Toward Kidney-Specific Causality Assessment Tool

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. Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Kaya, Mustafa [verfasserIn] Duru, Merve [verfasserIn] Gulmez, Sinem Ezgi [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2022

Schlagwörter:	causality assessment tool DIAKI drug-induced acute kidney injury drug safety pharmacovigilance pharmacoepidemiology

Übergeordnetes Werk:	Enthalten in: Clinical therapeutics - Amsterdam [u.a.] : Elsevier Science, 1995, 44
Übergeordnetes Werk:	volume:44

DOI / URN:	10.1016/j.clinthera.2022.05.008

Katalog-ID:	ELV009039414

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520			\|a 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.
650		4	\|a causality assessment tool
650		4	\|a DIAKI
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650		4	\|a pharmacoepidemiology
700	1		\|a Duru, Merve \|e verfasserin \|4 aut
700	1		\|a Gulmez, Sinem Ezgi \|e verfasserin \|0 (orcid)0000-0001-8815-9128 \|4 aut
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hierarchy_sort_str	2022
bklnumber	44.40 44.52
publishDate	2022
allfields	10.1016/j.clinthera.2022.05.008 doi (DE-627)ELV009039414 (ELSEVIER)S0149-2918(22)00193-X DE-627 ger DE-627 rda eng 610 DE-600 PHARM DE-84 fid 15,3 ssgn 44.40 bkl 44.52 bkl Kaya, Mustafa verfasserin (orcid)0000-0002-1266-7334 aut Toward Kidney-Specific Causality Assessment Tool 2022 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. causality assessment tool DIAKI drug-induced acute kidney injury drug safety pharmacovigilance pharmacoepidemiology Duru, Merve verfasserin aut Gulmez, Sinem Ezgi verfasserin (orcid)0000-0001-8815-9128 aut Enthalten in Clinical therapeutics Amsterdam [u.a.] : Elsevier Science, 1995 44 Online-Ressource (DE-627)320646033 (DE-600)2025417-9 (DE-576)261874578 1879-114X nnns volume:44 GBV_USEFLAG_U SYSFLAG_U GBV_ELV FID-PHARM SSG-OLC-PHA SSG-OPC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 44.40 Pharmazie Pharmazeutika 44.52 Therapie Medizin AR 44
spelling	10.1016/j.clinthera.2022.05.008 doi (DE-627)ELV009039414 (ELSEVIER)S0149-2918(22)00193-X DE-627 ger DE-627 rda eng 610 DE-600 PHARM DE-84 fid 15,3 ssgn 44.40 bkl 44.52 bkl Kaya, Mustafa verfasserin (orcid)0000-0002-1266-7334 aut Toward Kidney-Specific Causality Assessment Tool 2022 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. causality assessment tool DIAKI drug-induced acute kidney injury drug safety pharmacovigilance pharmacoepidemiology Duru, Merve verfasserin aut Gulmez, Sinem Ezgi verfasserin (orcid)0000-0001-8815-9128 aut Enthalten in Clinical therapeutics Amsterdam [u.a.] : Elsevier Science, 1995 44 Online-Ressource (DE-627)320646033 (DE-600)2025417-9 (DE-576)261874578 1879-114X nnns volume:44 GBV_USEFLAG_U SYSFLAG_U GBV_ELV FID-PHARM SSG-OLC-PHA SSG-OPC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 44.40 Pharmazie Pharmazeutika 44.52 Therapie Medizin AR 44
allfields_unstemmed	10.1016/j.clinthera.2022.05.008 doi (DE-627)ELV009039414 (ELSEVIER)S0149-2918(22)00193-X DE-627 ger DE-627 rda eng 610 DE-600 PHARM DE-84 fid 15,3 ssgn 44.40 bkl 44.52 bkl Kaya, Mustafa verfasserin (orcid)0000-0002-1266-7334 aut Toward Kidney-Specific Causality Assessment Tool 2022 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. causality assessment tool DIAKI drug-induced acute kidney injury drug safety pharmacovigilance pharmacoepidemiology Duru, Merve verfasserin aut Gulmez, Sinem Ezgi verfasserin (orcid)0000-0001-8815-9128 aut Enthalten in Clinical therapeutics Amsterdam [u.a.] : Elsevier Science, 1995 44 Online-Ressource (DE-627)320646033 (DE-600)2025417-9 (DE-576)261874578 1879-114X nnns volume:44 GBV_USEFLAG_U SYSFLAG_U GBV_ELV FID-PHARM SSG-OLC-PHA SSG-OPC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 44.40 Pharmazie Pharmazeutika 44.52 Therapie Medizin AR 44
allfieldsGer	10.1016/j.clinthera.2022.05.008 doi (DE-627)ELV009039414 (ELSEVIER)S0149-2918(22)00193-X DE-627 ger DE-627 rda eng 610 DE-600 PHARM DE-84 fid 15,3 ssgn 44.40 bkl 44.52 bkl Kaya, Mustafa verfasserin (orcid)0000-0002-1266-7334 aut Toward Kidney-Specific Causality Assessment Tool 2022 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. causality assessment tool DIAKI drug-induced acute kidney injury drug safety pharmacovigilance pharmacoepidemiology Duru, Merve verfasserin aut Gulmez, Sinem Ezgi verfasserin (orcid)0000-0001-8815-9128 aut Enthalten in Clinical therapeutics Amsterdam [u.a.] : Elsevier Science, 1995 44 Online-Ressource (DE-627)320646033 (DE-600)2025417-9 (DE-576)261874578 1879-114X nnns volume:44 GBV_USEFLAG_U SYSFLAG_U GBV_ELV FID-PHARM SSG-OLC-PHA SSG-OPC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 44.40 Pharmazie Pharmazeutika 44.52 Therapie Medizin AR 44
allfieldsSound	10.1016/j.clinthera.2022.05.008 doi (DE-627)ELV009039414 (ELSEVIER)S0149-2918(22)00193-X DE-627 ger DE-627 rda eng 610 DE-600 PHARM DE-84 fid 15,3 ssgn 44.40 bkl 44.52 bkl Kaya, Mustafa verfasserin (orcid)0000-0002-1266-7334 aut Toward Kidney-Specific Causality Assessment Tool 2022 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. causality assessment tool DIAKI drug-induced acute kidney injury drug safety pharmacovigilance pharmacoepidemiology Duru, Merve verfasserin aut Gulmez, Sinem Ezgi verfasserin (orcid)0000-0001-8815-9128 aut Enthalten in Clinical therapeutics Amsterdam [u.a.] : Elsevier Science, 1995 44 Online-Ressource (DE-627)320646033 (DE-600)2025417-9 (DE-576)261874578 1879-114X nnns volume:44 GBV_USEFLAG_U SYSFLAG_U GBV_ELV FID-PHARM SSG-OLC-PHA SSG-OPC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 44.40 Pharmazie Pharmazeutika 44.52 Therapie Medizin AR 44
language	English
source	Enthalten in Clinical therapeutics 44 volume:44
