Search

Background: The practice of palliative sedation continues to raise ethical questions among people, which in turn leads to its varied acceptance and practice across regions. As part of the Palliative Sedation European Union (EU) project, the aim of the present study was to determine the perceptions of palliative care experts regarding the practice of palliative sedation in eight European countries (The Netherlands, Belgium, Germany, UK, Italy, Spain, Hungary, and Romania). Methods: A specifically designed survey, including questions on the most frequently used medications for palliative sedation, their availability per countries and settings, and the barriers and facilitators to the appropriate practice of palliative sedation was sent to expert clinicians involved and knowledgeable in palliative care in the indicated countries. A purposive sampling strategy was used to select at least 18 participating clinicians per consortium country. Descriptive statistical analysis was conducted on the survey data. Results: Of the 208 expert clinicians invited to participate, 124 participants completed the survey. Midazolam was perceived to be the most frequently used benzodiazepine in all eight countries. 86% and 89% of expert clinicians in Germany and Italy, respectively, perceived midazolam was used "almost always", while in Hungary and Romania only about 50% or less of the respondents perceived this. Levomepromazine was the neuroleptic most frequently perceived to be used for palliative sedation in the Netherlands, Spain, Germany, and the United Kingdom. Between 38- 86% of all eight countries´ expert clinicians believed that opioid medications were "almost always" used during palliative sedation. The perceived use of IV hydration and artificial nutrition "almost always" was generally low, while the country where both IV hydration and artificial nutrition were considered to be "very often" given by a third of the expert clinicians, was in Hungary, with 36% and 27%, respectively. Conclusions: Our study provides insight about the differences in the perceived practice of medication during palliative sedation between eight European countries. In countries where palliative care services have been established longer perceptions regarding medication use during palliative sedation were more in line with the recommended European guidelines than in Central and Eastern European countries like Romania and Hungary. [ABSTRACT FROM AUTHOR]

Background: There is a lack of studies comparing the status of dental specialties worldwide. Therefore, this study aimed to analyze the differences and similarities between the number and types of dental specialties in 31 countries, including every continent, in the world. Materials and methods: Available official documents and webpages from regulatory bodies, official colleges and councils, and dental institutions were collected from 31 countries and analyzed to obtain reliable data on dental specialties. Differences were analyzed using the Lorentz curve and Gini test. Additionally, a cluster analysis was performed to obtain groups of countries with similar patterns in the number and types of dental specialties. Results: A total of 32 different specialties were officially recognized among all the analyzed countries. Orthodontics and oral surgery (100% and 93.1%, respectively) were the two most frequently officially recognized dental specialties worldwide. The total global degree of inequality in the 31 analyzed countries was 42.4%. The Anglo-Saxon countries showed the greatest similarity, approximately 15-fold higher than the European countries. Cluster analysis differentiated six main groups of countries according to the number and types of dental specialties. European countries formed one of the two largest clusters, and the other cluster was of Anglo-Saxon, Asian, African, and several Eastern European countries with a high number of specialties. Conclusions: Officially recognized dental specialties in the different continents and countries show an asymmetric organization. The number, names, and skills of officially recognized dental specialties exhibited significant differences, showing inequalities in their organization. The Anglo-Saxon pattern of dental specialties showed greater equality than the European pattern. Orthodontics was the only constant element among the different patterns. [ABSTRACT FROM AUTHOR]

Simple Summary: Patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor gene (EGFR) Exon 20 insertion mutations (Exon20ins) used to have poor outcomes after the failure of platinum-based therapies. Amivantamab, a drug that targets two proteins involved in NSCLC (EGFR/MET), was developed and studied in the CHRYSALIS clinical trial. This paper summarizes an analysis comparing outcomes for amivantamab from CHRYSALIS to the outcomes for a mix of treatments that were used in real-world clinical practice (real-world physician's choice [RWPC]). RWPC data were collected from hospitals across Europe in the CATERPILLAR real-world evidence (RWE) study. The outcomes of 114 patients from CHRYSALIS were compared to 55 lines of treatment (LOTs) from CATERPILLAR-RWE, accounting for differences in patient characteristics between the two populations. Overall, the results show that amivantamab was at least twice as good as RWPC for platinum pre-treated patients in terms of tumor response and survival rates. Patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor gene (EGFR) Exon 20 insertions (Exon20ins) at the second line and beyond (2L+) have an unmet need for new treatment. Amivantamab, a bispecific EGFR- and MET-targeted antibody, demonstrated efficacy in this setting in the phase 1b, open-label CHRYSALIS trial (NCT02609776). The primary objective was to compare the efficacy of amivantamab to the choices made by real-world physicians (RWPC) using an external control cohort from the real-world evidence (RWE) chart review study, CATERPILLAR-RWE. Adjustment was conducted to address differences in prognostic variables between cohorts using inverse probability weighting (IPW) and covariate adjustments based on multivariable regression. In total, 114 patients from CHRYSALIS were compared for 55 lines of therapy from CATERPILLAR-RWE. Baseline characteristics were comparable between the amivantamab and IPW-weighted RWPC cohorts. For amivantamab versus RWPC using IPW adjustment, the response rate ratio for the overall response was 2.14 (p = 0.0181), and the progression-free survival (PFS), time-to-next-treatment (TTNT) and overall survival (OS) hazard ratios (HRs) were 0.42 (p < 0.0001), 0.47 (p = 0.0063) and 0.48 (p = 0.0207), respectively. These analyses provide evidence of clinical and statistical benefits across multiple outcomes and adjustment methods, of amivantamab in platinum pre-treated patients with advanced NSCLC harboring EGFR Exon20ins. These results confirm earlier comparisons versus pooled national registry data. [ABSTRACT FROM AUTHOR]

