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A letter to the editor is presented in response to the article "Effects of varenicline on smoking cessation in patients with mild to moderate COPD: a randomized controlled trial," by D. P. Tashkin and colleagues that was published in the March 2011 issue, and a response by D. P. Tashkin and colleagues to the letter.

Experimental vaccines to treat smoking are tested in randomised clinical trials (RCTs) where participants receive real or placebo 'nicotine vaccination' plus additional support. RCTs are a standard method within the current conventions of evidence-based medicine. As yet, nicotine vaccines did not 'work' better than placebos. Interestingly, several trials showed high overall quit smoking rates. Understanding lifestyle change, scholars argue, requires insights into sociocultural context and embodied experiences. The question then arises how knowledge claims about behaviour change are made in the controlled setting of a clinical trial. Drawing from science and workplace studies, this paper analyses the case of a nicotine vaccination trial. With document analysis, fieldwork and 77 interviews we compared the daily practice of fact-making with the knowledge claims as represented front stage. Our qualitative study suggests that staff and volunteers performed much work in attending to social processes of behaviour change and trial participation. These efforts were underrepresented in the protocol-centred format of trial reports. The knowledge work of assistants in particular was largely absent in official documents. Accounting for experiments with nicotine and other lifestyle vaccines will require an integrative trial design that combines the biomedical rationale with perspectives from the humanities and social sciences. [ABSTRACT FROM AUTHOR]

Background: Numerous instruments have been developed to assess patient reported outcomes; most approaches however focus on a single condition. With the increasing prevalence of multimorbidity, this might no longer be appropriate. Moreover, a more comprehensive approach that facilitates shared decision making and stimulates self-management is most likely more valuable for clinical practice than a questionnaire alone. This study aims to transform the Assessment of Burden of Chronic Obstructive Pulmonary Disease (COPD) (ABC)-tool into the Assessment of Burden of Chronic Conditions (ABCC)-tool for COPD, asthma, and diabetes mellitus type 2 (DM2). The tool consists of a scale, a visualisation of the outcomes, and treatment advice. Methods: Requirements for the tool were formulated. Questionnaires were developed based on a literature study of existing questionnaires, clinical guidelines, interviews with patients and healthcare providers, and input from an expert group. Cut-off points and treatment advice were determined to display the results and to provide practical recommendations. Results: The ABCC-scale consists of a generic questionnaire and disease-specific questionnaires, which can be combined into a single individualized questionnaire for each patient. Results are displayed in one balloon chart, and each domain includes practical recommendations. Conclusions: The ABCC-tool is expected to facilitate conversations between a patient and a healthcare provider, and to help formulate treatment plans and care plans with personalised goals. By facilitating an integrated approach, this instrument can be applied in a variety of circumstances and disease combinations. [ABSTRACT FROM AUTHOR]

In the article, 'A Cost Analysis of School-Based Lifestyle Interventions', we calculated the societal costs of two school-based lifestyle interventions: 'the Healthy Primary School of the Future' and 'the Physical Activity School'. [ABSTRACT FROM AUTHOR]

Background: The prevalence of asthma-like symptoms in preschool children is high. Despite numerous efforts, there still is no clinically available diagnostic tool to discriminate asthmatic children from children with transient wheeze at preschool age. This leads to potential overtreatment of children outgrowing their symptoms, and to potential undertreatment of children who turn out to have asthma. Our research group developed a breath test (using GC-tof–MS for VOC-analysis in exhaled breath) that is able to predict a diagnosis of asthma at preschool age. The ADEM2 study assesses the improvement in health gain and costs of care with the application of this breath test in wheezing preschool children. Methods: This study is a combination of a multi-centre, parallel group, two arm, randomised controlled trial and a multi-centre longitudinal observational cohort study. The preschool children randomised into the treatment arm of the RCT receive a probability diagnosis (and corresponding treatment recommendations) of either asthma or transient wheeze based on the exhaled breath test. Children in the usual care arm do not receive a probability diagnosis. Participants are longitudinally followed up until the age of 6 years. The primary outcome is disease control after 1 and 2 years of follow-up. Participants of the RCT, together with a group of healthy preschool children, also contribute to the parallel observational cohort study developed to assess the validity of alternative VOC-sensing techniques and to explore numerous other potential discriminating biological parameters (such as allergic sensitisation, immunological markers, epigenetics, transcriptomics, microbiomics) and the subsequent identification of underlying disease pathways and relation to the discriminative VOCs in exhaled breath. Discussion: The potential societal and clinical impact of the diagnostic tool for wheezing preschool children is substantial. By means of the breath test, it will become possible to deliver customized and high qualitative care to the large group of vulnerable preschool children with asthma-like symptoms. By applying a multi-omics approach to an extensive set of biological parameters we aim to explore (new) pathogenic mechanisms in the early development of asthma, creating potentially interesting targets for the development of new therapies. Trial registration: Netherlands Trial Register, NL7336, Date registered 11–10-2018. [ABSTRACT FROM AUTHOR]

PURPOSE The Assessment of Burden of Chronic Conditions (ABCC) tool was developed to improve care by facilitating shared decision making and self-management. It assesses and visualizes the experienced burden of 1 or multiple chronic conditions and integrates it in daily care. The aim of this study is to evaluate whether the ABCC scale is valid and reliable in people with chronic obstructive pulmonary disease (COPD), asthma, or type 2 diabetes (T2D). METHODS The Saint George Respiratory Questionnaire (SGRQ), the Standardized Asthma Quality of Life Questionnaire (AQLQ-S), and the Audit of Diabetes Dependent Quality of Life Questionnaire (ADDQoL19) were compared with the ABCC scale to assess convergent validity. The internal consistency was evaluated using Cronbach's α. Test-retest reliability was evaluated at a 2-week interval. RESULTS A total of 65 people with COPD, 62 with asthma, and 60 with T2D were included. The ABCC scale correlated, in accordance with hypotheses, with the SGRQ (75% of correlations ≤0.7), AQLQ-S (100%), and ADDQoL19 (75%). The ABCC scale was internally consistent with a Cronbach's α of 0.90, 0.92, and 0.91 for the total score for people with COPD, asthma, and T2D, respectively. The ABCC scale had a good test-retest reliability with an intraclass correlation coefficient of 0.95, 0.93, and 0.95 for people with COPD, asthma, and T2D, respectively. CONCLUSIONS The ABCC scale is a valid and reliable questionnaire that can be used within the ABCC tool for people with COPD, asthma, or T2D. Future research should indicate whether this applies to people with multimorbidity, and what the effects and experiences are upon clinical use. [ABSTRACT FROM AUTHOR]

Experimental vaccines are being developed for the treatment of 'unhealthy lifestyles' and associated chronic illnesses. Policymakers and other stakeholders will have to deal with the ethical issues that this innovation path raises: are there morally justified reasons to integrate these innovative biotechnologies in future health policies? Should public money be invested in further research? Focusing on the case of an experimental nicotine vaccine, this article explores the ethical aspects of 'lifestyle vaccines' for public health. Based on findings from a qualitative study into a vaccine for smoking cessation, the article articulates possible value conflicts related to nicotine vaccination as an intervention in tobacco control. The 'vaccinization' of lifestyle disease piggybacks on the achievements of classic vaccines. Contrary to expectations of simplicity and success, quitting smoking with a vaccine requires a complex supportive network. Social justice and public trust may become important ethical challenges when deciding whether to use further public funds for research or whether to implement these innovative vaccines in the future. [ABSTRACT FROM AUTHOR]

Rationale: Few studies have examined determinants of physical activity in patients with chronic illnesses, like asthma. The aim of this study was to examine whether baseline maternal and paternal beliefs, support and parenting were associated with changes in sport participation of adolescents with asthma, and investigate the moderating effect of sex. Methods: In a population-based cohort study, during home visits in 2012 and 2013, 253 adolescents completed a questionnaire assessing their sport participation. Both parents reported their sport-specific parenting (support, general and asthma-specific beliefs, self-efficacy to encourage sport participation). The collected data was described using descriptive statistics. Path and multi-group analyses were used to examine whether baseline parental factors predicted change in adolescent sport participation, multi-group analyses examined the moderating effect of sex. For all analyses probability p value less than the accepted level of significance a=0.05 (p50.05) were taken as significant effects. Results: Few parental factors associated with changes in sport participation of the adolescents, sex did not moderate the associations. In the fully adjusted models, only maternal asthma-specific beliefs about sport participation were significantly positively associated with change in adolescent sport participation. Conclusion: Sport-specific parenting does not appear to be a determinant of sport participation in adolescents with asthma. Future research should consider other individual, social and environmental determinants to inform intervention development. [ABSTRACT FROM AUTHOR]

