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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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A randomized controlled trial of a smoking cessation intervention conducted among prisoners
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“We conducted our study in line with Consolidated Standards of Reporting Trials (CONSORT) guidelines [64], and adhered to the standard established by West in considering all participants lost to follow-up as continuing smokers [65].”
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“Point-prevalence abstinence was defined by selfreport and expired air carbon monoxide (CO) reading at last patient contact, with CO readings of 10 parts per million or lower deemed to indicate abstinence [24].”
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“(22) We also conducted a planned analysis of outcomes for patients with complete outcome data.”
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“Relevant items from the Russell Standard for tobacco studies were used to assess quality of tobacco use reporting (35).”
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What mediates the effect of confrontational counselling on smoking cessation in smokers with COPD?
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“This was assessed using the Russell standard procedures [28] counting participants lost to follow up as being smokers and smoking status was verified biochemically.”
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“Standards for measurement are provided in three existing documents issued by other groups: (1) the Society for Research on Nicotine and Tobacco Task Force (43), (2) West and colleagues (the Russell Standard) (44), and the (3) Smoking Cessation at Lung Examination (SCALE) Collaboration (45).”
InfluentialCrane, D., Ubhi, H. K., Brown, J., & West, R. (2019) · F1000Research · doi:10.12688/f1000research.16148.2 · Cited by 37
Self-citationCouples' daily self-regulation: The Health Action Process Approach at the dyadic level
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“Point prevalence of smoking abstinence at 6 months (no puff of tobacco in the previous 7 days) The Russell Standard: continuous 6-month (at 6 months) or 1-month (at 1 month) smoking abstinence allowing for smoking five or fewer cigarettes after the target quit date, but no cigarette in the past 7 days [17].”
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“No uniform standard has been established for when ‘smoking abstinence’ should be assessed [2].”
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Day‐to‐day mastery and self‐efficacy changes during a smoking quit attempt: Two studies
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“In trials with more than one measure of abstinence, we will prefer the measure with the strictest criteria, in line with the Russell Standard (West 2005).”
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“A grace period is considered the initial period directly after the intervention delivery, in which quitting and re-initiating smoking behaviour will not be counted as such [33, 34].”
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“This study had a number of methodological strengths, in particular that self-reports of abstinence were biochemically verified by urine cotinine measurements, which is considered a ‘best practice’ indicator in smoking cessation trials (West et al., 2005), confirming a deceit rate of zero.”
MethodThe Most "Successful" Method for Failing to Quit Smoking Is Unassisted Cessation
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Self-citationFeasibility of biochemical verification in a web-based smoking cessation study
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“,(8) outcome measures like the Russell Standard may be implemented without biochemical verification when there is no face-to-face contact with participants.”
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“This follows the Russel standard for smoking interventions, allowing for a grace period of 4 weeks (12-week program) [39].”
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“For trial outcomes, in accordance with the Russell standard [25], cessation was defined as self-reported abstinence or having smoked ≤5 times in total since the quit date and smokers who were lost to follow-up (n=1,181) were assumed to still be smoking.”
MethodSecond-hand smoke and the risk of tuberculosis: a systematic review and a meta-analysis
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Illicit drug use as a predictor of smoking cessation treatment outcome
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“Baseline eCO, ppm Median (range) 16 (0-41) 14 (2-34) 16 (0-41) Mean ± SD 16.”
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“7%) at end-of-pregnancy, smoking status was not available and it was assumed that they are smoking [47].”
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“The Russell Standard proposes that biochemical verification of abstinence should occur at 6 or 12 months following the quit date [24].”
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Urge to smoke over 52 weeks of abstinence
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“Our definition of continuous abstinence allows a total of five cigarettes after the quit day [52,53].”
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“Smoking abstinence was assessed using the Russell standard (West et al., 2005), which allowed a grace period of two weeks and imputes participants who are lost to follow-up as smokers.”
MethodTreatment for Tobacco Dependence: Effect on Brain Nicotinic Acetylcholine Receptor Density
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“…data from participants who did not complete treatment or did not have a usable second scan were included and non-completers were considered to be non-quitters (in accordance with the recent recommendations (Hughes et al, 2003; West et al, 2005) and use (Rigotti et al, 2009) of this classification).”
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“Prolonged abstinence was defined as self-reported prolonged abstinence with a maximum of five cigarettes after a grace period of 9 weeks, confirmed biochemically by exhaled carbon monoxide [CO 10 parts per million], as defined in the Russell Standard [23].”
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“Evaluations to consider include formalised pre-tests, process evaluation, campaign awareness and recall, community involvement and reach, changes in knowledge, attitudes and beliefs, behaviour change (with standardised and/or validated quit rates [42]), smoke-free behaviours, and access to cessation services.”
BackgroundPeri‐operative tobacco cessation interventions: a systematic review and meta‐analysis
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“It is convention that, in clinical trials of smoking cessation, any participants lost to follow-up are assumed to still be smoking [36].”
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“Although continuous abstinence is considered the gold standard outcome for smoking cessation [29], some studies have shown that smokers do not lie about their smoking status when asked about it directly [30].”
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Nicotinic receptor partial agonists as novel compounds for the treatment of smoking cessation
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“Intention to treat analyses will be applied [88] and smoking status is verified at T2 by a saliva sample.”
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“We echo the conclusion of the authors that more RCTs with long-term follow-ups (at least 6 months; Russell Standard [21]) are needed to provide evidence on the effectiveness of smoking cessation apps [17].”
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“The measurement of exhaled CO is also the preferred measurement to confirm tobacco abstinence [18].”
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“6%) of the returned readings were below 10 ppm (meeting the Russel Standard criteria for abstinence (West et al., 2005)), and eight (53.”
BackgroundInfluentialSelf-citation
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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