Dataset Information

How do smoking cessation medicines compare with respect to their neuropsychiatric safety? A protocol for a systematic review, network meta-analysis and cost-effectiveness analysis.

ABSTRACT:

Introduction

Cigarette smoking is one of the leading causes of early death in the UK and worldwide. Public health guidance recommends the use of varenicline, bupropion and nicotine replacement therapy (NRT) as smoking cessation aids in the UK. Additionally, the first electronic cigarette has been licensed for use as a smoking cessation medicine. However, there are ongoing concerns about the safety of these medicines. We present a protocol for a systematic review and network meta-analysis (NMA) to determine how these smoking cessation medicines compare to each other with respect to their neuropsychiatric safety in adult smokers. Secondary aims include updating the evidence regarding the effectiveness and cardiovascular safety of these medicines for use in a cost-effectiveness analysis.

Methods and analysis

We will include randomised controlled trials and observational studies with control groups comparing monotherapy with varenicline, bupropion, NRT or electronic cigarette and combination therapies to each other, placebo or usual care. The primary composite safety outcome will be serious adverse events, defined as events that resulted in death, were life threatening, required hospitalisation or resulted in significant disability or congenital/birth defect. The preferred effectiveness outcome will be sustained smoking cessation defined as abstinence for a minimum of 6?months as determined by biochemical validation. We will include trials identified by previous reviews and search relevant databases for newly published trials as well as contacting study authors to identify unpublished information. We will conduct fixed-effect and random-effect meta-analyses for each pairwise comparison of treatments and outcome; where these estimates differ, we will consider reasons for heterogeneity, quantified using the between-study variance (?²). For each outcome, we will construct a NMA in a Bayesian framework which will be compared with the pair-wise results, allowing us to rank treatments. The effectiveness estimates from the NMA will be entered into a probabilistic economic model.

Ethics and dissemination

Ethics approval is not required for this evidence synthesis study as it involves analysis of secondary data from randomised controlled trials and observational studies. The review will make an important contribution to the knowledge base around the effectiveness, safety and cost-effectiveness of smoking cessation medicines. Results will be disseminated to the general public, healthcare practitioners and clinicians, academics, industry and policy makers.

Prospero registration number

CRD42016041302.

SUBMITTER: Thomas KH

PROVIDER: S-EPMC5734370 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

How do smoking cessation medicines compare with respect to their neuropsychiatric safety? A protocol for a systematic review, network meta-analysis and cost-effectiveness analysis.

Thomas Kyla H KH Caldwell Deborah D Dalili Michael N MN Gunnell David D Munafò Marcus R MR Stevenson Matt M Welton Nicky J NJ

BMJ open 20170617 6

<h4>Introduction</h4>Cigarette smoking is one of the leading causes of early death in the UK and worldwide. Public health guidance recommends the use of varenicline, bupropion and nicotine replacement therapy (NRT) as smoking cessation aids in the UK. Additionally, the first electronic cigarette has been licensed for use as a smoking cessation medicine. However, there are ongoing concerns about the safety of these medicines. We present a protocol for a systematic review and network meta-analysis ...[more]

PMID: 28624760

Similar Datasets

Project description:ObjectivesSmoking is a leading cause of death worldwide. Cessation aids include varenicline, bupropion, nicotine replacement therapy (NRT), and e-cigarettes at various doses (low, standard and high) and used alone or in combination with each other. Previous cost-effectiveness analyses have not fully accounted for adverse effects nor compared all cessation aids. The objective was to determine the relative cost-effectiveness of cessation aids in the United Kingdom.MethodsAn established Markov cohort model was adapted to incorporate health outcomes and costs due to depression and self-harm associated with cessation aids, alongside other health events. Relative efficacy in terms of abstinence and major adverse neuropsychiatric events was informed by a systematic review and network meta-analysis. Base case results are reported for UK-licensed interventions only. Two sensitivity analyses are reported, one including unlicensed interventions and another comparing all cessation aids but removing the impact of depression and self-harm. The sensitivity of conclusions to model inputs was assessed by calculating the expected value of partial perfect information.ResultsWhen limited to UK-licensed interventions, varenicline standard-dose and NRT standard-dose were most cost-effective. Including unlicensed interventions, e-cigarette low-dose appeared most cost-effective followed by varenicline standard-dose + bupropion standard-dose combined. When the impact of depression and self-harm was excluded, varenicline standard-dose + NRT standard-dose was most cost-effective, followed by varenicline low-dose + NRT standard-dose.ConclusionAlthough found to be most cost-effective, combined therapy is currently unlicensed in the United Kingdom and the safety of e-cigarettes remains uncertain. The value-of-information analysis suggested researchers should continue to investigate the long-term effectiveness and safety outcomes of e-cigarettes in studies with active comparators.

