Cited by 1,285Smoking Behavior and CessationStatistical Methods in Clinical TrialsSubstance Abuse Treatment and Outcomes

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Outcome criteria in smoking cessation trials: proposal for a common standard

West, Robert, Hajek, Peter, Stead, Lindsay, Stapleton, John·2005·Addiction

DOI 10.1111/j.1360-0443.2004.00995.x

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Abstract

Smoking cessation treatment is now integrated into many health-care systems and a major research effort is under way to improve current success rates. Until now results from randomized clinical trials have been reported in many different ways, leading to problems of interpretation. We propose six standard criteria comprising the 'Russell Standard' (RS). These criteria are applicable to trials of cessation aids where participants have a defined target quit date and there is face-to-face contact with researchers or clinic staff, as follows. (1) Follow-up for 6 months (RS6) or 12 months (RS12) from the target quit date or the end of a predefined 'grace period'; (2) self-report of smoking abstinence over the whole follow-up period allowing up to five cigarettes in total; (3) biochemical verification of abstinence at least at the 6-month or 12-month follow-up point; (4) use of an 'intention-to-treat' approach in which data from all randomized smokers are included in the analysis unless they have died or moved to an untraceable address (participants who are included in the analysis are counted as smokers if their smoking status at the final follow-up cannot be determined); (5) following-up 'protocol violators' and using their true smoking status in the analysis; and (6) collecting follow-up data blind to smokers' allocation to trial group. We believe that these criteria provide the best compromise between practicability and surrogacy for long-term cessation and will enable meaningful comparison between studies. There may be good reasons why other outcome criteria would also be reported, and studies that involve interventions with special groups or where there is no designated target quit date or face to face contact would need to adapt these criteria accordingly.

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Background
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“In essence, we combined a multi-level model (with random effects for studies and groups) [41] with a model that accounts for the depen-”
MethodSelf-citation
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Result
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“This is consistent with the Russell standard (see Table 4), which recommends a follow-up of 6 or 12 months from the target quit date or the end of a predefined ‘grace period’ [11].”
BackgroundResultInfluential
Gradual Versus Abrupt Smoking Cessation
Lindson, N., Banting, M., West, R., Michie, S., Shinkins, B., & Aveyard, P. N. (2016) · Annals of Internal Medicine · doi:10.7326/m14-2805 · Cited by 102
“Russell Standard abstinence is validated by an exhaled CO concentration of less than 10 ppm (17).”
MethodInfluentialSelf-citation
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McEwen, A., West, R., & McRobbie, H. (2008) · Nicotine & Tobacco Research · doi:10.1080/14622200802027248 · Cited by 120
Self-citation
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Theodoulou, A., Chepkin, S. C., Ye, W., Fanshawe, T. R., Bullen, C., Hartmann‐Boyce, J., Livingstone‐Banks, J., Hajizadeh, A., & Lindson, N. (2023) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd013308.pub2 · Cited by 108
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“In nicotine research, prolonged abstinence and point-prevalence abstinence, with biochemical validation, are now standard measures for outcome trials (Hughes, 2007; Hughes et al., 2010; West et al., 2005).”
The impact of a lung cancer computed tomography screening result on smoking abstinence
van der Aalst, C. M., van Klaveren, R. J., van den Bergh, K. A. M., Willemsen, M. C., & de Koning, H. J. (2010) · European Respiratory Journal · doi:10.1183/09031936.00035410 · Cited by 99
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“Although this is a recommended analysis when having to deal with dropout [37], replacing more than 70% of the values on the primary outcome measures might increase the chances of making a type II error [34,38].”
