RCTs in tuberculosis treatment: patient perception and choice
Research type
Research Study
Full title
Randomized controlled trials in tuberculosis treatment. I. Patient perception and choice. An INTERTBLondon study.
IRAS ID
191554
Contact name
Graham Bothamley
Contact email
Sponsor organisation
Homerton University Hospital Foundation Trust
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
The best evidence for a new treatment is gained when patients do not know whether they will have the treatment or not. This is done by a process called “blinded randomization”, so that the doctors themselves also do not know whether the patient is having the treatment or not. However, this lack of choice can scare some patients. This may be especially true of patients with tuberculosis (TB), due to the stigma of the disease, their vulnerability as many are disadvantaged and their understanding of clinical trials. To prepare for treatment trials in tuberculosis in London, we need to know how patients feel about randomization and indeed whether their choice is sufficiently random on its own.
Patients will see the possible choice of tablets, a patient information sheet and then be asked: a) which course they would prefer if it were available; b) how likely they were to take part in randomization by marking on a line (a visual analogue scale); c) their preference for choice or randomization by marking on a line (a visual analogue scale). They would have the opportunity to make any comments. Routine clinical details would be recorded. They would also be asked about their understanding of English and their education. This would occur at 2 months, when the treatment normally changes and also at the end of standard treatment for TB.
We will then be able to measure how acceptable a treatment trial for the 2nd phase of TB treatment will be.REC name
East of England - Essex Research Ethics Committee
REC reference
15/EE/0473
Date of REC Opinion
11 Dec 2015
REC opinion
Favourable Opinion