Objective: Adolescents with asthma experience more psychosocial and physiological problems compared to their healthy peers. Physical activity (PA) might decrease these problems. This study was the first observational longitudinal study to examine whether habitual PA could predict changes in psychosocial outcomes (i.e. symptoms of anxiety and depression, quality of life [QOL] and stress) and asthma control over time in adolescents with asthma and whether gender moderated these relationships. Methods: Adolescents with asthma ( N = 253; aged 10-14 years at baseline) were visited at home in the spring/summer of 2012 and 2013. They completed questionnaires assessing their habitual PA, symptoms of anxiety and depression, QOL, perceived stress and asthma control. Path analyses using Mplus were conducted to examine longitudinal relationships among habitual PA, psychosocial outcomes and asthma control (controlled for body mass index, age and gender). Using multi-group analyses, we examined whether gender moderated these relationships. Results: Path analyses in the total group showed that habitual PA did not predict changes in psychosocial outcomes or asthma control over time. Multi-group analyses showed that gender moderated the relation of habitual PA with anxiety and depression. Habitual PA only significantly predicted a decrease in anxiety and depression over time for girls but not for boys. Conclusions: Increasing habitual PA in girls with asthma might decrease their symptoms of anxiety and depression. [ABSTRACT FROM AUTHOR]

Although environmental smoking (i.e., paternal and maternal smoking, sibling smoking, and peer smoking) is one of the most important factors for explaining adolescent smoking behavior, not all adolescents are similarly affected. The extent to which individuals are vulnerable to smoking in their environment might depend on genetic factors. The aim of this study was to examine the interplay between environmental smoking and genes encoding components of the dopaminergic system (i.e., dopamine receptor D2, D4, and dopamine transporter DAT1) in adolescent smoking onset. Data from two longitudinal studies were used. Study 1 consisted of 991 non-smoking early adolescents (mean age = 12.52, SD = .57) whereas study 2 consisted of 365 non-smoking middle to late adolescents (mean age = 14.16, SD = 1.07) who were followed for 16 and 48 months, respectively. Logistic regression analyses were conducted using Mplus. In study 1, we found positive associations between parents' and friends' smoking at the first measurement and smoking status 16 months later. In study 2 we found a positive association between friends' smoking and smoking onset 48 months later. Neither study demonstrated any interaction effects of the DRD2, DRD4, or DAT1 genotypes. In conclusion, the effects of environmental smoking on smoking onset are similar for adolescent carriers and non-carriers of these specific genes related to the dopaminergic system. [ABSTRACT FROM AUTHOR]

Background: In the absence of clear differences in effectiveness and cost-effectiveness between hospital-at-home schemes and usual hospital care, patient preference plays an important role. This study investigates patient preference for treatment place, associated factors and patient satisfaction with a community-based hospital-at-home scheme for COPD exacerbations. Methods: The study is part of a larger randomised controlled trial. Patients were randomised to usual hospital care or early assisted discharge which incorporated discharge at day 4 and visits by a home care nurse until day 7 of treatment (T + 4 days). The hospital care group received care as usual and was discharged from hospital at day 7. Patients were followed for 90 days (T + 90 days). Patient preference for treatment place and patient satisfaction (overall and per item) were assessed quantitatively and qualitatively using questionnaires at T + 4 days and T + 90 days. Factors associated with patient preference were analysed in the early assisted discharge group. Results: 139 patients were randomised. No difference was found in overall satisfaction. At T + 4 days, patients in the early assisted discharge group were less satisfied with care at night and were less able to resume normal daily activities. At T + 90 days there were no differences for the separate items. Patient preference for home treatment at T + 4 days was 42% in the hospital care group and 86% in the early assisted discharge group and 35% and 59% at T + 90 days. Patients' mental state was associated with preference. Conclusion: Results support the wider implementation of early assisted discharge for COPD exacerbations and this treatment option should be offered to selected patients that prefer home treatment. [ABSTRACT FROM AUTHOR]

Objective. To examine the unique contribution of perceptions held by mothers about their children's asthma in relation to the symptoms as reported by their children. Methods. Families with a child diagnosed with asthma participating in a larger smoking prevention study were invited to participate. For all, 89 children (mean age 10.1 years) and 87 mothers questionnaire and lung function data during home visits were provided. The main outcome of this study involved asthma symptoms as measured by the Pediatric Quality of Life Inventory. Mothers' and children's reports of symptoms, as well as the lung function parameter of percentage of predicted Forced Expiratory Volume in one second (% of predicted FEV1), were analyzed in relation to maternal illness perceptions. Results. Mothers' perceptions of illness were not associated with % of predicted FEV1 However, while controlling for gender and children's baseline asthma symptoms, four out of eight mothers' perceptions of illness (i.e., identity, consequences, concern, and emotional influence) were associated with children's asthma symptoms. Additional analyses controlling for % of predicted FEV1 in the models with subjective asthma symptoms reports of mother and child did not change the study findings. Conclusions. This pilot study provides evidence that, in addition to children's lung function and baseline symptoms, maternal perception of illness contributes to symptom-related quality of life (QoL) of children. More research on underlying mechanisms, which addresses the linking of mothers' perceptions of concern and emotion to the QoL symptoms as reported by children is necessary. [ABSTRACT FROM AUTHOR]

Background: Research has shown that adolescents with asthma are as likely as and sometimes even more likely to smoke than their peers without asthma. The current study examined whether the prevalence of the first active smoking experience differs for children (9–12 years of age) diagnosed with asthma compared with children who do not have asthma. The association between asthma and smoking was evaluated with logistic regression analysis, controlling for socio-economic status, parental smoking and child’s internalizing and externalizing behaviours. Method: A nation-wide sample of 1476 mother and child dyads participated, of which 220 children (14.9%) had been diagnosed with childhood asthma. Results: Children diagnosed with asthma were 2.45 times more likely to have taken a puff of a cigarette compared with children without asthma. In addition, the association between asthma and early smoking remained significant after including potential confounders in the regression equation. Discussion: Suggestions are provided for preventing school-aged children, especially youths with asthma, from smoking. Additional research is needed to gain further insights into the mechanisms underlying the higher likelihood of early smoking among children with asthma. [ABSTRACT FROM AUTHOR]

Introduction: A remarkable difference in care delivery pathways for Chronic Obstructive Pulmonary Disease (COPD) is the presence of hospital- at-home for COPD exacerbations in England and its absence in the Netherlands. The objective of this paper is to explain this difference. Methods: Descriptive COPD statistics and care delivery pathways on all care levels within the institutional context, followed by a comparison of care delivery pathways and an explanation of the difference with regard to hospital-at-home. Results: The Netherlands and England show broad similarities in their care delivery pathways for COPD patients. A major difference is the presence of hospital-at-home for COPD exacerbations in England and its absence in the Netherlands. Three possible explanations for this difference are presented: differences in the urgency for alternatives (higher urgency for alternative treatment models in England), the differences in funding (funding in England facilitated the development of hospital-at-home) and the differences in the substitution of tasks to nurses (substitution to nurses has taken place to a larger extent in England). Discussion and Conclusion: The difference between the Netherlands and England regarding hospital-at-home for COPD exacerbations can be explained in three ways. Hospital-at-home has proved to be a safe alternative for hospital care for selected patients, and should be considered as a treatment option for COPD exacerbations in the Netherlands. [ABSTRACT FROM AUTHOR]

