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

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/Design</p> <p>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.</p> <p>Discussion</p> <p>Ethical as well as methodological considerations of the study are discussed in this protocol. A significant and relevant effect of confrontational counselling would provide an argument in favour of early detection of current smokers with airflow limitation. Successful treatment of tobacco dependence in respiratory patients requires repeated intensive interventions. The results of this study may also show that respiratory nurses are able to deliver this treatment and that intensive smoking cessation counselling is more feasible.</p> <p>Trial registration:</p> <p>Netherlands Trial Register (ISRCTN 64481813).</p

Early diagnosis of asthma in young children by using non-invasive biomarkers of airway inflammation and early lung function measurements: study protocol of a case-control study

<p>Abstract</p> <p>Background</p> <p>Asthma is the most common chronic disease in childhood, characterized by chronic airway inflammation. There are problems with the diagnosis of asthma in young children since the majority of the children with recurrent asthma-like symptoms is symptom free at 6 years, and does not have asthma. With the conventional diagnostic tools it is not possible to differentiate between preschool children with transient symptoms and children with asthma. The analysis of biomarkers of airway inflammation in exhaled breath is a non-invasive and promising technique to diagnose asthma and monitor inflammation in young children. Moreover, relatively new lung function tests (airway resistance using the interrupter technique) have become available for young children. The primary objective of the ADEM study (Asthma DEtection and Monitoring study), is to develop a non-invasive instrument for an early asthma diagnosis in young children, using exhaled inflammatory markers and early lung function measurements. In addition, aetiological factors, including gene polymorphisms and gene expression profiles, in relation to the development of asthma are studied.</p> <p>Methods/design</p> <p>A prospective case-control study is started in 200 children with recurrent respiratory symptoms and 50 control subjects without respiratory symptoms. At 6 years, a definite diagnosis of asthma is made (primary outcome measure) on basis of lung function assessments and current respiratory symptoms ('golden standard'). From inclusion until the definite asthma diagnosis, repeated measurements of lung function tests and inflammatory markers in exhaled breath (condensate), blood and faeces are performed. The study is registered and ethically approved.</p> <p>Discussion</p> <p>This article describes the study protocol of the ADEM study. The new diagnostic techniques applied in this study could make an early diagnosis of asthma possible. An early and reliable asthma diagnosis at 2–3 years will have consequences for the management of the large group of young children with asthma-like symptoms. It will avoid both over-treatment of children with transient wheeze and under-treatment of children with asthma. This might have a beneficial influence on the prognosis of asthma in these young children. Besides, insight into the pathophysiology and aetiology of asthma will be obtained.</p> <p>Trial registration</p> <p>This study is registered by clinicaltrials.gov (NCT00422747).</p

Ambient and Indoor Air Pollution in Pregnancy and the risk of Low birth weight and Ensuing Effects in Infants (APPLE): A cohort study in Bangalore, South India

Background: Exposure to air pollution (IAP) from the combustion of solid fuels is a significant cause of morbidity and mortality in developing countries. Pregnant women exposed to higher pollutant levels are at higher risk of delivering a low-birth-weight (LBW) baby. There is a lack of standardized data regarding the levels and types of specific pollutants and how they impact LBW. We aim to prospectively assess the association between ambient and indoor air pollution levels in pregnancy and low birth weight and understand the subsequent risk of adiposity in these infants. Methods: We will conduct a prospective cohort study of 516 pregnant women recruited before 18 weeks of gestation in the urban slums of Bangalore, who have voluntarily consented to participate. We will estimate the level of air pollutants including coarse particulate matter 10 ug/m3 (PM10 ), fine particulate matter 2.5 ug/m3(PM2.5) and carbon monoxide (CO) parts per million (ppm) levels in both indoor and ambient environment. The follow-up of the delivered children will be done at delivery until the infant is two years old. The association between pollutants and LBW will be evaluated using logistic regression adjusting for potential confounders.Further, we will explore the mediation role of LBW in the hypothesized causal chain of air pollution and adiposity. Nested within a larger Maternal Antecedents of Adiposity and Studying the Transgenerational role of Hyperglycemia and Insulin (MAASTHI) cohort, we can estimate the absolute risk of having low birth weight caused by air pollution and other variables. Discussion: Understanding the association between exposures to ambient and indoor air pollution and low birth weight is essential in India. LBW babies have a higher risk of developing obesity and Non-Communicable Diseases (NCDs) during adulthood. The results from this study can inform the efforts for controlling the air pollution-related chronic diseases in India.</ns4:p

