6 results on '"Position paper"'
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2. COVID‐19 pandemic: Practical considerations on the organization of an allergy clinic—An EAACI/ARIA Position Paper.
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Pfaar, Oliver, Klimek, Ludger, Jutel, Marek, Akdis, Cezmi A., Bousquet, Jean, Breiteneder, Heimo, Chinthrajah, Sharon, Diamant, Zuzana, Eiwegger, Thomas, Fokkens, Wytske J., Fritsch, Hans‐Walter, Nadeau, Kari C., O'Hehir, Robyn E., O'Mahony, Liam, Rief, Winfried, Sampath, Vanitha, Schedlowski, Manfred, Torres, María José, Traidl‐Hoffmann, Claudia, and Wang, De Yun
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COVID-19 pandemic , *COVID-19 , *MEDICAL personnel , *SARS-CoV-2 - Abstract
Background: The coronavirus disease 2019 (COVID‐19) has evolved into a pandemic infectious disease transmitted by the severe acute respiratory syndrome coronavirus (SARS‐CoV‐2). Allergists and other healthcare providers (HCPs) in the field of allergies and associated airway diseases are on the front line, taking care of patients potentially infected with SARS‐CoV‐2. Hence, strategies and practices to minimize risks of infection for both HCPs and treated patients have to be developed and followed by allergy clinics. Method: The scientific information on COVID‐19 was analysed by a literature search in MEDLINE, PubMed, the National and International Guidelines from the European Academy of Allergy and Clinical Immunology (EAACI), the Cochrane Library, and the internet. Results: Based on the diagnostic and treatment standards developed by EAACI, on international information regarding COVID‐19, on guidelines of the World Health Organization (WHO) and other international organizations, and on previous experience, a panel of experts including clinicians, psychologists, IT experts, and basic scientists along with EAACI and the "Allergic Rhinitis and its Impact on Asthma (ARIA)" initiative have developed recommendations for the optimal management of allergy clinics during the current COVID‐19 pandemic. These recommendations are grouped into nine sections on different relevant aspects for the care of patients with allergies. Conclusions: This international Position Paper provides recommendations on operational plans and procedures to maintain high standards in the daily clinical care of allergic patients while ensuring the necessary safety measures in the current COVID‐19 pandemic. [ABSTRACT FROM AUTHOR]
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- 2021
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3. Placebo effects in allergen immunotherapy—An EAACI Task Force Position Paper.
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Pfaar, Oliver, Agache, Ioana, Bergmann, Karl‐Christian, Bindslev‐Jensen, Carsten, Bousquet, Jean, Creticos, Peter S., Devillier, Philippe, Durham, Stephen R., Hellings, Peter, Kaul, Susanne, Kleine‐Tebbe, Jörg, Klimek, Ludger, Jacobsen, Lars, Jutel, Marek, Muraro, Antonella, Papadopoulos, Nikolaos G., Rief, Winfried, Scadding, Glenis K., Schedlowski, Manfred, and Shamji, Mohamed H.
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PLACEBOS , *TASK forces , *ALLERGENS , *CLINICAL trials , *IMMUNOTHERAPY - Abstract
The placebo (Latin "I will please") effect commonly occurs in clinical trials. The psychological and physiological factors associated with patients' expectations about a treatment's positive and negative effects have yet to be well characterized, although a functional prefrontal cortex and intense bidirectional communication between the central nervous system and the immune system appear to be prerequisites for a placebo effect. The use of placebo raises certain ethical issues, especially if patients in a placebo group are denied an effective treatment for a long period of time. The placebo effect appears to be relatively large (up to 77%, relative to pretreatment scores) in controlled clinical trials of allergen immunotherapy (AIT), such as the pivotal, double‐blind, placebo‐controlled (DBPC) randomized clinical trials currently required by regulatory authorities worldwide. The European Academy of Allergy and Clinical Immunology (EAACI) therefore initiated a Task Force, in order to better understand the placebo effect in AIT and its specific role in comorbidities, blinding issues, adherence, measurement time points, variability and the natural course of the disease. In this Position Paper, the EAACI Task Force highlights several important topics regarding the placebo effect in AIT such as a) regulatory aspects, b) neuroimmunological and psychological mechanisms, c) placebo effect sizes in AIT trials, d) methodological limitations in AIT trial design and e) potential solutions in future AIT trial design. In conclusion, this Position Paper aims to examine the methodological problem of placebo in AIT from different aspects and also to highlight unmet needs and possible solutions for future trials. [ABSTRACT FROM AUTHOR]
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- 2021
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4. Management of KPC-producing Klebsiella pneumoniae infections.
