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.
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
B.F. van Esch, MD
PhD Candidate Apeldoorn Dizziness Centre
Albert Schweitzerlaan 31
7334 DZ Apeldoorn The Netherlands
- COS for clinical trials or clinical research
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.