Citations

ImportanceThere was a shift in patient volume from in-person to video telemedicine visits during the COVID-19 pandemic.ObjectiveTo determine the concordance of provisional diagnoses established at a video telemedicine visit with diagnoses established at an in-person visit for patients presenting with a new clinical problem.Design, Setting, and ParticipantsThis is a diagnostic study of patients who underwent a video telemedicine consultation followed by an in-person outpatient visit for the same clinical problem in the same specialty within a 90-day window. The provisional diagnosis made during the video telemedicine visit was compared with the reference standard diagnosis by 2 blinded, independent medical reviewers. A multivariate logistic regression model was used to determine factors significantly related to diagnostic concordance. The study was conducted at a large academic integrated multispecialty health care institution (Mayo Clinic locations in Rochester, Minnesota; Scottsdale and Phoenix, Arizona; and Jacksonville, Florida; and Mayo Clinic Health System locations in Iowa, Wisconsin, and Minnesota) between March 24 and June 24, 2020. Participants included Mayo Clinic patients residing in the US without age restriction. Data analysis was performed from December 2020 to June 2021.ExposuresNew clinical problem assessed via video telemedicine visit to home using Zoom Care Anyplace integrated into Epic.Main Outcomes and MeasuresConcordance of provisional diagnoses established over video telemedicine visits compared against a reference standard diagnosis.ResultsThere were 2393 participants in the analysis. The median (IQR) age of patients was 53 (37-64) years; 1381 (57.7%) identified as female, and 1012 (42.3%) identified as male. Overall, the provisional diagnosis established over video telemedicine visit was concordant with the in-person reference standard diagnosis in 2080 of 2393 cases (86.9%; 95% CI, 85.6%-88.3%). Diagnostic concordance by International Statistical Classification of Diseases and Related Health Problems, Tenth Revision chapter ranged from 64.7% (95% CI, 42.0%-87.4%) for diseases of the ear and mastoid process to 96.8% (95% CI, 94.7%-98.8%) for neoplasms. Diagnostic concordance by medical specialty ranged from 77.3% (95% CI, 64.9%-89.7%) for otorhinolaryngology to 96.0% (92.1%-99.8%) for psychiatry. Specialty care was found to be significantly more likely than primary care to result in video telemedicine diagnoses concordant with a subsequent in-person visit (odds ratio, 1.69; 95% CI, 1.24-2.30; P < .001).Conclusions and RelevanceThis diagnostic study of video telemedicine visits yielded a high degree of diagnostic concordance compared with in-person visits for most new clinical concerns. Some specific clinical circumstances over video telemedicine were associated with a lower diagnostic concordance, and these patients may benefit from timely in-person follow-up.

Importance In patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited. Objective To report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial. Design, Setting, and Participants SURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August and October 2021. Intervention Patients were randomized to TAVR with a self-expanding, supra-annular transcatheter or a surgical bioprosthesis. Main Outcomes and Measures The prespecified secondary end points of death or disabling stroke and other adverse events and hemodynamic findings at 5 years. An independent clinical event committee adjudicated all serious adverse events and an independent echocardiographic core laboratory evaluated all echocardiograms at 5 years. Results A total of 1660 individuals underwent an attempted TAVR (n = 864) or surgical (n = 796) procedure. The mean (SD) age was 79.8 (6.2) years, 724 (43.6%) were female, and the mean (SD) Society of Thoracic Surgery Predicted Risk of Mortality score was 4.5% (1.6%). At 5 years, the rates of death or disabling stroke were similar (TAVR, 31.3% vs surgery, 30.8%; hazard ratio, 1.02 [95% CI, 0.85-1.22]; P = .85). Transprosthetic gradients remained lower (mean [SD], 8.6 [5.5] mm Hg vs 11.2 [6.0] mm Hg; P < .001) and aortic valve areas were higher (mean [SD], 2.2 [0.7] cm 2 vs 1.8 [0.6] cm 2 ; P < .001) with TAVR vs surgery. More patients had moderate/severe paravalvular leak with TAVR than surgery (11 [3.0%] vs 2 [0.7%]; risk difference, 2.37% [95% CI, 0.17%- 4.85%]; P = .05). New pacemaker implantation rates were higher for TAVR than surgery at 5 years (289 [39.1%] vs 94 [15.1%]; hazard ratio, 3.30 [95% CI, 2.61-4.17]; log-rank P < .001), as were valve reintervention rates (27 [3.5%] vs 11 [1.9%]; hazard ratio, 2.21 [95% CI, 1.10-4.45]; log-rank P = .02), although between 2 and 5 years only 6 patients who underwent TAVR and 7 who underwent surgery required a reintervention. Conclusions and Relevance Among intermediate-risk patients with symptomatic severe aortic stenosis, major clinical outcomes at 5 years were similar for TAVR and surgery. TAVR was associated with superior hemodynamic valve performance but also with more paravalvular leak and valve reinterventions.

