Development of a Core Outcome Set and Minimum Reporting Set for intervention studies in growth restriction in the NEwbOrN (COSNEON): study protocol for a Delphi study.

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Show simple item record Knol, Martine en Wang, Helena en Bloomfield, Francis en Piet, Tabitha en Damhuis, Stefanie en Khalil, Asma en Ganzevoort, Wessel en Gordijn, Sanne en 2020-01-10T03:09:55Z en 2019-08-17 en
dc.identifier.citation Trials 20(1):511 17 Aug 2019 en
dc.identifier.issn 1745-6215 en
dc.identifier.uri en
dc.description.abstract BACKGROUND:Growth restriction in the newborn (GRN) can predispose to severe complications including hypoglycemia, sepsis, and necrotizing enterocolitis. Different interventions and treatments, such as feeding strategies, for GRN have specific benefits and risks. Comparing results from studies investigating intervention studies in GRN is challenging due to the use of different baseline and study characteristics and differences in reported study outcomes. In order to be able to compare study results and to allow pooling of data, uniform reporting of study characteristics (minimum reporting set [MRS]) and outcomes (core outcome set [COS]) are needed. We aim to develop both an MRS and a COS for interventional and treatment studies in GRN. METHODS/DESIGN:The MRS and COS will be developed according to Delphi methodology. First, a scoping literature search will be performed to identify study characteristics and outcomes in research focused on interventions/treatments in the GRN. An international group of stakeholders, including experts (clinicians working with GRN, and researchers who focus on GRN) and lay experts ([future] parents of babies with GRN), will be questioned to rate the importance of the study characteristics and outcomes in three rounds. After three rounds there will be two consensus meetings: a face-to-face meeting and an electronic meeting. During the consensus meetings multiple representatives of stakeholder groups will reach agreement upon which study characteristics and outcomes will be included into the COS and MRS. The second electronic consensus meeting will be used to test if an electronic meeting is as effective as a face-to-face meeting. DISCUSSION:In our opinion a COS alone is not sufficient to compare and aggregate trial data. Hence, to ensure optimum comparison we also will develop an MRS. Interventions in GRN infants are often complicated by coexisting preterm birth. A COS already has been developed for preterm birth. The majority of GRN infants are born at term, however, and we therefore chose to develop a separate COS for interventions in GRN, which can be combined (with expected overlap) in intervention studies enrolling preterm GRN babies. TRIAL REGISTRATION:Not applicable. This study is registered in the Core Outcome Measures for Effectiveness ( COMET ) database. Registered on 30 June 2017. en
dc.format.medium Electronic en
dc.language eng en
dc.relation.ispartofseries Trials en
dc.rights Items in ResearchSpace are protected by copyright, with all rights reserved, unless otherwise indicated. Previously published items are made available in accordance with the copyright policy of the publisher. en
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dc.rights.uri en
dc.rights.uri en
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dc.subject Humans en
dc.subject Fetal Growth Retardation en
dc.subject Growth Disorders en
dc.subject Consensus en
dc.subject Research Design en
dc.subject Delphi Technique en
dc.subject Infant, Newborn en
dc.subject Outcome Assessment, Health Care en
dc.title Development of a Core Outcome Set and Minimum Reporting Set for intervention studies in growth restriction in the NEwbOrN (COSNEON): study protocol for a Delphi study. en
dc.type Journal Article en
dc.identifier.doi 10.1186/s13063-019-3588-9 en
pubs.issue 1 en
pubs.begin-page 511 en
pubs.volume 20 en
dc.rights.holder Copyright: The authors en
pubs.publication-status Published en
dc.rights.accessrights en
pubs.subtype Clinical Trial Protocol en
pubs.subtype research-article en
pubs.subtype Journal Article en
pubs.elements-id 779300 en Liggins Institute en LiFePATH en
dc.identifier.eissn 1745-6215 en
pubs.record-created-at-source-date 2019-08-18 en
pubs.dimensions-id 31420053 en

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