To investigate practice type and location of native and immigrant general practitioners (GPs); effects of migration status concordance between GPs and patients on experiences of patients in key areas of primary care quality and discrimination. Secondary analysis of GP and patient survey data from QUALICOPC (Quality and Costs of Primary Care), a cross-sectional study of GPs and their patients in 34 countries, performed between 2011 and 2013. We explored practice type and location of native and immigrant GPs and the experiences of native patients and patients with a migration background of communication, continuity, comprehensiveness, accessibility, and discrimination, using multilevel analysis. Concordance was modelled as a cross-level interaction between migration status of GPs and patients. Percentages of immigrant GPs varied widely. In Europe, this was highest in England and Luxemburg (40% of GPs born abroad) and lowest in Bulgaria and Romania (1%). The practice population of immigrant GPs more often included an above average proportion of people from ethnic minorities. There were no differences in main effects of patient experiences following a visit to an immigrant or native GP, in four core areas of primary care or in discrimination. However, people from first-generation migrant background more often experienced discrimination, in particular when visiting a native GP. Patient experiences did not vary with GPs' migration status. Although experience of discrimination was uncommon, first-generation migrant patients experienced more discrimination. Primary care should provide non-discriminatory care, through GP awareness of unconscious bias and training to address this. There were large differences in percentage of migrant GPs between countries. Migrant GPs' practices had an above average proportion of people from ethnic minorities. In general, patients' experienced discrimination from GPs and practice staff was low, but first-generation migrant patients more often experienced discrimination. First-generation migrant patients more often experienced discrimination when they visited a native GP. [ABSTRACT FROM AUTHOR]

Background: Between-country differences have been described in antibiotic prescribing for respiratory tract infection (RTI) in primary care, but not yet for diagnostic testing procedures and prescribing confidence. Aim: To describe between-country differences in RTI management, particularly diagnostic testing and antibiotic prescribing, and investigate which factors relate to antibiotic prescribing and GPs' prescribing confidence. Design & setting: Prospective audit in 18 European countries. Method: An audit of GP-registered patient, clinical, and management characteristics for patients presenting with sore throat and/or lower RTI (n = 4982), and GPs' confidence in their antibiotic prescribing decision. Factors related to antibiotic prescribing and confidence were analysed using multi-level logistic regression. Results: Antibiotic prescribing proportions varied considerably: <20% in four countries, and >40% in six countries. There was also considerable variation in point-of-care (POC) testing (0% in Croatia, Moldova, and Romania, and >65% in Denmark and Norway, mainly for C-reactive protein [CRP] and group A streptococcal [strep A] infection), and in laboratory or hospital-based testing (<3% in Hungary, the Netherlands, and Spain, and >30% in Croatia, Georgia, Greece, and Moldova, mainly chest X-ray and white blood cell counting). Antibiotic prescribing was related to illness severity, comorbidity, age, fever, and country, but not to having performed a POC test. In nearly 90% of consultations, GPs were confident in their antibiotic prescribing decision. Conclusion: Despite high confidence in decisions about antibiotic prescribing, there is considerable variation in the primary care of RTI in European countries, with GPs prescribing antibiotics overall more often than is considered appropriate. POC testing may enhance the quality of antibiotic prescribing decisions if it can safely reverse decisions confidently made on clinical grounds alone to prescribe antibiotics. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to evaluate the practice of extracorporeal shockwave lithotripsy (ESWL) treatment from different aspects (indications, technical, and equipment-related characteristics) through a questionnaire response by the experienced endourologist in the European centers. Materials and Methods: A survey of 72 questions on four main topics was prepared by our team to evaluate the demographics of technical equipment, treatment applications, and pretreatment preparations. The survey was mailed to 200 endourologists, of whom 97 academic endourologists enrolled, 75% of them were from university or training hospitals and 69% have experience of >10 years in urology. Results: Of the urologist, 74% had direct access to ESWL-device, and the endourologist was mainly responsible for the ESWL unit with the 61% rate and was secondly the technician, which was trained on ESWL (25%). The factors that affect the decision for ESWL include the stone's size, location, density, composition, and kidney anatomy. Stone density was the most preferred for the ESWL decision and the cut-off value was <1000 hounsfield unit for the 71% of endourologists. Increased oral hydration and medical expulsive treatments were commonly used and recommended after the ESWL session. Routine antibiotic prophylaxis was not used by most of the endourologists (45%), and ureteroscopy (39%) was the most responded approach after steinstrasse formation. Conclusion: Survey answers revealed that most of the experienced European endourologists decide to treatment alternatives following the suggested guidelines and ESWL is still a valuable option for urinary stone treatment. [ABSTRACT FROM AUTHOR]

