Evidence map›Paper›PMID 35676635›Full record

ArticleBMC medical research methodology2022

A data-driven pipeline to extract potential adverse drug reactions through prescription, procedures and medical diagnoses analysis: application to a cohort study of 2,010 patients taking hydroxychloroquine with an 11-year follow-up.

P Sabatier, M Wack, J Pouchot, N Danchin, A S Jannot

Open access · goldAbstract read
In one paragraph

Article in BMC medical research methodology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.5field-weighted citation impact, top 43% 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

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. 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

5 authors at 2 institutions in 1 country.

P SabatierInria, HeKA, PariSantéCampus, 10 Rue d'Oradour-sur-Glane, 75015, Paris, France. pierre.sabatier@aphp.fr.
M WackInria, HeKA, PariSantéCampus, 10 Rue d'Oradour-sur-Glane, 75015, Paris, France.
J PouchotAP-HP: Department of Cardiology, Georges Pompidou European Hospital, 75015, Paris, France.
N DanchinAP-HP: Department of Internal Medicine, Georges Pompidou European Hospital, 75015, Paris, France.
A S JannotInria, HeKA, PariSantéCampus, 10 Rue d'Oradour-sur-Glane, 75015, Paris, France.
Institut national de recherche en informatique et en automatique · FRHôpital Européen Georges-Pompidou · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

contextReal-life data consist of exhaustive data which are not subject to selection bias. These data enable to study drug-safety profiles but are underused because of their temporality, necessitating complex models (i.e., safety depends on the dose, timing, and duration of treatment). We aimed to create a data-driven pipeline strategy that manages the complex temporality of real-life data to highlight the safety profile of a given drug.

methodsWe proposed to apply the weighted cumulative exposure (WCE) statistical model to all health events occurring after a drug introduction (in this paper HCQ) and performed bootstrap to select relevant diagnoses, drugs and interventions which could reflect an adverse drug reactions (ADRs). We applied this data-driven pipeline on a French national medico-administrative database to extract the safety profile of hydroxychloroquine (HCQ) from a cohort of 2,010 patients.

resultsThe proposed method selected eight drugs (metopimazine, anethole trithione, tropicamide, alendronic acid & colecalciferol, hydrocortisone, chlormadinone, valsartan and tixocortol), twelve procedures (six ophthalmic procedures, two dental procedures, two skin lesions procedures and osteodensitometry procedure) and two medical diagnoses (systemic lupus erythematous, unspecified and discoid lupus erythematous) to be significantly associated with HCQ exposure.

conclusionWe provide a method extracting the broad spectrum of diagnoses, drugs and interventions associated to any given drug, potentially highlighting ADRs. Applied to hydroxychloroquine, this method extracted among others already known ADRs.

Indexed as

Antirheumatic AgentsDrug-Related Side Effects and Adverse ReactionsCohort StudiesFollow-Up StudiesHumansHydroxychloroquinePrescriptionsAntirheumatic AgentsHydroxychloroquineAdverse drug reactionsHydroxychloroquineMassive dataMedico-administrative databases

Identifiers

PMID35676635
PMCPMC9175346
OpenAlexW4281719167

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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.