This study responds to the need for participatory, context-oriented approaches to address the growing health threat of indoor air pollution faced by marginalised communities of urban India. It explored the application of the co-designing model employed by Project Exhale in two non-notified slums in Bangalore, by analysing processes and tools of multi-stakeholder collaboration, the knowledge that emerged from them, and its translation into the designing of improved cookstoves. Bringing the end-users, designers and researchers onto a common platform led to the generation of contextual, user-knowledge and technical expertise, which were transferred to the development of the prototype. In this process, stoves' suitability concerns traditionally raised in literature are not seen as barriers to implementation, but issues that can be addressed and negotiated through participatory methods. The involved actors experienced a parting from pre-defined, traditional roles towards more flexible ones, as required by the project at different stages. Tools employed for the knowledge exchanged within this community of practice needed continuous exploration, negotiation and adjusting, as transferring the co-designing model in resource-limited settings demands higher flexibility and a grounding of activities in local experiences. [ABSTRACT FROM AUTHOR]

Background: This study estimated the lifetime cost-effectiveness and equity impacts associated with two lifestyle interventions in the Dutch primary school setting (targeting 4-12 year olds).Methods: The Healthy Primary School of the Future (HPSF; a healthy school lunch and structured physical activity) and the Physical Activity School (PAS; structured physical activity) were compared to the regular Dutch curriculum (N = 1676). An adolescence model, calculating weight development, and the RIVM Chronic Disease Model, calculating overweight-related chronic diseases, were linked to estimate the lifetime impact on chronic diseases, quality adjusted life years (QALYs), healthcare, and productivity costs. Cost-effectiveness was expressed as the additional costs/QALY gained and we used €20,000 as threshold. Scenario analyses accounted for alternative effect maintenance scenarios and equity analyses examined cost-effectiveness in different socioeconomic status (SES) groups.Results: HPSF resulted in a lifetime costs of €773 (societal perspective) and a lifetime QALY gain of 0.039 per child versus control schools. HPSF led to lower costs and more QALYs as compared to PAS. From a societal perspective, HPSF had a cost/QALY gained of €19,734 versus control schools, 50% probability of being cost-effective, and beneficial equity impact (0.02 QALYs gained/child for low versus high SES). The cost-effectiveness threshold was surpassed when intervention effects decayed over time.Conclusions: HPSF may be a cost-effective and equitable strategy for combatting the lifetime burden of unhealthy lifestyles. The win-win situation will, however, only be realised if the intervention effect is sustained into adulthood for all SES groups.Trial Registration: Clinicaltrials.gov ( NCT02800616 ). Registered 15 June 2016 - Retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: Empirical evidence shows that the relationship between health-seeking behaviour and diverse gender elements, such as gendered social status, social control, ideology, gender process, marital status and procreative status, changes across settings. Given the high relevance of social settings, this paper intends to explore how gender elements interact with health-seeking practices among men and women residing in an Indian urban slum, in consideration of the unique socio-cultural context that characterises India's slums. Methods: The study was conducted in Sahid Smriti Colony, a peri-urban slum of Kolkata, India. The referral technique was used for selecting participants, as people in the study area were not very comfortable in discussing their health issues and health-seeking behaviours. The final sample included 66 participants, 34 men and 32 women. Data was collected through individual face-to-face in-depth interviews with a semi-structured questionnaire. Results: The data analysis shows six categories of reasons underlying women's preferences for informal healers, which are presented in the form of the following themes: cultural competency of care, easy communication, gender-induced affordability, avoidance of social stigma and labelling, living with the burden of cultural expectations and geographical and cognitive distance of formal health care. In case of men ease of access, quality of treatment and expected outcome of therapies are the three themes that emerged as the reasons behind their preferences for formal care. Conclusion: Our results suggest that both men and women utilise formal and informal care, but with different motives and expectations, leading to contrasting health-seeking outcomes. These gender-induced contrasts relate to a preference for socio-cultural (women) versus technological (men) therapies and long (women) versus fast (men) treatment, and are linked to their different societal and familial roles. The role of women in following and maintaining socio-cultural norms leads them to focus on care that involves long discussions mixed with socio-cultural traits that help avoid economic and social sanctions, while the role of men as bread earners requires them to look for care that ensures a fast and complete recovery so as to avoid financial pressures. [ABSTRACT FROM AUTHOR]

Background: Slum dwellers display specific traits when it comes to disclosing their illnesses to professionals. The resulting actions lead to poor health-seeking behaviour and underutilisation of existing formal health facilities. The ways that slum people use to communicate their feelings about illness, the type of confidants that they choose, and the supportive and unsupportive social and cultural interactions to which they are exposed have not yet been studied in the Indian context, which constitutes an important knowledge gap for Indian policymakers and practitioners alike. To that end, this study examines the patterns of illness disclosure in Indian slums and the underpinning factors which shape the slum dwellers' disclosing attitude. Methods: In-depth, semi-structured interviews were conducted among 105 men and 113 women who experienced illness in the year prior to the study period. Respondents were selected from four urban slums in two Indian cities, Bangalore and Kolkata. Results: Findings indicate that women have more confidants at different social levels, while men have a limited network of disclosures which is culturally and socially mediated. Gender role limitations, exclusion from peer groups and unsupportive local situations are the major cause of disclosure delay or non-disclosure among men, while the main concerns for women are a lack of proper knowledge about illness, unsupportive responses received from other people on certain occasions, the fear of social stigma, material loss and the burden of the local situation. Prompt sharing of illness among men is linked with prevention intention and coping with biological problems, whereas factors determining disclosure for women relate to ensuring emotional and instrumental safety, preventing collateral damage of illness, and preventing and managing biological complications. Conclusions: The findings reveal that patterns of disclosure are not determined by the acknowledgment of illness but largely depend on the interplay between individual agency, disclosure consequences and the socio cultural environment. The results of this study can contribute significantly to mitigating the pivotal knowledge gap between health policymakers, practitioners and patients, leading to the formulation of policies that maximise the utilisation of health facilities in slums. [ABSTRACT FROM AUTHOR]

Background: A multi pronged community based strategy, known as National Rural Health Mission (NRHM), was implemented from 2005-06 to 2012-13 in India to curtail maternal and child health (MCH) disparities between poor and rich, rural and urban areas, and boys and girls,. This study aimed to determine the degree to which MCH plans of NRHM implemented, and resulted in improving the MCH outcomes and reducing the inequalities.Methods: An explanatory sequential mixed methods study was conducted, first to assess the degree of implementation of MCH plans by estimating the budget utilization rates of each MCH plan, and the effectiveness of these plans by comparing demographic health surveys data conducted post (2012-13), during (2007-08) and pre- (2002-04) NRHM implementation period, in the quantitative study. Then, perceptions and beliefs of stakeholders regarding extent and effectiveness of NRHM in Haryana were explored in the qualitative study during 2013. A logistic regression analysis was done for quantitative data, and inductive applied thematic analysis for qualitative data. The findings of the quantitative and qualitative parts of study were mixed at the interpretation level.Results: The MCH plans, like free ambulance service, availability of free drugs and logistics, accredited social health activists were fully implemented according to the budget spent on implementing these activities in Haryana. This was also validated by qualitative study. Availability of free medicines and treatment in the public health facilities had benefitted the poor patients the most. Accredited Social Health Activists scheme was also the most appreciated scheme that had increased the institutional delivery rates. There was acute shortage of human resources in-spite of full utilization of funds allocated for this plan. The results of the qualitative study validated the findings of quantitative study of significant (p < 0.05) improvement in MCH indicators and reduction in MCH disparities between higher and lower socioeconomic groups, and rural and urban areas.Conclusions: MCH plans of NRHM might have succeeded in improving the MCH outcomes and reducing the geographical and socioeconomic MCH inequalities by successfully implementing the schemes like accredited social health activists, free ambulance services, free treatment and medicines in hospitals for the poor and in rural areas. [ABSTRACT FROM AUTHOR]