BackgroundResultInfluential
A digital health intervention for cardiovascular disease management in primary care (CONNECT) randomized controlled trial
Redfern, J., Coorey, G., Mulley, J., Scaria, A., Neubeck, L., Hafiz, N., Pitt, C., Weir, K., Forbes, J., Parker, S., et al. (2020) · npj Digital Medicine · doi:10.1038/s41746-020-00325-z · Cited by 95
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Ybarra, M. L., Holtrop, J. S., Prescott, T. L., Rahbar, M. H., & Strong, D. R. (2013) · Nicotine & Tobacco Research · doi:10.1093/ntr/nts339 · Cited by 94
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USSHER, M. H., Faulkner, G., Angus, K., Hartmann‐Boyce, J., & Taylor, A. H. (2019) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd002295.pub6 · Cited by 99
Randomized controlled trial to assess the short‐term effectiveness of tailored web‐ and text‐based facilitation of smoking cessation in primary care (iQuit in Practice)
Naughton, F., Jamison, J., Boase, S., Sloan, M., Gilbert, H., Prevost, A. T., Mason, D., Smith, S., Brimicombe, J., Evans, R., et al. (2014) · Addiction · doi:10.1111/add.12556 · Cited by 93
“In addition to pre-specified outcome measures, two longer-term smoking outcome measures were assessed [24]; 6-month prolonged abstinence at 6-month follow-up and a strict continuous abstinence measure using all outcome timepoints: CO-validated 2-week point prevalence abstinence at 4 weeks, 4-week point prevalence abst…”
Method
Dependence and motivation to stop smoking as predictors of success of a quit attempt among smokers seeking help to quit
USSHER, M. H., Kakar, G., Hájek, P., & West, R. (2015) · Addictive Behaviors · doi:10.1016/j.addbeh.2015.10.020 · Cited by 93
Self-citation
Improving quit rates of web‐delivered interventions for smoking cessation: full‐scale randomized trial of WebQuit.org versus Smokefree.gov
Bricker, J. B., Mull, K. E., McClure, J. B., Watson, N. L., & Heffner, J. L. (2018) · Addiction · doi:10.1111/add.14127 · Cited by 91
“0.89 (0.75, 1.06) 0.393 aOdds ratios are adjusted for the three factors used in stratified randomization: daily smoking frequency, education and gender; bcomplete case analysis (i.e. exclusion of participants lost to follow-up) was specified a priori as the primary outcome; cthe missing = smoking outcomes are provided…”
Influential
Electronic cigarettes versus nicotine patches for smoking cessation in pregnancy: a randomized controlled trial
Hajek, P., Przulj, D., Pesola, F., Griffiths, C., Walton, R., McRobbie, H., Coleman, T., Lewis, S., Whitemore, R., Clark, M., et al. (2022) · Nature Medicine · doi:10.1038/s41591-022-01808-0 · Cited by 85
“The primary endpoint was prolonged abstinence from smoking from 2 weeks after the TQD until the end of pregnancy, defined as per Russell Standard 63 (up to five lapses allowed with no smoking at all during the previous week at the time of final follow-up).”
Interventions for smoking cessation and reduction in individuals with schizophrenia
Tsoi, D. T., Porwal, M., & Webster, A. C. (2013) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd007253.pub3 · Cited by 304
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Use of Varenicline for 4 Weeks Before Quitting Smoking
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Self-citation
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Phillips, C., Syed, Y., Parthaláin, N. M., Reyer Zwiggelaar, A., Claypole, T. C., & Lewis, K. E. (2012) · Journal of Breath Research · doi:10.1088/1752-7155/6/3/036003 · Cited by 89
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Aveyard, P. N., Brown, K., Saunders, C., Alexander, A., Johnstone, E. C., Munafo, M. R., & Murphy, M. F. (2007) · Thorax · doi:10.1136/thx.2006.071837 · Cited by 88
Pre‐cessation depressive mood predicts failure to quit smoking: the role of coping and personality traits*
Berlin, I., & Covey, L. S. (2006) · Addiction · doi:10.1111/j.1360-0443.2006.01616.x · Cited by 89
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Lindson, N., Pritchard, G., Hong, B., Fanshawe, T. R., Pipe, A., & Papadakis, S. (2021) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd011556.pub2 · Cited by 89
Cytisinicline for Smoking Cessation
Rigotti, N. A., Benowitz, N. L., Prochaska, J. J., Leischow, S. J., Nides, M. A., Blumenstein, B. A., Clarke, A., Cain, D. F., & Jacobs, C. A. (2023) · JAMA · doi:10.1001/jama.2023.10042 · Cited by 98
The combined effect of very low nicotine content cigarettes, used as an adjunct to usual Quitline care (nicotine replacement therapy and behavioural support), on smoking cessation: a randomized controlled trial
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Lifestyle-related effects of the web-based Kanker Nazorg Wijzer (Cancer Aftercare Guide) intervention for cancer survivors: a randomized controlled trial
Kanera, I. M., Bolman, C. A. W., Willems, R. A., Mesters, I., & Lechner, L. (2016) · Journal of Cancer Survivorship · doi:10.1007/s11764-016-0535-6 · Cited by 85
“With regard to smoking outcomes, for ITT, participants who were identified as smokers at baseline were accounted as smokers if their smoking status after 6 months could not be determined [83].”
