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Outcome criteria in smoking cessation trials: proposal for a common standard
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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“authors like Benowitz et al. (2020) and West et al. (2005) suggest that abstinence outcomes are also reliable in those studies in which biochemical verification is not feasible, such as those in which the data are collected by phone or through the internet or when personal contact is limited.”
From Evaluation of effectiveness and acceptability of a psychological treatment for smoking cessation combined with a smartphone App: A pilot study (2024) · cites this paper as West et al., 2005
In the citing paper
“Study participants who (a) did not attend a follow-up visit, or (b) did not have a CO measurement, or (c) whose measured CO value exceeded the threshold of 9 ppm defined as critical (West et al., 2005) were classified as smokers.”
From Hypnotherapy compared to cognitive-behavioral therapy for smoking cessation in a randomized controlled trial (2024) · cites this paper as West et al., 2005
In the citing paper
“The primary outcome measure was 12 months continuous abstinence (CA) according to the Russell standard (West et al., 2005). This is defined as self-report of having smoked no more than five cigarettes since the end of treatment (and during all assessments 1, 6, 9, and 12 months later), supported by negative biochemical validation (CO < 10 ppm).”
From Hypnotherapy compared to cognitive-behavioral therapy for smoking cessation in a randomized controlled trial (2024) · cites this paper as West et al., 2005
In the citing paper
“In accordance with the Russell standard (West et al., 2005), a CO measurement of 10 or more parts per million was defined as indicative of current smoking.”
From Hypnotherapy compared to cognitive-behavioral therapy for smoking cessation in a randomized controlled trial (2024) · cites this paper as West et al., 2005
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BackgroundNicotine receptor partial agonists for smoking cessation
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BackgroundElectronic Nicotine-Delivery Systems for Smoking Cessation
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Self-citationMobile phone-based interventions for smoking cessation
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“, 2004), it has been argued that a sustained period of abstinence is required to provide confidence that it will continue long-term (West et al., 2005).”
InfluentialSelf-citationSmoking reduction interventions for smoking cessation
Lindson, N., Klemperer, E., Hong, B., Ordóñez-Mena, J. M., & Aveyard, P. (2019) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd013183.pub2 · Cited by 133
The clinical significance of ‘small’ effects of smoking cessation treatments
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Self-citationCytisine for the treatment of nicotine addiction: from a molecule to therapeutic efficacy.
Tutka, P., & Zatoński, W. A. (2006) · PubMed · Cited by 125
Glasson, C., Chapman, K. L., & James, E. L. (2010) · Public Health Nutrition · doi:10.1017/s1368980010001643 · Cited by 130
Meta-analysis of the effectiveness of smoking cessation interventions in community pharmacy
Saba, M., Diep, J., Saini, B., & Dhippayom, T. (2014) · Journal of Clinical Pharmacy and Therapeutics · doi:10.1111/jcpt.12131 · Cited by 120
“Proposed smoking cessation success rate is dependent upon the duration of abstinence as well.(37) As sustained abstinence is required to provide long-term estimates, the time interval of follow-up is crucial.”
BackgroundThompson, T., Greaves, C. J., Ayres, R., Aveyard, P. N., Warren, F. C., Byng, R., Taylor, R. S., Campbell, J. L., USSHER, M. H., Michie, S., et al. (2015) · Trials · doi:10.1186/1745-6215-16-1 · Cited by 120
“cohabiting status, cohabiting with other smokers, whether they were the parent of a resident child under 16, job status, age at leaving fulltime education, ethnicity, weight, and height), smoking history (age on starting smoking, longest period of cessation in the last year, attempts at cutting down, cessation aids us…”
MethodSelf-citationRoberts, E., Eden Evins, A., McNeill, A., & Robson, D. (2016) · Addiction · doi:10.1111/add.13236 · Cited by 119
“The efficacy outcome is sustained smoking cessation, i.e. abstinence for 6 months or longer, as recommended by the Russell Standard [34], an internationally recognized standard for reporting smoking cessation trials.”
