Sexual Function Patient Reported Outcome Measure
Research type
Research Study
Full title
Development of a Sexual Function Patient Reported Outcome Measure (sex-PROM)
IRAS ID
336371
Contact name
Phil Tozer
Contact email
Sponsor organisation
London North West University NHS Trust
Duration of Study in the UK
1 years, 10 months, 1 days
Research summary
Sexual dysfunction after surgery involving the digestive system is common, however rarely discussed, investigated or treated within the hospital setting. A recent patient survey found that these surgeries can have a significant impact on the sexual lives of patients. Whilst traditional research has focused on easy-to-measure outcomes, such as morbidity, mortality or disease recurrence, we hope to direct attention towards the assessment of sexual function.
Our aim is to create a diagnostic tool that can be used to measure sexual function in patients undergoing benign pelvic colorectal surgery. This tool will help counsel patients before surgery regarding the risks of sexual dysfunction, in addition to being a useful tool of assessment within clinical research.
The study will be conducted from St Mark’s Hospital and the development of the instrument will involve patients who have undergone benign pelvic colorectal surgery. The study is expected to be carried out over two years.
A review of existing sexual function measurement instruments will be undertaken. This will include an assessment of their overall quality, in addition to how helpful and valuable they are for improving patient care and quality of life. This will be followed by patient interviews to identify key items to include in the new instrument. Expert input will be used to modify and combine items into a comprehensive questionnaire. This draft will undergo further pilot testing amongst a small group of patients. This will ensure that the instrument captures all important concepts and is understandable and relevant. Patients will be able to suggest further changes, which will be included at this stage.
The instrument will then undergo further retesting amongst a larger group of participants. Statistical tests will be carried out to ensure that the item is reliable and measures accurately what we intended it to measure.
REC name
Wales REC 6
REC reference
24/WA/0020
Date of REC Opinion
23 Jan 2024
REC opinion
Favourable Opinion