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

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

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

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

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

Follow-up care by patient's own general practitioner after contact with out-of-hours care. A descriptive study

BACKGROUND: Little is known about the care process after patients have contacted a GP cooperative for out-of-hours care. The objective of this study was to determine the proportion of patients who seek follow-up care after contact with a GP cooperative for out-of-hours care, and to gain insight into factors that are related to this follow-up care. METHODS: A total of 2805 patients who contacted a GP cooperative for out-of-hours care were sent a questionnaire. They were asked whether they had attended their own GP within a week after their contact with the cooperative, and for what reason. To investigate whether other variables are related to follow-up care, a logistic regression analysis was applied. Variables that entered in this analysis were patient characteristics (age, gender, etc.) and patient opinion on correctness of diagnosis, urgency and severity of the medical complaint. RESULTS: The response rate was 42%. In total, 48% of the patients received follow-up care from their own GP. Only 20% were referred or advised to attend their own GP. Others attended because their medical condition worsened or because they were concerned about their complaint. Variables that predicted follow-up care were the patient's opinion on the correctness of the diagnosis, patient's health insurance, and severity of the medical problem. CONCLUSION: Almost half of all patients in this study who contacted the GP cooperative for out-of-hours care attended their own GP during office hours within a week, for the same medical complaint. The most important factor that predicted follow-up care from the patient's own GP after an out-of-hours contact was the patient's degree of confidence in the diagnosis established at the GP cooperative. Despite the limited generalisability, this study is a first step in providing insight into the dimension of follow-up care after a patient has contacted the GP cooperative for out-of-hours primary care

Lessons learned from a living lab on the broad adoption of eHealth in primary health care

Background: Electronic health (eHealth) solutions are considered to relieve current and future pressure on the sustainability of primary health care systems. However, evidence of the effectiveness of eHealth in daily practice is missing. Furthermore, eHealth solutions are often not implemented structurally after a pilot phase, even if successful during this phase. Although many studies on barriers and facilitators were published in recent years, eHealth implementation still progresses only slowly. To further unravel the slow implementation process in primary health care and accelerate the implementation of eHealth, a 3-year Living Lab project was set up. In the Living Lab, called eLabEL, patients, health care professionals, small- and medium-sized enterprises (SMEs), and research institutes collaborated to select and integrate fully mature eHealth technologies for implementation in primary health care. Seven primary health care centers, 10 SMEs, and 4 research institutes participated. Objective: This viewpoint paper aims to show the process of adoption of eHealth in primary care from the perspective of different stakeholders in a qualitative way. We provide a real-world view on how such a process occurs, including successes and failures related to the different perspectives. Methods: Reflective and process-based notes from all meetings of the project partners, interview data, and data of focus groups were analyzed systematically using four theoretical models to study the adoption of eHealth in primary care. Results: The results showed that large-scale implementation of eHealth depends on the efforts of and interaction and collaboration among 4 groups of stakeholders: patients, health care professionals, SMEs, and those responsible for health care policy (health care insurers and policy makers). These stakeholders are all acting within their own contexts and with their own values and expectations. We experienced that patients reported expected benefits regarding the use of eHealth for self-management purposes, and health care professionals stressed the potential benefits of eHealth and were interested in using eHealth to distinguish themselves from other care organizations. In addition, eHealth entrepreneurs valued the collaboration among SMEs as they were not big enough to enter the health care market on their own and valued the collaboration with research institutes. Furthermore, health care insurers and policy makers shared the ambition and need for the development and implementation of an integrated eHealth infrastructure. Conclusions: For optimal and sustainable use of eHealth, patients should be actively involved, primary health care professionals need to be reinforced in their management, entrepreneurs should work closely with health care professionals and patients, and the government needs to focus on new health care models stimulating innovations. Only when all these parties act together, starting in local communities with a small range of eHealth tools, the potential of eHealth will be enforced

Effectiveness and cost-effectiveness of early assisted discharge for Chronic Obstructive Pulmonary Disease exacerbations: the design of a randomised controlled trial

Background: Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) are the main cause for hospitalisation. These hospitalisations result in a high pressure on hospital beds and high health care costs. Because of the increasing prevalence of COPD this will only become worse. Hospital at home is one of the alternatives that has been proved to be a safe alternative for hospitalisation in COPD. Most schemes are early assisted discharge schemes with specialised respiratory nurses providing care at home. Whether this type of service is cost-effective depends on the setting in which it is delivered and the way in which it is organised. Methods/Design: GO AHEAD (Assessment Of Going Home under Early Assisted Discharge) is a 3-months, randomised controlled, multi-centre clinical trial. Patients admitted to hospital for a COPD exacerbation are either discharged on the fourth day of admission and further treated at home, or receive usual inpatient hospital care. Home treatment is supervised by general nurses. Primary outcome is the effectiveness and cost effectiveness of an early assisted discharge intervention in comparison with usual inpatient hospital care for patients hospitalised with a COPD exacerbation. Secondary outcomes include effects on quality of life, primary informal caregiver burden and patient and primary caregiver satisfaction. Additionally, a discrete choice experiment is performed to provide insight in patient and informal caregiver preferences for different treatment characteristics. Measurements are performed on the first day of admission and 3 days, 7 days, 1 month and 3 months thereafter. Ethical approval has been obtained and the study has been registered. Discussion: This article describes the study protocol of the GO AHEAD study. Early assisted discharge could be an effective and cost-effective method to reduce length of hospital stay in the Netherlands which is beneficial for patients and society. If effectiveness and cost-effectiveness can be proven, implementation in the Dutch health care system should be considered. Trial registration: Netherlands Trial Register NTR1129