Remote Observational Research for Multiple Sclerosis: A Natural Experiment.

BACKGROUND AND OBJECTIVES: Prospective, deeply phenotyped research cohorts monitoring individuals with chronic neurologic conditions, such as multiple sclerosis (MS), depend on continued participant engagement. The COVID-19 pandemic restricted in-clinic research activities, threatening this longitudinal engagement, but also forced adoption of televideo-enabled care. This offered a natural experiment in which to analyze key dimensions of remote research: (1) comparison of remote vs in-clinic visit costs from multiple perspectives and (2) comparison of the remote with in-clinic measures in cross-sectional and longitudinal disability evaluations. METHODS: Between March 2020 and December 2021, 207 MS cohort participants underwent hybrid in-clinic and virtual research visits; 96 contributed 100 "matched visits," that is, in-clinic (Neurostatus-Expanded Disability Status Scale [NS-EDSS]) and remote (televideo-enabled EDSS [tele-EDSS]; electronic patient-reported EDSS [ePR-EDSS]) evaluations. Clinical, demographic, and socioeconomic characteristics of participants were collected. RESULTS: The costs of remote visits were lower than in-clinic visits for research investigators (facilities, personnel, parking, participant compensation) but also for participants (travel, caregiver time) and carbon footprint (p < 0.05 for each). Median cohort EDSS was similar between the 3 modalities (NS-EDSS: 2, tele-EDSS: 1.5, ePR-EDSS: 2, range 0.6.5); the remote evaluations were each noninferior to the NS-EDSS within ±0.5 EDSS point (TOST for noninferiority, p < 0.01 for each). Furthermore, year to year, the % of participants with worsening/stable/improved EDSS scores was similar, whether each annual evaluation used NS-EDSS or whether it switched from NS-EDSS to tele-EDSS. DISCUSSION: Altogether, the current findings suggest that remote evaluations can reduce the costs of research participation for patients, while providing a reasonable evaluation of disability trajectory longitudinally. This could inform the design of remote research that is more inclusive of diverse participants.

Foundational Telemedicine Workshop for First-Year Medical Students Developed During a Pandemic.

Introduction: In response to the COVID-19 pandemic and the need for social distancing, medical education curricula across the country had to be quickly transitioned from in-person experiences to remote sessions. Simultaneously, use of telemedicine in clinical practice skyrocketed. Despite telemedicine expansion and the opportunity afforded to teach these skills virtually, many institutions lacked telemedicine curricula. Methods: We developed and evaluated a foundational telemedicine workshop during a pandemic (158 students in 28 groups) guided by principles to maximize learner engagement during remote learning, including use of discrete, time-limited activities (self-assessment, templated group exercises, review of brief multimedia, and active role-play.). Results: Students completed pre- and postsession surveys to assess session impact. Of 158 students, 92 (58%) completed the presession survey, and 36 (23%) completed the postsession survey. There was an increase in confidence in all areas, particularly in skills related to starting the encounter, minimizing barriers, and taking the medical history. Learners reported the physical examination content as more useful than any other area and valued the exemplar videos provided. Discussion: The pandemic highlighted our own institution's need to develop telemedicine curricula to prepare medical students to provide this increasingly essential service. We developed a foundational telemedicine skills session that increased students' reported confidence in their telemedicine knowledge and skills. The session could be easily adapted by other schools interested in incorporating telemedicine into their preclerkship curriculum. Additional experiences providing opportunities to practice and receive feedback on telemedicine skills with standardized and real patients are warranted.

Consensus disease definitions for neurologic immune-related adverse events of immune checkpoint inhibitors.

