Search

Background: The aim of this paper is to present the development of the Feel4Diabetes Healthy Diet Score and to evaluate its clinical validity. Methods: Study population consisted of 3268 adults (63% women) from high diabetes risk families living in 6 European countries. Participants filled in questionnaires at baseline and after 1 year, reflecting the dietary goals of the Feel4Diabetes intervention. Based on these questions the Healthy Diet Score was constructed, consisting of the following components: breakfast, vegetables, fruit and berries, sugary drinks, whole-grain cereals, nuts and seeds, low-fat dairy products, oils and fats, red meat, sweet snacks, salty snacks, and family meals. Maximum score for each component was set based on its estimated relative importance regarding T2DM risk, higher score indicating better quality of diet. Clinical measurements included height, weight, waist circumference, heart rate, blood pressure, and fasting blood sampling, with analyses of glucose, total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides. Analysis of (co) variance was used to compare the Healthy Diet Score and its components between countries and sexes using baseline data, and to test differences in clinical characteristics between score categories, adjusted for age, sex and country. Pearson's correlations were used to study the association between changes from baseline to year 1 in the Healthy Diet Score and clinical markers. To estimate reproducibility, Pearson's correlations were studied between baseline and 1 year score, within the control group only. Results: The mean total score was 52.8 ± 12.8 among women and 46.6 ± 12.8 among men (p < 0.001). The total score and its components differed between countries. The change in the Healthy Diet Score was significantly correlated with changes in BMI, waist circumference, and total and LDL cholesterol. The Healthy Diet Score as well as its components at baseline were significantly correlated with the values at year 1, in the control group participants. Conclusion: The Feel4Diabetes Healthy Diet Score is a reproducible method to capture the dietary information collected with the Feel4Diabetes questionnaire and measure the level of and changes in the adherence to the dietary goals of the intervention. It gives a simple parameter that associates with clinical risk factors in a meaningful manner. Trial registration: Clinicaltrials.gov NCT02393872. Registered March 20, 2015. [ABSTRACT FROM AUTHOR]

Background: Accounting for patients' perspective has become increasingly important. Based on the Consumer Quality Index method (founded on Consumer Assessment of Healthcare Providers and Systems) a questionnaire was recently developed for Dutch cancer patients. As a next step, this study aimed to adapt and pilot this questionnaire for international comparison of cancer patients experience and satisfaction with care in six European countries.Method: The Consumer Quality Index was translated into the local language at the participating pilot sites using cross-translation. A minimum of 100 patients per site were surveyed through convenience sampling. Data from seven pilot sites in six countries was collected through an online and paper-based survey. Internal consistency was tested by calculating Cronbach's alpha and validity by means of cognitive interviews. Demographic factors were compared as possible influencing factors.Results: A total of 698 patients from six European countries filled the questionnaire. Cronbach's alpha was good or satisfactory in 8 out of 10 categories. Patient satisfaction significantly differed between the countries. We observed no difference in patient satisfaction for age, gender, education, and tumor type, but satisfaction was significantly higher in patients with a higher level of activation.Conclusion: This European Cancer Consumer Quality Index(ECCQI) showed promising scores on internal consistency (reliability) and a good internal validity. The ECCQI is to our knowledge the first to measure and compare experiences and satisfaction of cancer patients on an international level, it may enable healthcare providers to improve the quality of cancer care. [ABSTRACT FROM AUTHOR]

