External Validation of SHAPE Score: A Score to Predict Low-Risk Lower Gastrointestinal Bleeding in the Emergency Department

Lower gastrointestinal bleeding (LGIB) frequently leads to emergency department (ED) visits and hospitalizations, encompassing a spectrum of outcomes from spontaneous resolution to intrahospital mortality. The purpose of this study was to validate a scoring system designed to identify cases of low-risk LGIB, allowing for safe discharge from the ED. A retrospective analysis of all gastrointestinal bleeding cases presented at three EDs in 2020 was conducted, focusing specifically on patients with LGIB. The SHAPE score incorporates factors such as systolic blood pressure, hemoglobin levels, use of antiplatelet or anticoagulant medications, pulse rate, and episodes of bright blood per rectum. Out of 1112 patients presenting with LGIB to the ED, 55 were hospitalized, 20 required blood transfusions, 15 underwent colonoscopies, one underwent interventional radiology procedures, and two patients died. Employing a SHAPE score with a cutoff value of 1 yielded a specificity of 78.5% (95% CI (confidence interval) [75.8-81.0]), sensitivity of 76.8% (95% CI [63.6-87.0]), positive predictive value (PPV) of 17.0% (95% CI [12.6-22.2]), and negative predictive value (NPV) of 98.3% (95% CI [97.2-99.1]) for predicting the need for hospitalization and intrahospital intervention. When considering return visits to the ED within 7 days with the same presentation, the score demonstrated a specificity of 78.8% (95% CI [76.0-81.3]), sensitivity of 68.6% (95% CI [56.4-79.1]), PPV of 19% (95% CI [14.3-24.4]), and NPV of 97.2% (95% CI [95.8-98.2]). The SHAPE score demonstrates potential in predicting cases of low-risk LGIB, offering a high NPV for hospitalization, the need for intrahospital intervention, and return visits to the ED. However, these findings should be interpreted cautiously given the low prevalence of interventions and limitations in the study\u27s population and design

Trends in screening and treatment of osteoporosis after periprosthetic fractures from 2010 to 2020

UNLABELLED: Osteoporosis is often underrecognized and undertreated following periprosthetic fractures (PPF). Our study found that between 2010 and 2020, there has been no significant change in the rates of osteoporosis screening or treatment within 1 year following PPF. Orthopedic surgeons can play an integral role in helping to curtail the osteoporosis epidemic. PURPOSE: Periprosthetic fractures (PPF) typically occur from low-energy mechanisms and are pathognomonic for osteoporosis. However, osteoporosis is often underrecognized and undertreated. The aim of this study was to examine trends in dual energy X-ray absorptiometry (DXA) scans and treatment of osteoporosis after PPF between 2010 and 2020. METHODS: Patients older than 40 who experienced a lower extremity PPF between 2010 and 2020 and had no prior history of osteoporosis screening or treatment were identified utilizing a large national administrative database. Rates of bone mineral density (BMD) measurement using DXA and anti-osteoporotic treatment with pharmacotherapy, or either intervention within 1 year following experiencing a PPF were determined. The rate of change for these interventions was calculated using the compounded annual growth rate (CAGR), with linear regression used to determine whether trends were statistically significant. RESULTS: In total, 5.7% and 3.6% of patients were screened and treated for osteoporosis, respectively. Between 2010 and 2020, there was no significant change in rates of osteoporosis screening (CAGR + 0.1%; p = 0.13), treatment (CAGR - 2.4%; p = 0.29), or either intervention (CAGR - 1.1%; p = 0.77) within 1 year following PPF. Factors associated with intervention included older age, female sex, and increased comorbidities. CONCLUSION: Our study found that there has been no significant change in the rates of osteoporosis screening or treatment within 1 year following PPF. Orthopedic surgeons and allied healthcare workers can play an integral role in helping to curtail the osteoporosis epidemic

