IMPORTANCEYounger age, oligoclonal bands, and infratentorial and spinal cord lesions are factors associated with an increased 10-year risk of clinical conversion from radiologically isolated syndrome (RIS) to multiple sclerosis (MS). Whether disease-modifying therapy is beneficial for individuals with RIS is currently unknown. OBJECTIVES To evaluate the 2-year risk of a clinical event (onset of clinical symptoms of MS) prospectively, identify factors associated with developing an early clinical event, and simulate the sample size needed for a phase III clinical trial of individuals with RIS meeting 2009 RIS criteria. DESIGN, SETTING, AND PARTICIPANTS This cohort study used data on prospectively followed-up individuals with RIS identified at 1 of 26 tertiary centers for MS care in France that collect data for the Observatoire Français de la Sclérose en Plaques database. Participants were aged 10 to 80 years with 2 or more magnetic resonance imaging (MRI) scans after study entry and an index scan after 2000. All diagnoses were validated by an expert group, whose review included a double centralized MRI reading. Data were analyzed from July 2020 to January 2021. EXPOSURE Diagnosis of RIS. MAIN OUTCOMES AND MEASURES Risk of clinical event and associated covariates at index scan were analyzed among all individuals with RIS. Time to the first clinical event was compared by covariates, and sample size estimates were modeled based on identified risk factors. RESULTS Among 372 individuals with RIS (mean [SD] age at index MRI scan, 38.6 [12.1] years), 354individuals were included in the analysis (264 [74.6%] women). A clinical event was identified among 49 patients (13.8%) within 2 years, which was associated with an estimated risk of conversion of 19.2% (95% CI, 14.1%-24.0%). In multivariate analysis, age younger than 37 years (hazard ratio [HR], 4.04 [95% CI, 2.00-8.15]; P < .001), spinal cord lesions (HR, 5.11 [95% CI,]; P = .001), and gadolinium-enhancing lesions on index scan (HR, 2.09 [95% CI, 1.13-3.87]; P = .02) were independently associated with an increased risk of conversion to MS. Having 2 factors at the time of the index MRI scan was associated with a risk of 27.9% (95% CI, 13.5%-39.9%) of a seminal event within 2 years, increasing to 90.9% (95% CI, 41.1%-98.6%) for individuals with all 3 factors (3 risk factors vs none: HR, 23.34 [95% CI, 9.08-59.96]; P < .001). Overall, with 80% power to detect an effect size of 60% within 24 months, a total of 160 individuals with RIS were needed assuming an event rate of 20%. (continued) Key Points Question Are there clinical or demographic factors associated with time to clinical symptoms of multiple sclerosis among patients with radiologically isolated syndrome? Findings In this cohort study of 372 individuals with radiologically isolated syndrome, young age, the presence of spinal cord lesions, and gadoliniumenhancing lesions on the index magnetic resonance imaging scan were associated with increased risk of onset of clinical symptoms of multiple sclerosis. Meaning Thes...
BackgroundStudies of cancer prevalence have produced conflicting results concerning the relative risk of overall and specific sub-types of cancer in patients with multiple sclerosis (MS). Contemporary controls and information on tobacco use and alcohol consumption are generally missing from previous studies.ObjectivesTo evaluate lifetime cancer prevalence in a large cohort of MS patients relative to appropriate controls.MethodsWe conducted a case-control study, using a postal survey of a cohort of MS patients. Of the 1574 questionnaires sent, 1107 could be used for statistical analysis. Data from 1568 controls were prospectively collected using the same self-administered survey among consecutive out-patients in a single neurology department. Propensity scores matched on age, gender, and history of smoking and alcohol consumption were calculated.ResultsAmong the MS patients, 7.32% had ever presented with a cancer, whereas 12,63% of the controls had, leading to a bootstrap matched odds ratio (OR) of 0.63; 95% CI 0.57–0.70. Although only exploratory, the use of DMT (immunomodulators or immunosupressants) did not appear to increase this risk (p = 0.42). The disease course also did not affect cancer prevalence.ConclusionMS was associated with a reduced overall cancer risk.
Background Transitioning from pediatric to adult healthcare can be challenging and lead to severe consequences if done suboptimally. The Transition Readiness Assessment Questionnaire (TRAQ) was developed to assess adolescent and young adult (AYA) patients' transition readiness. In this study, we aimed to (1) document the psychometric properties of the French‐language version of the TRAQ (TRAQ‐FR), (2) assess agreements and discrepancies between AYA patients' and their primary caregivers' TRAQ‐FR scores, and (3) identify transition readiness contributors. Methods French‐speaking AYA patients (n = 175) and primary caregivers (n = 168) were recruited from five clinics in a tertiary Canadian hospital and asked to complete the TRAQ‐FR, the Pediatric Quality of Life Inventory™ 4.0 (PedsQL™ 4.0), and a sociodemographic questionnaire. The validity of the TRAQ‐FR was assessed using confirmatory factor analyses (CFA). Agreements and discrepancies were evaluated using intraclass correlation coefficients and paired‐sample t tests. Contributors of transition readiness were identified using regression analyses. Results The five‐factor model of the TRAQ was supported, with the TRAQ‐FR global scale showing good internal consistency for both AYA patients' and primary caregivers' scores (α = .85–.87). AYA patients and primary caregivers showed good absolute agreement on the TRAQ‐FR global scale with AYA patients scoring higher than primary caregivers (ICC = .80; d = .25). AYA patients' age and sex were found to be contributors of transition readiness. Conclusions The TRAQ‐FR was found to have good psychometric properties when completed by both AYA patients and primary caregivers. Additional research is needed to explore the predictive validity and clinical use of the TRAQ‐FR.
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