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Sample records for cessation rationale study

  1. Targeting Body Image Schema for Smoking Cessation among College Females: Rationale, Program Description, and Pilot Study Results

    Science.gov (United States)

    Napolitano, Melissa A.; Lloyd-Richardson, Elizabeth E.; Fava, Joseph L.; Marcus, Bess H.

    2011-01-01

    Smoking among young adults is a significant public health problem. Despite the negative health effects, many young women smoke for weight and body image reasons. Understanding the factors that prompt young women to initiate and continue smoking is important for designing smoking cessation interventions. The aim of the current article is to outline…

  2. Yoga as a complementary treatment for smoking cessation: rationale, study design and participant characteristics of the Quitting-in-Balance study

    Directory of Open Access Journals (Sweden)

    Jennings Ernestine

    2010-04-01

    Full Text Available Abstract Background Tobacco smoking remains the leading preventable cause of death among American women. Exercise has shown promise as an aid to smoking cessation because it reduces weight gain and weight concerns, improves affect, and reduces nicotine withdrawal symptoms and cigarette craving. Studies have shown that the practice of yoga improves weight control, and reduces perceived stress and negative affect. Yoga practice also includes regulation of breathing and focused attention, both of which may enhance stress reduction and improve mood and well-being and may improve cessation outcomes. Methods/Design This pilot efficacy study is designed to examine the rates of cessation among women randomized to either a novel, 8-week Yoga plus Cognitive Behavioral Therapy (CBT smoking cessation intervention versus a Wellness program plus the same CBT smoking cessation intervention. Outcome measures include 7-day point prevalence abstinence at end of treatment, 3 and 6 months follow up and potential mediating variables (e.g., confidence in quitting smoking, self-efficacy. Other assessments include measures of mindfulness, spirituality, depressive symptoms, anxiety and perceived health (SF-36. Discussion Innovative treatments are needed that address barriers to successful smoking cessation among men and women. The design chosen for this study will allow us to explore potential mediators of intervention efficacy so that we may better understand the mechanism(s by which yoga may act as an effective complementary treatment for smoking cessation. If shown to be effective, yoga can offer an alternative to traditional exercise for reducing negative symptoms that often accompany smoking cessation and predict relapse to smoking among recent quitters. Trial Registration ClinicalTrials NCT00492310

  3. First Breath prenatal smoking cessation pilot study: preliminary findings.

    Science.gov (United States)

    Jehn, Lisette; Lokker, Nicole; Matitz, Debra; Christiansen, Bruce

    2003-01-01

    Despite the many dangers associated with smoking during pregnancy, it remains a salient public health problem for Wisconsin women. The First Breath pilot program was developed in an attempt to reduce rates of smoking during pregnancy among low-income women. Preliminary results suggest that the First Breath counseling-based approach is effective, with a quit rate of 43.8% among First Breath enrollees at 1 month postpartum. Women receiving First Breath cessation counseling also had higher quit rates at every measurement period versus women in a comparison group who were receiving whatever cessation care was available in their county in the absence of First Breath. The First Breath pilot study has demonstrated success in helping pregnant women quit smoking and in creating a model for integration of cessation services into prenatal health care service provision. It is through this success that First Breath is expanding beyond the pilot study stage to a statewide program in 2003.

  4. Contributions of auriculotherapy in smoking cessation: a pilot study

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    Roberta de Paiva Silva

    2014-10-01

    Full Text Available Objective To evaluate the contribution of auriculotherapy in smoking cessation. Method Double-blind randomized controlled trial, conducted with 30 smokers allocated into two groups: Experimental Group (21 participants received 10 sessions of auriculotherapy at specific points for smoking and Control Group (nine participants received auriculotherapy in points that have no effect on the focus of research. Results Auriculotherapy contributed in reducing the number of cigarettes smoked in 61.9% of participants (p=0.002, in reducing the difficult to abstain from smoking in places where it is forbidden by 38% (p=0.050 and in not smoking when ill 23.8% (p=0.025. Conclusion Given the efficacy only in terms of reducing the number of cigarettes smoked and other parameters, we suggest that future studies consider the use of auriculotherapy combined with other treatment methods, in order to achieve better results in cessation/abstinence.

  5. Rationale and Design of the 'MITOCARE' Study

    DEFF Research Database (Denmark)

    Clemmensen, Peter

    2012-01-01

    Treatment of acute ST-elevation myocardial infarction (STEMI) by reperfusion using percutaneous coronary intervention (PCI) or thrombolysis has provided clinical benefits; however, it also induces considerable cell death. This process is called reperfusion injury. The continuing high rates...... resonance). The study is being financed under an EU-FP7 grant and conducted under the auspices of the MITOCARE research consortium, which includes experts from clinical and basic research centers, as well as commercial enterprises, throughout Europe. Results from this study will contribute to a better...

  6. Effects of Nicotine Dependence and Depressive Symptoms on Smoking Cessation: A Longitudinal Study Among Adolescents

    NARCIS (Netherlands)

    Scherphof, C.S.; Eijnden, R.J.J.M. van den; Harakeh, Z.; Raaijmakers, Q.A.W.; Kleinjan, M.; Engels, R.C.M.E.; Vollebergh, W.A.M.

    2013-01-01

    Nicotine dependence has been shown to hamper successful smoking cessation in adolescents. Nicotine dependence and depression are highly comorbid, but the relation between depression and smoking cessation is not yet fully understood. Therefore, the present study examines both the longitudinal recipro

  7. The efficacy of vigorous-intensity exercise as an aid to smoking cessation in adults with elevated anxiety sensitivity: study protocol for a randomized controlled trial

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    Smits Jasper A J

    2012-11-01

    Full Text Available Abstract Background Although cigarette smoking is a leading cause of death and disability in the United States (US, over 40 million adults in the US currently smoke. Quitting smoking is particularly difficult for smokers with certain types of psychological vulnerability. Researchers have frequently called attention to the relation between smoking and anxiety-related states and disorders, and evidence suggests that panic and related anxiety vulnerability factors, specifically anxiety sensitivity (AS or fear of somatic arousal, negatively impact cessation. Accordingly, there is merit to targeting AS among smokers to improve cessation outcome. Aerobic exercise has emerged as a promising aid for smoking cessation for this high-risk (for relapse group because exercise can effectively reduce AS and other factors predicting smoking relapse (for example, withdrawal, depressed mood, anxiety, and it has shown initial efficacy for smoking cessation. The current manuscript presents the rationale, study design and procedures, and design considerations of the Smoking Termination Enhancement Project (STEP. Methods STEP is a randomized clinical trial that compares a vigorous-intensity exercise intervention to a health and wellness education intervention as an aid for smoking cessation in adults with elevated AS. One hundred and fifty eligible participants will receive standard treatment (ST for smoking cessation that includes cognitive behavioral therapy (CBT and nicotine replacement therapy (NRT. In addition, participants will be randomly assigned to either an exercise intervention (ST+EX or a health and wellness education intervention (ST+CTRL. Participants in both arms will meet 3 times a week for 15 weeks, receiving CBT once a week for the first 7 weeks, and 3 supervised exercise or health and wellness education sessions (depending on randomization per week for the full 15-week intervention. Participants will be asked to set a quit date for 6 weeks after

  8. Parents who quit smoking and their adult children's smoking cessation: a 20-year follow-up study

    NARCIS (Netherlands)

    Bricker, J.B.; Otten, R.; Liu, J.L.; Peterson, A.V.

    2009-01-01

    Aims - Extending our earlier findings from a longitudinal cohort study, this study examines parents' early and late smoking cessation as predictors of their young adult children's smoking cessation. Design - Parents' early smoking cessation status was assessed when their children were aged 8 years;

  9. A Comparative Study on Tobacco Cessation Methods: A Quantitative Systematic Review

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    Gholamreza Heydari

    2014-01-01

    Conclusions: Results of this review indicate that the scientific papers in the most recent decade recommend the use of NRT and Champix in combination with educational interventions. Additional research is needed to compare qualitative and quantitative studies for smoking cessation.

  10. Predictors of smoking cessation in smokers with chronic periodontitis: a 24-month study

    DEFF Research Database (Denmark)

    Inoue, Gislene; Rosa, Ecinele F.; Fueta Gomes, Elaine

    2016-01-01

    The purpose of this 24-month study was to identify predictors of smoking cessation in a cohort of smokers with chronic periodontitis, attending a multidisciplinary smoking cessation program. Of the 286 subjects screened, 116 were included and received non-surgical periodontal treatment and smoking...... cessation therapy, which consisted of lectures, cognitive behavioral therapy, and pharmacotherapy, according to their individual needs. During initial periodontal treatment, dentists actively motivated the study subjects to stop smoking, using motivational interviewing techniques. Further smoking cessation...... counseling and support were also provided by the dentists, during periodontal maintenance sessions at 3, 6, 12 and 24 months of follow-up. Smoking status was assessed by means of a structured questionnaire, and was validated by exhaled carbon monoxide (CO) measurements. The Fagerström Test for Cigarette...

  11. A randomised controlled trial linking mental health inpatients to community smoking cessation supports: A study protocol

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    Clancy Richard

    2011-07-01

    Full Text Available Abstract Background Mental health inpatients smoke at higher rates than the general population and are disproportionately affected by tobacco dependence. Despite the advent of smoke free policies within mental health hospitals, limited systems are in place to support a cessation attempt post hospitalisation, and international evidence suggests that most smokers return to pre-admission smoking levels following discharge. This protocol describes a randomised controlled trial that will test the feasibility, acceptability and efficacy of linking inpatient smoking care with ongoing community cessation support for smokers with a mental illness. Methods/Design This study will be conducted as a randomised controlled trial. 200 smokers with an acute mental illness will be recruited from a large inpatient mental health facility. Participants will complete a baseline survey and will be randomised to either a multimodal smoking cessation intervention or provided with hospital smoking care only. Randomisation will be stratified by diagnosis (psychotic, non-psychotic. Intervention participants will be provided with a brief motivational interview in the inpatient setting and options of ongoing smoking cessation support post discharge: nicotine replacement therapy (NRT; referral to Quitline; smoking cessation groups; and fortnightly telephone support. Outcome data, including cigarettes smoked per day, quit attempts, and self-reported 7-day point prevalence abstinence (validated by exhaled carbon monoxide, will be collected via blind interview at one week, two months, four months and six months post discharge. Process information will also be collected, including the use of cessation supports and cost of the intervention. Discussion This study will provide comprehensive data on the potential of an integrated, multimodal smoking cessation intervention for persons with an acute mental illness, linking inpatient with community cessation support. Trial Registration

  12. A pilot study of a smoking cessation intervention for women living with HIV: study protocol

    Directory of Open Access Journals (Sweden)

    Kim SS

    2017-02-01

    Full Text Available Sun S Kim, Sabreen Darwish, Sang A Lee, Rosanna F DeMarco Department of Nursing, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, USA Background: Prevalence of cigarette smoking is substantially higher among people living with human immunodeficiency virus (HIV than the general population in the USA. Women living with HIV (WLHIV who smoke are at higher risk of developing acquired immunodeficiency syndrome and have a higher mortality rate than nonsmoking WLHIV. Compared to men, women generally require more intensive counseling for smoking cessation. The primary aim of this study is to examine the acceptability and feasibility of a videoconferencing smoking cessation intervention that is tailored to the specific needs of WLHIV. Methods: A total of 50 WLHIV will be randomized at a ratio of 1:1 to either a videoconferencing or a telephone counseling arm. Both arms have the same cessation intervention, that is, eight weekly individualized counseling sessions of 30-minute cognitive behavioral therapy plus active nicotine patches for 8 weeks. The only difference between the two arms is the delivery mode of the counseling, that is, telephone video call vs. telephone voice call. Data collection is scheduled at baseline and three follow-up points: 1, 3, and 6 months from the target quit day. Data will be analyzed using STATA 14. The primary outcome is a 6-month prolonged abstinence. Home-based salivary cotinine test will be conducted to verify self-reported smoking abstinence using a NicAlert® test strip, while a research coordinator monitors the whole process by a telephone video call. Conclusion: The study is a two-arm parallel-group pilot clinical trial of a smoking cessation intervention. It attempts to examine whether videoconferencing smoking cessation intervention will be acceptable and feasible for WLHIV and will yield a better cessation outcome than telephone counseling intervention. Findings may have the

  13. The Danish Alzheimer Intervention Study: Rationale, Study Design and Baseline Characteristics of the Cohort

    DEFF Research Database (Denmark)

    Waldemar, G.; Waldorff, F.B.; Buss, D.V.

    2011-01-01

    There is a lack of appropriately designed trials investigating the efficacy of psychosocial interventions for patients with mild dementia and their family caregivers. This paper reports the rationale and design of the Danish Alzheimer Disease Intervention Study and baseline characteristics...

  14. Breastfeeding cessation and symptoms of anxiety and depression: a longitudinal cohort study

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    Ystrom Eivind

    2012-05-01

    Full Text Available Abstract Background Neonatal anxiety and depression and breastfeeding cessation are significant public health problems. There is an association between maternal symptoms of anxiety and depression and early breastfeeding cessation. In earlier studies, the causality of this association was interpreted both ways; symptoms of anxiety and depression prepartum significantly impacts breastfeeding, and breastfeeding cessation significantly impacts symptoms of anxiety and depression. First, we aimed to investigate whether breastfeeding cessation is related to an increase in symptoms of anxiety and depression from pregnancy to six months postpartum. Second, we also investigated whether the proposed symptom increase after breastfeeding cessation was disproportionately high for those women already suffering from high levels of anxiety and depression during pregnancy. Methods To answer these objectives, we examined data from 42 225 women in the Norwegian Mother and Child Cohort Study (MoBa. Subjects were recruited in relation to a routine ultra-sound examination, and all pregnant women in Norway were eligible. We used data from the Medical Birth Registry of Norway and questionnaires both pre and post partum. Symptoms of anxiety and depression at six months postpartum were predicted in a linear regression analysis by WHO-categories of breastfeeding, symptoms of anxiety and depression prepartum (standardized score, and interaction terms between breastfeeding categories and prepartum symptoms of anxiety and depression. The results were adjusted for cesarean sections, primiparity, plural births, preterm births, and maternal smoking. Results First, prepartum levels of anxiety and depression were related to breastfeeding cessation (β 0.24; 95% CI 0.21-0.28, and breastfeeding cessation was predictive of an increase in postpartum anxiety and depression ( β 0.11; 95%CI 0.09-0.14. Second, prepartum anxiety and depression interacted with the relation between

  15. Physical activity as an aid to smoking cessation during pregnancy: Two feasibility studies

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    Marcus Bess

    2008-09-01

    Full Text Available Abstract Background Pharmacotherapies for smoking cessation have not been adequately tested in pregnancy and women are reluctant to use them. Behavioural support alone has a modest effect on cessation rates; therefore, more effective interventions are needed. Even moderate intensity physical activity (e.g. brisk walk reduces urges to smoke and there is some evidence it increases cessation rates in non-pregnant smokers. Two pilot studies assessed i the feasibility of recruiting pregnant women to a trial of physical activity for smoking cessation, ii adherence to physical activity and iii womens' perceptions of the intervention. Methods Pregnant smokers volunteered for an intervention combining smoking cessation support, physical activity counselling and supervised exercise (e.g. treadmill walking. The first study provided six weekly treatment sessions. The second study provided 15 sessions over eight weeks. Physical activity levels and continuous smoking abstinence (verified by expired carbon monoxide were monitored up to eight months gestation. Results Overall, 11.6% (32/277 of women recorded as smokers at their first antenatal booking visit were recruited. At eight months gestation 25% (8/32 of the women achieved continuous smoking abstinence. Abstinent women attended at least 85% of treatment sessions and 75% (6/8 achieved the target level of 110 minutes/week of physical activity at end-of-treatment. Increased physical activity was maintained at eight months gestation only in the second study. Women reported that the intervention helped weight management, reduced cigarette cravings and increased confidence for quitting. Conclusion It is feasible to recruit pregnant smokers to a trial of physical activity for smoking cessation and this is likely to be popular. A large randomised controlled trial is needed to examine the efficacy of this intervention.

  16. Predictors of smoking cessation in smokers with chronic periodontitis: a 24-month study

    Directory of Open Access Journals (Sweden)

    Gislene INOUE

    Full Text Available Abstract The purpose of this 24-month study was to identify predictors of smoking cessation in a cohort of smokers with chronic periodontitis, attending a multidisciplinary smoking cessation program. Of the 286 subjects screened, 116 were included and received non-surgical periodontal treatment and smoking cessation therapy, which consisted of lectures, cognitive behavioral therapy, and pharmacotherapy, according to their individual needs. During initial periodontal treatment, dentists actively motivated the study subjects to stop smoking, using motivational interviewing techniques. Further smoking cessation counseling and support were also provided by the dentists, during periodontal maintenance sessions at 3, 6, 12 and 24 months of follow-up. Smoking status was assessed by means of a structured questionnaire, and was validated by exhaled carbon monoxide (CO measurements. The Fagerström Test for Cigarette Dependence was used to assess smoking dependence. Of the 61 individuals that remained up to the 24-month examination, 31, 21 and 18 declared that they were not smoking at 3, 12 and 24 months, respectively. Smoking cessation after 24 months was associated with the male gender (OR = 3.77, 95%CI = 1.16–12.30, baseline CO levels less than 10ppm (OR = 5.81, 95%CI 1.76–19.23, not living or working with another smoker (OR = 7.38, 95%CI 1.76–30.98 and a lower mean Fagerström test score (OR = 5.63, 95%CI 1.55–20.43. We concluded that smoking cessation was associated with demographic, smoking history and cigarette dependence variables.

  17. Early cessation of triptorelin in in vitro fertilization : a double-blind, randomized study

    NARCIS (Netherlands)

    Simons, AHM; Roelofs, HJM; Schmoutziguer, APE; Roozenburg, BJ; van't Hof-van den Brink, EP; Schoonderwoerd, SA

    2005-01-01

    Objective: To compare the efficacy of two early cessation protocols of triptorelin treatment in controlled ovarian hyperstimulation with the conventional long protocol in in vitro ferfilization/intracytoplasmic sperm injection. Design: A double-blind, randomized, multicenter study. Setting: Three Du

  18. Culturally Tailored Smoking Cessation for Arab American Male Smokers in Community Settings: A Pilot Study

    OpenAIRE

    Haddad, Linda; Corcoran, Jacqueline

    2013-01-01

    Tobacco use is a serious public health problem among Arab Americans with limited English proficiency. The main goal of this study was to develop a culturally-tailored and linguistically-sensitive Arabic-language smoking cessation program. A secondary goal was to evaluate the feasibility of recruiting Arab Americans through a faith-based community organization which serves as a neighborhood social center for the city of Richmond’s Arab Americans. Eight first-generation Arab American men aged 2...

  19. Culturally-Tailored Smoking Cessation for American Indians: Study protocol for a randomized controlled trial

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    Shireman Theresa I

    2011-05-01

    Full Text Available Abstract Background Cigarette smoking is the number one cause of preventable death among American Indian and Alaska Natives, AI/ANs. Two out of every five AI/AN will die from tobacco-related diseases if the current smoking rates of AI/ANs (40.8% persist. Currently, there is no proven, effective culturally-tailored smoking cessation program designed specifically for a heterogeneous population of AI. The primary aim of this group randomized clinical trial is to test the efficacy of "All Nations Breath of Life" (ANBL program compared to a non-tailored "Current Best Practices" smoking cessation program among AI smokers. Methods We will randomize 56 groups (8 smokers per group to the tailored program or non-tailored program for a total sample size of 448 American Indian smokers. All participants in the proposed study will be offered pharmacotherapy, regardless of group assignment. This study is the first controlled trial to examine the efficacy of a culturally-tailored smoking cessation program for American Indians. If the intervention is successful, the potential health impact is significant because the prevalence of smoking is the highest in this population. Trial Registration ClinicalTrials.gov: NCT01106456

  20. Genetic polymorphisms in dopamine-related genes and smoking cessation in women: a prospective cohort study

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    Srinouanprachan Sengkeo

    2007-04-01

    Full Text Available Abstract Background Genes involved in dopaminergic neurotransmission have been suggested as candidates for involvement in smoking behavior. We hypothesized that alleles associated with reduced dopaminergic neurotransmission would be more common in continuing smokers than among women who quit smoking. Methods The study included 593 women aged 26–65 years who participated in a twelve month smoking cessation trial conducted in 1993–1994. Participants were contacted three years after the trial to obtain updated smoking history and biological specimens. Seven polymorphisms were assessed in genes involved in dopamine synthesis (tyrosine hydoxylase [TH], receptor activation (dopamine receptors [DRD2, DRD3, DRD4], reuptake (dopamine transporter [SLC6A3], and metabolism (catechol-o-methyltransferase [COMT]. Smoking cessation was assessed as "short-term" quitting (abstinence for the seven days before the conclusion of the trial and "long-term" quitting (abstinence for the six months before a subsequent interview conducted several years later. Results We observed no association of any polymorphism with either short- or long-term quitting. Although some relative risk estimates were consistent with weak associations, either the direction of effect was opposite of that hypothesized, or results of the short- and long-term cessation endpoints differed. However, effect modification on smoking cessation was observed between DRD2 Taq1A and SLC6A3 VNTR polymorphisms, DRD3 Ser/Gly and d,1-fenfluramine, and DRD4 VNTR and d,1-fenfluramine. Conclusion Although these results fail to support prior findings of independent associations of these polymorphisms with smoking status, our exploratory findings suggestive of gene-gene and gene-treatment interactions warrants further investigation.

  1. Effect of self-administered auricular acupressure on smoking cessation --a pilot study

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    Leung Lawrence

    2012-02-01

    Full Text Available Abstract Background Tobacco smoking is still a worldwide health risk. Current pharmacotherapies have at best, a success rate of no more than 50%. Auricular (ear acupressure has been purported to be beneficial in achieving smoking cessation in some studies, while in others has been deemed insignificant. We hereby describe the protocol for a three-arm randomised controlled trial to examine the possible benefits of self-administered acupressure for smoking cessation. Methods Sixty consenting participants with confirmed habit of tobacco smoking will be recruited and randomized into three arms to receive either auricular acupressure at five true acupoints (NADA protocol, auricular acupressure at five sham points, or no auricular acupressure at all. Participants having auricular acupressure will exert firm pressure to each acupoint bilaterally via the bead in the attached plasters whenever they feel the urge to smoke. The treatment phase will last for six weeks during which all participants will be assessed weekly to review their smoking log, state of abstinence, end-exhalation carbon monoxide levels and possible adverse effects including withdrawal reactions and stress levels. At any time, a successful quit date will be defined with continuous abstinence for the following consecutive 7 days. From then on, participants will be evaluated individually for continuous abstinence rate (CAR, end-exhalation carbon monoxide levels and adverse effects of stress and withdrawal at specified intervals up to 26 weeks. Expectancy of treatment will be assessed with a four-item Borkovec and Nau self-assessment credibility scale during and after intervention. Discussion We incorporate validated outcome measures of smoking cessation into our randomised controlled trial design with the objectives to evaluate the feasibility and possible benefits of self-administered auricular acupressure as a non-invasive alternative to pharmacotherapy for smoking cessation. Trial

  2. Self-reported smoking cessation interventions among dental practitioners: A cross-sectional study

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    Raghad Hashim

    2016-01-01

    Full Text Available Objective: The aim of this study is to determine the attitudes and practices of dentists toward smoking cessation intervention (SCI; to identify the barriers that prevent them from advising their patients to quit smoking and to determine the level of interest in future training in smoking cessation. Methods: Self-administered questionnaires were distributed to all (122 dentists practicing in private sectors in the Emirate of Ajman, United Arab Emirates. The questionnaire was personally administered, and the dental practitioners were given explanations regarding how to complete it. Only descriptive statistics was calculated. Results: More than half of the respondents (55% inquired about their patients smoking status, whereas 40% of the dentists documented it. The most common barrier cited by the respondents was the lack of training and preparation in the smoking cessation techniques, followed by lack of availability of educational material. Almost three-quarters of the respondent were interested in further training in SCI; being provided to them through full-day training course. Conclusions: Dentists require more access to appropriate forms of training in the SCI and more support needed to enable the dentist to help their patient to quit the habit. Providing training program to the dental practitioners in the United Arab Emirates to equip them with the required skill to deliver SCI would be highly beneficial.

  3. Acupressure for smoking cessation – a pilot study

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    Moody Russell C

    2007-03-01

    Full Text Available Abstract Background Tobacco smoking is a serious risk to health: several therapies are available to assist those who wish to stop. Smokers who approach publicly funded stop-smoking clinics in the UK are currently offered nicotine replacement therapy (NRT or bupropion, and group behaviour therapy, for which there is evidence of effectiveness. Acupuncture and acupressure are also used to help smokers, though a systematic review of the evidence of their effectiveness was inconclusive. The aim of this pilot project was to determine the feasibility of a study to test acupressure as an adjunct to one anti-smoking treatment currently offered, and to inform the design of the study. Methods An open randomised controlled pilot study was conducted within the six week group programme offered by the Smoking Advice Service in Plymouth, UK. All participants received the usual treatment with NRT and group behavioural therapy, and were randomised into three groups: group A with two auricular acupressure beads, group B with one bead, and group C with no additional therapy. Participants were taught to press the beads when they experienced cravings. Beads were worn in one ear for four weeks, being replaced as necessary. The main outcome measures assessed in the pilot were success at quitting (expired CO ≤ 9 ppm, the dose of NRT used, and the rating of withdrawal symptoms using the Mood and Symptoms Scale. Results From 49 smokers attending four clinics, 24 volunteered to participate, 19 attended at least once after quitting, and seven remained to the final week. Participants who dropped out reported significantly fewer previous quit attempts, but no other significant differences. Participants reported stimulating the beads as expected during the initial days after quitting, but most soon reduced the frequency of stimulation. The discomfort caused by the beads was minor, and there were no significant side effects. There were technical problems with adhesiveness of

  4. A randomised controlled trial of a smoking cessation intervention delivered by dental hygienists: a feasibility study

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    Jenkins William

    2007-05-01

    Full Text Available Abstract Background Tobacco use continues to be a global public health problem. Helping patients to quit is part of the preventive role of all health professionals. There is now increasing interest in the role that the dental team can play in helping their patients to quit smoking. The aim of this study was to determine the feasibility of undertaking a randomised controlled smoking cessation intervention, utilising dental hygienists to deliver tobacco cessation advice to a cohort of periodontal patients. Methods One hundred and eighteen patients who attended consultant clinics in an outpatient dental hospital department (Periodontology were recruited into a trial. Data were available for 116 participants, 59 intervention and 57 control, and were analysed on an intention-to-treat basis. The intervention group received smoking cessation advice based on the 5As (ask, advise, assess, assist, arrange follow-up and were offered nicotine replacement therapy (NRT, whereas the control group received 'usual care'. Outcome measures included self-reported smoking cessation, verified by salivary cotinine measurement and CO measurements. Self-reported measures in those trial participants who did not quit included number and length of quit attempts and reduction in smoking. Results At 3 months, 9/59 (15% of the intervention group had quit compared to 5/57 (9% of the controls. At 6 months, 6/59 (10% of the intervention group quit compared to 3/57 (5% of the controls. At one year, there were 4/59 (7% intervention quitters, compared to 2/59 (4% control quitters. In participants who described themselves as smokers, at 3 and 6 months, a statistically higher percentage of intervention participants reported that they had had a quit attempt of at least one week in the preceding 3 months (37% and 47%, for the intervention group respectively, compared with 18% and 16% for the control group. Conclusion This study has shown the potential that trained dental hygienists

  5. Smoking reduction and cessation reduce chronic cough in a general population: the Inter99 study

    DEFF Research Database (Denmark)

    Pisinger, Charlotta; Godtfredsen, Nina; Jørgensen, Torben

    2008-01-01

    Background: Chronic cough can be the first sign of chronic obstructive disease. A few, and mostly selected, studies exploring the effect of reduced daily tobacco consumption have shown a small effect on pulmonary symptoms. Aim: The aim of this study was to examine if smoking reduction (SR) (>= 50......% of daily tobacco consumption) or smoking cessation (SC) had an effect on chronic cough and phlegm. Methods: A total of 2408 daily smokers were included in a Danish population-based intervention study, Inter99. In the analyses, we included smokers with self-reported chronic cough or phlegm at baseline who...

  6. The role of smoking in social networks on smoking cessation and relapse among adults: A longitudinal study.

    Science.gov (United States)

    Blok, David J; de Vlas, Sake J; van Empelen, Pepijn; van Lenthe, Frank J

    2017-02-16

    Understanding the spread of smoking cessation and relapse within social networks may offer new approaches to further curb the smoking epidemic. Whether smoking behavior among social network members determines smoking cessation and relapse of adults however, is less known. For this study, longitudinal data of 4623 adults participating in the Dutch Longitudinal Internet Studies for the Social sciences (LISS) panel were collected in March 2013 with a follow-up in 2014. Logistic regression was used to examine the association between the proportion of smokers in social networks, and (1) smoking cessation (n=762) and (2) smoking relapse (n=1905). Analyses were adjusted for the size of the network, age, sex, and education. Respondents with the largest proportion of smokers in their social network were less likely to quit smoking (OR=0.25; 95% CI=0.11-0.66) and more likely to experience a relapse (6.08; 3.01-12.00). Smoking cessation and relapse were most strongly associated with the proportion of smokers among household members and friends. The proportion of smokers in family outside the household was not related to smoking cessation and smoking relapse. In conclusion, smoking behavior in social networks, especially among household members and friends, is strongly associated with smoking cessation and relapse. These findings further support the spread of smoking within social networks, and provide evidence for network-based interventions, particularly including household members and friends.

  7. Facilitators and Barriers to Effective Smoking Cessation: Counselling Services for Inpatients from Nurse-Counsellors’ Perspectives — A Qualitative Study

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    I-Chuan Li

    2014-05-01

    Full Text Available Tobacco use has reached epidemic levels around the World, resulting in a world-wide increase in tobacco-related deaths and disabilities. Hospitalization presents an opportunity for nurses to encourage inpatients to quit smoking. This qualitative descriptive study was aimed to explore nurse-counsellors’ perspectives of facilitators and barriers in the implementation of effective smoking cessation counselling services for inpatients. In-depth interviews were conducted with 16 nurses who were qualified smoking cessation counsellors and who were recruited from eleven health promotion hospitals that were smoke-free and located in the Greater Taipei City Area.  Data were collected from May 2012 to October 2012, and then analysed using content analysis based on the grounded theory approach. From nurse-counsellors’ perspectives, an effective smoking cessation program should be patient-centred and provide a supportive environment. Another finding is that effective smoking cessation counselling involves encouraging patients to modify their lifestyles. Time constraints and inadequate resources are barriers that inhibit the effectiveness of smoking cessation counselling programs in acute-care hospitals. We suggest that hospitals should set up a smoking counselling follow-up program, including funds, facilities, and trained personnel to deliver counselling services by telephone, and build a network with community smoking cessation resources.

  8. Smoking, Smoking Cessation, and Risk of Tooth Loss: The EPIC-Potsdam Study.

    Science.gov (United States)

    Dietrich, T; Walter, C; Oluwagbemigun, K; Bergmann, M; Pischon, T; Pischon, N; Boeing, H

    2015-10-01

    The aim of this study was to investigate the association between cigarette smoking and smoking cessation and the prevalence and incidence of tooth loss in a large cohort study in Germany. We analyzed data of 23,376 participants of the European Prospective Investigation into Cancer and Nutrition (EPIC)-Potsdam study recruited between 1994 and 1998 from the general population in Potsdam and other parts of Brandenburg, Germany, who had complete data on cigarette smoking, tooth loss, and covariates. Negative binomial regression and tooth-specific logistic regression models were fit to evaluate the association between smoking and the baseline prevalence and incidence of tooth loss during follow-up, respectively. Cigarette smoking was associated with higher prevalence of tooth loss at baseline as well as higher incidence of tooth loss during follow-up. The association between smoking and the incidence of tooth loss was stronger in men than women and stronger in younger versus older individuals. Heavy smoking (≥15 cigarettes/d) was associated with >3 times higher risk of tooth loss in men (odds ratio, 3.6; 95% confidence interval, 3.0, 4.4) and more than twice the risk of tooth loss in women (odds ratio, 2.5; 95% confidence interval, 2.1, 2.9) younger than 50 y when compared with never smokers. Smoking cessation was consistently associated with a reduction in tooth loss risk, with the risk of tooth loss approaching that of never smokers after approximately 10 to 20 y of cessation.

  9. TABADO: "Evaluation of a smoking cessation program among Adolescents in Vocational Training Centers": Study protocol

    Directory of Open Access Journals (Sweden)

    Martinet Yves

    2009-11-01

    Full Text Available Abstract Background Most of the efforts to reduce teenagers' tobacco addiction have focused on smoking prevention and little on smoking cessation. A smoking cessation program (TABADO study, associating pharmacologic and cognitive-behavioural strategy, on a particularly vulnerable population (vocational trainees, was developed. This study aims to evaluate the efficacy of the program which was offered to all smokers in a population aged 15 to 20 years in Vocational Training Centers (VTC. This paper presents the TABADO study protocol. Methods The study is quasi-experimental, prospective, evaluative and comparative and takes place during the 2 years of vocational training. The final population will be composed of 2000 trainees entering a VTC in Lorraine, France, during the 2008-2009 period. The intervention group (1000 trainees benefited from the TABADO program while no specific intervention took place in the "control" group (1000 trainees other than the treatment and education services usually available. Our primary outcome will be the tobacco abstinence rate at 12 months. Discussion If the program proves effective, it will be a new tool in the action against smoking in populations that have been seldom targeted until now. In addition, the approach could be expanded to other young subjects from socially disadvantaged backgrounds in the context of a public health policy against smoking among adolescents. Trial registration Clinical trial identification number is NTC00973570.

  10. Brief preoperative smoking cessation counselling in relation to breast cancer surgery: a qualitative study

    DEFF Research Database (Denmark)

    Thomsen, Thordis; Esbensen, Bente Appel; Samuelsen, Susanne

    2009-01-01

    of cancer diagnosis was difficult for some women. They relapsed to smoking as an ingrown response to emotional distress. The smoking intervention heightened the women's awareness of their addiction to smoking; however, they expressed a need for prolonged smoking cessation support. For others, the smoking......: In newly diagnosed breast cancer patients, brief preoperative smoking intervention motivated smoking cessation. However, prolonged intervention, pre- and postoperatively, may more effectively support cessation in breast cancer patients and should therefore be evaluated in this patient population....

  11. 'The smoking toolkit study': a national study of smoking and smoking cessation in England

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    Vangeli Eleni

    2011-06-01

    Full Text Available Abstract Background Up-to-date data tracking of national smoking patterns and cessation-related behaviour is required to evaluate and inform tobacco control strategies. The Smoking Toolkit Study (STS was designed for this role. This paper describes the methodology of the STS and examines as far as possible the representativeness of the samples. Methods The STS consists of monthly, cross sectional household interviews of adults aged 16 and over in England with smokers and recent ex-smokers in each monthly wave followed up by postal questionnaires three and six months later. Between November 2006 and December 2010 the baseline survey was completed by 90,568 participants. STS demographic, prevalence and cigarette consumption estimates are compared with those from the Health Survey for England (HSE and the General Lifestyle Survey (GLF for 2007-2009. Results Smoking prevalence estimates of all the surveys were similar from 2008 onwards (e.g 2008 STS = 22.0%, 95% C.I. = 21.4% to 22.6%, HSE = 21.7%, 95% C.I. = 20.9% to 22.6%, GLF = 20.8%, 95% C.I. = 19.7% to 21.9%, although there was heterogeneity in 2007 (chi-square = 50.30, p Conclusion There is reason to believe that the STS findings (see http://www.smokinginengland.info are generalisable to the adult population of England.

  12. Cost and clinical consequences of smoking cessation in outpatients after cardiovascular disease: a retrospective cohort study.

    Science.gov (United States)

    Sicras-Mainar, Antoni; Díaz-Cerezo, Silvia; de Burgoa, Verónica Sanz; Navarro-Artieda, Ruth

    2013-01-01

    This cohort retrospective study explored the cost and clinical consequences of smoking cessation in outpatients after cardiovascular events (CVEs), in Spain. A total of 2,540 patients (68.1 years; 60.7% male; 8.4% smokers, 52.9% ex-smokers, and 38.7% never smokers) fulfilling the selection criteria and followed up throughout a period of 36 months after the event were considered eligible for analysis. Total costs were higher among current smokers in comparison with ex-smokers and never smokers (€7,981 versus [vs] €7,322 and €5,619, respectively) (P < 0.001). Both health care costs (€6,273 vs €5,673 and €4,823, respectively) (P < 001) and loss of productivity at work costs (€1,708 vs €1,650 and €796, respectively) (P < 001) accounted for such differences. There was also a difference in CVE recurrence rates (18.6% vs 16.5% and 9.6%, respectively) (P < 01). Smoking cessation in CVE outpatients was associated with lower cost and risk of CVE recurrence compared with smokers, and their health status was similar to that of never smokers, in routine clinical practice in Spain.

  13. The effectiveness of workplace smoking cessation programmes: a meta-analysis of recent studies

    Science.gov (United States)

    Smedslund, G; Fisher, K; Boles, S; Lichtenstein, E

    2004-01-01

    Data sources: ABI/Inform, BRS, CHID, Dissertation Abstracts International, ERIC, Medline, Occupational Health and Safety Database, PsycInfo, Smoking and Health Database, SSCI, and Sociological Abstracts. Study selection: Controlled smoking cessation interventions at the workplace with at least six months follow up published from 1989 to 2001 and reporting quit rates (QRs). Data extraction: Two reviewers independently scanned titles/abstracts of relevant reports, and we reached consensus regarding inclusion/exclusion of the full text reports by negotiation. A third reviewer resolved disagreements. Two reviewers extracted data according to a coding manual. Consensus was again reached through negotiation and the use of a third reviewer. Data synthesis: 19 journal articles were found reporting studies conforming to the study's inclusion criteria. Interventions included self help manuals, physician advice, health education, cessation groups, incentives, and competitions. A total of 4960 control subjects were compared with 4618 intervention subjects. The adjusted random effects odds ratio was 2.03 (95% confidence interval 1.42 to 2.90) at six months follow up, 1.56 (95% CI 1.17 to 2.07) at 12 months, and 1.33 (95% CI 0.95 to 1.87) at more than 12 months follow up. Funnel plots were consistent with strong publication bias at the first two follow ups but not the third. In Fisher et al's 1990 study, the corresponding ORs were 1.18, 1.66, and 1.18. Conclusions: Smoking cessation interventions at the worksite showed initial effectiveness, but the effect seemed to decrease over time and was not present beyond 12 months. Compared to the Fisher (1990) analysis, the effectiveness was higher for the six month follow up. Disappointingly, we found methodological inadequacies and insufficient reporting of key variables that were similar to those found in the earlier meta-analysis. This prevented us from determining much about the most effective components of interventions. It is

  14. Inflammation and Exercise (INFLAME): study rationale, design, and methods

    Science.gov (United States)

    Thompson, Angela; Mikus, Catherine; Rodarte, Ruben Q.; Distefano, Brandy; Priest, Elisa L.; Sinclair, Erin; Earnest, Conrad P.; Blair, Steven N.; Church, Timothy S.

    2008-01-01

    Purpose The INFLAME study is designed to determine the effect of exercise training on elevated high-sensitivity C-Reactive Protein (CRP) concentrations in initially sedentary women and men. Methods INFLAME will recruit 170 healthy, sedentary women and men with elevated CRP (≥2.0 mg/L) to be randomized to either an exercise group or non-exercise control group. Exercising individuals will participate in four months of supervised aerobic exercise with a total energy expenditure of 16 kcal • kg−1 • week−1 (KKW). Exercise intensity will be 60–80% of maximal oxygen consumption (VO2 max). Outcome The primary outcome will be change in plasma CRP concentration. Secondary outcomes include visceral adiposity, the cytokines IL-6 and TNF-α, and heart rate variability (HRV) in order to examine potential biological mechanisms whereby exercise might affect CRP concentrations. Summary INFLAME will help us understand the effects of moderate to vigorous exercise on CRP concentrations in sedentary individuals. To our knowledge this will be the largest training study specifically designed to examine the effect of exercise on CRP concentrations. This study has the potential to influence therapeutic applications since CRP measurement is becoming an important clinical measurement in Coronary Heart Disease risk assessment. This study will also contribute to the limited body of literature examining the effect of exercise on the variables of visceral adiposity, cytokines, and heart rate variability. PMID:18024231

  15. Study protocol of a Dutch smoking cessation e-health program

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    Bolman Catherine

    2011-11-01

    Full Text Available Abstract Background The study aims to test the differential effects of a web-based text and a web-based video-driven computer-tailored approach for lower socio-economic status (LSES and higher socio-economic status (HSES smokers which incorporate multiple computer-tailored feedback moments. The two programs differ only in the mode of delivery (video- versus text-based messages. The paper aims to describe the development and design of the two computer-tailored programs. Methods/design Respondents who smoked at the time of the study inclusion, who were motivated to quit within the following six months and who were aged 18 or older were included in the program. The study is a randomized control trial with a 2 (video/text * 2(LSES/HSES design. Respondents were assigned either to one of the intervention groups (text versus video tailored feedback or to the control group (non-tailored generic advice. In all three conditions participants were asked to fill in the baseline questionnaire based on the I-Change model. The questionnaire assessed socio-demographics, attitude towards smoking, knowledge, self-efficacy, social influence, depression, level of addiction, action planning, goal actions, intention to quit smoking, seven-day point prevalence and continued abstinence. Follow-up measurements were conducted at six and twelve months after baseline. Discussion The present paper describes the development of the two computer-tailored smoking cessation programs, their components and the design of the study. The study results reveal different working mechanisms of multiple tailored smoking cessation interventions and will help us to gain more insight into effective strategies to target different subgroups, especially smokers with a lower socio-economic status. Trial registration Dutch Trial Register NTR3102

  16. Psychological barriers to tobacco cessation in Indian buprenorphine-naloxone maintained patients: A pilot study

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    Piyali Mandal

    2015-01-01

    Full Text Available Context: The prevalence of smoking in opioid agonist treatment programmes remains high, leading to significant tobacco related health hazards and mortality. This is the first study from India addressing tobacco cessation and related barriers among recipients of buprenorphine-naloxone maintenance treatment. Aims: The purpose of the study was to investigate Indian buprenorphine-naloxone maintained patients′ willingness to quit tobacco use, to determine its possible association with demographic, agonist maintenance treatment, tobacco use related variables and personal health and risk perceptions related to health hazards associated with tobacco use. Settings and Design: The study was cross-sectional, observational. It was conducted in the out-patient department of a national level de-addiction centre in India. Materials and Methods: Fifty-five males on buprenorphine-naloxone treatment were assessed using Tobacco Use Characteristics, Fagerstrom Test for Nicotine Dependence (FTND and FTND-ST, Readiness to Change questionnaire (RCQ, Smoker′s Perceived Health Risk Evaluation (SPHERE, Importance of Intervention scale and a semi-structured questionnaire. Statistical Analysis: Descriptive statistics, Kruskal-Wallis Chi-square test, Spearman rank order correlation, paired-t test, ANOVA (STATA 9.2 statistical package. Results: Around 65.4% of the subjects were smokers, 9% were using smokeless tobacco only whereas 25.6% were using both. Mean duration of tobacco use was 20 ± 1.5 years. Only 20% had past quit attempts. Only 24% were in action phase of change. Personal health and risk perceptions were poor and only 61.62% considered intervention tobacco smoking cessation important. Conclusions: Higher severity of nicotine dependence, low perception of harm from tobacco warrant immediate attention and need for on-site treatment opportunity.

  17. The Pediatric Obsessive-Compulsive Disorder Treatment Study II: rationale, design and methods

    OpenAIRE

    March John S; Khanna Muniya S; Sapyta Jeffrey J; Moore Phoebe S; Garcia Abbe M; Choate-Summers Molly L; Freeman Jennifer B; Foa Edna B; Franklin Martin E

    2009-01-01

    Abstract This paper presents the rationale, design, and methods of the Pediatric Obsessive-Compulsive Disorder Treatment Study II (POTS II), which investigates two different cognitive-behavior therapy (CBT) augmentation approaches in children and adolescents who have experienced a partial response to pharmacotherapy with a serotonin reuptake inhibitor for OCD. The two CBT approaches test a "single doctor" versus "dual doctor" model of service delivery. A specific goal was to develop and test...

  18. Cost and clinical consequences of smoking cessation in outpatients after cardiovascular disease: a retrospective cohort study

    Directory of Open Access Journals (Sweden)

    Sicras-Mainar A

    2013-08-01

    Full Text Available Antoni Sicras-Mainar,1 Silvia Díaz-Cerezo,2 Verónica Sanz de Burgoa,3 Ruth Navarro-Artieda41Directorate of Planning, Badalona Serveis Assistencials SA, Badalona, Spain; 2Health Economics and Outcomes Research Department, Pfizer, SLU, Alcobendas, Spain; 3Medical Department, Pfizer, SLU, Alcobendas, Spain; 4Medical Documentation Unit, Hospital Germans Trias i Pujol, Badalona, SpainAbstract: This cohort retrospective study explored the cost and clinical consequences of smoking cessation in outpatients after cardiovascular events (CVEs, in Spain. A total of 2,540 patients (68.1 years; 60.7% male; 8.4% smokers, 52.9% ex-smokers, and 38.7% never smokers fulfilling the selection criteria and followed up throughout a period of 36 months after the event were considered eligible for analysis. Total costs were higher among current smokers in comparison with ex-smokers and never smokers (€7,981 versus [vs] €7,322 and €5,619, respectively (P < 0.001. Both health care costs (€6,273 vs €5,673 and €4,823, respectively (P < 0.001 and loss of productivity at work costs (€1,708 vs €1,650 and €796, respectively (P < 0.001 accounted for such differences. There was also a difference in CVE recurrence rates (18.6% vs 16.5% and 9.6%, respectively (P < 0.01. Smoking cessation in CVE outpatients was associated with lower cost and risk of CVE recurrence compared with smokers, and their health status was similar to that of never smokers, in routine clinical practice in Spain.Keywords: mortality, health resources, health care costs

  19. Adolescent Psychological and Social Predictors of Young Adult Smoking Acquisition and Cessation: A 10-Year Longitudinal Study

    NARCIS (Netherlands)

    Otten, R.; Bricker, J.B.; Liu, J.M.; Comstock, B.A.; Peterson, A.V.

    2011-01-01

    Objective: A 10-year follow-up study to test the extent to which theory-based adolescent psychological and social factors directly predict and moderate the prediction of young adult smoking acquisition and cessation. Design: A prospective community-based sample. A total of 2,970 adolescents particip

  20. Nicotine Replacement Combined with a Novel Compound (ProBAN for Smoking Cessation: A Pilot Study

    Directory of Open Access Journals (Sweden)

    Richard Leigh

    2001-01-01

    Full Text Available BACKGROUND: Smoking cessation rates with available pharmacological therapies remain suboptimal. Anecdotal observations with a combination of sublingual pralidoxime and ipratropium (ProBAN suggested that these agents in combination with nicotine gum improved quit rates.

  1. What distinguishes successful from unsuccessful tobacco smoking cessation? Data from a study of young adults (TEMPO

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    Inès Khati

    2015-01-01

    Conclusions: Work and family circumstances, co-occurring substance use and psychological difficulties may influence smoking cessation in young adults. These characteristics should be considered by individual and collective interventions aiming to help young smokers quit successfully.

  2. Pragmatic, observational study of bupropion treatment for smoking cessation in general practice

    OpenAIRE

    Wilkes, S; Evans, A.; Henderson, M.; Gibson, J

    2005-01-01

    Background: Cigarette smoking remains the single largest cause of premature death in the United Kingdom. As part of the government's national service framework for coronary heart disease, smoking cessation forms a key part of the strategy.

  3. Physical activity as an aid to smoking cessation during pregnancy (LEAP trial: study protocol for a randomized controlled trial

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    Ussher Michael

    2012-10-01

    Full Text Available Abstract Background Many women try to stop smoking in pregnancy but fail. One difficulty is that there is insufficient evidence that medications for smoking cessation are effective and safe in pregnancy and thus many women prefer to avoid these. Physical activity (PA interventions may assist cessation; however, trials examining these interventions have been too small to detect or exclude plausible beneficial effects. The London Exercise And Pregnant smokers (LEAP trial is investigating whether a PA intervention is effective and cost-effective when used for smoking cessation by pregnant women, and will be the largest study of its kind to date. Methods/design The LEAP study is a pragmatic, multi-center, two-arm, randomized, controlled trial that will target pregnant women who smoke at least one cigarette a day (and at least five cigarettes a day before pregnancy, and are between 10 and 24 weeks pregnant. Eligible patients are individually randomized to either usual care (that is, behavioral support for smoking cessation or usual care plus a intervention (entailing supervised exercise on a treadmill plus PA consultations. The primary outcome of the trial is self-reported and biochemically validated continuous abstinence from smoking between a specified quit date and the end of pregnancy. The secondary outcomes, measured at 1 and 4 weeks after the quit date, and at the end of pregnancy and 6 months after childbirth, are PA levels, depression, self-confidence, and cigarette withdrawal symptoms. Smoking status will also be self-reported at 6 months after childbirth. In addition, perinatal measures will be collected, including antenatal complications, duration of labor, mode of delivery, and birth and placental weight. Outcomes will be analyzed on an intention-to-treat basis, and logistic regression models used to compare treatment effects on the primary outcome. Discussion This trial will assess whether a PA intervention is effective when used for

  4. The Cessation in Pregnancy Incentives Trial (CPIT: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Tappin David M

    2012-07-01

    Full Text Available Abstract Background Seventy percent of women in Scotland have at least one baby, making pregnancy an opportunity to help most young women quit smoking before their own health is irreparably compromised. By quitting during pregnancy their infants will be protected from miscarriage and still birth as well as low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. In the UK, the NICE guidelines: ‘How to stop smoking in pregnancy and following childbirth’ (June 2010 highlighted that little evidence exists in the literature to confirm the efficacy of financial incentives to help pregnant smokers to quit. Its first research recommendation was to determine: Within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? Design and methods This study is a phase II exploratory individually randomized controlled trial comparing standard care for pregnant smokers with standard care plus the additional offer of financial voucher incentives to engage with specialist cessation services and/or to quit smoking during pregnancy. Participants (n = 600 will be pregnant smokers identified at maternity booking who, when contacted by specialist cessation services, agree to having their details passed to the NHS Smokefree Pregnancy Study Helpline to discuss the trial. The NHS Smokefree Pregnancy Study Helpline will be responsible for telephone consent and follow-up in late pregnancy. The primary outcome will be self reported smoking in late pregnancy verified by cotinine measurement. An economic evaluation will refine cost data collection and assess potential cost-effectiveness while qualitative research interviews with clients and health professionals will assess the level of acceptance of this form of incentive payment. The research questions are: What is the likely therapeutic efficacy? Are incentives potentially cost-effective? Is individual randomization an

  5. Prisoners' attitudes towards cigarette smoking and smoking cessation: a questionnaire study in Poland

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    Konopa Krzysztof

    2006-07-01

    Full Text Available Abstract Background In the last decade Poland has successfully carried out effective anti-tobacco campaigns and introduced tobacco control legislation. This comprehensive strategy has focused on the general population and has led to a considerable decrease in tobacco consumption. Prisoners constitute a relatively small part of the entire Polish population and smoking habits in this group have been given little attention. The aim of the study was to assess the prevalence of cigarette smoking in Polish male prisoners, factors determining smoking in this group, prisoners' attitudes towards smoking cessation, and to evaluate prisoners' perception of different anti-tobacco measures. Methods An anonymous questionnaire including personal, demographic and smoking data was distributed among 944 male inmates. Of these, 907 men aged between 17 and 62 years (mean 32.3 years met the inclusion criteria of the study. For the comparison of proportions, a chi-square test was used with continuity correction whenever appropriate. Results In the entire group, 81% of the subjects were smokers, 12% – ex-smokers, and 7% – never smokers. Current smokers had significantly lower education level than non-smokers (p Conclusion The prevalence of cigarette smoking among Polish prisoners is high. However, a majority of smokers attempt to quit, and they should be encouraged and supported. Efforts to reduce cigarette smoking in prisons need to take into consideration the specific factors influencing smoking habits in prisons.

  6. Effects of sixty six adolescent tobacco use cessation trials and seventeen prospective studies of self-initiated quitting

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    Sussman S

    2002-01-01

    Full Text Available Abstract This paper provides a review of the last two and a half decades of research in adolescent and young-adult tobacco use cessation. A total of 66 tobacco cessation intervention studies – targeted or population – are reviewed. In addition, an exhaustive review is completed of adolescent self-initiated tobacco use cessation, involving 17 prospective survey studies. Average reach and retention across the intervention studies was 61% and 78%, respectively, and was higher when whole natural units were treated (e.g., classrooms, than when units created specifically for the program were treated (e.g., school-based clinics. The mean quit-rate at a three to 12-month average follow-up among the program conditions was 12%, compared to approximately 7% across control groups. A comparison of intervention theories revealed that motivation enhancement (19% and contingency-based reinforcement (16% programs showed higher quit-rates than the overall intervention cessation mean. Regarding modalities (channels of change, classroom-based programs showed the highest quit rates (17%. Computer-based (expert system programs also showed promise (13% quit-rate, as did school-based clinics (12%. There was a fair amount of missing data and wide variation on how data points were measured in the programs' evaluations. Also, there were relatively few direct comparisons of program and control groups. Thus, it would be difficult to conduct a formal meta-analysis on the cessation programs. Still, these data suggest that use of adolescent tobacco use cessation interventions double quit rates on the average. In the 17 self-initiated quitting survey studies, key predictors of quitting were living in a social milieu that is composed of fewer smokers, less pharmacological or psychological dependence on smoking, anti-tobacco beliefs (e.g., that society should step in to place controls on smoking and feeling relatively hopeful about life. Key variables relevant to the quitting

  7. Effects of sixty six adolescent tobacco use cessation trials and seventeen prospective studies of self-initiated quitting

    Directory of Open Access Journals (Sweden)

    Sussman S

    2003-01-01

    Full Text Available Abstract This paper provides a review of the last two and a half decades of research in adolescent and young-adult tobacco use cessation. A total of 66 tobacco cessation intervention studies – targeted or population – are reviewed. In addition, an exhaustive review is completed of adolescent self-initiated tobacco use cessation, involving 17 prospective survey studies. Average reach and retention across the intervention studies was 61% and 78%, respectively, and was higher when whole natural units were treated (e.g., classrooms, than when units created specifically for the program were treated (e.g., school-based clinics. The mean quit-rate at a three to 12-month average follow-up among the program conditions was 12%, compared to approximately 7% across control groups. A comparison of intervention theories revealed that motivation enhancement (19% and contingency-based reinforcement (16% programs showed higher quit-rates than the overall intervention cessation mean. Regarding modalities (channels of change, classroom-based programs showed the highest quit rates (17%. Computer-based (expert system programs also showed promise (13% quit-rate, as did school-based clinics (12%. There was a fair amount of missing data and wide variation on how data points were measured in the programs' evaluations. Also, there were relatively few direct comparisons of program and control groups. Thus, it would be difficult to conduct a formal meta-analysis on the cessation programs. Still, these data suggest that use of adolescent tobacco use cessation interventions double quit rates on the average. In the 17 self-initiated quitting survey studies, key predictors of quitting were living in a social milieu that is composed of fewer smokers, less pharmacological or psychological dependence on smoking, anti-tobacco beliefs (e.g., that society should step in to place controls on smoking and feeling relatively hopeful about life. Key variables relevant to the quitting

  8. Cost-effectiveness of face-to-face smoking cessation interventions: A dynamic modeling study

    NARCIS (Netherlands)

    T.L. Feenstra (Talitha); H.H. Hamberg-Van Reenen (Heleen); R.T. Hoogenveen (Rudolf); M.P.M.H. Rutten-van Mölken (Maureen)

    2005-01-01

    textabstractObjectives: To estimate the cost-effectiveness of five face-to-face smoking cessation interventions (i.e., minimal counseling by a general practitioner (GP) with, or without nicotine replacement therapy (NRT), intensive counseling with NRT, or bupropion, and telephone counseling) in term

  9. Barriers to the provision of smoking cessation assistance : a qualitative study among Romanian family physicians

    NARCIS (Netherlands)

    Panaitescu, Catalina; Moffat, Mandy A.; Williams, Sian; Pinnock, Hilary; Boros, Melinda; Oana, Cristian Sever; Alexiu, Sandra; Tsiligianni, Ioanna

    2014-01-01

    BACKGROUND: Smoking cessation is the most effective intervention to prevent and slow down the progression of several respiratory and other diseases and improve patient outcomes. Romania has legislation and a national tobacco control programme in line with the World Health Organization Framework for

  10. Cost-effectiveness of face-to-face smoking cessation interventions : a dynamic modeling study

    NARCIS (Netherlands)

    Feenstra, Talitha L; Hamberg-van Reenen, Heleen H; Hoogenveen, Rudolf T; Rutten-van Mölken, Maureen P M H

    2005-01-01

    OBJECTIVES: To estimate the cost-effectiveness of five face-to-face smoking cessation interventions (i.e., minimal counseling by a general practitioner (GP) with, or without nicotine replacement therapy (NRT), intensive counseling with NRT, or bupropion, and telephone counseling) in terms of costs p

  11. Effectiveness of smoking-cessation interventions for urban hospital patients: study protocol for a randomized controlled trial

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    Grossman Ellie

    2012-08-01

    Full Text Available Abstract Background Hospitalization may be a particularly important time to promote smoking cessation, especially in the immediate post-discharge period. However, there are few studies to date that shed light on the most effective or cost-effective methods to provide post-discharge cessation treatment, especially among low-income populations and those with a heavy burden of mental illness and substance use disorders. Methods/design This randomized trial will compare the effectiveness and cost-effectiveness of two approaches to smoking cessation treatment among patients discharged from two urban public hospitals in New York City. During hospitalization, staff will be prompted to ask about smoking and to offer nicotine replacement therapy (NRT on admission and at discharge. Subjects will be randomized on discharge to one of two arms: one arm will be proactive multi-session telephone counseling with motivational enhancement delivered by study staff, and the other will be a faxed or online referral to the New York State Quitline. The primary outcome is 30-day point-prevalence abstinence from smoking at 6-month follow-up post-discharge. We will also examine cost-effectiveness from a societal and a payer perspective, as well as explore subgroup analyses related to patient location of hospitalization, race/ethnicity, immigrant status, and inpatient diagnosis. Discussion This study will explore issues of implementation feasibility in a post-hospitalization patient population, as well as add information about the effectiveness and cost-effectiveness of different strategies for designing smoking cessation programs for hospitalized patients. Trial registration Clinicaltrials.gov ID# NCT01363245

  12. Tobacco use among urban Aboriginal Australian young people: a qualitative study of reasons for smoking, barriers to cessation and motivators for smoking cessation.

    Science.gov (United States)

    Cosh, Suzanne; Hawkins, Kimberley; Skaczkowski, Gemma; Copley, David; Bowden, Jacqueline

    2015-01-01

    Smoking prevalence among Aboriginal Australian young people greatly exceeds the prevalence in the broader population of Australian young people, yet limited research has explored the social context in which young Aboriginal Australians smoke. Four focus groups were conducted in 2009 with South Australian Aboriginal smokers aged 15-29 years residing in urban areas (n = 32) to examine attitudes and experiences surrounding smoking and quitting. The primary reasons for smoking initiation and maintenance among Aboriginal Australian young people were identified as stress, social influence and boredom. Motivators for quitting were identified as pregnancy and/or children, sporting performance (males only), cost issues and, to a lesser extent, health reasons. The barriers to cessation were identified as social influence, the perception of quitting as a distant event and reluctance to access cessation support. However, it appears that social influences and stress were particularly salient contributors to smoking maintenance among Aboriginal Australian young people. Smoking cessation interventions targeted at young urban Aboriginal Australian smokers should aim to build motivation to quit by utilising the motivators of pregnancy and/or children, sporting performance (males only), cost issues and, to a lesser extent, health reasons, while acknowledging the pertinent role of social influence and stress in the lives of young urban Aboriginal Australian smokers.

  13. A comparative study of historical droughts over Texas, USA and Murray-Darling Basin, Australia: Factors influencing initialization and cessation

    Science.gov (United States)

    Verdon-Kidd, Danielle C.; Scanlon, Bridget R.; Ren, Tong; Fernando, D. Nelun

    2017-02-01

    Water availability and food security are tightly coupled on a global scale. The occurrence of drought puts this balance at risk due to reductions in dryland farming production and water allocations to irrigated agriculture. Improved understanding of drought initiation and cessation would therefore be beneficial for drought planning and management. The study objective was to determine factors affecting drought initiation and cessation over the past century in two climatologically similar regions that represent net agricultural exporters; south central U.S. (Texas) and southeast Australia (Murray Darling Basin, MDB). Drought indices included the Standardized Precipitation Index (SPI, 1900-2014) for meteorological drought, the Normalized Difference Vegetation Index (NDVI, 1981-2014) for agricultural drought, and the Streamflow Drought Index (SDI, 1930-2014) for hydrological drought. Results show that meteorological drought tends to develop gradually over a period of up to six months, with agricultural drought developing shortly thereafter (within one month) in both regions. Evidence of hydrological drought was observed within one month (Texas) and within four months (MDB) on average after meteorological drought was established. Further, droughts appear to cease more quickly than they initiate over Texas, whereas rates of drought initiation and cessation are similar over the MDB. Drought breaking rainfall in Texas is generally a result of a southward shift in the Polar Jet Stream or a low-pressure trough over central North America, whereas drought cessation in the MDB is typically associated with a monsoon trough or low-pressure system in the Tasman Sea/Great Australian Bight. Improved knowledge of the climate mechanisms controlling the onset and termination of drought periods should enhance drought forecasts and improve drought management practices, particularly in regions where water security is a primary objective.

  14. Does Design Rationale Enhance Creativity?

    Directory of Open Access Journals (Sweden)

    Jing Wang

    2010-01-01

    Full Text Available Creativity and rationale are often viewed as two contrasting facets in software design. A lack in recognizing the facilitative relationship between creativity and rationale not only underestimates the benefits designers can obtain from rationale practices, but also confines the approaches that support creativity in software design. Our exploratory study provides empirical evidence of the positive correlation between rationale and creativity. Furthermore, we found that the feasibility of design alternatives and the comprehensiveness of tradeoff evaluation are critical to enhancing novelty, persuasiveness, and insightfulness. We also discuss future directions to further understand how these properties, or rationale quality in general, affects design creativity.

  15. Web-based smoking cessation intervention that transitions from inpatient to outpatient: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Harrington Kathleen F

    2012-08-01

    Full Text Available Abstract Background E-health tools are a new mechanism to expand patient care, allowing supplemental resources to usual care, including enhanced patient-provider communication. These applications to smoking cessation have yet to be tested in a hospitalized patient sample. This project aims to evaluate the effectiveness and cost-effectiveness of a tailored web-based and e-message smoking cessation program for current smokers that, upon hospital discharge, transitions the patient to continue a quit attempt when home (Decide2Quit. Design A randomized two-arm follow-up design will test the effectiveness of an evidence- and theoretically-based smoking cessation program designed for post-hospitalization. Methods A total of 1,488 patients aged 19 or older, who smoked cigarettes in the previous 30 days, are being recruited from 27 patient care areas of a large urban university hospital. Study-eligible hospitalized patients receiving usual tobacco cessation usual care are offered study referral. Trained hospital staff assist the 744 patients who are being randomized to the intervention arm with registration and orientation to the intervention website. This e-mail and web-based program offers tailored messages as well as education, self-assessment and planning aids, and social support to promote tobacco use cessation. Condition-blind study staff assess participants for tobacco use history and behaviors, tobacco use cost-related information, co-morbidities and psychosocial factors at 0, 3, 6, and 12 months. The primary outcome is self-reported 30-day tobacco abstinence at 6 months follow-up. Secondary outcomes include 7-day point prevalence quit rates at 3-, 6-, and 12-month follow-up, 30-day point prevalence quit rates at 3 and 12 months, biologically confirmed tobacco abstinence at 6-month follow-up, and multiple point-prevalence quit rates based on self-reported tobacco abstinence rates at each follow-up time period. Healthcare utilization and quality

  16. The Effect of Five Smoking Cessation Pharmacotherapies on Smoking Cessation Milestones

    Science.gov (United States)

    Japuntich, Sandra J.; Piper, Megan E.; Leventhal, Adam M.; Bolt, Daniel M.; Baker, Timothy B.

    2011-01-01

    Objective: Most smoking cessation studies have used long-term abstinence as their primary outcome measure. Recent research has suggested that long-term abstinence may be an insensitive index of important smoking cessation mechanisms. The goal of the current study was to examine the effects of 5 smoking cessation pharmacotherapies using Shiffman et…

  17. Effectiveness of proactive telephone counselling for smoking cessation in parents: Study protocol of a randomized controlled trial

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    Bricker Jonathan B

    2011-09-01

    Full Text Available Abstract Background Smoking is the world's fourth most common risk factor for disease, the leading preventable cause of death, and it is associated with tremendous social costs. In the Netherlands, the smoking prevalence rate is high. A total of 27.7% of the population over age 15 years smokes. In addition to the direct advantages of smoking cessation for the smoker, parents who quit smoking may also decrease their children's risk of smoking initiation. Methods/Design A randomized controlled trial will be conducted to evaluate the effectiveness of proactive telephone counselling to increase smoking cessation rates among smoking parents. A total of 512 smoking parents will be proactively recruited through their children's primary schools and randomly assigned to either proactive telephone counselling or a control condition. Proactive telephone counselling will consist of up to seven counsellor-initiated telephone calls (based on cognitive-behavioural skill building and Motivational Interviewing, distributed over a period of three months. Three supplementary brochures will also be provided. In the control condition, parents will receive a standard brochure to aid smoking cessation. Assessments will take place at baseline, three months after start of the intervention (post-measurement, and twelve months after start of the intervention (follow-up measurement. Primary outcome measures will include sustained abstinence between post-measurement and follow-up measurement and 7-day point prevalence abstinence and 24-hours point prevalence abstinence at both post- and follow-up measurement. Several secondary outcome measures will also be included (e.g., smoking intensity, smoking policies at home. In addition, we will evaluate smoking-related cognitions (e.g., attitudes towards smoking, social norms, self-efficacy, intention to smoke in 9-12 year old children of smoking parents. Discussion This study protocol describes the design of a randomized

  18. Implementation of a Smoking Cessation Treatment Study at Substance Abuse Rehabilitation Programs: Smoking Behavior and Treatment Feasibility Across Varied Community-based Outpatient Programs.

    Science.gov (United States)

    Reid, Malcolm S; Fallon, Bryan; Sonne, Susan; Nunes, Edward V; Lima, Jennifer; Jiang, Huiping; Tyson, Clare; Hiott, Robert; Arfken, Cynthia; Bohs, Rhonda; Orr, Deborah; Muir, Joan; Pihlgren, Eric; Loree, Amy; Fuller, Brett E; Giordano, Louis; Robinson, James; Rotrosen, John

    2007-09-01

    Cigarette smoking is widely prevalent among individuals in treatment for drug or alcohol dependence; however, the treatment of nicotine addiction in this population has numerous obstacles at both programmatic and patient levels. Despite these difficulties, recent studies have demonstrated moderate success in implementing smoking cessation treatment in drug rehabilitation programs. The National Drug Abuse Treatment Clinical Trials Network sponsored a smoking cessation study in 13 community-based outpatient substance abuse rehabilitation programs across the country. The study evaluated the effectiveness of smoking cessation treatment provided as an adjunct to substance abuse treatment-as-usual. This report summarizes the practical and clinical experiences encountered at each of the study sites with regard to implementing the smoking cessation treatment intervention. Smoking behavior of the treatment clientele was assessed by anonymous survey at each site. In addition, sites were systematically characterized by using program review and assessment tools completed by the respective staff and program directors at the site. Survey and recruitment data indicated that cigarette smoking is more prevalent and that smoking cessation treatment is more feasible, in methadone maintenance treatment programs. Other factors associated with smoking behavior and with the recruitment of drug- and alcohol-dependent individuals into the smoking cessation treatment study are described.

  19. Disparities in Prevalence of Smoking and Smoking Cessation during Pregnancy: A Population-Based Study

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    Josiane L. Dias-Damé

    2015-01-01

    Full Text Available Objective. To examine time trends in prevalence of smoking and smoking cessation during pregnancy by family income, maternal level of education, skin color, and age. Methods. We conducted three population-based surveys in 2007, 2010, and 2013 with newly delivered mothers living in the municipality of Rio Grande, Southern Brazil. Data were collected using questionnaires administered after delivery in all (two maternity units in the city, at Dr. Miguel Riet Corrêa Júnior Hospital and at Santa Casa de Misericórdia. Time trends were analyzed using chi-square test for linear trend. Results. Data of 7,572 women showed that the prevalence of smoking before pregnancy decreased from 28% (26.2–29.7 in 2007 to 22% (20.8–24.0 in 2013 (P<0.001. Prevalence of smoking during pregnancy decreased from 22% (20.4–23.7 in 2007 to 18% (16.6–19.5 in 2013 (P<0.001. This reduction varied across income ranging from 17% (poorest to 35% (richest (P<0.001. The lower the income, the higher the smoking prevalence during pregnancy. Smoking cessation was more prevalent among women of higher level of education and income. Conclusions. Smoking before and during pregnancy is still highly prevalent and the prevalence of cessation is low pointing to a need to strengthen actions targeting low-income, less educated, black pregnant women.

  20. Group hypnotherapy versus group relaxation for smoking cessation: an RCT study protocol

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    Dickson-Spillmann Maria

    2012-04-01

    Full Text Available Abstract Background A significant number of smokers would like to stop smoking. Despite the demonstrated efficacy of pharmacological smoking cessation treatments, many smokers are unwilling to use them; however, they are inclined to try alternative methods. Hypnosis has a long-standing reputation in smoking cessation therapy, but its efficacy has not been scientifically proven. We designed this randomised controlled trial to evaluate the effects of group hypnosis as a method for smoking cessation, and we will compare the results of group hypnosis with group relaxation. Methods/Design This is a randomised controlled trial (RCT to compare the efficacy of a single session of hypnosis with that of relaxation performed in groups of 8-15 smokers. We intend to include at least 220 participants in our trial. The inclusion criteria include smoking at least 5 cigarettes per day, not using other cessation methods and being willing to quit smoking. The intervention is performed by a trained hypnotist/relaxation therapist. Both groups first receive 40 min of mental preparation that is based on motivational interviewing. Then, a state of deep relaxation is induced in the hypnosis condition, and superficial relaxation is induced in the control condition. Suggestions are made in the hypnosis condition that aim to switch the mental self-image of the participants from that of smokers to that of non-smokers. Each intervention lasts for 40 min. The participants also complete questionnaires that assess their smoking status and symptoms of depression and anxiety at baseline, 2 weeks and 6 months post-intervention. In addition, saliva samples are collected to assess cotinine levels at baseline and at 6 months post-intervention. We also assess nicotine withdrawal symptoms at 2 weeks post-intervention. Discussion To the best of our knowledge, this RCT is the first to test the efficacy of group hypnosis versus group relaxation. Issues requiring discussion in the outcome

  1. Rationale and Design of the Echocardiographic Study of Hispanics / Latinos (ECHO-SOL)

    Science.gov (United States)

    Rodriguez, Carlos J.; Dharod, Ajay; Allison, Matthew A.; Shah, Sanjiv J.; Hurwitz, Barry; Bangdiwala, Shrikant I.; Gonzalez, Franklyn; Kitzman, Dalane; Gillam, Linda; Spevack, Daniel; Dadhania, Rupal; Langdon, Sarah; Kaplan, Robert

    2015-01-01

    Background Information regarding the prevalence and determinants of cardiac structure and function (systolic and diastolic) among the various Hispanic background groups in the United States is limited. Methods and Results The Echocardiographic Study of Latinos (ECHO-SOL) ancillary study recruited 1,824 participants through a stratified-sampling process representative of the population-based Hispanic Communities Health StudyStudy of Latinos (HCHS-SOL) across four sites (Bronx, NY; Chicago, Ill; San Diego, Calif; Miami, Fla). The HCHS-SOL baseline cohort did not include an echo exam. ECHO-SOL added the echocardiographic assessment of cardiac structure and function to an array of existing HCHS-SOL baseline clinical, psychosocial, and socioeconomic data and provides sufficient statistical power for comparisons among the Hispanic subgroups. Standard two-dimensional (2D) echocardiography protocol, including M-mode, spectral, color and tissue Doppler study was performed. The main objectives were to: 1) characterize cardiac structure and function and its determinants among Hispanics and Hispanic subgroups; and 2) determine the contributions of specific psychosocial factors (acculturation and familismo) to cardiac structure and function among Hispanics. Conclusion We describe the design, methods and rationale of currently the largest and most comprehensive study of cardiac structure and function exclusively among US Hispanics. ECHO-SOL aims to enhance our understanding of Hispanic cardiovascular health as well as help untangle the relative importance of Hispanic subgroup heterogeneity and sociocultural factors on cardiac structure and function. (Ethn Dis. 2015;25[2]:180–186) PMID:26118146

  2. Rationale and design of the Japan molecular epidemiology for lung cancer study.

    Science.gov (United States)

    Kawaguchi, Tomoya; Ando, Masahiko; Ito, Norimasa; Isa, Shun-Ichi; Tamiya, Akihiro; Shimizu, Shigeki; Saka, Hideo; Kubo, Akihito; Koh, Yasuhiro; Matsumura, Akihide

    2013-09-01

    We present the rationale for the Japan Molecular Epidemiology for Lung Cancer study designed to elucidate molecular mechanisms of carcinogenesis in smokers and never-smokers with non-small-cell lung cancer. This prospective, ongoing, multicenter study is being conducted nationwide in Japan. Although there is no doubt that active smoking is the major cause of lung cancer, the contribution of other possible factors, including environmental tobacco or wood smoke, human papilloma virus, radon, occupational exposures, and genetic susceptibility, is highly likely, based on studies of never-smokers with non-small-cell lung cancer. Because of the predominance of women in the never-smoker subgroup, the role of female hormones in lung cancer development has also been considered. We hypothesize that driver mutations, which are critical for the development of lung cancer, are triggered by the environmental factors with or without the influence of the hormone. The SWOG-led intergroup molecular epidemiology study S0424 was conducted to focus on these issues by using a detailed questionnaire and specimen collection in statistically significant cohorts of smokers and never-smokers from both sexes. The Japan Molecular Epidemiology for Lung Cancer study follows and extends the S0424 molecular epidemiology concept in principle by using a similar approach that will facilitate future comparisons between the studies but with a greater focus on more recently defined driver mutations and broad genomic sequencing.

