How generalisable to community samples are clinical trial results for treatment of nicotine dependence: a comparison of common eligibility criteria with respondents of a large representative general population survey

Strat, Yann Le; Rehm, Jürgen; Foll, Bernard Le

doi:10.1136/tc.2010.038703

Cited by 63 publications

(56 citation statements)

References 107 publications

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“…77,78 Yet, surprisingly few data exist on the impact of long-term NRT use in terms of health outcomes in the general population. Most data come from clinical trials, which have samples that tend to differ in important ways from general population samples 79 and in which NRT is provided free together with behavioural support, which may affect normal usage patterns. By contrast, most NRT in the UK is used without advice and bought over the counter, 80 and in many other countries (unlike in the UK) it is rarely provided for free on prescription.…”

Section: Rationale and Study Aimsmentioning

confidence: 99%

Evaluating Long-term Outcomes of NHS Stop Smoking Services (ELONS): a prospective cohort study

Dobbie

Hiscock

Leonardi‐Bee

et al. 2015

Health Technol Assess

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BackgroundNHS Stop Smoking Services (SSSs) provide free at the point of use treatment for smokers who would like to stop. Since their inception in 1999 they have evolved to offer a variety of support options. Given the changes that have happened in the provision of services and the ongoing need for evidence on effectiveness, the Evaluating Long-term Outcomes for NHS Stop Smoking Services (ELONS) study was commissioned.ObjectivesThe main aim of the study was to explore the factors that determine longer-term abstinence from smoking following intervention by SSSs. There were also a number of additional objectives.DesignThe ELONS study was an observational study with two main stages: secondary analysis of routine data collected by SSSs and a prospective cohort study of service clients. The prospective study had additional elements on client satisfaction, well-being and longer-term nicotine replacement therapy (NRT) use.SettingThe setting for the study was SSSs in England. For the secondary analysis, routine data from 49 services were obtained. For the prospective study and its added elements, nine services were involved. The target population was clients of these services.ParticipantsThere were 202,804 cases included in secondary analysis and 3075 in the prospective study.InterventionsA combination of behavioural support and stop smoking medication delivered by SSS practitioners.Main outcome measuresAbstinence from smoking at 4 and 52 weeks after setting a quit date, validated by a carbon monoxide (CO) breath test.ResultsJust over 4 in 10 smokers (41%) recruited to the prospective study were biochemically validated as abstinent from smoking at 4 weeks (which was broadly comparable with findings from the secondary analysis of routine service data, where self-reported 4-week quit rates were 48%, falling to 34% when biochemical validation had occurred). At the 1-year follow-up, 8% of prospective study clients were CO validated as abstinent from smoking. Clients who received specialist one-to-one behavioural support were twice as likely to have remained abstinent than those who were seen by a general practitioner (GP) practice and pharmacy providers [odds ratio (OR) 2.3, 95% confidence interval (CI) 1.2 to 4.6]. Clients who received group behavioural support (either closed or rolling groups) were three times more likely to stop smoking than those who were seen by a GP practice or pharmacy providers (OR 3.4, 95% CI 1.7 to 6.7). Satisfaction with services was high and well-being at baseline was found to be a predictor of abstinence from smoking at longer-term follow-up. Continued use of NRT at 1 year was rare, but no evidence of harm from longer-term use was identified from the data collected.ConclusionsStop Smoking Services in England are effective in helping smokers to move away from tobacco use. Using the 52-week CO-validated quit rate of 8% found in this study, we estimate that in the year 2012–13 the services supported 36,249 clients to become non-smokers for the remainder of their lives. This is a substantial figure and provides one indicator of the ongoing value of the treatment that the services provide. The study raises a number of issues for future research including (1) examining the role of electronic cigarettes (e-cigarettes) in smoking cessation for service clients [this study did not look at e-cigarette use (except briefly in the longer-term NRT study) but this is a priority for future studies]; (2) more detailed comparisons of rolling groups with other forms of behavioural support; (3) further exploration of the role of practitioner knowledge, skills and use of effective behaviour change techniques in supporting service clients to stop smoking; (4) surveillance of the impact of structural and funding changes on the future development and sustainability of SSSs; and (5) more detailed analysis of well-being over time between those who successfully stop smoking and those who relapse. Further research on longer-term use of non-combustible nicotine products that measures a wider array of biomarkers of smoking-related harm such as lung function tests or carcinogen metabolites.FundingThe National Institute for Health Research Health Technology Assessment programme. The UK Centre for Tobacco and Alcohol Studies provided funding for the longer-term NRT study.

