Validity of ICD‐9 and ICD‐10 codes used to identify acute liver injury: A study in three European data sources

Forns, Joan; Cainzos‐Achirica, Miguel; Hellfritzsch, Maja; Morros, Rosa; Poblador‐Plou, Beatriz; Hallas, Jesper; Giner-Soriano, Maria; Prados‐Torres, Alexandra; Pottegård, Anton; Martínez, Jordi; Castellsagué, Jordi; Jacquot, Emmanuelle; Deltour, Nicolas; Perez‐Gutthann, Susana; Pladevall, Manel

doi:10.1002/pds.4803

Cited by 24 publications

(23 citation statements)

References 21 publications

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“…Liver function was determined each follow up year by analysing serum levels of alkaline phosphatase (ALP), alanine transaminase (ALT) and gamma-glutamyl transpeptidase (GGT). Liver function was considered abnormal when after baseline, at least one of the values was as follows: ALP >2x129 IU/L; ALT>5x41 IU/L (men) or ALT>5x33 IU/L (women); GGT>61 IU/L (27).…”

Section: Liver Functionmentioning

confidence: 99%

Multimorbidity patterns, polypharmacy and their association with liver and kidney abnormalities in people over 65 years of age: a longitudinal study

Villén

Guisado-Clavero

Fernández-Bertolín

et al. 2020

Preprint

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Background: The implementation of individual clinical practice guidelines in patients with multimorbidity often results in polypharmacy. Our aim was to analyse medication use according to longitudinal multimorbidity patterns (MP) and determine during a 5-year period (2012-16) which MP are associated with abnormal liver and kidney function in primary care patients over 65 years of age living in Catalonia.Methods: Design: Longitudinal study (years 2012 to 2016) based on the electronic health records contained in Information System for Research in Primary Care database of the Catalan Institute of Health (SIDIAP). Variables: age, sex, MP, medication and polypharmacy (drug exposure obtained from the Pharmacy Invoice Registry). Medicines were classified in accordance with the Anatomical Therapeutic Chemical Classification System (ATC). Glomerular filtration rate was used to determine abnormal kidney function, and serum levels of alkaline phosphatase, alanine transaminase and gamma-glutamyl transpeptidase were used to diagnose abnormal liver function. Statistics: For medication use in MP, we calculated annual mean packages of each drug in each MP, and observed/expected ratios were obtained by dividing mean packages in the cluster by mean packages of the same drug in the overall population. Logistic regression models were fitted to estimate the association between MP at baseline and abnormal kidney and liver function tests during follow up.Results: 916,619 patients were included, and 743,827 completed the follow up. We identified one polypharmacy profile per MP, and concluded that the most prescribed drugs in each pattern corresponded to the diseases overrepresented in that specific MP. The median of drugs ranged from 3 (Cluster 1 - Non-Specific) to 8 (Cluster 10 - Multisystem Pattern). Abnormal kidney function was most commonly observed in the Cluster 4 - Cardio-Circulatory and Renal (Odds Ratio [OR] 2.19; Confidence interval [CI] 95% 2.15-2.23) and Cluster 3 - Minority Metabolic Autoimmune-Inflammatory (OR 2.16; CI 95% 2.12-2.20) MP. A higher risk of abnormal liver function was observed in the Cluster 8 - Digestive (OR 3.39; CI 95% 3.30-3.49), and Cluster 4 - Cardio-Circulatory and Renal (OR 1.96; CI 95% 1.91-2.02) MP.Conclusions: A higher risk of abnormal kidney and liver function was observed in specific MP. The long-term characterisation of MP and polypharmacy illustrates the burden of chronic multimorbidity and polypharmacy in the elderly population.

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Section: Liver Functionmentioning

confidence: 99%

Multimorbidity patterns, polypharmacy and their association with liver and kidney abnormalities in people over 65 years of age: a longitudinal study

Villén

Guisado-Clavero

Fernández-Bertolín

et al. 2020

Preprint

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“…The corresponding ICD‐10 code (K71.0, toxic liver disease with cholestasis) would presumably be more specific, but previous validation studies using this ICD‐10 code were not available. In the current study (see supplemental tables) and in the parent study, the PPVs of the ICD‐10 code K71.0 ranged between 50% and 80%. Although it is important to keep in mind that in both studies ALI rather than DILI was the outcome of interest, a recently published systematic review and meta‐analysis including 29 studies validating ALI or DILI showed a pooled PPV estimate for ALI of 13.4% (95% CI, 6.1%‐22.8%) and for DILI of 15.3% (95% CI, 9.5%‐22.2%) …”

