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1
Dziedziak, Paweł, and Tomasz Nielepkowicz. "Changes in the European Agreement ADR 2017 and their consequences for car inspection (PTI) in Poland." AUTOBUSY – Technika, Eksploatacja, Systemy Transportowe 19, no. 6 (June 30, 2018): 409–13. http://dx.doi.org/10.24136/atest.2018.103.
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The article discussed changes in the European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR 2017) regarding the requirements for the construction of vehicles in the context of car inspection (PTI) in Poland. The changes also apply to some of the documents submitted for PTI ispection and issued by an authorized car diagnostician after an additional test.
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Djukic, Luke P., Manudha T. Herath, Daniel C. Rodgers, Roderick Sweeting, and Honesto Buendia. "Analysis and testing of polymer matrix composites with thermoplastic liners having enhanced chemical resistance." Journal of Reinforced Plastics and Composites 36, no. 20 (May 26, 2017): 1487–502. http://dx.doi.org/10.1177/0731684417711027.
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Polymer matrix composite tanks offer major advantages to the transport industry in terms of increased payload and corrosion resistance compared to conventional steel tanks. Chemical resistance and versatility can be enhanced through the addition of a thermoplastic liner. This paper presents the results of chemical conditioning, testing and analysis of a linear low-density polyethylene liner, on its own and supported by carbon fiber reinforced polymer. Results are compared to ADR (European Agreement Concerning the International Carriage of Dangerous Goods by Road) requirements. The linear low-density polyethylene liner was tested in combination with 12–15% sodium hypochlorite and 98% sulphuric acid. The results indicate that the liner is suitable for service in tanks transporting these two chemicals. Liners were conditioned at 50℃ for periods of 1000 or 2000 h. Shore D hardness tests and three-point bend tests were performed, compared to unconditioned benchmarks, and found to pass ADR requirements. Finite element models were validated and used to facilitate understanding of the failure of the laminates. Predictions indicate that failure load increases with increased liner modulus, yield stress, and thickness. The models also indicate that the laminate strength and modulus is not significantly changed during chemical conditioning for the stated chemicals.
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MELENKO, Oksana. "Mediation as an Alternative Form of Dispute Resolution: Comparative-Legal Analysis." European Journal of Law and Public Administration 7, no. 2 (March 12, 2021): 46–63. http://dx.doi.org/10.18662/eljpa/7.2/126.
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The article under studies surveys the system of methods of alternative dispute resolution (ADR). It presents the definition of such structural concepts of ADR as negotiations, mediation, judicial conciliation, and arbitration. Particular emphasis is laid on the peculiarities of applying the ADR institutions in Ukraine and European countries, as well as on their advantages and disadvantages. To carry out a comparative-legal analysis of the alternative forms of dispute resolution, there has been developed a special system of indicators. The latter aims to assess the effectiveness of the ADR institutions.These indicators are: availability of the procedure; possibility to enter and leave the ADR process; public or private nature of the procedure; conciliatory and competitive nature of the procedure; conducting the procedure out of court or in court; presence of an intermediary in the ADR procedure; taking final decision on the dispute directly by the parties or a third party; freedom to choose a mediator in the dispute; substantiating the decision on the dispute on formal or informal norms, rules, standards; opportunity to go to court in case the decision is impossible to enforce; recognition of the dispute as the one being resolved; intermediary’s fee; cost and time saving. Relying on the comparative-legal analysis of the alternative forms of dispute resolution, it has been determined that most of the comparative advantages belong to the institution of mediation. However, there are a number of shortcomings that hinder the effective functioning of the institution of mediation. Among them are insufficient requirements for the mediator's competencies and lack of mechanisms for fulfilling the terms of the mediation agreement. Taking into account the existing drawbacks that hinder the effective development of the institution of mediation, the article offers a number of institutional innovations.They include: legislative establishment of the norm on the procedure of executing the mediation contract; enhancing the qualification requirements for the mediator (mandatory higher legal education); adoption of the law on mediation; consequently, introduction of amendments to material and procedural legislation regarding mediation procedure by means of remote (distance) regulation of legal disputes and actions that accompany this process with the use of special technical facilities (videoconferencing, electronic digital signature, electronic document management, electronic payments, etc.). In addition, the article singles out the main peculiarity of the institution of mediation, which favorably distinguishes it from other ADR institutions - humanism (human-centrism). Unlike mediation, other ADR institutions (negotiations, judicial conciliation, arbitration) are marked with a factual and mostly competitive procedure. Mediation, due to its being rather human than factual oriented, as well as because of its being focused rather on conciliation than on competition, has a wider range of opportunities to better meet the requirements of the parties to the dispute. The main asset of mediation is its high potential to unite the parties, to continue their business and social communication after the resolution of the dispute. The latter integration potential favorably distinguishes mediation from all other forms of alternative dispute resolution and, at the same time, indicates positive external effect (externalia), which lies in uniting society.
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SMAL, Tomasz, and Robert MALINOWSKI. "SAFETY IN TRANSPORT OF PERSONS AND GOODS IN POLAND." Journal of Science of the Gen. Tadeusz Kosciuszko Military Academy of Land Forces 186, no. 4 (October 2, 2017): 302–12. http://dx.doi.org/10.5604/01.3001.0010.7236.
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The problem of road safety is an important problem that accompanies mankind from the very beginning of the development of communication. Based on the statistics, the article presents the analysis of road traffic safety in our country over the past few years and shows how it shapes compared to other European Union countries. The main reasons, which lie behind the situation, are also identified as well as the ways and directions of actions that are taken to minimize the effects of road accidents. The pace of reduction of the number of fatalities and injured on Polish roads is still unsatisfactory and therefore far-reaching measures to counteract such a situation have to be taken. These steps are based on normative provisions and long-term actions supported by the media and various types of advertising campaigns. The article also presents the issues related to the road transport of dangerous goods, which, due to the specific nature of the cargo carried, is subjected to special treatment and governed by international regulations and arrangements under the ADR Agreement.
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Batarlienė, Nijolė. "Risk and Damage Assessment for Transportation of Dangerous Freight." Transport and Telecommunication Journal 19, no. 4 (December 1, 2018): 356–63. http://dx.doi.org/10.2478/ttj-2018-0030.
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Abstract The article provides information on transportation of dangerous freight. Legal acts regulating transportation of Dangerous freight are discussed. Major problems and non-compliances with The European Agreement concerning International Carriage of Dangerous Goods by Road (ADR) are distinguished. The type of risk that one encounters is analysed, as well as who is to take responsibility for transportation of dangerous freight. Transport accidents of dangerous substances are increasingly frequent and can cause serious injuries in inhabited areas or pollution of the environment. For quantitative risk assessment and mitigation planning, consequence calculations are necessary. The aim of this article is to present methods of the first approach for calculating costs and overall expenses of an accident and to demonstrate the main recommendations for the next development stage in the area of transport accident modelling. By the means of risk assessment models, it is possible to calculate the extent of the consequences and reduce the risks during the process of transportation. Based on Technology of Dangerous Freight Transportation, the accident calculation principles are suggested, which enables to assess the costs and to find a generalized accident rate. The calculation results are provided.
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Seechurn, Yashwantraj, and Ritish Boodhun. "Optimum Redesign of an Agricultural Water Bowser." Designs 2, no. 4 (November 5, 2018): 45. http://dx.doi.org/10.3390/designs2040045.
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There are many types of agricultural water bowsers on the market, which vary in geometry and size. However, in all such bowsers there are “unused spaces” between the bottom of the tank and the axle. The objective of this research was to design an agricultural water bowser with improved capacity by exploiting the “unused spaces”. This would allow a sufficient amount of water to be supplied to wide areas in a short time. Each concept of agricultural water bowser was generated as an integrated chassis water tank to be hitched to a tractor, and the best concept was chosen using a multi-criteria decision-making methodology (house of quality matrix and Pugh selection matrix). The selected design consisted of an U-shaped angle bent bottom sheet welded to a top circular sheet. The Agreement Dangerous Road (ADR) European standard was used for the sizing of the bowser and the selected material was S275 steel. The resultant forces on the shell of the bowser were calculated using analytical methods. A 3-D model of the bowser was developed in SolidWorks 2015, and the static structural analysis tool was used to examine stresses on the body for various types of loading, roads, and driving maneuvers. The shape and size of the bottom part of the proposed bowser increased the capacity of the tank by 20.3%.
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Jashari, Mr Sc Nexhat. "New legislation of republic of Kosovo in thefield of transport." ILIRIA International Review 2, no. 1 (June 30, 2012): 149. http://dx.doi.org/10.21113/iir.v2i1.168.
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In this output are treated issues related to the new legislation in Kosovo in the field of transport. in particular, there is elaborated the law in force, regulations, administrative directions and other sub-legal acts issued by the Ministry of Transport Post and Telecommunication.Special importance was paid on the harmonization respectively on the approximation of the new legislation in Kosovo in the field of transport with acquis communitaire, as well as other aspects of direct implementation of the EU legislation from this field in Kosovo. It also reviewed the application of Law on Obligations provisions as lex generalis in the field of transport and recommendations are given for better and overall regulation of the field of transport, by supplementing and amending laws and by proposing the issuance of other special laws from this field.in the field of transport with international report, such as: European Agreement Concerning the International Carriage of Dangerous Goods by Road (ADR), Regulations Concerning the International Carriage of Dangerous Goods by Rail (RID), Convention Concerning International Carriage by Rail (COTIF) , Convention Relating to the Contract of Carriage of Goods by Road CMR, The Convention on International Civil Aviation, - Chicago ConventionThe method used in this research is the comparative method.The result of this research is the ascertainment of the situation of new legislation in Kosovo, in relation to acquis communitaire, the effort and commitment of competent institutions for approximation with acquis communitaire .At the end as a conclusion there have been proposed the measures that should be taken in order to complete the legal framework in the field of transport.
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Półka, Marzena, Dorota Bielesza, and Anna Szajewska. "Review of Safety Requirements Regarding Trading and Storing of Pyrotechnical Articles in Poland." Safety & Fire Technology 56, no. 2 (2020): 76–90. http://dx.doi.org/10.12845/sft.56.2.2020.5.
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Aim: The objective of the paper was to identify and analyse relevant requirements regarding the safety of storage and usage of pyrotechnic materials, intended for civil use. The review was based on binding applicable Polish and European legal acts. The results of the review pointed to the ambiguity of the provisions regulating the issues of safe usage and storage of pyrotechnical materials. Introduction: Some pyrotechnic articles, when triggered by a proper impulse, can lead to a violent reaction resulting in the release of a large amount of heat, and the creation of a blast wave. The effects of this reaction have a destructive impact on buildings situated nearby and pose a hazard to human life. Use and storage of pyrotechnic articles against the set rules is associated with the risk of fire or explosion, therefore a number of requirements have been introduced in this area. Methodology: In Poland there are many legal acts applicable to explosives. One of the most important one is the Act of 21 June 2002 on explosives designated for civil use, which presents pyrotechnic materials with respect to the safety of their usage and storage. Several key requirements have also been specified in agreements ratified in Poland and in other international acts, such as for example: the European Agreement concerning the International Carriage of Dangerous Goods by Road(ADR), and the Directive of the European Parliament and of the Council 2013/29/EU of 12 June 2013 on the harmonisation of laws of the Member States relating to the making available on the market of pyrotechnic articles. Results: It was established that there is a need of adopting a legal solution for storing pyrotechnical products for temporary sales in containers located near commercial facilities (and serving as back-up facilities). Although the regulations are not clear-cut, such a solution is used in practice, thus it would be advisable to determine by means of legal acts whether it is permissible and what requirements should be fulfilled, for example by a container, in which pyrotechnic articles are temporarily stored. Conclusions: The specification presented in the article allows to see the need to minimize the hazards associated with the marketing of pyrotechnical materials and justifies the necessity of adopting a particularly diligent classification and use of nomenclature for these products. In case of storing pyrotechnical materials, it is erroneous to adopt the determination of class “G” for two variable of net mass values of the explosive (when determining safe distances for explosive storage facilities, including among others class 1, sub-classes 1.3, 1.4). The same applies to the hexogen equivalent of an explosive load (when determining safe distances for explosive storage facilities including class 1, sub-classes 1.1, 1.5 and 4.1). Such provisions are misleading and may cause erroneous interpretations of regulations.
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Enciso Cano, Víctor Ramón. "Evaluación del impacto comercial de las materias primas: una mirada al Acuerdo de Asociación Regional (AAR) entre UE-MERCOSUR." Investigación Agraria 18, no. 2 (December 1, 2016): 61–69. http://dx.doi.org/10.18004/investig.agrar.2016.diciembre.61-69.
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Claussen, Kathleen. "Stocktaking and Glimpsing at Trade Law's Next Generation." Proceedings of the ASIL Annual Meeting 111 (2017): 92–95. http://dx.doi.org/10.1017/amp.2017.69.
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These remarks are derived from a forthcoming work considering the future of international trade law. Compared with most features of the international legal system, the regional and bilateral trade law system is in the early stages of its evolution. For example, the United States is a party to fourteen free trade agreements currently in force, all but two of which have entered into force since 2000. The recent proliferation of agreements, particularly bilateral and regional agreements, is not unique to the United States. The European Union recently concluded trade agreement negotiations with Canada, Singapore, and Vietnam to add to its twenty-seven agreements in force and is negotiating approximately ten additional bilateral or multilateral agreements. In the Asia-Pacific Region, the number of regional and bilateral free trade agreements has grown exponentially since the conclusion of the Association of Southeast Asian Nations (ASEAN) Free Trade Area of 1992. At that time, the region counted five such agreements in force. Today, the number totals 140 with another seventy-nine under negotiation or awaiting entry into force. The People's Republic of China is negotiating half a dozen bilateral trade agreements at present to top off the sixteen already in effect. India likewise is engaged in at least ten trade agreement negotiations. The World Trade Organization (WTO) reports 267 agreements of this sort in force among its members as of July 1, 2016.
