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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“Long-Wittekind term abstinence is assessed following recommendations by West et al. [62], defined by the Russell Standard (RS) which incorporates six criteria: (1) continuous abstinence of 6 months starting with the quit date, (2) RS abstinence, that is, not having smoked more than five cigarettes…”
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“Those who declined to be involved in subsequent data collection were counted as smokers [20].”
Background
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“Additionally, smoking cessation literature suggests that when in-person contact is not feasible, self-reported abstinence seems to be a reliable measure (Benowitz et al., 2020; West et al., 2005).”
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“33 Publication bias was assessed using funnel plots.”
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“Gender Male 286 (47) 76 (44) 107 (50) 11 (35) 82 (47) Female 326 (53) 97 (56) 109 (50) 20 (65) 94 (53) Age (years, mean SD) 48 11 47 11 48 12 52 11 49 11 Reported comorbidities Cardiovascular diseases 83 (14) 20 (12) 29 (13) 5 (16) 28 (16) Asthma 53 (9) 22 (13) 8 (4) 6 (19) 17 (10) COPD 110 (18) 33 (19) 26 (12) 4 (13)…”
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“In the analysis of abstinence rates, patients lost to follow-up will be assumed to have returned to smoking [27, 28].”
Background
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“The primary outcome was quitting success at 4 weeks post quit day, as judged according to the Russell standard [14,15], meaning intention to treat and biochemically verified.”
Method
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“The positive impact of a ‘Russell Standard’ for evaluating clinical interventions is testament to the importance of common language in the field [7].”
Background
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Method
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Background
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Method
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Method
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“—All primary analyses on smoking cessation will be conducted using intent-to-treat and will code those lost to follow-up as smokers per the Russell Standard [63].”
Method
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BackgroundMethod
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“As recommended by the Russell Standard, [39] the primary analysis will be intention-to-treat (ITT); all consenting participants in the cohort will be included in the analysis.”
BackgroundMethodInfluential
intEgrating Smoking Cessation treatment As part of usual Psychological care for dEpression and anxiety (ESCAPE): A randomised and controlled, multi-centre, acceptability and feasibility trial with nested qualitative methods
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“[29].”
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Bryant, J., Roberts-Barker, K., Mills, Z., Booth, K., Foster, J., Mersha, A. G., Maddox, R., Chamberlain, C., Bonevski, B., Segan, C., et al. (2024) · BMJ Open · doi:10.1136/bmjopen-2024-088501 · Cited by 3
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“The following PICO model [18] was established to develop the research questions, search strategy, and the inclusion and exclusion criteria: [20,21].”
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Pope, I., Halicka, Z., Clark, L., Stirling, S., Clark, A., & Notley, C. J. (2025) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntaf200 · Cited by 3
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García, F. I. S., Derefinko, K. J., Bursac, Z., Hand, S. B., & Klesges, R. C. (2018) · Contemporary Clinical Trials · doi:10.1016/j.cct.2018.03.007 · Cited by 3
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“Abbreviations CO: Carbon monoxide; BfArM: Bundesinstitut für Arzneimittel und Medizin‑ produkte; EORTC QLQ: European Organization Research Treatment Cancer— Quality of Life Questionnaire; EQ VAS: European Quality of Life—visual analog scale; GCP: Good clinical practice; HADS: Hospital Anxiety and Depression Scale; MPS…”
MethodInfluential
Evaluation of Aboriginal and Torres Strait Islander smoking cessation interventions with pregnant women in Australia: utilising a culturally appropriate tool
Tane, M. P., Stevenson, L., Cameron, L., & Gould, G. S. (2022) · Australian Journal of Primary Health · doi:10.1071/py22023 · Cited by 3
The Effectiveness of Text Support for Stopping Smoking in Pregnancy (MiQuit): Multi-Trial Pooled Analysis Investigating Effect Moderators and Mechanisms of Action
Emery, J. L., Leonardi‐Bee, J., Coleman, T. J., McDaid, L., & Naughton, F. (2024) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntae026 · Cited by 3
“Outcome data were coded as “smoking” for all participants who were missing smoking outcomes (Russell Standard, considered a gold standard for the measurement of smoking cessation outcomes), 29 other than making a quit attempt, where a complete case analysis was used.”
Method
Mobile Phone–Based Personalized and Interactive Augmented Reality Pictorial Health Warnings for Enhancing a Brief Advice Model for Smoking Cessation: Pilot Randomized Controlled Trial
Guo, Z., Wu, Y. S., & Wang, M. P. (2024) · JMIR XR and spatial computing. · doi:10.2196/52893 · Cited by 3
“The intention to treat approach was adopted, assuming participants lost to follow-up did not change their smoking behaviors (eg, they made no quit attempts nor changed their daily cigarette consumption) [31].”