Background: Biomass fuel is used as a primary cooking source by more than half of the world's population, contributing to a high burden of disease. Although cleaner fuels are available, some households continue using solid fuels because of financial constraints and absence of infrastructure, especially in non-notified slums. The present study documents a randomised controlled study investigating the efficacy of improved cookstove on the personal exposure to air pollution and the respiratory health of women and children in an Indian slum. The improved cookstove was based on co-creation of a low-smoke chulha with local communities in order to support adaption and sustained uptake.Methods: The study will be conducted in a non-notified slum called Ashrayanagar in Bangalore, India. The study design will be a 1:1 randomised controlled intervention trial, including 250 households. The intervention group will receive an improved cookstove (low-smoke chulha) and the control group will continue using either the traditional cookstove (chulha) or a combination of the traditional stove and the kerosene/diesel stove. Follow-up time is 1 year. Outcomes include change in lung function (FEV1/FVC), incidence of pneumonia, change in personal PM2.5 and CO exposure, incidence of respiratory symptoms (cough, phlegm, wheeze and shortness of breath), prevalence of other related symptoms (headache and burning eyes), change in behaviour and adoption of the stove. Ethical clearance was obtained from the Institutional Ethics Committee of the Indian Institute of Public Health Hyderabad- Bengaluru Campus.Discussion: The findings from this study aim to provide insight into the effects of improved cookstoves in urban slums. Results can give evidence for the decrease of indoor air pollution and the improvement of respiratory health for children and women.Trial Registration: The trial was registered with clinicaltrials.gov on 21 June 2016 with the identifier NCT02821650 ; A Study to Test the Impact of an Improved Chulha on the Respiratory Health of Women and Children in Indian Slums. [ABSTRACT FROM AUTHOR]

Background: There is a growing emphasis on self-monitoring applications that allow patients to measure their own physical health parameters. A prerequisite for achieving positive effects is patients' willingness to self-monitor. The controllability of disease types, patients' perceived self-efficacy and health problems could play an essential role in this. The purpose of this study is to investigate the relationship between patients' willingness to self-monitor and a range of disease and patient specific variables including controllability of disease type, patients' perceived self-efficacy and health problems. Methods: Data regarding 627 participants with 17 chronic somatic disease types from a Dutch panel of people with chronic diseases have been used for this cross-sectional study. Perceived self-efficacy was assessed using the general self-efficacy scale, perceived health problems using the Physical Health Composite Score (PCS). Participants indicated their willingness to self-monitor. An expert panel assessed for 17 chronic disease types the extent to which patients can independently keep their disease in control. Logistic regression analyses were conducted. Results: Patients' willingness to self-monitor differs greatly among disease types: patients with diabetes (71.0%), asthma (59.6%) and hypertension (59.1%) were most willing to self-monitor. In contrast, patients with rheumatism (40.0%), migraine (41.2%) and other neurological disorders (42.9%) were less willing to self-monitor. It seems that there might be a relationship between disease controllability scores and patients' willingness to self-monitor. No evidence is found of a relationship between general self-efficacy and PCS scores, and patients' willingness to self-monitor. Conclusions: This study provides the first evidence that patients' willingness to self-monitor might be associated with disease controllability. Further research should investigate this association more deeply and should focus on how disease controllability influences willingness to self-monitor. In addition, since willingness to self-monitor differed greatly among patient groups, it should be taken into account that not all patient groups are willing to self-monitor. [ABSTRACT FROM AUTHOR]

A multi-strategy community intervention, known as National Rural Health Mission (NRHM), was implemented in India from 2005 to 2012. By improving the availability of and access to better-quality healthcare, the aim was to reduce maternal and child health (MCH) inequalities. This study was planned to explore the perceptions and beliefs of stakeholders about extent of implementation and effectiveness of NRHM’s health sector plans in improving MCH status and reducing inequalities. A total of 33 in-depth interviews (n = 33) with program managers, community representatives, mothers and 8 focus group discussions (n = 42) with health service providers were conducted from September to December 2013, in Haryana, post NRHM. Using NVivo software (version 9), an inductive applied thematic analysis was done based upon grounded theory, program theory of change and a framework approach. Almost all the participants reported that there was an improvement in overall health infrastructure through an increased availability of accredited social health activists, free ambulance services, and free treatment facilities in rural areas. This had increased the demand and utilization of MCH services, especially for those related to institutional delivery, even by the poor families. Service providers felt that acute shortage of human resources was a major health system level barrier. District-specific individual, community, and socio-political level barriers were also observed. Overall program managers, service providers and community representatives believed that NRHM had a role in improving MCH outcomes and in reduction of geographical and socioeconomic inequalities, through improvement in accessibility, availability and affordability of the MCH services in the rural areas and for the poor. Any reduction in gender-based inequalities, however, was linked to the adoption of small family sizes and an increase in educational levels. [ABSTRACT FROM AUTHOR]

Background: Early detection and intervention for chronic obstructive pulmonary disease (COPD) could potentially slow disease progress and minimize harm.Objectives: To assess the effectiveness of early intervention by a practice nurse-GP team on quality of life (QoL) and process of care in patients with newly diagnosed COPD, compared with usual care. Nurses and GPs in intervention practices were educated to develop and implement disease management plans for COPD.Methods: A 12-month, multicentre, pragmatic randomized controlled trial with blinded outcome assessment was conducted. Participants were current and former smokers aged 40 to 85 years newly identified as having COPD on post-bronchodilator spirometry. The primary outcome was health-related QoL, assessed with the St George's Respiratory Questionnaire (SGRQ). Secondary outcome measures were other QoL measures, lung function, disease knowledge, smoking and immunization status, inhaler technique and health service use.Results: Of the 10 234 patients from 36 practices in Sydney invited to a case-finding appointment, 1641 (16%) attended and 287 (18%) were diagnosed with COPD. Nineteen practices (144 patients) were randomized to the intervention group and 17 practices (110 patients) to the control group. Only 15.3% (n = 22) patients in the intervention group saw the nurse for COPD care following case finding. There was no between-group difference in SGRQ score at follow-up (mean difference -0.21; P = 0.86). Influenza vaccination was higher in the intervention group (OR 2.31: P = 0.035), but there were no other significant between-group differences in outcomes.Conclusion: Intervention uptake was low and had no additional beneficial effect, over usual care, on participants' health-related QoL. [ABSTRACT FROM AUTHOR]

The newly developed Assessment of Burden of COPD (ABC) scale is a 14-item self-administered questionnaire which measures the physical, psychological, emotional and/or social burden as experienced by patients with chronic obstructive pulmonary disease (COPD). The ABC scale is part of the ABC tool that visualises the outcomes of the questionnaire. The aim of this study was to assess the reliability and construct validity of the ABC scale. This multi-centre survey study was conducted in the practices of 19 general practitioners and 9 pulmonologists throughout the Netherlands. Next to the ABC scale, patients with COPD completed the Saint George Respiratory Questionnaire (SGRQ). Reliability analyses were performed with data from 162 cases. Cronbach's alpha was 0.91 for the total scale. Test-retest reliability, measured at a two week interval (n = 137), had an intra-class correlation coefficient of 0.92. Analyses for convergent validity were performed with data from 133 cases. Discriminant and known-groups validity was analysed with data from 162 cases. The ABC scale total score had a strong correlation with the total score of the SGRQ (r = 0.72, p < 0.001) but a weak correlation with the forced expired volume in 1 second predicted (r = -0.28, p < 0.001). Subgroups with more severe disease, defined by GOLD-stage, frequency of exacerbations, activity level and depression scored statistically significantly (p < 0.05) worse on almost all domains of the ABC scale than the less severe subgroups. The ABC scale seems a valid and reliable tool with good discriminative properties. [ABSTRACT FROM AUTHOR]

