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

  • Mirja Quante , Sarah Bruckmann , Tillman Wallborn , Nadine Wolf , Elena Sergeyev , Melanie Adler , Mara Hesse , Mandy Geserick , Stephanie Naumann , Christiane Koch , Harini Nivarthi , Christoph Engel , Antje Körner , Wieland Kiess and Andreas Hiemisch EMAIL logo

Abstract

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.


Corresponding author: Andreas Hiemisch, LIFE Leipzig Research Centre for Civilization Diseases, University of Leipzig, Phillip-Rosenthal-Str. 27, 04103 Leipzig, Germany, Phone: +49-341-97-26000, Fax: +49-341-97-26009, E-mail:

Acknowledgments

This publication is supported by LIFE – Leipzig Research Centre for Civilization Diseases, University of Leipzig. LIFE is funded by the European Union, by the European Regional Development Fund and by the Free State of Saxony within the framework of the excellence initiative. The German Research Foundation supports parts of this project (dental examination). Additional funding is being obtained.

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Received: 2014-2-14
Accepted: 2014-2-18
Published Online: 2014-4-1
Published in Print: 2015-1-1

©2015 by De Gruyter

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