scholarly journals EULAR recommendations for the management of Sjögren’s syndrome with topical and systemic therapies

2019 ◽  
Vol 79 (1) ◽  
pp. 3-18 ◽  
Author(s):  
Manuel Ramos-Casals ◽  
Pilar Brito-Zerón ◽  
Stefano Bombardieri ◽  
Hendrika Bootsma ◽  
Salvatore De Vita ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Task Force ◽  
Systemic Disease ◽  
Immunosuppressive Agents ◽  
Collaborative Study ◽  
Muscarinic Agonists ◽  
Eular Recommendations ◽  
Logical Sequence ◽  
Patient Representatives ◽  
Saliva Substitutes

The therapeutic management of Sjögren syndrome (SjS) has not changed substantially in recent decades: treatment decisions remain challenging in clinical practice, without a specific therapeutic target beyond the relief of symptoms as the most important goal. In view of this scenario, the European League Against Rheumatism (EULAR) promoted and supported an international collaborative study (EULAR SS Task Force) aimed at developing the first EULAR evidence and consensus-based recommendations for the management of patients with SjS with topical and systemic medications. The aim was to develop a rational therapeutic approach to SjS patients useful for healthcare professionals, physicians undergoing specialist training, medical students, the pharmaceutical industry and drug regulatory organisations following the 2014 EULAR standardised operating procedures. The Task Force (TF) included specialists in rheumatology, internal medicine, oral health, ophthalmology, gynaecology, dermatology and epidemiology, statisticians, general practitioners, nurses and patient representatives from 30 countries of the 5 continents. Evidence was collected from studies including primary SjS patients fulfilling the 2002/2016 criteria; when no evidence was available, evidence from studies including associated SjS or patients fulfilling previous sets of criteria was considered and extrapolated. The TF endorsed the presentation of general principles for the management of patients with SjS as three overarching, general consensus-based recommendations and 12 specific recommendations that form a logical sequence, starting with the management of the central triplet of symptoms (dryness, fatigue and pain) followed by the management of systemic disease. The recommendations address the use of topical oral (saliva substitutes) and ocular (artificial tear drops, topical non-steroidal anti-inflammatory drugs, topical corticosteroids, topical CyA, serum tear drops) therapies, oral muscarinic agonists (pilocarpine, cevimeline), hydroxychloroquine, oral glucocorticoids, synthetic immunosuppressive agents (cyclophosphamide, azathioprine, methotrexate, leflunomide and mycophenolate), and biological therapies (rituximab, abatacept and belimumab). For each recommendation, levels of evidence (mostly modest) and TF agreement (mostly very high) are provided. The 2019 EULAR recommendations are based on the evidence collected in the last 16 years in the management of primary 2002 SjS patients and on discussions between a large and broadly international TF. The recommendations synthesise current thinking on SjS treatment in a set of overarching principles and recommendations. We hope that the current recommendations will be broadly applied in clinical practice and/or serve as a template for national societies to develop local recommendations.

scholarly journals 2018 EULAR recommendations for physical activity in people with inflammatory arthritis and osteoarthritis

2018 ◽  
Vol 77 (9) ◽  
pp. 1251-1260 ◽  
Author(s):  
Anne-Kathrin Rausch Osthoff ◽  
Karin Niedermann ◽  
Jürgen Braun ◽  
Jo Adams ◽  
Nina Brodin ◽  
...  
Keyword(s):  
Physical Activity ◽  
Inflammatory Arthritis ◽  
Musculoskeletal Diseases ◽  
Task Force ◽  
The Public ◽  
Knee Oa ◽  
Eular Recommendations ◽  
Patient Representatives ◽  
Research And Education ◽  
Level Of Agreement

