Developing a core outcome set for clinical trials in olfactory disorders: a COMET initiative
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216275%3A25520%2F23%3A39921189" target="_blank" >RIV/00216275:25520/23:39921189 - isvavai.cz</a>
Result on the web
<a href="https://www.rhinologyjournal.com/Abstract.php?id=3082" target="_blank" >https://www.rhinologyjournal.com/Abstract.php?id=3082</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.4193/Rhin22.116" target="_blank" >10.4193/Rhin22.116</a>
Alternative languages
Result language
angličtina
Original language name
Developing a core outcome set for clinical trials in olfactory disorders: a COMET initiative
Original language description
Statement of problem: Evaluating the effectiveness of the management of Olfactory Dysfunction (OD) has been limited by a paucity of high-quality randomised and/or controlled trials. A major barrier is heterogeneity of outcomes in such studies. Core outcome sets (COS) -standardized sets of outcomes that should be measured/reported as determined by consensus-would help overcome this problem and facilitate future meta-analyses and/or systematic reviews (SRs). We set out to develop a COS for interventions for patients with OD.Methods: A long-list of potential outcomes was identified by a steering group utilising a literature review, thematic analysis of a wide range of stakeholders'views and systematic analysis of currently available Patient Reported Outcome Measures (PROMs). A subsequent e-Delphi process allowed patients and healthcare practitioners to individually rate the outcomes in terms of impor-tance on a 9-point Likert scale.Results: After 2 rounds of the iterative eDelphi process, the initial outcomes were distilled down to a final COS including sub-jective questions (visual analogue scores, quantitative and qualitative), quality of life measures, psychophysical testing of smell, baseline psychophysical testing of taste, and presence of side effects along with the investigational medicine/device and patient's symptom log.Conclusions: Inclusion of these core outcomes in future trials will increase the value of research on clinical interventions for OD.We include recommendations regarding the outcomes that should be measured, although future work will be required to further develop and revalidate existing outcome measures.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30206 - Otorhinolaryngology
Result continuities
Project
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Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2023
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Rhinology
ISSN
0300-0729
e-ISSN
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Volume of the periodical
61
Issue of the periodical within the volume
4
Country of publishing house
NL - THE KINGDOM OF THE NETHERLANDS
Number of pages
8
Pages from-to
312-319
UT code for WoS article
001045995500001
EID of the result in the Scopus database
2-s2.0-85166383766