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Cited by 1,285Smoking Behavior and CessationStatistical Methods in Clinical TrialsSubstance Abuse Treatment and Outcomes

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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  • Abstinence outcomes are reliable in studies in which biochemical verification is not feasible, such as those in which data are collected by phone or through the internet or when personal contact is limited.

    “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

  • Study participants who did not attend a follow-up visit, did not have a CO measurement, or whose measured CO value exceeded 9 ppm were classified as smokers.

    “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

  • The primary outcome measure was 12 months continuous abstinence (CA) according to the Russell standard, defined as self-report of having smoked no more than five cigarettes since the end of treatment, supported by negative biochemical validation (CO < 10 ppm).

    “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 accordance with the Russell standard, a CO measurement of 10 or more parts per million was defined as indicative of current smoking.

    “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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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 › Physiology › 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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