先天性膈疝的临床试验和结局报告忽视了长期健康和功能结局——呼吁核心结局。
Clinical trials and outcome reporting in congenital diaphragmatic hernia overlook long-term health and functional outcomes-A plea for core outcomes.
机构信息
Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, UK.
Department of Paediatric Respiratory Medicine, Alder Hey Children's Hospital NHS Foundation Trust, Liverpool, UK.
出版信息
Acta Paediatr. 2022 Aug;111(8):1481-1489. doi: 10.1111/apa.16409. Epub 2022 Jun 14.
AIM
To review the selection, measurement and reporting of outcomes in studies of interventions in Congenital Diaphragmatic Hernia (CDH).
METHODS
We searched the Cochrane Central Register of Controlled Trials from 2000-2020 for randomised trials and observational studies. Outcomes reported were classified into seven key domains modelled on the patient journey.
RESULTS
Our search yielded 118 papers; 27 were eligible. The most frequent domains measured were 'short-term markers of disease activity' (17/27), whereas long-term outcomes (3/27) and outcomes relating to functional health status (8/27) were reported infrequently. There was heterogeneity in the methods and timing of outcome reporting. Primary outcomes were varied and not always clearly stated.
CONCLUSION
Long-term health and functional outcomes involving interventional studies in CDH are infrequently reported, which hinders the process of shared decision-making and evidence-based healthcare. A CDH core outcome set is needed to standardise outcome reporting that is relevant to both families and healthcare teams.
目的
综述先天性膈疝（CDH）干预研究中结局的选择、测量和报告。
方法
我们从 2000 年至 2020 年检索了 Cochrane 对照试验中心注册库中的随机试验和观察性研究。报告的结局被分类为七个关键领域，这些领域是基于患者的就诊过程建模的。
结果
我们的搜索结果为 118 篇论文；其中 27 篇符合条件。测量最多的领域是“疾病活动的短期标志物”（17/27），而很少报告长期结局（3/27）和与功能健康状况相关的结局（8/27）。结局报告的方法和时间存在异质性。主要结局各不相同，且并不总是明确说明。
结论
涉及 CDH 干预研究的长期健康和功能结局很少被报告，这阻碍了共同决策和循证医疗保健的进程。需要制定一个 CDH 核心结局集，以标准化对家庭和医疗团队都相关的结局报告。
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