A review of the evidence of quit-lines: gaps in the evidence and how to close them Dr Lion Shahab CRUK Health Behaviour Research Centre Department of Epidemiology & Public Health University College London

Overview I.Why - the case for quitlines II.What - evidence for the efficacy of quitlines III.Where to – future questions to be answered IV.How - state of the art in assessing smoking cessation interventions

Goals of Tobacco Control To reduce the harm caused by tobacco use To reduce participation in tobacco use Reduce uptake Increase cessation To reduce the harmfulness of tobacco use I. Why – the case for quitlines

Approaches to Tobacco Control Slama, 2004 Legislation & Policy Basic Research Public Awareness Values Intervention Programmes I. Why – the case for quitlines

To reduce the harm caused by tobacco use To reduce participation in tobacco use Reduce uptake Increase cessation To reduce the harmfulness of tobacco use Goals of Tobacco Control To reduce the harm caused by tobacco use To reduce participation in tobacco use Reduce uptake Increase cessation To reduce the harmfulness of tobacco use I. Why – the case for quitlines

Predicted death-toll I. Why – the case for quitlines

Approaches to Tobacco Control – Impact on Prevalence Low ReachHigh Low Efficacy High Number of people quitting Efficacy x Reach = Impact on Prevalence I. Why – the case for quitlines

Low ReachHigh Low Efficacy High Approaches to Tobacco Control – Impact on Prevalence I. Why – the case for quitlines Basic Research Public Awareness Values Legislation & Policy Intervention Programmes

Advantages of quitlines Potential high efficacy –Can emulate individual counselling delivered on-site in smoking cessation services –Flexibility of application – stand alone, or as addition to online interventions, minimal/leaflet interventions or face-to-face support Potential wide reach –Easy access for users (flexible and near universal coverage) –Can attract additional smokers who would not normally seek help: those living in remote areas, with physical disabilities, those fearing stigmatisation Cheaper than other high-intensity interventions –Possibility of computerised delivery I. Why – the case for quitlines

Smokers 39 % Attempt to quit 1 21 % use treatment 1 18 % go cold turkey 1 12 % buy NRT 1 6 % get a prescription % use clinic 1 Success 8 % 8% 15 % 11 % 4% Rates 2 1 % % % % = 2.65 % stop smoking Sources: 1 Smoking Toolkit Study 2 Cochrane Database The path to smoking cessation 60 % Want to quit % use quitline 1 I. Why – the case for quitlines 0.08% of smokers = ex-smokers ~ life-years saved yearly

Telephone counselling for smoking cessation – a Cochrane review (2009) Types of telephone counselling –Proactive vs Reactive –Stand-alone vs Adjunctive RCT, quasi-randomised control trials 6-months abstinence 65 studies included with sample size of 73,000 participants II. What - evidence for the efficacy of quitlines

Study characteristics –Mostly from North America (52) –Older adults (average age 40) –Most evaluated proactive counselling (60) –Wide range of number of calls (1-12) –Call duration similar (10-20 min) –Mostly delivered by trained HP/counsellors Telephone counselling for smoking cessation – a Cochrane review (2009) II. What - evidence for the efficacy of quitlines

Reactive telephone counselling –Single call Self-help vs. telephone counselling (1) Different interventions (general vs. target) (2) –Multiple calls Reactive counselling at first call + self-help vs. further proactive calls (9) Telephone counselling for smoking cessation – a Cochrane review (2009) II. What - evidence for the efficacy of quitlines

Proactive telephone counselling –Multiple phone calls vs. self-help/minimal control (27) Telephone counselling for smoking cessation – a Cochrane review (2009) II. What - evidence for the efficacy of quitlines

Proactive telephone counselling –Multiple phone calls vs. self-help/minimal control (27) –Multiple phone calls + brief intervention/counselling vs. brief intervention/counselling alone (9) Telephone counselling for smoking cessation – a Cochrane review (2009) II. What - evidence for the efficacy of quitlines

Proactive telephone counselling –Multiple phone calls vs. self-help/minimal control (27) –Multiple phone calls + brief intervention/counselling vs. brief intervention/counselling alone (9) –Multiple phone calls + pharmacotherapy vs. pharmacotherapy along (9) Telephone counselling for smoking cessation – a Cochrane review (2009) II. What - evidence for the efficacy of quitlines

Proactive telephone counselling –Multiple phone calls vs. self-help/minimal control (27) –Multiple phone calls + brief intervention/counselling vs. brief intervention/counselling alone (9) –Multiple phone calls + pharmacotherapy vs. pharmacotherapy along (9) –Comparisons by different counselling intensities 1-2 (9); 3-6 (28); 7+ (7) Telephone counselling for smoking cessation – a Cochrane review (2009) II. What - evidence for the efficacy of quitlines

Proactive telephone counselling –Multiple phone calls vs. self-help/minimal control (27) –Multiple phone calls + brief intervention/counselling vs. brief intervention/counselling alone (9) –Multiple phone calls + pharmacotherapy vs. pharmacotherapy along (9) –Comparisons by different counselling intensities 1-2 (9); 3-6 (28); 7+ (7) –Comparison by motivation to stop smoking Smokers recruited for motivation (14) or not (30) Telephone counselling for smoking cessation – a Cochrane review (2009) II. What - evidence for the efficacy of quitlines

Review provides good evidence for effectiveness of telephone counselling Telephone counselling for smoking cessation – a Cochrane review (2009) II. What - evidence for the efficacy of quitlines Type of counsellingEvidence ReactiveSingle call Additional proactive support ProactiveVs. self-help/minimal Adjunct to behavioural support Adjunct to pharmacotherapy ? ?

