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特应性皮炎临床试验的 HOME 核心结局集。

The HOME Core outcome set for clinical trials of atopic dermatitis.

机构信息

Centre of Evidence Based Dermatology, School of Medicine, University of Nottingham, Nottingham, United Kingdom.

Center for Evidence-based Healthcare, Medical Faculty Carl Gustav Carus, Dresden, Germany.

出版信息

J Allergy Clin Immunol. 2022 Jun;149(6):1899-1911. doi: 10.1016/j.jaci.2022.03.017. Epub 2022 Mar 26.


DOI:10.1016/j.jaci.2022.03.017
PMID:35351441
Abstract

Core outcome sets are critically important outcomes that should be measured in clinical trials. Their absence in atopic dermatitis is a form of research waste and impedes combining evidence to inform patient care. Here, we articulate the rationale for core outcome sets in atopic dermatitis and review the work of the international Harmonising Outcome Measures for Eczema group from its inception in Munich, 2010. We describe core domain determination (what should be measured), to instrument selection (how domains should be measured), culminating in the complete core outcome measurement set in Tokyo, 2019. Using a "road map," Harmonising Outcome Measures for Eczema includes diverse research methods including Delphi and nominal group techniques informed by systematic reviews of properties of candidate instruments. The 4 domains and recommended instruments for including in all clinical trials of atopic dermatitis are patient symptoms, measured by Patient-Oriented Eczema Measure and peak Numerical Rating Scale 11 for itch intensity over 24 hours, clinical signs measured using the Eczema Area and Severity Index, quality of life measured by the Dermatology Life Quality Index series for adults, children, and infants, and long-term control measured by either Recap of atopic eczema or Atopic Dermatitis Control Tool.

摘要

核心结局集是临床研究中应测量的重要结局。特应性皮炎研究中缺乏核心结局集是一种研究浪费,阻碍了为患者提供护理的证据整合。在这里,我们阐述了特应性皮炎核心结局集的基本原理,并回顾了 2010 年慕尼黑国际特应性皮炎结局指标协调小组的工作。我们描述了核心领域的确定(应该测量什么),到工具的选择(如何测量领域),最终在 2019 年东京确定了完整的核心结局测量集。使用“路线图”,特应性皮炎结局指标协调包括多种研究方法,包括德尔菲法和名义群体技术,这些方法基于对候选工具特性的系统评价。特应性皮炎所有临床试验中应包含的 4 个领域和推荐工具为:患者症状,通过患者导向的湿疹量表和 24 小时内瘙痒强度的峰值数字评分量表 11 来测量;临床体征使用湿疹面积和严重程度指数测量;生活质量通过成人、儿童和婴儿的皮肤病生活质量指数系列来测量;长期控制通过特应性皮炎记录或特应性皮炎控制工具来测量。

相似文献

[1]
The HOME Core outcome set for clinical trials of atopic dermatitis.

J Allergy Clin Immunol. 2022-6

[2]
Recommended core outcome instruments for health-related quality of life, long-term control and itch intensity in atopic eczema trials: results of the HOME VII consensus meeting.

Br J Dermatol. 2021-7

[3]
Recommended core outcome instruments for health-related quality of life, long-term control and itch intensity in atopic eczema trials: results of the HOME VII consensus meeting.

Br J Dermatol. 2020-11-11

[4]
Measuring Atopic Eczema Control and Itch Intensity in Clinical Practice: A Consensus Statement From the Harmonising Outcome Measures for Eczema in Clinical Practice (HOME-CP) Initiative.

JAMA Dermatol. 2022-12-1

[5]
Report from the fourth international consensus meeting to harmonize core outcome measures for atopic eczema/dermatitis clinical trials (HOME initiative).

Br J Dermatol. 2016-7-19

[6]
Assessment of clinical signs of atopic dermatitis: a systematic review and recommendation.

J Allergy Clin Immunol. 2013-9-12

[7]
Implementation of the HOME core outcome set for clinical trials of atopic eczema-barriers and opportunities: the HOME IX meeting report.

Arch Dermatol Res. 2023-11

[8]
Measuring atopic eczema symptoms in clinical practice: The first consensus statement from the Harmonising Outcome Measures for Eczema in clinical practice initiative.

J Am Acad Dermatol. 2020-1-8

[9]
Evaluation of the measurement properties of symptom measurement instruments for atopic eczema: a systematic review.

Allergy. 2016-7-13

[10]
The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials.

J Allergy Clin Immunol. 2014-10

引用本文的文献

[1]
Defining "Flares" in Atopic Dermatitis: A Narrative Review.

Am J Clin Dermatol. 2025-9-1

[2]
Achieving Optimal Treatment Targets and Minimal Disease Activity with Upadacitinib for Moderate-to-Severe Atopic Dermatitis: Integrated Analysis of Phase 3 Studies (Measure Up 1 and 2).

Dermatol Ther (Heidelb). 2025-7-14

[3]
Assessing Atopic Dermatitis Control in Chinese Patients: Validation of the Chinese Version of Recap of Atopic Eczema Questionnaire (RECAP) and an Investigation into Its Interpretability.

Acta Derm Venereol. 2025-7-8

[4]
Knowledge assessment tools in atopic dermatitis patient education: a scoping review.

Allergy Asthma Clin Immunol. 2025-5-24

[5]
Standardizing outcomes in food allergy research: aligning clinical trials with patient priorities.

Curr Opin Allergy Clin Immunol. 2025-6-1

[6]
Patient-reported outcome assessment of adults and adolescents with atopic dermatitis: a cross-sectional qualitative interview study.

J Patient Rep Outcomes. 2025-4-10

[7]
Pyoderma gangrenosum refined elements for core item selection and evaluation (PRECISE-PG): a study protocol for reaching consensus on core outcome domain items in clinical trials of pyoderma gangrenosum.

Arch Dermatol Res. 2025-2-20

[8]
The Eczema Bathing Study: Weekly versus daily bathing for people with eczema? Protocol of an online, randomised controlled trial.

NIHR Open Res. 2025-1-17

[9]
Describing atopic dermatitis in real-world clinical practice: a retrospective health system analysis.

Arch Dermatol Res. 2025-2-7

[10]
Quality of Life in Adults with Atopic Dermatitis in Relation to Disease Severity: Nationwide Data in Japan.

Dermatol Ther (Heidelb). 2025-2

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