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Section: Rationale and Study Aimsmentioning

confidence: 99%

Evaluating Long-term Outcomes of NHS Stop Smoking Services (ELONS): a prospective cohort study

Dobbie

Hiscock

Leonardi‐Bee

et al. 2015

Health Technol Assess

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“…Clinical trial participants tend to receive more attention and more behavioral support than is typically offered to a primary care patient, and trial participants are often healthier and more motivated than their counterparts in the primary care setting. 6 These differences may contribute to significantly lower medication adherence rates and, as a result, to lower rates of smoking cessation in primary care patients.…”

Section: Variables and Definitionsmentioning

confidence: 99%

Adherence to Varenicline and Associated Smoking Cessation in a Community-Based Patient Setting

Liberman

Lichtenfeld²,

Galaznik³

et al. 2013

JMCP

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“…For example, in the tobacco-dependence fi eld, the median clinical trial has 12 exclusion criteria, and approximately two thirds of smokers in the general population are ineligible under one or more of them (Le Strat et al, 2011). For illicit drug dependence, a review of 98 clinical trials found that less than one third reported information suffi cient to calculate the proportion of screened patients who were eligible and the proportion of the eligible group who agreed to participate (Melberg and Humphreys, 2010).…”

mentioning

confidence: 99%

Representativeness of Patients Enrolled in Influential Clinical Trials: A Comparison of Substance Dependence With Other Medical Disorders

Humphreys

Maisel

Blodgett

et al. 2013

J. Stud. Alcohol Drugs

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ABSTRACT. Objective: The purpose of this study was to determine whether randomized trials of treatments for substance dependence differ from those for other medical disorders on quality of enrollment information reporting and sample representativeness. Method: Twenty highly cited clinical trials (publication date 2002-2010) of treatments for each of 14 prevalent disorders were identifi ed by structured literature search. The disorders were alcohol dependence, drug dependence, nicotine dependence, Alzheimer's disease, breast cancer, colorectal cancer, chronic obstructive pulmonary disease, depression, diabetes, HIV/AIDS, hypertension, ischemic heart disease, lung cancer, and schizophrenia. The 280 clinical trials were coded for number of individuals screened for eligibility, number of screened individuals meeting eligibility criteria, and number of eligible individuals refusing to participate. Results: Substance-dependence treatment trials were signifi cantly more likely to track and report enrollment information (75% vs. 45% of clinical trials for other disorders, p < .001). Substance-dependence trials did not differ from trials focused on other disorders on mean rate of non-enrollment. Across disorders, the primary driver of non-enrollment appeared to be clinical trial exclusion criteria rather than eligible patients refusing to enroll. Conclusions: Relative to other disorders, trials in the substancedependence fi eld do a better (although imperfect) job of tracking and reporting enrollment information. Low enrollment rates and unrepresentative samples are not challenges unique to treatment outcome studies in the substance-dependence fi eld. Across a range of disorders, clinical trials that use eligibility criteria judiciously are more likely to produce fi ndings that generalize to front-line clinical practice than are trials that restrict enrollment to a small and unrepresentative subset of patients. (J.

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How generalisable to community samples are clinical trial results for treatment of nicotine dependence: a comparison of common eligibility criteria with respondents of a large representative general population survey

Abstract: Further studies and interventions should explore the efficacy of tobacco treatment interventions in a larger segment of the population, notably in the subpopulations of people with nicotine dependence who smoke fewer than 10 cigarettes per day or who have comorbid depression.

Cited by 63 publications

References 107 publications

Evaluating Long-term Outcomes of NHS Stop Smoking Services (ELONS): a prospective cohort study

Evaluating Long-term Outcomes of NHS Stop Smoking Services (ELONS): a prospective cohort study

Adherence to Varenicline and Associated Smoking Cessation in a Community-Based Patient Setting

Representativeness of Patients Enrolled in Influential Clinical Trials: A Comparison of Substance Dependence With Other Medical Disorders

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