"Tobacco dependence treatment makes no sense because" : rebuttal of commonly-heard arguments against providing tobacco dependence treatment in the hospital setting.

BACKGROUND: The provision of tobacco dependence treatment in health care settings, particularly in countries lacking a history of strong tobacco control policy implementation, is limited by continued misconceptions on the part of health professionals and decision-makers regarding its worth and efficacy. In this paper, we rebut 9 arguments against the provision of tobacco dependence treatment that we have encountered in our experiences implementing and maintaining a dedicated smoking cessation service at a large university hospital in southern Germany. DISCUSSION: Broadly, the arguments relate to the nature of addiction, the efficacy and safety of stop-smoking medication and behavioural support, and the benefits and challenges of quitting. They include: (a) If smokers really want to quit, they will be able to do it alone (without help); (b) You can't forbid patients from doing what they want; (c) Patients will be upset if you talk to them about their smoking; (d) Stop-smoking medication has side effects that are more dangerous than smoking; (e) You have to be well trained to help smokers to quit (otherwise you can do more harm than good); (f) If you smoke yourself, you lack credibility; (g) If you have cancer, it is too late to quit; (h) Nicotine withdrawal is dangerous for heavy smokers; and (i) Smokers die earlier, thus reducing costs to the health system. SUMMARY: It is hoped that the counter-arguments presented here arm tobacco control advocates and practitioners working in health care settings, particularly in countries which have not prioritised tobacco control, to respond appropriately and convincingly to those opposed to the provision of tobacco dependence treatment.

Effectiveness of residential versus outpatient therapy for smoking cessation: The START randomized clinical trial.

BACKGROUND AND AIMS: Tobacco smoking represents a major cause for preventable death and morbidity. Results from non-randomized studies suggest that smoking cessation therapy in a residential setting might be a new viable way to facilitate smoking abstinence. We aimed to test the effects of residential multicomponent group therapy for smoking cessation compared with outpatient group therapy. DESIGN: Prospective parallel-group open-label randomized superiority trial, with assessments at baseline, 6 and 12 months. SETTING: Recruitment throughout Germany via media advertisements. PARTICIPANTS: Adult smokers (≥10 cigarettes/day) randomly assigned to residential (n = 157) or outpatient (n = 158) therapy. 51.8% female; mean age 53.2 years; mean years of smoking 34.4. INTERVENTION AND COMPARATOR: Residential 9-day smoking cessation group therapy comprising six daily therapy sessions and supportive interventions for cessation and daily structure embedded in the routines of a somatic rehabilitation center, compared with weekly outpatient smoking cessation group therapy (3-7 weeks) provided in routine care courses close to the participants' places of residence, both including at least 9 h of behavioral therapy. MEASUREMENTS: Co-primary outcomes were self-reported continuous 6- and 12-month abstinence (hierarchically ordered). Primary analyses were conducted in the therapy-uptake population including participants who started therapy with sensitivity analyses in the intention-to-treat population of all randomized participants. FINDINGS: Intervention uptake rates were 87.3% (n = 137) in the residential and 60.1% (n = 95) in the outpatient group. In the therapy-uptake population, abstinence rates were 46.7% in the residential versus 26.3% in the outpatient group at 6 months (odds ratio [OR] = 2.46, 95% confidence interval [CI] = 1.39-4.33, P = 0.0019) and 39.4% versus 24.2% at 12 months (OR = 2.04, 95% CI = 1.14-3.64, P = 0.017). Biochemically validated abstinence rates at 12 months were 33.1% in the residential versus 17.4% in the outpatient group (OR = 2.35, 95% CI = 1.22-4.51, P = 0.011). In the intention-to-treat population, self-reported and biochemically validated abstinence rates at 12 months were 34.4% in the residential versus 14.6% in the outpatient group (OR = 3.08, 95% CI = 1.77-5.34, P < 0.0001) and 28.6% versus 10.3% (OR = 3.48, 95% CI = 1.85-6.52, P = 0.0001), respectively. CONCLUSIONS: Residential therapy exclusively for smoking cessation is feasible and effective and could be a beneficial new treatment for smokers.

Residential treatment exclusively for smoking cessation in patients with Crohn's disease: Results from a pilot study.

INTRODUCTION: Cigarette smoking is a risk factor for the induction and severity of the course of Crohn's disease (CD). Hospital admission may be required for treatment of the disease but is generally not available solely for smoking cessation. Outpatient group therapy is readily available, however long-term quit rates are limited. Residential treatment for smoking cessation may offer a more intense contact between patient and therapist, and may result in higher abstinence rates in a sensitive group of patients. The objective of this pilot study is to evaluate the feasibility of implementing a residential program with hospital admission, exclusively for smoking cessation for patients suffering from CD. METHODS: Twelve eligible smokers suffering from CD were recruited for a 9-day inpatient smoking cessation treatment. Treatment consisted of single and group behavioral therapy together with supportive measures such as exercise therapy, relaxation techniques or nutritional counselling. Nicotine replacement therapy or prescription medication was offered according to the Fagerström test for nicotine dependence (FTND) score and treatment guidelines. Quit rates were assessed by CO-testing during hospital treatment and by follow-up calls 6 months after discharge. RESULTS: All recruited participants arrived on time for treatment and collectively stopped smoking on the 2nd day after admission. All participants completed the therapy process without relapse and left the hospital smoke-free (100% quit rate on discharge, CO monitored). Self-reported abstinence rates after 6 months were 72.7% for continuous abstinence and 81.8% for 7-day point prevalence abstinence. CONCLUSIONS: Residential treatment exclusively for smoking cessation is feasible and efficient and may be a valuable treatment option for patients suffering from CD.