Meaningful Equity, Diversity, and Inclusion (EDI) efforts may be stymied by concerns about whether proposed initiatives are performative or tokenistic. The purpose of this project was to analyze discussions by the Research in Medical Education (RIME) Program Planning committee about how best to recognize and support underrepresented in medicine (URiM) researchers in medical education to generate lessons learned that might inform local, national, and international actions to implement meaningful EDI initiatives. Ten RIME Program Planning Committee members and administrative staff participated in a focus group held virtually in August 2021. Focus group questions elicited opinions about “if and how” to establish a URiM research award. The focus group was recorded, transcribed, and thematically analyzed. Recognition of privilege, including who has it and who doesn’t, underpinned the focus group discussion, which revolved around 2 themes: (1) tensions between optics and semantics, and (2) potential unintended consequences of trying to level the medical education playing field. The overarching storyline threaded throughout the focus group discussion was intentionality. Focus group participants sought to avoid performativity by creating an award that would be meaningful to recipients and to career gatekeepers such as department chairs and promotion and tenure committees. Ultimately, participants decided to create an award that focused on exemplary Equity, Diversity, and Inclusion (EDI) scholarship, which was eventually named the “RIME URiM Research Award.” Difficult but productive conversations about EDI initiatives are necessary to advance underrepresented in medicine (URiM) scholarship. This transparent commentary may trigger further critical conversations.

Introduction: Bortezomib has been reported to favourably impact the outcomes of t(4;14) and del(17p) in multiple myeloma (MM), but its impact on gain 1q (+1q) is unknown. Methods: To address this, 250 patients treated with bortezomib-based induction were analysed. All myeloma samples had fluorescence in situ hybridization (FISH) performed on CD138-sorted bone marrow aspirate, and plasma cells were analysed using DNA probes specific for the following chromosomal aberrations: del(13q14), del(17p), t(14;16), t(4;14), and +1q. Presence of +1q was defined as the presence of at least three copies of 1q21 at the cut off level of 20% of bone marrow plasma cells. Results: +1q identified in 167 (66.8%) and associated with t(4;14) and high lactate dehydrogenase (LDH). +1q was not associated with response rate but shorter event-free survival (EFS) (median EFS 35 vs 55 months, p = 0.05) and overall survival (OS) (median OS 74 vs 168 months, p = 0.00025). Copy number and clone size did not impact survival. Multivariate analysis showed +1q was an independent adverse factor for OS together with International Staging System (ISS)3, high LDH, del(17p) and t(4;14). When a risk score of 1 was assigned to each independent adverse factor, OS was shortened incrementally by a risk score from 0 to 4. Post-relapse/progression survival was inferior in those with +1q (median 60 vs 118 months, p = 0.000316). Autologous stem cell transplantation (ASCT) improved OS for those with +1q (median OS 96 vs 49 months, p = 0.000069). Conclusion: +1q is an adverse factor for OS in MM uniformly treated with bortezomib-based induction but was partially mitigated by ASCT. A risk scoring system comprising +1q, LDH, high-risk FISH, and ISS is a potential tool for risk stratification in MM.

