Growth of Statewide Emergency Medical Services Bypass Policies for Acute Stroke.

This cross-sectional study evaluates growth of transport policies and policy components that directed emergency medical services (EMS) to bypass local emergency departments for the closest certified stroke centers as a proven treatment for stroke.

Hospital Presumptive Eligibility Emergency Medicaid Programs: An Opportunity for Continuous Insurance Coverage?

BACKGROUND: Lack of health insurance is a public health crisis, leading to foregone care and financial strain. Hospital Presumptive Eligibility (HPE) is a hospital-based emergency Medicaid program that provides temporary (up to 60 d) coverage, with the goal that hospitals will assist patients in applying for ongoing Medicaid coverage. It is unclear whether HPE is associated with successful longer-term Medicaid enrollment. OBJECTIVE: To characterize Medicaid enrollment 6 months after initiation of HPE and determine sociodemographic, clinical, and geographic factors associated with Medicaid enrollment. DESIGN: This was a cohort study of all HPE approved inpatients in California, using claims data from the California Department of Healthcare Services. SETTING: The study was conducted across all HPE-participating hospitals within California between January 1, 2016 and December 31, 2017. PARTICIPANTS: We studied California adult hospitalized inpatients, who were uninsured at the time of hospitalization and approved for HPE emergency Medicaid. Using multivariable logistic regression models, we compared HPE-approved patients who enrolled in Medicaid by 6 months versus those who did not. EXPOSURES: HPE emergency Medicaid approval at the time of hospitalization. MAIN OUTCOMES AND MEASURES: The primary outcome was full-scope Medicaid enrollment by 6 months after the hospital's presumptive eligibility approval. RESULTS: Among 71,335 inpatient HPE recipients, a total of 45,817 (64.2%) enrolled in Medicaid by 6 months. There was variability in Medicaid enrollment across counties in California (33%-100%). In adjusted analyses, Spanish-preferred-language patients were less likely to enrollin Medicaid (aOR 0.77, P<0.001). Surgical intervention (aOR 1.10, P<0.001) and discharge to another inpatient facility or a long-term care facility increased the odds of Medicaid enrollment (vs. routine discharge home: aOR 2.24 and aOR 1.96, P<0.001). CONCLUSION: California patients who enroll in HPE often enroll in Medicaid coverage by 6 months, particularly among patients requiring surgical intervention, repeated health care visits, and ongoing access to care. Future opportunities include prospective evaluation of HPE recipients to understand the impact that Medicaid enrollment has on health care utilization and financial solvency.

Disparities in Access, Quality, and Clinical Outcome for Latino Californians with Colon Cancer.

OBJECTIVE: To compare access, quality, and clinical outcomes between Latino and non-Latino White Californians with colon cancer. SUMMARY BACKGROUND DATA: Racial and ethnic disparities in cancer care remain understudied, particularly among patients who identify as Latino. Exploring potential mechanisms, including differential utilization of high-volume hospitals, is an essential first step to designing evidence-based policy solutions. METHODS: We identified all adults diagnosed with colon cancer between January 1, 2010 and December 31, 2020 from a statewide cancer registry linked to hospital administrative records. We compared survival, access (stage at diagnosis, receipt of surgical care, treatment at a high-volume hospital), and quality of care (receipt of adjuvant chemotherapy, adequacy of lymph node resection) between patients who identified as Latino and as non-Latino White. RESULTS: 75,543 patients met inclusion criteria, including 16,071 patients who identified as Latino (21.3%). Latino patients were significantly less likely to undergo definitive surgical resection (marginal difference [MD] -0.72 percentage points, 95% CI -1.19,-0.26), have an operation in a timely fashion (MD -3.24 percentage points, 95% CI -4.16,-2.32), or have an adequate lymphadenectomy (MD -2.85 percentage points, 95% CI -3.59,-2.12) even after adjustment for clinical and sociodemographic factors. Latino patients treated at high-volume hospitals were significantly less likely to die and more likely to meet access and quality metrics. CONCLUSIONS: Latino colon cancer patients experienced delays, segregation, and lower receipt of recommended care. Hospital-level colectomy volume appears to be strongly associated with access, quality, and survival--especially for patients who identify as Latino--suggesting that directing at-risk cancer patients to high-volume hospitals may improve health equity.

Usability of ENTRUST as an Assessment Tool for Entrustable Professional Activities (EPAs): A Mixed Methods Analysis.

OBJECTIVE: As the American Board of Surgery transitions to a competency-based model of surgical education centered upon entrustable professional activities (EPAs), there is a growing need for objective tools to determine readiness for entrustment. This study evaluates the usability of ENTRUST, an innovative virtual patient simulation platform to assess surgical trainees' decision-making skills in preoperative, intra-operative, and post-operative settings. DESIGN: This is a mixed-methods analysis of the usability of the ENTRUST platform. Quantitative data was collected using the system usability scale (SUS) and Likert responses. Analysis was performed with descriptive statistics, bivariate analysis, and multivariable linear regression. Qualitative analysis of open-ended responses was performed using the Nielsen-Shneiderman Heuristics framework. SETTING: This study was conducted at an academic institution in a proctored exam setting. PARTICIPANTS: The analysis includes n = 47 (PGY 1-5) surgical residents who completed an online usability survey following the ENTRUST Inguinal Hernia EPA Assessment. RESULTS: The ENTRUST platform had a median SUS score of 82.5. On bivariate and multivariate analyses, there were no significant differences between usability based on demographic characteristics (all p > 0.05), and SUS score was independent of ENTRUST performance (r = 0.198, p = 0.18). Most participants agreed that the clinical workup of the patient was engaging (91.5%) and felt realistic (85.1%). The most frequent heuristics represented in the qualitative analysis included feedback, visibility, match, and control. Additional themes of educational value, enjoyment, and ease-of-use highlighted participants' perspectives on the usability of ENTRUST. CONCLUSIONS: ENTRUST demonstrates high usability in this population. Usability was independent of ENTRUST score performance and there were no differences in usability identified in this analysis based on demographic subgroups. Qualitative analysis highlighted the acceptability of ENTRUST and will inform ongoing development of the platform. The ENTRUST platform holds potential as a tool for the assessment of EPAs in surgical residency programs.

