Causality assessment tool for drug-induced acute kidney injury in patients admitted to intensive care units: Requirements from a multicentre retrospective study in the Netherlands reusing data from electronic health records.

AIM: This study aimed to provide key requirements for a drug-induced acute kidney injury (d-AKI) causality assessment tool (CAT) for intensive care unit (ICU) patients, using vancomycin-induced AKI (v-AKI) as a test case. METHODS: A retrospective review was conducted by medical experts of electronic health records of ICU patients from 14 Dutch ICUs. At each ICU, a panel consisting of three medical experts was established. Each case was presented via an electronic case report form (eCRF) including criteria from the Naranjo and World Health Organization-Uppsala Monitoring Centre CATs, both enhanced by d-AKI features (N-CAT-d and W-CAT-d, respectively). After completing the eCRF, two causality scores based on the two CATs were presented to the experts, who subsequently provided their final judgement. Inter-rater variability was assessed using percentage agreement. The final panel judgement was established by consensus. RESULTS: In total, 41 ICU patients were assessed, resulting in 123 individual and 41 final expert panel judgements. The overall mean percentage agreement for the causality score was 34.4%, and that for the d-AKI-specific alternative aetiologies criterion was 70.0% (W-CAT-d) and 78.6% (N-CAT-d). The final panel judgements resulted in 15 cases (36.6%) being deemed possible or probable v-AKI and aligned with W-CAT-d causality scores in 24 (58.5%), aligned with N-CAT-d scores in 12 (29.3%) and diverged from both in 14 (34.1%) cases. CONCLUSIONS: The W-CAT-d showed greater alignment with the clinical judgements of ICU medical experts. The d-AKI-specific alternative aetiologies feature supports consistency in the evaluation of this crucial criterion. Additional refinements are necessary to better capture the complexity of ICU d-AKI cases.