Evidence map›Paper›PMID 29185238›Full record

Observational studyClinical drug investigation2018

Agreement Among Different Scales for Causality Assessment in Drug-Induced Liver Injury.

Saibal Das, Sapan K Behera, Alphienes S Xavier, Srinivas Velupula, Steven A Dkhar, Sandhiya Selvarajan

Abstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in Clinical drug investigation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Article
  6. Review
  7. Review
  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Saibal DasDepartment of Clinical Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605 006, India.
Sapan K BeheraDepartment of Clinical Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605 006, India.
Alphienes S XavierDepartment of Clinical Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605 006, India.
Srinivas VelupulaDepartment of Clinical Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605 006, India.
Steven A DkharDepartment of Clinical Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605 006, India.
Sandhiya SelvarajanDepartment of Clinical Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605 006, India. sandhiyaselvarajan@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveThe causality assessment of drug-induced liver injury (DILI) remains a challenge and eagerly awaits the development of reliable hepatotoxicity biomarkers. None of the different available algorithms used for the causality assessment of DILI has been universally accepted as the gold standard. This study was conducted to examine the agreement among different causality assessment scales in reporting DILI.

methodsThe World Health Organization-Uppsala Monitoring Center (WHO-UMC), Naranjo, Roussel Uclaf Causality Assessment Method (RUCAM), Maria & Victorino (M & V) and Digestive Disease Week-Japan (DDW-J) assessment scales were used to compare the causalities in all the reported cases of DILI in our adverse drug reaction (ADR) monitoring centre from January 2014 to June 2017. The probability of the causality assessment was classified as 'definite', 'probable', 'possible' and 'unlikely'. The agreement obtained among the causality assessments was analysed using the weighted kappa (κ

resultsA total of 33 cases of DILI were included in our analyses. Anti-tubercular therapy (ATT) and methotrexate were the drugs that most commonly caused DILI. The overall agreement among the different scales was poor. The best agreement was found between RUCAM and DDW-J scales (κ

conclusionThere were discrepancies among the different causality scales in assessing DILI. This might be due to the different definitions of causality criteria and subjective variability during assessment. A personalised assessment scale incorporating the latest information on specific risk factors and evidence-based criteria for DILI is warranted.

Indexed as

PharmacovigilanceWorld Health OrganizationAdolescentAdultAgedAlgorithmsBiomarkersChemical and Drug Induced Liver InjuryChildDrug-Related Side Effects and Adverse ReactionsFemaleHumansIndiaMaleMiddle AgedRetrospective StudiesBiomarkers

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.