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Review
. 2022 Aug;111(8):1481-1489.
doi: 10.1111/apa.16409. Epub 2022 Jun 14.

Clinical trials and outcome reporting in congenital diaphragmatic hernia overlook long-term health and functional outcomes-A plea for core outcomes

Leonie Lewis  1 , Ian Sinha  2 , Paul D Losty  1
Affiliations
Review

Clinical trials and outcome reporting in congenital diaphragmatic hernia overlook long-term health and functional outcomes-A plea for core outcomes

Leonie Lewis et al. Acta Paediatr. 2022 Aug.

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

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Conflict of interest statement

The authors have no competing interests to declare.

Figures

FIGURE 1
FIGURE 1
Seven key domains modelled on the patient journey
FIGURE 2
FIGURE 2
PRISMA flowchart
FIGURE 3
FIGURE 3
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