Background: Self-management is considered as an essential component of chronic care by primary care professionals. eHealth is expected to play an important role in supporting patients in their self-management. For effective implementation of eHealth it is important to investigate patients' expectations and needs regarding self-management and eHealth. The objectives of this study are to investigate expectations and needs of people with a chronic condition regarding self-management and eHealth for self-management purposes, their willingness to use eHealth, and possible differences between patient groups regarding these topics.Methods: Five focus groups with people with diabetes (n = 14), COPD (n = 9), and a cardiovascular condition (n = 7) were conducted in this qualitative research. Separate focus groups were organized based on patients' chronic condition. The following themes were discussed: 1) the impact of the chronic disease on patients' daily life; 2) their opinions and needs regarding self-management; and 3) their expectations and needs regarding, and willingness to use, eHealth for self-management purposes. A conventional content analysis approach was used for coding.Results: Patient groups seem to differ in expectations and needs regarding self-management and eHealth for self-management purposes. People with diabetes reported most needs and benefits regarding self-management and were most willing to use eHealth, followed by the COPD group. People with a cardiovascular condition mentioned having fewer needs for self-management support, because their disease had little impact on their life. In all patient groups it was reported that the patient, not the care professional, should choose whether or not to use eHealth. Moreover, participants reported that eHealth should not replace, but complement personal care. Many participants reported expecting feelings of anxiety by doing measurement themselves and uncertainty about follow-up of deviant data of measurements. In addition, many participants worried about the implementation of eHealth being a consequence of budget cuts in care.Conclusion: This study suggests that aspects of eHealth, and the way in which it should be implemented, should be tailored to the patient. Patients' expected benefits of using eHealth to support self-management and their perceived controllability over their disease seem to play an important role in patients' willingness to use eHealth for self-management purposes. [ABSTRACT FROM AUTHOR]

Introduction. Despite the high number of inactive patients with COPD, not all inactive patients are referred to physical therapy, unlike recommendations of general practitioner (GP) guidelines. It is likely that GPs take other factors into account, determining a subpopulation that is treated by a physical therapist (PT). The aim of this study is to explore the phenotypic differences between inactive patients treated in GP practice and inactive patients treated in GP practice combined with PT. Additionally this study provides an overview of the phenotype of patients with COPD in PT practice. Methods. In a cross-sectional study, COPD patient characteristics were extracted from questionnaires. Differences regarding perceived health status, degree of airway obstruction, exacerbation frequency, and comorbidity were studied in a subgroup of 290 inactive patients and in all 438 patients. Results. Patients treated in GP practice combined with PT reported higher degree of airway obstruction, more exacerbations, more vascular comorbidity, and lower health status compared to patients who were not referred to and treated by a PT. Conclusion. Unequal patient phenotypes in different primary care settings have important clinical implications. It can be carefully concluded that other factors, besides the level of inactivity, play a role in referral to PT. [ABSTRACT FROM AUTHOR]

Objective: The implemented multiple-strategy community intervention National Rural Health Mission (NRHM) between 2005 and 2012 aimed to reduce maternal and child health (MCH) inequalities across geographical, socioeconomic and gender categories in India. The objective of this study is to quantify the extent of reduction in these inequalities pre- and post-NRHM in Haryana, North India. Methods: Data of district-level household surveys (DLHS) held before (2002–04), during (2007–08), and after (2012–13) the implementation of NRHM has been used. Geographical, socioeconomic and gender inequalities in maternal and child health were assessed by estimating the absolute differences in MCH indicators between urban and rural areas, between the most advantaged and least advantaged socioeconomic groups and between male and female children. Logistic regression analyses were done to observe significant differences in these inequalities between 2005 and 2012. Results: There were significant improvements in all MCH indicators (p<0.05). The geographical and socioeconomic differences between urban and rural areas, and between rich and poor were significantly (p<0.05) reduced for pregnant women who had an institutional delivery (geographical difference declining from 22% to 7.6%; socioeconomic from 48.2% to 13%), post-natal care within 2 weeks of delivery (2.8% to 1.5%; 30.3% to 7%); and for children with full vaccination (10% to 3.5%, 48.3% to 14%) and who received oral rehydration solution (ORS) for diarrhea (11% to -2.2%; 41% to 5%). Inequalities between male and female children were significantly (p<0.05) reversed for full immunization (5.7% to -0.6%) and BCG immunization (1.9 to -0.9 points), and a significant (p<0.05) decrease was observed for oral polio vaccine (4.0% to 0%) and measles vaccine (4.2% to 0.1%). Conclusions: The implemented multiple-strategy community intervention National Rural Health Mission (NRHM) between 2005 and 2012 might have resulted in significant reductions in geographical, socioeconomic and gender inequalities in MCH in Haryana, as causal relationships cannot be established with descriptive research. [ABSTRACT FROM AUTHOR]

Background: Smokers with chronic obstructive pulmonary disease (COPD) seem to be a special subgroup of smokers that have a more urgent need to quit smoking but might find it more difficult to do so. This study aimed to explore which justifications for tobacco smoking and experiences of quitting were commonly shared in smokers with and without COPD, and which, if any, were specific to smokers with COPD. Methods: In ten primary healthcare centres in the Netherlands, we conducted semi-structured, in-depth interviews in 10 smokers with and 10 smokers without COPD. Results: Three themes were generated: 'balancing the impact on health of smoking', 'challenging of autonomy by social interference', 'prerequisites for quitting'. All participants trivialized health consequences of smoking; those with COPD seemed to be less knowledgeable about smoking and health. Both groups of smokers found autonomy very important. Smokers with COPD were indignant about a perceived lack of empathy in their communication with doctors. Furthermore, smokers with COPD in particular had little faith in the efficacy of smoking cessation aids. Lastly, motivation for quitting was dominated by fluctuation and smokers with COPD specifically maintained that their vision of life was linked with quitting. Conclusions: The participants showed many similarities in their reasoning about smoking and quitting. The corresponding themes argue for a less paternalistic regime in the communication with smokers with attention required for the motivational stage and room made for smokers' own views, and with clear information and education. Furthermore, addressing social interactions, health perceptions and moral agendas in the communication with smokers with COPD may help to make smoking cessation interventions more suitable for them. [ABSTRACT FROM AUTHOR]

Background: Infancy and childhood are characterized by rapid growth and development, which largely determine health status and well-being across the lifespan. Identification of modifiable risk factors and prognostic factors in critical periods of life will contribute to the development of effective prevention and intervention strategies. The LucKi Birth Cohort Study was designed and started in 2006 to follow children from birth into adulthood on a wide range of determinants, disorders, and diseases. During preschool and school years, the primary focus is on the etiology and prognosis of atopic diseases (eczema, asthma, and hay fever) and overweight/obesity.Methods/design: LucKi is an ongoing, dynamic, prospective birth cohort study, embedded in the Child and Youth Health Care (CYHC) practice of the 'Westelijke Mijnstreek' (a region in the southeast of the Netherlands). Recruitment (1-2 weeks after birth) and follow-up (until 19 years) coincide with routine CYHC contact moments, during which the child's physical and psychosocial development is closely monitored, and anthropometrics are measured repeatedly in a standardised way. Information gathered through CYHC is complemented with repeated parental questionnaires, and information from existing registries of pharmacy, hospital and/or general practice. Since the start already more than 5,000 children were included in LucKi shortly after birth, reaching an average participation rate of ~65 %.Discussion: The LucKi Birth Cohort Study provides a framework in which children are followed from birth into adulthood. Embedding LucKi in CYHC simplifies implementation, leads to low maintenance costs and high participation rates, and facilitates direct implementation of study results into CYHC practice. Furthermore, LucKi provides opportunities to initiate new (experimental) studies and/or to establish biobanking in (part of) the cohort, and contributes relevant information on determinants and health outcomes to policy and decision makers. Cohort details can be found on www.birthcohorts.net . [ABSTRACT FROM AUTHOR]

A multiple-strategy community intervention, known as National Rural Health Mission (NRHM), launched in India to improve the availability of and access to better-quality healthcare, especially for rural, poor mothers and children. The final goal of the intervention is to reduce maternal and child health inequalities across geographical areas, socioeconomic status groups, and sex of the child. Extensive, in-depth research is necessary to assess the effectiveness of NRHM, on multiple outcome dimensions. This paper presents the design of a new study, able to overcome the shortcomings of previous research. To propose a comprehensive, methodologically sound protocol to assess the extent of implementation and the effectiveness of NRHM measures to improve maternal and child health outcomes and reduce maternal and child health inequalities. A mixed-methods approach (quantitative and qualitative) is proposed for this study in Haryana, a state in North India. NRHM's health sector plans included health system strengthening, specific maternal and child healthcare strategies, and communitization. Mission documents and reports on progress, financial monitoring, and common and joint review will be reviewed in-depth to assess the extent of the implementation of plans. Data on maternal and child health indicators will be obtained from demographic health surveys held before, during, and after the implementation of the first phase of the NRHM (2005–2012) and compared over time. Differences in maternal and child health indicators will be used to measure maternal and child health inequalities; these will be compared pre- and post-NRHM. Focus group discussions (FGDs) with service providers and in-depth interviews with program managers, community representatives, and mothers will be conducted until data saturation is achieved, in two districts of Haryana. Using Nvivo software, an inductive qualitative content analysis will be performed to search for the broader themes across the interviews and FGDs. Ethical approval was obtained from the Ethics Committee of the Post Graduate Institute of Medical Education and Research. [ABSTRACT FROM AUTHOR]