Does tranexamic acid increase venous thromboembolism risk among trauma patients? A prospective multicenter analysis across 17 level I trauma centers.

IMPORTANCE: The early use of tranexamic acid (TXA) has demonstrated benefit among some trauma patients in hemorrhagic shock. The association between TXA administration and thromboembolic events (including deep vein thrombosis (DVT), pulmonary embolism (PE) and pulmonary thrombosis (PT)) remains unclear. We aimed to characterize the risk of venous thromboembolism (VTE) subtypes among trauma patients receiving TXA and to determine whether TXA is associated with VTE risk and mortality. METHODS: We analyzed a prospective, observational, multicenter cohort data from the Consortium of Leaders in the Study of Traumatic Thromboembolism (CLOTT) study group. The study was conducted across 17 US level I trauma centers between January 1, 2018, and December 31,2020. We studied trauma patients ages 18-40 years, admitted for at least 48 h with a minimum of 1 VTE risk factor and followed until hospital discharge or 30 days. We compared TXA recipients to non-recipients for VTE and mortality using inverse probability weighted Cox models. The primary outcome was the presence of documented venous thromboembolism (VTE). The secondary outcome was mortality. VTE was defined as DVT, PE, or PT. RESULTS: Among the 7,331 trauma patients analyzed, 466 (6.4%) received TXA. Patients in the TXA group were more severely injured than patients in the non-TXA group (ISS 16+: 69.1% vs. 48.5%, p < 0.001) and a higher percentage underwent a major surgical procedure (85.8% vs. 73.6%, p < 0.001). Among TXA recipients, 12.5% developed VTE (1.3% PT, 2.4% PE, 8.8% DVT) with 5.6% mortality. In the non-TXA group, 4.6% developed VTE (1.1% PT, 0.5% PE, 3.0% DVT) with 1.7% mortality. In analyses adjusting for patient demographic and clinical characteristics, TXA administration was not significantly associated with VTE (aHR 1.00, 95%CI: 0.69-1.46, p = 0.99) but was significantly associated with increased mortality (aHR 2.01, 95%CI: 1.46-2.77, p < 0.001). CONCLUSION: TXA was not clearly identified as an independent risk factor for VTE in adjusted analyses, but the risk of VTE among trauma patients receiving TXA remains high (12.5%). This supports the judicious use of TXA in resuscitation, with consideration of early initiation of DVT prophylaxis in this high-risk group.

Addressing knowledge gaps in Surgical Safety Checklist use: statistical process control analysis of a surgical quality improvement programme in Ethiopia.

BACKGROUND: The WHO Surgical Safety Checklist reduces morbidity and mortality after surgery, but uptake remains challenging. In particular, low-income countries have been found to have lower rates of checklist use compared with high-income countries. The aim of this study was to determine the impact of educational workshops on Surgical Safety Checklist use implemented as part of a quality improvement initiative in five hospitals in Ethiopia that had variable experience with the Surgical Safety Checklist. METHODS: From April 2019 to September 2020, each hospital implemented a 6-month surgical quality improvement programme, which included a Surgical Safety Checklist workshop. Statistical process control methodology was used to understand the variation in Surgical Safety Checklist compliance before and after workshops and a time-series analysis was performed using population-averaged generalized estimating equation Poisson regression. Checklist compliance was defined as correctly completing a sign in, timeout, and sign out. Incidence rate ratios of correct checklist use pre- and post-intervention were calculated and the change in mean weekly compliance was predicted. RESULTS: Checklist compliance data were obtained from 2767 operations (1940 (70 per cent) pre-intervention and 827 (30 per cent) post-intervention). Mean weekly checklist compliance improved from 27.3 to 41.2 per cent (mean difference 13.9 per cent, P = 0.001; incidence rate ratio 1.51, P = 0.001). Hospitals with higher checklist compliance at baseline had the greatest overall improvements in compliance, more than 50 per cent over pre-intervention, while low-performing hospitals showed no improvement. CONCLUSION: Surgical Safety Checklist workshops improved checklist compliance in hospitals with some experience with its use. Workshops had little effect in hospitals unfamiliar with the Surgical Safety Checklist, emphasizing the importance of multifactorial interventions and culture-change approaches. In receptive facilities, short workshops can accelerate behaviour change.

ENTRUST: A Serious Game-Based Virtual Patient Platform to Assess Entrustable Professional Activities in Graduate Medical Education.