Background Healthcare professionals are often reluctant to deprescribe fall-risk-increasing drugs (FRIDs). Lack of knowledge and skills form a significant barrier and furthermore, there is no consensus on which medications are considered as FRIDs despite several systematic reviews. To support clinicians in the management of FRIDs and to facilitate the deprescribing process, STOPPFall (Screening Tool of Older Persons Prescriptions in older adults with high fall risk) and a deprescribing tool were developed by a European expert group. Methods STOPPFall was created by two facilitators based on evidence from recent meta-analyses and national fall prevention guidelines in Europe. Twenty-four panellists chose their level of agreement on a Likert scale with the items in the STOPPFall in three Delphi panel rounds. A threshold of 70% was selected for consensus a priori. The panellists were asked whether some agents are more fall-risk-increasing than others within the same pharmacological class. In an additional questionnaire, panellists were asked in which cases deprescribing of FRIDs should be considered and how it should be performed. Results The panellists agreed on 14 medication classes to be included in the STOPPFall. They were mostly psychotropic medications. The panellists indicated 18 differences between pharmacological subclasses with regard to fall-risk-increasing properties. Practical deprescribing guidance was developed for STOPPFall medication classes. Conclusion STOPPFall was created using an expert Delphi consensus process and combined with a practical deprescribing tool designed to optimise medication review. The effectiveness of these tools in falls prevention should be further evaluated in intervention studies. [ABSTRACT FROM AUTHOR]

Background: Several new antidiabetic medicines (GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT-2 inhibitors) have been approved by the European Medicines Agency since 2006. The aim of this study was to evaluate the uptake of new antidiabetic medicines in European countries over a 10-year period. Methods: The study used IQVIA quarterly value and volume sales data January 2006–December 2016. The market uptake of new antidiabetic medicines together with intensity of prescribing policy for all antidiabetic medicines were estimated for Austria, Croatia, France, Germany, Hungary, Italy, Poland, Slovenia, Spain, Sweden, and the United Kingdom. The following measures were determined: number of available new active substances, median time to first continuous use, volume market share, and annual therapy cost. Results: All countries had at least one new antidiabetic medicine in continuous use and an increase in intensity of prescribing policy for all antidiabetic medicines was observed. A tenfold difference in median time to first continuous use (3–30 months) was found. The annual therapy cost in 2016 of new antidiabetic medicines ranged from EUR 363 to EUR 769. Among new antidiabetic medicines, the market share of DPP-4 inhibitors was the highest. Countries with a higher volume market share of incretin-based medicines (Spain, France, Austria, and Germany) in 2011 had a lower increase in intensity of prescribing policy. This kind of correlation was not found in the case of SGLT-2 inhibitors. Conclusions: This study found important differences and variability in the uptake of new antidiabetic medicines in the included countries. [ABSTRACT FROM AUTHOR]

Objective: The goal of this study was to investigate the current daily approach of urologists for the initial evaluation of men with lower urinary tract symptoms (LUTS) in accordance with the European Association of Urology (EAU) guidelines. Materials and Methods: An online survey was used to identify the daily practices of urologists for men over the age of 45 with LUTS. Based on the EAU guidelines, an 11-item questionnaire was created. A link to the SurveyMonkey questionnaire was sent to members of a national urology association along with an e-mail message. Moreover, the data were analysed after collecting all of the responses. Results: Out of 1.182 urologists who received an invitation message, 166 (14.04%) responded and completed the questionnaire. The mean age of the urologists who responded was 42.24+10.11. More than half of the participants (56.6%) work at centres that have a urology residency programme. Furthermore, the most commonly performed laboratory test in men with LUTS was urinalysis. Approximately 90% of urologists performed urinalysis. In addition, 84% of participants routinely measured prostate-specific antigen in every man between the ages of 45 and 75. In all men with LUTS, approximately half of the urologists routinely used renal function tests, urinary ultrasonography, post-void residual urine measurement, uroflowmetry, and symptom score assessment. For men with nocturia and/or storage phase symptoms, the majority of participants (69.9%) used a bladder diary. Moreover, urologists who worked at university hospitals were found to use bladder diaries significantly more frequently in their clinical practice (p=0.037). [ABSTRACT FROM AUTHOR]

Current health promotion and early cancer detection programmes yield different results depending on the social group and have a different impact among individuals. Thus, they may generate social inequalities in health. The Contest of Best Practices tackling social inequalities in cancer prevention is an initiative that emerged in the framework of the Innovative Partnership for Action Against Cancer Joint Action. This contest identifies interventions that have proven to be effective in reducing social inequalities in cancer prevention in European countries, with the aim of sharing lessons learned and inspiring solutions, as well as facilitating replication in other health systems and similar social settings. [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]

