Makatsori Melina, Senna Gianenrico, Pitsios Constantinos, Lleonart Ramon, Klimek Ludger, Nunes Carlos, Rukhadze Maia, Rogala Barbara, Gawlik Radoslaw, Panzner Petr, Pfaar Oliver, Calderon Moises
Royal Brompton and Harefield NHS Trust, London, UK ; Imperial College London, National Heart and Lung Institute, London, UK.
Allergy Department, Azienda Universitaria-Ospedaliera Integrata, Verona, Italy.
Clin Transl Allergy. 2015 Apr 27;5:17. doi: 10.1186/s13601-015-0060-0. eCollection 2015.
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.
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.
坚持变应原免疫疗法对其有效性至关重要。目前,在临床试验之外,即现实生活临床实践中,关于变应原免疫疗法依从性的数据有限。作为欧洲变态反应与临床免疫学会免疫疗法兴趣小组倡议的一部分,我们努力设计一项调查,以便前瞻性评估不同欧洲国家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:成年人,开始针对呼吸道过敏性疾病或膜翅目毒液过敏进行临床指示的变应原免疫疗法。设计了一项在线调查,以招募参与者并评估免疫疗法的依从性。选择了八个国家(捷克共和国、格鲁吉亚、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变应原和免疫疗法给药途径的差异。每个国家都有一名指定的国家协调员,该协调员已确定当地愿意让参与者参加这项调查的变态反应科。每位参与者将总共随访三年。为了评估依从性,将在线填写一份详细说明任何漏服剂量及原因的每四个月随访表。如果参与者停止治疗,将记录其原因。
在线调查软件的使用使我们能够开展这项调查并联系到不同国家的临床医生。45个中心共招募了1350多名参与者。希望这项前瞻性现实生活调查将使我们更好地了解影响皮下和舌下免疫疗法依从性的原因,并有助于制定改善依从性的方法。