Background
Pharmacological interventions for promoting smoking cessation during pregnancy
Claire, R., Chamberlain, C., Davey, M.-A., Cooper, S. E., Berlin, I., Leonardi-Bee, J., & Coleman, T. (2020) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd010078.pub3 · Cited by 188
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Yoong, S. L., Stockings, E., Chai, L. K., Tzelepis, F., Wiggers, J. H., Oldmeadow, C. J., Paul, C. L., Peruga, A., Kingsland, M., Attia, J., et al. (2018) · Australian and New Zealand Journal of Public Health · doi:10.1111/1753-6405.12777 · Cited by 84
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Large multi‐centre pilot randomized controlled trial testing a low‐cost, tailored, self‐help smoking cessation text message intervention for pregnant smokers (MiQuit)
Naughton, F., Cooper, S. E., Foster, K. A., Emery, J. L., Leonardi‐Bee, J., Sutton, S. R., Jones, M., USSHER, M. H., Whitemore, R., Leighton, M., et al. (2017) · Addiction · doi:10.1111/add.13802 · Cited by 83
“However, we assumed conservatively that women lost to follow-up were still smoking [27] and outcome ascertainment rates were slightly higher in the usual care group; both factors would tend to attenuate rather than inflate the observed intervention effect.”
Influential
Depression and smoking cessation: evidence from a smoking cessation clinic with 1-year follow-up
Stepankova, L., Kralikova, E., Zvolska, K., Pankova, A., Ovesna, P., Blaha, M., & Brose, L. S. (2017) · Annals of Behavioral Medicine · doi:10.1007/s12160-016-9869-6 · Cited by 78
“Patients lost to follow-up despite multiple attempts at contact (15%) were recorded as not abstinent [30].”
Factors associated with the efficacy of smoking cessation treatments and predictors of smoking abstinence in EAGLES
West, R., Evins, A. E., Benowitz, N. L., Russ, C., McRae, T. D., Lawrence, D., Aubin, L. S., Krishen, A., Maravić, M. C., & Anthenelli, R. M. (2018) · Addiction · doi:10.1111/add.14208 · Cited by 82
“We used weeks 9–24 (a period that includes the last 4 weeks of treatment and 12-week non-treatment follow-up) as this provided a measure that is closest to the Russell Standard, the recommended end-point to ensure greatest confidence in extrapolating to life-time abstinence [26].”
MethodSelf-citation
E‐cigarettes versus nicotine replacement treatment as harm reduction interventions for smokers who find quitting difficult: randomized controlled trial
Smith, K. M., Phillips‐Waller, A., Pesola, F., McRobbie, H. J., Przulj, D., Orzol, M., & Hájek, P. (2021) · Addiction · doi:10.1111/add.15628 · Cited by 85
“Participants lost to follow up were classified as non-abstainers/non-reducers as per Russell standard (17).”
BackgroundMethod
A randomized controlled trial of smartphone-based mindfulness training for smoking cessation: a study protocol
Garrison, K. A., Pal, P., Rojiani, R., Dallery, J., O’Malley, S. S., & Brewer, J. A. (2015) · BMC Psychiatry · doi:10.1186/s12888-015-0468-z · Cited by 74
“This trial will use an intention-to-treat approach [30].”
