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Accuracy of self-reported smoking abstinence in clinical trials of hospital-initiated smoking interventions.

ABSTRACT: AIMS:To estimate the prevalence and predictors of failed biochemical verification of self-reported abstinence among participants enrolled in trials of hospital-initiated smoking cessation interventions. DESIGN:Comparison of characteristics between participants who verified and those who failed to verify self-reported abstinence. SETTINGS:Multi-site randomized clinical trials conducted between 2010 and 2014 in hospitals throughout the United States. PARTICIPANTS:Recently hospitalized smokers who reported tobacco abstinence 6 months post-randomization and provided a saliva sample for verification purposes (n = 822). MEASUREMENTS:Outcomes were salivary cotinine-verified smoking abstinence at 10 and 15 ng/ml cut-points. Predictors and correlates included participant demographics and tobacco use; hospital diagnoses and treatment; and study characteristics collected via surveys and electronic medical records. FINDINGS:Usable samples were returned by 69.8% of the 1178 eligible trial participants who reported 7-day point prevalence abstinence. The proportion of participants verified as quit was 57.8% [95% confidence interval (CI) = 54.4, 61.2; 10 ng/ml cut-off] or 60.6% (95% CI = 57.2, 63.9; 15 ng/ml). Factors associated independently with verification at 10 ng/ml were education beyond high school education [odds ratio (OR) = 1.51; 95% CI = 1.07, 2.11], continuous abstinence since hospitalization (OR = 2.82; 95% CI = 2.02, 3.94), mailed versus in-person sample (OR = 3.20; 95% CI = 1.96, 5.21) and race. African American participants were less likely to verify abstinence than white participants (OR = 0.64; 95% CI = 0.44, 0.93). Findings were similar for verification at 15 ng/ml. Verification rates did not differ by treatment group. CONCLUSIONS:In the United States, high rates (40%) of recently hospitalized smokers enrolled in smoking cessation trials fail biochemical verification of their self-reported abstinence.

SUBMITTER: Scheuermann TS

PROVIDER: S-EPMC5673569 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Accuracy of self-reported smoking abstinence in clinical trials of hospital-initiated smoking interventions.

Scheuermann Taneisha S TS Richter Kimber P KP Rigotti Nancy A NA Cummins Sharon E SE Harrington Kathleen F KF Sherman Scott E SE Zhu Shu-Hong SH Tindle Hilary A HA Preacher Kristopher J KJ

Addiction (Abingdon, England) 20170823 12

<h4>Aims</h4>To estimate the prevalence and predictors of failed biochemical verification of self-reported abstinence among participants enrolled in trials of hospital-initiated smoking cessation interventions.<h4>Design</h4>Comparison of characteristics between participants who verified and those who failed to verify self-reported abstinence.<h4>Settings</h4>Multi-site randomized clinical trials conducted between 2010 and 2014 in hospitals throughout the United States.<h4>Participants</h4>Recen ...[more]

PMID: 28834608

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Project description:Background and aimIt is useful, for theoretical and practical reasons, to be able to specify functions for continuous abstinence over time in smoking cessation attempts. This study aimed to find the best-fitting models of mean proportion abstinent with different smoking cessation pharmacotherapies up to 52 weeks from the quit date.MethodsWe searched the Cochrane Database of Systematic Reviews to identify randomized controlled trials (RCTs) of pharmacological treatments to aid smoking cessation. For comparability, we selected trials that provided 12 weeks of treatment. Continuous abstinence rates for each treatment at each follow-up point in trials were extracted along with methodological details of the trial. Data points for each pharmacotherapy at each follow-up point were aggregated where the total across contributing studies included at least 1000 participants per data point. Continuous abstinence curves were modelled using a range of different functions from the quit date to 52-week follow-up. Models were compared for fit using R2 and Bayesian information criterion (BIC).ResultsStudies meeting our selection criteria covered three pharmacotherapies [varenicline, nicotine replacement therapy (NRT) and bupropion] and placebo. Power functions provided the best fit (R2 > 0.99, BIC < 17.0) to continuous abstinence curves from the target quit date in all cases except for varenicline, where a logarithmic function described the curve best (R2 = 0.99, BIC = 21.2). At 52 weeks, abstinence rates were 22.5% (23.0% modelled) for varenicline, 16.7% (16.0% modelled) for bupropion, 13.0% (12.4% modelled) for NRT and 8.3% (8.9% modelled) for placebo. For varenicline, bupropion, NRT and placebo, respectively, 55.9, 65.0, 62.3 and 56.5% of participants who were abstinent at the end of treatment were still abstinent at 52 weeks.ConclusionsMean continuous abstinence rates up to 52 weeks from initiation of smoking cessation attempts in clinical trials can be modelled using simple power functions for placebo, nicotine replacement therapy and bupropion and a logarithmic function for varenicline. This allows accurate prediction of abstinence rates from any time point to any other time point up to 52 weeks.

