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

The DOI matches its Crossref record; 15 of the 15 references it cites were found in a registry or an index.

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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Method
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Method
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Background
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Background
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“Prolonged abstinence is defined according to the Russell standard definition [38], applying the usual threshold of not smoking more than 5 cigarettes in the past 8 weeks (thus allowing for a 4-week grace period).”
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Method
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“In addition, following the Russell standard criteria (West et al., 2005), participants were considered to have achieved prolonged abstinence if they self-reported not smoking > 5 cigarettes from the end of the treatment to the 6-and 12-months follow-ups (Piper et al., 2020).”
BackgroundMethodInfluential
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MethodInfluential
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BackgroundMethodInfluential
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“Prolonged abstinence was defined using the Russell standard [20] of not having smoked more than 5 cigarettes in the past 8 weeks at the 3-month follow-up interval and in the past 5 months at the 6-month follow-up interval (thus allowing for a 4-week grace period from the start of the intervention…”
Method
Efficacy of e-cigarettes for smoking cessation in populations with psychiatric and/or substance use problems: A secondary analysis of a randomized controlled trial
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“These criteria require self-report of smoking status and biochemical veriﬁcation of abstinence amongothers(West,Hajek,Stad&Stapleton,2005).”
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Mansour, M. B., Crone, M. R., Sert, E., van Weert, H. C. P. M., Chavannes, N. H., & van Asselt, K. M. (2022) · BMJ Open · doi:10.1136/bmjopen-2021-055812 · Cited by 6
Non-monetary incentives for tobacco prevention among youth in Indonesia
Triyana, M., & White, J. S. (2022) · Journal of Health Economics · doi:10.1016/j.jhealeco.2022.102620 · Cited by 12
Active screening for lung cancer increases smoking abstinence in Australia
Marshall, H., Vemula, M., Hay, K. E., McCaul, E. M., Passmore, L. H., Yang, I. A., Bowman, R., & Fong, K. M. (2022) · Asia-Pacific Journal of Clinical Oncology · doi:10.1111/ajco.13879 · Cited by 6
“19 3–5 12 (41) 27 (42) 39 (42) 6–7 9 (31) 16 (25) 25 (27)”
Effectiveness of the spirometry-based motivational intervention to quit smoking: RESET randomised trial
Martín‐Luján, F., Santigosa-Ayala, A., Pallejà-Millán, M., Rey‐Reñones, C., Villalobos, F., Solà, R., & study, T. R. O. T. R. (2023) · European Journal of General Practice · doi:10.1080/13814788.2023.2276764 · Cited by 6
“…of whether they received the allocated intervention and subsequent withdrawal or deviation from the protocol), assuming a ‘worst-case’ strategy regarding smoking (participants who did not have laboratory-confirmed abstinence data at the end of the study were considered as active smokers) [19].”
Background
Invisible Social Control as Predictor of Daily Negative Affect and Smoking After a Self-Set Quit Date
Lüscher, J., Ochsner, S., Berli, C., Knoll, N., Stadler, G., Hornung, R., & Scholz, U. (2014) · Zeitschrift für Gesundheitspsychologie · doi:10.1026/0943-8149/a000126 · Cited by 6
“In addition, point prevalence of nonsmoking at the 3-week follow-up after quit date was biochemically verified with a carbon monoxide test (CO) of expired air (West et al., 2005).”
Method
Goal Disengagement, Well‐Being, and Goal Achievement in Romantic Couples Pursuing Health Behavior Change: Evidence from Two Daily Diary Studies
Lüscher, J., Berli, C., & Scholz, U. (2017) · Applied Psychology Health and Well-Being · doi:10.1111/aphw.12084 · Cited by 8
“While Study 2 did not employ an objective measure of smoking abstinence at the daily level, participants’ reports of smoking abstinence was biochemically verified with a CO test of expired air (West et al., 2005) following the diary period.”
