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

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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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MethodSelf-citation
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“34,35 Continuous abstinence was checked at each follow-up time point, i.e., by self-report at weeks 6 and 12, from the date of the previous interview: “Since [date] did you smoke at all, even part of a cigarette?” and among those who did: “In the past 6-weeks (that is, since [date]), have you…”
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Method
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“Studies of smoking cessation have not always complied with the Russell Standard [60], for example, not validating selfreported abstinence biochemically or reporting continuous abstinence.”
Method
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Self-citation
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Method
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“CA measures cessation over a period of time (Aveyard et al., 2009; Hughes et al., 2003b; West et al., 2005); in this study CA was defined as sustained abstinence over a five-month period, with a maximum permitted five cigarettes smoked during that period.”
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Stanton, N. L., Hood, K., Kelly, M. J., Nuttall, J., Gillespie, D., Verheij, T. J., Little, P. S., Godycki-Ćwirko, M., Goossens, H., & Butler, C. (2009) · European Respiratory Journal · doi:10.1183/09031936.00168409 · Cited by 27
“[20, 21] Throughout all analyses non-smokers are used as the reference category.”
Method
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Method
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“…binary, indicating whether an individual quit over a given period, and it is common to assume that missing values are failures — “missing=failure” (West et al. , 2005); while in weight loss trials, missing data is sometimes assumed to be unchanged since baseline — “baseline observation carried…”
Background
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Background
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Background
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MethodInfluential
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Background
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“), or if CO measurement could not be performed, participants were considered to be smokers (Russell’s Standard) [39].”
BackgroundMethodInfluential
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“Six months prolonged abstinence is a standard accepted for evidence of effectiveness in smoking cessation[20].”
BackgroundMethodInfluentialSelf-citation
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“This would be a serious limitation in randomised controlled trials because of the possibility of differential likelihood of falsely claiming abstinence by participants in the active treatment (West et al. 2005).”
BackgroundSelf-citation
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Walker, N. J., van Woerden, H. C., Kiparoglou, V., Yang, Y., Robinson, H., & Croghan, E. (2016) · BMC Public Health · doi:10.1186/s12889-016-3672-y · Cited by 24
“An initial model was fitted in which the response variable was a self-reported quit 4 weeks after the initial quit date supported by a blood Carbon Monoxide (CO) reading below 10 parts per million, in accordance with the Russell standard [28].”
Method
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“Prolonged abstinence (defined as sustained abstinence after an initial two week grace period as recommended by Hughes and colleagues [39] will be operationalised by: a) self-reported consumption of not more than five cigarettes since the quit date; and b) salivary cotinine levels of less that 15 ng/ml [40].”
Method
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“A 5-month period was chosen because the interventions (in the experimental conditions of the larger study not included in this study) lasted 3 months, and patients had to be abstinent from smoking since the end of the intervention for a minimum period at follow-up for it to be truly considered smoking cessation, as su…”
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“Participants who were lost to follow-up or who missed the Week 12 visit were coded as smokers (West et al., 2005).”
Self-citation
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Efficacy and safety of electronic cigarettes as a smoking cessation intervention: A systematic review and network meta-analysis
Quigley, J. M., Walsh, C., Lee, C., Long, J., Kennelly, H., McCarthy, A., & Kavanagh, P. M. (2021) · Tobacco Prevention & Cessation · doi:10.18332/tpc/143077 · Cited by 23
What Are the Effective Components of Group-Based Treatment Programs For Smoking Cessation? A Systematic Review and Meta-Analysis
Mersha, A. G., Bryant, J., Rahman, T., McGuffog, R., Maddox, R., & Kennedy, M. (2023) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntad068 · Cited by 23
Chronotype, Social Jetlag, and Nicotine Use
Ghotbi, N., Rabenstein, A., Pilz, L. K., Rüther, T., & Roenneberg, T. (2023) · Journal of Biological Rhythms · doi:10.1177/07487304231177197 · Cited by 24
“Abstinence was defined as stating not to have smoked during the past 7 days on each NUI and eCO-levels ≤ 5 ppm, indicating a verification of the self-reports (Middleton and Morice, 2000; Javors et al., 2005; Kapusta et al., 2010; West et al., 2005; Patrick et al., 1994).”