Background: Health care organizations need to be responsive to the needs of increasingly diverse patient populations. We compared the contents of six publicly available approaches to organizational responsiveness to diversity. The central questions addressed in this paper are: what are the most consistently recommended issues for health care organizations to address in order to be responsive to the needs of diverse groups that differ from the majority population? How much consensus is there between various approaches?Methods: We purposively sampled six approaches from the US, Australia and Europe and used qualitative textual analysis to categorize the content of each approach into domains (conceptually distinct topic areas) and, within each domain, into dimensions (operationalizations). The resulting classification framework was used for comparative analysis of the content of the six approaches.Results: We identified seven domains that were represented in most or all approaches: organizational commitment, empirical evidence on inequalities and needs, a competent and diverse workforce, ensuring access for all users, ensuring responsiveness in care provision, fostering patient and community participation, and actively promoting responsiveness. Variations in the operationalization of these domains related to different scopes, contexts and types of diversity. For example, approaches that focus on ethnic diversity mostly provide recommendations to handle cultural and language differences; approaches that take an intersectional approach and broaden their target population to vulnerable groups in a more general sense also pay attention to factors such as socio-economic status and gender.Conclusions: Despite differences in labeling, there is a broad consensus about what health care organizations need to do in order to be responsive to patient diversity. This opens the way to full scale implementation of organizational responsiveness in healthcare and structured evaluation of its effectiveness in improving patient outcomes. [ABSTRACT FROM AUTHOR]

Background: People experiencing homelessness (PEH) are known to be at higher risk of adverse health outcomes and premature mortality when compared to the housed population and often face significant barriers when attempting to access health services. This study aimed to better understand the specific health care needs of PEH and the barriers and facilitators associated with their timely and equitable access to health services in the European context. Methods: We conducted an exploratory cross-national qualitative study involving people with lived experience of homelessness and health and social care professionals in Austria, Greece, Spain, and the UK. A total of 69 semi-structured interviews comprising 15 social care professionals, 19 health care professionals, and 35 PEH were completed, transcribed, and analysed thematically. Results: Findings were organised into three overarching themes relating to the research question: (a) Health care needs of PEH, (b) Barriers to health care access, and (c) Facilitators to health care access. Overall, the general health of PEH was depicted as extremely poor, and mainstream health services were portrayed as ill-equipped to respond to the needs of this population. Adopting tailored approaches to care, especially involving trusted professionals in the delivery of care, was identified as a key strategy for overcoming existing barriers. Conclusions: The results of this study indicate there to be a high degree of consistency in the health care needs of PEH and the barriers and facilitators associated with their access to health care across the various European settings. Homelessness in itself is recognized to represent an essential social determinant of health, with PEH at risk of unequal access to health services. Changes are thus required to facilitate PEH's access to mainstream primary care. This can also be further complemented by investment in 'in-reach' services and other tailored and person-centred forms of health care. Trial registration: This study was registered retrospectively on June 6, 2022, in the registry of ClinicalTrials.gov under the number NCT05406687. [ABSTRACT FROM AUTHOR]

Background: The proportion of elderly is on the rise both in Europe and in Hungary. The challenge is to increase the number of years spent in good health as well as to improve quality of life of those 60 years and above. This study focuses on the impact of physical activity on this age group.Methods: A nationally representative sample of 2000 respondents were surveyed in an age range of 15-74. Our data concerns those being 60-74 years of age. The focus of our investigation was level and impact of physical activity in the group above. First, we used Chi-squared tests and correspondence analysis to identify the deviation in the answers of different groups in our sample. After we built a hierarchical linear regression model to get a deeper understanding of the impact of physical activity for elderly.Results: Those reporting no physical/sports activity at all have to do with the negative culture of exercising. Only 9.3% reported being engaged with any sports; 72% reported no regular exercising throughout their lives. The relationship between sport activity and self-reported health was significant (p = 0.009, Cramer's V = 0.2). Elderly were characterized by walking, hiking and less intense sports.Conclusions: Those who actively exercised in this research reported better health outcomes than those who stopped or had never been engaged in any sports. We conclude that of all variables tested, physical activity was most effective to improve personal health of the elderly in this sample. Compared to European data on physical activity of elderly populations, Hungary seems to fall behind and needs to consider concentrated efforts to improve the future health of its senior populace. [ABSTRACT FROM AUTHOR]

