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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 lion.shahab@ucl.ac.uk. Overview. Why - the case for quitlines
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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 lion.shahab@ucl.ac.uk
Overview • Why - the case for quitlines • What - evidence for the efficacy of quitlines • Where to – future questions to be answered • How - state of the art in assessing smoking cessation interventions
I. Why – the case for quitlines Goals of Tobacco Control
I. Why – the case for quitlines Approaches to Tobacco Control Basic Research Public Awareness Values Slama, 2004 Intervention Programmes Legislation & Policy
I. Why – the case for quitlines Goals of Tobacco Control
I. Why – the case for quitlines Predicted death-toll
I. Why – the case for quitlines Approaches to Tobacco Control – Impact on Prevalence Efficacy x Reach = Impact on Prevalence Low Efficacy High Low Reach High Number of people quitting
I. Why – the case for quitlines Approaches to Tobacco Control – Impact on Prevalence Intervention Programmes Legislation & Policy Basic Research Public Awareness Values Low Efficacy High Low Reach High
I. Why – the case for quitlines 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 The path to smoking cessation Smokers 60 % Want to quit1 Sources: 1 Smoking Toolkit Study 2 Cochrane Database 39 % Attempt to quit1 21 % use treatment1 18 % go ‘cold turkey’1 12 % buy NRT1 6 % get a prescription1 2.3 % use clinic1 0.7 % use quitline1 Success 8 % 8% 15 % 11 % 4% Rates2 1 % + 0.5 % + 0.35 % + 0.08 % + 0.72 = 2.65 % stop smoking 0.08% of 8.500.000 smokers = 6.800 ex-smokers ~ 15.000 life-years saved yearly
II. What - evidence for the efficacy of quitlines Telephone counselling for smokingcessation – 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 Telephone counselling for smokingcessation – a Cochrane review (2009) • 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
II. What - evidence for the efficacy of quitlines Telephone counselling for smokingcessation – a Cochrane review (2009) • 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)
II. What - evidence for the efficacy of quitlines Telephone counselling for smokingcessation – a Cochrane review (2009) • Proactive telephone counselling • Multiple phone calls vs. self-help/minimal control (27)
II. What - evidence for the efficacy of quitlines Telephone counselling for smokingcessation – a Cochrane review (2009) • Proactive telephone counselling • Multiple phone calls vs. self-help/minimal control (27) • Multiple phone calls + brief intervention/counselling vs. brief intervention/counselling alone (9)
II. What - evidence for the efficacy of quitlines Telephone counselling for smokingcessation – a Cochrane review (2009) • 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)
II. What - evidence for the efficacy of quitlines Telephone counselling for smokingcessation – a Cochrane review (2009) • 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)
II. What - evidence for the efficacy of quitlines Telephone counselling for smokingcessation – a Cochrane review (2009) • 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)
II. What - evidence for the efficacy of quitlines Telephone counselling for smokingcessation – a Cochrane review (2009) • Review provides good evidence for effectiveness of telephone counselling ? ?
II. What - evidence for the efficacy of quitlines Telephone counselling for smokingcessation – a Cochrane review (2009) • Review provides good evidence for effectiveness of telephone counselling • The more intensive, the better • No difference by motivation of smokers
III. Where to – future questions to be answered 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: can’t use ‘pure’ RCT • What is appropriate control condition? • Elicit further calls? Control (Self-help) 1837 Intervention (generic) 1837 Intervention (tailored) 1837
III. Where to – future questions to be answered 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) 1 session (£50) NNT=400 2 sessions (£100) NNT=200 3 sessions (£150) NNT=100 4 sessions (£200) NNT=50
III. Where to – future questions to be answered 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 165 mil. smokers 66 mil. smokers 16.5 mil. Attempt Use QL Stop 1.8 Would safe 242.000 human beings from disability and early death
III. Where to – future questions to be answered 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 Mass media campaign in Country B only • How best to increase uptake of telephone counselling? Country A Country B Use of quit-lines Before After Net change
III. Where to – future questions to be answered Remaining empirical uncertainties • How best to increase uptake of telephone counselling? Control (no info on QL) Control (NRT) Treatment (info on QL) Treatment (NRT+ QL number)
IV. How - assessing smoking cessation interventions 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 • inappropriate research question • inadequate sample size • inappropriate sample • inadequate recruitment rate • inappropriate study design • poorly specified intervention and control • inadequate implementation • weak outcome measure • failure to address potential bias • over-claiming from the results
IV. How - assessing smoking cessation interventions Key areas to consider • Study sample • Study design • Outcome assessment
Priorities to be balanced generalisation to population of interest safety cost practicability red tape IV. How - assessing smoking cessation interventions Study Sample Options to discuss • settings • General practice • University • Community • Other • size • method of recruitment • exclusion and inclusion criteria
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) IV. How - assessing smoking cessation interventions Study design Cigarette smokers 10 years
IV. How - assessing smoking cessation interventions The problem of causality • Direction: Stay middle class to avoid schizophrenic episodes!? Socioeconomic Status Schizophrenia • Higher order variables: If you want to live long, eat breakfast!? Smoking Behaviour Breakfast Longevity
Priorities theoretical significance clinical significance practicability Options to discuss smoking status motivation to smoke withdrawal symptoms IV. How - assessing smoking cessation interventions Outcome assessment
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 outside ISO testing machine Location of filter vent holes
Further reading • Stead, L. F., Perera, R., & Lancaster, T. (2006). Telephone counselling for smoking cessation. Cochrane Database Syst.Rev., 3, CD002850. • Borland, R. & Segan, C. J. (2006). The potential of quitlines to increase smoking cessation. Drug Alcohol Rev.,25, 73-78. • West, R., et al., Outcome criteria in smoking cessation trials: proposal for a common standard. Addiction, 2005. 100(3): p. 299-303. • Shiffman, S., R. West, and D. Gilbert, Recommendation for the assessment of tobacco craving and withdrawal in smoking cessation trials. Nicotine Tob Res, 2004. 6(4): p. 599-614. • Strecher, V.J., et al., Web-based smoking-cessation programs: results of a randomized trial. Am J Prev Med, 2008. 34(5): p. 373-81.