The barriers to smoking cessation in Swiss methadone and buprenorphine-maintained patients
Wapf, V., Schaub, M. P., Klaeusler, B., Boesch, L., Stohler, R., & Eich, D. (2008) · Harm Reduction Journal · doi:10.1186/1477-7517-5-10 · Cited by 23
SMS-based smoking cessation intervention among university students: study protocol for a randomised controlled trial (NEXit trial)
Müssener, U., Bendtsen, M., Karlsson, N. E., White, I. R., McCambridge, J., & Bendtsen, P. (2015) · Trials · doi:10.1186/s13063-015-0640-2 · Cited by 23
“We will also allow the IMOR to be 0 (missing = smoking, the Russell standard) [41].”
Method
A multicentre randomized trial of combined individual and telephone counselling for smoking cessation
Ramon, J. M., Nerín, I., Comino, A., Pinet, C., Abella, F., Carreras, J. M., Banqué, M., Baena, A., Morchón, S., Jiménez-Muro, A., et al. (2013) · Preventive Medicine · doi:10.1016/j.ypmed.2013.05.014 · Cited by 23
Factors underlying smoking relapse prevention: results of an international Delphi study
Elfeddali, I., Bolman, C. A. W., Mesters, I., Wiers, R. W. H. J., & de Vries, H. (2010) · Health Education Research · doi:10.1093/her/cyq053 · Cited by 23
“This is in line with the Russell Standard for outcome criteria in smoking cessation trials [50].”
Result
Increasing Varenicline Dose in Smokers Who Do Not Respond to the Standard Dosage
Hájek, P., McRobbie, H. J., Smith, K., Phillips, A. C., Cornwall, D., & Dhanji, A. (2014) · JAMA Internal Medicine · doi:10.1001/jamainternmed.2014.6916 · Cited by 23
A pharmacist-led system-change smoking cessation intervention for smokers admitted to Australian public hospitals (GIVE UP FOR GOOD): study protocol for a randomised controlled trial
Thomas, D., Abramson, M. J., Bonevski, B., Taylor, S. E., Poole, S. G., Weeks, G. R., Dooley, M. J., & George, J. (2013) · Trials · doi:10.1186/1745-6215-14-148 · Cited by 23
“Participants who die during the study will be excluded from the analysis [32].”
Background
Neighbourhood Deprivation and Outcomes of Stop Smoking Support – An Observational Study
Brose, L. S., & McEwen, A. (2016) · PLoS ONE · doi:10.1371/journal.pone.0148194 · Cited by 22
“(Clinical) is recorded if at follow-up the smoker reports continuous abstinence between weeks 2 and 4 and records an expired-air carbon monoxide reading of<10 parts per million [27].”
BackgroundResultInfluential
Motivational interviewing and the decisional balance procedure for cessation induction in smokers not intending to quit
Krigel, S., Grobe, J. E., Goggin, K., Harris, K. J., Moreno, J. L., & Catley, D. (2016) · Addictive Behaviors · doi:10.1016/j.addbeh.2016.08.036 · Cited by 23
Cognitive-behavioral treatment with behavioral activation for smokers with depressive symptomatology: study protocol of a randomized controlled trial
Becoña, E., Martínez-Vispo, C., Senra, C., López‐Durán, A., Rodríguez‐Cano, R., & del Río, E. F. (2017) · BMC Psychiatry · doi:10.1186/s12888-017-1301-7 · Cited by 25
“– Point-prevalence abstinence defined according to Russell Standard (RS) criteria [56].”