Abstract Gallbladder polyps (GPs) are a common incidental finding on ultrasound; however, important differences in recommended management exist among professional society guidelines. An electronic survey was sent to 189 fellows of the Society of Radiologists in Ultrasound. Main outcomes included preferences and current practice patterns for evaluation, management, and surveillance of GPs as well as personal lifetime experience with gallbladder sonography and GPs. A total of 64 subjects (34%) with experience in gallbladder sonography completed the study. The estimated combined total number of gallbladder scans seen by the responders was 3,071,880. None of fellows had ever seen a pedunculated GP <1 cm detected on ultrasound that was proven to be malignant at the time of detection or during subsequent follow-up. All of the fellows used size as a feature to stratify recommendations. The median size threshold currently used by Society of Radiologists in Ultrasound fellows for recommending ultrasound follow-up was 6 mm, and their preferred threshold was 7 mm. The median size threshold for recommending surgical consultation was 10 mm, and the preferred threshold was 10 mm. Wall thickening and shape were considered important factors by 76% and 67% of respondents, respectively. Society of Radiologists in Ultrasound fellows tend to provide recommendations most similar to the American College of Radiology and Canadian Association of Radiology guidelines for management of GPs. Many would prefer guidelines that result in fewer recommendations for follow-up and surgical consultation. Despite a substantial combined experience, this survey did not uncover any case of a small GP that was malignant.

OBJECTIVE Suprasellar meningioma resection via either the transcranial approach (TCA) or the endoscopic endonasal approach (EEA) is an area of controversy and active evaluation. Skull base surgeons increasingly consider patient-reported outcomes (PROs) when choosing an approach. No PRO measure currently exists to assess quality of life for suprasellar meningiomas. METHODS Adult patients undergoing suprasellar meningioma resection between 2013 and 2019 via EEA (n = 14) or TCA (n = 14) underwent semistructured interviews. Transcripts were coded using a grounded theory approach to identify themes as the basis for a PRO measure that includes all uniquely reported symptoms. To assess content validity, 32 patients and 15 surgeons used a Likert scale to rate the relevance of items on the resulting questionnaire and the general Patient-Reported Outcomes Measurement Information System–29 (PROMIS29). The mean scores were calculated for all items and compared for TCA versus EEA patient cohorts by using unpaired t-tests. Items on either questionnaire with mean scores ≥ 2.0 from patients were considered meaningful and were aggregated to form the novel Suprasellar Meningioma Patient-Reported Outcome Survey (SMPRO) instrument. RESULTS Qualitative analyses resulted in 55 candidate items. Relative to patients who underwent the EEA, those who underwent the TCA reported significantly worse future outlook before surgery (p = 0.01), tiredness from medications 2 weeks after surgery (p = 0.001), and word-finding and memory difficulties 3 months after surgery (p = 0.05 and < 0.001, respectively). The items that patients who received a TCA were most concerned about included medication-induced lethargy after surgery (2.9 ± 1.3), blurry vision before surgery (2.7 ± 1.5), and difficulty reading due to blurry vision before surgery (2.7 ± 2.7). Items that patients who received an EEA were most concerned about included blurry vision before surgery (3.5 ± 1.3), difficulty reading due to blurry vision before surgery (2.4 ± 1.3), and problems with smell postsurgery (2.9 ± 1.3). Although surgeons overall overestimated how concerned patients were about questionnaire items (p < 0.0005), the greatest discrepancies between patient and surgeon relevance scores were for blurry vision pre- and postoperatively (p < 0.001 and < 0.001, respectively) and problems with taste postoperatively (p < 0.001). Seventeen meningioma-specific items were considered meaningful, supplementing 8 significant PROMIS29 items to create the novel 25-item SMPRO. CONCLUSIONS The authors developed a disease- and approach-specific measure for suprasellar meningiomas to compare quality of life by operative approach. If demonstrated to be reliable and valid in future studies, this instrument may assist patients and providers in choosing a personalized surgical approach.

Abstract Objective Biomagnetic liver susceptometry (BLS) is a noninvasive method to quantify liver iron concentration (LIC). Here we report our findings from a prospective study which validates in vivo LIC from a SQUID biosusceptometer by in vitro LIC in fresh tissue and paraffin-embedded biopsies from patients at risk for iron overload.Materials and Methods LIC was measured by BLS and biopsy. LIC by biopsy were measured in 40 dry weight fresh tissue and paraffin-embedded liver biopsy samples. LIC from biopsies and total iron scores from histology were compared to biosusceptometry. In addition, the wet-to-dry weight ratio was determined.Results Liver iron concentrations measured by BLS and in 40 fresh tissue biopsies were related by a factor of 6.0 ± 0.2 (r2 = 0.88). Similar results were obtained from comparisons with deparaffinized biopsies (6.6±0.3, r2=0.87) and histology (6.7±1.3, r2=0.47). In contrast, a mean wet-to-dry weight ratio of 4.1 ± 0.7 was achieved from biopsies immediately weighed after the biopsy procedure.ConclusionLIC derived from two independent measures, the historical biopsy gold standard and biosusceptometry, were highly correlated. When comparing biosusceptometry with wet weight biopsies, the liver tissue sample size is critical.

