Prodromal Multiple Sclerosis: The PrOMS Study.

Project number: 
14-073
Approval date: 
Wednesday, August 6, 2014
Principal Investigator: 
Tremlett,Helen
Institution: 
University of British Columbia (UBC)
Funding Agency: 
National Multiple Sclerosis Society
Datasets requested: 
Hospital Separations (BC Ministry of Health)
consolidation - census geocodes
Mental Health (BC Ministry of Health)
MSP Registration & Premium Billing(BC Ministry of Health)
Consolidation - demographic (Ministry of Health)
Deaths (BC Vital Statistics Agency)
Medical Services Plan (BC Ministry of Health)
Consolidation registry (Ministry of Health)
PharmaNet
Research objective: 

Broad Study Aim:

Our study aims to investigate the period before diagnosis and identify a pre-MS trait, or prodrome.

Broad Study Hypotheses:

Among persons destined to be diagnosed with MS, after adjustment for possible confounders, we hypothesize that prodromal phase I (period before recognized symptoms of MS) will manifest a measurable signature, distinct from the matched general population or diseased (CIS) controls. We anticipate an excess of health services utilization, including physician and hospital visits, and prescriptions filled, with this excess including a significant mental health component.

The prodromal phase II (MS symptom onset to diagnosis) will be marked by an even greater increase in health services utilization when compared to the matched controls.

Patient characteristics will influence findings, with measurable differences between men, women and the MS disease courses (progressive vs. relapsing-onset).

Further Details:

In order to meet our broad study aim, the Specific Objectives are to:

1. Explore health services utilization patterns (hospital admissions, physician visits, emergency room visits, prescription utilization) in the phase I and II MS prodromes, relative to a matched (age, sex, calendar-year and geographical location) general population cohort.
2. Examine health services utilization patterns across the phases, and explore the impact of MS patient characteristics (e.g. progressive vs. relapsing onset) and temporal changes on utilization
3. Access a diseased control cohort - patients with clinically isolated syndrome (CIS) who did not develop MS (CIS-nonMS) - to help further explore the MS prodrome. The CIS cohort includes patients presenting with either optic neuritis or transverse myelitis involvement. Health services utilization will be compared between those who did and did not develop MS and a matched sample of the general population.

Summary approach and hypotheses for the specific objectives:

Our study capitalizes on the unique health system and research networks in Canada, and involves linkage of clinical databases with multiple large population-based databases, creating powerful datasets in four diverse geographical regions. ** Note: this DAR only applies to the BC data. Please see Methodology, DAR Page 15 of 30 for more details**

Among persons destined to be diagnosed with MS, after adjustment for possible confounders, we hypothesize that prodromal phase I will manifest a measurable signature, distinct from the matched general population or diseased (CIS) controls. We anticipate an excess of health services utilization, including physician and hospital visits, and prescriptions filled, with this excess including a significant mental health component. The prodromal phase II (MS symptom onset to diagnosis) will be marked by an even greater increase in health services utilization when compared to the matched controls. Patient characteristics will influence findings, with measurable differences between men, women and the MS disease courses (progressive vs. relapsing-onset).


Page last revised: December 5, 2017