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Bassetti, M., Giacobbe, D.R., Giamarellou, H., Viscoli, C., Daikos, G.L., Dimopoulos, G., De Rosa, F.G., Giamarellos-Bourboulis, E.J., Rossolini, G.M., Righi, E., Karaiskos, I., Tumbarello, M., Nicolau, D.P., Viale, P.L., and Poulakou, G.
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KLEBSIELLA pneumoniae , *PNEUMONIA treatment , *PHYSICIANS , *DEATH rate , *CLINICAL trials - Abstract
Background Klebsiella pneumoniae carbapenemase (KPC)-producing K. pneumoniae (KPC-KP) has become one of the most important contemporary pathogens, especially in endemic areas. Aims To provide practical suggestion for physicians dealing with the management of KPC-KP infections in critically ill patients, based on expert opinions. Sources PubMed search for relevant publications related to the management of KPC-KP infections. Contents A panel of experts developed a list of 12 questions to be addressed. In view of the current lack of high-level evidence, they were asked to provide answers on the bases of their knowledge and experience in the field. The panel identified several key aspects to be addressed when dealing with KPC-KP in critically ill patients (preventing colonization in the patient, preventing infection in the colonized patient and colonization of his or her contacts, reducing mortality in the infected patient by rapidly diagnosing the causative agent and promptly adopting the best therapeutic strategy) and provided related suggestions that were based on the available observational literature and the experience of panel members. Implications Diagnostic technologies could speed up the diagnosis of KPC-KP infections. Combination treatment should be preferred to monotherapy in cases of severe infections. For non–critically ill patients without severe infections, results from randomized clinical trials are needed for ultimately weighing benefits and costs of using combinations rather than monotherapy. Multifaceted infection control interventions are needed to decrease the rates of colonization and cross-transmission of KPC-KP. [ABSTRACT FROM AUTHOR]
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- 2018
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5. Position paper on requirements for toxicological studies in the specific case of radiopharmaceuticals.
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Koziorowski, J., Behe, M., Decristoforo, C., Ballinger, J., Elsinga, P., Ferrari, V., Kolenc Peitl, P., Todde, S., and Mindt, T.
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RADIOPHARMACEUTICALS , *CLINICAL trials , *PHARMACEUTICAL industry , *TOXICITY testing , *DRUG efficacy - Abstract
This is a position paper of the Radiopharmacy Committee of the EANM (European Association of Nuclear Medicine) addressing toxicology studies for application of new diagnostic and therapeutic radiopharmaceuticals (RP) that are not approved (i.e., not having a marketing authorization or a monograph in the European Pharmacopoeia), excluding endogenous and ubiquitous substances in humans. This paper discusses the requirements for clinical trials with radiopharmaceuticals for clinical research applications, not necessarily intended to aim at a marketing authorization. If marketing authorization is intended, scientific advice of the competent authorities is mandatory and cannot be replaced by this position paper. The position paper reflects the view of the Radiopharmacy Committee of the EANM and can be used as a basis for discussions with the responsible authorities. [ABSTRACT FROM AUTHOR]
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- 2016
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6. EORTC elderly task force position paper: Approach to the older cancer patient
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Pallis, A.G., Fortpied, C., Wedding, U., Van Nes, M.C., Penninckx, B., Ring, A., Lacombe, D., Monfardini, S., Scalliet, P., and Wildiers, H.
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GERIATRIC oncology , *DISEASES in older people , *CLINICAL trials , *DISEASE incidence , *CANCER treatment ,AGE factors in cancer - Abstract
As a result of an increasing life expectancy, the incidence of cancer cases diagnosed in the older population is rising. Indeed, cancer incidence is 11-fold higher in persons over the age of 65 than in younger ones. Despite this high incidence of cancer in older patients, solid data regarding the most appropriate approach and best treatment for older cancer patients are still lacking, mostly due to under-representation of these patients in prospective clinical trials. The clinical behaviour of common malignant diseases, e.g. breast, ovarian and lung cancers, lymphomas and acute leukaemias, may be different in older patients because of intrinsic variation of the neoplastic cells and the ability of the tumour host to support neoplastic growth. The decision to treat or not these patients should be based on patients’ functional age rather than the chronological age. Assessment of patients’ functional age includes the evaluation of health, functional status, nutrition, cognition and the psychosocial and economic context. The purpose of this paper is to focus on the influence of age on cancer presentation and cancer management in older cancer patients and to provide suggestions on clinical trial development and methodology in this population. [Copyright &y& Elsevier]
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- 2010
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