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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Background
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“They will, however, be excluded from the numerator and denominator of the cessation rate, in line with Russell standard criteria [27].”
BackgroundMethodResultInfluential
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Self-citation
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Background
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Background
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Background
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Method
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BackgroundMethodInfluential
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Background
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Background
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Method
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“15 21 Additionally, interventions with mood management components are expected to mitigate potential negative impacts of an unsuccessful quit attempt on mental health.”
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Background
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BackgroundMethod
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Hollands, G. J., Sutton, S. R., & Aveyard, P. N. (2021) · Journal of Substance Abuse Treatment · doi:10.1016/j.jsat.2021.108591 · Cited by 12
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“Time to first lapse, with a lapse episode defined here as any smoking, even a puff [39].”
Background
Does cigarette reduction while using nicotine replacement therapy prior to a quit attempt predict abstinence following quit date?
Lindson, N., Shinkins, B., West, R., Michie, S., & Aveyard, P. N. (2016) · Addiction · doi:10.1111/add.13330 · Cited by 13
Self-citation
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Begh, R. A., Smith, M. C., Ferguson, S. G., Shiffman, S. M., Munafo, M. R., & Aveyard, P. N. (2016) · Psychology of Addictive Behaviors · doi:10.1037/adb0000231 · Cited by 14
“Abstinence was verified at each clinic visit with a CO level <10 ppm (West et al., 2005).”
Method
Contingency management for tobacco smoking during opioid addiction treatment: a randomised pilot study
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A guidance was developed to identify participants with missing outcome data in randomized controlled trials
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“Participants for whom smoking cessation could not be confirmed (i.e. are lost to follow-up) were included in the analysis as failed quits in line with the Russell Standard [10].”
MethodResultInfluential
Comparative effectiveness of post-discharge strategies for hospitalized smokers: Study protocol for the Helping HAND 4 randomized controlled trial
Rigotti, N. A., Schnitzer, K., Davis, E. M., Regan, S., Chang, Y., Kelley, J. H. K., Notier, A. E., Gilliam, K., Douaihy, A. B., Levy, D. E., et al. (2020) · Trials · doi:10.1186/s13063-020-04257-7 · Cited by 13
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Elsey, H., Dogar, O. F., Ahluwalia, J. S., & Siddiqi, K. (2015) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2015.08.002 · Cited by 13
Treatment-seeking for alcohol problems: The influence of mirroring events and windows of opportunity
Roper, L., McGuire, J., Salmon, P., & Booth, P. G. (2012) · Addiction Research & Theory · doi:10.3109/16066359.2012.746318 · Cited by 17
Examining gender differences in received, provided, and invisible social control: an application of the dual-effects model
Lüscher, J., Ochsner, S., Knoll, N., Stadler, G., Hornung, R., & Scholz, U. (2014) · Anxiety Stress & Coping · doi:10.1080/10615806.2014.892585 · Cited by 13
“Moreover, smoking behavior was objectively quantified by expired air CO (West et al., 2005).”
BackgroundMethodInfluential
A mixed methods feasibility study of nicotine-assisted smoking reduction programmes delivered by community pharmacists – The RedPharm study
Farley, A., Tearne, S., Taskila, T. K., Williams, R. H., MacAskill, S., Etter, J., & Aveyard, P. N. (2017) · BMC Public Health · doi:10.1186/s12889-017-4116-z · Cited by 12
“self-report abstinence or up to five cigarettes smoked only, from day 15 after quit day onwards [15].”
Background
Subsidized pharmacological treatment for smoking cessation by the Spanish public health system: A randomized, pragmatic, clinical trial by clusters
Minué-Lorenzo, C., Olano-Espinosa, E., del Cura-González, I., Vizcaíno-Sánchez, J., Guillem, F. C., Granados-Garrido, J., Ruiz-Pacheco, M., Gámez-Cabero, M. I., Martinez-Suberviola, F. J., & Serrano, M. E. S. (2019) · Tobacco Induced Diseases · doi:10.18332/tid/111368 · Cited by 13
The association between probable personality disorders and smoking cessation and maintenance
Piñeiro, B., del Río, E. F., López‐Durán, A., Martínez, Ú., & Becoña, E. (2013) · Addictive Behaviors · doi:10.1016/j.addbeh.2013.03.017 · Cited by 12
Cost-effectiveness of point of care smoking cessation interventions in oncology clinics
Mullen, K. A., Hurley, K., Hewitson, S., Scoville, J., Grant, A., Thavorn, K., Kumar, E., & Warren, G. W. (2024) · British Journal of Cancer · doi:10.1038/s41416-024-02819-z · Cited by 12
“A common standard of intention to treat analysis in cessation outcomes was used; if the patient was not reached in follow-up, it was assumed they were still smoking unless they had died [27].”