BackgroundMethodResultInfluential
Attending community-based lung cancer screening influences smoking behaviour in deprived populations
Balata, H., Traverse-Healy, L., Knight, S., Armitage, C. J., Barber, P. V., Colligan, D., Elton, P., Kirwan, M., Lyons, J., McWilliams, L., et al. (2019) · Lung Cancer · doi:10.1016/j.lungcan.2019.10.025 · Cited by 23
Tobacco smoking, related harm and motivation to quit smoking in people with schizophrenia spectrum disorders
Caponnetto, P., Polosa, R., Robson, D., & Bauld, L. (2020) · Health Psychology Research · doi:10.4081/hpr.2020.9042 · Cited by 24
Behavioural interventions for smoking cessation: an overview and network meta-analysis
Hartmann‐Boyce, J., Fanshawe, T. R., Lindson, N., Livingstone‐Banks, J., Ordóñez-Mena, J. M., & Aveyard, P. N. (2018) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd013229 · Cited by 24
Effectiveness of a stepped primary care smoking cessation intervention (ISTAPS study): design of a cluster randomised trial
de Salud], G. I. [. S. S. T. E. A. P., Cabezas, C., Martín-Cantera, C., Granollers, S., Morera, C., Ballve, J. L., Carretero, E. Z., Bladé, J., Borras, M., Serra, A., et al. (2009) · BMC Public Health · doi:10.1186/1471-2458-9-48 · Cited by 24
The Indigenous Counselling and Nicotine (ICAN) QUIT in Pregnancy Pilot Study protocol: a feasibility step-wedge cluster randomised trial to improve health providers' management of smoking during pregnancy
Bar‐Zeev, Y., Bonevski, B., Bovill, M., Gruppetta, M., Oldmeadow, C. J., Palazzi, K. L., Atkins, L., Reath, J., & Gould, G. S. (2017) · BMJ Open · doi:10.1136/bmjopen-2017-016095 · Cited by 23
“At the 4-week and 12-week follow-ups, the survey includes additional questions to determine 7-day point prevalence smoking abstinence and continuous abstinence rates.(64)”
Predictors, Indicators, and Validated Measures of Dependence in Menthol Smokers
Frost-Pineda, K., Muhammad-Kah, R. S., Rimmer, L. T., & Liang, Q. (2014) · Journal of Addictive Diseases · doi:10.1080/10550887.2014.909696 · Cited by 22
“Smoking frequency, CPD, TTFC, and night waking to smoke have all been reported as significant predictors of cessation outcomes but are not always consistent across studies.(25,28,34,35) For example, the Baker et al.”
Receipt of Tobacco Treatment and One-Year Smoking Cessation Rates Following Lung Cancer Screening in the Veterans Health Administration
Heffner, J. L., Coggeshall, S. S., Wheat, C. L., Krebs, P. M., Feemster, L. C., Klein, D. E., Nici, L. L., Johnson, H. M., & Zeliadt, S. B. (2021) · Journal of General Internal Medicine · doi:10.1007/s11606-021-07011-0 · Cited by 22
The Joint Influence of Gender and Amount of Smoking on Weight Gain One Year after Smoking Cessation
Locatelli, I., Collet, T., Clair, C., Rodondi, N., & Cornuz, J. (2014) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph110808443 · Cited by 21
“relapses, whereas more recent and stringent studies have used “continuous” abstinence, which is defined as not smoking from baseline to follow-up [14].”
BackgroundInfluential
Effects of standardised cigarette packaging on craving, motivation to stop and perceptions of cigarettes and packs
Brose, L. S., Chong, C. B., Aspinall, E., Michie, S., & McEwen, A. (2014) · Psychology and Health · doi:10.1080/08870446.2014.896915 · Cited by 22
“A CO reading of less than 10 parts per million (ppm) was regarded as confirmation of temporary (12 h) abstinence as defined by the Russell Standard (West et al., 2005).”
Method
Development of an integrative cessation program for co-smokers of cigarettes and cannabis: demand analysis, program description, and acceptability
Becker, J., Hungerbuehler, I., Berg, O., Szamrovicz, M., Haubensack, A., Kormann, A., & Schaub, M. P. (2013) · Substance Abuse Treatment Prevention and Policy · doi:10.1186/1747-597x-8-33 · Cited by 24
Effectiveness of computer-tailored Smoking Cessation Advice in Primary Care (ESCAPE): a Randomised Trial
Gilbert, H. M., Nazareth, I., Sutton, S. R., Morris, R. W., & Godfrey, C. (2008) · Trials · doi:10.1186/1745-6215-9-23 · Cited by 22
An exploratory short‐term double‐blind randomized trial of varenicline versus nicotine patch for smoking cessation in women
Gray, K. M., McClure, E. A., Baker, N. L., Hartwell, K. J., Carpenter, M. J., & Saladin, M. E. (2015) · Addiction · doi:10.1111/add.12895 · Cited by 22
“tional method of measuring efficacy outcomes in smoking cessation trials is the Russell Standard (RS) [19].”