Ambient and Indoor Air Pollution in Pregnancy and the risk of Low birth weight and Ensuing Effects in Infants (APPLE): A cohort study in Bangalore, South India

Background: Exposure to air pollution (IAP) from the combustion of solid fuels is a significant cause of morbidity and mortality in developing countries. Pregnant women exposed to higher pollutant levels are at higher risk of delivering a low-birth-weight (LBW) baby. There is a lack of standardized data regarding the levels and types of specific pollutants and how they impact LBW. We aim to prospectively assess the association between ambient and indoor air pollution levels in pregnancy and low birth weight and understand the subsequent risk of adiposity in these infants. Methods: We will conduct a prospective cohort study of 516 pregnant women recruited before 18 weeks of gestation in the urban slums of Bangalore, who have voluntarily consented to participate. We will estimate the level of air pollutants including coarse particulate matter 10 ug/m3 (PM10 ), fine particulate matter 2.5 ug/m3(PM2.5) and carbon monoxide (CO) parts per million (ppm) levels in both indoor and ambient environment. The follow-up of the delivered children will be done at delivery until the infant is two years old. The association between pollutants and LBW will be evaluated using logistic regression adjusting for potential confounders.Further, we will explore the mediation role of LBW in the hypothesized causal chain of air pollution and adiposity. Nested within a larger Maternal Antecedents of Adiposity and Studying the Transgenerational role of Hyperglycemia and Insulin (MAASTHI) cohort, we can estimate the absolute risk of having low birth weight caused by air pollution and other variables. Discussion: Understanding the association between exposures to ambient and indoor air pollution and low birth weight is essential in India. LBW babies have a higher risk of developing obesity and Non-Communicable Diseases (NCDs) during adulthood. The results from this study can inform the efforts for controlling the air pollution-related chronic diseases in India.</ns4:p

Health Needs Assessment for the double burden of malnutrition –a community-based study on nutrition facilitators and barriers in rural Tanzania

Abstract Objective: The aim of this study is to explore nutrition-related health needs, the perceptions and beliefs regarding the double burden of malnutrition, as well as barriers and facilitators in accessing nutritious food among the local population in rural Tanzania. Design: A qualitative study design using semi-structured individual interviews and Focus-group-discussions (FGD) was used. Basic socio-demographic information was obtained from all participants. Setting: The study was conducted in four villages within the catchment area of the Shirati KMT Hospital in Rorya district, in north-western Tanzania. Participants: Men and women in the reproductive age as well as Community Health Workers were included. Results: In total, we performed 14 interviews (N=41), consisting of 4 FDGs, 1 dual and 9 individual interviews. The three most significant topics that were identified are the large knowledge gap concerning overweight and obesity as a health problem, changing weather patterns and its implications on food supply, and the socio- cultural drivers including gender roles and household dynamics. Conclusion: Environmental and sociocultural factors play a crucial role in the determinants for DBM, which underlines the importance of understanding the local context and the nutrition practices and beliefs of the communities. Future nutritional interventions should aim towards more inclusion of men in project implementation as well as support of women empowerment. CHW could play a key role in facilitating some of the suggested interventions, including nutritional counselling and increasing awareness on the drivers of the DBM

One year cost effectiveness of sirolimus eluting stents compared with bare metal stents in the treatment of single native de novo coronary lesions: an analysis from the RAVEL trial

OBJECTIVE: To assess the balance between costs and effects of the sirolimus eluting stent in the treatment of single native de novo coronary lesions in the RAVEL (randomised study with the sirolimus eluting Bx Velocity balloon expandable stent in the treatment of patients with de novo native coronary artery lesions) study. DESIGN: Multicentre, double blind, randomised trial. SETTING: Percutaneous coronary intervention for single de novo coronary lesions. PATIENTS: 238 patients with stable or unstable angina. INTERVENTIONS: Randomisation to sirolimus eluting stent or bare stent implantation. MAIN OUTCOME MEASURES: Patients were followed up to one year and the treatment effects were expressed as one year survival free of major adverse cardiac events (MACE). Costs were estimated as the product of resource utilisation and Dutch unit costs. RESULTS: At one year, the absolute difference in MACE-free survival was 23% in favour of the sirolimus eluting stent group. At the index procedure, sirolimus eluting stent implantation had an estimated additional procedural cost of 1286. At one year, however, the estimated additional cost difference had decreased to 54 because of the reduction in the need for repeat revascularisations in the sirolimus group (0.8% v 23.6%; p < 0.01). After adjustment of actual results for the consequences of angiographic follow up (correction based on data from the BENESTENT (Belgium Netherlands stent) II study), the difference in MACE-free survival was estimated at 11.1% and the addit

