Evidence map›Paper›PMID 36201545›Full record

ArticlePloS one2022

Risk of retinal detachment and exposure to fluoroquinolones, common antibiotics, and febrile illness using a self-controlled case series study design: Retrospective analyses of three large healthcare databases in the US.

Ajit A Londhe, Chantal E Holy, James Weaver, Sergio Fonseca, Angelina Villasis-Keever, Daniel Fife

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03479736 (A Self-Controlled Case Series Study of Fluoroquinolones Exposure and Collagen-related Serious Adverse Events), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.8field-weighted citation impact, top 30% 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.

NCT03479736 completednot on this map

A Self-Controlled Case Series Study of Fluoroquinolones Exposure and Collagen-related Serious Adverse Events

TypeobservationalSponsorJanssen Research & Development, LLCRan2017 to 2018Enrolled117,911ConditionsRetinal Detachment, Achilles Tendon, Aneurysm, DissectingArmsOral Fluoroquinolones (FQ), Other Antibiotics, Febrile Illness Not Treated with Antibiotics Will be Analyzed as an Exposure
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
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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

6 authors at 2 institutions in 1 country.

Ajit A LondheJanssen Pharmaceutical Research & Development, LLC, Titusville, NJ, United States of America.ORCID 0000-0002-0338-2919
Chantal E HolyJohnson & Johnson, New Brunswick, NJ, United States of America.ORCID 0000-0002-5901-1156
James WeaverJanssen Pharmaceutical Research & Development, LLC, Titusville, NJ, United States of America.
Sergio FonsecaJanssen Pharmaceutical Research & Development, LLC, Titusville, NJ, United States of America.
Angelina Villasis-KeeverJanssen Pharmaceutical Research & Development, LLC, Titusville, NJ, United States of America.ORCID 0000-0002-8421-2195
Daniel FifeJanssen Pharmaceutical Research & Development, LLC, Titusville, NJ, United States of America.
Janssen (United States) · USJohnson & Johnson (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe risk of retinal detachment (RD) following exposure to fluoroquinolone (FQ) has been assessed in multiple studies, however, results have been mixed. This study was designed to estimate the risk of RD following exposure to FQ, other common antibiotics, and febrile illness not treated with antibiotics (FINTA) using a self-controlled case series (SCCS) study design to reduce risk of confounding from unreported patient characteristics.

designRetrospective database analysis-SCCS.

settingPrimary and Secondary Care. STUDY POPULATION: 40,981 patients across 3 US claims databases (IBM® MarketScan® commercial and Medicare databases, Optum Clinformatics). OUTCOME: RD.

methodsExposures included FQ as a class of drugs, amoxicillin, azithromycin, trimethoprim with and without sulfamethoxazole, and FINTA. For the primary analysis, all drug formulations were included. For the post hoc sensitivity analyses, only oral tablets were included. Risk windows were defined as exposure period (or FINTA duration) plus 30 days. Patients of all ages with RD and exposures in 3 US claims databases between 2012 to 2017 were included. Diagnostics included p value calibration and pre-exposure outcome analyses. Incidence rate ratios (IRR) and 95% confidence interval (CI) comparing risk window time with other time were calculated.

resultsOur primary analysis showed an increased risk for RD in the 30 days prior to exposure to FQ or trimethoprim without sulfamethoxazole. This risk decreased but remained elevated for 30 days following first exposure. Our post-hoc analysis, which excluded ophthalmic drops, showed no increased risk for RD at any time, with FQ and other antibiotics.

conclusionOur results did not suggest an association between FQ and RD. Oral FQ was not associated with an increased risk for RD during the pre- or post-exposure period.

trial registrationClinicalTrials.gov identifier: NCT03479736-March 21, 2018.

Indexed as

FluoroquinolonesRetinal DetachmentAgedAmoxicillinAnti-Bacterial AgentsAzithromycinDelivery of Health CareHumansMedicareRetrospective StudiesSulfamethoxazoleTrimethoprimUnited StatesAmoxicillinAnti-Bacterial AgentsAzithromycinFluoroquinolonesSulfamethoxazoleTrimethoprim

Identifiers

PMID36201545
PMCPMC9536641
OpenAlexW4302363561

What OpenQuestion holds

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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.