Background: Public health organizations have been alerted to the high levels of sedentary behaviour (SB) among adolescents as well as to the health and social consequences of excess sedentary time. However, SB changes of the European Union (EU) adolescents over time have not been reported yet. This study aimed to identify SB of the EU adolescents (15-17 years) in four-time points (2002, 2005, 2013 and 2017) and to analyse the prevalence of SB according to the sex.Methods: SB of 2542 adolescents (1335 boys and 1207 girls) as a whole sample and country-by-country was analysed in 2002, 2005, 2013, and 2017 using the Sport and Physical Activity EU Special Eurobarometers' data. SB was measured using the sitting time question from the short version of the International Physical Activity Questionnaire (IPAQ), such that 4h30min of daily sitting time was the delineating point to determine excess SB behaviour (≥4h30min of sitting time) or not (≤4h30min of sitting time). A χ2 test was used to compare the prevalence of SB between survey years. Furthermore, SB prevalence between sexes was analysed using a Z-Score test for two population proportions.Results: The prevalence of SB among EU adolescents across each of the four survey years ranged from 74.2 and 76.8%, rates that are considered high. High levels of SB were also displayed by both sexes (girls: 76.8 to 81.2%; boys: 71.7 to 76.7%). No significant differences in the prevalence of SB among years (p > 0.05) were found for the whole sample, and for either girls or boys. Also, no significant differences in the prevalence of SB between girls and boys were found.Conclusion: The SB prevalence in European adolescents is extremely high (76.8% in 2017) with no differences between girls and boys. No significant improvements have been seen between 2002 and 2017. Eurobarometer should increase the adolescents' sample to make possible benchmarking comparisons among the EU countries and extend the survey to the younger children population. [ABSTRACT FROM AUTHOR]

Background: Assessment of diet and physical activity and their determinants still remains a demanding task, especially when the objective is to evaluate the efficacy of lifestyle interventions. In the context of the Feel4Diabetes study (a European community based intervention study in families with school aged children and at high risk of developing diabetes), we aimed to develop questionnaires for the assessment of food-frequency and eating behaviors, and physical activity and sedentary behaviors in both parents and school-aged children and a questionnaire for overall family's energy balance-related behaviors. Methods: Questionnaires were developed to be used in 6 countries under standardized harmonization procedures and included questions regarding not only food intake and physical activity, but also questions of their determinants. A reliability study was conducted in 191 pairs of parents and their children (N = 191). Parents completed the questionnaires on two occasions, within a 1–2 week interval. Reliability was tested by the intra-class correlation coefficients (ICC) of test-retest. Results: Most of the questions in all questionnaires had excellent reliability, assessed as an ICC of > 0.810. Mean ICCs for food-frequency and eating behaviors questionnaires were 0.838 and 0.787, and for physical activity and sedentary behaviors questionnaires were 0.734 and 0.793, in adults and children respectively. Mean ICC for overall family's energy balance-related behaviors and their determinants was 0.659. Conclusion: The developed questionnaires showed acceptable reliability and may be valuable tools in the assessment of children's and parents' behaviors related to diet, physical activity, sedentary behavior and overall energy balance in school- and community-based interventions. [ABSTRACT FROM AUTHOR]

