Evidence map›Paper›PMID 30051231›Full record

ArticleInternational journal of clinical pharmacy2018

Comparison of different methods for causality assessment of adverse drug reactions.

Sapan Kumar Behera, Saibal Das, Alphienes Stanley Xavier, Srinivas Velupula, Selvarajan Sandhiya

Abstract readComparative Study
PubMed Publisher
In one paragraph

Article in International journal of clinical pharmacy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 2 pooled it
6.0field-weighted citation impact, top 2% of its field
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

52 citing papers in PubMed, 2 syntheses or guidelines pooled it, 87 citations in OpenAlex.

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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

5 authors at 2 institutions in 1 country.

Sapan Kumar BeheraDepartment of Clinical Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.
Saibal DasDepartment of Clinical Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.
Alphienes Stanley XavierDepartment of Clinical Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.
Srinivas VelupulaDepartment of Clinical Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.
Selvarajan SandhiyaDepartment of Clinical Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India. sandhiyaselvarajan@gmail.com.
Jawaharlal Institute of Post Graduate Medical Education and Research · INKakatiya University · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background The causality assessment of adverse drug reactions (ADRs) remains a challenge, and none of the different available method of causality assessment used for assessing adverse reactions has been universally accepted as the gold standard. Objective To examine the agreement and correlation among three broad approaches for causality assessment of ADRs viz. World Health Organization-Uppsala Monitoring Centre (WHO-UMC) system, Naranjo algorithm, and updated Logistic method. Setting ADR monitoring centre (AMC) of a tertiary care teaching hospital in India. Method A total of 230 cases of ADR from April 2017 to August 2017 were retrospectively analyzed by each of these three methods. The agreement among the different methods was calculated by Cohen's kappa (κ), and Spearman's correlation was used to find the correlation among these methods. Main outcome measures Cohen's kappa value and Spearman's correlation coefficient for comparison among the different methods. Results The Cohen's κ used for analyzing the agreement between WHO-UMC system and Naranjo algorithm was 0.45, between WHO-UMC system and updated Logistic method was 0.405, and between Naranjo algorithm and updated Logistic method was 0.606. The Spearman's correlation coefficient was 0.793 for Naranjo algorithm vs. updated Logistic method, 0.735 for WHO-UMC system vs. Naranjo algorithm, and 0.696 for WHO-UMC system vs. updated Logistic method. Conclusion Causality assessment based on objective measurements (scores and probabilities) like updated Logistic method and Naranjo algorithm are less prone to subjective variations compared to the WHO-UMC system which is based on expert judgement.

Indexed as

Adverse Drug Reaction Reporting SystemsPharmacovigilanceAdultAlgorithmsBayes TheoremDrug-Related Side Effects and Adverse ReactionsFemaleHumansIndiaJudgmentLogistic ModelsMalePatient SafetyRegistriesReproducibility of ResultsRetrospective StudiesADRsAdverse drug reactionCausality assessmentNaranjo algorithmUpdated Logistic methodWHO-UMC system

Identifiers

PMID30051231
OpenAlexW2883577153

What OpenQuestion holds

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Registered trials

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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.