Validation study of German inpatient administrative health data for epidemiological surveillance and measurement of quality of care for sepsis: the OPTIMISE study protocol. Issue 10 (5th October 2020)

• Record Type: Journal Article
• Authors: Schwarzkopf, Daniel; Fleischmann-Struzek, Carolin; Schlattmann, Peter; Dorow, Heike; Ouart, Dominique; Edel, Andreas; Gonnert, Falk A; Götz, Jürgen; Gründling, Matthias; Heim, Markus; Jaschinski, Ulrich; Lindau, Simone; Meybohm, Patrick; Putensen, Christian; Sander, Michael; Reinhart, Konrad
• Other Names: author non-byline.; Ball Anja author non-byline.; Scholtz Kathrin author non-byline.; Spies Claudia author non-byline.; Schewe Jens Christian author non-byline.; Steinberg Verena author non-byline.; Behrend Susanne author non-byline.; Michel Corinna author non-byline.; Münster Stefan author non-byline.; Boden Beate author non-byline.; Göckeler Angelika author non-byline.; Zinn Sebastian author non-byline.; Neb Holger author non-byline.; Zacharowski Kai author non-byline.; Schmitt Elke author non-byline.; Helmer Philipp author non-byline.; Ngoc Khanh Le author non-byline.; Herzberg Moritz author non-byline.; Steinsberger Ferdinand Cornelius author non-byline.; Denn Sara Marie author non-byline.; Schneck Emmanuel author non-byline.; Koch Christian author non-byline.; Kühn Anja author non-byline.; Kuhn Sven-Olaf author non-byline.; Scheer Christian author non-byline.; Fuchs Christian author non-byline.; Schneider Gerhard author non-byline.; Meschede Jan author non-byline.; Holbeck Kirill author non-byline.
• Is Part Of: BMJ open. Volume 10:Issue 10(2020)
• Publication Date: 2020-10-05
• Subjects: quality in health care -- epidemiology -- public health -- adult intensive & critical care; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2019-035763
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : 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.