Perioperative smoking cessation in vascular surgery: challenges with a randomized controlled trial.
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ABSTRACT:
SUBMITTER: Kehlet M
PROVIDER: S-EPMC4595121 | biostudies-literature | 2015 Oct
REPOSITORIES: biostudies-literature
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Perioperative smoking cessation in vascular surgery: challenges with a randomized controlled trial.
Kehlet Mette M Heeseman Sabine S Tønnesen Hanne H Schroeder Torben V TV
Trials 20151005
<h4>Background</h4>The effect of intensive smoking cessation programs on postoperative complications has never before been assessed in soft tissue surgery when smoking cessation is initiated on the day of surgery.<h4>Methods</h4>A single-blinded randomized clinical trial conducted at two vascular surgery departments in Denmark. The intervention group was offered the Gold Standard Program (GSP) for smoking cessation intervention. The control group was offered the departments' standard care. Inclu ...[more]
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Project description:IntroductionCigarette smoking by surgical patients is associated with increased complications. E-cigarettes have emerged as a potential smoking cessation tool. We sought to determine the feasibility and acceptability of e-cigarettes, compared to nicotine patch, for perioperative smoking cessation in veterans.MethodsPreoperative patients were randomized to either the nicotine patch group (n = 10) or the e-cigarette group (n = 20). Both groups were given a free 6-week supply in a tapering dose. All patients received brief counseling, a brochure on perioperative smoking cessation, and referral to the California Smokers' Helpline. The primary outcome was rate of smoking cessation on day of surgery confirmed by exhaled carbon monoxide. Secondary outcomes included smoking habits, pulmonary function, adverse events, and satisfaction with the products on day of surgery and at 8-weeks follow-up.ResultsBiochemically verified smoking cessation on day of surgery was similar in both groups. Change in forced expiratory volume in one second (FEV1) was 592 ml greater in the e-cigarette group (95% CI [153-1,031] ml, p = 0.01) and change in forced expiratory volume in one second to forced vital capacity ratio (FEV1/FVC ratio) was 40.1% greater in the e-cigarette group (95% CI [18.2%-78.4%], p = 0.04). Satisfaction with the product was similar in both groups.DiscussionE-cigarettes are a feasible tool for perioperative smoking cessation in veterans with quit rates comparable to nicotine replacement patch. Spirometry appears to be improved 8-weeks after initiating e-cigarettes compared to nicotine patch, possibly due to worse baseline spirometry and more smoking reduction in the e-cigarette group. An adequately powered study is recommended to determine if these results can be duplicated.
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Project description:The use of nicotine replacement therapy before quitting smoking is called nicotine preloading. Standard smoking cessation protocols suggest commencing nicotine replacement therapy only on the first day of quitting smoking (quit day) aiming to reduce withdrawal symptoms and craving. However, other, more successful smoking cessation pharmacotherapies are used prior to the quit day as well as after. Nicotine preloading could improve quit rates by reducing satisfaction from smoking prior to quitting and breaking the association between smoking and reward. A systematic literature review suggests that evidence for the effectiveness of preloading is inconclusive and further trials are needed.This is a study protocol for a multicenter, non-blinded, randomized controlled trial based in the United Kingdom, enrolling 1786 smokers who want to quit, funded by the National Institute for Health Research, Health Technology Assessment program, and sponsored by the University of Oxford. Participants will primarily be recruited through general practices and smoking cessation clinics, and randomized (1:1) either to use 21 mg nicotine patches, or not, for four weeks before quitting, whilst smoking as normal. All participants will be referred to receive standard smoking cessation service support. Follow-ups will take place at one week, four weeks, six months and 12 months after quit day. The primary outcome will be prolonged, biochemically verified six-month abstinence. Additional outcomes will include point prevalence abstinence and abstinence of four-week and 12-month duration, side effects, costs of treatment, and markers of potential mediators and moderators of the preloading effect.This large trial will add substantially to evidence on the effectiveness of nicotine preloading, but also on its cost effectiveness and potential mediators, which have not been investigated in detail previously. A range of recruitment strategies have been considered to try and compensate for any challenges encountered in recruiting the large sample, and the multicentre design means that knowledge can be shared between recruitment teams. The pragmatic study design means that results will give a realistic estimate of the success of the intervention if it were to be rolled out as part of standard smoking cessation service practice.Current Controlled Trials ISRCTN33031001. Registered 27 April 2012.