Background: Prescribing in dental practice has a relatively small but important contribution to the quantity of antibiotics prescribed in primary care. This study aimed to analyse antibiotic prescribing in dentistry over time (2010–2016) in 4 different Northern European countries and their relative contribution to national outpatients consumption. Methods: This retrospective study evaluated the frequency and number of national antibiotic prescriptions written by dentists in England, Scotland, Norway and Sweden. The consumption of such antibiotics was measured using WHO defined daily doses (DDDs), DDDs per 100,000 inhabitants per day (DIDs100,000). Results: A total of more than 27 million prescriptions (27,026,599) archived between 2010 and 2016 from the four countries were analysed. The national contribution of Norwegian dentists to the total primary care prescription during this period was 8%. The corresponding figures for Sweden, Scotland and England were 7, 6, and 8%. Dental contribution to National antibiotic use in all four countries has decreased over the study time period for commonly prescribed antibiotics in dentistry, i.e., the beta-lactams (Phenoxymethyl penicillin/Amoxicillin) and metronidazole. There were less numbers of prescriptions by dentists in Norway and Sweden compared to England and Scotland. Marked differences in some classes of antibiotics were noted with Phenoxymethyl penicillin dominating in Sweden/Norway compared to Amoxicillin and Metronidazole in England/Scotland. In England and Scotland, dentists were the largest prescribers of metronidazole in primary care. Clindamycin prescriptions was higher in Norway and Sweden. Conclusion: Noticeable differences exist in prescribing patterns for the management of oral infections. High levels of metronidazole use in England and Scotland also require further analysis. All countries over the study period showed a decrease in total numbers of antibiotics prescribed. [ABSTRACT FROM AUTHOR]

Background: The International Duration Evaluation of Adjuvant Chemotherapy (IDEA) collaboration aimed to evaluate whether 3 months of adjuvant chemotherapy are noninferior to 6 months. Our study objectives were to characterize medical oncologists' perspectives toward the results of the IDEA collaboration and to evaluate how IDEA impacted prescribing patterns of adjuvant FOLFOX and CAPOX in colon cancer. Materials and Methods: A list of questions developed by four medical oncologists regarding IDEA results were formulated and distributed online to gastrointestinal medical oncologists globally. Descriptive statistics and chi‐square tests were used to summarize information. Results: Of 174 responses, 145 were complete and analyzed. Responses were obtained globally from South America (53%); the U.S. and Canada (28%); Europe, Australia, and New Zealand (12%); and Asia (7%). Most clinicians (98%) were aware of the IDEA study. Prior to IDEA, clinicians preferred FOLFOX over CAPOX (81% vs. 19%). Subsequent to IDEA, 55% of clinicians preferred CAPOX over FOLFOX (odds ratio, 5.0; 95% confidence interval, 3.0–8.5; p <.01 compared with pre‐IDEA). Two thirds (68%) of responders tailored duration of adjuvant therapy based on risk stratification. Most oncologists (76%) were more willing to discontinue oxaliplatin early if toxicities develop after the results of IDEA. Half of responders (50%) found that IDEA increased their confidence in decision making for adjuvant treatment; 36% were unchanged, and 15% indicated decreased confidence. Less than half (48%) were comfortable communicating the study results and the concept of a noninferiority trial with patients. Conclusion: IDEA appears to have shifted clinician preference from FOLFOX to CAPOX for adjuvant therapy, and most clinicians now use a risk‐stratified approach in determining duration of adjuvant therapy. Patient education resources may facilitate better communication of IDEA results to patients. Implications for Practice: This global survey illustrates that most gastrointestinal medical oncologists now use a risk‐stratified approach for determining the duration of adjuvant chemotherapy for stage III colon cancer. Clinicians are five times more likely to choose CAPOX over FOLFOX after the International Duration Evaluation of Adjuvant Chemotherapy (IDEA) collaboration results. This article reports medical oncologists' perspectives on the results of the IDEA Collaboration and assesses the real‐world update of this data. [ABSTRACT FROM AUTHOR]

Background This study was conducted to assess the variation in prescription practices for systemic antimicrobial agents used for prophylaxis among pediatric patients hospitalized in 41 countries worldwide. Methods Using the standardized Antibiotic Resistance and Prescribing in European Children Point Prevalence Survey protocol, a cross-sectional point-prevalence survey was conducted at 226 pediatric hospitals in 41 countries from October 1 to November 30, 2012. Results Overall, 17693 pediatric patients were surveyed and 36.7% of them received antibiotics (n = 6499). Of 6818 inpatient children, 2242 (32.9%) received at least 1 antimicrobial for prophylactic use. Of 11899 prescriptions for antimicrobials, 3400 (28.6%) were provided for prophylactic use. Prophylaxis for medical diseases was the indication in 73.4% of cases (2495 of 3400), whereas 26.6% of prescriptions were for surgical diseases (905 of 3400). In approximately half the cases (48.7% [1656 of 3400]), a combination of 2 or more antimicrobials was prescribed. The use of broad-spectrum antibiotics (BSAs), which included tetracyclines, macrolides, lincosamides, and sulfonamides/trimethoprim, was high (51.8% [1761 of 3400]). Broad-spectrum antibiotic use for medical prophylaxis was more common in Asia (risk ratio [RR], 1.322; 95% confidence interval [CI], 1.202–1.653) and more restricted in Australia (RR, 0.619; 95% CI, 0.521–0.736). Prescription of BSA for surgical prophylaxis also varied according to United Nations region. Finally, a high percentage of surgical patients (79.7% [721 of 905]) received their prophylaxis for longer than 1 day. Conclusions A high proportion of hospitalized children received prophylactic BSAs. This represents a clear target for quality improvement. Collectively speaking, it is critical to reduce total prophylactic prescribing, BSA use, and prolonged prescription. [ABSTRACT FROM AUTHOR]