Project description:IntroductionThis study evaluated whether introducing performance obligations (a policy intervention) to service agreements between hospitals (n = 15) and their local health authority: (1) improved provision of an evidence-based tobacco cessation intervention (the "Ottawa Model" for Smoking Cessation) and (2) changed the quality of the cessation intervention being delivered.MethodsInterrupted time series analysis was used to evaluate the change in the proportion of smoker patients provided the Ottawa Model 3 years before and 3 years after introducing the performance obligations. Changes in secondary outcomes related to program quality were described using mean differences, risk differences, and risk ratios, as appropriate.ResultsThe proportion and number of patients provided the Ottawa Model doubled in the 3-year period following introduction of the new policy-from 3453 patients (33.7%) in the year before to 6840 patients (62.8%) in the final assessment year. This resulted in a signification slope change (+9.2%; 95% confidence interval [CI] 4.5%, 13.9%; p = .01) between the pre- and post-obligation assessment periods, signifying the policy had a positive impact on performance. Quality and effectiveness of the in-hospital intervention remained steady.ConclusionsImplementation of performance obligations by a healthcare funder increased delivery of an evidence-based smoking cessation intervention across multiple hospitals. Given the known health and economic impacts of smoking cessation interventions, health authorities and hospitals should consider pairing adoption of systematic interventions, like the Ottawa Model, with policy to enhance reach and impact.Implications• The hospital-based Ottawa Model for Smoking Cessation (OMSC) intervention has been shown to increase smoking abstinence, while reducing mortality and healthcare utilization.• The uptake of systematic, evidence-based interventions, like the OMSC, by hospitals has been relatively low despite the known positive impacts.• The introduction of smoking cessation performance obligations by a healthcare funder resulted in more patients receiving an OMSC intervention while in hospital, with no corresponding change in intervention quality or effectiveness.• Healthcare funders and hospitals should consider pairing the adoption of effective, systematic interventions, like the OMSC, with policy to enhance reach and impact.

Project description:IntroductionSmoking is a key determinant of mortality among people living with HIV (PLWH).MethodsTo better understand the effects of smoking cessation interventions in PLWH, we conducted a pooled analysis of four randomized controlled trials of hospital-initiated smoking interventions conducted through the Consortium of Hospitals Advancing Research on Tobacco (CHART). In each study, cigarette smokers were randomly assigned to usual care or a smoking cessation intervention. The primary outcome was self-reported past 30-day tobacco abstinence at 6-month follow-up. Abstinence rates were compared between PLWH and participants without HIV and by treatment arm, using both complete-case and intention-to-treat analyses. Multivariable logistic regression was used to determine the effect of HIV status on 6-month tobacco abstinence and to determine predictors of smoking cessation within PLWH.ResultsAmong 5550 hospitalized smokers, there were 202 (3.6%) PLWH. PLWH smoked fewer cigarettes per day and were less likely to be planning to quit than smokers without HIV. At 6 months, cessation rates did not differ between intervention and control groups among PLWH (28.9% vs. 30.5%) or smokers without HIV (36.1% vs. 34.1%). In multivariable regression analysis, HIV status was not significantly associated with smoking cessation at 6 months. Among PLWH, confidence in quitting was the only clinical factor independently associated with smoking cessation (OR 2.0, 95% CI = 1.4 to 2.8, p < .01).ConclusionsHIV status did not alter likelihood of quitting smoking after hospital discharge, whether or not the smoker was offered a tobacco cessation intervention, but power was limited to identify potentially important differences.ImplicationsPLWH had similar quit rates to participants without HIV following a hospital-initiated smoking cessation intervention. The findings suggest that factors specific to HIV infection may not influence response to smoking cessation interventions and that all PLWH would benefit from efforts to assist in quitting smoking.Trial registration(1) Using "warm handoffs" to link hospitalized smokers with tobacco treatment after discharge: study protocol of a randomized controlled trial: NCT01305928. (2) Web-based smoking cessation intervention that transitions from inpatient to outpatient: NCT01277250. (3) Effectiveness of smoking-cessation interventions for urban hospital patients: NCT01363245. (4) Effectiveness of Post-Discharge Strategies for Hospitalized Smokers (HelpingHAND2): NCT01714323.

Project description:BACKGROUND:Postpartum relapse to cigarette smoking is common and relapse prevention interventions have indicated limited efficacy. Abstinence motivations and self-efficacy are two factors that might fluctuate during the postpartum period and predict smoking abstinence. The present study was a secondary analysis that examined statistical trends in motivations and self-efficacy to sustain postpartum abstinence and evaluated their association with sustained abstinence from pregnancy through 52 weeks postpartum. METHODS:Former smokers (N = 300) were recruited for a parent study evaluating two postpartum behavioral relapse prevention interventions. Participants completed assessments prenatally (baseline) and at 12, 24, and 52 weeks postpartum. Motivations to sustain abstinence for internal (intrinsic motivation) and external (extrinsic motivation) reasons, for the health of the baby (baby's health motivation), to maintain a healthy pregnancy (pregnancy motivation), and to avoid children becoming smokers (parenting motivation) were measured at each assessment. Confidence in maintaining abstinence, despite negative affective experiences (internal self-efficacy) and outside circumstances (external self-efficacy), was also assessed. Smoking was biochemically verified at each assessment. RESULTS:Linear mixed models indicated decreasing intrinsic, baby's health, and parenting motivations from baseline to 12 and 24 weeks postpartum and increasing motivations from 24 to 52 weeks postpartum (ps < .03). Higher baseline internal self-efficacy was associated with lower probability of relapse at 24 weeks postpartum (odds ratio, 0.92; 95% CI, 0.87-0.98), although this effect became nonsignificant after adjustment for multiple statistical tests. Abstinence motivations and external self-efficacy were not significantly associated with relapse (ps > .10). CONCLUSIONS:Levels of abstinence motivations fluctuated from pregnancy through postpartum. Future work should investigate more potent predictors of postpartum abstinence.

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Accuracy of self-reported smoking abstinence in clinical trials of hospital-initiated smoking interventions.

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Accuracy of self-reported smoking abstinence in clinical trials of hospital-initiated smoking interventions.

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