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We performed a systematic survey of original papers published in The Lancet throughout the years 1945, 1946, 1970 and 1995. The Lancet was chosen due to a conservative layout through these years, and the year 1946 added to the analysis to ponder for any war-induced bias. The general layout and structure of the journal were indeed maintained throughout these years. The number of authors per paper increased steadily (from 1.7 +/- 1.3 in 1945 to 6.4 +/- 3.4 in 1995), as well as the number of papers written on behalf of investigation groups (from 1 in 1945 to 37 in 1995). Major changes were observed in the area of origin of the papers, from an overwhelming British Isles' preponderance (87% of papers published in 1945) to a partake with Continental Europe, America and international groups (27, 33, 15 and 12%, respectively of the 1995 papers). The most often addressed fields of medicine shifted from war-, surgery- and microbiology-related subjects in 1945 towards cardiology-, oncology-, and virus-related works in 1995. The most impressive and enduring change was the increase in the use of statistical tools for data analysis and presentation (0.3% of papers in 1945 vs. 60% in 1995).

Background Value-based healthcare (VBHC) is a conceptual framework to improve the value of healthcare by health, care-process and economic outcomes. Benchmarking should provide useful information to identify best practices and therefore a good instrument to improve quality across healthcare organizations. This paper aims to provide a proof-of-concept of the feasibility of an international VBHC benchmarking in breast cancer, with the ultimate aim of being used to share best practices with a data-driven approach among healthcare organizations from different health systems. Methods In the VOICE community—a European healthcare centre cluster intending to address VBHC from theory to practice—information on patient-reported, clinical-related, care-process-related and economic-related outcomes were collected. Patient archetypes were identified using clustering techniques and an indicator set following a modified Delphi was defined. Benchmarking was performed using regression models controlling for patient archetypes and socio-demographic characteristics. Results Six hundred and ninety patients from six healthcare centres were included. A set of 50 health, care-process and economic indicators was distilled for benchmarking. Statistically significant differences across sites have been found in most health outcomes, half of the care-process indicators, and all economic indicators, allowing for identifying the best and worst performers. Conclusions To the best of our knowledge, this is the first international experience providing evidence to be used with VBHC benchmarking intention. Differences in indicators across healthcare centres should be used to identify best practices and improve healthcare quality following further research. Applied methods might help to move forward with VBHC benchmarking in other medical conditions. [ABSTRACT FROM AUTHOR]

This special issue of Social Studies of Science centers on the topic of regulation in medicine and, in particular, on the notion of regulatory objectivity, defined as a new form of objectivity in biomedicine that generates conventions and norms through concerted programs of action based on the use of a variety of systems for the collective production of evidence. The papers in the special issue suggest ways in which the notion of regulatory objectivity can be tested, extended, revised, or superseded by more appropriate notions. They insist on the need to examine more closely clinical-therapeutic (and not just clinical-research) activities, and to pay more attention to the activities of regulatory agencies such as the US Food and Drug Administration and to standard-setting organizations. They call attention to the professional and organizational activities surrounding the mobilization of conventions for regulating clinical practices. Finally, they provide material that can help us to think about how analytical notions such as regulatory objectivity may or may not inform interventionist research projects. [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: Hospital governance is broadening its orientation from cost and production controls towards 'improving performance on clinical outcomes'. Given this new focus one might assume that doctors are drawn into hospital management across OECD countries. Hospital performance in terms of patient health, quality of care and efficiency outcomes is supposed to benefit from their involvement. However, international comparative evidence supporting this idea is limited. Just a few studies indicate that there may be a positive relationship between medical doctors being part of hospital boards, and overall hospital performance. More importantly, the assumed relationship between these so-called doctor managers and hospital performance has remained a 'black-box' thus far. However, there is an increasing literature on the implementation of quality management systems in hospitals and their relation with improved performance. It seems therefore fair to assume that the relation between the involvement of doctors in hospital management and improved hospital performance is partly mediated via quality management systems. The threefold aim of this paper is to 1) perform a quick scan of the current situation with regard to doctor managers in hospital management in 19 OECD countries, 2) explore the phenomenon of doctor managers in depth in 7 OECD countries, and 3) investigate whether doctor involvement in hospital management is associated with more advanced implementation of quality management systems.Methods: This study draws both on a quick scan amongst country coordinators in OECD's Health Care Quality Indicator program, and on the DUQuE project which focused on the implementation of quality management systems in European hospitals.Results: This paper reports two main findings. First, medical doctors fulfil a broad scope of managerial roles at departmental and hospital level but only partly accompanied by formal decision making responsibilities. Second, doctor managers having more formal decision making responsibilities in strategic hospital management areas is positively associated with the level of implementation of quality management systems.Conclusions: Our findings suggest that doctors are increasingly involved in hospital management in OECD countries, and that this may lead to better implemented quality management systems, when doctors take up managerial roles and are involved in strategic management decision making. [ABSTRACT FROM AUTHOR]

