Search

Purpose: Despite the availability of clinical guidelines for hip fracture patients, adherence to these guidelines is challenging, potentially resulting in suboptimal patient care. The goal of this study was (1) to evaluate and benchmark the adherence to recently established quality indicators (QIs), and (2) to study clinical outcomes, in fragile hip fracture patients from different European countries. Methods: This observational, cross-sectional multicenter study was performed in 10 hospitals from 9 European countries including data of 298 consecutive patients. Results: A large variation both within and between hospitals were seen regarding adherence to the individual QIs. QIs with the lowest overall adherence rates were the administration of systemic steroids (5.4%) and tranexamic acid (20.1%). Indicators with the highest adherence rates (above 95%) were pre-operative (99.3%) and post-operative haemoglobin level assessment (100%). The overall median time to surgery was 22.6 h (range 15.7–42.5 h). The median LOS was 9.0 days (range 5.0–19.0 days). The most common complications were delirium (23.2%) and postsurgical constipation (25.2%). Conclusion: The present study shows large variation in the care for fragile patients with hip fractures indicating room for improvement. Therefore, hospitals should invest in benchmarking and knowledge-sharing. Large quality improvement initiatives with longitudinal follow up of both process and outcome indicators should be initiated. [ABSTRACT FROM AUTHOR]

Purpose: Our prospective international survey evaluated the impact of the early phase of the COVID-19 pandemic on the management gynaecological malignancies from the multidisciplinary physicians' perspective with particular focus on clinical infrastructures and trial participation. Methods: Our survey consisted of 53 COVID-related questions. It was sent to healthcare professionals in gynaecological oncology centres across Europe and Pan-Arabian region via the study groups and gynaecological societies from April 2020 to October 2020. All healthcare professionals treating gynaecological cancers were able to participate in our survey. Results: A total of 255 answers were collected from 30 countries. The majority (73%) of participants were gynaecological oncologists from university hospitals (71%) with at least an Intensive Care Unit with cardiopulmonary support available at their institutions. Most institutions continued to perform elective surgeries only for oncological cases (98%). Patients had to wait on average 2 weeks longer for their surgery appointments compared to previous years (range 0–12 weeks). Most cases that were prioritised for surgical intervention across all gynaecological tumours were early-stage disease (74%), primary situation (61%) and good ECOG status (63%). The radicality of surgery did not change in the majority of cases (78%) across all tumour types. During the pandemic, only 38% of clinicians stated they would start a new clinical trial. Almost half of the participants stated the pandemic negatively impacted the financial structure and support for clinical trials. Approximately 20% of clinicians did not feel well-informed regarding clinical algorithm for COVID-19 patients throughout the pandemic. Thirty percent stated that they are currently having trouble in providing adequate medical care due to staff shortage. Conclusion: Despite well-established guidelines, pandemic clearly affected clinical research and patientcare. Our survey underlines the necessity for building robust emergency algorithms tailored to gynaecological oncology to minimise negative impact in crises and to preserve access to clinical trials. [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: Minimal research has been done to determine how well European nursing students understand the core principles of academic integrity and how often they deviate from good academic practice. Aim: The aim of this study was to find out what educational needs nursing students have in terms of academic integrity. Research design: A quantitative cross-sectional study in the form of a survey of nursing students was conducted via questionnaire in the fall of 2020. Participants: The sample was composed of 79 students in the BScN and MScN programs at Zürich University of Applied Sciences. Ethical considerations: An application for a non-competence clearance was approved by the Ethics Committee in Zurich (BASEC No. Req-2020-00868). The survey was anonymous, and informed consent was obtained prior to participation. Results: The participants had a high level of confidence in their own knowledge but were in many cases unable to correctly identify clear-cut examples of misconduct and to differentiate them from questionable practices. About 13% of the participants admitted that during their university education they had copied shorter passages from other sources into their own text without marking them as quotes. Conclusions: The study documents extensive knowledge gaps among nursing students regarding both academic misconduct and questionable practices and indicates a need for improved academic integrity training. [ABSTRACT FROM AUTHOR]

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]

Background Research suggests that people in disadvantaged social positions are more likely to perceive barriers to accessing healthcare, especially to specialists and preventive services. In this study, we analyze if adversity during past employment histories (e.g. spells of unemployment) is linked to subsequent subjectively perceived barriers in healthcare access. Further, we investigate if the associations vary according to national healthcare access and quality indicators. Methods We use data from the Survey of Health, Ageing and Retirement in Europe with a study sample of 31 616 men and women aged 52–80 from 25 countries. Data include retrospective information on employment histories allowing us to derive characteristics of past careers, including the number of unemployment periods, main occupational position and pension contributions. Barriers to healthcare access are measured by self-perceived forgone care due to costs and unavailability of services. We apply multilevel Poisson regression for binary outcomes and test for cross-level interactions between career characteristics and national healthcare system characteristics. Results Career characteristics are linked to later self-perceived healthcare access barriers, consistently in the case of cost barriers and less consistently for unavailability of services. Associations are similar for men and women, and persist after controlling for current income, wealth and subjective health. We find no cross-level interactions between career characteristics and country-level healthcare access and quality indicators. Conclusion Self-perceived barriers to healthcare access are linked to people's past working lives. More in-depth investigation is needed to identify the reasons for the lingering effects of characteristics of employment history on reduced healthcare access. [ABSTRACT FROM AUTHOR]

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]

Improvement in the care of patients with metastatic breast cancer (MBC) can only occur if the adequate quality of care is implemented and verified, including access to multidisciplinary, specialised care given in accordance with high-quality guidelines. To this purpose, European Society of Breast Cancer Specialists and the Advanced Breast Cancer Global Alliance joined efforts to develop the first set of quality indicators (QI) specifically for MBC that should be routinely measured and evaluated to ensure that breast cancer centres meet the required standards. A working group of multidisciplinary European experts in breast cancer met to discuss each identified QI, reporting the definition, the minimum and target standard for breast cancer centres to achieve, and the motivation for selection. The level of evidence was determined according to the short version of the United States Agency for Healthcare Research and Quality classification. QI to measure access to and involvement in multidisciplinary and supportive care, appropriate pathological characterisation of disease, systemic therapies and radiotherapy were developed with the consensus of the working group. This is the first effort of a multistep project that aims to have QI for MBC routinely measured and evaluated to ensure that breast cancer centres achieve mandated standards in the care of patients with metastatic disease. • Quality Indicators (QI) for metastatic breast cancer (MBC) care. • QIs are essential to achieve high-quality care for MBC patients. • The breast centre MDT must take care of a minimum number of MBC patients. [ABSTRACT FROM AUTHOR]

