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Background: Sepsis is a life-threatening emergency, and early recognition and treatment in the emergency department (ED) is critical to improving outcomes., Methods: The authors implemented an interdisciplinary quality improvement (QI) project to standardize sepsis screening workflow across an academic health system consisting of a large tertiary care urban hospital, one freestanding ED, and two small rural affiliate hospitals (RA-1 and RA-2). The research team used the Institute for Healthcare Improvement Model for Improvement framework, consisting of iterative Plan-Do-Study-Act (PDSA) cycles. The primary outcome was rates of screening for sepsis at each site. Secondary outcomes included sepsis mortality and Centers for Medicare & Medicaid Services (CMS) sepsis bundle (SEP-1) compliance at our main medical center. Primary outcome was assessed using electronic dashboards extracting the ratio of ED encounters with electronic health record (EHR)-documented sepsis screening per total ED encounters. The SEP-1 bundle was assessed as percent compliance, and mortality was calculated as average observed to expected (O:E). Averages were compared from preintervention to after initiating improvements using two-tailed t-tests., Results: This QI project took place from December 2022 to December 2023 across four EDs that experience around 138,000 visits annually. A standardized workflow was established at ED triage with an EHR-based question and an associated nurse and physician defined response. Preintervention (October 2022 to November 2022) triage rates for sepsis were 1.7% (163/9,560), 25.3% (523/2,068), 11.0% (360/3,272), and 36.5% (915/2,506) at our main hospital, freestanding ED, RA-1, and RA-2, respectively. After four PDSA cycles, triage rates rose to 91.9% (4,927/5,360), 97.5% (1,032/1,059), 99.0% (1,845/1,863), and 97.4% (1,328/1,363), respectively (p < 0.005). Sepsis triage rates rose most slowly at the large academic medical center, where progressive PDSA cycles were needed to achieve > 90% screening for sepsis. Mean O:E mortality was 0.99 for the 9 months of available data preintervention and 0.83 in the 17 months postintervention (p = 0.07). CMS sepsis bundle compliance was 28.4% for the 15 months preintervention and 40.5% in the 17 months postintervention, (p = 0.14)., Conclusion: An interdisciplinary QI project leveraged EHR optimization to integrate with human workflows over four PDSA cycles to achieve standardized and improved screening for sepsis in the ED. This resulted in lower sepsis mortality and increased sepsis bundle compliance, though results were not statistically significant., (Copyright © 2024 The Joint Commission. Published by Elsevier Inc. All rights reserved.)

Introduction: Healthcare advances are hindered by underrepresentation in prospective research; sociodemographic, data, and measurement infidelity in retrospective research; and a paucity of guidelines surrounding equitable research practices., Objective: The Joint Research Practices Working Group was created in 2021 to develop and disseminate guidelines for the conduct of inclusive and equitable research., Methods: Volunteer faculty and staff from two research centers at the University of Pennsylvania initiated a multi-pronged approach to guideline development, including literature searches, center-level feedback, and mutual learning with local experts., Results: We developed guidelines for (1) participant payment and incentives; (2) language interpretation and translation; (3) plain language in research communications; (4) readability of study materials; and (5) inclusive language for scientific communications. Key recommendations include (1) offer cash payments and multiple payment options to participants when required actions are completed; (2) identify top languages of your target population, map points of contact, and determine available interpretation and translation resources; (3) assess reading levels of materials and simplify language, targeting 6th- to 8th-grade reading levels; (4) improve readability through text formatting and style, symbols, and visuals; and (5) use specific, humanizing terms as adjectives rather than nouns., Conclusions: Diversity, inclusion, and access are critical values for research conduct that promotes justice and equity. These values can be operationalized through organizational commitment that combines bottom-up and top-down approaches and through partnerships across organizations that promote mutual learning and synergy. While our guidelines represent best practices at one time, we recognize that practices evolve and need to be evaluated continuously for accuracy and relevance. Our intention is to bring awareness to these critical topics and form a foundation for important conversations surrounding equitable and inclusive research practices., (© 2023. The Author(s).)

Background: Growing recognition of racism perpetuated within academic institutions has given rise to anti-racism efforts in these settings. In June 2020, the university-based California Preterm Birth Initiative (PTBi) committed to an Anti-Racism Action Plan outlining an approach to address anti-Blackness. This case study assessed perspectives on PTBi's anti-racism efforts to support continued growth toward racial equity within the initiative., Methods: This mixed methods case study included an online survey with multiple choice and open-ended survey items (n = 27) and key informant interviews (n = 8) of leadership, faculty, staff, and trainees working within the initiative. Survey and interview questions focused on perspectives about individual and organizational anti-racism competencies, perceived areas of initiative success, and opportunities for improvement. Qualitative interview and survey data were coded and organized into common themes within assessment domains., Results: Most survey respondents reported they felt competent in all the assessed anti-racism skills, including foundational knowledge and responding to workplace racism. They also felt confident in PTBi's commitment to address anti-Blackness. Fewer respondents were clear on strategic plans, resources allocated, and how the anti-racism agenda was being implemented. Suggestions from both data sources included further operationalizing and communicating commitments, integrating an anti-racism lens across all activities, ensuring accountability including staffing and funding consistent with anti-racist approaches, persistence in hiring Black faculty, providing professional development and support for Black staff, and addressing unintentional interpersonal harms to Black individuals., Conclusions: This case study contributes key lessons which move beyond individual-level and theoretical approaches towards transparency and accountability in academic institutions aiming to address anti-Black racism. Even with PTBi's strong commitment and efforts towards racial equity, these case study findings illustrate that actions must have sustained support by the broader institution and include leadership commitment, capacity-building via ongoing coaching and training, broad incorporation of anti-racism practices and procedures, continuous learning, and ongoing accountability for both short- and longer-term sustainable impact., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Objectives: This quality improvement project sought to enhance clinical information sharing for interhospital transfers to an inpatient hepatology service comprised of internal medicine resident frontline providers (housestaff) with the specific aims of making housestaff aware of 100% of incoming transfers and providing timely access to clinical summaries., Interventions: In February 2020, an email notification system to senior medicine residents responsible for patient triage shared planned arrival time for patients pending transfer. In July 2020, a clinical data repository ("Transfer Log") updated daily by accepting providers (attending physicians and subspecialty fellows) became available to senior medicine residents responsible for triage., Methods: Likert scale surveys were administered to housestaff before email intervention (pre) and after transfer log intervention (post). The time from patient arrival to team assignment (TTA) in the electronic medical record was used as a proxy for time to patient assessment and was measured pre- and postinterventions; >2 hours to TTA was considered an extreme delay., Results: Housestaff reported frequency of access to clinical information as follows: preinterventions 4/31 (13%) sometimes/very often and 27/31 (87%) never/rarely; postinterventions 11/26 (42%) sometimes/very often and 15/26 (58%) never/rarely ( p  = 0.02). Preinterventions 12/39 (31%) felt "not at all prepared" versus 27/39 (69%) "somewhat" or "adequately"; postinterventions 2/24 (8%) felt "not at all prepared" versus 22/24 (92%) somewhat/adequately prepared ( p  = 0.06). There was a significant difference in mean TTA between pre- and posttransfer log groups (62 vs. 40 minutes, p  = 0.01) and a significant reduction in patients with extreme delays in TTA post-email (18/180 pre-email vs. 7/174 post-email, p  = 0.04)., Conclusion: Early notification and increased access to clinical information were associated with better sense of preparedness for admitting housestaff, reduction in TTA, and reduced frequency of extreme delays in team assignment., Competing Interests: None declared., (Thieme. All rights reserved.)

Aim: To investigate the association between receiving treatment at academic centers and overall survival in pancreatic ductal adenocarcinoma patients who do not receive definitive surgery of the pancreatic tumor. Methods: Using the National Cancer Database, patients who were diagnosed with pancreatic ductal adenocarcinoma between 2004 to 2016 were identified. Results: Of 262,209 patients, 101,003 (38.5%) received treatment at academic centers. In the multivariable Cox regression analysis, patients who received treatment at a nonacademic facility had significantly worse overall survival compared with patients who were treated at an academic center (hazard ratio: 1.279; 95% CI: 1.268-1.290; p = 0.001). Conclusion: Compared with treatment at academic centers, treatment at nonacademic centers was associated with significantly worse overall survival in patients with nonsurgically managed pancreatic ductal adenocarcinoma.

