Developing a core outcome set for clinical trials in olfactory disorders: a COMET initiative

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • C Philpott - , James Paget University Hospitals NHS Foundation Trust (Author)
  • K Kumaresan - , James Paget University Hospitals NHS Foundation Trust (Author)
  • A W Fjaeldstad - , University Clinic for Flavour (Author)
  • A Macchi - , University of Insubria (Author)
  • G Monti - , Aarhus University (Author)
  • J Frasnelli - , University of Quebec (Author)
  • I Konstantinidis - , Aristotle University of Thessaloniki (Author)
  • J Pinto - , The University of Chicago (Author)
  • J Mullol - , Barcelona Institute for Global Health (ISGlobal) Hospital Clínic (Author)
  • J Boardman - , Fifth Sense (Author)
  • J Vodička - , Regional Hospital and University of Pardubice (Author)
  • E Holbrook - , Harvard Medical School (HMS) (Author)
  • V R Ramakrishnan - , Indiana University School of Medicine (IUSM) (Author)
  • M Lechner - , University College London, Barts Health NHS Trust (Author)
  • T Hummel - , Department of Otorhinolaryngology, Head and Neck Surgery, University of East Anglia (Author)

Abstract

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.

Details

Original languageEnglish
Pages (from-to)312-319
Number of pages8
JournalRhinology
Volume61
Issue number4
Early online date27 May 2023
Publication statusPublished - 1 Aug 2023
Peer-reviewedYes

External IDs

Scopus 85166383766
WOS 001045995500001
unpaywall 10.4193/rhin22.116
Mendeley 1ee67e18-372f-3dfb-afff-e0c52ac787fb
ORCID /0000-0001-9713-0183/work/146645674

Keywords

ASJC Scopus subject areas

Keywords

  • Delphi Technique, Endpoint Determination, Humans, Olfaction Disorders/diagnosis, Outcome Assessment, Health Care, Quality of Life, Research Design, Treatment Outcome, Outcome measurement, Effectiveness trial, Core outcome set, Smell, Olfactory dysfunction

Library keywords