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Defining disease and outcome measures

Presenting Author: Mahmood Bhutta

Published online by Cambridge University Press:  03 June 2016

Mahmood Bhutta*
Affiliation:
Royal National Throat Nose and Ear Hospital
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Abstract

Type
Abstracts
Copyright
Copyright © JLO (1984) Limited 2016 

Learning Objectives: A review of diseases hypothesised to be due to disorder of the Eustachian tube and a critical review of disease classification. Discussion of future research on tuboplasty, including disease categorisation and outcome measures.

This is for the round table on “Balloon Tuboplasty”

For any treatment it is important that we define and segregate the disease(s) being treated, and evaluate effectiveness in terms of benefit to patient symptoms. Eustachian tuboplasty is a relatively new treatment for disorders of the middle ear, but to date most of the published literature has failed to segregate disease being treated, nor report on relevant outcomes.

I present a synopsis of diseases hypothesised to be due to an underlying dysfunction of the Eustachian tube. I argue that in most of the published literature such diseases are conflated (for example disorders classified under disorders of the Eustachian tube include glue ear, tympanic membrane retraction, and symptoms of aural fullness) but should be segregated. I suggest a nosology with disorders classified under “mucosal otitis media”, “squamous middle ear disease”, and “Eustachian Tube Dysfunction”, with the latter classification based upon a recent consensus statement. There is an inter-relation between such disease categories. However there is little evidence that a disorder of the Eustachian tube is the primary or initiating pathology underlying all of these diseases.

Whether the Eustachian tube is or is not a pathological mechanism for these diseases may be debated, but is largely irrelevant to the evaluation of treatment. Outcomes need to be reported with segregation of disease categories (as much as possible), and using patient reported outcome measures. Such measures may include hearing disability, otorrhoea, otalgia, aural fullness, and disease-specific or general quality of life.

This is a critical consideration in future trials of Eustachian tuboplasty if we are to better understand and define the role of this novel treatment.