来自 MASCC 粘膜炎研究小组和 ISOO 的粘膜炎评估指南:一项国际德尔菲研究。

IF 9.6 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL EClinicalMedicine Pub Date : 2024-06-06 eCollection Date: 2024-07-01 DOI:10.1016/j.eclinm.2024.102675
Ragda Abdalla-Aslan, Pierluigi Bonomo, Dorothy Keefe, Nicole Blijlevens, Katrina Cao, Yin Ting Cheung, Eduardo Rodrigues Fregnani, Robert Miller, Judith Raber-Durlacher, Joel Epstein, Ysabella Van Sebille, Elisa Kauark-Fontes, Abhishek Kandwal, Emma McCurdy-Franks, Joel Finkelstein, Victoria McCarvell, Yehuda Zadik, Giulia Ottaviani, Rui Amaral Mendes, Caroline Margina Speksnijder, Hannah Rose Wardill, Paolo Bossi
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引用次数: 0

摘要

背景:粘膜炎是传统和新兴癌症疗法中常见且影响较大的副作用,因此成为研究的热点。尽管粘膜炎是常见的副作用,但采用的评估方法不尽相同,指导性也不强,影响了证据的合成和转化。因此,多国癌症支持性治疗协会(MASCC)粘膜炎研究小组(MSG)旨在就如何在临床治疗和试验中使用现有的粘膜炎评估工具提出专家建议,以提高粘膜炎评估的一致性:本研究分两个阶段进行(2022 年 1 月至 2023 年 7 月)。第一阶段是对 MASCC-MSG 成员进行调查(2022 年 1 月至 2022 年 5 月),了解当前的做法、挑战和偏好。第二阶段采用德尔菲法(2023 年 2 月至 2023 年 5 月)编制和完善了一套初步建议。调查结果:72名 MASCC-MSG 成员完成了第一阶段的研究(37 名女性,34 名男性,主要是口腔护理专家)。研究发现,粘膜炎评估工具的使用存在很大差异,与患者报告结果衡量标准(PROMs,47% 对 3%,37% 合并使用)相比,临床医生的评估结果依赖性更高。世界卫生组织(WHO)和《不良事件通用术语标准》(CTCAE)量表最常用于在多种情况下评估粘膜炎。最初的建议由经验丰富的 MSG 成员审查,经过两轮德尔菲调查后,100 项建议中有 91 项达成了共识。例如,对于接受化疗的患者,临床医生在临床实践中评估口腔黏膜炎的推荐工具是 WHO(89.5% 的共识),评估胃肠道黏膜炎的推荐工具是 WHO 或 CTCAE(85.7% 的共识)。临床试验中推荐的PROM是口腔黏膜炎的OMD/WQ(93.3%的共识)和胃肠道黏膜炎的PRO-CTCAE(83.3%的共识):这些新建议为粘膜炎评估提供了急需的指导,可用于临床实践和研究,简化全球数据集的比较和综合,从而加快将新知识转化为临床实践:未获得资助。
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Guidance on mucositis assessment from the MASCC Mucositis Study Group and ISOO: an international Delphi study.

Background: Mucositis is a common and highly impactful side effect of conventional and emerging cancer therapy and thus the subject of intense investigation. Although common practice, mucositis assessment is heterogeneously adopted and poorly guided, impacting evidence synthesis and translation. The Multinational Association of Supportive Care in Cancer (MASCC) Mucositis Study Group (MSG) therefore aimed to establish expert recommendations for how existing mucositis assessment tools should be used, in clinical care and trials contexts, to improve the consistency of mucositis assessment.

Methods: This study was conducted over two stages (January 2022-July 2023). The first phase involved a survey to MASCC-MSG members (January 2022-May 2022), capturing current practices, challenges and preferences. These then informed the second phase, in which a set of initial recommendations were prepared and refined using the Delphi method (February 2023-May 2023). Consensus was defined as agreement on a parameter by >80% of respondents.

Findings: Seventy-two MASCC-MSG members completed the first phase of the study (37 females, 34 males, mainly oral care specialists). High variability was noted in the use of mucositis assessment tools, with a high reliance on clinician assessment compared to patient reported outcome measures (PROMs, 47% vs 3%, 37% used a combination). The World Health Organization (WHO) and Common Terminology Criteria for Adverse Events (CTCAE) scales were most commonly used to assess mucositis across multiple settings. Initial recommendations were reviewed by experienced MSG members and following two rounds of Delphi survey consensus was achieved in 91 of 100 recommendations. For example, in patients receiving chemotherapy, the recommended tool for clinician assessment in clinical practice is WHO for oral mucositis (89.5% consensus), and WHO or CTCAE for gastrointestinal mucositis (85.7% consensus). The recommended PROM in clinical trials is OMD/WQ for oral mucositis (93.3% consensus), and PRO-CTCAE for gastrointestinal mucositis (83.3% consensus).

Interpretation: These new recommendations provide much needed guidance on mucositis assessment and may be applied in both clinical practice and research to streamline comparison and synthesis of global data sets, thus accelerating translation of new knowledge into clinical practice.

Funding: No funding was received.

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来源期刊
EClinicalMedicine
EClinicalMedicine Medicine-Medicine (all)
CiteScore
18.90
自引率
1.30%
发文量
506
审稿时长
22 days
期刊介绍: eClinicalMedicine is a gold open-access clinical journal designed to support frontline health professionals in addressing the complex and rapid health transitions affecting societies globally. The journal aims to assist practitioners in overcoming healthcare challenges across diverse communities, spanning diagnosis, treatment, prevention, and health promotion. Integrating disciplines from various specialties and life stages, it seeks to enhance health systems as fundamental institutions within societies. With a forward-thinking approach, eClinicalMedicine aims to redefine the future of healthcare.
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