BackgroundMethod
Daily negative affect and smoking after a self‐set quit attempt: The role of dyadic invisible social support in a daily diary study
Lüscher, J., Stadler, G., Ochsner, S., Rackow, P., Knoll, N., Hornung, R., & Scholz, U. (2015) · British Journal of Health Psychology · doi:10.1111/bjhp.12135 · Cited by 79
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Frazer, K., McHugh, J., Callinan, J., & Kelleher, C. (2016) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd011856.pub2 · Cited by 79
What is the clinical effectiveness and cost-effectiveness of cytisine compared with varenicline for smoking cessation? A systematic review and economic evaluation
Leaviss, J., Sullivan, W., Ren, S., Everson-Hock, E., Stevenson, M., Stevens, J., Strong, M., & Cantrell, A. J. (2014) · Health Technology Assessment · doi:10.3310/hta18330 · Cited by 78
Efficacy and safety of bupropion for smoking cessation and reduction in schizophrenia: systematic review and meta-analysis
Tsoi, D. T.-Y., Porwal, M., & Webster, A. C. (2010) · The British Journal of Psychiatry · doi:10.1192/bjp.bp.109.066019 · Cited by 77
Addiction Research Methods
(2010) · Wiley eBooks · doi:10.1002/9781444318852 · Cited by 79
Effective behaviour change techniques in smoking cessation interventions for people with chronic obstructive pulmonary disease: A meta‐analysis
Bartlett, Y. K., Sheeran, P., & Hawley, M. (2013) · British Journal of Health Psychology · doi:10.1111/bjhp.12071 · Cited by 81
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Gould, G., McEwen, A., Watters, T., Clough, A. R., & van der Zwan, R. (2012) · Tobacco Control · doi:10.1136/tobaccocontrol-2012-050436 · Cited by 81
“27 29 31 35 38 41 42 Standardised reporting of smoking abstinence, which is considered best practice, was missing from most of the studies.(47) 48 Only three studies described how they assessed self-reported quit status: consumption over the last 7 days,(26) 29 38 while three studies biochemically validated abstinence…”
Method
Tobacco use cessation interventions for lesbian, gay, bisexual, transgender and queer youth and young adults: A scoping review
Baskerville, N. B., Dash, D., Shuh, A., Wong, K., Abramowicz, A., Yessis, J. L., & Kennedy, R. D. (2017) · Preventive Medicine Reports · doi:10.1016/j.pmedr.2017.02.004 · Cited by 78
“Consistency in the reporting of outcomes (Copley et al., 2006;West et al., 2005) greatly assists in the review of evidence and decision-making on the effectiveness of interventions.”
Background
Cytisine versus varenicline for smoking cessation in New Zealand indigenous Māori: a randomized controlled trial
Walker, N. K., Smith, B. D., Barnes, J., Verbiest, M. E. A., Parag, V., Pokhrel, S., Wharakura, M., Lees, T., Gutierrez, H. C., Jones, B., et al. (2021) · Addiction · doi:10.1111/add.15489 · Cited by 82
“prevalence abstinence (no cigarettes, not a single puff, in the previous 7 days) [27]; time to first cigarette smoked from the quit date, even a single puff (lapse); time to first relapse (time to smoking more than five cigarettes a day for 3 or more days in a row); number of cigarettes smoked”
BackgroundMethod
Effect of unguided e-cigarette provision on uptake, use, and smoking cessation among adults who smoke in the USA: a naturalistic, randomised, controlled clinical trial
Carpenter, M. J., Wahlquist, A. E., Dahne, J., Gray, K. M., Cummings, K. M., Warren, G. W., Wagener, T. L., Goniewicz, M. L., & Smith, T. T. (2023) · EClinicalMedicine · doi:10.1016/j.eclinm.2023.102142 · Cited by 75
The effectiveness of a computer-tailored smoking cessation intervention for participants in lung cancer screening: A randomised controlled trial
van der Aalst, C. M., de Koning, H. J., van den Bergh, K. A. M., Willemsen, M. C., & van Klaveren, R. J. (2011) · Lung Cancer · doi:10.1016/j.lungcan.2011.10.006 · Cited by 75
Cognitive Determinants of Health Behavior
Conner, M. T. (2010) · Springer eBooks · doi:10.1007/978-0-387-09488-5_2 · Cited by 80
Effect of nicotine patches in pregnancy on infant and maternal outcomes at 2 years: follow-up from the randomised, double-blind, placebo-controlled SNAP trial.
Cooper, S., Taggar, J., Lewis, S., Marlow, N., Dickinson, A., Whitemore, R., & Coleman, T. (2014) · The Lancet Respiratory Medicine · doi:10.1016/s2213-2600(14)70157-2 · Cited by 73
A Preliminary Benefit-Risk Assessment of Varenicline in Smoking Cessation
Cahill, K., Stead, L. F., & Lancaster, T. (2009) · Drug Safety · doi:10.2165/00002018-200932020-00005 · Cited by 73
Self-citation
Group-Randomized Trial of a Proactive, Personalized Telephone Counseling Intervention for Adolescent Smoking Cessation
Peterson, A. V., Kealey, K. A., Mann, S. L., Marek, P. M., Ludman, E. J., Liu, J., & Bricker, J. B. (2009) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/djp317 · Cited by 73
Gold Standard Program for Heavy Smokers in a Real-Life Setting
Neumann, T., Rasmussen, M., Heitmann, B. L., & Tønnesen, H. (2013) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph10094186 · Cited by 73
“To compare the results from this observational prospective study with results from randomized controlled studies, the abstinence was reported according to the Russell criteria [28], assuming in the worst case that all non-responders had relapsed.”