Method
Evaluating the Impact of a Game (Inner Dragon) on User Engagement Within a Leading Smartphone App for Smoking Cessation: Randomized Controlled Trial
White, J. S., Toussaert, S., Raiff, B. R., Salem, M. K., Chiang, A. Y., Crane, D., Warrender, E., Lyles, C. R., Abroms, L. C., Westmaas, J. L., et al. (2024) · Journal of Medical Internet Research · doi:10.2196/57839 · Cited by 13
Interventions for smokeless tobacco use cessation
Livingstone‐Banks, J., Vidyasagaran, A. L., Croucher, R., Siddiqui, F., Zhu, S., Kidwai, Z., Parkhouse, T., Mehrotra, R., & Siddiqi, K. (2025) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd015314.pub2 · Cited by 13
Vaporized Nicotine Products for Smoking Cessation Among People Experiencing Social Disadvantage
Courtney, R. J., Howard, B. C., Barker, D., Petrie, D., Borland, R., Shakeshaft, A. P., GARTNER, C. E., Mendelsohn, C. P., Boland, V. C., Henderson, A., et al. (2025) · Annals of Internal Medicine · doi:10.7326/annals-24-03531 · Cited by 12
Facets of the NEO-PI-R and smoking cessation
del Río, E. D., López-Durán, A., Rodríguez-Cano, R., Martínez, Ú., Martínez-Vispo, C., & Becoña, E. (2015) · Personality and Individual Differences · doi:10.1016/j.paid.2015.02.030 · Cited by 9
Nicotine metabolite ratio and smoking outcomes using nicotine replacement therapy and varenicline among smokers with and without psychiatric illness
Clyde, M. J., Pipe, A., Els, C., Reid, R. D., Fu, A. Y. N., Clark, A., & Tulloch, H. E. (2018) · Journal of Psychopharmacology · doi:10.1177/0269881118773532 · Cited by 12
Mobile chat-based support plus nicotine replacement therapy sampling to promote smoking cessation for community smokers: A randomized controlled trial
Zhao, S. Z., Wu, Y. S., Chau, S. L., Fong, D., Lam, T., & Wang, M. P. (2021) · Tobacco Induced Diseases · doi:10.18332/tid/133373 · Cited by 12
Efficacy and safety of combination behavioral activation for smoking cessation and varenicline for treating tobacco dependence among individuals with current or past major depressive disorder: A 2 × 2 factorial, randomized, placebo‐controlled trial
Hitsman, B. L., Papandonatos, G. D., Gollan, J. K., Huffman, M. D., NIAURA, R. S., Mohr, D. C., Veluz‐Wilkins, A. K., Lubitz, S. F., Hole, A. V., Leone, F. T., et al. (2023) · Addiction · doi:10.1111/add.16209 · Cited by 12
Developing a Tailored Smoking Cessation Intervention for Rheumatoid Arthritis Patients
Aimer, P., Stamp, L. K., Stebbings, S. M., Cameron, V. A., Kirby, S., Croft, S., & Treharne, G. J. (2015) · Musculoskeletal Care · doi:10.1002/msc.1106 · Cited by 12
Applying the RE-AIM Framework to Evaluate the Dissemination and Implementation of Clinical Practice Guidelines for Sexually Transmitted Infections
Jeong, H., Jo, H. S., Oh, M.-K., & Oh, H. S. (2015) · Journal of Korean Medical Science · doi:10.3346/jkms.2015.30.7.847 · Cited by 13
The Impact of CAROtid plaque Screening on Smoking (CAROSS) cessation and control of other cardiovascular risk factors: Rationale and design of a randomized controlled trial
Rodondi, N., Bovet, P., Hayoz, D., & Cornuz, J. (2008) · Contemporary Clinical Trials · doi:10.1016/j.cct.2008.03.001 · Cited by 12
Predictors of response to brief intervention in general practice against long-term benzodiazepine use
Heather, N., Paton, J., & Ashton, H. (2011) · Addiction Research & Theory · doi:10.3109/16066359.2011.569102 · Cited by 12
Cost effectiveness of full coverage of the medical management of smoking cessation in France
Chevreul, K., Cadier, B., Durand‐Zaleski, I., Chan, E., & Thomas, D. (2012) · Tobacco Control · doi:10.1136/tobaccocontrol-2012-050520 · Cited by 12
Does Effectiveness of Adolescent Smoking-Cessation Intervention Endure Into Young Adulthood? 7-Year Follow-Up Results from a Group-Randomized Trial
Peterson, A. V., Marek, P. M., Kealey, K. A., Bricker, J. B., Ludman, E. J., & Heffner, J. L. (2016) · PLoS ONE · doi:10.1371/journal.pone.0146459 · Cited by 14
“…of quitting: 6-months prolonged abstinence measured one year post-intervention, a high standard for short-term cessation that has been recommended as a preferred measure of abstinence by both the SRNT workshop on measures of abstinence in clinical trials [43], and the Russell Standards [51].”
