Background The Accreditation Council for Graduate Medical Education specifies that trainees must receive clinical outcomes and quality benchmark data at specific levels related to institutional patient populations. Program directors (PDs) are challenged to identify meaningful data and provide them in formats acceptable to trainees. Objective We sought to understand what types of patients, data/metrics, and data delivery systems trainees and PDs prefer for supplying trainees with clinical outcomes data. Methods Trainees (n = 21) and PDs (n = 12) from multiple specialties participated in focus groups during academic year 2017–2018. They described key themes for providing clinical outcomes data to trainees. Results Trainees and PDs differed in how they identified patients for clinical outcomes data for trainees. Trainees were interested in encounters where they felt a sense of responsibility or had autonomy/independent decision-making opportunities, continuity, or learned something new; PDs used broader criteria including all patients cared for by their trainees. Both groups thought trainees should be given trainee-level metrics and consistently highlighted the importance of comparison to peers and/or benchmarks. Both groups found value in “push” and “pull” data systems, although trainees wanted both, while PDs wanted one or the other. Both groups agreed that trainees should review data with specific faculty. Trainees expressed concern about being judged based on their patients' clinical outcomes. Conclusions Trainee and PD perspectives on which patients they would like outcomes data for differed, but they overlapped for types of metrics, formats, and review processes for the data.
BackgroundChronic demyelination is a major contributor to axonal vulnerability in multiple sclerosis (MS). Therefore, remyelination could provide a potent neuroprotective strategy. The ReBUILD trial was the first study showing evidence for successful remyelination following treatment with clemastine in people with MS (pwMS) with no evidence of disease activity or progression (NEDAP). Whether remyelination was associated with neuroprotection remains unexplored.MethodsPlasma neurofilament light chain (NfL) levels were measured from ReBUILD trial’s participants. Mixed linear effect models were fit for individual patients, epoch and longitudinal measurements to compare NfL concentrations between samples collected during the active and placebo treatment period.ResultsNfL concentrations were 9.6% lower in samples collected during the active treatment with clemastine (n=53, geometric mean=6.33 pg/mL) compared to samples collected during treatment with placebo (n=73, 7.00 pg/mL) (B=−0.035 [−0.068 to −0.001], p=0.041). Applying age- and body mass index-standardised NfL Z-scores and percentiles revealed similar results (0.04 vs 0.35, and 27.5 vs 33.3, p=0.023 and 0.042, respectively). Higher NfL concentrations were associated with more delayed P100 latencies (B=1.33 [0.26 to 2.41], p=0.015). In addition, improvement of P100 latencies between visits was associated with a trend for lower NfL values (B=0.003 [−0.0004 to 0.007], p=0.081). Based on a Cohen’s d of 0.248, a future 1:1 parallel-arm placebo-controlled study using a remyelinating agent with comparable effect as clemastine would need 202 subjects per group to achieve 80% power.ConclusionsIn pwMS, treatment with the remyelinating agent clemastine was associated with a reduction of blood NfL, suggesting that neuroprotection is achievable and measurable with therapeutic remyelination.Trial registration numberNCT02040298.
Background and ObjectivesWith the increasing use of visually evoked potentials (VEPs) as quantitative outcome parameters for myelin in clinical trials, an in-depth understanding of longitudinal VEP latency changes and their prognostic potential for subsequent neuronal loss will be required. In this longitudinal multicenter study, we evaluated the association and prognostic potential of VEP latency for retinal neurodegeneration, measured by optical coherence tomography (OCT), in relapsing-remitting MS (RRMS).MethodsWe included 293 eyes of 147 patients with RRMS (age [years, median ± SD] 36 ± 10, male sex 35%, F/U [years, median {IQR} 2.1 {1.5–3.9}]): 41 eyes had a history of optic neuritis (ON) ≥6 months before baseline (CHRONIC-ON), and 252 eyes had no history of ON (CHRONIC-NON). P100 latency (VEP), macular combined ganglion cell and inner plexiform layer volume (GCIPL), and peripapillary retinal nerve fiber layer thickness (pRNFL) (OCT) were quantified.ResultsP100 latency change over the first year predicted subsequent GCIPL loss (36 months) across the entire chronic cohort (p= 0.001) and in (and driven by) the CHRONIC-NON subset (p= 0.019) but not in the CHRONIC-ON subset (p= 0.680). P100 latency and pRNFL were correlated at baseline (CHRONIC-NONp= 0.004, CHRONIC-ONp< 0.001), but change in P100 latency and pRNFL were not correlated. P100 latency did not differ longitudinally between protocols or centers.DiscussionVEP in non-ON eyes seems to be a promising marker of demyelination in RRMS and of potential prognostic value for subsequent retinal ganglion cell loss. This study also provides evidence that VEP may be a useful and reliable biomarker for multicenter studies.
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