Background: Traumatic injury is the fourth leading cause of death globally. Half of all trauma deaths are due to bleeding and most of these will occur within 6 h of injury. Haemorrhagic shock following injury has been shown to induce a clotting dysfunction within minutes, and this early trauma-induced coagulopathy (TIC) may exacerbate bleeding and is associated with higher mortality and morbidity. In spite of improved resuscitation strategies over the last decade, current transfusion therapy still fails to correct TIC during ongoing haemorrhage and evidence for the optimal management of bleeding trauma patients is lacking. Recent publications describe increasing the use of Viscoelastic Haemostatic Assays (VHAs) in trauma haemorrhage; however, there is insufficient evidence to support their superiority to conventional coagulation tests (CCTs).Methods/design: This multicentre, randomised controlled study will compare the haemostatic effect of an evidence-based VHA-guided versus an optimised CCT-guided transfusion algorithm in haemorrhaging trauma patients. A total of 392 adult trauma patients will be enrolled at major trauma centres. Participants will be eligible if they present with clinical signs of haemorrhagic shock, activate the local massive haemorrhage protocol and initiate first blood transfusion. Enrolled patients will be block randomised per centre to either VHA-guided or CCT-guided transfusion therapy in addition to that therapy delivered as part of standard care, until haemostasis is achieved. Patients will be followed until discharge or 28 days. The primary endpoint is the proportion of subjects alive and free of massive transfusion (less than 10 units of red blood cells) at 24 h. Secondary outcomes include the effect of CCT- versus VHA-guided therapy on organ failure, total hospital and intensive care lengths of stay, health care resources needed and mortality. Surviving patients will be asked to complete a quality of life questionnaire (EuroQol EQ-5DTM) at day 90.Discussion: CCTs have traditionally been used to detect TIC and monitor response to treatment in traumatic major haemorrhage. The use of VHAs is increasing, but limited evidence exists to support the superiority of these technologies (or comparatively) for patient-centred outcomes. This knowledge gap will be addressed by this trial.Trial Registration: ClinicalTrials.gov, ID: NCT02593877 . Registered on 15 October 2015. Trial sponsor Queen Mary University of London The contact person of the above sponsor organisation is: Dr. Sally Burtles, Director of Research Services and Business Development, Joint Research Management Office, QM Innovation Building, 5 Walden Street, London E1 2EF; phone: 020 7882 7260; Email: sponsorsrep@bartshealth.nhs.uk Trial sites Academic Medical Centre, Amsterdam, The Netherlands Kliniken der Stadt Köln gGmbH, Cologne, Germany Rigshospitalet (Copenhagen University Hospital), Copenhagen, Denmark John Radcliff Hospital, Oxford, United Kingdom Oslo University Hospital, Oslo, Norway The Royal London Hospital, London, United Kingdom Centre for Trauma Sciences, Blizard Institute, Queen Mary University of London, London, United Kingdom Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom Sites that are planning to start recruitment in mid/late 2017 Nottingham University Hospitals, Queen's Medical Centre, Nottingham, United Kingdom University of Kansas Hospital (UKH), Kansas City, MO, USA Protocol version: 3.0/14.03.2017 (Additional file 1). [ABSTRACT FROM AUTHOR]

Background: Understanding of the physical, functional and psychosocial health problems and needs of cancer survivors requires cross-national and cross-cultural standardization of health-related quality of life (HRQoL) questionnaires that capture the full range of issues relevant to cancer survivors. To our knowledge, only one study has investigated in a comprehensive way whether a questionnaire used to evaluate HRQoL in cancer patients under active treatment is also reliable and valid when used among (long-term) cancer survivors. In this study we evaluated, in an international context, the psychometrics of HRQoL questionnaires for use among long-term, disease-free, survivors of testicular and prostate cancer.Methods: In this cross-sectional study, we recruited long-term survivors of testicular and prostate cancer from Northern and Southern Europe and from the United Kingdom who had participated in two phase III EORTC clinical trials. Participants completed the SF-36 Health Survey, the EORTC QLQ-C30 questionnaire, the QLQ-PR25 (for prostate cancer) or the QLQ-TC26 (for testicular cancer) questionnaires, and the Impact of Cancer questionnaire. Testicular cancer survivors also completed subscales from the Nordic Questionnaire for Monitoring the Age Diverse Workforce.Results: Two hundred forty-two men (66% response rate) were recruited into the study. The average time since treatment was more than 10 years. Overall, there were few missing questionnaire data, although scales related to sexuality, satisfaction with care and relationship concerns of men without partners were missing in more than 10% of cases. Debriefing showed that in general the questionnaires were accepted well. Many of the survivors scored at the upper extremes of the questionnaires, resulting in floor and ceiling effects in 64% of the scales. All of the questionnaires investigated met the threshold of 0.70 for group level reliability, with the exception of the QLQ-TC26 (mean reliability .64) and the QLQ-PR25 (mean reliability .69). The questionnaires were able to discriminate clearly between patients with and without comorbid conditions.Conclusions: The currently available HRQoL questionnaires exhibit acceptable psychometric properties and were well received by patients, but additional efforts are needed to ensure that the full range of survivor-specific issues is assessed. [ABSTRACT FROM AUTHOR]

