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
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Bu, J., Young, K. D., Hong, W., Ma, R., Song, H., Wang, Y., Zhang, W., Hampson, M., Hendler, T., & Zhang, X. (2019) · Brain · doi:10.1093/brain/awz114 · Cited by 43
Black, N., Eisma, M. C., Viechtbauer, W., Johnston, M., West, R., Hartmann‐Boyce, J., Michie, S., & de Bruin, M. (2020) · Addiction · doi:10.1111/add.14969 · Cited by 47
“The smoking cessation rates extracted from the studies were based on intent-to-treat analyses with missing responses treated as smokers (assumption: missing = smoking; [27]).”
MethodSelf-citationInterventions for tobacco cessation delivered by dental professionals
Holliday, R., Hong, B., McColl, E., Livingstone-Banks, J., & Preshaw, P. M. (2021) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd005084.pub4 · Cited by 78
“[DOI: 10.1002/14651858.CD008286.pub3] [CD008286] West 2005 West R, Hajek P, Stead L, Stapleton J. Outcome criteria in smoking cessation trials: proposal for a common standard.”
BackgroundMethodInfluentialBrose, L. S., West, R., & Stapleton, J. (2013) · Mayo Clinic Proceedings · doi:10.1016/j.mayocp.2012.11.013 · Cited by 45
Self-citationMetse, A. P., Wiggers, J. H., Wye, P. M., Wolfenden, L., Freund, M., Clancy, R., Stockings, E., Terry, M., Allan, J., Colyvas, K., et al. (2017) · Australian & New Zealand Journal of Psychiatry · doi:10.1177/0004867417692424 · Cited by 45
“If CO assessments were obtained >14 days after completion of the CATI interview (West et al., 2005), self-reported abstinence was used (Peckham et al.”
MethodPastorino, U., Ladisa, V., Trussardo, S., Sabia, F., Rolli, L., Valsecchi, C., Ledda, R. E., Milanese, G., Suatoni, P., Boeri, M., et al. (2022) · Journal of Thoracic Oncology · doi:10.1016/j.jtho.2022.07.007 · Cited by 49
Louwagie, G., Kanaan, M., Morojele, N. K., Van Zyl, A., Moriarty, A. S., Li, J., Siddiqi, K., Turner, A., Mdege, N. D., Omole, O. B., et al. (2022) · BMJ Open · doi:10.1136/bmjopen-2021-056496 · Cited by 44
Effects of interventions to combat tobacco addiction: Cochrane update of 2019 and 2020 reviews
Livingstone‐Banks, J., Lindson, N., Hartmann‐Boyce, J., & Aveyard, P. N. (2021) · Addiction · doi:10.1111/add.15769 · Cited by 40
The interplay of received social support and self-regulatory factors in smoking cessation
Ochsner, S., Łuszczyńska, A., Stadler, G., Knoll, N., Hornung, R., & Scholz, U. (2013) · Psychology and Health · doi:10.1080/08870446.2013.818674 · Cited by 45
“There is no practicable way to objectively verify abstinence over a longer time span, but the point prevalence measure provides at least a minimum assurance concerning abstinence at the follow-up point (Hughes, Keely, Niaura et al., 2003; West et al., 2005).”
BackgroundMethodInfluentialReus, V. I., & Smith, B. J. (2008) · International Journal of Clinical Practice · doi:10.1111/j.1742-1241.2008.01885.x · Cited by 44
Lüscher, J., Stadler, G., & Scholz, U. (2017) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntx079 · Cited by 44
Yuan, P., Westmaas, J. L., Thrul, J., Toussaert, S., Hilton, J. F., & White, J. S. (2023) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntad059 · Cited by 46
Ward, K. D., Asfar, T., Ali, R. A., Rastam, S., Weg, M. W. V., Eissenberg, T., & Maziak, W. (2012) · Addiction · doi:10.1111/j.1360-0443.2012.04048.x · Cited by 43
“Criteria for the primary end-point conformed to the ‘Russell standard’ [12], with the exception that a self-report of any smoking (rather than allowing up to five cigarettes in total) was used to define loss of abstinence.”
MethodMurray, R. L., Leonardi‐Bee, J., Marsh, J., Jayes, L., Li, J., Parrott, S., & Britton, J. R. (2013) · BMJ · doi:10.1136/bmj.f4004 · Cited by 43
Berndt, N. C., Bolman, C. A. W., Froelicher, E. S., Mudde, A. N., Candel, M. J. J. M., de Vries, H., & Lechner, L. (2013) · Journal of Behavioral Medicine · doi:10.1007/s10865-013-9522-9 · Cited by 43
“The self-report of CA allowed patients to have smoked a maximum of five cigarettes in total over the whole period following their quit date (West et al., 2005).”
