Tobacco Translating evidence and policy into clinical practice Dr Leonie Brose

Outline Evidence Translation Current policy Current practice

The design-evaluation cycle Treatment concept/ innovation Evaluation Implementation Evaluation 3 Randomised trials Quasi-experiments Efficacy Service monitoring Effectiveness

Smoking cessation efficacy: Brief advice 4 Stead et al 2013, Cochrane Relative risks (95% Confidence interval): VBA: 1.66 (1.42 to 1.94) More extensive advice: 1.84 (1.60 to 2.13) Interpretation: Assuming unassisted quit rate of 2 - 3%, brief physician advice can increase quitting by a further 1 - 3% (42 to 113% of 3% = 1-3%) Aveyard et al 2012, Addiction Advice increased quit attempts by 24% (95% CI: 16-33%) Offering behavioural support increased quit attempts by 117% (95% CI: %) Offering prescription increased quit attempts by 68% (95%CI: 48-89%)

Efficacy: Medication 5 Figure: Stead et al 2012, Cahill et al 2012, Cochrane reviews Compared with placebo Cahill et al, 2013, Review of medication reviews All those shown in figure and bupropion superior to placebo Bupropion equal to single NRT Combination NRT and varenicline superior to single NRT

Efficacy: Behavioural support 6 Strong evidence base Individual vs brief advice (Lancaster & Stead, 2005) Group vs self-help (Stead & Lancaster, 2009) Treat intervention with caution, evidence weak or inconsistent Internet vs nothing (Civljak et al, 2013) Text messaging vs control messages (Whittaker et al, 2012) Written materials: N=15,117 (Lancaster & Stead, 2005)

The design-evaluation cycle Treatment concept/ innovation Evaluation Implementation Evaluation 7 Randomised trials Quasi-experiments Efficacy Service monitoring Effectiveness

NHS Stop Smoking Services in England Available for any smoker making a quit attempt Set up in 1999/2000, world first Deliver behavioural support and medication to support quit attempt Various settings: Home, primary care, pharmacy, specialist clinics, workplace… Medication options: none, single or combination NRT, varenicline, rarely: bupropion, combinations of medications Support options: one-to-one support, groups, sometimes couple or family Increase chance of quitting 4-fold compared with no support (Ferguson et al, 2005)

126,890 treatment episodes in 24 services Assessed association between intervention characteristics and 4- week CO-verified success rates adjusting for key smoking and demographic characteristics 9 Major independent predictors of success were: Specialist treatment rather than primary care Group rather than one-to-one Use of varenicline or combination NRT rather than single NRT Major independent predictors of success were: Specialist treatment rather than primary care Group rather than one-to-one Use of varenicline or combination NRT rather than single NRT

Clinical Effectiveness Medication Interpretation: If Odds ratio (green line) above 1 and Confidence Interval (blue bar) does not cross 1, we are confident that this option increases the odds of quitting compared with the other option.

Clinical Effectiveness Support Type

Clinical Effectiveness Setting

Outline Evidence Translation Current policy Current practice

1.Intervention Development 2. Feasibility & Piloting 3. Evaluation (e.g. RCT, effectiveness, cost- effectiveness) 4. Evidence 5. Dissemination of findings (produce unbiased, usable report; ensure full publication accessible) 6. Evidence synthesis (e.g. systematic review) 8. Treatment manuals 9. Training 10. Clinical Practice (intervention/ care delivered by health care professionals, systems, organisations) 11. Receipt of evidence-based intervention/care by individual(s) 12. Enactment of targeted behaviour change by individual 13. Desired health outcomes 7. Evidence-based recommendations/ guidelines. Policy (?) Based on MRC guidance (Craig et al. 2008) and Chalmers & Glasziou (2009) Translating evidence into practice (Lorencatto, 2013)