Background: This paper critically reviews published tools and indicators currently used to measure maternity care performance within Europe, focusing particularly on whether and how current approaches enable systematic appraisal of processes of minimal (or non-) intervention in support of physiological or "normal birth". The work formed part of COST Actions IS0907: "Childbirth Cultures, Concerns, and Consequences: Creating a dynamic EU framework for optimal maternity care" (2011-2014) and IS1405: Building Intrapartum Research Through Health - an interdisciplinary whole system approach to understanding and contextualising physiological labour and birth (BIRTH) (2014-). The Actions included the sharing of country experiences with the aim of promoting salutogenic approaches to maternity care.Methods: A structured literature search was conducted of material published between 2005 and 2013, incorporating research databases, published documents in english in peer-reviewed international journals and indicator databases which measured aspects of health care at a national and pan-national level. Given its emergence from two COST Actions the work, inevitably, focused on Europe, but findings may be relevant to other countries and regions.Results: A total of 388 indicators were identified, as well as seven tools specifically designed for capturing aspects of maternity care. Intrapartum care was the most frequently measured feature, through the application of process and outcome indicators. Postnatal and neonatal care of mother and baby were the least appraised areas. An over-riding focus on the quantification of technical intervention and adverse or undesirable outcomes was identified. Vaginal birth (no instruments) was occasionally cited as an indicator; besides this measurement few of the 388 indicators were found to be assessing non-intervention or "good" or positive outcomes more generally.Conclusions: The tools and indicators identified largely enable measurement of technical interventions and undesirable health (or pathological medical) outcomes. A physiological birth generally necessitates few, or no, interventions, yet most of the indicators presently applied fail to capture (a) this phenomenon, and (b) the relationship between different forms and processes of care, mode of birth and good or positive outcomes. A need was identified for indicators which capture non-intervention, reflecting the reality that most births are low-risk, requiring few, if any, technical medical procedures. [ABSTRACT FROM AUTHOR]

Aim: To investigate nursing/midwifery students, Clinical Mentors, Link Teachers and Head Nurses experiences within "Dedicated Education Unit" model in 6 European clinical placements and analyse the necessary elements for a powerful clinical learning environment. Design: A multi‐country, phenomenological, qualitative study. Methods: Focus group interviews were performed to identify the personal and organizational factors of importance for students and nurses/midwives. Results: Data analysis produced 4 main themes (1) Clinical placement organization, (2) students' clinical knowledge and skill acquisition, (3) students, and nurses/midwives' experiences within the DEU model and (4) factors for creating an effective learning environment. Conclusions: A close educational‐service collaboration, a realistic clinical placement planning, a focus on student learning process and an investment in professionals' education and development among others, are elements to set up a powerful clinical learning environment. Implications for the profession: It is considered advisable and urgent to improve the working conditions of nurses/midwives and the learning environments of students as a strategy to alleviate the global shortage of nurses and respond to the increasingly demanding health needs of the population. Impact: Due to the close relationship between students' learning and features of the clinical environment nurse educators seek innovative models which allow students to manage patient care and their transition to professional practice. To implement new learning strategies, identifying students, nurses and midwives perceptions and suggestions is a powerful information to evaluate implementation process and outcomes. Public Contribution: Our findings could help academic and clinical managers to meet the human and organizational requirements to create a successful learning environment in every student placement. [ABSTRACT FROM AUTHOR]

Background: Since the early 1980s all European countries have given priority to reforming the management of health services. A distinctive feature of these reforms has also been the drive to co-opt professionals themselves into the management of services, taking on full time or part time (hybrid) management or leadership roles. However, although these trends are well documented in the literature, our understanding of the nature and impact of reforms and how they are re-shaping the relationship between medicine and management remains limited. Most studies have tended to be nationally specific, located within a single discipline and focused primarily on describing new management practices. This article serves as an Introduction to a special issue of BMC Health Services Research which seeks to address these concerns. It builds on the work of a European Union funded COST Action (ISO903) which ran between 2009 and 2013, focusing specifically on the changing relationship between medicine and management in a European context., Main Text: Prior to describing the contributions to the special issue, this Introduction sets the scene by exploring four main questions which have characterised much of the recent literature on medicine and management. First is the question of what we understand by the changing relationship between medicine and management and in particular which this means for the emergence of so called 'hybrid' clinical leader roles? A second question concerns the forces that have driven change, in particular those relating to the wider project of management reforms. Third, we raise questions of how medical professionals have responded to these changes and what factors have shaped their responses. Lastly we consider what some of the outcomes of greater medical involvement in management and leadership might be, both in terms of intended and unintended outcomes., Conclusions: The paper concludes by summarising the contributions to the special issue and highlighting the need to extend research in this area by focusing more on comparative dimensions of change. It is argued that future research would also benefit theoretically by drawing together insights from health policy and management literatures.