Method
Healing Hearts Together — an emotionally focused intervention for couples after a cardiac event: a randomized controlled trial protocol
Tulloch, H. E., Greenman, P. S., Reed, J. L., Susinski, S., Kasos, E., Tasca, G. A., Mielniczuk, L. M., Wells, G. A., Sun, L. Y., & Johnson, S. M. (2025) · Frontiers in Psychology · doi:10.3389/fpsyg.2025.1564666 · Cited by 3
“Smoking status is reported by participants and confirmed with CO concentration ( 10 ppm) in an expired breath sample, using the Russell standard (West et al., 2005).”
How stable are stop smoking practitioner success rates over time?
Brose, L. S., West, R., & McEwen, A. (2014) · Translational Behavioral Medicine · doi:10.1007/s13142-014-0261-4 · Cited by 3
Self-citation
Client Satisfaction With English Stop Smoking Services
May, S., & McEwen, A. (2011) · The Journal of Smoking Cessation · doi:10.1375/jsc.6.1.51 · Cited by 3
Updated information on smoking cessation management
Choi, M.-K., & Paek, Y. (2016) · Journal of Korean Medical Association · doi:10.5124/jkma.2016.59.11.872 · Cited by 3
Combining Education With Auricular Acupressure to Facilitate Smoking Cessation in Young Adults
Wang, Y.-Z., Wang, Y.-J., & Yeh, M. (2019) · Holistic Nursing Practice · doi:10.1097/hnp.0000000000000335 · Cited by 3
Enhanced smoking cessation support for newly abstinent smokers discharged from hospital (the Hospital to Home trial): a randomized controlled trial
Thorley, R., Britton, J. R., Nyakutsikwa, B., Breton, M. O., Lewis, S., & Murray, R. L. (2019) · Addiction · doi:10.1111/add.14720 · Cited by 3
“If patients reported abstinence from smoking in line with the Russell Standard (25) a researcher visited the patient at home, work or in a convenient community setting to validate smoking status by measuring exhaled CO.”
BackgroundMethod
Neither NRT aided gradual cessation nor abrupt cessation is superior in producing long-term abstinence: Reconciling conflicting results from two recent meta-analyses
Klemperer, E. M., & Lindson, N. (2019) · Tobacco Induced Diseases · doi:10.18332/tid/113378 · Cited by 3
Impact of a smoking cessation program on smoking prevalence and food security among food pantry users – a study protocol for a pragmatic cluster randomised controlled trial
Simmet, A., Teut, M., Schleicher, R., Bschaden, A., & Stroebele‐Benschop, N. (2020) · BMC Public Health · doi:10.1186/s12889-020-09232-0 · Cited by 3
“Smoking abstinence is defined as the self-reported continuous smoking cessation (≤ 5 cigarettes since the start date of their last attempt to quit) validated by the exhaled carbon monoxide test (< 10 ppm of carbon monoxide) [46].”
Method
Comparison of Motivational Short Interventions to Improve Smokers’ Health Behavior (The COSMOS Study): A Pragmatic Cluster-Randomized Two-Arm Trial in General Practice
Grischott, T., Senn, O., Frei, A. L., Rosemann, T. J., & Neuner‐Jehle, S. (2022) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntac159 · Cited by 3
Relationship of Weight Concerns to Body Mass Index in a Tobacco Treatment Program
Pánková, A., Králíková, E., Zvolská, K., Štěpánková, L., Roche, A. I., Clark, M. M., Schroder, D. R., & Croghan, I. T. (2023) · American Journal of Health Behavior · doi:10.5993/ajhb.47.2.21 · Cited by 3
Effectiveness of nicotine salt vapes, cytisine, and a combination of these products, for smoking cessation in New Zealand: protocol for a three-arm, pragmatic, community-based randomised controlled trial
Walker, N. K., Calder, A. J., Barnes, J., Laking, G. R., Parag, V., & Bullen, C. (2023) · BMC Public Health · doi:10.1186/s12889-023-16665-w · Cited by 4
“The primary outcome measure is six-month CA (Rus-sell Standard) defined as self-report of smoking not more than five cigarettes from the Quit date, supported by biochemical validation [30, 31].”
