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Introduction: Restricted fluid replacement strategy is one part of damage control resuscitation for patients with trauma haemorrhage. However, not all patients presenting with physiological symptoms suggestive of haemorrhage are bleeding. This descriptive study aims to compare demographics and injuries in adult and older trauma patients presenting to the Emergency Department with hypotension versus normotension. Methods: This was a retrospective, descriptive data analysis from a UK trauma registry. The records from one major trauma centre were analysed between 2014–2019, and every hypotensive (systolic blood pressure <90 mmHg) trauma patient investigated for injuries associated with hypotension. The hypotensive threshold for older patients was also adjusted to 110 mmHg for sub-cohort analysis. Results: 6245 trauma patients were included, of which 255 (4.1%) arrived hypotensive at the Emergency Department. Significant blood loss was identified in 32.2% of those cases. In 27.1%, multiple potential associations obscured the underlying mechanism for the hypotension but were more commonly associated with hypotension than with normotension. Over a third (37.5%) were ≥65 years old. Neurological injuries occurred more frequently in both older hypotensive groups than younger patients. Conclusions: This study sought to compare injuries of adult and older trauma patients to aid trauma teams with decision making. In severely injured hypotensive patients, significant blood loss was the principal association with hypotension. However, several factors can mimic bleeding in the hypotensive trauma patient, which should be carefully considered. A prospective study is needed to clarify the characteristics and causes of bleeding mimics. [ABSTRACT FROM AUTHOR]

Introduction: While prior research has identified racial disparities in prehospital analgesia for traumatic pain, little is known about non-traumatic pain. Using a national prehospital dataset, we sought to evaluate for racial and ethnic disparities in analgesia given by EMS for non-traumatic pain. Methods: We analyzed the 2018 and 2019 data from the ESO Data Collaborative, a collection of de-identified prehospital electronic health records from nearly 1,300 participating EMS agencies in the US. We included all transported, adult, non-traumatic encounters with a primary or secondary impression of a pain complaint, and we stratified encounters based on race and ethnicity as recorded by the EMS clinicians. We performed a mixed model analysis, modeling EMS agency as a random intercept and adjusting for age, sex, pain location, level of service, location of incident, and highest pain score. With non-Hispanic White patients as the reference group, we then evaluated the association between race/ethnicity and receiving any pain medication (acetaminophen, non-steroidal anti-inflammatories, or opioids), receiving opioid pain medication, and receiving pain medication within 20 minutes of EMS arrival. Results: We included 1,035,486 patients; 67.5% non-Hispanic White, 26.8% Black, 4.9% Hispanic, 0.5% Asian, 0.1% Native Hawaiian or Other Pacific Islander, and 0.2% American Indian or Alaska Native patients. 4.7% of patients received pain medications. Compared to White patients (5.1%), Black patients were less likely to receive pain medication (3.3%, aOR 0.7; 95% CI 0.7-0.7) and Hispanics were more likely to receive pain medication (7.6%, aOR 1.5; 95% CI 1.4-1.6). Black patients were also less likely to receive opioids (1.8% for Black v 3.0% for White, aOR 0.7; 95% CI 0.6-0.7), while Hispanic patients were more likely to receive opioids (4.9%, aOR 1.4; 95% CI 1.3-1.5). The odds of receiving pain medication within 20 minutes was lower for Black patients (aOR 0.9; 95% CI 0.8-0.95) but no different for Hispanic patients (aOR 1.0; 95% CI 0.9-1.1), when compared to White patients. Conclusion: Pain medication administration is uncommon for non-traumatic pain complaints. While Black patients were less likely than White patients to receive pain medications and receive pain medication within 20 minutes, Hispanics were more likely to receive pain medications. [ABSTRACT FROM AUTHOR]

