Suchergebnisse

There are various guidelines for the treatment of obesity, and thus the quality of these clinical guidelines has become a matter of concern. The objective was to describe and assess the quality of clinical guidelines for treatment of obesity in adults. We collected several studies, dated from 1998 to 2016, produced by different countries. The literature search included the National Guideline Clearinghouse (NGC), Guidelines International Network (GIN), PubMed (MEDLINE), Scopus, Web of Science, webpages of health institutions from different countries, and search sites, with the criterion: "clinical guidelines for treatment of obesity in adults and published until the 2016". The guidelines were assessed with the Appraisal of Guidelines for Research & Evaluation (AGREE II), according to the domains of the instrument. The search identified 21 guidelines: nine from Europe, six from North America, three from Latin America, and one each from Asia and Oceania and a transnational association. The Australian guideline had the best assessment. Of the six guidelines with the highest scores, five had been elaborated by the government sector responsible for the country's health. The domains "scope and purpose" and "clarity of presentation" had the highest score. Except for the Canadian guideline, the three guidelines drafted before the elaboration of AGREE II had the worst quality. In the domain "stakeholder involvement", only four guidelines (Australia, Scotland, France, and England) mentioned patient participation. Guideline development and quality enhancement are ongoing processes requiring systematic appraisal of the guideline production process and existing guidelines.

Rare diseases affect up to 29 million people in the European Union, and almost 50% of them affect the nervous system or muscles. Delays in diagnosis and treatment onset and insufficient treatment choices are common. Clinical practice guidelines (CPGs) may improve the diagnosis and treatment of patients and optimize care pathways, delivering the best scientific evidence to all clinicians treating these patients. Recommendations are set for developing and reporting high-quality CPGs on rare neurological diseases (RNDs) within the European Academy of Neurology (EAN), through a consensus procedure. A group of 27 experts generated an initial list of items that were evaluated through a two-step Delphi consensus procedure and a face-to-face meeting. The final list of items was reviewed by an external review group of 58 members. The consensus procedure yielded 63 final items. Items are listed according to the domains of the AGREE instruments and concern scope and purpose, stakeholder involvement, rigour of development, and applicability. Additional items consider reporting and ethical issues. Recommendations are supported by practical examples derived from published guidelines and are presented in two tables: (1) items specific to RND CPGs, and general guideline items of special importance for RNDs, or often neglected; (2) items for guideline development within the EAN. This guidance aims to provide solutions to the issues specific to RNDs. This consensus document, produced by many experts in various fields, is considered to serve as a starting point for further harmonization and for increasing the quality of CPGs in the field of RNDs.

Rare diseases affect up to 29 million people in the European Union, and almost 50% of them affect the nervous system or muscles. Delays in diagnosis and treatment onset and insufficient treatment choices are common. Clinical practice guidelines (CPGs) may improve the diagnosis and treatment of patients and optimize care pathways, delivering the best scientific evidence to all clinicians treating these patients. Recommendations are set for developing and reporting high-quality CPGs on rare neurological diseases (RNDs) within the European Academy of Neurology (EAN), through a consensus procedure. A group of 27 experts generated an initial list of items that were evaluated through a two-step Delphi consensus procedure and a face-to-face meeting. The final list of items was reviewed by an external review group of 58 members. The consensus procedure yielded 63 final items. Items are listed according to the domains of the AGREE instruments and concern scope and purpose, stakeholder involvement, rigour of development, and applicability. Additional items consider reporting and ethical issues. Recommendations are supported by practical examples derived from published guidelines and are presented in two tables: (1) items specific to RND CPGs, and general guideline items of special importance for RNDs, or often neglected; (2) items for guideline development within the EAN. This guidance aims to provide solutions to the issues specific to RNDs. This consensus document, produced by many experts in various fields, is considered to serve as a starting point for further harmonization and for increasing the quality of CPGs in the field of RNDs.

Evidence-based guidelines on the management of pancreatic cystic neoplasms (PCN) are lacking. This guideline is a joint initiative of the European Study Group on Cystic Tumours of the Pancreas, United European Gastroenterology, European Pancreatic Club, European-African Hepato-Pancreato-Biliary Association, European Digestive Surgery, and the European Society of Gastrointestinal Endoscopy. It replaces the 2013 European consensus statement guidelines on PCN. European and non-European experts performed systematic reviews and used GRADE methodology to answer relevant clinical questions on nine topics (biomarkers, radiology, endoscopy, intraductal papillary mucinous neoplasm (IPMN), mucinous cystic neoplasm (MCN), serous cystic neoplasm, rare cysts, (neo)adjuvant treatment, and pathology). Recommendations include conservative management, relative and absolute indications for surgery. A conservative approach is recommended for asymptomatic MCN and IPMN measuring 5 mm, and MPD diameter >10 mm. Lifelong follow-up of IPMN is recommended in patients who are fit for surgery. The European evidence-based guidelines on PCN aim to improve the diagnosis and management of PCN.

