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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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“The questions that need to be answered are 1) how long a person must be abstinent before they are “eligible” for a relapse; 2) when exactly a smoking event is a lapse versus a relapse; and 3) whether or not smoking cessation outcomes also subsume relapses [12, 13, 15].”
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Self-citationLeveraging Genomic Data in Smoking Cessation Trials in the Era of Precision Medicine: Why and How
Chen, L., Zawertailo, L. A., Piasecki, T. M., Kaprio, J. A., Foreman, M. G., Elliott, H. R., David, S. P., Bergen, A. W., Baurley, J. W., Tyndale, R. F., et al. (2017) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntx097 · Cited by 20
“A proposed alternative, the “Russell Standard Abstinence” definition, requires the conjunction of a self-report of smoking 5 or fewer cigarettes since the quit date and a negative biochemical test at the follow-up.(73) Both definitions incorporate allowances for a limited amount of smoking after the target quit date,”
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“Six months continuous abstinence will be defined by self-report as not having smoked more than five cigarettes for the entire 6-month period preceding the 7-month follow-up(25).”
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Rigotti, N. A., Benowitz, N. L., Prochaska, J. J., Rubinstein, M., Clarke, A., Blumenstein, B. A., Cain, D. F., & Jacobs, C. A. (2025) · JAMA Internal Medicine · doi:10.1001/jamainternmed.2025.0628 · Cited by 24
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“Prolonged abstinence, following the Russel standard [29], was defined at the 3-month follow-up as not smoking more than 5 cigarettes in the past 8 weeks.”
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“Smoking cessation rates are typically reported assuming that missing cases are smokers, which is the standard in this field and also used by the Cochrane Tobacco Addiction Group [28].”
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“Data were also analyzed and reported according to the Russell Standards for RCTs [17], which assume that non-responders have relapsed and they are thereby included in the analysis as smokers, to ensure that this study can be compared to randomized studies.”
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“In accordance with the Russell Standard [20], we will conduct an intention-to-treat analysis, and assume those lost to follow-up are smokers.”
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“Smoking status was defined if they smoked > 100 cigarettes in their lifetime and were still smoking or had given up less than one year ago (20) and alcoholism as daily intake of alcohol during the last one month.”
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“An additional question is sent in the SC RCT about tobacco use in the 14 days prior to 4 weeks after the set quit date, to comply with the Russell Standard and thus make the study better comparable to international smoking cessation studies [60].”
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BackgroundAddiction: a journal and its Invisible College*
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“The Russell Standard for smoking cessation is the gold standard for use in monitoring clinical practice and research [31].”
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“Secondary outcomes were: prolonged abstinence, assessed using a modified Russell Standard criteria [37]”
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Quitting smoking improves two-year survival after a diagnosis of non-small cell lung cancer
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“To assess continued and prolonged abstinence [43] we first ask when the participants’ last serious quit date was and then measure continued abstinence (“Have you smoked since this quit date?” No, not a puff; Yes, 1–5 cigarettes or other tobacco products; Yes, more than 5 cigarettes or other tobacco products) and prolo…”
Becoña, E., López‐Durán, A., del Río, E. F., & Martínez, Ú. (2014) · BMC Public Health · doi:10.1186/1471-2458-14-613 · Cited by 17
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“– Abstinence at 3, 6, and 18 months using the ‘Russell Standard’, a recently suggested standard for smoking cessation trials [42].”
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Analysis of Health Behavior Theories for Clustering of Health Behaviors
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“n (%) n (%) n (%) Age in years – Mean (SD) 38 (11) 37 (12) 38 (11) Gender Male Female 126 (52) 118 (48) 95 (51) 92 (49) 221 (51) 210 (49) Housing Own house Rental Supported/government housing Family/friends/motel/street/other 7 (3) 68 (28) 119 (49) 50 (20) 6 (3) 60 (32) 87 (47) 34 (18) 13 (3) 128 (30) 206 (48) 84 (19)…”
Self-citationPredictors of Smoking Cessation Among College Students in a Pragmatic Randomized Controlled Trial
Pardavila‐Belio, M. I., Ruiz‐Canela, M., & Canga‐Armayor, N. (2019) · Prevention Science · doi:10.1007/s11121-019-01004-6 · Cited by 18
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Validity of the timeline followback among treatment-seeking smokers in Germany
Collins, S. E., Eck, S., Torchalla, I., Schröter, M., & Batra, A. (2009) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2009.05.023 · Cited by 17
Schulz, D. N., Kremers, S., & de Vries, H. (2012) · BMC Public Health · doi:10.1186/1471-2458-12-360 · Cited by 19
Models of smoking cessation brief interventions in oral health
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Preoperative smoking cessation interventions: a systematic review and meta-analysis
Alsanad, M. A., Aljanoubi, M. A., Alenezi, F. K., Farley, A., Naidu, B. V., & Yeung, J. (2025) · Perioperative Medicine · doi:10.1186/s13741-024-00479-4 · Cited by 22
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“The primary outcomes include prolonged abstinence, following the Russell standard definition of not having smoked more than 5 cigarettes in the past 8 weeks (thus allowing for a 4-week grace period) [24].”
