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Validity of hospital ICD‐10‐GM codes to identify acute liver injury in Germany
Author(s) -
Timmer Antje,
Sordi Dominik,
Kappen Sanny,
Kohse Klaus Peter,
Schink Tania,
PerezGutthann Susana,
Jacquot Emmanuelle,
Deltour Nicolas,
Pladevall Manel
Publication year - 2019
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.4855
Subject(s) - medicine , confidence interval , icd 10 , pharmacoepidemiology , chronic liver disease , diagnosis code , liver disease , liver injury , gastroenterology , cirrhosis , population , pharmacology , psychiatry , medical prescription , environmental health
Abstract Purpose Acute liver injury (ALI) is an important adverse drug reaction. We estimated the positive predictive values (PPVs) of ICD‐10‐GM codes of ALI used in an international postauthorisation safety study (PASS). Methods Analyses used routine data (2007 to 2016, adults) from a German academic hospital in a cross‐sectional design. Two algorithms from the PASS were applied to extract potential cases from the hospital information system: specific end point (A) (discharge diagnosis of liver disease–specific codes) and less specific end point (B) (discharge and outpatient‐specific and nonspecific codes suggestive of liver injury). ALI cases were confirmed on the basis of plasma liver enzyme activity elevation. Secondary analysis was performed following exclusion of cases with known cancer, chronic liver, biliary and pancreatic disease, heart failure, and alcohol‐related disorders, as applied in the PASS. Results On the basis of ICD codes: outcome A, 154 cases (143 with case notes and lab data for case verification); outcome B, 485 cases (357 with case notes and lab data). ALI was confirmed in 71 outcome A cases, PPV of 49.7% (95% confidence interval [CI], 41.2%‐58.1%), and 100 outcome B cases, PPV of 28.0% (95% CI, 23.4%‐33.0%). Applying exclusion criteria increased PPV (95% CI) to 62.7% (50.0%‐74.2%) for outcome A and 45.7% (37.2%‐54.3%) for outcome B. Conclusions In safety studies on hepatotoxicity based on routine data using ICD‐10‐GM discharge codes and when validation of potential cases is not feasible, only the more specific codes should be used to describe ALI, and competing diagnoses for liver injury should be excluded to avoid substantial misclassification.