A prospective, observational study investigating the use of carbon monoxide screening to identify maternal smoking in a large university hospital in Ireland
Reynolds, C. M. E., Egan, B., Kennedy, R., O’Malley, E. G., Sheehan, S. R., & Turner, M. J. (2018) · BMJ Open · doi:10.1136/bmjopen-2018-022089 · Cited by 12
Nicotine preloading for smoking cessation: the Preloading RCT
Aveyard, P. N., Lindson, N., Tearne, S., Adams, R. L., Ahmed, K., Alekna, R., Banting, M., Healy, M., Khan, S. S. F., Rai, G., et al. (2018) · Health Technology Assessment · doi:10.3310/hta22410 · Cited by 12
ITM support for patients with chronic respiratory and cardiovascular diseases: a protocol for a randomised controlled trial
Redfern, J., Hyun, K. K., Singleton, A. C., Hafiz, N., Raeside, R., Spencer, L. M., Carr, B., Caterson, I. D., Cullen, J. S., Ferry, C., et al. (2019) · BMJ Open · doi:10.1136/bmjopen-2018-023863 · Cited by 12
N-acetylcysteine for cessation of tobacco smoking: rationale and study protocol for a randomised controlled trial
Arancini, L., Bortolasci, C. C., Dodd, S., Dean, O. M., & Berk, M. (2019) · Trials · doi:10.1186/s13063-019-3628-5 · Cited by 13
Varenicline versus nicotine replacement therapy for long-term smoking cessation: an observational study using the Clinical Practice Research Datalink
Davies, N. M., Taylor, A. E., Taylor, G. M. J., Itani, T., Jones, T., Martin, R. M., Munafo, M. R., Windmeijer, F. A. G., & Thomas, K. H. (2020) · Health Technology Assessment · doi:10.3310/hta24090 · Cited by 12
“The multiply imputed results were similar to our main results, which assumed that patients with no smoking status records in the follow-up period were continuing smokers (see Report Supplementary Material 1, Table S7).(28)”
Result
Randomised controlled trial of a just-in-time adaptive intervention (JITAI) smoking cessation smartphone app: the Quit Sense feasibility trial protocol
Naughton, F., Brown, C., High, J., Notley, C. J., Mascolo, C., Coleman, T. J., Barton, G., Shepstone, L., Sutton, S. R., Prevost, A. T., et al. (2021) · BMJ Open · doi:10.1136/bmjopen-2020-048204 · Cited by 14
Qualitätsmerkmale von Raucherbehandlungen – die Notwendigkeit für definierte Standards
Batra, A., Kröger, C. B., Lindinger, P., & Pötschke-Langer, M. (2008) · SUCHT - Zeitschrift für Wissenschaft und Praxis / Journal of Addiction Research and Practice · doi:10.1024/2008.02.06 · Cited by 12
Smoking bans for reducing smoking prevalence and tobacco consumption
Callinan, J. E., Clarke, A., Doherty, K., & Kelleher, C. (2006) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd005992 · Cited by 12
Engagement With a Mobile Chat-Based Intervention for Smoking Cessation: A Secondary Analysis of a Randomized Clinical Trial
Li, Y., Luk, T. T., Cheung, Y. T. D., Zhao, S., Zeng, Y., Tong, H. S. C., Lai, V. W. Y., & Wang, M. P. (2024) · JAMA Network Open · doi:10.1001/jamanetworkopen.2024.17796 · Cited by 13
Predictors of tobacco smoking abstinence among tuberculosis patients in South Africa
Louwagie, G. M. C., & Ayo-Yusuf, O. A. (2015) · Journal of Behavioral Medicine · doi:10.1007/s10865-015-9620-y · Cited by 11
“For the subgroup of participants who were offered carbon monoxide testing, self-reported abstinence was considered confirmed if the exhaled carbon monoxide levels were below 10 parts per million (West et al., 2005).”
Background
Tobacco Treatment Outcomes in Patients With and Without a History of Depression, Czech Republic, 2005–2010
Stepankova, L., Kralikova, E., Zvolska, K., Kmetova, A., Blaha, M., Bortlicek, Z., Sticha, M., Anders, M., Schroeder, D. R., & Croghan, I. T. (2013) · Preventing Chronic Disease · doi:10.5888/pcd10.130051 · Cited by 11
“The evaluation of the outcome was based on Russell Standard (RS) criteria (26).”
