The DOI matches its Crossref record; 15 of the 15 references it cites were found in a registry or an index.
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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In the citing paper
“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
Citations
Cites
The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration
Altman, D. G., Schulz, K. F., Moher, D., Egger, M., Davidoff, F., Elbourne, D., Gøtzsche, P. C., Lang, T., & for the CONSORT Group (2001) · Annals of Internal Medicine · doi:10.7326/0003-4819-134-8-200104170-00012 · Cited by 3,835
A Comparison of Sustained-Release Bupropion and Placebo for Smoking Cessation
Hurt, R. D., Sachs, D. P. L., Glover, E. D., Offord, K. P., Johnston, J. A., Dale, L. C., Khayrallah, M. A., Schroeder, D. R., Glover, P. N., Sullivan, C. R., et al. (1997) · New England Journal of Medicine · doi:10.1056/nejm199710233371703 · Cited by 1,262
Measures of abstinence in clinical trials: issues and recommendations
Hughes, J. R., Keely, J. P., NIAURA, R. S., Ossip-Klein, D. J., RICHMOND, R. L., & Swan, G. E. (2003) · Nicotine & Tobacco Research · doi:10.1093/ntr/5.1.13 · Cited by 1,058
Interventions for promoting smoking cessation during pregnancy
Lumley, J., Chamberlain, C., Dowswell, T., Oliver, S., Oakley, L., & Watson, L. (2009) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd001055.pub3 · Cited by 890
Treating Tobacco Use and Dependence
Goolsby, M. J. (2001) · Journal of the American Academy of Nurse Practitioners · doi:10.1111/j.1745-7599.2001.tb00227.x · Cited by 718
Measures of abstinence in clinical trials: issues and recommendations
Hughes, J. R., Keely, J. P., NIAURA, R. S., Ossip-Klein, D. J., RICHMOND, R. L., & Swan, G. E. (2003) · Nicotine & Tobacco Research · doi:10.1080/1462220031000070552 · Cited by 712
Interventions for promoting smoking cessation during pregnancy
Lumley, J., Oliver, S. R., Chamberlain, C., & Oakley, L. (2004) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd001055.pub2 · Cited by 675
Lancaster, T. (2000) · BMJ · doi:10.1136/bmj.321.7257.355 · Cited by 565
Effect of nicotine chewing gum as an adjunct to general practitioner's advice against smoking.
Russell, M. A., Merriman, R., Stapleton, J., & Taylor, W. (1983) · BMJ · doi:10.1136/bmj.287.6407.1782 · Cited by 248
Self-citationProchaska, J. O., Velicer, W. F., Fava, J. L., Ruggiero, L., Laforge, R. G., Rossi, J. S., Johnson, S. S., & Lee, P. A. (2001) · Preventive Medicine · doi:10.1006/pmed.2000.0767 · Cited by 157
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Randomized Controlled Trials and the Efficacy of Psychotropic Medications
Dunlop, B. W., & Ribeiro, C. M. D. F. (2022) · Springer eBooks · doi:10.1007/978-3-030-62059-2_4 · Cited by 2
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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