Background: Chronic obstructive pulmonary disease (COPD) is recognized as a systemic illness with significant extra-pulmonary features, such as exercise intolerance and muscle weakness. Pulmonary rehabilitation has been shown to be very effective in counteracting these consequences in patients with more advanced COPD. However, limited data is available on the efficacy of a physical exercise training programme in patients with mild to moderate COPD in primary care. Furthermore, it is unknown if improved exercise capacity translates into enhanced daily physical activities. The aim of this paper is to describe the design of a randomized controlled trial to assess the efficacy of a physical exercise training programme in patients with mild to moderate COPD. Methods/design: In this randomized controlled trial situated in the primary care setting, 102 patients with mild to moderate airflow obstruction (FEV1 ≥ 50% of predicted), dyspnoea and a physically inactive lifestyle will be randomized to an intervention or control group. The intervention group receives a 4-month physical exercise training programme at a local physiotherapy practice, which includes exercise training, resistance training, breathing exercises and advises on how to increase the level of physical activity. The control group receives usual care, i.e. advises on how to increase the level of physical activity and a sham treatment at a local physiotherapy practice of which no physiological training stimulus can be expected. Primary outcome is functional exercise capacity at 4-months measured on the six-minute walk distance. Secondary outcomes include peripheral muscle strength, physical activity in daily life, health related quality of life, Medical Research Council (MRC) dyspnoea score and patients' perceived effectiveness. Follow-up measurement will take place at 6 months after baseline. Discussion: This will be one of the first studies to evaluate the efficacy of a physical exercise training programme in patients with mild to moderate COPD completely recruited and assessed in primary care. The results of this trial may give a unique insight into the potential of the implementation of an easy, close-to-home rehabilitation programme. [ABSTRACT FROM AUTHOR]

Wheezing is one of the most common respiratory symptoms in preschool children under six years old. Currently, no tests are available that predict at early stage who will develop asthma and who will be a transient wheezer. Diagnostic tests of asthma are reliable in adults but the same tests are difficult to use in children, because they are invasive and require active cooperation of the patient. A non-invasive alternative is needed for children. Volatile Organic Compounds (VOCs) excreted in breath could yield such non-invasive and patient-friendly diagnostic. The aim of this study was to identify VOCs in the breath of preschool children (inclusion at age 2–4 years) that indicate preclinical asthma. For that purpose we analyzed the total array of exhaled VOCs with Gas Chromatography time of flight Mass Spectrometry of 252 children between 2 and 6 years of age. Breath samples were collected at multiple time points of each child. Each breath-o-gram contained between 300 and 500 VOCs; in total 3256 different compounds were identified across all samples. Using two multivariate methods, Random Forests and dissimilarity Partial Least Squares Discriminant Analysis, we were able to select a set of 17 VOCs which discriminated preschool asthmatic children from transient wheezing children. The correct prediction rate was equal to 80% in an independent test set. These VOCs are related to oxidative stress caused by inflammation in the lungs and consequently lipid peroxidation. In conclusion, we showed that VOCs in the exhaled breath predict the subsequent development of asthma which might guide early treatment. [ABSTRACT FROM AUTHOR]

Background: In children, the prevalence's of both obesity and asthma are disconcertingly high. Asthmatic children with obesity are characterised by less asthma control and a high need for asthma medication. As the obese asthmatic child is becoming more common in the clinical setting and the disease burden of the asthma-obesity phenotype is high, there is an increasing need for effective treatment in these children. In adults, weight reduction resulted in improved lung function, better asthma control and less need for asthma medication. In children this is hardly studied. The Mikado study aims to evaluate the effectiveness of a long term multifactorial weight reduction intervention, on asthma characteristics in children with asthma and a high body weight. Methods/design: The Mikado study is a two-armed, randomised controlled trial. In total, 104 participants will be recruited via online questionnaires, pulmonary paediatricians, the youth department of the Municipal Health Services and cohorts of existing studies. All participants will be aged 6-16 years, will have current asthma, a Body Mass Index in the overweight or obesity range, and no serious comorbidities (such as diabetes, heart diseases). Participants in the intervention arm will receive a multifactorial intervention of 18 months consisting of sessions concerning sports, parental involvement, individual counselling and lifestyle advices including dietary advices and cognitive behavioural therapy. The control group will receive usual care. The primary outcome variables will include Forced Expiratory Volume in one second and Body Mass Index - Standard Deviation Score. Secondary outcomes will include other lung function parameters (including dynamic and static lung function parameters), asthma control, asthma-specific quality of life, use of asthma medication and markers of systemic inflammation and airway inflammation. Discussion: In this randomised controlled trial we will study the potential of a multifactorial weight reduction intervention to improve asthma-related outcome measures in asthmatic children with overweight. Moreover, it will provide information about the underlying mechanisms in the relationship between asthma and a high body weight in children. These findings can contribute to optimal management programs and better clinical guidelines for children with asthma and overweight. Trial registration: Clinicaltrial.gov NCT00998413 [ABSTRACT FROM AUTHOR]

Although only few studies have shown direct links between dopaminergic system genes and smoking onset, this does not rule out the effect of a gene-environment interaction on smoking onset. Therefore, the aim of this study was to examine the associations between smoking-specific parenting (i.e., frequency and quality of communication and house rules) and smoking onset while considering the potential moderating role of dopaminergic system genes (i.e., DRD2, DRD4, and DAT1 genotypes). Data from five annual waves of the ‘Family and Health’ project were used. At time 1, the sample comprised 365 non-smoking adolescents (200 younger adolescents, mean age = 13.31, SD = .48; 165 older adolescents, mean age = 15.19, SD = .57). Advanced longitudinal analyses were used (i.e., logistic regression analyses, (dual) latent growth curves, and cross-lagged path models). The results showed a direct effect of quality of communication on smoking onset. No direct effects were found for frequency of communication and house rules. Furthermore, no direct and moderating effects of the DRD2, DRD4, or DAT1 genotypes were found. In conclusion, the findings indicated that the effects of smoking-specific parenting on smoking are similar for adolescent carriers and non-carriers of the dopaminergic system genes. [ABSTRACT FROM AUTHOR]

There is an increasing interest in the potential of exhaled biomarkers, such as volatile organic compounds (VOCs), to improve accurate diagnoses and management decisions in pulmonary diseases. The objective of this manuscript is to systematically review the current knowledge on exhaled VOCs with respect to their potential clinical use in asthma, lung cancer, chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), and respiratory tract infections. A systematic literature search was performed in PubMed, EMBASE, Cochrane database, and reference lists of retrieved studies. Controlled, clinical, English-language studies exploring the diagnostic and monitoring value of VOCs in asthma, COPD, CF, lung cancer and respiratory tract infections were included. Data on study design, setting, participant characteristics, VOCs techniques, and outcome measures were extracted. Seventy-three studies were included, counting in total 3,952 patients and 2,973 healthy controls. The collection and analysis of exhaled VOCs is non-invasive and could be easily applied in the broad range of patients, including subjects with severe disease and children. Various research groups demonstrated that VOCs profiles could accurately distinguish patients with a pulmonary disease from healthy controls. Pulmonary diseases seem to be characterized by a disease specific breath-print, as distinct profiles were found in patients with dissimilar diseases. The heterogeneity of studies challenged the inter-laboratory comparability. In conclusion, profiles of VOCs are potentially able to accurately diagnose various pulmonary diseases. Despite these promising findings, multiple challenges such as further standardization and validation of the diverse techniques need to be mastered before VOCs can be applied into clinical practice. [ABSTRACT FROM AUTHOR]