Patterns of e-Cigarette Use and Smoking Cessation Outcomes: Secondary Analysis of a Large Randomised Controlled Trial to Inform Clinical Advice
Pesola, F., Smith, K. M., Przulj, D., Ladmore, D., Phillips‐Waller, A., McRobbie, H. J., & Hájek, P. (2025) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntaf240 · Cited by 11
Promoting smoking cessation during pregnancy: A feasibility and pilot trial of a digital storytelling intervention delivered via text‐messaging
King, E., Cheyne, H., Abhyankar, P., Elders, A., Grindle, M., Hapca, A., Jones, C., O’Carroll, R. E., Steele, M., & Williams, B. (2022) · Patient Education and Counseling · doi:10.1016/j.pec.2021.12.019 · Cited by 11
“2 shows the Russell Standard Abstinence Rates, which measures the number of participants who have abstained from smoking for several weeks.”
MethodInfluential
Scaling up tobacco cessation within TB programmes: findings from a multi-country, mixed-methods implementation study
Elsey, H., Azdi, Z. A., Regmi, S., Baral, S., Fatima, R., Fieroze, F., Huque, R., Karki, J., Khan, D. M., Khan, A., et al. (2022) · Health Research Policy and Systems · doi:10.1186/s12961-022-00842-1 · Cited by 11
“Given the challenges of self-reported measures of cessation, biochemical validation of these quits would also have been necessary to assess the effectiveness of the scaled-up intervention within the learning sites [47].”
Background
Personalised multicomponent interventions for tobacco dependence management in low socioeconomic populations: a systematic review and meta-analysis
Huynh, N., Tariq, S., Charron, C. B., Hayes, T., Bhanushali, O., Kaur, T., Jama, S., Ambade, P., Bignell, T., Hegarty, T., et al. (2022) · Journal of Epidemiology & Community Health · doi:10.1136/jech-2021-216783 · Cited by 11
The Role of Financial Strain and Educational Attainment on Smoking Abstinence of African Americans and Whites Who Smoke
Maglalang, D. D., Avila, J. C., Ahluwalia, J. S., Murphy, C. M., Alexander, A. C., & Nollen, N. L. (2022) · Ethnicity & Disease · doi:10.18865/ed.32.3.223 · Cited by 11
Integrated Text Messaging (ITM) for people attending cardiac and pulmonary rehabilitation: A multicentre randomised controlled trial
Redfern, J., Singleton, A. C., Raeside, R., Santo, K., Hafiz, N., Spencer, L. M., Leung, R. W., Roberts, M., King, M., Cho, J., et al. (2023) · Annals of Physical and Rehabilitation Medicine · doi:10.1016/j.rehab.2023.101800 · Cited by 11
Evaluation of a hospital-initiated tobacco dependence treatment service: uptake, smoking cessation, readmission and mortality
Robins, J. E., Patel, I. S., McNeill, A. D., Moxham, J., Woodhouse, A., Absalom, G., Shehu, B., Bruce, G., Dewar, A., Molloy, A., et al. (2024) · BMC Medicine · doi:10.1186/s12916-024-03353-8 · Cited by 10
“However, those patients who were not able to be contacted were conservatively classified as smokers, as per published guidance [41].”
Background
Effects of Nicotine Deprivation and Replacement on BOLD-fMRI Response to Smoking Cues as a Function of DRD4 VNTR Genotype
Xu, X., Clark, U. S., David, S. P., Mulligan, R. C., Knopik, V. S., McGeary, J. E., MacKillop, J., McCaffery, J. M., NIAURA, R. S., & Sweet, L. H. (2014) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntu010 · Cited by 11
Factors moderating the relative effectiveness of varenicline and nicotine replacement therapy in clients using smoking cessation services
Walker, N., Gainforth, H. L., Kiparoglou, V., Robinson, H., van Woerden, H. C., & West, R. (2017) · Addiction · doi:10.1111/add.14004 · Cited by 10
“Our primary outcome measure was carbon monoxide (CO)-validated quit [17], in line with National Health Service (NHS) guidelines at 4 weeks, and this was supported by analysis of self-reported quit at 12 weeks (CO readings were only taken at the 4-week time-point).”
MethodSelf-citation
Reported patterns of vaping to support long-term abstinence from smoking: a cross-sectional survey of a convenience sample of vapers
Gentry, S. V., Ward, E., Dawkins, L., Holland, R., & Notley, C. J. (2020) · Harm Reduction Journal · doi:10.1186/s12954-020-00418-8 · Cited by 11
“Five episodes were required for relapse as per the Russell Standards which allow up to five cigarettes to be smoked for an individual still to be considered smoking abstinent [25].”
Method

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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