This paper provides an overview of the rapidly evolving paradigm of "Integrative Mental Health (IMH)." The paradigm of contemporary biomedical psychiatry and its contrast to non-allopathic systems of medicine is initially reviewed, followed by an exploration of the emerging paradigm of IMH, which aims to reconcile the bio-psycho-socio-spiritual model with evidence-based methods from traditional healing practices. IMH is rapidly transforming conventional understandings of mental illness and has significant positive implications for the day-to-day practice of mental health care. IMH incorporates mainstream interventions such as pharmacologic treatments, psychotherapy, and psychosocial interventions, as well as alternative therapies such as acupuncture, herbal and nutritional medicine, dietary modification, meditation, etc. Two recent international conferences in Europe and the United States show that interest in integrative mental health care is growing rapidly. In response, the International Network of Integrative Mental Health (INIMH: www.INIMH.org) was established in 2010 with the objective of creating an international network of clinicians, researchers, and public health advocates to advance a global agenda for research, education, and clinical practice of evidence-based integrative mental health care. The paper concludes with a discussion of emerging opportunities for research in IMH, and an exploration of potential clinical applications of integrative mental health care., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Work-integrated learning (WIL) responds to the labor market's requests by fostering students' competency acquisition and development through active methodologies and profession-oriented practices. This training system means that both academic and workplace tutors guide and supervise the student. The research goal was to identify the tutors' professional profiles in WIL. This study's qualitative methodology is based on data triangulation obtained by the Delphi method, focus groups and a literature review. The participants are international experts in WIL. The outcome of the research is a set of specific and transversal competencies and functions for both types of tutors who guide and supervise students throughout their learning process in a workplace-based university program. In conclusion, the results enabled the establishment of a basis on which to identify WIL professionals working in different territories, as well as create professional development training for such agents involved in this innovative system. [ABSTRACT FROM AUTHOR]

The article discusses the approach of clinical trials in Europe. There have always been challenges in terms of clinical trials in the region because everyone tries to understand Europe as a political entity. Furthermore, the clinical trials keep slipping between the gaps in European Union (EU) rules.

Background: Lifting The Burden (LTB) and European Headache Federation (EHF) have developed a set of headache service quality indicators, successfully tested in specialist headache centres. Their intended application includes all levels of care. Here we assess their implementation in primary care. Methods: We included 28 primary-care clinics in Germany (4), Turkey (4), Latvia (5) and Portugal (15). To implement the indicators, we interviewed 111 doctors, 92 nurses and medical assistants, 70 secretaries, 27 service managers and 493 patients, using the questionnaires developed by LTB and EHF. In addition, we evaluated 675 patients' records. Enquiries were in nine domains: diagnosis, individualized management, referral pathways, patient education and reassurance, convenience and comfort, patient satisfaction, equity and efficiency of headache care, outcome assessment and safety. Results: The principal finding was that Implementation proved feasible and practical in primary care. In the process, we identified significant quality deficits. Almost everywhere, histories of headache, especially temporal profiles, were captured and/or assessed inaccurately. A substantial proportion (20%) of patients received non-specific ICD codes such as R51 ("headache") rather than specific headache diagnoses. Headache-related disability and quality of life were not part of routine clinical enquiry. Headache diaries and calendars were not in use. Waiting times were long (e.g., about 60 min in Germany). Nevertheless, most patients (> 85%) expressed satisfaction with their care. Almost all the participating clinics provided equitable and easy access to treatment, and follow-up for most headache patients, without unnecessary barriers. Conclusions: The study demonstrated that headache service quality indicators can be used in primary care, proving both practical and fit for purpose. It also uncovered quality deficits leading to suboptimal treatment, often due to a lack of knowledge among the general practitioners. There were failures of process also. These findings signal the need for additional training in headache diagnosis and management in primary care, where most headache patients are necessarily treated. More generally, they underline the importance of headache service quality evaluation in primary care, not only to identify-quality failings but also to guide improvements. This study also demonstrated that patients' satisfaction is not, on its own, a good indicator of service quality. [ABSTRACT FROM AUTHOR]

Aims This study aims to explore the feasibility of using routine hospital discharge data, at the level of countries within Europe, to estimate the general population prevalence of alcohol dependence (AD). Methods We utilised the European Core Health Indicators data tool to extract the annual rate of hospital discharges due to any wholly attributable alcohol condition as defined by the ICD-10. For those counties with data available, we systematically searched Medline, EMBASE, PsychINFO and Google for studies reporting an estimate of the prevalence of AD from national cross-sectional surveys. We compared these prevalence estimates with those developed from prediction models based on hospital discharge data. Results The rate of hospital discharges due to any condition from the F10 diagnostic category (mental and behavioural disorders due to alcohol) was moderately correlated with AD prevalence (r  = 0.56), while the rate due to any condition from the K70 diagnostic category (alcoholic liver disease) was weakly correlated with AD prevalence (r  = 0.21). Two-thirds of the estimates from cross-sectional surveys were not significantly different to those generated using the F10 discharge rate prediction model. Conclusions Country-level AD prevalence estimates generated using annual F10 hospital discharge rates are likely to provide information of some utility, particularly when limited other sources of information are available or when examining relative trends over time or between regions. There is, however, currently insufficient evidence to make a definitive recommendation to use hospital discharge data to estimate the absolute prevalence of AD per country in Europe. [ABSTRACT FROM AUTHOR]