Review provides good evidence for effectiveness of telephone counselling The more intensive, the better No difference by motivation of smokers Telephone counselling for smoking cessation – a Cochrane review (2009) II. What - evidence for the efficacy of quitlines

Remaining empirical uncertainties Is reactive telephone counselling effective? What is the ideal number of proactive sessions? How best to increase uptake of telephone counselling? III. Where to – future questions to be answered

Remaining empirical uncertainties Is reactive telephone counselling effective? –Problems: cant use pure RCT –What is appropriate control condition? –Elicit further calls? III. Where to – future questions to be answered Control (Self-help) Intervention (generic) Intervention (tailored) 1837

Remaining empirical uncertainties Is reactive telephone counselling effective? What is the ideal number of proactive sessions? How best to increase uptake of telephone counselling? III. Where to – future questions to be answered

Remaining empirical uncertainties What is the ideal number of proactive sessions? –Problem: Have to make a priori assumptions about cost-effectiveness –NNT=100 at £100 (1 %) assumed to be cost-effective at QALY of £3000 (5 times better than average medical treatment) III. Where to – future questions to be answered 1 session (£50) 2 sessions (£100) 3 sessions (£150) 4 sessions (£200) NNT=400 NNT=200 NNT=100 NNT=50

Remaining empirical uncertainties Is reactive telephone counselling effective? What is the ideal number of proactive sessions? How best to increase uptake of telephone counselling? III. Where to – future questions to be answered

Remaining empirical uncertainties How best to increase uptake of telephone counselling? –Enormous benefits III. Where to – future questions to be answered 165 mil. smokers Attempt 66 mil. smokers Use QL 16.5 mil. Stop 1.8 Would safe human beings from disability and early death

Remaining empirical uncertainties How best to increase uptake of telephone counselling? –Enormous benefits –Use of mass media and development of closer relationship with health care system –Displaying phone numbers on tobacco or smoking cessation products –Best assessed with quasi-experimental or RCT design III. Where to – future questions to be answered

Remaining empirical uncertainties How best to increase uptake of telephone counselling? III. Where to – future questions to be answered BeforeAfter Use of quit-lines Country A Country B Mass media campaign in Country B only Net change

Remaining empirical uncertainties How best to increase uptake of telephone counselling? III. Where to – future questions to be answered Control (no info on QL) Treatment (info on QL) Control (NRT) Treatment (NRT+ QL number)

Remaining methodological uncertainties Studies often did not provide information on adequate randomisation or allocation concealment Abstinence was not consistently validated and many used point-prevalence Studies were underpowered IV. How - assessing smoking cessation interventions

10 common issues 1.inappropriate research question 2.inadequate sample size 3.inappropriate sample 4.inadequate recruitment rate 5.inappropriate study design 6.poorly specified intervention and control 7.inadequate implementation 8.weak outcome measure 9.failure to address potential bias 10.over-claiming from the results IV. How - assessing smoking cessation interventions

Key areas to consider Study sample Study design Outcome assessment IV. How - assessing smoking cessation interventions

Study Sample Priorities to be balanced generalisation to population of interest safety cost practicability red tape Options to discuss settings –General practice –University –Community –Other size method of recruitment exclusion and inclusion criteria IV. How - assessing smoking cessation interventions

Study design Priorities internal validity generalisation practicability Options to discuss design type –RCT (double-blind vs. unblinded) –Cluster randomised trial –Fractional factorial design –Quasi-experimental study –Longitudinal study –Cross-sectional survey intervention comparison condition(s) Cigarette smokers 10 years IV. How - assessing smoking cessation interventions

The problem of causality Direction: Stay middle class to avoid schizophrenic episodes!? Higher order variables: If you want to live long, eat breakfast!? Socioeconomic StatusSchizophrenia BreakfastLongevity Smoking Behaviour IV. How - assessing smoking cessation interventions

Outcome assessment Priorities theoretical significance clinical significance practicability Options to discuss smoking status motivation to smoke withdrawal symptoms IV. How - assessing smoking cessation interventions

Some principles: sample always base size on 80% power for what would be a meaningful effect size (usually 1-5% difference in pivotal trials, i.e. those that will form basis for recommendations) usually use dependent smokers (not students) recruit from community or healthcare settings minimise exclusion criteria in pivotal trials, allow for up to 50% wastage IV. How - assessing smoking cessation interventions

Some principles: design where ethical and practicable use RCT but not at the expense of getting a sensible answer do not overcomplicate with too many factors consider fractional factorial designs when trying to deconstruct multi-component interventions IV. How - assessing smoking cessation interventions

Some principles: outcome assessment pivotal studies require 6 months follow-up use self-report of continuous abstinence verified by CO do not use reduction use intent to treat aim for at least 70% follow-up rate for withdrawal symptoms and craving use MPSS or MNWS Location of filter vent holes Location of filter vent holes outside ISO testing machine IV. How - assessing smoking cessation interventions

Further reading Stead, L. F., Perera, R., & Lancaster, T. (2006). Telephone counselling for smoking cessation. Cochrane Database Syst.Rev., 3, CD Borland, R. & Segan, C. J. (2006). The potential of quitlines to increase smoking cessation. Drug Alcohol Rev., 25, West, R., et al., Outcome criteria in smoking cessation trials: proposal for a common standard. Addiction, (3): p Shiffman, S., R. West, and D. Gilbert, Recommendation for the assessment of tobacco craving and withdrawal in smoking cessation trials. Nicotine Tob Res, (4): p Strecher, V.J., et al., Web-based smoking-cessation programs: results of a randomized trial. Am J Prev Med, (5): p

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