A pragmatic cluster randomized controlled trial of early intervention for chronic obstructive pulmonary disease by practice nurse-general practitioner teams : Study Protocol

Background: Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of disability, hospitalization, and premature mortality. General practice is well placed to diagnose and manage COPD, but there is a significant gap between evidence and current practice, with a low level of awareness and implementation of clinical practice guidelines. Under-diagnosis of COPD is a world-wide problem, limiting the benefit that could potentially be achieved through early intervention strategies such as smoking cessation, dietary advice, and exercise. General practice is moving towards more structured chronic disease management, and the increasing involvement of practice nurses in delivering chronic care. Design: A pragmatic cluster randomised trial will test the hypothesis that intervention by a practice nurse-general practitioner (GP) team leads to improved health-related quality of life and greater adherence with clinical practice guidelines for patients with newly-diagnosed COPD, compared with usual care. Forty general practices in greater metropolitan Sydney Australia will be recruited to identify patients at risk of COPD and invite them to attend a case finding appointment. Practices will be randomised to deliver either practice nurse-GP partnership care, or usual care, to patients newly-diagnosed with COPD. The active intervention will involve the practice nurse and GP working in partnership with the patient in developing and implementing a care plan involving (as appropriate), smoking cessation, immunisation, pulmonary rehabilitation, medication review, assessment and correction of inhaler technique, nutritional advice, management of psycho-social issues, patient education, and management of co-morbidities. The primary outcome measure is health-related quality of life, assessed with the St George’s Respiratory Questionnaire 12 months after diagnosis. Secondary outcome measures include validated disease-specific and general health related quality of life measures, smoking and immunisation status, medications, inhaler technique, and lung function. Outcomes will be assessed by project officers blinded to patients’ randomization groups. Discussion: This study will use proven case-finding methods to identify patients with undiagnosed COPD in general practice, where improved care has the potential for substantial benefit in health and healthcare utilization. The study provides the capacity to trial a new model of team-based assessment and management of newly diagnosed COPD in Australian primary care

Out-of-hours primary care. Implications of organisation on costs

BACKGROUND: To perform out-of-hours primary care, Dutch general practitioners (GPs) have organised themselves in large-scale GP cooperatives. Roughly, two models of out-of-hours care can be distinguished; GP cooperatives working separate from the hospital emergency department (ED) and GP cooperatives integrated with the hospital ED. Research has shown differences in care utilisation between these two models; a significant shift in the integrated model from utilisation of ED care to primary care. These differences may have implications on costs, however, until now this has not been investigated. This study was performed to provide insight in costs of these two different models of out-of-hours care. METHODS: Annual reports of two GP cooperatives (one separate from and one integrated with a hospital emergency department) in 2003 were analysed on costs and use of out-of-hours care. Costs were calculated per capita. Comparisons were made between the two cooperatives. In addition, a comparison was made between the costs of the hospital ED of the integrated model before and after the set up of the GP cooperative were analysed. RESULTS: Costs per capita of the GP cooperative in the integrated model were slightly higher than in the separate model (ε 11.47 and ε 10.54 respectively). Differences were mainly caused by personnel and other costs, including transportation, interest, cleaning, computers and overhead. Despite a significant reduction in patients utilising ED care as a result of the introduction of the GP cooperative integrated within the ED, the costs of the ED remained the same. CONCLUSION: The study results show that the costs of primary care appear to be more dependent on the size of the population the cooperative covers than on the way the GP cooperative is organised, i.e. separated versus integrated. In addition, despite the substantial reduction of patients, locating the GP cooperative at the same site as the ED was found to have little effect on costs of the ED. Sharing more facilities and personnel between the ED and the GP cooperative may improve cost-efficiency