Validation study of German inpatient administrative health data for epidemiological surveillance and measurement of quality of care for sepsis: the OPTIMISE study protocol
,
Peter Schlattmann,
Michael Sander,
Christian Koch,
Emmanuel Schneck,
Claudia Spies,
Patrick Meybohm,
Kai Zacharowski,
Simone Lindau,
Philipp Helmer,
Christian Putensen,
Matthias Gründling,
Daniel Schwarzkopf,
Carolin Fleischmann-Struzek,
Heike Dorow,
Dominique Ouart,
Andreas Edel,
Falk A Gonnert,
Jürgen Götz,
Markus Heim,
Ulrich Jaschinski,
Konrad Reinhart,
Anja Ball,
Kathrin Scholtz,
Jens Christian Schewe,
Verena Steinberg,
Susanne Behrend,
Corinna Michel,
Stefan Münster,
Beate Boden,
Angelika Göckeler,
Sebastian Zinn,
Holger Neb,
Elke Schmitt,
Khanh Le Ngoc,
Moritz Herzberg,
Ferdinand Cornelius Steinsberger,
Sara Marie Denn,
Anja Kühn,
Sven-Olaf Kuhn,
Christian Scheer,
Christian Fuchs,
Gerhard Schneider,
Jan Meschede,
Kirill Holbeck
Affiliations
Peter Schlattmann
professor of statistics
Michael Sander
Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Gießen, UKGM, Justus-Liebig University Gießen, Gießen, Germany
Christian Koch
1 Department of Medical Oncology and Hematology, University Hospital Zurich and University of Zurich, Zurich, Switzerland
Emmanuel Schneck
Claudia Spies
Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité—Universitätsmedizin Berlin, Berlin, Germany
Patrick Meybohm
6 Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Würzburg, Würzburg, Germany
Kai Zacharowski
Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Germany, Klinikum der Johann Wolfgang Goethe-Universität Frankfurt, Frankfurt am Main, Hessen, Germany
Simone Lindau
Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Frankfurt am Main, Germany
Philipp Helmer
Christian Putensen
Department of Anaesthesiology and Intensive Care Medicine, University Hospital Bonn, Bonn, Germany
Matthias Gründling
Department of Anaesthesiology, Intensive Care Medicine, Emergency Medicine and Pain Medicine, University Medicine Greifswald, Greifswald, Germany
Daniel Schwarzkopf
Center for Infectious Diseases and Infection Control, Jena University Hospital, Jena, Germany
Carolin Fleischmann-Struzek
Center for Infectious Diseases and Infection Control, Jena University Hospital, Jena, Germany
Heike Dorow
Department of Anaesthesiology and Intensive Care Medicine, Jena University Hospital, Jena, Germany
Dominique Ouart
Department of Anaesthesiology and Intensive Care Medicine, Jena University Hospital, Jena, Germany
Andreas Edel
Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany
Falk A Gonnert
Department of Anaesthesiology and Intensive Care Medicine, SRH Wald-Klinikum Gera, Gera, Germany
Jürgen Götz
Department of Internal Medicine II – Intensive Care, Klinikum Lippe GmbH, Detmold, Germany
Markus Heim
Department of Anaesthesiology and Intensive Care, Technical University of Munich, TUM School of Medicine, Klinikum rechts der Isar, Munchen, Germany
Ulrich Jaschinski
Department of Anaesthesiology and Surgical Intensive Care Medicine, Universitätsklinikum Augsburg, Augsburg, Germany
Konrad Reinhart
Department of Anaesthesiology and Intensive Care Medicine, Jena University Hospital, Jena, Germany
Anja Ball
Kathrin Scholtz
Department of Anesthesiology and Intensive Care Medicine (CCM, CVK), Charite Universitatsmedizin Berlin, Berlin, Germany
Introduction Sepsis is a major cause of preventable deaths in hospitals. This study aims to investigate if sepsis incidence and quality of care can be assessed using inpatient administrative health data (IAHD).Methods and analysis Design: Retrospective observational validation study using routine data to assess the diagnostic accuracy of sepsis coding in IAHD regarding sepsis diagnosis based on medical record review. Procedure: A stratified sample of 10 000 patients with an age ≥15 years treated in between 2015 and 2017 in 10 German hospitals is investigated. All available information of medical records is screened by trained physicians to identify true sepsis cases (‘gold standard’) both according to current (‘sepsis-1’) definitions and new (‘sepsis-3’) definitions. Data from medical records are linked to IAHD on patient level using a pseudonym. Analyses: Proportions of cases with sepsis according to sepsis-1 and sepsis-3 definitions are calculated and compared with estimates from coding of sepsis in IAHD. Predictive accuracy (sensitivity, specificity) of different coding abstraction strategies regarding the gold standard is estimated. Predictive accuracy of mortality risk factors obtained from IAHD regarding the respective risk factors obtained from medical records is calculated. An IAHD-based risk model for hospital mortality is compared with a record-based risk model regarding model-fit and predicted risk of death. Analyses adjust for sampling weights. The obtained estimates of sensitivity and specificity for sepsis coding in IAHD are used to estimate adjusted incidence proportions of sepsis based on German national IAHD.Ethics and dissemination The study has been approved by the ethics commission of the Jena University Hospital (No. 2018-1065-Daten). The results of the study will be discussed in an expert panel to write a memorandum on improving the utility of IAHD for epidemiological surveillance and quality management of sepsis care.Trial registration number DRKS00017775; Pre-results.