Background: Effective, accessible, and affordable depression treatment is of high importance considering the large personal and economic burden of depression. Internet-based treatment is considered a promising clinical and cost-effective alternative to current routine depression treatment strategies such as face-to-face psychotherapy. However, it is not clear whether research findings translate to routine clinical practice such as primary or specialized mental health care. The E-COMPARED project aims to gain knowledge on the clinical and cost-effectiveness of blended depression treatment compared to treatment-as-usual in routine care.Methods/design: E-COMPARED will employ a pragmatic, multinational, randomized controlled, non-inferiority trial in eight European countries. Adults diagnosed with major depressive disorder (MDD) will be recruited in primary care (Germany, Poland, Spain, Sweden, and the United Kingdom) or specialized mental health care (France, The Netherlands, and Switzerland). Regular care for depression is compared to "blended" service delivery combining mobile and Internet technologies with face-to-face treatment in one treatment protocol. Participants will be followed up at 3, 6, and 12 months after baseline to determine clinical improvements in symptoms of depression (primary outcome: Patient Health Questionnaire-9), remission of depression, and cost-effectiveness. Main analyses will be conducted on the pooled data from the eight countries (n = 1200 in total, 150 participants in each country).Discussion: The E-COMPARED project will provide mental health care stakeholders with evidence-based information and recommendations on the clinical and cost-effectiveness of blended depression treatment.Trial Registration: France: ClinicalTrials.gov NCT02542891 . Registered on 4 September 2015; Germany: German Clinical Trials Register DRKS00006866 . Registered on 2 December 2014; The Netherlands: Netherlands Trials Register NTR4962 . Registered on 5 January 2015; Poland: ClinicalTrials.Gov NCT02389660 . Registered on 18 February 2015; Spain: ClinicalTrials.gov NCT02361684 . Registered on 8 January 2015; Sweden: ClinicalTrials.gov NCT02449447 . Registered on 30 March 2015; Switzerland: ClinicalTrials.gov NCT02410616 . Registered on 2 April 2015; United Kingdom: ISRCTN registry, ISRCTN12388725 . Registered on 20 March 2015. [ABSTRACT FROM AUTHOR]

Background: Health workforce (HWF) planning and monitoring processes face challenges regarding data and appropriate indicators. One such area fraught with difficulties is labour activity and, more specifically, defining headcount and full-time equivalent (FTE). This study aims to review national practices in FTE calculation formulas for selected EU Member States (MS).Methods: The research was conducted as a part of the Joint Action on European Health Workforce Planning and Forecasting. Definitions, categories and terms concerning the five sectoral professions were examined in 14 MS by conducting a survey. To gain a deeper understanding of the international data-reporting processes (Joint Questionnaire on Non-Monetary Health Care Statistics-JQ), six international expert interviews were conducted by using a semi-structured interview guide.Results: Of the 14 investigated countries, four MS indicated that they report FTE to the JQ and that they also calculate FTE data for national planning purposes. The other countries do not use FTE data for national purposes, but most of them do use special calculations and/or estimation methods for converting headcount to FTE. The findings revealed significant differences between national calculation methods when reporting FTE data to the JQ. This diversity in terms of calculations and estimations can lead to biases with respect to international comparisons. This finding was reinforced by the expert interviews, since the experts agreed that the activities of healthcare professionals are a fundamental factor in HWF monitoring and planning. Experts underscored that activity should also be measured by FTE, and not only by headcount.Conclusions: FTE and headcount are significant factors in HWF planning and monitoring; therefore, national data collections should place emphasis on collecting data and calculating the appropriate indicators. National FTE could serve as a call to action for HWF planners due to the lack of matching international FTE data. At the international level, it is beneficial to monitor the trends and numbers regarding human resources and working time. For the moment, the exchange of information and mutual assistance for developing the capacity to apply common methodology could be a first step towards the standardisation of data collections. [ABSTRACT FROM AUTHOR]