Objectives: Despite the important role of the community in the assessment and risk stratification of patients with thyroid nodules, evidence-based data on the Bethesda System for Reporting Thyroid Cytopathology (BSRTC) performance in community clinics is lacking. We aim to evaluate BSRTC performance of aspirations taken in community clinics compared with primary referral center., Methods: Patients who underwent thyroid surgery between 2013 and 2018 at our institution were divided according to the fine needle aspirations (FNA) settings: community FNA (cFNA) vs. institutional FNA (iFNA). Demographics, BSRTC results and final pathology were collected. Diagnostic values were calculated for BSRTC categories (sensitivity, specificity, positive predictive value [PPV], and negative predictive value [NPV]), and were compared between the groups., Results: A total of 268 nodules were included in the study; 77% (207) cFNA and 23% (61) iFNA. Patients in the community were younger (51.7 ± 15.1 vs. 56.6 years±14.8, p = 0.03) and with less epidemiology risk factors for thyroid cancer (1.9% vs 13.1%, p < 0.001). cFNA malignancy rate for BSRTC I-VI was 0%, 6.4%, 11.8%, 32.1%, 91.6% and 93.8% respectively. Best sensitivity was found for BSRTC III-VI in both groups (88% and 83%, cFNAs and iFNAs, respectively). Overall best performance was obtained for BSRTC V-VI for both groups (cfNA: 85%, 97%, 93%, 94% and 93%; iFNAs: 81%, 100%, 100%, 87% and 91%, for sensitivity, specificity, PPV, NPV and accuracy, respectively)., Conclusions: Community-performed FNAs demonstrate acceptable BSRTC distribution and malignancy rates, comparable with a primary referral academic hospital. This supports the universality of the BSRTC 2017 and its recommendations also in the community., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: Our objective with this quality improvement initiative was to reduce rates of severe intracranial hemorrhage (ICH) or death in the first week after birth among extremely preterm infants., Methods: The quality improvement initiative was conducted from April 2014 to September 2020 at the University of Alabama at Birmingham's NICU. All actively treated inborn extremely preterm infants without congenital anomalies from 22 + 0/7 to 27 + 6/7 weeks' gestation with a birth weight ≥400 g were included. The primary outcome was severe ICH or death in the first 7 days after birth. Balancing measures included rates of acute kidney injury and spontaneous intestinal perforation. Outcome and process measure data were analyzed by using p-charts., Results: We studied 820 infants with a mean gestational age of 25 + 3/7 weeks and median birth weight of 744 g. The rate of severe ICH or death in the first week after birth decreased from the baseline rate of 27.4% to 15.0%. The rate of severe ICH decreased from a baseline rate of 16.4% to 10.0%. Special cause variation in the rate of severe ICH or death in the first week after birth was observed corresponding with improvement in carbon dioxide and pH targeting, compliance with delayed cord clamping, and expanded use of indomethacin prophylaxis., Conclusions: Implementation of a bundle of evidence-based potentially better practices by using specific electronic order sets was associated with a lower rate of severe ICH or death in the first week among extremely preterm infants., Competing Interests: FINANCIAL DISCLOSURE: Golden Week Program is trademarked with the US Patent and Trademark Office (serial number 87856747). The authors have indicated they have no financial relationships relevant to this article to disclose., (Copyright © 2022 by the American Academy of Pediatrics.)

Introduction: Clinical record (CR) is the primary tool used by healthcare workers (HCWs) to record clinical information and its completeness can help achieve safer practices. CR is the most appropriate source in order to measure and evaluate the quality of care. In order to achieve a safety climate is fundamental to involve a responsive healthcare workforce thorough peer-review and feedbacks. This study aims to develop a peer-review tool for clinical records quality assurance, presenting the seven-year experience in the evolution of it; secondary aims are to describe the CR completeness and HCWs' diligence toward recording information in it., Methods: To assess the completeness of CRs a peer-review tool was developed in a large Academic Hospital of Northern Italy. This tool included measurable items that examined different themes, moments and levels of the clinical process. Data were collected every three months between 2010 and 2016 by appointed and trained HCWs from 42 Units; the hospital Quality Unit was responsible for of processing and validating them. Variations in the proportion of CR completeness were assessed using Cochran-Armitage test for trends., Results: A total of 9,408 CRs were evaluated. Overall CR completeness improved significantly from 79.6% in 2010 to 86.5% in 2016 (p<0.001). Doctors' attitude showed a trend similar to the overall completeness, while nurses improved more consistently (p<0.001). Most items exploring themes, moments and levels registered a significant improvement in the early years, then flattened in last years. Results of the validation process were always above the cut-off of 75%., Conclusions: This peer-review tool enabled the Quality Unit and hospital leadership to obtain a reliable picture of CRs completeness, while involving the HCWs in the quality evaluation. The completeness of CR showed an overall positive and significant trend during these seven years., Competing Interests: The authors have declared that no competing interests exist.

Background: Little is known regarding the impact of hospital academic status on outcomes following rectal cancer surgery. We compare these outcomes for nonmetastatic rectal adenocarcinoma at academic versus community institutions., Methods: The National Cancer Database (2010-2016) was queried for patients with nonmetastatic rectal adenocarcinoma who underwent resection. Propensity score matching was performed across facility cohorts to balance confounding covariates. Kaplan-Meier estimation and Cox-proportional hazards regression were used to analyze survival, other short and long-term outcomes were analyzed by way of logistic regression., Results: After matching, 15,096 patients were included per cohort. Academic centers were associated with significantly decreased odds of conversion and positive margins with significantly increased odds of ≥12 regional nodes examined. Academic programs also had decreased odds of 30 and 90-day mortality and decreased 5-year mortality hazard. After matching for facility volume, no significant differences in outcomes between centers was seen., Conclusions: No difference between academic and community centers in outcomes following surgery for non-metastatic rectal cancer was seen after matching for facility procedural volume., (Published by Elsevier Inc.)

Background: Western literature lacks large-scale population studies comparing the influence of academic and high-volume (HV) versus low-volume (LV) cancer centers on gastric cancer oncologic outcomes., Methods: The National Cancer Database from 2004 to 2016 was used., Results: 22871 patients were studied. Patients with stage III signet-ring cell gastric carcinoma (SRGC) received neoadjuvant treatment (NAT) more frequently at academic and HV comprehensive cancer centers (OR: 4.27 and 2.42; p < 0.0001 and 0.009) compared to community centers. Patients with stage III non-SRGC (NSRGC) had a 2.4 times higher odds of receiving NAT at academic centers. The R1 resection rate for NSRGC was lower at academic centers (OR: 0.67; p = 0.0018). Lymph node harvest ≥15 nodes was 1.6 and 1.9 times higher at academic centers for NSRGC and SRGC, respectively. Patients treated at academic centers had a significantly improved overall survival (OS)., Conclusions: Treatment at academic centers is associated with significant improvements in oncologic metrics and OS., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objective: The Centers for Disease Control and Prevention (CDC) and many state governments have issued guidelines for opioid prescribing for the treatment of chronic noncancer-associated pain. We sought to decrease practice variation and increase compliance with these guidelines in a tertiary academic rheumatology practice by developing an interdisciplinary opioid working group and using electronic health record (EHR)-integrated data feedback., Methods: Division leadership and providers established shared goals at interdisciplinary meetings involving rheumatology, pain medicine, nursing, and pharmacy. Interventions included educational sessions on opioid prescribing guidelines and the sharing of individual de-identified prescribing patterns. An opioid dashboard page within the EHR allowed every provider to see individualized and division-wide data that tracked process measures based on CDC and state-specific guidelines. Baseline data from June to August 2017 were compared with monthly data through December 2018., Results: At baseline, 40% of patients had an active opioid agreement (a Pennsylvania guideline and a New Jersey law), 25% had a urine drug screen result within 12 months of their most recent opioid prescription, and 24% had a concurrent benzodiazepine prescription. After 16 months, these percentages improved to 88%, 66%, and 16%, respectively. The average number of opioid tablets prescribed per month decreased from 59,733 to 48,966 (-18%; P = 0.02)., Conclusion: Shared goals developed through interdisciplinary input and readily accessible data feedback can markedly increase provider compliance with national and state-specific guidelines for opioid prescribing for the treatment of chronic noncancer-associated pain in rheumatology., (© 2020, American College of Rheumatology.)

