文献检索文档翻译深度研究
Suppr Zotero 插件Zotero 插件
邀请有礼套餐&价格历史记录

新学期,新优惠

限时优惠:9月1日-9月22日

30天高级会员仅需29元

1天体验卡首发特惠仅需5.99元

了解详情
不再提醒
插件&应用
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
高级版
套餐订阅购买积分包
AI 工具
文献检索文档翻译深度研究
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2025

袋鼠式护理核心结局集和核心测量集的制定:一项研究方案

Development of a core outcome set and core measurement set for kangaroo mother care: a study protocol.

作者信息

Li Ying Xin, Li Yuan, Li Xia, Peng Han Mei, Guo Xue Mei, Chen Qiong, Li Xiao Wen, Hu Yan Ling, Wan Xing Li

机构信息

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.

出版信息

BMJ Open. 2025 Jan 7;15(1):e089476. doi: 10.1136/bmjopen-2024-089476.


DOI:10.1136/bmjopen-2024-089476
PMID:39773785
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11749680/
Abstract

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).

摘要

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。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3c7/11749680/18b350167e0a/bmjopen-15-1-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3c7/11749680/18b350167e0a/bmjopen-15-1-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b3c7/11749680/18b350167e0a/bmjopen-15-1-g001.jpg

相似文献

[1]
Development of a core outcome set and core measurement set for kangaroo mother care: a study protocol.

BMJ Open. 2025-1-7

[2]
The future of Cochrane Neonatal.

Early Hum Dev. 2020-11

[3]
Development of an international core outcome set for treatment trials in necrotizing enterocolitis-a study protocol.

Trials. 2023-5-31

[4]
Developing a core outcome set on traditional Chinese medicine (COS-TCM) for chronic heart failure (CHF): a study protocol.

BMJ Open. 2021-7-2

[5]
Folic acid supplementation and malaria susceptibility and severity among people taking antifolate antimalarial drugs in endemic areas.

Cochrane Database Syst Rev. 2022-2-1

[6]
What should be measured and reported in clinical trials for the treatment of patients with acute pancreatitis? A study protocol for establishing a core outcome set.

BMJ Open. 2023-12-9

[7]
Developing a core outcome set for the treatment of pregnant women with pregestational diabetes-a study protocol.

Trials. 2020-12-11

[8]
Development of a core outcome set and outcome measurement set for physiotherapy trials in adults with Bronchiectasis (COS-PHyBE study): A protocol.

PLoS One. 2022

[9]
Core Outcome Set Development for Tension-Type Headache Treatment Using Traditional Chinese Medicine: Protocol for a Delphi Consensus Study.

JMIR Res Protoc. 2025-2-5

[10]
International development and implementation of a core measurement set for research and audit studies in implant-based breast reconstruction: a study protocol.

BMJ Open. 2020-1-20

本文引用的文献

[1]
A minimum data set-Core outcome set, core data elements, and core measurement set-For degenerative cervical myelopathy research (AO Spine RECODE DCM): A consensus study.

PLoS Med. 2024-8

[2]
National, regional, and global estimates of preterm birth in 2020, with trends from 2010: a systematic analysis.

Lancet. 2023-10-7

[3]
Clinical practice guideline for kangaroo mother care in preterm and low birth weight infants.

J Evid Based Med. 2022-12

[4]
Global, regional, and national causes of under-5 mortality in 2000-19: an updated systematic analysis with implications for the Sustainable Development Goals.

Lancet Child Adolesc Health. 2022-2

[5]
Developing a core outcome set on traditional Chinese medicine (COS-TCM) for chronic heart failure (CHF): a study protocol.

BMJ Open. 2021-7-2

[6]
Immediate "Kangaroo Mother Care" and Survival of Infants with Low Birth Weight.

N Engl J Med. 2021-5-27

[7]
Systematic review and meta-analysis suggest that the duration of Kangaroo mother care has a direct impact on neonatal growth.

Acta Paediatr. 2021-1

[8]
A Modified Nominal Group Technique (mNGT) - Finding Priorities in Research.

Am J Health Behav. 2020-5-1

[9]
Major causes of death in preterm infants in selected hospitals in Ethiopia (SIP): a prospective, cross-sectional, observational study.

Lancet Glob Health. 2019-8

[10]
Worldwide prevalence of mother-infant skin-to-skin contact after vaginal birth: A systematic review.

PLoS One. 2018-10-31

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

推荐工具

医学文档翻译智能文献检索