-
Je něco špatně v tomto záznamu ?
Developing a core outcome set for clinical trials in olfactory disorders: a COMET initiative
C. Philpott, K. Kumaresan, AW. Fjaeldstad, A. Macchi, G. Monti, J. Frasnelli, I. Konstantinidis, J. Pinto, J. Mullol, J. Boardman, J. Vodicka, E. Holbrook, VR. Ramakrishnan, M. Lechner, T. Hummel
Jazyk angličtina Země Nizozemsko
Typ dokumentu přehledy, časopisecké články
Odkazy
PubMed
37243690
DOI
10.4193/rhin22.116
Knihovny.cz E-zdroje
- MeSH
- delfská metoda MeSH
- hodnocení výsledků zdravotní péče MeSH
- kvalita života * MeSH
- lidé MeSH
- poruchy čichu * diagnóza terapie MeSH
- stanovení cílového parametru MeSH
- výsledek terapie MeSH
- výzkumný projekt MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
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 importance 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 subjective 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.
2nd ORL Department Aristotle University Thessaloniki Greece
5th Sense UK Charity Bicester United Kingdom
Department of Anatomy Universitat du Quebec a Trois Rivieres Canada
Department of Biomedicine Aarhus University Denmark
Department of Otolaryngology Head and Neck Surgery Indiana University School of Medicine Indiana
ENT University of Insubria Italian Academy of Rhinology Varese Italy
James Paget University Hospital Great Yarmouth United Kingdom
Section of Otolaryngology Head and Neck Surgery The University of Chicago Chicago IL USA
- 000
- 00000naa a2200000 a 4500
- 001
- bmc23016737
- 003
- CZ-PrNML
- 005
- 20231026105604.0
- 007
- ta
- 008
- 231013s2023 ne f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.4193/Rhin22.116 $2 doi
- 035 __
- $a (PubMed)37243690
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a ne
- 100 1_
- $a Philpott, C $u James Paget University Hospital, Great Yarmouth, United Kingdom
- 245 10
- $a Developing a core outcome set for clinical trials in olfactory disorders: a COMET initiative / $c C. Philpott, K. Kumaresan, AW. Fjaeldstad, A. Macchi, G. Monti, J. Frasnelli, I. Konstantinidis, J. Pinto, J. Mullol, J. Boardman, J. Vodicka, E. Holbrook, VR. Ramakrishnan, M. Lechner, T. Hummel
- 520 9_
- $a 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 importance 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 subjective 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.
- 650 _2
- $a lidé $7 D006801
- 650 12
- $a kvalita života $7 D011788
- 650 _2
- $a výzkumný projekt $7 D012107
- 650 _2
- $a delfská metoda $7 D003697
- 650 _2
- $a stanovení cílového parametru $7 D023381
- 650 _2
- $a hodnocení výsledků zdravotní péče $7 D017063
- 650 12
- $a poruchy čichu $x diagnóza $x terapie $7 D000857
- 650 _2
- $a výsledek terapie $7 D016896
- 655 _2
- $a přehledy $7 D016454
- 655 _2
- $a časopisecké články $7 D016428
- 700 1_
- $a Kumaresan, K $u James Paget University Hospital, Great Yarmouth, United Kingdom
- 700 1_
- $a Fjaeldstad, A W $u Flavour Clinic, University Clinic for Flavour, Balance and Sleep, Department of Otorhinolaryngology, Regional Hospital Godstrup, Denmark
- 700 1_
- $a Macchi, A $u ENT University of Insubria, Italian Academy of Rhinology, Varese, Italy
- 700 1_
- $a Monti, G $u Department of Biomedicine, Aarhus University, Denmark
- 700 1_
- $a Frasnelli, J $u Department of Anatomy, Universitat du Quebec a Trois-Rivieres, Canada
- 700 1_
- $a Konstantinidis, I $u 2nd ORL Department, Aristotle University, Thessaloniki, Greece
- 700 1_
- $a Pinto, J $u Section of Otolaryngology-Head and Neck Surgery, The University of Chicago, Chicago, IL, USA
- 700 1_
- $a Mullol, J $u Rhinology Unit and Smell Clinic, Hospital Clinic Barcelona, IDIBAPS, Universitat de Barcelona, CIBERES, Barcelona, Catalonia, Spain
- 700 1_
- $a Boardman, J $u Fifth Sense UK Charity, Bicester, United Kingdom
- 700 1_
- $a Vodicka, J $u Department of Otorhinolaryngology and Head and Neck Surgery, Regional Hospital and University of Pardubice, Czech Republic; Department of Otorhinolaryngology and Head and Neck Surgery, Regional Hospital and Faculty of Heath Studies, University of Pardubice, Czech Republic
- 700 1_
- $a Holbrook, E $u Department of Otolaryngology, Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, MA, USA
- 700 1_
- $a Ramakrishnan, V R $u Department of Otolaryngology-Head and Neck Surgery, Indiana University School of Medicine, Indiana
- 700 1_
- $a Lechner, M $u Division of Surgery and Interventional Science and UCL Cancer Institute, University College London and Barts Health NHS Trust, United Kingdom
- 700 1_
- $a Hummel, T $u Smell and Taste Clinic, Department of Otorhinolaryngology, Technische Universitat Dresden, Dresden Germany
- 773 0_
- $w MED00004229 $t Rhinology $x 0300-0729 $g Roč. 61, č. 4 (2023), s. 312-319
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/37243690 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y - $z 0
- 990 __
- $a 20231013 $b ABA008
- 991 __
- $a 20231026105559 $b ABA008
- 999 __
- $a ok $b bmc $g 2000326 $s 1203099
- BAS __
- $a 3
- BAS __
- $a PreBMC-MEDLINE
- BMC __
- $a 2023 $b 61 $c 4 $d 312-319 $e 2023Aug01 $i 0300-0729 $m Rhinology $n Rhinology $x MED00004229
- LZP __
- $a Pubmed-20231013