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Background: Open pelvic fractures are rare but complex injuries. Concomitant external and internal hemorrhage and wound infection-related sepsis result in a high mortality rate and treatment challenges. Here, we validated the World Society Emergency Society (WSES) classification system for pelvic injuries in open pelvic fractures, which are quite different from closed fractures, using the National Trauma Data Bank (NTDB). Methods: Open pelvic fracture patients in the NTDB 2015 dataset were retrospectively queried. The mortality rates associated with WSES minor, moderate and severe injuries were compared. A multivariate logistic regression model (MLR) was used to evaluate independent factors of mortality. Patients with and without sepsis were compared. The performance of the WSES classification in the prediction of mortality was evaluated by determining the discrimination and calibration. Results: A total of 830 open pelvic fracture patients were studied. The mortality rates of the mild, moderate and severe WSES classes were 3.5%, 11.2% and 23.8%, respectively (p < 0.001). The MLR analysis showed that the presence of sepsis was an independent factor of mortality (odds of mortality 9.740, p < 0.001). Compared with patients without sepsis, those with sepsis had significantly higher mortality rates in all WSES classes (minor: 40.0% vs. 3.1%, p < 0.001; moderate: 50.0% vs. 9.1%, p < 0.001; severe: 66.7% vs. 22.2%, p < 0.001). The receiver operating characteristic (ROC) curve showed an acceptable discrimination of the WSES classification alone for evaluating the mortality of open pelvic fracture patients [area under curve (AUC) = 0.717]. Improved discrimination with an increased AUC was observed using the WSES classification plus sepsis (AUC = 0.767). Conclusions: The WSES guidelines can be applied to evaluate patients with open pelvic fracture with accurate evaluation of outcomes. The presence of sepsis is recommended as a supplement to the WSES classification for open pelvic fractures. [ABSTRACT FROM AUTHOR]

Introduction: Health-related social needs are known drivers of health and health outcomes, yet work to date to examine health-related social needs using ICD-10 Z-codes remains limited. This study seeks to evaluate the differences in the prevalence of conditions as well as utilization and cost between patients with and without health-related social needs.Methods: Using the 2017 Florida State Emergency Department and State Inpatient Databases, this study identified patients with documented health-related social needs using ICD-10 Z-codes. The prevalence ratio was calculated for 14 conditions that are the leading causes of mortality and economic costs. In addition, ratios for the median total number of negative health events and total annual costs between patients with health-related social needs and those without health-related social needs across these conditions were calculated. Data analysis was conducted in 2021.Results: Of 4,477,772 patients, 46,081 (1.0%) had documented health-related social needs and had 4 times the negative health events and 9.3 times the total annual costs. Trends of increased negative health events and costs were seen across all examined conditions; patients with health-related social needs had 2.5-3.5 times the negative health events and 2-18 times greater total costs. The biggest difference in negative health events was seen in patients with unintentional injuries and depression and psychoses (3.5 times for patients with health-related social needs), whereas the biggest difference in total costs was for unintentional injuries (18.4 times for patients with health-related social needs).Conclusions: This study shows the increased prevalence of numerous high-priority conditions as well as increased utilization and costs among patients with documented health-related social needs. [ABSTRACT FROM AUTHOR]

Background: Apixaban and rivaroxaban are replacing vitamin K antagonists for the treatment of venous thromboembolism (VTE) in adults; however, head-to-head comparisons remain limited.Objective: To assess the effectiveness and safety of apixaban compared with rivaroxaban in patients with VTE.Design: Retrospective new-user cohort study.Setting: U.S.-based commercial health care insurance database from 1 January 2015 to 30 June 2020.Participants: Adults with VTE who were newly prescribed apixaban or rivaroxaban.Measurements: The primary effectiveness outcome was recurrent VTE, a composite of deep venous thrombosis and pulmonary embolism. The primary safety outcome was a composite of gastrointestinal and intracranial bleeding.Results: Of 49 900 eligible patients with VTE, 18 618 were new users of apixaban and 18 618 were new users of rivaroxaban. Median follow-up was 102 days (25th, 75th percentiles: 30, 128 days) among apixaban and 105 days (25th, 75th percentiles: 30, 140 days) among rivaroxaban users. After propensity score matching, apixaban (vs. rivaroxaban) was associated with a lower rate for recurrent VTE (hazard ratio, 0.77 [95% CI, 0.69 to 0.87]) and bleeding (hazard ratio, 0.60 [CI, 0.53 to 0.69]). The absolute reduction in the probability of recurrent VTE with apixaban versus rivaroxaban was 0.006 (CI, 0.005 to 0.011) within 2 months and 0.011 (CI, 0.011 to 0.013) within 6 months of initiation. The absolute reduction in the probability of gastrointestinal and intracranial bleeding with apixaban versus rivaroxaban was 0.011 (CI, 0.010 to 0.011) within 2 months and 0.015 (CI, 0.013 to 0.015) within 6 months of initiation.Limitation: Short follow-up.Conclusion: In this population-based cohort study, patients with VTE who were new users of apixaban had lower rates for recurrent VTE and bleeding than new users of rivaroxaban.Primary Funding Source: None. [ABSTRACT FROM AUTHOR]