Result
Reductions in biomarkers of exposure (BoE) to harmful or potentially harmful constituents (HPHCs) following partial or complete substitution of cigarettes with electronic cigarettes in adult smokers
O’Connell, G., Graff, D. W., & D’Ruiz, C. D. (2016) · Toxicology Mechanisms and Methods · doi:10.1080/15376516.2016.1196282 · Cited by 73
“…NO following smoking cessation (Chambers et al., 1998; Hogman et al., 2002; Jarvis et al., 1980; Malinovschi et al., 2006; Ripoll et al., 2012; Robbins et al., 1997; West et al., 2005; Yates et al., 2001); both of which may be indicative of immediate and future physiological benefits to the smoker.”
BackgroundResult
Measurement of cardiovascular and pulmonary function endpoints and other physiological effects following partial or complete substitution of cigarettes with electronic cigarettes in adult smokers
D’Ruiz, C. D., O'Connell, G., Graff, D. W., & Yan, X. (2017) · Regulatory Toxicology and Pharmacology · doi:10.1016/j.yrtph.2017.05.002 · Cited by 73
Efficacy of brief motivational interviewing on smoking cessation at tuberculosis clinics in Tshwane, South Africa: a randomized controlled trial
Louwagie, G. M. C., Okuyemi, K. S., & Ayo‐Yusuf, O. A. (2014) · Addiction · doi:10.1111/add.12671 · Cited by 72
E-cigarettes compared with nicotine replacement therapy within the UK Stop Smoking Services: the TEC RCT.
Hajek, P., Phillips-Waller, A., Przulj, D., Pesola, F., Smith, K. M., Bisal, N., Li, J., Parrott, S., Sasieni, P., Dawkins, L., et al. (2019) · Health Technology Assessment · doi:10.3310/hta23430 · Cited by 72
Pharmacological interventions for promoting smoking cessation during pregnancy
Coleman, T., Chamberlain, C., Davey, M.-A., Cooper, S. E., & Leonardi-Bee, J. (2015) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd010078.pub2 · Cited by 357
Current and Emerging Pharmacotherapies for Cessation of Tobacco Smoking
Gómez‐Coronado, N., Walker, A. J., Berk, M., & Dodd, S. (2017) · Pharmacotherapy The Journal of Human Pharmacology and Drug Therapy · doi:10.1002/phar.2073 · Cited by 74
“We found that the approaches used to report on outcomes of randomized clinical trials varied greatly.(6) The lack of standard criteria may hinder understanding and comparing those results.”
Method
Effect of a Mobile Phone Intervention on Quitting Smoking in a Young Adult Population of Smokers: Randomized Controlled Trial
Baskerville, N. B., Struik, L. L., Guindon, G. E., Norman, C. D., Whittaker, R., Burns, C. M., Hammond, D. G., Dash, D., & Brown, K. S. (2018) · JMIR mhealth and uhealth · doi:10.2196/10893 · Cited by 75
“The intention-to-treat principle was followed for the analysis of continuous abstinence and the outcomes 30-day and 7-day PPA using 3 approaches to handle missing information about smoking status: (1) imputation using the baseline observation carried forward or classifying nonresponders at 3 and 6 months as smokers in…”
Behavioural therapy for smoking cessation: the effectiveness of different intervention types for disadvantaged and affluent smokers
Hiscock, R., Murray, S., Brose, L. S., McEwen, A., Bee, J. L., Dobbie, F., & Bauld, L. (2013) · Addictive Behaviors · doi:10.1016/j.addbeh.2013.07.010 · Cited by 70
Predictors of Short-Term Success in Smoking Cessation in Relation to Attendance at a Smoking Cessation Program
Dorner, T. E., Trostl, A., Womastek, I., & Groman, E. (2011) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntr179 · Cited by 71
Interventions for smoking cessation and reduction in individuals with schizophrenia
Tsoi, D. T.-Y., Porwal, M., & Webster, A. C. (2010) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd007253.pub2 · Cited by 73
Vaccination against nicotine: an emerging therapy for tobacco dependence
Maurer, P., & Bachmann, M. F. (2007) · Expert Opinion on Investigational Drugs · doi:10.1517/13543784.16.11.1775 · Cited by 70
Prescribing Prevalence, Effectiveness, and Mental Health Safety of Smoking Cessation Medicines in Patients With Mental Disorders