Objectives/hypothesis: Despite controversy regarding their impact and validity, there is a rising national focus on patient satisfaction scores (PSS). We describe the landscape of online PSS as posted by academic otolaryngology practices., Study Design: Retrospective cross-sectional study., Methods: Websites of academic otolaryngology programs were reviewed for PSS scores, provider type, and geographic location. Gender was determined by picture or profile pronouns. Years of experience were determined by year of initial American Board of Otolaryngology-Head and Neck Surgery certification. We defined PSS derived from Press-Ganey or Clinician and Group Consumer Assessment of Healthcare Providers and Systems surveys as "standardized PSS". We determined potential associations between provider characteristics and standardized PSS., Results: Out of 115 Otolaryngology-Head and Neck Surgery academic programs, 40 (35%) posted a total of 64,638 online PSS surveys (nonstandardized plus standardized) of 507 unique otolaryngology care providers. Standardized PSS were posted for 473 providers (370 [78%] male; 446 physicians; 27 advanced practice providers). Median overall standardized PSS was 4.8 (interquartile range 4.7-4.9; range 3.8-5.0). PSS were similar between gender, provider type, and years of experience. Male providers had more surveys than female providers (149 vs. 93; P < .01). There was a linear relationship between number of surveys and years of experience (P < .01), but no relationship between number of surveys and overall standardized PSS., Conclusions: Patient satisfaction with otolaryngology providers at academic institutions is consistently high, as demonstrated by high online PSS with little variability. The limited variation in PSS may limit their usefulness in differentiating providers and quality of care., Level of Evidence: NA Laryngoscope, 131:2204-2210, 2021., (© 2021 The American Laryngological, Rhinological and Otological Society, Inc.)

The novel SARS-CoV-2 pandemic starting in 2019 profoundly changed the world, and thousands of residents of New York City were affected, leading to one of the most acute surges in regional hospital capacity. As the largest academic medical center in the Bronx, Montefiore Medical Center was immediately impacted, and the entire hospital was mobilized to address the needs of its community. In this article, we describe our experiences as a large academic anesthesiology department during this pandemic. Our goals were to maximize our staff's expertise, maintain our commitment to wellness and safety, and preserve the quality of patient care. Lessons learned include the importance of critical care training presence and leadership, the challenges of converting an ambulatory surgery center to an intensive care unit (ICU), and the management of effective communication. Lastly, we provide suggestions for institutions facing an acute surge, or subsequent waves of COVID-19, based on a single center's experiences., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Introduction/aims: The initial surge of the coronavirus disease-2019 (COVID-19) pandemic in early 2020 led to widespread cancellation of elective medical procedures in the United States, including nonurgent outpatient and inpatient electrodiagnostic (EDx) studies. As certain regions later showed a downtrend in daily new cases, EDx laboratories have reopened under the guidance of the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM). In our reopening experience guided by the AANEM, we measured relevant outcomes to determine further workflow adaptations. We aimed to detail our experience and share the lessons learned., Methods: We reviewed the clinical volumes, billing data, diagnosis distributions, and rates of COVID-19 exposure and transmission among patients and staff in our EDx laboratory during the first 6 months of reopening, starting on June 1, 2020. For context, we detailed the recent AANEM guidelines we adopted at our laboratory, supplemented by other consensus statements., Results: We completed 816 outpatient studies from June 1 to December 1, 2020, reaching 97% of the total volume and 97% of total billing compared with the same time period in 2019. The average relative value units per study were similar. There were no major shifts in diagnosis distributions. We completed 10 of 12 requested inpatient studies during this period. There were no known COVID-19 transmissions between patients and staff., Discussion: Our experience suggests that it is possible to safely operate an EDx laboratory under the guidance of the AANEM and other experts, with clinical volume and billing rates comparable to pre-pandemic baselines., (© 2021 Wiley Periodicals LLC.)

Having a strategic plan is important to reach organizational goals. Equally important is knowing how to develop and execute that plan. Also, such plans evolve and are executed in the context of the organization's culture, which is another critical success element. Using a garden metaphor, the arrangement of the plants in the garden is like the strategy. With a good strategy, the arrangement of the plants will be appealing. But the soil in the garden is the organizational culture. If the soil is fouled, no plants will grow, regardless of how appealing the garden plan. This "How We Do It" paper addresses the issue of developing and executing a strategy and then, in a companion piece, the related process of envisioning and cultivating an organizational culture. The strategic planning discussion invokes a "real-win-worth" paradigm to address the real-world case of assuring uniform, best-in-class ICU outcomes across multiple ICUs in a large academic medical center system., (Copyright © 2021 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

Summary: The coronavirus disease of 2019 pandemic became a global threat in a matter of weeks, with its future implications yet to be defined. New York City was swiftly declared the epicenter of the pandemic in the United States as case numbers grew exponentially in a matter of days, quickly threatening to overwhelm the capacity of the health care system. This burgeoning crisis led practitioners across specialties to adapt and mobilize rapidly. Plastic surgeons and trainees within the New York University Langone Health system faced uncertainty in terms of future practice, in addition to immediate and long-term effects on undergraduate and graduate medical education. The administration remained vigilant and adaptive, enacting departmental policies prioritizing safety and productivity, with early deployment of faculty for clinical support at the front lines. The authors anticipate that this pandemic will have far-reaching effects on the future of plastic surgery education, trends in the pursuit of elective surgical procedures, and considerable consequences for certain research endeavors. Undoubtedly, there will be substantial impact on the physical and mental well-being of health care practitioners across specialties. Coordinated efforts and clear lines of communication between the Department of Plastic Surgery and its faculty and trainees allowed a concerted effort toward the immediate challenge of tempering the spread of coronavirus disease of 2019 and preserving structure and throughput for education and research. Adaptation and creativity have ultimately allowed for early rebooting of in-person clinical and surgical practice. The authors present their coordinated efforts and lessons gleaned from their experience to inform their community's preparedness as this formidable challenge evolves., (Copyright © 2021 by the American Society of Plastic Surgeons.)

Objectives/hypothesis: The American Academy of Otolaryngology-Head and Neck Surgery has published clinical practice guidelines (CPGs) to guide management of common otolaryngologic (ENT) conditions. While these CPGs have been disseminated within specialty journals, many patients' first presentation of certain ENT complaints is to primary and acute care settings, including the emergency department (ED). It is less clear whether practice in these settings is concordant with specialty CPGs., Study Design: Retrospective cohort study., Methods: A retrospective review of medical records was performed at an academic tertiary care center with ED diagnoses of 1) Bell's palsy/facial weakness (BP) or 2) acute otitis externa (AOE) from May 2014-June 2018. Individual chart abstraction was performed for all encounters with these diagnoses for the purpose of assessing providers' adherence to CPGs., Results: During the study period, 224 patients were diagnosed with BP and 465 patients were diagnosed with AOE. Of the patients diagnosed with BP, 94% (n = 211/224) were prescribed oral steroids, concordant with guidelines, while 36% of these patients received head computed tomography (CT) scans and 43% received laboratory tests, counter to the guidelines. For those with a diagnosis of AOE, 28.6% received topical antibiotics only as primary treatment (n = 133/465) in accordance with guidelines while systemic antibiotics were prescribed in 42.2% (n = 196/465) discordant with the guidelines and 29.2% received both topical and systemic antibiotics (n = 136/465)., Conclusions: CPGs developed by subspecialty societies provide evidence-based recommendations for the care of patients with particular conditions, but may not be disseminated broadly outside of the specialty. Further research is required to understand the reasons behind divergent management of such conditions., Level of Evidence: 3 Laryngoscope, 131:1266-1270, 2021., (© 2020 American Laryngological, Rhinological and Otological Society Inc, "The Triological Society" and American Laryngological Association (ALA).)