Retooling the Massive Transfusion Protocol at a Veterans Affairs Medical Center

INTRODUCTION: Massive transfusion protocols (MTPs) ensure the timely and life-saving delivery of blood products to patients who are rapidly exsanguinating. Although essential, MTPs are also highly resource-intensive. Effective MTP implementation must balance the resources of the hospital with the needs of the patient population that they serve, as well as avoid instances of unjustified activations. Toward this goal, we implemented a set of policy improvements to our institution\u27s MTP aimed at ensuring appropriate clinical activation. MATERIALS AND METHODS: Following interdisciplinary discussions with clinical teams, we revamped our institution\u27s MTP in the spring of 2019, focusing on the improved training of junior clinicians by requiring final approval of all MTP activations by attendings and fellows, and providing opportunities to review MTP execution during quarterly meetings. Other changes included implementing blood warmers and streamlining the MTP ordering process. We then performed a retrospective study to evaluate the effects of our refurbished MTP on the frequency, characteristics, and outcomes of massive transfusions activated at the Washington DC Veterans Affairs Medical Center between March 2018 to February 2019 and March 2019 to February 2020 (before and after the policy change, respectively). Descriptive statistics were used to summarize the data. Fisher exact test, Wilcoxon test, and Poisson test were used to compare differences in categorical variables, continuous variables, and the rate of MTP activation, before and after policy changes were implemented, respectively. This study is exempt from the Institutional Review Board\u27s review. RESULTS: We did not detect statistically significant changes in patient and MTP-related parameters, nor survival outcomes following policy improvement. However, we observed a decreasing trend in MTP activations, and concomitantly, a significant increase in the number of days between MTP activations, from 12.5 days (median) in the first year to 41 days (median) in the second year (P = 0.0274). CONCLUSIONS: In summary, we developed an MTP tailored to the needs of our Veterans Affairs Medical Center, providing a reliable system for blood product administration to patients with real massive transfusion requirements while reducing unjustified MTP activations. We credit the reduction in MTP activations mainly to improved education and training of clinicians, which, in turn, changed their ordering behaviors. Fewer unjustified MTP activations decrease the potential for wastage of resources such as blood and blood components and preserves work hours of staff for patients with true transfusion needs. We believe our strategy may have a widespread and compounding effect on improving blood stewardship nationwide, given our trainees\u27 propensity to work at medical centers across the country and educate future trainees of their own

Long-Term Safety and Efficacy with Roflumilast Cream 0.15% in Patients Aged ≥6 Years with Atopic Dermatitis: A Phase 3 Open-Label Extension Trial

Safety and efficacy of roflumilast cream 0.15% for atopic dermatitis (AD) were demonstrated in two 4-week phase 3 trials. Evaluate long-term safety, tolerability, and efficacy of roflumilast cream 0.15% in AD. In this open-label extension (OLE) trial (INTEGUMENT-OLE; NCT04804605), patients aged ≥6 years who completed one of the 4-week phase 3 trials applied roflumilast for up to 52 weeks. After 4 weeks of once-daily application, patients who achieved Validated Investigator Global Assessment for AD (vIGA-AD) of clear (0) switched to twice-weekly (BIW) application to normal-appearing flare-prone areas (proactive treatment). Among 657 patients treated, 36.7% reported adverse events, including 4.7% that were treatment related. Application site pain and stinging/burning that caused definite discomfort at any visit were reported for 0.5% and 0.4%-2.1% of patients, respectively. Patients who achieved vIGA-AD 0 and switched to proactive BIW application maintained vIGA-AD 0/1 (almost clear) for a median of 281 days (Kaplan-Meier estimate). Roflumilast cream 0.15% was well tolerated for up to 56 weeks. BIW application to normal-appearing flare-prone sites maintained improvement in AD signs and symptoms, showing that proactive treatment represents an alternative to the current standard practice of reactive treatment

Impact of COVID-19 on Medicare Reimbursement and Glaucoma Procedure Utilization: A Payment-Volume Elasticity and Trends Analysis