  3. High risk cohort study for psychiatric disorders in childhood: rationale, design, methods and preliminary results.

    Science.gov (United States)

    Salum, Giovanni Abrahão; Gadelha, Ary; Pan, Pedro Mario; Moriyama, Tais Silveira; Graeff-Martins, Ana Soledade; Tamanaha, Ana Carina; Alvarenga, Pedro; Valle Krieger, Fernanda; Fleitlich-Bilyk, Bacy; Jackowski, Andrea; Sato, João Ricardo; Brietzke, Elisa; Polanczyk, Guilherme Vanoni; Brentani, Helena; de Jesus Mari, Jair; Do Rosário, Maria Conceição; Manfro, Gisele Gus; Bressan, Rodrigo Affonseca; Mercadante, Marcos Tomanik; Miguel, Eurípedes Constantino; Rohde, Luis Augusto

    2015-03-01

    The objective of this study is to present the rationale, methods, design and preliminary results from the High Risk Cohort Study for the Development of Childhood Psychiatric Disorders. We describe the sample selection and the components of each phases of the study, its instruments, tasks and procedures. Preliminary results are limited to the baseline phase and encompass: (i) the efficacy of the oversampling procedure used to increase the frequency of both child and family psychopathology; (ii) interrater reliability and (iii) the role of differential participation rate. A total of 9937 children from 57 schools participated in the screening procedures. From those 2512 (random = 958; high risk = 1554) were further evaluated with diagnostic instruments. The prevalence of any child mental disorder in the random strata and high-risk strata was 19.9% and 29.7%. The oversampling procedure was successful in selecting a sample with higher family rates of any mental disorders according to diagnostic instruments. Interrater reliability (kappa) for the main diagnostic instrument range from 0.72 (hyperkinetic disorders) to 0.84 (emotional disorders). The screening instrument was successful in selecting a sub-sample with "high risk" for developing mental disorders. This study may help advance the field of child psychiatry and ultimately provide useful clinical information.

  4. The Pediatric Obsessive-Compulsive Disorder Treatment Study II: rationale, design and methods

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    March John S

    2009-01-01

    Full Text Available Abstract This paper presents the rationale, design, and methods of the Pediatric Obsessive-Compulsive Disorder Treatment Study II (POTS II, which investigates two different cognitive-behavior therapy (CBT augmentation approaches in children and adolescents who have experienced a partial response to pharmacotherapy with a serotonin reuptake inhibitor for OCD. The two CBT approaches test a "single doctor" versus "dual doctor" model of service delivery. A specific goal was to develop and test an easily disseminated protocol whereby child psychiatrists would provide instructions in core CBT procedures recommended for pediatric OCD (e.g., hierarchy development, in vivo exposure homework during routine medical management of OCD (I-CBT. The conventional "dual doctor" CBT protocol consists of 14 visits over 12 weeks involving: (1 psychoeducation, (2, cognitive training, (3 mapping OCD, and (4 exposure with response prevention (EX/RP. I-CBT is a 7-session version of CBT that does not include imaginal exposure or therapist-assisted EX/RP. In this study, we compared 12 weeks of medication management (MM provided by a study psychiatrist (MM only with two types of CBT augmentation: (1 the dual doctor model (MM+CBT; and (2 the single doctor model (MM+I-CBT. The design balanced elements of an efficacy study (e.g., random assignment, independent ratings with effectiveness research aims (e.g., differences in specific SRI medications, dosages, treatment providers. The study is wrapping up recruitment of 140 youth ages 7–17 with a primary diagnosis of OCD. Independent evaluators (IEs rated participants at weeks 0,4,8, and 12 during acute treatment and at 3,6, and 12 month follow-up visits. Trial registration NCT00074815

  5. Cluster randomized trial in smoking cessation with intensive advice in diabetic patients in primary care. ITADI Study

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    Roura Pilar

    2010-02-01

    Full Text Available Abstract Background It is a priority to achieve smoking cessation in diabetic smokers, given that this is a group of patients with elevated cardiovascular risk. Furthermore, tobacco has a multiplying effect on micro and macro vascular complications. Smoking abstinence rates increase as the intensity of the intervention, length of the intervention and number and diversity of contacts with the healthcare professional during the intervention increases. However, there are few published studies about smoking cessation in diabetics in primary care, a level of healthcare that plays an essential role in these patients. Therefore, the aim of the present study is to evaluate the effectiveness of an intensive smoking cessation intervention in diabetic patients in primary care. Methods/Design Cluster randomized trial, controlled and multicentric. Randomization unit: Primary Care Team. Study population: 546 diabetic smokers older than 14 years of age whose disease is controlled by one of the primary care teams in the study. Outcome Measures: Continuous tobacco abstinence (a person who has not smoked for at least six months and with a CO level of less than 6 ppm measured by a cooximeter , evolution in the Prochaska and DiClemente's Transtheoretical Model of Change, number of cigarettes/day, length of the visit. Point of assessment: one- year post- inclusion in the study. Intervention: Brief motivational interview for diabetic smokers at the pre-contemplation and contemplation stage, intensive motivational interview with pharmacotherapy for diabetic smokers in the preparation-action stage and reinforcing intevention in the maintenance stage. Statistical Analysis: A descriptive analysis of all variables will be done, as well as a multilevel logistic regression and a Poisson regression. All analyses will be done with an intention to treatment basis and will be fitted for potential confounding factors and variables of clinical importance. Statistical packages

  6. The Reversal Intervention for Metabolic Syndrome (TRIMS study: rationale, design, and baseline data

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    Troughton Jacqui

    2011-05-01

    Full Text Available Abstract Background Recent attention has focused on strategies to combat the forecast epidemic of type-2 diabetes (T2DM and its major vascular sequelae. Metabolic syndrome (MetS comprises a constellation of factors that increase the risk of cardiovascular disease (CVD and T2DM. Our study aims to develop a structured self-management education programme for people with MetS, which includes management of cardiovascular and diabetes risk factors, and to determine its impact. This paper describes the rationale and design of the TRIMS study, including intervention development, and presents baseline data. Methods Subjects recruited from a mixed-ethnic population with MetS were randomised to intervention or control arms. The intervention arm received structured group education based on robust psychological theories and current evidence. The control group received routine care. Follow-up data will be collected at 6 and 12 months. The primary outcome measure will be reversal of metabolic syndrome in the intervention group subjects compared to controls at 12 months follow-up. Results 82 participants (44% male, 22% South Asian were recruited between November 2009 and July 2010. Baseline characteristics were similar for both the intervention (n = 42 and control groups (n = 40. Median age was 63 years (IQR 57 - 67, mean waist size 106 cm (SD ± 11, and prescribing of statins and anti-hypertensives was 51% in each case. Conclusion Results will provide information on changes in diabetes and CVD risk factors and help to inform primary prevention strategies in people with MetS from varied ethnic backgrounds who are at high risk of developing T2DM and CVD. Information gathered in relation to the programme's acceptability and effectiveness in a multi-ethnic population would ensure that our results are widely applicable. Trial registration The study is registered at ClinicalTrials.gov, study identifier: NCT01043770.

  7. Effectiveness of a stepped primary care smoking cessation intervention (ISTAPS study: design of a cluster randomised trial

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    Zarza Elvira

    2009-02-01

    Full Text Available Abstract Background There is a considerable body of evidence on the effectiveness of specific interventions in individuals who wish to quit smoking. However, there are no large-scale studies testing the whole range of interventions currently recommended for helping people to give up smoking; specifically those interventions that include motivational interviews for individuals who are not interested in quitting smoking in the immediate to short term. Furthermore, many of the published studies were undertaken in specialized units or by a small group of motivated primary care centres. The objective of the study is to evaluate the effectiveness of a stepped smoking cessation intervention based on a trans-theoretical model of change, applied to an extensive group of Primary Care Centres (PCC. Methods/Design Cluster randomised clinical trial. Unit of randomization: basic unit of care consisting of a family physician and a nurse, both of whom care for the same population (aprox. 2000 people. Intention to treat analysis. Study population: Smokers (n = 3024 aged 14 to 75 years consulting for any reason to PCC and who provided written informed consent to participate in the trial. Intervention: 6-month implementation of recommendations of a Clinical Practice Guideline which includes brief motivational interviews for smokers at the precontemplation – contemplation stage, brief intervention for smokers in preparation-action who do not want help, intensive intervention with pharmacotherapy for smokers in preparation-action who want help, and reinforcing intervention in the maintenance stage. Control group: usual care. Outcome measures: Self-reported abstinence confirmed by exhaled air carbon monoxide concentration of ≤ 10 parts per million. Points of assessment: end of intervention period and 1 and 2 years post-intervention; continuous abstinence rate for 1 year; change in smoking cessation stage; health status measured by SF-36. Discussion The

  8. Longitudinal changes in weight in relation to smoking cessation in participants of the EPIC-PANACEA study

    NARCIS (Netherlands)

    Travier, Noemie; Agudo, Antonio; May, Anne M.; Gonzalez, Carlos; Luan, Jian'an; Wareham, Nick J.; Bueno-de-Mesquita, H. Bas; van den Berg, Saskia W.; Slimani, Nadia; Rinaldi, Sabina; Clavel-Chapelon, Francoise; Boutron-Ruault, Marie-Christine; Palli, Domenico; Sieri, Sabina; Mattiello, Amalia; Tumino, Rosario; Vineis, Paolo; Norat, Teresa; Romaguera, Dora; Rodriguez, Laudina; Sanchez, Maria-Jose; Dorronsoro, Miren; Barricarte, Aurelio; Huerta, Jose M.; Key, Tim J.; Orfanos, Philippos; Naska, Androniki; Trichopoulou, Antonia; Rohrmann, Sabina; Kaaks, Rudolf; Bergmann, Manuela M.; Boeing, Heiner; Hallmans, Goran; Johansson, Ingegerd; Manjer, Jonas; Lindkvist, Bjorn; Jakobsen, Mariane U.; Overvad, Kim; Tjonneland, Anne; Halkjaer, Jytte; Lund, Eiliv; Braaten, Toni; Odysseos, Andreani; Riboli, Elio; Peeters, Petra H.

    2012-01-01

    Purpose. We assessed the association between smoking cessation and prospective weight change in the European population of the European Prospective Investigation into Cancer and Nutrition-Physical Activity, Nutrition, Alcohol, Cessation of smoking. Eating out of home And obesity (EPIC-PANACEA) proje

  9. Rationale, design and methods of the HEALTHY study behavior intervention component.

    Science.gov (United States)

    Venditti, E M; Elliot, D L; Faith, M S; Firrell, L S; Giles, C M; Goldberg, L; Marcus, M D; Schneider, M; Solomon, S; Thompson, D; Yin, Z

    2009-08-01

    HEALTHY was a multi-center primary prevention trial designed to reduce risk factors for type 2 diabetes in adolescents. Seven centers each recruited six middle schools that were randomized to either intervention or control. The HEALTHY intervention integrated multiple components in nutrition, physical education, behavior change and communications and promotion. The conceptual rationale as well as the design and development of the behavior intervention component are described. Pilot study data informed the development of the behavior intervention component. Principles of social learning and health-related behavior change were incorporated. One element of the behavior intervention component was a sequence of peer-led, teacher-facilitated learning activities known as FLASH (Fun Learning Activities for Student Health). Five FLASH modules were implemented over five semesters of the HEALTHY study, with the first module delivered in the second semester of the sixth grade and the last module in the second semester of the eighth grade. Each module contained sessions that were designed to be delivered on a weekly basis to foster self-awareness, knowledge, decision-making skills and peer involvement for health behavior change. FLASH behavioral practice incorporated individual and group self-monitoring challenges for eating and activity. Another element of the behavior intervention component was the family outreach strategy for extending changes in physical activity and healthy eating beyond the school day and for supporting the student's lifestyle change choices. Family outreach strategies included the delivery of newsletters and supplemental packages with materials to promote healthy behavior in the home environment during school summer and winter holiday breaks. In conclusion, the HEALTHY behavior intervention component, when integrated with total school food and physical education environmental changes enhanced by communications and promotional campaigns, is a feasible and

  10. Narrative reconstruction therapy for prolonged grief disorder—rationale and case study

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    Tuvia Peri

    2016-05-01

    Full Text Available Background: Prolonged grief disorder (PGD is a potentially disabling condition affecting approximately 10% of bereaved people. It has been suggested that the impaired integration of the loss memory, as expressed in recurrent memories of the loss and disorganization of memory, is involved in the development of PGD. Narrative reconstruction (NR, originally designed for the treatment of posttraumatic stress disorder (PTSD in an integrative therapy module, and consisting of exposure to the loss memory, detailed written reconstruction of the loss memory narrative and an elaboration of the personal significance of that memory for the bereaved, has been shown to be effective in the treatment of intrusion symptoms. Objective: In light of findings that cognitive behavior therapy (CBT, including cognitive restructuring and exposure, is effective in the treatment of PGD, we suggest the implementation of a somewhat novel therapy module, NR, for the treatment of intrusive phenomena in bereaved patients. Method: The rationale for the implementation of NR for PGD and a case study of the treatment of a woman suffering from PGD after the death of her father are presented. Therapy took place in a university outpatient training clinic. Results: Evaluations conducted before and after treatment and at a 3-month follow-up demonstrated the effectiveness of NR in reducing symptoms of PGD and depression. The analysis of spontaneous narratives recorded before and after treatment showed an increased organization of the narratives. Conclusions: This case report demonstrates an adaptation of NR for the treatment of PGD. The results provide preliminary support for the effectiveness of NR for PGD. The significance of the study and its limitations are discussed.

  11. Internet-based contingency management to promote smoking cessation: a randomized controlled study.

    Science.gov (United States)

    Dallery, Jesse; Raiff, Bethany R; Grabinski, Michael J

    2013-12-01

    We evaluated an Internet-based contingency management intervention to promote smoking cessation. Participants in the contingent group (n = 39) earned vouchers contingent on video confirmation of breath carbon monoxide (CO) ≤ 4 parts per million (ppm). Earnings for participants in the noncontingent group (n = 38) were independent of CO levels. Goals and feedback about smoking status were provided on participants' homepages. The median percentages of negative samples during the intervention in the noncontingent and contingent groups were 25% and 66.7%, respectively. There were no significant differences in absolute CO levels or abstinence at 3- and 6-month follow-ups. Compared to baseline, however, participants in both groups reduced CO by an estimated 15.6 ppm during the intervention phases. The results suggest that the contingency for negative COs promoted higher rates of abstinence during treatment, and that other elements of the system, such as feedback, frequent monitoring, and goals, reduced smoking.

  12. Rationale, design, and methodology for the optimizing outcomes in women with gestational diabetes mellitus and their infants study

    OpenAIRE

    Berry, Diane C.; Neal, Madeline; Hall, Emily G.; Schwartz, Todd A.; Verbiest, Sarah; Bonuck, Karen; Goodnight, William; Brody, Seth; Dorman, Karen F; Menard, Mary K; Stuebe, Alison M.

    2013-01-01

    Background Women who are diagnosed with gestational diabetes mellitus (GDM) are at increased risk for developing prediabetes and type 2 diabetes mellitus (T2DM). To date, there have been few interdisciplinary interventions that target predominantly ethnic minority low-income women diagnosed with GDM. This paper describes the rationale, design and methodology of a 2-year, randomized, controlled study being conducted in North Carolina. Methods/Design Using a two-group, repeated measures, experi...

  13. Predicting asthma in preschool children with asthma symptoms: study rationale and design

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    Hafkamp-de Groen Esther

    2012-10-01

    Full Text Available Abstract Background In well-child care it is difficult to determine whether preschool children with asthma symptoms actually have or will develop asthma at school age. The PIAMA (Prevention and Incidence of Asthma and Mite Allergy Risk Score has been proposed as an instrument that predicts asthma at school age, using eight easy obtainable parameters, assessed at the time of first asthma symptoms at preschool age. The aim of this study is to present the rationale and design of a study 1 to externally validate and update the PIAMA Risk Score, 2 to develop an Asthma Risk Appraisal Tool to predict asthma at school age in (specific subgroups of preschool children with asthma symptoms and 3 to test implementation of the Asthma Risk Appraisal Tool in well-child care. Methods and design The study will be performed within the framework of Generation R, a prospective multi-ethnic cohort study. In total, consent for postnatal follow-up was obtained from 7893 children, born between 2002 and 2006. At preschool age the PIAMA Risk Score will be assessed and used to predict asthma at school age. Discrimination (C-index and calibration will be assessed for the external validation. We will study whether the predictive ability of the PIAMA Risk Score can be improved by removing or adding predictors (e.g. preterm birth. The (updated PIAMA Risk Score will be converted to the Asthma Risk Appraisal Tool- to predict asthma at school age in preschool children with asthma symptoms. Additionally, we will conduct a pilot study to test implementation of the Asthma Risk Appraisal Tool in well-child care. Discussion Application of the Asthma Risk Appraisal Tool in well-child care will help to distinguish preschool children at high- and low-risk of developing asthma at school age when asthma symptoms appear. This study will increase knowledge about the validity of the PIAMA risk score and might improve risk assessment of developing asthma at school age in (specific subgroups

  14. Effects of the Cessation of Mass Screening for Neuroblastoma at 6 Months of Age: A Population-Based Study in Osaka, Japan

    Science.gov (United States)

    Ioka, Akiko; Inoue, Masami; Yoneda, Akihiro; Nakamura, Tetsuro; Hara, Junichi; Hashii, Yoshiko; Sakata, Naoki; Yamato, Kazumi; Tsukuma, Hideaki; Kawa, Keisei

    2016-01-01

    Background In 2004, the Japanese government halted the 6-month mass screening program for neuroblastoma. We investigated whether its cessation had led to an increase not only in mortality due to this disease but also in the incidence of advanced-stage disease among older children. Methods Study subjects were neuroblastoma patients retrieved from the population-based Osaka Cancer Registry. Trends of incidence and mortality from neuroblastoma were analyzed by calendar year and birth cohort. Prognostic factors, including stage and v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN) oncogene status, were compared before and after the cessation of mass screening. Results Age-standardized incidence rates in 2005–2009 (the cessation period of mass screening; 11.1 per million) were similar to those in 1975–1979 (the pre-screening period; 8.6 per million). Age-standardized mortality rates tended to decrease from 1975–1979 (4.0 per million) to 2005–2009 (2.7 per million) in parallel with the improvement in survival. Analysis by birth cohort indicated that the mortality rates in 2004–2005 (after cessation) for children 0–4 years of age were lower than those in 1975–1979 (O:E ratio 0.25; 95% confidence interval, 0.03–0.90). For children 1–9 years of age, there was a not significant difference in the distribution of stage, MYCN oncogene status, and DNA ploidy between 1991–2003 (the mass screening period) and 2004–2008 (after cessation). Conclusions The cessation of mass screening for neuroblastoma does not appear to have increased mortality due to this disease or incidence of advanced-stage disease among older children. PMID:26548355

  15. The QUIT-PRIMO provider-patient Internet-delivered smoking cessation referral intervention: a cluster-randomized comparative effectiveness trial: study protocol

    Directory of Open Access Journals (Sweden)

    Ford Daniel E

    2010-11-01

    Full Text Available Abstract Background Although screening for tobacco use is increasing with electronic health records and standard protocols, other tobacco-control activities, such as referral of patients to cessation resources, is quite low. In the QUIT-PRIMO study, an online referral portal will allow providers to enter smokers' email addresses into the system. Upon returning home, the smokers will receive automated emails providing education about tobacco cessation and encouragement to use the patient smoking cessation website (with interactive tools, educational resources, motivational email messages, secure messaging with a tobacco treatment specialist, and online support group. Methods The informatics system will be evaluated in a comparative effectiveness trial of 160 community-based primary care practices, cluster-randomized at the practice level. In the QUIT-PRIMO intervention, patients will be provided a paper information-prescription referral and then "e-referred" to the system. In the comparison group, patients will receive only the paper-based information-prescription referral with the website address. Once patients go to the website, they are subsequently randomized within practices to either a standard patient smoking cessation website or an augmented version with access to a tobacco treatment specialist online, motivational emails, and an online support group. We will compare intervention and control practice participation (referral rates and patient participation (proportion referred who go to the website. We will then compare the effectiveness of the standard and augmented patient websites. Discussion Our goal is to evaluate an integrated informatics solution to increase access to web-delivered smoking cessation support. We will analyze the impact of this integrated system in terms of process (provider e-referral and patient login and patient outcomes (six-month smoking cessation. Trial Registration Web-delivered Provider Intervention for

  16. [Venous thromboembolism's risk assessment: rationale, objectives, and methodology--the ARTE study].

    Science.gov (United States)

    França, Ana; De Sousa, Joaquim Abreu; Felicíssimo, Paulo; Ferreira, Daniel

    2011-12-01

    ), haemorrhagic events (major and minor haemorrhages) and death at 6 months after discharge. Each patient will be contacted by telephone at 3 and 6 months after discharge, in order to assess the occurrence of thromboembolic and haemorrhagic events, as well as any readmission. This article describes the ARTE study's rationale, objectives, and methodology.

  17. Smoking cessation medications

    Science.gov (United States)

    Smoking cessation - medications; Smokeless tobacco - medications; Medications for stopping tobacco ... Creating a plan to help you deal with smoking urges. Getting support from a doctor, counselor, or ...

  18. Prospective Study of One Million Deaths in India: Rationale, Design, and Validation Results.

    Directory of Open Access Journals (Sweden)

    2005-12-01

    Full Text Available BACKGROUND: Over 75% of the annual estimated 9.5 million deaths in India occur in the home, and the large majority of these do not have a certified cause. India and other developing countries urgently need reliable quantification of the causes of death. They also need better epidemiological evidence about the relevance of physical (such as blood pressure and obesity, behavioral (such as smoking, alcohol, HIV-1 risk taking, and immunization history, and biological (such as blood lipids and gene polymorphisms measurements to the development of disease in individuals or disease rates in populations. We report here on the rationale, design, and implementation of the world's largest prospective study of the causes and correlates of mortality. METHODS AND FINDINGS: We will monitor nearly 14 million people in 2.4 million nationally representative Indian households (6.3 million people in 1.1 million households in the 1998-2003 sample frame and 7.6 million people in 1.3 million households in the 2004-2014 sample frame for vital status and, if dead, the causes of death through a well-validated verbal autopsy (VA instrument. About 300,000 deaths from 1998-2003 and some 700,000 deaths from 2004-2014 are expected; of these about 850,000 will be coded by two physicians to provide causes of death by gender, age, socioeconomic status, and geographical region. Pilot studies will evaluate the addition of physical and biological measurements, specifically dried blood spots. Preliminary results from over 35,000 deaths suggest that VA can ascertain the leading causes of death, reduce the misclassification of causes, and derive the probable underlying cause of death when it has not been reported. VA yields broad classification of the underlying causes in about 90% of deaths before age 70. In old age, however, the proportion of classifiable deaths is lower. By tracking underlying demographic denominators, the study permits quantification of absolute mortality rates

  19. Prospective study of one million deaths in India: rationale, design, and validation results.

    Directory of Open Access Journals (Sweden)

    Prabhat Jha

    2006-02-01

    Full Text Available BACKGROUND: Over 75% of the annual estimated 9.5 million deaths in India occur in the home, and the large majority of these do not have a certified cause. India and other developing countries urgently need reliable quantification of the causes of death. They also need better epidemiological evidence about the relevance of physical (such as blood pressure and obesity, behavioral (such as smoking, alcohol, HIV-1 risk taking, and immunization history, and biological (such as blood lipids and gene polymorphisms measurements to the development of disease in individuals or disease rates in populations. We report here on the rationale, design, and implementation of the world's largest prospective study of the causes and correlates of mortality. METHODS AND FINDINGS: We will monitor nearly 14 million people in 2.4 million nationally representative Indian households (6.3 million people in 1.1 million households in the 1998-2003 sample frame and 7.6 million people in 1.3 million households in the 2004-2014 sample frame for vital status and, if dead, the causes of death through a well-validated verbal autopsy (VA instrument. About 300,000 deaths from 1998-2003 and some 700,000 deaths from 2004-2014 are expected; of these about 850,000 will be coded by two physicians to provide causes of death by gender, age, socioeconomic status, and geographical region. Pilot studies will evaluate the addition of physical and biological measurements, specifically dried blood spots. Preliminary results from over 35,000 deaths suggest that VA can ascertain the leading causes of death, reduce the misclassification of causes, and derive the probable underlying cause of death when it has not been reported. VA yields broad classification of the underlying causes in about 90% of deaths before age 70. In old age, however, the proportion of classifiable deaths is lower. By tracking underlying demographic denominators, the study permits quantification of absolute mortality rates

  20. The Strathclyde Evaluation of Children's Active Travel (SE-CAT: study rationale and methods

    Directory of Open Access Journals (Sweden)

    McMinn David

    2011-12-01

    Full Text Available Abstract Background The school commute is a prime opportunity to increase children's physical activity levels. However, active commuting has decreased over the past 40 years. Strategies that increase walking to school are therefore needed. Travelling Green (TG is a school-based active travel resource aimed at increasing children's walking to school. The resource consists of a curriculum-based program of lessons and goal setting activities. A previous study found that children who received the TG intervention increased self-reported distance travelled to school by active modes and reduced the distance travelled by inactive modes. This study was limited by self-reported outcome measures, a small sample, and no follow-up measures. A more robust evaluation of TG is required to address these limitations. This paper describes the rationale and methods for such an evaluation of Travelling Green, and describes the piloting of various active commuting measures in primary school children. Methods/Design Measures of active commuting were piloted in a sample of 26 children (aged 8-9 years over one school week. These measures were subsequently used in an 18-month quasi-experimental design to evaluate the effect of TG on commuting behaviour. Participants were 166 children (60% male aged 8-9 years from 5 primary schools. Two schools (n = 79 children received TG in September/October 2009. Three schools (n = 87 children acted as a comparison group, and subsequently received TG at a later date. Physical activity was measured using Actigraph GT1M accelerometers. Personal and environmental determinants of active commuting were measured via parent and child questionnaires, as were factors related to the Theory of Planned Behaviour and the construct of habit. Measures were taken pre- and post-intervention and at 5 and 12 months follow-up. Discussion The piloted protocol was practical and feasible and piloted measures were reliable and valid. All study data, including

  1. Child/Adolescent Anxiety Multimodal Study (CAMS: rationale, design, and methods

    Directory of Open Access Journals (Sweden)

    Waslick Bruce D

    2010-01-01

    Full Text Available Abstract Objective To present the design, methods, and rationale of the Child/Adolescent Anxiety Multimodal Study (CAMS, a recently completed federally-funded, multi-site, randomized placebo-controlled trial that examined the relative efficacy of cognitive-behavior therapy (CBT, sertraline (SRT, and their combination (COMB against pill placebo (PBO for the treatment of separation anxiety disorder (SAD, generalized anxiety disorder (GAD and social phobia (SoP in children and adolescents. Methods Following a brief review of the acute outcomes of the CAMS trial, as well as the psychosocial and pharmacologic treatment literature for pediatric anxiety disorders, the design and methods of the CAMS trial are described. Results CAMS was a six-year, six-site, randomized controlled trial. Four hundred eighty-eight (N = 488 children and adolescents (ages 7-17 years with DSM-IV-TR diagnoses of SAD, GAD, or SoP were randomly assigned to one of four treatment conditions: CBT, SRT, COMB, or PBO. Assessments of anxiety symptoms, safety, and functional outcomes, as well as putative mediators and moderators of treatment response were completed in a multi-measure, multi-informant fashion. Manual-based therapies, trained clinicians and independent evaluators were used to ensure treatment and assessment fidelity. A multi-layered administrative structure with representation from all sites facilitated cross-site coordination of the entire trial, study protocols and quality assurance. Conclusions CAMS offers a model for clinical trials methods applicable to psychosocial and psychopharmacological comparative treatment trials by using state-of-the-art methods and rigorous cross-site quality controls. CAMS also provided a large-scale examination of the relative and combined efficacy and safety of the best evidenced-based psychosocial (CBT and pharmacologic (SSRI treatments to date for the most commonly occurring pediatric anxiety disorders. Primary and secondary results

  2. Population-based cohort study of outpatients with pneumonia: rationale, design and baseline characteristics

    Directory of Open Access Journals (Sweden)

    Eurich Dean T

    2012-06-01

    Full Text Available Abstract Background The vast majority of research in the area of community-acquired pneumonia (CAP has been based on patients admitted to hospital. And yet, the majority of patients with CAP are treated on an ambulatory basis as outpatients, either by primary care physicians or in Emergency Departments. Few studies have been conducted in outpatients with pneumonia, and there is a paucity of data on short and long term morbidity or mortality and associated clinical correlates in this group of patients. Methods From 2000–2002, all CAP patients presenting to 7 Emergency Departments in Edmonton, Alberta, Canada were prospectively enrolled in a population-based registry. Clinical data, including pneumonia severity index (PSI were collected at time of presentation. Patients discharged to the community were then followed for up to 5 years through linkage to the provincial administrative databases. The current report provides the rationale and design for the cohort, as well as describes baseline characteristics and 30-day morbidity and mortality. Results The total sample included 3874 patients. After excluding patients who were hospitalized, died or returned to the Emergency Department the same day they were initially discharged (n = 451; 12 %, and patients who could not be linked to provincial administrative databases (n = 237; 6 %, the final cohort included 3186 patients treated according to a validated clinical management pathway and discharged back to the community. Mean age was 51 (SD = 20 years, 53 % male; 4 % resided in a nursing home, 95 % were independently mobile, and 88 % had mild (PSI class I-III pneumonia. Within 30-days, return to Emergency Department was common (25 % as was hospitalization (8 % and 1 % of patients had died. Conclusions To our knowledge, this represents the largest clinically-detailed outpatient CAP cohort assembled to date and will add to our understanding of the determinants and outcomes

  3. Selectively reduced responses to smoking cues in amygdala following extinction-based smoking cessation: results of a preliminary functional magnetic resonance imaging study.

    Science.gov (United States)

    McClernon, F Joseph; Hiott, F Berry; Liu, Jim; Salley, Alfred N; Behm, Frederique M; Rose, Jed E

    2007-09-01

    Preliminary studies suggest an extinction-based smoking cessation treatment using reduced nicotine content (RNC) cigarettes decreases self-report craving for cigarettes prior to quitting and may be an effective smoking cessation treatment. The aims of this study was to evaluate the effect of an extinction-based smoking cessation treatment on brain responses to smoking cues using blood-oxygen level-dependent (BOLD) functional magnetic resonance imaging (fMRI). Sixteen (n = 16) dependent smokers were scanned using BOLD fMRI at baseline, following 2-4 weeks of smoking RNC cigarettes while wearing a 21-mg nicotine patch, and 2-4 weeks following quitting smoking. During scanning, participants viewed smoking-related pictures (e.g. lit cigarette) and pictures of people engaged in everyday activities (e.g. using a stapler). Event-related BOLD responses to smoking and control cues were analyzed in regions of interest (ROIs) known to subserve reward, attention, motivation and emotion. The extinction-based treatment simultaneously attenuated responses to smoking cues in amygdala while potentiating responses to control cues. Exploratory analysis indicated that this pattern was also observed in the thalamus of future abstinent but not relapsing smokers. The results of this preliminary study suggest that an extinction-based treatment for smoking cessation alters brain responses to smoking and control cues in amygdala--a region previously associated with drug cue reactivity and extinction.

  4. The SmokefreeTXT (SFTXT) Study: Web and Mobile Data Collection to Evaluate Smoking Cessation for Young Adults

    Science.gov (United States)

    Brown, Derick; Parvanta, Sarah; Dolina, Suzanne; Kelly, Bridget; Dever, Jill; Southwell, Brian G; Sanders, Amy; Augustson, Erik

    2016-01-01

    Background Text messaging (short message service, SMS) has been shown to be effective in delivering interventions for various diseases and health conditions, including smoking cessation. While there are many published studies regarding smoking cessation text messaging interventions, most do not provide details about the study’s operational methods. As a result, there is a gap in our understanding of how best to design studies of smoking cessation text messaging programs. Objective The purpose of this paper is to detail the operational methods used to conduct a randomized trial comparing three different versions of the National Cancer Institute’s SmokefreeText (SFTXT) program, designed for smokers 18 to 29 years of age. We detail our methods for recruiting participants from the Internet, reducing fraud, conducting online data collection, and retaining panel study participants. Methods Participants were recruited through website advertisements and market research online panels. Screening questions established eligibility for the study (eg, 18 to 29 years of age, current smoker). Antifraud measures screened out participants who could not meet the study requirements. After completing a baseline survey, participants were randomized to one of three study arms, which varied by type and timing of text message delivery. The study offered US $20 gift cards as incentives to complete each of four follow-up surveys. Automated email reminders were sent at designated intervals to increase response rates. Researchers also provided telephone reminders to those who had not completed the survey after multiple email reminders. We calculated participation rates across study arms and compared the final sample characteristics to the Current Population Survey to examine generalizability. Results Recruitment methods drove 153,936 unique visitors to the SFTXT Study landing page and 27,360 began the screener. Based on the screening questions, 15,462 out of 27,360 responders (56.51%) were

  5. Physical activity as an aid to smoking cessation during pregnancy (LEAP) trial: study protocol for a randomized controlled trial

    OpenAIRE

    Ussher, M; Aveyard, P; Manyonda, I; Lewis, S.; West, R.; Lewis, B.; Marcus, B.; Taylor, AH; Barton, P.; Coleman, T

    2012-01-01

    Abstract Background Many women try to stop smoking in pregnancy but fail. One difficulty is that there is insufficient evidence that medications for smoking cessation are effective and safe in pregnancy and thus many women prefer to avoid these. Physical activity (PA) interventions may assist cessation; however, trials examining these interventions have been too small to detect or exclude plausible beneficial effects. The London Exercise And ...

  6. Impact of an Electronic Cigarette on Smoking Reduction and Cessation in Schizophrenic Smokers: A Prospective 12-Month Pilot Study

    Directory of Open Access Journals (Sweden)

    Pasquale Caponnetto

    2013-01-01

    Full Text Available Background: Cigarette smoking is a tough addiction to break. This dependence is the most common dual diagnosis for individuals with schizophrenia. Currently three effective drugs are approved for smoking cessation: nicotine replacement therapy (NRT, varenicline and bupropion. However, some serious side effects of varenicline have been reported, including depression, suicidal thoughts, and suicide. The use of bupropion also has side effects. It should not be used by people who have epilepsy or any condition that lowers the seizure threshold, nor by people who take a specific class of drugs called monoamine oxidase inhibitors. Hence, there are pharmacodynamic reason to believe they could precipitate or exacerbate psychosis. For its capacity to deliver nicotine and provide a coping mechanism for conditioned smoking cues by replacing some of the rituals associated with smoking gestures, electronic-cigarettes may reduce nicotine withdrawal symptoms without serious side effects. Our recent work with ECs in healthy smokers not intending to quit consistently show surprisingly high success rates. We hypothesised that these positive findings could be replicated in difficult patients with schizophrenia This tool may help smokers with schizophrenia remain abstinent during their quitting attempts or to reduce cigarette consumption. Efficacy and safety of these devices in long-term smoking cessation and/or smoking reduction studies have never been investigated for this special population. Methods: In this study we monitored possible modifications in smoking habits of 14 smokers (not intending to quit with schizophrenia experimenting with the “Categoria” e-Cigarette with a focus on smoking reduction and smoking abstinence. Study participants were invited to attend six study visits: at baseline, week-4, week-8, week-12 week-24 and week 52. Product use, number of cigarettes smoked, carbon monoxide in exhaled breath (eCO and positive and negative symptoms of

  7. Smoking Cessation for Crohn's Disease: Clearing the Haze.

    Science.gov (United States)

    Kaplan, Gilaad G

    2016-03-01

    The TABACROHN Study Group conducted a multicenter prospective cohort study, demonstrating that smoking cessation improved the prognosis of Crohn's disease. Patients who continued to smoke were 50% more likely to relapse compared with non-smokers. Smoking cessation reduced the risk of flaring, regardless of exposure to anti-tumor necrosis factor agents. Despite the evidence that smoking cessation is beneficial, many patients do not quit smoking after their diagnosis of Crohn's disease. Lack of awareness, physical addiction, and social context of smoking inhibit smoking cessation. In spite of this, comprehensive smoking cessation programs have been shown to be effective and reduce costs.

  8. Efficacy of confrontational counselling for smoking cessation in smokers with previously undiagnosed mild to moderate airflow limitation: study protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Huibers Marcus JH

    2007-11-01

    Full Text Available Abstract Background The use of spirometry for early detection of chronic obstructive pulmonary disease (COPD is still an issue of debate, particularly because of a lack of convincing evidence that spirometry has an added positive effect on smoking cessation. We hypothesise that early detection of COPD and confrontation with spirometry for smoking cessation may be effective when applying an approach we have termed "confrontational counselling"; a patient-centred approach which involves specific communication skills and elements of cognitive therapy. An important aspect is to confront the smoker with his/her airflow limitation during the counselling sessions. The primary objective of this study is to test the efficacy of confrontational counselling in comparison to regular health education and promotion for smoking cessation delivered by specialized respiratory nurses in current smokers with previously undiagnosed mild to moderate airflow limitation. Methods/Design The study design is a randomized controlled trial comparing confrontational counselling delivered by a respiratory nurse combined with nortriptyline for smoking cessation (experimental group, health education and promotion delivered by a respiratory nurse combined with nortriptyline for smoking cessation (control group 1, and "care as usual" delivered by the GP (control group 2. Early detection of smokers with mild to moderate airflow limitation is achieved by means of a telephone interview in combination with spirometry. Due to a comparable baseline risk of airflow limitation and motivation to quit smoking, and because of the standardization of number, duration, and scheduling of counselling sessions between the experimental group and control group 1, the study enables to assess the "net" effect of confrontational counselling. The study has been ethically approved and registered. Discussion Ethical as well as methodological considerations of the study are discussed in this protocol. A

  9. Smoking cessation and lung cancer screening

    DEFF Research Database (Denmark)

    Pedersen, Jesper Holst; Tønnesen, Philip; Ashraf, Haseem

    2016-01-01

    Smoking behavior may have a substantial influence on the overall effect of lung cancer screening. Non-randomized studies of smoking behavior during screening have indicated that computer tomography (CT) screening induces smoking cessation. Randomized studies have further elaborated that this effect...... and decrease smoking relapse rate. Also low smoking dependency and high motivation to quit smoking at baseline predicted smoking abstinence in screening trials. Lung cancer screening therefore seems to be a teachable moment for smoking cessation. Targeted smoking cessation counselling should be an integrated...... part of future lung cancer screening trials....

  10. Africa South of the Sahara, Rationale and Introduction: An Experimental Program of Study for Secondary School Social Studies Students. Teaching Guide.

    Science.gov (United States)

    Carnegie-Mellon Univ., Pittsburgh, PA. Project Africa.

    The articulation of a rationale for Project Africa's instructional program, the collection of materials for improving inquiry-oriented instruction at the secondary level about Africa south of the Sahara, and the preparation of teaching and study guides have been completed. This geographic region, rather than the whole continent, was chosen to…

  11. Enabling and sustaining the activities of lay health influencers: lessons from a community-based tobacco cessation intervention study.

    Science.gov (United States)

    Castañeda, Heide; Nichter, Mark; Nichter, Mimi; Muramoto, Myra

    2010-07-01

    The authors present findings from a community-based tobacco cessation project that trained lay health influencers to conduct brief interventions. They outline four major lessons regarding sustainability. First, participants were concerned about the impact that promoting cessation might have on social relationships. "Social risk" must be addressed during training to ensure long-term sustainability. Second, formal training provided participants with an increased sense of self-efficacy, allowed them to embrace a health influencer identity, and aided in further reducing social risk. Third, material resources functioned to mediate social tensions during health intervention conversations. A variety of resources should be made available to health influencers to accommodate type of relationship, timing, and location of the interaction. Finally, project design must be attentive to the creation of a "community of practice" among health influencers as an integral part of project sustainability. These lessons have broad implications for successful health promotion beyond tobacco cessation.

  12. [Smoking cessation therapies in Germany].

    Science.gov (United States)

    Kröger, C; Gradl, S

    2010-02-01

    Reducing the consumption of tobacco products in Germany is a health objective that is achievable with smoking cessation treatments for smokers. This objective turns out to be more successful when using different interventions for smoking cessation than with self-initiated smoking cessation methods. This survey describes the range of smoking cessation treatments in Germany and evaluates them on the basis of international guidelines.

  13. Cigarette smoke impairs granulosa cell proliferation and oocyte growth after exposure cessation in young Swiss mice: an experimental study

    Directory of Open Access Journals (Sweden)

    Paixão Larissa LO

    2012-09-01

    Full Text Available Abstract Background Cigarette smoke is associated with decreased female fertility, causing damage to ovarian function and disturbing follicle development. However, the effects of cigarette toxicants on ovarian function depend on duration and intensity of exposure. The aim of this study was to assess the effects of brief, intense exposure to tobacco smoke on granulosa cell number, oocyte growth, and follicle size during puberty in female Swiss mice. Methods Ten female Swiss mice aged 35 days were exposed to tobacco smoke from 3R4F reference research cigarettes. They were exposed to an automatic smoking machine 8 h/day, 7 days/week for 15 days. Ten age-matched controls were kept in a different room and exposed to ambient air. At the end of 15 days, five mice in each group were euthanized and the ovaries were analyzed for follicular morphometry and granulosa cell count. The remaining animals were kept for an additional 30 days for further analysis as an ex-smoker group and control group. Comparison between the two groups was evaluated by the Student’s t-test or a two-way ANOVA followed by Bonferroni post-test was applied for multiple comparisons. Results We found that cigarette smoke impaired antral follicular growth even after exposure cessation (p Conclusions The negative effects of cigarette smoking seem to last even after exposure has been interrupted. Moreover, brief exposure during puberty may induce silent oocyte disruption, which could in turn lead to decreased fecundity rates.

  14. Rationale for delayed-start study of pramipexole in Parkinson's disease: the PROUD study.

    Science.gov (United States)

    Schapira, Anthony H V; Albrecht, Stefan; Barone, Paolo; Comella, Cynthia L; McDermott, Michael P; Mizuno, Yoshikuni; Poewe, Werner; Rascol, Olivier; Marek, Kenneth

    2010-08-15

    Perhaps the most important unmet need in Parkinson's disease (PD) is the ability to slow or prevent progression of the neurodegeneration that underlies the motor and nonmotor features of this disorder. Pramipexole, a dopamine agonist used for the symptomatic treatment of PD, has demonstrated neuroprotective properties in laboratory studies. The PRamipexole On Underlying Disease (PROUD) study is a randomized, double-blind clinical trial evaluating the ability of pramipexole to modify disease progression using a delayed-start design. PD patients (n = 535) with mean age 62.5 years, mean duration since diagnosis of 4.4 months, and mean total Unified Parkinson's disease Rating Scale (UPDRS) score of 24.5 were recruited. In Phase I, patients were randomly assigned to be titrated to 1.5 mg pramipexole or placebo and maintained on study drug for 6-9 months. In Phase II, all patients were titrated to 1.5 mg pramipexole and maintained on study drug until the end of the study at 15 months. No rescue medication was allowed in the protocol. The primary endpoint is the change in total UPDRS score (parts I-III) from baseline to 15 months. A range of secondary endpoints separately assess UPDRS subscales, quality of life, depression, and impulse control disorders. A sub-study examined dopamine transporter uptake scans at baseline and 15 months. The results of PROUD will provide insight into the potential for early versus delayed treatment with pramipexole to modify motor outcome at 15 months in recently diagnosed PD patients.

  15. Living with diabetes: rationale, study design and baseline characteristics for an Australian prospective cohort study

    Directory of Open Access Journals (Sweden)

    Donald Maria

    2012-01-01

    Full Text Available Abstract Background Diabetes mellitus is a major global public health threat. In Australia, as elsewhere, it is responsible for a sizeable portion of the overall burden of disease, and significant costs. The psychological and social impact of diabetes on individuals with the disease can be severe, and if not adequately addressed, can lead to the worsening of the overall disease picture. The Living With Diabetes Study aims to contribute to a holistic understanding of the psychological and social aspects of diabetes mellitus. Methods/Design The Living With Diabetes Study is a 5-year prospective cohort study, based in Queensland, Australia. The first wave of data, which was collected via a mailed self-report survey, was gathered in 2008, with annual collections thereafter. Measurements include: demographic, lifestyle, health and disease characteristics; quality of life (EQ-5D, ADDQoL; emotional well-being (CES-D, LOT-R, ESSI; disease self-management (PAM; and health-care utilisation and patient-assessed quality of care (PACIC. 29% of the 14,439 adults who were invited to participate in the study agreed to do so, yielding a sample size of 3,951 people. Discussion The data collected by the Living With Diabetes Study provides a good representation of Australians with diabetes to follow over time in order to better understand the natural course of the illness. The study has potential to further illuminate, and give a comprehensive picture of the psychosocial implications of living with diabetes. Data collection is ongoing.

  16. Youth tobacco use cessation: 2008 update

    Directory of Open Access Journals (Sweden)

    Sussman Steve

    2009-01-01

    Full Text Available Abstract In this paper, an empirical review of 64 teen tobacco use cessation studies is provided. Examined include program contents, delivery modalities, number of contacts, and expected quit rates. In addition, means of recruitment and retention of smokers in programming are discussed. Also, promising contemporary methods of teen smoking cessation are examined, including use of pharmacologic adjuncts, electronic technology, and cigarette price increases (and no smoking policy. Conclusions are made regarding implications for developing and implementing teen tobacco use cessation programs.

  17. Learning from failure - rationale and design for a study about discontinuation of randomized trials (DISCO study

    Directory of Open Access Journals (Sweden)

    Kasenda Benjamin

    2012-08-01

    Full Text Available Abstract Background Randomized controlled trials (RCTs may be discontinued because of apparent harm, benefit, or futility. Other RCTs are discontinued early because of insufficient recruitment. Trial discontinuation has ethical implications, because participants consent on the premise of contributing to new medical knowledge, Research Ethics Committees (RECs spend considerable effort reviewing study protocols, and limited resources for conducting research are wasted. Currently, little is known regarding the frequency and characteristics of discontinued RCTs. Methods/Design Our aims are, first, to determine the prevalence of RCT discontinuation for specific reasons; second, to determine whether the risk of RCT discontinuation for specific reasons differs between investigator- and industry-initiated RCTs; third, to identify risk factors for RCT discontinuation due to insufficient recruitment; fourth, to determine at what stage RCTs are discontinued; and fifth, to examine the publication history of discontinued RCTs. We are currently assembling a multicenter cohort of RCTs based on protocols approved between 2000 and 2002/3 by 6 RECs in Switzerland, Germany, and Canada. We are extracting data on RCT characteristics and planned recruitment for all included protocols. Completion and publication status is determined using information from correspondence between investigators and RECs, publications identified through literature searches, or by contacting the investigators. We will use multivariable regression models to identify risk factors for trial discontinuation due to insufficient recruitment. We aim to include over 1000 RCTs of which an anticipated 150 will have been discontinued due to insufficient recruitment. Discussion Our study will provide insights into the prevalence and characteristics of RCTs that were discontinued. Effective recruitment strategies and the anticipation of problems are key issues in the planning and evaluation of trials

  18. The Association of Lone-Motherhood with Smoking Cessation and Relapse: Prospective Results from an Australian National Study

    Directory of Open Access Journals (Sweden)

    Gopal K. Singh

    2013-07-01

    Full Text Available The aims were to examine the association of lone-motherhood with smoking cessation and relapse, and to investigate the extent to which this association was accounted for by socioeconomic status (education, occupation, and income, social support, and mental health. We used data from 10 yearly waves (2001 to 2010 of the Household Income and Labour Dynamics in Australia (HILDA survey. Response rate in the first wave was 66%. Logistic regression was used to examine the effect of lone-motherhood and other covariates on smoking cessation (n = 2,878 and relapse (n = 3,242. Results showed that the age-adjusted odds of smoking cessation were 32% smaller among lone mothers than partnered mothers (p = 0.004. The age-adjusted odds of relapse was 172% greater among lone mothers than partnered mothers (p < 0.001. We found that socioeconomic status, social support, and mental health account for some of the association of lone motherhood and cessation and relapse. While efforts to reduce the smoking prevalence among lone mothers should focus on their material deprivation, availability of social support, and addressing mental health issues, other factors unique to the lives of lone mothers also need to be taken into account. More research is needed to discover other factors that can explain the association of lone-motherhood and smoking behavior.

  19. The association of lone-motherhood with smoking cessation and relapse: prospective results from an Australian national study.

    Science.gov (United States)

    Siahpush, Mohammad; Shaikh, Raees A; Tibbits, Melissa; Huang, Terry T-K; Singh, Gopal K

    2013-07-12

    The aims were to examine the association of lone-motherhood with smoking cessation and relapse, and to investigate the extent to which this association was accounted for by socioeconomic status (education, occupation, and income), social support, and mental health. We used data from 10 yearly waves (2001 to 2010) of the Household Income and Labour Dynamics in Australia (HILDA) survey. Response rate in the first wave was 66%. Logistic regression was used to examine the effect of lone-motherhood and other covariates on smoking cessation (n = 2,878) and relapse (n = 3,242). Results showed that the age-adjusted odds of smoking cessation were 32% smaller among lone mothers than partnered mothers (p = 0.004). The age-adjusted odds of relapse was 172% greater among lone mothers than partnered mothers (p social support, and mental health account for some of the association of lone motherhood and cessation and relapse. While efforts to reduce the smoking prevalence among lone mothers should focus on their material deprivation, availability of social support, and addressing mental health issues, other factors unique to the lives of lone mothers also need to be taken into account. More research is needed to discover other factors that can explain the association of lone-motherhood and smoking behavior.

  20. Long-term effects of smoking cessation support in primary care: results of a two-year longitudinal study in Brazil

    Directory of Open Access Journals (Sweden)

    Nádia Cristina Pinheiro Rodrigues

    2016-06-01

    Full Text Available ABSTRACT Objective The objective of this study was to evaluate the long-term effects of a Brazilian smoking cessation support program and the factors that are associated with its success. Methods A longitudinal study was conducted from 2012 to 2014 with 84 patients enrolled in smoking cessation support groups in a Primary Care Center from a poor community in Rio de Janeiro (Brazil. Support was provided according to Brazilian Tobacco Control Program and consisted of cognitive behavioral therapy in addition to nicotine replacement therapy. Logistic regression and the Cox proportional hazard models were used in the analysis. Results There was an increase of 34%, 48% and 97% in the chances of patients stop smoking for at least six months, 12 months and 24 months, respectively, for each new session that the patient participated. Patients that attended three or more meetings had a 79% lower risk of returning to smoking than those who went to less than three meetings. Conclusions Although not all patients who were enrolled in the program could be contacted for the study, our results indicate that about 40% of patients are able to stay smoke-free for at least three months due to the smoking cessation program, but less than 20% are able to remain smoke-free for two years. Initiatives to improve adherence to cognitive behavioral therapy meetings according to the specificity of the population may increase the effectiveness of the program.

  1. Smoking cessation is followed by a sharp but transient rise in the incidence of overt autoimmune hypothyroidism – A population‐based, case–control study

    DEFF Research Database (Denmark)

    Carlé, Allan; Bülow Pedersen, Inge; Knudsen, Nils;

    2012-01-01

    habits were verified by measuring urinary cotinine (a nicotine metabolite). Incident hypothyroidism was very common in people who had recently stopped smoking: OR vs never smokers (95%‐CI); quit smoking 10 years, 0·76 (0·38–1·51). Results were consistent in both sexes and irrespective of age. Within two......‐fold increased the first 2 years after cessation of smoking. Clearly, smoking cessation is vital to prevent death and severe disease. However, awareness of hypothyroidism should be high in people who have recently quit smoking, and virtually any complaint should lead to thyroid function testing.......Current smoking is associated with a low prevalence of thyroid autoantibodies. On the other hand, smoking withdrawal enhances thyroid autoantibody level and may be a risk factor for the development of hypothyroidism. The aim of this study was to assess the association between smoking habits...

  2. Cessation of smoking after first-ever stroke: a follow-up study

    DEFF Research Database (Denmark)

    Bak, Søren; Sindrup, Søren Hein; Alslev, Torben;

    2002-01-01

    and at follow-up were included in the present study. Among 198 patients (38.7%) who were current smokers on admission, 43 patients (21.7%) gave up smoking within 6 months of suffering a stroke. Sex, functional status, and sociodemographic characteristics were independently associated with persistent smoking...

  3. Reasons for not using smoking cessation aids

    OpenAIRE

    Völzke Henry; Meyer Christian; Ulbricht Sabina; Schumann Anja; Brose Leonie; Gross Beatrice; Rumpf Hans-Jürgen; John Ulrich

    2008-01-01

    Abstract Background Few smokers use effective smoking cessation aids (SCA) when trying to stop smoking. Little is known why available SCA are used insufficiently. We therefore investigated the reasons for not using SCA and examined related demographic, smoking behaviour, and motivational variables. Methods Data were collected in two population-based studies testing smoking cessation interventions in north-eastern Germany. A total of 636 current smokers who had never used SCA and had attempted...

  4. The effects on depression of Internet-administered behavioural activation and physical exercise with treatment rationale and relapse prevention: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Carlbring Per

    2013-02-01

    Full Text Available Abstract Background Despite their potential as low-threshold, low-cost and high-flexibility treatments of depression, behavioural activation and physical exercise have not yet been directly compared. This study will examine the effects of these interventions, administered via the Internet. The added effect of providing a treatment rationale will also be studied, as well as a relapse prevention program featuring cognitive behavioural therapy components. Methods/Design This randomised controlled trial will include 500 participants meeting the diagnostic criteria for major depression, recruited in multiple cycles and randomised to either a waiting list control group with delayed treatment, or one of the four treatment groups: (1 physical exercise without a clear treatment rationale; (2 physical exercise with treatment rationale; (3 behavioural activation with treatment rationale; or (4 behavioural activation without a clear treatment rationale. Post treatment, half of the participants will be offered a relapse prevention program. Primary outcome measure will be the Patient Health Questionnaire 9-item. Secondary measures include diagnostic criteria for depression, as well as self-reported anxiety, physical activity and quality of life. Measurements - done via telephone and the Internet - will be collected pre-treatment, weekly during treatment period, immediately post treatment and then monthly during a 24-month follow-up period. Discussion The results of this study will constitute an important contribution to the body of knowledge of the respective interventions. Limitations are discussed. Trial registration ClinicalTrials.gov: NCT01619930

  5. Studying the effects of classic hallucinogens in the treatment of alcoholism: rationale, methodology, and current research with psilocybin.

    Science.gov (United States)

    Bogenschutz, Michael P

    2013-03-01

    Recent developments in the study of classic hallucinogens, combined with a re-appraisal of the older literature, have led to a renewal of interest in possible therapeutic applications for these drugs, notably their application in the treatment of addictions. This article will first provide a brief review of the research literature providing direct and indirect support for the possible therapeutic effects of classic hallucinogens such as psilocybin and lysergic acid diethylamide (LSD) in the treatment of addictions. Having provided a rationale for clinical investigation in this area, we discuss design issues in clinical trials using classic hallucinogens, some of which are unique to this class of drug. We then discuss the current status of this field of research and design considerations in future randomized trials.

  6. Effectiveness of a Multi-Component Smoking Cessation Support Programme (McSCSP for Patients with Severe Mental Disorders: Study Design

    Directory of Open Access Journals (Sweden)

    Maria Paz Garcia-Portilla

    2013-12-01

    Full Text Available Only a few studies have examined the efficacy and safety of smoking cessation programmes in patients with mental disorders. The aim of this paper is to describe in detail the methodology used in the study as well as the Multi-component Smoking Cessation Support Programme in terms of pharmacological treatments and psychological interventions. An open-label 9-month follow-up study was conducted in Spain. A total of 82 clinically stable outpatients with schizophrenia, schizoaffective or bipolar disorder were enrolled. Treatment consisted of a programme specifically developed by the research team for individuals with severe mental disorders. The programme consisted of two phases: (1 weekly individual motivational therapy for 4–12 weeks, and (2 a 12-week active treatment phase. During this phase, at each study visit patients received a one- or two-week supply of medication (transdermal nicotine patches, varenicline or bupropion with instructions on how to take it, in addition to group psychotherapy for smoking cessation. Evaluations were performed: (1 at the time of enrolment in the study, (2 during the 12-week active treatment phase of the study (weekly for the first 4 weeks and then biweekly, and (3 after the end of this phase (two follow-up assessments at weeks 12 and 24. Evaluations included: (1 smoking history, (2 substance use, (3 psychopathology, (4 adverse events, and (5 laboratory tests. The importance of this study lies in addressing a topical issue often ignored by psychiatrists: the unacceptably high rates of tobacco use in patients with severe mental disorders.

  7. Effectiveness of a Multi-Component Smoking Cessation Support Programme (McSCSP) for Patients with Severe Mental Disorders: Study Design

    Science.gov (United States)

    Garcia-Portilla, Maria Paz; Garcia-Alvarez, Leticia; Saiz, Pilar Alejandra; Diaz-Mesa, Eva; Galvan, Gonzalo; Sarramea, Fernando; Garcia-Blanco, Josefa; Elizagarate, Edorta; Bobes, Julio

    2013-01-01

    Only a few studies have examined the efficacy and safety of smoking cessation programmes in patients with mental disorders. The aim of this paper is to describe in detail the methodology used in the study as well as the Multi-component Smoking Cessation Support Programme in terms of pharmacological treatments and psychological interventions. An open-label 9-month follow-up study was conducted in Spain. A total of 82 clinically stable outpatients with schizophrenia, schizoaffective or bipolar disorder were enrolled. Treatment consisted of a programme specifically developed by the research team for individuals with severe mental disorders. The programme consisted of two phases: (1) weekly individual motivational therapy for 4–12 weeks, and (2) a 12-week active treatment phase. During this phase, at each study visit patients received a one- or two-week supply of medication (transdermal nicotine patches, varenicline or bupropion) with instructions on how to take it, in addition to group psychotherapy for smoking cessation. Evaluations were performed: (1) at the time of enrolment in the study, (2) during the 12-week active treatment phase of the study (weekly for the first 4 weeks and then biweekly), and (3) after the end of this phase (two follow-up assessments at weeks 12 and 24). Evaluations included: (1) smoking history, (2) substance use, (3) psychopathology, (4) adverse events, and (5) laboratory tests. The importance of this study lies in addressing a topical issue often ignored by psychiatrists: the unacceptably high rates of tobacco use in patients with severe mental disorders. PMID:24368428

  8. Effectiveness of a multi-component Smoking Cessation Support Programme (McSCSP) for patients with severe mental disorders: study design.

    Science.gov (United States)

    Garcia-Portilla, Maria Paz; Garcia-Alvarez, Leticia; Saiz, Pilar Alejandra; Diaz-Mesa, Eva; Galvan, Gonzalo; Sarramea, Fernando; Garcia-Blanco, Josefa; Elizagarate, Edorta; Bobes, Julio

    2013-12-24

    Only a few studies have examined the efficacy and safety of smoking cessation programmes in patients with mental disorders. The aim of this paper is to describe in detail the methodology used in the study as well as the Multi-component Smoking Cessation Support Programme in terms of pharmacological treatments and psychological interventions. An open-label 9-month follow-up study was conducted in Spain. A total of 82 clinically stable outpatients with schizophrenia, schizoaffective or bipolar disorder were enrolled. Treatment consisted of a programme specifically developed by the research team for individuals with severe mental disorders. The programme consisted of two phases: (1) weekly individual motivational therapy for 4-12 weeks, and (2) a 12-week active treatment phase. During this phase, at each study visit patients received a one- or two-week supply of medication (transdermal nicotine patches, varenicline or bupropion) with instructions on how to take it, in addition to group psychotherapy for smoking cessation. Evaluations were performed: (1) at the time of enrollment in the study, (2) during the 12-week active treatment phase of the study (weekly for the first 4 weeks and then biweekly), and (3) after the end of this phase (two follow-up assessments at weeks 12 and 24). Evaluations included: (1) smoking history, (2) substance use, (3) psychopathology, (4) adverse events, and (5) laboratory tests. The importance of this study lies in addressing a topical issue often ignored by psychiatrists: the unacceptably high rates of tobacco use in patients with severe mental disorders.

  9. Depressive Symptoms, Drinking Problems, and Smoking Cessation in Older Smokers

    OpenAIRE

    Kenney, Brent A.; Holahan, Charles J.; Holahan, Carole K.; Brennan, Penny L.; Schutte, Kathleen K.; Moos, Rudolf H.

    2009-01-01

    This study modeled the predictive association between depressive symptoms and smoking cessation in a sample of 442 late-middle-aged smokers; assessments occurred at four time-points across a 10-year period. In addition, the study examined the role of baseline drinking problems in moderating the relationship between depressive symptoms and smoking cessation. Findings supported hypotheses. More depressive symptoms prospectively predicted a lower likelihood of smoking cessation. In addition, the...

  10. Validation of the "SmoCess-GP" instrument - a short patient questionnaire for assessing the smoking cessation activities of general practitioners: a cross-sectional study

    Directory of Open Access Journals (Sweden)

    Wolf Jürgen

    2010-02-01

    Full Text Available Abstract Background We developed an instrument assessing the extent of smoking cessation activities by general practitioners (GPs within the Cologne Smoking Study (CoSmoS. The objective of the present study was to examine further psychometric quality of the "SmoCess-GP" instrument (Smoking Cessation by General Practitioners. Methods 127 current smokers who had participated in the Cologne Smoking Study (CoSmoS were included in our analyses. Confirmatory factor analysis (CFA was conducted to examine the model fit and to retest the single-factor structure of the instrument using the Mplus software. Further construct validity was tested with bivariate analysis using an instrument which measures patients' trust in physicians. Results CFA supported the unidimensional structure of the instrument. The factor loadings exceed the threshold of ≥ 0.50. All indicator reliabilities were higher than 0.30. The composite reliability was 0.86 and the average variance extracted (AVE resulted in a value of 0.50. The calculation of global fit indices identified a CFI value of 1.00 and for TLI a value of 1.02. The root mean square error of approximation (RMSEA indicates that 0% of the information is not accounted for by the model. The chi-square value was χ2df = 6 = 4.63 (p = 0.59. Analysis of discriminant validity resulted in a non-significiant correlation of r = 0.092 (p = 0.350. Conclusions Results indicate preliminary evidence for the construct validity of the "SmoCess-GP" instrument which therefore appears to be a promising tool for analyzing the extent of smoking cessation advice offered by GPs from the patients' perspective. Future research should examine the psychometric properties in a population based sample, further improvements of the instrument and should apply other methods of validation.

  11. Health and economic effects from linking bedside and outpatient tobacco cessation services for hospitalized smokers in two large hospitals: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Fellows Jeffrey L

    2012-08-01

    Full Text Available Abstract Background Extended smoking cessation follow-up after hospital discharge significantly increases abstinence. Hospital smoke-free policies create a period of ‘forced abstinence’ for smokers, thus providing an opportunity to integrate tobacco dependence treatment, and to support post-discharge maintenance of hospital-acquired abstinence. This study is funded by the National Heart, Lung, and Blood Institute (1U01HL1053231. Methods/Design The Inpatient Technology-Supported Assisted Referral study is a multi-center, randomized clinical effectiveness trial being conducted at Kaiser Permanente Northwest (KPNW and at Oregon Health & Science University (OHSU hospitals in Portland, Oregon. The study assesses the effectiveness and cost-effectiveness of linking a practical inpatient assisted referral to outpatient cessation services plus interactive voice recognition (AR + IVR follow-up calls, compared to usual care inpatient counseling (UC. In November 2011, we began recruiting 900 hospital patients age ≥18 years who smoked ≥1 cigarettes in the past 30 days, willing to remain abstinent postdischarge, have a working phone, live within 50 miles of the hospital, speak English, and have no health-related barriers to participation. Each site will randomize 450 patients to AR + IVR or UC using a 2:1 assignment strategy. Participants in the AR + IVR arm will receive a brief inpatient cessation consult plus a referral to available outpatient cessation programs and medications, and four IVR follow-up calls over seven weeks postdischarge. Participants do not have to accept the referral. At KPNW, UC participants will receive brief inpatient counseling and encouragement to self-enroll in available outpatient services. The primary outcome is self-reported thirty-day smoking abstinence at six months postrandomization for AR + IVR participants compared to usual care. Additional outcomes include self-reported and biochemically confirmed

  12. Metabolic effects of smoking cessation.

    Science.gov (United States)

    Harris, Kindred K; Zopey, Mohan; Friedman, Theodore C

    2016-05-01

    Smoking continues to be the leading cause of preventable death in the USA, despite the vast and widely publicized knowledge about the negative health effects of tobacco smoking. Data show that smoking cessation is often accompanied by weight gain and an improvement in insulin sensitivity over time. However, paradoxically, post-cessation-related obesity might contribute to insulin resistance. Furthermore, post-cessation weight gain is reportedly the number one reason why smokers, especially women, fail to initiate smoking cessation or relapse after initiating smoking cessation. In this Review, we discuss the metabolic effects of stopping smoking and highlight future considerations for smoking cessation programs and therapies to be designed with an emphasis on reducing post-cessation weight gain.

  13. The intervention composed of aerobic training and non-exercise physical activity (I-CAN) study: Rationale, design and methods.

    Science.gov (United States)

    Swift, Damon L; Dover, Sara E; Nevels, Tyara R; Solar, Chelsey A; Brophy, Patricia M; Hall, Tyler R; Houmard, Joseph A; Lutes, Lesley D

    2015-11-01

    Recent data has suggested that prolonged sedentary behavior is independent risk factor for cardiovascular and all-cause mortality independent of adequate amounts of moderate to vigorous physical activity. However, few studies have prospectively evaluated if exercise training and increasing non-exercise physical activity leads to greater reduction in cardiometabolic risk compared to aerobic training alone. The purpose of the Intervention Composed of Aerobic Training and Non-Exercise Physical Activity (I-CAN) study is to determine whether a physical activity program composed of both aerobic training (consistent with public health recommendations) and increasing non-exercise physical activity (3000 steps above baseline levels) leads to enhanced improvements in waist circumference, oral glucose tolerance, systemic inflammation, body composition, and fitness compared to aerobic training alone in obese adults (N=45). Commercially available accelerometers (Fitbits) will be used to monitor physical activity levels and behavioral coaching will be used to develop strategies of how to increase non-exercise physical activity levels. In this manuscript, we describe the design, rationale, and methodology associated with the I-CAN study.

  14. Combined targeting of EGFR-dependent and VEGF-dependent pathways: rationale, preclinical studies and clinical applications.

    Science.gov (United States)

    Tortora, Giampaolo; Ciardiello, Fortunato; Gasparini, Giampietro

    2008-09-01

    Cellular heterogeneity, redundancy of molecular pathways and effects of the microenvironment contribute to the survival, motility and metastasis of cells in solid tumors. It is unlikely that tumors are entirely dependent on only one abnormally activated signaling pathway; consequently, treatment with an agent that interferes with a single target may be insufficient. Combined blockade of functionally linked and relevant multiple targets has become an attractive therapeutic strategy. The EGFR and ERBB2 (HER2) pathways and VEGF-dependent angiogenesis have a pivotal role in cancer pathogenesis and progression. Robust experimental evidence has shown that these pathways are functionally linked and has demonstrated a suggested role for VEGF in the acquired resistance to anti-ERBB drugs when these receptors are pharmacologically blocked. Combined inhibition of ERBB and VEGF signaling interferes with a molecular feedback loop responsible for acquired resistance to anti-ERBB agents and promotes apoptosis while ablating tumor-induced angiogenesis. To this aim, either two agents highly selective against VEGF and ERBB respectively, or, alternatively, a single multitargeted agent, can be used. Preclinical studies have proven the efficacy of both these approaches and early clinical studies have provided encouraging results. This Review discusses the experimental rationale for, preclinical studies of and clinical trials on combined blockade of ERBB and VEGF signaling.

  15. Effect of an electronic nicotine delivery device (e-Cigarette on smoking reduction and cessation: a prospective 6-month pilot study

    Directory of Open Access Journals (Sweden)

    Papale Gabriella

    2011-10-01

    Full Text Available Abstract Background Cigarette smoking is a tough addiction to break. Therefore, improved approaches to smoking cessation are necessary. The electronic-cigarette (e-Cigarette, a battery-powered electronic nicotine delivery device (ENDD resembling a cigarette, may help smokers to remain abstinent during their quit attempt or to reduce cigarette consumption. Efficacy and safety of these devices in long-term smoking cessation and/or smoking reduction studies have never been investigated. Methods In this prospective proof-of-concept study we monitored possible modifications in smoking habits of 40 regular smokers (unwilling to quit experimenting the 'Categoria' e-Cigarette with a focus on smoking reduction and smoking abstinence. Study participants were invited to attend a total of five study visits: at baseline, week-4, week-8, week-12 and week-24. Product use, number of cigarettes smoked, and exhaled carbon monoxide (eCO levels were measured at each visit. Smoking reduction and abstinence rates were calculated. Adverse events and product preferences were also reviewed. Results Sustained 50% reduction in the number of cig/day at week-24 was shown in 13/40(32.5% participants; their median of 25 cigs/day decreasing to 6 cigs/day (p Conclusion The use of e-Cigarette substantially decreased cigarette consumption without causing significant side effects in smokers not intending to quit (http://ClinicalTrials.gov number NCT01195597.

  16. Awareness of pictorial warning on cigarette packets and its impact on smoking cessation among smokers in Shimla, Himachal Pradesh: A cross-sectional study

    Directory of Open Access Journals (Sweden)

    Vinay Kumar Bhardwaj

    2016-01-01

    Full Text Available Background: Pictorial warnings are effective in promoting smoking cessation as shown by researches in the developed countries. The Government of India has also introduced pictorial warnings as one of the strategies among different tobacco control strategies. Objective: The objective of this study was to find the awareness of pictorial warnings present on cigarette packets and its impact on smoking cessation among cigarette smokers in Shimla, Himachal Pradesh. Materials and Methods: The study was conducted among 200 patients attending the outpatient department in the Department of Oral Medicine and Diagnosis from May 1, 2010 to August 31, 2010. Structured questionnaire consisted of demographic details, health-related issues of smoking, awareness about pictorial warning, and impact to quit smoking. Results: Among the study patients, maximum number of patients who were using any form of tobacco products were 35-44-year-old, and higher consumption was seen among the people from lower socioeconomic status. Younger age group, i.e., ≤25 years, those with higher socioeconomic status, urban residence, and literate were more aware about pictorial warning on cigarette packs and majority of them were about to quit smoking. Conclusion: Pictorial warning is an effective method to improve the awareness among smokers on the deleterious effects of smoking. The present study has shown significant results as the youngsters are less involved in the habit of smoking, aware about pictorial warning on the cigarette pack depicts, and motivated to quit smoking after knowing the harmful effects which the warning on packs reveals.

  17. Effect of preoperative smoking cessation interventions on postoperative complications and smoking cessation

    DEFF Research Database (Denmark)

    Thomsen, T; Tønnesen, H; Møller, A M

    2009-01-01

    BACKGROUND: The aim of this study was to examine the effect of preoperative smoking cessation interventions on postoperative complications and smoking cessation itself. METHODS: Relevant databases were searched for randomized controlled trials (RCTs) of preoperative smoking cessation interventions....... Trial inclusion, risk of bias assessment and data extraction were performed by two authors. Risk ratios for the above outcomes were calculated and pooled effects estimated using the fixed-effect method. RESULTS: Eleven RCTs were included containing 1194 patients. Smoking interventions were intensive......, medium intensity and less intensive. Follow-up for postoperative complications was 30 days. For smoking cessation it was from the day of surgery to 12 months thereafter. Overall, the interventions significantly reduced the occurrence of complications (pooled risk ratio 0.56 (95 per cent confidence...

