炎症性肠病的核心结局集:通过国际多利益相关者共识进程在临床实践中实施的发展和建议

Liselotte Fierens, Nicholas Carney, Gottfried Novacek, C Janneke van der Woude, Britta Siegmund, Francesc Casellas, Natalia Borruel, Anouk S Huberts, Elena Sonnenberg, Nathalie Gerold, Christian Primas, Charlotte R H Hedin, Tanja Stamm, Mette Julsgaard, Gionata Fiorino, Simona Radice, Michela Luciana Luisa Zini, Evelyn Gross, Cornelia Sander, Ingrid Arijs, Vasiliki-Rafaela Vakouftsi, Tunde Koltai, Health Outcomes Observatory H O Patient Advisory Board For Inflammatory Bowel Diseases, Health Outcomes Observatory H O Steering Committee, Iliàs Charlafti, Marc Ferrante
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引用次数: 0

摘要

背景和目的:标准化卫生结果测量支持提供护理,使数据驱动的学习系统和二级数据用于研究。作为健康结果观察站倡议的一部分,在现有知识的基础上,通过国际改进的德尔菲法确定了炎症性肠病(IBD)的核心结果集(COS)。方法:利益相关者在9分的重要性量表上对90个变量进行两次评级,允许根据每个利益相关者组显示的反馈修改分数。连续举行了两次共识会议,讨论结果并制定临床实践中测量的建议。≥80%的参与者得分为7分或更高,或基于共识会议协议的变量被纳入最终集。结果:共有来自20个不同国家的136名利益相关者(45名IBD患者(倡导者),74名医疗保健专业人员/研究人员,13名行业代表和4名监管机构)参与。最后一组包括18个病例组合变量,3个生物标志物(检测贫血的血红蛋白,检测炎症的c反应蛋白和粪便钙保护蛋白)的完整性和28个结局(包括16个患者报告的结局(PROs)和1个患者报告的经历)。建议在每次与IBD从业者接触时使用PRO-2和IBD控制问卷收集疾病特异性pro,并每年使用主观健康体验模型问卷、PROMIS全球健康和自我效能简表收集通用pro。结论:定义了IBD的COS,包括在临床实践中使用的建议。这套方案将在维也纳、柏林、巴塞罗那、鲁汶和鹿特丹开始实施,使患者能够更好地管理自己的护理。随后将在世界各地设立更多的中心。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A Core Outcome Set for Inflammatory Bowel Diseases: Development and Recommendations for Implementation in Clinical Practice Through an International Multi-stakeholder Consensus Process.

Background and aims: Standardising health outcome measurements supports delivery of care and enables data-driven learning systems and secondary data use for research. As part of the Health Outcomes Observatory [H2O] initiative, and building on existing knowledge, a core outcome set [COS] for inflammatory bowel diseases [IBD] was defined through an international modified Delphi method.

Methods: Stakeholders rated 90 variables on a 9-point importance scale twice, allowing score modification based on feedback displayed per stakeholder group. Two consecutive consensus meetings were held to discuss results and formulate recommendations for measurement in clinical practice. Variables scoring 7 or higher by ≥80% of the participants, or based on consensus meeting agreement, were included in the final set.

Results: In total, 136 stakeholders (45 IBD patients [advocates], 74 health care professionals/researchers, 13 industry representatives, and four regulators) from 20 different countries participated. The final set includes 18 case-mix variables, three biomarkers [haemoglobin to detect anaemia, C-reactive protein and faecal calprotectin to detect inflammation] for completeness, and 28 outcomes (including 16 patient-reported outcomes [PROs] and one patient-reported experience). The PRO-2 and IBD-Control questionnaires were recommended to collect disease-specific PROs at every contact with an IBD practitioner, and the Subjective Health Experience model questionnaire, PROMIS Global Health and Self-Efficacy short form, to collect generic PROs annually.

Conclusions: A COS for IBD, including a recommendation for use in clinical practice, was defined. Implementation of this set will start in Vienna, Berlin, Barcelona, Leuven, and Rotterdam, empowering patients to better manage their care. Additional centres will follow worldwide.

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