Quality of Life Clinical Trial
Official title:
Development of an Oral Epithelial Dysplasia Informational Needs Questionnaire
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: To evaluate the psychometric properties of the Oral Epithelial Dysplasia
Informational Needs Questionnaire (ODIN-Q), developed and revised in the preliminary work for
the proposed study, in a cohort of patients with OED.
Timescale: 19 months.
Clinical significance: This questionnaire can be useful in clinical practice. It could help
to meet the patient's information needs and plan educational interventions for those showing
unmet needs.
Oral epithelial dysplasia (OED) is a disease associated with an increased risk of oral cancer
between 6% and 36% compared to disease-free individuals. In the United Kingdom, oral cancer
is among the 15 most common cancers, with approximately 6,000 new cases per year and these
numbers are expected to rise in the few coming years.
Research showed the importance of patient education and the provision of information in
shared-decision making and management of chronic and cancer-linked disease such as perhaps
OED. However, patients may not be satisfied with the information provided by healthcare
professionals, despite the extensive nature of the information provided. Having unmet
informational needs may associate with higher anxiety levels which in turn could affect the
patient's well-being and cooperation with the treatment provided.
Avoiding these undesirable health outcomes requires the delivery of tailored and
patient-centred care that provides information based on what patients truly need and prefer.
One increasingly common method to do so is to obtain this information by informational needs
questionnaires. These questionnaires have been developed for other medical conditions
including chronic diseases and some cancers, but none of these is known to be appropriate to
use for OED specifically. Hence, a specific tool to determine the informational needs and
preferences of patients with OED may help to achieve these objectives effectively. The data
collected by this tool may help to acknowledge the impact of the illness on physical and
psychological well-being. Furthermore, this data could be used to produce a source of OED
information (such as a patient information leaflet) that reflects the IN of this patient
population.
In the preliminary work for this study, the Oral Epithelial Dysplasia Informational Needs
Questionnaire (ODIN-Q) was developed by adopting existing valid and reliable instruments that
explore the information need of patients with potentially malignant disease elsewhere in the
body, using experts input. The questions were then formulated and tested for content validity
by clinicians (n=12) and patients (n=5), with unclear, irrelevant, redundant, and
unacceptable items omitted. The final 35-item ODIN-Q includes two scales: (1) amount of
information already received (too much, enough, not enough and none) and (2) degree of
importance of the information (very, yes, not very, not at all).
Thus, the objectives of this study are to (1) test the newly developed 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.
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