Introduction: Adequate nutrition-support clinical practice requires recommendations based on the best available evidence, in order to help health professionals making decisions concerning the management of enteral nutritional support in pathologies of interest. Objective: To identify the key factors in the management of enteral nutrition, in order to prevent and treat malnutrition based upon the recommendations made in the best Practice Guidelines (CPG). Methods: A structured search of nutritional support in CPG was performed. Five referees independently selected the CPG among those published between 2005 and 2015. They used AGREE II in order assess quality and selected those CPG with a score no lower than 60% in the domains of methodological rigor and editorial independence. The findings were compared to the Colombian clinical practice. Results: 24 GPC were evaluated, of which 79.1% (n = 19) were developed by scientific societies, 12.6% (n = 3) by government agencies and 8.3% (n = 2) by CPG developing bodies. Selected CPG were those produced by NICE (global score 92%), and those developed by CENETEC, which scored 70.89% and 87.2%.8. Discussion: In order to decrease clinical-practice heterogeneity, take into account new therapeutic options and provide quality care, it is suggested to adopt the best CPG, such as those developed by governmental institutions and CPG developing agencies like CENETEC and NICE. Attention and implementation of their recommendations in Colombia has been poor, as the most consulted CPG are the ASPEN and ESPEN ones. Conclusion: Key elements recommended in the best nutrition CPG, are: income nutritional screening, nutritional risk monitoring, nutritional support for malnourished patients, nutritional support for patients with limiting food intake, specialized nutritional support, nutrition education, and creation of institutional nutrition committees. These elements would be useful to build societal trust in clinical practice. Encouraging consultation of high quality nutrition CPG would help to optimize capacities in the face of technical limitations in the health sector.

Nonadherence to antihypertensive medication is common, especially in those with apparent treatment-resistant hypertension (true treatment-resistant hypertension requires exclusion of nonadherence), and its routine detection is supported by clinical guidelines. Chemical adherence testing is a reliable and valid method to detect adherence, yet methods are unstandardized and are not ubiquitous. This article describes the principles of chemical adherence testing for hypertensive patients and provides a set of recommendations for centers wishing to develop the test. We recommend testing should be done in either of two instances: (1) in those who have resistant hypertension or (2) in those on 2 antihypertensives who have a less than 10 mm Hg drop in systolic blood pressure on addition of the second antihypertensive medication. Furthermore, we recommend that verbal consent is secured before undertaking the test, and the results should be discussed with the patient. Based on medications prescribed in United Kingdom, European Union, and United States, we list top 20 to 24 drugs that cover >95% of hypertension prescriptions which may be included in the testing panel. Information required to identify these medications on mass spectrometry platforms is likewise provided. We discuss issues related to ethics, sample collection, transport, stability, urine versus blood samples, qualitative versus quantitative testing, pharmacokinetics, instrumentation, validation, quality assurance, and gaps in knowledge. We consider how to best present, interpret, and discuss chemical adherence test results with the patient. In summary, this guidance should help clinicians and their laboratories in the development of chemical adherence testing of prescribed antihypertensive drugs.

Nonadherence to antihypertensive medication is common, especially in those with apparent treatment-resistant hypertension (true treatment-resistant hypertension requires exclusion of nonadherence), and its routine detection is supported by clinical guidelines. Chemical adherence testing is a reliable and valid method to detect adherence, yet methods are unstandardized and are not ubiquitous. This article describes the principles of chemical adherence testing for hypertensive patients and provides a set of recommendations for centers wishing to develop the test. We recommend testing should be done in either of two instances: (1) in those who have resistant hypertension or (2) in those on 2 antihypertensives who have a less than 10 mm Hg drop in systolic blood pressure on addition of the second antihypertensive medication. Furthermore, we recommend that verbal consent is secured before undertaking the test, and the results should be discussed with the patient. Based on medications prescribed in United Kingdom, European Union, and United States, we list top 20 to 24 drugs that cover >95% of hypertension prescriptions which may be included in the testing panel. Information required to identify these medications on mass spectrometry platforms is likewise provided. We discuss issues related to ethics, sample collection, transport, stability, urine versus blood samples, qualitative versus quantitative testing, pharmacokinetics, instrumentation, validation, quality assurance, and gaps in knowledge. We consider how to best present, interpret, and discuss chemical adherence test results with the patient. In summary, this guidance should help clinicians and their laboratories in the development of chemical adherence testing of prescribed antihypertensive drugs.