Background: As entrustable professional activities (EPAs) are implemented in graduate medical education, there is a great need for tools to efficiently and objectively evaluate clinical competence. Readiness for entrustment in surgery requires not only assessment of technical ability, but also the critical skill of clinical decision-making. Objective: We report the development of ENTRUST, a serious game-based, virtual patient case creation and simulation platform to assess trainees' decision-making competence. A case scenario and corresponding scoring algorithm for the Inguinal Hernia EPA was iteratively developed and aligned with the description and essential functions outlined by the American Board of Surgery. In this study we report preliminary feasibility data and validity evidence. Methods: In January 2021, the case scenario was deployed and piloted on ENTRUST with 19 participants of varying surgical expertise levels to demonstrate proof of concept and initial validity evidence. Total score, preoperative sub-score, and intraoperative sub-score were analyzed by training level and years of medical experience using Spearman rank correlations. Participants completed a Likert scale user acceptance survey (1=strongly agree to 7=strongly disagree). Results: Median total score and intraoperative mode sub-score were higher with each progressive level of training (rho=0.79, P<.001 and rho=0.69, P=.001, respectively). There were significant correlations between performance and years of medical experience for total score (rho=0.82, P<.001) and intraoperative sub-scores (rho=0.70, P<.001). Participants reported high levels of platform engagement (mean 2.06) and ease of use (mean 1.88). Conclusions: Our study demonstrates feasibility and early validity evidence for ENTRUST as an assessment platform for clinical decision-making.

Estimated Effect of Parathyroidectomy on Long-Term Kidney Function in Adults With Primary Hyperparathyroidism.

BACKGROUND: Multidisciplinary guidelines recommend parathyroidectomy to slow the progression of chronic kidney disease in patients with primary hyperparathyroidism (PHPT) and an estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m2. Limited data address the effect of parathyroidectomy on long-term kidney function. OBJECTIVE: To compare the incidence of a sustained decline in eGFR of at least 50% among patients with PHPT treated with parathyroidectomy versus nonoperative management. DESIGN: Target trial emulation was done using observational data from adults with PHPT, using an extended Cox model with time-varying inverse probability weighting. SETTING: Veterans Health Administration. PATIENTS: Patients with a new biochemical diagnosis of PHPT in 2000 to 2019. MEASUREMENTS: Sustained decline of at least 50% from pretreatment eGFR. RESULTS: Among 43 697 patients with PHPT (mean age, 66.8 years), 2928 (6.7%) had a decline of at least 50% in eGFR over a median follow-up of 4.9 years. The weighted cumulative incidence of eGFR decline was 5.1% at 5 years and 10.8% at 10 years in patients managed with parathyroidectomy, compared with 5.1% and 12.0%, respectively, in those managed nonoperatively. The adjusted hazard of eGFR decline did not differ between parathyroidectomy and nonoperative management (hazard ratio [HR], 0.98 [95% CI, 0.82 to 1.16]). Subgroup analyses found no heterogeneity of treatment effect based on pretreatment kidney function. Parathyroidectomy was associated with a reduced hazard of the primary outcome among patients younger than 60 years (HR, 0.75 [CI, 0.59 to 0.93]) that was not evident among those aged 60 years or older (HR, 1.08 [CI, 0.87 to 1.34]). LIMITATION: Analyses were done in a predominantly male cohort using observational data. CONCLUSION: Parathyroidectomy had no effect on long-term kidney function in older adults with PHPT. Potential benefits related to kidney function should not be the primary consideration for PHPT treatment decisions. PRIMARY FUNDING SOURCE: National Institute on Aging.

Simplifying Hospital Quality Comparisons for Vascular Surgery Using Center-Level Frailty Burden Rather Than Comorbidities.

BACKGROUND: Failure to rescue (FtR), or inpatient death following complication, is a publicly reported hospital quality measure. Previous work has demonstrated significant variation in the proportion of frail patients across hospitals. However, frailty is not incorporated into risk-adjustment algorithms for hospital quality comparisons and risk adjustment is made by comorbidity scores. Our aim was to assess the impact of frailty on FtR quality measurement and as a means of risk adjustment. METHODS: Patients undergoing open or endovascular aneurysm repair or lower extremity bypass in the Vascular Quality Initiative (VQI) at centers performing ≥ 25 vascular procedures annually (2003-2019) were included. Multivariable logistic regression evaluated in-hospital death using scaled hierarchical modeling clustering at the center level. Center FtR observed/expected ratios were compared with expected values adjusted for either standard comorbidity profiles or frailty as measured by the VQI Risk Analysis Index. Centers were divided into quartiles using VQI-linked American Hospital Association data to describe the hospital characteristics of centers whose ranks changed. RESULTS: A total of 63,143 patients (213 centers) were included; 1,630 patients (2.58%) were classified as FtR. After accounting for center-level variability, frailty was associated with FtR [scaled odds ratio 1.9 (1.8-2.0), P < 0.001]. The comorbidity-centric and frailty-based models performed similarly in predicting FtR with C-statistics of 0.85 (0.84-0.86) and 0.82 (0.82-0.84), respectively. Overall changes in ranking based on observed/expected ratios were not statistically significant (P = 0.48). High and low performing centers had similar ranking using comorbidity-centric and frailty-based methods; however, centers in the middle of the performance spectrum saw more variability in ranking alterations. Forty nine (23%) of hospitals improved their ranking by five or more positions when using frailty versus comorbidity risk adjustment. The centers in Quartile 4, those who performed the highest number of vascular procedures annually, experience on average a significant improvement in hospital ranking when frailty was used for risk adjustment, whereas centers performing the fewest number of vascular procedures and the lowest proportion of vascular surgery cases annually (Quartile 1) saw a significant worsening of ranking position (all P < 0.05). However, total number of surgical procedures annually, total hospital beds, for-profit status, and teaching hospital status were not significantly associated with changes in rank. CONCLUSIONS: A simple frailty-adjusted model has similar predictive abilities as a comorbidity-focused model for predicting a common quality metric that influences reimbursement. In addition to distilling the risk-adjustment algorithm to a few variables, frailty can be assessed preoperatively to develop quality improvement efforts for rescuing frail patients. Centers treating a greater proportion of frail patients and those who perform higher volumes of vascular surgery benefit from a risk adjustment strategy based on frailty.

Insurance churn after adult traumatic injury: A national evaluation among a large private insurance database.