Context: Insulinoma is the most common pancreatic functional neuroendocrine neoplasm, yet little information on recent clinical practice in patients with insulinoma, especially malignant insulinoma, is available.Objective: This work aims to clarify the characteristics and practice patterns in patients with insulinoma using a national inpatient database.Methods: Using the Japanese Diagnosis Procedure Combination database, we retrospectively identified patients with insulinoma admitted between 2010 and 2018. We compared background characteristics and therapeutic interventions between patients with benign and malignant insulinoma. We also estimated the incidence of insulinoma using the number of patients with newly diagnosed insulinoma in 2012.Results: We identified 844 patients with benign insulinoma and 102 patients with malignant insulinoma. Patients with malignant insulinoma were younger (median, 55.5 vs 66.0 years, P < .001) and less likely to be female (55.9% vs 65.3%, P = .061) than patients with benign insulinoma. Analysis of therapeutic interventions revealed that patients with malignant insulinoma more frequently received medications (71.6% vs 49.6%, P < .001) but less frequently underwent pancreatic surgery (57.8% vs 72.0%, P = .003). Older patients were a smaller proportion of those undergoing surgery and a larger proportion of those managed with medications without surgery (P < .001). The incidence of insulinoma was estimated to be 3.27 (95% CI, 2.93-3.61) individuals per million Japanese adult population per year.Conclusion: The present study using a nationwide database had a larger sample size than previous studies and revealed definitive differences in patient characteristics and therapeutic patterns between benign and malignant insulinoma. [ABSTRACT FROM AUTHOR]

Objective: To develop and validate a preconception risk prediction index for severe maternal morbidity (SMM), defined by the Centers for Disease Control and Prevention as indicators of a life-threatening complication, among infertile patients.Design: Retrospective analysis of live births and stillbirths from 2007 to 2017 among infertile women.Setting: National commercial claims database.Patient(s): Infertile women identified on the basis of diagnosis, testing, or treatment codes.Intervention(s): None.Main Outcome Measure(s): The primary outcome was SMM, identified as any indicator from the Centers for Disease Control and Prevention Index except blood transfusion alone, which was found to overestimate cases. Twenty preconception comorbidities associated with a risk of SMM were selected from prior literature. Targeted ensemble learning methods were used to rank the importance of comorbidities as potential risk factors for SMM. The independent strength of the association between each comorbidity and SMM was then used to define each comorbidity's risk score.Result(s): Among 94,097 infertile women with a delivery, 2.3% (n = 2,181) experienced an SMM event. The highest risk of SMM was conferred by pulmonary hypertension, hematologic disorders, renal disease, and cardiac disease. Associated significant risks were lowest for substance abuse disorders, prior cesarean section, age ≥40 years, gastrointestinal disease, anemia, mental health disorders, and asthma. The receiver operating characteristic area under the curve for the developed comorbidity score was 0.66. Calibration plots showed good concordance between the predicted and actual risk of SMM.Conclusion(s): We developed and validated an index to predict the probability of SMM on the basis of preconception comorbidities in patients with infertility. This tool may inform preconception counseling of infertile women and support maternal health research initiatives. [ABSTRACT FROM AUTHOR]