Regular physical activity (PA) is increasingly promoted for people with rheumatic and musculoskeletal diseases as well as the general population. We evaluated if the public health recommendations for PA are applicable for people with inflammatory arthritis (iA; Rheumatoid Arthritis and Spondyloarthritis) and osteoarthritis (hip/knee OA) in order to develop evidence-based recommendations for advice and guidance on PA in clinical practice. The EULAR standardised operating procedures for the development of recommendations were followed. A task force (TF) (including rheumatologists, other medical specialists and physicians, health professionals, patient-representatives, methodologists) from 16 countries met twice. In the first TF meeting, 13 research questions to support a systematic literature review (SLR) were identified and defined. In the second meeting, the SLR evidence was presented and discussed before the recommendations, research agenda and education agenda were formulated. The TF developed and agreed on four overarching principles and 10 recommendations for PA in people with iA and OA. The mean level of agreement between the TF members ranged between 9.8 and 8.8. Given the evidence for its effectiveness, feasibility and safety, PA is advocated as integral part of standard care throughout the course of these diseases. Finally, the TF agreed on related research and education agendas. Evidence and expert opinion inform these recommendations to provide guidance in the development, conduct and evaluation of PA-interventions and promotion in people with iA and OA. It is advised that these recommendations should be implemented considering individual needs and national health systems.

scholarly journals Development of EULAR recommendations for the reporting of clinical trial extension studies in rheumatology

2014 ◽  
Vol 74 (6) ◽  
pp. 963-969 ◽  
Author(s):  
Maya H Buch ◽  
Lucia Silva-Fernandez ◽  
Loreto Carmona ◽  
Daniel Aletaha ◽  
Robin Christensen ◽  
...  
Keyword(s):  
Ethical Issues ◽  
Task Force ◽  
Controlled Trial ◽  
Drop Out ◽  
Eular Recommendations ◽  
European League Against Rheumatism ◽  
Patient Representatives ◽  
Minimal Data ◽  
Definition Of ◽  
Randomised Controlled

ObjectivesOur initiative aimed to produce recommendations on post-randomised controlled trial (RCT) trial extension studies (TES) reporting using European League Against Rheumatism (EULAR) standard operating procedures in order to achieve more meaningful output and standardisation of reports.MethodsWe formed a task force of 22 participants comprising RCT experts, clinical epidemiologists and patient representatives. A two-stage Delphi survey was conducted to discuss the domains of evaluation of a TES and definitions. A ‘0–10’ agreement scale assessed each domain and definition. The resulting set of recommendations was further refined and a final vote taken for task force acceptance.ResultsSeven key domains and individual components were evaluated and led to agreed recommendations including definition of a TES (100% agreement), minimal data necessary (100% agreement), method of data analysis (agreement mean (SD) scores ranging between 7.9 (0.84) and 9.0 (2.16)) and reporting of results as well as ethical issues. Key recommendations included reporting of absolute numbers at each stage from the RCT to TES with reasons given for drop-out at each stage, and inclusion of a flowchart detailing change in numbers at each stage and focus (mean (SD) agreement 9.9 (0.36)). A final vote accepted the set of recommendations.ConclusionsThis EULAR task force provides recommendations for implementation in future TES to ensure a standardised approach to reporting. Use of this document should provide the rheumatology community with a more accurate and meaningful output from future TES, enabling better understanding and more confident application in clinical practice towards improving patient outcomes.

The end of the laboratory developed test as we know it? Recommendations from a national multidisciplinary taskforce of laboratory specialists on the interpretation of the IVDR and its complications

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Paul C. D. Bank ◽  
Leo H. J. Jacobs ◽  
Sjoerd A. A. van den Berg ◽  
Hanneke W. M. van Deutekom ◽  
Dörte Hamann ◽  
...  
Keyword(s):  
Clinical Practice ◽  
The Netherlands ◽  
Medical Devices ◽  
Task Force ◽  
Large Impact ◽  
Guidance Document ◽  
Scientific Societies ◽  
Clinical Laboratories ◽  
The Impact

AbstractThe in vitro diagnostic medical devices regulation (IVDR) will take effect in May 2022. This regulation has a large impact on both the manufacturers of in vitro diagnostic medical devices (IVD) and clinical laboratories. For clinical laboratories, the IVDR poses restrictions on the use of laboratory developed tests (LDTs). To provide a uniform interpretation of the IVDR for colleagues in clinical practice, the IVDR Task Force was created by the scientific societies of laboratory specialties in the Netherlands. A guidance document with explanations and interpretations of relevant passages of the IVDR was drafted to help laboratories prepare for the impact of this new legislation. Feedback from interested parties and stakeholders was collected and used to further improve the document. Here we would like to present our approach to our European colleagues and inform them about the impact of the IVDR and, importantly we would like to present potentially useful approaches to fulfill the requirements of the IVDR for LDTs.

