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Assessing the outcomes of prolonged cessation-induction and aid-to-cessation trials: floating prolonged abstinence.

ABSTRACT:

Introduction

A Society for Research on Nicotine and Tobacco working group recommended outcome measures for cessation-induction trials and aid-to-cessation trials. Cessation-induction trials aim to motivate unwilling quitters to make a quit attempt. Aid-to-cessation trials give either medication or behavioral interventions to increase the rate at which willing quitters succeed in their attempts. Nicotine-assisted reduction programs combine features of both types of interventions by giving nicotine replacement to unwilling quitters. Treatment can be prolonged more than a year, quit attempts can occur and succeed early or late in the program, and renewed quit attempts are an inherent part of the program. Conventional outcome measures are tied to a fixed but arbitrary point in follow-up and cannot capture the true outcome: Prolonged cessation anchored to the point at which a person makes a successful quit attempt.

Discussion

We propose that the outcome should be counted from the successful quit attempt that began during the treatment period and continues for a defined period, ideally 6 months. In particular, if a trial compared a short reduction program with a long reduction program, it would not be possible to obtain an unbiased assessment of the outcome of such a trial using a measure tied to a fixed point in follow-up. Floating prolonged abstinence could provide such an assessment and is suitable for either prolonged cessation-induction trial or combined cessation-induction and aid-to-cessation trials.

SUBMITTER: Aveyard P

PROVIDER: S-EPMC2671463 | biostudies-literature | 2009 May

REPOSITORIES: biostudies-literature

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Publications

Assessing the outcomes of prolonged cessation-induction and aid-to-cessation trials: floating prolonged abstinence.

Aveyard Paul P Wang Dechao D Connock Martin M Fry-Smith Anne A Barton Pelham P Moore David D

Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco 20090403 5

<h4>Introduction</h4>A Society for Research on Nicotine and Tobacco working group recommended outcome measures for cessation-induction trials and aid-to-cessation trials. Cessation-induction trials aim to motivate unwilling quitters to make a quit attempt. Aid-to-cessation trials give either medication or behavioral interventions to increase the rate at which willing quitters succeed in their attempts. Nicotine-assisted reduction programs combine features of both types of interventions by giving ...[more]

PMID: 19346506

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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:Although text-messaging interventions are effective for smoking cessation, few target teens in the USA and little is known about their effectiveness. The purpose of this manuscript is to examine correlates of dropout, response to smoking status prompts, and abstinence rates among subscribers of SmokeFreeTeen, a free, publicly available text-messaging smoking cessation intervention sponsored by the National Cancer Institute's SmokeFree.Gov initiative, on quit day through 1 month follow-up. In a sample of teens (N = 2,685), aged 13-19, we examined demographics, smoking frequency, cigarettes smoked per day, prequit intervention time (i.e., maximum of 14 days of prequit day preparation), and number of quit attempts as correlates of response and abstinence rates among program initiators (i.e., participants who reached quit day but dropped out on or before intervention end) and completers (i.e., participants who reached quit day and completed the intervention). We also conducted Cox regression analysis of time from quit day to dropout by daily and nondaily smoking status. Two-thirds (n = 1,733, 64.54%) dropped out before the intervention ended, with dropout rates peaking on quit day (n = 289, 13.10%). Response rate to smoking status prompts remained below 30% throughout the intervention. At intervention end and 1 month follow-up, abstinence was 2.63% and 2.55% among program initiators, whereas abstinence was 6.09% and 6.01% among program completers. Dropout, response, and abstinence rates did not consistently differ by subscriber characteristics. Prequit time was associated with decreased likelihood of dropping out (adjusted hazards ratio: 0.94, confidence interval [CI]: 0.93-0.95), responding to smoking status prompts (adjusted odds ratio [aOR]: 0.94, CI: 0.92-0.96), and being abstinent (aOR: 0.96, CI: 0.93-0.99) on quit day. Two or more quit attempts were associated with increased response (aOR: 1.61, CI: 1.16-2.23) and abstinence (aOR: 1.91, CI: 1.25-2.92) rates on Day 7. In a first assessment of SmokeFreeTeen outcomes, we document high dropouts and low response and abstinence rates. SmokeFreeTeen produced abstinence rates lower than comparable text-messaging interventions targeting teens and young adults. Improving SmokeFreeTeen's reach, engagement, and effectiveness is needed.