Background: One-lung ventilation in children remains a specialized practice with low case numbers even at tertiary centers, preventing an assessment of best practices. The authors hypothesized that certain case factors may be associated with a higher risk of intraprocedural hypoxemia in children undergoing thoracic surgery and one-lung ventilation.Methods: The Multicenter Perioperative Outcomes database and a local quality improvement database were queried for documentation of one-lung ventilation in children 2 months to 3 yr of age inclusive between 2010 and 2020. Patients undergoing vascular or other cardiac procedures were excluded. All records were reviewed electronically for the presence of hypoxemia, oxygen saturation measured by pulse oximetry (Spo2) less than 90% for 3 min or more continuously, and severe hypoxemia, Spo2 less than 90% for 5 min or more continuously during one-lung ventilation. Records were also assessed for hypercarbia, end-tidal CO2 greater than 60 mmHg for 5 min or more or a Paco2 greater than 60 on arterial blood gas. Covariates assessed for association with these outcomes included age, weight, American Society of Anesthesiologists (Schaumburg, Illinois) Physical Status 3 or greater, duration of one-lung ventilation, preoperative Spo2 less than 98%, bronchial blocker versus endobronchial intubation, left operative side, video-assisted thoracoscopic surgery, lower tidal volume ventilation (tidal volume less than or equal to 6 ml/kg plus positive end expiratory pressure greater than or equal to 4 cm H2O for more than 80% of the duration of one-lung ventilation), and type of procedure.Results: Three hundred six cases from 15 institutions were included for analysis. Hypoxemia and severe hypoxemia occurred in 81 of 306 (26%) patients and 56 of 306 (18%), respectively. Hypercarbia occurred in 153 of 306 (50%). Factors associated with lower risk of hypoxemia in multivariable analysis included left operative side (odds ratio, 0.45 [95% CI, 0.251 to 0.78]) and bronchial blocker use (odds ratio, 0.351 [95% CI, 0.177 to 0.67]). Additionally, use of a bronchial blocker was associated with a reduced risk of severe hypoxemia (odds ratio, 0.290 [95% CI, 0.125 to 0.62]).Conclusions: Use of a bronchial blocker was associated with a lower risk of hypoxemia in young children undergoing one-lung ventilation.Editor’s Perspective: [ABSTRACT FROM AUTHOR]

Background: Insomnia is associated with worsened clinical outcomes among Alzheimer's disease dementia (AD) patients, increased caregiver burden, and healthcare utilization.Objective: This study aimed to characterize the incremental healthcare burden of insomnia in AD using real-world data.Methods: A retrospective observational study was conducted on AD patients selected from the IBM® MarketScan Commercial and Medicare Supplemental Databases. AD patients with claims-based evidence of insomnia were direct matched to a non-insomnia cohort based on demographic factors. Healthcare utilization and associated costs were assessed for a 12-month follow-up period.Results: A total of 3,500 insomnia AD patients and 9,884 non-insomnia AD patients were analyzed. The insomnia cohort had a higher comorbidity burden at baseline (mean score on Charlson Comorbidity Index 2.5 versus 2.2, p < 0.001) and higher proportions of patients with baseline diagnoses for other conditions including depression: 40%, insomnia cohort versus 25%, non-insomnia (p < 0.001). AD patients with insomnia were more likely to have a claim for inpatient hospitalizations (39.8%versus 32.3%), emergency room services (56.4%versus 48.0%), and skilled-nursing services (42.6%versus 31.9%) (all p < 0.05). Mean total annual healthcare costs during the 12-month follow-up period were significantly higher among AD patients with insomnia as compared to those without. (Mean costs: $37,356 versus $27,990, p < 0.001).Conclusion: AD patients with comorbid insomnia are more likely to use higher-cost healthcare services such as inpatient hospitalization, and skilled nursing, and have higher total healthcare costs. This real-world analysis provides evidence that AD disease management should consider proper treatment of comorbid insomnia due to the incremental burden and cost implications. [ABSTRACT FROM AUTHOR]