Alzheimer's disease and related dementias (ADRD) are prevalent conditions in long-term care homes (LTCHs) with most LTCH residents living with ADRD in many countries. Despite the prevalence of ADRD in LTCHs, a recent examination of LTCH quality measurement programs in 4 countries revealed few LTCH quality measures addressed ADRD, most commonly as a risk adjuster. We sought to better understand how quality measurement programs address ADRD internationally. International comparative analysis. We examined LTCH quality measures in 4 European countries—Germany, Switzerland, Belgium, and the Netherlands. The specifications to calculate each measure were assessed to determine whether the measure was calculated without assessing for ADRD, included only residents with ADRD, excluded residents with ADRD, or was risk adjusted for the presence of ADRD among the LTCH residents. A total of 143 measures were examined across 4 quality measurement programs. Thirty-seven percent of the measures explicitly address ADRD. The programs addressed ADRD in starkly different ways. In Germany, most (13 of 15) measures addressed ADRD, and did so as an exclusion or inclusion criterion, and in Switzerland all the measures addressed ADRD through risk adjustment. In Flanders, Belgium, all measures were calculated without assessing for ADRD. In the Netherlands, one-third of the measures explicitly addressed ADRD by restricting the measure to psychogeriatric units. Although limited to examining measures from LTCH quality measurement programs in 4 European countries, this study adds evidence that ADRD tends not to be addressed by LTCH quality measures, but when ADRD is addressed, it tends to be through inclusion or exclusion criteria. LTCH regulators, policymakers, and providers can use this information to assess options for addressing ADRD in quality measurement programs. Future research is needed to assess how standard indicators of ADRD care quality differ across quality measurement programs. [ABSTRACT FROM AUTHOR]

• This ENMC workshop has seen the participation of many important stakeholders working together to improve trial readiness in FSHD: patients and patients' organizations (FSHD-Europe, FSHD-Society and FSHD Global), neuromuscular clinicians, geneticists, basic researchers, representatives of the TREAT-NMD network, the FSHD-CTRN and EMA. • COMs represent useful tools for the standardized collection of clinical features but need to be selected to match the clinical setting of use. For patient care, they need to be informative, with practical and time efficient utility so as not to detract from clinical care. For clinical trial purposes, the need to be reliable, valid, meaningful and sensitive to change to better depict therapeutic responses. • An optimized clinical evaluation and genetic test form is one of the goals of WG1 and 2. • A diagnostic flowchart for FSHD1 and FSHD2 has been proposed. • Another important unmet need for clinical trial readiness in FSHD is the identification of good therapeutic biomarkers, which ideally should be quantitative, non-invasive, applicable across the entire range of disease severity, sensitive to change, reliable and clinically meaningful. • The WG 3 will produce standard operating procedures (SOPs) for DUX4 detection. Similarly, large differences in the reporting of studies performed on animal models, thus hindering interpretation, repeatability and comparison of the results need to be addressed. Guidelines regarding minimum information for publication of work including animal models for FSHD will therefore be published. [ABSTRACT FROM AUTHOR]

The etiquette in clinical trial research requires companies to respect rules and to be precise and accurate. The new EU Clinical Trials Regulation 536/2014 (EU CTR) pushes companies and health authorities one step further -- to be more flexible and collab orative. The EU CTR aims to harmonise clinical trial applications in the EU, bring more innovation to Europe, and enable faster approval of clinical trials. However, the novel process of clinical trial application in its early stages is fraught with technical and logistic challenges. [ABSTRACT FROM AUTHOR]

Endoscopic full‐thickness resection (EFTR) using the full‐thickness resection device (FTRD) is an integral part of diagnostic and therapeutic endoscopy. Since its market launch in Europe in 2014, its safety and effectiveness have been proven in numerous studies. Adaptations in design as well as new techniques, such as hybrid EFTR, expand the spectrum of the FTRD system. The following review is intended to provide an overview of the clinical application and current evidence of EFTR with the FTRD system. [ABSTRACT FROM AUTHOR]

With advancements in basic science and clinical medicine, lung transplantation (LT) has evolved rapidly over the last three decades. However, it is unclear if significant regional variations exist in long-term outcomes after LT. To investigate potential differences, we performed a retrospective, comparative cohort analysis of adult patients undergoing deceased donor single or double LT in North America (NA) or Europe between January 2006 and December 2016. Data up to April 2019 were abstracted from the International Society for Heart and Lung Transplantation (ISHLT) Thoracic Organ Registry. We compared overall survival (OS) between North American and European LT centers in a propensity score matched analysis. In 3,115 well-matched pairs, though 30-day survival was similar between groups (NA 96.2% vs Europe 95.4%, p = 0.116), 5-year survival was significantly higher in European patients (NA 60.1% vs Europe 70.3%, p < 0.001). This survival difference persisted in a sensitivity analysis excluding Canadian patients. Prior observations suggest that these disparities are at least partly related to better access to care via universal healthcare models prevalent in Europe. Future studies are warranted to confirm our findings and explore other causal mechanisms. It is likely that potential solutions will require concerted efforts from healthcare providers and policymakers. [ABSTRACT FROM AUTHOR]

The aim of this study was to analyze the throwing velocity and effectiveness of elite male handball players during the European Championship 2020. A local positioning system was used for the first time in a European Championship to collect 6568 throw events from 337 players of 24 national teams during 65 matches. ANOVA (F = 80.8, p < 0.01, η2 = 0.058) revealed that back players throws were significantly faster (24.3–26.5 m/s) than the rest of the players (22.2–22.5 m/s). Similarly, throws made from the central zone showed the highest speed values of 28.0 m/s (F = 43.2, p < 0.01, η2 = 0.050). In regard to the goal hit zone, higher speeds were shown for throws in side zones (24.9–26.8 m/s) compared to central zones (23.0–23.8 m/s) (F = 49.0, p < 0.01, η2 = 0.063). Effectiveness was higher in wing players (62%–64%) than the rest (45%–56%) (F = 30.9, p < 0.01, η2 = 0.023). Interestingly, the two higher velocity categories (>22 m/s) showed similar effectiveness (~60%), which were higher than the preceding slower category of 17–22 m/s (39.7%) (F = 175.1, p < 0.01, η2 = 0.074). Regarding court zones, throws from first‐line zones (48%–60%), were more effective than from second line (38%–43%) (F = 13.1, p < 0.01, η2 = 0.016). With respect to the goal hit zone, effectiveness was higher in side (72%–77%) than in central zones (58%–64%) (F = 523.2, p < 0.01, η2 = 0.418). Coaches should improve the throwing velocity of players but also train at submaximal velocities (effective velocity) to save energy and reduce the potential risk of injury. Finally, training should be specialized according to the performance shown by players from different throwing zones, rather than from playing positions. [ABSTRACT FROM AUTHOR]