  18. The Study of the Effects of Diet on Metabolism and Nutrition (STEDMAN) weight loss project: Rationale and design.

    Science.gov (United States)

    Haqq, Andrea M; Lien, Lillian F; Boan, Jarol; Arlotto, Michelle; Slentz, Cris A; Muehlbauer, Michael J; Rochon, James; Gallup, Dianne; McMahon, Ross L; Bain, James R; Stevens, Robert; Millington, David; Butler, Mark D; Newgard, Christopher B; Svetkey, Laura P

    2005-12-01

    This paper outlines the rationale and design of the Study of the Effects of Diet on Metabolism and Nutrition (STEDMAN) weight loss project, in which detailed biologic profiling of three hundred and fifty obese individuals (body mass index (BMI): 30-50 kg/m(2)) will be conducted as they lose weight via seven distinct interventions. These profiles will be compared to those of fifty normal, healthy, control participants (BMI: 18.5-24.9 kg/m(2)). The interventions include the following: Roux-en-Y gastric bypass surgery, dietary interventions of differing macronutrient composition and diverse pharmacologic interventions. Outcome variables include eight conventional metabolites and CRP measured by standard clinical chemistry techniques, twenty hormones of energy balance and fuel homeostasis measured by radioimmunoassay (RIA) or by enzyme-linked Immunosorbent assay (ELISA), ten pro- and anti-inflammatory cytokines measured using Luminex xMAP technology, one hundred and one intermediary metabolites measured by targeted mass-spectrometry-based methods, and physiologic variables such as body composition measured by dual energy X-ray absorptiometry (DEXA), air displacement plethysmography, and abdominal computerized tomography (CT), insulin sensitivity measured by intravenous glucose tolerance test (IV-GTT) and metabolic rate measured by indirect calorimetry. Results from this study will expand our knowledge of the biology of obesity and weight regulation and may lead to targeted strategies for its treatment and control.

  19. Skirting around Critical Feminist Rationales for Teaching Women in Social Studies

    Science.gov (United States)

    Schmeichel, Mardi

    2015-01-01

    Feminist practices can provide firm theoretical grounding for the kind of social studies that scholars promote, especially in relation to efforts to include women in the curriculum. However, in P-12 social studies education, neither women nor feminism receive much attention. The study described in this article was a discourse analysis of 16…

  20. Twins eye study in Tasmania (TEST): rationale and methodology to recruit and examine twins.

    Science.gov (United States)

    Mackey, David A; Mackinnon, Jane R; Brown, Shayne A; Kearns, Lisa S; Ruddle, Jonathan B; Sanfilippo, Paul G; Sun, Cong; Hammond, Christopher J; Young, Terri L; Martin, Nicholas G; Hewitt, Alex W

    2009-10-01

    Visual impairment is a leading cause of morbidity and poor quality of life in our community. Unravelling the mechanisms underpinning important blinding diseases could allow preventative or curative steps to be implemented. Twin siblings provide a unique opportunity in biology to discover genes associated with numerous eye diseases and ocular biometry. Twins are particularly useful for quantitative trait analysis through genome-wide association and linkage studies. Although many studies involving twins rely on twin registries, we present our approach to the Twins Eye Study in Tasmania to provide insight into possible recruitment strategies, expected participation rates and potential examination strategies that can be considered by other researchers for similar studies. Five separate avenues for cohort recruitment were adopted: (1) piggy-backing existing studies where twins had been recruited, (2) utilizing the national twin registry, (3) word-of-mouth and local media publicity, (4) directly approaching schools, and finally (5) collaborating with other research groups studying twins.

  1. Correlates of Cessation Success among Romanian Adults

    Directory of Open Access Journals (Sweden)

    Dorota Kaleta

    2014-01-01

    Full Text Available Background. Tobacco smoking and its consequences are a serious public health problem in Romania. Evidence-based data on factors associated with successful smoking cessation are crucial to optimize tobacco control. The aim of the study was to determine the sociodemographic and other factors associated with smoking cessation success among adults. Materials and Methods. Data was from a sample of 4,517 individuals derived from the Global Adult Tobacco Survey (GATS. GATS is a cross-sectional, nationally representative household survey implemented in Romania in 2011. Data was analyzed with logistic regression. Results. Among females, the quit rate was 26.3% compared with 33.1% in males (P<0.02. We found disparities in cessation success among the analyzed groups of respondents. Being economically active, being aged 40 and above, and having an awareness of smoking health consequences were associated with long-term quitting smoking among men, while initiating smoking at a later age increased the odds of quitting smoking among women. However, cohabitation with nonsmokers was the strongest predictor of successful cessation among both genders. Conclusion. Programs increasing quit rates and encourage cessation among groups less likely to quit, adopting voluntary smoke-free homes, and increasing the awareness of smoking and tobacco pollution risks are needed.

  2. The Alberta Pregnancy Outcomes and Nutrition (APrON) cohort study : rationale and methods

    NARCIS (Netherlands)

    Kaplan, Bonnie J.; Giesbrecht, Gerald F.; Leung, Brenda M. Y.; Field, Catherine J.; Dewey, Deborah; Bell, Rhonda C.; Manca, Donna P.; O'Beirne, Maeve; Johnston, David W.; Pop, Victor J.; Singhal, Nalini; Gagnon, Lisa; Bernier, Francois P.; Eliasziw, Misha; McCargar, Linda J.; Kooistra, Libbe; Farmer, Anna; Cantell, Marja; Goonewardene, Laki; Casey, Linda M.; Letourneau, Nicole; Martin, Jonathan W.

    2014-01-01

    The Alberta Pregnancy Outcomes and Nutrition (APrON) study is an ongoing prospective cohort study that recruits pregnant women early in pregnancy and, as of 2012, is following up their infants to 3 years of age. It has currently enrolled approximately 5000 Canadians (2000 pregnant women, their offsp

  3. The Netherlands Study of Depression and Anxiety (NESDA): rationale, objectives and methods.

    NARCIS (Netherlands)

    Penninx, B.W.J.H.; Beekman, A.T.F.; Smit, J.H.; Zitman, F.G.; Nolen, W.A.; Spinhoven, P.; Cuijpers, P.; Jong, P.J. de; Marwijk, H.W.J. van; Assendelft, W.J.J.; Meer, K. van der; Verhaak, P.; Wensing, M.; Graaf, R. de; Hoogendijk, W.J.; Ormel, J.; Dyck, R. van

    2008-01-01

    The Netherlands Study of Depression and Anxiety (NESDA) is a multi-site naturalistic cohort study to: (1) describe the long-term course and consequences of depressive and anxiety disorders, and (2) to integrate biological and psychosocial research paradigms within an epidemiological approach in orde

  4. The Netherlands Study of Depression and Anxiety (NESDA) : rationale, objectives and methods

    NARCIS (Netherlands)

    Penninx, B.W.J.H.; Beekman, A.T.F.; Smit, J.H.; Zitman, F.G.; Nolen, W.A.; Spinhoven, P.; Cuijpers, P.; de Jong, P.J.; Van Marwijk, H.W.J.; Assendelft, W.J.J.; van der Meer, K.; Verhaak, P.; Wensing, M.; de Graaf, R.; Hoogendijk, W.J.; Ormel, J.; Van Dyck, R.

    2008-01-01

    The Netherlands Study of Depression and Anxiety (NESDA) is a multi-site naturalistic cohort study to: (1) describe the long-term course and consequences of depressive and anxiety disorders, and (2) to integrate biological and psychosocial research paradigms within an epidemiological approach in orde

  5. Rationale and design of the Feeding Dynamic Intervention (FDI) study for self-regulation of energy intake in preschoolers.

    Science.gov (United States)

    Eneli, Ihuoma U; Tylka, Tracy L; Hummel, Jessica; Watowicz, Rosanna P; Perez, Susana A; Kaciroti, Niko; Lumeng, Julie C

    2015-03-01

    In 2011, the Institute of Medicine Early Childhood Prevention Policies Report identified feeding dynamics as an important focus area for childhood obesity prevention and treatment. Feeding dynamics includes two central components: (1) caregiver feeding practices (i.e., determining how, when, where, and what they feed their children) and (2) child eating behaviors (i.e., determining how much and what to eat from what food caregivers have provided). Although there has been great interest in overweight and obesity prevention and treatment in young children, they have not focused comprehensively on feeding dynamics. Interventions on feeding dynamics that reduce caregivers' excessive controlling and restrictive feeding practices and encourage the development of children's self-regulation of energy intake may hold promise for tackling childhood obesity especially in the young child but currently lack an evidence base. This manuscript describes the rationale and design for a randomized controlled trial designed to compare a group of mothers and their 3-to 5-year old children who received an intervention focused primarily on feeding dynamics called the Feeding Dynamic Intervention (FDI) with a Wait-list Control Group (WLC). The primary aim of the study will be to investigate the efficacy of the FDI for decreasing Eating in the Absence of Hunger (EAH) and improving energy compensation (COMPX). The secondary aim will be to examine the effect of the FDI in comparison to the WLC on maternal self-reported feeding practices and child satiety responsiveness.

  6. Children, parents, and pets exercising together (CPET) randomised controlled trial: study rationale, design, and methods

    OpenAIRE

    Yam, P.S.; Morrison, R; Penpraze, V.; Westgarth, C.; D. S. Ward; Mutrie, N; Hutchison, P.; Young, D.; Reilly, J. J.

    2012-01-01

    Abstract Background Objectively measured physical activity is low in British children, and declines as childhood progresses. Observational studies suggest that dog-walking might be a useful approach to physical activity promotion in children and adults, but there are no published public health interventions based on dog-walking with children. The Children, Parents, and Pets Exercising Together Study aims to develop and evaluate a theory driven, generalisable, family-based, dog walking interve...

  7. The Alberta Pregnancy Outcomes and Nutrition (APrON) cohort study: rationale and methods.

    Science.gov (United States)

    Kaplan, Bonnie J; Giesbrecht, Gerald F; Leung, Brenda M Y; Field, Catherine J; Dewey, Deborah; Bell, Rhonda C; Manca, Donna P; O'Beirne, Maeve; Johnston, David W; Pop, Victor J; Singhal, Nalini; Gagnon, Lisa; Bernier, Francois P; Eliasziw, Misha; McCargar, Linda J; Kooistra, Libbe; Farmer, Anna; Cantell, Marja; Goonewardene, Laki; Casey, Linda M; Letourneau, Nicole; Martin, Jonathan W

    2014-01-01

    The Alberta Pregnancy Outcomes and Nutrition (APrON) study is an ongoing prospective cohort study that recruits pregnant women early in pregnancy and, as of 2012, is following up their infants to 3 years of age. It has currently enrolled approximately 5000 Canadians (2000 pregnant women, their offspring and many of their partners). The primary aims of the APrON study were to determine the relationships between maternal nutrient intake and status, before, during and after gestation, and (1) maternal mood; (2) birth and obstetric outcomes; and (3) infant neurodevelopment. We have collected comprehensive maternal nutrition, anthropometric, biological and mental health data at multiple points in the pregnancy and the post-partum period, as well as obstetrical, birth, health and neurodevelopmental outcomes of these pregnancies. The study continues to follow the infants through to 36 months of age. The current report describes the study design and methods, and findings of some pilot work. The APrON study is a significant resource with opportunities for collaboration.

  8. Rationale and Design of the Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis (GRADS) Study. Sarcoidosis Protocol.

    Science.gov (United States)

    Moller, David R; Koth, Laura L; Maier, Lisa A; Morris, Alison; Drake, Wonder; Rossman, Milton; Leader, Joseph K; Collman, Ronald G; Hamzeh, Nabeel; Sweiss, Nadera J; Zhang, Yingze; O'Neal, Scott; Senior, Robert M; Becich, Michael; Hochheiser, Harry S; Kaminski, Naftali; Wisniewski, Stephen R; Gibson, Kevin F

    2015-10-01

    Sarcoidosis is a systemic disease characterized by noncaseating granulomatous inflammation with tremendous clinical heterogeneity and uncertain pathobiology and lacking in clinically useful biomarkers. The Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis (GRADS) study is an observational cohort study designed to explore the role of the lung microbiome and genome in these two diseases. This article describes the design and rationale for the GRADS study sarcoidosis protocol. The study addresses the hypothesis that distinct patterns in the lung microbiome are characteristic of sarcoidosis phenotypes and are reflected in changes in systemic inflammatory responses as measured by peripheral blood changes in gene transcription. The goal is to enroll 400 participants, with a minimum of 35 in each of 9 clinical phenotype subgroups prioritized by their clinical relevance to understanding of the pathobiology and clinical heterogeneity of sarcoidosis. Participants with a confirmed diagnosis of sarcoidosis undergo a baseline visit with self-administered questionnaires, chest computed tomography, pulmonary function tests, and blood and urine testing. A research or clinical bronchoscopy with a research bronchoalveolar lavage will be performed to obtain samples for genomic and microbiome analyses. Comparisons will be made by blood genomic analysis and with clinical phenotypic variables. A 6-month follow-up visit is planned to assess each participant's clinical course. By the use of an integrative approach to the analysis of the microbiome and genome in selected clinical phenotypes, the GRADS study is powerfully positioned to inform and direct studies on the pathobiology of sarcoidosis, identify diagnostic or prognostic biomarkers, and provide novel molecular phenotypes that could lead to improved personalized approaches to therapy for sarcoidosis.

  9. Smoking Cessation Carries a Short-Term Rising Risk for Newly Diagnosed Diabetes Mellitus Independently of Weight Gain: A 6-Year Retrospective Cohort Study

    Directory of Open Access Journals (Sweden)

    Yi-Ting Sung

    2016-01-01

    Full Text Available Background. The effects of smoking on human metabolism are complex. Although smoking increases risk for diabetes mellitus, smoking cessation was also reported to be associated with weight gain and incident diabetes mellitus. We therefore conducted this study to clarify the association between smoking status and newly diagnosed diabetes mellitus. Methods. An analysis was done using the data of a mass health examination performed annually in an industrial park from 2007 to 2013. The association between smoking status and newly diagnosed diabetes mellitus was analyzed with adjustment for weight gain and other potential confounders. Results. Compared with never-smokers, not only current smokers but also ex-smokers in their first two years of abstinence had higher odds ratios (ORs for newly diagnosed diabetes mellitus (never-smokers 3.6%, OR as 1; current smokers 5.5%, OR = 1.499, 95% CI = 1.147–1.960, and p=0.003; ex-smokers in their first year of abstinence 7.5%, OR = 1.829, 95% CI = 0.906–3.694, and p=0.092; and ex-smokers in their second year of abstinence 9.0%, OR = 2.020, 95% CI = 1.031–3.955, and p=0.040. Conclusion. Smoking cessation generally decreased risk for newly diagnosed diabetes mellitus. However, increased odds were seen within the first 2 years of abstinence independently of weight gain.

  10. Rationale and design of INTERSTROKE: a global case-control study of risk factors for stroke

    DEFF Research Database (Denmark)

    O'Donnell, M; Serpault, Damien Xavier; Diener, C;

    2010-01-01

    Stroke is a major global health problem. It is the third leading cause of death and the leading cause of adult disability. INTERHEART, a global case-control study of acute myocardial infarction in 52 countries (29,972 participants), identified nine modifiable risk factors that accounted for >90% ...

  11. European Prospective Investigation into Cancer and Nutrition (EPIC) calibration study: rationale, design and population characteristics

    DEFF Research Database (Denmark)

    Slimani, N.; Kaaks, R.; Ferrari, P.;

    2002-01-01

    The European Prospective Investigation into Cancer and Nutrition (EPIC), which covers a large cohort of half a million men and women from 23 European centres in 10 Western European countries, was designed to study the relationship between diet and the risk of chronic diseases, particularly cancer...

  12. Why Communication Is Important: A Rationale for the Centrality of the Study of Communication.

    Science.gov (United States)

    Morreale, Sherwyn P.; Osborn, Michael M.; Pearson, Judy C.

    2000-01-01

    Presents annotations of articles, commentaries, and publications that emphasize the importance of communication and the role of the study of communication in contemporary life. Discusses six emergent themes. Concludes that communication education develops the whole person, improves the work of education, advances the interests of society, bridges…

  13. Rationale, design and methods of the HEALTHY study physical education intervention component

    Science.gov (United States)

    The HEALTHY primary prevention trial was designed to reduce risk factors for type 2 diabetes in middle school students. Middle schools at seven centers across the United States participated in the 3-year study. Half of them were randomized to receive a multi-component intervention. The intervention ...

  14. The Logic of School Gardens: A Phenomenological Study of Teacher Rationales

    Science.gov (United States)

    Jorgenson, Simon

    2013-01-01

    Despite the importance of teachers to the school garden movement, we still know very little about what drives particular teachers to incorporate a school garden into their pedagogy. In response, this article reports the findings of a study designed to investigate the internal processes and products involved in rationalising and sustaining…

  15. Rationale and protocol for using a smartphone application to study autism spectrum disorders: SMARTAUTISM

    Science.gov (United States)

    Bonnot, Olivier; Bonneau, Dominique; Doudard, Aude; Duverger, Philippe

    2016-01-01

    Introduction Longitudinal studies on the evolution of autism spectrum disorder (ASD) symptoms are limited and have primarily used repeated measurements performed several months apart. However, measurements of changes in everyday life should more closely reflect the ‘real life’ of the patient and his or her family. We propose to study the child's ASD symptoms and their effect on the quality of life, psychological status and anxiety of the child's parents over a 6-month period using SMARTAUTISM, a smartphone application. Method and analysis This is a prospective, longitudinal, exploratory, open study with a 6-month follow-up period. Data will be recorded longitudinally over multiple weeks under natural conditions. The factors affecting the quality of life and anxiety of parents of children with ASD and the children's functional symptoms will be examined, and the feasibility of using a smartphone application designed for parents of ASD patients will be assessed. Primary objective: Explore the evolution of a child's behaviour over 6 months and the (psychological and social) effects of these changes on the family. Secondary objective: Assess the feasibility of our application by examining the filling rate and application usage by parents for 6 months. 100 families containing 1 child diagnosed with ASD will be included. At baseline, sociodemographic, psychiatric and medical data will be recorded. The correlations of the general epidemiological variables (primary outcome measure) will be evaluated via multivariate analysis. The application filling rate (relative to the ideal filling rate) will be used to assess the feasibility of the application (secondary outcome measure). Ethics and dissemination The SMARTAUTISM study has the approval of the local ethics committee, and data security will be ensured via the use of encryption and a secure medical server. The use of this application will be proposed at autism resource centres across France. PMID:27881525

  16. Rationale, design and methods of the HEALTHY study nutrition intervention component.

    Science.gov (United States)

    Gillis, B; Mobley, C; Stadler, D D; Hartstein, J; Virus, A; Volpe, S L; El ghormli, L; Staten, M A; Bridgman, J; McCormick, S

    2009-08-01

    The HEALTHY study was a randomized, controlled, multicenter and middle school-based, multifaceted intervention designed to reduce risk factors for the development of type 2 diabetes. The study randomized 42 middle schools to intervention or control, and followed students from the sixth to the eighth grades. Here we describe the design of the HEALTHY nutrition intervention component that was developed to modify the total school food environment, defined to include the following: federal breakfast, lunch, after school snack and supper programs; a la carte venues, including snack bars and school stores; vending machines; fundraisers; and classroom parties and celebrations. Study staff implemented the intervention using core and toolbox strategies to achieve and maintain the following five intervention goals: (1) lower the average fat content of foods, (2) increase the availability and variety of fruits and vegetables, (3) limit the portion sizes and energy content of dessert and snack foods, (4) eliminate whole and 2% milk and all added sugar beverages, with the exception of low fat or nonfat flavored milk, and limit 100% fruit juice to breakfast in small portions and (5) increase the availability of higher fiber grain-based foods and legumes. Other nutrition intervention component elements were taste tests, cafeteria enhancements, cafeteria line messages and other messages about healthy eating, cafeteria learning laboratory (CLL) activities, twice-yearly training of food service staff, weekly meetings with food service managers, incentives for food service departments, and twice yearly local meetings and three national summits with district food service directors. Strengths of the intervention design were the integration of nutrition with the other HEALTHY intervention components (physical education, behavior change and communications), and the collaboration and rapport between the nutrition intervention study staff members and food service personnel at both school

  17. Better exercise adherence after treatment for cancer (BEAT Cancer) study: Rationale, design, and methods

    OpenAIRE

    Rogers, Laura Q; McAuley, Edward; Anton, Philip M.; Courneya, Kerry S.; Vicari, Sandra; Hopkins-Price, Patricia; Verhulst, Steven; Mocharnuk, Robert; Hoelzer, Karen

    2011-01-01

    Most breast cancer survivors do not engage in regular physical activity. Our physical activity behavior change intervention for breast cancer survivors significantly improved physical activity and health outcomes post-intervention during a pilot, feasibility study. Testing in additional sites with a larger sample and longer follow-up is warranted to confirm program effectiveness short and longer term. Importantly, the pilot intervention resulted in changes in physical activity and social cogn...

  18. Impact of Emerging Health Insurance Arrangements on Diabetes Outcomes and Disparities: Rationale and Study Design

    OpenAIRE

    Wharam, James Franklin; Soumerai, Steve; Trinacty, Connie; Eggleston, Emma; Zhang, Fang; LeCates, Robert F; Canning, Claire; Ross-Degnan, Dennis

    2013-01-01

    Consumer-directed health plans combine lower premiums with high annual deductibles, Internet-based quality-of-care information, and health savings mechanisms. These plans may encourage members to seek better value for health expenditures but may also decrease essential care. The expansion of high-deductible health plans (HDHPs) represents a natural experiment of tremendous proportion. We designed a pre–post, longitudinal, quasi-experimental study to determine the effect of HDHPs on diabetes q...

  19. Learning environments’ activity potential for preschoolers (LEAPP: study rationale and design

    Directory of Open Access Journals (Sweden)

    Patricia Tucker

    2013-09-01

    Full Text Available Background. The purpose of this paper is to provide an overview of the study protocol for the Learning Environments’ Activity Potential for Preschoolers (LEAPP study, the goal of which is to describe the activity levels of preschoolers attending various early learning venues and explore which attributes of these facilities (e.g. curriculum, policies, equipment, etc. support activity participation.Design and Methods. This cross-sectional study aimed to recruit approximately 30 early learning environments requesting participation from preschoolers aged 2.5-5 years. Data collection included: Actical accelerometers (MiniMitter, Oregon, USA to measure the activity levels of children for five consecutive days (15-second epoch length while in care; the Environment and Policy Assessment and Observation tool to explore the early learning environment’s impact on activity; anthropometric data; the Child Temperament Questionnaire to assess the influence of preschoolers’ temperament on physical activity; and demographic information from parents/guardians and early learning staff. ANOVA and linear regression analyses will be conducted to assess variances in activity levels among preschoolers attending different early learning types and to explore the impact of early learning environments on their activity levels. Independent sample t-tests will be used to examine differences in activity levels based on sex and weight status.Expected impact of the study for public health. This research will provide the first Canadian data to address environmental influences on preschoolers’ activity levels in differing early learning environments. Additionally, this work will highlight the extent to which activity levels vary among preschoolers enrolled in full-day kindergarten, centre-, and home-based childcare.

  20. ACCISS study rationale and design: activating collaborative cancer information service support for cervical cancer screening

    Directory of Open Access Journals (Sweden)

    Bullard Emily

    2009-12-01

    Full Text Available Abstract Background High-quality cancer information resources are available but underutilized by the public. Despite greater awareness of the National Cancer Institute's Cancer Information Service among low-income African Americans and Hispanics compared with Caucasians, actual Cancer Information Service usage is lower than expected, paralleling excess cancer-related morbidity and mortality for these subgroups. The proposed research examines how to connect the Cancer Information Service to low-income African-American and Hispanic women and their health care providers. The study will examine whether targeted physician mailing to women scheduled for colposcopy to follow up an abnormal Pap test can increase calls to the Cancer Information Service, enhance appropriate medical follow-up, and improve satisfaction with provider-patient communication. Methods/Design The study will be conducted in two clinics in ethnically diverse low-income communities in Chicago. During the formative phase, patients and providers will provide input regarding materials planned for use in the experimental phase of the study. The experimental phase will use a two-group prospective randomized controlled trial design. African American and Hispanic women with an abnormal Pap test will be randomized to Usual Care (routine colposcopy reminder letter or Intervention (reminder plus provider recommendation to call the Cancer Information Service and sample questions to ask. Primary outcomes will be: 1 calls to the Cancer Information Service; 2 timely medical follow-up, operationalized by whether the patient keeps her colposcopy appointment within six months of the abnormal Pap; and 3 patient satisfaction with provider-patient communication at follow-up. Discussion The study examines the effectiveness of a feasible, sustainable, and culturally sensitive strategy to increase awareness and use of the Cancer Information Service among an underserved population. The goal of linking a

  1. Perspectives on Smoking Cessation in Northern Appalachia.

    Science.gov (United States)

    Rodriguez, Elisa M; Twarozek, Annamaria Masucci; Erwin, Deborah O; Widman, Christy; Saad-Harfouche, Frances G; Fox, Chester H; Underwood, Willie; Mahoney, Martin C

    2016-04-01

    This study applies qualitative research methods to explore perspectives on cessation among smokers/former smokers recruited from an area of Northern Appalachia. Six focus groups, stratified by age group (18-39 years old and 40 years and older), were conducted among participants (n = 54) recruited from community settings. Participants described varied interest in and challenges with quitting smoking. Smokers 40 years and older more readily endorsed the health risks of smoking and had greater interest in quitting assistance. Participants expressed frustration with the US government for allowing a harmful product (e.g., cigarettes) to be promoted with minimal regulation. Use of social media was robust among both age groups; participants expressed limited interest in various social media/technology platforms for promoting smoking cessation. Findings from this understudied area of northern Appalachia reflect the heterogeneity of this region and contribute novel information about the beliefs, attitudes, and experiences of current and formers smokers with regard to cessation.

  2. The Cooperative Health Research in South Tyrol (CHRIS) study: rationale, objectives, and preliminary results.

    Science.gov (United States)

    Pattaro, Cristian; Gögele, Martin; Mascalzoni, Deborah; Melotti, Roberto; Schwienbacher, Christine; De Grandi, Alessandro; Foco, Luisa; D'Elia, Yuri; Linder, Barbara; Fuchsberger, Christian; Minelli, Cosetta; Egger, Clemens; Kofink, Lisa S; Zanigni, Stefano; Schäfer, Torsten; Facheris, Maurizio F; Smárason, Sigurður V; Rossini, Alessandra; Hicks, Andrew A; Weiss, Helmuth; Pramstaller, Peter P

    2015-11-05

    The Cooperative Health Research In South Tyrol (CHRIS) study is a population-based study with a longitudinal lookout to investigate the genetic and molecular basis of age-related common chronic conditions and their interaction with life style and environment in the general population. All adults of the middle and upper Vinschgau/Val Venosta are invited, while 10,000 participants are anticipated by mid-2017. Family participation is encouraged for complete pedigree reconstruction and disease inheritance mapping. After a pilot study on the compliance with a paperless assessment mode, computer-assisted interviews have been implemented to screen for conditions of the cardiovascular, endocrine, metabolic, genitourinary, nervous, behavioral, and cognitive system. Fat intake, cardiac health, and tremor are assessed instrumentally. Nutrient intake, physical activity, and life-course smoking are measured semi-quantitatively. Participants are phenotyped for 73 blood and urine parameters and 60 aliquots per participant are biobanked (cryo-preserved urine, DNA, and whole and fractionated blood). Through liquid-chromatography mass-spectrometry analysis, metabolite profiling of the mitochondrial function is assessed. Samples are genotyped on 1 million variants with the Illumina HumanOmniExpressExome array and the first data release including 4570 fully phenotyped and genotyped samples is now available for analysis. Participants' follow-up is foreseen 6 years after the first visit. The target population is characterized by long-term social stability and homogeneous environment which should both favor the identification of enriched genetic variants. The CHRIS cohort is a valuable resource to assess the contribution of genomics, metabolomics, and environmental factors to human health and disease. It is awaited that this will result in the identification of novel molecular targets for disease prevention and treatment.

  3. Children, parents, and pets exercising together (CPET randomised controlled trial: study rationale, design, and methods

    Directory of Open Access Journals (Sweden)

    Yam Philippa S

    2012-03-01

    Full Text Available Abstract Background Objectively measured physical activity is low in British children, and declines as childhood progresses. Observational studies suggest that dog-walking might be a useful approach to physical activity promotion in children and adults, but there are no published public health interventions based on dog-walking with children. The Children, Parents, and Pets Exercising Together Study aims to develop and evaluate a theory driven, generalisable, family-based, dog walking intervention for 9-11 year olds. Methods/design The Children, Parents, and Pets Exercising Together Study is an exploratory, assessor-blinded, randomised controlled trial as defined in the UK MRC Framework on the development and evaluation of complex interventions in public health. The trial will follow CONSORT guidance. Approximately 40 dog-owning families will be allocated randomly in a ratio of 1.5:1 to receive a simple behavioural intervention lasting for 10 weeks or to a 'waiting list' control group. The primary outcome is change in objectively measured child physical activity using Actigraph accelerometry. Secondary outcomes in the child, included in part to shape a future more definitive randomised controlled trial, are: total time spent sedentary and patterning of sedentary behaviour (Actigraph accelerometry; body composition and bone health from dual energy x-ray absorptiometry; body weight, height and BMI; and finally, health-related quality of life using the PedsQL. Secondary outcomes in parents and dogs are: changes in body weight; changes in Actigraph accelerometry measured physical activity and sedentary behaviour. Process evaluation will consist of assessment of simultaneous child, parent, and dog accelerometry data and brief interviews with participating families. Discussion The Children, Parents, and Pets Exercising Together trial should be the first randomised controlled study to establish and evaluate an intervention aimed at dog-based physical

  4. Rationale and design of INTERSTROKE: a global case-control study of risk factors for stroke

    DEFF Research Database (Denmark)

    O'Donnell, M; Serpault, Damien Xavier; Diener, C;

    2010-01-01

    Stroke is a major global health problem. It is the third leading cause of death and the leading cause of adult disability. INTERHEART, a global case-control study of acute myocardial infarction in 52 countries (29,972 participants), identified nine modifiable risk factors that accounted for >90...... with a first stroke within 72 h of hospital presentation in whom CT or MRI is performed. Proxy respondents are used for cases unable to communicate. Etiological and topographical stroke subtype is documented for all cases. Controls are hospital- and community-based, matched for gender, ethnicity and age (+/-5...

  5. The health outcomes and physical activity in preschoolers (HOPP study: rationale and design

    Directory of Open Access Journals (Sweden)

    Timmons Brian W

    2012-04-01

    Full Text Available Abstract Background The early years are the period of growth for which we know the least about the impact of physical activity. In contrast, we know that more than 90 % of school-aged Canadian children, for example, are not meeting physical activity recommendations. Such an activity crisis is a major contributor to recent trends in childhood obesity, to which preschoolers are not immune. The World Health Organization estimated that more than 42 million children under the age of 5 years were overweight world-wide in 2010. If an activity crisis exists during the preschool years, we should also be concerned about its broader impact on health. Unfortunately, the relationship between physical activity and health during the early years is poorly understood. The goal of the Health Outcomes and Physical activity in Preschoolers (HOPP study is to describe how the prevalence and patterns of physical activity in preschoolers are associated with indices of health. Methods The HOPP study is a prospective cohort study. We aim to recruit 400 3- to 5-year-old children (equal number of boys and girls and test them once per year for 3 years. Each annual assessment involves 2 laboratory visits and 7 consecutive days of physical activity monitoring with protocols developed in our pilot work. At visit 1, we assess body composition, aerobic fitness, short-term muscle power, motor skills, and have the parents complete a series of questionnaires related to their child’s physical activity, health-related quality of life and general behaviour. Over 7 consecutive days each child wears an accelerometer on his/her waist to objectively monitor physical activity. The accelerometer is programmed to record movement every 3 s, which is needed to accurately capture the intensity of physical activity. At visit 2, we assess vascular structure and function using ultrasound. To assess the associations between physical activity and health outcomes, our primary analysis will involve

  6. Impact of emerging health insurance arrangements on diabetes outcomes and disparities: rationale and study design.

    Science.gov (United States)

    Wharam, J Frank; Soumerai, Steve; Trinacty, Connie; Eggleston, Emma; Zhang, Fang; LeCates, Robert; Canning, Claire; Ross-Degnan, Dennis

    2013-01-01

    Consumer-directed health plans combine lower premiums with high annual deductibles, Internet-based quality-of-care information, and health savings mechanisms. These plans may encourage members to seek better value for health expenditures but may also decrease essential care. The expansion of high-deductible health plans (HDHPs) represents a natural experiment of tremendous proportion. We designed a pre-post, longitudinal, quasi-experimental study to determine the effect of HDHPs on diabetes quality of care, outcomes, and disparities. We will use a 13-year rolling sample (2001-2013) of members of an HDHP and members of a control group. To reduce selection bias, we will limit participants to those whose employers mandate a single health insurance type. The study will measure rates of monthly hemoglobin A1c, lipid, and albuminuria testing; availability of blood glucose test strips; and rates of retinal examinations, high-severity emergency department visits, and preventable hospitalizations. Results could be used to design health plan features that promote high-quality care and better outcomes among people who have diabetes.

  7. Hypertrophic Cardiomyopathy Registry: The rationale and design of an international, observational study of hypertrophic cardiomyopathy.

    Science.gov (United States)

    Kramer, Christopher M; Appelbaum, Evan; Desai, Milind Y; Desvigne-Nickens, Patrice; DiMarco, John P; Friedrich, Matthias G; Geller, Nancy; Heckler, Sarahfaye; Ho, Carolyn Y; Jerosch-Herold, Michael; Ivey, Elizabeth A; Keleti, Julianna; Kim, Dong-Yun; Kolm, Paul; Kwong, Raymond Y; Maron, Martin S; Schulz-Menger, Jeanette; Piechnik, Stefan; Watkins, Hugh; Weintraub, William S; Wu, Pan; Neubauer, Stefan

    2015-08-01

    Hypertrophic cardiomyopathy (HCM) is the most common monogenic heart disease with a frequency as high as 1 in 200. In many cases, HCM is caused by mutations in genes encoding the different components of the sarcomere apparatus. Hypertrophic cardiomyopathy is characterized by unexplained left ventricular hypertrophy, myofibrillar disarray, and myocardial fibrosis. The phenotypic expression is quite variable. Although most patients with HCM are asymptomatic, serious consequences are experienced in a subset of affected individuals who present initially with sudden cardiac death or progress to refractory heart failure. The Hypertrophic Cardiomyopathy Registry study is a National Heart, Lung, and Blood Institute-sponsored 2,750-patient, 44-site, international registry and natural history study designed to address limitations in extant evidence to improve prognostication in HCM (NCT01915615). In addition to the collection of standard demographic, clinical, and echocardiographic variables, patients will undergo state-of-the-art cardiac magnetic resonance for assessment of left ventricular mass and volumes as well as replacement scarring and interstitial fibrosis. In addition, genetic and biomarker analyses will be performed. The Hypertrophic Cardiomyopathy Registry has the potential to change the paradigm of risk stratification in HCM, using novel markers to identify those at higher risk.

  8. Design, rationale, and baseline demographics of SEARCH I: a prospective cluster-randomized study

    Directory of Open Access Journals (Sweden)

    Albers F

    2012-07-01

    Full Text Available Frank Albers,1 Asif Shaikh,2 Ahmar Iqbal,31Medical Affairs Respiratory, 2Clinical Development and Medical Affairs, Field Based Medicine-Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA; 3Respiratory Medical Affairs, Pfizer Inc, New York, NY, USAAbstract: Questionnaires are available to identify patients at risk for several chronic diseases, including COPD, but are infrequently utilized in primary care. COPD is often underdiagnosed, while at the same time the US Preventive Services Task Force recommends against spirometric screening for COPD in asymptomatic adults. Use of a symptom-based questionnaire and subsequent handheld spirometric device depending on the answers to the questionnaire is a promising approach to identify patients at risk for COPD. Screening, Evaluating and Assessing Rate CHanges of diagnosing respiratory conditions in primary care 1 (SEARCH I was a prospective cluster-randomized study in 168 US primary care practices evaluating the effect of the COPD-Population Screener (COPD-PS™ questionnaire. The effect of this questionnaire alone or sequentially with the handheld copd-6TM device was evaluated on new diagnoses of COPD and on respiratory diagnostic practice patterns (including referrals for pulmonary function testing, referrals to pulmonologists, new diagnoses of COPD, and new respiratory medication prescriptions. Participating practices entered a total of 9704 consecutive consenting subjects aged ≥ 40 years attending primary care clinics. Study arm results were compared for new COPD diagnosis rates between usual care and (1 COPD-PS plus copd-6 and (2 COPD-PS alone. A cluster-randomization design allowed comparison of the intervention effects at the practice level instead of individuals being the subjects of the intervention. Regional principal investigators controlled the flow of study information to sub-investigators at participating practices to reduce observation bias (Hawthorne effect. The

  9. Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE): rationale and study design

    DEFF Research Database (Denmark)

    Parving, Hans-Henrik; Brenner, Barry M; McMurray, John J V;

    2009-01-01

    , resuscitated death, myocardial infarction, stroke, unplanned hospitalization for heart failure, onset of end-stage renal disease or doubling of baseline serum creatinine concentration. Secondary endpoints include a composite CV endpoint and a composite renal endpoint. CONCLUSION: ALTITUDE will determine...... the residual renal and cardiovascular risk still remains high. Aliskiren a novel oral direct renin inhibitor that unlike ACEi and ARBs, lowers plasma renin activity, angiotensin I and angiotensin II levels, may thereby provide greater benefit compared to ACEi or ARB alone. METHODS: The primary objective...... of the ALTITUDE trial is to determine whether aliskiren 300 mg once daily, reduces cardiovascular and renal morbidity and mortality compared with placebo when added to conventional treatment (including ACEi or ARB). ALTITUDE is an international, randomized, double-blind, placebo-controlled, parallel-group study...

  10. Relationship between volition, physical activity and weight loss maintenance: Study rationale, design, methods and baseline characteristics

    DEFF Research Database (Denmark)

    Jørgensen, Sune Dandanell; Elbe, Anne-Marie; Pfister, Gertrud Ursula

    2017-01-01

    ) for an interdisciplinary prospective study with follow-up. The change in lifestyle and weight loss is promoted via a 3-month intensive lifestyle intervention at a private health school. The intervention consists of supervised training (1–3 hours/day), a healthy hypo-caloric diet (−500 to −700 kCal/day) and education...... in healthy lifestyle in classes/groups. The participants’ body weight and composition (Dual Energy X-ray absorptiometry), volitional skills (questionnaire), physical activity level (heart rate accelerometer / questionnaire) and maximal oxygen uptake (indirect calorimetry) are to be monitored before, after...... maintenance. Conclusions: If specific volitional skills are identified as predictors of adherence to physical activity and success in clinical weight loss maintenance, these can be trained in future intensive lifestyle interventions in order to optimize the success rate....

  11. A family smoking index to capture genetic influence in smoking: rationale and two validation studies.

    Science.gov (United States)

    Drobes, David J; Munafò, Marcus R; Leigh, Fiona; Saladin, Michael E

    2005-02-01

    Despite a growing appreciation that genetic factors may impart vulnerability toward smoking behavior, only a modest consensus has been created about the specific genetic mechanisms that may underlie various aspects of smoking. A core feature of genetic contribution toward any complex human behavior is familial resemblance. Most previous attempts to index familial smoking have classified individuals into discrete categories, based on the number of smokers in a family. We discuss the development of a continuous measure of familial smoking, the Family Smoking Index (FSI), which is based on the proportion of smokers in first- and second-degree family members and provides a more precise weighting according to genetic proximity. We present the psychometric characteristics of the FSI as well as initial validation data from two studies. We also describe current and future directions for continued FSI validation and application.

  12. Promoting smoking cessation among parents: Effects on smoking-related cognitions and smoking initiation in children

    NARCIS (Netherlands)

    Schuck, K.; Otten, R.; Kleinjan, M.; Bricker, J.B.; Engels, R.C.M.E.

    2015-01-01

    Background Parental smoking is associated with an increased risk of smoking among youth. Epidemiological research has shown that parental smoking cessation can attenuate this risk. This study examined whether telephone counselling for parents and subsequent parental smoking cessation affect smoking-

  13. Effects of Asthma on Nicotine Dependence Development and Smoking Cessation Attempts in Adolescence

    NARCIS (Netherlands)

    Ven, M.O.M. van de; Zundert, R.M.P. van; Engels, R.C.M.E.

    2013-01-01

    Objective. The aim of this study was to investigate whether asthma predicts the development of nicotine dependence and unsuccessful smoking cessation attempts in adolescent smokers. In addition, whether nicotine dependence could explain the relation between asthma and unsuccessful cessation attempts

  14. Successful Smoking Cessation in COPD : Association with Comorbidities and Mortality

    NARCIS (Netherlands)

    Kupiainen, H; Kinnula, V L; Lindqvist, A; Postma, D S; Boezen, H M; Laitinen, T; Kilpeläinen, M

    2012-01-01

    Smoking cessation is the cornerstone of COPD management, but difficult to achieve in clinical practice. The effect of comorbidities on smoking cessation and risk factors for mortality were studied in a cohort of 739 COPD patients recruited in two Finnish University Hospitals. The diagnosis of COPD w

  15. Neuroimaging studies of factors related to exercise: rationale and design of a 9 month trial.

    Science.gov (United States)

    Herrmann, Stephen D; Martin, Laura E; Breslin, Florence J; Honas, Jeffery J; Willis, Erik A; Lepping, Rebecca J; Gibson, Cheryl A; Befort, Christie A; Lambourne, Kate; Burns, Jeffrey M; Smith, Bryan K; Sullivan, Debra K; Washburn, Richard A; Yeh, Hung-Wen; Donnelly, Joseph E; Savage, Cary R

    2014-01-01

    The prevalence of obesity is high resulting from chronic imbalances between energy intake and expenditure. On the expenditure side, regular exercise is associated with health benefits, including enhanced brain function. The benefits of exercise are not immediate and require persistence to be realized. Brain regions associated with health-related decisions, such as whether or not to exercise or controlling the impulse to engage in immediately rewarding activities (e.g., sedentary behavior), include reward processing and cognitive control regions. A 9 month aerobic exercise study will be conducted in 180 sedentary adults (n = 90 healthy weight [BMI = 18.5 to 26.0 kg/m(2)]; n = 90 obese [BMI = 29.0 to 41.0 kg/m(2)) to examine the brain processes underlying reward processing and impulse control that may affect adherence in a new exercise regimen. The primary aim is to use functional magnetic resonance imaging (fMRI) to examine reward processing and impulse control among participants that adhere (exercise >80% of sessions) and those that do not adhere to a nine-month exercise intervention with secondary analyses comparing sedentary obese and sedentary healthy weight participants. Our results will provide valuable information characterizing brain activation underlying reward processing and impulse control in sedentary obese and healthy weight individuals. In addition, our results may identify brain activation predictors of adherence and success in the exercise program along with measuring the effects of exercise and improved fitness on brain activation.

  16. The Congenital Heart Disease Genetic Network Study: rationale, design, and early results.

    Science.gov (United States)

    Gelb, Bruce; Brueckner, Martina; Chung, Wendy; Goldmuntz, Elizabeth; Kaltman, Jonathan; Kaski, Juan Pablo; Kim, Richard; Kline, Jennie; Mercer-Rosa, Laura; Porter, George; Roberts, Amy; Rosenberg, Ellen; Seiden, Howard; Seidman, Christine; Sleeper, Lynn; Tennstedt, Sharon; Kaltman, Jonathan; Schramm, Charlene; Burns, Kristin; Pearson, Gail; Rosenberg, Ellen

    2013-02-15

    Congenital heart defects (CHD) are the leading cause of infant mortality among birth defects, and later morbidities and premature mortality remain problematic. Although genetic factors contribute significantly to cause CHD, specific genetic lesions are unknown for most patients. The National Heart, Lung, and Blood Institute-funded Pediatric Cardiac Genomics Consortium established the Congenital Heart Disease Genetic Network Study to investigate relationships between genetic factors, clinical features, and outcomes in CHD. The Pediatric Cardiac Genomics Consortium comprises 6 main and 4 satellite sites at which subjects are recruited, and medical data and biospecimens (blood, saliva, cardiovascular tissue) are collected. Core infrastructure includes an administrative/data-coordinating center, biorepository, data hub, and core laboratories (genotyping, whole-exome sequencing, candidate gene evaluation, and variant confirmation). Eligibility includes all forms of CHD. Annual follow-up is obtained for probands age is 5.5 years. The one third enrolled at age <1 year are contacted annually for follow-up information. The distribution of CHD favors more complex lesions. Approximately, 11% of probands have a genetic diagnosis. Adequate DNA is available from 97% and 91% of blood and saliva samples, respectively. Genomic analyses of probands with heterotaxy, atrial septal defects, conotruncal, and left ventricular outflow tract obstructive lesions are underway. The scientific community's use of Pediatric Cardiac Genomics Consortium resources is welcome.

  17. Rationale and design of the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) trial.

    Science.gov (United States)

    Holman, Rury R; Bethel, Mary Angelyn; George, Jyothis; Sourij, Harald; Doran, Zoë; Keenan, Joanne; Khurmi, Nardev S; Mentz, Robert J; Oulhaj, Abderrahim; Buse, John B; Chan, Juliana C; Iqbal, Nayyar; Kundu, Sudeep; Maggioni, Aldo P; Marso, Steven P; Öhman, Peter; Pencina, Michael J; Poulter, Neil; Porter, Lisa E; Ramachandran, Ambady; Zinman, Bernard; Hernandez, Adrian F

    2016-04-01

    Exenatide once-weekly is an extended release formulation of exenatide, a glucagon-like peptide-1 receptor agonist, which can improve glycemic control, body weight, blood pressure, and lipid levels in patients with type 2 diabetes mellitus (T2DM). The EXenatide Study of Cardiovascular Event Lowering (EXSCEL) will compare the impact of adding exenatide once-weekly to usual care with usual care alone on major cardiovascular outcomes. EXSCEL is an academically led, phase III/IV, double-blind, pragmatic placebo-controlled, global trial conducted in 35 countries aiming to enrol 14,000 patients with T2DM and a broad range of cardiovascular risk over approximately 5 years. Participants will be randomized (1:1) to receive exenatide once-weekly 2 mg or matching placebo by subcutaneous injections. The trial will continue until 1,360 confirmed primary composite cardiovascular end points, defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, have occurred. The primary efficacy hypothesis is that exenatide once-weekly is superior to usual care with respect to the primary composite cardiovascular end point. EXSCEL is powered to detect a 15% relative risk reduction in the exenatide once-weekly group, with 85% power and a 2-sided 5% alpha. The primary safety hypothesis is that exenatide once-weekly is noninferior to usual care with respect to the primary cardiovascular composite end point. Noninferiority will be concluded if the upper limit of the CI is <1.30. EXSCEL will assess whether exenatide once-weekly can reduce cardiovascular events in patients with T2DM with a broad range of cardiovascular risk. It will also provide long-term safety information on exenatide once-weekly in people with T2DM. ClinicalTrials.gov Identifier: NCT01144338.

  18. PROspective Multicenter Imaging Study for Evaluation of Chest Pain: Rationale and Design of the PROMISE Trial

    Science.gov (United States)

    Douglas, Pamela S.; Hoffmann, Udo; Lee, Kerry L.; Mark, Daniel B.; Al-Khalidi, Hussein R.; Anstrom, Kevin; Dolor, Rowena J.; Kosinski, Andrzej; Krucoff, Mitchell W.; Mudrick, Daniel W.; Patel, Manesh R.; Picard, Michael H.; Udelson, James E.; Velazquez, Eric J.; Cooper, Lawton

    2014-01-01

    Background Suspected coronary artery disease (CAD) is one of the most common, potentially life threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients. Methods The PROMISE study is a prospective, randomized trial comparing the effectiveness of two initial diagnostic strategies in patients with symptoms suspicious for CAD. Patients are randomized to either: 1) functional testing (exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram); or 2) anatomic testing with >=64 slice multidetector coronary computed tomographic angiography. Tests are interpreted locally in real time by subspecialty certified physicians and all subsequent care decisions are made by the clinical care team. Sites are provided results of central core lab quality and completeness assessment. All subjects are followed for ≥1 year. The primary end-point is the time to occurrence of the composite of death, myocardial infarction, major procedural complications (stroke, major bleeding, anaphylaxis and renal failure) or hospitalization for unstable angina. Results Over 10,000 symptomatic subjects were randomized in 3.2 years at 193 US and Canadian cardiology, radiology, primary care, urgent care and anesthesiology sites. Conclusion Multi-specialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient. PROMISE will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomic testing in symptomatic patients with suspected CAD. Quality of life, resource use, cost effectiveness and radiation exposure will be assessed. Clinical trials.gov identifier NCT01174550 PMID:24890527

  19. Danish pain specialists' rationales behind the choice of fentanyl transdermal patches and oral transmucosal systems-A Delphi study

    DEFF Research Database (Denmark)

    Jacobsen, Ramune; Møldrup, Claus; Christrup, Lona

    2009-01-01

    survey. Response rates were 45% in the brainstorming and 88% in the rating phases, respectively. Statistical analysis with SPSS for Windows 15.00 included descriptive statistics and factor analysis. Results. The most important rationale to choose fentanyl patches was that patients' clinical condition did...

  20. Study design, objectives, hypotheses, main findings, health consequences for the population exposed, rationale of future research

    Energy Technology Data Exchange (ETDEWEB)

    Trnovec, T.; Kocan, A. [Slovak Medical Univ., Bratislava (Slovakia); Bencko, V. [Charles Univ., Prague (Czech Republic); Langer, P. [Institute of Experimental Endocrinology SAS, Bratislava (Slovakia); Berg, M. van den [Rijksuniversiteit Utrecht (Netherlands); Bergman, A. [Stockholm Univ. (Sweden); Hustak, M. [Air Force Military Hospital, Kosics (Slovakia)

    2004-09-15

    In Slovakia, the Chemko Chemical Company, based in Strazske, in the Michalovce district, produced PCBs between 1959 and 1984, in the amount of more than 21,000 tons of commercial mixtures (Delor 103, 104, 105, 106, Delotherm DK and DH, Hydelor 137). PCBs were used for similar industrial purposes as in the west. Improper disposal from the Chemko plant via release of effluent directly into the Laborec River resulted in long-term contamination of sediment. As a result eastern Slovakia, the Michalovce district in particular, is recognized as one of the areas all over the world most heavily polluted with PCBs. Historical studies show that blood and adipose PCB levels were higher in Czechoslovakia than elsewhere in the 1970's and 1980's. Current data indicate that persons who eat locally raised food - pork, beef, poultry, eggs - in this district have elevated serum concentrations of PCBs. Environmental exposure to organochlorines in the Michalovce district indicate association with higher rates of certain cancers, but an inverse association with risk of breast cancer. An increased prevalence of thyroid disorders in the polluted area was also reported. This ''experimental setting in nature'' has attracted international scientific teams and two projects in the area are ongoing: Evaluating Human Health Risk from Low-dose and Long-term PCB Exposure, 5{sup th} FP Project QLK4-2000-00488, 2001- 2004; PCBRISK (http://www.pcbrisk.sk/) and Early Childhood Development and PCB Exposures in Slovakia, NCI/NIH, R01-CA96525 University of California, Davis, USA. This paper is serving as an introduction to papers of a session reporting on various health outcomes associated with PCB exposure. The objectives of the PCBRISK project were targeted at an evaluation of the human health risks of low-dose and long-term exposure to a group of persistent organochlorine pollutants, including polychlorinated biphenyls (PCBs) and their metabolites, organochlorine

  1. Multimodal intervention raises smoking cessation rate during pregnancy

    DEFF Research Database (Denmark)

    Hegaard, Hanne K; Kjaergaard, Hanne; Møller, Lars F;

    2003-01-01

    .003). The adjusted odds ratio (OR) for smoking cessation was 4.20 (95% CI 2.13-8.03). Logistic regression analysis showed a significant positive association of smoking cessation with low caffeine consumption in pregnancy, many years in school, no exposure to passive smoking outside the home, and previous attempts......BACKGROUND: The aim was to study the effect of a multimodal smoking cessation intervention regimen on a number of pregnant smokers. METHODS: A prospective intervention study was designed where participants were allocated to intervention or control based on their birth date. The study included 647...... pregnant smokers. The intervention group (n = 327) received initial individual smoking cessation counseling supplemented by an invitation to join, individually or in a group, a smoking cessation program with nicotine replacement therapy as a voluntary option. Intervention was designed as an integral part...

  2. A case for consideration of cultural diversity in heart failure management--Part 1: Rationale for the DISCOVER Study.

    Science.gov (United States)

    Davidson, Patricia M; Macdonald, Peter; Ang, Esther; Paull, Glenn; Choucair, Sam; Daly, John; Moser, Debra K; Dracup, Kathleen

    2004-10-01

    Heart failure is a condition increasing in prevalence and responsible for high health care utilization, morbidity and mortality. Randomised controlled trials of nurse-coordinated interventions have determined self-care and the incorporation of the patient and their family in care planning as critical elements of service delivery. Coping with a chronic illness, such as heart failure, forces the individual to adjust to changed physical, social and emotional functioning and to modify their lifestyle accordingly. Clinicians increasingly use models of care that focus care delivery on the community setting. In order to develop strategies to assist patients and their families with self-care it is important that clinicians understand the health-care seeking behaviours of all individuals targeted in the community. Australia is a culturally diverse nation, yet evaluations of models of care have been undertaken largely in individuals from predominately Anglo-Celtic origins. The end result of this approach is failure to understand the full range of diverse perspectives that individuals hold that can have an impact on self-care behaviours. Consideration of cultural diversity should extend beyond language to a broader appreciation of cultural values, health seeking beliefs and engagement of culturally unique communities. The 'Understanding the cultural experiences of individuals with chronic heart failure (CHF) in South East Health (DISCOVER) Study' seeks to uncover information on the health patterns, information needs and the adjustment process for overseas-born individuals with heart failure. Such information will assist clinicians to tailor health care service delivery and ensure the delivery of appropriate, quality care. This manuscript provides the background, rationale and methods for this study.

  3. The impact of a minimal smoking cessation intervention for pregnant women and their partners on perinatal smoking behaviour in primary health care: A real-life controlled study

    Directory of Open Access Journals (Sweden)

    Jenssen Jon A

    2008-09-01

    Full Text Available Abstract Background There is a demand for strategies to promote smoking cessation in high-risk populations like smoking pregnant women and their partners. The objectives of this study were to investigate parental smoking behaviour during pregnancy after introduction of a prenatal, structured, multi-disciplinary smoking cessation programme in primary care, and to compare smoking behaviour among pregnant women in the city of Trondheim with Bergen and Norway. Methods Sequential birth cohorts were established to evaluate the intervention programme from September 2000 to December 2004 in primary care as a part of the Prevention of Allergy among Children in Trondheim study (PACT. The primary outcome variables were self reported smoking behaviour at inclusion and six weeks postnatal. Data from the Medical Birth Registry of Norway (MBR were used to describe smoking cessation during pregnancy in Trondheim, Bergen and Norway 1999–2004. Results Maternal smoking prevalence at inclusion during pregnancy were 5% (CI 95% 4–6 in the intervention cohort compared to 7% (CI 95% 6–9, p = 0.03, in the control cohort. Of the pre-pregnancy maternal smokers 25% (CI 95% 20–31 and 32% (CI 95% 26–38, p = 0.17, were still smoking at inclusion in the intervention and control cohorts, respectively. Six weeks postnatal 72% (CI 95% 59–83 and 68% (CI 95% 57–77, p = 0.34 of the maternal smokers at inclusion still smoked. No significant difference in paternal smoking between the cohorts was found after the intervention period. Data from the MBR showed a significantly higher proportion of women who stopped smoking during pregnancy in Trondheim than in Bergen in 2003 and 2004, p = 0.03 and Conclusion No impact on parental smoking behaviour between the cohorts was observed after the smoking intervention programme. Of the women who stopped smoking during pregnancy most of them stopped smoking before the intervention. However, we observed a significantly higher quitting

  4. Study protocol for a pragmatic randomised controlled trial evaluating efficacy of a smoking cessation e-‘Tabac Info Service’: ee-TIS trial

    Science.gov (United States)

    Cambon, L; Bergman, P; Le Faou, Al; Vincent, I; Le Maitre, B; Pasquereau, A; Arwidson, P; Thomas, D; Alla, F

    2017-01-01

    Introduction A French national smoking cessation service, Tabac Info Service, has been developed to provide an adapted quitline and a web and mobile application involving personalised contacts (eg, questionnaires, advice, activities, messages) to support smoking cessation. This paper presents the study protocol of the evaluation of the application (e-intervention Tabac Info Service (e-TIS)). The primary objective is to assess the efficacy of e-TIS. The secondary objectives are to (1) describe efficacy variations with regard to users' characteristics, (2) analyse mechanisms and contextual conditions of e-TIS efficacy. Methods and analyses The study design is a two-arm pragmatic randomised controlled trial including a process evaluation with at least 3000 participants randomised to the intervention or to the control arm (current practices). Inclusion criteria are: aged 18 years or over, current smoker, having completed the online consent forms, possessing a mobile phone with android or apple systems and using mobile applications, wanting to stop smoking sooner or later. The primary outcome is the point prevalence abstinence of 7 days at 6 months later. Data will be analysed in intention to treat (primary) and per protocol analyses. A logistic regression will be carried out to estimate an OR (95% CI) for efficacy. A multivariate multilevel analysis will explore the influence on results of patients' characteristics (sex, age, education and socioprofessional levels, dependency, motivation, quit experiences) and contextual factors, conditions of use, behaviour change techniques. Ethics and dissemination The study protocol was reviewed by the ethical and deontological institutional review board of the French Institute for Public Health Surveillance on 18 April 2016. The findings of this study will allow us to characterise the efficacy of e-TIS and conditions of its efficacy. These findings will be disseminated through peer-reviewed articles. Trial registration

  5. Program Strategies for Adolescent Smoking Cessation

    Science.gov (United States)

    Fritz, Deborah J.; Wider, Lottchen Crane; Hardin, Sally B.; Horrocks, Michelle

    2008-01-01

    School nurses who work with adolescents are in an ideal position to promote smoking cessation. This opportunity is important because research suggests teens who smoke are likely to become habitual smokers. This study characterizes adolescents' patterns and levels of smoking, describes adolescents' perceptions toward smoking, and delineates quit…

  6. Knowledge gaps about smoking cessation in hospitalized patients and their doctors.

    OpenAIRE

    Raupach, Tobias; Merker, Jacqueline; Hasenfuß, Gerd; Andreas, Stefan; Pipe, Andrew

    2011-01-01

    BACKGROUND: Hospitalization is an opportune time for smoking cessation support; cessation interventions delivered by hospital physicians are effective. While general practitioners' and outpatients' knowledge and attitudes towards smoking cessation have been studied in great detail, in-patient cessation programmes have received less attention. DESIGN: Questionnaire-based survey of a convenience sample of hospital physicians and in-patients at Göttingen University Hospital, Germany. M...

  7. A new instrument to predict smoking cessation among patients with chronic obstructive pulmonary disease: an observational longitudinal study of the Trying To Quit smoking questionnaire.

    Science.gov (United States)

    Lundh, Lena; Alinaghizadeh, Hassan; Törnkvist, Lena; Gilljam, Hans; Galanti, Maria Rosaria

    2016-04-14

    The Trying To Quit smoking questionnaire (TTQ), was developed to measure pressure-filled mental states, use of destructive pressure-relief strategies and ambivalent thoughts about quitting smoking among patients with COPD. The aim of this study was to evaluate whether the TTQ (available in an extended and in a reduced version) can be used to predict smoking cessation outcomes in smokers with COPD. As higher TTQ scores indicate higher degree of psychological distress, we hypothesised that TTQ scores at baseline would be negatively correlated with the probability of making a quit attempt, reducing the intensity of smoking and achieving complete abstinence during the 3 months. Smokers with COPD were recruited during planned or unplanned visits to primary healthcare centres, and 109 completed the TTQ at baseline and 85% participated in the follow-up after 3 months. Logistic regression was used to measure the association between the original (19 items) and the brief (14 item) version of TTQ scores and three outcomes: making at least one quit attempt, reducing the intensity of smoking and achieving complete abstinence. In a primary analysis among all the participants higher total score in the original version of TTQ was significantly associated with a lower probability of quit attempts. In a secondary analysis of subgroups of patients classified according to their readiness to quit, high TTQ scores at baseline were associated with lower probability of complete abstinence among patients not ready to quit (adjusted odds ratio (OR)=0.72; 95% confidence interval (CI)=0.53-0.99). Among patients ready to quit, high score on pressure-filled mental states was associated with lower probability of quit attempts (OR=0.78; 95% CI=0.66-0.94) but with higher probability of reduced smoking (OR=1.32; 95% CI=1.05-1.66). Ambivalent thoughts were associated with lower probability of all outcomes, but estimates were not statistically significant. Destructive coping strategies were

  8. Prediction of initiation and cessation of breastfeeding from late pregnancy to 16 weeks: the Feeding Your Baby (FYB) cohort study

    Science.gov (United States)

    Donnan, Peter T; Dalzell, Janet; Symon, Andrew; Rauchhaus, Petra; Monteith-Hodge, Ewa; Kellett, Gillian; Wyatt, Jeremy C; Whitford, Heather M

    2013-01-01

    Objective To derive prediction models for both initiation and cessation of breastfeeding using demographic, psychological and obstetric variables. Design A prospective cohort study. Setting Women delivering at Ninewells Hospital, Dundee, UK. Data sources Demographic data and psychological measures were obtained during pregnancy by questionnaire. Birth details, feeding method at birth and at hospital discharge were obtained from the Ninewells hospital database, Dundee, UK. Breastfeeding women were followed up by text messages every 2 weeks until 16 weeks or until breastfeeding was discontinued to ascertain feeding method and feeding intentions. Participants Pregnant women over 30 weeks gestation aged 16 years and above, living in Dundee, booked to deliver at Ninewells Hospital, Dundee, and able to speak English. Main outcome measure Initiation and cessation of breastfeeding. Results From the total cohort of women at delivery (n=344) 68% (95% CI 63% to 73%) of women had started breastfeeding at discharge. Significant predictors of initiating breastfeeding were older age, parity, greater intention to breastfeed from a Theory of Planned Behaviour (TPB)-based questionnaire, higher Iowa Infant Feeding Assessment Scale (IIFAS) score as well as living with a husband or partner. For the final model, the AUROC was 0.967. For those who initiated breastfeeding (n=233), the strongest predictors of stopping were low intention to breastfeed from TPB, low IIFAS score and non-managerial/professional occupations. Conclusions The findings from this study will be used to inform the protocol for an intervention study to encourage and support prolonged breastfeeding as intentions appear to be a key intervention focus for initiation. The predictive models could be used to identify women at high risk of not initiating and also women at high risk of stopping for interventions to improve the longevity of breastfeeding. PMID:23906958

  9. Brief smoking cessation intervention in relation to breast cancer surgery: a randomized controlled trial

    DEFF Research Database (Denmark)

    Thomsen, Thordis; Tønnesen, Hanne; Okholm, Mette;

    2010-01-01

    Smokers are more prone to develop postoperative complications. Smoking cessation intervention beginning 4-8 weeks prior to surgery improves the postoperative outcome. Cancer patients, however, often undergo surgery less than 4 weeks after diagnosis. The primary objective of this study was therefore...... to examine if a brief smoking cessation intervention shortly before breast cancer surgery would influence postoperative complications and smoking cessation....

  10. Brief smoking cessation intervention in relation to breast cancer surgery: a randomized controlled trial

    DEFF Research Database (Denmark)

    Thomsen, Thordis; Tønnesen, Hanne; Okholm, Mette;

    2010-01-01

    Smokers are more prone to develop postoperative complications. Smoking cessation intervention beginning 4-8 weeks prior to surgery improves the postoperative outcome. Cancer patients, however, often undergo surgery less than 4 weeks after diagnosis. The primary objective of this study was therefo...... to examine if a brief smoking cessation intervention shortly before breast cancer surgery would influence postoperative complications and smoking cessation....

  11. Mindfulness Predicts Lower Affective Volatility among African Americans During Smoking Cessation

    OpenAIRE

    Adams, Claire E.; Chen, Minxing; GUO, LIN; Lam, Cho Y.; Stewart, Diana W.; Correa-Fernández, Virmarie; Cano, Miguel A.; Heppner, Whitney L.; Vidrine, Jennifer Irvin; Li, Yisheng; Ahluwalia, Jasjit S.; Cinciripini, Paul M.; Wetter, David W.

    2014-01-01

    Recent research suggests that mindfulness benefits emotion regulation and smoking cessation. However, the mechanisms by which mindfulness affects emotional and behavioral functioning are unclear. One potential mechanism, lower affective volatility, has not been empirically tested during smoking cessation. This study examined longitudinal associations among mindfulness and emotional responding over the course of smoking cessation treatment among predominantly low-socioeconomic status (SES) Afr...

  12. Do Smoking Cessation Websites Meet the Needs of Smokers with Severe Mental Illnesses?

    Science.gov (United States)

    Brunette, Mary F.; Ferron, Joelle C.; Devitt, Timothy; Geiger, Pamela; Martin, Wendy M.; Pratt, Sarah; Santos, Meghan; McHugo, Gregory J.

    2012-01-01

    Many people learn about smoking cessation through information on the Internet. Whether people with severe mental illnesses, who have very high rates of smoking, are able to use currently available websites about smoking cessation is unknown. The study reported here assessed whether four smoking cessation websites met usability guidelines and…

  13. A retrospective cohort study of cancer mortality in employees of a Russian chrysotile asbestos mine and mills: study rationale and key features.

    Science.gov (United States)

    Schüz, J; Schonfeld, S J; Kromhout, H; Straif, K; Kashanskiy, S V; Kovalevskiy, E V; Bukhtiyarov, I V; McCormack, V

    2013-08-01

    Chrysotile, a serpentine asbestos fibre, is the only type of asbestos produced and consumed in the world today. It is an established human carcinogen. We have begun fieldwork on a retrospective cohort study of employees of one of the world's largest chrysotile mine and mills, situated in Asbest, Russia. The primary aim of the study is to better characterize and quantify the risk of cancer mortality in terms of (i) the dose-response relationship of exposure with risk; (ii) the range of cancer sites affected, including female-specific cancers; and (iii) effects of duration of exposure and latency periods. This information will expand our understanding of the scale of the impending cancer burden due to chrysotile, including if chrysotile use ceased worldwide forthwith. Herein we describe the scientific rationale for conducting this study and the main features of its study design.

  14. Causes and consequences of cerebral small vessel disease. The RUN DMC study: a prospective cohort study. Study rationale and protocol

    Directory of Open Access Journals (Sweden)

    van der Vlugt Maureen J

    2011-02-01

    Full Text Available Abstract Background Cerebral small vessel disease (SVD is a frequent finding on CT and MRI scans of elderly people and is related to vascular risk factors and cognitive and motor impairment, ultimately leading to dementia or parkinsonism in some. In general, the relations are weak, and not all subjects with SVD become demented or get parkinsonism. This might be explained by the diversity of underlying pathology of both white matter lesions (WML and the normal appearing white matter (NAWM. Both cannot be properly appreciated with conventional MRI. Diffusion tensor imaging (DTI provides alternative information on microstructural white matter integrity. The association between SVD, its microstructural integrity, and incident dementia and parkinsonism has never been investigated. Methods/Design The RUN DMC study is a prospective cohort study on the risk factors and cognitive and motor consequences of brain changes among 503 non-demented elderly, aged between 50-85 years, with cerebral SVD. First follow up is being prepared for July 2011. Participants alive will be included and invited to the research centre to undergo a structured questionnaire on demographics and vascular risk factors, and a cognitive, and motor, assessment, followed by a MRI protocol including conventional MRI, DTI and resting state fMRI. Discussion The follow up of the RUN DMC study has the potential to further unravel the causes and possibly better predict the consequences of changes in white matter integrity in elderly with SVD by using relatively new imaging techniques. When proven, these changes might function as a surrogate endpoint for cognitive and motor function in future therapeutic trials. Our data could furthermore provide a better understanding of the pathophysiology of cognitive and motor disturbances in elderly with SVD. The execution and completion of the follow up of our study might ultimately unravel the role of SVD on the microstructural integrity of the white

  15. Cytisine for smoking cessation: a research agenda.

    Science.gov (United States)

    Etter, Jean-François; Lukas, Ronald J; Benowitz, Neal L; West, Robert; Dresler, Carolyn M

    2008-01-01

    Cytisine has a molecular structure somewhat similar to that of nicotine and varenicline. The concept for the new smoking cessation drug varenicline was based partly on cytisine. Like varenicline, cytisine is a partial agonist of nicotinic acetylcholine receptors, with high affinity for alpha4beta2 receptors. Cytisine has been used since the 1960s as a smoking cessation drug in Eastern and Central Europe, but has remained largely unnoticed elsewhere. Three placebo-controlled trials, conducted in East and West Germany in the 1960s and 1970s, suggest that cytisine, even with minimal behavioural support, may be effective in aiding smoking cessation. Cytisine tablets are very inexpensive to produce and could be a more affordable treatment than nicotine replacement, bupropion and varenicline. There is however a dearth of scientific research on the properties of cytisine, including safety, abuse liability and efficacy. This paper seeks to identify research priorities for molecular, animal and clinical studies. In particular, new studies are necessary to define the nicotinic receptor interaction profile of cytisine, to establish its pharmacokinetics and pharmacodynamics in humans, to determine whether animals self-administer cytisine, and to ascertain whether cytisine is safe and effective as a smoking cessation drug. Potentially, this research effort, contributing to wider use of an inexpensive drug, could save many lives.

  16. Menthol cigarettes and smoking cessation behavior

    Directory of Open Access Journals (Sweden)

    Hoffman Allison C

    2011-05-01

    Full Text Available Abstract Although much is known about smoking cessation behavior, the vast majority of research has not assessed menthol as an independent factor. The objective of this review is to assess the effects, if any, that use of menthol cigarettes has on smoking cessation success in adults and youth. A total of 20 articles are included in this review. Although some studies have found that menthol smokers have less success in quitting smoking, others fail to find significant differences between menthol and non-menthol smokers. Some clinical trials evaluating the efficacy of various cessation treatments have suggested that menthol smokers have poorer outcomes, however two secondary data analysis studies (which used the same original dataset failed to find any difference in success rate associated with particular treatments. Although there is some suggestion that smoking menthol cigarettes is associated with worse cessation outcomes, differences are not always found. However, if there was a difference, it was always in the direction of worse outcomes for menthol smokers. Given that Black/African American smokers prefer menthol cigarettes more than White smokers, possible interactions with race/ethnicity are discussed.

  17. The readings of smoking fathers: a reception analysis of tobacco cessation images.

    Science.gov (United States)

    Johnson, Joy L; Oliffe, John L; Kelly, Mary T; Bottorff, Joan L; LeBeau, Karen

    2009-09-01

    The purpose of this qualitative study was to examine how new fathers decode image-based anti-smoking messages and uncover the extent to which ideals of masculinity might influence men to take up and/or disregard smoking cessation messages. The authors analyzed 5 images that had been used to promote smoking cessation and arrived at a consensus about the dominant discourse encoded by each image. During face-to-face interviews, new fathers were invited to discuss the images; these interview data were coded and analyzed using a social constructionist gender analysis. The study findings highlight how most men negotiated or opposed dominant discourses of health that communicated the dangers of smoking by reproducing dominant ideals of masculinity, including explicit disregard for self-health. They accepted dominant social discourses of fathering that reproduced traditional notions of masculinity, such as the protector and provider. The authors conclude that tobacco interventions targeted to new fathers must (a) develop more awareness of the ability of audiences to select discourses that empower their own interpretive positioning with regard to media, and (b) deconstruct and engage with context and age-specific masculine ideals to avoid providing rationales for continued tobacco use.

  18. Dental students' attitudes toward tobacco cessation counseling.

    Science.gov (United States)

    Anders, Patrick L; Davis, Elaine L; McCall, W D

    2014-01-01

    The main objective of this study was to determine if level of education, gender, and tobacco history affected attitudes of dental students toward tobacco cessation counseling. A secondary objective was to examine the psychometric properties of the survey instrument. First- and fourth-year dental students at one school of dental medicine completed a survey examining attitudes toward tobacco cessation and perceived barriers to performing tobacco cessation counseling in a dental setting. Analyses were conducted to determine whether there were differences in attitudes by gender, level of education, or personal and family tobacco use. A main effect for education level was discovered. Fourth-year students were more likely than first-year students to consider the prescription of nicotine gum and transdermal patches to be within the scope and responsibility of the dental profession. No significant differences were seen with regard to gender or students' personal and family tobacco histories. Dental students were in general agreement that tobacco cessation counseling is within the responsibility of the dental profession, is within the scope of dental practice, and can be effective. Psychometric analysis revealed reliability of the survey instrument.

