Evidence map›Paper›PMID 40358656›Full record

ArticleEuropean archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery2025

Off-label drugs in laryngology- what should the doctor and the patient know about such therapies? A consensus statement of the European Laryngological Society.

Malgorzata Wierzbicka, Renata Kopczyk, Michal Zabrodsky, Cesare Piazza, Gauthier Desuter, Peter Klussmann, Ahmed Geneid, Frederic Dikkers

Abstract readConsensus Statement
PubMed Full text at PMC Publisher
In one paragraph

Article in European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

8 authors.

Malgorzata Wierzbicka *Research & Development Centre, Regional Specialist Hospital Wroclaw, Wroclaw, Poland.
Renata Kopczyk *Faculty of Management, Wroclaw University of Science and Technology, Wroclaw, Poland.
Michal ZabrodskyDepartment of Otorhinolaryngology and Head and Neck Surgery, First Faculty of Medicine, University Hospital Motol, Charles University, Prague, Czech Republic. michal.zabrodsky@fnmotol.cz.ORCID http://orcid.org/0000-0003-0296-2708
Cesare PiazzaUnit of Otorhinolaryngology-Head and Neck Surgery, ASST-Spedali Civili of Brescia, Brescia, Italy.
Gauthier DesuterENT, Head and Neck Surgery, Antwerp University Hospital, Edegem, Belgium.
Peter KlussmannDepartment of Otorhinolaryngology, Head and Neck Surgery, Medical Faculty, University of Cologne, Cologne, Germany.
Ahmed GeneidDepartment of Otolaryngology and Phoniatrics-Head and Neck Surgery, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.
Frederic DikkersDepartment of Otorhinolaryngology-Head and Neck Surgery, Amsterdam UMC Location AMC, University of Amsterdam, Amsterdam, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeOff-label drugs are being used in laryngology. Prescribing of a medicinal product is a decision taken within the relationship between a patient and his/her treating health care provider (HCP). The purpose of this article is to discuss the medicolegal aspects of off-label drug use, to provide recommendations for obtaining informed patient consent for off-label treatment and to propose the place and role of scientific societies and specialist boards in shaping good practices in this area. The final aim is to present recommendations concerning off-label usage and propose special clauses in informed patients consent.

methodsThe literature was reviewed regarding off-label applications in laryngology. Practical information on off-label use in various EU countries was collected.

resultsRegistration data and pharmacokinetics of cidofovir, bevacizumab, Gardasil

conclusionA patient's precise, explicit consent for the procedures including off-label drugs administration is mandatory. The second prerequisite is defining a need for creating based on recommendations by national or international scientific societies.

Indexed as

Informed ConsentOff-Label UseOtolaryngologyEuropeHumansSocieties, MedicalBevacizumabCidofovirGardasil®Hyaluronic acidLegislationMitomycin

Identifiers

PMID40358656
PMCPMC12122640

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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.