MethodEffect of Cytisine vs Varenicline on Smoking Cessation: A Randomized Clinical Trial
Courtney, R. J., McRobbie, H., Tutka, P., Weaver, N. A., Petrie, D., Mendelsohn, C. P., Shakeshaft, A., Talukder, S., Macdonald, C., Thomas, D., et al. (2021) · JAMA · doi:10.1001/jama.2021.7621 · Cited by 118
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Sex Differences in Smoking Cessation Pharmacotherapy Comparative Efficacy: A Network Meta-analysis
Smith, P. H., Weinberger, A. H., Zhang, J., Emme, E., Mazure, C. M., & McKee, S. A. (2016) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntw144 · Cited by 118
Tobacco cessation interventions for young people
Stanton, A., & Grimshaw, G. (2013) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003289.pub5 · Cited by 113
Nicotine receptor partial agonists for smoking cessation
Cahill, K., Stead, L. F., & Lancaster, T. (2008) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006103.pub3 · Cited by 116
Self-citationBullen, C., Williman, J. A., Howe, C., Laugesen, M., McRobbie, H. J., Parag, V., & Walker, N. K. (2013) · BMC Public Health · doi:10.1186/1471-2458-13-210 · Cited by 111
“intention to treat analysis, smoking five cigarettes in all [from the Quit date], plus biochemical verification of self-reported abstinence via exhaled carbon monoxide [CO] measurement, using the Bedfont Microplus device, of less than 10 parts per million) [27].”
MethodAction to Stop Smoking in Suspected Tuberculosis (ASSIST) in Pakistan
Siddiqi, K., Khan, A. Z., Ahmad, M., Dogar, O. F., Kanaan, M. N., Newell, J. N., & Thomson, H. (2013) · Annals of Internal Medicine · doi:10.7326/0003-4819-158-9-201305070-00006 · Cited by 110
“surement (piCO Smokerlyzer, Bedfont Scientific, Maidstone, United Kingdom) of 9 ppm or less (Russell standard) (21) at the 1- and 6-month follow-up visits.”
BackgroundMethodJones, M., Lewis, S., Parrott, S., Wormall, S., & Coleman, T. J. (2016) · Addiction · doi:10.1111/add.13309 · Cited by 113
“participants lost to follow-up were considered to be smoking [33].”
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Hiscock, R., Dobbie, F., & Bauld, L. (2015) · BioMed Research International · doi:10.1155/2015/274056 · Cited by 111
Hughes, J. R., Carpenter, M. J., & Naud, S. J. (2010) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntq078 · Cited by 111
Internet-based interventions for smoking cessation
Čivljak, M., Sheikh, A., Stead, L. F., & Car, J. (2010) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd007078.pub3 · Cited by 108
Self-citationInterventions for tobacco use cessation in people living with HIV and AIDS
Pool, E. R. M., Dogar, O. F., Lindsay, R. P., Weatherburn, P., & Siddiqi, K. (2016) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd011120.pub2 · Cited by 108
Performance of English stop smoking services in first 10 years: analysis of service monitoring data
West, R., May, S., West, M., Croghan, E., & McEwen, A. (2013) · BMJ · doi:10.1136/bmj.f4921 · Cited by 103
Self-citationMorgan, H. M., Hoddinott, P., Thomson, G., Crossland, N., Farrar, S., Yi, D., Hislop, J., Morán, V. H., MacLennan, G., Dombrowski, S. U., et al. (2015) · Health Technology Assessment · doi:10.3310/hta19300 · Cited by 110
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Kim, D., Yoo, S., Tegethoff, M., Meinlschmidt, G., & Lee, J. (2015) · Journal of Cognitive Neuroscience · doi:10.1162/jocn_a_00802 · Cited by 107
Metadata
- 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
- 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
- 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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