scholarly journals The 2020 “Padua Criteria” for Diagnosis and Phenotype Characterization of Arrhythmogenic Cardiomyopathy in Clinical Practice

2022 ◽  
Vol 11 (1) ◽  
pp. 279
Author(s):  
Francesca Graziano ◽  
Alessandro Zorzi ◽  
Alberto Cipriani ◽  
Manuel De Lazzari ◽  
Barbara Bauce ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Diagnostic Criteria ◽  
Tissue Characterization ◽  
Task Force ◽  
Positive Family History ◽  
Standard Test ◽  
Arrhythmogenic Cardiomyopathy ◽  
Increased Risk ◽  
Criteria For Diagnosis ◽  
The Right

Arrhythmogenic Cardiomyopathy (ACM) is a heredo-familial cardiac disease characterized by fibro-fatty myocardial replacement and increased risk of sudden cardiac death. The diagnosis of ACM can be challenging due to the lack of a single gold-standard test: for this reason, it is required to satisfy a combination of multiple criteria from different categories including ventricular morpho-functional abnormalities, repolarization and depolarization ECG changes, ventricular arrhythmias, tissue characterization findings and positive family history/molecular genetics. The first diagnostic criteria were published by an International Task Force (ITF) of experts in 1994 and revised in 2010 with the aim to increase sensitivity for early diagnosis. Limitations of the 2010 ITF criteria include the absence of specific criteria for left ventricle (LV) involvement and the limited role of cardiac magnetic resonance (CMR) as the use of the late gadolinium enhancement technique for tissue characterization was not considered. In 2020, new diagnostic criteria (“the Padua criteria”) were proposed. The traditional organization in six categories of major/minor criteria was maintained. The criteria for identifying the right ventricular involvement were modified and a specific set of criteria for identifying LV involvement was created. Depending on the combination of criteria for right and LV involvement, a diagnosis of classic (right dominant) ACM, biventricular ACM or left-dominant ACM is then made. The article reviews the rationale of the Padua criteria, summarizes the main modifications compared to the previous 2010 ITF criteria and provides three examples of the application of the Padua criteria in clinical practice.

scholarly journals The Birth of Endowiki, An Italian Online Platform for Continuous Medical Education In Endocrinology

2018 ◽  
Vol 1 (1) ◽  
pp. 10-13
Author(s):  
Roberto Attanasio ◽  
Luca Gualano ◽  
Irene Misischi ◽  
Silvia Caprioli ◽  
Enrico Papini ◽  
...  
Keyword(s):  
Medical Education ◽  
Clinical Practice ◽  
Metabolic Diseases ◽  
Task Force ◽  
Continuous Medical Education ◽  
Clinical Approach ◽  
Educational Tool ◽  
Clinical Context ◽  
Online Tools ◽  
Online Availability

Background Conventional tools for medical education are burdened by many drawbacks. Textbooks become rapidly outdated, meeting attendance is expensive, and results reported in journals are not easily suitable for clinical practice. Uptodate and Endotext are excellent online tools, but they have been developed for a clinical context far different from that of our country. Methodology Italian Association of Clinical Endocrinologists (AME) charged a task force aiming to develop an educational tool specifically tailored for Italian clinical endocrinologists. Required characteristics were clinical approach, modularity, continuous updating, full online availability (even by mobile devices), open sections and sections for registered members only, opportunity for individualization, indexing and search engine to facilitate browsing. Starting from an open-source platform, Joomla, several changes were implemented. Results Three editors, 2 central editorial secretaries, 30 section coordinators and over 350 authors have been involved in the writing of 21 different sections covering all fields of endocrine and metabolic diseases. The access to Endowiki is free for AME members and is fully open in sections for patients. All readers are requested to serve as referee, pointing to mistakes and need for revision. The system is attended daily by a mean of 250 individuals. Conclusions Endowiki stands alone as an opportunity for medical education in Italy. The big challenges will be the continuous updating and the link to the national certified system for CME.

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