Development of a core outcome set for clinical trials in Menière’s disease – a pilot survey of healthcare professionals and patients.

In clinical trials in Menière’s disease, assessment of the vertigo attack frequency is frequently measured, whilst the functional status, the quality of life (QoL), and long-term treatment effects are more rarely assessed. There is no uniformity across studies in the selection and measurement of outcomes within the domain of Menière’s disease. The development of a core outcome set has the potential to reduce heterogeneity between trials, lead to research that is more likely to have measured relevant outcomes including patient relevant outcomes and may ensure future trials contribute clinically relevant and usable information.
The aim of the current study is to pilot and develop a method to identify outcomes of relevance when evaluating the effects of interventions in future clinical trials for patients suffering from Menière’s disease.


Principal Investigator/supervisor
P.P.G. van Benthem, MD, Phd, Professor
Head of Department of ORL-HNS
Leiden University Medical Centre
PO Box 9600
2300 RC Leiden The Netherlands

Coordinating investigator
B.F. van Esch, MD
PhD Candidate Apeldoorn Dizziness Centre
Albert Schweitzerlaan 31
7334 DZ Apeldoorn The Netherlands

Further Study Information

Current Stage: Completed – pending publication
Date: February 2015 - October 2015
Funding source(s): This work was supported solely from institutional and/or departmental sources from the Leiden University Medical Centre, PO Box 9600 2300 RC Leiden The Netherlands and the Apeldoorn Dizziness Centre, Gelre Hospital, Albert Schweitzerlaan 31, 7334 DZ Apeldoorn, The Netherlands.

Health Area

Disease Category: Ear, nose, & throat

Disease Name: Menière’s disease

Target Population

Age Range: 18 - 90

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Conference participants
- Consumers (caregivers)
- Patient/ support group representatives
- Researchers

Study Type

- COS for clinical trials or clinical research


- Survey

Healthcare professionals (such as ENT-surgeons, General Practitioners, neurologists, audiologists, psychologists, committee members of Dutch associations for patients with Menière’s disease) and patients with Menière’s disease were asked to fill in an online survey to identify outcomes they considered relevant when reporting on efficacy of interventions in Menière’s disease. Participants were asked to the define the three most important outcomes in scientific research through open and closed questions.

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