BackgroundTrajectories of Engagement and Disengagement with a Story-Based Smoking Cessation App
Smith, W., Ploderer, B., Wadley, G., Webber, S. E., & Borland, R. (2017) · CHI Conference on Human Factors in Computing Systems · doi:10.1145/3025453.3026054 · Cited by 43
“A common criterion for successful quitting is to be smoke-free for 6 months [34].”
BackgroundAllocating treatment options to patient profiles: clinical art or science?
Bühringer, G. (2006) · Addiction · doi:10.1111/j.1360-0443.2006.01366.x · Cited by 42
Fucito, L. M., Redeker, N. S., Ball, S. A., Toll, B. A., Ikomi, J. T., & Carroll, K. M. (2013) · The Journal of Smoking Cessation · doi:10.1017/jsc.2013.19 · Cited by 43
Effectiveness of web‐based tailored smoking cessation advice reports (i Q uit): a randomized trial
Mason, D., Gilbert, H. M., & Sutton, S. R. (2012) · Addiction · doi:10.1111/j.1360-0443.2012.03972.x · Cited by 42
“The primary outcome measure did not include biochemical verification and so did not meet the Russell Standard [17].”
BackgroundUSSHER, M. H., Lewis, S., Aveyard, P. N., Manyonda, I., West, R., Lewis, B. A., Marcus, B. H., Riaz, M. A., Taylor, A. H., Barton, P. M., et al. (2015) · Health Technology Assessment · doi:10.3310/hta19840 · Cited by 43
Self-citationBrain Nicotinic Acetylcholine Receptor Availability and Response to Smoking Cessation Treatment
Brody, A. L., Mukhin, A. G., Mamoun, M. S., Luu, T., Neary, M. K., Liang, L., Shieh, J., Sugar, C. A., Rose, J. E., & Mandelkern, M. A. (2014) · JAMA Psychiatry · doi:10.1001/jamapsychiatry.2014.138 · Cited by 44
Marshall, H., Courtney, D., Passmore, L. H., McCaul, E. M., Yang, I. A., Bowman, R., & Fong, K. M. (2016) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntw010 · Cited by 42
McClure, J. B., Anderson, M. L., Bradley, K. A., An, L. C., & Catz, S. L. (2016) · JMIR mhealth and uhealth · doi:10.2196/mhealth.6002 · Cited by 42
“For the primary analysis, to be consistent with the Russell Standard [24] and the a priori defined outcomes, nonresponders were classified as smokers and included in the analysis.”
MethodDogar, O. F., Keding, A., Gabe, R., Marshall, A., Huque, R., Barua, D., Fatima, R., Khan, A., Zahid, R., Mansoor, S., et al. (2020) · The Lancet Global Health · doi:10.1016/s2214-109x(20)30312-0 · Cited by 42
Kralikova, E., Kmetova, A., Stepankova, L., Zvolska, K., Davis, R., & West, R. (2013) · Addiction · doi:10.1111/add.12219 · Cited by 41
“fewer than 10 parts per million (ppm), as specified in the Russell Standard [13].”
Self-citationDenial in alcohol and other drug use disorders: A critique of theory
Dare, P. A. S., & DeRigne, L. (2009) · Addiction Research & Theory · doi:10.3109/16066350902770441 · Cited by 44
Skov-Ettrup, L. S., Ringgaard, L. W., Dalum, P., Flensborg‐Madsen, T., Thygesen, L. C., & Tolstrup, J. S. (2014) · Health Education Research · doi:10.1093/her/cyt112 · Cited by 41
“The most commonly used method to deal with missing data in smoking cessation trials is to count non-responders as smokers [26].”
MethodInterdisciplinary COPD intervention in primary care: a cluster randomised controlled trial
Liang, J., Abramson, M. J., Russell, G. M., Holland, A. E., Zwar, N. A., Bonevski, B., Mahal, A. S., Eustace, P., Paul, E. M., Phillips, K., et al. (2019) · European Respiratory Journal · doi:10.1183/13993003.01530-2018 · Cited by 44
Dogar, O. F., Jawad, M., Shah, S., Newell, J. N., Kanaan, M. N., Khan, M. A., & Siddiqi, K. (2013) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntt211 · Cited by 42
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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