Method
Do in-person and computer-based brief alcohol interventions reduce tobacco smoking among general hospital patients? Secondary outcomes from a randomized controlled trial
Krolo-Wicovsky, F., Baumann, S., Tiede, A., Bischof, G., John, U., Gaertner, B., & Freyer‐Adam, J. (2023) · Addiction Science & Clinical Practice · doi:10.1186/s13722-023-00425-7 · Cited by 3
Does socioeconomic position moderate the associations between the content and delivery features of digital behaviour change interventions for smoking cessation and intervention effectiveness? A systematic review and meta-analysis
Leppin, C., Okpako, T., Brown, J., Garnett, C. V., & Perski, O. (2024) · Health Psychology Review · doi:10.1080/17437199.2024.2366189 · Cited by 5
“The most rigorous measure of abstinence (Piper et al., 2020; West et al., 2005) reported or made available by the study authors was extracted.”
Influential
Financial incentives to stop smoking: Potential financial consequences of different reward schedules
Valentelyte, G., Sheridan, A., Kavanagh, P. M., Doyle, F., & Sørensen, J. R. (2024) · Tobacco Prevention & Cessation · doi:10.18332/tpc/190617 · Cited by 3
“The QuitManager data capture the smoking quit rates and outcomes of all smoking individuals in Ireland who have used the Health Services Executive (HSE) stop smoking support program, in line with the Russell Standards for smoking cessation 10,11 .”
Method
Perioperative Intensive Smoking Cessation Intervention Among Smokers Who Underwent Transurethral Resection of Bladder Tumor (TURBT) in Two Different Settings: A Randomized Controlled Trial
Lydom, L. N., Lauridsen, S. V., Liljendahl, M. S., Schmedes, A., Joensen, U. N., & Tønnesen, H. (2025) · Cancers · doi:10.3390/cancers17040713 · Cited by 3
“We planned to strengthen this study by validating successful cessation by CO measurement and urine cotinine [29].”
Acceptability and outcome of an Internet-based smoking cessation programme.
Fraser, T., McRobbie, H. J., Bullen, C., Whittaker, R., & Barlow, D. (2010) · PubMed · Cited by 3
Assessment of the Effectiveness and Cost-Effectiveness of Tailored Web- and Text-Based Smoking Cessation Support in Primary Care (iQuit in Practice II): Protocol for a Randomized Controlled Trial
Proctor, J., Naughton, F., Sloan, M. A., Hopewell, S., Brimicombe, J. D., Prevost, A. T., Wilson, E., Coleman, T. J., & Sutton, S. R. (2020) · JMIR Research Protocols · doi:10.2196/17160 · Cited by 3
“A saliva sample for biochemical validation: Participants who respond to the first question with A1 or A2 also receive a saliva sampling kit for biochemical validation (cotinine and anabasine in saliva are important biomarkers for determining a participant’s smoking status) [39,40].”
One Way to Leave Your Lover: The Role of Treatment in Changing Addictive Behaviors
Sobell, M. B. (2007) · Springer eBooks · doi:10.1007/978-0-387-71287-1_7 · Cited by 3
Comparing models of smoking treatment in Glasgow: interim report
Bauld, L., Briggs, A. H., Boyd, K., Chesterman, J., Ferguson, J., Judge, K., & Wilson, M. P. (2008) · Cited by 3
Störungen durch Konsum von Alkohol und illegalen Drogen
Bühringer, G., & Metz, K. (2008) · Springer eBooks · doi:10.1007/978-3-540-79543-8_17 · Cited by 4
Smoking cessation in patients requiring bronchoscopy: The Bronchoscopy AntiSmoking Study (BASIS)
Martucci, P., Sestini, P., Canessa, P. A., Brancaccio, L., Guarino, C., Barbato, N., Lodi, M., Coloretti, I., Donno, M. D., Sini, A., et al. (2009) · Respiratory Medicine · doi:10.1016/j.rmed.2009.08.002 · Cited by 3
Advocacy Strategies for School-Based Sex Education in Guatemala: Applying the Transtheoretical Model to Results from an Impact Evaluation
McDonald, K. A., Papadopoulos, A., & Sunderland, E. (2012) · International Journal of Sexual Health · doi:10.1080/19317611.2011.640525 · Cited by 3
Changes in Motivation for Treatment in Precontemplating Dually Diagnosed Patients Receiving Assertive Community Treatment
Kortrijk, H. E., Mulder, C. L., van Vliet, D., van Leeuwen, C., Jochems, E. C., & Staring, A. B. P. (2013) · Community Mental Health Journal · doi:10.1007/s10597-012-9582-2 · Cited by 5
Successful Smoking Cessation: the Role of Self-efficacy, Mindfulness and Demographic Factors
Boogar, I. R., & Mirkouhi, M. G. (2013) · Majallah-i dānishgāh-i ̒ulūm-i pizishkī-i Māzandarān/Journal of Mazandaran University of Medical Sciences · Cited by 3
Cutting edge smoking cessation support: SCIMITAR+