Background: Rimonabant treatment, examined in Phase 3 trials, showed improvement of cardiovascular risk factors in obese patients. Objective: The objective of this Phase 4 trial is to assess the effectiveness of rimonabant plus lifestyle counselling when used in daily practice, namely in the general practice. The hypothesis was that the effectiveness in Phase 4 would be smaller than the efficacy in Phase 3 due to different patient selection and treatment conditions. At the end of this trial, rimonabant was suspended of all markets due to psychiatric side effects. Methods: This trial randomly assigned 222 patients with enlarged waist circumferences and hyperglycaemia or diabetes mellitus type 2, recruited from Dutch general practices, to double-blinded therapy with either placebo or rimonabant (20 mg/day) for 1 year in addition to lifestyle counselling. Results: Compared with placebo, the rimonabant group showed significant improvements in body weight, body mass index, high-density lipoprotein (HDL) cholesterol and the main outcome waist circumference after 1 year. The United Kingdom Prospective Diabetes Study risk calculation showed no significant difference. The rimonabant group showed statistically deterioration, compared with the placebo group, in the quality of life in the EuroQol and two domains of the SF-36: role limitations due to physical health problems and bodily pain. Conclusions: The unique real life data of this Phase 4 trial showed that the effectiveness of rimonabant in daily practice is indeed lower than in controlled circumstances (Phase 3). Rimonabant treatment showed improvement of obesity and the HDL cholesterol, but had no positive effect on the other cardiovascular risk factors and the quality of life. [ABSTRACT FROM AUTHOR]

Background Rimonabant treatment, examined in Phase 3 trials, showed improvement of cardiovascular risk factors in obese patients. Objective The objective of this Phase 4 trial is to assess the effectiveness of rimonabant plus lifestyle counselling when used in daily practice, namely in the general practice. The hypothesis was that the effectiveness in Phase 4 would be smaller than the efficacy in Phase 3 due to different patient selection and treatment conditions. At the end of this trial, rimonabant was suspended of all markets due to psychiatric side effects. Methods This trial randomly assigned 222 patients with enlarged waist circumferences and hyperglycaemia or diabetes mellitus type 2, recruited from Dutch general practices, to double-blinded therapy with either placebo or rimonabant (20 mg/day) for 1 year in addition to lifestyle counselling. Results Compared with placebo, the rimonabant group showed significant improvements in body weight, body mass index, high-density lipoprotein (HDL) cholesterol and the main outcome waist circumference after 1 year. The United Kingdom Prospective Diabetes Study risk calculation showed no significant difference. The rimonabant group showed statistically deterioration, compared with the placebo group, in the quality of life in the EuroQol and two domains of the SF-36: role limitations due to physical health problems and bodily pain. Conclusions The unique real life data of this Phase 4 trial showed that the effectiveness of rimonabant in daily practice is indeed lower than in controlled circumstances (Phase 3). Rimonabant treatment showed improvement of obesity and the HDL cholesterol, but had no positive effect on the other cardiovascular risk factors and the quality of life. [ABSTRACT FROM AUTHOR]

Objective To investigate whether smoke-free legislation in the Netherlands led to a decreased incidence of outof- hospital sudden circulatory arrest (SCA). Smoke-free legislation was implemented in two phases: a workplace ban in 2004 and an extension of this ban to the hospitality sector on 1 July 2008. Design Weekly incidence data on SCA were obtained from the ambulance registry of South Limburg, the Netherlands. Three time periods were distinguished: the pre-ban period (1 January 2002-1 January 2004), the first post-ban period (1 January 2004-1 July 2008) and the second post-ban period (1 July 2008-1 May 2010). Trends in absolute SCA incidence were analysed using Poisson regression, adjusted for population size, ambient temperature, air pollution and influenza rates. Results A total of 2305 SCA cases were observed (mean weekly incidence 5.3±2.3 SD). The adjusted Poisson regression model showed a small but significant increase in SCA incidence during the pre-ban period (+0.20% cases per week, p=0.044). This trend changed significantly after implementation of the first ban (with -0.24% cases per week, p=0.043), translating into a 6.8% (22 cases) reduction in the number of SCA cases after 1 year of smoke-free legislation. No further decrease was seen after the second smoking ban. Conclusions After introduction of a nationwide workplace smoking ban in 2004, a significant decrease in the incidence of out-of-hospital SCA was seen in South Limburg. Poor enforcement of the 2008 hospitality sector ban may account for the fact that no further decrease in the incidence of SCA was seen at this time. [ABSTRACT FROM AUTHOR]

To cite this article: van de Kant KDG, Jansen MA, Klaassen EMM, van der Grinten CP, Rijkers GT, Muris JWM, van Schayck OCP, Jöbsis Q, Dompeling E. Elevated inflammatory markers at preschool age precede persistent wheezing at school age. Pediatr Allergy Immunol 2012: 23: 259-264. Abstract Background: Wheeze is a heterogeneous symptom in preschool children. At preschool age it is hard to predict whether symptoms will pass or persist and develop into asthma. Our objective is to prospectively study whether inflammatory markers in exhaled breath condensate (EBC) and pre- and post-bronchodilator interrupter resistance (Rint) assessed at preschool age, are associated with wheezing phenotypes at school age. Methods: Children (N = 230) were recruited from the Asthma DEtection and Monitoring (ADEM) study. At preschool age [mean (SE): 3.3 (0.1) yr], pre- and post-bronchodilator Rint was assessed. EBC was collected using a closed glass condenser. Inflammatory markers (IL-2, IL-4, IL-8, IL-10, sICAM) were measured using multiplex immunoassay. Wheezing phenotypes at 5 yr of age were determined based on longitudinal assessment. Children were classified as: never (N = 47), early-transient (N = 89) or persistent wheezers (N = 94). Results: Persistent wheezers had elevated levels of all interleukins at preschool age compared to children who never wheezed (p < 0.05). EBC markers did not differ between the persistent and transient wheezers. There was no marked difference in Rint between wheezing phenotypes. Conclusions: We demonstrated that 5 yr old children with persistent wheeze already had elevated exhaled inflammatory markers at preschool age compared to never wheezers, indicating augmented airway inflammation in these children. [ABSTRACT FROM AUTHOR]

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 abstinence and prevent relapse. The results of this trial will give a unique insight in the potential of nicotine vaccination for relapse prevention. Trial registration: ClinicalTrials.gov: (NCT00995033) [ABSTRACT FROM AUTHOR]