PURPOSE: To examine how the COVID-19 pandemic impacted the relationship between Medicare reimbursement and glaucoma procedure service volume in the United States. DESIGN: Retrospective, longitudinal database study. PARTICIPANTS: A complete dataset of all glaucoma procedures performed on Medicare Part B beneficiaries from 2019 to 2022. METHODS: Linear mixed-effects model using Medicare Part B data, controlling for year, charges, denials, reimbursement-to-charge ratio (RCR), service setting, CPT code, state, Medicare population, number of ophthalmologists, and median income. RCR was calculated as the ratio of weighted mean reimbursement to weighted mean charge, representing the proportion of reimbursed charges. Weighted averages for denials, charges, and reimbursements (adjusted for inflation) were also calculated. MAIN OUTCOME MEASURES: Payment-volume elasticities, defined as the percent change in procedure volume per 1% change in Medicare payment, for traditional glaucoma surgeries (tubes and shunts), minimally invasive glaucoma surgeries (MIGS), and laser procedures. Additional measures included weighted averages of charges, reimbursements, denials, and RCR across procedure categories and service settings. RESULTS: Traditional surgeries showed a 2.3% decrease in volume per 1% payment increase (95% CI: -2.9% to -1.7%; p \u3c 0.001; Rc = 0.89) and a 10.2% decline in volume. Mean reimbursement for traditional surgeries decreased by 5%, with a 7.7% drop in RCR. Laser procedures exhibited a 6.7% volume decrease per 1% payment increase (95% CI: -7.1% to -6.2%; p \u3c 0.001; Rc = 0.97) and a 16% total decline, with no change in RCR. MIGS declined by 16% overall but demonstrated an 8.3% volume increase per 1% payment rise (95% CI: 7.9% to 8.7%; p \u3c 0.001; Rc = 0.90), with a 64% improvement in RCR. Overall, glaucoma procedure volumes fell by 15.6%, mean reimbursement decreased by 7.3%, and denied claims increased by 46.7%. ASCs experienced a 15.2% volume decline but an 11.5% increase in reimbursement, supported by a 39.7% rise in RCR. CONCLUSION: Glaucoma procedure volumes declined between 2019-2022, particularly for traditional surgeries and MIGS. Traditional and laser procedures had negative payment-volume elasticities, while MIGS showed positive elasticity. These findings suggest factors beyond reimbursement rates, like shifts to less invasive treatments and COVID-19 disruptions, significantly influenced clinical decision-making

Health System Expansion and Changes in Medicare Beneficiary Utilization of Safety Net Providers

BACKGROUND: Evidence is limited on insured patients\u27 use of safety net providers as vertically integrated health systems spread throughout the United States. OBJECTIVES: To examine whether market-level health system penetration is associated with: (1) switches in Medicare beneficiaries\u27 usual source of primary care from federally qualified health centers (FQHCs) to health systems; and (2) FQHCs\u27 overall Medicare patient and visit volume. RESEARCH DESIGN: Beneficiary-level discrete-time survival analysis and market-level linear regression analysis using Medicare fee-for-service claims data from 2013 to 2018. SUBJECTS: A total of 659,652 Medicare fee-for-service beneficiaries aged 65 and older lived in one of 27,386 empirically derived primary care markets whose usual source of care in 2013 was an FQHC or a non-FQHC-independent physician organization that predominantly served low-income patients. MEASURES: Beneficiary-year measure of the probability of switching to health system-affiliated physician organizations and market-year measures of the number of FQHC visits by Medicare beneficiaries, number of beneficiaries attributed to FQHCs, and FQHC Medicare market shares. RESULTS: During 2013-2018, 16.5% of beneficiaries who sought care from FQHCs switched to health systems. When health system penetration increases from the 25th to 75th percentile, the probability of Medicare FQHC patient switching increases by 4.6 percentage points, with 22 fewer Medicare FQHC visits and 4 fewer beneficiaries attributed to FQHCs per market year. Complex patients and patients who sought care from non-FQHC, independent physician organizations exhibited higher rates of switching to health systems. CONCLUSIONS: Health system expansion was associated with the loss of Medicare patients by FQHCs, suggesting potential negative spillovers of vertical integration on independent safety net providers

Calibrating a functional assay for variant classification in RYR1-related malignant hyperthermia susceptibility

PURPOSE: Identifying individuals with pathogenic variants for RYR1-related Malignant Hyperthermia Susceptibility (MHS) could reduce morbidity and mortality due to MH reactions. Realization of this goal requires knowledge of variant pathogenicity, and proper weighting of functional assays is important for accurate variant classification. Caffeine-induced Ca2+ release assays can be used to support pathogenicity per the ClinGen Variant Curation Expert Panel (VCEP). However, the caffeine-induced Ca2+ release assay lacks formal validation with known pathogenic and benign variants. METHODS: Fifteen benign/likely benign and six pathogenic/likely pathogenic RYR1 variants were used to calibrate the caffeine-induced Ca2+ release assay using a multi-mode microplate reader. Five variants of unknown significance (VUS) were assayed for possible reclassification. RESULTS: Our data support use of the caffeine-induced Ca2+ release assay at a moderate weight per the American College of Medical Genetics and Genomics pathogenicity criteria schema with a positive likelihood ratio of 12.14:1 (pathogenicity) and a negative likelihood ratio of 0.22:1 (4.5:1 benignity). Using this validated assay, two of five VUS were reclassified as likely benign. CONCLUSION: Formal validation of the caffeine-induced Ca2+ release assay supports the VCEP functional criteria weighting at moderate strength based on these data. Additional variants should be assayed to shift more from VUS to benign or pathogenic classifications