BACKGROUND: Traumatic injury leads to significant disability, with injured patients often requiring substantial health care resources to return to work and baseline health. Temporary disability or inability to work can result in changes or loss of employer-based private insurance coverage, which may significantly impact health care access and outcomes. Among privately insured patients, we hypothesized increased instability in insurance coverage for patients with higher severity of injury. METHODS: Adults 18 years and older presenting to a hospital with traumatic injury were evaluated for insurance churn using Clinformatics Data Mart private-payer claims. Insurance churn was defined as cessation of enrollment in the patient's private health insurance plan. Using Injury Severity Score (ISS), we compared insurance churn over the year following injury between patients with mild (ISS, <9), moderate (ISS, 9-15), severe (ISS, 16-24), and very severe (ISS, >24) injuries. Kaplan-Meier analysis was used to compare time with insurance churn by ISS category. Flexible parametric regression was used to estimate hazard ratios for insurance churn. RESULTS: Among 750,862 privately insured patients suffering from a traumatic injury, 50% experienced insurance churn within 1 year after injury. Compared with patients who remained on their insurance plan, patients who experienced insurance churn were younger and more likely male and non-White. The median time to insurance churn was 7.7 months for those with mild traumatic injury, 7.5 months for moderately or severely injured, and 7.1 months for the very severely injured. In multivariable analysis, increasing injury severity was associated with higher rates of insurance churn compared with mild injury, up to 14% increased risk for the very severely injured. CONCLUSION: Increasing severity of traumatic injury is associated with higher levels of health coverage churn among the privately insured. Lack of continuous access to health services may prolong recovery and further aggravate the medical and social impact of significant traumatic injury. LEVEL OF EVIDENCE: Economic and Value Based Evaluations; Level III.

Emergency Medicaid programs may be an effective means of providing sustained insurance among trauma patients: A statewide longitudinal analysis.

BACKGROUND: Hospital Presumptive Eligibility (HPE) is a temporary Medicaid insurance at hospitalization that offsets costs of care, increases access to postdischarge resources, and provides patients with a path to sustain coverage through Medicaid. Because HPE only lasts up to 60 days, we aimed to determine Medicaid insurance status 6 months after injury among HPE-approved trauma patients and identify factors associated with successful sustainment. METHODS: Using a customized longitudinal claims data set for HPE-approved patients from the California Department of Health Care Services, we analyzed adults with a primary trauma diagnosis (International Classification of Diseases version 10) who were HPE approved in 2016 and 2017. Our primary outcome was Medicaid sustainment at 6 months. Univariate and multivariate analyses were performed. RESULTS: A total of 9,749 trauma patients with HPE were analyzed; 6,795 (69.7%) sustained Medicaid at 6 months. Compared with patients who did not sustain, those who sustained had higher Injury Severity Score (ISS > 15: 73.5% vs. 68.7%, p < 0.001), more frequent surgical intervention (74.8% vs. 64.5%, p < 0.001), and were more likely to be discharged to postacute services (23.9% vs. 10.4%, p < 0.001). Medicaid sustainment was high among patients who identified as White (86.7%), Hispanic (86.7%), Black (84.3%), and Asian (83.7%). Medicaid sustainment was low among the 2,505 patients (25.7%) who declined to report race, ethnicity, or preferred language (14.8% sustainment). In adjusted analyses, major injuries (ISS > 16) (vs. ISS < 15: adjusted odds ratio [aOR], 1.51; p = 0.02) and surgery (aOR, 1.85; p < 0.001) were associated with increased likelihood of Medicaid sustainment. Declining to disclose race, ethnicity, or language (aOR, 0.05; p < 0.001) decreased the likelihood of Medicaid sustainment. CONCLUSION: Hospital Presumptive Eligibility programs are a promising pathway for securing long-term insurance coverage for trauma patients, particularly among the severely injured who likely require ongoing access to health care services. Patient and provider interviews would help to elucidate barriers for patients who do not sustain. LEVEL OF EVIDENCE: Prognostic and Epidemiological; Level IV.

Risk of Permanent Hypoparathyroidism Requiring Calcitriol Therapy in a Population-Based Cohort of Adults Older Than 65 Undergoing Total Thyroidectomy for Graves' Disease.

Objective: Total thyroidectomy for Graves' disease (GD) is associated with rapid treatment of hyperthyroidism and low recurrence rates. However, it carries the risk of surgical complications including permanent hypoparathyroidism, which contributes to long-term impaired quality of life. The objective of this study was to determine the incidence of permanent hypoparathyroidism requiring calcitriol therapy among a population-based cohort of older adults undergoing total thyroidectomy for GD in the United States. Methods: We performed a population-based cohort study using 100% Medicare claims from beneficiaries older than 65 years with GD who underwent total thyroidectomy from 2007 to 2017. We required continuous enrollment in Medicare Parts A, B, and D for 12 months before and after surgery to ensure access to comprehensive claims data. Patients were excluded if they had a preoperative diagnosis of thyroid cancer or were on long-term preoperative calcitriol. Our primary outcome was permanent hypoparathyroidism, which was identified based on persistent use of calcitriol between 6 and 12 months following thyroidectomy. We used multivariable logistic regression to identify characteristics associated with permanent hypoparathyroidism, including patient age, sex, race/ethnicity, neighborhood disadvantage, Charlson-Deyo Comorbidity Index, urban or rural residence, and frailty. Results: We identified 4650 patients who underwent total thyroidectomy for GD during the study period and met the inclusion criteria (mean age = 72.8 years [standard deviation = 5.5], 86% female, and 79% white). Among this surgical cohort, 104 (2.2% [95% confidence interval, CI = 1.8-2.7%]) patients developed permanent hypoparathyroidism requiring calcitriol therapy. Patients who developed permanent hypoparathyroidism were on average older (mean age 74.1 vs. 72.8 years) than those who did not develop permanent hypoparathyroidism (p = 0.04). On multivariable regression, older age was the only patient characteristic associated with permanent hypoparathyroidism (odds ratio age ≥76 years = 1.68 [CI = 1.13-2.51] compared with age 66-75 years). Conclusions: The risk of permanent hypoparathyroidism requiring calcitriol therapy among this national, U.S. population-based cohort of older adults with GD treated with total thyroidectomy was low, even when considering operations performed by a heterogeneous group of surgeons. These findings suggest that the risk of hypoparathyroidism should not be a deterrent to operative management for GD in older adults who are appropriate surgical candidates.

