Oral Epithelial Dysplasia Informational Needs Questionnaire (ODIN-Q)

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Precancerous Conditions; Patient Engagement; Patient Participation; Oral Disease; Patient Satisfaction; Health Behavior; Precancerous Lesions; Oral Leukoplakia; Dental Diseases; Oral Lichen Planus; Dysplasia; Patient Preference; Information Seeking Behavior; Oral Epithelial Dysplasia; Oral Submucous Fibrosis; Oral Leukoplakia of Tongue; Oral Leukoplakia of Lips; Oral Leukoplakia of Gingiva; Oral Erythroplakia; Chronic Hyperplastic Candidosis; Oral Submucosal Fibrosis, Including of Tongue; Information Needs; Preference, Patient
• Intervention / Treatment: Other: No intervention is planned for this study

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 128

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, Wc1x 8ld
    • University College London Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants will be patients diagnosed with OED as per current standard diagnostic criteria.

Description

Inclusion Criteria:

• Adults aged 18 or above at the time of the screening visit.
• Good command of English language both written and spoken.
• Being able to consent.
• Diagnosed with OED by histopathological examination as per the 2017 classification of head and neck tumours by the World Health Organization.
• No concurrent malignancy in the head and neck or elsewhere.

Exclusion Criteria:

• Individuals under 18 years old.
• Unable to speak and read English.
• Concurrent malignancy in the head and neck or elsewhere.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with oral epithelial dysplasia; INCLUSION CRITERIA These include: Adults aged 18 or above at the time of the screening visit.; Good command of English language both written and spoken [this is necessary as questionnaires are in English and cannot be translated unless through a cross-cultural validation study].; Being able to consent.; Diagnosed with OED as per current standard diagnostic criteria.; No concurrent malignancy in the head and neck or elsewhere.

Other: No intervention is planned for this study; No intervention was/is planned for this study. The study is questionnaire-based (observational).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ODIN-Q validation	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 (Phase 1).	14 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlations between information needs and other variables measured in the study	To investigate the correlation between psychological variables (e.g. anxiety and depression), quality of life (QoL) and information needs by analysis of the data collected by ODIN-Q, Krantz Health Opinion Survey, Hospital Anxiety and Depression Scale, Modified Dental Anxiety Scale and the Oral Health Impact Profile-14 (phase 1).	14 months
Develop a patient information leaflet about oral epithelial dysplasia	To develop and assess the satisfaction with a patient information leaflet [PIL] about OED (phase 2).	14 months

Collaborators and Investigators

• Sponsor: University College, London
• Collaborators: University College London Hospitals

Publications and helpful links

General Publications

• Alsoghier A, Ni Riordain R, Fedele S, Porter S. Web-based information on oral dysplasia and precancer of the mouth - Quality and readability. Oral Oncol. 2018 Jul;82:69-74. doi: 10.1016/j.oraloncology.2018.05.003. Epub 2018 May 17.

Helpful Links

• Preparatory work to inform the current study

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2018
• Primary Completion (Actual): December 21, 2019
• Study Completion (Actual): December 21, 2019

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): April 2, 2020
• Last Update Submitted That Met QC Criteria: March 31, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Quality of Life; patient education; Patient Preference; Patient Participation; Patient Satisfaction; Dysplasia; Precancerous Conditions; Information Seeking Behavior; Oral Disease; oral epithelial dysplasia; Precancerous Lesions; Dental Diseases; information needs; patient information leaflet
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Pathological Conditions, Anatomical; Skin Diseases, Papulosquamous; Mouth Neoplasms; Lichenoid Eruptions; Fibrosis; Carcinoma in Situ; Hyperplasia; Mouth Diseases; Precancerous Conditions; Leukoplakia; Leukoplakia, Oral; Lichen Planus, Oral; Lichen Planus; Stomatognathic Diseases; Oral Submucous Fibrosis
• Other Study ID Numbers: 18/0203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No