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| ID | Type | Description | Link |
|---|---|---|---|
| 222 | Other Grant/Funding Number | MS Society UK |
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| Name | Class |
|---|---|
| Guy's and St Thomas' NHS Foundation Trust | OTHER |
| King's College Hospital NHS Trust | OTHER |
| Moorfields Eye Hospital NHS Foundation Trust | OTHER |
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The goal of this observational study is to determine whether genetic information, together with clinical information, can be used to improve prediction of future multiple sclerosis (MS) diagnosis after a first-time episode of optic neuritis. The study will also investigate visual outcomes, quality of life, healthcare use, and the acceptability of using genetic information to predict future health outcomes in people with optic neuritis.
The main outcomes that we aim to assess are:
If consented, participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants Who Have Experienced Optic Neuritis | Participants with a history of a first episode of optic neuritis recruited from the 3 participating NHS hospitals. Participants will undergo retrospective review of clinical records, complete questionnaires, and may provide a saliva sample for genetic analysis. Participants will be invited to consent to longer term prospective outcome assessment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention: Observational Cohort | Other | Not applicable - No intervention as this is an observation study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incident Multiple Sclerosis Diagnosis Following a First Episode of Optic Neuritis | Occurrence of a diagnosis of multiple sclerosis following a first episode of optic neuritis. | Extracted from retrospective record at baseline, and reviewed before study end to capture any new events occurring during the 12 month study period. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity (LogMAR) | Visual acuity (LogMAR) measured at first diagnosis of optic neuritis and at subsequent follow-up assessments. | From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years). |
| Visual Field Mean Deviation (dB) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants aged 16 and above with a history of a first episode of optic neuritis recruited from one of the three participating NHS sites in London (Guy's and St Thomas' NHS Foundation Trust, King's College Hospital NHS Foundation Trust and Moorfields Eye Hospital NHS Foundation Trust)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tasanee Braithwaite, Doctor of Medicine (Oxon) | Contact | +44 20 7188 7188 | tasanee.braithwaite@kcl.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Tasanee Braithwaite | King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moorfields Eye Hospital NHS Foundation Trust | London | EC1V 2PD | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36932161 | Background | Panthagani J, O'Donovan C, Aiyegbusi OL, Liu X, Bayliss S, Calvert M, Pesudovs K, Denniston AK, Moore DJ, Braithwaite T. Evaluating patient-reported outcome measures (PROMs) for future clinical trials in adult patients with optic neuritis. Eye (Lond). 2023 Oct;37(15):3097-3107. doi: 10.1038/s41433-023-02478-z. Epub 2023 Mar 17. | |
| 32200476 |
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DNA
Visual field mean deviation (Decibels) measured at first diagnosis of optic neuritis and at subsequent follow-up assessments |
| 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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 | 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). | 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). | 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) | 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 | 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. | 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. | 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) | 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. | Baseline recruitment and repeated at 3-12 months later |
| Guy's and St Thomas' NHS Foundation Trust | London | SE1 7EH | United Kingdom |
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| King's College Hospital NHS Foundation Trust | London | SE5 9RS | United Kingdom |
|
| Braithwaite T, Wiegerinck N, Petzold A, Denniston A. Vision Loss from Atypical Optic Neuritis: Patient and Physician Perspectives. Ophthalmol Ther. 2020 Jun;9(2):215-220. doi: 10.1007/s40123-020-00247-9. Epub 2020 Mar 21. |
| 38867071 | Background | Laviers H, Petzold A, Braithwaite T. How far should I manage acute optic neuritis as an ophthalmologist? A United Kingdom perspective. Eye (Lond). 2024 Aug;38(12):2238-2245. doi: 10.1038/s41433-024-03164-4. Epub 2024 Jun 12. |
| 31740484 | Background | Petzold A, Braithwaite T, van Oosten BW, Balk L, Martinez-Lapiscina EH, Wheeler R, Wiegerinck N, Waters C, Plant GT. Case for a new corticosteroid treatment trial in optic neuritis: review of updated evidence. J Neurol Neurosurg Psychiatry. 2020 Jan;91(1):9-14. doi: 10.1136/jnnp-2019-321653. Epub 2019 Nov 18. No abstract available. |
| 33017023 | Background | Braithwaite T, Subramanian A, Petzold A, Galloway J, Adderley NJ, Mollan SP, Plant GT, Nirantharakumar K, Denniston AK. Trends in Optic Neuritis Incidence and Prevalence in the UK and Association With Systemic and Neurologic Disease. JAMA Neurol. 2020 Dec 1;77(12):1514-1523. doi: 10.1001/jamaneurol.2020.3502. |
| 38418465 | Background | Loginovic P, Wang F, Li J, Ferrat L, Mirshahi UL, Rao HS, Petzold A, Tyrrell J, Green HD, Weedon MN, Ganna A, Tuomi T, Carey DJ; UKBB Eye & Vision Consortium; FinnGen; Geisinger-Regeneron DiscovEHR Collaboration; Oram RA, Braithwaite T. Applying a genetic risk score model to enhance prediction of future multiple sclerosis diagnosis at first presentation with optic neuritis. Nat Commun. 2024 Feb 28;15(1):1415. doi: 10.1038/s41467-024-44917-9. |
| ID | Term |
|---|---|
| D009902 | Optic Neuritis |
| D009103 | Multiple Sclerosis |
| D009471 | Neuromyelitis Optica |
| D012507 | Sarcoidosis |
| D000096442 | Genetic Risk Score |
| ID | Term |
|---|---|
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009188 | Myelitis, Transverse |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D020022 | Genetic Predisposition to Disease |
| D004198 | Disease Susceptibility |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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