Background: Food allergen immunotherapy (FA‐AIT) practice is known to vary globally. This project aims to identify and characterize European centres performing FA‐AIT. Methods: An EAACI task force conducted an online survey to gather relevant information regarding FA‐AIT practice and setting‐specific resources after reviewing the published literature and congress abstracts throughout Europe. Results: We identified 102 FA‐AIT centres in 18 countries; only Spain (n = 39) and France (n = 16) had ≥10 such centres. Overall, most facilities were hospital‐based (77.5%), publicly funded (80.4%) and delivered FA‐AIT as routine clinical care (80.4%). On average, departments had 3 allergists/paediatric allergists and 2 nurses. Surveyed centres had provided FA‐AIT for a median of 9 years [1–24] to a median of 105 [5–2415] patients. The estimated total number of treated patients was 24875, of whom 41.3% received AIT for milk, 34.2% egg, 12.8% peanut and 11.7% other foods. Anaphylaxis to AIT doses requiring over 4–6 h of observation was reported by 70.6% of centres, ICU admissions by 10.8% and eosinophilic esophagitis by 45.1%. Quality of life and sustained unresponsiveness were evaluated in 20.6% and 54.9% of centres, respectively. The main contraindications for food AIT were severe asthma (57%‐63%), eosinophilic esophagitis (56%‐48%) and age below 5 years (47%‐41%). Conclusions: In Europe, FA‐AIT is provided mostly in clinical practice. Significant variation is seen in the number of centres per country, facility characteristics and inclusion/exclusion criteria, and in certain aspects of protocols. Potential inequality in access to AIT has been identified as well as the need for education and guidance for treatment standardization. [ABSTRACT FROM AUTHOR]

Multiple factors that influence the learning experience of nursing students while they are in clinical training have been identified, such as the clinical learning environment, the supervision provided by supervisors, and the level of cooperation with the nurse teacher. The objective was to examine whether the relationship between the clinical placement duration and overall satisfaction with clinical training is mediated by the supervisory relationship and learning environment. A secondary analysis was conducted using the data from a cross‐sectional study conducted in 17 higher educational institutions in nine European countries with the Clinical Learning Environment, Supervision and Nurse Teacher scale (n = 1903 pre‐registration nursing students). Satisfaction with the supervisor and a good learning environment mediated the relationship between clinical placement duration and overall satisfaction as perceived by the students. Nursing students with longer clinical placement durations were more satisfied with clinical training as a result of both their satisfaction with their supervisor and their perceptions of good learning environment. The optimal duration a nursing student should remain in the different practice settings is approximately 7 weeks. [ABSTRACT FROM AUTHOR]

Background: The selection of quality indicators demonstrating the efficiency and relevance of nursing practice in patient outcomes in the intensive care unit remains a challenge. Aim: The aim of this study was to develop a set of potential quality indicators to quantify nursing care provided to critically ill patients through a consensus method. Design: This was a three‐phase study including a European survey of intensive care unit (ICU) nurses (phase one) followed by a two‐phase face‐to‐face consensus meeting of experts from Cyprus. Method: Two distinct panels of experts were asked to rate each quality indicator using a 4‐point Likert scale in phases one and two. The level of consensus was set at 60%. In phase three, scores of the content validity index for items and scales were considered for the final selection of quality indicators. Results: The phase one survey included 139 ICU nurses from 13 European countries, and phases two and three included seven ICU experts from Cyprus. "Consensus in" was achieved for 12 items at the end of phase two. Three of the quality indicators were significantly different by country: (a) falls (P =.006), (b) accidental removal of nasogastric tube (P <.001), and (c) accidental removal of intravascular catheters (P <.001). Only falls was significantly correlated with higher academic qualifications of the participants (P =.002). Conclusions: Fifteen items have been identified as potential indicators for adult ICU nursing quality. These need to be prospectively studied to determine the extent to which they can accurately capture nursing care quality in this setting. Relevance to clinical practice: The study provides a set of relevant quality indicators. A nursing set for the ICU may serve as the basis for nursing management and facilitate the strategy dedicated to the vision of health care quality assurance. [ABSTRACT FROM AUTHOR]

The purpose of this study was to explore nursing students' perceptions of their final clinical learning environment and its association with their self‐assessed competence, satisfaction with nursing education, and turnover intentions at graduation in six European countries. A multi‐country comparative cross‐sectional study was conducted with nursing students (n = 1746) from the Czech Republic, Finland, Italy, Portugal, Slovakia, and Spain using the Nurse Competence Scale and the Clinical Learning Environment and Supervision scale. Nursing students' overall perceptions of their final clinical learning environment and supervision were positive in all the countries studied. The correlation between the students' perceptions of their final clinical learning environment and competence was statistically significant and positive. Satisfaction with the nursing program and clinical practicum and no consideration of career change were related to positive perceptions of the final clinical learning environment. Highlighting the importance of the supervisory relationship and pedagogical atmosphere, nursing students' positive perceptions of the final clinical learning environment and supervision contribute to a better level of self‐assessed competence and satisfaction with the nursing program and clinical practicum, leading to lower turnover intentions. [ABSTRACT FROM AUTHOR]

Background and aim: This study reports the outcomes from an international study that implemented a set of person-centred nursing key performance indicators across a range of services provided to sick children. It aims to explore the factors that influenced the successful implementation of those indicators, and assess the impact of the evidence generated on person-centred practice across the children's services. Methods: Twelve organisations across Australia and Europe participated, with data collected in 2015 and 2016 and analysed using thematic analysis. Semi-structured interviews and focus groups were conducted with staff, including executive sponsors, managers, facilitators and clinical nursing teams. The COREQ guidelines were considered in the conduct and reporting of this study. Results: The results describe the impact of implementing the key performance indicators from the perspective of nurses operating at different levels within organisations. The following six themes became apparent: credibility of the key performance indicators; uncovering the whole picture; embracing nursing; engaging in the process; connecting with others; and achieving healthful outcomes. Conclusion: The findings from this study confirm an emerging relationship between the nature of evidence generated by the person-centred nursing key performance indicators and its use in practice. Also highlighted was the importance of facilitation in the process of data collection and in understanding the data and the context in which it is used. Implications for practice: This study will be of interest to clinical nurses, educators, managers and facilitators of cultural change. • The data generated through the implementation of the person-centred nursing key performance indicators evidences the global contribution of nursing across services provided to children and their families • Engaging staff at all levels in an organisation enhances implementation of evidence that is meaningful for nursing practice • The triangulated evidence generated by the key performance indicators and accompanying measurement tools offers feedback that can drive improvements in nursing practice. [ABSTRACT FROM AUTHOR]

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]

The purposes of this paper are: to assess how comprehensive sexuality education (CSE) is implemented in schools in the World Health Organisation's European Region; and to investigate the evidence supporting its effectiveness. Data were collected in 2016–2017, using a validated questionnaire sent to representatives of governmental and nongovernmental institutions in 25 countries of the WHO European Region. Theresults demonstrated that, in nine countries, sexuality education can be classified as comprehensive; in ten countries it is non-comprehensive; in four countries there is no programme in place; and two countries were excluded from theanalysis. In contrast to non-comprehensive sexuality educationprogrammes, CSE programmes address a wider range of topics, including the social, emotional and interpersonal aspects of sexuality. Furthermore, teachers are more often trained to deliver sexuality education and participatory teachingmethods are widely used. CSE programmes are more valued by pupils as a source of information on sexuality, based on national survey results. The availability of CSE programmes coincides with more effective contraceptive use andlower teenage fertility rates. However, more rigorous research is needed to establish a causal relationship between CSE and adolescent sexual and reproductive health indicators. [ABSTRACT FROM AUTHOR]