One example of training

Very brief advice training trailer 16

Theoretical domains and questions for investigating implementation of evidence-based guidelines (Michie et al, 2005) DomainQuestions (examples) KnowledgeDo they know about the guideline? SkillsDo they know how to do x? Social/professional role and identity What is the purpose of the guidelines? What do they think about the credibility of the source? Beliefs about capabilities (self- efficacy) How difficult or easy is it for them to do x? How confident are they that they can do x despite the difficulties? Beliefs about consequencesWhat do they think will happen if they do not do x? Motivation and goalsHow much do they feel they need to do x? Memory, attention and decision processes Will they remember to do x? How? How much attention will they have to pay to do x? Environmental context and resources Are there competing tasks and time constraints? Are the necessary resources available? Social influences (Norms)To what extent do social influences facilitate or hinder x? EmotionDoes doing x evoke an emotional response?Does emotion affect x? Behavioural regulationAre there procedures or ways of working that encourage x? Nature of the behavioursWho needs to do what differently when, where, how, how often and with whom?

Outline Evidence Translation Current policy Current practice

19 Department of Health (1999) Smoking Kills

Tobacco Control Plan 2010 Aspirations: Reduce smoking prevalence by end of In adults to ≤18.5% 2010: 21%, 2012: 19% -Among 15 year olds to ≤12% 2010: 15%, 2012: 10% -In pregnancy at time of delivery to ≤11% 2010: 12% Strands 1.Stopping promotion of tobacco 2.Making Tobacco less affordable 3.Effective regulation of tobacco products 4.Helping tobacco users to quit 5.Reducing exposure to second-hand smoke 6.Effective communications for tobacco control

National Institute of Health and Care Excellence (NICE) Pathway

Policy/Practice Guidance on – Commissioning – Delivery – Data recording Statistics on Services – Clients – Support – Outcomes Self-reported and CO-verified abstinence 4 weeks after quit date

Outline Obtaining evidence and current evidence Translation of evidence to practice Current policy Current practice

24 Relative success rates of quit attempts in England Significantly better than no aid adjusting for confounding variables, p<0.001 Data from based on smokers who tried to stop in the past year who report still not smoking at the survey adjusting for other predictors of success (age, dependence, time since quit attempt, social grade, recent prior quit attempts, abrupt vs gradual cessation): N=11,584www.smokinginengland.info

Impact of NHS Stop-Smoking Services: Impact: Number of 4-week quitters generated over and above assumed rate for medication alone (West et al, 2013)

27 Variation in success rates of English Stop Smoking Services 2012/13

Relative medication effectiveness varies across services Combi NRT more effective Varenicline more effective

Differences between practitioners 29 Differences between practitioners accounted for 7.6% of the variance in success rates, a larger differences than is typically found between active and placebo NRT 46,237 one-to-one treatment episodes delivered by 303 stop- smoking specialists Differences in 4-week CO verified success rates between them, adjusting for all other factors

Behaviour Change Techniques (BCTs) Method for specifying the components of complex behaviour change interventions Definition: BCTs – Aim to change behaviour – Are the proposed "active ingredient" of interventions – Are the smallest component compatible with retaining the proposed active ingredients – Can be used alone or in combination with other BCTs – Are observable and replicable – Can have a measurable effect on a specified behaviour – Are the smallest unit that has the POTENTIAL (in the right circumstances) to bring about behaviour change

Examined Behaviour Change Techniques specified in treatment manuals of 43 stop-smoking services and associated inclusion of each of these with success rates BCTs found to be linked to success rates: 32 Strengthen ex-smoker identity Measure CO Reward abstinence Advise on changing routine Advise on coping with cravings Strengthen ex-smoker identity Measure CO Reward abstinence Advise on changing routine Advise on coping with cravings Advise on medication use Ask about experiences when using medication Give options for additional support Elicit client views Advise on medication use Ask about experiences when using medication Give options for additional support Elicit client views

Why specialists get better success rates than non-specialists Data from survey of 573 specialists and 466 non-specialists used to identify factors mediating differences in success rates Important: 33 Greater use of abrupt rather than gradual cessation approach Stronger emphasis on medication use Number of days training received Number of sessions observed when starting out Better supervision Greater use of abrupt rather than gradual cessation approach Stronger emphasis on medication use Number of days training received Number of sessions observed when starting out Better supervision