Taylor, G. M. J., Itani, T., Thomas, K. H., Rai, D., Jones, T., Windmeijer, F., Martin, R. M., Munafò, M. R., Davies, N. M., & Taylor, A. E. (2020) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntz072 · Cited by 68
Mind–body practices: An alternative, drug-free treatment for smoking cessation? A systematic review of the literature
Carim-Todd, L., Mitchell, S. H., & Oken, B. S. (2013) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2013.04.014 · Cited by 82
A feasibility study with embedded pilot randomised controlled trial and process evaluation of electronic cigarettes for smoking cessation in patients with periodontitis
Holliday, R., Preshaw, P. M., Ryan, V., Sniehotta, F. F., McDonald, S., Bauld, L., & McColl, E. (2019) · Pilot and Feasibility Studies · doi:10.1186/s40814-019-0451-4 · Cited by 69
Nicotine receptor partial agonists for smoking cessation
Livingstone‐Banks, J., Fanshawe, T. R., Thomas, K. H., Theodoulou, A., Hajizadeh, A., Hartman, L., & Lindson, N. (2023) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006103.pub9 · Cited by 77
Effect of a workplace-based group training programme combined with financial incentives on smoking cessation: a cluster-randomised controlled trial
van den Brand, F. A., Nagelhout, G. E., Winkens, B., Chavannes, N. H., & van Schayck, O. C. P. (2018) · The Lancet Public Health · doi:10.1016/s2468-2667(18)30185-3 · Cited by 70
Systematic Review and Meta-Analysis of the Impact of Depression on Subsequent Smoking Cessation in Patients With Coronary Heart Disease
Doyle, F., Rohde, D., Rutkowska, A., Morgan, K., Cousins, G., & McGee, H. M. (2013) · Psychosomatic Medicine · doi:10.1097/psy.0000000000000020 · Cited by 67
Association of COMT Val108/158Met genotype with smoking cessation
Munafò, M. R., Johnstone, E. C., Guo, B., Murphy, M. F. G., & Aveyard, P. (2008) · Pharmacogenetics and Genomics · doi:10.1097/fpc.0b013e3282f44daa · Cited by 68
Combining smoking cessation interventions with LDCT lung cancer screening: A systematic review
Iaccarino, J. M., Duran, C., Slatore, C. G., Wiener, R. S., & Kathuria, H. (2019) · Preventive Medicine · doi:10.1016/j.ypmed.2019.02.016 · Cited by 68
Effectiveness of specialist group treatment for smoking cessation vs. one-to-one treatment in primary care
McEwen, A., West, R., & McRobbie, H. (2006) · Addictive Behaviors · doi:10.1016/j.addbeh.2005.12.014 · Cited by 67
Self-citation
Smoking Cessation in the ITALUNG Lung Cancer Screening: What Does “Teachable Moment” Mean?
Pistelli, F., Aquilini, F., Falaschi, F., Puliti, D., Ocello, C., Pegna, A. L., Carozzi, F. M., Picozzi, G., Zappa, M., Mascalchi, M., et al. (2019) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntz148 · Cited by 67
Interventions for recruiting smokers into cessation programmes
Belisario, J. S. M., Bruggeling, M. N., Gunn, L. H., Brusamento, S., & Car, J. (2012) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd009187.pub2 · Cited by 72
A randomised controlled trial of a consumer-focused e-health strategy for cardiovascular risk management in primary care: the Consumer Navigation of Electronic Cardiovascular Tools (CONNECT) study protocol
Redfern, J., Usherwood, T. P., Harris, M., Rodgers, A., Hayman, N. E., Panaretto, K. S., Chow, C. K., Lau, A. Y. S., Neubeck, L., Coorey, G., et al. (2014) · BMJ Open · doi:10.1136/bmjopen-2013-004523 · Cited by 67
The relationship between smokers' motivation to quit and intensity of tobacco control at the population level: a comparison of five European countries
Thyrian, J. R., Panagiotakos, D. B., Polychronopoulos, E., West, R., Zatoński, W. A., & John, U. (2008) · BMC Public Health · doi:10.1186/1471-2458-8-2 · Cited by 68
Self-citation
Accuracy of self‐reported smoking abstinence in clinical trials of hospital‐initiated smoking interventions
Scheuermann, T. S., Richter, K. P., Rigotti, N. A., Cummins, S. E., Harrington, K. F., Sherman, S. E., Zhu, S., Tindle, H. A., & Preacher, K. J. (2017) · Addiction · doi:10.1111/add.13913 · Cited by 67
“Assessing smoking abstinence is a challenge for smoking cessation trials [1,2].”
