社区环境中脑瘫儿童和青少年胸部健康的核心结局集与测量指标:CHESTI研究方案
Core outcome set and measures of chest health in children and young people with cerebral palsy in the community setting: the CHESTI study protocol.
作者信息
Knight Lozano Rachel, Morris Christopher, Shannon Harriet, Bell Kayleigh, Malyon Hugh, Melluish Julia, Latour Jos
机构信息
University of Plymouth, Plymouth, UK
University of Exeter Medical School, Exeter, UK.
出版信息
BMJ Open. 2025 Aug 11;15(8):e105309. doi: 10.1136/bmjopen-2025-105309.
INTRODUCTION
Poor chest health is the leading cause of early mortality in children with cerebral palsy (CP). It is also the most common reason to seek healthcare, accruing significant costs and reducing quality-of-life for children and families. Clinical trials examining chest health interventions in CP are characterised by inconsistent outcome measures, limiting the capacity for evidence synthesis to inform clinical application. The study aims to develop a core outcome set (COS) and related measurement instruments to assess, monitor and evaluate chest health in children with CP, both in research and routine clinical practice. The COS will reflect the views of children, young people, parent/carers, clinicians and researchers, emphasising under-represented groups in research and those at risk of poorer chest health.
METHODS AND ANALYSIS
A 3-phase methodology will be conducted in line with the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. (1) Candidate outcomes will be identified through a qualitative evidence synthesis and interviews with key stakeholders. Findings will be mapped to COMET-taxonomy, generating a list of candidate outcomes. (2) An international e-Delphi survey will invite stakeholders to rate the importance of each outcome, followed by a consensus meeting to ratify the COS. (3) A structured review, guided by health measurement taxonomy, will evaluate relevant instruments, with a final meeting to agree on recommended measures for each COS domain.
ETHICS AND DISSEMINATION
Ethical approval was provided by the University of Plymouth Research Ethics Committee for the qualitative interview study (ID5116), e-Delphi study and consensus meeting (ID5636). Study findings will be published open access in a peer-reviewed journal and presented at relevant national and international conferences.
STUDY REGISTRATION
COMET registration: 2590 (https://www.comet-initiative.org/Studies/Details/2590) PROSPERO REGISTRATION NUMBER: CRD42024562735.
引言
胸部健康状况不佳是脑瘫(CP)患儿早期死亡的主要原因。它也是寻求医疗保健的最常见原因,会产生高昂的费用,并降低儿童及其家庭的生活质量。针对CP患儿胸部健康干预措施的临床试验的特点是结局指标不一致,这限制了证据综合以指导临床应用的能力。本研究旨在制定一套核心结局集(COS)及相关测量工具,以在研究和常规临床实践中评估、监测和评价CP患儿的胸部健康状况。该COS将反映儿童、青少年、家长/照顾者、临床医生和研究人员的观点,重点关注研究中代表性不足的群体以及胸部健康状况较差风险较高的群体。
方法与分析
将按照有效性试验核心结局指标(COMET)倡议开展三阶段方法。(1)通过定性证据综合和与关键利益相关者的访谈确定候选结局。研究结果将映射到COMET分类法,生成候选结局列表。(2)开展国际电子德尔菲调查,邀请利益相关者对每个结局的重要性进行评分,随后召开共识会议批准COS。(3)在健康测量分类法的指导下进行结构化审查,评估相关工具,最后召开会议就每个COS领域的推荐测量方法达成一致。
伦理与传播
普利茅斯大学研究伦理委员会已为定性访谈研究(ID5116)、电子德尔菲研究和共识会议(ID5636)提供伦理批准。研究结果将在同行评审期刊上以开放获取的方式发表,并在相关的国内和国际会议上展示。
研究注册
COMET注册编号:2590(https://www.comet-initiative.org/Studies/Details/2590);PROSPERO注册号:CRD42024562735。
相似文献
Health Technol Assess. 2001
本文引用的文献
Dev Med Child Neurol. 2024-7
Dev Med Child Neurol. 2022-12
BMJ Open Respir Res. 2021-10