Evidence map›Paper›PMID 38749694›Full record

ArticleBMJ open2024

Study protocol: the biologics in severe chronic rhinosinusitis with nasal polyps survey.

Valentin Favier, Clémentine Daveau, Florent Carsuzaa, Maxime Fieux, Clair Vandersteen, Laurent Castillo, Jean Francois Papon, Ludovic de Gabory, Nicolas Saroul, Benjamin Verillaud and 9 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05228041 (Real Life Assessment of Biologics Efficacy in Severe Chronic Rhinosinusitis With Nasal Polyps), which is not on this 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.

NCT05228041 active not recruitingnot on this map

Real Life Assessment of Biologics Efficacy in Severe Chronic Rhinosinusitis With Nasal Polyps

TypeobservationalSponsorUniversity Hospital, LilleRan2022 to 2027Enrolled100ConditionsChronic Rhinosinusitis With Nasal PolypsArmsBiologic treatments available in CRSwNP (dupilumab, mepolizumab and benralizumab according to their marketing approval)
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

19 authors.

Valentin FavierOtorhinolaryngology, Head and Neck Surgery and Maxillofacial Surgery department, CHU Montpellier, Montpellier, France.ORCID 0000-0002-7999-951X
Clémentine DaveauOtorhinolaryngology - Head and Neck department, Hospices civils de Lyon, F-69004 Lyon, France.
Florent CarsuzaaOtorhinolaryngology and Audiophonology department, CHU Poitiers, F-86000 Poitiers, France.
Maxime FieuxOtorhinolaryngology department, Centre Hospitalier Lyon-Sud, Pierre-Benite, France.ORCID 0000-0001-8317-2286
Clair VandersteenOtorhinolaryngology department, CHU Nice - Université Côte d'Azur, Nice, France.
Laurent CastilloOtorhinolaryngology department, CHU Nice - Université Côte d'Azur, Nice, France.
Jean Francois PaponOtorhinolaryngology - Head and neck department - Université Paris-Saclay, Assistance Publique - Hopitaux de Paris - Bicêtre Hospital, Paris, Île-de-France, France.
Ludovic de GaboryOtorhinolaryngology-Head and Neck Surgery department, CHU Bordeaux, Bordeaux, France.ORCID 0000-0003-0113-6121
Nicolas SaroulOtolaryngology Head and Neck Surgery department, CHU Clermont-Ferrand, Clermont-Ferrand, France.
Benjamin VerillaudOtorhinolaryngology department, Assistance Publique - Hopitaux de Paris - Lariboisière Hospital, Paris, Île-de-France, France.
Cécile RumeauOtorhinolaryngology - Head and Neck department, Université de Lorraine, CHU Nancy, F-54000 Vandoeuvre les Nancy, France.
Roger JankowskiOtorhinolaryngology - Head and Neck department, Université de Lorraine, CHU Nancy, F-54000 Vandoeuvre les Nancy, France.
Justin MichelOtorhinolaryngology- Head and Neck department, Aix-Marseille-University, Marseille, France.
Guillaume de BonnecazeOtorhinolaryngology - Head and Neck department, Larrey Hospital, Toulouse, France.
Jean-Baptiste LecanuOtorhinolaryngology - Head and Neck department, Arthur Vernes Institute, F-75006 Paris, France.
Andre CosteOtorhinolaryngology - Head and Neck department, AP-HP Henri Mondor Hospital, F-94010 Créteil, Île-de-France, France.
Emilie BéquignonOtorhinolaryngology - Head and Neck department, Centre Hospitalier Intercommunal Créteil, F-94010 Créteil, France.
Olivier MalardOtorhinolaryngology department, CHU Nantes, Nantes, France.
Geoffrey MortuaireOtorhinolaryngology - Head and neck department - U1286 - INFINITE - Institute for Translational Research in Inflammation, Huriez Hospital, F-59000 Lille, France geoffrey.mortuaire@chu-lille.fr.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionChronic rhinosinusitis with nasal polyps (CRSwNP) is a frequent condition affecting approximately 2% of the population. Medical treatment consists long-term use of intranasal corticosteroids and short-term use of oral corticosteroids, in adjunct with saline solution rinses. Surgical management is proposed in patients who failed after medical treatment. In France, two biologics are reimbursed in case of severe uncontrolled CRSwNP despite medical treatment and endoscopic sinus surgery. Waiting for head-to-head biologics comparison, studies should report the efficacy and safety of biologics in large real-life cohorts. This study protocol describes the aims and methods of a prospective, observational, national, multicentric cohort of patients with CRSwNP treated with biologics. METHODS AND ANALYSIS: The BIOlogics in severe nasal POlyposis SurvEy is a French multicentre prospective observational cohort study. The main aim is to assess the efficacy and tolerance of biologics in patients with CRSwNP, with or without association with other type 2 diseases, and to determine the strategies in case of uncontrolled disease under biologics. Patients over 18 years old requiring biologics for CRSwNP in accordance with its marketing approval in France (ie, severe nasal polyposis, with lack of control under nasal corticosteroid, systemic corticosteroids and surgery) are invited to participate. Collected data include topical history of surgical procedures and biologics, medication and use of systemic corticosteroids, visual analogical scales for specific symptoms, Sino-Nasal Outcome Test-22 questionnaire, nasal polyp score, asthma control test, Lund-Mackay score on CT scan and IgE concentration and eosinophilic count on blood sample.

trial registrationNCT05228041/DRI_2021/0030.

Indexed as

Biological ProductsNasal PolypsRhinitisSinusitisChronic DiseaseFranceHumansMulticenter Studies as TopicObservational Studies as TopicOmalizumabProspective StudiesRhinosinusitisBiological ProductsOmalizumabAdult otolaryngologyAsthmaEndoscopic surgeryIMMUNOLOGY

Identifiers

PMID38749694
PMCPMC11097834

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.