McDuff Kiera, Bhéreur Anne, Kadakia Zeal, Corrales-Medina Vicente F, Gross Douglas P, Janaudis-Ferreira Tania, Lam Grace, Naik Hiten, Paterson Theone S E, Sanchez-Ramirez Diana C, Sasseville Maxime, Sekar Anisha, Vohra Sunita, Bayley Mark, Birch Susan, Busse Jason W, Cameron Jill I, Kaup Cara, Cheung Angela, Churchill Katie, Edgell Heather, Goulding Susie, Hamilton Clayon, Jaglal Susan, Kumar Pawan, Levin Adeera, Munblit Daniel, Naye Florian, O'Hara Margaret, Plaismond James, Rutledge Mark, Supper Jean-Marc Wilfried, Quinn Kieran, Wasilewski Marina B, Wilkins Annette, O'Brien Kelly K
Department of Physical Therapy, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
Department of Family Medicine and Emergency Medicine, Faculty of Medicine, Université de Montréal, Montreal, Quebec, Canada.
BMJ Open. 2025 Sep 2;15(9):e094497. doi: 10.1136/bmjopen-2024-094497.
INTRODUCTION: Our aim is to develop a Framework of Measurement for people living with Long COVID and their caregivers for use in Long COVID research and clinical practice. Specifically, we will characterise evidence pertaining to outcome measurement and identify implementation considerations for use of outcome measures among adults and children living with Long COVID and their caregivers. METHODS AND ANALYSIS: We will conduct a scoping study involving: (1) an evidence review and (2) a two-phased consultation, using methodological steps outlined by the Arksey and O'Malley Framework and Joanna Briggs Institute. We will answer the following question: What is known about outcome measures used to describe, evaluate or predict health outcomes among adults and children living with Long COVID and their caregivers? EVIDENCE REVIEW: we will review peer review published and grey literature to identify existing outcome measures and their reported measurement properties with people living with Long COVID and their caregivers. We will search databases including MEDLINE, Embase, CINAHL, PsycINFO and Scopus for articles published since 2020. Two authors will independently review titles and abstracts, followed by full text to select articles that discuss or use outcome measures for Long COVID health outcomes, pertain to adults or children living with Long COVID and/or their caregivers and are based in research or clinical settings. We will extract data including article characteristics, terminology and definition of Long COVID, health outcomes assessed, characteristics of outcome measures, measurement properties and implementation considerations. We will collate and summarise data to establish a preliminary Framework of Measurement. Consultation phase 1: we will conduct an environmental scan involving a cross-sectional web-based questionnaire among individuals with experience using or completing outcome measures for Long COVID, to identify outcome measures not found in the evidence review and explore implementation considerations for outcome measurement in the context of Long COVID. Consultation phase 2: we will conduct focus groups to review the preliminary Framework of Measurement and to highlight implementation considerations for outcome measurement in Long COVID. We will analyse questionnaire and focus group data using descriptive and content analytical approaches. We will refine the Framework of Measurement based on the focus group consultation using community-engaged approaches with the research team. ETHICS AND DISSEMINATION: Protocol approved by the University of Toronto Health Sciences Research Ethics Board (protocol #46503) for the consultation phases of the study. Outcomes will include a Framework of Measurement, to enhance measurement of health outcomes in Long COVID research and clinical practice. Knowledge translation will also occur in the form of publications and presentations.
引言：我们的目标是为患有长期新冠后遗症的患者及其护理人员开发一个测量框架，用于长期新冠后遗症的研究和临床实践。具体而言，我们将对与结局测量相关的证据进行特征描述，并确定在患有长期新冠后遗症的成人和儿童及其护理人员中使用结局测量指标的实施注意事项。 方法与分析：我们将开展一项范围界定研究，包括：（1）证据审查和（2）两阶段咨询，采用阿克西和奥马利框架以及乔安娜·布里格斯研究所概述的方法步骤。我们将回答以下问题：关于用于描述、评估或预测患有长期新冠后遗症的成人和儿童及其护理人员健康结局的结局测量指标，我们了解哪些情况？ 证据审查：我们将审查同行评审发表的文献和灰色文献，以确定现有的结局测量指标及其在患有长期新冠后遗症的患者及其护理人员中的报告测量属性。我们将搜索包括MEDLINE、Embase、CINAHL、PsycINFO和Scopus在内的数据库，查找自2020年以来发表的文章。两位作者将独立审查标题和摘要，随后审查全文，以选择讨论或使用长期新冠后遗症健康结局的结局测量指标、涉及患有长期新冠后遗症的成人或儿童及其护理人员且基于研究或临床环境的文章。我们将提取数据，包括文章特征、长期新冠后遗症的术语和定义、评估的健康结局、结局测量指标的特征、测量属性和实施注意事项。我们将整理和汇总数据，以建立初步的测量框架。咨询阶段1：我们将进行一次环境扫描，通过基于网络的横断面问卷对有使用或完成长期新冠后遗症结局测量指标经验的个人进行调查，以识别在证据审查中未发现的结局测量指标，并探讨在长期新冠后遗症背景下结局测量的实施注意事项。咨询阶段2：我们将开展焦点小组讨论，以审查初步的测量框架，并突出长期新冠后遗症结局测量的实施注意事项。我们将使用描述性和内容分析方法分析问卷和焦点小组数据。我们将根据焦点小组咨询意见，采用社区参与方法与研究团队一起完善测量框架。 伦理与传播：该研究的咨询阶段方案已获得多伦多大学健康科学研究伦理委员会批准（方案编号#46503）。研究结果将包括一个测量框架，以加强长期新冠后遗症研究和临床实践中健康结局的测量。知识转化也将以出版物和报告的形式进行。
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