Project description:ObjectiveWe conducted a prospective cohort study of the Clinical Practice Research Database to estimate rates of varenicline and nicotine replacement therapy (NRT) prescribing and the relative effects on smoking cessation, and mental health.MethodsWe used multivariable logistic regression, propensity score matched regression, and instrumental variable analysis. Exposure was varenicline or NRT prescription. Mental disorders were bipolar, depression, neurotic disorder, schizophrenia, or prescriptions of antidepressants, antipsychotics, hypnotics/anxiolytics, mood stabilizers. Outcomes were smoking cessation, and incidence of neurotic disorder, depression, prescription of antidepressants, or hypnotics/anxiolytics. Follow-ups were 3, 6, and 9 months, and at 1, 2, and 4 years.ResultsIn all patients, NRT and varenicline prescribing declined during the study period. Seventy-eight thousand four hundred fifty-seven smokers with mental disorders aged ≥18 years were prescribed NRT (N = 59 340) or varenicline (N = 19 117) from September 1, 2006 to December 31, 2015. Compared with smokers without mental disorders, smokers with mental disorders had 31% (95% CI: 29% to 33%) lower odds of being prescribed varenicline relative to NRT, but had 19% (95% CI: 15% to 24%) greater odds of quitting at 2 years when prescribed varenicline relative to NRT. Overall, varenicline was associated with decreased or similar odds of worse mental health outcomes than NRT in patients both with and without mental disorders, although there was some variation when analyses were stratified by mental disorder subgroup.ConclusionsSmoking cessation medication prescribing may be declining in primary care. Varenicline was more effective than NRT for smoking cessation in patients with mental disorders and there is not clear consistent evidence that varenicline is adversely associated with poorer mental health outcomes.ImplicationsPatients with mental disorders were less likely to be prescribed varenicline than NRT. We triangulated results from three analytical techniques. We found that varenicline was more effective than NRT for smoking cessation in patients with mental disorders. Varenicline was generally associated with similar or decreased odds of poorer mental health outcomes (ie, improvements in mental health) when compared with NRT. We report these findings cautiously as our data are observational and are at risk of confounding.

Project description:BackgroundSmoking cessation represents an opportunity to reduce both short and long-term effects of smoking on complications after lumbar fusion and smoking-related morbidity and mortality. However, the cost-effectiveness of smoking-cessation interventions prior to lumbar fusion is not fully known.MethodsWe created a decision-analytic Markov model to evaluate the cost-effectiveness of 5 smoking-cessation strategies (behavioral counseling, nicotine replacement therapy [NRT], bupropion or varenicline monotherapy, and a combined intervention) prior to single-level, instrumented lumbar posterolateral fusion (PLF) from the health payer perspective. Probabilities, costs, and utilities were obtained from published sources. We calculated the costs and quality-adjusted life years (QALYs) associated with each strategy over multiple time horizons and accounted for uncertainty with probabilistic sensitivity analyses (PSAs) consisting of 10,000 second-order Monte Carlo simulations.ResultsEvery smoking-cessation intervention was more effective and less costly than usual care at the lifetime horizon. In the short term, behavioral counseling, NRT, varenicline monotherapy, and the combined intervention were also cost-saving, while bupropion monotherapy was more effective but more costly than usual care. The mean lifetime cost savings for behavioral counseling, NRT, bupropion monotherapy, varenicline monotherapy, and the combined intervention were $3,291 (standard deviation [SD], $868), $2,571 (SD, $479), $2,851 (SD, $830), $6,767 (SD, $1,604), and $34,923 (SD, $4,248), respectively. The minimum efficacy threshold (relative risk for smoking cessation) for lifetime cost savings varied from 1.01 (behavioral counseling) to 1.15 (varenicline monotherapy). A PSA revealed that the combined smoking-cessation intervention was always more effective and less costly than usual care.ConclusionsEven brief smoking-cessation interventions yield large short-term and long-term cost savings. Smoking-cessation interventions prior to PLF can both reduce costs and improve patient outcomes as health payers/systems shift toward value-based reimbursement (e.g., bundled payments) or population health models.Level of evidenceEconomic Level II. See Instructions for Authors for a complete description of levels of evidence.

