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Development of a gastroschisis core outcome set
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  • Published on:
    Response to comments from Dr Mark W Davies and Drs Golumbek and Guidici
    • Benjamin Allin, Dr National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford OX37LF, UK

    Response to comment from Dr Mark W Davies:

    We agree that neurodevelopmental outcome may be an important outcome to measure following any neonatal surgery and would certainly welcome any study that reported this outcome in infants with gastroschisis. However following a rigorous consensus process as we have described, neurodevelopmental outcome was not selected as part of the core outcome set. We emphasise that the outcomes within the core outcome set are not the only outcomes that should be measured in future research but are the minimum recommended. Additional outcomes such as neurodevelopmental outcomes may of course be reported.

    Response to comment from Drs Golumbek and Guidici

    Drs Golumbek and Guidici are quite correct that characteristics of infants with gastroschisis, such as complexity of the condition at birth, may affect their prognosis. We are quite clear that this core outcome set should be used for observational studies which follow-up a cohort of infants based on these characteristics, as well as trials or observational studies which follow-up infants who have been managed using different surgical approaches. We agree that some of these outcomes are not specific to gastroschisis, but our aim was not to produce a core outcome set that had only gastroschisis specific outcomes within it, but one that contained the most important outcomes for infants with gastroschisis – some of which may apply equally to other infants. Growth at birth is not...

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    Conflict of Interest:
    None declared.
  • Published on:
    To the editor
    • Sergio Golombek, Neonatologist M.Fareri Children's hospital at Westchester Medical Center/New York Medical College
    • Other Contributors:
      • Lidia Giudici, Pediatrician - Neonatologist

    Dear Nick Brown
    Editor in chief, Arch Dis Child Fetal Neonatal

    We read with interest the study titled “Development of a gastroschisis core outcome set” by Benjamin Saul Raywood Allin et al1, and we have several questions and comments.
    The aim of the authors is to design a core outcome set to be used in research in order to reduce outcome reporting heterogeneity and to help improve the clinical relevance of the research. The authors state that “Many gastroschisis studies investigate outcomes that are not relevant to patients or clinical practice”. However, they don´t clarify how they arrived to this hypothesis.
    This study has developed a gastroschisis core outcome set consisting of eight outcomes that are important to parents, people born with gastroschisis and clinicians.
    The eight outcomes are death, sepsis, growth, number of operations, time on parenteral nutrition, liver disease, number of severe gastrointestinal complications and quality of life. Regarding growth, it should be noticed that children born with gastroschisis are frequently intrauterine growth restricted, and therefore, this issue should be clarified - it is not always an outcome; gastrointestinal complications are also (up to 25% of gastroschisis population in some reports) a frequent component of the malformation itself, so this should be clarified when speaking of “complications”.
    In high income countries, adverse outcomes are related to the presence of complex gast...

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    Conflict of Interest:
    None declared.
  • Published on:
    Development of a gastroschisis core outcome set: missed opportunity .
    • Mark W Davies, Neonatologist Grantley Stable Neonatal Unit, Royal Brisbane & Women’s Hospital, Brisbane, Australia

    Any surgery as a neonate carries increased risk of adverse neurodevelopmental outcomes and any neonatal study should include them. They are different from overall quality of life.

    Conflict of Interest:
    None declared.