Section: Discussionmentioning

confidence: 53%

“…Three of five databases participating in the agomelatine PASS were amenable for direct validation of cases within the respective database . The PPVs ranged from 60% to 84% for the primary PASS outcome (specific end point after exclusion of cases with known competing causes of ALI) . Case numbers in two of these databases were very small, explaining in part the large variability in observed PPVs.…”

Section: Discussionmentioning

confidence: 99%

“…[39][40][41] The PPVs ranged from 60% to 84% for the primary PASS outcome (specific end point after exclusion of cases with known competing causes of ALI). 31,42 Case numbers in two of these databases were very small, explaining in part the large variability in observed PPVs. For the less specific outcomes, case numbers were larger and estimates more precise.…”

Section: Interpretation Of the Ppv As Compared With Other Workmentioning

confidence: 96%

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Validity of hospital ICD‐10‐GM codes to identify acute liver injury in Germany

Timmer

Sordi

Kappen

et al. 2019

Pharmacoepidemiology and Drug

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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.

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“…Potential cases were adjudicated by trained clinicians based on review of information abstracted from medical records. This information included timing and results of liver enzymes and information on presence or absence of excluding conditions [ 33 ]. Thus, the clinical reviewers were adjudicating whether the individual potential cases met the study definition criteria of ALI and whether excluding conditions were present, not whether they met criteria for causality between antidepressant use and liver injury.…”

Section: Methodsmentioning

confidence: 99%

Risk of Acute Liver Injury in Agomelatine and Other Antidepressant Users in Four European Countries: A Cohort and Nested Case–Control Study Using Automated Health Data Sources

et al. 2019

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Background Agomelatine is a melatonin receptor agonist and serotonin 5-HT 2C receptor antagonist indicated for depression in adults. Hepatotoxic reactions like acute liver injury (ALI) are an identified risk in the European risk management plan for agomelatine. Hepatotoxic reactions have been reported for other antidepressants, but population studies quantifying these risks are scarce. Antidepressants are widely prescribed, and users often have risk factors for ALI (e.g. metabolic syndrome). Objective The goal was to estimate the risk of ALI associated with agomelatine and other antidepressants (fluoxetine, paroxetine, sertraline, escitalopram, mirtazapine, venlafaxine, duloxetine, and amitriptyline) when compared with citalopram in routine clinical practice. Method A nested case–control study was conducted using data sources in Denmark, Germany, Spain, and Sweden (study period 2009–2014). Three ALI endpoints were defined using International Classification of Diseases (ICD) codes: primary (specific codes) and secondary (all codes) endpoints used only hospital discharge codes; the tertiary endpoint included both inpatient and outpatient settings (all codes). Validation of endpoints was implemented. Adjusted odds ratios (ORs) and 95% confidence intervals (CIs) for current use were estimated for each data source and combined. Results We evaluated 3,238,495 new antidepressant and 74,440 agomelatine users. For the primary endpoint, the OR for agomelatine versus citalopram was 0.48 (CI 0.13–1.71). Results were also < 1 when no exclusion criteria were applied (OR 0.37; CI 0.19–0.74), when all exclusion criteria except alcohol and drug abuse were applied (OR 0.47; CI 0.20–1.07), and for the secondary (OR 0.40; CI 0.05–3.11) and tertiary (OR 0.79; CI 0.50–1.25) endpoints. Regarding other antidepressants versus citalopram, most OR point estimates were also below one, although with varying widths of the 95% CIs. The result of the tertiary endpoint and the sensitivity analyses of the primary endpoint were the most precise. Conclusion In this study, using citalopram as a comparator, agomelatine was not associated with an increased risk of ALI hospitalisation. The results for agomelatine should be interpreted in the context of the European risk minimisation measures in place. Those measures may have induced selective prescribing and could explain the lower risk of ALI for agomelatine when compared with citalopram. Most other antidepressants evaluated had ORs suggesting a lower risk than citalopram, but additional studies are required to confirm or refute these results. Electronic supplementary material The online version of this article (10.1007/s40263-019-00611-9) contains supplementary material, which is available to authorized users.

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Validity of ICD‐9 and ICD‐10 codes used to identify acute liver injury: A study in three European data sources

Cited by 24 publications

References 21 publications

Multimorbidity patterns, polypharmacy and their association with liver and kidney abnormalities in people over 65 years of age: a longitudinal study

Multimorbidity patterns, polypharmacy and their association with liver and kidney abnormalities in people over 65 years of age: a longitudinal study

Validity of hospital ICD‐10‐GM codes to identify acute liver injury in Germany

Risk of Acute Liver Injury in Agomelatine and Other Antidepressant Users in Four European Countries: A Cohort and Nested Case–Control Study Using Automated Health Data Sources

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