Background: The aim of this project was to collect real-world evidence and describe treatment patterns for stage III non-small cell lung cancer in Central and Eastern Europe. Based on real-world evidence, an expert opinion was developed, and the unmet needs and quality indicators were identified. Patients and methods: A systematic literature search and a multidisciplinary expert panel of 10 physicians from 7 countries used a modified Delphi process to identify quality indicators and unmet needs in patients with stage III non-small cell lung cancer. The profound questionnaire was used to characterize treatment patterns used for stage III non-small cell lung cancer, and a systematic review identified patterns in Central and Eastern Europe. The first questionnaire was completed by a group of medical oncologists, radiation oncologists and pneumologists. The panel of experts attended an in-person meeting to review the results of the questionnaire and to process a second round Delphi. An additional survey was then compiled and completed by the panel. Results: A complete consensus was reached by the panel of experts on a set of evidence-based clinical recommendations. The experience-based questionnaire generated a highly variable map of treatment patterns within the region. A list of unmet needs and barriers to quality care were developed with near-unanimous consent of the panel of experts. Conclusions: The current landscape of diagnostic and therapeutic approaches in Central and Eastern European countries is highly variable. We identified several significant barriers, mainly related to the availability of diagnostic and imaging methods and low rates of chemoradiotherapy with curative intention as initial treatment for unresectable stage III NSCLC. [ABSTRACT FROM AUTHOR]

Objectives: In healthcare, a variety of quality management practices are used. Although they are important sources for quality improvement initiatives, they do not focus on each particular process. On the other hand, 'Control Objectives for Information and Related Technologies' (COBIT) offers a well-defined process representation structure for representing potential process improvements. The objective of this study was to adopt the COBIT structure for healthcare processes and assess the applicability of such process representations.Design: A two-round Delphi technique was applied: in round 1, open-ended interviews were performed with the participants; in round 2, the participants responded to the web questionnaire.Settings: The participants provided their opinion between 11 September 2018 and 26 June 2019.Participants: It included 37 members of an expert panel from 8 European countries.Intervention: N/A.Main Outcome Measures: In round 1, strengths, weaknesses, opportunities and threats indicators of using the proposed structure in healthcare were identified. These were evaluated on a 9-point Likert scale in round 2.Results: All participants noted that elements of the COBIT process representation structure were suitable for representing healthcare processes. The consensus was reached only for strengths and opportunities indicators.Conclusions: A set of processes represented with the suggested structure has the potential to become a valid reference in healthcare quality improvements initiatives, as COBIT in IT domain. Despite the fact that the expert panel members confirmed the applicability of the COBIT process representation structure for healthcare processes, the identified weaknesses and threats cannot be ignored. [ABSTRACT FROM AUTHOR]

Copyright of Nosileftiki is the property of Hellenic Nurses' Association and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Aims: This article describes and discusses the extension of performance measurement using an episode-based approach so that the measurement includes primary care, and social and long-term-care services. By using data on incident stroke patients from the capital areas of four Nordic countries, this pilot study: (a) extended the disease-based performance analysis to include new indicators that better describe patient care pathways at different levels of care; (b) described and compared the performance of care given in the four areas; (c) evaluated how additional information changed the rankings of performance between the areas; and (d) described the trends in performance in the capital areas. Methods: The construction of data was based on a common protocol that used routinely collected national registers and statistics linked with local municipal registers. We created new variables describing the timing of discharge to home and institutionalisation, as well as describing the use and cost of primary and social hospital services. Risk adjustment was performed with four different sets of confounders. Results: Differences existed in various performance indicators between the four metropolitan areas. The ranking was sensitive to the risk-adjustment method. The study showed that for stroke patients a performance comparison with data that are only from secondary and tertiary care, and without a valid severity measure, is not sufficient for international comparisons. Conclusions: Extending and deepening international performance analysis in order to cover patient pathways, including primary care and social services, is very useful for benchmarking activities when focusing on diseases affecting older people. [ABSTRACT FROM AUTHOR]

Copyright of Interscientific Health Care is the property of University of Thessaly, Medical School / Technological Education Institute, Nursing Department and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

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]

Purpose: The French academic libraries directors association (ADBU) launched and updated a European comparative study on Key Performance Indicators (KPI) in Academic Libraries over the 2013–2017 period. The purpose of this paper is to briefly present the ADBU initiative; its main focus is how to use these figures to ground decision making process, notably so as to better assess the contribution of libraries in student success or research performance. Design/methodology/approach: As universities and academic libraries are facing research evolutions and teaching/learning new models, a strong increase in students' number is observed everywhere in Europe. This trend will most probably continue in the coming years and the pressure on academic libraries will grow. That is why the French ADBU took the initiative to launch a European comparative study on key and performance indicators in Academic Libraries over the 2013–2016 period. Data were updated in 2019, covering 2017 figures and including additional countries. Findings: Thanks to the European partners and the help of a consultant firm, the first observations were updated with the 2017 figures and the country scope grew broader. Libraries buildings and equipment, space and seats per student, opening days and hours, frequentation rate, library services, users training, staff per student/documentary budgets/total expenditure, staff training, documentation loans/consultation/downloads: these KPI are gathered and can be compared in both relative and absolute value. Originality/value: The ADBU initiative is unique, results are widely shared. [ABSTRACT FROM AUTHOR]

Background: Previous studies of radiological damage in rheumatoid arthritis (RA) have used candidate-gene approaches, or evaluated single genome-wide association studies (GWAS). We undertook the first meta-analysis of GWAS of RA radiological damage to: (1) identify novel genetic loci for this trait; and (2) test previously validated variants. Methods: Seven GWAS (2,775 RA cases, of a range of ancestries) were combined in a meta-analysis. Radiological damage was assessed using modified Larsen scores, Sharp van Der Heijde scores, and erosive status. Single nucleotide polymophsim (SNP) associations with radiological damage were tested at a single time-point using regression models. Primary analyses included age and disease duration as covariates. Secondary analyses also included rheumatoid factor (RF). Meta-analyses were undertaken in trans-ethnic and European-only cases. Results: In the trans-ethnic primary meta-analysis, one SNP (rs112112734) in close proximity to HLA-DRB1, and strong linkage disequilibrium with the shared-epitope, attained genome-wide significance (P = 4.2x10-8). In the secondary analysis (adjusting for RF) the association was less significant (P = 1.7x10-6). In both trans-ethnic primary and secondary meta-analyses 14 regions contained SNPs with associations reaching P<5x10-6; in the European primary and secondary analyses 13 and 10 regions contained SNPs reaching P<5x10-6, respectively. Of the previously validated SNPs for radiological progression, only rs660895 (tagging HLA-DRB1*04:01) attained significance (P = 1.6x10-5) and had a consistent direction of effect across GWAS. Conclusions: Our meta-analysis confirms the known association between the HLA-DRB1 shared epitope and RA radiological damage. The lack of replication of previously validated non-HLA markers highlights a requirement for further research to deliver clinically-useful prognostic genetic markers. [ABSTRACT FROM AUTHOR]