Method
Tobacco Treatment Guideline for High Risk Groups: A pilot study in patients with Chronic Obstructive Pulmonary Disease
Trofor, A. C., Papadakis, S., Lotrean, L. M., Buculei, I., Vyzikidou, V. K., Evangelopoulou, V., Vardavas, C. I., & BEHRAKIS, P. K. (2018) · Tobacco Induced Diseases · doi:10.18332/tid/85944 · Cited by 6
The effects of a short-term physician training on smoking cessation in a university pulmonary department
Bauer, A., Brenner, L., Moser, J., Trudzinski, F. C., Köllner, V., & Bals, R. (2020) · PubMed Central · doi:10.3205/000282 · Cited by 6
Do Daily Compensatory Health Beliefs Predict Intention to Quit and Smoking Behavior? A Daily Diary Study during Smoking Cessation
Amrein, M. A., Lüscher, J., Berli, C., Radtke, T., & Scholz, U. (2020) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph17176419 · Cited by 6
“It is recommended to combine self-report measures and objective measures at the same time [34].”
Background
The efficacy and safety of varenicline alone versus in combination with nicotine lozenges for smoking cessation among hospitalised smokers (VANISH): study protocol for a randomised, placebo-controlled trial
Gobarani, R. K., Abramson, M. J., Bonevski, B., Weeks, G. R., Dooley, M. J., Smith, B. J., Veale, A., Webb, A. R., Kirsa, S. W., Thomas, D., et al. (2020) · BMJ Open · doi:10.1136/bmjopen-2020-038184 · Cited by 7
Effectiveness of training stop‐smoking advisers to deliver cessation support to the UK national proposed standard versus usual care in Malaysia: a two‐arm cluster‐randomized controlled trial
Wee, L. H., West, R., Tee, G. H., Yeap, L. L. L., Chan, C. M. H., Ho, B. K., Perialathan, K., Mohamed, M. H. N., Michie, S., & Jackson, S. E. (2020) · Addiction · doi:10.1111/add.15346 · Cited by 5
“Two approaches to address missing values were used: (1) intention-to-treat (ITT) with smokers whowere lost to follow-up retained in the analyses and classified as continuing smokers (missing-equals-smoking imputation), as recommended in the Russell Standard [24] based on the assumption that missing outcomes are not mi…”
BackgroundMethodInfluentialSelf-citation
The effect of area-level disadvantage and race on smoking abstinence in a clinical trial.
Nollen, N. L., Mayo, M. S., Onge, J. M. S., Scheuermann, T. S., Cox, L. S., Chae, D. H., Leavens, E. L. S., & Ahluwalia, J. S. (2021) · Experimental and Clinical Psychopharmacology · doi:10.1037/pha0000493 · Cited by 6
International expert consensus on electronic nicotine delivery systems and heated tobacco products: a Delphi survey
Berlin, I., Sadowski, I. J., Humair, J., & Cornuz, J. (2021) · BMJ Open · doi:10.1136/bmjopen-2020-045724 · Cited by 6
Evaluation of an individually tailored smoking-cessation intervention for patients with rheumatoid arthritis in an outpatient clinic
Karlsson, M. L., Hertzberg-Nyquist, K., Saevarsdóttir, S., Lundberg, I. E., Demmelmaier, I., Pettersson, S., & Chatzidionysiou, K. (2023) · Scandinavian Journal of Rheumatology · doi:10.1080/03009742.2023.2172903 · Cited by 6
“Quitting smoking can be defined in different ways, often self-reported in combination with biochemical verification (41), and it can be problematic to compare studies that use different approaches to defining and verifying smoking cessation.”
Background
IMPACT smoking cessation support for people with severe mental illness in South Asia (IMPACT 4S): A protocol for a randomised controlled feasibility trial of a combined behavioural and pharmacological support intervention
Mazumdar, P., Zavala, G. A., Aslam, F., Muliyala, K. P., Chaturvedi, S. K., Kandasamy, A., Nizami, A. T., Haq, B. U., Kellar, I., Jackson, C., et al. (2023) · PLoS ONE · doi:10.1371/journal.pone.0287185 · Cited by 7
E‐cigarette support for smoking cessation: Identifying the effectiveness of intervention components in an on‐line randomized optimization experiment
Kimber, C., Sideropoulos, V., Cox, S., Frings, D., Naughton, F., Brown, J., McRobbie, H. J., & Dawkins, L. (2023) · Addiction · doi:10.1111/add.16294 · Cited by 7
“Participants lost to follow-up were classified as smoking on the basis of the assumption of missing not at random (MNAR; Little ’ s test, P < 0.001), in accordance with the Russell Standard criteria for smoking abstinence [46].”
