Evidence map›Paper›PMID 26248609›Full record

ArticlePharmacoepidemiology and drug safety2016

The risk of acute liver injury among users of antibiotic medications: a comparison of case-only studies.

Ruth Brauer, Ana Ruigómez, Olaf Klungel, Robert Reynolds, Maurille Feudjo Tepie, Liam Smeeth, Ian Douglas

Open access · hybridAbstract readComparative Study
In one paragraph

Article in Pharmacoepidemiology and drug safety, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.2field-weighted citation impact, top 20% 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

3 citing papers in PubMed, 9 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

7 authors at 5 institutions in 4 countries.

Ruth BrauerFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, United Kingdom.ORCID http://orcid.org/0000-0001-8934-347X
Ana RuigómezFundación Centro Español de Investigación Farmacoepidemiológica, (CEIFE), Madrid, Spain.
Olaf KlungelFaculty of Science, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands.
Robert ReynoldsEpidemiology, Pfizer Research and Development, New York, USA.
Maurille Feudjo TepieAmgen NV, London, United Kingdom.
Liam SmeethFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, United Kingdom.
Ian DouglasFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, United Kingdom.
London School of Hygiene & Tropical Medicine · GBAmgen (United States) · USCentro Español de Investigación Farmacoepidemiológica · ESPfizer (United States) · USUtrecht University · NL

Funding

Medical Research Council G0802403Medical Research Council MR/K006584/1Wellcome Trust 098504
6 · The paper itself

Abstract

purposeThe aims of this study were two-fold: (i) to investigate the effect of exposure to antibiotic agents on the risk of acute liver injury using a self-controlled case series and case-crossover study and (ii) to compare the results between the case-only studies.

methodsFor the self-controlled case series study relative incidence ratios (IRR) were calculated by dividing the rate of acute liver injury experienced during patients' periods of exposure to antibiotics to patients' rate of events during non-exposed time using conditional Poisson regression. For the case-crossover analysis we calculated Odds Ratios (OR) using conditional logistic regression by comparing exposure during 14- and 30-day risk windows with exposure during control moments.

resultsUsing the self-controlled case series approach, the IRR was highest during the first 7 days after receipt of a prescription (10.01, 95% CI 6.59-15.18). Omitting post-exposure washout periods lowered the IRR to 7.2. The highest estimate in the case-crossover analysis was found when two 30-day control periods 1 year prior to the 30-day ALI risk period were retained in the analysis: OR = 6.5 (95% CI, 3.95-10.71). The lowest estimate was found when exposure in the 14-day risk period was compared to exposure in four consecutive 14-day control periods immediately prior to the risk period (OR = 3.05, 95% CI, 2.06-4.53).

conclusionAn increased relative risk of acute liver injury was consistently observed using both self-controlled case series and case-crossover designs. Case-only designs can be used as a viable alternative study design to study the risk of acute liver injury, albeit with some limitations.

Indexed as

Anti-Bacterial AgentsCase-Control StudiesChemical and Drug Induced Liver InjuryCross-Over StudiesFemaleHumansMaleRisk FactorsAnti-Bacterial Agentsacute liver injuryantibiotic agentscase-crossoverCPRDpharmacoepidemiologyself-controlled case series

Identifiers

PMID26248609
PMCPMC4916501
OpenAlexW1831866033

What OpenQuestion holds

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LicenceCC BY
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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.