Li Ying Xin, Li Yuan, Li Xia, Peng Han Mei, Guo Xue Mei, Chen Qiong, Li Xiao Wen, Hu Yan Ling, Wan Xing Li
Department of Neonatology Nursing, West China Second University Hospital, Sichuan University, Chengdu, Sichuan, China.
Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education, Chengdu, Sichuan, China.
BMJ Open. 2025 Jan 7;15(1):e089476. doi: 10.1136/bmjopen-2024-089476.
BACKGROUND: Kangaroo mother care (KMC) is a care of preterm and low birthweight infants carried skin-to-skin contact with the mother's chest and breastfeeding when possible. KMC has been proven to reduce mortality and morbidity in these infants. However, research on KMC has been limited by significant variability and inconsistency in reported outcomes across studies. These discrepancies hinder the inclusion of KMC clinical research in systematic reviews or meta-analyses, reducing its research value, leading to resource wastage and raising concerns about selective reporting biases. A core outcome set (COS), which defines a list of critical outcomes, can help harmonise the outcomes reported across studies in the same healthcare field. Further, how these outcomes should be measured and/or reported is defined in a core measurement set (CMS). This study aims to develop both a COS and a CMS for KMC to standardise outcome reporting, improve the quality assessments in clinical trials and facilitate data integration. This protocol outlines the methodology for developing a COS and CMS for KMC. METHODS AND ANALYSIS: The development of the COS and CMS for KMC will follow six phases: (1) a systematic review, (2) semistructured interviews, (3) merging outcomes, (4) two/three rounds of international Delphi survey, (5) a consensus meeting and (6) development of the CMS. In phases 1 and 2, we will conduct a systematic review and semistructured interviews to identify potential core outcomes and measurements, which will form an initial outcome pool. In phase 3, these outcomes will be categorised into domains based on the core outcome measures for effectiveness (COMET) classification, creating a long list of outcomes for the Delphi survey. In phase 4, the Delphi survey will involve two/three rounds with key stakeholders, including neonatal clinical experts (including doctors and nurses), users of COS (including editors, public health experts, experts in evidence-based medicine and researchers), parents of neonates and policymakers, to refine the candidate core outcomes and measurements. In phase 5, an online consensus meeting with representatives of all stakeholders will finalise the COS. In phase 6, the CMS will be following Consensus-based Standards for the selection of health Measurement Instruments guidelines, which involve conceptual considerations, finding existing outcome measurement instruments, assessing their quality and selecting appropriate instruments for the COS. Parents of neonates will participate in phases 2, 4 and 5. ETHICS AND DISSEMINATION: Ethical approval of this study has been granted by the Medical Ethics Committee of West China Second University Hospital (Medical Research 2024 ethics approval no. 167). The finalised COS and CMS will be disseminated through publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: We have registered the COS in the COMET database (http://www.comet-initiative.org/Studies/Details/2940).
背景:袋鼠式护理(KMC)是一种对早产儿和低体重儿的护理方式,即让婴儿与母亲胸部进行皮肤接触,并尽可能进行母乳喂养。KMC已被证明可降低这些婴儿的死亡率和发病率。然而,关于KMC的研究受到各研究报告结果显著差异和不一致性的限制。这些差异阻碍了KMC临床研究纳入系统评价或荟萃分析,降低了其研究价值,导致资源浪费,并引发了对选择性报告偏倚的担忧。核心结局集(COS)定义了一系列关键结局,有助于统一同一医疗领域各研究报告的结局。此外,核心测量集(CMS)定义了这些结局应如何测量和/或报告。本研究旨在为KMC制定COS和CMS,以规范结局报告,改善临床试验中的质量评估,并促进数据整合。本方案概述了为KMC制定COS和CMS的方法。 方法与分析:为KMC制定COS和CMS将遵循六个阶段:(1)系统评价,(2)半结构化访谈,(3)合并结局,(4)两轮/三轮国际德尔菲调查,(5)共识会议,(6)制定CMS。在第1和第2阶段,我们将进行系统评价和半结构化访谈,以确定潜在的核心结局和测量指标,形成初始结局池。在第3阶段,这些结局将根据有效性核心结局指标(COMET)分类法归入不同领域,为德尔菲调查创建一长列结局清单。在第4阶段,德尔菲调查将包括与关键利益相关者进行两轮/三轮调查,这些利益相关者包括新生儿临床专家(包括医生和护士)、COS使用者(包括编辑、公共卫生专家、循证医学专家和研究人员)、新生儿父母和政策制定者,以完善候选核心结局和测量指标。在第5阶段,与所有利益相关者代表举行的在线共识会议将确定COS。在第6阶段,CMS将遵循基于共识的健康测量工具选择标准指南,其中包括概念性考量、查找现有的结局测量工具、评估其质量以及为COS选择合适的工具。新生儿父母将参与第2、4和5阶段。 伦理与传播:本研究已获得四川大学华西第二医院医学伦理委员会的伦理批准(医学研究2024伦理批准号167)。最终确定的COS和CMS将通过在同行评审期刊上发表进行传播。 试验注册号:我们已在COMET数据库(http://www.comet-initiative.org/Studies/Details/2940)中注册了COS。
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