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Project description:OBJECTIVE:Greater depressive symptoms and low positive affect (PA) are associated with poor smoking cessation outcomes. Smoking cessation approaches that incorporate a focus on PA may benefit smokers trying to quit. The purpose of this study was to conduct a pilot randomized clinical trial to compare standard smoking cessation treatment (ST) with smoking cessation treatment that targets positive affect, termed positive psychotherapy for smoking cessation (PPT-S). METHOD:Smokers who were seeking smoking cessation treatment were assigned by urn randomization to receive, along with 8 weeks of nicotine replacement therapy, either ST (n = 31) or PPT-S (n = 35). Seven-day point prevalence smoking abstinence was biochemically confirmed at 8, 16, and 26 weeks. RESULTS:Compared to ST, a greater percentage of participants in PPT-S were abstinent at 8 weeks, 16 weeks, and 26 weeks, but these differences were nonsignificant. In a more statistically powerful longitudinal model, participants in PPT-S had a significantly higher odds of abstinence (adjusted odds ratio [AOR] = 2.75; 95% CI = 1.02, 7.42; p = .046) across follow-ups compared to those in ST. The positive effect of PPT-S was stronger for those higher in PA (OR = 6.69, 95% CI = 1.16, 38.47, p = .03). Greater use of PPT-S strategies during the initial 8 weeks of quitting was associated with a less steep decline in smoking abstinence rates over time (OR = 2.64, 95% CI = 1.06, 6.56, p =.04). CONCLUSION:This trial suggests substantial promise for incorporating PPT into smoking cessation treatment.
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Project description:INTRODUCTION:Far too few smokers receive recommended interventions at their healthcare visits, highlighting the importance of identifying effective, low-cost smoking interventions that can be readily delivered. Self-help interventions (e.g., written materials) would meet this need, but they have shown low efficacy. The purpose of this RCT was to determine the efficacy of a self-help intervention with increased duration and intensity. DESIGN:Randomized parallel trial design involving enrollment between April 2010 and August 2011 with follow-up data for 24 months. SETTING/PARTICIPANTS:U.S. national sample of daily smokers (N=1,874). INTERVENTION:Participants were randomized to one of three arms of a parallel trial design: Traditional Self-Help (TSH, n=638), Standard Repeated Mailings (SRM, n=614), or Intensive Repeated Mailings (IRM, n=622). TSH received an existing self-help booklet for quitting smoking. SRM received eight different cessation booklets mailed over a 12-month period. IRM received monthly mailings of ten booklets and additional material designed to enhance social support over 18 months. MAIN OUTCOME MEASURES:The primary outcome was 7-day point-prevalence abstinence collected at 6, 12, 18, and 24 months. RESULTS:Data were analyzed between 2013 and 2015. A dose-response effect was found across all four follow-up points. For example, by 24 months, IRM produced the highest abstinence rate (30.0%), followed by SRM (24.4%) and TSH (18.9%). The difference in 24-month abstinence rates between IRM and TSH was 11.0% (95% CI=5.7%, 16.3%). Cost analyses indicated that, compared with TSH, the incremental cost per quitter who received SRM and IRM was $560 and $361, respectively. CONCLUSIONS:Self-help interventions with increased intensity and duration resulted in significantly improved abstinence rates that extended 6 months beyond the end of the intervention. Despite the greater intensity, the interventions were highly cost effective, suggesting that widespread dissemination in healthcare settings could greatly enhance quitting. TRIAL REGISTRATION:This study is registered at www.clinicaltrials.gov NCT01352195.
