ABSTRACT
Purpose
Current nonspecific causality assessment tools lack the assessment of drug-induced
acute kidney injury (DIAKI). We recently published an editorial letter for developing
a specific causality assessment tool for DIAKI. The purpose of the present review
was to suggest the possible required parameters and outline the path to developing
a kidney-specific causality assessment tool (KSCAT).
Methods
A stepwise approach for developing a KSCAT is important as this will be first version
of this new tool. Thus, as a first step, we performed a screening of previously published
articles on nonspecific and liver-specific causality assessment tools to define possible
parameters. The suggested parameters for KSCAT fall into 3 categories: (1) drug-related;
(2) kidney-related; and (3) terminology. A tri-polar method was then created that
consists of definitive adverse drug reactions (ADRS), terminology, and without ADRS
to suggest that the new KSCAT be efficient, specific, user friendly, and less time-consuming.
Finally, a pyramid model is suggested to offer the perspectives of experts in the
fields of pharmacovigilance, pharmacoepidemiology, and nephrology, as well as decision
makers, while developing a KSCAT.
Findings
Causality assessment tools, either nonspecific or organ-specific, fall into 3 categories:
(1) expert judgment; (2) algorithms; and (3) probabilistic methods. None of the current
causality assessment tools is sufficient for assessing the causality of kidney-related
ADRs and for screening the expanded definition of ADR included in European Union Directive
2010/84/EU.
Implications
The causal relationship between drug(s) and DIAKI may be difficult and may not be
assessed appropriately with the use of nonspecific tools or approaches. The aim of
this article was to reiterate the need for KSCAT development and to propose the associated
steps by stating the main principles: namely, the definition of ADR, suggested parameters
to be included in the KSCAT, and integration of technology. Our ultimate desire is
to invite experts to develop this new tool using an interdisciplinary approach and
to benefit from our review in pursuing the next steps. The development of a KSCAT
should start with regular and interdisciplinary consortium meetings of experts; the
tool should then be tested for its usability, specificity, and practicality; and,
finally, it should be used in real-life pharmacovigilance practices, as well as in
research by health authorities, regulators, decision-makers, scientists, and clinicians.
A KSCAT would support the provision of reliable and reproducible measures of the relationship
likelihood in suspected cases of ADR to overcome uncertainty and provide a standardized
approach.
Keywords
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Article info
Publication history
Published online: June 17, 2022
Accepted:
May 23,
2022
Identification
Copyright
© 2022 Elsevier Inc.
