CORE-Kids：儿童骨折结局综合研究计划制定核心结局集的方案。
CORE-Kids: a protocol for the development of a core outcome set for childhood fractures.
机构信息
Trauma Outcomes Group, University of Nottingham, Nottingham, UK
School of Health Sciences, University of Nottingham, Nottingham, UK.
出版信息
BMJ Open. 2020 Feb 28;10(2):e036224. doi: 10.1136/bmjopen-2019-036224.
INTRODUCTION
Limb fractures in children are common yet there are few trials that compare treatments for these injuries. There is significant heterogeneity in the outcomes reported in the paediatric orthopaedic literature, which limits the ability to compare study results and draw firm conclusions. The aim of the CORE-Kids Study is to develop a core outcome set for use in research studies of childhood limb fractures. A core outcome set will provide a minimum set of outcomes to be measured in all trials to minimise the heterogeneity of outcomes reported and minimise reporting bias. A core outcome set ensures that outcomes are reported that are relevant to families as well as clinicians. The core outcome set will include additional upper and lower limb modules.
METHODS
The development of the core outcome set will require four phases to evaluate:What are the outcomes that are relevant to professionals?What are the outcomes that are relevant to families?What are the most important of these outcomes?Which outcomes should be included in the core outcome set?This will be completed through a systematic review of trials to identify the outcomes domains that are relevant to trialists. A series of semi-structured interviews will be completed with families to identify the outcome domains that are relevant to families. These outcome domains will be used in a three-round Delphi Study to analyse the importance of these outcome domains to a range of stakeholders including parents, clinicians and researchers. Following this, the core outcome set will be decided at a consensus meeting.
ETHICS AND DISSEMINATION
Ethical approval has been awarded HRA/REC IRAS number 262503. Date of approval 06/08/2019. Dissemination will be through scientific literature and international societies.
TRIAL REGISTRATION
Core Outcome Measures in Effectiveness Trials Initiative, registration number: 1274. Date of registration 13/12/2018.
PROSPERO REGISTRATION NUMBER
CRD42018106605.
简介
儿童肢体骨折较为常见，但针对此类损伤的治疗方法鲜有研究进行对比。儿科骨科文献报道的结果存在较大异质性，这限制了研究结果的比较和得出明确结论的能力。CORE-Kids 研究旨在制定一个儿童肢体骨折研究中使用的核心结局集。核心结局集将提供一个最小的结局集，以便在所有试验中进行测量，从而最大限度地减少报告结局的异质性和报告偏倚。核心结局集确保报告的结局与家庭以及临床医生都相关。该核心结局集将包括额外的上下肢模块。
方法
核心结局集的制定需要经过四个阶段进行评估：
与专业人员相关的结局有哪些？
与家庭相关的结局有哪些？
这些结局中最重要的是哪些？
哪些结局应纳入核心结局集？
这将通过系统综述试验来完成，以确定与试验人员相关的结局领域。将与家庭进行一系列半结构化访谈，以确定与家庭相关的结局领域。这些结局领域将在三轮 Delphi 研究中使用，以分析这些结局领域对包括父母、临床医生和研究人员在内的一系列利益相关者的重要性。在此之后，将在共识会议上决定核心结局集。
伦理与传播
已获得 HRA/REC IRAS 编号 262503 的伦理批准。批准日期为 2019 年 8 月 6 日。传播将通过科学文献和国际学会进行。
试验注册
有效性试验核心结局测量倡议，注册号：1274。注册日期为 2018 年 12 月 13 日。
PROSPERO 注册号：CRD42018106605。
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