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Project description:BACKGROUND:Several large studies have shown that the risk of cardiovascular, respiratory, and wound-healing complications (including death) within 30 days of surgery is greater for smokers than for nonsmokers. However, there is evidence that even short-term perioperative smoking cessation may reduce postoperative morbidity. Over the past few years, it has become more evident that short message service (SMS)-based interventions can help individuals quit smoking. OBJECTIVE:The overall aim of this project is to fill the knowledge gap on whether an SMS-based smoking-cessation intervention can be effective in helping patients stop smoking perioperatively. The aim of this trial is to evaluate the effectiveness of an SMS-based intervention on smoking behavior of patients undergoing elective surgery. METHODS:A two-arm parallel-group randomized controlled trial will be conducted at 20 surgical departments in southeast Sweden. Smokers undergoing elective surgery who own a mobile phone will be included. Power calculations indicate that it will be necessary to randomize 434 participants. One group will be given access to a novel 12-week SMS program, which includes daily SMS messages with behavior change-enforcing text content and hyperlinks to interactive modules, while the other group will not be given access to the intervention. Both groups will have access to the surgical departments' current routine for smoking cessation prior to surgery. Primary outcome measures, prolonged abstinence, and point prevalence of smoking cessation will be measured through questionnaires at 3, 6, and 12 months after randomization. Logistic regression models adjusted using baseline characteristics will be explored to identify potential effects of the intervention. RESULTS:Recruitment started in late October 2018 and is expected to last for a maximum of 30 months. The first results are expected to be available approximately 3 months after the final date of recruitment. CONCLUSIONS:Owing to the structural problems and scarcity of time and resources, patients at most Swedish surgical departments are simply instructed to quit smoking, and perhaps, referred to a primary health care clinic. An SMS-based smoking-cessation aid can be effective in helping individuals quit smoking and is a very simple and time-efficient tool for surgical departments to use. TRIAL REGISTRATION:ISRCTN Registry ISRCTN33869008; http://www.isrctn.com/ISRCTN33869008. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/12511.
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Project description:BackgroundPostmenopausal smokers have difficulty quitting smoking and experience considerable weight gain with smoking cessation. We examined whether adjunctive smoking treatment with exercise, compared to a relaxation control condition, could improve cigarette abstinence, decrease cigarettes smoked per day (CPD), and ameliorate changes in body mass index (BMI) in postmenopausal smokers.MethodsWomen (N = 301) signed informed consent and were randomized to treatment at two sites (Universities of Connecticut and Minnesota). We randomized groups of participants to a comprehensive group treatment program that included 12 weeks of varenicline and either a moderate exercise or relaxation component for 6 months. Participants were followed for a year after medication treatment.ResultsOverall, 17.3% of patients reported carbon monoxide-verified continuous abstinence for the 9- to 12-week period, and 11.6% reported prolonged abstinence at 1 year, with no significant differences between treatment conditions. CPD reported at study visits showed significant main effects for time in weeks, for site, and for treatment. The Exercise condition reported smoking fewer CPD over time, and that advantage widened over time. In terms of BMI, significant effects for time in weeks, and for the interaction of Week × Treatment condition, reflected gradually increasing BMI in these women over time, but with the increase in BMI slower in the Exercise condition.ConclusionsExercise, compared to relaxation, was associated with a reduced BMI and CPD in postmenopausal women, but did not increase end of treatment or prolonged abstinence. Further research is needed to devise exercise programs that increase smoking cessation rates in postmenopausal women.ImplicationsThis study adds to the literature on the effectiveness of a moderate exercise intervention compared to a relaxation control condition as an adjunctive treatment for smoking cessation in postmenopausal women. Our exercise program did not increase end of treatment or prolonged abstinence rates in postmenopausal women; however, there was a beneficial effect on smoking reduction and reduced body mass index. Additional research is needed to devise exercise programs that increase smoking cessation rates in postmenopausal women.
