Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS and Department of Biomedical Sciences, Humanitas University, Milan, Italy.
Department of Emergency and Organ Transplantation, School and Chair of Allergology and Clinical Immunology, University of Bari - Aldo Moro, Bari, Italy.
Allergy. 2021 Sep;76(9):2663-2672. doi: 10.1111/all.14773.
Although there is a considerable body of knowledge about allergen immunotherapy (AIT), there is a lack of data on the reliability of real-world evidence (RWE) in AIT, and consequently, a lack of information on how AIT effectively works in real life.
To address the current unmet need for an appraisal of the quality of RWE in AIT, the European Academy of Allergy and Clinical Immunology Methodology Committee recently initiated a systematic review of observational studies of AIT, which will use the RELEVANT tool and the Grading of Recommendations Assessment, Development and Evaluation approach (GRADE) to rate the quality of the evidence base as a whole. The next step will be to develop a broadly applicable, pragmatic "real-world" database using systematic data collection. Based on the current RWE base, and perspectives and recommendations of authorities and scientific societies, a hierarchy of RWE in AIT is proposed, which places pragmatic trials and registry data at the positions of highest level of evidence.
There is a need to establish more AIT registries that collect data in a cohesive way, using standardized protocols.
This will provide an essential source of real-world data that can be easily shared, promoting evidence-based research and quality improvement in study design and clinical decision-making.
尽管有相当多的关于变应原免疫治疗（AIT）的知识，但关于 AIT 真实世界证据（RWE）的可靠性的数据却很少，因此，关于 AIT 在现实生活中如何有效发挥作用的信息也很少。
为了解决目前对 AIT 中 RWE 质量评估的需求，欧洲过敏与临床免疫学学会方法学委员会最近启动了一项对 AIT 的观察性研究的系统评价，该评价将使用 RELEVANT 工具和推荐评估、制定与评估分级方法（GRADE）对整个证据基础的质量进行评级。下一步将是使用系统的数据收集来开发一个广泛适用的、实用的“真实世界”数据库。基于当前的 RWE 基础，以及权威机构和科学协会的观点和建议，提出了 AIT 中的 RWE 层次结构，将实用试验和登记数据置于最高证据水平的位置。
需要建立更多的 AIT 登记处，以连贯的方式收集数据，并使用标准化的方案。
这将提供一个重要的真实世界数据来源，可以方便地共享，促进研究设计和临床决策中的基于证据的研究和质量改进。
