Evidence map›Paper›PMID 18095744›Full record

SynthesisDrug safety2008

Methods for causality assessment of adverse drug reactions: a systematic review.

Taofikat B Agbabiaka, Jelena Savović, Edzard Ernst

Registry-linked trialAbstract readSystematic Review
PubMed Publisher
In one paragraph

Synthesis in Drug safety, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05002192 (A Retrospective, Real-world Study of Eucalyptol, Limonene and Pinene Enteric Soft Capsules Used in the Expectorant Treatment of Community-acquired Pneumonia), which is not on this map. Cited by 148 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
148citing papers in PubMed, 4 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.

NCT05002192 unknown statusnot on this mapstarted 2020, after this paper: background citation

A Retrospective, Real-world Study of Eucalyptol, Limonene and Pinene Enteric Soft Capsules Used in the Expectorant Treatment of Community-acquired Pneumonia

TypeobservationalSponsorBeijing Grand Johamu Pharmaceutical Company, Ltd.Ran2020 to 2022Enrolled10,000ConditionsCommunity-acquired PneumoniaArmsEucalyptol, Limonene and Pinene Enteric Soft Capsule, Ambroxol injection, Other oral mucolytic drugs
3 · Its place in the literature

Who cites it

148 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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88 more citing papers are in PubMed but not listed here.

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

3 authors.

Taofikat B AgbabiakaComplementary Medicine, Peninsula Medical School, Universities of Exeter and Plymouth, Exeter, UK. taofikat.agbabiaka@pms.ac.uk
Jelena Savović
Edzard Ernst

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Numerous methods for causality assessment of adverse drug reactions (ADRs) have been published. The aim of this review is to provide an overview of these methods and discuss their strengths and weaknesses. We conducted electronic searches in MEDLINE (via PubMed), EMBASE and the Cochrane databases to find all assessment methods. Thirty-four different methods were found, falling into three broad categories: expert judgement/global introspection, algorithms and probabilistic methods (Bayesian approaches). Expert judgements are individual assessments based on previous knowledge and experience in the field using no standardized tool to arrive at conclusions regarding causality. Algorithms are sets of specific questions with associated scores for calculating the likelihood of a cause-effect relationship. Bayesian approaches use specific findings in a case to transform the prior estimate of probability into a posterior estimate of probability of drug causation. The prior probability is calculated from epidemiological information and the posterior probability combines this background information with the evidence in the individual case to come up with an estimate of causation. As a result of problems of reproducibility and validity, no single method is universally accepted. Different causality categories are adopted in each method, and the categories are assessed using different criteria. Because assessment methods are also not entirely devoid of individual judgements, inter-rater reliability can be low. In conclusion, there is still no method universally accepted for causality assessment of ADRs.

Indexed as

CausalityAdverse Drug Reaction Reporting SystemsDatabases as TopicDecision Support TechniquesHumansOutcome Assessment, Health CareReproducibility of ResultsRisk Assessment

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.