Defining Essential Surgery in the US During the COVID-19 Pandemic Response.

This cohort study compares the volume of performed surgical procedures classified as essential, urgent, and nonurgent before and after elective surgeries were restricted during the COVID-19 pandemic in the US.

A Systematic Review of the Recruitment and Outcome Reporting by Sex and Race/Ethnicity in Stent Device Development Trials for Endovascular Abdominal Aortic Aneurysm Repair.

BACKGROUND: Women and racial/ethnic minority groups have been shown to experience poor outcomes after endovascular aortic aneurysm repair (EVAR). One potential reason is the rare inclusion of these populations in initial phases of device development. The objective of this systematic review is to understand enrollment and outcome reporting by sex and race/ethnicity in industry-funded EVAR device development trials. METHODS: MEDLINE, PubMed, and Embase were searched from inception to January 2022 without language restrictions using the following terminology: "stent", "graft", "endograft", "device", and "abdominal aortic aneurysm" (AAA). CLINICALTRIALS: gov was also searched from inception to January 2022 for "AAA." Two independent reviewers screened and extracted data. All phase I-III and postmarket evaluation trials that included patients ≥18 years of age, who underwent EVAR were assessed. Participation-to-prevalence ratios (PPRs) were calculated to estimate representation of participants by sex and race/ethnicity in trials compared with their share of disease burden. RESULTS: Among the 4,780 retrieved articles, 55 industry-funded trials met inclusion criteria for this review. A total of 51 trials (93%) reported enrollment by sex/gender, and only 7 trials (13%) reported enrollment by race/ethnicity of the participants. A median of 19 (interquartile range [IQR]: 4.5, 51) women participants were recruited compared to 171 (IQR: 57, 311.5) men, and 17 (IQR: 7.5, 21.5) racial/minority patients were recruited compared to 241 (IQR: 123, 463.5) White participants. Women represent 16.6% of the disease population, and the median PPR is 0.62 (IQR: 0.42, 0.88), which has remained constant over time (Figure 1). None of the device trials reported outcomes based on sex/gender or race/ethnicity. CONCLUSIONS: This systematic review highlights the disparities in recruitment and outcome reporting based on sex and race/ethnicity in EVAR device development trials. While most trials may be underpowered to study these differences, recent registry studies show differential outcomes based on sex and race/ethnicity of vascular patients. Therefore, it is imperative to include and report outcomes in these participants, starting from the initial device development phases to improve generalizability of device-use and understand sources of variation in device performance.

Adverse Cardiovascular Outcomes Among Older Adults With Primary Hyperparathyroidism Treated With Parathyroidectomy Versus Nonoperative Management.

OBJECTIVE: The authors sought to compare the incidence of adverse cardiovascular (CV) events in older adults with primary hyperparathyroidism (PHPT) treated with parathyroidectomy versus nonoperative management. BACKGROUND: PHPT is a common endocrine disorder that is associated with increased CV mortality, but it is not known whether parathyroidectomy reduces the incidence of adverse CV events. METHODS: The authors conducted a population-based, longitudinal cohort study of Medicare beneficiaries diagnosed with PHPT (2006-2017). Multivariable, inverse probability weighted Cox proportional hazards regression was used to determine the associations of parathyroidectomy with major adverse cardiovascular events (MACEs), CV disease-related hospitalization, and CV hospitalization-associated mortality. RESULTS: The authors identified 210,206 beneficiaries diagnosed with PHPT from 2006 to 2017. Among 63,136 (30.0%) treated with parathyroidectomy and 147,070 (70.0%) managed nonoperatively within 1 year of diagnosis, the unadjusted incidence of MACE was 10.0% [mean follow-up 59.1 (SD 35.6) months] and 11.5% [mean follow-up 54.1 (SD 34.0) months], respectively. In multivariable analysis, parathyroidectomy was associated with a lower incidence of MACE [hazard ratio (HR): 0.92; 95% confidence interval (95% CI): 0.90-0.94], CV disease-related hospitalization (HR: 0.89; 95% CI: 0.87-0.91), and CV hospitalization-associated mortality (HR: 0.76; 95% CI: 0.71-0.81) compared to nonoperative management. At 10 years, parathyroidectomy was associated with adjusted absolute risk reduction for MACE of 1.7% (95% CI: 1.3%-2.1%), for CV disease-related hospitalization of 2.5% (95% CI: 2.1%-2.9%), and for CV hospitalization-associated mortality of 1.4% (95% CI: 1.2%-1.6%). CONCLUSIONS: In this large, population-based cohort study, parathyroidectomy was associated with a lower long-term incidence of adverse CV outcomes when compared with nonoperative management for older adults with PHPT, which is relevant to surgical decision making for patients with a long life expectancy.

Host microRNAs are decreased in pediatric solid-organ transplant recipients during EBV+ Post-transplant Lymphoproliferative Disorder.

