Early Prediction of Outcomes Following Optic Neuritis: Development and Acceptability of a Prognostic Tool

Visual Acuity (LogMAR)

Visual acuity (LogMAR) measured at first diagnosis of optic neuritis and at subsequent follow-up assessments.

Time frame: From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).

Visual Field Mean Deviation (dB)

Visual field mean deviation (Decibels) measured at first diagnosis of optic neuritis and at subsequent follow-up assessments

Time frame: From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).

Colour Vision (Number of Ishihara Plates Correctly Identified)

Colour vision assessed using Ishihara pseudoisochromatic plates and reported as the number of plates correctly identified.

Time frame: From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).

Number of Healthcare Consultations Following Optic Neuritis Diagnosis

Number of healthcare consultations attended following optic neuritis diagnosis, reported by consultation type, including primary care appointments, emergency department attendances, neuro-ophthalmology, neurology, and other relevant specialist clinics.

Time frame: 12 months

Number of Investigations Performed Following Optic Neuritis Diagnosis

Number of investigations performed following optic neuritis diagnosis, reported by investigation type, including OCT, visual field testing, MRI, VEP, blood tests, and CSF analysis.

Time frame: 12 months

Time to Diagnostic Investigations Following Optic Neuritis Diagnosis (Days)

Time interval (days) from optic neuritis diagnosis to each investigation, reported by investigation type.

Time frame: 12 months

Time to Treatment Following Optic Neuritis Diagnosis (Days)

Time interval (Days) from optic neuritis diagnosis to initiation of first treatment course, reported by treatment type.

Time frame: 12 months

Number of Treatment Episodes Following Optic Neuritis Diagnosis

Number of treatment episodes received following optic neuritis diagnosis, reported by treatment type (e.g. intravenous corticosteroids, oral corticosteroids, plasma exchange, intravenous immunoglobulin, disease-modifying therapies).

Time frame: 12 months

Health-Related Quality of Life (EuroQol 5-Dimension 5-Level Questionnaire [EQ-5D-5L])

Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L). The EQ-5D-5L descriptive system comprises five domains, each scored on five levels. Higher levels indicate worse health status and poorer health-related quality of life.

Time frame: Measured at baseline recruitment and repeated 3-12 months later

Vision-Related Quality of Life (National Eye Institute Visual Function Questionnaire-25 [NEI-VFQ-25])

Vision-related quality of life assessed using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) composite score. Scores range from 0 to 100, with higher scores indicating better vision-related quality of life.

Time frame: Baseline and repeated 3-12 months later

Optic Neuritis-Related Quality of Life (Semi-Structured Questionnaire)

Participant-reported optic neuritis-related quality of life and lived experiences, including symptoms, treatment impacts, emotional well-being, activities of daily living, social participation and personal relationships, explored using a bespoke semi-structured questionnaire

Time frame: Measured at baseline recruitment and repeated 3-12 months later

Fatigue (Patient-Reported Outcomes Measurement Information System [PROMIS] Fatigue 6a)

Fatigue assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 6a instrument. Raw scores are converted to T-scores with a mean of 50 and standard deviation of 10 in the reference population. Higher scores indicate greater fatigue (worse outcome).

Time frame: Baseline recruitment and repeated once 3-12 months later

Depression (Patient-Reported Outcomes Measurement Information System [PROMIS] Depression 4a)

Depression assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 4a instrument. Raw scores are converted to T-scores with a mean of 50 and standard deviation of 10 in the reference population. Higher scores indicate more severe depressive symptoms (worse outcome).

Time frame: Baseline recruitment and repeated once 3-12 months later

Work Productivity Loss (Adapted iMTA Productivity Cost Questionnaire [iPCQ])

Participant-reported work productivity loss associated with optic neuritis or related diseases, including absenteeism, presenteeism and changes to employment. Measured using the Adapted iMTA Productivity Cost Questionnaire (iPCQ)

Time frame: Baseline recruitment and repeated once 3-12 months later

Healthcare Resource Utilisation: Appointments, Emergency Department Attendances and Hospital Admissions (Adapted iMTA Medical Consumption Questionnaire [iMCQ])

Participant-reported utilisation of healthcare services related to optic neuritis or associated diseases, including appointments with healthcare professionals, emergency department attendances, and hospital admissions

Time frame: Baseline recruitment and repeated once 3-12 months later

Healthcare Resource Utilisation: Investigations and Treatment Interventions (Adapted iMTA Medical Consumption Questionnaire [iMCQ])

Participant-reported utilisation of diagnostic investigations and therapeutic interventions related to optic neuritis or associated diseases, including imaging, laboratory investigations, electrophysiological testing, and treatments received.

Time frame: Baseline recruitment and repeated once 3-12 months later

Informal Care Received (Hours)

Participant-reported hours of informal care received from family members, friends or acquaintances because of optic neuritis or associated diseases.

Time frame: Baseline recruitment and repeated once 3-12 months later

Out-of-Pocket Costs (Pounds Sterling)

Participant-reported personal expenditure related to optic neuritis and associated diseases in the first year after optic neuritis began (e.g. health insurance, prescription costs, optician/sight tests, low vision aids)

Time frame: Baseline recruitment and repeated once 3-12 months later

Knowledge, Attitudes and Practices/Behaviours Regarding Genetic Risk Prediction (KAP Questionnaire)

This will be explored using a knowledge, attitudes and practices/behaviour questionnaire to explore how participants feel about the use of genetic information to predict future health outcome risk including multiple sclerosis.

Time frame: Baseline recruitment and repeated at 3-12 months later