Method
Maintaining abstinence from smoking after a period of enforced abstinence – systematic review, meta-analysis and analysis of behaviour change techniques with a focus on mental health
Brose, L. S., Simonavičius, E., & McNeill, A. D. (2017) · Psychological Medicine · doi:10.1017/s0033291717002021 · Cited by 22
“Primary outcome: (i) Biochemically verified continuous smoking abstinence at longest follow-up (West et al. 2005).”
BackgroundInfluential
STOP smoking and alcohol drinking before OPeration for bladder cancer (the STOP-OP study), perioperative smoking and alcohol cessation intervention in relation to radical cystectomy: study protocol for a randomised controlled trial
Lauridsen, S. V., Thomsen, T., Thind, P. O., & Tønnesen, H. (2017) · Trials · doi:10.1186/s13063-017-2065-6 · Cited by 22
“These are regarded as valid, replicable outcome measures and less likely to be biased by faulty recall [31, 32].”
Background
Measuring fidelity to behavioural support delivery for smoking cessation and its association with outcomes
Dogar, O. F., Boehnke, J. R., Lorencatto, F., Sheldon, T., & Siddiqi, K. (2019) · Addiction · doi:10.1111/add.14804 · Cited by 18
Atherosclerosis Screening by Noninvasive Imaging for Cardiovascular Prevention: A Systematic Review
Rodondi, N., Auer, R., Sulzer, V. D. B., Ghali, W. A., & Cornuz, J. (2011) · Journal of General Internal Medicine · doi:10.1007/s11606-011-1833-3 · Cited by 22
“For smoking cessation, no studies provided a confirmation of smoking cessation by biochemical validation, as recommended.(46) These limitations were inherent to the available studies and confirm the need for more RCTs in this field.”
An Exploratory Analysis of the Smoking and Physical Activity Outcomes From a Pilot Randomized Controlled Trial of an Exercise Assisted Reduction to Stop Smoking Intervention in Disadvantaged Groups
Thompson, T., Greaves, C. J., Ayres, R., Aveyard, P. N., Warren, F. C., Byng, R., Taylor, R. S., Campbell, J. L., USSHER, M. H., Green, C., et al. (2015) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntv099 · Cited by 24
“…promoted through this innovative approach). r It is usual for smoking cessation intervention trials to use intention to treat (ITT) analyses with an assumption that a participant lost to follow-up is still smoking 24 , which essentially reflects an assumption of baseline values carried forward.”
BackgroundSelf-citation
Effect of varenicline directly observed therapy versus varenicline self‐administered therapy on varenicline adherence and smoking cessation in methadone‐maintained smokers: a randomized controlled trial
Nahvi, S., Adams, T. R., Ning, Y. M., Zhang, C., & Arnsten, J. H. (2020) · Addiction · doi:10.1111/add.15240 · Cited by 21
“To account for missing abstinence data, we first considered missing to be equal to smoking (60).”
Method
Intensiveversusshort face-to-face smoking cessation interventions: a meta-analysis
Rasmussen, M., Lauridsen, S. V., Pedersen, B., Backer, V., & Tønnesen, H. (2022) · European Respiratory Review · doi:10.1183/16000617.0063-2022 · Cited by 21
An Automated, Online Feasibility Randomized Controlled Trial of a Just-In-Time Adaptive Intervention for Smoking Cessation (Quit Sense)
Naughton, F., Hope, A., Brown, C., Grant, K., Barton, G., Notley, C. J., Mascolo, C., Coleman, T. J., Shepstone, L., Sutton, S. R., et al. (2023) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntad032 · Cited by 23
“Number of active engagements: median (q25,q75), maximum, minimum (N = 69a) 11 (2, 39); 0, 271”
Volitional processes and daily smoking: examining inter- and intraindividual associations around a quit attempt
Berli, C., Ochsner, S., Stadler, G., Knoll, N., Hornung, R., & Scholz, U. (2014) · Journal of Behavioral Medicine · doi:10.1007/s10865-014-9598-x · Cited by 22
“As West et al. (2005) point out, a CO test is the preferred method of detecting recent smoking and provides at least a minimum assurance concerning abstinence.”