Efficacy of a short-term residential smoking cessation therapy versus standard outpatient group therapy ('START-Study'): study protocol of a randomized controlled trial.

BACKGROUND: In Germany, evidence-based outpatient smoking cessation therapies are widely available. Long-term abstinence rates, however, are limited. Studies suggest that short-term residential therapy enables a higher level of environmental control, more intense contact and greater support among patients and from therapists, which could result in higher abstinence rates. The aim of the current START-study is to investigate the long-term efficacy of a short-term residential therapy exclusively for smoking cessation, conducted by a mobile team of expert therapists. METHODS: A randomized controlled trial (RCT) is conducted to examine the efficacy of residential behavior therapeutic smoking cessation therapy compared to standard outpatient behavior therapeutic smoking cessation group therapy. Adult smokers consuming 10 or more cigarettes per day, who are willing to stop smoking, are randomized in a ratio of 1:1 between therapy groups. The primary endpoint is sustained abstinence for 6-month and 12-month periods. Secondary endpoints include smoking status after therapy, 7-day point abstinence after the 6-month and 12-month follow-ups, level of physical dependence, cost-effectiveness, use of nicotine replacement products, health-related quality of life, self-efficacy expectation for tobacco abstinence, motivational and volitional determinants of behavior change, self-reported depressive symptom severity, adverse events and possible side effects. Assessments will take place at baseline, post-therapy, and at 6-month and 12-month intervals after smoking cessation. DISCUSSION: There is a high demand for long-term effective smoking cessation therapies. This study represents the first prospective RCT to examine the long-term efficacy of a residential smoking cessation therapy program compared to standard outpatient group therapy as an active control condition. The residential therapeutic concept may serve as a new model to substantially enhance future cessation therapies and improve the understanding of therapeutic impact factors on tobacco abstinence. Utilizing a mobile team, the model could be applied efficiently to medical centers that do not have permanent and trained personnel for smoking cessation at their disposal. TRIAL REGISTRATION: German Register for Clinical Trials (Deutsches Register für Klinische Studien), DRKS00013466. Retrospectively registered on 1 April 2019. https://www.drks.de/drks_web/navigate.do?navigationId=start.

Implementation and effectiveness of a hospital smoking cessation service in Germany.

OBJECTIVE: Hospitalized smokers are often highly motivated to quit and receptive to assistance. There are few published accounts of hospital-based smoking cessation programmes implemented outside of a trial setting, particularly outside North America. We describe the implementation and effectiveness of a dedicated smoking cessation service in Freiburg, Germany. METHODS: Measures of implementation (e.g. number of patients referred and consenting to participate, receipt of post-discharge support) and effectiveness are presented. RESULTS: In the first 2 years of the service, 1432 patients were referred. Over half (55.3%) of counselled smokers agreed to participate. Sustained abstinence for 6 months was achieved by 28.0% (missing cases coded as smokers), whereas 7-day point prevalence rates were between 30 and 35% at 3, 6 and 12 months. Those who received 4+ post-discharge calls were more likely to achieve sustained abstinence, as were older smokers, those with higher self-efficacy, and cardiovascular patients. CONCLUSION: Hospitalized patients in Germany are receptive to the offer of bedside counselling and to phone support post-discharge, and success rates are comparable to those achieved in other countries. PRACTICE IMPLICATIONS: The findings argue strongly for the routine identification of smokers upon hospital admission, and the availability of cessation support both during hospitalization and following discharge.

"Translocatory proteins" and "protein transduction domains": a critical analysis of their biological effects and the underlying mechanisms.

It has been suggested that several proteins, termed "translocatory" or "messenger" proteins, can move between living cells-exiting the cell of synthesis via an uncharacterized secretory pathway and entering adjacent cells by a nonendocytic mechanism that is active even at 4 degrees C. These activities, which have been mapped to short, highly basic regions termed "protein transduction domains" (PTDs), have engendered considerable interest in the gene therapy and vaccine research communities. If these proteins, and PTDs, are to be used in human or veterinary medicine, it is vital that the mechanisms underlying their effects be understood. This article presents a critical evaluation of the current literature and describes recent findings that indicate that the effects of these sequences might be explained by well-established biological principles.

Targeting plasmid-encoded proteins to the antigen presentation pathways.

The antigen presentation pathways constitute a fulcrum on which adaptive immunity is balanced, and their manipulation should allow us to induce designer immune responses. The ease and rapidity with which DNA vaccines can be constructed and altered make them ideal candidates with which to test the various targeting strategies that have been conceived to date. These approaches and the mechanisms that may (or may not) underlie their success are reviewed in this article.