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Peffenköver, Marie, and Johan Adriaensen. "Detecting Looming Vetoes: Getting the European Parliament’s Consent in Trade Agreements." Politics and Governance 9, no. 3 (July 30, 2021): 74–84. http://dx.doi.org/10.17645/pag.v9i3.4014.
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Since the implementation of the Lisbon Treaty, the European Parliament wields the power of consent over international (trade) agreements, enabling it to threaten a veto. Due to the extensive financial and reputational costs associated with a veto, the European Commission (hereinafter Commission) was expected to read these threats effectively. However, the Commission’s responses to such threats have varied greatly. Building on a fine-grained causal mechanism derived from information processing theory and an extensive process-tracing analysis of seven free trade agreements post-Lisbon, we explain why the Commission has responded differently to looming vetoes. Our analysis reveals that the variation in Commission responses derives from imperfections in its information-processing system, the ‘early-warning system,’ which had to be adapted to the new institutional equilibrium post-Lisbon. Because of this adaption process, factors exogenous to the parliamentary context (‘externalities’) as well as internal uncertainties (‘internalities’) add constant unpredictability to the Commission’s reading of the European Parliament.
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Fautrel, B., B. Combe, N. Rincheval, and M. Dougados. "Level of agreement of the 1987 ACR and 2010 ACR/EULAR rheumatoid arthritis classification criteria: an analysis based on ESPOIR cohort data." Annals of the Rheumatic Diseases 71, no. 3 (October 28, 2011): 386–89. http://dx.doi.org/10.1136/annrheumdis-2011-200259.
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BackgroundIn 2010, new classification criteria for rheumatoid arthritis (RA) were developed.ObjectiveTo assess agreement between 1987 American College of Rheumatology (ACR) and 2010 ACR/European League Against Rheumatism (EULAR) criteria and the potential source of discordance, based on ESPOIR cohort data.Methods813 early arthritis patients were included in ESPOIR between 2002 and 2005. Between-criteria agreement was based on the κ coefficient. Discordance was explored by logistic regression.ResultsData for 811 patients were available, with their main characteristics as follows: women 77%, swollen joint count 7.2, tender joint count 8.4, disease activity score in 28 joints 5.2, rheumatoid factor 46%, anticitrullinated protein antibody (ACPA) 39%, structural damage 22%. At baseline, 579 (71.4%) patients met the 1987 ACR criteria and 641 (79.0%) the 2010 criteria. Agreement at baseline was discordant for 168 patients: 115 satisfied the 2010 criteria and 53 the 1987 criteria. Concordance between the two sets was fair, with a κ coefficient of 0.45 and 0.42 at baseline and year 2, respectively. The main sources of discordance were the number and symmetry of joint involvement, as well as ACPA status.Conclusion2010 ACR/EULAR criteria identified more patients with RA than did 1987 criteria. The 2010 criteria failed to identify RA patients with symmetrical seronegative arthritis and limited joint involvement.
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de Miguel Beriain, Iñigo, Elena Atienza-Macías, and Emilio Armaza Armaza. "The European Union Integrated Political Crisis Response Arrangements: Improving the European Union’s Major Crisis Response Coordination Capacities." Disaster Medicine and Public Health Preparedness 9, no. 3 (March 17, 2015): 234–38. http://dx.doi.org/10.1017/dmp.2015.10.
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AbstractIn recent years, the European Union (EU) has progressively assumed more and more of a primary role in crisis response coordination. The EU Integrated Political Crisis Response arrangements (IPCR) were recently approved to facilitate this task. These new agreements, which substitute for the Crisis Coordination Agreements, will add more flexibility to crisis response mechanisms in the EU. They will also strengthen cooperation between the different relevant agents in a major crisis situation and create new useful tools, such as the Integrated Situational Awareness and Analysis. Their real performance still needs to be fully tested, but some weakness can already be foreseen. This article provides a deep analysis of this new legislation. (Disaster Med Public Health Preparedness. 2015;9:234-238)
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Mossel, Esther, Konstantina Delli, Jolien F. van Nimwegen, Alja J. Stel, Frans G. M. Kroese, Fred K. L. Spijkervet, Arjan Vissink, Suzanne Arends, and Hendrika Bootsma. "Ultrasonography of major salivary glands compared with parotid and labial gland biopsy and classification criteria in patients with clinically suspected primary Sjögren’s syndrome." Annals of the Rheumatic Diseases 76, no. 11 (July 28, 2017): 1883–89. http://dx.doi.org/10.1136/annrheumdis-2017-211250.
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ObjectiveTo assess the validity of ultrasound of major salivary glands (sUS) compared with parotid and labial gland biopsies, sialometry, anti-SSA/Ro antibody status and classification criteria in patients clinically suspected with primary Sjögren’s syndrome (pSS).Methods103 consecutive outpatients with clinically suspected pSS underwent sUS. Parenchymal echogenicity, homogeneity, hypoechogenic areas, hyperechogenic reflections and clearness of salivary gland border were scored according to the Hocevar scoring system. Total ultrasound score was calculated as the sum of these domains (range 0–48).ResultsAbsolute agreement between sUS and parotid (83%) and labial (79%) gland biopsy outcome was good. Negative sUS predicts negative parotid gland biopsy, and positive sUS predicts positive labial gland biopsy. Compared with the American European Consensus Group (AECG) classification, sUS showed an absolute agreement of 82%, sensitivity of 71% and specificity of 92%. Compared with the American College of Rheumatology (ACR) classification, absolute agreement was 86%, sensitivity was 77% and specificity was 92%. Compared with the ACR-European League Against Rheumatism (EULAR) classification, absolute agreement was 80%, sensitivity was 67% and specificity was 94%. Positive sUS predicts classification, but negative sUS does not exclude classification. The combination of positive sUS with presence of anti-SSA/Ro antibodies or negative sUS with absence of anti-SSA/Ro antibodies showed a high predictive value for classification as pSS or non-pSS.ConclusionIn our prospective inception cohort study derived from daily clinical practice, absolute agreement between sUS and salivary gland biopsies was slightly higher for parotid compared with labial gland biopsies. The combination of positive sUS and presence of anti-SSA/Ro antibodies highly predicts classification according to the AECG, ACR and ACR-EULAR classification criteria.
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Carlson, Geoffrey. "European Communities – Definitive Anti-Dumping Measures on Certain Iron or Steel Fasteners from China – Recourse to Article 21.5 of the DSU by China (EC–Fasteners (China) (Article 21.5–China), DS397)." World Trade Review 15, no. 4 (September 19, 2016): 703–5. http://dx.doi.org/10.1017/s1474745616000331.
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This compliance proceeding under Article 21.5 of the Dispute Settlement Understanding (DSU) concerned measures taken by the European Union to implement the recommendations and rulings of the Dispute Settlement Body (DSB) in EC–Fasteners (China). In EC–Fasteners (China), the DSB found, inter alia, that a European Communities measure imposing definitive antidumping duties on imports of certain iron or steel fasteners from China was inconsistent with certain aspects of the Anti-Dumping Agreement (ADA). The European Union's measures taken to comply with the recommendations and rulings of the DSB consisted, inter alia, of an anti-dumping review investigation regarding fasteners from China (the Review Investigation) conducted by the Commission of the European Union (the Commission). The conduct of the Commission in the Review Investigation was the focus of this compliance proceeding.
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Manurung, Hendra. "IMPROVING FREE TRADE AGREEMENT (FTA) BETWEEN INDONESIA-EUROPEAN UNION (EU) THROUGH COMPREHENSIVE ECONOMIC PARTNERSHIP (CEPA)." Jurnal Asia Pacific Studies 2, no. 1 (June 9, 2018): 23. http://dx.doi.org/10.33541/japs.v2i1.667.
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This study aims to elaborate potential effects of a Comprehensive Economic Partnership Agreement (CEPA) on the trading of goods and services between the European Union (EU) and Indonesia addressing issues considered to be impeding the conclusion of CEPA negotiations. Suppose the agreement between the EU and Indonesia improve economic relations while creating benefits for both. Indonesia and the EU began negotiation on the CEPA preparation in 2012. The CEPA has been presented as having the ability to help both parties take full advantage of unexploited economic relations. The CEPA is expected to be a comprehensive agreement discussing various aspects of economic relations and moved beyond being a simple agreement for removing trade barriers. The liberalization of international trade in goods remains to be an important aspect of the CEPA, investment promotion and facilitation, the improvement of trade in services, and the creation of improved competition policy practices would promote greater economic relations. Indonesia expects three major contributions from the CEPA, i.e.: First, the most obvious one relates to promotion of increased trade between Indonesia and the EU. The agreement’s focus on trade liberalization will increase the intensity of trade relations by lowering trade barriers, and by facilitating trade; Second, expected contribution concerns the impact of liberalization on trade and investments in services; Third, enhanced technological advance and skills transfer in the goods, services and investment. A free trade agreement between the EU and Indonesia provides a more stable, balanced, and long-term framework to enhance trade and investment.
Keywords: the EU, Indonesia, CEPA, liberalization, free trade
Abstrak
Penelitian ini bertujuan untuk menjelaskan potensi efek dari Perjanjian Kemitraan Ekonomi Komprehensif (CEPA) mengenai perdagangan barang dan jasa antara Uni Eropa dan Indonesia, dan dalam penanganan isu-isu utama yang dianggap dapat menghambat perundingan CEPA. Seharusnya kesepakatan antara Uni Eropa dan Indonesia akan memperbaiki dinamika hubungan ekonomi yang ada, sekaligus menciptakan berbagai manfaat bagi keduanya. Indonesia dan Uni Eropa mulai melakukan negosiasi persiapan CEPA di tahun 2012. CEPA digambarkan memampukan kedua belah pihak memanfaatkan sepenuhnya hubungan ekonomi yang tidak saling mengeksploitasi hubungan ekonomi antara Uni Eropa dan Indonesia. CEPA diharapkan menjadi kesepakatan komprehensif dalam membahas berbagai aspek hubungan ekonomi tersebut, dan karenanya telah melampaui kesepakatan sederhana untuk penghapusan hambatan perdagangan. Sementara liberalisasi perdagangan internasional barang tetap sebagai aspek penting CEPA, promosi investasi dan fasilitasi, peningkatan perdagangan jasa, dan penciptaan praktik kebijakan persaingan yang lebih baik dalam promosi hubungan ekonomi yang lebih luas. Indonesia berharap adanya tiga kontribusi utama dari CEPA, yaitu: Pertama, yang paling nyata berkaitan dengan promosi peningkatan perdagangan antara Indonesia dan Uni Eropa. Fokus kesepakatan pada liberalisasi perdagangan dapat meningkatkan intensitas hubungan perdagangan dengan menurunkan berbagai hambatan dagang, dan dengan memfasilitasi perdagangan; Kedua, kontribusi CEPA diharapkan berdampak pada liberalisasi perdagangan dan investasi jasa; Ketiga, peningkatan kemajuan teknologi dan keterampilan di sektor barang, jasa dan investasi. Adanya perjanjian perdagangan bebas (FTA) antara Uni Eropa dan Indonesia akan memberikan kerangka kerjasama yang lebih stabil, seimbang, dan berjangka panjang dalam peningkatan hubungan perdagangan dan investasi antar kawasan.
Kata kunci: Uni Eropa, Indonesia, Perjanjian Kemitraan Ekonomi Komprehensif (CEPA), liberalisasi, pasar bebas
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Studenic, Paul, David Felson, Maarten de Wit, Farideh Alasti, Tanja A. Stamm, Josef S. Smolen, and Daniel Aletaha. "Testing different thresholds for patient global assessment in defining remission for rheumatoid arthritis: are the current ACR/EULAR Boolean criteria optimal?" Annals of the Rheumatic Diseases 79, no. 4 (February 5, 2020): 445–52. http://dx.doi.org/10.1136/annrheumdis-2019-216529.
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ObjectivesThis study aimed to evaluate different patient global assessment (PGA) cut-offs required in the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean remission definition for their utility in rheumatoid arthritis (RA).MethodsWe used data from six randomised controlled trials in early and established RA. We increased the threshold for the 0–10 score for PGA gradually from 1 to 3 in steps of 0.5 (Boolean1.5 to Boolean3.0) and omitted PGA completely (BooleanX) at 6 and 12 months. Agreement with the index-based (Simplified Disease Activity Index (SDAI)) remission definition was analysed using kappa, recursive partitioning (classification and regression tree (CART)) and receiver operating characteristics. The impact of achieving each definition on functional and radiographic outcomes after 1 year was explored.ResultsData from 1680 patients with early RA and 920 patients with established RA were included. The proportion of patients achieving Boolean remission increased with higher thresholds for PGA from 12.4% to 19.7% in early and 5.9% to 12.3% in established RA at 6 months. Best agreement with SDAI remission occurred at PGA cut-offs of 1.5 and 2.0, while agreement decreased with higher PGA (CART: optimal agreement at PGA≤1.6 cm; sensitivity of PGA≤1.5 95%). Changing PGA thresholds at 6 months did not affect radiographic progression at 12 months (mean ꙙsmTSS for Boolean, 1.5, 2.0, 2.5, 3.0, BooleanX: 0.35±5.4, 0.38±5.14, 0.41±5.1, 0.37±4.9, 0.34±4.9, 0.27±4.7). However, the proportion attaining HAQ≤0.5 was 90.2%, 87.9%, 85.2%, 81.1%, 80.7% and 73.1% for the respective Boolean definitions.ConclusionIncreasing the PGA cut-off to 1.5 cm would provide high consistency between Boolean with the index-based remission; the integer cut-off of 2.0 cm performed similarly.