Background: In situations of unmet medical need or in the interests of public health, expedited approval pathways, including conditional marketing authorisation (CMA) and accelerated assessment (AA), speed up European Medicines Agency (EMA) marketing authorisation recommendations for medicinal products. CMAs are based on incomplete benefit-risk assessment data and authorisation remains conditional until regulator-imposed confirmatory postmarketing measures are fulfilled. For products undergoing AA, complete safety and efficacy data should be available, and postauthorisation measures may include only standard requirements of risk management and pharmacovigilance plans. In the pivotal trials supporting products assessed by expedited pathways, surrogate endpoints reduce drug development time compared with waiting for the intended clinical outcomes. Whether surrogate endpoints supporting products authorised through CMA and AA pathways reliably predict clinical benefits of therapy has not been studied systematically. Our objectives were to determine the extent to which surrogate endpoints are used and to assess whether their validity had been confirmed according to published hierarchies.Methods and Findings: We used European Public Assessment Reports (EPARs) to identify the primary endpoints in the pivotal trials supporting products authorised through CMA or AA pathways during January 1, 2011 to December 31, 2018. We excluded products that were vaccines, topical, reversal, or bleeding prophylactic agents or withdrawn within the study time frame. Where pivotal trials reported surrogate endpoints, we conducted PubMed searches for evidence of validity for predicting clinical outcomes. We used 2 published hierarchies to assess validity level. Surrogates with randomised controlled trials supporting the surrogate-clinical outcome relationship were rated as 'validated'. Fifty-one products met the inclusion criteria; 26 underwent CMAs, and 25 underwent AAs. Overall, 26 products were for oncology indications, 10 for infections, 8 for genetic disorders, and 7 for other systems disorders. Five products (10%), all AAs, were authorised based on pivotal trials reporting clinical outcomes, and 46 (90%) were authorised based on surrogate endpoints. No studies were identified that validated the surrogate endpoints. Among a total of 49 products with surrogate endpoints reported, most were rated according to the published hierarchies as being 'reasonably likely' (n = 30; 61%) or of having 'biological plausibility' (n = 46; 94%) to predict clinical outcomes. EPARs did not consistently explain the nature of the pivotal trial endpoints supporting authorisations, whether surrogate endpoints were validated or not, or describe the endpoints to be reported in the confirmatory postmarketing studies. Our study has limitations: we may have overlooked relevant validation studies; the findings apply to 2 expedited pathways and may not be generalisable to products authorised through the standard assessment pathway.Conclusions: The pivotal trial evidence supporting marketing authorisations for products granted CMA or AA was based dominantly on nonvalidated surrogate endpoints. EPARs and summary product characteristic documents, including patient information leaflets, need to state consistently the nature and limitations of endpoints in pivotal trials supporting expedited authorisations so that prescribers and patients appreciate shortcomings in the evidence about actual clinical benefit. For products supported by nonvalidated surrogate endpoints, postauthorisation measures to confirm clinical benefit need to be imposed by the regulator on the marketing authorisation holders. [ABSTRACT FROM AUTHOR]

Introduction: Quality assurance and improvement of cancer screening programs require up-to-date monitoring systems and evidence-based indicators. National quality reports exist but the definition and calculation of indicators vary making comparisons between countries difficult. The aim is to stimulate collaborative research and quality improvements in screening through freely available, comparable and regularly updated quality indicators. The project currently includes data on cervical cancer screening but population-based screening programs for breast cancer and colorectal cancer may be included in the future. Material and methods: Through a network of Nordic and Baltic screening managers, population-based individual screening data from each country were converted to standard format in each collaborative center, aggregated by the same R program script and then uploaded to the NordScreen online platform. Registry data included all cervical tests except for Finland where only tests based on invitation are included. Results: The NordScreen collaboration has so far collated standardized indicators based on 32.8 million screening tests from four Nordic countries and Estonia. Interactive comparison of test coverage and distribution of women by number of tests are currently possible online. In 2016, the test coverage within a time interval of 5.5 years in the age group 30–64 year-olds was between 78 and 84% in Iceland, Norway and Sweden whereas 70% in Finland. The application allows users to choose indicator specifications interactively. Conclusions: NordScreen is a pilot model for comparable, reliable and accessible cross-country comparisons of cancer screening. Comparability between countries is enhanced by a uniform data structure and standardized calculations. The comparison of coverage rates to national figures shows that the methods used nationally and in the NordScreen project produce similar results. [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]

RebiQoL was a phase IV multicenter randomized study to assess the impact of a telemedicine patient support program (MSP) on health-related quality of life (HRQoL) in patients with relapsing-remitting MS (RRMS) being administered with Rebif with the RebiSmart device. The primary endpoint was to assess the impact of MSP compared to patients only receiving technical support for RebiSmart on HRQoL at 12 months, using the psychological part of Multiple Sclerosis Impact Scale (MSIS-29), in patients administered with Rebif. A total of 97 patients diagnosed with RRMS were screened for participation in the study of which 3 patients did not fulfill the eligibility criteria and 1 patient withdrew consent. Of the 93 randomized patients, 46 were randomized to MSP and 47 to Technical support only. The demographic characteristics of the patients were well-balanced in the two arms. There were no statistical differences (linear mixed model) in any of the primary (difference of 0.48, 95% CI: -8.30–9.25, p = 0.91) or secondary outcomes (p>0.05). Although the study was slightly underpowered, there was a trend towards better adherence in the MSP group (OR 3.5, 95% CI 0.85–14.40, p = 0.08) although not statistically significant. No unexpected adverse events occurred. This study did not show a statistically significant effect of the particular form of teleintervention used in this study on HRQoL as compared to pure technical support, for MS patients already receiving Rebif with the RebiSmart device. Trial Registration: ClinicalTrials.gov: . [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: Schizophrenia is a severe condition that affects approximately 1% of the population. Certain elements of antipsychotic treatment can only be examined in large population, thus the need for population-based real-world analyses has been increasing. Patients and methods: Hungarian National Health Fund database includes all healthcare data of the population of Hungary. All patients diagnosed with schizophrenia between 01.01.2006 and 31.12.2015 were included in the study. We analyzed all patients with newly initiated second-generation antipsychotic during the inclusion period (01.01.2012–31.12.2013). Patients were followed for 2 years. All-cause treatment discontinuation served as the primary outcome of the study. Patients with newly initiated long-acting injectable treatments were further investigated in stratified analyses based on their previous treatment. Results: 106,624 patients had schizophrenia diagnosis during the study period. 12,232 patients met the inclusion criteria for newly initiating second-generation antipsychotic during the inclusion period. The proportion of patients still on treatment after 1 year for oral treatments varied between 17% (oral risperidone) and 31% (oral olanzapine) while the analogous data for long acting injectables were between 32% (risperidone long acting) and 64% (paliperidone long acting one monthly). The 2-year data were similarly in favor of long-actings. Median time to discontinuation in the oral group varied between 57 days (clozapine) and 121 days (olanzapine). The median time to discontinuation for long-actings was significantly longer: between 176 and 287 days; in case of paliperidone long acting, median was not reached during the observation period. Patients receiving long-acting treatment switched from another long-acting remained on the newly initiated treatment significantly longer than those switched from orals. Conclusion: Our results indicate the superiority of second generation long-acting antipsychotics with regard to rates of treatment discontinuation and periods of persistence to the assigned medication. [ABSTRACT FROM AUTHOR]