Influential
Measured, opportunistic, unexpected and naïve quitting: a qualitative grounded theory study of the process of quitting from the ex-smokers’ perspective
Smith, A. L., Carter, S. M., Dunlop, S. M., Freeman, B., & Chapman, S. (2017) · BMC Public Health · doi:10.1186/s12889-017-4326-4 · Cited by 7
Effektivität eines kognitiv-verhaltenstherapeutischen Raucherentwöhnungsprogramms mit pharmakologischer Unterstützung
Felten, D., Raupach, T., Sessler, C., Lüthje, L., Hasenfuss, G. P., & Andreas, S. (2006) · DMW - Deutsche Medizinische Wochenschrift · doi:10.1055/s-2006-924947 · Cited by 6
Reply to discrepant results for smoking and cessation among electronic cigarette users
Borderud, S. P., Li, Y., Burkhalter, J. E., Sheffer, C. E., & Ostroff, J. S. (2015) · Cancer · doi:10.1002/cncr.29306 · Cited by 6
Smoking cessation services for young people
Grimshaw, G. M., & Stanton, A. (2008) · BMJ · doi:10.1136/bmj.a1394 · Cited by 6
Incentives to quit smoking in primary care
Bize, R., & Cornuz, J. (2008) · BMJ · doi:10.1136/bmj.39506.386759.80 · Cited by 6
Gender, smoking, and tobacco cessation with pharmacological treatment in a cluster randomized clinical trial
Minué-Lorenzo, C., Olano-Espinosa, E., Minué-Estirado, M., Sánchez-Rodrigo, J.-M. V., Guillem, F. C., Granados-Garrido, J., Ruiz-Pacheco, M., Gámez-Cabero, M. I., Martinez-Suberviola, F. J., Serrano, M. E. S., et al. (2024) · Tobacco Induced Diseases · doi:10.18332/tid/177260 · Cited by 5
“The main outcome variables were continued abstinence after 12 months according to Russell’s criteria 16 (self-report of smoking not more than five cigarettes from the start of the abstinence period at the final follow-up), and abstinence biochemically validated with CO-oximetry.”
Method
Cytisinicline for smoking cessation in individuals with self-reported COPD: a post hoc analysis of the ORCA-2 and ORCA-3 trials
Prochaska, J. J., Rubinstein, M., Perdok, R. J., Blumenstein, B. A., & Jacobs, C. A. (2025) · Thorax · doi:10.1136/thorax-2025-223880 · Cited by 5
Motivational smoking cessation counselling and community‐based follow‐up after hospitalisation for vascular disease: A randomised controlled trial
Pleym, K., Sverre, E., Weedon‐Fekjær, H., Kahlon, M. S., Stugaard, M., Husebye, E., Tonstad, S., Dammen, T., & Munkhaugen, J. (2025) · Addiction · doi:10.1111/add.70249 · Cited by 5
“Additionally, we assessed self-reported smoking abstinence at 1 month (7-day point prevalence), and then continuous smoking abstinence after 3 and 12 months [21].”