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Project description:BackgroundTobacco dependence is the leading cause of preventable death and disabilities worldwide and nicotine is the main substance responsible for the addiction to tobacco. A vaccine against nicotine was tested in a 6-month randomized, double blind phase II smoking cessation study in 341 smokers with a subsequent 6-month follow-up period.Methodology/principal findings229 subjects were randomized to receive five intramuscular injections of the nicotine vaccine and 112 to receive placebo at monthly intervals. All subjects received individual behavioral smoking cessation counseling. The vaccine was safe, generally well tolerated and highly immunogenic, inducing a 100% antibody responder rate after the first injection. Point prevalence of abstinence at month 2 showed a statistically significant difference between subjects treated with Nicotine-Qbeta (47.2%) and placebo (35.1%) (P = 0.036), but continuous abstinence between months 2 and 6 was not significantly different. However, in subgroup analysis of the per-protocol population, the third of subjects with highest antibody levels showed higher continuous abstinence from month 2 until month 6 (56.6%) than placebo treated participants (31.3%) (OR 2.9; P = 0.004) while medium and low antibody levels did not increase abstinence rates. After 12 month, the difference in continuous abstinence rate between subjects on placebo and those with high antibody response was maintained (difference 20.2%, P = 0.012).ConclusionsWhereas Nicotine-Qbeta did not significantly increase continuous abstinence rates in the intention-to-treat population, subgroup analyses of the per-protocol population suggest that such a vaccination against nicotine can significantly increase continuous abstinence rates in smokers when sufficiently high antibody levels are achieved. Immunotherapy might open a new avenue to the treatment of nicotine addiction.Trial registrationSwiss Medical Registry 2003DR2327; ClinicalTrials.gov NCT00369616.
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Project description:IntroductionCardiovascular disease (CVD) can be detected and quantified by analysis of the electrocardiogram (ECG); however the effects of smoking and smoking cessation on the ECG have not been characterized.MethodsStandard 12-lead ECGs were performed at baseline and 3 years after subjects enrolled in a prospective, randomized, placebo-controlled clinical trial of smoking cessation pharmacotherapies. ECGs were interpreted using the Minnesota Code ECG Classification. The effects of (i) smoking burden on the prevalence of ECG findings at baseline, and (ii) smoking and smoking cessation on ECG changes after 3 years were investigated by multivariable and multinomial regression analyses.ResultsAt baseline, 532 smokers were (mean [SD]) 43.3 (11.5) years old, smoked 20.6 (7.9) cigarettes/day, with a smoking burden of 26.7 (18.6) pack-years. Major and minor ECG criteria were identified in 87 (16.4%) and 131 (24.6%) of subjects, respectively. After adjusting for demographic data and known CVD risk factors, higher pack-years was associated with major ECG abnormalities (p = 0.02), but current cigarettes/day (p = 0.23) was not. After 3 years, 42.9% of subjects were abstinent from smoking. New major and minor ECG criteria were observed in 7.2% and 15.6% of subjects respectively, but in similar numbers of abstinent subjects and continuing smokers (p>0.2 for both). Continuing smokers showed significant reduction in current smoking (-8.4 [8.8] cigarettes/day, p<0.001) compared to baseline.ConclusionsIn conclusion, major ECG abnormalities are independently associated with lifetime smoking burden. After 3 years, smoking cessation was not associated with a decrease in ECG abnormalities, although cigarettes smoked/day decreased among continuing smokers.
| S-EPMC3633867 | biostudies-literature
Project description:BackgroundAt present, effectively implementing smoking cessation programs in the health care system constitutes a major challenge. A unique opportunity to initiate smoking cessation focuses on smokers scheduled for surgery. These patients are not only highly motivated to quit smoking but also likely to benefit from a reduction in postoperative complications which may translate into a decrease of costs. Nevertheless, surgical patients are not routinely informed about the benefits of preoperative smoking cessation. Potential reasons for this missed opportunity may be the lack of time and training of surgeons and anaesthesiologists. We therefore aim to analyse the impact of a preoperative high-intensity smoking cessation intervention on surgical complications up to a 90-day postoperative period in patients of various surgical disciplines. The hypothesis is that a preoperative smoking cessation program improves outcomes in smokers undergoing intermediate to high-risk surgery.MethodsThe present study is a single-centre, randomized trial with two parallel groups of smokers scheduled for surgery comparing surgery alone and surgery with preoperative smoking cessation. We plan to randomize 251 patients. The primary objective is to compare complications between patients with an institutional multifaceted smoking cessation intervention starting 4 weeks before surgery compared to patients in the advice-only group (control group) within a 90-day postoperative period. The primary endpoint is the Comprehensive Complication Index (CCI®) within 90 days of surgery. Secondary outcomes include the length of hospital stay, cost of care, quality of life, smoking abstinence, and reduction in nicotine consumption.DiscussionThe hypothesis is that a preoperative smoking cessation program improves outcomes in smokers undergoing surgery.Trial registrationBASEC #2021-02004; ClinicalTrials.gov: NCT05192837 . Registered on January 14, 2022.
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