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CADDIE2—evaluation of a clinical decision-support system for early detection of systemic inflammatory response syndrome in paediatric intensive care: study protocol for a diagnostic study
  1. Antje Wulff1,
  2. Sara Montag2,
  3. Bianca Steiner3,
  4. Michael Marschollek1,
  5. Philipp Beerbaum2,
  6. André Karch4,
  7. Thomas Jack2
  1. 1 Peter L. Reichertz Institute for Medical Informatics, TU Braunschweig and Hannover Medical School, Hannover, Germany
  2. 2 Department of Pediatric Cardiology and Intensive Care Medicine, Hannover Medical School, Hannover, Germany
  3. 3 Peter L. Reichertz Institute for Medical Informatics, TU Braunschweig and Hannover Medical School, Braunschweig, Germany
  4. 4 Institute of Epidemiology and Social Medicine, University of Muenster, Muenster, Germany
  1. Correspondence to Antje Wulff; antje.wulff{at}plri.de

Abstract

Introduction Systemic inflammatory response syndrome (SIRS) is one of the most critical indicators determining the clinical outcome of paediatric intensive care patients. Clinical decision support systems (CDSS) can be designed to support clinicians in detection and treatment. However, the use of such systems is highly discussed as they are often associated with accuracy problems and ‘alert fatigue’. We designed a CDSS for detection of paediatric SIRS and hypothesise that a high diagnostic accuracy together with an adequate alerting will accelerate the use. Our study will (1) determine the diagnostic accuracy of the CDSS compared with gold standard decisions created by two blinded, experienced paediatricians, and (2) compare the system’s diagnostic accuracy with that of routine clinical care decisions compared with the same gold standard.

Methods and analysis CADDIE2 is a prospective diagnostic accuracy study taking place at the Department of Pediatric Cardiology and Intensive Care Medicine at the Hannover Medical School; it represents the second step towards our vision of cross-institutional and data-driven decision-support for intensive care environments (CADDIE). The study comprises (1) recruitment of up to 300 patients (start date 1 August 2018), (2) creation of gold standard decisions (start date 1 May 2019), (3) routine SIRS assessments by physicians (starts with recruitment), (4) SIRS assessments by a CDSS (start date 1 May 2019), and (5) statistical analysis with a modified approach for determining sensitivity and specificity and comparing the accuracy results of the different diagnostic approaches (planned start date 1 July 2019).

Ethics and dissemination Ethics approval was obtained at the study centre (Ethics Committee of Hannover Medical School). Results of the main study will be communicated via publication in a peer-reviewed journal.

Trial registration number ClinicalTrials.gov NCT03661450; Pre-results.

  • clinical decision support systems
  • clinical trial
  • systemic inflammatory response syndrome

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Footnotes

  • Contributors AW was responsible for design and implementation of the presented clinical decision-support system and the outline of the study protocol, and has drafted the manuscript. TJ provided clinical expertise for the use case and the design of the underlying knowledge model, leaded the proof-of-concept study and co-drafted the manuscript. AK was primarily responsible for the design of the statistical analysis, the sample size calculation and the authoring of the corresponding sections. BS and SM helped in the conception of the general study approach but especially for definition of goals and outcome measures, timing and patient recruitment; SM is responsible for patient recruitment and monitors the study at the ward. PB and MM provided clinical expertise for study design, revised the manuscript critically, and gave subject-specific advices as well as the final approval of the manuscript version to be published. All authors read and approved the final manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Ethics approval Ethics approval was given by the Ethics Committee of Hannover Medical School (approval number 7804_BO_S_2018).

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

  • Patient consent for publication Not required.

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