There are many differences between Asian regions in terms of the regulatory requirements and operational procedures in conducting international academic clinical trials for the approval of new drugs. The National Cancer Center Hospital in Japan has launched an international investigator-initiated registration-directed trial (IIRDT) in Japan, Korea, Taiwan, and Singapore, aiming at obtaining pharmaceutical approval in participating regions. Differences in regulatory and operational procedures were identified while coordinating the trial. In Japan, regulatory authority reviews should be performed after approval by institutional review boards for IIRDT, whereas in other regions these can be done in parallel. There were disparities in Good Manufacturing Practice-related documents between regions. Several differences were found regarding investigational product (IP) management, specifically concerning labeling, import/export procedures, and customs clearance costs. On the other hand, safety reporting procedures were relatively well-harmonized in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH-E2A). Regions also differed in per-patient costs, due to varying regulations for academic registration-directed trials. In conclusion, the observed differences among Asian regions should be harmonized to facilitate international academic trials in Asia and thus resolve unmet patient needs worldwide. Study Highlights WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC? International clinical trials have become common because they make it possible to accrue patients faster and obtain new drug approval in wider areas. However, pharmaceutical regulatory differences hinder the efficient conduct of international clinical trials, especially in academia. WHAT QUESTION DID THIS STUDY ADDRESS? We conducted an academic international clinical trial on new drug applications in four Asian countries and clarified pharmaceutical regulatory differences and operational difficulties. WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE? The study identified differences between countries in terms of regulatory affairs, institutional review board (IRB) review processes, investigational new drug (IND) dossiers, investigational product (IP) management procedures, and clinical trial costs, while safety reporting procedures were relatively harmonized. Japan utilizes investigator-initiated registration-directed trials, an advanced regulatory system for new drug application by academia, but the other countries do not. HOW MIGHT THIS CHANGE CLINICAL PHARMACOLOGY OR TRANSLATIONAL SCIENCE? Harmonization of pharmaceutical regulations and trial initiation procedures, and regulatory reform of clinical trial costs are important to accelerate academic international clinical trials for new drug applications., (© 2020 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of the American Society for Clinical Pharmacology and Therapeutics.)

Objectives: The combined impact of variable surgeon prescribing preferences and low resident prescribing comfort level can lead to significant disparity in opioid prescribing patterns for the same surgery in the same academic surgical practice. We report the results of a resident led initiative to standardize postoperative prescription practices within the Department of Otolaryngology at a single tertiary-care academic hospital in order to reduce overall opioid distribution., Study Design: Retrospective cohort study., Methods: Following approval by the Institutional Review Board, performed a retrospective review of 12 months before (July 2016-June 2017) and after (July 2017-June 2018) implementation of the Postoperative Analgesia Protocol, which included all adults undergoing tonsillectomy, septoplasty, thyroidectomy, parathyroidectomy, tympanoplasty, middle ear exploration, stapedectomy, and ossicular chain reconstruction., Results: Seven hundred and thirty eight procedures met inclusion criteria. Following implementation, total morphine milligram equivalents decreased by 26% (P < .0001). The number of patients requiring opioid refills decreased by 49%, and morphine milligram equivalents received as refills decreased by 16% (P < .001). Thyroid and parathyroid surgery had the greatest reduction in morphine milligram equivalents prescribed (84%, P < .001), followed by septoplasty (30%, P = .001) and tonsillectomy (18%, P < .001). The number of patients receiving refills of opioid medications decreased for all procedures (tonsillectomy 54%; septoplasty 67%; thyroid/parathyroid surgery 80%, middle ear surgery 100%)., Conclusions: While every patient and surgery must be treated individually, this study demonstrates that a resident led standardization of pain control regimes can result in significant reductions in total quantity of opioids prescribed., Level of Evidence: IV Laryngoscope, 131:982-988, 2021., (Published 2020. This article is a U.S. Government work and is in the public domain in the USA.)

Academic institutions need to maintain publication lists for thousands of faculty and other scholars. Automated tools are essential to minimize the need for direct feedback from the scholars themselves who are practically unable to commit necessary effort to keep the data accurate. In relying exclusively on clustering techniques, author disambiguation applications fail to satisfy key use cases of academic institutions. Algorithms can perfectly group together a set of publications authored by a common individual, but, for them to be useful to an academic institution, they need to programmatically and recurrently map articles to thousands of scholars of interest en masse. Consistent with a savvy librarian's approach for generating a scholar's list of publications, identity-driven authorship prediction is the process of using information about a scholar to quantify the likelihood that person wrote certain articles. ReCiter is an application that attempts to do exactly that. ReCiter uses institutionally-maintained identity data such as name of department and year of terminal degree to predict which articles a given scholar has authored. To compute the overall score for a given candidate article from PubMed (and, optionally, Scopus), ReCiter uses: up to 12 types of commonly available, identity data; whether other members of a cluster have been accepted or rejected by a user; and the average score of a cluster. In addition, ReCiter provides scoring and qualitative evidence supporting why particular articles are suggested. This context and confidence scoring allows curators to more accurately provide feedback on behalf of scholars. To help users to more efficiently curate publication lists, we used a support vector machine analysis to optimize the scoring of the ReCiter algorithm. In our analysis of a diverse test group of 500 scholars at an academic private medical center, ReCiter correctly predicted 98% of their publications in PubMed., Competing Interests: The authors have declared that no competing interests exist.

Inpatient psychiatric facilities can face significant challenges in containing infectious outbreaks during the COVID-19 pandemic. The main objective of this study was to characterize the epidemiology, testing data, and containment protocols of COVID-19 in a large academic medical center during the height of the COVID-19 outbreak. A retrospective cohort analysis was conducted on hospitalized individuals on five inpatient psychiatric units from March 1 st  to July 8 th , 2020. Demographic data collected include age, race, gender, ethnicity, diagnosis, and admission status (one or multiple admissions). In addition, a Gantt chart was used to assess outbreak data and timelines for one unit. Testing data was collected for patients admitted to inpatient psychiatric units, emergency room visits, and employees. 964 individuals were hospitalized psychiatrically. The study population included ethnically diverse patients with various mental illnesses. We also describe infection prevention strategies, screening, and triage protocols utilized to safely continue patient flow during and beyond the study period with a low patient and employee infection rate. In summary, our study suggests that early implementation of triage, screening, extensive testing, and unit-specific interventions can help prevent and contain the spread of COVID-19 in inpatient psychiatric units and help facilitate safe delivery of care during a pandemic., (Copyright © 2021. Published by Elsevier B.V.)

Problem: The Food and Drug Administration Amendments Act of 2007 (FDAAA) and the National Institutes of Health (NIH) require that many clinical trials register and report results on ClinicalTrials.gov. Noncompliance with these policies denies research participants and scientists access to potentially relevant findings and could lead to monetary penalties or loss of funding. After discovering hundreds of potentially noncompliant trials affiliated with the institution, the Johns Hopkins University School of Medicine (JHUSOM) sought to develop a program to support research teams with registration and reporting requirements., Approach: JHUSOM conducted a baseline assessment of institutional compliance in 2015, launched the ClinicalTrials.gov Program in June 2016, and expanded the program to the Sidney Kimmel Comprehensive Cancer Center in April 2018. The program is innovative in its comprehensive approach, and it was among the first to bring a large number of trials into compliance., Outcomes: From September 2015 to September 2020, JHUSOM brought completed and ongoing trials into compliance with FDAAA and NIH policies and maintained almost perfect compliance for new trials. During this period, the proportion of trials potentially noncompliant with the FDAAA decreased from 44% (339/774) to 2% (32/1,304)., Next Steps: JHUSOM continues to develop and evaluate tools and procedures that facilitate trial registration and results reporting. In collaboration with other academic medical centers, JHUSOM plans to share resources and to identify and disseminate best practices. This report identifies practical lessons for institutions that might develop similar programs., (Copyright © 2020 by the Association of American Medical Colleges.)

Objectives/hypothesis: To compare personal protective equipment (PPE) guidelines, specifically respirator use, among international public health agencies, academic hospitals, and otolaryngology-head and neck surgery (OHNS) departments in the United States for the care of coronavirus-19 (COVID-19) patients., Study Design: Cross sectional survey., Methods: Review of publicly available public health and academic hospitals guidelines along with review of communication among otolaryngology departments., Results: Among 114 academic institutions affiliated with OHNS residencies, 20 (17.5%) institutions provided public access to some form of guidance on PPE and 73 (64%) provided information on screening or diagnostic testing. PPE guidelines were uniquely described based on several variables: location of care, COVID-19 status, involvement of aerosol generating or high-risk procedures, and physical distance from the patient. Six hospital guidelines were highlighted. Across these six institutions, there was agreement that N95 respirators were needed for high-risk patients undergoing high-risk procedures. Variations existed among institutions for scenarios with low-risk patients. Definitions of the low-risk patient and high-risk procedures were inconsistent among institutions. Three of the highlighted institutions had OHNS departments recommending higher level of airway protection than the institution., Conclusions: OHNS departments typically had more stringent PPE guidance than their institution. Discrepancies in communicating PPE use were frequent and provide inconsistent information on how healthcare workers should protect themselves in the COVID-19 pandemic. Identification of these inconsistencies serves as an opportunity to standardize communication and develop evidence-based guidelines., Level of Evidence: V Laryngoscope, 131:E746-E754, 2021., (© 2020 American Laryngological, Rhinological and Otological Society Inc, "The Triological Society" and American Laryngological Association (ALA).)

