ODIN-Q Information Needs in Oral Epithelial Dysplasia (V1.0)
Research type
Research Study
Full title
Development and Validation of an Oral Epithelial Dysplasia Informational Needs Questionnaire
IRAS ID
242552
Contact name
Richeal Ni Riordain
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2018/05/158, Data Protection number
Duration of Study in the UK
1 years, 6 months, 20 days
Research summary
Background: Oral epithelial dysplasia (OED) is a condition with an increased risk of oral cancer. Due to the current changes in the factors associated with these diseases (because of human papillomavirus), it is expected that those who have no history of smoking or alcohol, young (<50 years old), and white male would be commonly affected. Those individuals require a higher need for information, preferred a more active role in decision-making, and have a longer lifespan than older individuals. There remain no detailed studies of whether the informational needs delivered to patients with OED met their needs or indeed what information such patient may wish. A few tools are available to evaluate the IN of patients with head and neck disorders. However, the items of these instruments were dedicated to a particular disease (e.g. cancer) and hence are not applicable to be used for OED.
Project aims: The primary objective of this study is to (1) test the newly developed Oral Epithelial Dysplasia Informational Needs Questionnaire (ODIN-Q) in a cohort of patients with OED; (2) to investigate the correlations between patients' informational needs and both of psychological variables (e.g. anxiety and depression) and quality of life; and (3) to develop and a Patient Information Leaflet [PIL] for OED based on patients' needs and preferences.
Timescale: 19 months.
Clinical significance: This questionnaire can be useful in the clinical practice. It could help to meet the patient’s information needs and plan educational interventions for those showing unmet needs. Being supported with appropriate information about the disease is important to help patients making their informed decisions about management plans and reduce uncertainty.
REC name
London - City & East Research Ethics Committee
REC reference
18/LO/1340
Date of REC Opinion
6 Aug 2018
REC opinion
Further Information Favourable Opinion