Financial incentives for quitting smoking in pregnancy: Are they cost‐effective?
McMeekin, N., Sinclair, L., Robinson‐Smith, L., Mitchell, A. J., Bauld, L., Tappin, D. M., & Boyd, K. (2023) · Addiction · doi:10.1111/add.16176 · Cited by 15
“Participants with missing quitter outcome data, both for the primary outcome and late-pregnancy quit rate, were assumed to be smokers, as per Russell standard best practice [34].”
MethodKennedy, M., Maddox, R., Mersha, A. G., Chamberlain, C., Segan, C., Clarke, K., Donaldson, B., Roberts-Barker, K., Forster, J., Booth, K., et al. (2024) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntae106 · Cited by 16
Mullen, K. A., Walker, K. L., Hobler, L. A., Wells, G. A., Moroz, I., Pipe, A., Patzer, K., Aitken, D., & Reid, R. D. (2019) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntz186 · Cited by 16
Smokeless tobacco cessation in S outh A sian communities: a multi‐centre prospective cohort study
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A randomised trial of glucose tablets to aid smoking cessation
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“When abstinence is reported, it will be verified by exhaled carbon monoxide (CO) levels using a MICRO+ Smokerlyzer, with a cut-off of < 10 ppm [42,63].”
BackgroundMethodViews from the Coalface: What Do English Stop Smoking Service Personnel Think about E-Cigarettes?
Hiscock, R., Bauld, L., Arnott, D., Dockrell, M. J., Ross, L., & McEwen, A. (2015) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph121215048 · Cited by 15
“Clients who are lost to follow up are included in the denominator in an “intention to treat” approach [22].”
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Boredom susceptibility as predictor of smoking cessation outcomes: Sex differences
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“· 6-month continuous smoking abstinence: The Russell Standard defines continuous abstinence as a self-report of not smoking more than 5 cigarettes from the start of the abstinence period (in this case 6 months), supported by a negative biochemical test (exhaled Carbon Monoxide (CO) < 10 ppm) at final follow-up [40].”
MethodVaping cessation interventions: a systematic review and meta-analysis
Heshmati, J., Pandey, A., Benjamen, J., Furqan, M., Salman, M., Visintini, S. M., Mullen, K. A., Guyatt, G., Pipe, A., & Mir, H. R. (2025) · Tobacco Control · doi:10.1136/tc-2024-058798 · Cited by 15
“54 In addition, RCTs should aim to evaluate accessible and easily reproducible methods for vaping cessation including but not limited to text messaging, counselling, mobile applications, exercise, nutrition and pharmacotherapy.”
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Perceived Stress and Smoking Cessation: The Role of Smoking Urges
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“Expert recommendations [52,58] suggest that studies with limited in-person contact or data collected through the Internet or telephone, in which biochemical verification is not feasible, nevertheless provide reliable abstinence outcomes.”
BackgroundPhysician advice for smoking cessation in primary care: time for a paradigm shift?
Bell, K., Bowers, M., McCullough, L., & Bell, J. (2011) · Critical Public Health · doi:10.1080/09581596.2011.572155 · Cited by 15
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“Randomised studies usually report the effect of an intervention according to the Russell Standards [25], which assume that non-responders have relapsed.”
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“The minimum standard in randomised trials of smoking cessation intervention is biochemically verified cessation at 6 months [32].”
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McNeill, A. D., & Robson, D. (2017) · Addiction · doi:10.1111/add.14043 · Cited by 15
“This requirement and other outcome criteria for smoking cessation trials were set out by a group of academics as the ‘Russell Standard’ in honour of Russell [8].”
Background
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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