The diagnostic process for patients presenting with cognitive decline and suspected dementia is complex. Physicians face challenges distinguishing between normal aging, mild cognitive impairment, Alzheimer's disease, and other dementias. Although there is some evidence for improving attitudes towards the importance of prompt diagnosis, there is limited information describing how physicians approach this diagnostic challenge in practice. This was explored in the present study. Across-sectional survey of primary care and specialist physicians, in 5 European countries, Canada, and the United States, was conducted. Participants were asked about their use of cognitive screening tools and diagnostic technologies, as well as the rationales and barriers for use. In total, 1365 physicians participated in the survey, 63% of whom were specialists. Most physicians stated they use objective cognitive tools to aid the early detection of suspected mild cognitive impairment or Alzheimer's disease in patients. The Mini-Mental State Examination was the most common tool used for initial screening; respondents cited speed and ease of use but noted its lack of specificity. Cerebrospinal fluid biomarker and amyloid positron emission tomography tests, respectively, had been used by only 26% and 32% of physicians in the preceding 6 months, although patterns of use varied across countries. The most commonly cited reasons for not ordering such tests were invasiveness (for cerebrospinal fluid biomarker testing) and cost (for amyloid positron emission tomography imaging). Data reported by physicians reveal differences in the approaches to the diagnostics process in Alzheimer's. A higher proportion of primary care physicians in the United States are routinely incorporating cognitive assessment tools into annual visits, but this is due to country differences in clinical practice. The value of screening tools and regular use could be discussed further with physicians; however, lack of specificity associated with cognitive tools and the investment required from patients and the healthcare system are limiting factors. [ABSTRACT FROM AUTHOR]

Objective: The aim of the study was to develop and test an instrument, underpinned by a recognized theoretical framework, that examines how staff perceive person-centred practice, using proven methods of instrument design and psychometric analysis.Design: The study used a mixed method multiphase research design involving: two Delphi studies to agree definitions and items to measure the constructs aligned to the person-centred practice theoretical framework (Phase 1); and a large-scale quantitative cross-sectional survey (Phase 2).Setting: Phase 1 was an international study involving representatives from seven countries across Europe and Australia, with Phase 2 conducted in one country across five organizations.Participants: Two international panels of experts (n = 33) in person-centred practice took part in the Delphi study and a randomly selected sample of registered nurses (n = 703, 23.8%) drawn from across a wide range of clinical settings completed the Person-centred Practice Inventory - Staff (PCPI-S).Main Outcome Measures: The main outcome is to establish a measure of staff perceptions of person-centred Practice.Results: Broad consensus on definitions relating to 17 constructs drawn from a person-centred practice framework was achieved after two rounds; likewise with the generation of 108 items to measure the constructs; a final instrument comprising 59 items with proven psychometric properties was achieved.Conclusions: The PCPI-S is psychometrically acceptable instrument validated by an international expert panel that maps specifically to a theoretical framework for person-centred practice and provides a generic measure of person-centredness. [ABSTRACT FROM AUTHOR]

Background: Despite a steady stream of headlines suggesting they will transform the future of healthcare, high-tech regenerative medicines have, to date, been quite inaccessible to patients, with only eight having been granted an EU marketing licence in the last 7 years. Here, we outline some of the historical reasons for this paucity of licensed innovative regenerative medicines. We discuss the challenges to be overcome to expedite the development of this complex and rapidly changing area of medicine, together with possible reasons to be more optimistic for the future.Discussion: Several factors have contributed to the scarcity of cutting-edge regenerative medicines in clinical practice. These include the great expense and difficulties involved in planning how individual therapies will be developed, manufactured to commercial levels and ultimately successfully delivered to patients. Specific challenges also exist when evaluating the safety, efficacy and cost-effectiveness of these therapies. Furthermore, many treatments are used without a licence from the European Medicines Agency, under "Hospital Exemption" from the EC legislation. For products which are licensed, alternative financing approaches by healthcare providers may be needed, since many therapies will have significant up-front costs but uncertain benefits and harms in the long-term. However, increasing political interest and more flexible mechanisms for licensing and financing of therapies are now evident; these could be key to the future growth and development of regenerative medicine in clinical practice.Conclusions: Recent developments in regulatory processes, coupled with increasing political interest, may offer some hope for improvements to the long and often difficult routes from laboratory to marketplace for leading-edge cell or tissue therapies. Collaboration between publicly-funded researchers and the pharmaceutical industry could be key to the future development of regenerative medicine in clinical practice; such collaborations might also offer a possible antidote to the innovation crisis in the pharmaceutical industry. [ABSTRACT FROM AUTHOR]