Objective: To study the potential benefit of testicular sperm compared with ejaculated sperm for men with oligospermia.Design: After exemption from institutional review board approval, we performed a retrospective cohort study using the Mayo Clinic Assisted Reproductive Technology database.Setting: Single academic center.Patient(s): Couples with nonazoospermic male factor infertility (total motile sperm <25 million per ejaculate) undergoing intracytoplasmic sperm injection with sperm obtained by testicular sperm extraction (TESE) or ejaculated sperm between 2016 and 2019.Intervention(s): In vitro fertilization, Intracytoplasmic sperm injection, TESE.Main Outcome Measure(s): The primary outcome was live birth rate. The secondary outcomes were fertilization rate, blastulation rate, pregnancy rate, and miscarriage rate.Result(s): Subjects in the two groups were similar in age, body mass index, and ovarian reserve. Baseline sperm parameters were similar in the two groups: total motile sperm (5.4 in the ejaculate sperm group vs. 3.6 million motile per ejaculate), except that baseline motility was higher in the group that used ejaculated sperm (40% vs. 29%). The total number of mature oocytes retrieved was similar in the two groups, but the use of TESE was associated with a 20% decrease in fertilization (60.0% vs. 80.6%) and half the number of blastocyst embryos (two vs. four) compared with ejaculated sperm. Compared with ejaculated sperm, use of TESE did not improve the miscarriage rate (11% vs. 9%) or the live birth rate (50.0% vs. 31.3%).Conclusion(s): Patients with male factor infertility and oligozoospermia did not have improved ICSI outcomes with the use of TESE samples compared with ejaculated sperm. [ABSTRACT FROM AUTHOR]

Objective: To investigate the associations between pre-pregnancy body mass index (BMI) and neonatal outcomes in women undergoing autologous frozen-thawed embryo transfer (FET).Design: Retrospective cohort study.Setting(s): University-affiliated reproductive medical center.Patient(s): A total of 16,240 women with singleton deliveries achieved by autologous FET.Intervention(s): None.Main Outcome Measure(s): Neonatal outcomes included preterm birth (PTB), low birth weight (LBW), small-for-gestational age (SGA), large-for-gestational age (LGA), fetal macrosomia, and birth defects.Result(s): After adjusting for confounding factors, our study showed that in autologous FET cycles, the overweight women (23 kg/m2≤ BMI <27.5 kg/m2) were associated with increased rates of PTB (adjusted odds ratio [aOR], 1.226; 95% confidence interval [CI], 1.060-1.418), macrosomia (aOR, 1.692; 95% CI, 1.491-1.921), and LGA (aOR, 1.980; 95% CI, 1.715-2.286); and the obese women (BMI ≥27.5 kg/m2) were significantly associated with increased PTB (aOR, 1.503; 95% CI, 1.167-1.936), early PTB (aOR, 2.829; 95% CI, 1.679-4.765), very LBW (aOR, 3.087; 95% CI, 1.720-5.542), macrosomia (aOR, 2.325; 95% CI, 1.862-2.904), and LGA (aOR, 3.235; 95% CI, 2.561-4.085). The rate of SGA infants was higher in the underweight women (BMI <18.5 kg/m2) (aOR, 1.687; 95% CI, 1.375-2.071) than that in the normal-weight women (18.5 kg/m2≤ BMI ≤23 kg/m2). No significant difference was observed in the risk of birth defects between normal-weight cases and other BMI categories.Conclusion(s): Among women undergoing FET, pre-pregnancy BMI affected neonatal outcomes of singletons. BMI in Asian categories for overweight and obese showed significant increases in PTB, macrosomia, and LGA; early PTB and very LBW only increased in obese cases. In addition, underweight status was associated with increased risk of SGA. In contrast, there was no association between pre-pregnancy BMI and birth defects in FET cycles. [ABSTRACT FROM AUTHOR]