Digital medical records have enabled us to employ clinical data in many new and innovative ways. However, these advances have brought with them a complex set of demands for healthcare institutions regarding data sharing with topics such as data ownership, the loss of privacy, and the protection of the intellectual property. The lack of clear guidance from government entities often creates conflicting messages about data policy, leaving institutions to develop guidelines themselves. Through discussions with multiple stakeholders at various institutions, we have generated a set of guidelines with 10 key principles to guide the responsible and appropriate use and sharing of clinical data for the purposes of care and discovery. Industry, universities, and healthcare institutions can build upon these guidelines toward creating a responsible, ethical, and practical response to data sharing., (© The Author(s) 2020. Published by Oxford University Press on behalf of the American Medical Informatics Association.)

Introduction: In order to recruit high-potential trainees, surgery residency and fellowship programs must first understand what competencies and attributes are required for success in their respective programs. This study performed a systematic analysis to define organizational culture and competency expectations across training programs within one academic surgery department., Methods: Subject matter experts rated the importance and frequency of 22 competencies and completed a 44-item organizational culture inventory along 1 to 5 Likert-type scales., Results: Importance and frequency attributions of competencies varied significantly among programs (p < .05 by ANOVA), but there was substantial agreement on organizational culture; self-directed (x̄ = 3.8), perfectionist (x̄ = 3.7) and social (x̄ = 3.7) attributes were most representative of the program, while oppositional (x̄ = 1.8), competitive (x̄ = 2.5) and hierarchical (x̄ = 2.7) characteristics were least representative., Conclusions: Residency and fellowship programs within the same department have shared perceptions of the culture and values of their institution, but seek different competencies among entering trainees., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objective: To quantify and characterize the burden of urological patients admitted to emergency department (ED) in Lombardy during Italian COVID-19 outbreak, comparing it to a reference population from 2019., Methods: We retrospectively analysed all consecutive admissions to ED from 1 January to 9 April in both 2019 and 2020. According to the ED discharge ICD-9-CM code, patients were grouped in urological and respiratory patients. We evaluated the type of access (self-presented/ambulance), discharge priority code, ED discharge (hospitalization, home), need for urological consultation or urgent surgery., Results: The number of urological diagnoses in ED was inversely associated to COVID-19 diagnoses (95% confidence interval -0.41/-0.19; Beta = -0.8; P < .0001). The average access per day was significantly lower after 10 March 2020 (1.5 ± 1.1 vs 6.5 ± 2.6; P < .0001), compared to reference period. From 11 March 2020, the inappropriate admissions to ED were reduced (10/45 vs 96/195; P = .001). Consequently, the patients admitted were generally more demanding, requiring a higher rate of urgent surgeries (4/45 vs 4/195; P = .02). This reflected in an increase of the hospitalization rate from 12.7% to 17.8% (Beta = 0.88; P < .0001) during 2020., Conclusion: Urological admissions to ED during lockdown differed from the same period of 2019 both qualitatively and quantitatively. The spectrum of patients seems to be relatively more critical, often requiring an urgent management. These patients may represent a challenge due to the difficult circumstances caused by the pandemic., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objective: Global outbreak of the novel coronavirus disease 2019 (COVID-19) has forced healthcare systems worldwide to reshape their facilities and protocols. Although not considered the frontline specialty in managing COVID-19 patients, neurosurgical service and training were also significantly affected. This article focuses on the impact of the COVID-19 outbreak at a low- and/or middle-income country (LMIC) academic tertiary referral hospital, the university and hospital policies and actions for the neurosurgical service and training program during the outbreak, and the contingency plan for future reference on preparedness for service and education., Methods: The authors collected data from several official databases, including the Indonesian Ministry of Health database, East Java provincial government database, hospital database, and neurosurgery operative case log. Policies and regulations information was obtained from stakeholders, including the Indonesian Society of Neurological Surgeons, the hospital board of directors, and the dean's office., Results: The curve of confirmed COVID-19 cases in Indonesia had not flattened by the 2nd week of June 2020. Surabaya, the second-largest city in Indonesia, became the epicenter of the COVID-19 outbreak in Indonesia. The neurosurgical service experienced a significant drop in cases (50% of cases from normal days) along all lines (outpatient clinic, emergency room, and surgical ward). Despite a strict preadmission screening, postoperative COVID-19 infection cases were detected during the treatment course of neurosurgical patients, and those with a positive COVID-19 infection had a high mortality rate. The reduction in the overall number of cases treated in the neurosurgical service had an impact on the educational and training program. The digital environment found popularity in the educational term; however, digital resources could not replace direct exposure to real patients. The education stakeholders adjusted the undergraduate students' clinical postings and residents' working schemes for safety reasons., Conclusions: The neurosurgery service at an academic tertiary referral hospital in an LMIC experienced a significant reduction in cases. The university and program directors had to adapt to an off-campus and off-hospital policy for neurosurgical residents and undergraduate students. The hospital instituted a reorganization of residents for service. The digital environment found popularity during the outbreak to support the educational process.

Objective: To evaluate adherence to the American Urologic Association (AUA) best practice statement guidelines regarding antibiotic duration in the perioperative setting for endoscopic urologic surgery. We assessed concordance to these guidelines among adult urologists at a single academic institution and its correlation with postoperative positive urine cultures as it relates to the revised 2019 best practice statement., Methods: We performed a retrospective review of all adult endoscopic ambulatory urologic surgeries performed over an 18-month period by urologists at our institution. Patient demographics, pre- and postoperative urine cultures, operative details, stent or foley use, and antibiotic prescriptions were reviewed. Chi-squared and linear regression analyses were done., Results: Three hundred thirty patients were included for analysis. Sixty-two percent of patients were prescribed postoperative antibiotics, for an average of 4 days. Trimethoprim/Sulfamethoxazole and fluroquinolones were most often prescribed (43% and 38%, respectively). Intraoperative stent placement, positive urine culture within 30 days prior to surgery, and a positive urine culture within 1 year prior to surgery predicted antibiotic prescription. No significant differences were seen in rates of positive postoperative urine culture rates between cohorts that received antibiotics postoperatively vs those who did not., Conclusions: At our academic institution, we observed poor concordance with the AUA best practice statement for perioperative antibiotic prescription after ambulatory endoscopic urologic surgery. Rates of positive postoperative cultures were low and not associated with receipt or duration of antibiotic prescription at the time of surgery, supporting minimal use of antibiotics for most endoscopic cases., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: With health care practice consolidation, the increasing geographic scope of health care systems, and the advancement of mobile telecommunications, there is increasing interest in telemedicine-based health care consultations. Anesthesiology has had experience with telemedicine consultation for preoperative evaluation since 2004, but the majority of studies have been conducted in rural settings. There is a paucity of literature of use in metropolitan areas. In this article, we describe the implementation of a telemedicine-based anesthesia preoperative evaluation and report the program's patient satisfaction, clinical case cancellation rate outcomes, and cost savings in a large metropolitan area (Los Angeles, CA)., Methods: This is a descriptive study of a telemedicine-based preoperative anesthesia evaluation process in an academic medical center within a large metropolitan area. In a 2-year period, we evaluated 419 patients scheduled for surgery by telemedicine and 1785 patients who were evaluated in-person., Results: Day-of-surgery case cancellations were 2.95% and 3.23% in the telemedicine and the in-person cohort, respectively. Telemedicine patients avoided a median round trip driving distance of 63 miles (Q1 24; Q3 119) and a median time saved of 137 (Q1 95; Q3 195) and 130 (Q1 91; Q3 237) minutes during morning and afternoon traffic conditions, respectively. Patients experienced time-based savings, particularly from traveling across a metropolitan area, which amounted to $67 of direct and opportunity cost savings. From patient satisfaction surveys, 98% (129 patients out of 131 completed surveys) of patients who were consulted via telemedicine were satisfied with their experience., Conclusions: This study demonstrates the implementation of a telemedicine-based preoperative anesthesia evaluation from an academic medical center in a metropolitan area with high patient satisfaction, cost savings, and without increase in day-of-procedure case cancellations.