Randomized trial of nicotine replacement therapy ( NRT) , bupropion and NRT plus bupropion for smoking cessation: effectiveness in clinical practice
Stapleton, J., West, R., Hájek, P., Wheeler, J., Vangeli, E., Abdi, Z., OʼGara, C., McRobbie, H. J., Humphrey, K., Ali, R. J., et al. (2013) · Addiction · doi:10.1111/add.12304 · Cited by 66
“By definition, all those classified as RS6 abstinent were also DH4 and PP6 abstinent.”
BackgroundMethodInfluentialSelf-citation
Reductions in biomarkers of exposure, impacts on smoking urge and assessment of product use and tolerability in adult smokers following partial or complete substitution of cigarettes with electronic cigarettes
D’Ruiz, C. D., Graff, D. W., & Robinson, E. (2016) · BMC Public Health · doi:10.1186/s12889-016-3236-1 · Cited by 65
“Moreover, the study findings associated with exhaled breath biomarkers in the cessation and exclusive use groups were consistent with other research findings associated with reductions in exhaled CO and increases in NO following smoking cessation [28–35]; both of which are indicative of immediate and future health ben…”
Result
Physical activity for smoking cessation in pregnancy: randomised controlled trial
USSHER, M. H., Lewis, S., Aveyard, P. N., Manyonda, I., West, R., Lewis, B. A., Marcus, B. H., Riaz, M. A., Taylor, A. H., Daley, A., et al. (2015) · BMJ · doi:10.1136/bmj.h2145 · Cited by 66
“25 Using logistic regression we compared the proportion of women reporting continuous smoking abstinence at the end of pregnancy between study groups, with adjustment for recruitment centre.”
MethodSelf-citation
Factors That Explain Differences in Abstinence Between Black and White Smokers: A Prospective Intervention Study
Nollen, N. L., Mayo, M. S., Sanderson Cox, L., Benowitz, N. L., Tyndale, R. F., Ellerbeck, E. F., Scheuermann, T. S., & Ahluwalia, J. S. (2019) · JNCI: Journal of the National Cancer Institute · doi:10.1093/jnci/djz001 · Cited by 62
“Participants who had missing outcome data at weeks 4, 12, and 26 were considered smokers per the Russell Standard (90).”
Method
Mobile applications for the treatment of tobacco use and dependence
Vilardaga, R., Casellas-Pujol, E., McClernon, J. F., & Garrison, K. A. (2019) · Current Addiction Reports · doi:10.1007/s40429-019-00248-0 · Cited by 64
Effect of offering different levels of support and free nicotine replacement therapy via an English national telephone quitline: randomised controlled trial
Ferguson, J., Docherty, G., Bauld, L., Lewis, S., Lorgelly, P. K., Boyd, K., McEwen, A., & Coleman, T. J. (2012) · BMJ · doi:10.1136/bmj.e1696 · Cited by 63
Technology-based interventions for tobacco and other drug use in university and college students: a systematic review and meta-analysis
Gulliver, A., Farrer, L. M., Chan, J. K., Tait, R. J., Bennett, K., Calear, A. L., & Griffiths, K. M. (2015) · Addiction Science & Clinical Practice · doi:10.1186/s13722-015-0027-4 · Cited by 63
“Given that abstinence is regarded as the benchmark for smoking cessation interventions [50], the metaanalysis examined tobacco interventions that used abstinence as an outcome measure and included a control group (n = 6).”
Method
Using breath carbon monoxide to validate self-reported tobacco smoking in remote Australian Indigenous communities
MacLaren, D. J., Conigrave, K. M., Robertson, J. A., Ivers, R. G., Eades, S., & CLOUGH, A. R. (2010) · Population Health Metrics · doi:10.1186/1478-7954-8-2 · Cited by 63
“Data were included in the analysis if: (i) self-reported smokers reported smoking tobacco within the preceding 24 hours; or (ii) self-reported nonsmokers reported never smoking tobacco or not smoking tobacco for ≥6 months[43].”
Method
Effect of exercise type on smoking cessation: a meta-analysis of randomized controlled trials
Klinsophon, T., Thaveeratitham, P., Sitthipornvorakul, E., & Janwantanakul, P. (2017) · BMC Research Notes · doi:10.1186/s13104-017-2762-y · Cited by 63
“Continuous abstinence corresponded more closely to the treatment goal [72].”
