4.1 Article

Managing incidental findings and disclosure of results in a paediatric research cohort - the LIFE Child Study cohort

Journal

JOURNAL OF PEDIATRIC ENDOCRINOLOGY & METABOLISM
Volume 28, Issue 1-2, Pages 75-82

Publisher

WALTER DE GRUYTER GMBH
DOI: 10.1515/jpem-2014-0079

Keywords

children; ethics; incidental findings (IFs); population-based cohort studies

Funding

  1. LIFE - Leipzig Research Centre for Civilization Diseases, University of Leipzig
  2. European Union
  3. European Regional Development Fund
  4. Free State of Saxony
  5. German Research Foundation

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Objective: To assess the frequency of incidental findings (IFs) in the population-based Leipzig Research Centre for Civilization Diseases (LIFE) Child Study within 1 year. Methods: From July 2011 to June 2012, 969 children participated in the study. The IFs were analysed with respect to age, gender, type of examination and clinical action taken. Results: The IFs were detected in 63 participants (6.5%), including five children who presented with two IFs simultaneously. Eleven children received a new, hence previously unknown, clinical diagnosis. Alternatively, 18 IFs could not be confirmed or were of a transient and self-limiting condition. The frequency of IFs varied widely depending on the type of examination, but did not differ by gender. Conclusion: Although IFs were common events, there was no finding with a profound clinical impact on the subject's life. Our current IF management protocol may be useful in creating management plans for other cohort studies.

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