Objective: The recent COVID-19 outbreak has forced notable adjustments to surgical procedure preparation, including neurosurgical services. However, due to the uniqueness of the recent situation, neurosurgical centers, especially those located in low-resource settings, are facing several challenges such as a lack of coordination, poor equipment, and shortage of medical personnel. Therefore, several guidelines from local authorities and international neurosurgical bodies have been published to help clinicians manage their patients. In addition, the academic health system (AHS), which is an integrated system containing a medical institution, universities, and a teaching hospital, may play some role in the management of patients during COVID-19. The objective of this study was to describe how each hospital in the authors' network adjusted their neurosurgical practice and how the AHS of the Universitas Gadjah Mada (UGM) played its role in the adaptation process during the pandemic., Methods: The authors gathered both local and national data about the number of COVID-19 infections from the government's database. To assess the contribution of the AHS to the efforts of each hospital to address the pandemic, questionnaires were given to 6 neurosurgeons, 1 resident, and 2 general surgeons about the management of neurosurgical cases during the pandemic in their hospitals., Results: The data illustrate various strategies to manage neurosurgical cases by hospitals within the authors' networks. The hospitals were grouped into three categories based on the transmission risk in each region. Most of these hospitals stated that UGM AHS had a positive impact on the changes in their strategies. In the early phase of the outbreak, some hospitals faced a lack of coordination between hospitals and related stakeholders, inadequate amount of personal protective equipment (PPE), and unclear regulations. As the nation enters a new phase, almost all hospitals had performed routine screening tests, had a sufficient amount of PPE for the medical personnel, and followed both national and international guidelines in caring for their neurosurgical patients., Conclusions: The management of neurosurgical procedures during the outbreak has been a challenging task and a role of the AHS in improving patient care has been experienced by most hospitals in the authors' network. In the future, the authors expect to develop a better collaboration for the next possible pandemic.

Background: Critical thyroid nodule features are contained in unstructured ultrasound (US) reports. The Thyroid Imaging, Reporting, and Data System (TI-RADS) uses five key features to risk stratify nodules and recommend appropriate intervention. This study aims to analyze the quality of US reporting and the potential benefit of Natural Language Processing (NLP) systems in efficiently capturing TI-RADS features from text reports., Materials and Method: This retrospective study used free-text thyroid US reports from an academic center (A) and community hospital (B). Physicians created "gold standard" annotations by manually extracting TI-RADS features and clinical recommendations from reports to determine how often they were included. Similar annotations were created using an automated NLP system and compared with the gold standard., Results: Two hundred eighty-two reports contained 409 nodules at least 1-cm in maximum diameter. The gold standard identified three nodules (0.7%) which contained enough information to calculate a complete TI-RADS score. Shape was described most often (92.7% of nodules), whereas margins were described least often (11%). A median number of two TI-RADS features are reported per nodule. The NLP system was significantly less accurate than the gold standard in capturing echogenicity (27.5%) and margins (58.9%). One hundred eight nodule reports (26.4%) included clinical management recommendations, which were included more often at site A than B (33.9 versus 17%, P < 0.05)., Conclusions: These results suggest a gap between current US reporting styles and those needed to implement TI-RADS and achieve NLP accuracy. Synoptic reporting should prompt more complete thyroid US reporting, improved recommendations for intervention, and better NLP performance., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Postoperative opioid use can lead to dependence, contributing to the opioid epidemic in the United States. New persistent opioid use after minor surgeries occurs in 5.9% of patients. With increased documentation of persistent opioid use postoperatively, surgeons must pursue interventions to reduce opioid use perioperatively., Methods: We performed a prospective cohort study to assess the feasibility of a preoperative intervention via patient education or counseling and changes in provider prescribing patterns to reduce postoperative opioid use. We included adult patients undergoing thyroidectomy and parathyroidectomy from January 22, 2019 to February 28, 2019 at a tertiary referral, academic endocrine surgery practice. Surveys were administered to assess pain and patient satisfaction postoperatively. Prescription, demographic, and comorbidity data were collected from the electronic health record., Results: Sixty six patients (74.2% women, mean age 58.6 [SD 14.9] y) underwent thyroidectomy (n = 35), parathyroidectomy (n = 24), and other cervical endocrine operations (n = 7). All patients received a preoperative educational intervention in the form of a paper handout. 90.9% of patients were discharged with prescriptions for nonopioid pain medications, and 7.6% were given an opioid prescription on discharge. Among those who received an opioid prescription, the median quantity of opioids prescribed was 135 (IQR 120-150) oral morphine equivalents. On survey, four patients (6.1%) reported any postoperative opioid use, and 94.6% of patients expressed satisfaction with their preoperative education and postoperative pain management., Conclusions: Clear and standardized education regarding postoperative pain management is feasible and associated with high patient satisfaction. Initiation of such education may support efforts to minimize unnecessary opioid prescriptions in the population undergoing endocrine surgery., (Published by Elsevier Inc.)

Objectives: Non-publication and publication bias are topics of considerable importance to the scientific community. These issues may limit progress toward the 3R principle for animal research, promote waste of public resources, and generate biased interpretations of clinical outcomes. To investigate current publishing practices and to gain some understanding of the extent to which research results are reported, we examined publication rates of research projects that were approved within an internal funding program of the Faculty of Medicine at a university medical center in Germany, which is exemplary for comparable research funding programs for the promotion of young researchers in Germany and Europe., Methods: We analyzed the complete set (n = 363) of research projects that were supported by an internal funding program between 2004 and 2013. We divided the projects into four different proposal types that included those that required an ethics vote, those that included an animal proposal, those that included both requirements, and those that included neither requirement., Results: We found that 65% of the internally funded research projects resulted in at least one peer-reviewed publication; this increased to 73% if other research contributions were considered, including abstracts, book and congress contributions, scientific posters, and presentations. There were no significant differences with respect to publication rates based on (a) the clinic/institute of the applicant, (b) project duration, (c) scope of funding or (d) proposal type., Conclusion: To the best of our knowledge, this is the first study to explore publication rates associated with early-career medical research funding. As >70% of the projects ultimately generated some form of publication, the program was overall effective toward this goal; however, non-publication of research results is still prevalent. Further research will explore the reasons underlying non-publication. We hope to use these findings to develop strategies that encourage publication of research results., Competing Interests: The authors have declared that no competing interests exist.

Purpose of Review: The aim of the study was to investigate patient satisfaction amongst academic pain management centers and associated factors., Recent Findings: Approximately 25% of pain management centers perform better than other practices on Press Ganey surveys. The majority of respondents (96%) indicated that pain management practices were uniquely positioned to receive poorer scores on patient satisfaction surveys. The majority of respondents (20/26), who reported a reason, indicated that limiting opioid prescribing led to poor patient satisfaction scores. Eighty-three percent of respondents indicated that they received pressure from administrators to improve patient satisfaction scores. The opioid epidemic in the USA must be addressed in order to diminish the senseless loss of life that is occurring in staggering numbers. The quality of care physicians provide has increasingly been assessed via patient satisfaction surveys. The results of these surveys often are utilized to provide financial incentives to physicians to obtain higher satisfaction scores. In the field of pain management, physicians may experience pressure to prescribe opioids in order to obtain higher patient satisfaction scores.

Context.—: Declining reimbursement shifts hospital laboratories from system assets to cost centers. This has resulted in increased outsourcing of laboratory services, which can jeopardize a hospital systems' ability to respond to a health care crisis., Objectives.—: To demonstrate that investment in a core laboratory serving an academic medical center equipped a regional health system to respond to the Coronavirus disease 2019 (COVID-19) pandemic., Design.—: COVID-19 diagnostic testing data were analyzed. Volumes were evaluated by result date (March 16, 2020-May 6, 2020), and the average of received-to-verified turnaround time was calculated and compared for in-house and send-out testing, and different in-house testing methodologies., Results.—: Daily viral diagnostic testing capacity increased by greater than 3000% (from 21 tests per day to 658 tests per day). Total viral diagnostic testing reported by the core laboratory increased by 128 times during 22 days of test method validation and 826 times during the analysis period, while average turnaround time per day for send-out testing increased from 3.7 days to 21 days. Decreased overall average turnaround time was observed at the core laboratory (0.45 days) versus send-out testing (7.63 days) (P < .001)., Conclusions.—: Investment in a core laboratory provided the health system with the necessary expertise and resources to mount a robust response to the pandemic. Local access to testing allowed rapid triage of patients and conservation of scarce personal protective equipment (PPE). In addition, the core laboratory was able to support regional health departments and several hospitals outside of the system., (© 2020 College of American Pathologists.)