Introduction: Chronic nonbacterial osteomyelitis (CNO) is a rare autoinflammatory bone disorder primarily affecting children and adolescents. It can lead to chronic pain, bony deformities and fractures. The pathophysiology of CNO is incompletely understood. Scientific evidence suggests dysregulated expression of pro- and anti-inflammatory cytokines to be centrally involved. Currently, treatment is largely based on retrospective observational studies and expert opinion. Treatment usually includes nonsteroidal anti-inflammatory drugs and/or glucocorticoids, followed by a range of drugs in unresponsive cases. While randomised clinical trials are lacking, retrospective and prospective non-controlled studies suggest effectiveness of TNF inhibitors and bisphosphonates. The objective of the Bayesian consensus meeting was to quantify prior expert opinion. Methods: Twelve international CNO experts were randomly chosen to be invited to a Bayesian prior elicitation meeting. Results: Results showed that a typical new patient treated with pamidronate would have an 84% chance of improvement in their pain score relative to baseline at 26 weeks and an 83% chance on adalimumab. Experts thought there was a 50% chance that a new typical patient would record a pain score of 28mm (pamidronate) to 30mm (adalimumab) or better at 26 weeks. There was a modest trend in prior opinion to indicate an advantage of pamidronate vs adalimumab, with a 68% prior chance that pamidronate is superior to adalimumab by some margin. However, it is clear that there is considerable uncertainty about the precise relative merits of the two treatments. Conclusions: The rarity of CNO leads to challenges in conducting randomised controlled trials with sufficient power to provide a definitive outcome. We address this using a Bayesian design, and here describe the process and outcome of the elicitation exercise to establish expert prior opinion. This opinion will be tested in the planned prospective CNO study. The process for establishing expert consensus opinion in CNO will be helpful for developing studies in other rare paediatric diseases. [ABSTRACT FROM AUTHOR]

Background: Because of the potential mutagenic effects of chemo- and radiotherapy, there is concern regarding increased risk of congenital malformations (CMs) among children of fathers with cancer. Previous register studies indicate increased CM risk among children conceived after paternal cancer but lack data on oncological treatment. Increased CM risk was recently reported in children born before paternal cancer. This study aims to investigate whether anti-neoplastic treatment for testicular germ-cell cancer (TGCC) implies additional CM risk.Methods and Findings: In this nationwide register study, all singletons born in Sweden 1994-2014 (n = 2,027,997) were included. Paternal TGCC diagnoses (n = 2,380), anti-neoplastic treatment, and offspring CMs were gathered from the Swedish Norwegian Testicular Cancer Group (SWENOTECA) and the Swedish Medical Birth Register. Children were grouped based on +/- paternal TGCC; treatment regimen: surveillance (n = 1,340), chemotherapy (n = 2,533), or radiotherapy (n = 360); and according to time of conception: pre- (n = 2,770) or post-treatment (n = 1,437). Odds ratios (ORs) for CMs were calculated using logistic regression with adjustment for parental ages, maternal body mass index (BMI), and maternal smoking. Children conceived before a specific treatment acted as reference for children conceived after the same treatment. Among children fathered by men with TGCC (n = 4,207), 184 had a CM. The risk of malformations was higher among children of fathers with TGCC compared with children fathered by men without TGCC (OR 1.28, 95% confidence interval [CI] 1.19-1.38, p = 0.001, 4.4% versus 3.5%). However, no additional risk increase was associated with oncological treatment when comparing post-treatment-to pretreatment-conceived children (chemotherapy, OR = 0.82, 95% CI 0.54-1.25, p = 0.37, 4.1% versus 4.6%; radiotherapy, OR = 1.01, 95% CI 0.25-4.12, p = 0.98, 3.2% versus 3.0%). Study limitations include lack of data on use of cryopreserved or donor sperm and on seminoma patients for the period 1995-2000-both tending to decrease the difference between the groups with TGCC and without TGCC. Furthermore, the power of analyses on chemotherapy intensity and radiotherapy was limited.Conclusions: No additional increased risk of CMs was observed in children of men with TGCC treated with radio- or chemotherapy. However, paternal TGCC per se was associated with modestly increased risk for offspring malformations. Clinically, this information can reassure concerned patients. [ABSTRACT FROM AUTHOR]

Background: NTZ is approved in Russia for the treatment of highly active relapsing remitting multiple sclerosis and is reimbursed via federal budget program. However, no data about NTZ treatment in Russia and the effect of federal reimbursement have been performed so far. Objective: To characterize the population of patients receiving natalizumab and assess the efficacy and risk-management plan (RMP) implementation of NTZ therapy in routine clinical practice in Russia. Methods: We analyzed data for 334 patients, who received at least one infusion of NTZ. Relapse rate, MRI activity, NEDA-3 status after 2 years were assessed. Anti-JC virus antibodies status and RMP implementation were evaluated. Drop-out rate and reasons for therapy discontinuation were analyzed. Results: Patients switched to natalizumab in Russia are mainly female (63%), with median EDSS score of 3.5 and high disease activity: 93% had at least 1 relapse and 58% had both T1Gd+ and new T2 lesion a year before therapy initiation. Introduction of federal reimbursement allowed patients with less relapses to start therapy with natalizumab. The only predictor of 6-month progression was EDSS score at the baseline of therapy (HR = 2.1375, 95%CI 1.0026–4.5570, p = 0.0492). 82% patients reached NEDA-3 at 24 month of therapy. 25% of patients discontinued NTZ for reasons: tolerability (14.5%), JCV antibody status (61%), and patient’s decision (17%). RMP was implemented in only 36% patients. Conclusion: Natalizumab appeared to have high efficacy in Russian clinical practice. Federal reimbursement allowed less active patients to start natalizumab. More efforts should be done to improve RMP implementation. [ABSTRACT FROM AUTHOR]

