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In April 2020, in light of COVID-19-related blood shortages, the US Food and Drug Administration (FDA) reduced the deferral period for men who have sex with men (MSM) from its previous duration of 1 year to 3 months. Although originally born out of necessity, the decades-old restrictions on MSM donors have been mitigated by significant advancements in HIV screening, treatment, and public education. The severity of the ongoing COVID-19 pandemic—and the urgent need for safe blood products to respond to such crises—demands an immediate reconsideration of the 3-month deferral policy for MSM. We review historical HIV testing and transmission evidence, discuss the ethical ramifications of the current deferral period, and examine the issue of noncompliance with donor deferral rules. We also propose an eligibility screening format that involves an individual risk-based screening protocol and, unlike current FDA guidelines, does not effectively exclude donors on the basis of gender identity or sexual orientation. Our policy proposal would allow historically marginalized community members to participate with dignity in the blood donation process without compromising blood donation and transfusion safety outcomes.

Background Treatment options to assist patients to produce a more perceptually feminine voice include voice therapy (VT) and surgeries to elevate pitch such as the Wendler glottoplasty (WG). The Trans Woman Voice Questionnaire (TWVQ) is a validated quality of life measure for trans women's self-reported perceptions of their voice and is frequently administered before and after such interventions. The 30 statements broadly pertain to how feminine a patient feels their voice is, how effortful it is to produce their voice, and how their voice impacts them psychosocially, making it a useful and specific outcome measure when treating trans females for voice concerns. Objective To compare quality of life outcomes between VT and VT with adjunct WG (VT+WG) based on changes in ratings of individual statements on the TWVQ. Materials and Methods A retrospective case series of 31 trans female patients treated was completed. A total of 17 patients underwent VT and 14 underwent VT with adjunctive WG. Ratings for each of the 30 TWVQ statements were compared before and after treatment for each group. Wilcoxon rank-sum tests were used to compare rating changes before and after treatment. Spearman rank-order correlation tests were used to assess the association between total TWVQ score and “current voice” rating. Results WG was associated with statistically significantly improved ratings for every statement on the TWVQ except one. In contrast, VT was associated with statistically significant improvements in 16 of the 30 statements, which largely pertained to patient emotions surrounding their voice rather than physical aspects such as pitch and dysphonia. Furthermore, while both WG+VT and VT improved the “current voice” rating significantly, WG improved the score by nearly 1 unit more. Lastly, we found a positive association between the total TWVQ score and current voice rating, indicating that lower scores were associated with more self-perceived feminine-sounding voices (P Conclusions Both VT and VT+WG result in improvements in the TWVQ. The specific statements on the TWVQ offer insight into specific quality of life treatment outcomes, with VT associated with improvements in mostly psychosocial aspects of voice production and VT+WG with both psychosocial and physical aspects.

Chronic kidney disease (CKD) and acute kidney injury (AKI) are common, heterogeneous, and morbid diseases. Mechanistic characterization of CKD and AKI in patients may facilitate a precision medicine approach to prevention, diagnosis, and treatment. The Kidney Precision Medicine Project aims to ethically and safely obtain kidney biopsies from participants with CKD or AKI, create a reference kidney atlas, and characterize disease subgroups to stratify patients based on molecular features of disease, clinical characteristics, and associated outcomes. An additional aim is to identify critical cells, pathways, and targets for novel therapies and preventive strategies. This project is a multicenter prospective cohort study of adults with CKD or AKI who undergo a protocol kidney biopsy for research purposes. This investigation focuses on kidney diseases that are most prevalent and therefore substantially burden the public health, including CKD attributed to diabetes or hypertension and AKI attributed to ischemic and toxic injuries. Reference kidney tissues (for example, living kidney donor biopsies) will also be evaluated. Traditional and digital pathology will be combined with transcriptomic, proteomic, and metabolomics analysis of the kidney tissue as well as deep clinical phenotyping for supervised and unsupervised subgroup analysis and systems biology analysis. Participants will be followed prospectively for ten years to ascertain clinical outcomes. Cell types, locations, and functions will be characterized in health and disease in an open, searchable, online kidney tissue atlas. All data from the Kidney Precision Medicine Project will be made readily available for broad use by scientists, clinicians, and patients.