Objective:To assess the quality of antibiotic prescribing in primary care in Belgium, the Netherlands and Sweden using European disease-specific antibiotic prescribing quality indicators (APQI) and taking into account the threshold to consult and national guidelines. Design:A retrospective observational database study. Setting:Routine primary health care registration networks in Belgium, the Netherlands and Sweden. Subjects:All consultations for one of seven acute infections [upper respiratory tract infection (URTI), sinusitis, tonsillitis, otitis media, bronchitis, pneumonia and cystitis] and the antibiotic prescriptions in 2012 corresponding to these diagnoses. Main outcome measures:Consultation incidences for these diagnoses and APQI values (a) the percentages of patients receiving an antibiotic per diagnosis, (b) the percentages prescribed first-choice antibiotics and (c) the percentages prescribed quinolones. Results:The consultation incidence for respiratory tract infection was much higher in Belgium than in the Netherlands and Sweden. Most of the prescribing percentage indicators (a) were outside the recommended ranges, with Belgium deviating the most for URTI and bronchitis, Sweden for tonsillitis and the Netherlands for cystitis. The Netherlands and Sweden prescribed the recommended antibiotics (b) to a higher degree and the prescribing of quinolones exceeded the proposed range for most diagnoses (c) in Belgium. The interpretation of APQI was found to be dependent on the consultation incidences. High consultation incidences were associated with high antibiotic prescription rates. Taking into account the recommended treatments from national guidelines improved the results of the APQI values for sinusitis in the Netherlands and cystitis in Sweden. Conclusion:Quality assessment using European disease-specific APQI was feasible and their inter-country comparison can identify opportunities for quality improvement. Their interpretation, however, should take consultation incidences and national guidelines into account. Differences in registration quality might limit the comparison of diagnosis-linked data between countries, especially for conditions such as cystitis where patients do not always see a clinician before treatment.Key pointsThe large variation in antibiotic use between European countries points towards quality differences in prescribing in primary care. • The European disease-specific antibiotic prescribing quality indicators (APQI) provide insight into antibiotic prescribing, but need further development, taking into account consultation incidences and country-specific guidelines. • The incidence of consultations for respiratory tract infections was almost twice as high in Belgium compared to the Netherlands and Sweden. • Comparison between countries of diagnosis-linked data were complicated by differences in data collection, especially for urinary tract infections. [ABSTRACT FROM PUBLISHER]

The substantial evidence base for interventional ultrasound approaches to renal diagnostic sampling and therapeutic access exists. This review comments on the evidence-based recommendations on ultrasound-guided renal access which have been published recently within the framework of Guidelines on Interventional Ultrasound (InVUS) of the European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB) from a clinical practice point of view. Specific aspects of tissue handling and workup, procedural approach and patient interaction are discussed. Indications, contraindications, risk factors and methods to reduce these risks are considered. [ABSTRACT FROM AUTHOR]

Background: Statistical measurements alone are insufficient to ensure robust data for point prevalence surveys (PPS) of healthcare-associated infections (HAI). Data quality is determined by the type of data, data collection methods and available resources. Data collectors’ views regarding the acceptability of data collection process for validation studies are also important to consider. Aim: To explore data collectors’ views on the acceptability of data collection processes used for a European validation PPS of HAI and antimicrobial use (AMU). Methods: An anonymous online survey was conducted with 67 data collectors from 10 European countries involved in the study. Findings: Twenty-five (64.1%) participants viewed AMU data collection as easy/quite easy whereas only five (12.8%) thought HAI data collection was easy/quite easy. Six (17%) participants indicated that incentives and 21 (56.8%) that disincentives were possibly/definitely present for reporting cases of HAI. Engagement of staff was not thought to have adversely affected data collection as only one (2.6%) and five (15.4%) participants thought involvement of hospital PPS teams and administration was low/very low, respectively. Discussion: Participants believed the approaches used were appropriate but that more training was required prior to data collection, some case definitions should be reviewed and the number of variables reduced. [ABSTRACT FROM AUTHOR]

Background: Medication overuse headache (MOH) is a very disabling and costly disorder due to indirect costs, medication and healthcare utilization. The aim of the study was to describe general demographic and clinical characteristics of MOH, along with the national referral pathways and national painkillers distribution in several European and Latin American (LA) Countries. Methods: This descriptive cross-sectional observational study included 669 patients with MOH referred to headache-centers in Europe and LA as a part of the COMOESTAS project. Information about acute medication and healthcare utilization were collected by extensive questionnaires, supplemented with structured patient interviews. Results: Triptans were overused by 31 % European patients and by 6 % in LA ( p < 0.001), whereas ergotamines were overused by 4 % in Europe and 72 % in LA ( p < 0.001). Simple analgesics were overused by 54 % in Europe and by 33 % in LA ( p < 0.001), while combination-analgesics were more equally overused (24 % in Europe and 29 % in LA). More European patients (57 %) compared with LA patients (27 %) visited general practitioners ( p < 0.001), and 83 % of European patients compared to 38 % in LA consulted headache specialists ( p < 0.001). A total of 20 % in Europe and 30 % in LA visited emergency rooms ( p = 0.007). Conclusion: There are marked variations between LA and Europe in healthcare pathways and in acute medication overuse regarding patients with MOH. This should be considered when planning prevention campaigns against MOH. [ABSTRACT FROM AUTHOR]