  19. Rationale, design, methodology and sample characteristics for the family partners for health study: a cluster randomized controlled study

    Directory of Open Access Journals (Sweden)

    Berry Diane C

    2012-03-01

    Full Text Available Abstract Background Young children who are overweight are at increased risk of becoming obese and developing type 2 diabetes and cardiovascular disease later in life. Therefore, early intervention is critical. This paper describes the rationale, design, methodology, and sample characteristics of a 5-year cluster randomized controlled trial being conducted in eight elementary schools in rural North Carolina, United States. Methods/Design The first aim of the trial is to examine the effects of a two-phased intervention on weight status, adiposity, nutrition and exercise health behaviors, and self-efficacy in overweight or obese 2nd, 3 rd, and 4th grade children and their overweight or obese parents. The primary outcome in children is stabilization of BMI percentile trajectory from baseline to 18 months. The primary outcome in parents is a decrease in BMI from baseline to 18 months. Secondary outcomes for both children and parents include adiposity, nutrition and exercise health behaviors, and self-efficacy from baseline to 18 months. A secondary aim of the trial is to examine in the experimental group, the relationships between parents and children's changes in weight status, adiposity, nutrition and exercise health behaviors, and self-efficacy. An exploratory aim is to determine whether African American, Hispanic, and non-Hispanic white children and parents in the experimental group benefit differently from the intervention in weight status, adiposity, health behaviors, and self-efficacy. A total of 358 African American, non-Hispanic white, and bilingual Hispanic children with a BMI ≥ 85th percentile and 358 parents with a BMI ≥ 25 kg/m2 have been inducted over 3 1/2 years and randomized by cohort to either an experimental or a wait-listed control group. The experimental group receives a 12-week intensive intervention of nutrition and exercise education, coping skills training and exercise (Phase I, 9 months of continued monthly contact

  20. A Case-Control Study of the Protective Effect of Alcohol, Coffee, and Cigarette Consumption on Parkinson Disease Risk : Time-Since-Cessation Modifies the Effect of Tobacco Smoking

    NARCIS (Netherlands)

    van der Mark, Marianne; Nijssen, Peter C. G.; Vlaanderen, Jelle; Huss, Anke; Mulleners, Wim M.; Sas, Antonetta M. G.; van Laar, Teus; Kromhout, Hans; Vermeulen, Roel

    2014-01-01

    The aim of this study was to investigate the possible reduced risk of Parkinson Disease (PD) due to coffee, alcohol, and/or cigarette consumption. In addition, we explored the potential effect modification by intensity, duration and time-since-cessation of smoking on the association between cumulati

  1. Duration of smoking cessation for the prevention of surgical wound healing complications

    Directory of Open Access Journals (Sweden)

    Barbara Vieira Cavichio

    2014-02-01

    Full Text Available The study aimed to find scientific evidence about the duration of preoperative smoking cessation required to reduce surgical wound healing complications. An integrative review was performed in the databases, Latin American and Caribbean Literature on Health Sciences (LILACS and Medical Literature Analysis and Retrieval System Online (MEDLINE, from 08/17/2012 to 09/17/2012, using the keywords: tobacco use cessation and wound healing; tobacco use cessation and preoperative period; tobacco use cessation and perioperative period (LILACS and tobacco use cessation and perioperative period; tobacco use cessation and wound healing (MEDLINE. Out of the 81 eligible studies, 12 were included. The duration of smoking cessation needed to reduce healing complications was at least four weeks (four studies with level of evidence I, three studies with level of evidence II, two studies with level of evidence IV, and one study with level of evidence VII.

  2. Hanford waste-form release and sediment interaction: A status report with rationale and recommendations for additional studies

    Energy Technology Data Exchange (ETDEWEB)

    Serne, R.J. (Pacific Northwest Lab., Richland, WA (USA)); Wood, M.I. (Westinghouse Hanford Co., Richland, WA (USA))

    1990-05-01

    This report documents the currently available geochemical data base for release and retardation for actual Hanford Site materials (wastes and/or sediments). The report also recommends specific laboratory tests and presents the rationale for the recommendations. The purpose of this document is threefold: to summarize currently available information, to provide a strategy for generating additional data, and to provide recommendations on specific data collection methods and tests matrices. This report outlines a data collection approach that relies on feedback from performance analyses to ascertain when adequate data have been collected. The data collection scheme emphasizes laboratory testing based on empiricism. 196 refs., 4 figs., 36 tabs.

  3. Situational temptation scores and smoking cessation in general care.

    Science.gov (United States)

    Breitling, Lutz Philipp; Twardella, Dorothee; Raum, Elke; Brenner, Hermann

    2009-06-01

    The construct of self-efficacy, which is assessed either in confidence- or temptation-related instruments, presumably predicts transitions between the transtheoretical model stages of change and ultimately smoking cessation outcome. To elucidate its predictive potential for smoking cessation in a general care setting, we examined the association of baseline scores of the situational temptations inventory with month 12 smoking status in 577 heavy smokers participating in a cluster-randomized study of physician training and financial incentives for smoking cessation in Germany. At follow-up, abstinence could be validated in 56 patients. The temptation sub- and total scores were not bivariately associated with altered odds of smoking cessation, in contrast to established predictors like the Fagerstrom test of nicotine dependence and the stages of change. They were associated with the Fagerstrom scores, but not with the stages of change. Controlling for both cessation predictors, in particular the positive/social temptation subscore was associated with quitting. Additional studies are needed to fully understand how situational temptations relate to smoking cessation outcomes and explain variance beyond that of more established predictors of cessation.

  4. Interventions for preoperative smoking cessation

    DEFF Research Database (Denmark)

    Møller, A; Villebro, N

    2005-01-01

    Smokers have a substantially increased risk of intra- and postoperative complications. Preoperative smoking intervention may be effective in decreasing this incidence. The preoperative period may be a well chosen time to offer smoking cessation interventions due to increased patient motivation....

  5. Menthol Cigarettes, Time to First Cigarette, and Smoking Cessation

    Directory of Open Access Journals (Sweden)

    Sanders Edward

    2017-01-01

    Full Text Available The goal of the present work is to determine if menthol and non-menthol cigarette smokers differ with respect to time to first cigarette (TTFC and successful smoking cessation via a meta-analysis of published results. For 13 independent estimates, menthol smokers were slightly but statistically significantly more likely to exhibit TTFC ≤ 5 min (random-effects odds ratio (OR = 1.12; 95% confidence interval (CI, 1.04–1.21, while 17 independent estimates provided a non-significant difference for TTFC ≤ 30 min (random-effects OR = 1.06; 95% CI, 0.96–1.16. For cessation studies, meta-analysis of 30 published estimates indicated a decreased likelihood for menthol cigarette smokers to quit (random-effects OR = 0.87; 95% CI, 0.80–0.96. There was no difference between cessation rates for Caucasian menthol and non-menthol cigarette smokers, but the results support that African American menthol cigarette smokers find it more difficult to quit. Adjustment of cessation for socioeconomic status eliminated any statistically significant advantage for smoking cessation in non-menthol smokers. In conclusion, these results suggest that the observed differences in cessation rates between menthol and non-menthol cigarette smokers are likely explained by differences in socioeconomic status and also suggest that TTFC may not be a robust predictor of successful smoking cessation.

  6. Negative rebound in hippocampal neurogenesis following exercise cessation.

    Science.gov (United States)

    Nishijima, Takeshi; Kamidozono, Yoshika; Ishiizumi, Atsushi; Amemiya, Seiichiro; Kita, Ichiro

    2017-03-01

    Physical exercise can improve brain function, but the effects of exercise cessation are largely unknown. This study examined the time-course profile of hippocampal neurogenesis following exercise cessation. Male C57BL/6 mice were randomly assigned to either a control (Con) or an exercise cessation (ExC) group. Mice in the ExC group were reared in a cage with a running wheel for 8 wk and subsequently placed in a standard cage to cease the exercise. Exercise resulted in a significant increase in the density of doublecortin (DCX)-positive immature neurons in the dentate gyrus (at week 0). Following exercise cessation, the density of DCX-positive neurons gradually decreased and was significantly lower than that in the Con group at 5 and 8 wk after cessation, indicating that exercise cessation leads to a negative rebound in hippocampal neurogenesis. Immunohistochemistry analysis suggests that the negative rebound in neurogenesis is caused by diminished cell survival, not by suppression of cell proliferation and neural maturation. Neither elevated expression of ΔFosB, a transcription factor involved in neurogenesis regulation, nor increased plasma corticosterone, were involved in the negative neurogenesis rebound. Importantly, exercise cessation suppressed ambulatory activity, and a significant correlation between change in activity and DCX-positive neuron density suggested that the decrease in activity is involved in neurogenesis impairment. Forced treadmill running following exercise cessation failed to prevent the negative neurogenesis rebound. This study indicates that cessation of exercise or a decrease in physical activity is associated with an increased risk for impaired hippocampal function, which might increase vulnerability to stress-induced mood disorders.

  7. Smoking Cessation Intervention After Ischemic Stroke or Transient Ischemic Attack. A Randomized Controlled Pilot Trial

    DEFF Research Database (Denmark)

    Brunner Frandsen, Nicole; Sørensen, Margit; Hyldahl, Tanja Kirstine;

    2012-01-01

    BACKGROUND: Smoking cessation is widely recommended for secondary stroke prevention. However, little is known about the efficacy of smoking cessation intervention after stroke or transient ischemic attack (TIA). METHODS: Ninety-four smokers under age 76, admitted with ischemic stroke or TIA were......-report and verified by measurement of exhaled carbon monoxide (CO). Fewer patients than expected were recruited, which renders this report a pilot study. RESULTS: The 6-month self-reported smoking cessation rate was 37.8% in the minimal intervention group and 42.9% in the intensive intervention group. Smoking...... randomized to minimal smoking cessation intervention or intensive smoking cessation intervention. All patients attended a 30-min individual counseling by the study nurse. Patients randomized to intensive smoking cessation intervention also participated in a 5-session outpatient smoking cessation program...

  8. Factors Predicting the Provision of Smoking Cessation Services Among Occupational Health Nurses in Thailand.

    Science.gov (United States)

    Chatdokmaiprai, Kannikar; Kalampakorn, Surintorn; McCullagh, Marjorie; Lagampan, Sunee; Keeratiwiriyaporn, Sansanee

    2017-01-01

    The purpose of this study was to identify factors predicting occupational health nurses' provision of smoking cessation services. Data were collected via a self-administered questionnaire distributed to 254 occupational health nurses in Thailand. Analysis by structural equation modeling revealed that self-efficacy directly and positively influenced smoking cessation services, and mediated the relationship between workplace factors, nurse factors, and smoking cessation services. The final model had good fit to the data, accounting for 20.4% and 38.0% of the variance in self-efficacy and smoking cessation services, respectively. The findings show that self-efficacy is a mediator that influences provision of smoking cessation services by occupational health nurses. Interventions to enhance nurses' self-efficacy in providing smoking cessation services are expected to promote provision of smoking cessation services to workers.

  9. Depressive Symptoms, Drinking Problems, and Smoking Cessation in Older Smokers

    Science.gov (United States)

    Kenney, Brent A.; Holahan, Charles J.; Holahan, Carole K.; Brennan, Penny L.; Schutte, Kathleen K.; Moos, Rudolf H.

    2009-01-01

    This study modeled the predictive association between depressive symptoms and smoking cessation in a sample of 442 late-middle-aged smokers; assessments occurred at four time-points across a 10-year period. In addition, the study examined the role of baseline drinking problems in moderating the relationship between depressive symptoms and smoking cessation. Findings supported hypotheses. More depressive symptoms prospectively predicted a lower likelihood of smoking cessation. In addition, the presence of baseline drinking problems strengthened the relationship between depressive symptoms and a lower likelihood of smoking cessation. Understanding the mechanisms underlying depression and cigarette smoking among older adults is applicable to secondary prevention and treatment and suggests additional public health benefits from treating depression in older persons. PMID:19372009

  10. Significance of Haemodynamic and Haemostatic Factors in the Course of Different Manifestations of Cerebral Small Vessel Disease: The SHEF-CSVD Study—Study Rationale and Protocol

    Directory of Open Access Journals (Sweden)

    Jacek Staszewski

    2013-01-01

    Full Text Available Rationale. This paper describes the rationale and design of the SHEF-CSVD Study, which aims to determine the long-term clinical and radiological course of cerebral small vessel disease (CSVD and to evaluate haemostatic and haemodynamic prognostic factors of the condition. Design. This single-centre, prospective, non-interventional cohort study will follow 150 consecutive patients with different clinical manifestations of CSVD (lacunar ischaemic stroke, vascular dementia, vascular parkinsonism or spontaneous deep, intracerebral haemorrhage and 50 age- and sex-matched controls over a period of 24 months. The clinical and radiological course will be evaluated basing on a detailed neurological, neuropsychological and MRI examinations. Haemodynamic (cerebral vasoreactivity, 24 h blood pressure control and haemostatic factors (markers of endothelial and platelet dysfunction, brachial artery flow-mediated dilatation test will be determined. Discussion. The scheduled study will specifically address the issue of haemodynamic and haemostatic prognostic factors and their course over time in various clinical manifestations of CSVD. The findings may aid the development of prophylactic strategies and individualised treatment plans, which are critical during the early stages of the disease.

  11. The transtheoretical model use for smoking cessation

    OpenAIRE

    Kafiye EROĞLU; Koyun, Ayşe

    2014-01-01

    Available Online at http://iassr.org/journal 2013 (c) EJRE published by International Association of Social Science Research - IASSR European Journal of Research on Education ISSN: 2147-6284 European Journal of Research on Education, 2014, Special Issue: Contemporary Studies in Social Science, 130-134 The transtheoretical model use for smoking cessation Ayşe Koyun a *, Kafiye Eroğlu b aAfyon Kocatepe University, Afyon School of Health, Afyonkarahisar, 03200...

  12. Adaptation, Implementation Plan, and Evaluation of an Online Tobacco Cessation Training Program for Health Care Professionals in Three Spanish-Speaking Latin American Countries: Protocol of the Fruitful Study

    Science.gov (United States)

    Company, Assumpta; Guillen, Olga; Margalef, Mercè; Arrien, Martha Alicia; Sánchez, Claudia; Cáceres de León, Paula

    2017-01-01

    Background Tobacco cessation training programs to treat tobacco dependence have measureable effects on patients’ smoking. Tobacco consumption in low- and middle-income countries (LMICs) is high and slowly decreasing, but these countries usually lack measures to face the epidemic, including tobacco cessation training programs for health professionals and organizations. Based on a previous online smoking cessation training program for hospital workers in Spain, the Fruitful Study aims to increase smoking cessation knowledge, attitudes, self-confidence, and performance interventions among health care professionals of three Spanish-speaking low- and middle-income Latin American and Caribbean (LAC) countries. Objective The purpose of this paper is to describe the methodology and evaluation strategy of the Fruitful Study intended to adapt, implement, and test the effectiveness of an online, evidence-based tobacco cessation training program addressed to health professionals from Bolivia, Guatemala, and Paraguay. Methods This study will use a mixed-methods design with a pre-post evaluation (quantitative approach) and in-depth interviews and focus groups (qualitative approach). The main outcomes will be (1) participants’ attitudes, knowledge, and behaviors before and after the training; and (2) the level of implementation of tobacco control policies within the hospitals before and after the training. Results To date, adaptation of the materials, study enrollment, and training activities have been completed. During the adaptation, the main mismatches were language background and content adaptation. Several aids were developed to enable students’ training enrollment, including access to computers, support from technicians, and reminders to correctly complete the course. Follow-up data collection is in progress. We have enrolled 281 hospital workers. Results are expected at the beginning of 2017 and will be reported in two follow-up papers: one about the formative

  13. Rationale and design of the plate or pin (pop study for dislocated midshaft clavicular fractures: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Meylaerts Sven AG

    2011-07-01

    Full Text Available Abstract Background To describe the rationale and design of a future study comparing results of plate fixation and Elastic Stable Intramedullary Nailing (ESIN with a Titanium Elastic Nail (TEN for adults with a dislocated midshaft clavicular fracture. Methods/Design Prospective randomized multicenter clinical trial in two level 1 and one level 2 trauma centers. 120 patients between 18 and 65 years of age will be included. They are randomized to either plate fixation or ESIN with a TEN with a one year follow-up. Sixty patients will be treated with plate fixation and 60 patients will be treated with ESIN. Primary outcome parameter is the Disabilities of the Arm, Shoulder and Hand score after 6 months. Secondary outcome parameters are Constant Shoulder Score, complications, experienced pain, radiologic consolidation and cosmetics after both procedures. Discussion Prospective randomized studies comparing operative techniques for treatment of dislocated midshaft clavicular fracture are lacking. By studying shoulder function, complications, quality of life, radiographic union, cosmetics as well as experienced pain, a complete efficacy assessment of both procedures will be performed. Trial registration The POP study is registered in the Dutch Trial Register (NTR NTR2438.

  14. Disseminating a smoking cessation intervention to childhood and young adult cancer survivors: baseline characteristics and study design of the partnership for health-2 study

    Directory of Open Access Journals (Sweden)

    Levy Andrea

    2011-05-01

    Full Text Available Abstract Background Partnership for Health-2 (PFH-2 is a web-based version of Partnership for Health, an evidence-based smoking cessation intervention for childhood cancer survivors. This paper describes the PFH-2 intervention and baseline data collection. Methods 374 childhood and young adult cancer survivors were recruited from five cancer centers and participated in the baseline assessment. At baseline, participants completed measures of their smoking behavior, self-efficacy and stage of change for quitting smoking as well as psychological and environmental factors that could impact their smoking behavior. Results At baseline, 93% of survivors smoked in the past seven days; however, 89% smoked a pack or less during this period. Forty-seven percent were nicotine dependent, and 55% had made at least one quit attempt in the previous year. Twenty-two percent of survivors were in contemplation for quitting smoking; of those 45% were somewhat or very confident that they could quit within six months. Sixty-three percent were in preparation for quitting smoking; however, they had relatively low levels of confidence that they could quit smoking in the next month. In multivariate analyses, stage of change, self-efficacy, social support for smoking cessation, smoking policy at work and home, fear of cancer recurrence, perceived vulnerability, depression, BMI, and contact with the healthcare system were associated with survivors' smoking behavior. Discussions/Conclusions A large proportion of the sample was nicotine dependent, yet motivated to quit. Individual- interpersonal- and environmental-level factors were associated with survivors' smoking behavior. Smoking is particularly dangerous for childhood and young adult cancer survivors. This population may benefit from a smoking cessation intervention designed to build self-efficacy and address other known predictors of smoking behavior.

  15. Maximizing the Impact of Digital Media Campaigns to Promote Smoking Cessation: A Case Study of the California Tobacco Control Program and the California Smokers' Helpline.

    Science.gov (United States)

    Lee, Youn Ok; Momin, Behnoosh; Hansen, Heather; Duke, Jennifer; Harms, Kristin; McCartney, Amanda; Neri, Antonio; Kahende, Jennifer; Zhang, Lei; Stewart, Sherri L

    2014-01-01

    Digital media are often used to encourage smoking cessation by increasing quitline call volume through direct promotion to smokers or indirect promotion to smoker proxies. The documentation of a program's experiences utilizing digital media is necessary to develop both the knowledge base and a set of best practices. This case study highlights the use of digital media in a proxy-targeted campaign to promote the California Smokers' Helpline to health care professionals from October 2009 to September 2012. We describe the iterative development of the campaign's digital media activities and report campaign summaries of web metrics (website visits, webinar registrations, downloads of online materials, online orders for promotional materials) and media buy (gross impressions) tracking data. The campaign generated more than 2.7 million gross impressions from digital media sources over 3 years. Online orders for promotional materials increased almost 40% over the course of the campaign. A clearly defined campaign strategy ensured that there was a systematic approach in developing and implementing campaign activities and ensuring that lessons learned from previous years were incorporated. Discussion includes lessons learned and recommendations for future improvements reported by campaign staff to inform similar efforts using digital media.

  16. Home versus Office blood pressure MEasurements : Reduction of Unnecessary treatment Study: Rationale and Study design of the HOMERUS Trial

    NARCIS (Netherlands)

    Verberk, WJ; Kroon, AA; Kessels, AGH; Dirksen, C; Nelemans, PJ; Lenders, JWM; Thien, TABM; van Montfrans, GA; Smit, AJ; de Leeuw, PW

    2003-01-01

    The Home versus Office MEasurements, Reduction of Unnecessary treatment Study (HOMERUS) is a multicentre prospective study, primarily designed to examine in subjects with mild to moderate hypertension whether treatment decisions based on home blood pressure measurements can lead to reduction in the

  17. Smoking cessation in women: findings from qualitative research.

    Science.gov (United States)

    Puskar, M

    1995-11-01

    The purpose of this descriptive exploratory study is to describe the experience of successful smoking cessation in adult women. The convenience sample included 10 women, ages 25 to 42, who had abstained from smoking for at least 6 months but not longer than 3 years. A semistructured interview format was used to elicit descriptions of the experience of successful smoking cessation from these subjects. The interview format explored the experience, including initial contemplation, the process of quitting, and maintenance of smoking abstinence. Interviews were audiotaped, transcribed, and then analyzed using methods outlined by Miles and Huberman [1]. Four themes emerged from the data: evolving commitment to health and personal growth, being stigmatized, changing conceptualization of smoking, and smoking cessation as a relational phenomenon. These findings were consistent with Pender's Health Promotion Model and have implications for nurse practitioners who counsel women on smoking cessation.

  18. Population-based multicase-control study in common tumors in Spain (MCC-Spain: rationale and study design

    Directory of Open Access Journals (Sweden)

    Gemma Castaño-Vinyals

    2015-07-01

    Discussion: This study, conducted within the Spanish Consortium for Biomedical Research in Epidemiology & Public Health (CIBERESP, is a unique initiative to evaluate etiological factors for common cancers and will promote cancer research and prevention in Spain.

  19. Interventions for preoperative smoking cessation

    DEFF Research Database (Denmark)

    Thomsen, Thordis; Villebro, Nete; Møller, Ann Merete

    2014-01-01

    BACKGROUND: Smokers have a substantially increased risk of postoperative complications. Preoperative smoking intervention may be effective in decreasing this incidence, and surgery may constitute a unique opportunity for smoking cessation interventions. OBJECTIVES: The objectives of this review...... are to assess the effect of preoperative smoking intervention on smoking cessation at the time of surgery and 12 months postoperatively, and on the incidence of postoperative complications. SEARCH METHODS: We searched the Cochrane Tobacco Addiction Group Specialized Register in January 2014. SELECTION CRITERIA......: Randomized controlled trials that recruited people who smoked prior to surgery, offered a smoking cessation intervention, and measured preoperative and long-term abstinence from smoking or the incidence of postoperative complications or both outcomes. DATA COLLECTION AND ANALYSIS: The review authors...

  20. Interventions for preoperative smoking cessation

    DEFF Research Database (Denmark)

    Thomsen, Thordis; Villebro, N.; Møller, Ann Merete;

    2010-01-01

    Background Smokers have a substantially increased risk of postoperative complications. Preoperative smoking intervention may be effective in decreasing this incidence, and surgery may constitute a unique opportunity for smoking cessation interventions. Objectives The objective of this review...... was to assess the effect of preoperative smoking intervention on smoking cessation at the time of surgery and 12 months postoperatively and on the incidence of postoperative complications. Search strategy The specialized register of the Cochrane Tobacco Addiction Group was searched using the free text......; pooled RR 10.76 (95% confidence interval (CI) 4.55 to 25.46, two trials) and RR 1.41 (95% CI 1.22 to 1.63, five trials) respectively. Four trials evaluating the effect on long-term smoking cessation found a significant effect; pooled RR 1.61 (95% CI 1.12 to 2.33). However, when pooling intensive...

  1. Case study research as bridge builder between science and the society. The rationale behind the ASTRA 2005 winter storm study

    Energy Technology Data Exchange (ETDEWEB)

    Haanpaeae, S.; Peltonen, L.

    2007-07-01

    The challenge of climate change as a complex global issue is that it demands locally grounded solutions that bring together actors from various fields. As a 'wicked' problem climate change adaptation demands deliberation between different subsystems of society, including scientific research. While answering the complex needs of the society, it has to be re-evaluated what 'good' science means. This brings about a need for socially robust knowledge. The need for contextualisation of scientific knowledge is supported by theoretical development in the fields of policy analysis and risk governance. It also entails an epistemic shift away from the 'quest for certainty' towards a pragmatist understanding of knowledge. The underlying request is to integrate expert knowledge with the needs of other stakeholders - to bring in the people to add to the policy formation a notion of emotional knowledge. As a research method, case studies readily contextualise scientific information and therefore offer valuable insights into the underlying social values of the problems at hand. As locally grounded narratives they can offer a shortcut to the formation of a new kind of expertise needed as the demands from the society reform the claims on scientific information. It is argued that developing the science-policy interface and risk communication can both benefit from a contextual research approach using case studies. Such studies have critical and persuasive functions, and they provide a basis for further case-based learning exercises with opportunities for awareness raising, institutional capacity building and practical adaptation measures. (orig.)

  2. Reasons for not using smoking cessation aids

    Directory of Open Access Journals (Sweden)

    Völzke Henry

    2008-04-01

    Full Text Available Abstract Background Few smokers use effective smoking cessation aids (SCA when trying to stop smoking. Little is known why available SCA are used insufficiently. We therefore investigated the reasons for not using SCA and examined related demographic, smoking behaviour, and motivational variables. Methods Data were collected in two population-based studies testing smoking cessation interventions in north-eastern Germany. A total of 636 current smokers who had never used SCA and had attempted to quit or reduce smoking within the last 12 months were given a questionnaire to assess reasons for non-use. The questionnaire comprised two subscales: "Social and environmental barriers" and "SCA unnecessary." Results The most endorsed reasons for non-use of SCA were the belief to be able to quit on one's own (55.2%, the belief that help is not necessary (40.1%, and the belief that smoking does not constitute a big problem in one's life (36.5%. One quarter of all smokers reported that smoking cessation aids are not helpful in quitting and that the aids cost too much. Smokers intending to quit agreed stronger to both subscales and smokers with lower education agreed stronger to the subscale "Social and environmental barriers". Conclusion Main reasons for non-use of SCA are being overly self-confident and the perception that SCA are not helpful. Future interventions to increase the use of SCA should address these reasons in all smokers.

  3. Update on smoking cessation therapies.

    LENUS (Irish Health Repository)

    Glynn, Deirdre A

    2009-04-01

    As a reflection of an exponential increase in smoking rates throughout the world during the last century, the economic and human burden of mortality and morbidity related to smoking is now clearly defined. Smoking cessation is associated with health benefits for people of all ages. In this paper we provide a comprehensive review of current licensed pharmacological smoking cessation agents including efficacy and safety profiles, with comparisons of individual therapies available. Furthermore, we offer a prospective on the need for further testing of other agents including novel avenues of therapy.

  4. Accuracy of self-reported smoking cessation during pregnancy

    Science.gov (United States)

    TONG, VAN T.; ALTHABE, FERNANDO; ALEMÁN, ALICIA; JOHNSON, CAROLYN C.; DIETZ, PATRICIA M.; BERRUETA, MABEL; MORELLO, PAOLA; COLOMAR, MERCEDES; BUEKENS, PIERRE; SOSNOFF, CONNIE S.; FARR, SHERRY L.; MAZZONI, AGUSTINA; CIGANDA, ALVARO; BECÚ, ANA; GONZALEZ, MARIA G. BITTAR; LLAMBI, LAURA; GIBBONS, LUZ; SMITH, RUBEN A.; BELIZÁN, JOSÉ M.

    2015-01-01

    Evidence of bias of self-reported smoking cessation during pregnancy is reported in high-income countries but not elsewhere. We sought to evaluate self-reported smoking cessation during pregnancy using biochemical verification and to compare characteristics of women with and without biochemically confirmed cessation in Argentina and Uruguay. In a cross-sectional study from October 2011 to May 2012, women who attended one of 21 prenatal clinics and delivered at selected hospitals in Buenos Aires, Argentina and Montevideo, Uruguay, were surveyed about their smoking cessation during pregnancy. We tested saliva collected from women <12 h after delivery for cotinine to evaluate self-reported smoking cessation during pregnancy. Overall, 10.0% (44/441) of women who self-reported smoking cessation during pregnancy had biochemical evidence of continued smoking. Women who reported quitting later in pregnancy had a higher percentage of nondisclosure (17.2%) than women who reported quitting when learning of their pregnancy (6.4%). PMID:25350478

  5. Rationale and design of a study using a standardized locally procured macronutrient supplement as adjunctive therapy to HIV treatment in Kenya.

    Science.gov (United States)

    Sztam, Kevin A; Ndirangu, Murugi; Sheriff, Muhsin; Arpadi, Stephen M; Hawken, Mark; Rashid, Juma; Deckelbaum, Richard J; El Sadr, Wafaa M

    2013-01-01

    Poor nutritional status at initiation of antiretroviral therapy (ART) is predictive of mortality. Decreased dietary intake is a major determinant of weight loss in HIV. Despite a biological rationale to treat undernutrition in adults receiving ART, few studies have provided data on feasibility, safety, effectiveness, and sustainability of specific macronutrient supplements with HIV treatment in adults, especially supplements such as a food basket, a supplement approach seldom evaluated in spite of its wide use. We present the rationale and design for a study of a locally procured macronutrient supplement given to HIV-infected patients initiating ART with a body mass index (BMI) ≤20.0 kg/m(2). The objective was to determine feasibility of procurement, distribution, safety and to obtain preliminary effectiveness data for a locally procured supplement. The design was a comparative study for 200 adult participants at two Kenya government-supported clinics. The primary outcome was BMI at 24 weeks. Supplement duration was 24 weeks, total follow-up was 48 weeks, and the study included a comparison site. Novel aspects of this study include use of a standardized macronutrient supplement to protect the participant against household food sharing, and a complementary micronutrient supplement. Comprehensive data collected included dietary intake, HIV-related quality-of-life, food security, neuropsychiatric assessments, laboratory studies, and household geomapping. Assessments were made at baseline, at 24 weeks, and at 48 weeks post-ART initiation. Challenges included establishing a partnership with local millers, distribution from the HIV clinic, food safety, and tracking of participants. These findings will help inform nutrition support programming in Kenya and similar settings, and provide needed data regarding use of macronutrient supplements as an adjunctive intervention with ART.

  6. Expansion of Medicaid Covered Smoking Cessation Services

    Data.gov (United States)

    U.S. Department of Health & Human Services — Expansionof Medicaid Covered Smoking Cessation Services - Maternal Smoking and Birth Outcomes. To assess whether Medicaid coverage of smoking cessation services...

  7. Implementing a fax referral program for quitline smoking cessation services in urban health centers: a qualitative study

    OpenAIRE

    2009-01-01

    Abstract Background Fax referral services that connect smokers to state quitlines have been implemented in 49 U.S. states and territories and promoted as a simple solution to improving smoker assistance in medical practice. This study is an in-depth examination of the systems-level changes needed to implement and sustain a fax referral program in primary care. Methods The study involved implementation of a fax referral system paired with a chart stamp prompting providers to identify smoking p...

  8. Smoking Patterns and Smoking Cessation Willingness-A Study among Beneficiaries of Government Welfare Assistance in Poland.

    Science.gov (United States)

    Milcarz, Katarzyna; Makowiec-Dąbrowska, Teresa; Bak-Romaniszyn, Leokadia; Kaleta, Dorota

    2017-01-27

    This study examines the prevalence and tobacco use patterns among adult social assistance beneficiaries and their interest in quitting. The results are based on data collected in a cross-sectional survey conducted among adults in the Piotrkowski district. A sample of 3636 social assistance beneficiaries produced a total of 1817 respondents who completed face-to-face questionnaires. Overall, 37.1% of the respondents, including 52.8% men and 29.6% women, were current smokers. Over one third of the smokers reported their willingness to quit. In the study population, several characteristics were significantly associated with the current daily smoking: male gender, low educational attainment, unemployment or temporary employment, lack of awareness of smoking-associated health risks, use of e-cigarettes, and exposure to environmental tobacco smoke (ETS). The intention to quit smoking among the daily smokers was positively correlated with their awareness of smoking-associated health risks, lack of previous quit attempts, and low exposure to ETS. Smoking prevalence among social assistance recipients tends to be higher than in the general population, but more than half of the smokers are willing to quit. There is an urgency to develop policies tailored to the needs of these disadvantaged population groups.

  9. Implementing a fax referral program for quitline smoking cessation services in urban health centers: a qualitative study

    Directory of Open Access Journals (Sweden)

    Cantrell Jennifer

    2009-12-01

    Full Text Available Abstract Background Fax referral services that connect smokers to state quitlines have been implemented in 49 U.S. states and territories and promoted as a simple solution to improving smoker assistance in medical practice. This study is an in-depth examination of the systems-level changes needed to implement and sustain a fax referral program in primary care. Methods The study involved implementation of a fax referral system paired with a chart stamp prompting providers to identify smoking patients, provide advice to quit and refer interested smokers to a state-based fax quitline. Three focus groups (n = 26 and eight key informant interviews were conducted with staff and physicians at two clinics after the intervention. We used the Chronic Care Model as a framework to analyze the data, examining how well the systems changes were implemented and the impact of these changes on care processes, and to develop recommendations for improvement. Results Physicians and staff described numerous benefits of the fax referral program for providers and patients but pointed out significant barriers to full implementation, including the time-consuming process of referring patients to the Quitline, substantial patient resistance, and limitations in information and care delivery systems for referring and tracking smokers. Respondents identified several strategies for improving integration, including simplification of the referral form, enhanced teamwork, formal assignment of responsibility for referrals, ongoing staff training and patient education. Improvements in Quitline feedback were needed to compensate for clinics' limited internal information systems for tracking smokers. Conclusions Establishing sustainable linkages to quitline services in clinical sites requires knowledge of existing patterns of care and tailored organizational changes to ensure new systems are prioritized, easily integrated into current office routines, formally assigned to specific

  10. Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study

    Directory of Open Access Journals (Sweden)

    Chaudhry Shazia H

    2009-07-01

    Full Text Available Abstract Background Cluster randomized trials are an increasingly important methodological tool in health research. In cluster randomized trials, intact social units or groups of individuals, such as medical practices, schools, or entire communities – rather than individual themselves – are randomly allocated to intervention or control conditions, while outcomes are then observed on individual cluster members. The substantial methodological differences between cluster randomized trials and conventional randomized trials pose serious challenges to the current conceptual framework for research ethics. The ethical implications of randomizing groups rather than individuals are not addressed in current research ethics guidelines, nor have they even been thoroughly explored. The main objectives of this research are to: (1 identify ethical issues arising in cluster trials and learn how they are currently being addressed; (2 understand how ethics reviews of cluster trials are carried out in different countries (Canada, the USA and the UK; (3 elicit the views and experiences of trial participants and cluster representatives; (4 develop well-grounded guidelines for the ethical conduct and review of cluster trials by conducting an extensive ethical analysis and organizing a consensus process; (5 disseminate the guidelines to researchers, research ethics boards (REBs, journal editors, and research funders. Methods We will use a mixed-methods (qualitative and quantitative approach incorporating both empirical and conceptual work. Empirical work will include a systematic review of a random sample of published trials, a survey and in-depth interviews with trialists, a survey of REBs, and in-depth interviews and focus group discussions with trial participants and gatekeepers. The empirical work will inform the concurrent ethical analysis which will lead to a guidance document laying out principles, policy options, and rationale for proposed guidelines. An

  11. Nonjudging facet of mindfulness predicts enhanced smoking cessation in Hispanics.

    Science.gov (United States)

    Spears, Claire Adams; Houchins, Sean C; Stewart, Diana W; Chen, Minxing; Correa-Fernández, Virmarie; Cano, Miguel Ángel; Heppner, Whitney L; Vidrine, Jennifer I; Wetter, David W

    2015-12-01

    Although most smokers express interest in quitting, actual quit rates are low. Identifying strategies to enhance smoking cessation is critical, particularly among underserved populations, including Hispanics, for whom many of the leading causes of death are related to smoking. Mindfulness (purposeful, nonjudgmental attention to the present moment) has been linked to increased likelihood of cessation. Given that mindfulness is multifaceted, determining which aspects of mindfulness predict cessation could help to inform interventions. This study examined whether facets of mindfulness predict cessation in 199 Spanish-speaking smokers of Mexican heritage (63.3% male, mean age of 39 years, 77.9% with a high school education or less) receiving smoking cessation treatment. Primary outcomes were 7-day abstinence at weeks 3 and 26 postquit (biochemically confirmed and determined using an intent-to-treat approach). Logistic random coefficient regression models were utilized to examine the relationship between mindfulness facets and abstinence over time. Independent variables were subscales of the Five Facet Mindfulness Questionnaire (Observing, Describing, Acting With Awareness, Nonjudging, and Nonreactivity). The Nonjudging subscale (i.e., accepting thoughts and feelings without evaluating them) uniquely predicted better odds of abstinence up to 26 weeks postquit. This is the first known study to examine whether specific facets of mindfulness predict smoking cessation. The ability to experience thoughts, emotions, and withdrawal symptoms without judging them may be critical in the process of quitting smoking. Results indicate potential benefits of mindfulness among smokers of Mexican heritage and suggest that smoking cessation interventions might be enhanced by central focus on the Nonjudging aspect of mindfulness.

  12. Design considerations for a study to evaluate the impact of smoking cessation treatment on stimulant use outcomes in stimulant-dependent individuals.

    Science.gov (United States)

    Winhusen, Theresa; Stitzer, Maxine; Woody, George; Brigham, Gregory; Kropp, Frankie; Ghitza, Udi; Lindblad, Robert; Adinoff, Bryon; Green, Cindy; Sharma, Gaurav; Somoza, Eugene

    2012-01-01

    Cigarette smoking is prevalent in cocaine/methamphetamine-dependent patients and associated with significant morbidity and mortality, yet, the provision of smoking cessation treatment in conjunction with substance use disorder (SUD) treatment is not standard practice. This is due, in part, to clinician concern that combining smoking cessation treatment with SUD treatment could lead to poorer SUD outcomes. The NIDA Clinical Trials Network is conducting a 10-week, two-group, randomized trial to evaluate the impact of providing smoking cessation treatment (SCT) with SUD treatment as usual (TAU), compared to TAU alone, in smokers who are in outpatient treatment for cocaine or methamphetamine dependence. Approximately 528 participants, recruited from 12 community treatment programs, will be randomized into the trial. The present paper describes key design decisions made during protocol development. The trial is designed to evaluate the relationship between cigarette smoking and stimulant use, which prior research suggests is linked, and should contribute to our understanding of how best to address the co-occurring problems of nicotine dependence and cocaine/methamphetamine-dependence. Unique aspects of the trial include the primary question of interest, which concerns the impact of providing SCT on SUD outcomes rather than on smoking outcomes, and the intensity of the SCT chosen, which includes bupropion, nicotine replacement, and two psychosocial interventions.

  13. Model for implementing cognitive behavioural therapy for smartphone app based smoking cessation program

    Directory of Open Access Journals (Sweden)

    Abdullah Alsharif

    2015-11-01

    Full Text Available Smoking cessation programs are widely implemented to assist smokers in the process of quitting smoking. Cognitive Behavioural Therapy (CBT is a psychological approach that is increasingly used in smoking cessation programs. CBT has also been implemented for smoking cessation programs and has been successful in helping smokers to quit. Another advantage of CBT is that it can be combined with different tools and technologies and hence made to deliver effective health intervention programs. The recent advancements in smartphone technologies have been widely explored to develop smoking cessation apps as tools to assist with quitting smoking. However, most existing smartphone apps lack follow-up and adherence to clinical guidelines for treatment. To date, there are no studies which have explored implementing CBT modules into smoking cessation apps. Therefore, there is a need for implementing behavioural change mechanisms in smoking cessation apps to help smokers quit effectively. In this study, we propose a new approach that combines mobile health technology and CBT methods to provide an effective smoking cessation program. The ubiquitous presence of smartphones and the various communication benefits they provide are utilized by our proposed system to provide a CBT paradigm into smoking cessation app systems and hence enhance their success potential. Currently, the proposed system is at the implementation stage, which is soon to be followed by a clinical trial to study the impact of this system on smoking cessation.

  14. Rationale for Student Dress Codes: A Review of School Handbooks

    Science.gov (United States)

    Freeburg, Elizabeth W.; Workman, Jane E.; Lentz-Hees, Elizabeth S.

    2004-01-01

    Through dress codes, schools establish rules governing student appearance. This study examined stated rationales for dress and appearance codes in secondary school handbooks; 182 handbooks were received. Of 150 handbooks containing a rationale, 117 related dress and appearance regulations to students' right to a non-disruptive educational…

  15. Interventions for preoperative smoking cessation

    DEFF Research Database (Denmark)

    Thomsen, Thordis; Villebro, Nete; Møller, Ann Merete

    2010-01-01

    Background Smokers have a substantially increased risk of postoperative complications. Preoperative smoking intervention may be effective in decreasing this incidence, and surgery may constitute a unique opportunity for smoking cessation interventions. Objectives The objective of this review...... was to assess the effect of preoperative smoking intervention on smoking cessation at the time of surgery and 12 months postoperatively and on the incidence of postoperative complications. Search strategy The specialized register of the Cochrane Tobacco Addiction Group was searched using the free text...... and keywords (surgery) or (operation) or (anaesthesia) or (anesthesia). MEDLINE, EMBASE and CINAHL were also searched, combining tobacco- and surgery-related terms. Most recent search April 2010. Selection criteria Randomized controlled trials that recruited people who smoked prior to surgery, offered...

  16. Rationale Management Challenges in Requirements Engineering

    NARCIS (Netherlands)

    Liang, Peng; Avgeriou, Paris; He, Keqing

    2010-01-01

    Rationale and rationale management have been playing an increasingly prominent role in software system development mainly due to the knowledge demand during system evaluation, maintenance, and evolution, especially for large and complex systems. The rationale management for requirements engineering,

  17. Smoking cessation: an application of theory of planned behavior to understanding progress through stages of change.

    Science.gov (United States)

    Bledsoe, Linda K

    2006-07-01

    The purpose of this research was to investigate variables relevant to smoking cessation early in the process of change through an application of the Theory of Planned Behavior [Ajzen, I. (1985). From intentions to actions: A theory of planned behavior. In J. Kuhl and J. Beckman (Eds). Action-control: From cognition to behavior (pp.11-39). Heidelberg: Springer.] to the temporal structure provided by the Transtheoretical Model. Study 1 was a preliminary elicitation study (n=68) conducted to ground the concepts used in the model testing in Study 2 [Ajzen, I., Fishbein, M. (1980). Understanding attitudes and predicting social behavior, Englewood Cliffs, NJ: Prentice-Hall.]. Study 2 tested the proposed model fit with data from a sample of 230 adult smokers. Structural equation modeling did not support the Theory of Planned Behavior as a model of motivation for progress through the stages of change and highlighted measurement issues with perceived behavioral control. A modified model using the Theory of Reasoned Action provided a good fit to the data, accounting for approximately 64% of the variance in intention to quit smoking and stage of change. This research addresses the need for a more complete theoretical rationale for progress through stages of change.

  18. Study rationale and design of OPTIMISE, a randomised controlled trial on the effect of benchmarking on quality of care in type 2 diabetes mellitus

    Directory of Open Access Journals (Sweden)

    Hermans Michel P

    2011-09-01

    Full Text Available Abstract Background To investigate the effect of physician- and patient-specific feedback with benchmarking on the quality of care in adults with type 2 diabetes mellitus (T2DM. Methods Study centres in six European countries were randomised to either a benchmarking or control group. Physicians in both groups received feedback on modifiable outcome indicators (glycated haemoglobin [HbA1c], glycaemia, total cholesterol, high density lipoprotein-cholesterol, low density lipoprotein [LDL]-cholesterol and triglycerides for each patient at 0, 4, 8 and 12 months, based on the four times yearly control visits recommended by international guidelines. The benchmarking group also received comparative results on three critical quality indicators of vascular risk (HbA1c, LDL-cholesterol and systolic blood pressure [SBP], checked against the results of their colleagues from the same country, and versus pre-set targets. After 12 months of follow up, the percentage of patients achieving the pre-determined targets for the three critical quality indicators will be assessed in the two groups. Results Recruitment was completed in December 2008 with 3994 evaluable patients. Conclusions This paper discusses the study rationale and design of OPTIMISE, a randomised controlled study, that will help assess whether benchmarking is a useful clinical tool for improving outcomes in T2DM in primary care. Trial registration NCT00681850

  19. Conocimiento y actitud del odontólogo frente al manejo del tabaquismo: estudio comparativo entre España, Italia y Venezuela The participation of dentists in smoking cessation: comparative study of Venezuelan, Spanish and Italian dentists

    Directory of Open Access Journals (Sweden)

    M. Villarroel Dorrego

    2009-08-01

    Full Text Available Introducción: El Odontólogo es capaz de ejercer un gran impacto en el tabaquismo a través de su contacto con los pacientes y la detección precoz de lesiones bucales. El objetivo de este estudio fue determinar el conocimiento y la actitud de los odontólogos frente al tabaquismo en tres países distintos. Materiales y métodos: Se realizó una encuesta a 293 odontólogos, 93 de ellos localizados en Caracas (OV, 90 con práctica odontológica en Madrid (OE y 110 en Milán (OI. Resultados: 46 OE y 22 OI indicaron ser fumadores, mientras que tan solo 10 OV admitieron ser fumadores. 80 (86,02% OV, 66 (73,33% OE y todos los OI refirieron registrar en la historia datos relacionados con tabaquismo en la primera consulta del paciente. La mayoría motiva a sus pacientes a dejar de fumar, sin embargo, 72,04% (67 OV, 55,55% (50 OE y 100% OI no recomiendan ninguna terapia de apoyo. Sólo 7 odontólogos (2,38% (2 OV y 5 OE reconocieron el medicamento Bupropion pero ningún odontólogo lo ha indicado. Finalmente, 137 odontólogos han diagnosticado cáncer bucal, de los cuales 108 eran OI. Conclusiones: Los odontólogos, independientemente del país, tienen actitudes positivas para participar en el control del tabaquismo, pero no manejan la información relacionada ni ejercen un rol activo en la cesación. Probablemente esta situación se deba a la falta de entrenamiento durante sus estudios de pre y/o postgrado lo cual amerita una revisión de los planes curriculares de Odontología a nivel mundial.Introduction: Health care professionals have an important role in tobacco control. Dentists are capable of having a great impact in smoking cessation due to their regular contact with patients and the rapid detection of oral signs produced by smoking. Unfortunately, there are few dentists actively involved in smoking control. The aim of this study was to investigate various aspects of dentists' beliefs and practices with respect to smoking cessation. Materials

  20. Coping Strategies Used by Adolescents during Smoking Cessation

    Science.gov (United States)

    Jannone, Laura; O'Connell, Kathleen A.

    2007-01-01

    The purpose of this study was to examine coping strategies used by teens as they attempted to quit smoking. The teens were attending a school-based cessation program titled "Quit 2 Win" that was offered in four high schools. This study examined situations in which teens were tempted to smoke. The study compares coping strategies teens reported in…

  1. [Smoking cessation in pneumological routine care].

    Science.gov (United States)

    Hering, Th; Andres, J; Gebhardt, R; Grah, Ch; Schultz, Th

    2011-11-01

    Continuous cigarette smoking clearly influences the course and prognosis of diseases like COPD/emphysema and asthma bronchiale in an adverse manner. However smoking cessation as a therapy measure is not a common part of general health-care in Germany as reimbursement of the central component of psychosocial support (behavioural therapy - BT) is allowed only to a minor degree and of pharmacotherapy support (nicotine replacement, varenicline, bupropione) is completely excluded by the legislator. This prospective "real-life" study with 198 participants shows, that with the abolition of the reimbursement barrier for cognitive behavioural therapy in the setting of a pneumological practice/clinic a high long-term abstinence of 45.4 % (point prevalence after 12 months) can be achieved. Apart from the reimbursement of BT, predominant success factors were the implementation of the measure in the practice/clinic, where patients are under long-term treatment and the application of a two-stage motivational model for the participation. Reimbursement of smoking cessation pharmacotherapy was not possible in this study. Thus, pharmacotherapy was applied to fewer than necessary patients and was predominantly too short and in a too low dosage.

  2. A Cluster-Randomized Controlled Trial Evaluating the Effectiveness and Cost-Effectiveness of Tobacco Cessation on Prescription in Swedish Primary Health Care: A Protocol of the Motivation 2 Quit (M2Q) Study

    Science.gov (United States)

    Lindgren, Peter; Sundberg, Carl Johan; Petzold, Max; Tomson, Tanja

    2016-01-01

    Background In Sweden, the prevalence of tobacco use is disproportionately high among socioeconomically disadvantaged groups. Previous research and clinical experience suggest that prescribed lifestyle interventions in the primary health care (PHC) setting such as Physical Activity on Prescription are effective in changing behavior. However, there is a lack of evidence for if and how such a prescription approach could be effectively transferred into the tobacco cessation context. Objective The aim of this trial is to evaluate the effectiveness and cost-effectiveness of Tobacco Cessation on Prescription (TCP) compared to current practice for tobacco cessation targeting socioeconomically disadvantaged groups in the PHC setting in Sweden. Methods The design is a pragmatic cluster-randomized controlled trial. The sample will consist of 928 daily tobacco users with Swedish social security numbers and permanent resident permits, recruited from 14-20 PHC centers located in socioeconomically disadvantaged areas in Stockholm County. The primary outcome will be measured in self-reported 7-day abstinence at 6 and 12 months after the intervention. The secondary outcomes will be measured in daily tobacco consumption, number of quit attempts, and health-related quality of life at 6 and 12 months after the intervention. Data will be collected through questionnaires and review of electronic medical records. Cost-effectiveness will be estimated through decision analytic modeling and measured by the incremental cost per quality-adjusted life year. Results In the first set of PHC centers participating in the study, eight centers have been included. Recruitment of individual study participants is currently ongoing. Inclusion of a second set of PHC centers is ongoing with expected study start in September 2016. Conclusions If TCP is found effective and cost-effective compared to standard treatment, the method could be implemented to facilitate tobacco cessation for socioeconomically

  3. A randomized, open-label pilot comparison of gabapentin and bupropion SR for smoking cessation.

    Science.gov (United States)

    White, William D; Crockford, David; Patten, Scott; El-Guebaly, Nady

    2005-10-01

    This 6-week, randomized, open-label pilot study estimated the treatment effect size of gabapentin (n = 17) compared with bupropion SR (n = 19) for smoking cessation, thereby allowing sample size calculations for a definitive comparison study. The primary outcome measure was smoking cessation. Secondary outcome measures included smoking reduction and withdrawal severity. Gabapentin was less efficacious than bupropion for smoking cessation but was associated with fewer dropouts from adverse effects. Withdrawal severity was less with bupropion. Bupropion remains the first-line non-nicotine pharmacotherapy for smoking cessation. Further study is required to determine if gabapentin has any useful role in smoking cessation. Based on our primary outcome measure, 79 subjects would be required in each treatment group of a two-armed study to achieve 90% power for detecting a difference in efficacy between gabapentin and bupropion.

  4. Social-cognitive predictors of intended and actual benzodiazepine cessation among chronic benzodiazepine users

    NARCIS (Netherlands)

    Ten Wolde, Geeske B.; Dijkstra, Arie; Van Empelen, Pepijn; Neven, Arie Knuistingh; Zitman, Frans G.

    2008-01-01

    Long-term benzodiazepine use is associated with a variety of negative health consequences. Cessation of long-term use is therefore an important health goal. In a prospective study among chronic benzodiazepinc users (N=356) social-cognitive factors of benzodiazepine cessation were examined with a nin

  5. Randomized Controlled Trial of Behavioral Activation Smoking Cessation Treatment for Smokers with Elevated Depressive Symptoms

    Science.gov (United States)

    MacPherson, Laura; Tull, Matthew T.; Matusiewicz, Alexis K.; Rodman, Samantha; Strong, David R.; Kahler, Christopher W.; Hopko, Derek R.; Zvolensky, Michael J.; Brown, Richard A.; Lejuez, C. W.

    2010-01-01

    Objective: Depressive symptoms are associated with poor smoking cessation outcomes, and there remains continued interest in behavioral interventions that simultaneously target smoking and depressive symptomatology. In this pilot study, we examined whether a behavioral activation treatment for smoking (BATS) can enhance cessation outcomes. Method:…

  6. The efficacy and safety of a nicotine conjugate vaccine (NicVAX® or placebo co-administered with varenicline (Champix® for smoking cessation: study protocol of a phase IIb, double blind, randomized, placebo controlled trial

    Directory of Open Access Journals (Sweden)

    Hoogsteder Philippe HJ

    2012-12-01

    Full Text Available Abstract Background A potential new treatment in smoking cessation and relapse prevention is nicotine vaccination which is based on active immunization against the nicotine molecule. This immunization will elicit the immune system to produce nicotine-specific antibodies that sequester nicotine in the blood stream, after inhaling tobacco products. The resulting antibody-antigen is too large to cross the blood–brain barrier and is therefore postulated to attenuate the rewarding effect of nicotine by preventing the latter from reaching its receptors in the brain and causing the release of dopamine. The aim of this paper is to describe the design of a phase IIb, multi-center, double blind, randomized, placebo controlled trial to assess the efficacy of the nicotine vaccine NicVAX® co-administered with varenicline (Champix® and intensive counseling as an aid in smoking cessation and relapse prevention. Methods/design Two centers will include a total of 600 smokers who are motivated to quit smoking. At week −2 these smokers will be randomized, in a 1:1 ratio, to either 6 injections of NicVAX® or placebo, both co-administered with 12-weeks of varenicline treatment, starting at week 0. The target quit day will be set after 7 days of varenicline treatment at week 1. Smokers will be followed up for 54 weeks. The primary outcome is defined as biochemically validated prolonged smoking abstinence from week 9 to 52. Secondary outcomes include safety, immunogenicity, smoking abstinence from week 37 to 52, abstinence from week 9 to 24, abstinence in the subset of subjects with the highest antibody response, and lapse/relapse rate. Discussion This is the first study to assess the efficacy of a nicotine conjugate vaccine in combination with an evidence-based smoking cessation pharmacotherapy (varenicline to quit smoking. Although NicVAX® is primarily designed as an aid to smoking cessation, our study is designed to explore its potential to maintain

  7. In the Clinic. Smoking Cessation.

    Science.gov (United States)

    Patel, Manish S; Steinberg, Michael B

    2016-03-01

    This issue provides a clinical overview of smoking cessation, focusing on health consequences of smoking, prevention of smoking-related disease, treatment, and practice improvement. The content of In the Clinic is drawn from the clinical information and education resources of the American College of Physicians (ACP), including MKSAP (Medical Knowledge and Self-Assessment Program). Annals of Internal Medicine editors develop In the Clinic in collaboration with the ACP's Medical Education and Publishing divisions and with the assistance of additional science writers and physician writers.

  8. A randomised trial of the Flinders Program to improve patient self-management competencies in a range of chronic conditions: study rationale and protocol

    Directory of Open Access Journals (Sweden)

    Malcolm W. Battersby

    2010-03-01

    Full Text Available BackgroundSupporting self management is seen as an important healthservice strategy in dealing with the large and increasing healthburden of chronic conditions. Several types of selfmanagementprograms are available. Evidence to datesuggests that disease-specific and lay-led self managementprograms provide only part of the support needed forimproved outcomes. The Flinders Program is promising as ageneric self management intervention, which can becombined with targeted disease-specific and lay-ledinterventions, but it has yet to be evaluated for a range ofchronic conditions using a rigorous controlled trial design. Thispaper gives the rationale for a randomised controlled trial andprocess evaluation of the Flinders Program of chroniccondition self-management in community practice, and detailsand justifies the design of such a study.MethodThe design for a randomised trial and associated processevaluation, suited to evaluation of a complex and behaviouralintervention as it is applied in actual practice, is presented andjustified.ConclusionA randomised trial of the Flinders Program is required and afunctional design is presented. Results from this trial,currently underway, will test the effectiveness of the FlindersProgram in improving patient competencies in selfmanagementof chronic conditions in practice conditions.A process evaluation alongside the trial will exploresystem, provider and patient factors associated withgreater and lesser Program effectiveness.

  9. Motivational Interviewing for Smoking Cessation: A Meta-Analytic Review

    Science.gov (United States)

    Hettema, Jennifer E.; Hendricks, Peter S.

    2010-01-01

    Objective: Motivational interviewing (MI) is a treatment approach that has been widely examined as an intervention for tobacco dependence and is recommended in clinical practice guidelines. Previous reviews evaluating the efficacy of MI for smoking cessation noted effects that were modest in magnitude but included few studies. The current study is…

  10. Design and rationale of the HCC BRIDGE study in China: a longitudinal, multicenter cohort trial in hepatocellular carcinoma

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    Qiao You-Lin

    2011-05-01

    Full Text Available Abstract Background More than 50% of the worldwide cases of hepatocellular carcinoma occur in China, and this malignancy currently represents the country's second leading cause of cancer death in cities and the leading cause in rural areas. Despite recent advances in the control and management of hepatocellular carcinoma within China, this disease remains a major health care issue. The global HCC BRIDGE study, designed to assess patterns of hepatocellular carcinoma therapy use and associated outcomes across real-world clinical practice, has recently been expanded as a national study in China, allowing a detailed analysis of hepatocellular carcinoma in this important country. Methods/Design The global HCC BRIDGE study is a multiregional longitudinal cohort trial including patients newly diagnosed with hepatocellular carcinoma between January 1, 2005, and June 30, 2011, who are receiving treatment for hepatocellular carcinoma via sites in the Asia-Pacific, European, and North American regions. The HCC BRIDGE China national study comprises the portion of the global HCC BRIDGE study conducted within mainland China. Patients will be followed from time of diagnosis of hepatocellular carcinoma (post-January 1, 2005 to time of death or December 31, 2011, whichever comes first. Data will be collected on demographic/clinical characteristics, relevant laboratory values, hepatocellular carcinoma/underlying liver disease treatment, tumor response, adverse events, hospitalizations, and overall survival. The primary study end point is overall survival; secondary end points are disease progression, treatment-limiting adverse events, and treatment failure. Results At the time of writing, 15 sites have selected for participation across all 7 traditional regions of China (North, North-East, East, South, South-West, North-West, and Central. The anticipated study population from the China national study is approximately 9000 patients. Discussion Findings from the

  11. Isolating the Role of Psychological Dysfunction in Smoking Cessation Failure: Relations of Personality and Psychopathology to Attaining Smoking Cessation Milestones

    Science.gov (United States)

    Leventhal, Adam M.; Japuntich, Sandra J.; Piper, Megan E.; Jorenby, Douglas E.; Schlam, Tanya R.; Baker, Timothy B.

    2012-01-01

    Research exploring psychological dysfunction as a predictor of smoking cessation success may be limited by nonoptimal predictor variables (i.e., categorical psychodiagnostic measures vs. continuous personality-based manifestations of dysfunction) and imprecise outcomes (i.e., summative point prevalence abstinence vs. constituent cessation milestone measures). Accordingly, this study evaluated the unique and overlapping relations of broad-spectrum personality traits (positive emotionality, negative emotionality, and constraint) and past-year psychopathology (anxiety, mood, and substance use disorder) to point prevalence abstinence and three smoking cessation milestones: (1) initiating abstinence; (2) first lapse; and (3) transition from lapse to relapse. Participants were daily smokers (N=1365) enrolled in a smoking cessation treatment study. In single predictor regression models, each manifestation of internalizing dysfunction (lower positive emotionality, higher negative emotionality, and anxiety and mood disorder) predicted failure at one or more cessation milestone. In simultaneous predictor models, lower positive and higher negative emotionality significantly predicted failure to achieve milestones after controlling for psychopathology. Psychopathology did not predict any outcome when controlling for personality. Negative emotionality showed the most robust and consistent effects, significantly predicting failure to initiate abstinence, earlier lapse, and lower point prevalence abstinence rates. Substance use disorder and constraint did not predict cessation outcomes, and no single variable predicted lapse-to-relapse transition. These findings suggest that personality-related manifestations of internalizing dysfunction are more accurate markers of affective sources of relapse risk than mood and anxiety disorders. Further, individuals with high trait negative emotionality may require intensive intervention to promote the initiation and early maintenance of

  12. Neural correlates of message tailoring and self-relatedness in smoking cessation programming

    Science.gov (United States)

    Chua, Hannah Faye; Liberzon, Israel; Welsh, Robert C.; Strecher, Victor J.

    2011-01-01

    BACKGROUND Smoking leads to illnesses including addiction, cancer, and cardiovascular and respiratory diseases. Different intervention programs have become available. In the past decade, providing tailored smoking cessation messages has been shown to be more effective in inducing smoking cessation than one-size-fits-all interventions. However, little is known about the brain responses of smokers when they receive tailored smoking cessation messages. METHODS A neuroimaging study using blocked and event-related designs examined neural activity in 24 smokers exposed to high-tailored and low-tailored smoking cessation messages. RESULTS: In both blocked and event-related conditions, rostral medial prefrontal cortex and precuneus/posterior cingulate were engaged more during the processing of high-tailored smoking cessation messages than low-tailored smoking cessation messages. CONCLUSION The activation patterns of smokers to tailored cessation messages show involvement of brain areas commonly implicated in self-related processing. Results seem to add support to the suggested role of self-relevance in tailored cessation programs, where previous studies have shown a potential mediating role of self-relevance on smoking abstinence. The findings are relevant to understanding the cognitive mechanisms underlying tailored message processing and may point to new directions for testing response to health communications programming. PMID:18926523

  13. Impact of integrated upper limb spasticity management including botulinum toxin A on patient-centred goal attainment:rationale and protocol for an international, prospective, longitudinal cohort study (ULIS III)

    OpenAIRE

    Turner-Stokes, Lynne Frances; Ashford, Stephen; Jacinto, Jorge; Maisonobe, Pascal; Balcaitiene, Jovita; Fheodoroff, Klemens

    2016-01-01

    OBJECTIVES: Describe the rationale and protocol for the Upper Limb International Spasticity (ULIS)-III study, which aims to evaluate the impact of integrated spasticity management, involving multiple botulinum toxin A (BoNT-A) injection cycles and concomitant therapies, on patient-centred goal attainment. Outline novel outcome assessment methods for ULIS-III and report initial evaluation data from goal setting in early stages of the study.DESIGN: Large international longitudinal cohort study ...

  14. Determinants of smoking cessation in COPD patients treated in the outpatient setting

    DEFF Research Database (Denmark)

    Tøttenborg, Sandra S; Thomsen, Reimar W; Johnsen, Søren P

    2016-01-01

    BACKGROUND: The beneficial effects of smoking cessation on the progression of COPD are well established. Nevertheless, many patients with COPD continue to smoke. METHODS: In this nationwide hospital-based prospective follow-up study, we examined rates of smoking cessation and clinical and sociode......BACKGROUND: The beneficial effects of smoking cessation on the progression of COPD are well established. Nevertheless, many patients with COPD continue to smoke. METHODS: In this nationwide hospital-based prospective follow-up study, we examined rates of smoking cessation and clinical...... and sociodemographic determinants of smoking cessation in 3,233 patients with COPD who smoked on outpatient contact during 2008 to 2012. Using multivariate Cox regression, we calculated hazard ratios (HRs) of quitting. RESULTS: Within 1 and 5 years from first outpatient contact, the probability of quitting was 19...... Medical Research Council (MRC) dyspnea scale score reinforce that young and socioeconomically disadvantaged patients have more difficulties achieving...

  15. Effect of training cessation on muscular performance: a meta-analysis.

    Science.gov (United States)

    Bosquet, L; Berryman, N; Dupuy, O; Mekary, S; Arvisais, D; Bherer, L; Mujika, I

    2013-06-01

    The purpose of this study was to assess the effect of resistance training cessation on strength performance through a meta-analysis. Seven databases were searched from which 103 of 284 potential studies met inclusion criteria. Training status, sex, age, and the duration of training cessation were used as moderators. Standardized mean difference (SMD) in muscular performance was calculated and weighted by the inverse of variance to calculate an overall effect and its 95% confidence interval (CI). Results indicated a detrimental effect of resistance training cessation on all components of muscular performance: [submaximal strength; SMD (95% CI) = -0.62 (-0.80 to -0.45), P  65 years old). The effect was also larger in inactive people for maximal force and maximal power when compared with recreational athletes. Resistance training cessation decreases all components of muscular strength. The magnitude of the effect differs according to training status, age or the duration of training cessation.

  16. Design and rationale for RE-VERSE AD : A phase 3 study of idarucizumab, a specific reversal agent for dabigatran

    NARCIS (Netherlands)

    Pollack, Charles V.; Reilly, Paul A.; Bernstein, Richard; Dubiel, Robert; Eikelboom, John; Glund, Stephan; Huisman, Menno V.; Hylek, Elaine; Kam, Chak-Wah; Kamphuisen, Pieter W.; Kreuzer, Joerg; Levy, Jerrold H.; Sellke, Frank; Stangier, Joachim; Steiner, Thorsten; Wang, Bushi; Weitz, Jeffrey I.

    2015-01-01

    Idarucizumab, a Fab fragment directed against dabigatran, produced rapid and complete reversal of the anticoagulation effect of dabigatran in animals and in healthy volunteers. The Study of the REVERSal Effects of Idarucizumab in Patients on Active Dabigatran (RE-VERSE AD (TM)) is a global phase 3 p

  17. Rationale, design, and baseline characteristics of the Canagliflozin Cardiovascular Assessment Study (CANVAS)-A randomized placebo-controlled trial

    NARCIS (Netherlands)

    Neal, Bruce; Perkovic, Vlado; de Zeeuw, Dick; Mahaffey, Kenneth W.; Fulcher, Greg; Stein, Peter; Desai, Mehul; Shaw, Wayne; Jiang, Joel; Vercruysse, Frank; Meininger, Gary; Matthews, David

    2013-01-01

    Sodium glucose co-transporter 2 inhibition is a novel mode of treatment for type 2 diabetes mellitus (T2DM). The sodium glucose co-transporter 2 inhibitor canagliflozin lowered blood glucose, blood pressure, and body weight, with increased risk of urogenital infections in Phase 2 studies. Effects on

  18. Occipital nerve stimulation in medically intractable, chronic cluster headache. The ICON study: Rationale and protocol of a randomised trial

    NARCIS (Netherlands)

    Wilbrink, Leopoldine A.; Teernstra, Onno P.M.; Haan, Joost; Zwet, van Erik W.; Evers, Silvia M.A.A.; Spincemaille, Geert H.; Veltink, Peter H.; Mulleners, Wim; Brand, Ronald; Huygen, Frank J.P.M.; Jensen, Rigmor H.; Paemeleire, Koen; Goadsby, Peter J.; Visser-Vandewalle, Veerle; Ferrari, Michel D.

    2013-01-01

    Background: About 10% of cluster headache patients have the chronic form. At least 10% of this chronic group is intractable to or cannot tolerate medical treatment. Open pilot studies suggest that occipital nerve stimulation (ONS) might offer effective prevention in these patients. Controlled neurom

  19. Effect of trans fatty acid isomers from ruminant sources on risk factors of cardiovascular disease: study design and rationale.

    Science.gov (United States)

    Gebauer, Sarah K; Destaillats, Frederic; Mouloungui, Zéphirin; Candy, Laure; Bezelgues, Jean-Baptiste; Dionisi, Fabiola; Baer, David J

    2011-07-01

    Substantial evidence clearly demonstrates the deleterious effects of industrially-produced trans fatty acids (TFA); however, data are lacking from large, well controlled human feeding studies that directly compare the effects of industrially-produced and naturally-occurring TFA. The purpose of the current study is to determine whether consumption of TFA derived from different sources differentially affect risk factors of cardiovascular disease (CVD). The study was a randomized, crossover design, controlled-feeding intervention designed to compare the effects of the following diet treatments on risk factors of CVD: low TFA diet (base diet, 34% energy from fat; 0.1% energy from TFA), base diet with vaccenic acid (3.0% energy), base diet with mixed isomers of TFA from partially hydrogenated vegetable oil (3.0% energy), and base diet with cis-9, trans-11 CLA (1.0% energy). The added energy from TFA replaced energy from stearic acid. Participants were required to be between the ages of 25 and 65 years, have a body mass index between 20 and 38 kg/m(2), total cholesterol affect markers of cardiovascular risk, in the context of a highly controlled feeding study.

  20. Prosthetic valves in adult patients with congenital heart disease : Rationale and design of the Dutch PROSTAVA study

    NARCIS (Netherlands)

    Freling, H. G.; van Slooten, Y. J.; van Melle, J. P.; Mulder, B. J. M.; van Dijk, A. P. J.; Hillege, H. L.; Post, M. C.; Sieswerda, G. Tj; Jongbloed, M. R. M.; Willems, T. P.; Pieper, P. G.

    2012-01-01

    Data on long-term complications in adult patients with congenital heart disease (ACHD) and a prosthetic valve are scarce. Moreover, the influence of prosthetic valves on quality of life (QoL) and functional outcome in ACHD patients with prosthetic valves has not been studied. The primary objective o

  1. Prosthetic valves in adult patients with congenital heart disease: Rationale and design of the Dutch PROSTAVA study

    NARCIS (Netherlands)

    Freling, H.G.; Slooten, Y.J. van; Melle, J.P. van; Mulder, B.J.; Dijk, A.P. van; Hillege, H.L.; Post, M.C.; Sieswerda, G.T.; Jongbloed, M.R.; Willems, T.P.; Pieper, P.G.

    2012-01-01

    BACKGROUND: Data on long-term complications in adult patients with congenital heart disease (ACHD) and a prosthetic valve are scarce. Moreover, the influence of prosthetic valves on quality of life (QoL) and functional outcome in ACHD patients with prosthetic valves has not been studied. OBJECTIVES:

  2. Markers of achievement for assessing and monitoring gender equity in translational research organisations: a rationale and study protocol

    Science.gov (United States)

    Edmunds, Laurel D; Pololi, Linda H; Greenhalgh, Trisha; Kiparoglou, Vasiliki; Henderson, Lorna R; Williamson, Catherine; Grant, Jonathan; Lord, Graham M; Channon, Keith M; Lechler, Robert I; Buchan, Alastair M

    2016-01-01

    Introduction Translational research organisations (TROs) are a core component of the UK's expanding research base. Equity of career opportunity is key to ensuring a diverse and internationally competitive workforce. The UK now requires TROs to demonstrate how they are supporting gender equity. Yet, the evidence base for documenting such efforts is sparse. This study is designed to inform the acceleration of women's advancement and leadership in two of the UK's leading TROs—the National Institute for Health Research (NIHR) Biomedical Research Centres (BRCs) in Oxford and London—through the development, application and dissemination of a conceptual framework and measurement tool. Methods and analysis A cross-sectional retrospective evaluation. A conceptual framework with markers of achievement and corresponding candidate metrics has been specifically designed for this study based on an adapted balanced scorecard approach. It will be refined with an online stakeholder consultation and semistructured interviews to test the face validity and explore practices and mechanisms that influence gender equity in the given settings. Data will be collected via the relevant administrative databases. A comparison of two funding periods (2007–2012 and 2012–2017) will be carried out. Ethics and dissemination The University of Oxford Clinical Trials and Research Governance Team and the Research and Development Governance Team of Guy's and St Thomas’ National Health Service (NHS) Foundation Trust reviewed the study and deemed it exempt from full ethics review. The results of the study will be used to inform prospective planning and monitoring within the participating NIHR BRCs with a view to accelerating women's advancement and leadership. Both the results of the study and its methodology will be further disseminated to academics and practitioners through the networks of collaborating TROs, relevant conferences and articles in peer-reviewed journals. PMID:26743702

  3. Rationale and methods of the European Study on Cardiovascular Risk Prevention and Management in Daily Practice (EURIKA

    Directory of Open Access Journals (Sweden)

    Jiménez Francisco

    2010-06-01

    Full Text Available Abstract Background The EURIKA study aims to assess the status of primary prevention of cardiovascular disease (CVD across Europe. Specifically, it will determine the degree of control of cardiovascular risk factors in current clinical practice in relation to the European guidelines on cardiovascular prevention. It will also assess physicians' knowledge and attitudes about CVD prevention as well as the barriers impeding effective risk factor management in clinical practice. Methods/Design Cross-sectional study conducted simultaneously in 12 countries across Europe. The study has two components: firstly at the physician level, assessing eight hundred and nine primary care and specialist physicians with a daily practice in CVD prevention. A physician specific questionnaire captures information regarding physician demographics, practice settings, cardiovascular prevention beliefs and management. Secondly at the patient level, including 7641 patients aged 50 years or older, free of clinical CVD and with at least one classical risk factor, enrolled by the participating physicians. A patient-specific questionnaire captures information from clinical records and patient interview regarding sociodemographic data, CVD risk factors, and current medications. Finally, each patient provides a fasting blood sample, which is sent to a central laboratory for measuring serum lipids, apolipoproteins, hemoglobin-A1c, and inflammatory biomarkers. Discussion Primary prevention of CVD is an extremely important clinical issue, with preventable circulatory diseases remaining the leading cause of major disease burden. The EURIKA study will provide key information to assess effectiveness of and attitudes toward primary prevention of CVD in Europe. A transnational study creates opportunities for benchmarking good clinical practice across countries and improving outcomes. (ClinicalTrials.gov number, NCT00882336.

  4. The Prevention of Early Asthma in Kids study: design, rationale and methods for the Childhood Asthma Research and Education network.