Post-transplant lymphoproliferative disorder (PTLD) is a serious complication of solid organ transplantation. Predisposing factors include primary Epstein-Barr virus (EBV) infection, reactivation of EBV in recipient B cells, and decreased T cell immunity due to immunosuppression. In our previous studies EBV infection was demonstrated to markedly alter the expression of host B cell microRNA (miR). Specifically, miR-194 expression was uniquely suppressed in EBV+ B cell lines from PTLD patients and the 3'untranslated region of IL-10 was determined to be targeted by miR-194. Although EBV has been shown to regulate host miR expression in B cell lymphoma cell lines, the expression of miRs in the circulation of patients with EBV-associated PTLD has not been studied. The objective of this study was to determine if changes in miR expression are associated with EBV+ PTLD. In this study, we have shown that miR-194 is significantly decreased in EBV+PTLD tumors and that additional miRs, including miRs-17, 19 and 106a are also reduced in EBV+PTLD as compared to EBV-PTLD. We quantitated the levels of miRs-17, 19, 106a, 155, and 194 in the plasma and extracellular vesicles (EV; 50-70 nm as determined by nanoparticle tracking analysis) from pediatric recipients of solid organ transplants with EBV+ PTLD+ that were matched 1:2 with EBV+ PTLD- pediatric transplant recipients as part of the NIH-sponsored Clinical Trials in Organ Transplantation in Children, (CTOTC-06) study. Levels of miRs-17, 19, 106a, and 194 were reduced in the plasma and extracellular vesicles (EV) of EBV+ PTLD+ group compared to matched controls, with miRs-17 (p = 0.034; plasma), miRs-19 (p = 0.029; EV) and miR-106a (p = 0.007; plasma and EV) being significantly reduced. Similar levels of miR-155 were detected in the plasma and EV of all pediatric SOT recipients. Importantly, ~90% of the cell-free miR were contained within the EV supporting that EBV+ PTLD tumor miR are detected in the circulation and suggesting that EVs, containing miRs, may have the potential to target and regulate cells of the immune system. Further development of diagnostic, mechanistic and potential therapeutic uses of the miRs in PTLD is warranted.

Assessment of Second Primary Cancer Risk Among Men Receiving Primary Radiotherapy vs Surgery for the Treatment of Prostate Cancer.

Importance: Shared decision-making is an important part of the treatment selection process among patients with prostate cancer. Updated information is needed regarding the long-term incidence and risk of second primary cancer after radiotherapy vs nonradiotherapy treatments, which may help to inform discussions of risks and benefits for men diagnosed with prostate cancer. Objective: To assess the current incidence and risk of developing a second primary cancer after receipt of radiotherapy vs nonradiotherapy treatments for prostate cancer. Design, Setting, and Participants: This retrospective cohort study used the Veterans Affairs Corporate Data Warehouse to identify 154 514 male veterans 18 years and older who had localized prostate cancer (tumor stages T1-T3) diagnosed between January 1, 2000, and December 31, 2015, and no cancer history. A total of 10 628 patients were excluded because of (1) incomplete treatment information for the year after diagnosis, (2) receipt of both radiotherapy and a surgical procedure in the year after diagnosis, (3) receipt of radiotherapy more than 1 year after diagnosis, (4) occurrence of second primary cancer or death within 1 year or less after diagnosis, (5) prostate-specific antigen value greater than 99 ng/mL within 6 months before diagnosis, or (6) no recorded Veterans Health Administration service after diagnosis. The remaining 143 886 patients included in the study had a median (IQR) follow-up of 9 (6-13) years. Data were analyzed from May 1, 2021, to May 22, 2022. Main Outcomes and Measures: Diagnosis of a second primary cancer more than 1 year after prostate cancer diagnosis. Results: Among 143 886 male veterans (median [IQR] age, 65 [60-71] years) with localized prostate cancer, 750 (0.5%) were American Indian or Alaska Native, 389 (0.3%) were Asian, 37 796 (26.3%) were Black or African American, 933 (0.6%) were Native Hawaiian or other Pacific Islander, 91 091 (63.3%) were White, and 12 927 (9.0%) were of unknown race; 7299 patients (5.1%) were Hispanic or Latino, 128 796 (89.5%) were not Hispanic or Latino, and 7791 (5.4%) were of unknown ethnicity. A total of 52 886 patients (36.8%) received primary radiotherapy, and 91 000 (63.2%) did not. A second primary cancer more than 1 year after prostate cancer diagnosis was present in 4257 patients (3.0%), comprising 1955 patients (3.7%) in the radiotherapy cohort and 2302 patients (2.5%) in the nonradiotherapy cohort. In the multivariable analyses, patients in the radiotherapy cohort had a higher risk of second primary cancer compared with those in the nonradiotherapy cohort at years 1 to 5 after diagnosis (hazard ratio [HR], 1.24; 95% CI, 1.13-1.37; P < .001), with higher adjusted HRs in the subsequent 15 years (years 5-10: 1.50 [95% CI, 1.36-1.65; P < .001]; years 10-15: 1.59 [95% CI, 1.37-1.84; P < .001]; years 15-20: 1.47 [95% CI, 1.08-2.01; P = .02). Conclusions and Relevance: In this cohort study, patients with prostate cancer who received radiotherapy were more likely to develop a second primary cancer than patients who did not receive radiotherapy, with increased risk over time. Although the incidence and risk of developing a second primary cancer were low, it is important to discuss the risk with patients during shared decision-making about prostate cancer treatment options.

A Tool to Estimate Risk of 30-day Mortality and Complications After Hip Fracture Surgery: Accurate Enough for Some but Not All Purposes? A Study From the ACS-NSQIP Database.