Introduction: Neuropsychiatric disturbance is common in individuals with Lewy body dementia (LBD). Despite this, there is minimal research regarding suicide risks in this population.Methods: This study was a retrospective review of a prospectively-collected database at a tertiary movement disorders clinic. Database participants with an LBD diagnosis at their most recent visit and at least one complete Beck Depression Inventory-II (BDI-II) were included. Additional measures included demographics and measures of cognition, psychiatric symptoms, motor function, and the Parkinson Disease Questionnaire-39. The frequency of suicidal ideation was assessed using question 9 of the BDI-II. Features associated with a BDI-II score greater than zero were assessed using logistic regression.Results: The database included 95 individuals with LBD and at least one BDI-II (visit years 2010-2020). Most participants were older men who identified as white. Eighteen individuals (18.9%; 95% CI 12.3%-28.0%) reported thoughts of killing themselves without an intent to carry them out (BDI-II = 1). No participants reported a desire or plan to kill themselves. The presence of SI was associated with measures of depression, anxiety, and emotional well-being, but not with demographics, measures of disease severity, or other psychiatric concerns.Conclusion: These findings emphasize the importance of routine screening for psychiatric symptoms in LBD and intervention when such concerns are identified. Interventions could include pharmacologic (e.g. depression treatment) and non-pharmacologic (e.g. firearm screening) approaches. More research is needed to assess suicidal ideation and suicide risks in large and more diverse LBD populations. Prospective studies should include measures of additional potential contributors to suicidality. [ABSTRACT FROM AUTHOR]

Frostbite is a high morbidity, high-cost injury that can lead to digit or limb necrosis requiring amputation. Our primary aim is to describe the rate of readmission following frostbite injury. Our secondary aims are to describe the overall burden of care, cost, and characteristics of repeat hospitalizations of frostbite-injured people. Hospitalizations following frostbite injury (index and readmissions) were identified in the 2016 and 2017 Nationwide Readmission Database. Multivariable logistic regression was clustered by hospital and additionally adjusted for severe frostbite injury, gender, year, payor group, severity, and comorbidity index. Population estimates were calculated and adjusted for by using survey weight, sampling clusters, and stratum. In the 2-year cohort, 1065 index hospitalizations resulted in 1907 total hospitalizations following frostbite injury. Most patients were male (80.3%), lived in metropolitan/urban areas (82.3%), and nearly half were insured with Medicaid (46.4%). Of the 842 readmissions, 53.7% were associated with complications typically associated with frostbite injury. Overall, 29% of frostbite injuries resulted in at least one amputation. The average total cost and total length of stay of readmissions were $236,872 and 34.7 days. Drug or alcohol abuse, homelessness, Medicaid insurance, and discharge against medical advice (AMA) were independent predictors of unplanned readmission. Factors associated with multiple readmissions include discharge AMA and Medicare insurance, but not drug or alcohol abuse or homelessness. The population-based estimated unplanned readmission rate following frostbite injury was 35.4% (95% confidence interval 32.2%-38.6%). This is the first study examining readmissions following frostbite injury on a national level. Drug or alcohol abuse, homelessness, Medicaid insurance, and discharge AMA were independent predictors of unplanned readmission, while only AMA discharge and Medicare insurance were associated with multiple readmissions. Supportive resources (community and hospital-based) may reduce unplanned readmissions of frostbite-injured patients with those additional risk factors. [ABSTRACT FROM AUTHOR]

Background: Single-arm trial (SAT) data is increasingly reviewed for drug approvals by regulators and Health Technology Assessment (HTA) bodies. Supplementary data in the form of external comparators (ECs) can be used to provide clinical context to support these drug evaluations. In this study we characterized HTAs for SAT-based submissions, the use of supplementary EC data and outcomes from HTA review.Methods: HTA Accelerator database was used to describe SAT-based HTA submissions with decisions (2011-2019).Results: A total of 433 SAT-based HTA submissions were identified between 2011 and 2019 with a 13-fold increase during this period. Around 65%(283/433) were in oncology or hem-oncology. Around 52%(226/433) of submissions contained some type of EC data, including prior clinical trials (24%, 104) and real-world data (RWD) (20%, 87), but 40%(175) contained no EC data. The overall acceptance rate for SAT-based submissions was 48% and with RWD EC data acceptance was 59%. In the latest 5-year period (2015-2019), use of RWD ECs increased 22% as a proportion of submissions per year, whereas, prior trial ECs decreased (-14%) and use of no EC remained stable (-2%). Between 2015 to 2017 and 2018 to 2019, acceptance rate for RWD ECs increased by 20% (41% in 2015-2017 to 61% in 2018-2019) whereas prior trial EC use decreased by 10% and no EC submissions decreased 16%. Of 226 submissions using ECs, only 29%(66) used an adjusted indirect treatment comparison method.Conclusions: SAT-based submissions to HTA bodies are rapidly evolving in terms of composition and acceptance. Types of EC and methodological approach used are important determinants of positive outcomes. [ABSTRACT FROM AUTHOR]