Expanding the US Food and Drug Administration-approved indications for immune checkpoint inhibitors in patients with cancer has resulted in therapeutic success and immune-related adverse events (irAEs). Neurologic irAEs (irAE-Ns) have an incidence of 1%-12% and a high fatality rate relative to other irAEs. Lack of standardized disease definitions and accurate phenotyping leads to syndrome misclassification and impedes development of evidence-based treatments and translational research. The objective of this study was to develop consensus guidance for an approach to irAE-Ns including disease definitions and severity grading. A working group of four neurologists drafted irAE-N consensus guidance and definitions, which were reviewed by the multidisciplinary Neuro irAE Disease Definition Panel including oncologists and irAE experts. A modified Delphi consensus process was used, with two rounds of anonymous ratings by panelists and two meetings to discuss areas of controversy. Panelists rated content for usability, appropriateness and accuracy on 9-point scales in electronic surveys and provided free text comments. Aggregated survey responses were incorporated into revised definitions. Consensus was based on numeric ratings using the RAND/University of California Los Angeles (UCLA) Appropriateness Method with prespecified definitions. 27 panelists from 15 academic medical centers voted on a total of 53 rating scales (6 general guidance, 24 central and 18 peripheral nervous system disease definition components, 3 severity criteria and 2 clinical trial adjudication statements); of these, 77% (41/53) received first round consensus. After revisions, all items received second round consensus. Consensus definitions were achieved for seven core disorders: irMeningitis, irEncephalitis, irDemyelinating disease, irVasculitis, irNeuropathy, irNeuromuscular junction disorders and irMyopathy. For each disorder, six descriptors of diagnostic components are used: disease subtype, diagnostic certainty, severity, autoantibody association, exacerbation of pre-existing disease or de novo presentation, and presence or absence of concurrent irAE(s). These disease definitions standardize irAE-N classification. Diagnostic certainty is not always directly linked to certainty to treat as an irAE-N (ie, one might treat events in the probable or possible category). Given consensus on accuracy and usability from a representative panel group, we anticipate that the definitions will be used broadly across clinical and research settings.

Development of a Low-Resource Operating Room and a Wide-Awake Orthopedic Surgery Program During the COVID-19 Pandemic.

Introduction. The COVID-19 pandemic resulted in significant medication, supply and equipment, and provider shortages, limiting the resources available for provision of surgical care. In response to mandates restricting surgery to high-acuity procedures during this period, our institution developed a multidisciplinary Low-Resource Operating Room (LROR) Taskforce in April 2020. This study describes our institutional experience developing an LROR to maintain access to urgent surgical procedures during the peak of the COVID-19 pandemic. Methods. A delineation of available resources and resource replacement strategies was conducted, and a final institution-wide plan for operationalizing the LROR was formed. Specialty-specific subgroups then convened to determine best practices and opportunities for LROR utilization. Orthopedic surgery performed in the LROR using wide-awake local anesthesia no tourniquet (WALANT) is presented as a use case. Results. Overall, 19 limited resources were identified, spanning across the domains of physical space, drugs, devices and equipment, and personnel. Based on the assessment, the decision to proceed with creation of an LROR was made. Sixteen urgent orthopedic surgeries were successfully performed using WALANT without conversion to general anesthesia. Conclusion. In response to the COVID-19 pandemic, a LROR was successfully designed and operationalized. The process for development of a LROR and recommended strategies for operating in a resource-constrained environment may serve as a model for other institutions and facilitate rapid implementation of this care model should the need arise in future pandemic or disaster situations.

Maintaining Access to Orthopaedic Surgery During Periods of Operating Room Resource Constraint: Expanded Use of Wide-Awake Surgery During the COVID-19 Pandemic.

INTRODUCTION: Wide-awake local anesthesia no tourniquet (WALANT) presents a nonstandard anesthetic approach initially described for use in hand surgery that has gained interest and utilization across a variety of orthopaedic procedures. In response to operating room resource constraints imposed by the COVID-19 pandemic, our orthopaedic service rapidly adopted and expanded its use of WALANT. METHODS: A retrospective review of 16 consecutive cases performed by 7 surgeons was conducted. Patient demographics, surgical details, and perioperative outcomes were assessed. The primary end point was WALANT failure, defined as intraoperative conversion to general anesthesia. RESULTS: No instances of WALANT failure requiring conversion to general anesthesia occurred. In recovery, one patient (6%) required narcotics for pain control, and the average postoperative pain numeric rating scale was 0.6. The maximum pain score experienced was 4 in the patient requiring postoperative narcotics. The average time in recovery was 42 minutes and ranged from 8 to 118 minutes. CONCLUSION: The WALANT technique was safely and effectively used in 16 cases across multiple orthopaedic subspecialties, including three procedures not previously described in the literature. WALANT techniques hold promise for use in future disaster scenarios and should be evaluated for potential incorporation into routine orthopaedic surgical care.