Background: The factors related to the treatment of nausea during pregnancy have not yet been investigated in several countries simultaneously. The present study aimed to describe differences in self-reported nausea during pregnancy and the patterns of use for both conventional and herbal medicines across countries. The factors related to nausea and its treatment and the relationships between different self-reported co-morbidities and nausea were also investigated.Methods: This cross-sectional study used data collected by a web-based questionnaire distributed between October 2011 and February 2012 in several countries within five regions: Western, Northern, and Eastern Europe, North America, and Australia. Women who were pregnant or had a child less than one year old were eligible to participate.Results: A total of 9113 women were included in the study, whereof 6701 (73.5%) had experienced nausea during pregnancy. Among respondents with nausea, conventional medicines were used by 1201 (17.9%) women and herbal medicines by 556 (8.3%) women. The extent of self-reported nausea and its treatment varied by country. Education, working status, and folic acid use were significantly associated with the use of conventional medicines against nausea. Respondents who had nausea also had a high burden of co-morbidity.Conclusion: The prevalence of nausea was high across all participating countries but its treatment varied, possibly due to cultural differences and differences in attitudes towards medicines. A high degree of co-morbidity was found among respondents with nausea. [ABSTRACT FROM AUTHOR]

Background: It is possible that some people who quit smoking experience improved mental health after cessation and therefore remain abstinent, whereas other people who quit may experience worse mental health after cessation and therefore be more likely to relapse to smoking. Thus, in this study we aimed to examine the association between an enduring change in mental health following the cessation period and future risk of relapse.Methods: A secondary analysis of prospective data pooled from five placebo-controlled randomised trials for smoking reduction conducted in Europe, USA and Australia. Change in mental health (SF-36, scored 0-100) was measured from baseline to four months for those who were biologically-validated as point-prevalence abstainers at four month follow-up. Thereafter we assessed whether relapse to smoking by 12 months was more likely in those whose mental health had worsened between baseline and four months compared with those who saw no change or an improvement.Results: After adjustment for baseline mental health and other major covariates, there was no greater tendency to relapse at 12 months for those whose mental health worsened after cessation compared with those who had no change or an improvement. The odds ratio and 95% confidence interval was 1.01 (0.97 to 1.05).Conclusions: People whose mental health worsens after smoking cessation are at no greater risk of subsequent relapse to smoking than those whose mental health stays the same or improves. [ABSTRACT FROM AUTHOR]