Background: Nabiximols (THC/CBD Oromucosal Spray, Sativex) is used as an add-on therapy to treat moderate to severe spasticity of Multiple Sclerosis (MS). Objectives: To examine the impact of physiotherapy (PT) programs on effectiveness and persistence of nabiximols treatment in people with MS-related spasticity. Methods: This is an observational multicenter study with a follow-up period of 12 weeks, conducted in routine care settings in Italy. Patients with moderate to severe MS-related spasticity who started nabiximols were included. Spasticity was evaluated by the patient-rated 0–10 numerical rating scale (NRS). Clinical data were collected at baseline (T0), 4 weeks (T1) and 12 weeks (T2) months after enrollment. Results: A total of 297 MS patients were selected, 290 completed the 3 months follow-up period. Mean NRS scores were 7.6 ± 1.1 at T0, 5.8 ± 1.4 at T1 and 5.5 ± 1.5 at T2. At T1, 77% of patients reached ≥20% improvement (initial response, IR); 22% reached ≥30% improvement (clinically relevant response, CRR). At T1, patients undergoing PT had a higher probability to reach CRR (Odds Ratio = 2.6 95% CI 1.3–5.6, p = 0.01). Nabiximols was discontinued in 30/290 (10.3%) patients at T1 (early discontinuers) and in 71/290 (24.5%) patients at T2 (late discontinuers). The probability of being late discontinuers was reduced in patients undergoing PT (Hazard Ratio = 0.41; 95% CI 0.23–0.69, p = 0.001). Conclusions: Our real-life study confirms nabiximols’ effectiveness in MS-related spasticity and suggests that the association of a PT program may improve overall response and persistence to nabiximols treatment. [ABSTRACT FROM AUTHOR]

Background: Despite improvements in treatment for rheumatoid arthritis (RA), psoriatic arthritis (PsA) and spondyloarthritis (axSpA), several key unmet needs remain, such as fatigue. The objective of this study was to describe the severity of fatigue, disease characteristics and socioeconomic factors in people with RA, PsA and axSpA. Methods: The study was designed as a cross-sectional survey collecting patient characteristics such as disease characteristics, socioeconomic factors and fatigue in people with RA, PsA and axSpA in Denmark. Respondents were consecutively recruited for the study over a six-month period in 2018 via routine visits to outpatient rheumatology clinics. Study nurses collected information on diagnosis, current disease-related treatment and disease activity from medical journals. People were invited to complete a questionnaire related to socioeconomic factors and containing the FACIT-Fatigue subscale. Descriptive statistics were analyzed using SAS. Results: We invited 633 people to participate, and 488 (77%) completed the questionnaire. Women constituted 62% of respondents, and the mean age was 53.5 years. Respondents had on average been diagnosed between 11 and 15 years ago. Overall, 79% had no changes to their disease-related treatment during the past year, and the average disease activity as indicated by DAS28 for RA and PsA was 2.48 and 2.36, respectively, and BASDAI for axSpA was 28.40. Fatigue was present in all three diagnoses (mean: 34.31). The mean fatigue score varied from respondents answering that they suffered from no or little fatigue (mean: 45.48) to extreme fatigue (mean: 10.11). Analyses demonstrated that the respondents were not considerably different from nonrespondents, and the study population is considered representative compared with Danish RA and axSpA patients in the Danish National Rheumatology Registry, the DANBIO database. Conclusion: We found that the majority of the study population were fatigued (61%). They had low disease activity and few disease-related treatment changes. [ABSTRACT FROM AUTHOR]

Background: The objective of the present study was to evaluate effectiveness, complications and cost-effectiveness of any surgical or non-surgical treatment for radius or ulna fractures in elderly patients. Secondary objectives were to analyze present treatment traditions of distal radius fractures (DRF) in Sweden and to calculate resource usage for its treatment. Methods and findings: The assessment contains a systematic review of clinical and health economic studies comparing treatment options for radius or ulna fractures. The results regarding the effectiveness of the treatments are summarized in meta-analyses. In addition, the assessment contains a cost analysis for different treatment options commonly used for DRF care, and an analysis of registry data on the incidence and treatment of DRF. In total 31 randomized controlled trials were included in meta-analyses. When comparing functional outcome for plate fixation versus non-surgical treatment for DRF, there were no clinically important differences at one-year follow-up (mean difference [MD], -3.29, 95% CI, -7.03; 0.44). Similar results were found when comparing plating and percutaneous methods with respect to functional outcome (standardized mean difference [SMD], -0.07, 95% CI, -0.21; 0.07) and grip strength (MD, -3.47, 95% CI, -11.21; 4.28). There were no differences for minor complications, (risk difference [RD], -0.01, 95% CI, -0.07; 0.05) whereas major complications were less common for the percutaneous group, (RD, 0.02, 95% CI, 0.02; 0.03). Given the low number of studies, the evidence above was rated as moderate certainty. The cost for plate fixation versus plaster cast was estimated to 1698 compared to 137 US dollars. For DRF, plate fixation increased in Sweden between 2005 and 2013, and was the most common surgical method in 2013. Conclusions: Surgical treatment of moderately displaced distal radius fractures in elderly patients offers no clear benefit compared to non-surgical treatment. Plating procedures have become more common during the second millennium and involve higher costs and higher risk of major complications than percutaneous options. [ABSTRACT FROM AUTHOR]