Objective: To assess characteristics of patients with hip fractures and investigate the extent of osteoporosis-related care they receive at a tertiary referral center in Lebanon., Methods: A retrospective review of charts of 400 patients admitted with a hip fracture to the American University of Beirut-Medical Center, between January 1, 2011 and December 31, 2015. We reviewed medical records of adults admitted with a nonpathologic/nontraumatic hip fracture, and evaluated basic demographics and relevant clinical information, associated risk factors, and the management received., Results: The mean age of the population was 78 ± 10 years and men constituted 37%. Women were more likely to be assessed and/or treated. On admission, 21% were taking calcium and 18% vitamin D supplementation. During hospitalization, vitamin D level was assessed in only 39% of patients; a dietary and an osteoporosis consult were requested on only 32% and 22% of the cases, respectively. One-fourth to a third of patients were discharged on calcium or vitamin D, and less than 5% on bisphosphonates. Bone mineral density was measured in a minority although 21% had a history of previous contralateral hip fracture. One year mortality rate in a subset where follow-up available was 12% in men and 7% in women., Conclusion: A large care gap in the management of patients admitted with hip fracture persists despite clear national osteoporosis guidelines. This study provides a strong impetus for establishing and monitoring a fracture liaison service to understand and address barriers to providing optimal care to patients with osteoporosis., (Copyright © 2019 The International Society for Clinical Densitometry. Published by Elsevier Inc. All rights reserved.)

Purpose: To describe our medical center's pharmacy services preparedness process and offer guidance to assist other institutions in preparing for surges of critically ill patients such as those experienced during the coronavirus disease 2019 (COVID-19) pandemic., Summary: The leadership of a department of pharmacy at an urban medical center in the US epicenter of the COVID-19 pandemic proactively created a pharmacy action plan in anticipation of a surge in admissions of critically ill patients with COVID-19. It was essential to create guidance documents outlining workflow, provide comprehensive staff education, and repurpose non-intensive care unit (ICU)-trained clinical pharmacotherapy specialists to work in ICUs. Teamwork was crucial to ensure staff safety, develop complete scheduling, maintain adequate drug inventory and sterile compounding, optimize the electronic health record and automated dispensing cabinets to help ensure appropriate prescribing and effective management of medication supplies, and streamline the pharmacy workflow to ensure that all patients received pharmacotherapeutic regimens in a timely fashion., Conclusion: Each hospital should view the COVID-19 crisis as an opportunity to internally review and enhance workflow processes, initiatives that can continue even after the resolution of the COVID-19 pandemic., (© American Society of Health-System Pharmacists 2020. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: The American College of Surgeons Commission on Cancer has incorporated documentation of critical elements outlined in Operative Standards for Cancer Surgery into revised standards for cancer center accreditation. This study assessed the current documentation of critical elements in partial mastectomy (PM) and sentinel lymph node biopsy (SLNB) operative reports., Materials and Methods: Operative reports for PM + SLNB at a single academic institution from 2013 to 2018 were reviewed for compliance and surveyor interobserver reliability with the Oncologic Elements of Operative Record defined in Operative Standards and compared with a nonredundant American Society of Breast Surgeons Mastery of Breast Surgery (MBS) quality measure for specimen orientation., Results: Ten reviewers each evaluated 66 PM + SLNB operative reports for 13 Oncologic Elements and one MBS measure. No operative records reported all critical elements for PM + SLNB or PM alone. Residents completed 36.4% of operative reports: Element documentation was similar for PM but varied significantly for SLNB between resident and attending authorship. Combined reporting performance and interrater reliability varied across all elements and was highest for the use of SLNB tracer (97.1% and κ = 0.95, respectively) and lowest for intraoperative assessment of SLNB (30.6%, κ = 0.43). MBS specimen orientation had both high proportion reported (87.0%) and interrater reliability (κ = 0.84)., Conclusions: Adherence to reporting critical elements for PM and SLNB varied. Whether differential compliance was tied to discrepancies in documentation or reviewer abstraction, clarification of synoptic choices may improve reporting consistency. Evolving techniques or technologies will require continuous appraisal of mandated reporting for breast surgery., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Protecting first-line health care providers against work-related coronavirus disease 2019 (COVID-19) infection at the onset of the pandemic has been a crucial challenge in the United States. Anesthesiologists in particular are considered at risk, since aerosol-generating procedures, such as intubation and extubation, have been shown to significantly increase the odds for respiratory infections during severe acute respiratory syndrome (SARS) outbreaks. This study assessed the incidence of COVID-19-like symptoms and the presence of COVID-19 antibodies after work-related COVID-19 exposures, among physicians working in a large academic hospital in New York City (NYC)., Methods: An e-mail survey was addressed to anesthesiologists and affiliated intensive care providers at Columbia University Irving Medical Center on April 15, 2020. The survey assessed 4 domains: (1) demographics and medical history, (2) community exposure to COVID-19 (eg, use of NYC subway), (3) work-related exposure to COVID-19, and (4) development of COVID-19-like symptoms after work exposure. The first 100 survey responders were invited to undergo a blood test to assess antibody status (presence of immunoglobulin M [IgM]/immunoglobulin G [IgG] specific to COVID-19). Work-related exposure was defined as any episode where the provider was not wearing adequate personal protective equipment (airborne or droplet/contact protection depending on the exposure type). Based on the clinical scenario, work exposure was categorized as high risk (eg, exposure during intubation) or low risk (eg, exposure during doffing)., Results: Two hundred and five health care providers were contacted and 105 completed the survey (51%); 91 completed the serological test. Sixty-one of the respondents (58%) reported at least 1 work-related exposure and 54% of the exposures were high risk. Among respondents reporting a work-related exposure, 16 (26.2%) reported postexposure COVID-19-like symptoms. The most frequent symptoms were myalgia (9 cases), diarrhea (8 cases), fever (7 cases), and sore throat (7 cases). COVID-19 antibodies were detected in 11 of the 91 tested respondents (12.1%), with no difference between respondents with (11.8%) or without (12.5%) a work-related exposure, including high-risk exposure. Compared with antibody-negative respondents, antibody-positive respondents were more likely to use NYC subway to commute to work and report COVID-19-like symptoms in the past 90 days., Conclusions: In the epicenter of the United States' pandemic and within 6-8 weeks of the COVID-19 outbreak, a small proportion of anesthesiologists and affiliated intensive care providers reported COVID-19-like symptoms after a work-related exposure and even fewer had detectable COVID-19 antibodies. The presence of COVID-19 antibodies appeared to be associated with community/environmental transmission rather than secondary to work-related exposures involving high-risk procedures.

Background: Benchmarking group surgical anesthesia productivity continues to be an important but challenging goal for anesthesiology groups. Benchmarking is important because it provides objective data to evaluate staffing needs and costs, identify potential operating room management decisions that could reduce costs or improve efficiency, and support ongoing negotiations and discussions with health system leadership. Unfortunately, good and meaningful benchmarking data are not readily available. Therefore, a survey of academic anesthesiology departments was done to provide current benchmarking data., Methods: A survey of members of the Society of Academic Associations of Anesthesiology and Perioperative Medicine (SAAAPM) was performed. The survey collected data by facility and included type of facility, number and type of staff and anesthetizing sites each weekday, and the billed American Society of Anesthesiologists (ASA) units and number of cases over 12 months. The facility types included academic medical center (AMC), community hospital (Community), children's hospital (Children), and ambulatory surgical center (ASC). All anesthesia care billed using ASA units were included, except for obstetric anesthesia. Any care not billed or billed using relative value units (RVUs) were excluded. Percentage of nonoperating room anesthetizing sites, staffing ratio, and surgical anesthesia productivity measurements "per case" and "per site" were calculated., Results: Of the 135 society members, 63 submitted complete surveys for 140 facilities (69 AMC, 26 Community, 7 Children, and 38 ASC). In the survey, overall median productivity for AMC and Children was similar (12,592 and 12,364 total ASA units per anesthetizing site), while the ASC had the lowest median overall productivity (8911 total ASA units per anesthetizing site). By size of facility, in the survey, the smaller facilities (<10 sites, ASC or non-ASC) had lower median overall productivity as compared to larger facilities. For AMC and Children, >20% of anesthetizing sites were nonoperating room anesthetizing sites. Anesthesiology residents worked primarily in AMC and Children. In ASC and Community, residents worked only in 18% and 35% of facilities, respectively. More than half the AMCs reported at least 1 break certified nurse anesthetist (CRNA) each day., Conclusions: To make data-driven decisions on clinical productivity, anesthesiology leaders need to be able to make meaningful comparisons at the facility level. For a group that provides care in multiple facilities, one can make internal comparisons among facilities and follow measurements over time. It is valuable for leaders to also be compare their facilities with industry-wide measurements, in other words, benchmark their facilities. These results provide benchmarking data for academic anesthesiology departments.