Method
An uncontrolled trial of cytisine (Tabex) for smoking cessation: Table 1
Zatoński, W. A., Cedzyńska, M., Tutka, P., & West, R. (2006) · Tobacco Control · doi:10.1136/tc.2006.016097 · Cited by 61
Self-citation
The role of self‐efficacy, recovery self‐efficacy, and preparatory planning in predicting short‐term smoking relapse
Elfeddali, I., Bolman, C. A. W., Candel, M. J. J. M., Wiers, R. W. H. J., & de Vries, H. (2011) · British Journal of Health Psychology · doi:10.1111/j.2044-8287.2011.02032.x · Cited by 63
“This deﬁnition of relapse conforms to the Russell Standard (West et al. , 2005).”
BackgroundMethod
Randomized controlled trial of a social support (‘buddy’) intervention for smoking cessation
May, S., West, R., Hájek, P., McEwen, A., & McRobbie, H. J. (2006) · Patient Education and Counseling · doi:10.1016/j.pec.2006.02.008 · Cited by 61
Self-citation
The Missing=Smoking Assumption: A Fallacy in Internet-Based Smoking Cessation Trials?
Blankers, M., Smit, E. S., van der Pol, P., de Vries, H., Hoving, C., & van Laar, M. (2015) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntv055 · Cited by 61
A Randomized Trial of Motivational Interviewing
Catley, D., Goggin, K., Harris, K. J., Richter, K. P., Williams, K. B., Patten, C. A., Resnicow, K., Ellerbeck, E. F., Bradley‐Ewing, A., Lee, H. S., et al. (2015) · American Journal of Preventive Medicine · doi:10.1016/j.amepre.2015.10.013 · Cited by 61
Randomized Controlled Trial of a Smartphone Application as an Adjunct to Acceptance and Commitment Therapy for Smoking Cessation
O’Connor, M., Whelan, R., Bricker, J., & McHugh, L. (2020) · Behavior Therapy · doi:10.1016/j.beth.2019.06.003 · Cited by 55
Needle Trap Device-GC-MS for Characterization of Lung Diseases Based on Breath VOC Profiles
Monedeiro, F., Monedeiro-Milanowski, M., Ratiu, I., Brożek, B., Ligor, T., & Buszewski, B. (2021) · Molecules · doi:10.3390/molecules26061789 · Cited by 60
The Effectiveness of Secondary Prevention Lifestyle Interventions Designed to Change Lifestyle Behavior following Stroke: Summary of a Systematic Review
Lawrence, M., Kerr, S., McVey, C., & Godwin, J. (2012) · International Journal of Stroke · doi:10.1111/j.1747-4949.2012.00771.x · Cited by 60
Smoking reduction interventions for smoking cessation
Lindson, N., Klemperer, E. M., & Aveyard, P. N. (2018) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd013183 · Cited by 60

Authors: West, R., Hajek, P., Stead, L., & Stapleton, J.
Affiliations: University College London (GB)
University of Oxford (GB)
King's College London (GB)
Corresponding author: West, Robert
ORCID: West, Robert
Venue: Addiction
Publisher: Wiley
Published: 2005-03
Volume: 100
Issue: 3
Pages: 299-303
ISSN: 0965-2140 (ISSN-L)
1360-0443
DOI: 10.1111/j.1360-0443.2004.00995.x
OpenAlex: W2138106394
Cited by: 1,285
References: 15
Citations by year: 2026: 38 · 2025: 68 · 2024: 84 · 2023: 77 · 2022: 79 · 2021: 69 · 2020: 75 · 2019: 85 · 2018: 58 · 2017: 84 · 2016: 64 · 2015: 77 · 2014: 67 · 2013: 70 · 2012: 56
FWCI: 17.98
Type: journal article
Language: en
Open access: closed
Licence: onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations: Addiction (publishedVersion)
PubMed (publishedVersion)
UCL Discovery (University College London) (submittedVersion)
Topics: Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Smoking Behavior and Cessation
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
Keywords: smoking cessation, outcome criteria, cessation aids, smoking abstinence, intention-to-treat analysis, grace period, trial comparability
MeSH terms: Humans, Research Design, Randomized Controlled Trials as Topic, Smoking Cessation, Outcome Assessment, Health Care

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Outcome criteria in smoking cessation trials: proposal for a common standard

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