Background: Substantial variations are still to be found in the strength of general practice/family medicine (GP/FM) across Europe regarding governance, workforce competence and performance, as well as academic development and position. Governments are encouraged by the WHO to secure high quality primary health care to their population, a necessity for reaching the goal "Health for all". The present study aimed at investigating the opinions of council members of the European Academy of Teachers in General Practice (EURACT) on necessary actions to strengthen the position of GP/FM in their country. Methods: The study used a mixed methods exploratory sequential design. EURACT representatives from 32 European countries first participated in brain-storming on how to strengthen GP/FM in Europe. Later, representatives from 37 countries were asked to individually score the relevance of the proposed actions for their country on a 9-point Likert scale. They were also asked to evaluate the status of GP/FM in their country on four dimensions. Results: Respondents from 30 European countries returned complete questionnaires. To build and secure GP/FM as an academic discipline comprising teaching and research was seen as essential, regardless the present status of GP/FM in the respective country. To build GP/FM as a specialty on the same level as other specialties was seen as important in countries where GP/FM held a strong or medium strong position. The importance of common learning objectives and a defined bibliography were stated by respondents from countries where GP/FM presently has a weak position. Conclusions: In order to strengthen GP/FM throughout Europe, EURACT and other professional organizations must establish common goals and share expertise between countries. To influence decision makers through information on cost-effectiveness of a GP/FM-based health care system is also important. [ABSTRACT FROM AUTHOR]

Background: Demographic changes are leading to an ageing population in Europe, and predict an increase in the number of nursing home residents over the next 30 years. Nursing home residents need specialised healthcare services such as radiology due to both chronic and acute illnesses. Mobile radiography, x-ray examinations performed in the nursing homes, may be a good way of providing services to this population. The aim of this systematic review was to identify the outcomes of mobile radiography services for nursing home residents and society.Methods: A systematic review based on searches in the Medline, Cochrane, PubMed, Embase and Svemed + databases was performed. Titles and abstracts were screened according to a predefined set of inclusion criteria: empirical studies in the geriatric population, and reports of mobile radiography services in a clinical setting. All publications were quality appraised using MMAT or CASP appraisal tools. Data were extracted using a summary table and results were narratively synthesised.Results: Ten publications were included. Three overarching outcomes were identified: 1) reduced number of hospitalisations and outpatient examinations or treatments, 2) reduced number of transfers between nursing homes and hospitals and 3) increased access to x-ray examinations. These outcomes were interlinked with the more specific outcomes for residents and society reported in the literature. For residents there was a reduction in burdensome transfers and waiting time and adequate treatment and care increased. For society, released resources could be used more efficiently, and overall costs were reduced substantially.Conclusions: This review indicates that mobile radiography services for nursing home residents in the western world are of comparable quality to hospital-based examinations and have clear potential benefits. Mobile radiography reduced transfers to and from hospital, increased the number of examinations carried out and facilitated timely diagnosis and access to treatments. Further research is needed to formally evaluate potential improvements in care quality and cost-effectiveness. [ABSTRACT FROM AUTHOR]

Background: Severe aortic stenosis (AS) is a common, serious valve disease in which no effective medical therapy is available and, if not treated by intervention, has a 5-year survival of only 40-60%. Despite the availability of guidelines supporting the effective use of surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) to treat the majority of these patients, adherence to these guidelines in clinical practice is still unsatisfactory. Several recent studies have emphasised the necessity for improved communication between multidisciplinary teams, with the aim to ensure that severe AS patients receive appropriate treatment.Methods/design: IMPULSE is a prospective, multicentre, European registry designed to gather data over 12 months on the treatment decisions made by referring physicians for patients newly diagnosed with severe AS. Each patient has a follow-up of 3 months. The study will consist of two observational phases to assess the appropriateness and rate of referral based on current guidelines prior to and after an interventional phase aiming to determine whether a simple quality of care intervention improves patient management.Discussion: Data will be analysed firstly, to determine the appropriateness of treatment decisions for the management of severe AS in current European clinical practice, and secondly, to evaluate the effectiveness of facilitated data relay from a designated echocardiography department nurse to the referring physician early after diagnosis in improving quality of care. Additionally, variables will be identified that are associated with inappropriate decision-making. Collectively, the aim will be to design a clinical pathway that will improve the timely management of patients with newly diagnosed severe AS. [ABSTRACT FROM AUTHOR]

Background: Following the amendment of the Pharmaceutical Affairs Law in Japan in 2003 researchers were permitted to begin investigator-initiated trials (IITs). In subsequent years, however, the number of IITs remained low. In other countries in Asia as well as in Europe, North America, and South Africa, the number of IITs has increased over the past decade. The differences in the characteristics of IITs between Japan and other countries are unknown. Some studies have analyzed the characteristics of all clinical trials according to registry databases, but there has been less research focusing on IITs. Aims: The purpose of this study is to analyze the characteristics of IITs in the registry and in the three Japanese registries, to identify differences in IITs between Japan and other countries. Methods: Using Thomson Reuters Pharma™, trials sponsored by academia and government as IITs in 2010 and registered in were identified. IITs from 2004 to 2012 in Japan were identified in the three Japanese registries: the University Hospital Medical Information Network Clinical Trials Registry, the Japan Pharmaceutical Information Center Clinical Trials Information, and the Japan Medical Association Center for Clinical Trials, Clinical Trials Registry. Characterization was made of the trial purposes, phases, participants, masking, arms, design, controls, and other data. Results: New and revised IITs registered in during 2010 averaged about 40% of all sponsor-identified trials. IITs were nearly all early-phase studies with small numbers of participants. A total of 56 Japanese IITs were found over a period of 8 years, and these were also almost nearly all early-phase studies with small numbers of participants. Conclusion: There appear to be no great differences between Japan and other countries in terms of characteristics of IITs. These results should prompt a new review of the IIT environment in Japan. [ABSTRACT FROM AUTHOR]

