 95% CI 1.61 to 3.41) both doubled the odds of cessation. Evidence is lacking that adding bupropion or nortriptyline to NRT provides a long-term benefit. Three trials of extended therapy with bupropion to prevent relapse did not find evidence of a significant long-term benefit. Bupropion and nortriptyline appear to be equally effective and of similar efficacy to NRT. Pooling three trials comparing bupropion to varenicline showed lower odds of quitting with bupropion (OR 0.60, 95% CI 0.46 to 0.78). There is a risk of about 1 in 1000 of seizures associated with bupropion use. Nortriptyline has the potential for serious side-effects but none have been seen in the few small trials for smoking cessation. There were six trials of selective serotonin reuptake inhibitors; four of fluoxetine, one of sertraline and one of paroxetine. None detected significant long-term effects and there was no evidence of a significant benefit when results were pooled. There was one trial of the monoamine oxidase inhibitor moclobemide, and one of the atypical antidepressant venlafaxine. Neither detected a significant longterm benefit. Lancaster and Stead (2005) identified 21 trials with over 7000 participants; 18 trials compared individual counselling to a minimal behavioural intervention; and 4 compared different types or intensities of counselling. Individual counselling was more effective than control. The odds ratio for successful smoking cessation was 1.56 (95% confidence interval 1.32 to 1.84). In a sub-group of 3 trials where all participants received nicotine replacement therapy the point estimate of effect was smaller and did not reach significance (odds ratio 1.34, 95% confidence interval 0.98 to 1.83). We Technical Report Smoking cessation interventions and strategies page 100

14 failed to detect a greater effect of intensive counselling compared to brief counselling (odds ratio 0.98, 95% confidence interval 0.61 to 1.56). Lancaster and Stead (2005) identified that in 11 trials in which self help was compared to no intervention there was a pooled effect that just reached statistical significance (N = 13,733; odds ratio [OR] 1.24, 95% confidence interval [CI] 1.07 to 1.45). This excluded 2 trials with strongly positive outcomes that introduced significant heterogeneity. Four further trials in which the control group received alternative written materials showed no evidence for an effect of the smoking self-help materials. We failed to find evidence of benefit from adding self-help materials to face-to-face advice, or to nicotine replacement therapy. There were 17 trials using materials tailored for the characteristics of individual smokers, where meta-analysis supported a small benefit of tailored materials (N = 20,414; OR 1.42, 95% CI 1.26 to 1.61). Evidence is strongest for tailored materials compared to no intervention, but also supports tailored materials as more helpful than standard materials. Other smaller trials failed to detect benefits from using additional materials or targeted materials, or to find differences between different self-help programmes Møller and Villebro (2005) had 4 trials meeting the inclusion criteria. All trials significantly reduced preoperative smoking but the effect sizes were heterogeneous so a pooled effect was not estimated. Only 2 trials reported the effect of the smoking intervention on wound complications, and results were heterogenous. There was a significant reduction in wound-related complications, cardiopulmonary complications and the overall risk of any complication in 1 trial, and no evidence of a difference in complications in the other. The effect on longer term smoking cessation was not significant in either of the 2 trials with follow-up beyond the perioperative period. Rice and Stead (2004) found the intervention to significantly increase the likelihood of quitting in 20 studies. There was heterogeneity among the study results, but pooling using a random effects model did not alter the estimate of a statistically significant effect. There was limited indirect evidence that interventions were more effective for hospital inpatients with cardiovascular disease than for inpatients with other conditions. Interventions in non-hospitalised patients also showed evidence of benefit. Five studies comparing different nurse-delivered interventions failed to detect significant benefit of using additional components. Five studies of nurse counselling on smoking cessation during a screening health check or part of multifactorial secondary prevention in general practice (not included in the main meta-analysis) found nursing intervention had less effect under these conditions. Rigotti, Munafo and Stead (2007) identified intensive counselling interventions that began during hospital stay and continued with supportive contacts for at least one month after discharge increased smoking cessation rates after discharge (Odds Ratio (OR) 1.65, 95% confidence interval (CI) 1.44 to 1.90; 17 trials). No statistically significant benefit was found for less intensive counselling interventions. One study that tested a single brief (<=15 minutes) in-hospital intervention found it not to be effective (OR 1.16, 95% CI 0.80 to 1.67). Counselling of longer duration during the hospital stay was not associated with a higher quit rate (OR 1.08, 95% CI 0.89 to 1.29, 8 trials). Even counselling that began in the hospital but had less than one month of supportive contact after discharge did not show significant benefit (OR 1.09, 