Evidence map›Paper›PMID 25934554›Full record

Observational studyBMC pulmonary medicine2015

Effectiveness of Montelukast on asthma control in infants: methodology of a French claims data study.

Manon Belhassen, Gérard de Pouvourville, Laurent Laforest, Jacques Brouard, Jacques de Blic, Brigitte Fauroux, Valérie Laigle, Céline Chanut-Vogel, Liliane Lamezec, Eric Van Ganse

Abstract readComparative StudyObservational Study
In one paragraph

Observational study in BMC pulmonary medicine, 2015. 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
–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.

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.

  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

10 authors.

Manon BelhassenMerck Sharp & Dohme, Paris, France. manon.belhassen@univ-lyon1.fr.
Gérard de PouvourvilleESSEC, Paris, France. b00072308@essec.edu.
Laurent LaforestClaude Bernard University, UMR CNRS 5558, Lyon, France. laurent.laforest@univ-lyon1.fr.
Jacques BrouardPediatric Medicine University Hospital, Caen, France. brouard-j@chu-caen.fr.
Jacques de BlicPediatric Medicine Necker University Hospital, Paris, France. deblicj@gmail.com.
Brigitte FaurouxPediatric Noninvasive Ventilation and Sleep Unit, Necker University Hospital, Paris, France. brigitte.fauroux@nck.aphp.fr.
Valérie LaigleMerck Sharp & Dohme, Paris, France. valerie.laigle@merck.com.
Céline Chanut-VogelMerck Sharp & Dohme, Paris, France. celine.chanut.vogel@merck.com.
Liliane LamezecMerck Sharp & Dohme, Paris, France. liliane.lamezec@merck.com.
Eric Van GanseClaude Bernard University, UMR CNRS 5558, Lyon, France. eric.van-ganse@univ-lyon1.fr.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis pilot study, conducted on a 1/97th representative sample of French claims data, prepared a project to assess the effectiveness of Montelukast (MTL-4) as add-on therapy for asthma in infants (6-24 months) compared to inhaled corticosteroids (ICS), based on real-world data. Due to the very recent opening of French claims data for effectiveness research, and the complex structure of this data source, we first tested the feasibility of identifying infants with asthma and outcome criteria, and the ability to perform relevant comparisons.

methodsWe identified a cohort of infants with uncontrolled asthma and receiving ≥2 consecutive dispensations of any respiratory drug (R03 ATC classification) during a 6-month period. Uncontrolled asthma was identified either from exacerbations or from markers of acute loss of asthma control; date of occurrence of an event (exacerbation and/or acute loss of asthma control) was defined as index date. The study groups comprised infants receiving MTL-4 +/- ICS (MTL-4 group) or ICS without MTL-4 (ICS group) at index date. These two groups were matched on gender, age, quarter of index date, therapy before index date, past asthma-related hospitalization (ever), and were followed for 6 months. The outcome was the rate of infants with uncontrolled asthma, defined as above.

resultsThis pilot cohort study included 1,149 infants with asthma (mean age 14.1 months, 64% boys). Of these, 51 and 768 were assigned to the MTL-4 and ICS groups, respectively. Uncontrolled asthma occurred in 78.8% and 78.4% of infants in these groups, respectively (oral corticosteroids were dispensed to 49% and 61%, respectively). Assessment of uncontrolled asthma, exposure to MTL-4 and ICS, and occurrence of outcomes were achieved. For the development of matching criteria, we defined a new marker of severity (therapeutic typologies).

conclusionThese data support the feasibility of the final project, to be conducted on claims data from the whole French population. We also showed that, with appropriate methodology and by using valid criteria, French claims data are an adequate resource for conducting comparative effectiveness studies in pediatric asthma. Finally, the algorithm used to identify infants with asthma could be applied to other studies using claims data.

Indexed as

AcetatesAdministration, InhalationAdrenal Cortex HormonesAnti-Asthmatic AgentsAsthmaCohort StudiesCyclopropanesDatabases, FactualFemaleFranceHumansInfantMalePilot ProjectsQuinolinesSulfidesAcetatesAdrenal Cortex HormonesAnti-Asthmatic AgentsCyclopropanesmontelukastQuinolinesSulfides

Identifiers

PMID25934554
PMCPMC4450509

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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.