    Science.gov (United States)

    Guilbert, Theresa W; Morgan, Wayne J; Krawiec, Marzena; Lemanske, Robert F; Sorkness, Chris; Szefler, Stanley J; Larsen, Gary; Spahn, Joseph D; Zeiger, Robert S; Heldt, Gregory; Strunk, Robert C; Bacharier, Leonard B; Bloomberg, Gordon R; Chinchilli, Vernon M; Boehmer, Susan J; Mauger, Elizabeth A; Mauger, David T; Taussig, Lynn M; Martinez, Fernando D

    2004-06-01

    Pediatric asthma remains an important public health concern as its prevalence and cost to the health care system is rising. In order to promote innovative research in asthma therapies, the National Heart, Lung and Blood Institute created the Childhood Asthma Research and Education Network in 1999. As its first study, the steering committee of the Childhood Asthma Research and Education Network designed a randomized clinical trial to determine if persistent asthma could be prevented in children at a high risk to develop the disease. This communication presents the design of its first clinical trial, the Prevention of Asthma in Kids (PEAK) trial and the organization of the Childhood Asthma Research and Education Network that developed and implemented this trial. Studies of the natural history of asthma have shown that, in persistent asthma, the initial asthma-like symptoms and loss of lung function occur predominately during the first years of life. Therefore, in the Prevention of Asthma in Kids study, children 2 and 3 years old with a positive asthma predictive index were randomized to twice daily treatment with fluticasone 88 microg or placebo via metered-dose inhaler and Aerochamber for 2 years. The double blind treatment period was followed by a 1-year observational period. Lung function was measured by spirometry and oscillometry technique at 4-month intervals throughout the study. Bronchodilator reversibility and exhaled nitric oxide (ENO) studies were performed at the end of the treatment and observation periods. The primary outcome measure was the number of asthma-free days. Other secondary outcomes included number of exacerbations, use of asthma medications and lung function. These measures were chosen to reflect the progression of the disease from intermittent wheezing to persistent asthma and measurement of the extent of airflow limitation and airway reactivity.

  5. Rationale and design of a long term follow-up study of women who did and did not receive HPV 16/18 vaccination in Guanacaste, Costa Rica.

    Science.gov (United States)

    Gonzalez, Paula; Hildesheim, Allan; Herrero, Rolando; Katki, Hormuzd; Wacholder, Sholom; Porras, Carolina; Safaeian, Mahboobeh; Jimenez, Silvia; Darragh, Teresa M; Cortes, Bernal; Befano, Brian; Schiffman, Mark; Carvajal, Loreto; Palefsky, Joel; Schiller, John; Ocampo, Rebeca; Schussler, John; Lowy, Douglas; Guillen, Diego; Stoler, Mark H; Quint, Wim; Morales, Jorge; Avila, Carlos; Rodriguez, Ana Cecilia; Kreimer, Aimée R

    2015-04-27

    The Costa Rica Vaccine Trial (CVT) was a randomized clinical trial conducted between 2004 and 2010, which randomized 7466 women aged 18 to 25 to receive the bivalent HPV-16/18 vaccine or control Hepatitis-A vaccine. Participants were followed for 4 years with cross-over vaccination at the study end. In 2010 the long term follow-up (LTFU) study was initiated to evaluate the 10-year impact of HPV-16/18 vaccination, determinants of the immune response, and HPV natural history in a vaccinated population. Herein, the rationale, design and methods of the LTFU study are described, which actively follows CVT participants in the HPV-arm 6 additional years at biennial intervals (3 additional study visits for 10 years of total follow-up), or more often if clinically indicated. According to the initial commitment, women in the Hepatitis-A arm were offered HPV vaccination at cross-over; they were followed 2 additional years and exited from the study. 92% of eligible CVT women accepted participation in LTFU. To provide underlying rates of HPV acquisition and cervical disease among unvaccinated women to compare with the HPV-arm during LTFU, a new unvaccinated control group (UCG) of women who are beyond the age generally recommended for routine vaccination was enrolled, and will be followed by cervical cancer screening over 6 years. To form the UCG, 5000 women were selected from a local census, of whom 2836 women (61% of eligible women) agreed to participate. Over 90% of participants complied with an interview, blood and cervical specimen collection. Evaluation of comparability between the original (Hepatitis-A arm of CVT) and new (UCG) control groups showed that women's characteristics, as well as their predicted future risk for cervical HPV acquisition, were similar, thus validating use of the UCG. LTFU is poised to comprehensively address many important questions related to long-term effects of prophylactic HPV vaccines.

  6. Controlled study of myocardial recovery after interval training in heart failure: SMARTEX-HF - rationale and design

    DEFF Research Database (Denmark)

    Støylen, Asbjørn; Conraads, Viviane; Halle, Martin;

    2011-01-01

    Background: The large randomized controlled multicentre clinical trial, HF-ACTION, recently demonstrated that a programme of recommendation of regular exercise training at moderate intensity is safe, improves quality of life, and reduces the combined endpoint of all-cause death and hospitalization...... interval training at high relative intensity would yield significantly larger effects in terms of left ventricular remodelling compared to moderate continuous exercise training. Study design: In a three-armed randomized multicentre study of stable heart failure patients with left ventricular ejection...... of regular exercise (RE) of the individual patients' own preference based on clinical practice at the local centre. The primary endpoint is reverse remodelling, defined as change in left ventricular end-diastolic diameter assessed by echocardiography. Secondary endpoints include peak oxygen uptake (VO(2peak...

  7. Rationale, design, methodology and sample characteristics for the Vietnam pre-conceptual micronutrient supplementation trial (PRECONCEPT: a randomized controlled study

    Directory of Open Access Journals (Sweden)

    Nguyen Phuong H

    2012-10-01

    Full Text Available Abstract Background Low birth weight and maternal anemia remain intractable problems in many developing countries. The adequacy of the current strategy of providing iron-folic acid (IFA supplements only during pregnancy has been questioned given many women enter pregnancy with poor iron stores, the substantial micronutrient demand by maternal and fetal tissues, and programmatic issues related to timing and coverage of prenatal care. Weekly IFA supplementation for women of reproductive age (WRA improves iron status and reduces the burden of anemia in the short term, but few studies have evaluated subsequent pregnancy and birth outcomes. The Preconcept trial aims to determine whether pre-pregnancy weekly IFA or multiple micronutrient (MM supplementation will improve birth outcomes and maternal and infant iron status compared to the current practice of prenatal IFA supplementation only. This paper provides an overview of study design, methodology and sample characteristics from baseline survey data and key lessons learned. Methods/design We have recruited 5011 WRA in a double-blind stratified randomized controlled trial in rural Vietnam and randomly assigned them to receive weekly supplements containing either: 1 2800 μg folic acid 2 60 mg iron and 2800 μg folic acid or 3 MM. Women who become pregnant receive daily IFA, and are being followed through pregnancy, delivery, and up to three months post-partum. Study outcomes include birth outcomes and maternal and infant iron status. Data are being collected on household characteristics, maternal diet and mental health, anthropometry, infant feeding practices, morbidity and compliance. Discussion The study is timely and responds to the WHO Global Expert Consultation which identified the need to evaluate the long term benefits of weekly IFA and MM supplementation in WRA. Findings will generate new information to help guide policy and programs designed to reduce the burden of anemia in women and

  8. HEALTHY study rationale, design and methods: moderating risk of type 2 diabetes in multi-ethnic middle school students.

    Science.gov (United States)

    Hirst, Kathryn; Baranowski, Tom; DeBar, Lynn; Foster, Gary D; Kaufman, Francine; Kennel, Phyllis; Linder, Barbara; Schneider, Margaret; Venditti, Elizabeth M; Yin, Zenong

    2009-08-01

    The HEALTHY primary prevention trial was designed and implemented in response to the growing numbers of children and adolescents being diagnosed with type 2 diabetes. The objective was to moderate risk factors for type 2 diabetes. Modifiable risk factors measured were indicators of adiposity and glycemic dysregulation: body mass index > or =85th percentile, fasting glucose > or =5.55 mmol l(-1) (100 mg per 100 ml) and fasting insulin > or =180 pmol l(-1) (30 microU ml(-1)). A series of pilot studies established the feasibility of performing data collection procedures and tested the development of an intervention consisting of four integrated components: (1) changes in the quantity and nutritional quality of food and beverage offerings throughout the total school food environment; (2) physical education class lesson plans and accompanying equipment to increase both participation and number of minutes spent in moderate-to-vigorous physical activity; (3) brief classroom activities and family outreach vehicles to increase knowledge, enhance decision-making skills and support and reinforce youth in accomplishing goals; and (4) communications and social marketing strategies to enhance and promote changes through messages, images, events and activities. Expert study staff provided training, assistance, materials and guidance for school faculty and staff to implement the intervention components. A cohort of students were enrolled in sixth grade and followed to end of eighth grade. They attended a health screening data collection at baseline and end of study that involved measurement of height, weight, blood pressure, waist circumference and a fasting blood draw. Height and weight were also collected at the end of the seventh grade. The study was conducted in 42 middle schools, six at each of seven locations across the country, with 21 schools randomized to receive the intervention and 21 to act as controls (data collection activities only). Middle school was the unit of

  9. Diet and lifestyle interventions in postpartum women in China: study design and rationale of a multicenter randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Fu Juan

    2010-02-01

    Full Text Available Abstract Background "Doing the month", or "sitting month", is a traditional practice for postpartum women in China and other Asian countries, which includes some taboos against well-accepted healthy diet and lifestyles in general population. Previous studies have shown this practice may be associated with higher prevalence of postpartum problems. The current multicenter randomized controlled trial (RCT aims to evaluate outcomes of diet and lifestyle interventions in Chinese postpartum women. Methods/Design The current multicenter RCT will be conducted in three representative areas in China, Shandong province, Hubei province and Guangdong province, which locate in northern, central and southern parts of China, respectively. Women who attend routine pregnancy diagnosis in hospitals or maternal healthcare centers will be invited to take part in this study. At least 800 women who meet our eligibility criteria will be recruited and randomly assigned to the intervention group (n > = 400 and the control group (n > = 400. A three-dimension comprehensive intervention strategy, which incorporates intervention measures simultaneously to individual postpartum woman, their family members and community environment, will be utilized to maximize the effectiveness of intervention. Regular visiting and follow-up will be done in both group; nutrition and health-related measurements will be assessed both before and after the intervention. Discussion To our knowledge, this current study is the first and largest multicenter RCT which focus on the effectiveness of diet and lifestyle intervention on reducing the incidence rate of postpartum diseases and improving health status in postpartum women. We hypothesize that the intervention will reduce the incidence rates of postpartum diseases and improve nutrition and health status due to a balanced diet and reasonable lifestyle in comparison with the control condition. If so, the results of our study will provide

  10. Upper limb international spasticity study: rationale and protocol for a large, international, multicentre prospective cohort study investigating management and goal attainment following treatment with botulinum toxin A in real-life clinical practice

    OpenAIRE

    Turner-Stokes, Lynne; Fheodoroff, Klemens; Jacinto, Jorge; Maisonobe, Pascal; Zakine, Benjamin

    2013-01-01

    Objectives This article provides an overview of the Upper Limb International Spasticity (ULIS) programme, which aims to develop a common core dataset for evaluation of real-life practice and outcomes in the treatment of upper-limb spasticity with botulinum toxin A (BoNT-A). Here we present the study protocol for ULIS-II, a large, international cohort study, to describe the rationale and steps to ensure the validity of goal attainment scaling (GAS) as the primary outcome measure. Methods and a...

  11. Smoking behavior, attitudes, and cessation counseling among healthcare professionals in Armenia

    Directory of Open Access Journals (Sweden)

    Movsisyan Narine K

    2012-11-01

    Full Text Available Abstract Background Smoking cessation counseling by health professionals has been effective in increasing cessation rates. However, little is known about smoking cessation training and practices in transition countries with high smoking prevalence such as Armenia. This study identified smoking-related attitudes and behavior of physicians and nurses in a 500-bed hospital in Yerevan, Armenia, the largest cancer hospital in the country, and explored barriers to their effective participation in smoking cessation interventions. Methods This study used mixed quantitative and qualitative methods. Trained interviewers conducted a survey with physicians and nurses using a 42-item self-administered questionnaire that assessed their smoking-related attitudes and behavior and smoking cessation counseling training. Four focus group discussions with hospital physicians and nurses explored barriers to effective smoking cessation interventions. The focus group sessions were audio-taped, transcribed, and analyzed. Results The survey response rate was 58.5% (93/159 for physicians and 72.2% (122/169 for nurses. Smoking prevalence was almost five times higher in physicians compared to nurses (31.2% vs. 6.6%, p  Conclusions This study was the first to explore differences in smoking-related attitudes and behavior among hospital physicians and nurses in Yerevan, Armenia. The study found substantial behavioral and attitudinal differences in these two groups. The study revealed a critical need for integrating cessation counseling training into Armenia’s medical education. As nurses had more positive attitudes toward cessation counseling compared to physicians, and more often reported having cessation training, they are an untapped resource that could be more actively engaged in smoking cessation interventions in healthcare settings.

  12. Studying variability in human brain aging in a population-based German cohort – Rationale and design of 1000BRAINS

    Directory of Open Access Journals (Sweden)

    Svenja eCaspers

    2014-07-01

    Full Text Available The ongoing 1000 brains study (1000BRAINS is an epidemiological and neuroscientific investigation of structural and functional variability in the human brain during aging. The two recruitment sources are the 10-year follow-up cohort of the German Heinz Nixdorf Recall (HNR Study, and the HNR MultiGeneration Study cohort, which comprises spouses and offspring of HNR subjects. The HNR is a longitudinal epidemiological investigation of cardiovascular risk factors, with a comprehensive collection of clinical, laboratory, socioeconomic, and environmental data from population-based subjects aged 45-75 years on inclusion. HNR subjects underwent detailed assessments in 2000, 2006, and 2011, and completed annual postal questionnaires on health status. 1000BRAINS accesses these HNR data and applies a separate protocol comprising: neuropsychological tests of attention, memory, executive functions & language; examination of motor skills; ratings of personality, life quality, mood & daily activities; analysis of laboratory and genetic data; and state-of-the-art magnetic resonance imaging (MRI, 3 Tesla of the brain. The latter includes (i 3D-T1- and 3D-T2-weighted scans for structural analyses and myelin mapping; (ii three diffusion imaging sequences optimized for diffusion tensor imaging, high-angular resolution diffusion imaging for detailed fibre tracking and for diffusion kurtosis imaging; (iii resting-state and task-based functional MRI; and (iv fluid-attenuated inversion recovery and MR angiography for the detection of vascular lesions and the mapping of white matter lesions. The unique design of 1000BRAINS allows: (i comprehensive investigation of various influences including genetics, environment and health status on variability in brain structure and function during aging; and (ii identification of the impact of selected influencing factors on specific cognitive subsystems and their anatomical correlates.

  13. Late outcomes after acute pulmonary embolism: rationale and design of FOCUS, a prospective observational multicenter cohort study.

    Science.gov (United States)

    Konstantinides, Stavros V; Barco, Stefano; Rosenkranz, Stephan; Lankeit, Mareike; Held, Matthias; Gerhardt, Felix; Bruch, Leonard; Ewert, Ralf; Faehling, Martin; Freise, Julia; Ghofrani, Hossein-Ardeschir; Grünig, Ekkehard; Halank, Michael; Heydenreich, Nadine; Hoeper, Marius M; Leuchte, Hanno H; Mayer, Eckhard; Meyer, F Joachim; Neurohr, Claus; Opitz, Christian; Pinto, Antonio; Seyfarth, Hans-Jürgen; Wachter, Rolf; Zäpf, Bianca; Wilkens, Heinrike; Binder, Harald; Wild, Philipp S

    2016-11-01

    Acute pulmonary embolism (PE) is a frequent cause of death and serious disability. The risk of PE-associated mortality and morbidity extends far beyond the acute phase of the disease. In earlier follow-up studies, as many as 30 % of the patients died during a follow-up period of up to 3 years, and up to 50 % of patients continued to complain of dyspnea and/or poor physical performance 6 months to 3 years after the index event. The most feared 'late sequela' of PE is chronic thromboembolic pulmonary hypertension (CTEPH), the true incidence of which remains obscure due to the large margin of error in the rates reported by mostly small, single-center studies. Moreover, the functional and hemodynamic changes corresponding to early, possibly reversible stages of CTEPH, have not been systematically investigated. The ongoing Follow-Up after acute pulmonary embolism (FOCUS) study will prospectively enroll and systematically follow, over a 2-year period and with a standardized comprehensive program of clinical, echocardiographic, functional and laboratory testing, a large multicenter prospective cohort of 1000 unselected patients (all-comers) with acute symptomatic PE. FOCUS will possess adequate power to provide answers to relevant remaining questions regarding the patients' long-term morbidity and mortality, and the temporal pattern of post-PE abnormalities. It will hopefully provide evidence for future guideline recommendations regarding the selection of patients for long-term follow-up after PE, the modalities which this follow-up should include, and the findings that should be interpreted as indicating progressive functional and hemodynamic post-PE impairment, or the development of CTEPH.

  14. Evaluation of primary care midwifery in the Netherlands: design and rationale of a dynamic cohort study (DELIVER

    Directory of Open Access Journals (Sweden)

    Manniën Judith

    2012-03-01

    Full Text Available Abstract Background In the Netherlands, midwives are autonomous medical practitioners and 78% of pregnant women start their maternity care with a primary care midwife. Scientific research to support evidence-based practice in primary care midwifery in the Netherlands has been sparse. This paper describes the research design and methodology of the multicenter multidisciplinary prospective DELIVER study which is the first large-scale study evaluating the quality and provision of primary midwifery care. Methods/Design Between September 2009 and April 2011, data were collected from clients and their partners, midwives and other healthcare professionals across the Netherlands. Clients from twenty midwifery practices received up to three questionnaires to assess the expectations and experiences of clients (e.g. quality of care, prenatal screening, emotions, health, and lifestyle. These client data were linked to data from the Netherlands Perinatal Register and electronic client records kept by midwives. Midwives and practice assistants from the twenty participating practices recorded work-related activities in a diary for one week, to assess workload. Besides, the midwives were asked to complete a questionnaire, to gain insight into collaboration of midwives with other care providers, their tasks and attitude towards their job, and the quality of the care they provide. Another questionnaire was sent to all Dutch midwifery practices which reveals information regarding the organisation of midwifery practices, provision of preconception care, collaboration with other care providers, and provision of care to ethnic minorities. Data at client, midwife and practice level can be linked. Additionally, partners of pregnant women and other care providers were asked about their expectations and experiences regarding the care delivered by midwives and in six practices client consults were videotaped to objectively assess daily practice. Discussion In total, 7685

  15. International Study to Predict Optimized Treatment for Depression (iSPOT-D, a randomized clinical trial: rationale and protocol

    Directory of Open Access Journals (Sweden)

    Cooper Nicholas J

    2011-01-01

    Full Text Available Abstract Background Clinically useful treatment moderators of Major Depressive Disorder (MDD have not yet been identified, though some baseline predictors of treatment outcome have been proposed. The aim of iSPOT-D is to identify pretreatment measures that predict or moderate MDD treatment response or remission to escitalopram, sertraline or venlafaxine; and develop a model that incorporates multiple predictors and moderators. Methods/Design The International Study to Predict Optimized Treatment - in Depression (iSPOT-D is a multi-centre, international, randomized, prospective, open-label trial. It is enrolling 2016 MDD outpatients (ages 18-65 from primary or specialty care practices (672 per treatment arm; 672 age-, sex- and education-matched healthy controls. Study-eligible patients are antidepressant medication (ADM naïve or willing to undergo a one-week wash-out of any non-protocol ADM, and cannot have had an inadequate response to protocol ADM. Baseline assessments include symptoms; distress; daily function; cognitive performance; electroencephalogram and event-related potentials; heart rate and genetic measures. A subset of these baseline assessments are repeated after eight weeks of treatment. Outcomes include the 17-item Hamilton Rating Scale for Depression (primary and self-reported depressive symptoms, social functioning, quality of life, emotional regulation, and side-effect burden (secondary. Participants may then enter a naturalistic telephone follow-up at weeks 12, 16, 24 and 52. The first half of the sample will be used to identify potential predictors and moderators, and the second half to replicate and confirm. Discussion First enrolment was in December 2008, and is ongoing. iSPOT-D evaluates clinical and biological predictors of treatment response in the largest known sample of MDD collected worldwide. Trial registration International Study to Predict Optimised Treatment - in Depression (iSPOT-D ClinicalTrials.gov Identifier

  16. Rationale for assessing safety and efficacy of drug candidates alone and in combination with medical devices: The case study of SpinalonTM.

    Science.gov (United States)

    Guertin, Pierre A

    2016-12-07

    The aim of this review is to describe the rationale and main underlying reasons for undertaking, during clinical development, the study of drug candidates used separately and/or in combination with other technologies. To ease comprehension, reference will be made to the case of SpinalonTM, a new fixed-dose combination (FDC) product composed of levodopa/carbidopa/buspirone. This drug is capable of triggering, within minutes after a single administration orally, 45 minute- episodes of basic involuntary 'reflex' walking in paraplegic animals. Daily administration during one month was shown to lead to increased performance over time, with health benefits onto musculoskeletal and cardiovascular systems. A double-blind, dose-escalation, randomized phase I/IIa study with 45 spinal cord-injured subjects successfully provided the maximal tolerated dose (MTD) and preliminary evidence of efficacy. As an attempt to explore how efficacy may be optimized, a phase IIb study with 150 subjects was designed to compare the effects of repeated administration in different conditions (arms). Tests with a motorized treadmill, a harness for body weight support, a transdermal spinal cord stimulator and/or an exoskeleton were proposed because: 1) these devices are unlikely to alter safety but, 2) they are reasonably expected to increase spinal locomotor neuron activation, reflex walking induction, and musculoskeletal/cardiovascular benefits. This approach would normally allow the phase III study to demonstrate clearly, with fewer subjects and at lower costs, long-term benefits on health of SpinalonTM used in optimized conditions and settings. This innovative strategy in drug development may contribute to further describe the mechanisms of action as well as optimized conditions of use for patients. Adapted to the development of other products, such an approach may enable greater safety, efficacy, clinical utility and compliance to be sought for next-generation CNS drugs.

  17. Aspirin for the prevention of cognitive decline in the elderly: rationale and design of a neuro-vascular imaging study (ENVIS-ion

    Directory of Open Access Journals (Sweden)

    Reid Christopher M

    2012-02-01

    Full Text Available Abstract Background This paper describes the rationale and design of the ENVIS-ion Study, which aims to determine whether low-dose aspirin reduces the development of white matter hyper-intense (WMH lesions and silent brain infarction (SBI. Additional aims include determining whether a changes in retinal vascular imaging (RVI parameters parallel changes in brain magnetic resonance imaging (MRI; b changes in RVI parameters are observed with aspirin therapy; c baseline cognitive function correlates with MRI and RVI parameters; d changes in cognitive function correlate with changes in brain MRI and RVI and e whether factors such as age, gender or blood pressure influence the above associations. Methods/Design Double-blind, placebo-controlled trial of three years duration set in two Australian academic medical centre outpatient clinics. This study will enrol 600 adults aged 70 years and over with normal cognitive function and without overt cardiovascular disease. Subjects will undergo cognitive testing, brain MRI and RVI at baseline and after 3 years of study treatment. All subjects will be recruited from a 19,000-patient clinical outcome trial conducted in Australia and the United States that will evaluate the effects of aspirin in maintaining disability-free longevity over 5 years. The intervention will be aspirin 100 mg daily versus matching placebo, randomized on a 1:1 basis. Discussion This study will improve understanding of the mechanisms at the level of brain and vascular structure that underlie the effects of aspirin on cognitive function. Given the limited access and high cost of MRI, RVI may prove useful as a tool for the identification of individuals at high risk for the development of cerebrovascular disease and cognitive decline. Trial Registration clinicaltrials.gov Identifier: NCT01038583

  18. Stroke risk associated with balloon based catheter ablation for atrial fibrillation: Rationale and design of the MACPAF Study

    Directory of Open Access Journals (Sweden)

    Schultheiss Heinz-Peter

    2010-07-01

    Full Text Available Abstract Background Catheter ablation of the pulmonary veins has become accepted as a standard therapeutic approach for symptomatic paroxysmal atrial fibrillation (AF. However, there is some evidence for an ablation associated (silent stroke risk, lowering the hope to limit the stroke risk by restoration of rhythm over rate control in AF. The purpose of the prospective randomized single-center study "Mesh Ablator versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation" (MACPAF is to compare the efficacy and safety of two balloon based pulmonary vein ablation systems in patients with symptomatic paroxysmal AF. Methods/Design Patients are randomized 1:1 for the Arctic Front® or the HD Mesh Ablator® catheter for left atrial catheter ablation (LACA. The predefined endpoints will be assessed by brain magnetic resonance imaging (MRI, neuro(psychological tests and a subcutaneously implanted reveal recorder for AF detection. According to statistics 108 patients will be enrolled. Discussion Findings from the MACPAF trial will help to balance the benefits and risks of LACA for symptomatic paroxysmal AF. Using serial brain MRIs might help to identify patients at risk for LACA-associated cerebral thromboembolism. Potential limitations of the study are the single-center design, the existence of a variety of LACA-catheters, the missing placebo-group and the impossibility to assess the primary endpoint in a blinded fashion. Trial registration clinicaltrials.gov NCT01061931

  19. High-dose N-acetylcysteine in the prevention of COPD exacerbations: rationale and design of the PANTHEON Study.

    Science.gov (United States)

    Zheng, Jin-Ping; Wen, Fu-Qiang; Bai, Chun-Xue; Wan, Huan-Ying; Kang, Jian; Chen, Ping; Yao, Wan-Zhen; Ma, Li-Jun; Xia, Qi-Kui; Gao, Yi; Zhong, Nan-Shan

    2013-04-01

    Chronic obstructive pulmonary disease (COPD) is characterized by persistent airflow limitation; from a pathophysiological point of view it involves many components, including mucus hypersecretion, oxidative stress and inflammation. N-acetylcysteine (NAC) is a mucolytic agent with antioxidant and anti-inflammatory properties. Long-term efficacy of NAC 600mg/d in COPD is controversial; a dose-effect relationship has been demonstrated, but at present it is not known whether a higher dose provides clinical benefits. The PANTHEON Study is a prospective, ICS stratified, randomized, double-blind, placebo-controlled, parallel-group, multi-center trial designed to assess the efficacy and safety of high-dose (1200 mg/daily) NAC treatment for one year in moderate-to-severe COPD patients. The primary endpoint is the annual exacerbation rate. Secondary endpoints include recurrent exacerbations hazard ratio, time to first exacerbation, as well as quality of life and pulmonary function. The hypothesis, design and methodology are described and baseline characteristics of recruited patients are presented. 1006 COPD patients (444 treated with maintenance ICS, 562 ICS naive, aged 66.27±8.76 yrs, average post-bronchodilator FEV1 48.95±11.80 of predicted) have been randomized at 34 hospitals in China. Final results of this study will provide objective data on the effects of high-dose (1200 mg/daily) long-term NAC treatment in the prevention of COPD exacerbations and other outcome variables.

  20. Study exploring depression and cardiovascular diseases amongst Arabic speaking patients living in the State of Qatar: Rationale and methodology.

    Science.gov (United States)

    Donnelly, Tam Truong; Al Suwaidi, Jassim M; Alqahtani, Awad; Assad, Nidal; Qader, Najla Abdul; Byrne, Carolyn; Singh, Rajvir; Fung, Tak Shing

    2012-01-01

    In Qatar, cardiovascular diseases are the leading cause of death. Studies show that depression is associated with an increased morbidity and mortality among cardiovascular patients. Thus, early detection of, and intervention for, depression among cardiovascular patients can reduce cardiovascular morbidity and mortality, and save health care costs. To date there is no study in the Gulf region exploring depression among cardiovascular patients. The goals of our three-phase research program are to (1) understand the mental health issues, specifically depression, as experienced by cardiovascular patients living in the State of Qatar; (2) identify and implement strategies that would prevent depression and assist patients to deal with depression; and (3) evaluate, facilitate, and sustain strategies that are effective at reducing depression and foster its treatment among cardiovascular patients. This paper describe phase I of the research program. Using both quantitative and qualitative research methodologies, we will investigate (1) the prevalence and severity of depression among patients who have confirmed diagnosis of cardiovascular diseases (2) how contextual factors such as social, cultural, and economic factors contribute to the risk of depression and its management among cardiovascular patients, and (3) formulate effective intervention strategies that are expected to increase awareness, prevention of and treatment for depression among cardiovascular patients, thus reducing cardiovascular diseases morbidity and mortality in Qatar.

  1. Barriers, facilitators and preferences for the physical activity of school children. Rationale and methods of a mixed study

    Directory of Open Access Journals (Sweden)

    Martínez-Andrés María

    2012-09-01

    Full Text Available Abstract Background Physical activity interventions in schools environment seem to have shown some effectiveness in the control of the current obesity epidemic in children. However the complexity of behaviors and the diversity of influences related to this problem suggest that we urgently need new lines of insight about how to support comprehensive population strategies of intervention. The aim of this study was to know the perceptions of the children from Cuenca, about their environmental barriers, facilitators and preferences for physical activity. Methods/Design We used a mixed-method design by combining two qualitative methods (analysis of individual drawings and focus groups together with the quantitative measurement of physical activity through accelerometers, in a theoretical sample of 121 children aged 9 and 11 years of schools in the province of Cuenca, Spain. Conclusions Mixed-method study is an appropriate strategy to know the perceptions of children about barriers and facilitators for physical activity, using both qualitative methods for a deeply understanding of their points of view, and quantitative methods for triangulate the discourse of participants with empirical data. We consider that this is an innovative approach that could provide knowledges for the development of more effective interventions to prevent childhood overweight.

  2. The Moli-Sani Project, a randomized, prospective cohort study in the Molise region in Italy; design, rationale and objectives

    Directory of Open Access Journals (Sweden)

    Licia Iacoviello

    2007-06-01

    Full Text Available

    Background: Cardiovascular disease and malignancies account for more than 70% of all causes of mortality and morbidity in Italy. There is a subtle balance between genetic determinants and lifestyle, that often defines the line between health and sickness. So far studies aiming at identifying risk factors have mainly come from Northern Europe and the USA. It was to understand this balance between genetics and environmental determinants better, and to tailor appropriate preventive strategies for Italian and other Southern European populations, that theMoli-sani project was launched, transforming a small Italian region into a large scientific laboratory: the “Molise lab”.

    Methods: Each participant receives a thorough medical check-up at no cost to either him/her or the national health service, resulting in thousands of hours of free public health care. With a completely computerized system, Moli-sani is a “paperless” study, in which researchers and participants communicate using recently developed technologies such as mobile phone text messages (SMS. The newly established biological data bank (the “MoliBank” will be one of the largest in Europe. Results: Early results of 8000 participants so far show a slightly worrying pattern of risk factors for a Mediterranean population. The prevalence of obesity, hypertension and metabolic syndrome is growing at rates close to those of other Western countries. Hypertension and, to a lesser extent, high blood glucose levels, are under-diagnosed and underestimated by patients, and appropriate therapy appears under-used and not very successful. However, cholesterol management appears more efficient.

    Conclusions: Paying particular attention towards innovation and new technologies, theMoli-sani project has placed itself at the cutting edge of a new paradigm crossing research and prevention.

  3. 78 FR 13236 - TRICARE: Smoking Cessation Program

    Science.gov (United States)

    2013-02-27

    ... effectiveness considerations. 2. Counseling. In person smoking cessation counseling from a TRICARE authorized... review and recommend drugs based on their clinical and cost effectiveness. After this formal process... the TRICARE smoking cessation program to include a reduction of tobacco advertising in...

  4. NCI launches smoking cessation support for teens

    Science.gov (United States)

    A new effort to help teens quit smoking will use one of today’s teen’s most constant companions—the mobile phone. Developed by smoking cessation experts, SmokefreeTXT is a free text message cessation service that provides 24/7 encouragement, advice, and

  5. Dental Practitioners and Smoking Cessation in Ireland

    Directory of Open Access Journals (Sweden)

    Sheila Keogan

    2015-10-01

    Smoking prevalence is low among dentists in Ireland. Most recognized the need to provide adequate smoking cessation support and advice to patients but felt under-trained to do so. Most were not aware of existing referral pathways to specialist smoking cessation services and, thus, referral rates were low.

  6. Methods and rationale used in a matched cohort study of the incidence of new primary cancers following prostate cancer

    Directory of Open Access Journals (Sweden)

    Cronin-Fenton DP

    2013-10-01

    Full Text Available Deirdre P Cronin-Fenton,1 Sussie Antonsen,1 Karynsa Cetin,2 John Acquavella,2 Andre Daniels,3 Timothy L Lash1,4 1Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; 2Center for Observational Research, Amgen Incorporated, Thousand Oaks, CA, USA; 3Global Regulatory Affairs and Safety, Amgen Incorporated, Thousand Oaks, CA, USA; 4Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA Objectives: We describe several methodological issues that were addressed in conducting a Danish population-based matched cohort study comparing rates of new primary cancers (NPCs in men with and without prostate cancer (PC. Methods: We matched 30,220 men with PC to 151,100 men without PC (comparators on age (±2 years and PC diagnosis/index date. We focused on several methodological issues: 1 to address survival differences between the cohorts we compared rates with and without censoring comparators on the date their matched PC patient died or was censored; 2 to address diagnostic bias, we excluded men with a history of cancer from the comparator cohort; 3 to address prostate cancer immunity, we graphed the hazard of NPC in both cohorts, with and without prostate cancer as an outcome; 4 we used empirical Bayes methods to explore the effect of adjusting for multiple comparisons. Results: After 18 months of follow-up, cumulative person-time was lower in the PC than comparator cohort due to higher mortality among PC patients. Terminating person-time in comparators at the matched PC patient's death or loss to follow-up resulted in comparable person-time up to 30 months of follow-up and lower person-time among comparators thereafter. The hazard of NPC was lower among men with PC than comparators throughout follow-up. There was little difference in rates beyond the first four years of follow-up after removing PC as an outcome. Empirical Bayes adjustment for multiple comparisons had little effect on the

  7. Antibiotics for bronchiectasis exacerbations in children: rationale and study protocol for a randomised placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Chang Anne B

    2012-08-01

    Full Text Available Abstract Background Despite bronchiectasis being increasingly recognised as an important cause of chronic respiratory morbidity in both indigenous and non-indigenous settings globally, high quality evidence to inform management is scarce. It is assumed that antibiotics are efficacious for all bronchiectasis exacerbations, but not all practitioners agree. Inadequately treated exacerbations may risk lung function deterioration. Our study tests the hypothesis that both oral azithromycin and amoxicillin-clavulanic acid are superior to placebo at improving resolution rates of respiratory exacerbations by day 14 in children with bronchiectasis unrelated to cystic fibrosis. Methods We are conducting a bronchiectasis exacerbation study (BEST, which is a multicentre, randomised, double-blind, double-dummy, placebo-controlled, parallel group trial, in five centres (Brisbane, Perth, Darwin, Melbourne, Auckland. In the component of BEST presented here, 189 children fulfilling inclusion criteria are randomised (allocation-concealed to receive amoxicillin-clavulanic acid (22.5 mg/kg twice daily with placebo-azithromycin; azithromycin (5 mg/kg daily with placebo-amoxicillin-clavulanic acid; or placebo-azithromycin with placebo-amoxicillin-clavulanic acid for 14 days. Clinical data and a paediatric cough-specific quality of life score are obtained at baseline, at the start and resolution of exacerbations, and at day 14. In most children, blood and deep nasal swabs are also collected at the same time points. The primary outcome is the proportion of children whose exacerbations have resolved at day 14. The main secondary outcome is the paediatric cough-specific quality of life score. Other outcomes are time to next exacerbation; requirement for hospitalisation; duration of exacerbation; and spirometry data. Descriptive viral and bacteriological data from nasal samples and blood markers will also be reported. Discussion Effective, evidence-based management

  8. The Nutrition and Enjoyable Activity for Teen Girls (NEAT girls randomized controlled trial for adolescent girls from disadvantaged secondary schools: rationale, study protocol, and baseline results

    Directory of Open Access Journals (Sweden)

    Okely Anthony D

    2010-10-01

    Full Text Available Abstract Background Child and adolescent obesity predisposes individuals to an increased risk of morbidity and mortality from a range of lifestyle diseases. Although there is some evidence to suggest that rates of pediatric obesity have leveled off in recent years, this has not been the case among youth from low socioeconomic backgrounds. The purpose of this paper is to report the rationale, study design and baseline findings of a school-based obesity prevention program for low-active adolescent girls from disadvantaged secondary schools. Methods/Design The Nutrition and Enjoyable Activity for Teen Girls (NEAT Girls intervention will be evaluated using a group randomized controlled trial. NEAT Girls is a 12-month multi-component school-based intervention developed in reference to Social Cognitive Theory and includes enhanced school sport sessions, interactive seminars, nutrition workshops, lunch-time physical activity (PA sessions, PA and nutrition handbooks, parent newsletters, pedometers for self-monitoring and text messaging for social support. The following variables were assessed at baseline and will be completed again at 12- and 24-months: adiposity, objectively measured PA, muscular fitness, time spent in sedentary behaviors, dietary intake, PA and nutrition social-cognitive mediators, physical self-perception and global self-esteem. Statistical analyses will follow intention-to-treat principles and hypothesized mediators of PA and nutrition behavior change will be explored. Discussion NEAT Girls is an innovative intervention targeting low-active girls using evidence-based behavior change strategies and nutrition and PA messages and has the potential to prevent unhealthy weight gain and reduce the decline in physical activity and poor dietary habits associated with low socio-economic status. Few studies have reported the long-term effects of school-based obesity prevention programs and the current study has the potential to make an

  9. The Genetic Response to Short-term Interventions Affecting Cardiovascular Function: Rationale and Design of the HAPI Heart Study

    Science.gov (United States)

    Mitchell, Braxton D.; McArdle, Patrick F.; Shen, Haiqing; Rampersaud, Evadnie; Pollin, Toni I.; Bielak, Lawrence F.; Jaquish, Cashell; Douglas, Julie A.; Roy-Gagnon, Marie-Hélène; Sack, Paul; Naglieri, Rosalie; Hines, Scott; Horenstein, Richard B.; Chang, Yen-Pei C.; Post, Wendy; Ryan, Kathleen A.; Brereton, Nga Hong; Pakyz, Ruth E.; Sorkin, John; Damcott, Coleen M.; O’Connell, Jeffrey R.; Mangano, Charles; Corretti, Mary; Vogel, Robert; Herzog, William; Weir, Matthew R.; Peyser, Patricia A.; Shuldiner, Alan R.

    2008-01-01

    Background The etiology of cardiovascular disease (CVD) is multifactorial. Efforts to identify genes influencing CVD risk have met with limited success to date, likely due to the small effect sizes of common CVD risk alleles and the presence of gene by gene and gene by environment interactions. Methods The Heredity and Phenotype Intervention (HAPI) Heart Study was initiated in 2002 to measure the cardiovascular response to four short-term interventions affecting cardiovascular risk factors and to identify the genetic and environmental determinants of these responses. The measurements included blood pressure responses to the cold pressor stress test and to a high salt diet, triglyceride excursion in response to a high fat challenge, and response in platelet aggregation to aspirin therapy. Results The interventions were carried out in 868 relatively healthy Amish adults from large families. The heritabilities of selected response traits for each intervention ranged from 8–38%, suggesting that some of the variation associated with response to each intervention can be attributed to the additive effects of genes. Conclusions Identifying these response genes may identify new mechanisms influencing CVD and may lead to individualized preventive strategies and improved early detection of high-risk individuals. PMID:18440328

  10. Computer-administered neurobehavioral evaluation system for occupational and environmental epidemiology. Rationale, methodology, and pilot study results

    Energy Technology Data Exchange (ETDEWEB)

    Baker, E.L.; Letz, R.; Fidler, A.

    1985-03-01

    To facilitate the conduct of epidemiologic studies of populations at risk for or suffering from central nervous system (CNS) dysfunction due to environmental agents, a computer-administered neurobehavioral evaluation system has been developed. The system includes a set of testing programs designed to run on a microcomputer and questionnaires to facilitate interpretation of results. Standard tasks evaluating memory, psychomotor function, verbal ability, visuospatial ability, and mood were selected and adapted for computer presentation following the recommendation of an expert committee of the World Health Organization and the National Institute for Occupational Safety and Health. In two pilot surveys, test performance was found to be influenced by age, education level, and socioeconomic status in ways consistent with prior research findings. Performance on tests of short-term memory and reaction time was negatively correlated with intensity of organic solvent exposure among industrial painters. In view of the ease of administration and data handling, high subject acceptability, and sensitivity to the effects of known neurotoxic agents, computer-based assessment of CNS function holds promise for future epidemiologic research.

  11. Teen smoking cessation help via the Internet: a survey of search engines.

    Science.gov (United States)

    Edwards, Christine C; Elliott, Sean P; Conway, Terry L; Woodruff, Susan I

    2003-07-01

    The objective of this study was to assess Web sites related to teen smoking cessation on the Internet. Seven Internet search engines were searched using the keywords teen quit smoking. The top 20 hits from each search engine were reviewed and categorized. The keywords teen quit smoking produced between 35 and 400,000 hits depending on the search engine. Of 140 potential hits, 62% were active, unique sites; 85% were listed by only one search engine; and 40% focused on cessation. Findings suggest that legitimate on-line smoking cessation help for teens is constrained by search engine choice and the amount of time teens spend looking through potential sites. Resource listings should be updated regularly. Smoking cessation Web sites need to be picked up on multiple search engine searches. Further evaluation of smoking cessation Web sites need to be conducted to identify the most effective help for teens.

  12. Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study: Rationale and design for a randomized controlled trial evaluating rheumatoid arthritis risk education to first-degree relatives

    OpenAIRE

    Sparks, Jeffrey A.; Iversen, Maura D.; Kroouze, Rachel Miller; Mahmoud, Taysir G.; Triedman, Nellie A.; Kalia, Sarah S.; Atkinson, Michael L.; Lu, Bing; Deane, Kevin D.; Costenbader, Karen H.; Green, Robert C.; Elizabeth W. Karlson

    2014-01-01

    We present the rationale, design features, and protocol of the Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study (ClinicalTrials.gov NCT02046005). The PRE-RA Family Study is an NIH-funded prospective, randomized controlled trial designed to compare the willingness to change behaviors in first-degree relatives of rheumatoid arthritis (RA) patients without RA after exposure to RA risk educational programs. Consented subjects are randomized to receive education concernin...

  13. Factors Associated with Successful Smoking Cessation in Korean Adult Males: Findings from a National Survey.

    Directory of Open Access Journals (Sweden)

    Youngmee Kim

    2014-11-01

    Full Text Available Smoking cessation rates have remained stagnant globally. This study was conducted to explore the factors associated with successful smoking cessation among South Korean adult males using nationally representative data from the Korea National Health and Nutrition Examination Survey (KNHANES from 2007 to 2012. A comparison was made between successful quitters and those who failed to quit after attempts to stop smoking.A total of 7,839 males, aged 19-65 years, were included in this cross-sectional study. The outcome measures were the success and failure rates in smoking cessation, sociodemographic and clinical characteristics, health behaviors, perceived health status, quality of life, and mental health. Multiple logistic regression analyses were used to examine the various factors associated with smoking cessation success.The cessation success and failure rates were 45.5% and 54.5%, respectively. Smoking cessation was related to older age, marriage, higher income, smoking larger amounts of cigarettes, use of willpower, alcohol abstinence, cancer history, better mental health, and higher levels of quality of life, after controlling for multiple variables. Second-hand smoke exposure at home and using nicotine replacement therapy were associated with a lower likelihood of smoking cessation.A smoke-free environment, use of willpower, alcohol abstinence, and better stress management are important for smoking cessation. Unlike previous studies, not using nicotine replacement therapy and higher levels of daily cigarette consumption were associated with successful smoking cessation, suggesting that motivation appears to be important to smoking cessation in Korean adult male population.

  14. Gender and determinants of smoking cessation

    DEFF Research Database (Denmark)

    Osler, M; Prescott, E; Godtfredsen, N;

    1999-01-01

    BACKGROUND: The less favorable trend in smoking prevalence in women compared to men may be due to lower cessation rates. We analyzed determinants of spontaneous smoking cessation with particular reference to gender differences. METHODS: Data on smoking were collected by questionnaire in three...... the relation of determinants to having quit after 5 and 10-16 years. RESULTS: The prevalence of quitting was 12 and 22% at first and second follow-up, respectively. At both reexaminations, quitting smoking was positively associated with male sex and cigar smoking and negatively associated with the amount...... of tobacco smoked, inhalation, and alcohol consumption. Furthermore, in women, smoking cessation was positively associated with level of education and body mass index (BMI). Smoking cessation was not affected by cohabitation status, leisure activity, or bronchitis symptoms. CONCLUSIONS: Smoking cessation...

  15. Osteopathic medical student administered smoking cessation counseling is an effective tool

    Directory of Open Access Journals (Sweden)

    Barbara Capozzi

    2016-01-01

    Full Text Available Background: Physician counseling on the risks of tobacco smoking and the benefits of cessation has been shown to be an effective method of increasing the rate of smoking cessation. Using the "Help Your Patients Quit Smoking: A Coaching Guide" also referred to as the "7A′s of Smoking Cessation" guideline from the New York City Department of Health and Mental Hygiene is thought to be effective to convey the importance of smoking cessation. Aim: To study the efficacy of the "7A′s of Smoking Cessation" guideline counseling conducted by osteopathic medical students. Materials and Methods: Osteopathic medical students were trained to counsel smokers for 3-10 min based on New York City Department of Health′s "7A′s of Smoking Cessation" guidelines by a licensed physician. Students then counseled health fair participants who were cigarette smokers for 3-10 min. Postcounseling, participants were administered an 4 question survey to evaluate the effect counseling had on their desire to quit smoking. Survey data were collected and analyzed. Institutional Review Board approval was obtained for this study. Results: A total of 13 anonymous health fair participants who were also smokers were administered both counseling sessions and surveys. 11/13 (84.6% participants stated that the session motivated them to quit smoking. 9/13 (69.2% participants responded that they were now motivated to discuss smoking cessation with their doctor after being counseled. Of these participants 12/13 (92.3% had previously attempted to quit smoking without success. Conclusion: Participants reported an increased willingness to stop smoking after being counseled by osteopathic medical students. Participants also reported an increased motivation to discuss smoking cessation with their physician. These findings indicate that smoking cessation counseling administered by osteopathic medical students effectively in encouraging smokers to consider reduction or cessation of tobacco

  16. Electronic cigarettes for smoking cessation.

    Science.gov (United States)

    Bullen, Christopher

    2014-11-01

    Electronic cigarettes (e-cigarettes) are novel vaporising devices that, similar to nicotine replacement treatments, deliver nicotine but in lower amounts and less swiftly than tobacco smoking. However, they enjoy far greater popularity than these medications due in part to their behaviour replacement characteristics. Evidence for their efficacy as cessation aids, based on several randomised trials of now obsolete e-cigarettes, suggests a modest effect equivalent to nicotine patch. E-cigarettes are almost certainly far less harmful than tobacco smoking, but the health effects of long-term use are as yet unknown. Dual use is common and almost as harmful as usual smoking unless it leads to quitting. Population effects, such as re-normalising smoking behaviour, are a concern. Clinicians should be knowledgeable about these products. If patients who smoke are unwilling to quit or cannot succeed using evidence-based approaches, e-cigarettes may be an option to be considered after discussing the limitations of current knowledge.

  17. Rationale and study protocol for a multi-component Health Information Technology (HIT) screening tool for depression and post-traumatic stress disorder in the primary care setting.

    Science.gov (United States)

    Biegler, Kelly; Mollica, Richard; Sim, Susan Elliott; Nicholas, Elisa; Chandler, Maria; Ngo-Metzger, Quyen; Paigne, Kittya; Paigne, Sompia; Nguyen, Danh V; Sorkin, Dara H

    2016-09-01

    The prevalence rate of depression in primary care is high. Primary care providers serve as the initial point of contact for the majority of patients with depression, yet, approximately 50% of cases remain unrecognized. The under-diagnosis of depression may be further exacerbated in limited English-language proficient (LEP) populations. Language barriers may result in less discussion of patients' mental health needs and fewer referrals to mental health services, particularly given competing priorities of other medical conditions and providers' time pressures. Recent advances in Health Information Technology (HIT) may facilitate novel ways to screen for depression and other mental health disorders in LEP populations. The purpose of this paper is to describe the rationale and protocol of a clustered randomized controlled trial that will test the effectiveness of an HIT intervention that provides a multi-component approach to delivering culturally competent, mental health care in the primary care setting. The HIT intervention has four components: 1) web-based provider training, 2) multimedia electronic screening of depression and PTSD in the patients' primary language, 3) Computer generated risk assessment scores delivered directly to the provider, and 4) clinical decision support. The outcomes of the study include assessing the potential of the HIT intervention to improve screening rates, clinical detection, provider initiation of treatment, and patient outcomes for depression and post-traumatic stress disorder (PTSD) among LEP Cambodian refugees who experienced war atrocities and trauma during the Khmer Rouge. This technology has the potential to be adapted to any LEP population in order to facilitate mental health screening and treatment in the primary care setting.

  18. [Social deprivation and time perception, the impact on smoking cessation].

    Science.gov (United States)

    Merson, Frédéric; Perriot, Jean

    2011-01-01

    Smoking addiction and smoking behaviour are closely related to social deprivation. The aim of this study was to evaluate the impact of social deprivation and time perspective on smoking cessation in order to improve the support provided to socially deprived persons seeking to quit smoking. The study examined the impact of social disadvantages and time perspective on smoking cessation. 192 patients (including 45% of socially disadvantaged people) participated in the study. Social deprivation was measured using the EPICES scale, while time perspective was measured using the short version of the Zimbardo Time Perspective Inventory. Data relating to individuals' characteristics, smoking addiction, behaviour and smoking cessation were collected as part of this research. Compared to the rest of the population, socially disadvantaged people were found to be more likely to stop smoking for financial reasons (p < 0.0001). The study also found that their attempts to quit smoking are more likely to fail (p = 0,006). In addition, socially disadvantaged people suffer more frequently from anxio-depressive disorders (p < 0.0001) and are also prone to a higher level of nicotine dependence (p < 0.0001). The 'Past-Negative' and ?Present-Fatalistic' dimensions of time perspective, toward which socially disadvantaged people are more likely to lean (p < 0.0001), are associated with failed smoking cessation. The ?Future' dimension, in which socially disadvantaged people are less likely to project themselves (p < 0.0002), is a predictive factor of smoking cessation. The results highlight the importance of taking into account social deprivation and time perspective in helping socially disadvantaged patients to quit smoking.

  19. Open label smoking cessation with varenicline is associated with decreased glutamate levels and functional changes in anterior cingulate cortex: preliminary findings

    Directory of Open Access Journals (Sweden)

    Muriah Dawn Wheelock

    2014-07-01

    Full Text Available Rationale: Varenicline, the most effective single agent for smoking cessation, is a partial agonist at α4β2 nicotinic acetylcholine receptors. Increasing evidence implicates glutamate in the pathophysiology of addiction and one of the benefits of treatment for smoking cessation is the ability to regain cognitive control. Objective: To evaluate the effects of 12 week varenicline administration on glutamate levels in the dorsal anterior cingulate cortex (dACC and functional changes within the cognitive control network.Methods: We used single-voxel proton magnetic resonance spectroscopy (1H-MRS in the dACC and functional MRI (fMRI during performance of a Stroop color-naming task before and after smoking cessation with varenicline in 11 healthy smokers (open label design. Using the dACC as a seed region, we evaluated functional connectivity changes using a psychophysiological interaction (PPI analysis. Results: We observed a significant decrease in dACC glutamate + glutamine (Glx/Cr levels as well as significant blood oxygen level-dependent signal (BOLD decreases in the rostral ACC/medial orbitofrontal cortex and precuneus/posterior cingulate cortex. These BOLD changes are suggestive of alterations in default mode network (DMN function and are further supported by the results of the PPI analysis that revealed changes in connectivity between the dACC and regions of the DMN. Baseline measures of nicotine dependence and craving positively correlated with baseline Glx/Cr levels.Conclusions: These results suggest possible mechanisms of action for varenicline such as reduction in Glx levels in dACC and shifts in BOLD activities between large scale brain networks. They also suggest a role for ACC Glx in the modulation of behavior. Due to the preliminary nature of this study (lack of control group and small sample size, future studies are needed to replicate these findings.

  20. Mindfulness predicts lower affective volatility among African Americans during smoking cessation.

    Science.gov (United States)

    Adams, Claire E; Chen, Minxing; Guo, Lin; Lam, Cho Y; Stewart, Diana W; Correa-Fernández, Virmarie; Cano, Miguel A; Heppner, Whitney L; Vidrine, Jennifer Irvin; Li, Yisheng; Ahluwalia, Jasjit S; Cinciripini, Paul M; Wetter, David W

    2014-06-01

    Recent research suggests that mindfulness benefits emotion regulation and smoking cessation. However, the mechanisms by which mindfulness affects emotional and behavioral functioning are unclear. One potential mechanism, lower affective volatility, has not been empirically tested during smoking cessation. This study examined longitudinal associations among mindfulness and emotional responding over the course of smoking cessation treatment among predominantly low-socioeconomic status (SES) African American smokers, who are at high risk for relapse to smoking and tobacco-related health disparities. Participants (N = 399, 51% female, mean age = 42, 48% with annual income mindfulness. Negative affect, positive affect, and depressive symptoms were assessed at five time points during smoking cessation treatment (up to 31 days postquit). Volatility indices were calculated to quantify within-person instability of emotional symptoms over time. Over and above demographic characteristics, nicotine dependence, and abstinence status, greater baseline trait mindfulness predicted lower volatility of negative affect and depressive symptoms surrounding the quit attempt and up to 1 month postquit, ps mindfulness and smoking cessation, these results are the first to show that mindfulness is linked to lower affective volatility (or greater stability) of negative emotions during the course of smoking cessation. The present study suggests that mindfulness is linked to greater emotional stability and augments the study of mindfulness in diverse populations. Future studies should examine the effects of mindfulness-based interventions on volatility and whether lower volatility explains effects of mindfulness-based treatments on smoking cessation.

  1. The Influence of Antismoking Television Advertisements on Cessation by Race/Ethnicity, Socioeconomic Status, and Mental Health Status

    OpenAIRE

    Nonnemaker, James M.; Allen, Jane A.; Davis, Kevin C.; Kian Kamyab; Duke, Jennifer C.; Farrelly, Matthew C.

    2014-01-01

    Disparities in tobacco use and smoking cessation by race/ethnicity, education, income, and mental health status remain despite recent successes in reducing tobacco use. It is unclear to what extent media campaigns promote cessation within these population groups. This study aims to (1) assess whether exposure to antitobacco advertising is associated with making a quit attempt within a number of population subgroups, and (2) determine whether advertisement type differentialy affects cessation ...

  2. Clinico-epidemiological profile of tobacco users attending a tobacco cessation clinic in a teaching hospital in Bangalore city

    OpenAIRE

    George D′Souza; Dorothy P Rekha; Priya Sreedaran; Srinivasan, K.; Mony, Prem K

    2012-01-01

    Background: Tobacco-attributable mortality in India is estimated to be at least 10%. Tobacco cessation is more likely to avert millions of deaths before 2050 than prevention of tobacco use initiation. Objective: To describe the clinico-epidemiological profile of attendees of a tobacco cessation clinic in a teaching hospital in Bangalore city. Materials and Methods: A descriptive study of 189 attendees seen over 2 years in the Tobacco Cessation Clinic of a tertiary-care teaching hospital in Ba...

  3. Humanities Program: Critique and Rationale.

    Science.gov (United States)

    Pinar, William Frederick

    The psychological impact of schooling is examined within the context of a new school of British psychoanalytic thought. It is concluded that schooling is maddening, in the sense used by Laing, Cooper, and others. A rationale for a sane humanities program is established consisting of two components: the nuclear and the cortical. The nuclear is the…

  4. Effect of genetic testing for risk of type 2 diabetes mellitus on health behaviors and outcomes: study rationale, development and design

    Directory of Open Access Journals (Sweden)

    Cho Alex H

    2012-01-01

    Full Text Available Abstract Background Type 2 diabetes is a prevalent chronic condition globally that results in extensive morbidity, decreased quality of life, and increased health services utilization. Lifestyle changes can prevent the development of diabetes, but require patient engagement. Genetic risk testing might represent a new tool to increase patients' motivation for lifestyle changes. Here we describe the rationale, development, and design of a randomized controlled trial (RCT assessing the clinical and personal utility of incorporating type 2 diabetes genetic risk testing into comprehensive diabetes risk assessments performed in a primary care setting. Methods/Design Patients are recruited in the laboratory waiting areas of two primary care clinics and enrolled into one of three study arms. Those interested in genetic risk testing are randomized to receive either a standard risk assessment (SRA for type 2 diabetes incorporating conventional risk factors plus upfront disclosure of the results of genetic risk testing ("SRA+G" arm, or the SRA alone ("SRA" arm. Participants not interested in genetic risk testing will not receive the test, but will receive SRA (forming a third, "no-test" arm. Risk counseling is provided by clinic staff (not study staff external to the clinic. Fasting plasma glucose, insulin levels, body mass index (BMI, and waist circumference are measured at baseline and 12 months, as are patients' self-reported behavioral and emotional responses to diabetes risk information. Primary outcomes are changes in insulin resistance and BMI after 12 months; secondary outcomes include changes in diet patterns, physical activity, waist circumference, and perceived risk of developing diabetes. Discussion The utility, feasibility, and efficacy of providing patients with genetic risk information for common chronic diseases in primary care remain unknown. The study described here will help to establish whether providing type 2 diabetes genetic risk

  5. Assessment of successful smoking cessation by psychological factors using the Bayesian network approach.

    Science.gov (United States)

    Yang, Xiaorong; Li, Suyun; Pan, Lulu; Wang, Qiang; Li, Huijie; Han, Mingkui; Zhang, Nan; Jiang, Fan; Jia, Chongqi

    2016-07-01

    The association between psychological factors and smoking cessation is complicated and inconsistent in published researches, and the joint effect of psychological factors on smoking cessation is unclear. This study explored how psychological factors jointly affect the success of smoking cessation using a Bayesian network approach. A community-based case control study was designed with 642 adult male successful smoking quitters as the cases, and 700 adult male failed smoking quitters as the controls. General self-efficacy (GSE), trait coping style (positive-trait coping style (PTCS) and negative-trait coping style (NTCS)) and self-rating anxiety (SA) were evaluated by GSE Scale, Trait Coping Style Questionnaire and SA Scale, respectively. Bayesian network was applied to evaluate the relationship between psychological factors and successful smoking cessation. The local conditional probability table of smoking cessation indicated that different joint conditions of psychological factors led to different outcomes for smoking cessation. Among smokers with high PTCS, high NTCS and low SA, only 36.40% successfully quitted smoking. However, among smokers with low pack-years of smoking, high GSE, high PTCS and high SA, 63.64% successfully quitted smoking. Our study indicates psychological factors jointly influence smoking cessation outcome. According to different joint situations, different solutions should be developed to control tobacco in practical intervention.

  6. Effectiveness of regular reporting of spirometric results combined with a smoking cessation advice by a primary care physician on smoking quit rate in adult smokers: a randomized controlled trial. ESPIROTAB study

    Directory of Open Access Journals (Sweden)

    Martínez-González Silvia

    2011-06-01

    Full Text Available Abstract Background Undiagnosed airflow limitation is common in the general population and is associated with impaired health and functional status. Smoking is the most important risk factor for this condition. Although primary care practitioners see most adult smokers, few currently have spirometers or regularly order spirometry tests in these patients. Brief medical advice has shown to be effective in modifying smoking habits in a large number of smokers but only a small proportion remain abstinent after one year. The aim of this study is to evaluate the effectiveness of regular reporting of spirometric results combined with a smoking cessation advice by a primary care physician on smoking quit rate in adult smokers. Methods/design Intervention study with a randomized two arms in 5 primary care centres. A total of 485 smokers over the age of 18 years consulting their primary care physician will be recruited. On the selection visit all participants will undergo a spirometry, peak expiratory flow rate, test of smoking dependence, test of motivation for giving up smoking and a questionnaire on socio-demographic data. Thereafter an appointment will be made to give the participants brief structured advice to give up smoking combined with a detailed discussion on the results of the spirometry. After this, the patients will be randomised and given appointment for follow up visits at 3, 6, 12 and 24 months. Both arms will receive brief structured advice and a detailed discussion of the spirometry results at visit 0. The control group will only be given brief structured advice about giving up smoking on the follow up. Cessation of smoking will be tested with the carbon monoxide test. Discussion Early identification of functional pulmonary abnormalities in asymptomatic patients or in those with little respiratory symptomatology may provide "ideal educational opportunities". These opportunities may increase the success of efforts to give up smoking and

  7. West End Walkers 65+: A randomised controlled trial of a primary care-based walking intervention for older adults: Study rationale and design

    Directory of Open Access Journals (Sweden)

    Rowe David A

    2011-02-01

    Full Text Available Abstract Background In Scotland, older adults are a key target group for physical activity intervention due to the large proportion who are inactive. The health benefits of an active lifestyle are well established but more research is required on the most effective interventions to increase activity in older adults. The 'West End Walkers 65+' randomised controlled trial aims to examine the feasibility of delivering a pedometer-based walking intervention to adults aged ≥65 years through a primary care setting and to determine the efficacy of this pilot. The study rationale, protocol and recruitment process are discussed in this paper. Methods/Design The intervention consisted of a 12-week pedometer-based graduated walking programme and physical activity consultations. Participants were randomised into an immediate intervention group (immediate group or a 12-week waiting list control group (delayed group who then received the intervention. For the pilot element of this study, the primary outcome measure was pedometer step counts. Secondary outcome measures of sedentary time and physical activity (time spent lying/sitting, standing or walking; activPAL™ monitor, mood (Positive and Negative Affect Schedule, functional ability (Perceived Motor-Efficacy Scale for Older Adults, quality of life (Short-Form (36 Health Survey version 2 and loneliness (UCLA Loneliness Scale were assessed. Focus groups with participants and semi-structured interviews with the research team captured their experiences of the intervention. The feasibility component of this trial examined recruitment via primary care and retention of participants, appropriateness of the intervention for older adults and the delivery of the intervention by a practice nurse. Discussion West End Walkers 65+ will determine the feasibility and pilot the efficacy of delivering a pedometer-based walking intervention through primary care to Scottish adults aged ≥65 years. The study will also

  8. Smoking cessation support for pregnant women: role of mobile technology

    Directory of Open Access Journals (Sweden)

    Heminger CL

    2016-04-01

    Full Text Available Christina L Heminger, Jennifer M Schindler-Ruwisch, Lorien C AbromsDepartment of Prevention and Community Health, Milken Institute School of Public Health, The George Washington University, Washington, DC, USA Background: Smoking during pregnancy has deleterious health effects for the fetus and mother. Given the high risks associated with smoking in pregnancy, smoking cessation programs that are designed specifically for pregnant smokers are needed. This paper summarizes the current landscape of mHealth cessation programs aimed at pregnant smokers and where available reviews evidence to support their use. Methods: A search strategy was conducted in June–August 2015 to identify mHealth programs with at least one component or activity that was explicitly directed at smoking cessation assistance for pregnant women. The search for text messaging programs and applications included keyword searches within public health and medical databases of peer-reviewed literature, Google Play/iTunes stores, and gray literature via Google. Results: Five unique short message service programs and two mobile applications were identified and reviewed. Little evidence was identified to support their use. Common tools and features identified included the ability to set your quit date, ability to track smoking status, ability to get help during cravings, referral to quitline, and tailored content for the individual participant. The theoretical approach utilized was varied, and approximately half of the programs included pregnancy-related content, in addition to cessation content. With one exception, the mHealth programs identified were found to have low enrollment. Conclusion: Globally, there are a handful of applications and text-based mHealth programs available for pregnant smokers. Future studies are needed that examine the efficacy of such programs, as well as strategies to best promote enrollment. Keywords: mHealth, smoking cessation, pregnancy, text messaging

  9. Abstinence and Use of Community-Based Cessation Treatment After a Motivational Intervention Among smokers with Severe Mental Illness.

    Science.gov (United States)

    Ferron, Joelle C; Devitt, Timothy; McHugo, Gregory J; A Jonikas, Jessica; Cook, Judith A; Brunette, Mary F

    2016-05-01

    Motivational interventions help people with mental illness try to quit smoking, but few studies have evaluated factors associated with this groups' cessation with community treatment. We examined predictors of abstinence after a brief motivational intervention among smokers with severe mental illness. Education, stage of change post intervention, and use of cessation treatment predicted any 1-week period of self-reported abstinence over 6 months (29%). Cessation treatment mediated the relationship between stage of change and abstinence. Because treatment was the key modifiable predictor of abstinence, future research should establish strategies that improve motivation for, access to, and retention in cessation treatment. Clinical Trials Identifier NCT01412866.

  10. Smoking cessation strategies in patients with COPD

    DEFF Research Database (Denmark)

    Warnier, Miriam J; van Riet, Evelien E S; Rutten, Frans H

    2013-01-01

    Smoking cessation is the cornerstone of treatment of chronic obstructive pulmonary disease (COPD) patients. This systematic review evaluates the effectiveness of behavioural and pharmacological smoking cessation strategies in COPD patients. MEDLINE was searched from January 2002 to October 2011....... Randomised controlled trials evaluating the effect of smoking cessation interventions for COPD patients, published in English, were selected. The methodological quality of included trials was assessed using the Delphi list by two reviewers independently. The relative risks of smoking cessation due...... to be of acceptable quality. Pharmacological therapy combined with behavioural counselling was more effective than each strategy separately. In COPD patients, the intensity of counselling did not seem to influence the results, nor did the choice of drug therapy make a difference. This systematic review makes clear...

  11. Smokeless tobacco: challenges, products and, cessation.

    Science.gov (United States)

    Rankin, K Vendrell; Jones, Daniel L; Benton, Elain

    2010-06-01

    Tobacco companies continue to develop and aggressively market new products for oral use. Most new products are intended to dissolve in the mouth and swallow rather than spit out the juices. These products effectively circumvent smoke-free policies, decrease tobacco cessation efforts, and create individuals who use both smokeless tobacco (ST) and cigarettes. All ST products contain nicotine, carcinogens, and pose multiple health risks. The cancer and health risks associated with ST use extend well beyond the changes in the oral cavity and the risk of oral cancer. Unlike cigarettes, the contents of ST vary widely by brand and product posing difficulty in the use of the available pharmacotherapy for cessation. Although no uniform guidelines exist for the use of pharmacotherapy for smokeless tobacco cessation, research suggests that use of these drugs is effective. The most important motivator for quitting ST cessation remains in the hands of the dentist.

  12. Perioperative smoking cessation in vascular surgery

    DEFF Research Database (Denmark)

    Kehlet, M.; Heesemann, Sabine; Tonnesen, H.;

    2015-01-01

    Background: 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. Methods: 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. Inclusion criteria were patients with planned open peripheral vascular surgery and who were daily smokers. According...... intervention and 21 as controls. There was no difference in 30-day complication rates or 6-week abstinence rates between the two groups. Conclusions: A trial assessing the effect of smoking cessation on postoperative complications on the day of soft tissue surgery is still needed. If another trial...

  13. 33 CFR 279.9 - Objective rationale.

    Science.gov (United States)

    2010-07-01

    ... 33 Navigation and Navigable Waters 3 2010-07-01 2010-07-01 false Objective rationale. 279.9... DEFENSE RESOURCE USE: ESTABLISHMENT OF OBJECTIVES § 279.9 Objective rationale. (a) Statement of objectives... objective(s) and providing the rationale, impact, and basic management measures for their...

  14. An educational campaign to increase chiropractic intern advising roles on patient smoking cessation

    Directory of Open Access Journals (Sweden)

    Strasser Sheryl M

    2006-10-01

    Full Text Available Abstract Background Tobacco use, particularly smoking, is the most preventable cause of death in the United States. More than 400,000 premature deaths are associated with its use and the health care costs are in the billions. All health care provider groups should be concerned with patients who continue to smoke and use tobacco. The US Preventive Services Taskforce and Health People 2010 guidelines encourage providers to counsel smokers on cessation. Current studies, though limited regarding chiropractic advising practices indicate a low engagement rate when it comes to providing cessation information. Objective To test a campaign regarding initial impact aimed at increasing chiropractic interns advising on cessation and delivery of information to smokers on cessation. Discussion Chiropractic interns do engage patients on smoking status and can be encouraged to provide more cessation messages and information to patients. The initial impact assessment of this campaign increased the provision of information to patients by about 25%. The prevalence of smoking among chiropractic patients, particularly at teaching clinics may be lower than the national averages. Conclusion Chiropractic interns can and should be encouraged to advise smokers about cessation. A systematic method of intake information on smoking status is needed and a standardized education protocol for chiropractic colleges is needed. Chiropractic colleges should assess the adequacy of their advising roles and implement changes to increase cessation messages to their patients as soon as possible.

  15. Kefir protective effects against nicotine cessation-induced anxiety and cognition impairments in rats

    Directory of Open Access Journals (Sweden)

    Negin Noori

    2014-01-01

    Conclusion: This study revealed that Kefir had a potential effect on the treatment of nicotine cessation-induced depression, anxiety and cognition impairment in the animal model. Kefir may be useful for adjunct therapy for nicotine abandonment treatment protocols.

  16. Reach and uptake of Internet- and phone-based smoking cessation interventions

    DEFF Research Database (Denmark)

    Skov-Ettrup, L S; Dalum, P; Ekholm, O;

    2014-01-01

    To study whether demographic and smoking-related characteristics are associated with participation (reach) in a smoking cessation trial and subsequent use (uptake) of two specific smoking interventions (Internet-based program and proactive telephone counseling)....

  17. Space Resource Roundtable Rationale

    Science.gov (United States)

    Duke, Michael

    1999-01-01

    Recent progress in the U.S. Space Program has renewed interest in space resource issues. The Lunar Prospector mission conducted in NASA's Discovery Program has yielded interesting new insights into lunar resource issues, particularly the possibility that water is concentrated in cold traps at the lunar poles. This finding has not yet triggered a new program of lunar exploration or development, however it opens the possibility that new Discovery Missions might be viable. Several asteroid missions are underway or under development and a mission to return samples from the Mars satellite, Phobos, is being developed. These exploration missions are oriented toward scientific analysis, not resource development and utilization, but can provide additional insight into the possibilities for mining asteroids. The Mars Surveyor program now includes experiments on the 2001 lander that are directly applicable to developing propellants from the atmosphere of Mars, and the program has solicited proposals for the 2003/2005 missions in the area of resource utilization. These are aimed at the eventual human exploration of Mars. The beginning of construction of the International Space Station has awakened interest in follow-on programs of human exploration, and NASA is once more studying the human exploration of Moon, Mars and asteroids. Resource utilization will be included as objectives by some of these human exploration programs. At the same time, research and technology development programs in NASA such as the Microgravity Materials Science Program and the Cross-Enterprise Technology Development Program are including resource utilization as a valid area for study. Several major development areas that could utilize space resources, such as space tourism and solar power satellite programs, are actively under study. NASA's interests in space resource development largely are associated with NASA missions rather than the economic development of resources for industrial processes. That

  18. Nicotine receptor partial agonists for smoking cessation

    Directory of Open Access Journals (Sweden)

    Kate Cahill

    found that more participants taking cytisine stopped smoking compared with placebo at longest follow-up, with a pooled RR of 3.98 (95% confidence interval (CI 2.01 to 7.87. One trial of dianicline (602 people failed to find evidence that it was effective (RR 1.20, 95% CI 0.82 to 1.75. Fifteen trials compared varenicline with placebo for smoking cessation; three of these also included a bupropion treatment arm. We also found one open-label trial comparing varenicline plus counselling with counselling alone. We found one relapse prevention trial, comparing varenicline with placebo, and two open-label trials comparing varenicline with nicotine replacement therapy (NRT. We also included one trial in which all the participants were given varenicline, but received behavioural support either online or by phone calls, or by both methods. This trial is not included in the analyses, but contributes to the data on safety and tolerability. The included studies covered 12,223 participants, 8100 of whom used varenicline. The pooled RR for continuous or sustained abstinence at six months or longer for varenicline at standard dosage versus placebo was 2.27 (95% CI 2.02 to 2.55; 14 trials, 6166 people, excluding one trial evaluating long term safety. Varenicline at lower or variable doses was also shown to be effective, with an RR of 2.09 (95% CI 1.56 to 2.78; 4 trials, 1272 people. The pooled RR for varenicline versus bupropion at one year was 1.52 (95% CI 1.22 to 1.88; 3 trials, 1622 people. The RR for varenicline versus NRT for point prevalence abstinence at 24 weeks was 1.13 (95% CI 0.94 to 1.35; 2 trials, 778 people. The two trials which tested the use of varenicline beyond the 12-week standard regimen found the drug to be well-tolerated during long-term use. The main adverse effect of varenicline was nausea, which was mostly at mild to moderate levels and usually subsided over time. A meta-analysis of reported serious adverse events occurring during or after active treatment and

  19. Smoking Cessation/Prevention in the Air Force: How Adequate

    Science.gov (United States)

    2007-11-02

    FNP , Com. Member Approval DaW APPROVED: F.G. Abdellah, EdD, ScD, RN, FAAN Date Dean CURRICULUM VITAE Name: Cheryl Anita Udensi Permanent Address...sample of charts and client interview was employed to compare providers’ documented practice protocols with established guidelines set by the Department of...validity in smoking cessation practices was utilized. A pilot study was done to determine intercoder reliability. Descriptive statistics were utilized to

  20. Effectiveness of Switching Smoking-Cessation Medications Following Relapse

    OpenAIRE

    Heckman, Bryan W.; Cummings, K. Michael; Kasza, Karin A.; Borland, Ron; Burris, Jessica L; Geoffrey T Fong; McNeill, Ann; Carpenter, Matthew J.

    2017-01-01

    Introduction Nicotine dependence is a chronic disorder often characterized by multiple failed quit attempts (QAs). Yet, little is known about the sequence of methods used across multiple QAs or how this may impact future ability to abstain from smoking. This prospective cohort study examines the effectiveness of switching smoking-cessation medications (SCMs) across multiple QAs. Methods Adult smokers (aged ≥18 years) participating in International Tobacco Control surveys in the United Kingdom...

