Table 4.
LiverTox paradox: Promised data versus presented data.
Promised Data | Presented Data and Gaps |
---|---|
Cases of iDILI with RUCAM scores [1]. | Evidence is missing that RUCAM was ever used in any iDILI case included in the LiverTox database or presented on the website [2]. |
A complete and accurate summary of information about the clinical features of liver injury for each drug [1]. | Clinical summaries were incomplete due to a lack of a diagnostic algorithm such as RUCAM to assess causality [2]. Instead, causality gradings were arbitrarily published considering the number of published case reports. |
A website with comprehensive and evidence-based detailed information on iDILI cases [1]. | Information was incomplete and not evidence-based, because the causality was not assessed with a robust method such as RUCAM [2] that would have assessed the exclusion of alternative causes. |
A separate section on detailed information about formal CAMs such as RUCAM [1]. | The section is not up to date. References are, for instance, to 2 reports of RUCAM in 1993 [15,16] and not actualized in 2016 [2] with the updated version [27], followed by additional information [28,29]. |
Providing standardized definitions of terms used [1]. | Standard criteria of liver injury such as ALT higher than 5 × ULN and/or ALP higher than 2 × ULN [12,27] are not presented [2]. |