To cite this article: Maas T, Dompeling E, Muris JWM, Wesseling G, Knottnerus JA, van Schayck OCP. Prevention of asthma in genetically susceptible children: A multifaceted intervention trial focussed on feasibility in general practice. Pediatr Allergy Immunol 2011: 22: 794-802. Abstract Background: Although the effectiveness of the multifaceted allergen-reducing interventions for the prevention of asthma in susceptible children was showed to be proven, the feasibility was not clear. Methods: The research question of the PREVention of asthma in susceptible children (PREVASC) trial was focused on the assessment of the effectiveness and feasibility of a multifaceted intervention on the prevention of allergic asthma in general practice. The effectiveness and feasibility of an intervention aimed at the simultaneous reduction in the environmental exposures to inhalant- and food allergens in susceptible children was investigated. A total of 476 children susceptible for developing asthma were initially included during pregnancy and were randomly divided over an intervention group of n = 222 children whose parents were offered a multifaceted environmental exposure-reducing intervention. Controls (n = 221) received usual care. The main outcome was 'diagnosis of allergic asthma at age 6'. Results: A significant reduction in inhalant allergen exposure levels of house dust mite [(Der p1), p = 0.043], cat [(Fel d1), p = 0.037], and dog [(Can f1), p = 0.012] was reached. Significantly more intervention group children started using cow's milk and solids after the age of 6 months (p ≤ 0.001). No statistical difference, however, was reached between groups on the duration of breast-feeding (p = 0.635) and the reduction in smoke exposure (p = 0829). At age 6, the intervention had no influence on the development of main outcome allergic asthma (OR = 1.010 (CI 0.580-1.758). Conclusion: Other primary preventive asthma-reducing interventions were shown to be effective in reducing the occurrence of asthma for at least the first 7-8 yr of life. The multifaceted PREVASC allergic asthma primary preventive intervention was effective in reducing the exposure to inhalant and food allergens, but was not feasible for the parents. A lack of sufficient room for improvement focus on stimulating adherence seemed to be involved. It is suggested that a multifaceted environmental exposure-reducing intervention may have to be adapted to the personal circumstances of patients at baseline. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Wheezing disorders in childhood vary widely in clinical presentation and disease course. During the last years, several ways to classify wheezing children into different disease phenotypes have been proposed and are increasingly used for clinical guidance, but validation of these hypothetical entities is difficult. Methodology/Principal Findings: The aim of this study was to develop a testable disease model which reflects the full spectrum of wheezing illness in preschool children. We performed a qualitative study among a panel of 7 experienced clinicians from 4 European countries working in primary, secondary and tertiary paediatric care. In a series of questionnaire surveys and structured discussions, we found a general consensus that preschool wheezing disorders consist of several phenotypes, with a great heterogeneity of specific disease concepts between clinicians. Initially, 24 disease entities were described among the 7 physicians. In structured discussions, these could be narrowed down to three entities which were linked to proposed mechanisms: a) allergic wheeze, b) non-allergic wheeze due to structural airway narrowing and c) nonallergic wheeze due to increased immune response to viral infections. This disease model will serve to create an artificial dataset that allows the validation of data-driven multidimensional methods, such as cluster analysis, which have been proposed for identification of wheezing phenotypes in children. Conclusions/Significance: While there appears to be wide agreement among clinicians that wheezing disorders consist of several diseases, there is less agreement regarding their number and nature. A great diversity of disease concepts exist but a unified phenotype classification reflecting underlying disease mechanisms is lacking. We propose a disease model which may help guide future research so that proposed mechanisms are measured at the right time and their role in disease heterogeneity can be studied. [ABSTRACT FROM AUTHOR]

Background: A strong increase in smoking is noted especially among adolescents. In the Netherlands, about 5% of all 10-year olds, 25% of all 13-year olds and 62% of all 17-year olds report ever smoking. In the U.S., an intervention program called "Smoke-free Kids" was developed to prevent children from smoking. The present study aims to assess the effects of this home-based smoking prevention program in the Netherlands. Methods/Design: A randomized controlled trial is conducted among 9 to 11-year old children of primary schools. Participants are randomly assigned to the intervention and control conditions. The intervention program consists of five printed activity modules designed to improve parenting skills specific to smoking prevention and parent-child communication regarding smoking. These modules will include additional sheets with communication tips. The modules for the control condition will include solely information on smoking and tobacco use. Initiation of cigarette smoking (first instance of puffing on a lighted cigarette), susceptibility to cigarette smoking, smoking-related cognitions, and anti-smoking socialization will be the outcome measures. To collect the data, telephone interviews with mothers as well as with their child will be conducted at baseline. Only the children will be examined at post-intervention follow-ups (6, 12, 24, and 36 months after the baseline). Discussion: This study protocol describes the design of a randomized controlled trial that will evaluate the effectiveness of a home-based smoking prevention program. We expect that a significantly lower number of children will start smoking in the intervention condition compared to control condition as a direct result of this intervention. If the program is effective, it is applicable in daily live, which will facilitate implementation of the prevention protocol. Trial registration: Netherlands Trial Register NTR1465 [ABSTRACT FROM AUTHOR]

To determine the effect of an out-of-hours primary care physician (PCP) cooperative on the caseload at the emergency department (ED) and to study characteristics of patients utilizing out-of-hours care. A pre–post intervention design was used. During a 3-week period before and a 3-week period after establishing the PCP cooperative, all patient records with out-of-hours primary and emergency care were analyzed. Primary care in Maastricht (the Netherlands) is delivered by 59 PCPs. Primary care physicians formerly organized out-of-hours care in small locum groups. In January 2000, out-of-hours primary care was reorganized, and a PCP cooperative was established. This cooperative is located at the ED of the University Hospital Maastricht, the city's only hospital, which has no emergency medicine specialists. The number of patients utilizing out-of-hours care, their age and sex, diagnoses, post-ED care, and serious adverse events. After establishing the PCP cooperative, the proportion of patients utilizing emergency care decreased by 53%, and the proportion of patients utilizing primary care increased by 25%. The shift was the largest for patients with musculoskeletal disorders or skin problems. There were fewer hospital admissions, and fewer subsequent referrals to the patient's own PCP and medical specialists. No substantial change in new outpatient visits at the hospital or in mortality occurred. In the city of Maastricht, the Netherlands, the PCP cooperative reduced the use of hospital emergency care during out-of-hours care. [ABSTRACT FROM AUTHOR]

This paper studies the effects of patient education, tailored to individual needs of patients as part of an asthma self-management program. A tailored education program was designed which took into account individual information needs of patients by using a feedback instrument. Totally 98 steroid dependent asthmatics entered the tailored education program, 95 patients received usual care. Outcome measures were information exchanged and patient satisfaction. Study duration was 6 months. Patients in the tailored education group showed a significant reduction in information need (P=0.005). Patient satisfaction increased from 87.9 to 93.7 in this group while this did not change in the usual care group (P=0.000). Use of this tailored education program improved the GP-patient interaction within the context of a clinically effective asthma self-management program. Findings from this study may be applicable to other chronic conditions as well. [ABSTRACT FROM AUTHOR]

Background: While any type of field-based research is challenging, building action-oriented, participatory research in resource-constrained settings can be even more so. Objective: In this article, we aim to examine and provide insights into some of the practical challenges that were faced during the course of a participatory project based in two non-notified slums in Bangalore, India, aiming to build solutions to indoor air pollution from cooking on traditional cook stoves. Methods: The article draws upon experiences of the authors as field researchers engaged in a community-based project that adopted an exploratory, iterative design to its planning and implementation, which involved community visits, semi-structured interviews, prioritization workshops, community forums, photo voice activities, chulha-building sessions and cooking trials. Results: The main obstacles to field work were linked to fostering open, continued dialogue with the community, aimed at bridging the gap between the 'scientific' and the 'local' worlds. Language and cultural barriers led to a reliance on interpreters, which affected both the quality of the interaction as well as the relationship between the researchers and the community that was built out of that interaction. The transience in housing and location of members of the community also led to difficulties in following up on incomplete information. Furthermore, facilitating meaningful participation from the people within the context of restricted resources, differing priorities, and socio-cultural diversity was particularly challenging. These were further compounded by the constraints of time and finances brought on by the embeddedness of the project within institutional frameworks and conventional research requirements of a fixed, pre-planned and externally determined focus, timeline, activities and benchmarks for the project. Conclusions: This article calls for revisiting of scientific conventions and funding prerequisites, in order to create spaces that support flexible, emergent and adaptive field-based research projects which can respond effectively to the needs and priorities of the community. [ABSTRACT FROM AUTHOR]

A response from authors of the article "The first reference equations for the 6-minute walk distance over a 10 m course" published in a 2014 issue of the journal is presented.

Rationale As primary care practice space is mostly limited to 10 m, the 6-minute walk test (6MWT) over a 10 m course is a frequently used alternative to evaluate patients' performance in COPD. Considering that course length significantly affects distance walked in 6 minutes (6MWD), this study aims to develop appropriate reference equations for the 10 m 6MWT. Methods 181 healthy subjects, aged 40- 90 years, performed two standardised 6MWTs over a straight 10 m course in a cross-sectional study. Results Average distance achieved was 578±108 m and differed between males and females (p<0.001). Resulting sex-specific reference equations from multiple regression analysis included age, body mass index and change in heart rate, explaining 62% of the variance in 6MWD for males and 71% for females. Conclusions The presented reference equations are the first to evaluate 6MWD over a 10 m course and expand the usefulness of the 6MWT. [ABSTRACT FROM AUTHOR]