Feasibility study of a Novel Efficacy Assessment Tool (NEAT)
Research type
Research Study
Full title
Feasibility study of a novel assessment tool measuring treatment efficacy in patients suffering from Trimethylaminuria. A mixed methods exploratory study.
IRAS ID
224441
Contact name
Mary Halter
Contact email
Sponsor organisation
St George’s, University of London
Duration of Study in the UK
0 years, 4 months, 0 days
Research summary
The aim of this study is to assess the feasibility, validity and reliability of an assessment tool which aims to provide a quantitative measure of treatment efficacy in patients diagnosed with a metabolic condition called Trimethylaminuria (TMAU). This condition is characterised by an unpleasant smell resembling rotting fish and is also known as Fish Odour Syndrome.
The study will be conducted in two phases using quantitative (numerical ratings by patients) and qualitative (views of patients) data collection research methods.
In phase one, patients already diagnosed with Trimethylaminuria will be asked to complete a newly formed questionnaire which was co-produced by the researchers and 18 ‘experts’ in TMAU (people living with TMAU, medical consultants and dieticians) using a Modified Delphi technique (a practical and structured method of obtaining opinions on a given question from a range of experts).
Following the completion of the questionnaire the patients will be invited to an interview during which they will have an opportunity to express their views on how acceptable and easy it was to complete the questionnaire and make suggestions on how to improve it.
In phase two, the questionnaire will be assessed for its reliability using a quantitative statistical test called Ordinal Alpha and explore the feasibility of recruiting newly diagnosed patients with Trimethylaminuria (as it is a rare condition) to complete the questionnaire on three occassions:
- to fill in the same questionnaire on two consecutive days to assess how reliable this assessment tool is
- and again three months later to see if the questionnaire can pick up any changes about the condition.REC name
London - Surrey Borders Research Ethics Committee
REC reference
17/LO/0600
Date of REC Opinion
27 Apr 2017
REC opinion
Favourable Opinion