Influential
Psychosocial interventions for supporting women to stop smoking in pregnancy
Freijah, I., Jones, K., Coleman, T. J., Perlen, S., Kennedy, M., Passey, M. E., McKenzie, J. E., & Chamberlain, C. (2026) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd001055.pub6 · Cited by 6
Efficacy of an individual-tailored smoking cessation intervention APP among Chinese smokers: study protocol for a randomized controlled trial
Xie, X., Liang, L., Nan, Y., Zhang, L., & Xiao, L. (2024) · BMC Public Health · doi:10.1186/s12889-023-16496-9 · Cited by 5
“6-month continued abstinence will be defined using the Russell 6 Standard [36] but without biochemical verification (i.e., tolerate fewer than five incidents of smoking from the quit date) and will be measured through the question “Have you smoked at all since (date of the start of the continuous…”
Method
Varenicline and Nicotine Replacement Therapy for Smokers Admitted to Hospitals
Weeks, G. R., Gobarani, R. K., Abramson, M. J., Bonevski, B., Webb, A. R., Thomas, D., Paul, E. M., Sarwar, M. R., Smith, B. J., Perinpanathan, S., et al. (2024) · JAMA Network Open · doi:10.1001/jamanetworkopen.2024.18120 · Cited by 6
Sex-specific predictive factors of smoking cessation in subjects at high cardiovascular risk
Allagbé, I., Zeller, M., Thomas, D., Airagnes, G., Limosin, F., Boussadi, A., Chague, F., & Faou, A.-L. L. (2024) · Archives of cardiovascular diseases · doi:10.1016/j.acvd.2024.06.001 · Cited by 5
Design and methods of a randomized trial testing the novel Wellness Intervention for Smokers Living with HIV (WISH)
McClure, J. B., Catz, S. L., Chalal, C., Ciuffetelli, R., Coggeshall, S. S., DeFaccio, R., Fleehart, S., Heffner, J. L., Thompson, E., Williams, E. C., et al. (2021) · Contemporary Clinical Trials · doi:10.1016/j.cct.2021.106486 · Cited by 5
Smoking Cessation Rates among Patients with Rheumatoid Arthritis and Osteoarthritis Following the ‘Gold Standard Programme’ (GSP): A Prospective Analysis from the Danish Smoking Cessation Database
Laugesen, M., Rasmussen, M., Christensen, R., Tønnesen, H., & Bliddal, H. (2022) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph19105815 · Cited by 5
“The primary outcome was successful quitting, reported as continuous abstinence instead of point prevalence, which could be considered a strength [32].”
Background
An economic evaluation of an online computer-tailored smoking cessation intervention that includes message frame-tailoring: A randomized controlled trial
Altendorf, M. B., van Weert, J. C. M., Hoving, C., & Smit, E. S. (2022) · PLOS Digital Health · doi:10.1371/journal.pdig.0000094 · Cited by 5
“In line with the Russell Standard, in this second sensitivity analysis missing data for smoking abstinence were replaced according to a conservative “negative” scenario, that is, participants lost to follow-up were considered to still be smoking [23,24].”
Method
Protocol from a randomized clinical trial of multiple pharmacotherapy adaptations based on treatment response in African Americans who smoke
Nollen, N. L., Cox, L. S., Mayo, M. S., Ellerbeck, E. F., Arnold, M. J., Salzman, G. A., Shanks, D., Woodward, J. M., Greiner, K. A., & Ahluwalia, J. S. (2022) · Contemporary Clinical Trials Communications · doi:10.1016/j.conctc.2022.101032 · Cited by 5
“Missing data All primary analyses on smoking cessation will be conducted using intent-to-treat; those lost to follow-up will be classified as an individual who smokes per the Russell Standard [68].”
Method
Tabakentwöhnung bei COPD
Andreas, S., Kotz, D., Batra, A., Hellmann, A., Mühlig, S., Nowak, D., Schultz, K., Worth, H., & Schüler, S. (2023) · Pneumologie · doi:10.1055/a-2020-4284 · Cited by 5
“Ein CO-Wert ≥10ppm gilt hierbei als Indikator für Tabakrauchen [9].”
Background
Use of the Smoking Cessation App Ex-Smokers iCoach and Associations With Smoking-Related Outcomes Over Time in a Large Sample of European Smokers: Retrospective Observational Study
Mansour, M. B., Busschers, W. B., Crone, M. R., van Asselt, K. M., van Weert, H. C. P. M., Chavannes, N. H., & Meijer, E. (2023) · Journal of Medical Internet Research · doi:10.2196/45223 · Cited by 7
“Although data were not collected in a controlled trial setting, previous studies of relatively low-demand smoking cessation interventions showed few discrepancies between self-reported and biochemically validated abstinence [44,45].”