Project description:IntroductionProject CLIQ (Community Link to Quit) was a proactive population-outreach strategy using an electronic health records-based smoker registry and interactive voice recognition technology to connect low- to moderate-income smokers with cessation counseling, medications, and social services. A randomized trial demonstrated that the program increased cessation. We evaluated the cost-effectiveness of CLIQ from a provider organization's perspective if implemented outside the trial framework.MethodsWe calculated the cost, cost per smoker, incremental cost per additional quit, and, secondarily, incremental cost per additional life year saved of the CLIQ system compared to usual care using data from a 2011-2013 randomized trial assessing the effectiveness of the CLIQ system. Sensitivity analyses considered economies of scale and initial versus ongoing costs.ResultsOver a 20-month period (the duration of the trial) the program cost US $283 027 (95% confidence interval [CI] $209 824-$389 072) more than usual care in a population of 8544 registry-identified smokers, 707 of whom participated in the program. The cost per smoker was $33 (95% CI 28-40), incremental cost per additional quit was $4137 (95% CI $2671-$8460), and incremental cost per additional life year saved was $7301 (95% CI $4545-$15 400). One-time costs constituted 28% of costs over 20 months. Ongoing costs were dominated by personnel costs (71% of ongoing costs). Sensitivity analyses showed sharp gains in cost-effectiveness as the number of identified smokers increased because of the large initial costs.ConclusionsThe CLIQ system has favorable cost-effectiveness compared to other smoking cessation interventions. Cost-effectiveness will be greatest for health systems with high numbers of smokers and with the high smoker participation rates.ImplicationsHealth information systems capable of establishing registries of patients who are smokers are becoming more prevalent. This economic analysis illustrates the cost implications for health care systems adopting a proactive tobacco treatment outreach strategy for low- and middle-income smokers. We find that under many circumstances, the CLIQ system has a favorable cost-per-quit compared to other population-based tobacco treatment strategies. The strategy could be widely disseminable if health systems leverage economies of scale.

Project description:ImportanceGuidelines recommend cancer care clinicians offer smoking cessation treatment. Cost analyses will help stakeholders understand and plan for implementation of cessation programs.ObjectiveTo estimate the incremental cost per quit (ICQ) of adopting an intensive smoking cessation intervention among patients undergoing treatment at cancer care clinics, from a clinic perspective.Design, setting, and participantsThis economic evaluation, a secondary analysis of the Smokefree Support Study (conducted 2013-2018; completed 2021), used microcosting methods and sensitivity analyses to estimate the ICQ of the interventions. Participants included patients undergoing treatment for a broad range of solid tumors and lymphomas who reported current smoking and were receiving care at cancer care clinics within 2 academic medical centers.ExposuresIntensive smoking cessation treatment (up to 11 counseling sessions with free medications), standard of care (up to 4 counseling sessions with medication advice), or usual care (referral to the state quitline).Main outcomes and measuresTotal costs, component-specific costs, and the ICQ of the intensive smoking cessation treatment relative to both standard of care (comparator in the parent randomized trial) and usual care (a common comparator outside this trial) were calculated. Overall and post hoc site-specific estimates are provided. Because usual care was not included in the parent trial, sensitivity analyses were conducted to assess how assumptions about usual care quit rates affected study outcomes (ie, base case [from a published smoking cessation trial among patients with thoracic cancer], best case, and conservative case scenarios).ResultsThe per-patient costs of offering intensive smoking cessation treatment, standard of care, and usual care were $1989, $1482, and $0, respectively. For intensive treatment, the dominant costs were treatment (35%), staff supervision (26%), and patient enrollment (24%). Relative to standard of care, intensive treatment had an overall ICQ of $3906, and one site had an ICQ of $2892. Relative to usual care, intensive treatment had an ICQ of $9866 overall (base case), although at one site, the ICQ was $5408 (base case) and $3786 (best case).Conclusions and relevanceIn this economic evaluation study, implementation of an intensive smoking cessation treatment intervention was moderately to highly cost-effective, depending on existing smoking cessation services in place.