INTRODUCTION: The NICE clinical guidelines on psychosocial interventions for the treatment of schizophrenia and psychosis in adults are based on the results of randomized controlled trials (RCTs), which may not be studies with a pragmatic design, leading to uncertainty on applicability or recommendations to everyday clinical practice. AIM: To assess the level of pragmatism of the evidence used to develop the NICE guideline for psychosocial interventions in psychoses. MATERIAL AND METHODS: We conducted a systematic and critical appraisal of RCTs used to develop the 'psychological therapy and psychosocial interventions' section of the NICE guideline on the treatment and management of psychosis and schizophrenia in adults, published in 2014. For each study we assessed pragmatism using the pragmatic-explanatory continuum indicator summary-2 (PRECIS-2) and the Cochrane risk of bias tool. The mean score of PRECIS-2, averaging across nine domains, was calculated to describe the level of pragmatism of each individual study. RESULTS: A total of 143 studies were included in the analysis. Based on the PRECIS-2 tool, 16.8% were explanatory, 33.6% pragmatic, and 49.7% were rated in an intermediate category. Compared to explanatory studies, pragmatic studies showed a lower risk of bias. Additionally, pragmatism did not significantly improve over time, and no associations were found between pragmatism and a number of trial characteristics. However, studies with a UK leading investigator had the highest mean score of pragmatism. Cognitive behavioural therapy (CBT), art therapy, family intervention, psychoeducation, and adherence therapy, showed the higher average pragmatism scores. CONCLUSIONS: Two third of studies used to produce NICE recommendations on psychosocial interventions for the treatment of schizophrenia and psychosis in adults are based on studies that did not employ a pragmatic design.

Allergic rhinitis (AR) and asthma represent global health problems for all age groups. Asthma and rhinitis frequently coexist in the same subjects. Allergic Rhinitis and its Impact on Asthma (ARIA) was initiated during a World Health Organization workshop in 1999 (published in 2001). ARIA has reclassified AR as mild/moderate-severe and intermittent/persistent. This classification closely reflects patients' needs and underlines the close relationship between rhinitis and asthma. Patients, clinicians, and other health care professionals are confronted with various treatment choices for the management of AR. This contributes to considerable variation in clinical practice, and worldwide, patients, clinicians, and other health care professionals are faced with uncertainty about the relative merits and downsides of the various treatment options. In its 2010 Revision, ARIA developed clinical practice guidelines for the management of AR and asthma comorbidities based on the Grading of Recommendation, Assessment, Development and Evaluation (GRADE) system. ARIA is disseminated and implemented in more than 50 countries of the world. Ten years after the publication of the ARIA World Health Organization workshop report, it is important to make a summary of its achievements and identify the still unmet clinical, research, and implementation needs to strengthen the 2011 European Union Priority on allergy and asthma in children.

Allergic rhinitis (AR) and asthma represent global health problems for all age groups. Asthma and rhinitis frequently coexist in the same subjects. Allergic Rhinitis and its Impact on Asthma (ARIA) was initiated during a World Health Organization workshop in 1999 (published in 2001). ARIA has reclassified AR as mild/moderate-severe and intermittent/persistent. This classification closely reflects patients' needs and underlines the close relationship between rhinitis and asthma. Patients, clinicians, and other health care professionals are confronted with various treatment choices for the management of AR. This contributes to considerable variation in clinical practice, and worldwide, patients, clinicians, and other health care professionals are faced with uncertainty about the relative merits and downsides of the various treatment options. In its 2010 Revision, ARIA developed clinical practice guidelines for the management of AR and asthma comorbidities based on the Grading of Recommendation, Assessment, Development and Evaluation (GRADE) system. ARIA is disseminated and implemented in more than 50 countries of the world. Ten years after the publication of the ARIA World Health Organization workshop report, it is important to make a summary of its achievements and identify the still unmet clinical, research, and implementation needs to strengthen the 2011 European Union Priority on allergy and asthma in children.

Regulatory approaches for allergen immunotherapy (AIT) products and the availability of high-quality AIT products are inherently linked to each other. While allergen products are available in many countries across the globe, their regulation is very heterogeneous. First, we describe the regulatory systems applicable for AIT products in the European Union (EU) and in the United States (US). For Europe, a depiction of the different types of relevant procedures, as well as the committees involved, is provided and the fundamental role of national agencies of the EU member states in this complex and unique network is highlighted. Furthermore, the regulatory agencies from Australia, Canada, Japan, Russia, and Switzerland provided information on the system implemented in their countries for the regulation of allergen products. While AIT products are commonly classified as biological medicinal products, they are made available by varying types of procedures, most commonly either by obtaining a marketing authorization or by being distributed as named patient products. Exemptions from marketing authorizations in exceptional cases, as well as import of allergen products from other countries, are additional tools applied by countries to ensure availability of needed AIT products. Several challenges for AIT products are apparent from this analysis and will require further consideration.

