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dc.contributor.authorHayashi, Paul H.
dc.contributor.authorLucena-González, María Isabel 
dc.contributor.authorFontana, Robert J.
dc.contributor.authorBjornsson, Einar S.
dc.contributor.authorAithal, Guruprasad P.
dc.contributor.authorBarnhart, Huiman
dc.contributor.authorGonzález-Jiménez, Andrés
dc.contributor.authorYang, Qinghong
dc.contributor.authorGu, Jiezhun
dc.contributor.authorAndrade-Bellido, Raúl Jesús 
dc.contributor.authorHoofnagle, Jay H.
dc.date.accessioned2022-04-01T10:33:21Z
dc.date.available2022-04-01T10:33:21Z
dc.date.created2022
dc.date.issued2022
dc.identifier.urihttps://hdl.handle.net/10630/23905
dc.description.abstractBackground and Aims: Roussel Uclaf Causality Assessment Method (RUCAM) for DILI has been hindered by subjectivity and poor reliability. We sought to improve the RUCAM using data from the Drug-Induced Liver Injury Network (DILIN) and the Spanish DILI Registry, published literature, and it- erative computer modeling. Approach and Results: RUCAM criteria were updated, clarified, and com- puterized. We removed criteria 3 (risk factors) for lack of added value and cri- teria 4 because we felt it more useful to assess each drug separately. Criteria 6 (drug-specific risk) was anchored to LiverTox likelihood scores. Iterative testing in subsets of 50–100 single-agent, nonherbal cases from both regis- tries was done to optimize performance. We used classification tree analysis to establish diagnostic cutoffs for this revised electronic causality assessment method (RECAM) and compared RECAM with RUCAM for correlation with expert opinion diagnostic categories in 194 DILI cases (98 DILIN, 96 Spanish DILI). Area under receiver operator curves for identifying at least probable DILI were the same at 0.89 for RECAM and RUCAM. However, RECAM diagnostic categories have better observed overall agreement with expert opinion (0.62 vs. 0.56 weighted kappa, p = 0.14), and had better sensitivity to detect extreme diagnostic categories (73 vs. 54 for highly likely or high probable, p = 0.02; 65 vs. 48 for unlikely/excluded, p = 0.08) than RUCAM diagnostic categories. Conclusions: RECAM is an evidence-based update that is at least as capa- ble as RUCAM in diagnosing DILI compared with expert opinion but is better than RUCAM at the diagnostic extremes. RECAM’s increased objectivity and clarity will improve precision, reliability, and standardization of DILI diagnosis, but further refinement and validation in other cohorts are needed.es_ES
dc.description.sponsorshipFunding information The Drug-Induced Liver Injury (DILN) Network is structured as a U01 cooperative agreement with funds provided by the National Institute of Diabetes and Digestive and Kidney Diseases (U24-DK065176, U01-DK065201, U01-DK065184, U01-DK065211, U01DK065193, U01-DK065238, U01-DK083023, U01-DK083027, U01-DK082992, U01-DK083020, and U01-DK100928). Additional support is provided by CTSA grants (UL1 RR025761, UL1TR000083, UL1 RR024134, UL1 RR024986, UL1 RR024982, UL1 RR024150), the Intramural Research Program of the National Institutes of Health, the National Cancer Institute (ClinicalTrials.gov number: NCT00345930), and the 2016 American Association for the Study of Liver Disease (AASLD) Innovations Fund. The Spanish DILI Registry is funded by grants from Instituto de Salud Carlos III, cofounded by Fondo Europeo de Desarrollo Regional - FEDER (PI 18/01804 and PT 20/00127) and Agencia Española del Medicamento. Plataforma ISCiii de Investigación Clínica and CIBERehd are funded by ISCIII.es_ES
dc.language.isoenges_ES
dc.publisherWileyes_ES
dc.rightsinfo:eu-repo/semantics/openAccesses_ES
dc.subjectHígado - Enfermedadeses_ES
dc.subjectEnfermedades - Diagnósticoes_ES
dc.subject.otherDILIes_ES
dc.subject.otherDrug-induced liver injuryes_ES
dc.subject.otherRUCAMes_ES
dc.subject.otherCausalityes_ES
dc.subject.otherScalees_ES
dc.subject.otherCriteriaes_ES
dc.titleA revised electronic version of RUCAM for the diagnosis of DILIes_ES
dc.typeinfo:eu-repo/semantics/articlees_ES
dc.centroFacultad de Medicinaes_ES
dc.type.hasVersioninfo:eu-repo/semantics/publishedVersiones_ES


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