BACKGROUND: Surgical repair of hip fracture carries substantial short-term risks of mortality and complications. The risk-reward calculus for most patients with hip fractures favors surgical repair. However, some patients have low prefracture functioning, frailty, and/or very high risk of postoperative mortality, making the choice between surgical and nonsurgical management more difficult. The importance of high-quality informed consent and shared decision-making for frail patients with hip fracture has recently been demonstrated. A tool to accurately estimate patient-specific risks of surgery could improve these processes. QUESTIONS/PURPOSES: With this study, we sought (1) to develop, validate, and estimate the overall accuracy (C-index) of risk prediction models for 30-day mortality and complications after hip fracture surgery; (2) to evaluate the accuracy (sensitivity, specificity, and false discovery rates) of risk prediction thresholds for identifying very high-risk patients; and (3) to implement the models in an accessible web calculator. METHODS: In this comparative study, preoperative demographics, comorbidities, and preoperatively known operative variables were extracted for all 82,168 patients aged 18 years and older undergoing surgery for hip fracture in the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) between 2011 and 2017. Eighty-two percent (66,994 of 82,168 ) of patients were at least 70 years old, 21% (17,007 of 82,168 ) were at least 90 years old, 70% (57,260 of 82,168 ) were female, and 79% (65,301 of 82,168 ) were White. A total of 5% (4260 of 82,168) of patients died within 30 days of surgery, and 8% (6786 of 82,168) experienced a major complication. The ACS-NSQIP database was chosen for its clinically abstracted and reliable data from more than 600 hospitals on important surgical outcomes, as well as rich characterization of preoperative demographic and clinical predictors for demographically diverse patients. Using all the preoperative variables in the ACS-NSQIP dataset, least absolute shrinkage and selection operator (LASSO) logistic regression, a type of machine learning that selects variables to optimize accuracy and parsimony, was used to develop and validate models to predict two primary outcomes: 30-day postoperative mortality and any 30-day major complications. Major complications were defined by the occurrence of ACS-NSQIP complications including: on a ventilator longer than 48 hours, intraoperative or postoperative unplanned intubation, septic shock, deep incisional surgical site infection (SSI), organ/space SSI, wound disruption, sepsis, intraoperative or postoperative myocardial infarction, intraoperative or postoperative cardiac arrest requiring cardiopulmonary resuscitation, acute renal failure needing dialysis, pulmonary embolism, stroke/cerebral vascular accident, and return to the operating room. Secondary outcomes were six clusters of complications recently developed and increasingly used for the development of surgical risk models, namely: (1) pulmonary complications, (2) infectious complications, (3) cardiac events, (4) renal complications, (5) venous thromboembolic events, and (6) neurological events. Tenfold cross-validation was used to assess overall model accuracy with C-indexes, a measure of how well models discriminate patients who experience an outcome from those who do not. Using the models, the predicted risk of outcomes for each patient were used to estimate the accuracy (sensitivity, specificity, and false discovery rates) of a wide range of predicted risk thresholds. We then implemented the prediction models into a web-accessible risk calculator. RESULTS: The 30-day mortality and major complication models had good to fair discrimination (C-indexes of 0.76 and 0.64, respectively) and good calibration throughout the range of predicted risk. Thresholds of predicted risk to identify patients at very high risk of 30-day mortality had high specificity but also high false discovery rates. For example, a 30-day mortality predicted risk threshold of 15% resulted in 97% specificity, meaning 97% of patients who lived longer than 30 days were below that risk threshold. However, this threshold had a false discovery rate of 78%, meaning 78% of patients above that threshold survived longer than 30 days and might have benefitted from surgery. The tool is available here: https://s-spire-clintools.shinyapps.io/hip_deploy/ . CONCLUSION: The models of mortality and complications we developed may be accurate enough for some uses, especially personalizing informed consent and shared decision-making with patient-specific risk estimates. However, the high false discovery rate suggests the models should not be used to restrict access to surgery for high-risk patients. Deciding which measures of accuracy to prioritize and what is "accurate enough" depends on the clinical question and use of the predictions. Discrimination and calibration are commonly used measures of overall model accuracy but may be poorly suited to certain clinical questions and applications. Clinically, overall accuracy may not be as important as knowing how accurate and useful specific values of predicted risk are for specific purposes.Level of Evidence Level III, therapeutic study.

Validity Evidence for ENTRUST as an Assessment of Surgical Decision-Making for the Inguinal Hernia Entrustable Professional Activity (EPA).

OBJECTIVE: As the American Board of Surgery (ABS) moves toward implementation of Entrustable Professional Activities (EPAs), there is a growing need for objective evaluation of readiness for entrustment of residents. This requires not only assessment of technical skills and knowledge, but also surgical decision-making in preoperative, intraoperative, and postoperative settings. We developed and piloted an Inguinal Hernia EPA Assessment on ENTRUST, a serious game-based online virtual patient simulation platform to assess trainees' decision-making competence. DESIGN: This is a prospective analysis of resident performance on the ENTRUST Inguinal Hernia EPA Assessment using bivariate analyses. SETTING: This study was conducted at an academic institution in a proctored exam setting. PARTICIPANTS: Forty-three surgical residents completed the ENTRUST Inguinal Hernia EPA Assessment. RESULTS: Four case scenarios for the Inguinal Hernia EPA and corresponding scoring algorithms were iteratively developed by expert consensus aligned with ABS EPA descriptions and functions. ENTRUST Inguinal Hernia Grand Total Score was positively correlated with PGY-level (p < 0.0001). Preoperative, Intraoperative, and Postoperative Total Scores were also positively correlated with PGY-level (p = 0.001, p = 0.006, and p = 0.038, respectively). Total Case Scores were positively correlated with PGY-level for cases representing elective unilateral inguinal hernia (p = 0.0004), strangulated inguinal hernia (p < 0.0001), and elective bilateral inguinal hernia (p = 0.0003). Preoperative Sub-Scores were positively correlated with PGY-level for all cases (p < 0.01). Intraoperative Sub-Scores were positively correlated with PGY-level for strangulated inguinal hernia and bilateral inguinal hernia (p = 0.0007 and p = 0.0002, respectively). Grand Total Score and Intraoperative Sub-Score were correlated with prior operative experience (p < 0.0001). Prior video game experience did not correlate with performance on ENTRUST (p = 0.56). CONCLUSIONS: Performance on the ENTRUST Inguinal Hernia EPA Assessment was positively correlated to PGY-level and prior inguinal hernia operative performance, providing initial validity evidence for its use as an objective assessment for surgical decision-making. The ENTRUST platform holds potential as tool for assessment of ABS EPAs in surgical residency programs.

