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Prospective adherence to specific immunotherapy in Europe (PASTE) survey protocol

机译:预期遵守欧洲特定免疫疗法(PASTE)调查方案

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Background Adherence to allergen immunotherapy is important for its effectiveness. There is currently limited data available on allergen immunotherapy adherence outside of clinical trials i.e. in real-life clinical practice. As part of a European Academy of Allergy and Clinical Immunology Immunotherapy Interest group initiative, we endeavoured to design a survey in order to prospectively evaluate adherence to subcutaneous and sublingual immunotherapy across different European countries. Method/Design The inclusion criteria for this prospective, multi-country survey were set as: adults, starting clinically indicated allergen immunotherapy for respiratory allergic disorders or Hymenoptera venom allergy. An online survey was designed in order to enrol participants and assess adherence to immunotherapy. Eight countries (Czech Republic, Georgia, Germany, Greece, Italy, Poland, Portugal, Spain) were selected to reflect different parts of Europe and differences in allergens and routes of immunotherapy administration. Each country has an allocated National co-ordinator that has identified local Allergy departments willing to enrol participants in this survey. Each participant will be followed up for a total of three years. In order to assess adherence, a 4-monthly follow-up form detailing any missed doses and reasons will be completed online. In case of a participant discontinuing treatment, reasons for this will be recorded. Discussion The use of online survey software has enabled us to make this survey a reality and reach clinicians in different countries. Forty-five centres have enrolled a total of over 1,350 participants. It is hoped that this prospective real life survey will enable us to gain a better understanding of reasons that affect adherence to subcutaneous and sublingual immunotherapy and assist in developing ways to improve this.
机译:背景技术坚持过敏原免疫疗法对其有效性至关重要。目前,在临床试验之外,即在现实生活中,有关过敏原免疫疗法依从性的数据有限。作为欧洲过敏和临床免疫学免疫疗法兴趣小组计划的一部分,我们努力设计一项调查,以前瞻性评估欧洲不同国家对皮下和舌下免疫疗法的依从性。方法/设计这项前瞻性,多国调查的纳入标准设定为:成人,从临床开始就针对呼吸道过敏性疾病或膜翅目毒液过敏的过敏原免疫治疗。设计了一个在线调查,以招募参与者并评估对免疫疗法的依从性。选择了八个国家(捷克共和国,乔治亚州,德国,希腊,意大利,波兰,葡萄牙,西班牙)以反映欧洲不同地区以及过敏原和免疫疗法施用途径的差异。每个国家都有一个分配的国家协调员,该协调员确定了愿意招募参加此次调查的当地过敏部门。每位参与者将进行为期三年的随访。为了评估依从性,将在网上完成一个为期4个月的跟踪表,详细列出任何错过的剂量和原因。如果参与者中止治疗,则将记录其原因。讨论在线调查软件的使用使我们能够使这一调查成为现实,并覆盖不同国家的临床医生。 45个中心总共招募了1,350多名参与者。希望这项前瞻性的现实生活调查将使我们能够更好地理解影响坚持皮下和舌下免疫疗法依从性的原因,并协助开发改善方法。

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