Background: Triple therapy including Telaprevir or Boceprevir still represents in many European countries the standard of care for patients with Hepatitis C Virus genotype 1 infection. The number of patients who received this treatment resulted generally lower than expected. We investigated, among naïve patients, number and characteristics of treatment candidates who were started on triple or dual therapy in comparison to those who were deferred. Patients and Methods: 621 naïve treatment candidates were prospectively evaluated at each center. Factors associated with decision to defer or treat with dual or triple therapy were investigated by univariate and multivariate analyses. Rates of Sustained Virological Response and safety profile were analysed. Results: Of candidates to treatment, 33% did not received it. It was mostly due to high risk of Interferon-induced decompensation. Of 397 patients who were started on treatment, 266 (67%) received triple, 131 dual. Among patient receiving treatment, unfavorable IL28B, severe liver damage and higher albumin were independently associated with the physician decision to administer triple therapy. Sustained Virological Response after dual therapy was 66.4%, after triple 73.7% (p = 0.14). 142 patients received Telaprevir. The choice of Telaprevir-based therapy was associated with higher Body Mass Index and advanced liver disease. Sustained Virological Response rates were 71.1% after Telaprevir and 76.6% after Boceprevir. Conclusions: Individualizing treatment with available regimens allows to maximize Sustained Virological Response and to reduce the number of patients who remain untreated. High proportion of patients with severe liver damage urgently need Interferon free treatment. [ABSTRACT FROM AUTHOR]

Introduction: Evidence-based recommendations are needed to guide the acute management of the bleeding trauma patient. When these recommendations are implemented patient outcomes may be improved. Methods: The multidisciplinary Task Force for Advanced Bleeding Care in Trauma was formed in 2005 with the aim of developing a guideline for the management of bleeding following severe injury. This document represents an updated version of the guideline published by the group in 2007 and updated in 2010. Recommendations were formulated using a nominal group process, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) hierarchy of evidence and based on a systematic review of published literature. Results: Key changes encompassed in this version of the guideline include new recommendations on the appropriate use of vasopressors and inotropic agents, and reflect an awareness of the growing number of patients in the population at large treated with antiplatelet agents and/or oral anticoagulants. The current guideline also includes recommendations and a discussion of thromboprophylactic strategies for all patients following traumatic injury. The most significant addition is a new section that discusses the need for every institution to develop, implement and adhere to an evidence-based clinical protocol to manage traumatically injured patients. The remaining recommendations have been re-evaluated and graded based on literature published since the last edition of the guideline. Consideration was also given to changes in clinical practice that have taken place during this time period as a result of both new evidence and changes in the general availability of relevant agents and technologies. Conclusions: A comprehensive, multidisciplinary approach to trauma care and mechanisms with which to ensure that established protocols are consistently implemented will ensure a uniform and high standard of care across Europe and beyond. [ABSTRACT FROM AUTHOR]

Background: The European Union (EU) lacks adequate capacity for public health monitoring. The creation of a stable European Health Information System would help Member States to carry out evidence-based health policy. Such a system would also benefit EU health priorities by providing European wide comparable information. This study is the first comprehensive assessment of the availability of general health data in Europe. Methods: The main aim was to assess the availability of the European Community Health Indicators (ECHI) in each EU Member State. This was done by means of a review of international health databases, an online survey and face-to-face discussions with experts in 31 European countries. Results: The European average availability score for all ECHI indicators was 74% ranging from 56% to 84%. In most countries, about half of the ECHI indicators can be derived from routinely collected health information. This is true for demographic information, mortality and hospital discharge-based morbidity. However, many important ECHI indicators are lacking in most European countries. These include population representative data for health determinants, the provision and use of health care services, injuries, the quality of health care and health promotion. Conclusion: Valid health information is essential for improving people's health across Europe. There is an urgent need to develop harmonized methods for gathering and disseminating representative health data. These methods should be developed jointly by DG Health and Consumers, Eurostat and EU Member States. [ABSTRACT FROM PUBLISHER]