Do Proposed Quality Measures for Carpal Tunnel Release Reveal Important Quality Gaps and Are They Reliable?

BACKGROUND: The American Academy of Orthopaedic Surgeons recently proposed quality measures for the initial surgical treatment of carpal tunnel syndrome (CTS). One measure addressed avoidance of adjunctive surgical procedures during carpal tunnel release; and a second measure addressed avoidance of routine use of clinic-based occupational and/or physical therapy (OT/PT) after carpal tunnel release. However, for quality measures to serve their intended purposes, they must be tested in real-world data to establish that gaps in quality exist and that the measures yield reliable performance information. QUESTIONS/PURPOSES: (1) Is there an important quality gap in clinical practice for avoidance of adjunctive surgical procedures during carpal tunnel release? (2) Is there an important quality gap in avoiding routine use of clinic-based occupational and/or physical therapy after carpal tunnel release? (3) Do these two quality measures have adequate beta-binomial signal-to-noise ratio (SNR) and split-sample reliability (SSR)? METHODS: This retrospective comparative study used a large national private insurance claims database, the 2018 Optum Clinformatics® Data Mart. Ideally, healthcare quality measures are tested within data reflective of the providers and payors to which the measures will be applied. We previously tested these measures in a large public healthcare system and a single academic medical center. In this study, we sought to test the measures in the broader context of patients and providers using private insurance. For both measures, we included the first carpal tunnel release from 28,083 patients performed by one of 7236 surgeons, irrespective of surgical specialty (including, orthopaedic, plastic, neuro-, and general surgery). To calculate surgeon-level descriptive and reliability statistics, analyses were focused on the 66% (18,622 of 28,083) of patients who received their procedure from one of the 24% (1740 of 7236) of surgeons with at least five carpal tunnel releases in the database. No other inclusion/exclusion criteria were applied. To determine whether the measures reveal important gaps in treatment quality (avoidance of adjunctive procedures and routine therapy), we calculated descriptive statistics (median and interquartile range) of the performance distribution stratified by surgeon-level annual volume of carpal tunnel releases in the database (5+, 10+, 15+, 20+, 25+, and 30+). Like the Centers for Medicare & Medicaid Services (CMS), we considered a measure "topped out" if median performance was greater than 95%, meaning the opportunity for further quality improvement is low. We calculated the surgeon-level beta-binomial SNR and SSR for each measure, each stratified by the number of carpal tunnel releases performed by each surgeon in the database. These are standard measures of reliability in health care quality measurement science. The SNR quantifies the proportion of variance that is between rather than within surgeons, and the SSR is the correlation of performance scores when each surgeons' patients are split into two random samples and then corrected for sample size. RESULTS: We found that 2% (308 of 18,622) of carpal tunnel releases involved an adjunctive procedure. The results showed that avoidance of adjunctive surgical procedures during carpal tunnel release had a median (IQR) performance of 100% (100% to 100%) at all case volumes. Only 8% (144 of 1740) of surgeons with at least five cases in the database had less than 100% performance, and only 5% (84 of 1740) had less than 90% performance. This means adjunctive procedures were rarely performed and an important quality gap does not exist based on the CMS criterion. Regarding the avoidance of routine therapy, there was a larger quality gap: For surgeons with at least five cases in the database, median performance was 89% (75% to 100%), and 25% (435 of 1740) of these surgeons had less than 75% performance. This signifies that the measure is not topped out and may reveal an important quality gap. Most patients receiving clinic-based OT/PT had only one visit in the 6 weeks after surgery. Median (IQR) SNRs of the first measure, which addressed avoidance of adjunctive surgical procedures, and the second measure, which addresses avoidance of routine use clinic-based OT/PT, were 1.00 (1.00 to 1.00) and 0.86 (0.67 to 1.00), respectively. The SSR for these measures were 0.87 (95% CI 0.85 to 0.88) and 0.75 (95% CI 0.73 to 0.77), respectively. All of these reliability statistics exceed National Quality Forum's emerging minimum standard of 0.60. CONCLUSION: The first measure, the avoidance of adjunctive surgical procedures during carpal tunnel release, lacked an important quality gap suggesting it is unlikely to be useful in driving improvements. The second measure, avoidance of routine use of clinic-based OT/PT, revealed a larger quality gap and had very good reliability, suggesting it may be useful for quality monitoring and improvement purposes. CLINICAL RELEVANCE: As healthcare systems and payors use the second measure, avoidance of routine use of clinic-based OT/PT, to encourage adherence to clinical practice guidelines (such as provider profiling, public reporting, and payment policies), it will be critically important to consider what proportion of patients receiving OT/PT should be considered routine practice and therefore inconsistent with guidelines. The value or potential harm of this measure depends on this judgement.