  1. Profile of women who carried out smoking cessation treatment: a systematic review

    Science.gov (United States)

    Pereira, Caroline Figueira; de Vargas, Divane

    2015-01-01

    OBJECTIVE Analyze the profile of women, in health services, who carry out treatment for smoking cessation. METHODS Systematic review that used the following sources of information: Cummulative Index to Nursing and Allied Health Literature (CINAHL), PubMed, Biblioteca Virtual em Saúde (BVS), Scopus and Web of Science. We included quantitative studies that addressed the characterization of women, in health services, who carried out treatment for smoking cessation, resulting in 12 articles for analysis. The assessment of the methodological quality of the studies was performed using the instrument MAStARI from Joanna Briggs Institute. RESULTS The predominant profile of women who carried out treatment for smoking cessation in health services was composed of white, married, employed, and highly level educated women. Women who carried out the treatment for smoking cessation in specialized services had a more advanced age, were white, were married and had a diagnosis of depression. The quality level of most studies was moderate. CONCLUSIONS The profile of women who carry out treatment for smoking cessation, either in general or specialized health services, is composed of white, married, and highly level educated women. Publications about smoking women are scarce and the lack of Brazilian studies characterizing the profile of women who start treatment for smoking cessation shows the need for studies that explore this subject. PMID:26247386

  2. Profile of women who carried out smoking cessation treatment: a systematic review.

    Science.gov (United States)

    Pereira, Caroline Figueira; de Vargas, Divane

    2015-01-01

    OBJECTIVE Analyze the profile of women, in health services, who carry out treatment for smoking cessation. METHODS Systematic review that used the following sources of information: Cummulative Index to Nursing and Allied Health Literature (CINAHL), PubMed, Biblioteca Virtual em Saúde (BVS), Scopus and Web of Science. We included quantitative studies that addressed the characterization of women, in health services, who carried out treatment for smoking cessation, resulting in 12 articles for analysis. The assessment of the methodological quality of the studies was performed using the instrument MAStARI from Joanna Briggs Institute. RESULTS The predominant profile of women who carried out treatment for smoking cessation in health services was composed of white, married, employed, and highly level educated women. Women who carried out the treatment for smoking cessation in specialized services had a more advanced age, were white, were married and had a diagnosis of depression. The quality level of most studies was moderate. CONCLUSIONS The profile of women who carry out treatment for smoking cessation, either in general or specialized health services, is composed of white, married, and highly level educated women. Publications about smoking women are scarce and the lack of Brazilian studies characterizing the profile of women who start treatment for smoking cessation shows the need for studies that explore this subject.

  3. Profile of women who carried out smoking cessation treatment: a systematic review

    Directory of Open Access Journals (Sweden)

    Caroline Figueira Pereira

    2015-01-01

    Full Text Available OBJECTIVE Analyze the profile of women, in health services, who carry out treatment for smoking cessation. METHODS Systematic review that used the following sources of information: Cummulative Index to Nursing and Allied Health Literature (CINAHL, PubMed, Biblioteca Virtual em Saúde (BVS, Scopus and Web of Science. We included quantitative studies that addressed the characterization of women, in health services, who carried out treatment for smoking cessation, resulting in 12 articles for analysis. The assessment of the methodological quality of the studies was performed using the instrument MAStARI from Joanna Briggs Institute. RESULTS The predominant profile of women who carried out treatment for smoking cessation in health services was composed of white, married, employed, and highly level educated women. Women who carried out the treatment for smoking cessation in specialized services had a more advanced age, were white, were married and had a diagnosis of depression. The quality level of most studies was moderate. CONCLUSIONS The profile of women who carry out treatment for smoking cessation, either in general or specialized health services, is composed of white, married, and highly level educated women. Publications about smoking women are scarce and the lack of Brazilian studies characterizing the profile of women who start treatment for smoking cessation shows the need for studies that explore this subject.

  4. The impact of carotid plaque screening on motivation for smoking cessation.

    Science.gov (United States)

    Rodondi, Nicolas; Auer, Reto; Devine, Patrick J; O'Malley, Patrick G; Hayoz, Daniel; Cornuz, Jacques

    2008-03-01

    Showing smokers their own atherosclerotic plaques might increase motivation for smoking cessation, since they underestimate their own risk for smoking-related diseases. To assess the feasibility and optimal processes of studying the impact of carotid atherosclerotic plaque screening in smokers, we enrolled 30 daily cigarette smokers, aged 40-70 years, in an observational pre-post pilot study. All smokers underwent smoking cessation counseling, nicotine replacement therapy, a carotid ultrasound, an educational tutorial on atherosclerosis, baseline and 2-month motivation to change assessment, and assessment of smoking cessation at 2 months. Participants had a mean smoking duration of 34 years (SD = 7). Carotid plaques were present in 22 smokers (73%). Between baseline and 2 months after plaque screening, motivation for smoking cessation increased from 7.4 to 8.4 out of 10 (p = .02), particularly in those with plaques (7.2 to 8.7, p = .008). At 2 months, the smoking quit rate was 63%, with a quit rate of 73% in those with plaques vs. 38% in those without plaques (p = .10). Perceived stress, anxiety, and depression did not increase after screening. 96% of respondents answered correctly at least 80% of questions regarding atherosclerosis knowledge at baseline and after 2 months. In conclusion, studying the process of screening for carotid plaques for the purpose of increasing motivation for smoking cessation, in addition to counseling and drug therapy for smoking cessation in long-term smokers, appears feasible. The impact of carotid plaque screening on smoking cessation should be examined in larger randomized controlled trials with sufficient power to assess the impact on long-term smoking cessation rates.

  5. Smoking cessation after 12 months with multi-component therapy.

    Science.gov (United States)

    Raich, Antònia; Martínez-Sánchez, Jose Maria; Marquilles, Emili; Rubio, Lídia; Fu, Marcela; Fernández, Esteve

    2015-03-01

    Smoking is one of the most important causes of morbidity and mortality in developed countries. One of the priorities of public health programmes is the reduction of its prevalence, which would involve millions of people quitting smoking, but cessation programs often have modest results, especially within certain population groups. The aim of this study was to analyze the variables determining the success of a multicomponent therapy programme for smoking cessation. We conducted the study in the Smoking Addiction Unit at the Hospital of Manresa, with 314 patients (91.4% of whom had medium or high-level dependency). We observed that higher educational level, not living with a smoker, following a multimodal programme or smoking cessation with psychological therapy, and pharmacological treatment are relevant factors for quitting smoking. Abstinence rates are not associated with other factors, such as sex, age, smoking behaviour characteristics or psychiatric history. The combination of pharmacological and psychological treatment increased success rates in multicomponent therapy. Psychological therapy only also obtained positive results, though somewhat more modest.

  6. The Effects of Mild Gestational Hyperglycemia on Exclusive Breastfeeding Cessation

    Directory of Open Access Journals (Sweden)

    Sergio Verd

    2016-11-01

    Full Text Available Gestational diabetes increases the risk of a range of adverse perinatal outcomes, including breastfeeding failure, but the best cut-off point for gestational diabetes is unknown. The purpose of this study was to evaluate the association between mild gestational glucose tolerance impairment and the early cessation of exclusive breastfeeding (EBF. This is an observational study of 768 women with full term pregnancies that were screened for gestational diabetes at 24–28 weeks gestation. Subjects were divided into two groups: those with a normal 1-h glucose challenge test and those with an elevated 1-h glucose challenge test but still did not qualify for gestational diabetes. We constructed multivariable logistic regression models using data from 616 women with normal gestational glucose tolerance and 152 women with an isolated positive 1-h glucose challenge test. The risk of early exclusive breastfeeding cessation was found to increase in women with mildly impaired glucose tolerance during pregnancy (adjusted OR, 1.65; 95% CI: 1.11, 2.45. Risks of early EBF cessation were also independently associated with the amount of neonatal weight loss and admission to the neonatal ward. Instead, parity was associated with a decreased risk for shorter EBF duration. Insulin resistance—even in the absence of gestational diabetes mellitus—may be an impeding factor for EBF.

  7. Comparing factors affecting commencement and cessation of betel quid chewing behavior in Taiwanese adults

    Directory of Open Access Journals (Sweden)

    Kuo Hsiao-Ching

    2008-06-01

    Full Text Available Abstract Background Betel quid is the fourth most common used substance in the world after tobacco, alcohol and caffeine. Although factors related to betel quid chewing or cessation of behaviors were reported previously, few studies simultaneously compared both behaviors in the same population. In addition, it is essential to consider time-to-event concept, since the chance of developing or stopping habit may vary over time. The purpose of this study was to compare the risk factors for commencement and cessation of betel quid chewing behaviors in a time-to-event setting. Methods A stratified multi-stage cluster sampling with selection probabilities proportional to size (PPS was designed for Taiwanese adults with aged 18 years old and above. Kaplan-Meier estimates and Cox proportional hazard regression models were used to compare and calculate the hazard rate ratios for related factors to commencement or cessation of chewing habits. Results In Taiwan, men had a higher betel quid chewing rate (M: 20.9%, W: 1.2%, but woman chewers had a lower cessation rate (M: 27.5%, W: 12.7%. The hazard rate ratio (HRR of having chewing habit changed from 4.22 (men vs women univariately to 1.38 multivariablely, which indicated gender differences were confounded by other factors. In multivariable analysis, the risk factors of gender, education and ethnicity were significantly associated with both starting and cessation of betel quid chewing behavior. The factors of occupation, cigarette smoking and alcohol drinking were only associated with starting habit. Conclusion Commencement or cessation of chewing behavior involves a scenario of time, hence it is preferable to use a time-to-event approach for the comparison. The cessation rates of betel quid chewing were decreasingly associated with the daily consumption of betel quid. Hence, reducing of daily amount in betel quid cessation program may be associated with future stopping habit.

  8. Motivation as a strategy for smoking cessation

    Directory of Open Access Journals (Sweden)

    Lucia Soares Buss Coutinho

    2014-03-01

    Full Text Available Objective: to know the motivational aspects related to smoking cessation. Methods: semi-structured interviews were conducted with nine former smokers in their homes, located in a neighbourhood of Lages-SC, whose primary care service has a Residency Programme in Family and Community Medicine. This sample was obtained by convenience, following the inclusion criteria: patients over 18 years classified as former smokers. The analyses of the interviews were performed using the Discourse of the Collective Subject. Results: the accounts presented showed that motivation is a tool for smoking cessation, emphasizing that it is not external to the people; on the contrary, it depends on their own will. Conclusion: the process of smoking cessation is complex and multifactorial, requiring the health professional to be watchful and skilful in order to create an environment that motivates people to take care of their own health.

  9. Do electronic cigarettes help with smoking cessation?

    Science.gov (United States)

    2014-11-01

    Smoking causes around 100,000 deaths each year in the UK, and is the leading cause of preventable disease and early mortality. Smoking cessation remains difficult and existing licensed treatments have limited success. Nicotine addiction is thought to be one of the primary reasons that smokers find it so hard to give up, and earlier this year DTB reviewed the effects of nicotine on health. Electronic cigarettes (e-cigarettes) are nicotine delivery devices that aim to mimic the process of smoking but avoid exposing the user to some of the harmful components of traditional cigarettes. However, the increase in the use of e-cigarettes and their potential use as an aid to smoking cessation has been subject to much debate. In this article we consider the regulatory and safety issues associated with the use of e-cigarettes, and their efficacy in smoking cessation and reduction.

  10. Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study: rationale and design for a randomized controlled trial evaluating rheumatoid arthritis risk education to first-degree relatives.

    Science.gov (United States)

    Sparks, Jeffrey A; Iversen, Maura D; Miller Kroouze, Rachel; Mahmoud, Taysir G; Triedman, Nellie A; Kalia, Sarah S; Atkinson, Michael L; Lu, Bing; Deane, Kevin D; Costenbader, Karen H; Green, Robert C; Karlson, Elizabeth W

    2014-09-01

    We present the rationale, design features, and protocol of the Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study (ClinicalTrials.gov NCT02046005). The PRE-RA Family Study is an NIH-funded prospective, randomized controlled trial designed to compare the willingness to change behaviors in first-degree relatives of rheumatoid arthritis (RA) patients without RA after exposure to RA risk educational programs. Consented subjects are randomized to receive education concerning their personalized RA risk based on demographics, RA-associated behaviors, genetics, and biomarkers or to receive standard RA information. Four behavioral factors associated with RA risk were identified from prior studies for inclusion in the risk estimate: cigarette smoking, excess body weight, poor oral health, and low fish intake. Personalized RA risk information is presented through an online tool that collects data on an individual's specific age, gender, family history, and risk-related behaviors; presents genetic and biomarker results; displays relative and absolute risk of RA; and provides personalized feedback and education. The trial outcomes will be changes in willingness to alter behaviors from baseline to 6 weeks, 6 months, and 12 months in the three intervention groups. The design and the execution of this trial that targets a special population at risk for RA, while incorporating varied risk factors into a single risk tool, offer distinct challenges. We provide the theoretical rationale for the PRE-RA Family Study and highlight particular design features of this trial that utilize personalized risk education as an intervention.

  11. Reduced probability of smoking cessation in men with increasing number of job losses and partnership breakdowns

    DEFF Research Database (Denmark)

    Kriegbaum, Margit; Larsen, Anne Mette; Christensen, Ulla

    2011-01-01

    Background Unemployment and partnership breakdowns are common stressful life events, but their association with smoking cessation has been investigated in only a few studies. Objective To investigate how history of employment and cohabitation affects the probability of smoking cessation and to st......Background Unemployment and partnership breakdowns are common stressful life events, but their association with smoking cessation has been investigated in only a few studies. Objective To investigate how history of employment and cohabitation affects the probability of smoking cessation...... by a questionnaire. Results The probability of smoking cessation decreased with the number of job losses (ranging from 1 OR 0.54 (95% CI 0.46 to 0.64) to 3+ OR 0.41 (95% CI 0.30 to 0.55)) and of broken partnerships (ranging from 1 OR 0.74 (95% CI 0.63 to 0.85) to 3+ OR 0.50 (95% CI 0.39 to 0.63)). Furthermore......, smoking cessation was associated with the duration of the periods of unemployment (ranging from 1–5 years (OR 0.75, 95% CI 0.65 to 0.85) to 10–23 years (OR 0.29, 95% CI 0.22 to 0.38)) and with living without a partner for >5 years (ranging from 6–9 years to 10–23 years (OR 0.80, 95% CI 0.66 to 0.97) to 10...

  12. Smoking and management methods. The practice of smoking cessation programme in University Hospital of Larissa.

    Directory of Open Access Journals (Sweden)

    Zarogiannis S.,

    2009-04-01

    Full Text Available Background: Smoking is the most important, preventable cause of premature death and this addiction can be regarded as a chronic, recurrent disease. The benefits of smoking cessation are unquestionable and all health care professionals should become more active in recommending it. Aim: To characterise the population seeking medical support for smoking cessation and to investigate the effectiveness of a smoking cessation programme performed, in the University Hospital of Larissa, for outpatients. Materials and Methods: Retrospective analysis of medical records of outpatients in follow-up between March 2004 and October 2007. Age, gender, level of education, smoking habits, compliance in pharmacological treatment, gain weight and abstinence and relapse rates were evaluated.Results: Were studied 376 smokers, 60% male with an average age of 46.9 years. Men, upper graduated smokers have higher cessation rates whereas, in heavy smokers with high degree of dependence was observed lower cessation rates. The continuous abstinence rate at 12 months was 38%, and among pharmacological treatment, varenicline resulted elevated rate of quit smoking. The rate of relapse was found in 39%.Conclusions: This study suggests that smoking cessation programmes may be highly effective in helping smoking withdrawal and should be a strongly recommended component of daily clinical practice.

  13. Association between Positivity and Smoking Cessation

    Directory of Open Access Journals (Sweden)

    Maria Caterina Grassi

    2014-01-01

    Full Text Available The literature documents that personality characteristics are associated with healthy lifestyles, including smoking. Among positive traits, Positivity (POS, defined as a general disposition conducive to facing experience under a positive outlook has shown robust associations with psychological health. Thus, the present study investigated the extent to which POS is able to predict (i relapse after quitting smoking and (ii the desire to smoke again. All participants (481 had previously attended a Group Counselling Program (GCP for Smoking Cessation (from 2005 through 2010. They were contacted through telephone interview. Among participants, 244 were ex-smokers (age: years 56.3±10.08, 52% female and 237 were still-smokers (age: years 55.0±9.63; 63.5% female. The association of POS with “craving to smoke” levels was assessed with multivariate linear regression analysis while controlling also for important differences in personality such as conscientiousness and general self-efficacy, as well as for gender and age. Results showed that POS was significantly and negatively associated with smoking status and with craving to smoke. Among covariates (i.e., conscientiousness, generalized self-efficacy, gender was associated with smoking status and with craving to smoke. Altogether these findings corroborate the idea that POS plays a significant role in sustaining individuals' efforts to quit smoking.

  14. Systems-Level Smoking Cessation Activities by Private Health Plans

    Directory of Open Access Journals (Sweden)

    Sharon Reif, PhD

    2011-01-01

    Full Text Available IntroductionThe US Public Health Service urges providers to screen patients for smoking and advise smokers to quit. Yet, these practices are not widely implemented in clinical practice. This study provides national estimates of systems-level strategies used by private health insurance plans to influence provider delivery of smoking cessation activities.MethodsData are from a nationally representative survey of health plans for benefit year 2003, across product types offered by insurers, including health maintenance organizations (HMOs, preferred provider organizations, and point-of-service products, regarding alcohol, tobacco, drug, and mental health services. Executive directors of 368 health plans responded to the administrative module (83% response rate. Medical directors of 347 of those health plans, representing 771 products, completed the clinical module in which health plan respondents were asked about screening for smoking, guideline distribution, and incentives for guideline adherence.ResultsOnly 9% of products require, and 12% verify, that primary care providers (PCPs screen for smoking. HMOs are more likely than other product types to require screening. Only 17% of products distribute smoking cessation guidelines to PCPs, and HMOs are more likely to do this. Feedback to PCPs was most frequently used to encourage guideline adherence; financial incentives were rarely used. Furthermore, health plans that did require screening often conducted other cessation activities.ConclusionFew private health plans have adopted techniques to encourage the use of smoking cessation activities by their providers. Increasing health plan involvement is necessary to reduce tobacco use and concomitant disease in the United States.

  15. Successful Smoking Cessation in COPD: Association with Comorbidities and Mortality

    Directory of Open Access Journals (Sweden)

    H. Kupiainen

    2012-01-01

    Full Text Available Smoking cessation is the cornerstone of COPD management, but difficult to achieve in clinical practice. The effect of comorbidities on smoking cessation and risk factors for mortality were studied in a cohort of 739 COPD patients recruited in two Finnish University Hospitals. The diagnosis of COPD was done for the first time on average 5.5 years prior to the enrollment. Data from the medical records and followup questionnaires (years 0, 1, 2, and 4 have been analyzed. The patients’ lung function varied greatly; mean FEV1 58% of predicted. A total of 60.2% of men and 55.6% of women had been able to quit smoking. Alcohol abuse (OR 2.1, 95% CI 1.4–3.3 and psychiatric conditions (OR 1.8, 95% CI 1.2–2.7 were strongly related to low success rates of quitting. Among current smokers high nicotine dependency was again explained by alcohol abuse and psychiatric conditions. Non-quitters were younger than quitters, but their mortality rates remained significantly higher even when the model was adjusted for impairment of lung functions and comorbidities. In conclusion, co-existing addiction and psychiatric diseases significantly decreased the success rates in smoking cessation and increased mortality among the patients.

  16. [Smoking cessation in Germany in 2007. Patterns of outpatient smoking cessation counselling and treatment].

    Science.gov (United States)

    Etzel, M; Mons, U; Schmitt, S; Lang, P; Pötschke-Langer, M

    2008-12-01

    A qualified and comprehensive supply of outpatient smoking cessation counselling and treatment is essential to help smokers quit. In order to assess the status quo, structure and regional differences of the smoking cessation services available in Germany, a complete market survey was conducted in 2007. Descriptive results on the structure and characteristics of smoking cessation services show that there are distinct regional differences, especially in the New Laender, where the supply is insufficient. Overall, about a quarter of the providers of smoking cessation services lack specialised additional skills required for smoking cessation counselling, treatment or therapy of addicts. Especially medical practitioners more often lack such additional skills compared to other occupational groups. The smoking cessation services generally used the programs "Rauchfrei in 10 Schritten" and "Das Rauchfrei Programm", and the method of cognitive behavioural therapy. However, more than half of the services still use a method which is not evidence-based. Since February 2008 data on all supplies and suppliers of smoking cessation services, who gave their permission, have been published online and can be accessed at www.anbieter-raucherberatung.de.

  17. Stages of smoking cessation among Malaysian adults--findings from national health morbidity survey 2006.

    Science.gov (United States)

    Lim, Kuang Hock; Ibrahim, Normala; Ghazali, Sumarni Mohd; Kee, Chee Cheong; Lim, Kuang Kuay; Chan, Ying Ying; Teh, Chien Huey; Tee, Eng Ong; Lai, Wai Yee; Nik Mohamad, Mohd Haniki; Sidek, Sherina Mohd

    2013-01-01

    Increasing the rate of smoking cessation will reduce the burden of diseases related to smoking, including cancer. Understanding the process of smoking cessation is a pre-requisite to planning and developing effective programs to enhance the rate of smoking cessation.The aims of the study were to determine the demographic distribution of smokers across the initial stages of smoking cessation (the pre-contemplation and contemplation stages) and to identify the predictors of smoking cessation among Malaysian adult smokers. Data were extracted from a population-based, cross-sectional survey carried out from April 2006 to July 2006. The distribution of 2,716,743 current smokers across the pre-contemplation stage (no intention to quit smoking in the next six months) or contemplation stage (intended to quit smoking in the next six months) was described. Multivariable logistic regression analysis was used to examine the relationship between socio-demographic variables and the stages of smoking cessation. Of the 2,716,743 current smokers, approximately 30% and 70% were in the pre-contemplative and contemplative stages of smoking cessation respectively. Multivariable analysis showed that male gender, low education level, older age group, married and those from higher income group and number of cigarettes smoked were associated with higher likelihood of pre-contemplation to cease smoking in the next six months. The majority of current smokers in Malaysia were in the contemplative stage of smoking cessation. Specific interventions should be implemented to ensure the pre-contemplative smokers proceed to the contemplative stage and eventually to the preparation stage.

  18. Barriers and promoters of an evidenced-based smoking cessation counseling during prenatal care in Argentina and Uruguay.

    Science.gov (United States)

    Colomar, Mercedes; Tong, Van T; Morello, Paola; Farr, Sherry L; Lawsin, Catalina; Dietz, Patricia M; Aleman, Alicia; Berrueta, Mabel; Mazzoni, Agustina; Becu, Ana; Buekens, Pierre; Belizán, José; Althabe, Fernando

    2015-07-01

    In Argentina and Uruguay, 10.3 and 18.3 %, respectively, of pregnant women smoked in 2005. Brief cessation counseling, based on the 5A's model, has been effective in different settings. This qualitative study aims to improve the understanding of factors influencing the provision of smoking cessation counseling during pregnancy in Argentina and Uruguay. In 2010, we obtained prenatal care providers', clinic directors', and pregnant smokers' opinions regarding barriers and promoters to brief smoking cessation counseling in publicly-funded prenatal care clinics in Buenos Aires, Argentina and Montevideo, Uruguay. We interviewed six prenatal clinic directors, conducted focus groups with 46 health professionals and 24 pregnant smokers. Themes emerged from three issue areas: health professionals, health system, and patients. Health professional barriers to cessation counseling included inadequate knowledge and motivation, perceived low self-efficacy, and concerns about inadequate time and large workload. They expressed interest in obtaining a counseling script. Health system barriers included low prioritization of smoking cessation and a lack of clinic protocols to implement interventions. Pregnant smokers lacked information on the risks of prenatal smoking and underestimated the difficulty of smoking cessation. Having access to written materials and receiving cessation services during clinic waiting times were mentioned as promoters for the intervention. Women also were receptive to non-physician office staff delivering intervention components. Implementing smoking cessation counseling in publicly-funded prenatal care clinics in Argentina and Uruguay may require integrating counseling into routine prenatal care and educating and training providers on best-practices approaches.

  19. Examining physicians’ preparedness for tobacco cessation services in India: Findings from primary care public health facilities in two Indian states

    Directory of Open Access Journals (Sweden)

    Rajmohan Panda

    2013-03-01

    Full Text Available BackgroundA total of 275 million tobacco users live throughout India and are in need of tobacco cessation services. However, the preparation of physicians to deliver this service at primary care health facilities remains unknown.AimsThe study aimed to examine the primary care physicians’ preparedness to deliver tobacco cessation services in two Indian states.MethodResearchers surveyed physicians working in primary care public health facilities, primarily in rural areas using a semistructured interview schedule. Physicians’ preparedness was defined in the study as those possessing knowledge of tobacco cessation methods and exhibiting a positive attitude towards the benefits of tobacco cessation counselling as well as being willing to be part of tobacco prevention or cessation program.ResultsOverall only 17% of physicians demonstrated adequate preparation to provide tobacco cessation services at primary care health facilities in both the States. The findings revealed minimal tobacco cessation training during formal medical education (21.3% and on-the-job training (18.9%. Factors, like sex and age of service provider, type of health facility, location of health facility and number of patients attended by the service provider, failed to show significance during bivariate and regression analysis. Preparedness was significantly predicted by state health system.ConclusionThe study highlights a lack of preparedness of primary care physicians to deliver tobacco cessation services. Both the curriculum in medical school and on-the-job training require an addition of a learning component on tobacco cessation. The addition of this component will enable existing primary care facilities to deliver tobacco cessation services.

  20. Rationale, Design and Methods of the Ecological Study of Sexual Behaviors and HIV/STI among African American Men Who Have Sex with Men in the Southeastern United States (The MARI Study.

    Directory of Open Access Journals (Sweden)

    DeMarc A Hickson

    Full Text Available This paper describes the rationale, design, and methodology of the Ecological Study of Sexual Behaviors and HIV/STI among African American Men Who Have Sex with Men (MSM in the Southeastern United States (U.S.; known locally simply as the MARI Study.Participants are African American MSM aged 18 years and older residing in the deep South.Between 2013 and 2015, 800 African American MSM recruited from two study sites (Jackson, MS and Atlanta, GA will undergo a 1.5-hour examination to obtain anthropometric and blood pressure measures as well as to undergo testing for sexually transmitted infections (STI, including HIV. Intrapersonal, interpersonal, and environmental factors are assessed by audio computer-assisted self-interview survey. Primary outcomes include sexual risk behaviors (e.g., condomless anal sex and prevalent STIs (HIV, syphilis, gonorrhea, and Chlamydia.The MARI Study will typify the HIV environmental 'riskscape' and provide empirical evidence into novel ecological correlates of HIV risk among African American MSM in the deep South, a population most heavily impacted by HIV. The study's anticipated findings will be of interest to a broad audience and lead to more informed prevention efforts, including effective policies and interventions, that achieve the goals of the updated 2020 U.S. National HIV/AIDS Strategy.

  1. Rationales behind the choice of administration form with fentanyl

    DEFF Research Database (Denmark)

    Jacobsen, Ramune; Møldrup, Claus; Christrup, Lona

    2010-01-01

    BACKGROUND AND AIM: The aim of this study was to describe the rationale behind the choice of fentanyl administration forms among Danish general practitioners (GPs). METHODS: Thirty-eight Danish GPs were contacted via an Internet survey system to perform a Delphi survey. In the brainstorming phase...... in two rating rounds, respectively. The most important reason to choose fentanyl patches was that patients' clinical condition did not allow them to take analgesia orally. OTFCs were primarily seen as a self-administrative alternative to injections in case of breakthrough pain. The main reasons...... for not choosing OTFCs were intolerance to fentanyl and price. The most important possible rationale to choose fentanyl nasal spray was easy administration. The most important possible reasons to not choose fenanyl nasal spray were application side effects. CONCLUSIONS: The rationale behind the choice...

  2. [The medical rationale category and a new epistemology in health].

    Science.gov (United States)

    do Nascimento, Marilene Cabral; de Barros, Nelson Filice; Nogueira, Maria Inês; Luz, Madel Therezinha

    2013-12-01

    This article is an analytical report on the 20-year trajectory of the 'medical rationale' category that emerged in the early 1990s in the area of Social and Human Sciences in Health in the field of Public Health. Its objective was to study complex and therapeutic medical systems and traditional, complementary and alternative medicines. Based on a critical review of the literature, it presents some aspects of the cultural, political, institutional and social context of its emergence, as well as its main contributions and developments on a theoretical level and on social policies and practices in health. The southern epistemology concept of Boaventura de Sousa Santos is used to reflect upon the contribution of the 'medical rationale' category to the critique of the post-modern scientific rationale and to the creation of a new epistemology in health.

  3. Rapid fall in lung density following smoking cessation in COPD

    DEFF Research Database (Denmark)

    Shaker, Saher B; Stavngaard, Trine; Laursen, Lars Christian;

    2011-01-01

    Whether smoking-induced lung inflammation subsides after smoking cessation is currently a matter of debate. We used computed tomography (CT) to evaluate the effect of smoking cessation on lung density in patients with COPD.......Whether smoking-induced lung inflammation subsides after smoking cessation is currently a matter of debate. We used computed tomography (CT) to evaluate the effect of smoking cessation on lung density in patients with COPD....

  4. Drug cessation in complex older adults: Time for action

    OpenAIRE

    2014-01-01

    textabstractBackground: general opinion is growing that drug cessation in complex older patients is warranted in certain situations. From a clinical viewpoint, drug cessation seems most warranted in four situations, i.e., falls, delirium, cognitive impairment and endof-life situations. To date, little information about the effects of drug cessation in these four situations is available. Objectives: to identify the effects and effectiveness of drug cessation on falls, delirium and cognitive im...

  5. Training health professionals in smoking cessation (Review)

    NARCIS (Netherlands)

    Carson, K.V.; Verbiest, M.E.; Crone, M.R.; Brinn, M.P.; Esterman, A.J.; Assendelft, W.J.J.; Smith, B.J.

    2012-01-01

    BACKGROUND: Cigarette smoking is one of the leading causes of preventable death world wide. There is good evidence that brief interventions from health professionals can increase smoking cessation attempts. A number of trials have examined whether skills training for health professionals can lead th

  6. When Regional Innovation Policies Meet Policy Rationales and Evidence

    DEFF Research Database (Denmark)

    Borrás, Susana; Jordana, Jacint

    2016-01-01

    In spite of recent advancements regarding regional innovation policy rationales and evidence, there are few analyses about the actual features of existing regional innovation policies. Nevertheless, a policy analysis perspective is important in order to recognize their distinctive patterns across...... regions, and to understand how rationales and evidence can be translated into policy-making. To this purpose, this paper develops a framework to study the extent to which regional innovation policies have changed during the past few years. Since the mid-2000s, there has been an important development...

  7. Assessment of changes in nicotine dependence, motivation, and symptoms of anxiety and depression among smokers in the initial process of smoking reduction or cessation: a short-term follow-up study

    Directory of Open Access Journals (Sweden)

    Luciana Rizzieri Figueiró

    2013-01-01

    Full Text Available Introduction: The first days of a quit attempt represent an important challenge to long-term abstinence, especially because of the changes that take place over this period. Objective: To examine whether smokers who have recently changed their smoking behavior show changes in the intensity of nicotine dependence, motivational stage, or symptoms of anxiety and depression relative to smokers without recent changes in smoking behavior. Methods: Smokers attending a support group for smoking cessation in Porto Alegre, southern Brazil, were invited to participate. The program consisted of four weekly sessions. Smokers answered questionnaires covering intensity of nicotine dependence, stage of motivation, and symptoms of anxiety and depression at baseline and in the fourth week. Urine was collected at both time points, tested for cotinine concentration, and used to determine the final status of smokers. Results: Of the 54 smokers included in the study, 20 (37% stopped smoking or decreased tobacco use. Both smokers who stopped or reduced tobacco use and those who did not change their behavior presented a decrease in nicotine dependence scores (p = 0.001. Conversely, only the smokers who changed behavior presented an increase in scores in the maintenance stage (p < 0.001. Conclusion: When modifying tobacco use, smokers face a difficult process, marked by several changes. A better understanding of these changes and their implications for treatment are discussed.

  8. A before-after implementation trial of smoking cessation guidelines in hospitalized veterans

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    Reisinger Heather

    2009-09-01

    Full Text Available Abstract Background Although most hospitalized smokers receive some form of cessation counseling during hospitalization, few receive outpatient cessation counseling and/or pharmacotherapy following discharge, which are key factors associated with long-term cessation. US Department of Veterans Affairs (VA hospitals are challenged to find resources to implement and maintain the kind of high intensity cessation programs that have been shown to be effective in research studies. Few studies have applied the Chronic Care Model (CCM to improve inpatient smoking cessation. Specific objectives The primary objective of this protocol is to determine the effect of a nurse-initiated intervention, which couples low-intensity inpatient counseling with sustained proactive telephone counseling, on smoking abstinence in hospitalized patients. Key secondary aims are to determine the impact of the intervention on staff nurses' attitudes toward providing smoking cessation counseling; to identify barriers and facilitators to implementation of smoking cessation guidelines in VA hospitals; and to determine the short-term cost-effectiveness of implementing the intervention. Design Pre-post study design in four VA hospitals Participants Hospitalized patients, aged 18 or older, who smoke at least one cigarette per day. Intervention The intervention will include: nurse training in delivery of bedside cessation counseling, electronic medical record tools (to streamline nursing assessment and documentation, to facilitate prescription of pharmacotherapy, computerized referral of motivated inpatients for proactive telephone counseling, and use of internal nursing facilitators to provide coaching to staff nurses practicing in non-critical care inpatient units. Outcomes The primary endpoint is seven-day point prevalence abstinence at six months following hospital admission and prolonged abstinence after a one-month grace period. To compare abstinence rates during the

  9. Enhancing field GP engagement in hospital-based studies. Rationale, design, main results and participation in the diagest 3-GP motivation study

    Directory of Open Access Journals (Sweden)

    Berkhout Christophe

    2012-06-01

    Full Text Available Abstract Background Diagest 3 was a study aimed at lowering the risk of developing type 2 diabetes within 3 years after childbirth. Women with gestational diabetes were enrolled in the study. After childbirth, the subjects showed little interest in the structured education programme and did not attend workshops. Their general practitioners (GPs were approached to help motivate the subjects to participate in Diagest 3, but the GPs were reluctant. The present study aimed to understand field GPs’ attitudes towards hospital-based studies, and to develop strategies to enhance their involvement and reduce subject drop-out rates. Methods We used a three-step process: step one used a phenomenological approach exploring the beliefs, attitudes, motivations and environmental factors contributing to the GPs’ level of interest in the study. Data were collected in face-to-face interviews and coded by hand and with hermeneutic software to develop distinct GP profiles. Step two was a cross-sectional survey by questionnaire to determine the distribution of the profiles in the GP study population and whether completion of an attached case report form (CRF was associated with a particular GP profile. In step three, we assessed the impact of the motivation study on participation rates in the main study. Results Fifteen interviews were conducted to achieve data saturation. Theorisation led to the definition of 4 distinct GP profiles. The response rate to the questionnaire was 73%, but dropped to 52% when a CRF was attached. The link between GP profiles and the rate of CRF completion remains to be verified. The GPs provided data on the CRF that was of comparable quality to those collected in the main trial. Our analysis showed that the motivation study increased overall participation in the main study by 23%, accounting for 16% (24/152 of all final visits for 536 patients who were initially enrolled in the Diagest 3 study. Conclusions When a hospital-led study

  10. Clinical Evaluation of Effects of Chronic Resveratrol Supplementation on Cerebrovascular Function, Cognition, Mood, Physical Function and General Well-Being in Postmenopausal Women—Rationale and Study Design

    Directory of Open Access Journals (Sweden)

    Hamish Michael Evans

    2016-03-01

    Full Text Available Background: This methodological paper presents both a scientific rationale and a methodological approach for investigating the effects of resveratrol supplementation on mood and cognitive performance in postmenopausal women. Postmenopausal women have an increased risk of cognitive decline and dementia, which may be at least partly due to loss of beneficial effects of estrogen on the cerebrovasculature. We hypothesise that resveratrol, a phytoestrogen, may counteract this risk by enhancing cerebrovascular function and improving regional blood flow in response to cognitive demands. A clinical trial was designed to test this hypothesis. Method: Healthy postmenopausal women were recruited to participate in a randomised, double-blind, placebo-controlled (parallel comparison dietary intervention trial to evaluate the effects of resveratrol supplementation (75 mg twice daily on cognition, cerebrovascular responsiveness to cognitive tasks and overall well-being. They performed the following tests at baseline and after 14 weeks of supplementation: Rey Auditory Verbal Learning Test, Cambridge Semantic Memory Battery, the Double Span and the Trail Making Task. Cerebrovascular function was assessed simultaneously by monitoring blood flow velocity in the middle cerebral arteries using transcranial Doppler ultrasound. Conclusion: This trial provides a model approach to demonstrate that, by optimising circulatory function in the brain, resveratrol and other vasoactive nutrients may enhance mood and cognition and ameliorate the risk of developing dementia in postmenopausal women and other at-risk populations.

  11. Working Inside for Smoking Elimination (Project W.I.S.E. study design and rationale to prevent return to smoking after release from a smoke free prison

    Directory of Open Access Journals (Sweden)

    Mello Jennifer

    2011-10-01

    Full Text Available Abstract Background Incarcerated individuals suffer disproportionately from the health effects of tobacco smoking due to the high smoking prevalence in this population. In addition there is an over-representation of ethnic and racial minorities, impoverished individuals, and those with mental health and drug addictions in prisons. Increasingly, prisons across the U.S. are becoming smoke free. However, relapse to smoking is common upon release from prison, approaching 90% within a few weeks. No evidence based treatments currently exist to assist individuals to remain abstinent after a period of prolonged, forced abstinence. Methods/Design This paper describes the design and rationale of a randomized clinical trial to enhance smoking abstinence rates among individuals following release from a tobacco free prison. The intervention is six weekly sessions of motivational interviewing and cognitive behavioral therapy initiated approximately six weeks prior to release from prison. The control group views six time matched videos weekly starting about six weeks prior to release. Assessments take place in-person 3 weeks after release and then for non-smokers every 3 months up to 12 months. Smoking status is confirmed by urine cotinine. Discussion Effective interventions are greatly needed to assist these individuals to remain smoke free and reduce health disparities among this socially and economically challenged group. Trial Registration NCT01122589

  12. Partial nicotinic acetylcholine (α4β2 agonists as promising new medications for smoking cessation

    Directory of Open Access Journals (Sweden)

    Singh J

    2008-01-01

    Full Text Available Objective: To review the pharmacology, clinical efficacy and safety of partial agonists of a4β 2 nicotinic acetylcholine receptor. Data Sources: Primary literature and review articles were obtained via a PUBMED search (1988-August 2006 using the key terms smoking cessation, partial agonist alpha4beta2 nicotinic acetylcholine receptor, varenicline, cytisine and SSR591813. Additional studies and abstracts were identified from the bibliographies of reviewed literature. Study Selection and Data Extraction: Studies and review articles related to varenicline, cytisine and the partial agonist alpha4beta2 nicotinic acetylcholine receptor were reviewed. Data Synthesis: Smoking is widely recognized as a serious health problem. Smoking cessation has major health benefits. According to the US Public Health Services, all patients attempting to quit smoking should be encouraged to use one or more effective pharmacotherapy. Currently, along with nicotine replacement therapy, bupropion, nortriptyline and clonidine, are the mainstay of pharmacotherapy. More than ¾ of patients receiving treatment for smoking cessation return to smoking within the first year. Nicotine, through stimulating α4β 2 nAChR, releases dopamine in the reward pathway. Partial agonist of α4β 2 nAChR elicits moderate and sustained release of dopamine, which is countered during the cessation attempts; it simultaneously blocks the effects of nicotine by binding with α4β 2 receptors during smoking. Recently, varenicline, a partial agonist at α4β 2 nAChR, has been approved by the FDA (Food and Drug Administration for smoking cessation. Conclusion: Partial agonist α4β 2 nAChR appears to be a promising target in smoking cessation. Varenicline of this group is approved for treatment of smoking cessation by the FDA in May 2006.

  13. Awareness, practices, and barriers regarding smoking cessation treatment among physicians in Saudi Arabia.

    Science.gov (United States)

    Jradi, Hoda

    2017-01-01

    Smoking cessation counseling and therapy provided by physicians play an important role in helping smokers quit. Awareness and practices of the clinical practice guidelines for tobacco dependence (in particular the 5A's: Ask, Assist, Assess, Advise, and Arrange) among physicians and perceived barriers for their implementation is needed to improve care for individuals who smoke/use tobacco products in Saudi Arabia. A cross-sectional self-administered survey was conducted among 124 general and family practitioners in primary health care clinics belonging to 2 major medical centers in Riyadh city, Saudi Arabia. Descriptive statistics were reported for all survey variables. Logistic regression was used to examine the predictors of physicians' use of the 5A's for smoking cessation counseling and therapy. Among the 216 contacted physicians, 124 responded (57.4%). The majority (63.7%) were males, between the ages of 40 and 49 years (52.4%), practicing full-time (95.2%), and had not received smoking cessation training during medical school education or residency training (68.6%). Approximately 85.5% reported some experience with the guidelines (heard, read, or used). Asking (71.8%) and advising (87.9%) were the most implemented for smoking cessation, while assisting (15.3%) and arranging for follow-up (17.7%) were the least implemented. Most (96.0%) did not prescribe pharmacotherapy and 53.2% reported documenting the patient's smoking status. Reported barriers were mostly lack of time (72.6%) and lack of training (66.9%). Awareness of the guidelines, physician's smoking status, perceived competence in ability to provide smoking cessation counseling and therapy, reporting the ineffectiveness of smoking cessation therapy as a barrier, and the perceived benefit of reducing patient's physical symptoms were independently statistically significant predictors of the implementation of the 5A's for smoking cessation therapy. This preliminary study showed that smoking cessation

  14. The effects of nocturnal hemodialysis compared to conventional hemodialysis on change in left ventricular mass: Rationale and study design of a randomized controlled pilot study

    Directory of Open Access Journals (Sweden)

    Klarenbach Scott

    2006-02-01

    Full Text Available Abstract Background Nocturnal hemodialysis (NHD is an alternative to conventional three times per week hemodialysis (CvHD and has been reported to improve several health outcomes. To date, no randomized controlled trial (RCT has compared NHD and CvHD. We have undertaken a multi-center RCT in hemodialysis patients comparing the effect of NHD to CvHD on left ventricular (LV mass, as measured by cardiac magnetic resonance imaging (cMR. Methodology/design All patients in Alberta, Canada, expressing an interest in performing NHD are eligible for the study. Patients enrolled in the study will be randomized to either NHD or CvHD for a six month period. All patients will have a full clinical assessment, including collection of biochemical and cMR data at baseline and at 6 months. Both groups of patients will be monitored biweekly to optimize blood pressure (BP to a goal of Discussion To our knowledge, this study will be the first RCT evaluating health outcomes in NHD. The impact of NHD on LV mass represents a clinically important outcome which will further elucidate the potential benefits of NHD and guide future clinical endpoint studies.

  15. A Community-Based Intervention to Prevent Obesity Beginning at Birth among American Indian Children: Study Design and Rationale for the PTOTS Study

    Science.gov (United States)

    Karanja, Njeri; Aickin, Mikel; Lutz, Tam; Mist, Scott; Jobe, Jared B.; Maupome, Gerardo; Ritenbaugh, Cheryl

    2012-01-01

    Eating and physical activity behaviors associated with adult obesity have early antecedents, yet few studies have focused on obesity prevention interventions targeting very young children. Efforts to prevent obesity beginning at birth seem particularly important in populations at risk for early-onset obesity. National estimates indicate that…

  16. The Role of Facebook in Crush the Crave, a Mobile- and Social Media-Based Smoking Cessation Intervention: Qualitative Framework Analysis of Posts

    OpenAIRE

    Struik, Laura Louise; Baskerville, Neill

    2014-01-01

    Background Social networking sites, particularly Facebook, are increasingly included in contemporary smoking cessation interventions directed toward young adults. Little is known about the role of Facebook in smoking cessation interventions directed toward this age demographic. Objective The aim of this study was to characterize the content of posts on the Facebook page of Crush the Crave, an evidence-informed smoking cessation intervention directed toward young adults aged 19 to 29 years. Me...

  17. A randomized controlled trial of long term effect of BCM guided fluid management in MHD patients (BOCOMO study: rationales and study design

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    Liu Li

    2012-09-01

    Full Text Available Abstract Background Bioimpedance analysis (BIA has been reported as helpful in identifying hypervolemia. Observation data showed that hypervolemic maintenance hemodialysis (MHD patients identified using BIA methods have higher mortality risk. However, it is not known if BIA-guided fluid management can improve MHD patients’ survival. The objectives of the BOCOMO study are to evaluate the outcome of BIA guided fluid management compared with standard care. Methods This is a multicenter, prospective, randomized, controlled trial. More than 1300 participants from 16 clinical sites will be included in the study. The enrolment period will last 6 months, and minimum length of follow-up will be 36 months. MHD patients aged between 18 years and 80 years who have been on MHD for at least 3 months and meet eligibility criteria will be invited to participate in the study. Participants will be randomized to BIA arm or control arm in a 1:1 ratio. A portable whole body bioimpedance spectroscopy device (BCM—Fresenius Medical Care D GmbH will be used for BIA measurement at baseline for both arms of the study. In the BIA arm, additional BCM measurements will be performed every 2 months. The primary intent-to-treat analysis will compare outcomes for a composite endpoint of death, acute myocardial infarction, stroke or incident peripheral arterial occlusive disease between groups. Secondary endpoints will include left ventricular wall thickness, blood pressure, medications, and incidence and length of hospitalization. Discussions Previous results regarding the benefit of strict fluid control are conflicting due to small sample sizes and unstable dry weight estimating methods. To our knowledge this is the first large-scale, multicentre, prospective, randomized controlled trial to assess whether BIS-guided volume management improves outcomes of MHD patients. The endpoints of the BOCOMO study are of utmost importance to health care providers. In order to obtain

  18. Multimodal intervention raises smoking cessation rate during pregnancy

    DEFF Research Database (Denmark)

    Hegaard, Hanne K; Kjaergaard, Hanne; Møller, Lars F

    2003-01-01

    of the midwives' prenatal care. All pregnant smokers in the usual care group (n = 320) received standard counseling from a midwife. Outcome was self-reported smoking cessation in the 37th week of pregnancy and the reported cessation was validated by cotinine saliva concentration. RESULTS: Self-reported cessation.......003). The adjusted odds ratio (OR) for smoking cessation was 4.20 (95% CI 2.13-8.03). Logistic regression analysis showed a significant positive association of smoking cessation with low caffeine consumption in pregnancy, many years in school, no exposure to passive smoking outside the home, and previous attempts...

  19. A Rationale for Mixed Methods (Integrative) Research Programmes in Education

    Science.gov (United States)

    Niaz, Mansoor

    2008-01-01

    Recent research shows that research programmes (quantitative, qualitative and mixed) in education are not displaced (as suggested by Kuhn) but rather lead to integration. The objective of this study is to present a rationale for mixed methods (integrative) research programs based on contemporary philosophy of science (Lakatos, Giere, Cartwright,…

  20. Adverse events associated with nicotine replacement therapy (NRT for smoking cessation. A systematic review and meta-analysis of one hundred and twenty studies involving 177,390 individuals

    Directory of Open Access Journals (Sweden)

    Lockhart Ian

    2010-07-01

    Full Text Available Abstract Background Nicotine replacement therapy (NRT is the most common form of smoking cessation pharmacotherapy and has proven efficacy for the treatment of tobacco dependence. Although expectations of mild adverse effects have been observed to be independent predictors of reduced motivation to use NRT, adverse effects associated with NRT have not been precisely quantified. Objective A systematic review and meta-analysis aimed to identify all randomized clinical trials (RCTs of NRT versus inert controls and all observational studies to determine the magnitude of reported adverse effects with NRT. Methods Searches of 10 electronic databases from inception to November 2009 were conducted. Study selection and data extraction were carried out independently in duplicate. RCTs were pooled using a random effects method with Odds Ratio [OR] as the effect measure, while proportions were pooled from observational studies. A meta-regression analysis was applied to examine whether the nicotine patch is associated with different adverse effects from those common to orally administered NRT. Results Ninety-two RCTs involving 32,185 participants and 28 observational studies involving 145, 205 participants were identified. Pooled RCT evidence of varying NRT formulations found an increased risk of heart palpitations and chest pains (OR 2.06, 95% Confidence Interval [CI] 1.51-2.82, P Conclusion The use of NRT is associated with a variety of side effects. In addition to counseling and medical monitoring, clinicians should inform patients of potential side effects which are associated with the use of NRT for the treatment of tobacco dependence.

  1. A Phase III Study of Durvalumab (MEDI4736) With or Without Tremelimumab for Previously Treated Patients With Advanced NSCLC: Rationale and Protocol Design of the ARCTIC Study.

    Science.gov (United States)

    Planchard, David; Yokoi, Takashi; McCleod, Michael J; Fischer, Jürgen R; Kim, Young-Chul; Ballas, Marc; Shi, Kelvin; Soria, Jean-Charles

    2016-05-01

    Anti-programmed cell death-1 and anti-programmed cell death ligand-1 (PD-L1) monotherapies have shown promising clinical activity in advanced, refractory non-small-cell lung cancer (NSCLC), but antitumor activity appears to be greater in patients with PD-L1(+) tumors compared with patients harboring PD-L1(-) tumors. Combining the anti-PD-L1 antibody durvalumab and the anti-cytotoxic T-lymphocyte antigen 4 antibody tremelimumab offers the potential for antitumor activity in patients with advanced NSCLC, regardless of PD-L1 tumor status. ARCTIC (NCT02352948) is a global, phase III, randomized, open-label multicenter study in patients with advanced NSCLC assessing the safety and clinical activity of durvalumab versus standard of care (SoC; erlotinib, gemcitabine, or vinorelbine) in patients with PD-L1(+) tumors (≥25% of tumor cells with membrane staining using VENTANA PD-L1 [SP263] CDx Assay) (Sub-study A) and the combination of durvalumab + tremelimumab or either agent as monotherapy versus SoC in patients with PD-L1(-) tumors (Sub-study B). Eligible patients are those with locally advanced or metastatic NSCLC (Stage IIIB/IV), without epidermal growth factor receptor tyrosine kinase activating mutations or anaplastic lymphoma kinase rearrangements, who have received at least 2 prior systemic regimens, including 1 platinum-based chemotherapy regimen. Co-primary endpoints are progression-free survival and overall survival. Secondary endpoints include the proportion of patients alive at 12 months, objective response rate, duration of response, progression-free survival at 6 and 12 months, safety and tolerability, pharmacokinetics, immunogenicity, and quality of life. The exploratory endpoints will assess potential biomarkers of treatment response. Recruitment started in January 2015 and is ongoing.

  2. Enhancing physical and social environments to reduce obesity among public housing residents: rationale, trial design, and baseline data for the Healthy Families study.

    Science.gov (United States)

    Quintiliani, Lisa M; DeBiasse, Michele A; Branco, Jamie M; Bhosrekar, Sarah Gees; Rorie, Jo-Anna L; Bowen, Deborah J

    2014-11-01

    Intervention programs that change environments have the potential for greater population impact on obesity compared to individual-level programs. We began a cluster randomized, multi-component multi-level intervention to improve weight, diet, and physical activity among low-socioeconomic status public housing residents. Here we describe the rationale, intervention design, and baseline survey data. After approaching 12 developments, ten were randomized to intervention (n=5) or assessment-only control (n=5). All residents in intervention developments are welcome to attend any intervention component: health screenings, mobile food bus, walking groups, cooking demonstrations, and a social media campaign; all of which are facilitated by community health workers who are residents trained in health outreach. To evaluate weight and behavioral outcomes, a subgroup of female residents and their daughters age 8-15 were recruited into an evaluation cohort. In total, 211 households completed the survey (RR=46.44%). Respondents were Latino (63%), Black (24%), and had ≤ high school education (64%). Respondents reported ≤2 servings of fruits & vegetables/day (62%), visiting fast food restaurants 1+ times/week (32%), and drinking soft drinks daily or more (27%). The only difference between randomized groups was race/ethnicity, with more Black residents in the intervention vs. control group (28% vs. 19%, p=0.0146). Among low-socioeconomic status urban public housing residents, we successfully recruited and randomized families into a multi-level intervention targeting obesity. If successful, this intervention model could be adopted in other public housing developments or entities that also employ community health workers, such as food assistance programs or hospitals.

  3. Effectiveness of Oral Nutritional Supplementation for Older Women after a Fracture: Rationale, Design and Study of the Feasibility of a Randomized Controlled Study

    Directory of Open Access Journals (Sweden)

    Lockwood Keri A

    2011-06-01

    Full Text Available Abstract Background Malnutrition is a problem for many older people recovering from a hip and other major fractures. Oral supplementation with high calorie high protein nutrients is a simple intervention that may help older people with fractures to improve their recovery in terms of rehabilitation time, length of hospital stay and mortality. This paper reports a pilot study to test the feasibility of a trial initiated in a hospital setting with an oral supplement to older people with recent fractures. Method A randomized controlled trial with 44 undernourished participants admitted to a hospital following a fracture. The intervention group (n = 23 received a high calorie high protein supplement for forty days in addition to their diet of choice. The control group (n = 21 received high protein milk during their hospital stay in addition to their diet of choice and their usual diet when discharged from hospital. Results All participants were women and their mean age was 85.3 (± 6.1 years. Twenty nine (65% participants had a hip fracture. At baseline no differences were measured between the two groups regarding their nutritional status, their cognitive ability or their abilities in activities of daily living. There were no significant differences between the intervention and control group with reference to nutritional or functional parameters at 40 day and 4 month follow-ups. Median length of stay in hospital was 18.0 days, with 12 participants being readmitted for a median of 7.0 days. Conclusion It is feasible to perform a randomised trial in a hospital and community setting to test the effect of an oral high energy high protein supplement for older people. Due to the limited number of participants and incomplete adherence with use of the supplements no conclusion can be drawn about the efficacy or effectiveness of this intervention.

  4. Effect of smoking cessation on airway inflammation of rats with chronic bronchitis

    Institute of Scientific and Technical Information of China (English)

    LI Qing-yun; HUANG Shao-guang; WAN Huan-ying; WU Hua-cheng; ZHOU Tong; LI Min; DENG Wei-wu

    2007-01-01

    Background Smoking is the major cause of airway inflammation in chronic obstructive pulmonary disease (COPD),and smoking cessation is regarded as one of the important strategies for prevention and treatment of the inflammation.The inflammation of the chronic airway may be present and deteriorated even if the COPD patients stop smoking.Whether and how early smoking cessation affects the progress of inflammation is still obscure. This study was conducted to find the appropriate time for smoking cessation to terminate the airway inflammation in rats with smoke-induced chronic bronchitis.Methods A rat model of COPD was established by passively inhaling smoke mixture. Fifty-four young male Sprague-Dawley rats were randomly divided into 9 groups with different periods of smoke exposure and different time points of cessation. The inflammation markers to be detected included inflammatory cells in the bronchoalveolar lavage fluid (BALF), the myeloperoxidose (MPO) activity, the morphologic changes and the expression of ICAM-1 on the airway epithelium.Results When smoking was terminated at early stage, the inflammatory markers and related indexes were different from those of the typical chronic bronchitis group (group M7) (P<0.01). The pathologic score of group SC7 (2 weeks of smoking cessation after occurrence of typical chronic bronchitis ) was not different from that of group M7, and the level of ICAM-1 was still up-regulated (compared to group M7, P>0.05). Meanwhile, most of inflammatory cells in BALF were neutrophils compared to other groups (P<0.01).When smoking was terminated, the MPO activity was significantly lower than that of group M7 (P<0.01).Conclusions Smoking cessation at early stage can effectively inhibit the inflammatory reaction of COPD. Once chronic bronchitis occurs, little could be improved by smoking cessation.

  5. Acute uncomplicated appendicitis study: rationale and protocol for a multicentre, prospective randomised controlled non-inferiority study to evaluate the safety and effectiveness of non-operative management in children with acute uncomplicated appendicitis

    Science.gov (United States)

    Xu, Jane; Liu, Yingrui Cyril; Adams, Susan; Karpelowsky, Jonathan

    2016-01-01

    Introduction This article presents an overview of a prospective randomised controlled non-inferiority study designed to evaluate the safety and effectiveness of non-operative management (NOM) with operative management in children with acute uncomplicated appendicitis (AUA). Here, we present the study protocol for this APRES study, a multicentre Australian study. The rationale and details of future analysis, in particular, non-inferiority calculations, cost-effectiveness, feasibility and acceptability of each intervention. Design A multicentre, prospective randomised controlled clinical trial, conducted in 2 Australian tertiary paediatric hospitals. Participants Children who meet the inclusion criteria of an age between 5 and 15 years and a clinical diagnosis of AUA will be invited to participate, and after consent will be randomised via a computer-based program into treatment groups. The study started in June 2016, and the target recruitment is 220 patients. Interventions Children in the control group will be treated with prophylactic antibiotics and appendicectomy, and those in the intervention group will be treated with antibiotic therapy alone. Primary outcome measures include unplanned or unnecessary operation and complications at 30 days. Secondary outcomes include longer term complications within 1 year, length of stay, time off work and school analgesic requirements and cost. Analysis Data analyses will be on the intention-to-treat principle using non-inferiority analysis. Analysis will include the Pearson χ2 test for categorical variables and independent sample t-test or Mann-Whitney test for continuous variables. Non-inferiority for NOM will be tested using 1-sided Wald tests with an α level of 0.05. Ethics and dissemination The research has been approved by the Human Research Ethics Committee of the Sydney Children's Hospital Network. In addition, results will be reported through academic journals, seminars and conference presentations. Trial

  6. [Smoking cessation in patients with COPD].

    Science.gov (United States)

    Andreas, S; Batra, A; Behr, J; Chenot, J-F; Gillissen, A; Hering, T; Herth, F J F; Kreuter, M; Meierjürgen, R; Mühlig, S; Nowak, D; Pfeifer, M; Raupach, T; Schultz, K; Sitter, H; Walther, J W; Worth, H

    2014-04-01

    Chronic obstructive pulmonary disease (COPD) is a leading cause of death worldwide. Cigarette smoking is the main cause of COPD. Quitting smoking is thus the most effective treatment strategy and central in COPD prevention. A number of guidelines on prevention, diagnosis, therapy and rehabilitation of COPD have been published. To help implementing and standardizing smoking cessation in COPD a guideline was published 2008 in Germany focusing on this complex issue. The present guideline is an update of the 2008 guideline and has a high grade of evidence (S3 according to the AWMF; Arbeitsgemeinschaft wissenschaftlicher medizinischer Fachgesellschaften). The guideline gives comprehensive and practical information on how to integrate smoking cessation as an central part of COPD therapy.

  7. Perceived effectiveness of cessation advertisements: the importance of audience reactions and practical implications for media campaign planning.

    Science.gov (United States)

    Davis, Kevin C; Nonnemaker, James; Duke, Jennifer; Farrelly, Matthew C

    2013-01-01

    Cessation television ads are often evaluated with measures of perceived effectiveness (PE) that gauge smokers' reactions to the ads. Although measures of PE have been validated for other genres of public service announcements, no studies to our knowledge have demonstrated the predictive validity of PE for cessation TV ads specifically. We analyzed data from a longitudinal Web survey of smokers in the United States to assess whether measures of PE for cessation TV ads are causally antecedent to cessation-related outcomes. These data consisted of baseline and 2-week follow-up surveys of 3,411 smokers who were shown a number of cessation TV ads and were asked to provide their appraisals of PE for those messages. We found that baseline PE for the ads was associated with increased negative feelings about smoking, increased outcome expectations about the benefits of quitting, increased consideration of the benefits of quitting, increased desire to quit, and increased intentions to quit smoking at follow-up. Results suggest that measures of PE for cessation TV ads can be powerful predictors of likely ad success. Hence, our findings support the use of PE in quantitative ad pretesting as part of a standard regimen of formative research for cessation television campaigns.

  8. “Hike up yer Skirt, and Quit.” What Motivates and Supports Smoking Cessation in Builders and Renovators

    Directory of Open Access Journals (Sweden)

    Kim L. Bercovitz

    2013-02-01

    Full Text Available Construction-related occupations have very high smoking prevalence rates and are an identified priority population for efforts to promote cessation. This study sought to identify the smoking cessation supports and services which best suited this workforce group, and to identify gaps in reach of preventive health services. We performed qualitative text analysis on pre-existing conversations about smoking cessation among workers in this sector. The material appeared on a discussion forum about residential construction from 1998 and 2011. Roughly 250 unique user names appeared in these discussions. The qualitative analysis addressed knowledge, motivation, environmental influences, and positive and negative experiences with supports for cessation. Self-identified smokers tended to want to quit and described little social value in smoking. Actual quit attempts were attributed to aging and tangible changes in health and fitness. Peer-to-peer social support for cessation was evident. Advice given was to avoid cigarettes and smokers, to focus on personal skills, personal commitment, and the benefits of cessation (beyond the harms from smoking. Many discussants had received medical support for cessation, but behavioural counselling services appeared underutilized. Our findings support efforts toward more complete bans on workplace smoking and increased promotion of available behavioural support services among dispersed blue-collar workers.

  9. A national evaluation of community-based youth cessation programs: end of program and twelve-month outcomes.

    Science.gov (United States)

    Curry, Susan J; Mermelstein, Robin J; Emery, Sherry L; Sporer, Amy K; Berbaum, Michael L; Campbell, Richard T; Flay, Brian; Warnecke, Richard B

    2013-03-01

    Most youth cessation treatment research consists of efficacy studies in which treatments are evaluated under optimal conditions of delivery. Less is known about the effectiveness of youth cessation treatments delivered in real-world, community based settings. A national sample of 41 community-based youth cessation programs participated in a longitudinal evaluation to identify site, program, and participant characteristics associated with successful cessation. Validated quit rates were comparable to those in randomized controlled trials; 7-day abstinence at the end of program averaged 14% and 30-day abstinence at 12 months averaged 12%. Multivariate GEE models explored predictors of smoking cessation at the end of the programs and at 12 months. Results showed correlates of both short- and long-term cessation. Findings point to the importance of both individual and community-level variables, including motivation, opportunities for and encouragement to engage in activities outside of academics, having youth participate in treatment before they become highly dependent smokers, and community norms and ordinances that discourage youth purchase, use and possession of tobacco. Providing evidence-based treatment to youth in community-based settings results in successful cessation.

  10. Long-Term Benefits of Smoking Cessation on Gastroesophageal Reflux Disease and Health-Related Quality of Life.

    Directory of Open Access Journals (Sweden)

    Yukie Kohata

    Full Text Available Smoking is associated with gastroesophageal reflux disease (GERD. Varenicline, a nicotinic receptor partial agonist, is used to aid smoking cessation. The purpose of this study was to prospectively examine the long-term benefits of smoking cessation on GERD and health-related quality of life (HR-QOL.Patients treated with varenicline were asked to fill out a self-report questionnaire about their smoking habits, gastrointestinal symptoms, and HR-QOL before and 1 year after smoking cessation. The prevalence of GERD, frequency of symptoms, and HR-QOL scores were compared. We also investigated associations between clinical factors and newly-developed GERD.A total of 141 patients achieved smoking cessation (success group and 50 did not (failure group at 1 year after the treatment. The GERD improvement in the success group (43.9% was significantly higher than that in the failure group (18.2%. The frequency of reflux symptoms significantly decreased only in the success group. There were no significant associations between newly developed GERD and clinical factors including increased body mass index and successful smoking cessation. HR-QOL significantly improved only in the success group.Smoking cessation improved both GERD and HR-QOL. Smoking cessation should be recommended for GERD patients.

  11. Reduction in oxidatively generated DNA damage following smoking cessation

    Directory of Open Access Journals (Sweden)

    Freund Harold G

    2011-05-01

    Full Text Available Abstract Background Cigarette smoking is a known cause of cancer, and cancer may be in part due to effects of oxidative stress. However, whether smoking cessation reverses oxidatively induced DNA damage unclear. The current study sought to examine the extent to which three DNA lesions showed significant reductions after participants quit smoking. Methods Participants (n = 19 in this study were recruited from an ongoing 16-week smoking cessation clinical trial and provided blood samples from which leukocyte DNA was extracted and assessed for 3 DNA lesions (thymine glycol modification [d(TgpA]; formamide breakdown of pyrimidine bases [d(TgpA]; 8-oxo-7,8-dihydroguanine [d(Gh] via liquid chromatography tandem mass spectrometry (LC-MS/MS. Change in lesions over time was assessed using generalized estimating equations, controlling for gender, age, and treatment condition. Results Overall time effects for the d(TgpA (χ2(3 = 8.068, p fpA (χ2(3 = 8.477, p h (χ2(3 = 37.599, p gpA and d(PfpA lesions show relatively greater rebound at Week 16 compared to the d(Gh lesion (88% of baseline for d(TgpA, 64% of baseline for d(PfpA, vs 46% of baseline for d(Gh. Conclusions Overall, results from this analysis suggest that cigarette smoking contributes to oxidatively induced DNA damage, and that smoking cessation appears to reduce levels of specific damage markers between 30-50 percent in the short term. Future research may shed light on the broader array of oxidative damage influenced by smoking and over longer durations of abstinence, to provide further insights into mechanisms underlying carcinogenesis.

  12. Workplace tobacco cessation program in India: A success story

    Directory of Open Access Journals (Sweden)

    Mishra Gauravi

    2009-01-01

    Full Text Available Context: This paper describes the follow-up interventions and results of the work place tobacco cessation study. Aims: To assess the tobacco quit rates among employees, through self report history, and validate it with rapid urine cotinine test; compare post-intervention KAP regarding tobacco consumption with the pre-intervention responses and assess the tobacco consumption pattern among contract employees and provide assistance to encourage quitting. Settings and Design: This is a cohort study implemented in a chemical industry in rural Maharashtra, India. Materials and Methods: All employees (104 were interviewed and screened for oral neoplasia. Active intervention in the form of awareness lectures, focus group discussions and if needed, pharmacotherapy was offered. Medical staff from the industrial medical unit and from a local referral hospital was trained. Awareness programs were arranged for the family members and contract employees. Statistical Analysis Used: Non-parametric statistical techniques and kappa. Results: Forty eight per cent employees consumed tobacco. The tobacco quit rates increased with each follow-up intervention session and reached 40% at the end of one year. There was 96% agreement between self report tobacco history and results of rapid urine cotinine test. The post-intervention KAP showed considerable improvement over the pre-intervention KAP. 56% of contract employees used tobacco and 55% among them had oral pre-cancerous lesions. Conclusions: A positive atmosphere towards tobacco quitting and positive peer pressure assisting each other in tobacco cessation was remarkably noted on the entire industrial campus. A comprehensive model workplace tobacco cessation program has been established, which can be replicated elsewhere.

  13. Smoking Cessation: The Role of the Anesthesiologist.

    Science.gov (United States)

    Yousefzadeh, Amir; Chung, Frances; Wong, David T; Warner, David O; Wong, Jean

    2016-05-01

    Smoking increases the risk of postoperative morbidity and mortality. Smoking cessation before surgery reduces the risk of complications. The perioperative period may be a "teachable moment" for smoking cessation and provides smokers an opportunity to engage in long-term smoking cessation. Anesthesiologists as the perioperative physicians are well-positioned to take the lead in this area and improve not only short-term surgical outcomes but also long-term health outcomes and costs. Preoperative interventions for tobacco use are effective to reduce postoperative complications and increase the likelihood of long-term abstinence. If intensive interventions (counseling, pharmacotherapy, and follow-up) are impractical, brief interventions should be implemented in preoperative clinics as a routine practice. The "Ask, Advise, Connect" is a practical strategy to be incorporated in the surgical setting. All anesthesiologists should ask their patients about smoking and strongly advise smokers to quit at every visit. Directly connecting patients to existing counseling resources, such as telephone quitlines, family physicians, or pharmacists using fax or electronic referrals, greatly increases the reach and the impact of the intervention.

  14. The relationship between maternal depression and smoking cessation during pregnancy--a cross-sectional study of pregnant women from 15 European countries.

    Science.gov (United States)

    Smedberg, Janne; Lupattelli, Angela; Mårdby, Ann-Charlotte; Øverland, Simon; Nordeng, Hedvig

    2015-02-01

    Epidemiologic studies have reported an association between depression and continuing smoking during pregnancy. However, differences in study design and methodology challenge study comparability. The purpose of this study was to examine the relationship between maternal depression and continuing smoking among pregnant European women while adjusting for maternal characteristics. This multinational, web-based study evaluated pregnant women in 15 European countries recruited from October 2011 to February 2012. Data on depression status, smoking habits, maternal socio-demographic characteristics, and life-style factors were collected via an anonymous online questionnaire. Associations were estimated with logistic regression. Of 4,295 women included, 1,481 (34.5 %) reported smoking before pregnancy, and 391 (26.4 %) continued smoking during pregnancy whereof 127 (32.5 %) were depressed. The association between depression and continuing smoking during pregnancy were uniform across the European countries (OR 2.02, 95 % CI 1.50-2.71), with about twice the prevalence of continuing smoking among the depressed. There was a strong relationship between continuing smoking in pregnancy and low education level (OR 4.46, 95 % CI 2.72-7.32), which coincided with risky pregnancy behavior such as failure to attend pregnancy/birth preparation courses (OR 1.80, 95 % CI 1.19-2.72) and follow recommended use of folic acid (OR 1.81, 95 % CI 1.23-2.65). Women who perceived the risk for the fetus of continued smoking during pregnancy as higher were the least likely to continue smoking during pregnancy (OR 0.72, 95 % CI 0.68-0.77). This underlines the clustering of risk in some pregnant women, and the results should guide antenatal care of depressed women struggling to quit smoking during pregnancy.

  15. Design and rationale of the GAUSS-2 study trial: a double-blind, ezetimibe-controlled phase 3 study of the efficacy and tolerability of evolocumab (AMG 145) in subjects with hypercholesterolemia who are intolerant of statin therapy.

    Science.gov (United States)

    Cho, Leslie; Rocco, Michael; Colquhoun, David; Sullivan, David; Rosenson, Robert S; Dent, Ricardo; Xue, Allen; Scott, Rob; Wasserman, Scott M; Stroes, Erik

    2014-03-01

    Statins effectively lower low-density lipoprotein cholesterol (LDL-C), reducing cardiovascular morbidity and mortality. Most patients tolerate statins well, but approximately 10% to 20% experience side effects (primarily muscle-related) contributing to diminished compliance or discontinuation of statin therapy and subsequent increase in cardiovascular risk. Statin-intolerant patients require more effective therapies for lowering LDL-C. Proprotein convertase subtilisin/kexin type 9 (PCSK9) is a compelling target for LDL-C-lowering therapy. Evolocumab (AMG 145) is a fully human monoclonal antibody that binds PCSK9, inhibiting its interaction with the LDL receptor to preserve LDL-receptor recycling and reduce LDL-C. Phase 2 studies have demonstrated the safety, tolerability, and preliminary efficacy of subcutaneous evolocumab in diverse populations, including statin-intolerant patients. This article describes the rationale and design of the Goal Achievement After Utilizing an anti-PCSK9 Antibody in Statin-Intolerant Subjects 2 (GAUSS-2) trial, a randomized, double-blind, ezetimibe-controlled, multicenter phase 3 study to evaluate the effects of 12 weeks of evolocumab 140 mg every 2 weeks or 420 mg every month in statin-intolerant patients with hypercholesterolemia. Eligible subjects were unable to tolerate effective doses of ≥2 statins because of myalgia, myopathy, myositis, or rhabdomyolysis that resolved with statin discontinuation. The primary objective of the study is to assess the effects of evolocumab on percentage change from baseline in LDL-C. Secondary objectives include evaluation of safety and tolerability, comparison of the effects of evolocumab vs ezetimibe on absolute change from baseline in LDL-C, and percentage changes from baseline in other lipids. Recruitment of approximately 300 subjects was completed in August 2013.

  16. The Escitalopram versus Electric Current Therapy for Treating Depression Clinical Study (ELECT-TDCS: rationale and study design of a non-inferiority, triple-arm, placebo-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    André Russowsky Brunoni

    Full Text Available CONTEXT AND OBJECTIVE: Major depressive disorder (MDD is a common psychiatric condition, mostly treated with antidepressant drugs, which are limited due to refractoriness and adverse effects. We describe the study rationale and design of ELECT-TDCS (Escitalopram versus Electric Current Therapy for Treating Depression Clinical Study, which is investigating a non-pharmacological treatment known as transcranial direct current stimulation (tDCS.DESIGN AND SETTING: Phase-III, randomized, non-inferiority, triple-arm, placebo-controlled study, ongoing in São Paulo, Brazil.METHODS: ELECT-TDCS compares the efficacy of active tDCS/placebo pill, sham tDCS/escitalopram 20 mg/day and sham tDCS/placebo pill, for ten weeks, randomizing 240 patients in a 3:3:2 ratio, respectively. Our primary aim is to show that tDCS is not inferior to escitalopram with a non-inferiority margin of at least 50% of the escitalopram effect, in relation to placebo. As secondary aims, we investigate several biomarkers such as genetic polymorphisms, neurotrophin serum markers, motor cortical excitability, heart rate variability and neuroimaging.RESULTS: Proving that tDCS is similarly effective to antidepressants would have a tremendous impact on clinical psychiatry, since tDCS is virtually devoid of adverse effects. Its ease of use, portability and low price are further compelling characteristics for its use in primary and secondary healthcare. Multimodal investigation of biomarkers will also contribute towards understanding the antidepressant mechanisms of action of tDCS.CONCLUSION: Our results have the potential to introduce a novel technique to the therapeutic arsenal of treatments for depression.

