COHESION: core outcomes in neonatal encephalopathy (protocol).
COHESION: core outcomes in neonatal encephalopathy (protocol).
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DOI：
10.1186/s13063-021-05030-0
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发表时间：
2021-02-08
期刊：
影响因子：
2.5
通讯作者：
Devane D
中科院分区：
文献类型：
--
作者：
Quirke FA;Healy P;Bhraonáin EN;Daly M;Biesty L;Hurley T;Walker K;Meher S;Haas DM;Bloomfield FH;Kirkham JJ;Molloy EJ;Devane D
新生儿脑病是一种复杂的婴儿综合征，主要影响大脑和其他器官。主要原因是到达大脑的血液中缺乏氧气。新生儿脑病可导致死亡或生命后期并发症，包括癫痫发作、运动障碍和脑瘫。新生儿脑病的治疗选择主要限于治疗性低温，尽管其他潜在的治疗方法正在出现。然而，由于试验之间测量和报告的结果存在异质性和不一致性，因此对治疗效果的评估具有挑战性。在本文中，我们详细介绍了我们将如何制定一个核心结果集，以标准化新生儿脑病治疗干预措施的测量和报告结果。我们将系统地回顾文献，以确定之前在随机试验和随机试验的系统评价中报道的结果。我们将确定对诊断患有新生儿脑病并接受过新生儿脑病治疗的婴儿的父母或照顾者重要的结果。为此，我们将与高收入国家和中低收入国家的父母或照顾者进行面对面或视频电话会议访谈。具有新生儿脑病专业知识的利益相关者（父母/照顾者、医疗保健提供者和研究人员）将使用三轮德尔菲调查或随机分配利益相关者的“实时”德尔菲调查，对在线德尔菲调查中确定的结果的重要性进行评级。协商一致会议将通过视频会议的方式举行，以便由利益攸关方代表组成的国际小组讨论和表决将纳入最终核心成果集（COS）的成果。新生儿脑病的治疗需要更多的研究。对新生儿脑病治疗干预措施有效性评估中测量和报告的结果进行标准化，将改善证据综合，并改善该领域系统评价和荟萃分析中报告的结果。总的来说，这种COS将允许改进治疗方法，减少研究中的异质性，并加强整体患者护理。本研究已在核心疗效指标（COMET）数据库http://www.comet-initiative.org/Studies/Details/1270中注册。
Neonatal encephalopathy is a complex syndrome in infants that predominantly affects the brain and other organs. The leading cause is a lack of oxygen in the blood reaching the brain. Neonatal encephalopathy can result in mortality or complications later in life, including seizures, movement disorders and cerebral palsy. Treatment options for neonatal encephalopathy are limited mainly to therapeutic hypothermia, although other potential treatments are emerging. However, evaluations of the effectiveness of treatments are challenging because of heterogeneity and inconsistency in outcomes measured and reported between trials. In this paper, we detail how we will develop a core outcome set to standardise outcomes measured and reported upon for interventions for the treatment of neonatal encephalopathy. We will systematically review the literature to identify outcomes reported previously in randomised trials and systematic reviews of randomised trials. We will identify outcomes important to parents or caregivers of infants diagnosed with and who have received treatment for neonatal encephalopathy. We will do this by conducting in person or by video teleconferencing interviews with parents or caregivers in high-income and low- to middle-income countries. Stakeholders with expertise in neonatal encephalopathy (parents/caregivers, healthcare providers and researchers) will rate the importance of identified outcomes in an online Delphi survey using either a three-round Delphi survey or a “Real-Time” Delphi survey to which stakeholders will be allocated at random. Consensus meetings will take place by video conference to allow for an international group of stakeholder representatives to discuss and vote on the outcomes to include in the final core outcome set (COS). More research is needed on treatments for neonatal encephalopathy. Standardising outcomes measured and reported in evaluations of the effectiveness of interventions for the treatment of neonatal encephalopathy will improve evidence synthesis and improve results reported in systematic reviews and meta-analysis in this area. Overall, this COS will allow for improved treatments to be identified, heterogeneity in research to be reduced, and overall patient care to be enhanced. This study is registered in the Core Outcome Measures for Effectiveness (COMET) database http://www.comet-initiative.org/Studies/Details/1270.
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影响因子：
2.5
作者：
Biggane AM;Brading L;Ravaud P;Young B;Williamson PR
通讯作者：
Williamson PR
DOI：
10.1111/j.1744-6155.2009.00212.x
发表时间：
2009-10-01
影响因子：
1.3
作者：
Magilvy, Joan K.;Thomas, Eileen
通讯作者：
Thomas, Eileen
影响因子：
15.8
作者：
Kirkham JJ;Davis K;Altman DG;Blazeby JM;Clarke M;Tunis S;Williamson PR
通讯作者：
Williamson PR
影响因子：
--
作者：
El Farargy, M S;Soliman, N A
通讯作者：
Soliman, N A
影响因子：
4.5
作者：
MacLennan, Steven;Williamson, Paula R.;Lam, Thomas
通讯作者：
Lam, Thomas