Abstract TP53 mutations are frequent in IDH-mutant astrocytomas but unusual in oligodendroglioma and the clinical significance of TP53 mutations in oligodendroglioma are not well characterized. We reviewed genetically defined oligodendroglioma (i.e., IDH-mutant, whole-arm 1p/19q-codeleted diffuse glioma) cases that were molecularly profiled (2017-2020) at our institution and identified 7 cases with TP53 mutation (9%; n=76). Molecular testing was performed using targeted neuro-oncology NGS panel (50-gene mutation and/or 187-gene mutation/rearrangement) and OncoScan™ microarray. Four (of 7) patients were female. Median age at diagnosis was 43 years (range, 23-63). Most common presenting symptom was seizures (3 of 7). All tumors were supratentorial. Histologically, 3 tumors were WHO grade II and 4 were WHO grade III. Two (of 3) patients with a WHO grade II tumor underwent biopsy and radiotherapy at diagnosis followed by temozolomide at recurrence (progression at 67 and 157 months after diagnosis; overall survival of 124 and 201 months). Three (of 4) patients with a WHO grade III tumor were diagnosed within the last two years and are currently progression-free after standard therapy. Molecularly, in addition to TP53 mutation(s), all cases had an IDH1 and TERT promoter mutation as well as other gene mutation(s) including FUBP1 (n=5), SETD2 (n=4), PIK3R1 (n=4), PIK3CA (n=3), NF1 (n=3) and CIC (n=3). In 3 (of 7) cases, the mutational profile with high mutation count enriched for C &gt;T/G &gt;A transitions was highly suggestive of a hypermutation phenotype (2 cases were recurrent tumors treated with temozolomide; a recurrent and a treatment-naïve tumor had mismatch repair gene mutation). Five (of 7) cases, including the 3 hypermutant cases, lacked functional TP53 (1 case with 2 mutations, 2 cases with 1 mutation plus loss of other copy, 2 cases with 1 mutation plus copy neutral loss-of-heterozygosity). TP53 mutations are uncommon in oligodendroglioma and appear enriched in hypermutant tumors.

Abstract Introduction/Objective The first human case of SARS-CoV-2 infection was reported in December of 2019. By late February 2020 evidence of community transmission in the United States was documented and soon it developed into a global pandemic. On March 11, 2020, the Mayo Clinic Arizona’s Microbiology Laboratory introduced a PCR test for diagnosis of SARS-CoV-2 infection. Even as testing demands exponentially increased, the hospital relied on timely results to assist in directing patient care. In order to provide timely results in the face of continuously emerging supply chain threats, we needed to increase our capacity for SARS-CoV-2 PCR testing by reducing technologist time and reagent waste, without impacting turnaround time or other quality metrics such as repeat rate. Methods/Case Report Technologist time was measured in hands-on time per specimen. Reagent use was defined by the volume of lysis buffer (the primary rate limiting reagent due to supply chain constraints) used per sample. Turnaround time was measured from receipt in lab until result verification and the rerun rate is the percent of specimens with an internal control (IC) failure, an indicator of specimen or process quality. Unnecessary steps were determined using a process map, spaghetti diagram and waste walk. Improvements included simplifying steps, changes to protocols and lab design. Impacts of the improvements were measured for 5 months post-implementation. Results (if a Case Study enter NA) Process improvements reduced technologist time per sample by 30.8 seconds and decreased critical reagent needs by 23.6%. Improvements led to $104,000 in just reagent savings over 5 months. Turnaround time and rerun rates were not negatively impacted. Conclusion By creating the leanest possible workflow, we were able to meet the demands for accurate and timely SARS-CoV-2 results. In future workflows, we will continue to implement lean processes and ensure the most efficient use of limited resources.