Robson, D., & McNeill, A. D. (2019) · The Lancet Psychiatry · doi:10.1016/s2215-0366(19)30131-2 · Cited by 3
Development of a biochemical marker to detect current breast milk intake
Addison, R., Hill, L., Bode, L., Robertson, B., Choudhury, B., Young, D., Wright, C. M., Relton, C., García, A. L., & Tappin, D. M. (2019) · Maternal and Child Nutrition · doi:10.1111/mcn.12859 · Cited by 3
Comparison between success rates for smokers re‐treated by a smokers’ clinic and success rates for smokers treated for the first time
Štěpánková, L., Králíková, E., Zvolská, K., Pánková, A., Adamcekova, Z., Kuhn, M., & Noland, D. H. (2020) · Addiction · doi:10.1111/add.15175 · Cited by 3
Investigating Changes in Patients’ Smoking Behavior, Tobacco Dependence, and Motivation to Stop Smoking Following a “Smoke-Free” Mental Health Inpatient Stay: Results From a Longitudinal Survey in England
Ainscough, T., Mitchell, A. S., Hewitt, C. E., Horspool, M. J., Stewart, P., Ker, S., Colley, L., Paul, C., Hough, P., Hough, S., et al. (2020) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntaa258 · Cited by 3
Contested knowledge: Introducing Fillmore, Kerr, Stockwell, Chikritzhs, and Bostrom ()
Heim, D. (2006) · Addiction Research & Theory · doi:10.1080/16066350500537622 · Cited by 3
Substance abuse treatment and the stages of change, by Gerard J. Connors, Carlo C. DiClemente, Mary Marden Velasquez, & Dennis M. Donovan
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Personalized chat‐based support for smoking cessation among smokers with mental health symptoms in the workplace: A randomized controlled trial.
Yao, Y., Luk, T. T., Lau, O. S., Wu, Y. S., Weng, X., Ng, C. H., Cheung, Y. T. D., Lam, T. H., & Wang, M. P. (2025) · Addiction · doi:10.1111/add.70013 · Cited by 3
ENHANCE-D: protocol for a pragmatic, 3-arm, randomised controlled trial comparing the impact of enhanced smoking cessation interventions to very brief advice for adult smokers in dental care settings
Holliday, R., Wilson, N., Ryan, V., Butcher, C., Homer, T. M., Watts, P., Kareithi, D. N., Blaylock, P., Ternent, L., Finch, R., et al. (2025) · Trials · doi:10.1186/s13063-025-08954-z · Cited by 15
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Efficacy of cognitive behavioral therapy‐based smartphone app for smoking cessation in China: A randomized controlled trial
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Mobile Chat Messaging for Smoking Relapse Prevention
Luk, T. T., Su, X., Wong, V., Chan, H. C.-H., Wong, G. N.-T., Lee, J. K. H., Ho, S. Y., Lam, T. H., Cheung, Y. T. D., & Wang, M. P. (2026) · JAMA Internal Medicine · doi:10.1001/jamainternmed.2025.7439 · Cited by 2
Approach Bias Modification as an Add-On to Smoking Cessation Treatment: A Randomized Controlled Trial
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Training health professionals in smoking cessation
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Supporting smoking cessation in pregnancy
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Could Smokers’ Socio-Demographic and Housing Factors Affect and Influence the Choice Between Smoking Cessation Therapies?
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A pilot study of the Tobacco Treatment Guidelines for High-Risk Groups (TOB-G) for pregnant and postpartum women
Papadakis, S., Vyzikidou, V. K., Vivilaki, V. G., Vardavas, C. I., Loukopoulou, A. N., Peleki, T., Evangelopoulou, V., & BEHRAKIS, P. K. (2018) · European Journal of Midwifery · doi:10.18332/ejm/99543 · Cited by 2
The estimand framework and its application in substance use disorder clinical trials: a case study
Roydhouse, J. K., Floden, L. L., Tomko, R. L., Gray, K. M., & Bell, M. L. (2021) · The American Journal of Drug and Alcohol Abuse · doi:10.1080/00952990.2021.1976199 · Cited by 2
“Additionally, although this approach can produce biased results (34,35), it is one of the criteria in the Russell Standard (36), which is frequently used in smoking cessation trials.”
The effect of individual-level smoking cessation interventions on socioeconomic inequalities in tobacco smoking
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Mixed methods evaluation of the ‘real-world’ implementation of group-based behavioral stop smoking support through Facebook
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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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