Background: Newer direct-acting antiviral therapies are increasingly becoming the therapy of choice in patients with hepatitis C virus (HCV) infection. Here, we report the safety and effectiveness of sofosbuvir/velpatasvir (SOF/VEL) and ledipasvir/sofosbuvir (LDV/SOF) in real-world cohorts in Germany. Methods: Patients initiated on SOF/VEL 12 weeks or LDV/SOF 8, 12 or 24 weeks regimens in a single German centre were included in this study. Data on treatment outcomes and adverse events (AE) were analysed in patients with available sustained virologic response 12 weeks after cessation of treatment (SVR12) information overall and by subgroups. Results: This study included 115 patients who received SOF/VEL from July-2016 to July-2017, and 249 patients who received LDV/SOF from November-2014 to September-2015. Overall, SVR12 was achieved in 99% of patients on SOF/VEL ± ribavirin 12 weeks independent of HCV genotype, treatment history, or cirrhosis status, and in 96% of patients treated with LDV/SOF 8 weeks or LDV/SOF ± ribavirin 12 or 24 weeks. In genotype 1 treatment-naïve, non-cirrhotic patients, ≥99% achieved SVR12 across SOF/VEL and LDV/SOF regimens. Likewise, 100% of genotype 3-cirrhotic patients on SOF/VEL ± ribavirin regimens achieved SVR12. Grade 3/4 AE were reported in 13 (5.2%) patients on LDV/SOF and in 1 (<1%) patient on SOF/VEL. Conclusion: Overall, SOF/VEL and LDV/SOF achieved high SVR rates in a broad patient population. We showed the effectiveness of SOF/VEL as a pan-genotypic regimen, and regardless of treatment history or cirrhosis status. Use of such therapies improves outcomes and contributes towards the global efforts to eradicate HCV. [ABSTRACT FROM AUTHOR]

Introduction: Rational use of antibiotics and strict adherence to practice guidelines is essential to prevent antibiotic resistance. The best surgical prophylaxis protocol requires tailoring of the available guidelines in accordance to the local bacterial flora. We designed a protocol for surgical prophylaxis to check the rampant abuse of antibiotics in the department of urology and evaluated its feasibility. Materials and Methods: Patients admitted for elective major surgeries under a single unit of our department over a period of 5 months were included in the study. A protocol for antibiotic prophylaxis was designed based on the European Association of Urology guidelines and the local hospital antibiogram. Single-dose intravenous cefuroxime was administered to the patients undergoing clean and clean-contaminated surgeries. Extended protocols were formulated for contaminated surgeries. Postoperative course and complications were recorded. Effectiveness was defined as adherence to the protocol (without an addition or a change in antibiotic regimen) along with an uneventful postoperative course. Prospectively maintained data were analyzed using descriptive statistics. Results: Data of 277 patients were analyzed. The mean age was 48.37 ± 17.39 years and 27.1% had comorbidities. Majority of the surgeries were clean contaminated (81%), and 60.3% of the total were endoscopic. The protocol was effective in 89.5% of the patients (248/277). The failure rate was higher for the contaminated procedures (41.7%) (odds ratio -- 6.43; confidence interval = 1.51--27.2, P < 0.001). Post-operative sepsis with or without shock was the commonest cause (16/29, 55.2%) of protocol failure. Fourteen out of the 16 patients who developed sepsis had undergone endourological surgeries. Conclusions: Protocol-based perioperative antibiotic prophylaxis in urological surgeries is feasible. Similar protocols should be developed and validated at other major centers to limit the unnecessary use of antibiotics and prevent the emergence of antibiotic resistance. [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]

Quality care in breast cancer is higher if patients are treated in a Breast Center with a dedicated and specialized multidisciplinary team. Quality control is an essential activity to ensure quality care, which has to be based on the monitoring of specific quality indicators. Eusoma has proceeded with the up-dating of the 2017 Quality indicators for non-metastatic breast cancer based on the new diagnostic, locoregional and systemic treatment modalities. To proceed with the updating, EUSOMA setup a multidisciplinary working group of BC experts and patients' representatives. It is a comprehensive set of QIs for early breast cancer care, which are classified as mandatory , recommended , or observational. For the first time patient reported outcomes (PROMs) have been included. As used in the 2017 EUSOMA QIs, evidence levels were based on the short version of the US Agency for Healthcare Research and Quality. This is a set of quality indicators representative for the different steps of the patient pathway in non-metastatic setting, which allow Breast Centres to monitor their performance with referring standards, i.e minimum standard and target. Monitoring these Quality Indicators, within the Eusoma datacentre will allow to have a state of the art picture at European Breast Centres level and the development of challenging research projects. • Set of comprehensive quality indicators in breast cancer care. • Breast Cancer Care quality indicators to monitor Breast Centre performance. • Breast Cancer quality indicators based on the patient pathway. [ABSTRACT FROM AUTHOR]

Purpose Governance of healthcare organisations and health systems requires many different competencies, with a great emphasis on evidence and information governance, which are traditional fields of librarians' expertise. However, stakeholders are unaware of how health and hospital libraries are contributing with specific activities and what are the trends in library support for health/clinical governance in Europe, mainly because traditional methods of measuring impact are restricted to specific library activities or are not showing direct impact long term. The paper aims to discuss these issues.Design/methodology/approach A model combining components of clinical and health governance (C/HG), related library activity types, and the possible impact was developed based on a literature review and tested by a European expert panel. A web-based survey was offered to the members of the European Association for Health Information and Libraries (EAHIL) to offer further insight into activities and examples of contribution to C/HG.Findings Librarians from 25 European countries participated in the survey. The model proves that librarians in Europe are involved in supporting most identified components of C/HG, with examples of clinical effectiveness and research, education and training, patient and public involvement, partnership engagement, formulating strategic direction, etc.Research limitations/implications The authors were unable to cover the roles of libraries in all European countries in this paper, but dialogue and research will continue within the EAHIL group.Originality/value No such comparative research has been undertaken before, looking at what activities and tasks libraries undertake to support C/HG. This research has highlighted valuable services and tools that can be replicated in libraries across health care organisations and at the same time promote libraries and librarians as significant actors in organisational governance. [ABSTRACT FROM AUTHOR]

From the end of the 15th century, syphilis spread worldwide, posing a serious threat to public health. Venereal syphilis has been a major research topic, not only in clinical medicine but also in paleopathology, especially because it is a disease of questionable origin and of high prevalence until the discovery of antibiotics. Syphilis in history has been studied extensively in Europe and the Americas, though less so in Asia. In this review, based on extant historical documents and available paleopathological data, we pinpoint the introduction and trace the spread of venereal syphilis in Korea to the end of the 19th century. This review provides fundamental information that will be of great help to future research on pre-20th century syphilis in Korea. [ABSTRACT FROM AUTHOR]

The turn of the 18th and 19th c. is a period in the history of medicine where the division of the main modernisation course in clinical medicine was made. Two competing movements were distinguished at that time: physical, the foundations of which referred to the philosophy of the English and French Enlightenment (the so-called Medical Enlightenment) and romantic, which was critical of the philosophy and attempted to base the foundations of medicine on German idealism. The rivalry began in 1797 when the basis of the romantic movement was determined and ended in 1849 when the movement was removed through administrative channels from universities in German Protestant states. Then, the unification of the theoretical foundations of clinical medicine in Europe took place, while the epigones of the romantic movement were included in the area of alternative medicine by academic communities. Both of the movements involved dozens of medical doctrines, which strove to solve practical therapeutic problems in relation to different theories. The aim of the article is to present the rivalry between both modernisation movements on the basis of my earlier studies, the results of which were included in the publications from 1990-2016, and references with particular emphasis on the role of therapeutic doctrines and their philosophical foundations. [ABSTRACT FROM AUTHOR]

