10 research outputs found
Clinical trials in allergen immunotherapy in the age group of children and adolescents: Current concepts and future needs
International audienceAllergen immunotherapy (AIT) is the only treatment option available for allergic patients with disease-modifying intention. Both efficacy and safety has been demonstrated for multiple trials in children, adolescents and adults. Though regulatory requirements for marketing authorization have been clearly outlined and an increasing number of high quality trials has been initiated, multiple concepts and details in study design may be further elaborated, harmonized and improved. An international group of experts in the field of AIT has thoroughly reviewed and discussed current concepts and provided an outlook on further improvement especially in the age group of children and adolescents. Emphasis of the group's discussion as a basis for this article was put on (i) the regulatory background of marketing authorization of AIT products including the 'Pediatric Investigational Plan', (ii) patient reported outcomes and endpoints in AIT trials, (iii) considerations regarding the 'minimal clinically important difference', (iv) the role of placebo effects in AIT clinical trials and clinical routine and (v) the potential of mobile Health for future development of AIT. Current concepts in AIT have been optimized throughout the recent decades, but there remains room for improvement e.g., in the topics outlined in this article
国际过敏与鼻科学共识声明 : 变应性鼻炎
Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/150599/1/ICARPrimaryAuthorCOIForms1.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/150599/2/ICARSecondaryAuthorCOIForms.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/150599/3/ICARPrimaryAuthorCOIForms2.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/150599/4/ICARAuthorCOI2017.8.15.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/150599/5/alr22073_c.pd
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International Consensus Statement on Allergy and Rhinology: Allergic Rhinitis
BackgroundCritical examination of the quality and validity of available allergic rhinitis (AR) literature is necessary to improve understanding and to appropriately translate this knowledge to clinical care of the AR patient. To evaluate the existing AR literature, international multidisciplinary experts with an interest in AR have produced the International Consensus statement on Allergy and Rhinology: Allergic Rhinitis (ICAR:AR).MethodsUsing previously described methodology, specific topics were developed relating to AR. Each topic was assigned a literature review, evidence-based review (EBR), or evidence-based review with recommendations (EBRR) format as dictated by available evidence and purpose within the ICAR:AR document. Following iterative reviews of each topic, the ICAR:AR document was synthesized and reviewed by all authors for consensus.ResultsThe ICAR:AR document addresses over 100 individual topics related to AR, including diagnosis, pathophysiology, epidemiology, disease burden, risk factors for the development of AR, allergy testing modalities, treatment, and other conditions/comorbidities associated with AR.ConclusionThis critical review of the AR literature has identified several strengths; providers can be confident that treatment decisions are supported by rigorous studies. However, there are also substantial gaps in the AR literature. These knowledge gaps should be viewed as opportunities for improvement, as often the things that we teach and the medicine that we practice are not based on the best quality evidence. This document aims to highlight the strengths and weaknesses of the AR literature to identify areas for future AR research and improved understanding
国际过敏与鼻科学共识声明 : 变应性鼻炎
Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/150599/1/ICARPrimaryAuthorCOIForms1.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/150599/2/ICARSecondaryAuthorCOIForms.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/150599/3/ICARPrimaryAuthorCOIForms2.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/150599/4/ICARAuthorCOI2017.8.15.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/150599/5/alr22073_c.pd