Introduction: The quality of presentations at medical conferences is of major importance. The publication rate (PR) following congress presentation is an indicator of the extent and quality of a scientific society's activity. The purpose of this study was to investigate publication rates in the Spine Society of Europe (SSE), compare them with the results for American spine societies, and determine factors affecting publication. Materials and methods: All 839 abstracts of podium and poster presentations at SSE congresses held in 2000-2003 were investigated. PRs in peer-reviewed journals within a period of 5 years were assessed. Subgroup analyses were performed for different study types. The consistency of abstracts with publications was also analyzed. Results: The overall PR was 37.8%, with a mean of 17.7 ± 15.7 months between congress and publication and a mean impact factor of 1.8 ± 1.0 at the time of publication. Comparatively high PRs were found for podium presentations versus posters, studies with higher versus lower levels of evidence, experimental versus clinical studies, prospective versus retrospective studies, randomized versus nonrandomized studies, studies reporting significant main results versus those without, and multicenter studies versus single-center studies. Biomechanical studies also achieved high PRs. Conclusion: The PR was similar to that of NASS (40%) and only slightly inferior to that of SRS (47%) and ISSLS (45%). This shows the high quality of presentations at SSE congresses. The fate of unpublished abstracts is worth further consideration. It is questionable whether it is acceptable to cite abstracts that have not passed a journal's peer-review process and to implement their results in clinical practice. [ABSTRACT FROM AUTHOR]

Background: Quality indicators are increasingly being implemented in Europe for policy and management purposes. Many of these indicators were initially developed and implemented in the USA. However, the suitability of directly adopting indicators that have been developed in a different health care system can be questioned. Therefore, we investigate the validity behind the readmission rate indicator in the European setting. Methods: A systematic literature study was conducted to identify the status of scientific research on the validity of this indicator (January 1999 and April 2010). Descriptive information as well as information on the data source, indicator definition, risk adjustment factors, and conclusions was assessed. Results: The majority of the 486 included studies focused on the actual use of the indicator as an outcome measure in European countries. Only 21 studies specifically addressed its validity, or important prerequisites of validity. There is little consensus over the time-frame used to calculate the indicator, the type of readmission that is included, and the case-mix adjustment applied. Conclusions: Despite the increase in Europe of the use of the readmission rate as a measure of quality of care, the amount of research performed on its validity is scarce. Those studies that report on validity replicate earlier, mainly US findings (<1999) of methodological problems and express reservations on its large-scale use. The readmission rate as an indicator should be used with care. Users should address issues related to definition, time-frame and case-mix adjustment as part of the process to enhance validity in the European settings. [ABSTRACT FROM AUTHOR]

The article presents the findings of a research conducted on examining the perceptions of public health experts from Central and Eastern European countries on public health challenges in their countries. It discusses the methodology of the research. The study identifies the factors including the need for public health funding, clinical medicine, and the problems of proving the effectiveness of disease prevention. It concludes that an effective public health interventions is urgently needed.

Abstract Introduction: Coerced admission to psychiatric hospitals, defined by legal status or patient's subjective experience, is common. Evidence on clinical outcomes however is limited. This study aimed to assess symptom change over a three month period following coerced admission and identify patient characteristics associated with outcomes. Method: At study sites in 11 European countries consecutive legally involuntary patients and patients with a legally voluntary admission who however felt coerced, were recruited and assessed by independent researchers within the first week after admission. Symptoms were assessed on the Brief Psychiatric Rating Scale. Patients were re-assessed after one and three months. Results: The total sample consisted of 2326 legally coerced patients and 764 patients with a legally voluntary admission who felt coerced. Symptom levels significantly improved over time. In a multivariable analysis, higher baseline symptoms, being unemployed, living alone, repeated hospitalisation, being legally a voluntary patient but feeling coerced, and being initially less satisfied with treatment were all associated with less symptom improvement after one month and, other than initial treatment satisfaction, also after three months. The diagnostic group was not linked with outcomes. Discussion: On average patients show significant but limited symptom improvements after coerced hospital admission, possibly reflecting the severity of the underlying illnesses. Social factors, but not the psychiatric diagnosis, appear important predictors of outcomes. Legally voluntary patients who feel coerced may have a poorer prognosis than legally involuntary patients and deserve attention in research and clinical practice. [ABSTRACT FROM AUTHOR]

Between just 1995 and 2003, the number of new chemical entities fell from 45 to 25, while the costs increased by two and a half times in the same period. Firms in the USA accounted for more than half of biotech drugs from 1982 to 2003. European firms are losing competitiveness. In this hostile environment for investment in pharmaceutical R&D, providing quick access to market for real innovations is the main challenge for regulatory agencies. More initiatives, more entrepreneurial spirit and easier work regulation are needed to facilitate the growth of firms in this field, especially in emerging economies like the Spanish. A new open source model proposes the use of pre-competitive public platforms formed by young and qualified human capital carrying out research in areas not sufficiently attractive for private initiatives, followed by the introduction of pharmaceutical companies to carry out the clinical research. The last step would be fast and effective approval by assessment agencies. Governments should, therefore, facilitate the regulation of socially effective innovations, bringing in manufacturers to take part in the post-clinical trial period after entering the market. The gathering of incentives between regulatory agencies and pharmaceutical industry must be approached through innovation and authorization stimulating systems. [ABSTRACT FROM AUTHOR]