Despite the introduction of evidence-based recommendations for postoperative pain management (POPM), the consensus is that pain control remains suboptimal. Barriers to achieving patient-satisfactory analgesia include deficient knowledge regarding POPM among staff, lack of instructions, insufficient pain assessments and sub-optimal treatment. Effective monitoring of POPM is essential to enable policy makers and healthcare providers to improve the quality of care. Quality indicators (QIs) are quantitative measures of clinical practice that can monitor, evaluate and guide the quality of care provided to patients. QIs can be used to assess various aspects relating to the care process and they have proven useful in improving health outcomes in diseases such as myocardial infarction. In this commentary we critically analyze the evidence regarding the use of QIs in acute POPM based upon the experience of pain specialists from Europe and the USA who are members of the Change Pain Advisory Board. We also undertook a literature review to see what has been published on QIs in acute pain with the goal of assessing which QIs have been developed and used, and which ones have been successful/unsuccessful. In the hospital sector the development and implementation of QIs is complex. The nature of POPM requires a highly trained, multidisciplinary team and it is at this level that major improvements can be made. Greater involvement of patients regarding pain management is also seen as a priority area for improving clinical outcomes. Changes in structure and processes to deliver high-level quality care need to be regularly audited to ensure translation into better outcomes. QIs can help drive this process by providing an indicator of current levels of performance. In addition, outcomes QIs can be used to benchmark levels of performance between different healthcare providers. [ABSTRACT FROM AUTHOR]

In 2010, EUSOMA published a position paper, describing a set of benchmark quality indicators (QIs) that could be adopted by breast centres to allow standardised auditing and quality assurance and to establish an agreed minimum standard of care. Towards the end of 2014, EUSOMA decided to update the paper on QIs to consider and incorporate new scientific knowledge in the field. Several new QIs have been included to address the need for improved follow-up care of patients following primary treatments. With regard to the management of elderly patients, considering the complexity, the expert group decided that, for some specific quality indicators, if centres fail to meet the minimum standard, older patients will be excluded from analysis, provided that reasons for non-adherence to the QI are specified in the clinical chart and are identified at the review of the clinical records. In this way, high standards are promoted, but centres are able to identify and account for the effect of non-standard treatment in the elderly. In the paper, there is no QI for outcome measurements, such as relapse rate or overall survival. However, it is hoped that this will be developed in time as the databases mature and user experience increases. All breast centres are required to record outcome data as accurately and comprehensively as possible to allow this to occur. In the paper, different initiatives undertaken at international and national level to audit quality of care through a set of QIs have been mentioned. [ABSTRACT FROM AUTHOR]

Aim of the study The European Society of Breast Cancer Specialists (EUSOMA) has fostered a voluntary certification process for breast centres to establish minimum standards and ensure specialist multidisciplinary care. Prospectively collected anonymous information on primary breast cancer cases diagnosed and treated in the units is transferred annually to a central EUSOMA data warehouse for continuous monitoring of quality indicators (QIs) to improve quality of care. Units have to comply with the EUSOMA Breast Centre guidelines and are audited by peers. The database was started in 2006 and includes over 110,000 cancers from breast centres located in Germany, Switzerland, Belgium, Austria, The Netherlands, Spain, Portugal and Italy. The aim of the present study is assessing time trends of QIs in EUSOMA-certified breast centres over the decade 2006–2015. Materials and methods Previously defined QIs were calculated for 22 EUSOMA-certified breast centres (46122 patients) during 2006–2015. Results On the average of all units, the minimum standard of care was achieved in 8 of 13 main EUSOMA QIs in 2006 and in all in 2015. All QIs, except removal of at least 10 lymph nodes at axillary clearance and oestrogen receptor–negative tumours (T > 1 cm or N+) receiving adjuvant chemotherapy, improved significantly in this period. The desirable target was reached for two QIs in 2006 and for 7 of 13 QIs in 2015. Conclusion The EUSOMA model of audit and monitoring QIs functions well in different European health systems and results in better performance of QIs over the last decade. QIs should be evaluated and adapted on a regular basis, as guidelines change over time. [ABSTRACT FROM AUTHOR]

Objective: This study aims to assess the efficacy of Electronic Monitoring Feedback (EMF) as an intervention to improve medication adherence (i.e. dose- or full adherence) and clinical outcomes in adult patients. Methods: A systematic search was performed in Medline, EMBASE, PsycINFO and Web of Science and reported according to the PRISMA guidelines. Randomised controlled trials (RCTs) comparing EMF with usual care were identified to systematically summarise the evidence for use of EMF in improving medication adherence and clinical outcomes. The GRADE approach was used to assess the quality of the body of evidence. Results: Of 9,993 initially-identified studies, ten studies (four of high-quality and six of low-quality) were included. The sample size of the studies included varied from 18 to 205 patients. Four of the six studies (66.7%) reported a significant positive effect of EMF on mean dose adherence levels, whereas a significant positive effect of EMF on mean full adherence levels was found in all of the included studies (100%, five out of five of the studies included). A significant positive effect of EMF on clinical outcomes was reported in one of the seven studies included. The overall effect of EMF on mean dose- and full adherence was positive and the overall effect of EMF on clinical outcomes was inconclusive. Conclusion: Considering the positive effect of EMF on medication adherence, EMF might be a promising intervention to enhance medication adherence. However, the effect of EMF on clinical outcomes was inconclusive. Prior to implementing EMF in clinical practice, future research with high-quality studies (e.g. adequate sample sizes, follow-up periods and no interfering co-interventions) is required to examine the (long-term) efficacy of EMF. [ABSTRACT FROM AUTHOR]

Introduction: Authorization of orphan medicinal products (OMPs) is often based on studies with several methodological shortcomings. Hence, data are difficult to interpret and efficacy does not always correspond to real-world effectiveness. We investigated to what extent an efficacy-effectiveness gap exists for OMPs for metabolic diseases and set out to explore which factors contribute to it. Methods: We included all OMPs for rare metabolic diseases authorized in the EU up to 1 January 2016. Efficacy data were obtained from European Public Assessment Reports, relative effectiveness data from the Dutch National Healthcare Institute website, and real-world effectiveness data from literature and interviews with experts and patients. Efficacy and effectiveness were scored as 'no effect', 'unclear' or 'good' based upon a prespecified scoring system. Results: We identified 31 authorized OMPs, of which 21 had post-marketing studies available, thus making it possible to score real-world effectiveness. Eight of 21 (38%) OMPs had a 'good' real-world effectiveness. The use of a clinical or validated surrogate primary endpoint and a representative study population seemed to be related to good effectiveness in the real world, as were type of marketing authorization, study population and disease prevalence. Conclusions: This study revealed that less than half of the authorized OMPs are effective in the real world. Since the type of primary endpoint used in the pivotal study seems to be associated with good real-world effectiveness, it is important to agree upon study endpoints through early dialogues among relevant stakeholders. [ABSTRACT FROM AUTHOR]