UK Registry of Eustachian Tube Balloon Dilation
Research type
Research Database
IRAS ID
284804
Contact name
Matthew Smith
Contact email
Research summary
UK Registry of Eustachian Tube Balloon Dilation
REC name
South West - Central Bristol Research Ethics Committee
REC reference
23/SW/0068
Date of REC Opinion
2 Jun 2023
REC opinion
Favourable Opinion
Data collection arrangements
Clinicians will use their account to register a patient using an NHS number that has been ‘hashed’ before submission to create a unique study ID. Hashing is a form of irreversible encryption used in many applications such as banking. All data entry by clinicians will be done online into the secure REDCap software set up for the database.
Clinicians will enter anonymised routinely collected data such as; basic demographics, symptoms, treatments previously used, examination and test findings and questionnaire results. Clinicians will also enter basic information about the way the operation was performed and the medical device used. Follow up information about treatment outcome (examination and questionnaire results) and any complications will be submitted.
Following registration on the database, patients agreeing to email address submission will be sent an email with the option to set up a personal REDCap account. Patients will be able to enter questionnaire data, and access the data they previously entered to track their own progress.
Clinicians will be contacted with a reminder email where initial follow up data are missing. Patients will receive an email and a reminder to enter data if not initially doing so at 3, 12 and 24 months.
Research programme
Obstructive Eustachian tube dysfunction (OETD) is a very common condition for which many patients seek treatment. Balloon dilation of the Eustachian tube (BDET) is approved for use in the UK as a treatment for OETD but a lack evidence has meant that it remains difficult for clinicians and patients to know who the technique may benefit, and what the associated risks and success rates may be. It is also not known how variations in the surgical technique may impact on patient outcome. An online research database is therefore proposed to collect data from all BDET cases performed within the UK, compiling both routinely collected data, and additional patient-submitted data from consenting individuals. The database will be analysed on a regular basis with results released to contributors for clinical governance. Once a large enough data set has been acquired the study committee will perform an in-depth analysis, and disseminate findings to support policy making and research into ways to improve the technique, or improve patient selection to ensure that only those who will benefit receive the treatment. Working with patient representatives we will develop a patient leaflet outlining the dilation procedure, and summarising the database and other published outcome data.
Research database title
UK Registry of Eustachian Tube Balloon Dilation
Establishment organisation
Cambridge University Hospitals NHS Foundation Trust
Establishment organisation address
Hills Road
Cambridge
CB2 0QQ