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
214012
Contact name
Mary Halter
Contact email
Sponsor organisation
St George’s, University of London
Duration of Study in the UK
0 years, 10 months, 31 days
Research summary
This is a feasibility study aiming to develop an assessment tool (questionnaire) to measure treatment efficacy in patients who have been diagnosed with a metabolic condition called Trimethylaminuria. This condition is characterized by an unpleasant smell resembling rotting fish and is also known as Fish Odour Syndrome.
The study will be conducted in three phases using quantitative (numerical) and qualitative (views of experts in the field and patients) data collection research methods.
In phase one, a potential list of questions, which will be generated from a qualitative study and findings from the literature, will be reviewed by experts in the field such as medical doctors and nurses.
The review process will be structured by using a qualitative research method called Modified Delphi technique. This method is a practical and structured method of obtaining opinions on a given question from a range of experts and is usually used to gain consensus among a group of experts that constitute the Delphi panel.
In phase two, patients diagnosed with Trimethylaminuria will be asked to complete the newly formed questionnaire from phase one of the study. 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 three, 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 before and after receiving treatment.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
16/LO/1860
Date of REC Opinion
21 Oct 2016
REC opinion
Unfavourable Opinion