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Research: Clinical Trials And Outcome Reporting In Congenital Diaphragmatic Hernia Overlook Long-Term Health and Functional Outcomes – A Plea For Core Outcomes

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Research: Clinical Trials And Outcome Reporting In Congenital Diaphragmatic Hernia Overlook Long-Term Health and Functional Outcomes – A Plea For Core Outcomes

Acta Paediatr

. 2022 May 14. doi: 10.1111/apa.16409. Online ahead of print. https://pubmed.ncbi.nlm.nih.gov/35567507/

Clinical Trials And Outcome Reporting In Congenital Diaphragmatic Hernia Overlook Long-Term Health and Functional Outcomes – A Plea For Core Outcomes

Leonie Lewis 1Ian Sinha 2Paul D Losty 1Affiliations expand

Abstract

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 health care. A CDH core outcome set is needed to standardise outcome reporting that is relevant to both families and healthcare teams.

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