Validation of the English Version of the Drug Hypersensitivity Quality of Life Questionnaire

July 22, 2024 updated by: University Hospitals, Leicester

The English Version of the Drug Hypersensitivity Quality of Life Questionnaire: Validity and Reliability in the British Population.

We aim to validate the English (UK) translation of the DrHy-Q, and test its reliability in the UK population. This will facilitate for the subsequent economical evaluation of penicillin allergy delabelling.

This research project is part of an MSc in Allergy undertaken by the principal applicant, Dr Patricia Romero, supervised through Imperial College London.

Target population are patients with a drug allergy diagnosed by an Allergist prospectively at the Drug Allergy Clinic.

Is the English version of the Drug Hypersensitivity Quality of Life Questionnaire suitable to be used in the UK population?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

146

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Leicester, United Kingdom, LE39QP
        • University Hospitals Leicester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Our target population are patients with diagnosed drug allergy.

Description

Inclusion Criteria:

  • • Age >18 years

    • Ability to read English and consent.
    • Confirmed diagnosis of a drug hypersensitivity reaction.
    • Written informed consent

Exclusion Criteria:

  • • < 18y/o.

    • Not able to read English. No mental capacity to consent or unwilling to consent.
    • Unconfirmed diagnosis of a drug hypersensitivity reaction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of the English version of the Drug Hypersensitivity Questionnaire
Time Frame: March 2023 May 2024
Reliability and validity
March 2023 May 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals, Leicester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2023

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

July 22, 2024

First Submitted That Met QC Criteria

July 22, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Actual)

July 26, 2024

Last Update Submitted That Met QC Criteria

July 22, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 151058

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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