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Stępkowski, Łukasz. "The Notion of Effectiveness in the Law of the European Union." Studia nad Autorytaryzmem i Totalitaryzmem 38, no. 2 (March 28, 2017): 81–96. http://dx.doi.org/10.19195/2300-7249.38.2.4.
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THE NOTION OF EFFECTIVENESS IN THE LAW OF THE EUROPEAN UNIONThe work submitted herein aims to address the question of effectiveness of EU law. Effectiveness of that law is subject to an ongoing controversy, as there is no agreement in legal literature either on the legal status of effectiveness or its use by the Court of Justice of the European Union. The author undertakes to outline the grounding of effectiveness in EU law in relation to both written law and jurisprudence of the Court. The work assumes the use of the descriptive approach in the legal doctrine, specifically the explanatory non-normative legal doctrine by A.R. Mackor. In this manner, this paper elects to present descriptive statements with extensive use of the Court’s case law as a feature to establish the content of applicable law. This work takes account of the law and jurisprudence as they were on 11th of October 2015.
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Ward, Michael M., Lori C. Guthrie, Maria I. Alba, and Abhijit Dasgupta. "Origins of Discordant Responses among 3 Rheumatoid Arthritis Improvement Criteria." Journal of Rheumatology 45, no. 6 (April 1, 2018): 745–52. http://dx.doi.org/10.3899/jrheum.170788.
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Objective.We examined agreement between the American College of Rheumatology (ACR), European League Against Rheumatism (EULAR), and Simplified Disease Activity Index (SDAI) response criteria in rheumatoid arthritis (RA) and tested whether discordant responses were associated with patients’ baseline characteristics or changes in RA activity encapsulated by the different criteria.Methods.In a prospective longitudinal study, we examined responses of 243 patients with active RA to escalation of antirheumatic treatment. We computed agreement between pairs of response criteria using κ coefficients and identified patient characteristics associated with unique responses to individual criteria.Results.We found that 110 patients (45.3%) had an ACR 20% improvement (ACR20) response, 135 (55.5%) had a EULAR moderate/good response, and 83 (34.1%) had an SDAI50 response. Agreement was moderate to good (ACR20/EULAR κ 0.57; ACR20/SDAI50 κ 0.64; EULAR/SDAI50 κ 0.59). All who had SDAI50 response also had a EULAR response. Patient characteristics at baseline generally did not distinguish those who responded to both, 1, or neither criterion. Discordance was most often because of improvements in the erythrocyte sedimentation rate or C-reactive protein level among EULAR and SDAI50 responders, which were not as common among ACR20 responders. Based on receiver-operating characteristic curves, SDAI35 response had a better balance of sensitivity and specificity relative to ACR20 and EULAR moderate/good responses than SDAI50.Conclusion.Discordant responses to RA improvement criteria are most often because of differences in responses of acute-phase reactants. SDAI35 response had higher sensitivity for improvement, as reflected by other response criteria, than SDAI50 response.
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van Assen, S., N. Agmon-Levin, O. Elkayam, R. Cervera, M. F. Doran, M. Dougados, P. Emery, et al. "EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases." Annals of the Rheumatic Diseases 70, no. 3 (December 3, 2010): 414–22. http://dx.doi.org/10.1136/ard.2010.137216.
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ObjectivesTo develop evidence-based European League Against Rheumatism (EULAR) recommendations for vaccination in patients with autoimmune inflammatory rheumatic diseases (AIIRD).MethodsA EULAR task force was composed of experts representing 11 European countries, consisting of eight rheumatologists, four clinical immunologists, one rheumatologist/clinical immunologist, one infectious disease physician, one nephrologist, one paediatrician/rheumatologist and one clinical epidemiologist. Key questions were formulated and the eligible spectrum of AIIRD, immunosuppressive drugs and vaccines were defined in order to perform a systematic literature review. A search was made of Medline from 1966 to October 2009 as well as abstracts from the EULAR meetings of 2008 and 2009 and the American College of Rheumatology (ACR) meetings of 2007 and 2008. Evidence was graded in categories I–IV, the strength of recommendations was graded in categories A–D and Delphi voting was applied to determine the level of agreement between the experts of the task force.ResultsEight key questions and 13 recommendations addressing vaccination in patients with AIIRD were formulated. The strength of each recommendation was determined. Delphi voting revealed a very high level of agreement with the recommendations among the experts of the task force. Finally, a research agenda was proposed.ConclusionRecommendations for vaccination in patients with AIIRD based on the currently available evidence and expert opinion were formulated. More research is needed, particularly regarding the incidence of vaccine-preventable infectious diseases and the safety of vaccination in patients with AIIRD.
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Heinikoski, Saila. "Calls of Duty: Romanian Politicians’ Deontological Discursive Strategies for Securing Free Movement in the European Union." New Perspectives 25, no. 3 (October 2017): 43–66. http://dx.doi.org/10.1177/2336825x1702500303.
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This article discusses how the right to free movement within the European Union is presented as a matter of obligation, a duty of the other EU member states, in the discourse of Romanian Presidents and Prime Ministers (2005–2015). An examination of speeches and other statements from these politicians illuminates Romanian political reactions during the period when Romania became an EU member state, and reflects perceptions of Europeanness and European agreements. These issues take on an additional contemporary significance in the context of the Brexit negotiations, and they also add to the broader debate on whether EU norms and obligations are seen as being both just and equally applied. By analysing different types of argumentative topoi, I examine the deontological (obligation-based) argumentation employed in the free movement context. Furthermore, I examine to what extent these arguments are invoked in support of the right to free movement and who this right applies to. I argue that for Romanian politicians, deontological free movement arguments are connected to other states’ compliance with European treaties and to demands for equal application of European rules without discrimination, or the delegation of responsibility to others. This manifested itself most frequently in the calls for the EU and its member states to do their duty by treating Romanians equally to other EU citizens.
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Ternant, D., J. Elhasnaoui, N. Szely, S. Hacein-Bey, A. Gleizes, C. Richez, J. Manson, et al. "AB0310 TROUGH CONCENTRATION AND ESTIMATED CLEARANCE CAN DETECT IMMUNOGENICITY TO ADALIMUMAB IN RA PATIENTS: A PROSPECTIVE LONGITUDINAL MULTICENTRE STUDY." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1453.1–1454. http://dx.doi.org/10.1136/annrheumdis-2020-eular.2809.
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Background:Anti-Drug Antibodies (ADA) to adalimumab increase drug clearance in rheumatoid arthritis (RA).Objectives:To study the ability of drug concentration or estimating clearance to identify ADA to adalimumab.Methods:Adalimumab concentration was measured with a validated ELISA. ADA was measured using a capture ELISA (Theradiag®) and the Meso scale discovery (MSD) platform. Using a bayesian PK model, adalimumab clearance was estimated at 1, 3, 6 and 12 months. Predictions for ADA presence were calculated, and the correlation between ADA and adalimumab clearance was analysed.Results:We analyzed 108 samples from 53 RA patients. Serum concentrations and clearance estimates showed good prediction performance for ADA presence (Table 1). There was a correlation between adalimumab clearance and ADA (Figure 1).Table 1.Immunogenicity prediction of adalimumab, using trough concentration or estimated clearanceTime of visitADA methodAdalimumab trough concentrationAdalimumab estimated clearanceAUC ROCp-valueAUC ROCp-valueMonth 1THER.55.6411.52.8358MSD.65.0821.61.1872Month 3THER.89.0006.91.0003MSD.73.0096.72.0131Month 6THER.95.0035.95.0035MSD.85.0004.84.0006Month 12THER.87.0045.86.0057MSD.88.0002.88.0002Figure 1.correlation between adalimumab estimated clearance and ADA as provided by the Meso scale discovery (MSD) plateformConclusion:Adalimumab concentration and clearance should be considered as reliable predictors for ADA presence in RA patients.Acknowledgments:Measurement of adalimumab serum concentrations was performed within the ‘Centre pilote de suivi biologique des anticorps thérapeutiques’ (CePiBAc)– Pilot centre for therapeutic antibodies monitoring platform of Tours University Hospital, which was cofinanced by the European Regional Development Fund (ERDF). We thank Oscar Knight, Delphine Delord and Fabien Giannoni (ABIRISK lab technician), Caroline Brochon and Anne Claire Duveau (CePIBAc), Aliette Decock-Giraudaud (Centre de ressource-Biobank), Sophie Tourdot (ABRISIK Project manager), Aline Doublet (Assistance Publique Hopitaux de Paris, Agnès Hincelin-Méry (Sanofi, Chilly-Mazarin, France). This work has received support from the Innovative Medicines Initiative Joint Undertaking (IMI JU) under grant agreement no. 115303, the resources of which are composed of financial contributions from the European Union’s Seventh Framework Programme (FP7/2007-2013) and European Federation of Pharmaceutical Industries and Associations (EFPIA) companies’ in-kind contributions.Disclosure of Interests:David Ternant Consultant of: Sanofi and Amgen., Jamal Elhasnaoui: None declared, Natacha Szely: None declared, Salima Hacein-Bey: None declared, Aude Gleizes: None declared, Christophe Richez Consultant of: Abbvie, Amgen, Mylan, Pfizer, Sandoz and UCB., Jessica Manson: None declared, Martin SOUBRIER: None declared, Olilvier Brocq: None declared, Jérôme Avouac: None declared, Anna Fogdell-Hahn Grant/research support from: Biogen Idec and Pfizer., Consultant of: Pfizer, Biogen, Merck-Serono, and Sanofi-Genzyme., Pierre Dönnes: None declared, Gilles Paintaud Grant/research support from: Amgen, Genzyme (Sanofi), Lilly, Merck, Novartis, and Roche Pharma., Consultant of: Chugai, Novartis and Shire (Takeda), with remunerations received by his institution., Céline Desvignes: None declared, Florian Deisenhammer: None declared, Sebastian Spindeldreher Employee of: Novartis, Marc Pallardy: None declared, Xavier Mariette Consultant of: BMS, Gilead, Medimmune, Novartis, Pfizer, Servier, UCB, Denis Mulleman Grant/research support from: Non-governmental organisation Lions Club Tours Val de France, French Society for Rheumatology., Consultant of: Pfizer, Novartis.
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Castrejón, Isabel, Maxime Dougados, Bernard Combe, Francis Guillemin, Bruno Fautrel, and Theodore Pincus. "Can Remission in Rheumatoid Arthritis Be Assessed Without Laboratory Tests or a Formal Joint Count? Possible Remission Criteria Based on a Self-report RAPID3 Score and Careful Joint Examination in the ESPOIR Cohort." Journal of Rheumatology 40, no. 4 (February 1, 2013): 386–93. http://dx.doi.org/10.3899/jrheum.121059.
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Objective.To explore 5 possible criteria for remission in rheumatoid arthritis (RA) based on a patient self-report index, the Routine Assessment of Patient Index Data (RAPID3), with a careful joint examination and possible physician global estimate (DOCGL), but without a formal joint count or laboratory test.Methods.The ESPOIR early RA cohort of 813 French patients recruited in 2002–2005 was analyzed to identify patients in remission 6 months after enrollment, according to 2 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria: Boolean ≤ 1 for total tender joint count-28, swollen joint count-28, C-reactive protein, and patient global estimate (PATGL), and Simplified Disease Activity Index (SDAI) ≤ 3.3. Agreement with 7 other remission criteria was analyzed — Disease Activity Score-28 (DAS28) ≤ 2.6, Clinical Disease Activity Index (CDAI) ≤ 2.8, and 5 candidate criteria based on RAPID3, joint examination, and DOCGL: “RAPID3R” (RAPID3 ≤ 3.0); “RAPID3R+SJ1” (RAPID3 ≤ 3.0, ≤ 1 swollen joint); “RAPID3R+SJ1+D1” (RAPID3 ≤ 3.0, ≤ 1 swollen joint, DOCGL ≤ 1); “RAPID3R+SJ0” (RAPID3 ≤ 3.0, 0 swollen joints); and “RAPID3R+SJ0+D1” (RAPID3 ≤ 3.0, 0 swollen joints, DOCGL ≤ 1), according to kappa statistics, sensitivity, and specificity. Residual global, articular, and questionnaire abnormalities according to each criteria set were analyzed.Results.Among 813 ESPOIR patients, 720 had complete data to compare all 9 possible criteria. Substantial agreement with the Boolean criteria was seen for SDAI, CDAI, RAPID3R+SJ1, RAPID3R+SJ1+D1, RAPID3R+SJ0, and RAPID3R+SJ0+D1 (92.2%–94.7%, kappa 0.67–0.79), versus only moderate agreement for DAS28 or RAPID3R (79.9%–85.8%, kappa 0.46–0.55).Conclusion.Remission according to CDAI and RAPID3R+SJ1, but not DAS28 or RAPID3R, is similar to that of the ACR/EULAR criteria. RAPID3 scores require a complementary careful joint examination for clinical decisions, do not preclude formal joint counts or other indices, and may be useful in busy clinical settings.