OBJECTIVE Burnout is defined as work-related emotional exhaustion, depersonalization, and decreased sense of accomplishment. Virtual reality (VR) has emerged as an effective treatment modality for various conditions related to anxiety, however, few studies have assessed its role for stress management in residents. We hypothesize that VR-based mindfulness meditation can reduce resident burnout in real-world settings. STUDY DESIGN Prospective randomized crossover trial. METHODS Resident participants completed the validated Maslach Burnout Inventory (MBI). One group used a VR-based meditation app; the second group received no intervention. After a 2-month rotation, all subjects completed an MBI and crossed over to the other arm. Wilcoxon rank-sum tests were used to compare MBI scores before and after intervention, and to compare results by gender and postgraduate year. Mann-Whitney U tests were used to assess qualitative differences between participants. RESULTS Eighteen residents completed the study. Five participants were female and 13 were male. Weekly use of VR-guided meditation and paced breathing was associated with a significant decrease in emotional exhaustion (P = .009), and on subgroup analysis, male gender specifically was associated with a decrease in emotional exhaustion (P = .027). In the post-intervention survey, 42.9% subjects reported that VR encouraged them to employ paced breathing techniques, 71.4% reported that they would use the technology if regularly available, and 21.4% reported they would use paced breathing in the future. CONCLUSION VR-based therapy may serve as a successful tool in stress management and reduce the rate of burnout among otolaryngology residents. LEVEL OF EVIDENCE NA Laryngoscope, 131:1972-1976, 2021.

OBJECTIVES The ideal timing and technique of tracheostomy vary among patients and may impact outcomes. We aim to examine the association between tracheostomy timing, placement technique, and patient demographics on survival. STUDY DESIGN Retrospective cohort study. METHODS A retrospective review was performed for all patients who underwent tracheostomy in 2016 and 2017 at one urban academic tertiary-care hospital. Kaplan-Meier curves were created based on combinations of tracheostomy timing and technique (early percutaneous, early non-percutaneous, late percutaneous, and late non-percutaneous). Cox proportional hazard models were used to determine multivariable effects of timing, technique, and other demographic factors. Primary outcome measures were tracheostomy-related mortality and overall survival. Secondary outcomes were in-hospital, 30-day, and 90-day mortality. RESULTS Our study included 523 patients. There were six tracheostomy-related deaths, with hemorrhage and tracheoesophageal fistula being the most common causes. Tracheostomy timing and technique combinations were not associated with differences in all-cause mortality or survival following discharge. Cox proportional hazard models showed that Charlson Comorbidity Index (CCI) and unknown partner status were associated with a decrease in survival (P

The purpose of this study is to define value in bundled total joint arthroplasty (TJA) from the differing perspectives of the patient, payer/employer, and hospital/provider.Demographic, psychosocial, clinical, financial, and patient-reported outcomes (PROs) data from 2017 to 2018 elective TJA cases at a multihospital academic health system were queried. Value was defined as improvement in PROs (preoperatively to 1 year postoperatively) for patients, improvement in PROs per $1000 of bundle cost for payers, and the normalized sum of improvement in PROs and hospital bundle margin for providers. Bivariate analysis was used to compare high value vs low value (50th percentile vs50th percentile). Multivariate analysis was performed to identify predictors.A total of 280 patients had PRO data, of which 71 had Medicare claims data. Diabetes (odds ratio [OR], 0.45; P = .02) predicted low value for patients; female gender (OR, 0.25), hypertension (OR, 0.17), pulmonary disease (OR, 0.12), and skilled nursing facility discharge (OR, 0.17) for payers (P ≤ .03 for all); and pulmonary disease (OR, 0.16) and skilled nursing facility discharge (OR, 0.19) for providers (P ≤ .04 for all).This is the first article to define value in TJA under a bundle payment model from multiple perspectives, providing a foundation for future studies analyzing value-based TJA.