Background Variation in prescription of antibiotics in primary care can indicate poor clinical practice that contributes to the increase of resistant strains. General Practitioners (GPs), as a professional group, are expected to have a fairly homogeneous prescribing style. In this paper, we describe variation in prescribing style within and across groups of GPs from six countries. Methods Cross-sectional study with the inclusion of 457 GPs and 6394 sore throat patients. We describe variation in prescribing antibiotics for sore throat patients across six countries and assess whether variation in "prescribing style" - understood as a subjective tendency to prescribe - has an important effect on variation in prescription of antibiotics by using the concept of prescribing style as a latent variable in a multivariable model. We report variation as a Median Odds Ratio (MOR) which is the transformation of the random effect variance onto an odds ratio; Thus, MOR = 1 means similar odds or strict homogeneity between GPs' prescribing style, while a MOR higher than 1 denotes heterogeneity in prescribing style. Results In all countries some GPs always prescribed antibiotics to all their patients, while other GPs never did. After adjusting for patient and GP characteristics, prescribing style in the group of GPs from Russia was about three times more heterogeneous than the prescribing style in the group of GPs from Denmark - Median Odds Ratio ( 6.8, 95%CI 3.1;8.8 ) and ( 2.6, 95%CI 2.2;4.4 ) respectively. Conclusion Prescribing style is an important source of variation in prescription of antibiotics within and across countries, even after adjusting for patient and GP characteristics. Interventions aimed at influencing the prescribing style of GPs must encompass context-specific actions at the policy-making level alongside GP-targeted interventions to enable GPs to react more objectively to the external demands that are in place when making the decision of prescribing antibiotics or not. [ABSTRACT FROM AUTHOR]

The mortality associated with invasive fungal infections remains high with that involving rare yeast pathogens other than Candida being no exception. This is in part due to the severe underlying conditions typically predisposing patients to these healthcare-related infections (most often severe neutropenia in patients with haematological malignancies), and in part due to the often challenging intrinsic susceptibility pattern of the pathogens that potentially leads to delayed appropriate antifungal treatment. A panel of experts of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Fungal Infection Study Group (EFISG) and the European Confederation of Medical Mycology (ECMM) undertook a data review and compiled guidelines for the diagnostic tests and procedures for detection and management of rare invasive yeast infections. The rare yeast pathogens were defined and limited to the following genera/species: Cryptococcus adeliensis, Cryptococcus albidus, Cryptococcus curvatus, Cryptococcus flavescens, Cryptococcus laurentii and Cryptococcus uniguttulatus (often published under the name Filobasidium uniguttulatum), Malassezia furfur, Malassezia globosa, Malassezia pachydermatis and Malassezia restricta, Pseudozyma spp., Rhodotorula glutinis, Rhodotorula minuta and Rhodotorula mucilaginosa, Sporobolomyces spp., Trichosporon asahii, Trichosporon asteroides, Trichosporon dermatis, Trichosporon inkin, Trichosporon jirovecii, Trichosporon loubieri, Trichosporon mucoides and Trichosporon mycotoxinivorans and ascomycetous ones: Geotrichum candidum, Kodamaea ohmeri, Saccharomyces cerevisiae (incl. S. boulardii) and Saprochaete capitatae (Magnusiomyces (Blastoschizomyces) capitatus formerly named Trichosporon capitatum or Geotrichum (Dipodascus) capitatum) and Saprochaete clavata. Recommendations about the microbiological investigation and detection of invasive infection were made and current knowledge on the most appropriate antifungal and supportive treatment was reviewed. In addition, remarks about antifungal susceptibility testing were made. [ABSTRACT FROM AUTHOR]

In accordance with the adaptation of the Postgraduate Diploma in Surgical Nursing at the Vall d'Hebron University Nursing Hospital to the EHEA framework, one of the new methods to be introduced in 2008-09 was the student portfolio. Aim: To construct and consolidate a design for the evaluation using the portfolio, which involves students and nurses in the process of reflecting on learning in surgical care processes. Methodology: The area of activity was clinical practicals for the Postgraduate Diploma in Surgical Nursing during the 2008-09 academic year. 45 students constituted the subjects of the study. 2 members of teaching staff and 62 surgical nurses were also involved as tutors.. Stages: 1) Design of the minimum portfolio content. 2) Presentation of the portfolio to students and nurse tutors. 3) Monitoring of the portfolio during the period of clinical practicals. 4) Analysis of the completed portfolios. 5) Evaluation session with the surgical nurse tutors at the end of the course. Results: Reflection did not appear explicitly in most of the portfolios, but the commentaries showed the importance of including it and reinforcing it with the nurse tutor. Conclusions: The portfolio became an instrument of communication between teaching staff, students and nurse tutors reinforcing the involvement of the latter in the learning process. On the basis of the results strategies were implemented for the improvement and consolidation of the portfolio for the 2009-10 academic year. [ABSTRACT FROM AUTHOR]

The European Society of Cardiology heart failure guidelines firmly recommend regular physical activity and structured exercise training (ET), but this recommendation is still poorly implemented in daily clinical practice outside specialized centres and in the real world of heart failure clinics. In reality, exercise intolerance can be successfully tackled by applying ET. We need to encourage the mindset that breathlessness may be evidence of signalling between the periphery and central haemodynamic performance and regular physical activity may ultimately bring about favourable changes in myocardial function, symptoms, functional capacity, and increased hospitalization-free life span and probably survival. In this position paper, we provide practical advice for the application of exercise in heart failure and how to overcome traditional barriers, based on the current scientific and clinical knowledge supporting the beneficial effect of this intervention. [ABSTRACT FROM PUBLISHER]

The article discusses the Standards for Independent Ethics Committee (IECs) by the European Forum for Good Clinical Practice (EFGCP) on the quality assurance process including audits, inspections, and internal standard operating procedures in Europe. Ethics Working party, a subgroup of EFGCP, develops a guidance document for quality assurance program. He explores the "Guidance for Auditing Quality Systems of Independent Ethics Committees in Europe 2008" that outlines the audit approach.

