标准化食物过敏研究的结果:使临床试验与患者的优先级保持一致。

IF 3 4区 医学 Q2 ALLERGY
Daniel Munblit, Christian Apfelbacher, Anastasia Demidova, Audrey DunnGalvin, Robert J Boyle
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引用次数: 0

摘要

综述目的:本综述探讨了免疫球蛋白E (IgE)介导的食物过敏(FA)干预研究的临床结果,强调了对以患者为中心的结果的未满足需求。随着对FA治疗的研究,特别是食物免疫疗法的扩展,标准化结果测量是至关重要的。在这里,我们讨论了结果应该如何反映FA对人们生活的多维影响。最新发现:目前的证据表明,临床试验结果与患者和护理人员最重视的结果之间存在差异。虽然试验通常优先考虑反应阈值或免疫标志物的变化,但患者和护理人员强调需要减少严重反应,改善生活质量,增强对疾病管理的信心。这种差异突出了协调工作对指导FA研究的重要性。食物过敏的核心结果测量(COMFA)倡议最近通过涉及患者、护理人员、临床医生和研究人员的国际共识过程确定了两个核心结果——“过敏症状”和“生活质量”。结果如“脱敏”和“缓解/持续无反应”被认为是重要的,但不是最关键的。摘要:为FA干预研究制定和实施COS对于使研究与患者优先事项保持一致至关重要,确保常规临床护理的有意义改善。标准化的结果测量将产生强有力的证据,为临床实践提供信息,并赋予患者和护理人员有关FA管理决策的权力。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Standardizing outcomes in food allergy research: aligning clinical trials with patient priorities.

Purpose of review: This review explores the clinical outcomes used in immunoglobulin E (IgE)-mediated food allergy (FA) intervention studies, emphasizing unmet need for patient-centred outcomes. Standardizing outcome measurement is critical as research into FA treatments, particularly food immunotherapy, expands. Here we discuss how outcomes should reflect the multidimensional impact of FA on people's lives.

Recent findings: Current evidence reveals a discrepancy between clinical trial outcomes and those most valued by patients and carers. While trials often prioritize changes in reactivity thresholds or immunological markers, patients and carers emphasize need in reducing severe reactions, improving quality of life, and enhancing confidence in disease management. This disparity highlights importance of harmonization efforts to guide FA research.The Core Outcome Measures for Food Allergy (COMFA) initiative recently identified two core outcomes - 'allergic symptoms' and 'quality of life' - through an international consensus process involving patients, caregivers, clinicians, and researchers. Outcomes like 'desensitization' and 'remission/sustained unresponsiveness' were considered important but were not seen as the most critical.

Summary: Developing and implementing a COS for FA intervention studies is essential to align research with patient priorities, ensuring meaningful improvements in routine clinical care. Standardized outcome measurement will generate robust evidence, inform clinical practice, and empower patients and caregivers in decision-making about FA management.

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来源期刊
CiteScore
5.90
自引率
3.60%
发文量
109
审稿时长
6-12 weeks
期刊介绍: This reader-friendly, bimonthly resource provides a powerful, broad-based perspective on the most important advances from throughout the world literature. Featuring renowned guest editors and focusing exclusively on one to three topics, every issue of Current Opinion in Allergy and Clinical Immunology delivers unvarnished, expert assessments of developments from the previous year. Insightful editorials and on-the-mark invited reviews cover key subjects such as upper airway disease; mechanisms of allergy and adult asthma; paediatric asthma and development of atopy; food and drug allergies; and immunotherapy.
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