Project description:AIMS:To perform an economic evaluation of a work-place smoking cessation group training programme with incentives compared with a training programme without incentives. DESIGN:A trial-based cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) from a societal perspective and an employer's perspective. SETTING:Sixty-one companies in the Netherlands. PARTICIPANTS:A total of 604 tobacco-smoking employees. INTERVENTION AND COMPARATOR:A 7-week work-place smoking cessation group training programme. The intervention group earned gift vouchers of €350 for 12 months' continuous abstinence. The comparator group received no incentives. MEASUREMENTS:Online questionnaires were administered to assess quality of life (EQ-5D-5 L) and resource use during the 14-month follow-up period (2-month training period plus 12-month abstinence period). For the CEA the primary outcome measure was carbon monoxide (CO)-validated continuous abstinence; for the CUA the primary outcome was quality-adjusted life years (QALY). Bootstrapping and sensitivity analyses were performed to account for uncertainty. Incremental cost-effectiveness ratio (ICER) tables were used to determine cost-effectiveness from a life-time perspective. FINDINGS:Of the participants in the intervention group, 41.1% had quit smoking compared with 26.4% in the control group. From a societal perspective with a 14-month follow-up period, the ICER per quitter for an intervention with financial incentives compared with no incentives was €11?546. From an employer's perspective, the ICER was €5686. There was no significant difference in QALYs between the intervention and control group within the 14-month follow-up period. The intervention was dominated by the comparator in the primary analysis at a threshold of €20?000 per QALY. In the sensitivity analysis, these results were uncertain. A life-time perspective showed an ICER of €1249 (95% confidence interval = €850-2387) per QALY. CONCLUSIONS:Financial incentives may be cost-effective in increasing quitting smoking, particularly from a life-time perspective.

Project description:BackgroundIn rural America, cigarette smoking is prevalent and health care providers lack the time and resources to help smokers quit. Telephone quitlines are important avenues for cessation services in rural areas, but they are poorly integrated with local health care resources.ObjectiveThe intent of the study was to assess the comparative effectiveness and cost effectiveness of two models for delivering expert tobacco treatment at a distance: telemedicine counseling that was integrated into smokers' primary care clinics (Integrated Telemedicine-ITM) versus telephone counseling, similar to telephone quitline counseling, delivered to smokers in their homes (Phone).MethodsSmokers (n=566) were recruited offline from 20 primary care and safety net clinics across Kansas. They were randomly assigned to receive 4 sessions of ITM or 4 sessions of Phone counseling. Patients in ITM received real-time video counseling, similar to Skype, delivered by computer/webcams in clinic exam rooms. Three full-time equivalent trained counselors delivered the counseling. The counseling duration and content was the same in both groups and was available in Spanish or English. Both groups also received identical materials and assistance in selecting and obtaining cessation medications. The primary outcome was verified 7-day point prevalence smoking abstinence at month 12, using an intent-to-treat analysis.ResultsThere were no significant baseline differences between groups, and the trial achieved 88% follow-up at 12 months. Verified abstinence at 12 months did not significantly differ between ITM or Phone (9.8%, 27/280 vs 12%, 34/286; P=.406). Phone participants completed somewhat more counseling sessions than ITM (mean 2.6, SD 1.5 vs mean 2.4, SD 1.5; P=.0837); however, participants in ITM were significantly more likely to use cessation medications than participants in Phone (55.9%, 128/280 vs 46.1%, 107/286; P=.03). Compared to Phone participants, ITM participants were significantly more likely to recommend the program to a family member or friend (P=.0075). From the combined provider plus participant (societal) perspective, Phone was significantly less costly than ITM. Participants in ITM had to incur time and mileage costs to travel to clinics for ITM sessions. From the provider perspective, counseling costs were similar between ITM (US $45.46, SD 31.50) and Phone (US $49.58, SD 33.35); however, total provider costs varied widely depending on how the clinic space for delivering ITM was valued.ConclusionsFindings did not support the superiority of ITM over telephone counseling for helping rural patients quit smoking. ITM increased utilization of cessation pharmacotherapy and produced higher participant satisfaction, but Phone counseling was significantly less expensive. Future interventions could combine elements of both approaches to optimize pharmacotherapy utilization, counseling adherence, and satisfaction. Such an approach could commence with a telemedicine-delivered clinic office visit for pharmacotherapy guidance, and continue with telephone or real-time video counseling delivered via mobile phones to flexibly deliver behavioral support to patients where they most need it-in their homes and communities.Trial registrationClinicaltrials.gov NCT00843505; http://clinicaltrials.gov/ct2/show/NCT00843505 (Archived by WebCite at http://www.webcitation.org/6YKSinVZ9).

Dataset Information

How do smoking cessation medicines compare with respect to their neuropsychiatric safety? A protocol for a systematic review, network meta-analysis and cost-effectiveness analysis.

Introduction

Methods and analysis

Ethics and dissemination

Prospero registration number

Publications

How do smoking cessation medicines compare with respect to their neuropsychiatric safety? A protocol for a systematic review, network meta-analysis and cost-effectiveness analysis.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets