English Validation Drug Hypersensitivity Quality of Life Questionnaire
Research type
Research Study
Full title
The English version of the Drug Hypersensitivity Quality of Life Questionnaire: validity and reliability in the British Population.
IRAS ID
309652
Contact name
Patricia Romero
Contact email
Sponsor organisation
University Hospitals Leicester
Clinicaltrials.gov Identifier
151058, EDGE
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
Drug Hypersensitivity Reactions are the adverse effects of drugs taken at a dose which is tolerated by normal subjects and clinically resembles allergy .
It has been shown that patients with allergies have an impairment in their quality of life. Questionnaires have been developed to measure the impact of drug allergies on quality of life. One of the few studies in this topic showed that patients with drug allergies have reduced quality of life (QoL) and more anxiety. However, we don’t have the data in the UK as these questionnaires haven’t been yet translated and validated for English. An Italian group developed a specific questionnaire named Drug Hypersensitivity Quality of Life Questionnaire (DrHY-Q), that evaluates the impact of having a drug allergy in the quality of life of the patients. This questionnaire has been validated in different countries and languages such as Spanish, Portuguese, Thai, Turkish and Dutch.
We aim to develop the English version of this questionnaire and assess the validity and reliability of the English(UK) version of the DrHy-Q.
We have already received the authorisation from the developers of the original questionnaire for working on this validated translation. Now, in this study, we aim to validate the usage of this questionnaire in patients with a diagnosis of drug allergy.
The English questionnaire version will be filled by patients attended University Hospital of Leicester Adult Alllergy Service diagnosed with a drug allergy , we will also recruit patients from Leeds Teaching Hospital, Manchester University NHS Foundation Trust and St Bartholomew's Hospital, Barts Health NHS Trust.
We aim to complete the study within one year.
The stages of the project are translation and cross cultural adaptation of the original Italian Questionnaire, followed by the statistical analysis to prove its validity.REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
23/EM/0007
Date of REC Opinion
13 Mar 2023
REC opinion
Further Information Favourable Opinion