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Cairncross, Alec. "From the Treasury Diaries of Sir Alec Cairncross: Four Anglo-French Conflicts 1967–8." Contemporary European History 6, no. 1 (March 1997): 117–31. http://dx.doi.org/10.1017/s0960777300004070.
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In the 1960s, when I was Head of the (UK) Government Economic Service, I kept a private diary of conversations and events which has just been published. The excerpts from the diary which appear below relate to what I learned in 1967–8 about French attitudes to issues of international importance in which the United Kingdom was involved. The diary deals with four such issues: (1) the British application to join the European Economic Community; (2) the proposals to add to international liquidity through the creation of a new unit or, alternatively, of Special Drawing Rights (SDRs); (3) the British devaluation of 1967; and (4) the Bonn Conference in November 1968, at which it was widely expected that agreement would be reached to devalue the franc and revalue the mark.
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Messerschmidt, J., M. C. Geibel, T. Blumenstock, H. Chen, N. M. Deutscher, A. Engel, D. G. Feist, et al. "Calibration of TCCON column-averaged CO<sub>2</sub>: the first aircraft campaign over European TCCON sites." Atmospheric Chemistry and Physics Discussions 11, no. 5 (May 12, 2011): 14541–82. http://dx.doi.org/10.5194/acpd-11-14541-2011.
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Abstract. The Total Carbon Column Observing Network (TCCON) is a ground-based network of Fourier Transform Spectrometer (FTS) sites around the globe, where the column abundances of CO2, CH4, N2O, CO and O2 are measured. CO2 is constrained with a precision better than 0.25 %. To achieve a similarly high accuracy, calibration to World Meteorological Organization (WMO) standards is required. This paper introduces the first aircraft calibration campaign of five European TCCON sites and a mobile FTS instrument. A series of WMO standards in-situ profiles were obtained over European TCCON sites via aircraft and compared with retrievals of CO2 column amounts from the TCCON instruments. The results of the campaign show that the FTS measurements are consistently biased 1.0 % ± 0.2 % low with respect to WMO standards, in agreement with previous TCCON calibration campaigns. The standard a priori profile for the TCCON FTS retrievals is shown to not add a bias. The same calibration factor is generated using aircraft profiles as a priori and with the TCCON standard a priori. With a calibration to WMO standards, the highly precise TCCON CO2 measurements of total column concentrations provide a suitable database for the calibration and validation of nadir-viewing satellites.
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Messerschmidt, J., M. C. Geibel, T. Blumenstock, H. Chen, N. M. Deutscher, A. Engel, D. G. Feist, et al. "Calibration of TCCON column-averaged CO<sub>2</sub>: the first aircraft campaign over European TCCON sites." Atmospheric Chemistry and Physics 11, no. 21 (November 2, 2011): 10765–77. http://dx.doi.org/10.5194/acp-11-10765-2011.
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Abstract. The Total Carbon Column Observing Network (TCCON) is a ground-based network of Fourier Transform Spectrometer (FTS) sites around the globe, where the column abundances of CO2, CH4, N2O, CO and O2 are measured. CO2 is constrained with a precision better than 0.25% (1-σ). To achieve a similarly high accuracy, calibration to World Meteorological Organization (WMO) standards is required. This paper introduces the first aircraft calibration campaign of five European TCCON sites and a mobile FTS instrument. A series of WMO standards in-situ profiles were obtained over European TCCON sites via aircraft and compared with retrievals of CO2 column amounts from the TCCON instruments. The results of the campaign show that the FTS measurements are consistently biased 1.1% ± 0.2% low with respect to WMO standards, in agreement with previous TCCON calibration campaigns. The standard a priori profile for the TCCON FTS retrievals is shown to not add a bias. The same calibration factor is generated using aircraft profiles as a priori and with the TCCON standard a priori. With a calibration to WMO standards, the highly precise TCCON CO2 measurements of total column concentrations provide a suitable database for the calibration and validation of nadir-viewing satellites.
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Pimentel-Quiroz, V., A. Sánchez-Torres, C. Reategui Sokolova, R. V. Gamboa Cárdenas, C. Sánchez-Schwartz, M. Medina Chinchon, F. Zevallos Miranda, et al. "THU0316 VALIDATION OF ACR/EULAR PROVISIONAL CLASSIFICATION CRITERIA FOR ANCA-ASSOCIATED VASCULITIS IN A LATIN-AMERICAN TERTIARY CENTER." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 387.2–387. http://dx.doi.org/10.1136/annrheumdis-2020-eular.5092.
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Background:There is lack studies about performance of new criteria set for ANCA-Associated Vasculitis (AAV) in Latin-America.Objectives:To validate the new classification criteria for AAV in a real-life cohort of patients with these conditions.Methods:We performed a review of medical records from January 1990 to December 2019 at Hospital Nacional Guillermo Almenara Irigoyen from Peru. AAV was diagnosed by experienced rheumatologists based on the ACR 1990 criteria, Chapel Hill 2012 consensus, EMEA criteria and their experience and clinical acumen. Granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA) and eosinophilic granulomatosis with polyangiitis (EGPA) were diagnosed. Renal limited vasculitis was considered as MPA. To evaluate the performance of the new criteria, we classified all patients using “former criteria set” (including the 1990 ACR criteria for GPA and EGPA and the 1994 Chapel Hill Consensus Conference for MPA) and the EMEA (European Medicines Agency) criteria set. At the same time, we classified all patients using the ACR/EULAR Provisional criteria (new criteria set). The values for sensitivity, specificity and level of agreement (using Cohen’s kappa) of all sets of criteria were calculated using the clinical diagnosis as gold standard.Results:Two hundred twelve patients were identified; 12 of them were excluded (eight did not have ANCA and four had incomplete data). Female/male ratio was 1.9:1 [130 (65%)/70 (35%)] and their mean (SD) age at diagnosis was 59.3 (12.6) years. One hundred fifty-four (77%) had MPA, 41 (20.5%) GPA and 5 (2.5%) EGPA. One hundred ninety-six patients had ANCA-IIF results [p-ANCA: 131 (66.8%), c-ANCA: 43 (21.9%), negative-ANCA: 22 (11.3%)] and 190 patients had ANCA-ELISA results [MPO: 129 (67.9%), PR3: 37 (19.5%), negative-ANCA: 24 (12.6%)]. Type of diagnosis according to criteria set used is depicted in Table 1. The new criteria set had better agreement (kappa: 0.653) than the EMEA criteria (kappa: 0.506) and the former criteria set (kappa: 0.305). Performance of the criteria sets is depicted in Table 2.Table 1.Type of AAV according to criteria set used.TYPE OF AAVClinical diagnosisFormer criteriaNew criteriaEMEAcriteriaMPA, n (%)154 (77)76 (38)137 (68.5)110 (56.0)GPA, n (%)41 (20.5)30 (15)39 (19.5)39 (19.5)EGPA, n (%)5 (2.5)2 (1)4 (2)2 (1.0)Not classifiable, n (%)NA92 (46)20 (10)44 (22.0)PAN5 (2.5)PAN: Polyarteritis nodosa. NA: Not applicable.Table 2.Performance of the different criteria sets in AAV patients.DIAGNOSISCRITERIA SETSESPKappaMPAFormer49.4100.00.309EMEA69.993.90.471New87.093.50.713GPAFormer68.398.70.744EMEA92.799.40.938New80.596.20.781EGPAFormer40.0100.00.565EMEA40.0100.00.565New60.099.50.659SE: Sensitivity. SP: Specificity.Conclusion:The ACR/EULAR Provisional Criteria for AAV have better agreement with the clinical diagnosis of AAV in Latin-American patients from a real-life cohort.Disclosure of Interests:Victor Pimentel-Quiroz: None declared, Alfredo Sánchez-Torres: None declared, Cristina Reategui Sokolova: None declared, Rocío Violeta Gamboa Cárdenas Grant/research support from: Pfizer, César Sánchez-Schwartz: None declared, Mariela Medina Chinchon: None declared, Francisco Zevallos Miranda: None declared, Erika Noriega: None declared, Jose Alfaro Lozano Speakers bureau: Lilly, Jorge-M Cucho-V: None declared, Zoila Rodriguez Bellido: None declared, Cesar Pastor Asurza: None declared, Eduardo Acevedo-Vásquez: None declared, Risto Perich Campos Consultant of: Pfizer, Speakers bureau: Pfizer, Graciela S Alarcon: None declared, Manuel F. Ugarte-Gil Grant/research support from: Jannsen, Pfizer
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Mok, C. C., Y. K. Chung, C. Lee, L. Y. Ho, and C. H. To. "POS0771 VALIDATION OF THE 2019 EUROPEAN LEAGUE AGAINST RHEUMATISM/AMERICAN COLLEGE OF RHEUMATOLOGY (EULAR/ACR) CLASSIFICATION CRITERIA FOR SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) IN HONG KONG CHINESE." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 639.2–640. http://dx.doi.org/10.1136/annrheumdis-2021-eular.3394.
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Objectives:To validate the 2019 EULAR/ACR classification criteria for SLE in Hong Kong Chinese patients and compare its performance with the 2012 Systemic Lupus International Collaborating Clinics (SLICC) and 1997 American college of rheumatology (ACR) criteria.Methods:We retrospectively reviewed the medical records of consecutive patients who attended the Rheumatology clinics in Tuen Mun and Pok Oi hospitals between May and September 2019. Patients with anti-nuclear antibody (ANA) ≥1:80 were included and patients with ANA <1:80 or no ANA results were excluded. Patients were evaluated and cross-checked for the fulfilment of the 1997 ACR, 2012 SLICC and 2019 EULAR/ACR criteria by two investigators (YKC,CL). Medical records were then reviewed by an expert panel consisting of 3 senior rheumatologists, who were blinded for the results of the criteria evaluation, for a diagnosis of SLE based on the clinical judgement and therapeutic decisions. Teleconferences were arranged by the panel to discuss the discrepancies of the final diagnosis and agreement was made by voting. The three SLE criteria were evaluated against the clinical diagnosis of SLE as judged by the expert panel on the sensitivity and specificity, which was calculated by 2x2 contingency tables (“condition positive” = clinical diagnosis of SLE; “test positive” = criteria positive for SLE) with standard formulas (sensitivity = true positive/[true positive + false negative]; specificity = true negative / [true negative + false positive]). Receiver operating characteristic (ROC) curve was used to study the optimal cut-off points from the EULAR/ACR criteria for the highest summation of specificity and sensitivity.Results:3967 patients were screened; 1542 patients who were positive for ANA (≥1:80) were included (88.3% women). The mean age of these patients at first rheumatology clinic attendance was 45.6±15.0 years and the duration of follow-up was 7.5±7.0 years. A total of 567 patients were judged to have SLE by the expert panel (discrepancy of clinical diagnosis in 135 patients resolved with voting). The sensitivity and specificity of the three SLE classification criteria in our patients are listed in Table 1. ROC analysis showed that the best cut-off for a clinical diagnosis of SLE using the EULAR/ACR criteria was 10 points (area under the curve [AUC] 0.977; sensitivity 89.2% and specificity 89.6%). Similar figures were obtained for subgroups of patients stratified by gender and different age ranges.Conclusion:In our cohort of Hong Kong Chinese patients, the 2019 EULAR/ACR criteria is more sensitive but less specific when compared with 1997 ACR criteria for classifying SLE. On the other hand, the EULAR/ACR criteria is less sensitive but more specific than the 2012 SLICC criteria. The specificity of the EULAR/ACR criteria for SLE is higher in male than female patients. In our patients older than 50 years, the EULAR/ACR criteria is less sensitive but more specific for a classification of SLE. Overall, the performance of the EULAR/ACR criteria for a diagnosis of SLE in our study is similar to that reported in recent Asian studies although the sensitivity is lower, which may be related to the inclusion of ANA+ patients only.References:Classification criteriaSensitivitySpecificity1997 ACR85.9%94.4%2012 SLICC97.5%86.4%2019 EULAR/ACR with 10 points as cut-off89.2%89.6%2019 EULAR/ACR with 9 points as cut-off93.6%68.7%2019 EULAR/ACR with 11 points as cut-off86.9%92.4%2019 EULAR/ACR with 10 points as cut-off (men)88.9%94.5%2019 EULAR/ACR with 10 points as cut-off (women)89.2%88.8%2019 EULAR/ACR with 10 points as cut-off (age >50 years)78.7%94.1%2019 EULAR/ACR with 10 points as cut-off (age ≤50 years)91.7%84.1%Disclosure of Interests:None declared
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Herrera, S., J. C. Diaz-Coronado, D. Hernandez-Parra, Y. Durango-Durango, C. Perez-Rios, M. Posada-Velásquez, J. Rojas-Londoño, et al. "THU0269 CLINICAL COMPARISON OF NEW CRITERIA FOR SYSTEMIC LUPUS ERYTHEMATOSUS IN A COLOMBIAN COHORT." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 361.2–361. http://dx.doi.org/10.1136/annrheumdis-2020-eular.6527.