The high burden of infectious diseases in adults aged 60 years and older is disproportionate, considering that many of these diseases are vaccine-preventable. Based on careful analysis of the reasons for vaccination barriers/failures in the European population, the two European geriatric and gerontological societies (the European Union Geriatric Medicine Society [EUGMS] and the International Association of Gerontology and Geriatrics - European Region [IAGG-ER]) propose careful adaptation of current vaccine guidelines to promote preventive aspects, concerning both life threatening-diseases (influenza, pneumococcal pneumonia and tetanus/diphtheria) and diseases which adversely impact patients' quality of life (pertussis and herpes zoster). This consensus statement is designed to support official recommendations and improve the willingness to vaccinate the most rapidly growing segment of the population. The following guidelines are based on the importance of the sustainability of vaccine programs from midlife till extreme old age: - Promote healthy aging by optimizing health determinants of daily functions, active participation in society and individual quality of life; - Provide useful information to contribute toward harmonizing vaccine strategies at European level; - Support the public health, social and economic values of vaccination. Both healthcare professionals and consumers associations have a critical role to play in the implementation of such consensus clinical guidelines.

Based on the two main frameworks for evaluating scientific evidence--SEC and GRADE--European cardiovascular prevention guidelines recommend interventions across all life stages using a combination of population-based and high-risk strategies with diet as the cornerstone of prevention. The evaluation of cardiovascular risk (CVR) incorporates HDL levels and psychosocial factors, a very high risk category, and the concept of age-risk. They also recommend cognitive-behavioural methods (e.g., motivational interviewing, psychological interventions, led by health professionals and with the participation of the patient's family, to counterbalance psychosocial stress and reduce CVR through the institution of positive habits such as a healthy diet, physical activity, smoking cessation, and adherence to treatment. Additionally, public health interventions--such as smoking ban in public areas or the elimination of trans fatty acids from the food chain--are also essential. Other innovations include abandoning antiplatelet therapy in primary prevention and the recommendation of maintaining blood pressure (BP) within the 130-139/80-85 mmHg range in diabetic patients and individuals with high CVR. Finally, due to the significant impact on patient progress and medical costs, special emphasis is given to the low therapeutic adherence levels observed. In sum, improving cardiovascular prevention requires a true partnership among the political class, public administrations, scientific and professional associations, health foundations, consumer associations, patients and their families. Such partnership would promote population-based and individual strategies by taking advantage of the broad spectrum of scientific evidence available, from clinical trials to observational studies and mathematical models to evaluate population-based interventions, including cost-effectiveness analyses. Las guías europeas de prevención cardiovascular contemplan dos sistemas de evaluación de la evidencia (SEC y GRADE) y recomiendan combinar las estrategias poblacional y de alto riesgo, interviniendo en todas las etapas de la vida, con la dieta como piedra angular de la prevención. La valoración del RCV incorpora los niveles de HDL y los factores psicosociales, una categoría de muy alto riesgo y el concepto edad-riesgo. Se recomienda el uso de métodos cognitivo-conductuales (entrevista motivadora, intervenciones psicológicas), aplicados por profesionales sanitarios, con la participación de familiares de los pacientes, para contrarrestar el estrés psicosocial y reducir el RCV mediante dietas saludables, entrenamiento físico, abandono del tabaco y cumplimiento terapéutico. También se requieren medidas de salud pública, como la prohibición de fumar en lugares públicos o eliminar los ácidos grasos trans de la cadena alimentaria. Otras novedades consisten en desestimar el tratamiento antiagregante en prevención primaria y la recomendación de mantener la PA dentro del rango 130-139/80-85 mmHg en pacientes diabéticos o con RCV alto. Se destaca el bajo cumplimiento terapéutico observado, porque influye en el pronóstico de los pacientes y en los costes sanitarios. Para mejorar la prevención cardiovascular se precisa una verdadera alianza entre políticos, administraciones, asociaciones científicas y profesionales de la salud, fundaciones de salud, asociaciones de consumidores, pacientes y sus familias, que impulse las estrategias poblacional e individual, mediante el uso de toda la evidencia científica disponible, desde ensayos clínicos hasta estudios observacionales y modelos matemáticos para evaluar intervenciones a nivel poblacional, incluyendo análisis de coste-efectividad.

Holger Thiele was the PI of the CULPRIT-SHOCK trial, which was funded the European Union 7th Framework Program (FP7/2007-2013) and by the German Heart Research Foundation and the German Cardiac Society. ; Sí