ABSTRACT
Background: Prospective, deeply phenotyped research cohorts monitoring people with multiple sclerosis (MS) depend on careful participant engagement that was threatened by COVID19- related restrictions to in-clinic visits. Coincidentally, there was forced adoption of televideo-enabled care. Objective(s): To leverage a natural experiment of "going virtual" during the pandemic to evaluate two hypotheses pertaining to remote MS research: that (1) global costs of remote visits are lower, and (2) disability evaluations are non-inferior. Method(s): Between 3/2020 and 12/2021, 207 UCSF EPIC/ ORIGINS MS cohort participants underwent hybrid in-clinic and virtual research visits. Among these, 96 contributed 100 'matched visits', i.e. in-clinic (Neurostatus, NS-EDSS) and remote (televideo-, tele-EDSS;electronic patient-reported, ePR-EDSS) evaluations within 14 days. Clinical and socio/ demographic characteristics were collected. First, visit costs were compared. Then, the quality of data extracted was compared using non-inferiority design with NS-EDSS as primary outcome. Result(s): The 96 participants contributing 100 matched visits had mean age 41.4 years (SD 11.7) and MS duration 1.4 years (SD 3.4);69% were female and 72% White, 8% lived in lowincome zip codes;median driving distance was 70 miles (mean 545). The costs of remote visits to participants (travel, caregiver time), to research (facilities, personnel, parking, participant compensation), and carbon footprint were all lower than in-person visits (p<0.05 for each). Median cohort EDSS was similar, whether evaluated using NS-EDSS (2), tele-EDSS (1.5) or ePREDSS (2), with range 0-6.5. Utilizing a TOST for Non-inferiority, both remote evaluations were non-inferior to NS-EDSS within+/-0.5 EDSS point (p<0.01 for each). Year-to-year, the % of participants with worsening/stable/improved EDSS scores was similar, whether the annual evaluations both used NS-EDSS, or whether the annual evaluation switched from NS-EDSS to tele-EDSS. Discussion(s): "Going virtual" during the pandemic represented a natural experiment in which to test hypotheses about remote research visits. These visits lowered costs for investigators and participants. Further, remote assessments were non-inferior to NS-EDSS and for more precision, could be supplemented with biosensors. Together, these insights support the conduct of research that is more inclusive to participants regardless of geography, race, income, opportunity costs or ability level.
ABSTRACT
Objective: To compare clinical and MS-specific outcomes among people with MS (PwMS) who received SARs-CoV-2 vaccines, determine whether outcomes among vaccinated individuals vary by MS clinical features (including DMT use), and examine vaccine hesitancy among unvaccinated individuals. Background: The effects of the SARs-CoV-2 vaccine and infection on clinical outcomes, including relapse risk, have been insufficiently explored in PwMS. These knowledge gaps may contribute to vaccine hesitancy and highlight a need for information about COVID experiences in PwMS. Design/Methods: Online surveys were administered to PwMS with questions regarding prevalence and severity of SARs-CoV-2 infection, vaccine status and type, reasons for vaccine deferral, and post-vaccination side effects. Respondents also had the option to consent to chart review for verification of clinical outcomes. Associations between infection, post-vaccination side effects and neurologic symptoms, and clinical characteristics were compared using chisquare tests, 2-sample T-tests, and logistic regression models. Results: Of n=333 respondents, n=292 were vaccinated and n=38 were unvaccinated. Average time between vaccine and survey administration was 4 months. Among those vaccinated, 58% reported post-vaccination side effects, most commonly among mRNA vaccine type (p=0.02), younger patients (p<0.01), and relapsing-remitting MS (p=0.03). After vaccination, 12% endorsed MS symptom recrudescence (fatigue, pain), while 3% endorsed new neurologic symptoms. Per chart review (n=187), no respondents experienced post-vaccination radiographic changes or required DMT change. N=62 participants reported SARs-CoV-2 infection, more frequent in younger individuals (1-year OR=0.958, 10-year OR=0.649, p<0.01). Neither DMT use nor B-cell based therapy were associated with vaccine side effects, recrudescence of MS symptoms, new neurologic symptoms, or SARs-CoV-2 infection. Conclusions: Our findings provide new data to suggest that among PwMS who received SARsCoV-2 vaccination, clinical disease worsening is rare and mostly associated with symptom recrudesce as opposed to new relapse. Common post-vaccination side effects may occur more often with the mRNA vaccines and in younger individuals.