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Background:Due to heterogeneity of the disease, there has been several classification criteria for Systemic Lupus Erythematosus (SLE). These have considered the knowledge obtained through the years and have strived for increased sensibility and specificity. Recently, both EULAR and ACR have proposed new criteria for disease classification that mandate a positive ANA result to apply the criteria.Objectives:To compare the 2019 EULAR/ACR classification criteria (1) with the Systemic Lupus International Collaborating Clinics (SLICC) 2012 classification criteria (2) and the American College of Rheumatology (ACR) 1997 classification criteria in a Colombian cohort (3).Methods:A cross-section retrospective study was done with data collected between 2014 and 2018 from a population diagnosed with SLE by a group of rheumatology in an autoimmunity referral centre and followed for one year. The new 2019 EULAR/ACR classification criteria were applied to the information collected from the clinical records. Three sets of criteria were compared using Cohen´s kappa coefficient and concordance was evaluatedResults:We obtained information for 480 patients, in this analysis were mostly females (96%). Anti-nuclear antibody (ANA) results were available for 95% of the patients. According to SLICC classification criteria the diagnosis of SLE was definite in 92% of patients, 81% by ACR 1997 and 89% using ACR/EULAR 2019. The sensibility was 93% and 97% for ACR/EULAR 2019 and SLICC 2012, and the specificity was 67% and 48% respectively. The concordance analysis between the two sets of criteria showed agreement of 92% (kappa 0.52 p <0.001) in the whole group.Conclusion:We found good agreement between SLICC 2012 criteria and EULAR/ACR 2019 classification criteria. In contrast with previous studies, where the new criteria had a sensitivity of 96.1% and specificity of 93.4%, in our cohort the sensitivity was maintained in 93% but the specificity decreased to 67%. A possible explanation could be the ANA negativity that was seen in 5% of the patients and would force to discard patients with false negative results. Despite this, the agreement of the criteria is good and should continue to be applied in our population, without abandoning the expert’s clinical criteria.References:[1]Aringer M, Costenbader K, Daikh D, et al. 2019 European League against Rheumatism/American College of rheumatology classification criteria for systemic lupus erythematosus. Ann Rheum Dis2019;78:1151–9[2]Petri M, Orbai A-M, Alarcón GS, et al. Derivation and validation of the systemic lupus international collaborating clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum2012;64:2677–86.[3]Hochberg MC. Updating the American College of rheumatology revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum1997;40:1725.Disclosure of Interests:Sebastian Herrera Speakers bureau: academic conference, Juan camilo Diaz-Coronado: None declared, Deicy Hernandez-Parra: None declared, Yecenia Durango-Durango: None declared, Carolina Perez-Rios: None declared, Marcela Posada-Velásquez: None declared, Jennifer Rojas-Londoño: None declared, Manuela Vallejo-Patiño: None declared, Katherine Marín: None declared, Carlos Guerrero-Calderón: None declared, Sara jaramillo: None declared, Veronica Usuga-Graciano: None declared, Martha Isabel López-Flórez: None declared, Camilo Restrepo-Raigosa: None declared, Juan Pablo Restrepo-Hincapié: None declared, Catalina Carvajal-Naranjo: None declared, Sarita Restrepo-Upegui: None declared, Ricardo Pineda.Tamayo: None declared
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Van Hoovels, Lieve, Julie Jacobs, Bert Vander Cruyssen, Stefanie Van den Bremt, Patrick Verschueren, and Xavier Bossuyt. "Performance characteristics of rheumatoid factor and anti-cyclic citrullinated peptide antibody assays may impact ACR/EULAR classification of rheumatoid arthritis." Annals of the Rheumatic Diseases 77, no. 5 (January 23, 2018): 667–77. http://dx.doi.org/10.1136/annrheumdis-2017-212365.
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ObjectivesRheumatoid factor (RF) and anti-cyclic citrullinated protein/peptide antibodies (ACPA) are integrated in the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for rheumatoid arthritis (RA). The objectives of this study were to evaluate the technical and diagnostic performance of different RF and ACPA assays and to evaluate whether differences in performance impact RA classification.MethodsSamples from 594 consecutive patients who for the first time consulted a rheumatologist (44 of whom were diagnosed with RA) and 26 extra newly diagnosed patients with RA were analysed with six different RF assays (Menarini, Thermo Fisher, Inova, Roche, Abbott, Euroimmun) and seven different ACPA assays (Menarini, Thermo Fisher, Inova, Roche, Abbott, Euro Diagnostica, Euroimmun).ResultsWe found differences in analytical performance between assays. There was poor numerical agreement between the different RF and ACPA assays. For all assays, the likelihood ratio for RA increased with increasing antibody levels. The areas under the curve of receiver operating characteristic analysis of the RF (range 0.676–0.709) and ACPA assays (range 0.672–0.769) only differed between some ACPA assays. Nevertheless, using the cut-off proposed by the manufacturer, there was a large variation in sensitivity and specificity between assays (mainly for RF). Consequently, depending on the assay used, a subgroup of patients (13% for RF, 1% for ACPA and 9% for RF/ACPA) might or might not be classified as RA according to the 2010 ACR/EULAR criteria.ConclusionDue to poor harmonisation of RF and ACPA assays and of test result interpretation, RA classification according to 2010 ACR/EULAR criteria may vary when different assays are used.
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Sarafidis, Pantelis A., Francesca Mallamaci, Charalampos Loutradis, Robert Ekart, Claudia Torino, Antonios Karpetas, Vasileios Raptis, et al. "Prevalence and control of hypertension by 48-h ambulatory blood pressure monitoring in haemodialysis patients: a study by the European Cardiovascular and Renal Medicine (EURECA-m) working group of the ERA-EDTA." Nephrology Dialysis Transplantation 34, no. 9 (July 10, 2018): 1542–48. http://dx.doi.org/10.1093/ndt/gfy147.
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Abstract Background Population-specific consensus documents recommend that the diagnosis of hypertension in haemodialysis patients be based on 48-h ambulatory blood pressure (ABP) monitoring. However, until now there is just one study in the USA on the prevalence of hypertension in haemodialysis patients by 44-h recordings. Since there is a knowledge gap on the problem in European countries, we reassessed the problem in the European Cardiovascular and Renal Medicine working group Registry of the European Renal Association-European Dialysis and Transplant Association. Methods A total of 396 haemodialysis patients underwent 48-h ABP monitoring during a regular haemodialysis session and the subsequent interdialytic interval. Hypertension was defined as (i) pre-haemodialysis blood pressure (BP) ≥140/90 mmHg or use of antihypertensive agents and (ii) ABP ≥130/80 mmHg or use of antihypertensive agents. Results The prevalence of hypertension by 48-h ABP monitoring was very high (84.3%) and close to that by pre-haemodialysis BP (89.4%) but the agreement of the two techniques was not of the same magnitude (κ statistics = 0.648; P <0.001). In all, 290 participants were receiving antihypertensive treatment. In all, 9.1% of haemodialysis patients were categorized as normotensives, 12.6% had controlled hypertension confirmed by the two BP techniques, while 46.0% had uncontrolled hypertension with both techniques. The prevalence of white coat hypertension was 18.2% and that of masked hypertension 14.1%. Of note, hypertension was confined only to night-time in 22.2% of patients while just 1% of patients had only daytime hypertension. Pre-dialysis BP ≥140/90 mmHg had 76% sensitivity and 54% specificity for the diagnosis of BP ≥130/80 mmHg by 48-h ABP monitoring. Conclusions The prevalence of hypertension in haemodialysis patients assessed by 48-h ABP monitoring is very high. Pre-haemodialysis BP poorly reflects the 48 h-ABP burden. About a third of the haemodialysis population has white coat or masked hypertension. These findings add weight to consensus documents supporting the use of ABP monitoring for proper hypertension diagnosis and treatment in this population.
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Grimshaw, Kate, Kirsty Logan, Sinead O'Donovan, Mairead Kiely, Karine Patient, Jolanda van Bilsen, Kirsten Beyer, et al. "Modifying the infant's diet to prevent food allergy." Archives of Disease in Childhood 102, no. 2 (August 16, 2016): 179–86. http://dx.doi.org/10.1136/archdischild-2015-309770.
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Recommendations and guidelines on the prevention of food allergy have changed in recent decades. The aim of this review of the current evidence and ongoing studies is to provide a comprehensive and up to date picture of prevention of food allergy for healthcare professionals. The review was undertaken as part of the European Union funded Integrated Approaches to Food Allergy and Allergen Management (iFAAM) study. This is a wide ranging project bringing together expertise across the breadth of food allergy research. Specifically, the review discusses dietary manipulation in food allergy prevention, and covers the possible preventive strategies of allergen avoidance, early allergen introduction, general nutrition and supplements, as well as other strategies, such as prebiotics and probiotics. The review concludes that despite agreement that allergen avoidance strategies should not be undertaken for allergy prevention, there is currently no consensus regarding what actions should be recommended beyond exclusive breastfeeding for the first 4–6 months of life. Recent and upcoming trial results, which are detailed in this review, should help inform the debate and add clarity to the topic.
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Rintelen, Bernhard, Judith Sautner, Pia Haindl, Harsono Mai, Hans-Peter Brezinschek, and Burkhard F. Leeb. "Remission in Rheumatoid Arthritis: A Comparison of the 2 Newly Proposed ACR/EULAR Remission Criteria with the Rheumatoid Arthritis Disease Activity Index-5, a Patient Self-report Disease Activity Index." Journal of Rheumatology 40, no. 4 (February 1, 2013): 394–400. http://dx.doi.org/10.3899/jrheum.120952.
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Objective.We analyzed whether a patient self-report remission criterion, such as that according to the Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5), meets the criteria of the 2011 proposed American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) definition of remission.Methods.The 2 approaches of the ACR/EULAR proposal [Boolean- and Simplified Disease Activity Index (SDAI)-based] as well as the RADAI-5 were used to assess whether patients with RA are in remission. Sensitivity, specificity, positive and negative predictive values (PPV, NPV), and kappa analyses were performed to illustrate the relationship among the different approaches defining remission at a group level.Results.In total, 705 patients' assessments were included. Eighty-nine patients were classified as being in remission according to the Boolean-based and 169 according to the SDAI-based definition of the ACR/EULAR proposals, and 154 according to the RADAI-5. Sixty-eight assessments were classified as being in remission according to all 3 definitions. In the case of RADAI-5 remission, sensitivity was 78%, specificity 86%, PPV 45%, and NPV 96%, indicating remission according to the Boolean-based definition; and 60%, 92%, 66%, and 90%, respectively, indicating remission according to the SDAI-based definition. In the case of remission according to the SDAI-based ACR/EULAR definition, sensitivity was 52%, specificity 100%, PPV 98%, and NPV 87%, also indicating remission according to the Boolean definition; while according to the Boolean definition the values were 98%, 87%, 52%, and 100%, respectively. Kappa statistics showed fair to good agreement for all 3 definitions.Conclusion.Nearly twice as many assessments were classified as being in remission using the SDAI-based or the RADAI-5 definitions when compared to the Boolean-based definition. Remission according to the RADAI-5 also was highly specific for both ACR/EULAR criteria. Sensitivity for the RADAI-5 criterion was even better for the Boolean-based definition than that for the SDAI-based definition.
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Fazaa, A., H. Boussaa, K. Ouenniche, S. Miladi, M. Sellami, L. Souabni, S. Kassab, S. Chekili, K. Ben Abdelghani, and A. Laatar. "OPTIMAL ASSESSMENT OF FATIGUE IN RHEUMATOID ARTHRITIS: VISUAL ANALOG SCALE VERSUS FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY – FATIGUE." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 1113.3–1114. http://dx.doi.org/10.1136/annrheumdis-2021-eular.3346.
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Background:Fatigue is an important outcome for patients with rheumatoid arthritis (RA). As recommended by the European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) task force in 2008, fatigue should be measured in all RA clinical trials whenever possible. Despite these recommendations, it is largely ignored and rarely assessed in clinical practice.Objectives:The aim of this study was to compare the scales being used to measure fatigue in RA.Methods:We conducted a cross-sectional study including patients with RA (ACR/EULAR 2010). Patients with other acute or chronic diseases that may induce fatigue (such as cancer, infection or depression) were excluded. Demographic and disease-related data were collected. Fatigue was assessed using two scores. The fatigue Visual Analog Scale (VAS) ranging between 0 and 100 cm. Fatigue was considered mild if the fatigue VAS was <20 cm, moderate if 20≤VAS<50 and severe if VAS>50 cm. The Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) which is a short 13-item questionnaire validated in RA. The score FACIT-F ranges between 0 and 52. Fatigue was considered mild if the FACIT-F score was ≥40, moderate if 20≤FACIT-F<40 and severe if 0≤FACIT-F<20. We used Cohen’s kappa (κ) to determine the agreement between fatigue VAS and FACIT-F. The κ result was interpreted as follows: values ≤ 0 as indicating no agreement and 0.01–0.20 as none to slight, 0.21–0.40 as fair, 0.41– 0.60 as moderate, 0.61–0.80 as substantial, and 0.81–1.00 as almost perfect agreement. A p value inferior to 0.05 was considered significant.Results:We included 100 RA patients (84 women and 16 men) with a mean age of 49.5±10 years old [18-65]. The mean disease duration was 87.3 months [1-360]. RF and ACPA were positive in 75% and 72.6% of cases respectively. The mean pain VAS was 49 cm [0-100]. The mean numbers of tender and swollen joints were 5.3 [0-36] and 1 [0-9] respectively. The mean levels of ESR and CRP were 38.1 mm [10-120] and 10.8 mg/l [2-61] respectively. The mean DAS28 ESR was 3.68 [1.90-8.33].The mean fatigue VAS was 49.1 cm [5-100]. Fatigue was mild in 9% of patients, moderate in 31% of patients, and severe in 60% of patients.The mean FACIT-F score was 27.1 [0-51]. Fatigue was mild in 26% of patients, moderate in 57% of patients and severe in 17% of patients.A fair agreement was noted between the two scores (κ=0.303, p<0.001).The fatigue VAS and FACIT-F were both correlated with the following variables: pain VAS (r=0.685, p<0.001 and r=-0.605, p<0.001), ESR (r=0.384, p<0.001 and r=-0.405, p<0.001), and DAS28 ESR (r=0.684, p<0.001 and r=-0.744, p<0.001).Conclusion:The fatigue VAS and FACIT-F are easy, brief and valid measures for monitoring this symptom and its effects on patients with RA. A fair agreement was noted between the two scores.Disclosure of Interests:None declared
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Singh, Ruchi. "Reversing type 2 diabetes: journal review and a case study." Advances in Obesity, Weight Management & Control 10, no. 5 (October 30, 2020): 163–67. http://dx.doi.org/10.15406/aowmc.2020.10.00322.