Project description:ImportanceMillions of Americans are forced to quit smoking as they enter tobacco-free prisons and jails, but most return to smoking within days of release. Interventions are needed to sustain tobacco abstinence after release from incarceration.ObjectiveTo evaluate the extent to which the WISE intervention (Working Inside for Smoking Elimination), based on motivational interviewing (MI) and cognitive behavioral therapy (CBT), decreases relapse to smoking after release from a smoke-free prison.DesignParticipants were recruited approximately 8 weeks prior to their release from a smoke-free prison and randomized to 6 weekly sessions of either education videos (control) or the WISE intervention.SettingA tobacco-free prison in the United States.ParticipantsA total of 262 inmates (35% female).Main outcome measureContinued smoking abstinence was defined as 7-day point-prevalence abstinence validated by urine cotinine measurement.ResultsAt the 3-week follow-up, 25% of participants in the WISE intervention (31 of 122) and 7% of the control participants (9 of 125) continued to be tobacco abstinent (odds ratio [OR], 4.4; 95% CI, 2.0-9.7). In addition to the intervention, Hispanic ethnicity, a plan to remain abstinent, and being incarcerated for more than 6 months were all associated with increased likelihood of remaining abstinent. In the logistic regression analysis, participants randomized to the WISE intervention were 6.6 times more likely to remain tobacco abstinent at the 3-week follow up than those randomized to the control condition (95% CI, 2.5-17.0). Nonsmokers at the 3-week follow-up had an additional follow-up 3 months after release, and overall 12% of the participants in the WISE intervention (14 of 122) and 2% of the control participants (3 of 125) were tobacco free at 3 months, as confirmed by urine cotinine measurement (OR, 5.3; 95% CI, 1.4-23.8).Conclusions and relevanceForced tobacco abstinence alone during incarceration has little impact on postrelease smoking status. A behavioral intervention provided prior to release greatly improves cotinine-confirmed smoking cessation in the community.Trial registrationclinicaltrials.gov Identifier: NCT01122589.

Project description:BackgroundEcological momentary assessment (EMA) is a methodology involving repeated surveys to collect in-situ self-reports that describe respondents' current or recent experiences. Audiology literature comparing in-situ and retrospective self-reports is scarce.PurposeTo compare the sensitivity of in-situ and retrospective self-reports in detecting the outcome difference between hearing aid technologies, and to determine the association between in-situ and retrospective self-reports.Research designAn observational study.Study sampleThirty-nine older adults with hearing loss.Data collection and analysisThe study was part of a larger clinical trial that compared the outcomes of a prototype hearing aid (denoted as HA1) and a commercially available device (HA2). In each trial condition, participants wore hearing aids for 4 weeks. Outcomes were measured using EMA and retrospective questionnaires. To ensure that the outcome data could be directly compared, the Glasgow Hearing Aid Benefit Profile was administered as an in-situ self-report (denoted as EMA-GHABP) and as a retrospective questionnaire (retro-GHABP). Linear mixed models were used to determine if the EMA- and retro-GHABP could detect the outcome difference between HA1 and HA2. Correlation analyses were used to examine the association between EMA- and retro-GHABP.ResultsFor the EMA-GHABP, HA2 had significantly higher (better) scores than HA1 in the GHABP subscales of benefit, residual disability, and satisfaction (p = 0.029-0.0015). In contrast, the difference in the retro-GHABP score between HA1 and HA2 was significant only in the satisfaction subscale (p = 0.0004). The correlations between the EMA- and retro-GHABP were significant in all subscales (p = 0.0004 to <0.0001). The strength of the association ranged from weak to moderate (r = 0.28-0.58). Finally, the exit interview indicated that 29 participants (74.4%) preferred HA2 over HA1.ConclusionThe study suggests that in-situ self-reports collected using EMA could have a higher sensitivity than retrospective questionnaires. Therefore, EMA is worth considering in clinical trials that aim to compare the outcomes of different hearing aid technologies. The weak to moderate association between in-situ and retrospective self-reports suggests that these two types of measures assess different aspects of hearing aid outcomes.

Dataset Information

Assessing the outcomes of prolonged cessation-induction and aid-to-cessation trials: floating prolonged abstinence.

Introduction

Discussion

Publications

Assessing the outcomes of prolonged cessation-induction and aid-to-cessation trials: floating prolonged abstinence.

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