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Error disclosure in neonatal intensive care: a multicentre, prospective, observational study
  1. Loïc Passini1,
  2. Stephane Le Bouedec2,
  3. Gilles Dassieu1,
  4. Audrey Reynaud3,
  5. Camille Jung4,
  6. Marie-Laurence Keller1,
  7. Aline Lefebvre5,6,7,
  8. Therese Katty8,
  9. Jean-Marc Baleyte7,9,
  10. Richard Layese10,11,
  11. Etienne Audureau10,11,
  12. Laurence Caeymaex1,4,9
  13. SEPREVEN Study Group
    1. 1 Neonatal Intensive care Unit, Centre Hospitalier Intercommunal de Créteil, Créteil, France
    2. 2 Neonatal Intensive Care Unit, CHU Angers, Angers, France
    3. 3 Association SOS Préma, Neuilly sur Seine, France
    4. 4 Clinical Research Center, Centre Hospitalier Intercommunal de Creteil, Creteil, France
    5. 5 Department of Child and Adolescent Psychiatry, APHP, Paris, France
    6. 6 Human Genetics and Cognitive Functions, Institut Pasteur, UMR 3571 CNRS, University Paris Diderot, Paris, France
    7. 7 Child and Adolescent Psychiatry Creteil, Centre Hospitalier Intercommunal de Creteil, Creteil, France
    8. 8 Health Law Manager, Centre Hospitalier Intercommunal de Creteil, Creteil, France
    9. 9 Faculty of Health, University Paris Est Creteil, Creteil, France
    10. 10 INSERM IMRB, CEpiA Team, University Paris Est Creteil, Creteil, France, Créteil, France
    11. 11 Unité de Recherche Clinique (URC), Hôpital Henri Mondor, Assistance Publique - Hôpitaux de Paris APHP, Créteil, France
    1. Correspondence to Dr Laurence Caeymaex, Centre Hospitalier Intercommunal de Créteil, Créteil, France; Laurence.Caeymaex{at}


    Importance Surveys based on hypothetical situations suggest that health-care providers agree that disclosure of errors and adverse events to patients and families is a professional obligation but do not always disclose them. Disclosure rates and reasons for the choice have not previously been studied.

    Objective To measure the proportion of errors disclosed by neonatal intensive care unit (NICU) professionals to parents and identify motives for and barriers to disclosure.

    Design Prospective, observational study nested in a randomised controlled trial (Study on Preventing Adverse Events in Neonates (SEPREVEN); Event disclosure was not intended to be related to the intervention tested.

    Setting 10 NICUs in France with a 20-month follow-up, starting November 2015.

    Participants n=1019 patients with NICU stay ≥2 days with ≥1 error.

    Exposure Characteristics of errors (type, severity, timing of discovery), patients and professionals, self-reported motives for disclosure and non-disclosure.

    Main outcome and measures Rate of error disclosure reported anonymously and voluntarily by physicians and nurses; perceived parental reaction to disclosure.

    Results Among 1822 errors concerning 1019 patients (mean gestational age: 30.8±4.5 weeks), 752 (41.3%) were disclosed. Independent risk factors for non-disclosure were nighttime discovery of error (OR 2.40; 95% CI 1.75 to 3.30), milder consequence (for moderate consequence: OR 1.85; 95% CI 0.89 to 3.86; no consequence: OR 6.49; 95% CI 2.99 to 14.11), a shorter interval between admission and error, error type and fewer beds. The most frequent reported reasons for non-disclosure were parental absence at its discovery and a perceived lack of serious consequence.

    Conclusion and relevance In the particular context of the SEPREVEN randomised controlled trial of NICUs, staff did not disclose the majority of errors to parents, especially in the absence of moderate consequence for the infant.

    Trial registration number NCT02598609.

    • attitudes
    • communication
    • medical error, measurement/epidemiology
    • patient safety
    • paediatrics

    Data availability statement

    No data are available. Data collected for the study are legally unavailable.

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    Data availability statement

    No data are available. Data collected for the study are legally unavailable.

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    • Collaborators SEPREVEN Study Group: Dominique Astruc, Valérie Biran, Leila Marcus, Laurent Beghin, Bernard Guillois, Radia Remichi, Faiza Harbi, Xavier Durrmeyer, Florence Casagrande, Nolwenn Lesaché, Darina Todorova, Ali Bilal, Damien Olivier, Audrey Reynaud, Cécile Jacquin, Jean-Christophe Roze, Claude Danan, Fabrice Decobert.

    • Contributors The Study on Preventing Adverse Events in Neonates (SEPREVEN) Study Group is working on preventing adverse events in neonates. LC acts as guarantor for this study.

    • Funding This study was funded by Solidarity and Health Ministry, France (grant number: 13-0401).

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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