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Type 2 diabetes (T2D) has for quite some time been recognized as a serious interminable malady dependent on conventional methods for treatment. Exploration currently exists that proposes reversal is conceivable through different implies that have as of late been grasped in the rules. This account audit looks at the proof for T2D reversal utilizing every one of the three strategies, including points of interest and constraints for each. Techniques: A research was performed, and an aggregate of unique articles containing data relating to diabetes reversal or abatement were incorporated. Results: Evidence exists that T2D reversal is attainable utilizing bariatric medical procedure, low-calorie nutrient dense and moderate protein diet (LCNP), or starch limitation (LC). Bariatric medical procedure has been suggested for the therapy of T2D since 2016 by a global diabetes agreement gathering. Both the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) presently suggest a LC eating example and backing the momentary utilization of LCNP for weight reduction. Nonetheless, just T2D treatment, not reversal, is talked about in their rules. End: Given the condition of proof for T2D reversal, medical services suppliers should be taught on reversal choices so they can effectively take part in guiding patients who may want this way to deal with their sickness
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Bohleber, Pascal, Tobias Erhardt, Nicole Spaulding, Helene Hoffmann, Hubertus Fischer, and Paul Mayewski. "Temperature and mineral dust variability recorded in two low-accumulation Alpine ice cores over the last millennium." Climate of the Past 14, no. 1 (January 10, 2018): 21–37. http://dx.doi.org/10.5194/cp-14-21-2018.
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Abstract. Among ice core drilling sites in the European Alps, Colle Gnifetti (CG) is the only non-temperate glacier to offer climate records dating back at least 1000 years. This unique long-term archive is the result of an exceptionally low net accumulation driven by wind erosion and rapid annual layer thinning. However, the full exploitation of the CG time series has been hampered by considerable dating uncertainties and the seasonal summer bias in snow preservation. Using a new core drilled in 2013 we extend annual layer counting, for the first time at CG, over the last 1000 years and add additional constraints to the resulting age scale from radiocarbon dating. Based on this improved age scale, and using a multi-core approach with a neighbouring ice core, we explore the time series of stable water isotopes and the mineral dust proxies Ca2+ and insoluble particles. Also in our latest ice core we face the already known limitation to the quantitative use of the stable isotope variability based on a high and potentially non-stationary isotope/temperature sensitivity at CG. Decadal trends in Ca2+ reveal substantial agreement with instrumental temperature and are explored here as a potential site-specific supplement to the isotope-based temperature reconstruction. The observed coupling between temperature and Ca2+ trends likely results from snow preservation effects and the advection of dust-rich air masses coinciding with warm temperatures. We find that if calibrated against instrumental data, the Ca2+-based temperature reconstruction is in robust agreement with the latest proxy-based summer temperature reconstruction, including a “Little Ice Age” cold period as well as a medieval climate anomaly. Part of the medieval climate period around AD 1100–1200 clearly stands out through an increased occurrence of dust events, potentially resulting from a relative increase in meridional flow and/or dry conditions over the Mediterranean.
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Haidl, Theresa, Dennis Hedderich, Marlene Rosen, Thorsten Lichtenstein, Nathalie Kaiser, Mauro Seves, Anne Ruef, et al. "M1. INVESTIGATING THE RELATIONSHIP BETWEEN CHILDHOOD TRAUMA AND PSYCHIATRIC DISEASE USING MACHINE LEARNING TECHNIQUES." Schizophrenia Bulletin 46, Supplement_1 (April 2020): S133. http://dx.doi.org/10.1093/schbul/sbaa030.313.
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Abstract Background Childhood trauma (CT) is associated with an increased risk for psychiatric disorders like major depression and psychosis. However, the pathophysiological relationship between CT, psychiatric disease and structural brain alterations is still unknown. Methods PRONIA (‘Personalized Prognostic Tools for Early Psychosis Mangement’) is a prospective collaboration project funded by the European Union under the 7th Framework Programme (grant agreement n° 602152). Considering a broad set of variables (sMRI, rsMRI, DTI, psychopathological, life event related and sociobiographic data, neurocognition, genomics and other blood derived parameters) as well as advanced statistical methods, PRONIA aims at developing an innovative multivariate prognostic tool enabling an individualized prediction of illness trajectories and outcome. Seven clinical centers in five European countries and in Australia participate in the evaluation of three clinical groups (subjects clinically at high risk of developing a psychosis (CHR), patients with a recent onset psychosis (ROP) and patients with a recent onset depression (ROD)) as well as healthy controls (HC). To investigate the high-dimensional patterns of CT experience, measured by the childhood trauma questionnaire (CTQ), in HC and our three patient groups (PAT) (n=643), we used a Support Vector Machine (SVM). Furthermore, we tested whether patient-specific CT exposure is associated with structural brain changes by VBM analyses. Results We found that patients and HC could be separated very well by their CTQ pattern, whereas the different patient groups showed no specific CTQ pattern. Furthermore, an association with extensive grey matter changes suggests an impact on brain maturation which may put individuals at increased risk for mental disease. Discussion We have demonstrated in this large multi-center cohort that adverse experiences in childhood contribute transdiagnostically to the riskr for developing a psychiatric disease. The observed association between CTQ scores and structural changes suggests an impact of adverse childhood experiences on brain development. Resulting alterations may add to a neurobiological vulnerability for depression and psychosis. A role of both features for other mental disorders could be assumed and warrants further investigation.
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Saeki, T., M. Kawano, T. Nagasawa, Y. Ubara, Y. Taniguchi, M. Yanagita, S. Nishi, et al. "FRI0503 VALIDATION OF THE 2019 ACR/EULAR CLASSIFICATION CRITERIA FOR IGG4-RELATED DISEASE IN A JAPANESE KIDNEY DISEASE COHORT: A MULTI-CENTER RETROSPECTIVE STUDY BY THE IGG4-RELATED KIDNEY DISEASE (IGG4-RKD) WORKING GROUP OF THE JAPANESE SOCIETY OF NEPHROLOGY." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 849.1–850. http://dx.doi.org/10.1136/annrheumdis-2020-eular.1097.
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Background:The 2019 ACR/EULAR classification criteria for IgG4-RD have recently been published1). In the criteria, patients with an inclusion criteria score of >20 without exclusion criteria are classified as having IgG4-RD.Objectives:To validate the 2019 ACR/EULAR classification criteria for IgG4-RD in a Japanese kidney disease cohort.Methods:The study involved Japanese patients diagnosed as having kidney disease between April 2012 and May 2019, for whom sufficient clinical information and data on serum IgG4 values and/or immunohistological staining for IgG4 in renal biopsy samples were known. These patients were classified as having IgG4-RKD or non-IgG4-RKD (mimickers) based on the 2019 ACR/EULAR classification criteria for IgG4-RD, and the results were evaluated by expert opinion.Results:Among 105 included patients, the expert panel diagnosed 55 as having true IgG4-RKD and 50 as mimickers. The final diagnoses among the mimickers were vasculitis (n=11), idiopathic tubulointerstitial nephritis (TIN) (n=5), drug-induced TIN (n=5), Sjögren’s syndrome (n=4) and others. Among the 55 true IgG4-RKD patients, 4 had exclusion criteria, and 50 of the remaining 51 had an inclusion criteria score of ≥20 points (sensitivity 90.9%). On the other hand, 49 of the 50 mimickers were classified as having non-IgG4-RKD (specificity 98.0%) (Table 1).Table 1.General characteristics and prevalence of individual items of true IgG4-RKD and non-IgG4-RKD (mimicker)IgG4-RKD(true IgG4-RKD)(n=55)Non-IgG4-RKD(mimicker)(n=50)PAge at diagnosis,mean ±SD (years)69.9 ± 9.456.7 ± 17.4<0.001Male (%)76.4440.001Elevated serum IgG454/55 (98.2%)18/50 (36.0%)<0.001Serum IgG4 (mg/dl), mean±SD1028 ± 796226 ± 261<0.001Dense IgG4+Plasma cells (>10/hpf) in the kidney biopsy48/51 (94.1%)13/40 (32.5%)<0.001Storiform fibrosis in the kidney biopsy28/51 (54.9%)3/50 (6%)<0.001Hypocomplementemia39/55 (70.1%)7/42 (16.7%)<0.001Renal pelvis thickening/soft tissue5/55 (9%)1/50 (2%)0.20Bilateral renal cortex low-density areas29/55 (52.7%)7/50 (14.0%)<0.001Exclusion criteria present4/55 (7.3%)22/50 (44%)<0.001Total inclusion criteria points >20 without exclusion criteria50/55 (90.9%)1/50 (2%)<0.001Conclusion:The 2019 ACR/EULAR classification criteria for IgG4-RD showed good agreement with expert classification in this Japanese kidney disease cohort.References:[1] Wallace ZS, et al. The 2019 American College of Rheumatology/European League Against Rheumatism classification criteria for IgG4-related disease. Ann Rheum Dis. 79:77-87, 2020Disclosure of Interests:None declared
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Sun, Shan, Benjamin W. Green, Rainer Bleck, and Stanley G. Benjamin. "Subseasonal Forecasting with an Icosahedral, Vertically Quasi-Lagrangian Coupled Model. Part II: Probabilistic and Deterministic Forecast Skill." Monthly Weather Review 146, no. 5 (May 1, 2018): 1619–39. http://dx.doi.org/10.1175/mwr-d-18-0007.1.
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Abstract Subseasonal forecast skill of the global hydrostatic atmospheric Flow-Following Icosahedral Model (FIM) coupled to an icosahedral-grid version of the Hybrid Coordinate Ocean Model (iHYCOM) is evaluated through 32-day predictions initialized weekly using a four-member time-lagged ensemble over the 16-yr period 1999–2014. Systematic biases in forecasts by the coupled system, referred to as FIM–iHYCOM, are described in a companion paper (Part I). This present study (Part II) assesses probabilistic and deterministic model skill for predictions of surface temperature, precipitation, and 500-hPa geopotential height in different seasons at different lead times ranging from 1 to 4 weeks. The coupled model appears to have reasonable agreement with reanalysis in terms of simulated weekly variability in sea surface temperatures, except in extratropical regions because the ocean model cannot explicitly resolve eddies there. This study also describes the ability of the model to simulate midlatitude tropospheric blocking frequency, Madden–Julian oscillation patterns, and sudden stratospheric warming events—all of which have been shown to be relevant on subseasonal time scales. The metrics used here indicate that the subseasonal forecast skill of the model is comparable to that of several operational models, including the National Oceanic and Atmospheric Administration’s (NOAA’s) operational Climate Forecast System version 2 and the European Centre for Medium-Range Weather Forecasts model. Therefore, FIM–iHYCOM—as a participant in NOAA’s Subseasonal Experiment—is expected to add value to multimodel ensemble forecasts produced through this effort.
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Talia, Chiara, Edwin-Amalraj Raja, Sohinee Bhattacharya, and Paul A. Fowler. "Testing the twin testosterone transfer hypothesis—intergenerational analysis of 317 dizygotic twins born in Aberdeen, Scotland." Human Reproduction 35, no. 7 (June 19, 2020): 1702–11. http://dx.doi.org/10.1093/humrep/deaa091.