Background: Enhanced Recovery After Surgery (ERAS) protocols use evidence-based perioperative practices that reduce morbidity and length of stay and improve patient satisfaction. ERAS is considered standard of care; however, utilization remains low and substantial practice variation exists. The aim of this study was to pragmatically characterize variation in colorectal surgery practice and identify predictors of ERAS utilization., Methods: A survey of general surgeons identified using the Ontario College of Physicians and Surgeons database was conducted. Information on basic demographic characteristics, utilization of ERAS and predictors of ERAS implementation was collected. Nine ERAS behaviours were analyzed. Multivariable analysis was used to determine effects of demographic, hospital and surgeon covariates on ERAS utilization., Results: Seven hundred and ninety-seven general surgeons were invited to participate in the survey, and 235 general surgeons representing 84 Ontario hospitals responded (30% response rate). Surgeons practising in academic settings and in large community hospitals represented 30% and 47% of the respondents, respectively. A total of 20% of the respondents used all 9 ERAS behaviours consistently. Rates of diet advancement on postoperative day 0, intravenous fluid restriction and having catheter and line procedures were significantly higher among respondents who adhered to ERAS protocols than among those who did not (74% v. 54%, p = 0.004; 92% v. 80%, p = 0.01; and 91% v. 41%, p < 0.001, respectively). Respondents from academic settings reported practising nearly 1 more ERAS behaviour than those from small community hospitals (odds ratio [OR] 0.86, 95% confidence interval [CI] 0.42 to 1.31, p < 0.001). Multivariable analysis demonstrated that colorectal fellowship training or exposure to ERAS during training did not significantly affect ERAS behaviour utilization (OR 0.32, 95% CI -0.31 to 0.94, p = 0.16; OR 0.28, 95% CI -0.26 to 0.82, p = 0.16, respectively)., Conclusion: Substantial practice variation in colorectal surgery still exists. Individual ERAS principles are commonly followed; however, ERAS behaviours are not widely formalized into hospital protocols.

Cell therapy is a promising treatment. One of the key aspects of cell processing products is ensuring sterility of cell-processing facilities (CPFs). The objective of this study was to assess the environmental risk factors inside and outside CPFs. We monitored the temperature, humidity, particle number, colony number of microorganisms, bacteria, fungi, and harmful insects in and around our CPF monthly over one year. The temperature in the CPF was constant but the humidity fluctuated depending on the humidity outside. The particle number correlated with the number of entries to the room. Except for winter, colonies of microorganisms and harmful insects were detected depending on the cleanliness of the room. Seven bacterial and two fungal species were identified by PCR analyses. Psocoptera and Acari each accounted for 41% of the total trapped insects. These results provide useful data for taking the appropriate steps to keep entire CPFs clean., Competing Interests: The authors have declared that no competing interests exist.

Phenomenon: Universities offer a variety of voluntary faculty development to ensure quality education, but face inconsistent faculty participation. Therefore, all Dutch universities require all faculty to obtain a teaching qualification certificate. Yet, like other medical centers, University Medical Center Utrecht continued to struggle with faculty nonparticipation. It has been postulated that clinician teachers may face unique challenges with responsibilities for patient care in addition to teaching and research, challenges that cannot be overcome by merely mandating faculty development or a teaching certificate. This project was conducted to gain insight into factors that hinder faculty participation and better understand what is needed to enhance faculty engagement in their professional development as teachers. Approach: UMC Utrecht has had a teaching certificate requirement for over 20 years. In 2015-2016, we conducted a local needs assessment, gathering faculty perspectives about the teaching certification process. To convey seriousness of purpose and promote commitment to change, we formally engaged key stakeholders from the outset, obtained grant funding for the needs assessment, and had an outside consultant lead the project. Faculty who were stalled or never started were questioned via semi-structured interviews. A focus group with those actively in the process of obtaining their certificate discussed perceived challenges in the process and recommended solutions. Faculty who obtained their teaching certificate completed an anonymous evaluation form. All evaluation comments and transcripts were thematically analyzed using open and axial coding. A literature review was performed to contextualize our findings and identify potential solutions. We compared our initial themes to these findings and found key challenge/solution categories, which we subsequently developed into a novel framework. Findings from the study and literature review were organized using this framework and shared with different stakeholders, all of whom engaged in problem-solving. Ideas and potential solutions were incorporated into a final report with recommendations for improving faculty support and provided to the institutional leadership. Findings: Of 23 faculty teachers approached, 8 (34.8%) agreed to be interviewed; 7 of 25 (28.0%) participated in the focus group; and 83 of 156 (53.2%) completed the evaluation. From the transcripts and evaluation comments, three themes emerged related to context and barriers: (a) skill development versus certification; (b) workplace priorities and culture, and (c) visibility and feasibility of the teacher's role. Triangulation of these themes with the literature revealed four challenge/solution categories - Competence, Context, Community, and Career . This 4-C framework facilitated communication of findings, structured the development of an action plan in response to the findings, and assured implementation of new initiatives for faculty support beyond competence development. Insights: Simply adopting requirements for faculty development may be insufficient and even invoke resistance. Improving faculty participation in faculty development and the quality of education requires institutional attention to not just faculty Competence needs, but also the factors of Context , Community , and Career that together comprise the culture experienced by faculty teachers. With institutional buy-in and commitment to change, the 4-C framework can help focus institutional attention on existing gaps in all four domains and guide the development of comprehensive solutions.

Plastic surgeons have the unique perspective of working with all types of patients and care teams from almost all specialties in surgery and medicine, which creates unique challenges in times of distress. As the initial epicenter of coronavirus disease 2019 cases in the United States, the University of Washington program was required to rapidly develop strategies to deal with the escalating crisis. All aspects of the program were affected, including the need to triage the urgency of plastic surgery care, safe staffing of plastic surgery teams, and the role of plastic surgery in the greater hospital community. In addition, as a residency training program, limiting the impact of resident education and maintaining a sense of community and connection among members of the program developed into important considerations. The authors hope that the narrative of their experience will provide insight into the decisions made in the University of Washington health care system but also remind others that they are not alone in dealing with the challenges of this pandemic.

Background: Initial opioid exposure for most individuals with substance use disorder comes from the healthcare system, and overprescription of opioids in ambulatory operations is common. This report describes an academic medical center's experience implementing opioid-free thyroid and parathyroid operations., Materials and Methods: This is a retrospective chart review of patients undergoing a thyroid or parathyroid operation before and after implementation of an opioid-free analgesia protocol. The primary endpoint was new postoperative opioid prescription. Secondary endpoints included prescription characteristics and predictors of new opioid prescription., Results: A total of 515 patients were enrolled in the study: 240 in the control or "pre-intervention" cohort (May through October 2017) and 275 in the intervention or "post" cohort (May through October 2018). Patients in the intervention cohort were significantly less likely to receive an opioid prescription (12.0% versus 59.6%, P < 0.001). When opioids were prescribed, they were used for shorter durations and at lower doses in the intervention cohort. Among the patients prescribed opioids in the intervention cohort (N = 33), the only significant predictor of postoperative opioid use was preoperative opioid use (P = 0.001)., Conclusions: Opioids may not be required after thyroidectomy and parathyroidectomy, especially for opioid-naïve patients. Future research should examine patient satisfaction with opioid-sparing analgesia., (Published by Elsevier Inc.)