What a good stop smoking service delivers Per 5,000 smokers treated – A benefit of: 1,000 long-term ex-smokers 2,000 healthy life years £16 million in savings to society per year – For an outlay of: £1.25 million including medicines 34 There is almost no other public service that can provide this scale of benefit at so little cost

Questions? Thank you! Many thanks to Professor Robert West and Dr Fabiana Lorencatto for sharing slides Leonie Brose Lecturer in Addictions

References I Efficacy reviews Aveyard, P., et al., Brief opportunistic smoking cessation interventions: a systematic review and meta- analysis to compare advice to quit and offer of assistance. Addiction, (6): Cahill, K., L.F. Stead, and T. Lancaster, Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev, : CD Cahill, K., et al., Pharmacological interventions for smoking cessation: an overview and network meta- analysis. Cochrane Database Syst Rev, : CD Civljak, M., et al., Internet-based interventions for smoking cessation. Cochrane Database Syst Rev, : CD Lancaster, T. and L.F. Stead, Individual behavioural counselling for smoking cessation. Cochrane Database Syst Rev, 2005(2): CD Lancaster, T. and L.F. Stead, Self-help interventions for smoking cessation. Cochrane Database Syst Rev, 2005(3): p CD Stead, L.F., et al., Physician advice for smoking cessation. Cochrane Database Syst Rev, : CD Stead, L.F., et al., Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev, : CD Stead, L.F. and T. Lancaster, Group behaviour therapy programmes for smoking cessation. Cochrane Database Syst Rev, 2005(2): CD Whittaker, R., et al., Mobile phone-based interventions for smoking cessation. Cochrane Database Syst Rev, : CD

References II Policy, practice, effectiveness Brose, L.S., et al., What makes for an effective stop-smoking service? Thorax, (10): Brose, L.S., A. McEwen, and R. West, Does it matter who you see to help you stop smoking? Short-term quit rates across specialist stop smoking practitioners in England. Addiction, (11): Brose, L.S., R. West, and J.A. Stapleton, Comparison of the effectiveness of varenicline and combination nicotine replacement therapy for smoking cessation in clinical practice. Mayo Clin Proc, (3): Department of Health, Smoking kills: A White Paper on Tobacco Department of Health, Healthy Lives, Healthy People: A Tobacco Control Plan for England Department of Health, Local Stop Smoking Services Ferguson, J., et al., The English smoking treatment services: one-year outcomes. Addiction, Suppl 2: p Lorencatto, F. Translating evidence into practice: behavioural support for smoking cessation, PhD Thesis. McDermott, M.S., et al., Factors associated with differences in quit rates between "specialist" and "community" stop-smoking practitioners in the English stop-smoking services. Nicotine Tob Res, (7): Michie, S., et al., Development of a taxonomy of behaviour change techniques used in individual behavioural support for smoking cessation. Addict Behav, (4): Michie, S., et al., Making psychological theory useful for implementing evidence based practice: a consensus approach. Qual Saf Health Care, (1): p The NHS Information Centre, Statistics on NHS Stop Smoking Services: England, April 2012 – March , Leeds: The Health and Social Care Information Centre. West, R., et al., Behavior change techniques used by the English Stop Smoking Services and their associations with short-term quit outcomes. Nicotine Tob Res, (7): West, R., et al., Performance of English stop smoking services in first 10 years: analysis of service monitoring data. BMJ, : f

Delivers combination of – Behavioural support Multiple sessions taking the smoker through the first 4 weeks of abstinence at least Evidence-based behaviour change techniques – Pharmacotherapy NRT, bupropion or varenicline for 8-12 weeks Client led, recommends combination NRT or varenicline – Provided by trained specialist with manual, supervision, support Essential features of a stop smoking service Monitored using information on Smokers Treatment provided Outcomes (using ‘Russell Standard’) 38