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特应性皮炎临床试验中实施 HOME 核心结局集的障碍和机遇:HOMEIX 会议报告。

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

机构信息

Department of Dermatology, Oregon Health and Science University, 3303 S. Bond Avenue, Portland, Oregon, 97239, USA.

Centre of Evidence Based Dermatology, School of Medicine, University of Nottingham, Nottingham, UK.

出版信息

Arch Dermatol Res. 2023 Nov;315(9):2617-2622. doi: 10.1007/s00403-023-02647-w. Epub 2023 Jul 11.


DOI:10.1007/s00403-023-02647-w
PMID:37432466
Abstract

The Harmonising Outcome Measures for Eczema (HOME) initiative established a core outcome set (COS) for atopic eczema (AE) clinical trials in 2019. This set encompasses four core outcome domains and corresponding measurement instruments: clinical signs (EASI), patient-reported symptoms (POEM and NRS 11 point for worst itch over the last 24 h), quality of life (DLQI/CDLQI/IDQoLI), and long-term control (Recap or ADCT). Following its roadmap, the HOME initiative is now focused on supporting implementation of the COS. To identify barriers and facilitators to implementation of the COS, and to guide the effort to promote COS uptake, a virtual consensus meeting was held over 2 days (September 25-26, 2021) attended by 55 participants (26 healthcare professionals, 16 methodologists, 5 patients, 4 industry representatives, and 4 students). Implementation themes were identified by a pre-meeting survey distributed to HOME members, presentations, and whole-group discussion. Participants were divided into five multi-professional small groups which ranked their top 3 most important themes, followed by whole-group discussion and anonymous consensus voting (consensus criteria: < 30% disagreement). Three most important implementation themes were identified and agreed upon: (1) awareness and stakeholder engagement, (2) universal applicability of the COS, and (3) ensuring minimum administrative burden. Working groups to address these issues are now a priority for the HOME initiative. The results from this meeting will inform the development of a HOME Implementation Roadmap in an effort to support other COS groups planning for effective implementation of their core sets.

摘要

“湿疹结局测量协调倡议”(HOME)于 2019 年为特应性皮炎临床试验建立了一个特应性皮炎核心结局集(COS)。该集合包括四个核心结局领域和相应的测量工具:临床体征(EASI)、患者报告的症状(POEM 和过去 24 小时内最严重瘙痒的 NRS 11 分)、生活质量(DLQI/CDLQI/IDQoLI)和长期控制(Recap 或 ADCT)。根据其路线图,HOME 倡议目前专注于支持 COS 的实施。为了确定实施 COS 的障碍和促进因素,并指导努力促进 COS 的采用,于 2021 年 9 月 25 日至 26 日举行了为期两天的虚拟共识会议,共有 55 名参与者(26 名医疗保健专业人员、16 名方法学家、5 名患者、4 名行业代表和 4 名学生)参加。通过向 HOME 成员分发会前调查、演示文稿和全体讨论,确定了实施主题。参与者分为五个多专业小组,对前 3 个最重要的主题进行了排名,然后进行了全体讨论和匿名共识投票(共识标准:<30%的分歧)。确定并同意了三个最重要的实施主题:(1)意识和利益相关者的参与,(2)COS 的普遍适用性,以及(3)确保最低行政负担。现在,处理这些问题的工作组是 HOME 倡议的优先事项。本次会议的结果将为 HOME 实施路线图的制定提供信息,以支持其他 COS 小组计划有效实施其核心集。

相似文献

[1]
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

[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]
The Harmonising Outcome Measures for Eczema (HOME) implementation roadmap.

Br J Dermatol. 2023-11-16

[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]
Towards global consensus on outcome measures for atopic eczema research: results of the HOME II meeting.

Allergy. 2012-7-30

[7]
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

[8]
The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials.

J Allergy Clin Immunol. 2014-10

[9]
Patient-Oriented Eczema Measure (POEM), a core instrument to measure symptoms in clinical trials: a Harmonising Outcome Measures for Eczema (HOME) statement.

Br J Dermatol. 2017-3-2

[10]
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

引用本文的文献

[1]
Correlation between disease severity indices and quality of life measurement tools in atopic dermatitis patients.

Biomedica. 2024-8-29

本文引用的文献

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

J Allergy Clin Immunol. 2022-6

[2]
Use of core outcome sets was low in clinical trials published in major medical journals.

J Clin Epidemiol. 2022-2

[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. 2021-7

[4]
A systematic review finds Core Outcome Set uptake varies widely across different areas of health.

J Clin Epidemiol. 2021-1

[5]
Assessing the relevance and uptake of core outcome sets (an agreed minimum collection of outcomes to measure in research studies) in Cochrane systematic reviews: a review.

BMJ Open. 2020-9-6

[6]
The value of core outcome sets in health psychology.

Br J Health Psychol. 2020-9

[7]
Assessing uptake of the Harmonising Outcome Measures for Eczema (HOME) Core Outcome Set and recommended instruments.

Br J Dermatol. 2020-9

[8]
The increasing complexity of the core outcomes landscape.

J Clin Epidemiol. 2019-5-23

[9]
Engaging Stakeholders and Promoting Uptake of OMERACT Core Outcome Instrument Sets.

J Rheumatol. 2017-8-1

[10]
Core Outcome Sets.

Arch Dis Child Educ Pract Ed. 2018-6

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