Should we adopt a laparoscopy first strategy? A comparison of 30-day outcomes between converted open from laparoscopic and planned open colectomy for volvulus

While the majority of colectomy for volvulus is performed by an open approach, laparoscopy can be used as a potentially safer alternative. However, conversion to open is needed when the laparoscopic approach is unsuccessful. This study aimed to compare the 30-day outcomes of patients who had converted open from laparoscopy vs planned open colectomy for volvulus to assess a possible laparoscopy first strategy. In addition, this study identified risk factors associated with the conversion during laparoscopy. National Surgical Quality Improvement Program (NSQIP) targeted colectomy database from 2012 to 2022 was utilized. Patients with volvulus as the primary indication for laparoscopic and open colectomy were selected. Patients who had a conversion from laparoscopic to open surgery and planned open surgery were further identified. A 1:5 propensity-score matching was applied to converted open and planned open to match sex, race and ethnicity, age, baseline characteristics, preoperative preparation, and indication for surgery (if emergent). Thirty-day postoperative outcomes were examined. There were 1774 (22.10%) and 6254 (77.90%) patients who underwent laparoscopic and planned open colectomy for volvulus, respectively. From laparoscopy, 336 (18.94%) patients were converted to open surgery and 1,680 planned open cases were matched to the converted open cases. After propensity-score matching, patients underwent converted open and planned open had a comparable mortality rate (5.06% vs 3.99%, p = 0.37). However, patients who underwent converted open surgery had higher risks of renal complications (2.68% vs 0.60%, p \u3c 0.01), bleeding requiring transfusion (9.82% vs 6.55%, p = 0.04), and wound complications (17.86% vs 12.26%, p = 0.01). Risk factors associated with conversion from laparoscopic to open colectomy included perforation (aOR = 4.767, p \u3c 0.01), obstruction (aOR = 2.223, p \u3c 0.01), sepsis 48 h before surgery (aOR = 2.952, p \u3c 0.01), chronic kidneys disease (aOR = 1.602, p = 0.01) and preoperative infection (aOR = 1.489, p = 0.03). These identified risk factors demonstrated both strong discriminative (c-statistics = 0.713) and predictive (Brier score = 0.132) powers for open conversion. While laparoscopy for colonic volvulus may offer safer outcomes, a ubiquitous laparoscopy first strategy may be approached with caution. The increased risks of complications upon conversion to open surgery, particularly in patients with identified risk factors, suggest that careful patient selection may be crucial

Themes in the Management of Pediatric Brain Death Contestation: Exploratory Qualitative Work From Multidisciplinary Health Professionals in the United States

OBJECTIVES: To explore health professionals\u27 experiences of contested pediatric brain death/death by neurologic criteria (BD/DNC) cases, including factors contributing to conflict, resource needs and utilization, perceived utility of supports available, and case resolution and aftermath. DESIGN AND METHODS: Inductive thematic analysis of semistructured interviews with members of the Society of Critical Care Medicine (SCCM) Contestation of Pediatric Brain Death Task Force. SETTING: Ten institutions across seven U.S. states and the District of Columbia. PARTICIPANTS: Nineteen Task Force members were interviewed in 2023, including pediatric intensivists, neurologists, nurses, respiratory therapists, attorneys, palliative care clinicians, social workers, ethicists, and hospital leadership. Task Force members were recruited primarily because of their experience with contested BD/DNC, although some were recruited because of expertise in other relevant topics, such as communication, information acquisition in BD/DNC, and health equity. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We identified five themes relevant to managing pediatric BD/DNC contestation: 1) personnel to consider involving, including subspecialty consultation, social work, hospital leadership and administration, ethics teams, legal counsel, and security; 2) timelines to maintain, including factors to consider when deciding the most appropriate family accommodations; 3) support for families and patients, including strategies to enhance communication, identifying and mitigating mistrust, and connecting families with support both within and outside the hospital; 4) support for staff, including disseminating information throughout the care team, staff support for one another, and establishing written documentation and policies; and 5) complementary strategies that may augment approaches to BD/DNC contestation, such as policies addressing requests for potentially inappropriate treatment. CONCLUSIONS: Family contestation of pediatric BD/DNC challenges all parties involved. The five themes identified from our qualitative analysis of interviews with experienced professionals do not constitute SCCM clinical practice guidance, but they will be used to inform the development of approaches to BD/DNC contestation through further scholarship and community consultation