Background: The European Influenza Surveillance Scheme (EISS) has collected clinical and virological data on influenza since 1996 in an increasing number of countries. The EISS dataset was used to characterise important epidemiological features of influenza activity in Europe during eight winters (1999-2007). The following questions were addressed: 1) are the sentinel clinical reports a good measure of influenza activity? 2) how long is a typical influenza season in Europe? 3) is there a west-east and/or south-north course of peak activity ('spread') of influenza in Europe? Methods: Influenza activity was measured by collecting data from sentinel general practitioners (GPs) and reports by national reference laboratories. The sentinel reports were first evaluated by comparing them to the laboratory reports and were then used to assess the timing and spread of influenza activity across Europe during eight seasons. Results: We found a good match between the clinical sentinel data and laboratory reports of influenza collected by sentinel physicians (overall match of 72% for +/- 1 week difference). We also found a moderate to good match between the clinical sentinel data and laboratory reports of influenza from non-sentinel sources (overall match of 60% for +/- 1 week). There were no statistically significant differences between countries using ILI (influenza-like illness) or ARI (acute respiratory disease) as case definition. When looking at the peak-weeks of clinical activity, the average length of an influenza season in Europe was 15.6 weeks (median 15 weeks; range 12-19 weeks). Plotting the peak weeks of clinical influenza activity reported by sentinel GPs against the longitude or latitude of each country indicated that there was a west-east spread of peak activity (spread) of influenza across Europe in four winters (2001-2002, 2002-2003, 2003-2004 and 2004-2005) and a south-north spread in three winters (2001-2002, 2004-2005 and 2006-2007). Conclusion: We found that: 1) the clinical data reported by sentinel physicians is a valid indicator of influenza activity; 2) the length of influenza activity across the whole of Europe was surprisingly long, ranging from 12-19 weeks; 3) in 4 out of the 8 seasons, there was a west-east spread of influenza, in 3 seasons a south-north spread; not associated with type of dominant virus in those seasons. [ABSTRACT FROM AUTHOR]

The article discusses a comprehensive assessment of the economic impact of migraine and other headaches in Europe. The vast majority of the total costs, nearly 90%, are due to indirect costs in the form of absenteeism and reduced effectiveness when at work with migraine. This means that even though outcomes and direct costs may have been underestimated due to inclusion of older studies conducted prior to the establishment of the triptans, there remains substantial room for improving patient diagnosis and management. The article provides valuable information for prioritizing research on a national and regional level.

Cancer is one of the main healthcare problems in Europe. Although significant progress has recently been made, long-term survival is still disappointing for most common solid tumours. The explosion of information has strengthened the need to create and sustain coordinated interaction between technology, biology, clinical research, clinical practice and health policy. A simple process based on automatic and passive translation from bench to clinical research and eventually to the bed side is usually assumed but cannot be taken for granted. A critical role might be played by Outcome Research (OR), defined as the discipline that describes, interprets, and predicts the impact of various influences, especially interventions, on final endpoints (from survival to satisfaction with care) that matter to decision makers (from patients to society at large), with special emphasis on the use of patient-reported outcomes (PRO). Recently, under pressure from several parts of society, the FDA, recognizing the need for faster drug approval, has modified existing regulations and created new rules to allow anti-cancer drugs to be approved more quickly and, in certain but quite common circumstances, single arm trials and surrogate endpoints to be used as measures of clinical benefit. In this context, the faster approval process may lead to drugs being marketed without there being a complete picture of how effective or safe they are. The FDA move to speed up drug approval, together with the use of not fully validated surrogate endpoints, give OR the unique opportunity to help understand the value of drugs that have received accelerated approval. Despite this opportunity, OR has yet to demonstrate its role in this specific setting and provide proof of the validity, reliability and added value of its primary endpoint measures when evaluated in a broader context. The implementation of lines of OR in the development and evaluation of anti-cancer drugs hinges upon the availability of specific knowledge, methods, instruments and resources and upon their appropriate integration in the mainstream of clinical research. In the USA specific interdisciplinary projects have been launched by the NCI. In Europe there is a lack of such initiatives. The correct placement of OR in the anti-cancer drug development process will guarantee the highest possible standard of validity and reliability of OR at European level and better integration of both translational and outcome research in the mainstream of clinical research into anti-cancer drugs, thus speeding up the introduction of the results of patient-oriented translational clinical research into clinical practice. [ABSTRACT FROM AUTHOR]

The authors discuss the factors and processes influencing health inequalities in European urban areas. They mention that health inequalities tend to be significant in urban areas because they include neighborhoods which consist of deprived and poor populations. They propose a framework consisting of factors such as urban governance, physical environment, socioeconomic environment, and settings to analyze health inequalities and implementing policies to reduce them in urban settings.

The article discusses the undertakings in producing new advanced therapies to standardize medicinal products in Europe. It notes that clinical sources as well as the medicinal products' long term efficacy and safety are important information that should be provided. It mentions that setting of proper analysis relative to clinical procedures along with nonclinical data demands for scientific justification.

The article provides insight on the difficulties involved in conducting a European multi-center study under the new European Union (EU) Clinical Trials Directive. It says that the directive and implementing guidelines imposed many administrative requirements that were not present or not similarly developed in the member states. It says the new directive did not meet the primary objective of harmonizing and simplifying the legislation regarding clinical trials.