The number of people living with advanced cancer and chronic disease has increased worldwide. Many of these patients could benefit from palliative care, focusing on optimising the quality of life of patients and their families facing problems resulting from lifethreatening diseases. However, fragmentation and discontinuity of palliative care services often result in suboptimal palliative care. In order to overcome these problems, models using an integrated care approach are increasingly advocated in palliative care services. Although several models and definitions of Integrated Palliative Care (IPC) have been developed, the effects of integrated care are still under-investigated. Knowledge of the key components that constitute successful palliative care integration is still lacking. This mixed methods study will examine the experiences of patients, family caregivers and professional caregivers in order to provide insight into the mechanisms that constitute successful palliative care integration. Methods/Design Prospective multiple embedded case study. Three to five integrated palliative care initiatives will be selected in Belgium, Germany, Hungary, The Netherlands and the United Kingdom. Data collection will involve Social Network Analysis (SNA), a patient diary, semi-structured interviews, and questionnaires: Palliative care Outcome Scale (POS), Canhelp Lite, Caregiver Reaction Assessment (CRA). Patients and family caregivers will be followed in 4 consecutive contact moments over 3 months. The diary will be kept weekly by patients. One focus group per initiative will be conducted with professional caregivers. Interviews and focus groups will be tape recorded, transcribed and qualitatively analysed using NVivo 10. SPSS Statistics 20 will be used for statistical analysis. Discussion This study will provide valuable knowledge about barriers, opportunities and good practices in palliative care integration in the selected initiatives across countries. This knowledge can be used in the benchmark of integrated palliative care initiatives across Europe. It will add to the scientific evidence for IPC services internationally and will contribute to improvements in the quality of care and the quality of living and dying of severely ill patients and their relatives in Europe. [ABSTRACT FROM AUTHOR]

Background: Little is known about factors that determine health status decline in clinical trials of COPD.Objectives: To examine health status changes over 3 years in the TORCH study of salmeterol+fluticasone propionate (SFC) vs. salmeterol alone, fluticasone propionate alone or placebo.Methods: St George's Respiratory Questionnaire (SGRQ) was administered at baseline then every 6 months.Measurements and Main Results: Data from 4951 patients in 28 countries were available. SFC produced significant improvements over placebo in all three SGRQ domains during the study: (Symptoms -3.6 [95% CI -4.8, -2.4], Activity -2.8 [95% CI -3.9, -1.6], Impacts -3.2 [95% CI -4.3, -2.1]) but the pattern of change over time differed between domains. SGRQ deteriorated faster in patients with Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages III & IV relative to GOLD stage II (p < 0.001). There was no difference in the relationship between deterioration in SGRQ Total score and forced expiratory volume in one second (FEV1) decline (as % predicted) in men and women. Significantly faster deterioration in Total score relative to FEV1 % predicted was seen in older patients (≥ 65 years) and there was an age-related change in Total score that was independent of change in FEV1. The relationship between deterioration in FEV1 and SGRQ did not differ in different world regions, but patients in Asia-Pacific showed a large improvement in score that was unrelated to FEV1 change.Conclusions: In addition to treatment effects, health status changes in clinical trials may be influenced by demographic and disease-related factors. Deterioration in health status appears to be fastest in older persons and those with severe airflow limitation.Trial Registration: ClinicalTrials.gov: NCT00268216. [ABSTRACT FROM AUTHOR]

Background: The long-term efficacy and safety of aclidinium bromide, a novel, long-acting muscarinic antagonist, were investigated in patients with moderate to severe chronic obstructive pulmonary disease (COPD).Methods: In two double-blind, 52-week studies, ACCLAIM/COPD I (n=843) and II (n=804), patients were randomised to inhaled aclidinium 200 μg or placebo once-daily. Patients were required to have a post-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity ratio of ≤70% and FEV1<80% of the predicted value. The primary endpoint was trough FEV1 at 12 and 28 weeks. Secondary endpoints were health status measured by St George's Respiratory Questionnaire (SGRQ) and time to first moderate or severe COPD exacerbation.Results: At 12 and 28 weeks, aclidinium improved trough FEV1 versus placebo in ACCLAIM/COPD I (by 61 and 67 mL; both p<0.001) and ACCLAIM/COPD II (by 63 and 59 mL; both p<0.001). More patients had a SGRQ improvement≥4 units at 52 weeks with aclidinium versus placebo in ACCLAIM/COPD I (48.1% versus 39.5%; p=0.025) and ACCLAIM/COPD II (39.0% versus 32.8%; p=0.074). The time to first exacerbation was significantly delayed by aclidinium in ACCLAIM/COPD II (hazard ratio [HR] 0.7; 95% confidence interval [CI] 0.55 to 0.92; p=0.01), but not ACCLAIM/COPD I (HR 1.0; 95% CI 0.72 to 1.33; p=0.9). Adverse events were minor in both studies.Conclusion: Aclidinium is effective and well tolerated in patients with moderate to severe COPD.Trial Registration: ClinicalTrials.gov: NCT00363896 (ACCLAIM/COPD I) and NCT00358436 (ACCLAIM/COPD II). [ABSTRACT FROM AUTHOR]