  17. Project EX: A Program of Empirical Research on Adolescent Tobacco Use Cessation

    Directory of Open Access Journals (Sweden)

    Miyano James

    2004-09-01

    Full Text Available Abstract This paper presents the Project EX research program. The historical background for Project EX is presented, including a brief summary of reasons youth fail to quit tobacco use, the disappointing status of previous cessation research, and the teen cessation trial that provided the template for the current project (Project TNT. Next, program development studies for Project EX are described. Through use of focus groups, a theme study (concept evaluation of written activity descriptions, a component study, and pilot studies, an eight-session program was developed. This program involves novel activities (e.g., "talk show enactments," games, and alternative medicine-type activities such as yoga and meditation in combination with motivation enhancement and cognitive-behavioral strategies to motivate and instruct in cessation initiation and maintenance efforts. The outcomes of the first experimental trial of Project EX, a school-based clinic program, are described, followed by a posthoc analysis of its effects mediation. A second EX study, a multiple baseline single group pilot study design in Wuhan, China, is described next. Description of a second experimental trial follows, which tested EX with nicotine gum versus a natural herb. A third experimental trial that tests a classroom prevention/cessation version of EX is then introduced. Finally, the implications of this work are discussed. The intent-to-treat quit rate for Project EX is approximately 15% across studies, double that of a standard care comparison. Effects last up to a six-month post-program at regular and alternative high schools. Through a systematic protocol of empirical program development and field trials, an effective and replicable model teen tobacco use cessation program is established. Future cessation work might expand on this work.

  18. Project EX: A Program of Empirical Research on Adolescent Tobacco Use Cessation.

    Science.gov (United States)

    Sussman, Steve; McCuller, William J; Zheng, Hong; Pfingston, Yvonne M; Miyano, James; Dent, Clyde W

    2004-09-15

    This paper presents the Project EX research program. The historical background for Project EX is presented, including a brief summary of reasons youth fail to quit tobacco use, the disappointing status of previous cessation research, and the teen cessation trial that provided the template for the current project (Project TNT). Next, program development studies for Project EX are described. Through use of focus groups, a theme study (concept evaluation of written activity descriptions), a component study, and pilot studies, an eight-session program was developed. This program involves novel activities (e.g., "talk show enactments," games, and alternative medicine-type activities such as yoga and meditation) in combination with motivation enhancement and cognitive-behavioral strategies to motivate and instruct in cessation initiation and maintenance efforts. The outcomes of the first experimental trial of Project EX, a school-based clinic program, are described, followed by a posthoc analysis of its effects mediation. A second EX study, a multiple baseline single group pilot study design in Wuhan, China, is described next. Description of a second experimental trial follows, which tested EX with nicotine gum versus a natural herb. A third experimental trial that tests a classroom prevention/cessation version of EX is then introduced. Finally, the implications of this work are discussed. The intent-to-treat quit rate for Project EX is approximately 15% across studies, double that of a standard care comparison. Effects last up to a six-month post-program at regular and alternative high schools. Through a systematic protocol of empirical program development and field trials, an effective and replicable model teen tobacco use cessation program is established. Future cessation work might expand on this work.

  19. Cardiovascular Risk Behavior among Sedentary Female Smokers and Smoking Cessation Outcomes

    Directory of Open Access Journals (Sweden)

    Quiles Zandra

    2005-01-01

    Full Text Available Abstract Background We examined female sedentary smokers' additional cardiovascular disease (CVD risk behaviors and their associations to smoking cessation. Methods This study was part of a randomized controlled trial testing the effectiveness of exercise and nicotine gum in smoking cessation. Included in the analyses were 148 participants. Dietary habits and alcohol consumption were measured as additional CVD risk behaviors. High-fat diet and heavy alcohol use were considered those risk behaviors. Nicotine dependence, length of the longest quit attempt, depressive symptoms, self-efficacy, and education were examined as other baseline variables. Abstinence from tobacco was recorded through 12 months. Results Diet was related to depressive symptoms at baseline. Alcohol use was related to nicotine dependence and education level. Heavy alcohol use alone and accumulation of two added risk behaviors predicted poorer smoking cessation outcome. Although diet alone was not associated with cessation outcome the high-fat diet interacted with depressive symptoms, such that the depressed women with high-fat diet were significantly more likely to relapse in their quit attempt compared to other subgroups. Conclusion Non-moderate alcohol use alone and accumulation of multiple CVD risk behaviors seem to be associated with lower success in smoking cessation.

  20. Factors affecting commencement and cessation of smoking behaviour in Malaysian adults

    Directory of Open Access Journals (Sweden)

    Ghani Wan

    2012-03-01

    Full Text Available Abstract Background Tobacco consumption peak in developed countries has passed, however, it is on the increase in many developing countries. Apart from cigarettes, consumption of local hand-rolled cigarettes such as bidi and rokok daun are prevalent in specific communities. Although factors associated with smoking initiation and cessation has been investigated elsewhere, the only available data for Malaysia is on prevalence. This study aims to investigate factors associated with smoking initiation and cessation which is imperative in designing intervention programs. Methods Data were collected from 11,697 adults by trained recording clerks on sociodemographic characteristics, practice of other risk habit and details of smoking such as type, duration and frequency. Smoking commencement and cessation were analyzed using the Kaplan-Meier estimates and log-rank tests. Univariate and multivariate Cox proportional hazard regression models were used to calculate the hazard rate ratios. Results Males had a much higher prevalence of the habit (61.7% as compared to females (5.8%. Cessation was found to be most common among the Chinese and those regularly consuming alcoholic beverages. Kaplan-Meier plot shows that although males are more likely to start smoking, females are found to be less likely to stop. History of betel quid chewing and alcohol consumption significantly increase the likelihood of commencement (p Conclusions Gender, ethnicity, history of quid chewing and alcohol consumption have been found to be important factors in smoking commencement; while ethnicity, betel quid chewing and type of tobacco smoked influences cessation.

  1. Cardiovascular Risk Behavior among Sedentary Female Smokers and Smoking Cessation Outcomes

    Directory of Open Access Journals (Sweden)

    Terwal Donna

    2005-12-01

    Full Text Available Abstract Background We examined female sedentary smokers' additional cardiovascular disease (CVD risk behaviors and their associations to smoking cessation. Methods This study was part of a randomized controlled trial testing the effectiveness of exercise and nicotine gum in smoking cessation. Included in the analyses were 148 participants. Dietary habits and alcohol consumption were measured as additional CVD risk behaviors. High-fat diet and heavy alcohol use were considered those risk behaviors. Nicotine dependence, length of the longest quit attempt, depressive symptoms, self-efficacy, and education were examined as other baseline variables. Abstinence from tobacco was recorded through 12 months. Results Diet was related to depressive symptoms at baseline. Alcohol use was related to nicotine dependence and education level. Heavy alcohol use alone and accumulation of two added risk behaviors predicted poorer smoking cessation outcome. Although diet alone was not associated with cessation outcome the high-fat diet interacted with depressive symptoms, such that the depressed women with high-fat diet were significantly more likely to relapse in their quit attempt compared to other subgroups. Conclusion Non-moderate alcohol use alone and accumulation of multiple CVD risk behaviors seem to be associated with lower success in smoking cessation.

  2. Sustained increase in platelet aggregation after the cessation of clopidogrel.

    Science.gov (United States)

    Djukanovic, Nina; Todorovic, Zoran; Zamaklar-Trifunovic, Danijela; Protic, Dragana; Dzudovic, Boris; Ostojic, Miodrag; Obradovic, Slobodan

    2016-02-01

    This study shows that the abrupt cessation of one-year clopidogrel treatment was not associated with thrombotic events in a prospective, multicentre study that enrolled 200 patients subjected to coronary stent implantation and treated with aspirin + clopidogrel 1 year after the stent placement. The aim of the study was to investigate the causes of a sustained increase of platelet aggregability, considering that the values of platelet aggregation stimulated with ADP + PGE1 (ADPHS values) significantly increased 10-90 days after the cessation of clopidogrel. Values of platelet aggregation induced by thrombin receptor activating peptide (TRAP values) and arachidonic acid (ASPI values) were divided into quartiles on the basis of ADPHS values 10 days after stopping clopidogrel (ADPHS10 ). There was a significant difference between TRAP values divided into quartiles according to ADPHS10 , 10, 45 and 90 days after stopping clopidogrel (P clopidogrel (P = 0.028 and 0.003). The results of the study indicate that patients with early pronounced rebound phenomena to clopidogrel termination have a long-term (at least 90 days) increased platelet aggregation to other agonists such as thrombin-related activated protein and arachidonic acid, suggesting the complex mutual relationship of various factors/agonists influencing the function of platelets.

  3. Bioethics: A Rationale and a Model

    Science.gov (United States)

    Barman, Charles R.; Rusch, John J.

    1978-01-01

    Discusses the rationale for and development of an undergraduate bioethics course. Based on experiences with the course, general suggestions are offered to instructors planning to add bioethics to existing curricula. (MA)

  4. The importance of resilience and stress to maintaining smoking abstinence and cessation: a qualitative study in Australia with people diagnosed with depression.

    Science.gov (United States)

    Tsourtos, George; Ward, Paul R; Muller, Robert; Lawn, Sharon; Winefield, Anthony H; Hersh, Deborah; Coveney, John

    2011-05-01

    This study explored stress in relation to smoking and how non-smokers (never-smoked and ex-smokers) are 'resilient' to smoking in a population where there is a high prevalence of smoking (people diagnosed with depression). In-depth oral history interviews were conducted with 34 adult participants from metropolitan Adelaide, and who were medically diagnosed with depression. Participants were recruited according to their smoking status (currently smoking, ex-smoker, and never-smoked). Smoking was taken-up and maintained for a number of reasons that included perceived high levels of stress. Resilience to stress in relation to smoking was also a major theme. Non-smoking participants tended to be more resilient to stress. Ex-smokers were able to quit for a number of varied reasons during critical transition points in their lives. The never-smoked participants reported successful strategies to cope with stress but not all of them were necessarily healthy. There was often interplay between external factors and the individual's internal properties that led to a building or an erosion of resilience. Smokers and ex-smokers have indicated a strong relationship between stress and tobacco use. Ex-smokers and the never-smoked participants have demonstrated how being 'resilient' to stress can be important to smoking abstinence. The finding that external factors can interact with internal properties to build resilience in relation to stress and smoking is important for policy and practice.

  5. Physicians are a key to encouraging cessation of smoking among people living with HIV/AIDS: a cross-sectional study in the Kathmandu Valley, Nepal

    Directory of Open Access Journals (Sweden)

    Pandey Basu D

    2011-08-01

    Full Text Available Abstract Background HIV care providers may be optimally positioned to promote smoking behaviour change in their patients, among whom smoking is both highly prevalent and uniquely harmful. Yet research on this front is scant, particularly in the developing country context. Hence, this study describes smoking behaviour among people living with HIV/AIDS (PLWHA in the Kathmandu Valley of Nepal, and assesses the association between experience of physician-delivered smoking status assessment and readiness to quit among HIV-positive smokers. Methods We conducted a cross-sectional survey of PLWHA residing in the Kathmandu Valley, Nepal. Data from 321 adult PLWHA were analyzed using multiple logistic regression for correlates of current smoking and, among current smokers, of motivational readiness to quit based on the transtheoretical model (TTM of behaviour change. Results Overall, 47% of participants were current smokers, with significantly higher rates among men (72%, ever- injecting drug users (IDUs, recent (30-day alcohol consumers, those without any formal education, and those with higher HIV symptom burdens. Of 151 current smokers, 34% were thinking seriously of quitting within the next 6 months (contemplation or preparation stage of behaviour change. Adjusting for potential confounders, experience of physician-delivered smoking status assessment during any visit to a hospital or clinic in the past 12 months was associated with greater readiness to quit smoking (AOR = 3.34; 95% CI = 1.05,10.61. Conclusions Roughly one-third of HIV-positive smokers residing in the Kathmandu Valley, Nepal, are at the contemplation or preparation stage of smoking behaviour change, with rates significantly higher among those whose physicians have asked about their smoking status during any clinical interaction over the past year. Systematic screening for smoking by physicians during routine HIV care may help to reduce the heavy burden of smoking and smoking

  6. Volitional reduction of anterior cingulate cortex activity produces decreased cue craving in smoking cessation: a preliminary real-time fMRI study.

    Science.gov (United States)

    Li, Xingbao; Hartwell, Karen J; Borckardt, Jeffery; Prisciandaro, James J; Saladin, Michael E; Morgan, Paul S; Johnson, Kevin A; Lematty, Todd; Brady, Kathleen T; George, Mark S

    2013-07-01

    Numerous research groups are now using analysis of blood oxygen level-dependent (BOLD) functional magnetic resonance imaging (fMRI) results and relaying back information about regional activity in their brains to participants in the scanner in 'real time'. In this study, we explored the feasibility of self-regulation of frontal cortical activation using real-time fMRI (rtfMRI) neurofeedback in nicotine-dependent cigarette smokers during exposure to smoking cues. Ten cigarette smokers were shown smoking-related visual cues in a 3 Tesla MRI scanner to induce their nicotine craving. Participants were instructed to modify their craving using rtfMRI feedback with two different approaches. In a 'reduce craving' paradigm, participants were instructed to 'reduce' their craving, and decrease the anterior cingulate cortex (ACC) activity. In a separate 'increase resistance' paradigm, participants were asked to increase their resistance to craving and to increase middle prefrontal cortex (mPFC) activity. We found that participants were able to significantly reduce the BOLD signal in the ACC during the 'reduce craving' task (P=0.028). There was a significant correlation between decreased ACC activation and reduced craving ratings during the 'reduce craving' session (P=0.011). In contrast, there was no modulation of the BOLD signal in mPFC during the 'increase resistance' session. These preliminary results suggest that some smokers may be able to use neurofeedback via rtfMRI to voluntarily regulate ACC activation and temporarily reduce smoking cue-induced craving. Further research is needed to determine the optimal parameters of neurofeedback rtfMRI, and whether it might eventually become a therapeutic tool for nicotine dependence.

  7. The Gold Standard Program for Smoking Cessation is Effective for Participants Over 60 Years of Age

    DEFF Research Database (Denmark)

    Flamand, Mette Kehlet; Schroeder, Torben V; Tønnesen, Hanne

    2015-01-01

    BACKGROUND: Tobacco smoking is more prevalent among the elderly than among the young, and the elderly also have the most frequent contact with the health care system. The aim of this study was to evaluate the effectiveness of the Gold Standard Program, which is an intensive six-week smoking...... cessation program, on continuous self-reported abstinence rates after six months, on participants over the age of 60 years in a real life setting. METHODS: This was a retrospective cohort study from the national Danish smoking cessation database. RESULTS: The database registered 7369 participants over...... recommendation for smoking cessation (OR 1.12), being compliant with program (OR 1.35) and being abstinent at end of course (OR 13.3). CONCLUSIONS: Participants over the age of 60 years had significantly higher continuous abstinence rates after six months than the participants less than 60 years. It is never too...

  8. Use and Effectiveness of Quitlines for Smokers With Diabetes: Cessation and Weight Outcomes, Washington State Tobacco Quit Line, 2008

    OpenAIRE

    Schauer, Gillian L.; Bush, Terry; Cerutti, Barbara; Mahoney, Lisa; Thompson, Juliet R; Zbikowski, Susan M

    2013-01-01

    Introduction Having diabetes and smoking increases the risk of morbidity and mortality. However, cessation-related weight gain, a common side effect during quitting, can further complicate diabetes. Evidence-based telephone quitlines can support quitting but have not been studied adequately in populations with chronic diseases such as diabetes. The purpose of this study was to evaluate the use and effectiveness of a tobacco quitline among tobacco users with diabetes. Cessation-related weight ...

  9. The relation between media promotions and service volume for a statewide tobacco quitline and a web-based cessation program

    Directory of Open Access Journals (Sweden)

    Schillo Barbara A

    2011-12-01

    Full Text Available Abstract Background This observational study assessed the relation between mass media campaigns and service volume for a statewide tobacco cessation quitline and stand-alone web-based cessation program. Methods Multivariate regression analysis was used to identify how weekly calls to a cessation quitline and weekly registrations to a web-based cessation program are related to levels of broadcast media, media campaigns, and media types, controlling for the impact of external and earned media events. Results There was a positive relation between weekly broadcast targeted rating points and the number of weekly calls to a cessation quitline and the number of weekly registrations to a web-based cessation program. Additionally, print secondhand smoke ads and online cessation ads were positively related to weekly quitline calls. Television and radio cessation ads and radio smoke-free law ads were positively related to web program registration levels. There was a positive relation between the number of web registrations and the number of calls to the cessation quitline, with increases in registrations to the web in 1 week corresponding to increases in calls to the quitline in the subsequent week. Web program registration levels were more highly influenced by earned media and other external events than were quitline call volumes. Conclusion Overall, broadcast advertising had a greater impact on registrations for the web program than calls to the quitline. Furthermore, registrations for the web program influenced calls to the quitline. These two findings suggest the evolving roles of web-based cessation programs and Internet-use practices should be considered when creating cessation programs and media campaigns to promote them. Additionally, because different types of media and campaigns were positively associated with calls to the quitline and web registrations, developing mass media campaigns that offer a variety of messages and communicate through

  10. Tobacco cessation: what role can dental professionals play?

    Directory of Open Access Journals (Sweden)

    Abhishek Mehta

    2012-06-01

    Full Text Available Introduction: Tobacco dependence is classified as a disease by the International Classification of Diseases (ICD-10, but, medical and dental professionals have neither seriously taken this fact nor made any serious attempt to tackle this disease. Apart from supporting wider tobacco control measures, oral health professionals can help patients to stop using tobacco. This may be the single most important service dentists can provide for their patients’ overall health. Objective: This review is prepared with the object to help both clinicians and oral health professionals to scale up their involvement in tobacco control activities, including advocacy and smoking cessation programs. Literature review: Studies have shown that Studies have shown that 70% smokers indicate smokers indicatethat they want to quit, but a meagre 2% succeed. The dental practice The dental practice setting provides a unique opportunity to assist tobacco users in achieving tobacco abstinence. Still, More than 40% of dentists do not routinely ask about tobacco use and 60% do not routinely advise tobacco users to quit, while 61.5% of dentists believe their patients do not expect tobacco cessation services. Conclusion: Interventions by dentist has been found to be effective in helping people to quit tobacco consumption. A step-wise approach and patience must be adopted while dealing with such patients.

  11. Smoking Cessation and the Microbiome in Induced Sputum Samples from Cigarette Smoking Asthma Patients.

    Directory of Open Access Journals (Sweden)

    Christian Munck

    Full Text Available Asthma is a common disease causing cough, wheezing and shortness of breath. It has been shown that the lung microbiota in asthma patients is different from the lung microbiota in healthy controls suggesting that a connection between asthma and the lung microbiome exists. Individuals with asthma who are also tobacco smokers experience more severe asthma symptoms and smoking cessation is associated with improved asthma control. In the present study we investigated if smoking cessation in asthma patients is associated with a change in the bacterial community in the lungs, examined using induced sputum. We found that while tobacco smokers with asthma have a greater bacterial diversity in the induced sputum compared to non-smoking healthy controls, smoking cessation does not lead to a change in the microbial diversity.

  12. [Real-Life Evaluation of the Compact Program for Smoking Cessation].

    Science.gov (United States)

    Hering, T; Andres, J; Ruhr, H-J; Berkling, K

    2015-10-01

    Smoking cessation as a therapeutic intervention has largely not the significance that it should have according to its potential influence on diseases in the pulmonary practice. Barriers against smoking cessation apart from the addiction character of tobacco dependence are mainly the almost complete absence of reimbursement as well as concerns regarding low achievable long-term abstinence. The presented study shows that despite these barriers smoking cessation in pulmonology practice is successful if carried out by using a 2-step motivation of the participants. The long-term abstinence success of 46 % after 12 months (point prevalence) presented here was achieved with the use of behavioral therapy and medical support. Success factors are doctor's office setting and consequent information and encouragement for medical support (mostly varenicline).

  13. The effect of smoking cessation on airway inflammation in young asthma patients

    DEFF Research Database (Denmark)

    Westergaard, C G; Porsbjerg, C; Backer, V

    2014-01-01

    BACKGROUND: Smoking has been shown to have several detrimental effects on asthma, including poor symptom control, attenuated treatment response and accelerated decline in lung function. In spite of this, smoking is at least as common among asthma patients as in the rest of the population....... The aggravations of smoking on asthma may be caused by effects on airway inflammation, which has been found to be changed in asthmatic smokers. It is not known whether these smoking-induced airway inflammation changes are reversible after smoking cessation. OBJECTIVE: The aim of this study was to assess airway...... changes in asthmatic smokers before and during smoking cessation. METHODS: Forty-six smokers with asthma, all steroid-free (age range: 19-40), were recruited. All participants attempted smoking cessation over a period of 3 months. Visits were performed at weeks 0, 6 and 12 and included induced sputum, Fe...

  14. Indiana family physician attitudes and practices concerning smoking cessation.

    Science.gov (United States)

    Saywell, R M; Jay, S J; Lukas, P J; Casebeer, L L; Mybeck, K C; Parchman, M L; Haley, A J

    1996-01-01

    Most physicians are aware of the health benefits of smoking cessation and agree they have a responsibility to help smokers quit. Many physicians, however, do not regularly address smoking cessation with their patients. Questionnaires were sent to 2,095 family practice physicians in Indiana. Information obtained included: demographic data; office-based smoking cessation practices; counseling; and physicians' perceptions of intervention outcomes. Most physicians (86%) asked new patients if they smoked, and 23% questioned patients about their exposure to passive smoke. Younger physicians, female physicians and urban physicians were more likely to ask new patients if they smoked. A formal smoking cessation program was used by 28% of the responding physicians. Among those not using a program, 7% reported plans to implement one in the coming year, 40% were not planning to implement one, and 53% were unsure. Physician and practice characteristics were not correlated with the use of smoking cessation programs. Only 11% of physicians considered their smoking cessation counseling skills to be excellent; 27% indicated the need for improvement in skills. One-half (52%) believed their counseling efforts were effective; almost half (45%) believed that current reimbursement policies limited their involvement in smoking cessation interventions. Most respondents have not instituted smoking cessation programs in their practices. It is likely that a combination of strategies, including both undergraduate, graduate and continuing medical education programs and reform in reimbursement practices for cessation programs, will be required to achieve significant increases in long-term smoking abstinence rates.

  15. Public policy to maximize tobacco cessation.

    Science.gov (United States)

    McGoldrick, Daniel E; Boonn, Ann V

    2010-03-01

    Tobacco use kills more than 400,000 Americans every year. For smokers, quitting is the biggest step they can take to improve their health, but it is a difficult step. Fortunately, policy-based interventions can both encourage smokers to quit and help them succeed. Evidence shows that tobacco tax increases encourage smokers to quit-recent state and federal increases have created dramatic surges in calls to quitlines. Similarly, smokefree workplace laws not only protect workers and patrons from secondhand smoke but also encourage smokers to quit, help them succeed, and create a social environment less conducive to smoking. The impact of policy changes can be amplified by promoting quitting around the date they are implemented. Outreach to health practitioners can alert them to encourage their patients to quit. Earned and paid media can also be used to motivate smokers to quit when policy changes are put into effect. Although these policies and efforts regarding them can generate great demand for evidence-based cessation services such as counseling and medication, it is important to make these resources available for those wanting to quit. Public and private health insurance plans should provide coverage for cessation services, and states should invest tobacco tax and/or tobacco settlement dollars in smoking-cessation programs as recommended by the CDC. Finally, the Family Smoking Prevention and Tobacco Control Act has given the U.S. Food and Drug Administration new authority to regulate tobacco products and marketing, and to prevent tobacco companies from deceptively marketing new products that discourage smokers from quitting and keep them addicted.

  16. Web-Based Antismoking Advertising to Promote Smoking Cessation: A Randomized Controlled Trial

    Science.gov (United States)

    Muennig, Peter; El-Sayed, Abdulrahman M

    2016-01-01

    Background Although hundreds of millions of dollars are spent each year on public health advertising, the advertisement content, design, and placement are usually developed by intuition rather than research. Objective The objective of our study was to develop a methodology for testing Web-based advertisements to promote smoking cessation. Methods We developed 10 advertisements that varied by their content (those that empower viewers to quit, help viewers to quit, or discuss the effects of smoking). We then conducted a series of Web-based randomized controlled trials that explored the effects of exposing users of Microsoft’s Bing search engine to antismoking advertisements that differed by content, placement, or other characteristics. Finally, we followed users to explore whether they conducted subsequent searches for smoking cessation products or services. Results The advertisements were shown 710,106 times and clicked on 1167 times. In general, empowering advertisements had the greatest impact (hazard ratio [HR] 2.6, standard error [SE] 0.09 relative to nonempowering advertisements), but we observed significant variations by gender. For instance, we found that men exposed to smoking cessation advertisements were less likely than women to subsequently conduct smoking cessation searches (HR 0.2, SE 0.07), but that this likelihood increased 3.5 times in men exposed to advertisements containing empowering content. Women were more influenced by advertisements that emphasized the health effects of smoking. We also found that appearing at the top right of the page (HR 2.1, SE 0.07) or at the bottom rather than the top of a list (HR 1.1, SE 0.02) can improve smoking cessation advertisements’ effectiveness in prompting future searches related to smoking cessation. Conclusions Advertising should be targeted to different demographic groups in ways that are not always intuitive. Our study provides a method for testing the effectiveness of Web-based antismoking

  17. Dental vs. Medical Students' Comfort with Smoking Cessation Counseling: Implications for Dental Education.

    Science.gov (United States)

    Allen, Staci Robinson; Kritz-Silverstein, Donna

    2016-08-01

    The aim of this study was to determine if dental and medical students have similar feelings of professional responsibility, comfort, and confidence with counseling patients about smoking cessation during their clinical years. All third- and fourth-year osteopathic medical (N=580) and dental students (N=144) at Western University of Health Sciences were invited to participate in a survey in April-July 2014, either electronically or in person, regarding their perceived professional responsibility, comfort, and confidence in counseling smokers about quitting and major constraints against counseling smokers about quitting. Respondents' demographic characteristics, smoking history, and history of living with a smoker were also assessed. Response rates were 21% (124/580) for medical and 82% (118/144) for dental students. Most of the responding medical (99.2%) and dental (94.9%) students reported feeling it was their professional responsibility to counsel patients about smoking cessation. Medical student respondents were significantly more comfortable and confident counseling patients about smoking cessation than dental student respondents (p0.10). There were no differences by age, but students who were former smokers were significantly more comfortable and confident counseling about smoking cessation than were nonsmokers (p=0.001). While almost all of the responding students reported feeling responsible for counseling patients about smoking cessation, the medical students and former smokers were more comfortable and confident performing this counseling. These results suggest the need for additional training in counseling techniques for dental students and nonsmokers. Future studies should assess the impact of medical and dental students' smoking cessation counseling.

  18. The effect of Varenicline on smoking cessation in a group of young asthma patients

    DEFF Research Database (Denmark)

    Westergaard, Christian G; Porsbjerg, Celeste; Backer, Vibeke

    2015-01-01

    BACKGROUND: Tobacco use causes long-term morbidity and mortality. In patients with asthma, the frequency of smokers is high; however, asthmatic smokers experience more pronounced symptoms, accelerated loss of lung function and treatment resistance. Varenicline is an effective drug in smoking...... cessation, when investigated in COPD patients and general populations. The aim of the present study was to evaluate the effect of Varenicline on tobacco cessation in young asthmatics. METHODS: In a randomized, placebo-controlled, double-blinded trial, 52 asthmatic current smokers (age 19-40) ≥ 10 cigarettes...

  19. The cessation and detoxification effect of tea filters on cigarette smoke

    Institute of Scientific and Technical Information of China (English)

    2010-01-01

    To treat tobacco addiction,a tea filter was developed and studied for smoking cessation.This work reports the smoking cessation effect of tea when it was used as a component of cigarette filters.In one trial it was found that after using the tea filters for 2 months,the volunteer smokers decreased their cigarette consumption by 56.5%,and 31.7% of them stopped smoking.This work identified a new method and material,tea filter and theanine,which inhibit tobacco and nicotine addiction and provide an effective strategy for treating tobacco addiction.

  20. Smoking cessation in cardiac patients: the influence of action plans, coping plans and self-efficacy on quitting smoking.

    Science.gov (United States)

    de Hoog, Natascha; Bolman, Catherine; Berndt, Nadine; Kers, Esther; Mudde, Aart; de Vries, Hein; Lechner, Lilian

    2016-06-01

    Smoking cessation is the most effective action for cardiac patients who smoke to improve their prognosis, yet more than one-half of cardiac patients continue to smoke after hospital admission. This study examined the influence of action plans, coping plans and self-efficacy on intention to quit and smoking cessation in cardiac patients. Cardiac patients completed a baseline questionnaire (N = 245) assessing demographic characteristics, smoking behavior, intention, self-efficacy, relapse self-efficacy and action and coping plans. Six months later (N = 184) continued abstinence from smoking was assessed. Self-efficacy predicted intention to quit smoking and was an indirect predictor of continued abstinence, through intention. Intention to quit smoking and making action plans both directly influenced continued abstinence. Future interventions to facilitate smoking cessation in cardiac patients should put strong emphasis on enhancing self-efficacy and on making specific action plans to increase the likelihood of smoking cessation.

  1. Rationale and methods of the integrated biomarker and imaging study (IBIS): combining invasive and non-invasive imaging with biomarkers to detect subclinical atherosclerosis and assess coronary lesion biology.

    Science.gov (United States)

    Van Mieghem, Carlos A G; Bruining, Nico; Schaar, Johannes A; McFadden, Eugene; Mollet, Nico; Cademartiri, Filippo; Mastik, Frits; Ligthart, Jurgen M R; Granillo, Gaston A Rodriguez; Valgimigli, Marco; Sianos, Georgios; van der Giessen, Willem J; Backx, Bianca; Morel, Marie-Angele M; Van Es, Gerrit-Anne; Sawyer, Jonathon D; Kaplow, June; Zalewski, Andrew; van der Steen, Anton F W; de Feyter, Pim; Serruys, Patrick W

    2005-08-01

    Death or myocardial infarction, the most serious clinical consequences of atherosclerosis, often result from plaque rupture at non-flow limiting lesions. Current diagnostic imaging with coronary angiography only detects large plaques that already impinge on the lumen and cannot accurately identify those that have a propensity to cause unheralded events. Accurate evaluation of the composition or of the biomechanical characteristics of plaques with invasive or non-invasive methods, alone or in conjunction with assessment of circulating biomarkers, could help identify high-risk patients, thus providing the rationale for aggressive treatments in order to reduce future clinical events. The IBIS (Integrated Biomarker and Imaging Study) study is a prospective, single-center, non-randomized, observational study conducted in Rotterdam. The aim of the IBIS study is to evaluate both invasive (quantitative coronary angiography, intravascular ultrasound (IVUS) and palpography) and non-invasive (multislice spiral computed tomography) imaging techniques to characterize non-flow limiting coronary lesions. In addition, multiple classical and novel biomarkers will be measured and their levels correlated with the results of the different imaging techniques. A minimum of 85 patients up to a maximum of 120 patients will be included. This paper describes the study protocol and methodological solutions that have been devised for the purpose of comparisons among several imaging modalities. It outlines the analyses that will be performed to compare invasive and non-invasive imaging techniques in conjunction with multiple biomarkers to characterize non-flow limiting subclinical coronary lesions.

  2. A Nurse-Led Smoking Cessation Clinic--Quit Rate Results and Views of Participants

    Science.gov (United States)

    Thompson, K. A.; Parahoo, A. K.; Blair, N.

    2007-01-01

    This study evaluated the success of a community nurse-led smoking cessation clinic, based in one trust in Northern Ireland. The clinic operated a group therapy approach. The study employed quantitative and qualitative methods of data collection to measure smoking behaviour and to gain the views of participants. Smoking behaviour was measured by…

  3. Factors associated with breastfeeding cessation in nursing mothers in a peer support programme in Eastern Lancashire

    Directory of Open Access Journals (Sweden)

    Verma Arpana

    2010-01-01

    Full Text Available Abstract Background The UK has one of the lowest breastfeeding rates worldwide and in recent years the Government has made breastfeeding promotion one of its priorities. The UNICEF UK Baby Friendly Initiative is likely to increase breastfeeding initiation but not duration. Other strategies which involve provision of support for breastfeeding mothers in the early weeks after birth are therefore required to encourage UK mothers to breastfeed for the recommended duration. This paper examines the effects of maternal socio-demographic factors, maternal obstetric factors, and in-hospital infant feeding practices on breastfeeding cessation in a peer support setting. Methods Data on mothers from Blackburn with Darwen (BwD and Hyndburn in Eastern Lancashire who gave birth at the Royal Blackburn Hospital and initiated breastfeeding while in hospital were linked to the Index of Multiple Deprivation (IMD. The data were analysed to describe infant feeding methods up to 6 months and the association between breastfeeding cessation, and maternal factors and in-hospital infant feeding practices. Results The mean breastfeeding duration was 21.6 weeks (95% CI 20.86 to 22.37 weeks and the median duration was 27 weeks (95% CI 25.6 to 28.30 weeks. White mothers were 69% more likely to stop breastfeeding compared with non-White mothers (HR: 0.59; 95% CI, 0.52 to 0.67 [White mothers were the reference group]. Breastfeeding cessation was also independently associated with parity and infant feeding practices in hospital. There were no significant associations between breastfeeding cessation and marital status, mode of delivery, timing of breastfeeding initiation and socio-economic deprivation. Conclusion In this study ethnicity, parity and in-hospital infant feeding practices remained independent predictors of breastfeeding cessation in this peer support setting. However other recognised predictors such as marital status, mode of delivery, timing of breastfeeding

  4. The return on investment of a Medicaid tobacco cessation program in Massachusetts.

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    Patrick Richard

    Full Text Available BACKGROUND AND OBJECTIVE: A high proportion of low-income people insured by the Medicaid program smoke. Earlier research concerning a comprehensive tobacco cessation program implemented by the state of Massachusetts indicated that it was successful in reducing smoking prevalence and those who received tobacco cessation benefits had lower rates of in-patient admissions for cardiovascular conditions, including acute myocardial infarction, coronary atherosclerosis and non-specific chest pain. This study estimates the costs of the tobacco cessation benefit and the short-term Medicaid savings attributable to the aversion of inpatient hospitalization for cardiovascular conditions. METHODS: A cost-benefit analysis approach was used to estimate the program's return on investment. Administrative data were used to compute annual cost per participant. Data from the 2002-2008 Medical Expenditure Panel Survey and from the Behavioral Risk Factor Surveillance Surveys were used to estimate the costs of hospital inpatient admissions by Medicaid smokers. These were combined with earlier estimates of the rate of reduction in cardiovascular hospital admissions attributable to the tobacco cessation program to calculate the return on investment. FINDINGS: Administrative data indicated that program costs including pharmacotherapy, counseling and outreach costs about $183 per program participant (2010 $. We estimated inpatient savings per participant of $571 (range $549 to $583. Every $1 in program costs was associated with $3.12 (range $3.00 to $3.25 in medical savings, for a $2.12 (range $2.00 to $2.25 return on investment to the Medicaid program for every dollar spent. CONCLUSIONS: These results suggest that an investment in comprehensive tobacco cessation services may result in substantial savings for Medicaid programs. Further federal and state policy actions to promote and cover comprehensive tobacco cessation services in Medicaid may be a cost-effective approach

  5. Self-reported smoking cessation activities among Swiss primary care physicians

    Directory of Open Access Journals (Sweden)

    Ruffieux Christiane

    2009-03-01

    Full Text Available Abstract Background Individual counselling, pharmacotherapy, and group therapy are evidence-based interventions that help patients stop smoking. Acupuncture, hypnosis, and relaxation have no demonstrated efficacy on smoking cessation, whereas self-help material may only have a small benefit. The purpose of this study is to assess physicians' current clinical practice regarding smokers motivated to stop smoking. Methods The survey included 3385 Swiss primary care physicians. Self-reported use of nine smoking cessation interventions was scored. One point was given for each positive answer about practicing interventions with demonstrated efficacy, i.e. nicotine replacement therapy, bupropion, counselling, group therapy, and smoking cessation specialist. No points were given for the recommendation of acupuncture, hypnosis, relaxation, and self-help material. Multivariable logistic analysis was performed to identify factors associated with a good practice score, defined as ≥ 2. Results The response rate was 55%. Respondents were predominately over the age of 40 years (88%, male (79%, and resided in urban areas (74%. Seventeen percent reported being smokers. Most of the physicians prescribed nicotine replacement therapy (84%, bupropion (65%, or provided counselling (70%. A minority of physicians recommended acupuncture (26%, hypnosis (8%, relaxation (7%, or self-help material (24%. A good practice score was obtained by 85% of respondents. Having attended a smoking cessation-training program was the only significant predictor of a good practice score (odds ratio: 6.24, 95% CI 1.95–20.04. Conclusion The majority of respondents practice recommended smoking cessation interventions. However, there is room for improvement and implementing an evidence-based smoking cessation-training program could provide additional benefit.

  6. Home-based versus hospital-based cardiac rehabilitation after myocardial infarction or revascularisation: design and rationale of the Birmingham Rehabilitation Uptake Maximisation Study (BRUM: a randomised controlled trial [ISRCTN72884263

    Directory of Open Access Journals (Sweden)

    Lane Deirdre

    2003-09-01

    Full Text Available Abstract Background Cardiac rehabilitation following myocardial infarction reduces subsequent mortality, but uptake and adherence to rehabilitation programmes remains poor, particularly among women, the elderly and ethnic minority groups. Evidence of the effectiveness of home-based cardiac rehabilitation remains limited. This trial evaluates the effectiveness and cost-effectiveness of home-based compared to hospital-based cardiac rehabilitation. Methods/design A pragmatic randomised controlled trial of home-based compared with hospital-based cardiac rehabilitation in four hospitals serving a multi-ethnic inner city population in the United Kingdom was designed. The home programme is nurse-facilitated, manual-based using the Heart Manual. The hospital programmes offer comprehensive cardiac rehabilitation in an out-patient setting. Patients We will randomise 650 adult, English or Punjabi-speaking patients of low-medium risk following myocardial infarction, coronary angioplasty or coronary artery bypass graft who have been referred for cardiac rehabilitation. Main outcome measures Serum cholesterol, smoking cessation, blood pressure, Hospital Anxiety and Depression Score, distance walked on Shuttle walk-test measured at 6, 12 and 24 months. Adherence to the programmes will be estimated using patient self-reports of activity. In-depth interviews with non-attendees and non-adherers will ascertain patient views and the acceptability of the programmes and provide insights about non-attendance and aims to generate a theory of attendance at cardiac rehabilitation. The economic analysis will measure National Health Service costs using resource inputs. Patient costs will be established from the qualitative research, in particular how they affect adherence. Discussion More data are needed on the role of home-based versus hospital-based cardiac rehabilitation for patients following myocardial infarction and revascularisation, which would be provided by the

  7. Assessing the 1992 Presidential and Vice Presidential Debates: The Public Rationale.

    Science.gov (United States)

    Winkler, Carol K.; Black, Catherine F.

    1993-01-01

    Reports on the rationales used by viewers in determining winners and conclusions about televised political campaign debates. Studies responses of 370 viewers of the 1992 presidential and vice presidential debates. Analyzes data and determines trends suggested by the results. (HB)

  8. Predictors of long-term smoking cessation: results from the global adult tobacco survey in Poland (2009–2010

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    Kaleta Dorota

    2012-11-01

    Full Text Available Abstract Background Expanding the information on determinants of smoking cessation is crucial for developing and implementing more effective tobacco control measures at the national as well as European levels. Data on smoking cessation and its social correlates among adults from middle-income countries of Central and Eastern Europe are still poorly reported in the literature. The aim of the study was to analyze the association of socio-demographic indicators with long term tobacco smoking cessation (quit smoking for at least one year prior to interview among adults. Moreover, we evaluated motives for giving up smoking from former smokers. Methods Data on former as well as current smokers’ socio-demographic and smoking-related characteristics were derived from the Global Adult Tobacco Survey (GATS. GATS is a cross-sectional, nationally representative household survey implemented in Poland between 2009 and 2010. GATS collected data on a representative sample of 7,840 individuals including 1,206 individuals who met the criteria of long-term smoking cessation and 2,233 current smokers. Smoking cessation rate was calculated as the number of former smokers divided by the number of ever smokers. Logistic regression analyses were used to obtain odds ratios (ORs and 95% confidence interval (CI of the broad number of variables on successful cessation of smoking. Results Among females the quit rate was 30.4% compared to 37.9% in males (p  Conclusion Results indicated that smoking cessation policies focused on younger age groups are vital for curbing tobacco epidemic in Poland and should become a public health main concern. There is also the need for interventions to raise awareness on smoking health risks and quitting benefits are crucial to increase cessation potential among adult smokers. Nevertheless further effort needs to be done to prevent smoking uptake.

  9. Barriers and Promoters of an Evidenced-Based Smoking Cessation Counseling During Prenatal Care in Argentina and Uruguay

    Science.gov (United States)

    Tong, Van T.; Morello, Paola; Farr, Sherry L.; Lawsin, Catalina; Dietz, Patricia M.; Aleman, Alicia; Berrueta, Mabel; Mazzoni, Agustina; Becu, Ana; Buekens, Pierre; Belizán, José; Althabe, Fernando

    2015-01-01

    In Argentina and Uruguay, 10.3 and 18.3 %, respectively, of pregnant women smoked in 2005. Brief cessation counseling, based on the 5A’s model, has been effective in different settings. This qualitative study aims to improve the understanding of factors influencing the provision of smoking cessation counseling during pregnancy in Argentina and Uruguay. In 2010, we obtained prenatal care providers’, clinic directors’, and pregnant smokers’ opinions regarding barriers and promoters to brief smoking cessation counseling in publicly-funded prenatal care clinics in Buenos Aires, Argentina and Montevideo, Uruguay. We interviewed six prenatal clinic directors, conducted focus groups with 46 health professionals and 24 pregnant smokers. Themes emerged from three issue areas: health professionals, health system, and patients. Health professional barriers to cessation counseling included inadequate knowledge and motivation, perceived low self-efficacy, and concerns about inadequate time and large workload. They expressed interest in obtaining a counseling script. Health system barriers included low prioritization of smoking cessation and a lack of clinic protocols to implement interventions. Pregnant smokers lacked information on the risks of prenatal smoking and underestimated the difficulty of smoking cessation. Having access to written materials and receiving cessation services during clinic waiting times were mentioned as promoters for the intervention. Women also were receptive to non-physician office staff delivering intervention components. Implementing smoking cessation counseling in publicly-funded prenatal care clinics in Argentina and Uruguay may require integrating counseling into routine prenatal care and educating and training providers on best-practices approaches. PMID:25500989

  10. Educational Rationale Metadata for Learning Objects

    Directory of Open Access Journals (Sweden)

    Tom Carey

    2002-10-01

    Full Text Available Instructors searching for learning objects in online repositories will be guided in their choices by the content of the object, the characteristics of the learners addressed, and the learning process embodied in the object. We report here on a feasibility study for metadata to record process-oriented information about instructional approaches for learning objects, though a set of Educational Rationale [ER] tags which would allow authors to describe the critical elements in their design intent. The prototype ER tags describe activities which have been demonstrated to be of value in learning, and authors select the activities whose support was critical in their design decisions. The prototype ER tag set consists descriptors of the instructional approach used in the design, plus optional sub-elements for Comments, Importance and Features which implement the design intent. The tag set was tested by creators of four learning object modules, three intended for post-secondary learners and one for K-12 students and their families. In each case the creators reported that the ER tag set allowed them to express succinctly the key instructional approaches embedded in their designs. These results confirmed the overall feasibility of the ER tag approach as a means of capturing design intent from creators of learning objects. Much work remains to be done before a usable ER tag set could be specified, including evaluating the impact of ER tags during design to improve instructional quality of learning objects.

  11. IL-17A and serum amyloid A are elevated in a cigarette smoke cessation model associated with the persistence of pigmented macrophages, neutrophils and activated NK cells.

    Directory of Open Access Journals (Sweden)

    Michelle J Hansen

    Full Text Available While global success in cessation advocacy has seen smoking rates fall in many developed countries, persistent lung inflammation in ex-smokers is an increasingly important clinical problem whose mechanistic basis remains poorly understood. In this study, candidate effector mechanisms were assessed in mice exposed to cigarette smoke (CS for 4 months following cessation from long term CS exposure. BALF neutrophils, CD4+ and CD8+ T cells and lung innate NK cells remained significantly elevated following smoking cessation. Analysis of neutrophil mobilization markers showed a transition from acute mediators (MIP-2α, KC and G-CSF to sustained drivers of neutrophil and macrophage recruitment and activation (IL-17A and Serum Amyoid A (SAA. Follicle-like lymphoid aggregates formed with CS exposure and persisted with cessation, where they were in close anatomical proximity to pigmented macrophages, whose number actually increased 3-fold following CS cessation. This was associated with the elastolytic protease, MMP-12 (macrophage metallo-elastase which remained significantly elevated post-cessation. Both GM-CSF and CSF-1 were significantly increased in the CS cessation group relative to the control group. In conclusion, we show that smoking cessation mediates a transition to accumulation of pigmented macrophages, which may contribute to the expanded macrophage population observed in COPD. These macrophages together with IL-17A, SAA and innate NK cells are identified here as candidate persistence determinants and, we suggest, may represent specific targets for therapies directed towards the amelioration of chronic airway inflammation.

  12. Ultrasound enhanced prehospital thrombolysis using microbubbles infusion in patients with acute ST elevation myocardial infarction: Rationale and design of the Sonolysis study.

    NARCIS (Netherlands)

    Slikkerveer, J.; Dijkmans, P.A.; Sieswerda, G.T.; Doevendans, P.A.; Dijk, A.P.J. van; Verheugt, F.W.A.; Porter, T.R.; Kamp, O.

    2008-01-01

    ABSTRACT: BACKGROUND -: Experimental studies have shown that ultrasound contrast agents enhance the effectiveness of thrombolytic agents in the presence of ultrasound in vitro and in vivo. Recently, we have launched a clinical pilot study, called "Sonolysis", to study this effect in patients with ST

  13. 20 CFR 410.432 - Cessation of disability.

    Science.gov (United States)

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Cessation of disability. 410.432 Section 410..., TITLE IV-BLACK LUNG BENEFITS (1969- ) Total Disability or Death Due to Pneumoconiosis § 410.432 Cessation of disability. (a) Where it has been determined that a miner is totally disabled under §...

  14. The public health impact of smoking and smoking cessation

    NARCIS (Netherlands)

    Mulder, I.

    2003-01-01

    Despite the overwhelming evidence that smoking cessation reduces the risk for several chronic diseases, information on the magnitude of these public health benefits is scarce. It has furthermore been suggested that smoking cessation also improves health-related quality of life, but this has not been

  15. Internet and Cell Phone Based Smoking Cessation Programs among Adolescents

    Science.gov (United States)

    Mehta, Purvi; Sharma, Manoj

    2010-01-01

    Smoking cessation among adolescents is a salient public health issue, as it can prevent the adoption of risky health behaviors and reduce negative impacts on health. Self-efficacy, household and social support systems, and perceived benefits are some important cessation determinants. With the popular use of the Internet and cell phone usage among…

  16. Multimodal intervention raises smoking cessation rate during pregnancy

    DEFF Research Database (Denmark)

    Hegaard, Hanne K; Kjaergaard, Hanne; Møller, Lars F

    2003-01-01

    .003). The adjusted odds ratio (OR) for smoking cessation was 4.20 (95% CI 2.13-8.03). Logistic regression analysis showed a significant positive association of smoking cessation with low caffeine consumption in pregnancy, many years in school, no exposure to passive smoking outside the home, and previous attempts...

  17. Drug cessation in complex older adults: Time for action

    NARCIS (Netherlands)

    T.J.M. van der Cammen (Tischa); C. Rajkumar (Chakravarthi); G. Onder (Graziano); C.S. Sterke (Carolyn); M. Petrovic (Mirko)

    2014-01-01

    textabstractBackground: general opinion is growing that drug cessation in complex older patients is warranted in certain situations. From a clinical viewpoint, drug cessation seems most warranted in four situations, i.e., falls, delirium, cognitive impairment and endof-life situations. To date, litt

  18. Long-term effects of a preoperative smoking cessation programme

    DEFF Research Database (Denmark)

    Villebro, Nete Munk; Pedersen, Tom; Møller, Ann M;

    2008-01-01

    Preoperative smoking intervention programmes reduce post-operative complications in smokers. Little is known about the long-term effect upon smoking cessation.......Preoperative smoking intervention programmes reduce post-operative complications in smokers. Little is known about the long-term effect upon smoking cessation....

  19. The Forced Cessation of Logging and the Management of Impacts on Workers.

    Science.gov (United States)

    McGuffog, Ingrid D.; Western, John S.

    1995-01-01

    A social impact study in Queensland (Australia) was conducted to determine how structural adjustment packages mitigate the negative outcomes that can result from worker redundancy. The cessation of logging resulted in job layoffs that the government addressed with a Worker's Special Adjustment Package. (SLD)

  20. Preconception care: preliminary estimates of costs and effects of smoking cessation and folic acid supplementation.

    NARCIS (Netherlands)

    Weerd, S. de; Polder, J.J.; Cohen-Overbeek, T.E.; Zimmermann, L.J.; Steegers, E.A.P.

    2004-01-01

    OBJECTIVE: To assess costs and effectiveness of preconception counseling for all women planning pregnancy in The Netherlands with regard to folic acid supplementation and smoking cessation counseling. STUDY DESIGN: Costs and effects were estimated based on 200,000 women approached yearly and uptake

  1. Excuses to continue smoking : The role of disengagement beliefs in smoking cessation

    NARCIS (Netherlands)

    Kleinjan, Marloes; van den Eijnden, Regina J. J. M.; Dijkstra, Arie; Brug, Johannes; Engels, Rutger C. M. E.; van der Eijnden, J.J.M.

    2006-01-01

    Background: The aim of the present study was to investigate the role of disengagement beliefs in smoking cessation. The association of disengagement beliefs with forward transition through the transtheoretical stages of change and self-reported quitting were examined, with and without adjusting for

  2. Design and Testing of an Interactive Smoking Cessation Intervention for Inner-City Women

    Science.gov (United States)

    McDaniel, Anna M.; Casper, Gail R.; Hutchison, Sondra K.; Stratton, Renee M.

    2005-01-01

    The purpose of this study was to design and test the usability of a computer-mediated smoking cessation program for inner-city women. Design and content were developed consistent with principles of user-centered design. Formative and summative evaluation strategies were utilized in its testing. The summative evaluation was designed to test…

  3. Cognitive-Behavioral Therapy to Promote Smoking Cessation among African American Smokers: A Randomized Clinical Trial

    Science.gov (United States)

    Webb, Monica S.; de Ybarra, Denise Rodriguez; Baker, Elizabeth A.; Reis, Isildinha M.; Carey, Michael P.

    2010-01-01

    Objective: The health consequences of tobacco smoking disproportionately affect African Americans, but research on whether efficacious interventions can be generalized to this population is limited. This study examined the efficacy of group-based cognitive-behavioral therapy (CBT) for smoking cessation among African Americans. Method: Participants…

  4. How important are parents and partners for smoking cessation in adulthood? An event history analysis

    NARCIS (Netherlands)

    Monden, Christiaan W.S.; Graaf, Nan Dirk de; Kraaykamp, Gerbert

    2003-01-01

    Background. The aim of this study is to assess the effect of parental and partner’s education and smoking behavior on an individual’s chance of smoking cessation over the life course. Methods. Self-reported life histories of smoking behavior, education, and relationships were recorded in face-to-fac

  5. Tobacco Cessation Training in Clinical Psychology and Clinical Social Work Programs

    Science.gov (United States)

    Kleinfelder, JoAnn

    2009-01-01

    The purpose of this study was to explore the tobacco and smoking cessation training and curriculum in graduate clinical psychology and graduate clinical social work programs. The current status of the clinical graduate programs' tobacco education curricula was evaluated by using the Transtheoretical Model's Stages of Change. Perceived barriers to…

  6. Teen Perceptions of Facilitator Characteristics in a School-Based Smoking Cessation Program

    Science.gov (United States)

    Jarrett, Traci; Horn, Kimberly; Zhang, Jianjun

    2009-01-01

    Background: Facilitators are often responsible for the implementation of public health programs, yet little is known about how they influence outcomes. Not-On-Tobacco (N-O-T) is a youth smoking-cessation program implemented by trained facilitators. The purpose of this study was to investigate teens' perceptions of facilitator characteristics and…

  7. The rationale for early intervention in schizophrenia and related disorders

    DEFF Research Database (Denmark)

    Nordentoft, Merete; Jeppesen, Pia; Petersen, Lone

    2009-01-01

    and the initiation of treatment. The average duration of untreated psychosis is around 1–2 years. During this period, brain function may continue to deteriorate and social networks can be irreversibly damaged. Studies have consistently linked longer duration of untreated psychosis with poorer outcomes......, adherence to treatment, comorbid drug abuse, relapse and readmission. Some benefits persist after cessation of the intervention. Conclusions: Early intervention in schizophrenia is justified to reduce the negative personal and social impact of prolonged periods of untreated symptoms. Furthermore, phase...

  8. 基于iP ho ne的免费戒烟应用程序内容分析及研究%The study on content analysis of iPhone Apps for smoking cessation

    Institute of Scientific and Technical Information of China (English)

    徐倩; 赵文龙; 浦科学; 顾盼

    2013-01-01

    目的:分析2012年12月29日来自苹果商店iTunes 69款与戒烟相关的手机应用程序(Apps)的内容,得到其与美国公共卫生服务烟草临床指南的相关程度,为 A pps开发提供参考和建议。方法根据美国国家烟草控制协作中心的条目将Apps分为5类,再将每个Apps的内容与美国公共卫生服务烟草临床指南作对比,给出相应的评分。结果69款戒烟Apps平均得分为10.6,其中最高得分34.5,平均占用储存空间为2.8M。在5种类型的Apps中仅有13.9%与指南相关程度高,其中日历类有21.0%的A pps与指南相关程度高,催眠类A pps与指南相关程度最低。结论 A pps的内容与指南的相关程度低,应当以美国公共卫生服务烟草临床指南为准则,开发出质量更高的戒烟A pps。%Objective To examine the content of the 69 iPhone applications(Apps) for smoking cessation that were distributed through the online iTunes store and explore Apps′level of adherence to the U .S .Public Health Service′s 2008 Clinical Practice Guideline for Treating Tobacco Use and Dependence (called guidelines) for the purpose of developing high quality Apps ,as of De-cember 29 ,2012 .Methods All Apps was categorized into 5 types based on National Tobacco Cessation Collaborative .In order to get the Apps′level of adherence to guidelines ,the content of every application was compared with guidelines respectively .Results Apps identified for smoking cessation were found to have low levels of adherence to key guidelines .Conclusion It is necessary that current and future Apps should be developed around evidence-based practices and guidelines to get reliable Apps for smoking cessa-tion .

  9. Predicting the outcome of chronic kidney disease by the estimated nephron number: The rationale and design of PRONEP, a prospective, multicenter, observational cohort study

    Directory of Open Access Journals (Sweden)

    Imasawa Toshiyuki

    2012-03-01

    Full Text Available Abstract Background The nephron number is thought to be associated with the outcome of chronic kidney disease (CKD. If the nephron number can be estimated in the clinical setting, it could become a strong tool to predict renal outcome. This study was designed to estimate the nephron number in CKD patients and to establish a method to predict the outcome by using the estimated nephron number. Methods/Design The hypothesis of this study is that the estimated nephron number can predict the outcome of a CKD patient. This will be a multicenter, prospective (minimum 3 and maximum 5 years follow-up study. The subjects will comprise CKD patients aged over 14 years who have undergone a kidney biopsy. From January 2011 to March 2013, we will recruit 600 CKD patients from 10 hospitals belonging to the National Hospital Organization of Japan. The primary parameter for assessment is the composite of total mortality, renal death, cerebro-cardiovascular events, and a 50% reduction in the eGFR. The secondary parameter is the rate of eGFR decline per year. The nephron number will be estimated by the glomerular density in biopsy specimens and the renal cortex volume. This study includes one sub-cohort study to establish the equation to calculate the renal cortex volume. Enrollment will be performed at the time of the kidney biopsy, and the data will consist of a medical interview, ultrasound for measurement of the kidney size, blood or urine test, and the pathological findings of the kidney biopsy. Patients will continue to have medical consultations and receive examinations and/or treatment as usual. The data from the patients will be collected once a year after the kidney biopsy until March 2016. All data using this study are easily obtained in routine clinical practice. Discussion This study includes the first trials to estimate the renal cortex volume and nephron number in the general clinical setting. Furthermore, this is the first prospective study to

  10. The effects of smoking and smoking cessation on nasal mucociliary clearance, mucus properties and inflammation

    Directory of Open Access Journals (Sweden)

    Daniela Mitiyo Odagiri Utiyama

    Full Text Available OBJECTIVE: The aim of the present study was to assess nasal mucociliary clearance, mucus properties and inflammation in smokers and subjects enrolled in a Smoking Cessation Program (referred to as quitters. METHOD: A total of 33 subjects with a median (IQR smoking history of 34 (20-58 pack years were examined for nasal mucociliary clearance using a saccharine transit test, mucus properties using contact angle and sneeze clearability tests, and quantification of inflammatory and epithelial cells, IL-6 and IL-8 concentrations in nasal lavage fluid. Twenty quitters (mean age: 51 years, 9 male were assessed at baseline, 1 month, 3 months and 12 months after smoking cessation, and 13 smokers (mean age: 52 years, 6 male were assessed at baseline and after 12 months. Clinicaltrials.gov: NCT02136550. RESULTS: Smokers and quitters showed similar demographic characteristics and morbidities. At baseline, all subjects showed impaired nasal mucociliary clearance (mean 17.6 min, although 63% and 85% of the quitters demonstrated significant nasal mucociliary clearance improvement at 1 month and 12 months, respectively. At 12 months, quitters also showed mucus sneeze clearability improvement (∼26%, an increased number of macrophages (2-fold and no changes in mucus contact angle or cytokine concentrations. CONCLUSION: This study showed that smoking cessation induced early improvements in nasal mucociliary clearance independent of mucus properties and inflammation. Changes in mucus properties were observed after only 12 months of smoking cessation.

  11. Predictors of betel quid chewing behavior and cessation patterns in Taiwan aborigines

    Directory of Open Access Journals (Sweden)

    Chang Shun-Jen

    2006-11-01

    Full Text Available Abstract Background Betel quid, chewed by about 600 million people worldwide, is one of the most widely used addictive substances. Cessation factors in betel quid chewers are unknown. The present study explores prevalence and the quit rate of betel quid chewing in Taiwan aborigines. Our goal was to delineate potential predictors of chewing cessation. Methods A stratified random community-based survey was designed for the entire aborigines communities in Taiwan. A total of 7144 participants were included between June 2003 and May 2004 in this study. Information on sociodemographic characteristics, such as gender, age, obesity, education years, marital status, ethnicity, and habits of betel quid chewing, smoking and drinking was collected by trained interviewers. Results The prevalence of betel quid chewers was 46.1%. Betel quid chewing was closely associated with obesity (OR = 1.61; 95% CI: 1.40–1.85. Betel quid chewers were most likely to use alcohol and cigarettes together. Quit rate of betel quid chewers was 7.6%. Betel quid chewers who did not drink alcohol were more likely to quit (OR = 1.89; 95% CI: 1.43–2.50. Alcohol use is a significant factor related to cessation of betel quid chewing, but smoking is not. Conclusion Taiwan aborigines have a high prevalence of betel quid chewers and a low quit rate. Alcohol use is strongly association with betel quid chewing. Efforts to reduce habitual alcohol consumption might be of benefit in cessation of betel quid chewing.

  12. [Use of medication in combination with a modern group programme for smoking cessation].

    Science.gov (United States)

    Erfurt, L; Kröger, C B

    2015-02-01

    This study examined the acceptance, use and -adherence with regard to stop-smoking medication in addition to a smoking cessation programme. In a multi-centre field study with quasi-experimental control group design, the participants of a smoking cessation programme were asked about their smoking behaviour at the beginning and at the end of the course. A sample of 1 319 participants was contacted via telephone one year after the end of the course. Among the 1 052 participants, who could be interviewed, 312 subjects (29.7%) reported to have used stop-smoking medication while 85.2% of the medication users preferred nicotine replacement therapy. The objective medication adherence was 13.2%. 79.3% of the medication users believed that they had used the medication adherently. There were no significant differences between participants who started use of medication and non-users (long-term abstinence rate: no medication 34.6% vs. medication 31.7%; p=0.34). The outcome of a modern smoking cessation group programme could not be improved by providing additional stop-smoking medication. This finding and the lack of medication adherence raise doubts about the effectiveness of offering stop-smoking medication in addition to an intensive cognitive-behavioural-based smoking cessation programme that focusses on behavioural changes.

  13. Experience of a smoking cessation program among high school students in Taiwan.

    Science.gov (United States)

    Chang, Chi-Ping; Lee, Ting-Ting; Mills, Mary Etta

    2014-01-01

    In Taiwan, the prevalence of smoking among teenagers has led to a required smoking cessation program in schools. Students caught smoking in school are required to participate in a weekly smoking cessation class. The purpose of this study was to explore the experience of high school students in a smoking cessation program. Fifteen adolescents participated in a one-on-one in-depth semistructured interview, and the content was analyzed for patterns based on the methods of Miles and Huberman. In addition, Lewin's change theory of drive forces and restraining forces was used to describe the change in behavior as a result of the program. Five major themes were identified: the onset of smoking-change influenced by families and friends; intention to quit smoking-driving force; the irresistible temptation to smoke-restraining force; limited change effects-more attention and assistance needed; and change in attitude rather than behavior-smoking remained unchanged. Changes were seen in the perceptions and attitudes of these students toward smoking at the end of the program; however, none of them were able to really quit. Most participants revealed that they used improper means to pass the carbon monoxide test requirement that was used as a measure of not smoking. Alternative future intervention strategies for further study include change in health policy to support nicotine replacement methods for heavy adolescent smoker, use of teacher support, and exercise programs to support students going through the smoking cessation period.

  14. A Randomized Clinical Trial of a Web-Based Tobacco Cessation Education Program

    Science.gov (United States)

    Mahabee-Gittens, E. Melinda; Andrews, Judy A.; Christiansen, Steven M.; Byron, David J.

    2013-01-01

    OBJECTIVES: We report the results of a randomized clinical trial of a 3-hour, web-based, tobacco cessation education program, the Web-Based Respiratory Education About Tobacco and Health (WeBREATHe) program, for practicing pediatric respiratory therapists (RTs), registered nurses (RNs), and nurse practitioners (NPs). METHODS: Two hundred fifteen RTs (n = 40), RNs (n = 163), and NPs (n = 12) employed at the Children’s Hospital of Philadelphia and the Children’s Hospital, University of Colorado at Denver, participated in this study. All study activities were completed online. After consenting, participants were randomly assigned to either the training (intervention) or delayed training (control) condition. The training condition consisted of a 3-hour continuing education unit course plus ongoing online resources. Participants were assessed at baseline, 1 week, and 3 months after enrollment. RESULTS: Participants in the training condition were more likely to increase their tobacco cessation intervention behaviors than their delayed training counterparts (F[1, 213] = 32.03, P < .001). Training participants showed significantly greater levels of advise (F[1, 213] = 7.22, P < .001); assess (F[1, 213] = 19.56, P < .001); and particularly assist/arrange (F[1213] = 35.52, P < .001). In addition, training condition participants rated the program highly on measures of consumer satisfaction. CONCLUSIONS: The WeBREATHe program is the first evidence-based education program in tobacco cessation designed specifically for pediatric RTs, RNs, and NPs. Engagement in WeBREATHe increased participants’ tobacco cessation-related behaviors. PMID:23319529

  15. Project EX-India: A classroom-based tobacco use prevention and cessation intervention program.

    Science.gov (United States)

    Sidhu, Anupreet Kaur; Sussman, Steve; Tewari, Abha; Bassi, Shalini; Arora, Monika

    2016-02-01

    Tobacco use experimentation is most frequent between the ages of 15–24 in India. Therefore, programming to counteract tobacco use among adolescents is needed. There is a lack of evidence-based teen tobacco use prevention and cessation programs. The current study provides an outcome evaluation of the Project EX tobacco use prevention and cessation program among Indian adolescents (16–18 years). An eight-session classroom-based curriculum was adapted to the Indian context and translated from English to Hindi (local language). Next, it was tested using a quasi-experimental design with 624 Indian students at baseline, involving two program and two control schools, with a three-month post-program follow-up. Project EX involves motivation enhancement (e.g., talk shows and games) and coping skills (e.g., complementary and alternative medicine) components. Program participants rated complementary and alternative medicine (CAM) activities like meditation, yoga and healthy breathing higher than talk shows and games. Compared to the standard care control condition, the program condition revealed a prevention effect, but not a cessation effect. Implications for prevention/cessation programming among Indian teens are discussed. This study was approved by the Independent Ethics Committee, Mumbai.

  16. Interpersonal communication as an indirect pathway for the effect of antismoking media content on smoking cessation.

    Science.gov (United States)

    van den Putte, Bas; Yzer, Marco; Southwell, Brian G; de Bruijn, Gert-Jan; Willemsen, Marc C

    2011-05-01

    In the context of health campaigns, interpersonal communication can serve at least 2 functions: (a) to stimulate change through social interaction and (b) in a secondary diffusion process, to further disseminate message content. In a 3-wave prospective study of 1,079 smokers, the authors demonstrate that mass media messages (antismoking campaigns and news coverage relevant to smoking cessation) have an indirect effect on smoking cessation intention and behavior via interpersonal communication. Exposure to campaigns and news coverage prompts discussion about the campaigns, and, in turn, about smoking cessation. Interpersonal communication regarding smoking cessation then influences intention to quit smoking and attempts to quit smoking. The study finds evidence not only for the social interaction function of interpersonal communication, but also for the secondary diffusion function. A substantial number of smokers who are not directly exposed to the antismoking campaigns are nevertheless indirectly exposed via communication with people who have seen these campaigns. These results imply that encouragement of interpersonal communication can be an important campaign objective.

  17. Who Should Benefit from REDD+? Rationales and Realities

    Directory of Open Access Journals (Sweden)

    Cecilia Luttrell

    2013-12-01

    Full Text Available Benefit-sharing mechanisms are a central design aspect of REDD+ because they help to create the necessary incentives to reduce carbon emissions. However, if stakeholders do not perceive the benefit sharing as fair, the legitimacy of REDD+, and support for the mechanism, will be weakened. In this paper, drawing on data from CIFOR's Global Comparative Study on REDD+, we analyze national policy processes in 6 countries and incipient benefit-sharing arrangements in 21 REDD+ project sites. Through our analysis of current practices and debates, we identify six rationales that have been put forward to justify how benefits should be distributed and to whom. These rationales encompass a range of perspectives. Some hold that benefit sharing should be related to actual carbon emission reductions or to costs incurred in achieving the reduction of emissions; others emphasize the importance of a legal right to benefit, the need to consider aspects such as poverty reduction or the appropriateness of rewarding those with a history of protecting the forest. Each rationale has implications for the design of benefit-sharing mechanisms and the equity of their outcomes. We point out that, given the wide range of rationales and interests at play, the objectives of REDD+ and benefit sharing must be clearly established and the term "benefit" defined before effective benefit-sharing mechanisms can be designed. For stakeholders to support REDD+, the legitimacy of decision-making institutions, consideration of context, and attention to process are critical. Building legitimacy requires attention not only to fair distributional outcomes but also to consensus on relevant institutions' authority to make decisions and to procedural equity.

  18. Kelston Beverages Pilot Study: Rationale, design and implementation of a community and school based intervention to reduce sugary drink consumption among children and youth.

    Science.gov (United States)

    Sundborn, G; Ni Mhurchu, C; Ness, C; Latu, H; Jackson, R

    2014-03-01

    The Kelston Beverages Study was designed to increase awareness of the sugar content of sugary drinks, the poor health consequences that high intake of these drinks have, and inform on ways to reduce intake of students. The aims of this pilot study were to refine interventions and processes designed to raise awareness of the harms that sugar sweetened beverages (SSBs) have on health, and to reduce their consumption among the youth of a small West Auckland suburb. There were three arms to this interventional study, one in schools, another in community organisations (churches, sports clubs and community groups), and the final arm is in the local retail sector. The school arm was the most extensive component and initially involved a survey of children's knowledge and consumption of sugar sweetened beverages (SSBs) using a brief questionnaire. The study evaluated any SSB policies in schools and for schools that did not have policies, opportunities were scoped to develop and implement them; a canteen AUDIT focussed particularly on beverages was carried out; and finally a student partnered social marketing exercise was undertaken that comprised 2 competitions, one to design a poster, and another to write and perform a rap. Children were re-surveyed at the completion of the intervention (7 months later) to determine change in knowledge and self-reported consumption of SSBs. Both the community organisations and retail arms of this study focussed on raising awareness into the harmful effects of SSBs and establishing healthy beverage policy in the respective organisations. Promising results with regards to acceptability, feasibility, and recruitment as well as valuable learnings with regard to process support the development of a proposal to conduct a cluster randomised trial of the interventions successfully tested in this pilot study.

  19. Rationale and methods of the cardiometabolic valencian study (escarval-risk for validation of risk scales in mediterranean patients with hypertension, diabetes or dyslipidemia

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    Trillo Jose L

    2010-11-01

    Full Text Available Abstract Background The Escarval-Risk study aims to validate cardiovascular risk scales in patients with hypertension, diabetes or dyslipidemia living in the Valencia Community, a European Mediterranean region, based on data from an electronic health recording system comparing predicted events with observed during 5 years follow-up study. Methods/Design A cohort prospective 5 years follow-up study has been designed including 25000 patients with hypertension, diabetes and/or dyslipidemia attended in usual clinical practice. All information is registered in a unique electronic health recording system (ABUCASIS that is the usual way to register clinical practice in the Valencian Health System (primary and secondary care. The system covers about 95% of population (near 5 million people. The system is linked with database of mortality register, hospital withdrawals, prescriptions and assurance databases in which each individual have a unique identification number. Diagnoses in clinical practice are always registered based on IDC-9. Occurrence of CV disease was the main outcomes of interest. Risk survival analysis methods will be applied to estimate the cumulative incidence of developing CV events over time. Discussion The Escarval-Risk study will provide information to validate different cardiovascular risk scales in patients with hypertension, diabetes or dyslipidemia from a low risk Mediterranean Region, the Valencia Community.

  20. Predicting cardiovascular disease morbidity and mortality in chronic kidney disease in Spain. The rationale and design of NEFRONA: a prospective, multicenter, observational cohort study

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    Roig Jordi

    2010-07-01

    Full Text Available Abstract Background Cardiovascular disease (CVD is the leading cause of morbidity and mortality in patients with chronic kidney disease (CKD. Cardiovascular risk assessment in this population is hampered by the failure of traditional risk factors to fully account for the elevated CVD risk (reverse epidemiology effect and the presence of emerging risk factors specifically related to kidney failure. Therefore, diagnostic tools capable of improving cardiovascular risk assessment beyond traditional risk factors are currently warranted. We present the protocol of a 4-year prospective study aimed to assess the predictive value of non-invasive imaging techniques and biomarkers for CVD events and mortality in patients with CKD. Methods From November 2009 to October 2010, 4137 asymptomatic adult patients with stages 2 to 5 CKD will be recruited from nephrology services and dialysis units throughout Spain. During the same period, 843 participants without CKD (control group will be recruited from lists of primary care physicians, only at baseline. During the follow-up, CVD events and mortality will be recorded from all CKD patients. Clinical and laboratory characteristics will be collected in a medical documentation sheet. Three trained itinerant teams will carry out a carotid ultrasound to assess intima-media thickness and presence of plaques. A composite atherosclerosis score will be constructed based on carotid ultrasound data and measurement of ankle-brachial index. In CKD patients, presence and type of calcifications will be assessed in the wall of carotid, femoral and brachial arteries, and in cardiac valves, by ultrasound. From all participants, blood samples will be collected and stored in a biobank to study novel biomarkers. Conclusions The NEFRONA study is the first large, prospective study to examine the predictive value of several non-invasive imaging techniques and novel biomarkers in CKD patients throughout Spain. Hereby, we present the

  1. The rationale for Business English Syllabus

    Institute of Scientific and Technical Information of China (English)

    谭玉娣

    2016-01-01

    The syllabus is designed for a one-year business English course for 33 staff from Sino-Silicates Company.This rationale will analyse the arrangement of the syllabus from the following aspects:needs analysis,product-oriented,culture,in-class activity and material selection.