Background Context: Improving value is an established point of emphasis to reduce the rapidly rising health care costs in the United States. Back pain is a major driver of costs with a substantial fraction caused by lumbar radiculopathy. The most common surgical treatment for lumbar radiculopathy is microdiscectomy. Research is sparse regarding variables driving cost in microdiscectomies and often limited by cost data derived from payer-based Medicare data.Purpose: To identify targets for cost reduction by determining variables associated with significant cost variation in microdiscectomies, using cost data derived from the Value Driven Outcomes tool and actual system costs.Study Design: Single-center, retrospective study of prospectively collected registry data.Patient Sample: Six hundred twenty-two patients identified by CPT code and manually screened for initial, unilateral, single-level lumbar discectomy performed between 2014 and 2018 at a single institution.Outcome Measures: Primary outcome measures include total direct cost, clinical length of stay, and OR minutes. Total Direct Cost was further differentiated into facility and nonfacility costs.Methods: Univariate and multivariate generalized linear models (GLM) were used to identify variables associated with variation in primary outcome measures. Costs were normalized by mean cost for patients with normal body mass index (BMI) and a healthy American Society of Anesthesiologists (ASA) classification. Average marginal effects were reported as percentage of normalized costs.Results: Advanced age, male gender, Hispanic, black, unemployment, obesity, higher ASA class, insurance status, and being retired were positively associated with costs in univariate analysis. Asian, Native American, outpatient procedures, and being a student were associated with decreases in costs. In multivariate analysis, we found that obesity led to higher average marginal total direct (9%), total facility (15%), and facility OR costs (22%), as well as 24 more OR minutes per surgery. While being overweight was not associated with greater total direct costs, it was associated with higher total facility (8%), and facility OR costs (12%), with 11 more OR minutes per surgery. Age was associated with a longer LOS but not with OR costs. As expected, outpatient surgical costs, LOS, and OR time were significantly lower than inpatient procedures. Severe systematic disease was associated with greater total and nonfacility costs. In addition, Medicare patients had higher facility costs (14%) compared to privately insured patients.Conclusions: Significant drivers of total direct cost in multivariate GLM analysis were obesity, severe systemic disease and inpatient surgery. Average LOS was increased due to age and inpatient status, conversely it was decreased by unemployment and retirement. Significant variables in OR time were male sex, Hispanic race and both obese and overweight BMIs. [ABSTRACT FROM AUTHOR]

Background: This study aimed to establish and validate an easy-to-operate novel scoring system based on simple and readily available clinical indices for predicting the progression of chronic kidney disease (CKD).Methods: We retrospectively evaluated 1045 eligible CKD patients from a publicly available database. Factors included in the model were determined by univariate and multiple Cox proportional hazard analyses based on the training set.Results: Independent prognostic factors including etiology, hemoglobin level, creatinine level, proteinuria, and urinary protein/creatinine ratio were determined and contained in the model. The model showed good calibration and discrimination. The area under the curve (AUC) values generated to predict 1-, 2-, and 3-year progression-free survival in the training set were 0.947, 0.931, and 0.939, respectively. In the validation set, the model still revealed excellent calibration and discrimination, and the AUC values generated to predict 1-, 2-, and 3-year progression-free survival were 0.948, 0.933, and 0.915, respectively. In addition, decision curve analysis demonstrated that the model was clinically beneficial. Moreover, to visualize the prediction results, we established a web-based calculator ( https://ncutool.shinyapps.io/CKDprogression/ ).Conclusion: An easy-to-operate model based on five relevant factors was developed and validated as a conventional tool to assist doctors with clinical decision-making and personalized treatment. [ABSTRACT FROM AUTHOR]