Background: Consumers' conviction of the benefits of probiotics is influenced by their existing beliefs and by the information they receive from healthcare professionals. The attitude of healthcare professionals towards commercially available probiotics will, therefore, determine how trustworthy and beneficial these products are perceived by consumers. Furthermore, due to European Union legislation, companies are prohibited from displaying information on product packaging; therefore, consumers are dependent primarily on healthcare professionals for correct information and guidance on the use of these products. The aim of this pilot study was to explore the understanding and use of probiotics in clinical practice by professionals who are involved in child healthcare in different European countries and to assess how much they value the scientific evidence behind these products. Methods: The study was performed using a cross-sectional, descriptive, 30-question online questionnaire circulated among healthcare professionals belonging to three professional categories that are typically involved in childhood probiotic prescription: paediatricians, dieticians and general practitioners. The questionnaire was developed using web-based standard guidelines, and the questions were modelled on those used in previously published probiotics studies. Results: Overall, 27,287 healthcare professionals belonging to three major European scientific societies were contacted by the organizations participating in the study. In total, 1360 valid questionnaires were recorded, and the results were statistically analysed. Conclusions: The results emphasize the importance for healthcare professionals to be properly educated and updated on probiotics. An improved knowledge about probiotics led to increased prescriptive confidence. To disseminate accurate information on probiotics, healthcare professionals look for appropriate and scientifically validated educational platforms to acquire information, explore concerns and barriers and look for positive approaches towards recommending probiotics. [ABSTRACT FROM AUTHOR]

Background: Family carers manage a wide range of responsibilities in the lives and care of patients receiving palliative care. They fulfil multiple roles and perform activities within different settings. This has immediate consequences on family carers’ every-day lives. According to literature, family carers in palliative care are both part of the formal and informal care network, but also persons in need of support. This article aims to investigate 1) burdens and rewards associated with family caregiving and 2) what family carers find helpful in their contact with professionals from integrated palliative care initiatives (IPC-i) and other services. Methods: Family carers looking after patients with cancer, chronic obstructive pulmonary disease or chronic heart failure were purposefully recruited at 22 IPC-i in Belgium, Germany, Hungary, the Netherlands and the United Kingdom in the course of the project “Patient-centred palliative care pathways in advanced cancer and chronic disease” (InSup-C). Semi-structured interviews (n = 156) and 87 quantitative questionnaires (CRA, POS, CANHELP Lite) were conducted with family carers. Interviews were analysed with transnationally agreed thematic codes (MAXQDA or NVivo). Statistical tests (SPSS) were carried out in accordance with the characteristic value of the items and distributions. Results: On average, quantitative data showed moderate burden, but the qualitative findings indicated that this burden might be underrated. There is some evidence that IPC-i with well-developed professional care networks and communication systems relieved family carers’ burden by direct and indirect interventions; e.g. provision of night shift nurses or psychological support. Needs of family carers were similar in all participating countries. However, in all countries IPC-i mostly offered one-off events for family carers, lacking systematic or institutionalised support structures. Conclusions: Data suggest that, most IPC-i did not pay enough attention to the needs of most family carers, and did not offer proactive care and access to supportive resources to them (e.g. training, respite care, access to resources). We recommend recognizing family carers as part of the ‘unit of care’ and partner in caregiving, to improve their knowledge about, and access to, and the support available. [ABSTRACT FROM AUTHOR]