Simple Summary: Recent studies have mostly focused on the treatment of advanced mycosis fungoides and Sézary syndrome and less on the treatment of relapsed or refractory (R/R) cases of cutaneous T-cell lymphoma (CTCL). There is also a paucity of data on the treatment and outcomes of primary cutaneous anaplastic large cell lymphoma and other rare CTCL subtypes. This European observational study provided real-world data on the current treatments used in the management of CTCL across three lines of therapy. As a result, there was a significant level of heterogeneity in treatment types than expected by European guidelines. These findings highlight the lack of consensus in relapsed CTCL, as well as the urgent unmet treatment needs. The treatment pattern of cutaneous T-cell lymphoma (CTCL) remains diverse and patient-tailored. The objective of this study was to describe the treatment patterns and outcomes in CTCL patients who were refractory or had relapsed (R/R) after a systemic therapy. A retrospective chart review study was conducted at 27 sites in France, Germany, Italy, Spain and the United Kingdom (UK) of patients who received a first course of systemic therapy and relapsed or were refractory. Data were collected longitudinally from diagnosis to first-, second- and third-line therapy. The study included 157 patients, with a median follow-up of 3.2 years. In total, 151 proceeded to second-line and 90 to third-line therapy. In the first line (n = 147), patients were treated with diverse therapies, including single- and multi-agent chemotherapy in 67 (46%), retinoids in 39 (27%), interferon in 31 (21%), ECP in 4 (3%), corticosteroids in 3 (2%) and new biological agents in 3 (2%). In the second line, the use of chemotherapy and retinoids remained similar to the first line, while the use of new biologics increased slightly. In sharp contrast to the first line, combination chemotherapy was extremely diverse. In the third line, the use of chemotherapy remained high and diverse as in the second line. From the time of first R/R, the median PFS was 1.2 years and the median OS was 11.5 years. The presented real-world data on the current treatments used in the management of R/R CTCL in Europe demonstrate the significant heterogeneity of systemic therapies and combination therapies, as expected from the European guidelines. [ABSTRACT FROM AUTHOR]

Editorial. Focuses on clinical practice guidelines aimed at improving the process and outcome of health care in Europe. Definition of quality care; Illustration of inappropriate use of medical care in Europe; Benefit of promoting a concerted international effort on the improvement of health care.

Migraine is a common and burdensome neurological condition which affects mainly female patients during their childbearing years. Valproate has been widely used for the prophylaxis of migraine attacks and is also included in the main European Guidelines. Previous (2014) European recommendations on limiting the use of valproate in women of childbearing age did not achieve their objective in terms of limiting the use of valproate in women of childbearing age and raising awareness regarding the hazardous effect of valproate to children exposed in utero. The teratogenic and foetotoxic effects of valproate are well documented, and more recent studies show that there is an even greater neurodevelopmental risk to children exposed to valproate in the womb. The latest 2018 European review from the European Medicines Agency, with the active participation of the European Headache Federation, concluded that not enough has been done to mitigate the risks associated with in utero exposure to valproate. The review called for more extensive restrictions to the conditions for prescribing, better public awareness, and a more effective education campaign in migrainous women. [ABSTRACT FROM AUTHOR]

Focuses on the impact of the application of medical standardized protocols into the clinical practice of medical professionals in Europe. Applicability of the transferring clinical research and trials into practice; Consistency of approaches when involving clinical governance; Accessibility of transport and other compounding factors.

The article reports the updates on ethical approval system from European Forum for Good Clinical Practice (EFGCP). The author presents a table that shows the ethical procedures in different countries including Germany, France, and Spain. A workshop was organized by EFGCP that explores the differences between ethics committees on the one hand, investigators, and sponsors of research project.

Objectives. To evaluate composite measures of response without acute-phase reactants in RA patients. Specifically, Clinical Disease Activity Index (CDAI)-derived response criteria were compared with the European League Against Rheumatism (EULAR) response criteria, and the modified ACR (mACR) response criteria were compared to the ACR response criteria. Methods. Data from 10 108 RA patients enrolled in the Consortium of Rheumatology Researchers of North America registry were examined, including 649 patients initiating DMARD therapy. CDAI cut-off points for disease activity levels and responses were derived using receiver operating characteristic curves with the DAS28 and EULAR response criteria as gold standards. The κ-statistics were applied to assess agreement between CDAI-derived and EULAR-defined responses, as well as ACR20 and ACR50 with mACR20- and mACR50-defined responses, respectively. Results. For the components of the EULAR response, the derived CDAI cut-off points for DAS28 levels of 3.2 and 5.1 were 7.6 and 19.6, respectively. The derived CDAI cut-off points were 4.3 and 10.0 for DAS28 changes of 0.6 and 1.2, respectively. There were moderate to substantial agreements between CDAI-derived and EULAR responses (κ = 0.57–0.71). Agreement of ACR20 and ACR50 with mACR20 and mACR50 responses, respectively, was excellent (κ = 0.88–0.95). Conclusions. Agreement between composite measures of response without acute-phase reactants and standard measures ranged from moderate to excellent. The mACR20 and mACR50 criteria as well as CDAI-derived response criteria, can serve as composite measures of response in clinical practice and research settings without access to acute-phase reactants. [ABSTRACT FROM AUTHOR]