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Abstract STUDY QUESTION Does having a male co-twin influence the female twin’s reproductive outcomes? SUMMARY ANSWER Women with a male co-twin had the same chances of being pregnant and having children compared to same-sex twin pairs. WHAT IS KNOWN ALREADY According to the twin testosterone transfer (TTT) hypothesis, in an opposite-sex twin pregnancy, testosterone transfer from the male to the female co-twin occurs. A large body of literature supports the negative impact of prenatal testosterone exposure on female’s reproductive health in animal models; however, evidence from human studies remains controversial. STUDY DESIGN, SIZE, DURATION This cohort study included all dizygotic female twins in the Aberdeen Maternity and Neonatal Databank (Scotland) born before 1 January 1979. The 317 eligible women were followed up for 40 years for any pregnancies and the outcome of those pregnancies recorded in the same database. PARTICIPANTS/MATERIALS, SETTING, METHODS Fertility outcomes (number of pregnancies, number of livebirths and age at first pregnancy) were compared between women with a male co-twin (exposed group, n = 151) and those with a female co-twin (unexposed group, n = 166). Population averaged models were used to estimate odds ratios (OR) and 95% CI for all outcomes with adjusting for potential confounders. MAIN RESULTS AND THE ROLE OF CHANCE There were no differences in chances of having pregnancies (adj. OR 1.33; 95% CI 0.72, 2.45) and livebirths (adj. OR 1.22; 95% CI 0.68, 2.18) between women from same-sex and opposite-sex twin pairs. Women with a male co-twin were more likely to smoke during pregnancy and, in the unadjusted model, were younger at their first pregnancy (OR 2.13; 95% CI 1.21, 3.75). After adjusting for confounding variables (year of birth and smoking status) the latter finding was no longer significant (OR 1.67; 95% CI 0.90, 3.20). LIMITATIONS, REASONS FOR CAUTION The dataset was relatively small. For women without a pregnancy recorded in the databank, we assumed that they had not been pregnant. WIDER IMPLICATIONS OF THE FINDINGS Despite the evidence from animal studies concerning the adverse effects of prenatal testosterone exposure on female health, our results do not support the TTT hypothesis. The finding that women with a male co-twin are more likely to smoke during pregnancy highlights the importance of considering post-socialisation and social effects in twin studies. STUDY FUNDING/COMPETING INTEREST(S) European Union’s Horizon 2020 research and innovation programme under the Marie Skłodowska-Curie project PROTECTED (grant agreement No. 722634) and FREIA project (grant agreement No. 825100). No competing interests. TRIAL REGISTRATION NUMBER N/A
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Bozan, F., S. Saavedra, K. Vergara, A. Goecke, and H. Gatica. "AB0554 CONCORDANCE IN THE CLASSIFICATION CRITERIA IN A PATIENT COHORT WITH IDIOPATHIC INFLAMMATORY MYOPATHIES (IIM)." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1573.2–1573. http://dx.doi.org/10.1136/annrheumdis-2020-eular.5662.
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Background:Differents classifications criteria for IIM exist. New classification criteria are superior to previous in capturing different subgroups of IIM.Objectives:To compare the concordance and disparity of Bohan and Peter and EULAR/ACR 2017 classification criteria at the level of diagnostic certainty, in a group of chilean patients with IIM.Methods:40 adults patients with IIM (27 Dermatomyositis (DM) and 13 Polimyositis (PM)), according Bohan and Peter criteria were analized. The patients were reclassified with EULAR/ACR criteria. The level of diagnostic certainty (definitive, probable and possible) was registered for both Classification Criteria. The concordance and disparity between criteria was evaluated. Concordance and disparity analysis were made considering the strict agreement between level of certainty of both criteria, using Cohen´s Kappa coefficient. The analysis was done for the complete cohort and for separated groups.Patients with discordance belonging to the same subgroup were evaluated using contingency tables. The direction of the change (gain or lost of certainty) and the relation with diagnostic subgroup was also analized. Descriptive statistics is expressed as diagnostic categories, number of patients and rates.Results:For the complete cohort and for DM and PM groups the concordance was low. For 27 patients with DM, the observed concordance rate was 63% (16 definitives, 1 probable). The observed disparity rate was 37%. The direction of the change was gain of one level of certainty in 14.5% and two levels in 22.2% of patients applying EULAR/ACR criteria compared to Bohan y Peter criteria. For 13 pacients with PM, the observed concordance rate was 46% (3 definitives and 3 probables). The observed disparity rate was 54%. The direction of the change was loss of certainty. The loss of certainty was one level in 85,7% (one patient change from probable to posible). Only one patiente had gain of certainty of one level (14.3%).Conclusion:The strict concordance between both classification criteria was low. The observed concordances were better in patients with DM that PM. The disparities involved gain of level of diagnostic certainty in DM patients, while in PM patients there was mostly lost of level of certainty.References:[1]Bohan A, Peter JB. Polymyositis and dermatomyositis (first of two parts). NEJM 1975;292:344-7.[2]Bohan A, Peter JB. Polymyositis and dermatomyositis (second of two parts). NEJM 1975;292:403-7.[3]2017 European League Against Rheumatism/American Colllege of Rheumatology Classification Criteria for Adult and Juvenile Idiopathic Inflammatory Myopathies and Their major Subgroups. Arthritis Rheum 2017;0:1-12.Disclosure of Interests: :None declared
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Hamilton, R., S. Shields, A. Mcgucken, J. Macdonald, M. Perry, A. Dunlop, E. Gribben, and P. Galloway. "AB0309 MEASURING THE DIFFERENCE: COMPARISON OF MEASUREMENT OF FREE INFLIXIMAB ANTI-DRUG ANTIBODIES." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1453.2–1453. http://dx.doi.org/10.1136/annrheumdis-2020-eular.665.
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Background:Infliximab (IFX) was one of the first TNF alpha inhibitors to be licenced in inflammatory arthritis and is still commonly used today. Studies have shown that approximately 50% of primary IFX responders will suffer from secondary loss of response within the first 12 months of treatment (1). The development of Anti-Drug Antibodies (ADA’s) plays a significant role in this treatment failure (2).Monitoring of ADA’s helps identify those patients who fail to respond to treatment due to low IFX trough levels. In this scenario the presence of ADA’s can aid decision-making regarding increasing IFX dosing or switching biologic therapy to optimise treatment. (3).Objectives:Despite their potential importance the detection of ADAs varies widely depending on the type of assays used. The aim of this study was to determine the qualitative concordance of three commercially available ELISA kits for measurement of free ADAs to IFX on the Grifols Triturus analyser.Methods:150 patient samples from patients with inflammatory conditions and low IFX trough drug levels (≤0.6µg/ml) were analysed for free ADAs using Promonitor, Lisa Tracker and IDKmonitor kits on the Grifols Triturus automated ELISA analyser.Results:Kappa coefficient (κ) analysis indicated a moderate agreement between the Promonitor and IDKmonitor assays (κ =0.484 (95% CI, 0.357 to 0.611)) and the IDKmonitor and Lisa Tracker assays (κ = 0.485 (95% CI, 0.348-0.621)) as well as substantial agreement between the Promonitor and Lisa Tracker assays (κ =0.768 (95% CI, 0.667-0.870)). Figure 1 shows the distribution of samples identified as free ADA positive by each kit.Figure 1.Distribution of samples identified as free ADA positive by Promonitor, Lisa Tracker, and IDKmonitor assays. Fifty samples were considered positive by all assays. Three samples were considered positive by Promonitor and Lisa Tracker, and eight samples were considered positive by Lisa Tracker and IDKmonitor. No samples were considered positive by Promonitor and IDKmonitor. One sample was considered positive by Promonitor only, seven samples were considered positive by Lisa Tracker only, and twenty-six samples were considered positive by IDKmonitorConclusion:All kits appear amenable for utilisation in a high-throughput laboratory though a true quantitative comparison between these kits was precluded by the absence of any certified reference material for free ADAs to IFX.Although broad qualitative agreement was found between the three kits, they should not be used interchangeably for patient management.Further research is required to estimate the impact of free ADAs on efficiency of IFX treatment and patient management.References:[1]Quistrebert J, Hässler S, Bachelet D et al.Incidence and risk factors for adalimumab and infliximab anti-drug antibodies in rheumatoid arthritis: A European retrospective multicohort analysis. Seminars in Arthritis and Rheumatism Volume 48, Issue 6, June 2019, Pages 967-975 2.[2]Moots RJ, Xavier RM, Mok CC, Rahman MU, Tsai W-C, Al-Maini MH, et al. (2017)The impact of anti-drug antibodies on drug concentrations and clinical outcomes in rheumatoid arthritis patients treated with adalimumab, etanercept, or infliximab: Results from a multinational, real-world clinical practice, non-interventional study. PLoS ONE 12(4): e0175207.https://doi.org/10.1371/journal.pone.0175207[3]Smolen JS, Landewé R, Bijlsma J, et al.EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs:2016 update.Annals of the Rheumatic Diseases 2017;76:960-977.Disclosure of Interests:Rhona Hamilton: None declared, Stephanie Shields: None declared, Andrew McGucken: None declared, Jonathan MacDonald: None declared, Martin Perry Grant/research support from: Grifols, Abbvie, Sandoz unrestricted educational grant, Consultant of: Abbvie, Gilead, Celltrion Advisory Board, Speakers bureau: Sandoz, Allan Dunlop: None declared, Elaine Gribben: None declared, Peter Galloway: None declared
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Fersch, Benjamin, Harald Kunstmann, András Bárdossy, Balaji Devaraju, and Nico Sneeuw. "Continental-Scale Basin Water Storage Variation from Global and Dynamically Downscaled Atmospheric Water Budgets in Comparison with GRACE-Derived Observations." Journal of Hydrometeorology 13, no. 5 (October 1, 2012): 1589–603. http://dx.doi.org/10.1175/jhm-d-11-0143.1.
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Abstract Since 2002, the Gravity Recovery and Climate Experiment (GRACE) has provided gravity-derived observations of variations in the terrestrial water storage. Because of the lack of suitable direct observations of large-scale water storage changes, a validation of the GRACE observations remains difficult. An approach that allows the evaluation of terrestrial water storage variations from GRACE by a comparison with those derived from aerologic water budgets using the atmospheric moisture flux divergence is presented. In addition to reanalysis products from the European Centre for Medium-Range Weather Forecasts and the National Centers for Environmental Prediction, high-resolution regional atmospheric simulations were produced with the Weather Research and Forecast modeling system (WRF) and validated against globally gridded observational data of precipitation and 2-m temperature. The study encompasses six different climatic and hydrographic regions: the Amazon basin, the catchments of Lena and Yenisei, central Australia, the Sahara, the Chad depression, and the Niger. Atmospheric-related uncertainty bounds based on the range of the ensemble of estimated terrestrial water storage variations were computed using different configurations of the regional climate model WRF and different global reanalyses. Atmospheric-related uncertainty ranges with those originating from the GRACE products of GeoForschungsZentrum Potsdam, the Center for Space Research, and the Jet Propulsion Laboratory were also compared. It is shown that dynamically downscaled atmospheric fields are able to add value to global reanalyses, depending on the geographical location of the considered catchments. Global and downscaled atmospheric water budgets are in reasonable agreement (r ≈ 0.7 − 0.9) with GRACE-derived terrestrial mass variations. However, atmospheric- and satellite-based approaches show shortcomings for regions with small storage change rates (<20–25 mm month−1).
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Minas, Stephen. "Marine Technology Transfer under a BBNJ Treaty: A Case for Transnational Network Cooperation." AJIL Unbound 112 (2018): 144–49. http://dx.doi.org/10.1017/aju.2018.46.
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Our ability to protect and sustainably use the high seas is ultimately subject to our ability to understand this vast and remote environment. The success of an international legally binding instrument (ILBI) for the conservation and sustainable use of marine biological diversity of areas beyond national jurisdiction (BBNJ) will depend, in part, on utilizing technology to access ocean life, to analyze it, and to implement measures for its conservation and sustainable use. Indeed, technology, broadly defined, is integral to meeting the ILBI's objectives: not just the mandate to address “capacity-building and the transfer of marine technology,” but also the sustainable use and conservation of marine genetic resources, the implementation of environmental impact assessments, and biodiversity conservation measures such as area-based management tools. To maximize marine technology deployment to protect marine biodiversity in areas beyond national jurisdiction, transferring technology to developing countries will be critical. Provisions for the transfer of technology, generally from developed to developing countries, are included in many international environmental agreements and declarations, but these provisions have often proven difficult to implement. Part of the difficulty is that the relevant technology is dispersed among states; universities, research institutes and other nonstate actors; and private industry. The particular challenge in crafting an ILBI is, as the European Union has identified, to avoid repeating existing provisions and instead to “focus on added value.” One opportunity for an ILBI to add value on technology transfer is to further develop a network model to facilitate marine technology transfer.
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Bajraktari, Ismet H., Sylejman Rexhepi, Idriz Berisha, Ali Lahu, Avni Kryeziu, Bastri Durmishi, Halit Bajraktari, and Elton Bahtiri. "Prevalence of Asymptomatic Arterial Hypertension and Its Correlation with Inflammatory Activity in Early Rheumatoid Arthritis." Open Access Macedonian Journal of Medical Sciences 5, no. 5 (August 10, 2017): 641–44. http://dx.doi.org/10.3889/oamjms.2017.146.
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BACKGROUND: Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease that worsens during the course of the disease and can cause disability. Early RA refers to the onset of symptoms within the past 3 months. In RA, increased levels of mediators of inflammation may cause arterial stiffness consequently leading to arterial hypertension.AIM: The aim of this cross-sectional study was to assess the prevalence of asymptomatic arterial hypertension in early RA patients as well as the correlation with parameters of inflammation.METHODS: One hundred and seventy-nine early RA patients diagnosed in agreement with ACR/EULAR (American College of Rheumatology/ European League against Rheumatism) 2010 criteria were consecutively included in the study. CRP (C-reactive protein) and anti CCP (Antibodies to cyclic citrullinated peptides) serum levels, WBC (white blood cells) count and ESR (Erythrocyte sedimentation rate), likewise DAS-28 (28-joint disease activity score) was determined in all included patients. Parametric tests were used to compare the characteristics of the groups and to test the correlation of the variables.RESULTS: Statistical data analysis revealed that a majority of the patients were females (n = 141; 78.7%); the mean age at RA onset was 49.13 ± 12.13 years. Overall prevalence of hypertension was 44.13 % (n = 79). In comparison with the normotensive patients, the hypertensive patients were older and had significantly higher values of CRP, ESR, anti-CCP and DAS-28. A highly significant positive correlation between all the study parameters and systolic and diastolic blood pressure was observed.CONCLUSION: Presence of significantly higher values of CRP, ESR, anti-CCP and DAS-28 in hypertensive patients indicate that inflammation is associated with an increased risk of hypertension. In this context, early screening for arterial hypertension and adequate therapeutic measures should be considered in early RA patients.