  2. An Expanding Rationale for Cooperative Education.

    Science.gov (United States)

    Abitia, Fred

    1985-01-01

    The author discusses cooperative education: how it is viewed by private enterprise and where it fits into higher education's framework. The cooperative education program at California Polytechnic State University is examined: faculty responsibility, rationale for the program's existence, and reasons for the program's importance. (CT)

  3. Psychological risk factors of micro- and macrovascular outcomes in primary care patients with type 2 diabetes: rationale and design of the DiaDDZoB Study

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    Pop Victor JM

    2010-07-01

    Full Text Available Abstract Background Depression is a common psychiatric complication of diabetes, but little is known about the natural course and the consequences of depressive symptoms in primary care patients with type 2 diabetes. While depression has been related to poor glycemic control and increased risk for macrovascular disease, its association with microvascular complications remains understudied. The predictive role of other psychological risk factors such as Type D (distressed personality and the mechanisms that possibly link depression and Type D personality with poor vascular outcomes are also still unclear. Methods/Design This prospective cohort study will examine: (1 the course of depressive symptoms in primary care patients with type 2 diabetes; (2 whether depressive symptoms and Type D personality are associated with the development of microvascular and/or macrovascular complications and with the risk of all-cause or vascular mortality; and (3 the behavioral and physiological mechanisms that may mediate these associations. The DiaDDZoB Study is embedded within the larger DIAZOB Primary Care Diabetes study, which covers a comprehensive cohort of type 2 diabetes patients treated by over 200 primary care physicians in South-East Brabant, The Netherlands. These patients will be followed during their lifetime and are assessed annually for demographic, clinical, lifestyle and psychosocial factors. Measurements include an interviewer-administered and self-report questionnaire, regular care laboratory tests and physical examinations, and pharmacy medication records. The DiaDDZoB Study uses data that have been collected during the original baseline assessment in 2005 (M0; N = 2,460 and the 2007 (M1; N = 2,225 and 2008 (M2; N = 2,032 follow-up assessments. Discussion The DiaDDZoB Study is expected to contribute to the current understanding of the course of depression in primary care patients with type 2 diabetes and will also test whether depressed

  4. Primary radiotherapy after tumour excision as an alternative to mastectomy for early breast cancer. Rationale and preliminary results of a prospective study.

    Science.gov (United States)

    Browde, S; Nissenbaum, M M

    1983-09-28

    A conservative approach to the management of breast cancer is gaining acceptance. The evidence from many retrospective and prospective studies indicates that breast-preserving surgery and radiation therapy give results equal to those of mastectomy. Relapse affecting the breast alone has been shown not to be detrimental to survival, while the psychological benefits to the patients have been gratifying. A prospective study of early breast cancer treated by conservative surgery and radiation was commenced at the Johannesburg Hospital in 1980. The results in 57 patients are reported. So far there have been 2 cases of local recurrence. In the majority of cases satisfactory cosmetic results were achieved. It is considered that lumpectomy with axillary dissection to establish nodal status followed by irradiation is the treatment of choice for stage I and II carcinoma of the breast.

  5. Ultrasound enhanced prehospital thrombolysis using microbubbles infusion in patients with acute ST elevation myocardial infarction: Rationale and design of the Sonolysis study

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    van Dijk Arie PJ

    2008-12-01

    Full Text Available Abstract Background - Experimental studies have shown that ultrasound contrast agents enhance the effectiveness of thrombolytic agents in the presence of ultrasound in vitro and in vivo. Recently, we have launched a clinical pilot study, called "Sonolysis", to study this effect in patients with ST-elevation myocardial infarction based on proximal lesions of the infarct-related artery. Methods/design - In our multicenter, randomized, placebo controlled clinical trial we will include patients between 18 and 80 years of age with their first ST-elevation myocardial infarction based on a proximal lesion of the infarct-related artery. After receiving a single bolus alteplase 50 mg IV (Actilyse® Boehringer Ingelheim GmbH, a loading dose of aspirin 500 mg, and heparin 5000 IU in the ambulance according to the prehospital thrombolysis protocol, patients, following oral informed consent, are randomized to undergo 15 minutes of pulsatile ultrasound with intravenous administration of ultrasound contrast agent or placebo without ultrasound. Afterwards coronary angiography and, if indicated, percutaneous coronary intervention will take place. A total of 60 patients will be enrolled in approximately 1 year. The primary endpoints are based on the coronary angiogram and consist of TIMI flow, corrected TIMI frame count, and myocardial blush grade. Follow-up includes 12-lead ECG, 2D-echocardiography, cardiac MRI, and enzyme markers to obtain our secondary endpoints, including the infarct size, wall motion abnormalities, and the global left ventricular function. Discussion - The Sonolysis study is the first multicenter, randomized, placebo controlled clinical trial investigating the therapeutic application of ultrasound and microbubbles in acute ST-elevation myocardial infarction patients. A positive finding may stimulate further research and technical innovations to implement the treatment in the ambulance and maybe obtain even more patency at an earlier stage

  6. The China Patient-Centred Evaluative Assessment of Cardiac Events (China PEACE)-Prospective Study of 3-Vessel Disease: rationale and design

    Science.gov (United States)

    Rao, Chenfei; Bongiovanni, Tasce; Li, Xi; Gao, Huawei; Zhang, Heng; Li, Jing; Zhao, Yan; Yuan, Xin; Hua, Kun; Hu, Shengshou; Krumholz, Harlan M; Jiang, Lixin; Zheng, Zhe

    2016-01-01

    Introduction Complex coronary artery disease (left main and three-vessel disease) carries high risks of adverse events and cost burden. However, in China, little is known about which patients are directed toward which treatment strategies and what outcomes are being achieved. Methods and analysis Using the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) research network, this prospective study of three-Vessel Disease, the China PEACE-3VD study, has a plan to consecutively register over 4000 patients with a diagnosis of 3VD and/or left-main disease by elective coronary angiography at 24 large cardiovascular centres in China. We centrally conducted medical record abstraction and SYNTAX Score calculation for all registered patients. The sites invited patients to the prospective cohort, and conducted 1-year follow-up on major events, including cardiac events, symptoms, secondary prevention and quality of life. The estimated entire sample size of eligible patients of 4000 was determined based on both feasibility and consideration of adequate statistical precision for describing the treatment decisions, guidelines adherence and appropriateness of treatment for patients with complex coronary artery diseases. The study is designed to investigate patient, clinician and hospital factors associated with each treatment strategy (percutaneous coronary intervention, coronary artery bypass grafting or medical therapy) as well as appropriateness of treatment choice, current guideline compliance and patient-reported outcomes for patients with complex coronary artery disease in large cardiovascular centres in China, as a foundation for enhanced knowledge in the field and to assist quality improvement initiatives. Ethics and dissemination The study protocol was approved by the ethics committee at the China National Center for Cardiovascular Diseases. Findings will be shared with participating hospitals, policymakers and the academic community, to promote

  7. Two doses of rivaroxaban versus aspirin for prevention of recurrent venous thromboembolism. Rationale for and design of the EINSTEIN CHOICE study.

    Science.gov (United States)

    Weitz, Jeffrey I; Bauersachs, Rupert; Beyer-Westendorf, Jan; Bounameaux, Henri; Brighton, Timothy A; Cohen, Alexander T; Davidson, Bruce L; Holberg, Gerlind; Kakkar, Ajay; Lensing, Anthonie W A; Prins, Martin; Haskell, Lloyd; van Bellen, Bonno; Verhamme, Peter; Wells, Philip S; Prandoni, Paolo

    2015-08-31

    Patients with unprovoked venous thromboembolism (VTE) are at high risk for recurrence. Although rivaroxaban is effective for extended VTE treatment at a dose of 20 mg once daily, use of the 10 mg dose may further improve its benefit-to-risk ratio. Low-dose aspirin also reduces rates of recurrent VTE, but has not been compared with anticoagulant therapy. The EINSTEIN CHOICE study is a multicentre, randomised, double-blind, active-controlled, event-driven study comparing the efficacy and safety of two once daily doses of rivaroxaban (20 and 10 mg) with aspirin (100 mg daily) for the prevention of recurrent VTE in patients who completed 6-12 months of anticoagulant therapy for their index acute VTE event. All treatments will be given for 12 months. The primary efficacy objective is to determine whether both doses of rivaroxaban are superior to aspirin for the prevention of symptomatic recurrent VTE, while the principal safety outcome is the incidence of major bleeding. The trial is anticipated to enrol 2,850 patients from 230 sites in 31 countries over a period of 27 months. In conclusion, the EINSTEIN CHOICE study will provide new insights into the optimal antithrombotic strategy for extended VTE treatment by comparing two doses of rivaroxaban with aspirin (clinicaltrials.gov NCT02064439).

  8. The lung cancer exercise training study: a randomized trial of aerobic training, resistance training, or both in postsurgical lung cancer patients: rationale and design

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    Crawford Jeffrey

    2010-04-01

    Full Text Available Abstract Background The Lung Cancer Exercise Training Study (LUNGEVITY is a randomized trial to investigate the efficacy of different types of exercise training on cardiorespiratory fitness (VO2peak, patient-reported outcomes, and the organ components that govern VO2peak in post-operative non-small cell lung cancer (NSCLC patients. Methods/Design Using a single-center, randomized design, 160 subjects (40 patients/study arm with histologically confirmed stage I-IIIA NSCLC following curative-intent complete surgical resection at Duke University Medical Center (DUMC will be potentially eligible for this trial. Following baseline assessments, eligible participants will be randomly assigned to one of four conditions: (1 aerobic training alone, (2 resistance training alone, (3 the combination of aerobic and resistance training, or (4 attention-control (progressive stretching. The ultimate goal for all exercise training groups will be 3 supervised exercise sessions per week an intensity above 70% of the individually determined VO2peak for aerobic training and an intensity between 60 and 80% of one-repetition maximum for resistance training, for 30-45 minutes/session. Progressive stretching will be matched to the exercise groups in terms of program length (i.e., 16 weeks, social interaction (participants will receive one-on-one instruction, and duration (30-45 mins/session. The primary study endpoint is VO2peak. Secondary endpoints include: patient-reported outcomes (PROs (e.g., quality of life, fatigue, depression, etc. and organ components of the oxygen cascade (i.e., pulmonary function, cardiac function, skeletal muscle function. All endpoints will be assessed at baseline and postintervention (16 weeks. Substudies will include genetic studies regarding individual responses to an exercise stimulus, theoretical determinants of exercise adherence, examination of the psychological mediators of the exercise - PRO relationship, and exercise-induced changes

  9. Rationale, design, and cohort enrolment of a prospective observational study of the clinical performance of the new contraceptive implant (Femplant in Pakistan

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    Azmat SK

    2014-05-01

    Full Text Available Syed Khurram Azmat,1 Waqas Hameed,1 Anja Lendvay,2 Babar Tasneem Shaikh,3 Ghulam Mustafa,1 Muhammad Ahmed Siddiqui,1 Sajid Brohi,1 Asif Karim,1 Muhammad Ishaque,1 Wajahat Hussain,1 Mohsina Bilgrami,1 Paul J Feldblum2 1Research, Monitoring and Evaluation Department, Marie Stopes Society, Karachi, Pakistan; 2FHI 360, Durham, NC, USA; 3Health Services Academy, Islamabad, Pakistan Introduction: The use of hormonal implants has gained positive traction in family planning programs in recent times. Compared to other popular methods, such as long-term reversible intrauterine devices, the use of hormonal implants as a family planning method has distinct advantages in terms of long-term efficiency and better user compliance and availability. This paper presents a study protocol to document and evaluate the efficacy, safety, and acceptability of Femplant (contraceptive implant in Pakistan during the first year of its use among married women of reproductive age (18–44 years at clinics in two provinces of Pakistan (Sindh and Punjab. Materials and methods: A total of 724 married women were enrolled in a noncomparative prospective observational study. The study involved six government clinics from the Population Welfare Department in Sindh Province and 13 clinics run by the Marie Stopes Society (a local nongovernmental organization in both provinces. The participation of women was subject to voluntary acceptance and medical eligibility. All respondents were interviewed at baseline and subsequently at each scheduled visit during the study period. Side effects, complications and adverse events, if any, were recorded for every participant at each visit to the facility. Discussion: Over the next 5-year period (2013–2018, 27 million hormonal implants will be made available in lower- to middle-income countries by international donors and agencies. The evidence generated from this study will identify factors affecting the acceptability and satisfaction of end

  10. Climate for innovation, 12-step orientation, and tobacco cessation treatment.

    Science.gov (United States)

    Muilenburg, Jessica L; Laschober, Tanja C; Eby, Lillian T

    2014-04-01

    This study examined the relationship between (1) three indicators of climate for innovation (clinician skills, absence of program obstacles, policy-related incentives) and adoption extensiveness of both behavioral treatments for tobacco cessation (TC) and system-level support for TC in substance use disorder treatment programs, (2) a program's 12-step treatment orientation and adoption extensiveness, and (3) whether 12-step treatment orientation moderates the relationship between climate for innovation and adoption extensiveness. Data were obtained from a random sample of 1006 program administrators. Hierarchical regression results showed that both absence of program obstacles and policy-related incentives are positively related to adoption extensiveness. Twelve-step treatment orientation is neither related to adoption extensiveness nor a moderator of the relationship between climate for innovation and adoption extensiveness. Although the adoption of both behavioral treatments for TC and system-level support for TC is not extensive, we conclude that a 12-step treatment orientation neither hampers nor promotes adoption extensiveness.

  11. Supplement use in sport: is there a potentially dangerous incongruence between rationale and practice?

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    Naughton Declan P

    2007-05-01

    Full Text Available Abstract Background Supplement use by athletes is complex and research supports the alarming notion of misinformed decisions regarding supplements. Hypothesis A frequent divergence between the type of supplements chosen by athletes and the rationale dictating the supplement use is hypothesized. Thus, a potentially dangerous incongruence may exist between rationale and practice. Testing the hypothesis In the continued absence of reliable data on supplement use, an alternative approach of studying the reasons underlying supplement use in athletes is proposed to determine whether there is an incongruence between rationale and practice. Existing data from large scale national surveys can be used to investigate this incongruence. Implications of the hypothesis In this report, analyses of distinctive patterns between the use and rationale for use of supplements among athletes are recommended to explore this potentially dangerous phenomenon.

  12. The Australian Twin Study of Gambling (OZ-GAM): rationale, sample description, predictors of participation, and a first look at sources of individual differences in gambling involvement.

    Science.gov (United States)

    Slutske, Wendy S; Meier, Madeline H; Zhu, Gu; Statham, Dixie J; Blaszczynski, Alex; Martin, Nicholas G

    2009-02-01

    Two major challenges to conducting a community-based twin study of pathological gambling (PG) disorder are that: (a) it is relatively rare, and (b) individuals with the disorder in the community may be difficult to locate and recruit. We describe a new study of 4,764 individuals recruited from the Australian Twin Registry in which we attempt to effectively deal with the first challenge and examine the impact of the second challenge. The lifetime prevalence of DSM-IV PG in this Australian twin sample was 2.2%, which is 400-500% higher than has been obtained in prevalence surveys conducted in the United States. A number of predictors of non-participation were identified, including a lifetime PG disorder diagnosis, but these did not have a large net effect on the estimated number of individuals with PG or related characteristics in the twin sample. Results of biometric modeling suggested that the effect of genetic, shared family environmental, and nonshared environmental influences on the propensity to engage in 11 different specific forms of gambling (e.g., playing the lottery, betting on horse or dog races, playing electronic gaming machines) were generally moderate, low, and moderate, respectively, with mean parameter estimates obtained of 43%, 10%, and 46%. An intriguing comparison with results from a 1963 US adolescent twin study conducted by Loehlin and Nichols (1976) suggests that: (a) propensity genes for gambling involvement may be more likely to be expressed in the heavy-gambling Australian culture, or that (b) the family environment has a transient effect on the gambling behavior of young people.

  13. A randomised controlled trial of an enhanced interdisciplinary community based group program for people with Parkinson’s disease: study rationale and protocol

    Directory of Open Access Journals (Sweden)

    Catherine Peters

    2012-03-01

    Full Text Available Parkinson’s disease (PD is a progressive, chronic neurodegenerative disorder for which there is no known cure. Physical exercise programs may be used to assist with the physical management of PD. Several studies have demonstrated that community based physical therapy programs are effective in reducing physical aspects of disability among people with PD. While multidisciplinary therapy interventions may have the potential to reduce disability and improve the quality of life of people with PD, there is very limited clinical trial evidence to support or refute the use of a community based multidisciplinary or interdisciplinary programs for people with PD. A two group randomized trial is being undertaken within a community rehabilitation service in Brisbane, Australia. Community dwelling adults with a diagnosis of Idiopathic Parkinson’s disease are being recruited. Eligible participants are randomly allocated to a standard exercise rehabilitation group program or an intervention group which incorporates physical, cognitive and speech activities in a multi-tasking framework. Outcomes will be measured at 6-week intervals for a period of six months. Primary outcome measures are the Montreal Cognitive Assessment (MoCA and the Timed Up and Go (TUG cognitive test. Secondary outcomes include changes in health related quality of life, communication, social participation, mobility, strength and balance, and carer burden measures. This study will determine the immediate and long-term effectiveness of a unique multifocal, interdisciplinary, dual-tasking approach to the management of PD as compared to an exercise only program. We anticipate that the results of this study will have implications for the development of cost effective evidence based best practice for the treatment of people with PD living in the community.

  14. Rationale, design and methodology for Intraventricular Pressure Gradients Study: a novel approach for ventricular filling assessment in normal and falling hearts

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    Vouga Luís

    2011-05-01

    Full Text Available Abstract Background Intraventricular pressure gradients have been described between the base and the apex of the left ventricle during early diastolic ventricular filling, as well as, their increase after systolic and diastolic function improvement. Although, systolic gradients have also been observed, data are lacking on their magnitude and modulation during cardiac dysfunction. Furthermore, we know that segmental dysfunction interferes with the normal sequence of regional contraction and might be expected to alter the physiological intraventricular pressure gradients. The study hypothesis is that systolic and diastolic gradients, a marker of normal left ventricular function, may be related to physiological asynchrony between basal and apical myocardial segments and they can be attenuated, lost entirely, or even reversed when ventricular filling/emptying is impaired by regional acute ischemia or severe aortic stenosis. Methods/Design Animal Studies: Six rabbits will be completely instrumented to measuring apex to outflow-tract pressure gradient and apical and basal myocardial segments lengthening changes at basal, afterloaded and ischemic conditions. Afterload increase will be performed by abruptly narrowing or occluding the ascending aorta during the diastole and myocardial ischemia will be induced by left coronary artery ligation, after the first diagonal branch. Patient Studies: Patients between 65-80 years old (n = 12, both genders, with severe aortic stenosis referred for aortic valve replacement will be selected as eligible subjects. A high-fidelity pressure-volume catheter will be positioned through the ascending aorta across the aortic valve to measure apical and outflow-tract pressure before and after aortic valve replacement with a bioprosthesis. Peak and average intraventricular pressure gradients will be recorded as apical minus outflow-tract pressure and calculated during all diastolic and systolic phases of cardiac cycle

  15. Rate of cardiac arrhythmias and silent brain lesions in experienced marathon runners: rationale, design and baseline data of the Berlin Beat of Running study

    Directory of Open Access Journals (Sweden)

    Haeusler Karl

    2012-08-01

    Full Text Available Abstract Background Regular exercise is beneficial for cardiovascular health but a recent meta-analysis indicated a relationship between extensive endurance sport and a higher risk of atrial fibrillation, an independent risk factor for stroke. However, data on the frequency of cardiac arrhythmias or (clinically silent brain lesions during and after marathon running are missing. Methods/ Design In the prospective observational “Berlin Beat of Running” study experienced endurance athletes underwent clinical examination (CE, 3 Tesla brain magnetic resonance imaging (MRI, carotid ultrasound imaging (CUI and serial blood sampling (BS within 2-3 days prior (CE, MRI, CUI, BS, directly after (CE, BS and within 2 days after (CE, MRI, BS the 38th BMW BERLIN-MARATHON 2011. All participants wore a portable electrocardiogram (ECG-recorder throughout the 4 to 5 days baseline study period. Participants with pathological MRI findings after the marathon, troponin elevations or detected cardiac arrhythmias will be asked to undergo cardiac MRI to rule out structural abnormalities. A follow-up is scheduled after one year. Results Here we report the baseline data of the enrolled 110 athletes aged 36-61 years. Their mean age was 48.8 ± 6.0 years, 24.5% were female, 8.2% had hypertension and 2.7% had hyperlipidaemia. Participants have attended a mean of 7.5 ± 6.6 marathon races within the last 5 years and a mean of 16 ± 36 marathon races in total. Their weekly running distance prior to the 38th BMW BERLIN-MARATHON was 65 ± 17 km. Finally, 108 (98.2% Berlin Beat-Study participants successfully completed the 38th BMW BERLIN-MARATHON 2011. Discussion Findings from the “Berlin Beats of Running” study will help to balance the benefits and risks of extensive endurance sport. ECG-recording during the marathon might contribute to identify athletes at risk for cardiovascular events. MRI results will give new insights into the link

  16. Smokers' attitudes and behaviors related to consumer demand for cessation counseling in the medical care setting.

    Science.gov (United States)

    Weber, Deanne; Wolff, Lisa S; Orleans, Tracy; Mockenhaupt, Robin E; Massett, Holly A; Vose, Kathryn Kahler

    2007-05-01

    This study describes a new segmentation strategy exploring smokers' interest levels in counseling in the medical care setting in order to understand how public health communications can be designed to increase consumer demand for cessation services within this population. A subsample of 431 smokers from a large, nationally representative mail survey was analyzed and categorized into three cessation-demand groups: Low demand (LD), medium demand (MD), and high demand (HD). HD smokers were most likely to be heavy smokers, to make quitting a high priority, and to have self-efficacy in quitting. MD and LD smokers were less likely than HD smokers to have been told to quit smoking by a health care provider in the past or to believe that counseling is effective. The first step in the regression analysis revealed that age, cigarettes smoked per month, whether smokers were currently trying to quit, and whether they were ever told to quit smoking by their health care provider accounted for 21% of the variance in smokers' interest in smoking cessation counseling, F(4, 234) = 16.49, pconsumer demand for cessation counseling.

  17. Smoking cessation counselling for pregnant and postpartum women among midwives, gynaecologists and paediatricians in Germany.

    Science.gov (United States)

    Röske, Kathrin; Hannöver, Wolfgang; Thyrian, Jochen René; John, Ulrich; Hannich, Hans-Joachim

    2009-01-01

    The incorporation of guidelines for the treatment of tobacco smoking into routine care requires positive attitudes, counselling skills and knowledge about additional help available for smokers. The study assesses performance of smoking cessation intervention, attitudes, training status and knowledge about additional help for smokers in the care for pregnant and parenting women by midwives, gynaecologists and paediatricians. A survey of all midwives, gynaecologists and paediatricians registered for primary medical care in the federal state Saarland, Germany, was conducted. Participation in the postal questionnaires was 85 %. Depending on profession, 90 % to 100 % see smoking cessation counselling as their assignment, 17 % to 80 % screen for, 48 % to 90 % document smoking status, and 55 % to 76 % offer brief or extensive counselling. 61 % to 87 % consider training to enhance their knowledge and/or counselling skills necessary. The compliance of providers with the necessity to give support in smoking cessation is very high. However, the current status of cessation counselling does not sufficiently correspond to the evidence based requirements. Reports in medical press and advanced training courses should support health care providers and establish smoking as an inherent topic of the anamnesis and treatment of current and former pregnant or parenting smokers.

  18. Smoking Cessation Counselling for Pregnant and Postpartum Women among Midwives, Gynaecologists and Paediatricians in Germany

    Directory of Open Access Journals (Sweden)

    Wolfgang Hannöver

    2009-01-01

    Full Text Available The incorporation of guidelines for the treatment of tobacco smoking into routine care requires positive attitudes, counselling skills and knowledge about additional help available for smokers.The study assesses performance of smoking cessation intervention, attitudes, training status and knowledge about additional help for smokers in the care for pregnant and parenting women by midwives, gynaecologists and paediatricians. A survey of all midwives, gynaecologists and paediatricians registered for primary medical care in the federal state Saarland, Germany, was conducted. Participation in the postal questionnaires was 85 %. Depending on profession, 90 % to 100 % see smoking cessation counselling as their assignment, 17 % to 80 % screen for, 48 % to 90 % document smoking status, and 55 % to 76 % offer brief or extensive counselling. 61 % to 87 % consider training to enhance their knowledge and/or counselling skills necessary. The compliance of providers with the necessity to give support in smoking cessation is very high. However, the current status of cessation counselling does not sufficiently correspond to the evidence based requirements. Reports in medical press and advanced training courses should support health care providers and establish smoking as an inherent topic of the anamnesis and treatment of current and former pregnant or parenting smokers.

  19. Predicting self-initiated marijuana use cessation among youth at continuation high schools

    Directory of Open Access Journals (Sweden)

    Melissa A. Little

    2013-07-01

    Full Text Available The current article reports a large scale study of the prediction of marijuana use cessation among individuals attending alternative high schools who were regular users at baseline. Based on the Triadic Influence Theory, predictors of marijuana use cessation at one-year follow-up were organized by type of influence (e.g., interpersonal, cultural and attitudinal, and intrapersonal and level of influence (e.g., distal and ultimate. Among the 522 students who were past 30-day marijuana users at baseline, quitting was defined as having not used marijuana in the last 30 days at one-year follow-up (43% of baseline users. To account for the level of influence we employed a theory-based analytic strategy, hierarchical regression. In the final multivariate model, lower level of baseline marijuana use and less of a likelihood to endorse pro-drug-use myths remained predictors of marijuana use cessation one year later. Implications of these findings include the need to develop cessation programs that reduce psychological dependence on marijuana use, and correct cognitive misperceptions about drug use in order to help adolescents make decisions that lead to health-promoting behaviors.

  20. A qualitative analysis of messages to promote smoking cessation among pregnant women

    Science.gov (United States)

    Hoek, Janet; Gifford, Heather; Maubach, Ninya; Newcombe, Rhiannon

    2014-01-01

    Objectives Although aware that smoking while pregnant presents serious risks to their unborn children, some women continue to smoke and rationalise their dissonance rather than quit. We explored metaphors women used to frame smoking and quitting, then developed cessation messages that drew on these metaphors and examined the perceived effectiveness of these. Participants We used a two-phase qualitative study. Phase one involved 13 in-depth interviews with women who were smoking (or who had smoked) while pregnant. Phase two comprised 22 in-depth interviews with a new sample drawn from the same population. Analyses Data were analysed using thematic analysis, which promoted theme identification independently of the research protocol. Results Participants often described smoking as a choice, a frame that explicitly asserted control over their behaviour. This stance allowed them to counter-argue messages to quit, and distanced them from the risks they created and faced. Messages tested in phase 2 used strong affective appeals as well as themes that stimulated cognitive reflection. Without exception, the messages depicting unwell or distressed children elicited strong emotional responses, were more powerful cessation stimuli, and elicited fewer counter-arguments. Conclusions Cessation messages that evoke strong affective responses capitalise on the dissonance many women feel when smoking while pregnant and stimulate stronger consideration of quitting. Given the importance of promoting cessation among pregnant women, future campaigns could make greater use of emotional appeals and place less emphasis on informational approaches, which often prompt vigorous counter-arguments. PMID:25431224

  1. Do studies on cortical plasticity provide a rationale for using non-invasive brain stimulation as a treatment for Parkinson's disease patients?

    Science.gov (United States)

    Koch, Giacomo

    2013-11-06

    Animal models of Parkinson's disease (PD) have shown that key mechanisms of cortical plasticity such as long-term potentiation (LTP) and long-term depression (LTD) can be impaired by the PD pathology. In humans protocols of non-invasive brain stimulation, such as paired associative stimulation (PAS) and theta-burst stimulation (TBS), can be used to investigate cortical plasticity of the primary motor cortex. Through the amplitude of the motor evoked potential these transcranial magnetic stimulation methods allow to measure both LTP-like and LTD-like mechanisms of cortical plasticity. So far these protocols have reported some controversial findings when tested in PD patients. While various studies described evidence for reduced LTP- and LTD-like plasticity, others showed different results, demonstrating increased LTP-like and normal LTD-like plasticity. Recent evidence provided support to the hypothesis that these different patterns of cortical plasticity likely depend on the stage of the disease and on the concomitant administration of l-DOPA. However, it is still unclear how and if these altered mechanisms of cortical plasticity can be taken as a reliable model to build appropriate protocols aimed at treating PD symptoms by applying repetitive sessions of repetitive TMS (rTMS) or transcranial direct current stimulation (tDCS). The current article will provide an up-to-date overview of these issues together with some reflections on future studies in the field.

  2. Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of Heart Failure With Preserved Ejection Fraction: Rationale and Study Design of a Prospective Randomized Controlled Trial.

    Science.gov (United States)

    Palau, Patricia; Domínguez, Eloy; López, Laura; Heredia, Raquel; González, Jessika; Ramón, Jose María; Serra, Pilar; Santas, Enrique; Bodi, Vicente; Sanchis, Juan; Chorro, Francisco J; Núñez, Julio

    2016-08-01

    Heart failure with preserved ejection fraction (HFpEF) has become the most prevalent form of heart failure in developed countries. Regrettably, there is no evidence-based effective therapy for HFpEF. We seek to evaluate whether inspiratory muscle training, functional electrical stimulation, or a combination of both can improve exercise capacity as well as left ventricular diastolic function, biomarker profile, quality of life (QoL), and prognosis in patients with HFpEF. A total of 60 stable symptomatic patients with HFpEF (New York Heart Association class II-III/IV) will be randomized (1:1:1:1) to receive a 12-week program of inspiratory muscle training, functional electrical stimulation, a combination of both, or standard care alone. The primary endpoint of the study is change in peak exercise oxygen uptake; secondary endpoints are changes in QoL, echocardiogram parameters, and prognostic biomarkers. As of March 21, 2016, thirty patients have been enrolled. Searching for novel therapies that improve QoL and autonomy in the elderly with HFpEF has become a health care priority. We believe that this study will add important knowledge about the potential utility of 2 simple and feasible physical interventions for the treatment of advanced HFpEF.

  3. Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective ventilation during general anesthesia for open abdominal surgery

    Directory of Open Access Journals (Sweden)

    Hedenstierna Göran

    2011-05-01

    Full Text Available Abstract Background Post-operative pulmonary complications add to the morbidity and mortality of surgical patients, in particular after general anesthesia >2 hours for abdominal surgery. Whether a protective mechanical ventilation strategy with higher levels of positive end-expiratory pressure (PEEP and repeated recruitment maneuvers; the "open lung strategy", protects against post-operative pulmonary complications is uncertain. The present study aims at comparing a protective mechanical ventilation strategy with a conventional mechanical ventilation strategy during general anesthesia for abdominal non-laparoscopic surgery. Methods The PROtective Ventilation using HIgh versus LOw positive end-expiratory pressure ("PROVHILO" trial is a worldwide investigator-initiated multicenter randomized controlled two-arm study. Nine hundred patients scheduled for non-laparoscopic abdominal surgery at high or intermediate risk for post-operative pulmonary complications are randomized to mechanical ventilation with the level of PEEP at 12 cmH2O with recruitment maneuvers (the lung-protective strategy or mechanical ventilation with the level of PEEP at maximum 2 cmH2O without recruitment maneuvers (the conventional strategy. The primary endpoint is any post-operative pulmonary complication. Discussion The PROVHILO trial is the first randomized controlled trial powered to investigate whether an open lung mechanical ventilation strategy in short-term mechanical ventilation prevents against postoperative pulmonary complications. Trial registration ISRCTN: ISRCTN70332574

  4. Rationale, design and methodology of a double-blind, randomized, placebo-controlled study of escitalopram in prevention of Depression in Acute Coronary Syndrome (DECARD

    Directory of Open Access Journals (Sweden)

    Hansen Jørgen

    2009-04-01

    Full Text Available Abstract Background The prevalence of depression in patients with acute coronary syndrome, i.e. myocardial infarction and unstable angina, is higher than in the general population. The prevalence of anxiety is higher as well. Both depression and anxiety are associated with poor cardiac outcomes and higher mortality. Comorbid depression in patients with acute coronary syndrome often goes undiagnosed, and it is therefore a challenging task to prevent this risk factor. The study of DEpression in Coronary ARtery Disease (DECARD is designed to examine if it is possible to prevent depression in patients with acute coronary syndrome. Methods Two hundred forty non-depressed patients with acute coronary syndrome are randomized to treatment with either escitalopram or placebo for 1 year. Psychiatric and cardiac assessment of patients is performed to evaluate the possibility of preventing depression. Diagnosis of depression and Hamilton Depression Scale are the primary outcome measures. Discussion This is the first study of prevention of depression in patients after acute coronary syndrome with a selective serotonin reuptake inhibitor. Trial Registration http://www.ClinicalTrials.gov. Identifier: NCT00140257

  5. Establishing a model workplace tobacco cessation program in India

    Directory of Open Access Journals (Sweden)

    Mishra Gauravi

    2009-01-01

    Full Text Available Background: Tobacco use is highly prevalent and culturally accepted in rural Maharashtra, India. Aims: To study the knowledge, attitude, and practices (KAP regarding tobacco consumption, identify reasons for initiation and continuation of tobacco use, identify prevalence of tobacco consumption and its relation with different precancerous lesions, provide professional help for quitting tobacco, and develop local manpower for tobacco cessation activities. Settings, Design, Methods and Material: The present study was conducted for one year in a chemical industrial unit in Ratnagiri district. All employees (104 were interviewed and screened for oral neoplasia. Their socio-demographic features, habits, awareness levels etc. were recorded. Active intervention in the form of awareness lectures, focus group discussions, one-to-one counseling and, if needed, pharmacotherapy was offered to the tobacco users. Results: All employees actively participated in the program. Overall, 48.08% of the employees were found to use tobacco, among which the smokeless forms were predominant. Peer pressure and pleasure were the main reasons for initiation of tobacco consumption, and the belief that, though injurious, it would not harm them, avoiding physical discomfort on quitting and relieving stress were important factors for continuation of the habit. Employees had poor knowledge regarding the ill-effects of tobacco. 40% of tobacco users had oral precancerous lesions, which were predominant in employees consuming smokeless forms of tobacco. Conclusions: Identifying reasons for initiation and continuation of tobacco consumption along with baseline assessment of knowledge, attitudes, and practices regarding tobacco use, are important in formulating strategies for a comprehensive workplace tobacco cessation program.

  6. Can initial perceptions about quitting predict smoking cessation among Malaysian smokers?

    Science.gov (United States)

    Yasin, Siti Munira; Masilamani, Retneswari; Ming, Moy Foong; Koh, David; Zaki, Rafdzah Ahmad

    2012-03-01

    Perceived risks and benefits of quitting smoking may be important factors in successful treatment. This study examined the association between initial perceived risks and benefits of quitting smoking and outcomes during a two month smoking cessation attempt. Participants (n = 185) were treatment-seeking smokers attending two smoking cessation clinics in Klang Valley, Malaysia. They received structured behavioral therapy and free Nicotine Replacement Therapy (NRT). Prior to treatment, a 12 item Perceived Risks and Benefits Questionnaire (PRBQ) was administered. This was used to assess the smoker's initial perceptions during their quit attempt. Participants were re-contacted at the end of two months to determine their smoking status. The results show participants intending to quit demonstrated a greater understanding of the benefits of quitting smoking than the risks of quitting. Those with a higher education level had a greater understanding of the benefits of quitting (p = 0.02). PRBQ items, such as perceived risks of quitting (ie weight gain, negative affect, social ostracism, loss of enjoyment and craving) were not associated with abstinence at two months. However, those who perceived a benefit of higher physical attraction post-cessation were less likely to have stopped smoking at two months (OR 0.18; 95% CI 0.08-0.45). Other perceived benefits at baseline, such as health, general well-being, self-esteem, finances and social approval, were not associated with smoking cessation at two months. The results suggest that in our study population, smokers' baseline perceptions of the benefits of cessation of smoking prior to therapy are not associated with quit results at two months. Counseling patients regarding the advantages and disadvantages of quitting may have changed their perceptions during quitting process and should be further explored in future studies.

  7. A randomized controlled trial of tai chi for long-term low back pain (TAI CHI: Study rationale, design, and methods

    Directory of Open Access Journals (Sweden)

    Hall Amanda M

    2009-05-01

    Full Text Available Abstract Background Low back pain persisting for longer than 3 months is a common and costly condition for which many current treatments have low-moderate success rates at best. Exercise is among the more successful treatments for this condition, however, the type and dosage of exercise that elicits the best results is not clearly defined. Tai chi is a gentle form of low intensity exercise that uses controlled movements in combination with relaxation techniques and is currently used as a safe form of exercise for people suffering from other chronic pain conditions such as arthritis. To date, there has been no scientific evaluation of tai chi as an intervention for people with back pain. Thus the aim of this study will be to examine the effects of a tai chi exercise program on pain and disability in people with long-term low back pain. Methods and design The study will recruit 160 healthy individuals from the community setting to be randomised to either a tai chi intervention group or a wait-list control group. Individuals in the tai chi group will attend 2 tai chi sessions (40 minutes/week for 8 weeks followed by 1 tai chi session/week for 2 weeks. The wait-list control will continue their usual health care practices and have the opportunity to participate in the tai chi program once they have completed the follow-up assessments. The primary outcome will be bothersomeness of back symptoms measured with a 0–10 numerical rating scale. Secondary outcomes include, self-reports of pain-related disability, health-related quality of life and global perceived effect of treatment. Statistical analysis of primary and secondary outcomes will be based on the intention to treat principle. Linear mixed models will be used to test for the effect of treatment on outcome at 10 weeks follow up. This trial has received ethics approval from The University of Sydney Human Research Ethics Committee. HREC Approval No.10452 Discussion This study will be the first

  8. Effects of roflumilast in COPD patients receiving inhaled corticosteroid/long-acting β2-agonist fixed-dose combination: RE2SPOND rationale and study design

    Directory of Open Access Journals (Sweden)

    Rennard SI

    2016-08-01

    Full Text Available Stephen I Rennard,1,2 Fernando J Martinez,3,4 Klaus F Rabe,5–7 Sanjay Sethi,8 Emilio Pizzichini,9 Andrew McIvor,10 Shahid Siddiqui,11 Antonio Anzueto,12 Haiyuan Zhu13 1Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, USA; 2AstraZeneca, Cambridge, UK; 3Joan and Sanford I Weill Department of Medicine, Weill Cornell University, New York, NY, 4Department of Internal Medicine, Michigan Health System, Ann Arbor, MI, USA; 5LungenClinic Grosshansdorf, Großhansdorf, 6Department of Medicine, University Kiel, Kiel, 7Airway Research Center North, German Center for Lung Research, Großhansdorf, Germany; 8Department of Medicine, University at Buffalo, State University of New York, Buffalo, NY, USA; 9Department of Medicine, Universidade Federal de Santa Catarina, Santa Catarina, Brazil; 10Firestone Institute of Respiratory Health, St Joseph’s Healthcare, McMaster University, Hamilton, ON, Canada; 11AstraZeneca, Gaithersburg, MD, 12South Texas Veterans Health Care System at San Antonio, University of Texas Health Science Center, San Antonio, TX, 13Allergan plc, Jersey City, NJ, USA Background: Roflumilast, a once-daily, selective phosphodiesterase-4 inhibitor, reduces the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. The RE2SPOND study is examining whether roflumilast, when added to an inhaled corticosteroid/long-acting β2-agonist (ICS/LABA fixed-dose combination (FDC, further reduces exacerbations. The methodology is described herein. Methods: In this Phase IV, multicenter, double-blind, placebo-controlled, parallel-group trial, participants were randomized 1:1 (stratified by long-acting muscarinic antagonist use to receive roflumilast or placebo, plus ICS/LABA FDC, for 52 weeks. Eligible participants had severe COPD associated with chronic bronchitis, had two or more moderate–severe exacerbations within 12 months, and were receiving ICS

  9. Bridging the gap in heart failure prevention: rationale and design of the Nurse-led Intervention for Less Chronic Heart Failure (NIL-CHF) Study

    DEFF Research Database (Denmark)

    Carrington, Melinda J; Stewart, Simon; de Courten, Barbora

    2010-01-01

    AIMS: The primary objective of the Nurse-led Intervention for Less Chronic Heart Failure (NIL-CHF) Study is to develop a programme of care that cost-effectively prevents the development of chronic heart failure (CHF). Methods NIL-CHF is a randomized controlled trial of a hybrid, home- and clinic......-based, nurse-led multidisciplinary intervention targeting hospitalized patients at risk of developing CHF. A target of 750 patients aged >/=45 years will be exposed to usual post-discharge care or the NIL-CHF intervention. The composite primary endpoint is all-cause mortality or CHF-related admission during 3......-5 years of follow-up. After 12 months recruitment, approximately 300 eligible patients (40% of target) have been randomized. Overall, 73% are male and the mean age is 65 +/- 10 years. The most common antecedents for CHF thus far are hypertension (70%, 95% CI, 64-75%), coronary artery disease (51%, 95% CI...

  10. Assessing the effect of Measurement-Based Care depression treatment on HIV medication adherence and health outcomes: rationale and design of the SLAM DUNC Study.

    Science.gov (United States)

    Pence, Brian W; Gaynes, Bradley N; Williams, Quinn; Modi, Riddhi; Adams, Julie; Quinlivan, E Byrd; Heine, Amy; Thielman, Nathan; Mugavero, Michael J

    2012-07-01

    Depression affects 20-30% of people living with HIV/AIDS (PLWHA) in the U.S. and predicts greater sexual risk behaviors, lower antiretroviral (ARV) medication adherence, and worse clinical outcomes. Yet little experimental evidence addresses the critical clinical question of whether depression treatment improves ARV adherence and clinical outcomes in PLWHA with depression. The Strategies to Link Antidepressant and Antiretroviral Management at Duke, UAB, and UNC (SLAM DUNC) Study is a randomized clinical effectiveness trial funded by the National Institute for Mental Health. The objective of SLAM DUNC is to test whether a depression treatment program integrated into routine HIV clinical care affects ARV adherence. PLWHA with depression (n=390) are randomized to enhanced usual care or a depression treatment model called Measurement-Based Care (MBC). MBC deploys a clinically supervised Depression Care Manager (DCM) to provide evidence-based antidepressant treatment recommendations to a non-psychiatric prescribing provider, guided by systematic and ongoing measures of depressive symptoms and side effects. MBC has limited time requirements and the DCM role can be effectively filled by a range of personnel given appropriate training and supervision, enhancing replicability. In SLAM DUNC, MBC is integrated into HIV care to support HIV providers in antidepressant prescription and management. The primary endpoint is ARV adherence measured by unannounced telephone-based pill counts at 6 months with follow-up to 12 months and secondary endpoints including viral load, health care utilization, and depressive severity. Important outcomes of this study will be evidence of the effectiveness of MBC in treating depression in PLWHA and improving HIV-related outcomes.

  11. Rationale and design of three observational, prospective cohort studies including biobanking to evaluate and improve diagnostics, management strategies and risk stratification in venous thromboembolism: the VTEval Project

    Science.gov (United States)

    Frank, Bernd; Ariza, Liana; Lamparter, Heidrun; Grossmann, Vera; Prochaska, Jürgen H; Ullmann, Alexander; Kindler, Florentina; Weisser, Gerhard; Walter, Ulrich; Lackner, Karl J; Espinola-Klein, Christine; Münzel, Thomas; Konstantinides, Stavros V; Wild, Philipp S

    2015-01-01

    Introduction Venous thromboembolism (VTE) with its two manifestations deep vein thrombosis (DVT) and pulmonary embolism (PE) is a major public health problem. The VTEval Project aims to investigate numerous research questions on diagnosis, clinical management, treatment and prognosis of VTE, which have remained uncertain to date. Methods and analysis The VTEval Project consists of three observational, prospective cohort studies on VTE comprising cohorts of individuals with a clinical suspicion of acute PE (with or without DVT), with a clinical suspicion of acute DVT (without symptomatic PE) and with an incidental diagnosis of VTE (PE or DVT). The VTEval Project expects to enrol a total of approximately 2000 individuals with subsequent active and passive follow-up investigations over a time period of 5 years per participant. Time points for active follow-up investigations are at months 3, 6, 12, 24 and 36 after diagnosis (depending on the disease cohort); passive follow-up investigations via registry offices and the cancer registry are performed 48 and 60 months after diagnosis for all participants. Primary short-term outcome is defined by overall mortality (PE-related death and all other causes of death), primary long-term outcome by symptomatic VTE (PE-related death, recurrence of non-fatal PE or DVT). The VTEval Project includes three ‘all-comer’ studies and involves the standardised acquisition of high-quality data, covering the systematic assessment of VTE including symptoms, risk profile, psychosocial, environmental and lifestyle factors as well as clinical and subclinical disease, and it builds up a large state-of-the-art biorepository containing various materials from serial blood samplings. Ethics and dissemination The VTEval Project has been approved by the local data safety commissioner and the responsible ethics committee (reference no. 837.320.12 (8421-F)). Trial results will be published in peer-reviewed journals and presented at national and

  12. Rationale and design of the Miami Healthy Heart Initiative: a randomized controlled study of a community health worker intervention among Latino patients with poorly controlled diabetes

    Directory of Open Access Journals (Sweden)

    Carrasquillo O

    2014-02-01

    Full Text Available Olveen Carrasquillo,1,2 Elizabeth Patberg,1 Yisel Alonzo,1 Hua Li,2 Sonjia Kenya1 1Department of Medicine, 2Public Health Sciences, University of Miami, Miller School of Medicine, Miami, FL, USA Background: Type 2 diabetes mellitus disproportionately affects the Latino community. Latinos with diabetes are also less likely to have adequate control of cardiovascular risk factors such as cholesterol and blood pressure. Community health workers (CHWs are increasingly being used to address various health disparity conditions, including diabetes. However, evidence of their effectiveness from randomized controlled trials is limited. Methods: The Miami Health Heart Initiative is a randomized controlled trial of 300 Latino patients with diabetes. Patients with hemoglobin A1c (HbA1c ≥8.0% were recruited from Miami-Dade's public hospital system. At baseline, all patients underwent phlebotomy, physical examination, and a structured 90-minute research interview. They were then randomized to either usual care or a CHW intervention called Cariño. For participants in the Cariño arm of the study, CHW services included assistance with nonmedical social services, health education, and patient navigation in which the CHWs serve as a bridge between patients and the health care system. These services were delivered through home visits, phone calls, and group visits. At 12 months, all subjects had a follow-up examination. The primary outcomes at 1 year are changes in systolic blood pressure, low-density lipoprotein, and HbA1c. Secondary outcomes include medication adherence, medication intensification, diabetes self-efficacy, physical activity, and self-reported fruit and vegetable intake. Discussion: The Miami Healthy Heart Initiative is one of the first rigorously conducted randomized controlled trials to provide evidence on the impact of CHWs on diabetes intermediate outcomes among Latinos. If the data support our primary hypotheses, the study would lend added

  13. The Alberta population-based prospective evaluation of the quality of life outcomes and economic impact of bariatric surgery (APPLES study: background, design and rationale

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    McCargar Linda

    2010-10-01

    Full Text Available Abstract Background Extreme obesity affects nearly 8% of Canadians, and is debilitating, costly and ultimately lethal. Bariatric surgery is currently the most effective treatment available; is associated with reductions in morbidity/mortality, improvements in quality of life; and appears cost-effective. However, current demand for surgery in Canada outstrips capacity by at least 1000-fold, causing exponential increases in already protracted, multi-year wait-times. The objectives and hypotheses of this study were as follows: 1. To serially assess the clinical, economic and humanistic outcomes in patients wait-listed for bariatric care over a 2-year period. We hypothesize deterioration in these outcomes over time; 2. To determine the clinical effectiveness and changes in quality of life associated with modern bariatric procedures compared with medically treated and wait-listed controls over 2 years. We hypothesize that surgery will markedly reduce weight, decrease the need for unplanned medical care, and increase quality of life; 3. To conduct a 3-year (1 year retrospective and 2 year prospective economic assessment of bariatric surgery compared to medical and wait-listed controls from the societal, public payor, and health-care payor perspectives. We hypothesize that lower indirect, out of pocket and productivity costs will offset increased direct health-care costs resulting in lower total costs for bariatric surgery. Methods/design Population-based prospective cohort study of 500 consecutive, consenting adults, including 150 surgically treated patients, 200 medically treated patients and 150 wait-listed patients. Subjects will be enrolled from the Edmonton Weight Wise Regional Obesity Program (Edmonton, Alberta, Canada, with prospective bi-annual follow-up for 2 years. Mixed methods data collection, linking primary data to provincial administrative databases will be employed. Major outcomes include generic, obesity-specific and preference

  14. Distance learning strategies for weight management utilizing social media: A comparison of phone conference call versus social media platform. Rationale and design for a randomized study.

    Science.gov (United States)

    Willis, Erik A; Szabo-Reed, Amanda N; Ptomey, Lauren T; Steger, Felicia L; Honas, Jeffery J; Al-Hihi, Eyad M; Lee, Robert; Vansaghi, Lisa; Washburn, Richard A; Donnelly, Joseph E

    2016-03-01

    Management of obesity in the context of the primary care physician visit is of limited efficacy in part because of limited ability to engage participants in sustained behavior change between physician visits. Therefore, healthcare systems must find methods to address obesity that reach beyond the walls of clinics and hospitals and address the issues of lifestyle modification in a cost-conscious way. The dramatic increase in technology and online social networks may present healthcare providers with innovative ways to deliver weight management programs that could have an impact on health care at the population level. A randomized study will be conducted on 70 obese adults (BMI 30.0-45.0 kg/m(2)) to determine if weight loss (6 months) is equivalent between weight management interventions utilizing behavioral strategies by either a conference call or social media approach. The primary outcome, body weight, will be assessed at baseline and 6 months. Secondary outcomes including waist circumference, energy and macronutrient intake, and physical activity will be assessed on the same schedule. In addition, a cost analysis and process evaluation will be completed.

  15. Do studies on cortical plasticity provide a rationale for using non invasive brain stimulation as a treatment for Parkinson’s disease patients?

    Directory of Open Access Journals (Sweden)

    Giacomo eKoch

    2013-11-01

    Full Text Available Animal models of Parkinson’s disease (PD have shown that key mechanisms of cortical plasticity such as long-term potentiation (LTP and long-term depression (LTD can be impaired by the PD pathology. In humans protocols of non-invasive brain stimulation, such as paired associative stimulation (PAS and theta burst stimulation (TBS, can be used to investigate cortical plasticity of the primary motor cortex. Through the amplitude of the motor evoked potential (MEP these transcranial magnetic stimulation methods allow to measure both LTP-like and LTD-like mechanisms of cortical plasticity. So far these protocols have reported some controversial findings when tested in PD patients. While various studies described evidence for reduced LTP- and LTD-like plasticity, others showed different results, demonstrating increased LTP-like and normal LTD-like plasticity. Recent evidence provided support to the hypothesis that these different patterns of cortical plasticity likely depend on the stage of the disease and on the concomitant administration of levo-dopa. However, it still unclear how and if these altered mechanisms of cortical plasticity can be taken as a reliable model to build appropriate protocols aimed at treating PD symptoms b

  16. Effect of serial infusions of reconstituted high-density lipoprotein (CER-001) on coronary atherosclerosis: rationale and design of the CARAT study

    Science.gov (United States)

    Andrews, Jordan; Janssan, Alex; Nguyen, Tracy; Pisaniello, Anthony D.; Scherer, Daniel J.; Kastelein, John J. P.; Merkely, Bela; Nissen, Steven E.; Ray, Kausik; Schwartz, Gregory G.; Worthley, Stephen G.; Keyserling, Connie; Dasseux, Jean-Louis; Butters, Julie; Girardi, Jacinta; Miller, Rosemary

    2017-01-01

    Background High-density lipoprotein (HDL) is believed to have atheroprotective properties, but an effective HDL-based therapy remains elusive. Early studies have suggested that infusion of reconstituted HDL promotes reverse cholesterol transport and vascular reactivity. The CER-001 Atherosclerosis Regression Acute Coronary Syndrome Trial (CARAT) is investigating the impact of infusing an engineered pre-beta HDL mimetic containing sphingomyelin (SM) and dipalmitoyl phosphatidlyglycerol (CER-001) on coronary atheroma volume in patients with a recent acute coronary syndrome (ACS). Methods The CARAT is a phase 2, multicenter trial in which 292 patients with an ACS undergoing intracoronary ultrasonography and showing percent atheroma volume (PAV) greater than 30% are randomly assigned to treatment with ten infusions of CER-001 3 mg/kg or matching placebo, administered at weekly intervals. Intracoronary ultrasonography is repeated at the end of the treatment period. Results The primary endpoint is the nominal change in PAV. Safety and tolerability will also be evaluated. Conclusions CARAT will establish whether serial 3 mg/kg infusions of an engineered pre-beta HDL mimetic containing SM and dipalmitoyl phosphatidlyglycerol (CER-001) will regress atherosclerotic plaque in patients with a recent ACS. PMID:28164012

  17. The Effect of Remote Ischemic Conditioning and Glyceryl Trinitrate on Perioperative Myocardial Injury in Cardiac Bypass Surgery Patients: Rationale and Design of the ERIC-GTN Study.

    Science.gov (United States)

    Hamarneh, Ashraf; Sivaraman, Vivek; Bulluck, Heerajnarain; Shanahan, Hilary; Kyle, Bonnie; Ramlall, Manish; Chung, Robin; Jarvis, Claire; Xenou, Maria; Ariti, Cono; Cordery, Roger; Yellon, Derek M; Hausenloy, Derek J

    2015-11-01

    Remote ischemic conditioning (RIC) using transient limb ischemia/reperfusion has been reported to reduce perioperative myocardial injury in patients undergoing coronary artery bypass grafting and/or valve surgery. The role of intravenous glyceryl trinitrate (GTN) therapy administered during cardiac surgery as a cardioprotective agent and whether it interferes with RIC cardioprotection is not clear and is investigated in the ERIC-GTN trial ( http://www.clinicaltrials.gov: NCT01864252). The ERIC-GTN trial is a single-site, double-blind, randomized, placebo-controlled study. Consenting adult patients (age > 18 years) undergoing elective coronary artery bypass grafting ± valve surgery with blood cardioplegia will be eligible for inclusion. Two hundred sixty patients will be randomized to 1 of 4 treatment groups following anesthetic induction: (1) RIC alone, a RIC protocol comprising three 5-minute cycles of simultaneous upper-arm and thigh cuff inflation/deflation followed by an intravenous (IV) placebo infusion; (2) GTN alone, a simulated sham RIC protocol followed by an IV GTN infusion; (3) RIC + GTN, a RIC protocol followed by an IV GTN infusion; and (4) neither RIC nor GTN, a sham RIC protocol followed by IV placebo infusion. The primary endpoint will be perioperative myocardial injury as quantified by the 72-hour area-under-the-curve serum high-sensitivity troponin T. The ERIC-GTN trial will determine whether intraoperative GTN therapy is cardioprotective during cardiac surgery and whether it affects RIC cardioprotection.

  18. Childhood obesity prevention in rural settings: background, rationale, and study design of ‘4-Health,’ a parent-only intervention

    Directory of Open Access Journals (Sweden)

    Lynch Wesley C

    2012-04-01

    Full Text Available Abstract Background Childhood obesity in rural communities is a serious but understudied problem. The current experiment aims to assess a wide range of obesity risk factors among rural youth and to offer an 8-month intervention program for parents to reduce obesity risk in their preteen child. Methods/Design A two-group, repeated measures design is used to assess the effectiveness of the 4-Health intervention program. Assessments include anthropometric measures, child self-evaluations, parent self-evaluations, and parent evaluations of child. County Extension agents from 21 rural Montana counties recruit approximately 150 parent–child dyads and counties are semi-randomly assigned to the active intervention group (4-Health Educational Program or a “best-practices” (Healthy Living Information control group. Discussion This study will shed light on the effectiveness of this parent-only intervention strategy in reducing obesity risk factors among rural preteens. The 4-Health program is designed to provide information and skills development for busy rural parents that will increase healthy lifestyles of their preteen children and improve the parents’ ability to intervene effectively in the lives of their families during this critical developmental period. Trial registration ClinicalTrials.gov ID: NCT01510587

  19. Menaquinone-7 Supplementation to Reduce Vascular Calcification in Patients with Coronary Artery Disease: Rationale and Study Protocol (VitaK-CAC Trial).

    Science.gov (United States)

    Vossen, Liv M; Schurgers, Leon J; van Varik, Bernard J; Kietselaer, Bas L J H; Vermeer, Cees; Meeder, Johannes G; Rahel, Braim M; van Cauteren, Yvonne J M; Hoffland, Ge A; Rennenberg, Roger J M W; Reesink, Koen D; de Leeuw, Peter W; Kroon, Abraham A

    2015-10-28

    Coronary artery calcification (CAC) develops early in the pathogenesis of atherosclerosis and is a strong and independent predictor of cardiovascular disease (CVD). Arterial calcification is caused by an imbalance in calcification regulatory mechanisms. An important inhibitor of calcification is vitamin K-dependent matrix Gla protein (MGP). Both preclinical and clinical studies have shown that inhibition of the vitamin K-cycle by vitamin K antagonists (VKA) results in elevated uncarboxylated MGP (ucMGP) and subsequently in extensive arterial calcification. This led us to hypothesize that vitamin K supplementation may slow down the progression of calcification. To test this, we designed the VitaK-CAC trial which analyses effects of menaquinone-7 (MK-7) supplementation on progression of CAC. The trial is a double-blind, randomized, placebo-controlled trial including patients with coronary artery disease (CAD). Patients with a baseline Agatston CAC-score between 50 and 400 will be randomized to an intervention-group (360 microgram MK-7) or a placebo group. Treatment duration will be 24 months. The primary endpoint is the difference in CAC-score progression between both groups. Secondary endpoints include changes in arterial structure and function, and associations with biomarkers. We hypothesize that treatment with MK-7 will slow down or arrest the progression of CAC and that this trial may lead to a treatment option for vascular calcification and subsequent CVD.

  20. Integrating a family-focused approach into child obesity prevention: Rationale and design for the My Parenting SOS study randomized control trial

    Directory of Open Access Journals (Sweden)

    Campbell Marci

    2011-06-01

    Full Text Available Abstract Background More than 20% of US children ages 2-5 yrs are classified as overweight or obese. Parents greatly influence the behaviors their children adopt, including those which impact weight (e.g., diet and physical activity. Unfortunately, parents often fail to recognize the risk for excess weight gain in young children, and may not be motivated to modify behavior. Research is needed to explore intervention strategies that engage families with young children and motivate parents to adopt behaviors that will foster healthy weight development. Methods This study tests the efficacy of the 35-week My Parenting SOS intervention. The intervention consists of 12 sessions: initial sessions focus on general parenting skills (stress management, effective parenting styles, child behavior management, coparenting, and time management and later sessions apply these skills to promote healthier eating and physical activity habits. The primary outcome is change in child percent body fat. Secondary measures assess parent and child dietary intake (three 24-hr recalls and physical activity (accelerometry, general parenting style and practices, nutrition- and activity-related parenting practices, and parent motivation to adopt healthier practices. Discussion Testing of these new approaches contributes to our understanding of how general and weight-specific parenting practices influence child weight, and whether or not they can be changed to promote healthy weight trajectories. Trial Registration ClinicalTrials.gov: NCT00998348

  1. Rationale and study design for a randomised controlled trial to reduce sedentary time in adults at risk of type 2 diabetes mellitus: project stand (Sedentary Time ANd diabetes

    Directory of Open Access Journals (Sweden)

    Wilmot Emma G

    2011-12-01

    Full Text Available Abstract Background The rising prevalence of Type 2 Diabetes Mellitus (T2DM is a major public health problem. There is an urgent need for effective lifestyle interventions to prevent the development of T2DM. Sedentary behaviour (sitting time has recently been identified as a risk factor for diabetes, often independent of the time spent in moderate-to-vigorous physical activity. Project STAND (Sedentary Time ANd Diabetes is a study which aims to reduce sedentary behaviour in younger adults at high risk of T2DM. Methods/Design A reduction in sedentary time is targeted using theory driven group structured education. The STAND programme is subject to piloting and process evaluation in line with the MRC framework for complex interventions. Participants are encouraged to self-monitor and self-regulate their behaviour. The intervention is being assessed in a randomised controlled trial with 12 month follow up. Inclusion criteria are a aged 18-40 years with a BMI in the obese range; b 18-40 years with a BMI in the overweight range plus an additional risk factor for T2DM. Participants are randomised to the intervention (n = 89 or control (n = 89 arm. The primary outcome is a reduction in sedentary behaviour at 12 months as measured by an accelerometer (count Conclusions This is the first UK trial to address sedentary behaviour change in a population of younger adults at risk of T2DM. The results will provide a platform for the development of a range of future multidisciplinary interventions in this rapidly expanding high-risk population. Trial registration Current controlled trials ISRCTN08434554, MRC project 91409.

  2. Study rationale and protocol: prospective randomized comparison of metal ion concentrations in the patient's plasma after implantation of coated and uncoated total knee prostheses

    Directory of Open Access Journals (Sweden)

    Günther Klaus-Peter

    2009-10-01

    Full Text Available Abstract Background Any metal placed in a biological environment undergoes corrosion. Thus, with their large metallic surfaces, TKA implants are particularly prone to corrosion with subsequent release of metal ions into the human body which may cause local and systemic toxic effects and hypersensitivity reactions, and increase cancer risk. To address this problem, a new 7-layer zirconium coating developed especially for cobalt-chrome orthopaedic implants was tested biomechanically and found to lower metal ion release. The purpose of the proposed clinical trial is to compare the metal ion concentration in patients' plasma before and after implantation of a coated or uncoated TKA implant. Methods/Design In this randomised controlled trial, 120 patients undergoing primary TKA will be recruited at the Department of Orthopaedic Surgery of the University Hospital in Dresden, Germany, and randomised to either the coated or uncoated prosthesis. Outcome assessments will be conducted preoperatively and at 3 months, 12 months and 5 years postoperatively. The primary clinical endpoint will be the chromium ion concentration in the patient's plasma after 1 and 5 years. Secondary outcomes include cobalt, molybdenum and nickel ion concentrations after 1 and 5 years, allergy testing for hypersensitivity against one of these metals, the Knee Society Score to assess clinical and physical function of the knee joint, the self-assessment Oxford Score and the Short Form 36 quality of live questionnaire. Discussion The metal ion concentration in the patient's plasma has been shown to increase after TKA, its eventual adverse effects being widely debated. In the light of this discussion, ways to reduce metal ion release from orthopaedic implants should be studied in detail. The results of this investigation may lead to a new method to achieve this goal. Trials register Clinicaltrials registry NCT00862511

  3. The effect of preoperative smoking cessation or preoperative pulmonary rehabilitation on outcomes after lung cancer surgery: a systematic review.

    Science.gov (United States)

    Schmidt-Hansen, Mia; Page, Richard; Hasler, Elise

    2013-03-01

    The preferred treatment for lung cancer is surgery if the disease is considered resectable and the patient is considered surgically fit. Preoperative smoking cessation and/or preoperative pulmonary rehabilitation might improve postoperative outcomes after lung cancer surgery. The objectives of this systematic review were to determine the effectiveness of (1) preoperative smoking cessation and (2) preoperative pulmonary rehabilitation on peri- and postoperative outcomes in patients who undergo resection for lung cancer. We searched MEDLINE, PreMedline, Embase, Cochrane Library, Cinahl, BNI, Psychinfo, Amed, Web of Science (SCI and SSCI), and Biomed Central. Original studies published in English investigating the effect of preoperative smoking cessation or preoperative pulmonary rehabilitation on operative and longer-term outcomes in ≥ 50 patients who received surgery with curative intent for lung cancer were included. Of the 7 included studies that examined the effect of preoperative smoking cessation (n = 6) and preoperative pulmonary rehabilitation (n = 1) on outcomes after lung cancer surgery, none were randomized controlled trials and only 1 was prospective. The studies used different smoking classifications, the baseline characteristics differed between the study groups in some of the studies, and most had small sample sizes. No formal data synthesis was therefore possible. The included studies were marked by methodological limitations. On the basis of the reported bodies of evidence, it is not possible to make any firm conclusions about the effect of preoperative smoking cessation or of preoperative pulmonary rehabilitation on operative outcomes in patients undergoing surgery for lung cancer.

  4. CYP2C19 genotype-guided antiplatelet therapy in ST-segment elevation myocardial infarction patients-Rationale and design of the Patient Outcome after primary PCI (POPular) Genetics study

    NARCIS (Netherlands)

    Bergmeijer, Thomas O.; Janssen, Paul W.A.; Schipper, Jurjan C.; Qaderdan, Khalid; Ishak, Maycel; Ruitenbeek, Rianne S.; Asselbergs, Folkert W.; van 't Hof, Arnoud W.J.; Dewilde, Willem J.M.; Spanó, Fabrizio; Herrman, Jean-Paul R.; Kelder, Johannes C.; Postma, Maarten J.; de Boer, Anthonius; Deneer, Vera H.M.; ten Berg, Jurriën M.

    2014-01-01

    RATIONALE: In patients with ST-segment elevation myocardial infarction (STEMI) who undergo primary percutaneous coronary intervention (pPCI), the use of dual antiplatelet therapy is essential to prevent atherothrombotic complications. Therefore, patients are treated with acetylsalicylic acid and clo

  5. Smoking cessation through a novel behavior modification technique.

    Science.gov (United States)

    May, Robin; Tofler, Geoffrey H; Bartrop, Roger; Heinrich, Paul; Baird, John; Jozefiak, Edward; de Burgh, Simon

    2010-07-01

    Smoking remains a major public health problem. Experiencing a myocardial infarction (MI) can be a teachable moment that results in smoking cessation when previous efforts have failed. We tested the feasibility of providing a simulated and personalized experience of an MI to facilitate quitting smoking. Smokers, who were recruited from the community, had photographs taken of themselves, their partner, and family. These photographs were inserted into a video depicting the subject as a smoker experiencing an MI with potential consequences to themselves (death or disability) and their family. The subject watched the video and a psychologist used motivational interviewing to reinforce quitting efficacy. Thirteen subjects (11 men, 2 women) 45 +/- 12 years of age with no smoking-related illness and a nonsmoking partner were studied. At week 1, 7 of 13 subjects (54%) reported stopping smoking, and the other 6 had decreased consumption. Daily cigarette consumption at week 1 decreased from 17.3 +/- 9.3 at baseline to 2.7 +/- 4.9 (p <0.005) and expired carbon monoxide levels from 15.7 +/- 9 to 3.1 +/- 3.2 parts per million (p <0.005). Seven subjects had observable responses to the video including "looking uncomfortable" and "red eyes, difficulty speaking." Self-reports included "made me aware of the important things" and "it felt very real." At 6 months, 7 of 13 subjects (54%) were still abstinent. Five of the 7 nonsmoking subjects used an additional antismoking aid. In conclusion, it is feasible to create a simulated and personalized teachable moment and these findings provide encouragement for evaluating this novel method for smoking cessation and other behavior modifications.

  6. Factors associated with cessation of sunbed use among Danish women

    DEFF Research Database (Denmark)

    Wøhlk, Ida Marie Rye; Philipsen, Peter Alshede; Wulf, Hans Christian

    2016-01-01

    with cessation were: age above 24, medium to high level of education, non-smoking, not being bothered by appearing white on the beach, and being unconcerned about friends' sunbed use. Binary logistic regression further showed a significant association between cessation and low income, after adjusting for age....... The most indicated reason for cessation was fear of skin cancer. CONCLUSION: Sunbed use could possibly be reduced by introducing a lower age limit of 18 and demanding staffed tanning salons. The age limit would allow young people to become more mature and self-confident before deciding on using a sunbed...

  7. AB007. The effect of auricular acupuncture and acupressure in smoking cessation

    Science.gov (United States)

    Ioannis, Stathourakis

    2016-01-01

    Background Smoking is often associated with many types of cancer, increased cardiovascular and pulmonary morbidity. In 2006, it has been estimated that the annual number of deaths due to smoking approached 5,000,000, and is expected to double by 2030. The practice of auricular acupuncture is based on the theory that there are certain points in the ear flap corresponding to major organ systems of the human body and can be manipulated to lead to a therapeutic effect on the corresponding organ. The purpose of the study is to evaluate the effectiveness of auricular acupuncture for assisting people with the aim of stopping smoking. Methods A review of the literature has been done in PubMed database on the auricular acupuncture method for efficacy of the conservative treatment for smoking cessation with Keywords: auricular, acupuncture, smoking and cessation. Results The effectiveness of using acupuncture reported that is close to 45%, which is on par with other pharmacological methods. According to Ballal et al., the execution of acupuncture to quit smoking for six weeks produced a success rate of 50.1%, 45.5% of subjects reduced their consumption to 5 cigarettes and 4.3% failed to reduce smoking. Furthermore, Hackett et al. reported success rate of 50% after 12 months of electric acupuncture to the ear. After using acupuncture treatment in 514 persons, Choy et al. reported a success rate of 88%, and relapse rate of 31% in the second year of treatment. Conclusions The auricular acupuncture is effective in smoking cessation and should be considered as an alternative to help smokers, especially those whose previous attempts using conventional methods were in vain. Also the combination with existing methods seems ideal. The survey results also showed that the therapeutic effects of acupuncture in smoking cessation is similar to that of nicotine gum method and behavioral therapy, suggesting that acupuncture is neither superior nor inferior to other methods for smoking

  8. Predictors of smoking cessation among staff in public Universities in Klang Valley, Malaysia.

    Science.gov (United States)

    Yasin, Siti Munira; Masilamani, Retneswari; Ming, Moy Foong; Koh, David

    2011-01-01

    Smoking cessation studies are often performed in clinic based settings. The present example aimed to find predictors of success among staff in worksite smoking cessation programmes in two major public universities in Klang Valley, Malaysia. All staff from both universities received an open invitation via staff e-mail and letters to participate. At the start of treatment, participants were administered the Rhode Island Stress and Coping Questionnaire and Family Support Redding's Questionnaire. Behaviour therapy with free nicotine replacement therapy (NRT) were given as treatment. After two months, they were contacted to determine their smoking status. 185 staff from University A (n=138) and University B (n=47), responded and voluntarily showed interest to quit. There was no significant difference in respondents with respect to socio demographic characteristics and smoking history. After two months of treatment, quit rates were 24% in University A vs. 38 % in University B (p>0.05). Univariate predictors of cessation were adherence to NRT (p<0.001), smoking fewer cigarettes per day (p<0.05) and the number of behaviour therapy sessions attended (p<0.001). Logistic regression identified 3 significant predictors of smoking cessation. Participants attending more than one session (OR= 27.00; 95% CI : 6.50; 111.6), and having higher pre-treatment general stress (OR= 2.15; 95% CI: 1.14; 4.05) were more likely to quit, while a higher number of cigarettes smoked (OR= 0.19: 95% CI: 0.06; 0.59) reduced the likelihood of quitting. Increasing age, ability to cope with stress and family support were not significant predictors. We conclude that factors such as the number of counseling sessions, the amount of cigarettes smoked at baseline, adherence to NRT and pretreatment stress are important considerations for success in a worksite smoking cessation programme.

  9. Design and rationale for the PREVAIL study

    DEFF Research Database (Denmark)

    Klausen, Susanne Hwiid; Mikkelsen, Ulla Ramer; Hirth, Asle

    2012-01-01

    :1 randomized to an intervention group or a control group. Individually fully automated tailored e-Health encouragements--SMS, Internet, and mobile applications--aimed at increasing physical activity are delivered to the participants in the intervention group once a week. The Bandura's Social Cognitive Theory...

  10. RCT of a client-centred, caseworker-delivered smoking cessation intervention for a socially disadvantaged population

    Directory of Open Access Journals (Sweden)

    Girgis Afaf

    2011-01-01

    Full Text Available Abstract Background Disadvantaged groups are an important target for smoking cessation intervention. Smoking rates are markedly higher among severely socially disadvantaged groups such as indigenous people, the homeless, people with a mental illness or drug and alcohol addiction, and the unemployed than in the general population. This proposal aims to evaluate the efficacy of a client-centred, caseworker delivered cessation support intervention at increasing validated self reported smoking cessation rates in a socially disadvantaged population. Methods/Design A block randomised controlled trial will be conducted. The setting will be a non-government organisation, Community Care Centre located in New South Wales, Australia which provides emergency relief and counselling services to predominantly government income assistance recipients. Eligible clients identified as smokers during a baseline touch screen computer survey will be recruited and randomised by a trained research assistant located in the waiting area. Allocation to intervention or control groups will be determined by time periods with clients randomised in one-week blocks. Intervention group clients will receive an intensive client-centred smoking cessation intervention offered by the caseworker over two face-to-face and two telephone contacts. There will be two primary outcome measures obtained at one, six, and 12 month follow-up: 1 24-hour expired air CO validated self-reported smoking cessation and 2 7-day self-reported smoking cessation. Continuous abstinence will also be measured at six and 12 months follow up. Discussion This study will generate new knowledge in an area where the current information regarding the most effective smoking cessation approaches with disadvantaged groups is limited. Trial registration number ISRCTN: ISRCTN85202510

  11. Rationale and design of XAMOS

    DEFF Research Database (Denmark)

    Turpie, Alexander G G; Schmidt, André C; Kreutz, Reinhold;

    2012-01-01

    , noninterventional, parallel-group study to gain insight into the safety (major bleeding, side effects) and effectiveness (prevention of symptomatic thromboembolic events) of rivaroxaban in daily clinical practice. XAMOS will follow 15,000 patients after ma