Short-term effectiveness of the national German quitline for smoking cessation: results of a randomized controlled trial
Maspero, S., Delle, S., Kraus, L., Pogarell, O. M., Hoch, E., Bachner, J., & Lochbühler, K. (2024) · BMC Public Health · doi:10.1186/s12889-024-18104-w · Cited by 5
Is a percentage a percentage? Systematic review of the effectiveness of Scandinavian behavioural modification smoking cessation programmes
Poulsen, P. B., Dollerup, J., & Møller, A. M. (2009) · The Clinical Respiratory Journal · doi:10.1111/j.1752-699x.2009.00144.x · Cited by 5
“cal verification advocated for in the Russell Standards (11) despite the fact that this may lead to an overestimation of the effectiveness.”
BackgroundMethodInfluential
Efficacy of Team-Based Financial Incentives for Smoking Cessation in the Workplace
Yeo, C. D., Lee, H. Y., Ha, J. H., Kang, H. H., Kang, J. Y., Kim, S. K., Kim, M. S., Moon, H. S., & Lee, S. H. (2014) · Yonsei Medical Journal · doi:10.3349/ymj.2015.56.1.295 · Cited by 6
A randomised controlled trial of a theory-based interactive internet-based smoking cessation intervention (‘StopAdvisor’): Study protocol
Michie, S., Brown, J., Geraghty, A. W. A., Miller, S., Yardley, L., Gardner, B., Shahab, L., Stapleton, J., & West, R. (2013) · The Journal of Smoking Cessation · doi:10.1017/jsc.2013.21 · Cited by 5
Self-citation
Trial Protocol: Communicating DNA-based risk assessments for Crohn's disease: a randomised controlled trial assessing impact upon stopping smoking
Whitwell, S., Mathew, C. G., Lewis, C. M., Forbes, A., Watts, S., Sanderson, J. D., Hollands, G. J., Prevost, A. T., Armstrong, D., Kinmonth, A. L., et al. (2011) · BMC Public Health · doi:10.1186/1471-2458-11-44 · Cited by 5
“Seven-day smoking cessation at six months At six months abstinence from smoking in the preceding seven days will be assessed using the Russell standard procedures [21], counting participants lost to follow up as being smokers, and self-reported smoking status will be verified biochemically.”
Method
Toward Rational, Evidence‐Based, and Clinically Relevant Measures to Determine Improvement Following Treatment for Alcohol Use Disorder
Johnson, B. A. (2017) · Alcoholism Clinical and Experimental Research · doi:10.1111/acer.13341 · Cited by 5
Nutzung und Nutzen der E‑Zigarette im Rahmen eines strukturierten verhaltenstherapeutischen Gruppenprogramms
Kröger, C. B., Ofner, S., & Piontek, D. (2017) · Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz · doi:10.1007/s00103-017-2657-z · Cited by 5
Smoking cessation Through Optimisation of clinical care in Pregnancy: the STOP randomised controlled trial
McDonnell, B. P., Dicker, P., Keogan, S., Clancy, L., & Regan, C. L. (2019) · Trials · doi:10.1186/s13063-019-3653-4 · Cited by 5
Behaviour Change for the Sharing Economy
Deleris, L. A., & Aonghusa, P. M. (2020) · Springer eBooks · doi:10.1007/978-3-030-35032-1_11 · Cited by 5
A systematic review of factors associated with sustained smoking abstinence in people experiencing severe mental illness following participation in a smoking intervention
Davies, K., Courtney, R. J., Summersby-Mitchell, M., Morell, R., Briggs, N., & Lappin, J. (2023) · Australian & New Zealand Journal of Psychiatry · doi:10.1177/00048674221147206 · Cited by 5
“A consistent approach to defining abstinence, as outlined in the Russell Standard, would improve comparability between studies and bring clarity to the interpretation of their effectiveness (West et al., 2005).”
MethodInfluential

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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