95% CI 0.91 to 1.31, 6 trials). Adding NRT did not produce a statistically significant increase in cessation over what was achieved by intensive counselling alone (OR 1.47, 95% CI 0.92 to 2.35, 5 studies). A similar pattern of results was observed in smokers admitted to hospital because of cardiovascular disease. In this sub-group, intensive intervention with follow-up support increased the odds of smoking cessation (OR 1.81, 95% CI 1.54 to 2.15, 11 trials), but less intensive interventions did not. One trial of intensive intervention including counselling and pharmacotherapy for smokers admitted with CVD assessed clinical and health care utilization endpoints. It found significant reductions in all-cause mortality and hospital readmission rates over a 2 year follow-up period. Silagy, Lancaster, Stead, Mant and Fowler (2004) identified 103 trials contributed to primary comparison between any type of NRT and a placebo or non-nrt control group. The RR of abstinence for any form of NRT relative to control was 1.77 (95% confidence interval [CI]: 1.66 to 1.81) for gum, 1.81 (95% CI: 1.63 to 2.02) for patches, 2.35 (95% CI: 1.63 to 3.38) for nasal spray, 2.14 (95% CI: 1.44 to 3.18) for inhaled nicotine and 2.05 (95% CI: 1.62 to 2.59) for nicotine sublingual Technical Report Smoking cessation interventions and strategies page 101

15 tablet/lozenge. These odds were largely independent of the duration of therapy, the intensity of additional support provided or the setting in which the NRT was offered. In highly dependent smokers there was a significant benefit of 4 mg gum compared to 2 mg gum. Evidence was weak concerning combinations of forms of NRT are more effective. Higher doses of nicotine patch may produce small increases in quit rates. Stead and Hughes (1997) identified no trials that met the full criteria including long-term follow-up. Stead and Lancaster (2005) identified 16 studies comparing a group program to a self-help program. There was increased cessation with the use of a group program (N = 4395, odds ratio (OR) 2.04, 95% confidence interval (CI) 1.60 to 2.60). Group programs proved more effective than no intervention controls (7 trials, N = 815, OR 2.17, 95% CI 1.37 to 3.45). There was no evidence that group therapy was more effective than a similar intensity of individual counselling. There was variation in the extent to which those offered group therapy accepted the treatment. Evidence was limited regarding programs including components for increasing cognitive and behavioural skills and avoiding relapse were more effective than same length or shorter programs without these components. This analysis was sensitive to the way in which one study with multiple conditions was included. We did not find an effect of manipulating the social interactions between participants in a group program on outcome. White, Rampes and Campbell (2006) found that the only comparison for which there was sufficient studies was acupuncture compared to sham acupuncture. The fixed-effect odds ratio (OR) for the short-term effect was 1.36 (95% confidence interval 1.07 to 1.72), but the studies were heterogeneous and the result strongly influenced by one individual positive study. The significant short-term effect was lost with the random-effects model for pooling, or by removing the outlying study that led to heterogeneity. The long-term result shows no effect of acupuncture compared with sham acupuncture. There was no consistent evidence that acupuncture is superior to no treatment, and equally no evidence that the effect of acupuncture differed from that of other anti-smoking interventions, or that any particular acupuncture technique is superior to other techniques. Reviewers' conclusions Barth, Critchley and Bengel (2006) concluded that smoking cessation interventions work in promoting abstinence for up to 1 year, provided that they are sufficiently intense intervention strategies with a minimum of 1 month. Further studies are needed to compare different psychosocial intervention strategies, or to combine psychosocial intervention with NRT or bupropion. David, Lancaster, Stead and Evins (2006) concluded that based on 4 trials it was not possible to confirm or refute if naltrexone helped smokers quit their habit. Confidence intervals are compatible with both clinically significant benefit and possible negative effects of naltrexone in promoting abstinence. Gourlay, Stead and Benowitz (2004) decided that based on a small number of trials in which bias was probable, clonidine was effective in helping people stop smoking. There were side effects limiting the usefulness of clonidine for smoking cessation. Hajek and Stead (2001) concluded that there is not enough evidence suggesting that aversive therapy such as rapid smoking promotes smoking cessation. Milder versions of aversive smoking seem to lack specific efficacy. Hughes, Stead and Lancaster (2007) found that the antidepressants bupropion and nortriptyline aid long-term smoking cessation but selective serotonin reuptake inhibitors (e.g. fluoxetine) do not. Evidence suggested that the mode of action of bupropion and nortriptyline is independent of their antidepressant effect and that they have similar efficacy to nicotine replacement. Adverse events with both medications are rarely serious or lead to stopping medication. Lancaster and Stead (2005) concluded that smoking cessation counselling can help smokers to quit. Technical Report Smoking cessation interventions and strategies page 102