sourceStr	Enthalten in Clinical therapeutics 44 volume:44
format_phy_str_mv	Article
bklname	Pharmazie Pharmazeutika Therapie
institution	findex.gbv.de
topic_facet	causality assessment tool DIAKI drug-induced acute kidney injury drug safety pharmacovigilance pharmacoepidemiology
dewey-raw	610
isfreeaccess_bool	false
container_title	Clinical therapeutics
authorswithroles_txt_mv	Kaya, Mustafa @@aut@@ Duru, Merve @@aut@@ Gulmez, Sinem Ezgi @@aut@@
publishDateDaySort_date	2022-01-01T00:00:00Z
hierarchy_top_id	320646033
dewey-sort	3610
id	ELV009039414
language_de	englisch
fullrecord	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">ELV009039414</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230524161100.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">230510s2022 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1016/j.clinthera.2022.05.008</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)ELV009039414</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(ELSEVIER)S0149-2918(22)00193-X</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rda</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="082" ind1="0" ind2="4"><subfield code="a">610</subfield><subfield code="q">DE-600</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">PHARM</subfield><subfield code="q">DE-84</subfield><subfield code="2">fid</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">15,3</subfield><subfield code="2">ssgn</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">44.40</subfield><subfield code="2">bkl</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">44.52</subfield><subfield code="2">bkl</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Kaya, Mustafa</subfield><subfield code="e">verfasserin</subfield><subfield code="0">(orcid)0000-0002-1266-7334</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Toward Kidney-Specific Causality Assessment Tool</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2022</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">nicht spezifiziert</subfield><subfield code="b">zzz</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">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. 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author	Kaya, Mustafa
spellingShingle	Kaya, Mustafa ddc 610 fid PHARM ssgn 15,3 bkl 44.40 bkl 44.52 misc causality assessment tool misc DIAKI misc drug-induced acute kidney injury misc drug safety misc pharmacovigilance misc pharmacoepidemiology Toward Kidney-Specific Causality Assessment Tool
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topic_title	610 DE-600 PHARM DE-84 fid 15,3 ssgn 44.40 bkl 44.52 bkl Toward Kidney-Specific Causality Assessment Tool causality assessment tool DIAKI drug-induced acute kidney injury drug safety pharmacovigilance pharmacoepidemiology
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title	Toward Kidney-Specific Causality Assessment Tool
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title_auth	Toward Kidney-Specific Causality Assessment Tool
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.
abstractGer	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.
abstract_unstemmed	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.
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title_short	Toward Kidney-Specific Causality Assessment Tool
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up_date	2024-07-06T21:46:44.002Z
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fullrecord_marcxml	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">ELV009039414</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230524161100.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">230510s2022 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1016/j.clinthera.2022.05.008</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)ELV009039414</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(ELSEVIER)S0149-2918(22)00193-X</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rda</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="082" ind1="0" ind2="4"><subfield code="a">610</subfield><subfield code="q">DE-600</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">PHARM</subfield><subfield code="q">DE-84</subfield><subfield code="2">fid</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">15,3</subfield><subfield code="2">ssgn</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">44.40</subfield><subfield code="2">bkl</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">44.52</subfield><subfield code="2">bkl</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Kaya, Mustafa</subfield><subfield code="e">verfasserin</subfield><subfield code="0">(orcid)0000-0002-1266-7334</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Toward Kidney-Specific Causality Assessment Tool</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2022</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">nicht spezifiziert</subfield><subfield code="b">zzz</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">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.</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">causality assessment tool</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">DIAKI</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">drug-induced acute kidney injury</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">drug safety</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">pharmacovigilance</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">pharmacoepidemiology</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Duru, Merve</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" 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