Background Heart failure (HF) is a condition that affects approximately 6.2 million people in the United States and has a 5-year mortality rate of approximately 42%. With the prevalence expected to exceed 8 million cases by 2030, projections estimate that total annual HF costs will increase to nearly US $70 billion. Recently, the advent of remote monitoring technology has significantly broadened the scope of the physician’s reach in chronic disease management. Objective The goal of our program, named the Heart Health Program, was to examine the feasibility of using digital health monitoring in real-world home settings, ascertain patient adoption, and evaluate impact on 30-day readmission rate. Methods A digital medicine software platform developed at Mount Sinai Health System, called RxUniverse, was used to prescribe a digital care pathway including the HealthPROMISE digital therapeutic and iHealth mobile apps to patients’ personal smartphones. Vital sign data, including blood pressure (BP) and weight, were collected through an ambulatory remote monitoring system that comprised a mobile app and complementary consumer-grade Bluetooth-connected smart devices (BP cuff and digital scale) that send data to the provider care teams. Care teams were alerted via a Web-based dashboard of abnormal patient BP and weight change readings, and further action was taken at the clinicians’ discretion. We used statistical analyses to determine risk factors associated with 30-day all-cause readmission. Results Overall, the Heart Health Program included 58 patients admitted to the Mount Sinai Hospital for HF. The 30-day hospital readmission rate was 10% (6/58), compared with the national readmission rates of approximately 25% and the Mount Sinai Hospital’s average of approximately 23%. Single marital status (P=.06) and history of percutaneous coronary intervention (P=.08) were associated with readmission. Readmitted patients were also less likely to have been previously prescribed angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers (P=.02). Notably, readmitted patients utilized the BP and weight monitors less than nonreadmitted patients, and patients aged younger than 70 years used the monitors more frequently on average than those aged over 70 years, though these trends did not reach statistical significance. The percentage of the 58 patients using the monitors at least once dropped from 83% (42/58) in the first week after discharge to 46% (23/58) in the fourth week. Conclusions Given the increasing burden of HF, there is a need for an effective and sustainable remote monitoring system for HF patients following hospital discharge. We identified clinical and social factors as well as remote monitoring usage trends that identify targetable patient populations that could benefit most from integration of daily remote monitoring. In addition, we demonstrated that interventions driven by real-time vital sign data may greatly aid in reducing hospital readmissions and costs while improving patient outcomes.

Summary Objectives Radiation treatment for laryngeal cancer has been shown to cause tissue changes to the vocal folds, which can result in degradation of voice. Our objective in this study was to investigate changes in perceptual, acoustic, and patient-reported outcomes over an extended period of follow-up after radiation. Design Retrospective review. Methods All patients treated with radiation for early-stage laryngeal carcinoma (in situ, T1, or T2) by a single surgeon from 2011–2018 were reviewed. Demographics and treatment information were recorded. Only patients with at least two dates of follow-up with acoustic data (cepstral spectral index of dysphonia [CSID]) and patient-reported surveys (voice handicap index-10 [VHI-10]) were included. Voice samples were rated by two senior speech-language pathologists on the grade, roughness, breathiness, asthenia, and strain scale. Results Of 115 patients with early-stage laryngeal cancer, 31 patients met inclusion criteria. The average follow-up from time of treatment was 9.6 years (range 3.0–20.3 years), and the average time in between the first and last voice recordings was 2.6 years (range 0.3–5.5 years). The lesions represented were carcinoma in situ (n = 4), T1 (n = 22), and T2 (n = 5). The VHI-10 scores worsened slightly (mean increase +0.27, median +1) from first to last measurements as did the CSID score (median increase +7.0, median +7.4), though neither reached statistical significance when correlated with time since radiation (P = 0.269 and P = 0.0850). Perceptual analysis as rated by two speech-language pathologists raters showed excellent inter-rater reliability (Cronbach's alpha = 0.84), with no significant change over time (mean +0.39, median, with P = 0.347). Grade, roughness, breathiness, asthenia, and strain, VHI-10, and CSID were all correlated (all pairwise comparisons P Conclusion Perceptual, acoustic, and patient-reported outcomes years after radiation for early-stage laryngeal cancer do not show voice degradation over time in this preliminary analysis. Further research with a larger cohort may elucidate voice changes in this population.