BackgroundMethod
A pilot randomised controlled trial of the feasibility of using body scan and isometric exercises for reducing urge to smoke in a smoking cessation clinic
Al-Chalabi, L., Prasad, N., Steed, L., Stenner, S., Aveyard, P. N., Beach, J., & USSHER, M. H. (2008) · BMC Public Health · doi:10.1186/1471-2458-8-349 · Cited by 21
Spanish Adaptation of the NDSS (Nicotine Dependence Syndrome Scale) and Assessment of Nicotine-Dependent Individuals at Primary Care Health Centers in Spain
Becoña, E., López‐Durán, A., del Río, E. F., Míguez, M. C., & Castro, J. (2010) · The Spanish Journal of Psychology · doi:10.1017/s1138741600002596 · Cited by 21
Pick up the pieces and go home – on the demise of health psychology
Kaptein, A. A. (2011) · Health Psychology Review · doi:10.1080/17437199.2010.520114 · Cited by 26
Response Parameters for SMS Text Message Assessments Among Pregnant and General Smokers Participating in SMS Cessation Trials
Naughton, F., Riaz, M. A., & Sutton, S. R. (2015) · Nicotine & Tobacco Research · doi:10.1093/ntr/ntv266 · Cited by 20
Smokers making a quit attempt using e-cigarettes with or without nicotine or prescription nicotine replacement therapy: Impact on cardiovascular function (ISME-NRT) - a study protocol
Klonizakis, M., Crank, H., Gumber, A., & Brose, L. S. (2017) · BMC Public Health · doi:10.1186/s12889-017-4206-y · Cited by 20
“To obtain an index of skin blood flow, cutaneous red cell flux will be measured by placing an iontophoresis laser-Doppler probe (PF481 – 1; Perimed AB), connected to a laser Doppler fluxmeter (PF5001; Perimed AB). b) Micro-vascular function at 6 months (measured as described for a). c) Smoking status at 3 and 6 months…”
Influential
Effects of varenicline therapy in combination with advanced behavioral support on smoking cessation and quality of life in inpatients with acute exacerbation of COPD, bronchial asthma, or community-acquired pneumonia: A prospective, open-label, preference-based, 52-week, follow-up trial
Politis, A., Ioannidis, V., Gourgoulianis, K. I., Daniil, Z. D., & Hatzoglou, C. (2017) · Chronic Respiratory Disease · doi:10.1177/1479972317740128 · Cited by 21
“Abstinence is defined by exhaled carbon dioxide (CO) level of less than 9 parts per million (ppm).(22) Secondary outcomes were (a) changes in QoL assessed through the comparison of scores obtained on the domains of the SF36 questionnaire and (b) possible predictors of successful smoking abstinence investigated with a…”
Method
Smokers’ Views on Personal Carbon Monoxide Monitors, Associated Apps, and Their Use: An Interview and Think-Aloud Study
Herbeć, A., Perski, O., Shahab, L., & West, R. (2018) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph15020288 · Cited by 21
“CO levels, measured as particles per million (ppm), can help distinguish between different levels of smoking, with levels below 10 ppm commonly used as indicators of abstinence [11,12].”
BackgroundMethodSelf-citation
Smoking Decisions: Altered Reinforcement Learning Signals Induced by Nicotine State
Baker, T. E., Zeighami, Y., Dagher, A., & Holroyd, C. B. (2018) · Nicotine & Tobacco Research · doi:10.1093/ntr/nty136 · Cited by 22

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 › 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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Outcome criteria in smoking cessation trials: proposal for a common standard

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