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Smolen, Josef S., Robert Landewé, Johannes Bijlsma, Gerd Burmester, Katerina Chatzidionysiou, Maxime Dougados, Jackie Nam, et al. "EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update." Annals of the Rheumatic Diseases 76, no. 6 (March 6, 2017): 960–77. http://dx.doi.org/10.1136/annrheumdis-2016-210715.
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Recent insights in rheumatoid arthritis (RA) necessitated updating the European League Against Rheumatism (EULAR) RA management recommendations. A large international Task Force based decisions on evidence from 3 systematic literature reviews, developing 4 overarching principles and 12 recommendations (vs 3 and 14, respectively, in 2013). The recommendations address conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs) (methotrexate (MTX), leflunomide, sulfasalazine); glucocorticoids (GC); biological (b) DMARDs (tumour necrosis factor (TNF)-inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), abatacept, rituximab, tocilizumab, clazakizumab, sarilumab and sirukumab and biosimilar (bs) DMARDs) and targeted synthetic (ts) DMARDs (Janus kinase (Jak) inhibitors tofacitinib, baricitinib). Monotherapy, combination therapy, treatment strategies (treat-to-target) and the targets of sustained clinical remission (as defined by the American College of Rheumatology-(ACR)-EULAR Boolean or index criteria) or low disease activity are discussed. Cost aspects were taken into consideration. As first strategy, the Task Force recommends MTX (rapid escalation to 25 mg/week) plus short-term GC, aiming at >50% improvement within 3 and target attainment within 6 months. If this fails stratification is recommended. Without unfavourable prognostic markers, switching to—or adding—another csDMARDs (plus short-term GC) is suggested. In the presence of unfavourable prognostic markers (autoantibodies, high disease activity, early erosions, failure of 2 csDMARDs), any bDMARD (current practice) or Jak-inhibitor should be added to the csDMARD. If this fails, any other bDMARD or tsDMARD is recommended. If a patient is in sustained remission, bDMARDs can be tapered. For each recommendation, levels of evidence and Task Force agreement are provided, both mostly very high. These recommendations intend informing rheumatologists, patients, national rheumatology societies, hospital officials, social security agencies and regulators about EULAR's most recent consensus on the management of RA, aimed at attaining best outcomes with current therapies.
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Fleischmann, Roy, Désirée van der Heijde, Andrew S. Koenig, Ronald Pedersen, Annette Szumski, Lisa Marshall, and Eustratios Bananis. "How much does Disease Activity Score in 28 joints ESR and CRP calculations underestimate disease activity compared with the Simplified Disease Activity Index?" Annals of the Rheumatic Diseases 74, no. 6 (August 20, 2014): 1132–37. http://dx.doi.org/10.1136/annrheumdis-2013-204920.
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ObjectivesDisease Activity Score in 28 joints calculated with C-reactive protein (DAS28-CRP) is used instead of erythrocyte sedimentation rate (DAS28-ESR) to assess rheumatoid arthritis disease activity; however, values for remission and low disease activity (LDA) for DAS28-CRP have not been validated. American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) guidelines suggest remission should be calculated by Simplified Disease Activity Index (SDAI) rather than DAS28-ESR. We examined values of remission and LDA of DAS28-CRP that correspond to the respective cut-off points for DAS28-ESR and SDAI from five clinical trials.MethodsDAS28-CRP cut-offs that best correspond to DAS28-ESR remission <2.6 and LDA ≤3.2 were obtained by cumulative distribution plots, receiver operating curves and maximum concordance and averaged for each approach, treatment group and study. Level of agreement between DAS28-CRP and DAS28-ESR remission and LDA cut-offs was compared against each other and versus SDAI remission ≤3.3 and LDA ≤11.ResultsPercentage of patients who achieved remission and LDA by DAS28-ESR cut-offs was greater for DAS28-CRP versus DAS28-ESR regardless of patient population or treatment group. Discordance between CRP and ESR cut-offs ranged from 4%–26% and 8%–23% for remission and LDA, respectively, and 19%–40% and 6%–11% for DAS28-CRP versus SDAI, respectively. Estimated (range) remission and LDA thresholds were 2.4 (2.2–2.6) and 2.9 (2.6–3.3), 1.9 (1.6–2.2) and 3.1 (3.1–3.3) and 2.2 (1.1–2.9) and 3.6 (3.4–4.0) for DAS28-CRP versus DAS28-ESR, DAS28-CRP versus SDAI and DAS28-ESR versus SDAI, respectively.ConclusionsDAS28-CRP underestimates disease activity when using cut-off points validated for DAS28-ESR; therefore, DAS28-ESR cut-off values should not be applied to DAS28-CRP. Although DAS28-CRP and DAS28-ESR cut-offs for LDA ≤3.2 correspond to SDAI LDA, neither corresponds well to SDAI remission.
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Wang, Hansheng, Na Wei, Yijun Tang, Yunyun Wang, Guoshi Luo, Tao Ren, Chang Xiong, Hongbo Li, Meifang Wang, and Xin Qian. "The Utility of Rapid On-Site Evaluation during Bronchoscopic Biopsy: A 2-Year Respiratory Endoscopy Central Experience." BioMed Research International 2019 (December 8, 2019): 1–7. http://dx.doi.org/10.1155/2019/5049248.
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Background. Rapid on-site evaluation (ROSE) is commonly used to evaluate the adequacy of biopsy materials in fine-needle aspiration; however, the diagnostic performance of ROSE during fiber optic bronchoscopy (FOB) biopsy under direct vision is rarely reported. Here, we evaluated the role of ROSE during FOB biopsy of visible lesion in trachea or bronchi. Methods. The role of ROSE was prospectively evaluated in consecutive bronchoscopy specimens obtained between January 2016 and January 2018. The agreement and accuracy between ROSE and final histopathological interpretation were assessed. The frequency and possible reasons for discrepancy between ROSE and definitive histopathology results were identified. Histological and cytological classification was performed according to the International Association for the Study of Lung Cancer, the American Thoracic Society, and the European Respiratory Society (IASLC/ATS/ERS) criteria of lung ADCs classification. Results. The study enrolled 651 patients, of which 33 were excluded because of insufficient cells. Final diagnosis of malignancy was achieved in 462 cases (74.8%), whereas 156 cases (25.2%) were nonmalignant. ROSE and pathology were well correlated for the diagnosis of squamous cell carcinoma (SCC) (Kappa = 0.718, p<0.05), adenocarcinoma (AdC) (Kappa = 0.662; p<0.05) and small cell lung cancer (SCLC) (Kappa = 0.955; p<0.05). In 24 cases diagnosed as malignant by ROSE and nonmalignant by pathology, the lesion tissues were surgically excised and re-analyzed, and the 24 cases were finally confirmed as malignant by pathology. Conclusions. ROSE technique allows bronchoscopists to obtain viable and adequate material for the diagnosis of histopathology, and provides them with an onsite preliminary diagnosis especially in cases with inconclusive macroscopic appearance. ROSE and pathology should be used in combination to increase the accuracy of diagnosis.
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Błeszyński, Jan. "REEMISJA W ŚWIETLE ZMIAN PRAWA AUTORSKIEGO." Zeszyty Prawnicze 3, no. 2 (May 10, 2017): 43. http://dx.doi.org/10.21697/zp.2003.3.2.03.
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REEMISSION IN THE LIGHT OF CHANGES IN THE COPYRIGHT LAWSummaryAn author’s output, artistic performances, rights to phonograms and videograms, rights to radio and television broadcast, constitute an essential element of the media market. The audiences respond and in the result prospects for advantages depend on the attractiveness of the authors’ and their artistic input. It is obvious, that the broadcasters’ dream is that the program is both: attractive to the audience and cheap. Broadcasters’ economic domination results in the possibility to force lower remuneration paid to authors and artists. This domination, however, is only an illusion, because the worse economic conditions for artists and authors are, the lower quality of programs we can get. It is impossible to expect an author or artist to accept unprofitable conditions.The amendments to the Copyright Act with regard to radio-television rights were introduced in 1998 in order to adapt Polish copyright for EU requirements. At this opportunity, several other changes were introduced, which were not conditioned by those requirements, and sometimes were even contradictory to them!The promoter of the amendment to the Copyright Act introduced in 1998 and 1999 was Andrzej Zakrzewski - the Minister of Culture and National Heritage at that time. It was meant to be a continuation of the changes introduced in 1994. A great number of provisions adopted in 1994 did not provide for the protection standards required by the EU laws, which was due to the necessity to make the consequences of the adaptation „softer”. An example is the amendment to radio-television rights.The drafts of of the amendments prepared in 1998 introduced cancellation of the statutory license to a reemission and replacing it by agreements concluded with organizations of collective management. Issues related to broadcasts and reemission were placed in Article 21, which resulted in the repeal of Article 23 Section 4 of the Copyright Act of 1994.Contrary to the above draft, in a report presented to the Commission of Culture and Mass Media, the repeal of Article 24 Section 3 as well as the definition of a „reemission” were decided to be crossed out. In the course of debates on the amendments, Senate voted for replacing the phrase „reemission” with the term „parallel and integral dissemination” and repealing Art. 24 Section 3.The amendment of 9 June 2000 upheld Art. 24 Section 3, which was a technical mistake resulting from internal discrepancies within the act of law introducing the amendments. The amendment of 28 October 2002 removed this provision. The proposal to repeal Art. 24 Section 3 was accompanied with a proposal to add to Article 2 1 a new section no. 4 stating, that: „in case of any discrepancies resulting from the agreement, referred to in Section 3, Article 108 Section 5 shall apply”. The reason for such an amendment was to soften the consequences of removing the statutory license with regard to a reemission in 2000.Article 108 Section 3 of the Copyright Act of 1994 in its first version, with regard to the discrepancies resulting from Remuneration Schedules approved of by the Copyright Commission consisting of 7 members, provided for a jurisdiction of the Copyright Commission consisting of 3 members. The Copyright Commission consisting of 3 members, deciding on „discrepancies resulting from the agreement on reemission”, threatens the authors’ rights. It is necessary to indicate, that an author is vested with an exclusive right to dispose of his work. In a situation where there is a statutory license, an author is only vested with a right to remuneration. In any situation, however, an organization of the collective management acts for his benefit. Extending the scope of the Copyright Commission’s jurisdiction cannot lead to limiting the authors’ rights. An extended jurisdiction of the Copyright Commission in fact creates such a limitation. Instead of negotiating a license to a reemission, including an author’s remuneration, apart from the collective management body, a cable operator may obtain a license for a reemission issued by the Copyright Commission consisting of 3 members.After the aforementioned amendment came into force, the issue of a statutory license with regard to cable television became a subject of intensive media discussion. Just a few months after the amendment was introduced, the deputies proposed to go back to the statutory license with regard to a reemission. As a result, a new amendment was adopted, which reintroduced the statutory license. The aforementioned changes, however, were made being aware of their contradiction to the EU standards. Opponents of these changes raised arguments speaking for the necessity of further amendments. Some of them are as follows. A cable operator was to have just a few days to identify television programs’ broadcasters, start negotiations, and conclude appropriate agreements. This argument took no account of the fact, that a removal of the statutory license with regard to reemission was made in 2000.As a result, the introduced amendment repeals Article 21 Section 3 and 4 of the Copyright Act of 2002 and replaced it with a new Article 211 which shall come into force on the date when Poland joins the European Union. It means, that in place of temporarily removed provisions abolishing the statutory license, it has been brought into the light again, due to the European Union obligations.The changes adopted in 2002 were appealed, however, because of being contradictory to the Polish Constitution - too short vacatio legis. Constitutional Tribunal in its decision of 16 September 2003 did not agree with this view. It means, that Constitutional Tribunal did not share the argument which justified bringing the statutory license in 2003 into the light again.
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Buchalik, Lucjan. "THE NEW ASPECT OF THE MUNICIPAL MUSEUM IN ŻORY. HISTORY AND COLLECTION." Muzealnictwo 58, no. 1 (August 7, 2017): 0. http://dx.doi.org/10.5604/01.3001.0010.2668.
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Two attempts were made to found the Museum in Żory, each time when the anniversary of the town’s founding was being celebrated. The Municipal Cultural Centre then organised exhibitions devoted to the town’s history. Since the interest in celebrations dropped off once they were finished, the museum was never founded. In 1999 the concept was changed, and African culture started to predominate. The interest in such an exhibition was huge, and thus the Municipal Museum was founded in December 2000. It has two branches, one devoted to the history and culture of the region, and one devoted to non-European cultures. At the beginning, museum professionals were aware of the fact that the museum’s existence depended on social acceptance. It was decided to focus on animation activities, which effectively attracted a lot of visitors. At the same time, both the regional and West African collections were created. Since the museum was founded quite recently, the majority of the collection is made up of objects from the 2nd half of the 20th century and the beginning of the 21st century. Having its own premises was a serious problem for the museum. After many years of struggle, an agreement was concluded with the Katowice Special Economic Zone (KSSE) to add a wing to the historical Haering villa from 1908 which it owned. In autumn 2014 the construction work finished and the museum gained its own premises. The museum presents two permanent exhibitions: "Our identity" and "The Polish way of learning about the world". The former presents the history and culture of the region and town, from their beginnings until today. The latter is devoted to research carried out by Polish scientists in various parts of the globe. The museum acquires objects mainly through its own field work, as well as from collections gathered by Polish scientists during their research. Purchasing historical and expensive objects at antique shops and markets is rare.