A Patient Reported Outcome Measure for Vulval Conditions
Research type
Research Study
Full title
Development and Psychometric Analysis of a Patient Reported Outcome Measure for Patients Attending a Specialist Vulval Clinic
IRAS ID
272216
Contact name
TESSA HANLEY
Contact email
Sponsor organisation
The Liverpool University Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Vulval dermatoses (skin conditions) and vulval pain syndromes are a common occurrence in the dermatology clinic encompassing a very heterogeneous (wide ranging) group of conditions. These are known to have a considerable impact on quality of life, causing not only restrictions in physical functioning, but also having profound effects on sexual, social and psychological welfare. Whilst several quality of life measures have been created to measure the disease impact of general dermatological conditions, few have been specifically derived to assess the impact of vulval conditions. This is of importance because health related quality of life outcomes measures are being increasingly used in clinical practice in order to develop services and aid with clinical decision making. Furthermore it is vital to have a quality of life measure which accurately reflects the profound impact that vulval conditions have on a patients quality of life.
The aim of this study is to create a vulval specific quality of life measure, which will holistically cover all aspects of vulval disease. The quality of life measure created should be concise and practical, for use in any busy vulval dermatology clinic.
Patients will be recruited to take part in the research through their attendance at specialist vulval dermatology clinics across two secondary care centres. Patients who consent to take part will receive semi structured questionnaires which will ask a number of open-ended questions about aspects of their vulval condition that may have affected them. Based on these answers and professional consensus a new vulval specific quality of life measure will be developed, which will be trialled in clinic on consenting patients. The validity (how well something measures what it is supposed to) of this measure will be assessed through number of statistical tests.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
20/EM/0225
Date of REC Opinion
5 Jan 2021
REC opinion
Further Information Favourable Opinion