Context: Mortality data in patients with adrenal insufficiency are inconsistent, possibly due to temporal and geographical differences between patients and their reference populations.Objective: To compare mortality risk and causes of death in adrenal insufficiency with an individually matched reference population.Methods: A retrospective cohort study was done using a UK general practitioner database (CPRD). A total of 6821 patients with adrenal insufficiency (primary, 2052; secondary, 3948) were compared with 67564 individually-matched controls (primary, 20366; secondary, 39134). Main outcomes were all-cause and cause-specific mortality, and hospital admission from adrenal crisis.Results: With follow-up of 40 799 and 406 899 person-years for patients and controls respectively, the hazard ratio (HR [95% CI]) for all-cause mortality was 1.68 [1.58-1.77]. HRs were greater in primary (1.83 [1.66-2.02]) than in secondary (1.52 [1.40-1.64]) disease; primary versus secondary disease (1.16 [1.03-1.30]). The leading cause of death was cardiovascular disease (HR 1.54 [1.32-1.80]), along with malignant neoplasms and respiratory disease. Deaths from infection were also relatively high (HR 4.00 [2.15-7.46]). Adrenal crisis contributed to 10% of all deaths. In the first 2 years following diagnosis, the patients' mortality rate and hospitalization from adrenal crisis were higher than in later years.Conclusion: Mortality was increased in adrenal insufficiency, especially primary, even with individual matching and was observed early in the disease course. Cardiovascular disease was the major cause but mortality from infection was also high. Adrenal crisis was a common contributor. Early education for prompt treatment of infections and avoidance of adrenal crisis hold potential to reduce mortality. [ABSTRACT FROM AUTHOR]

Background: Stigma and high-care needs can present barriers to the provision of high-quality primary care for people with opioid use disorder (OUD) and those prescribed opioids for chronic pain. We explored the likelihood of securing a new primary care provider (PCP) among people with varying histories of opioid use who had recently lost access to their PCP.Methods and Findings: We conducted a retrospective cohort study using linked administrative data among residents of Ontario, Canada whose enrolment with a physician practicing in a primary care enrolment model (PEM) was terminated between January 2016 and December 2017. We assigned individuals to 3 groups based upon their opioid use on the date enrolment ended: long-term opioid pain therapy (OPT), opioid agonist therapy (OAT), or no opioid. We fit multivariable models assessing the primary outcome of primary care reattachment within 1 year, adjusting for demographic characteristics, clinical comorbidities, and health services utilization. Secondary outcomes included rates of emergency department (ED) visits and opioid toxicity events. Among 154,970 Ontarians who lost their PCP, 1,727 (1.1%) were OAT recipients, 3,644 (2.4%) were receiving long-term OPT, and 149,599 (96.5%) had no recent prescription opioid exposure. In general, OAT recipients were younger (median age 36) than those receiving long-term OPT (59 years) and those with no recent prescription opioid exposure (44 years). In all exposure groups, the majority of individuals had their enrolment terminated by their physician (range 78.1% to 88.8%). In the primary analysis, as compared to those not receiving opioids, OAT recipients were significantly less likely to find a PCP within 1 year (adjusted hazard ratio [aHR] 0.55, 95% confidence interval [CI] 0.50 to 0.61, p < 0.0001). We observed no significant difference between long-term OPT and opioid unexposed individuals (aHR 0.96; 95% CI 0.92 to 1.01, p = 0.12). In our secondary analysis comparing the period of PCP loss to the year prior, we found that rates of ED visits were elevated among people not receiving opioids (adjusted rate ratio (aRR) 1.20, 95% CI 1.18 to 1.22, p < 0.0001) and people receiving long-term OPT (aRR 1.37, 95% CI 1.28 to 1.48, p < 0.0001). We found no such increase among OAT recipients, and no significant increase in opioid toxicity events in the period following provider loss for any exposure group. The main limitation of our findings relates to their generalizability outside of PEMs and in jurisdictions with different financial incentives incorporated into primary care provision.Conclusions: In this study, we observed gaps in access to primary care among people who receive prescription opioids, particularly among OAT recipients. Ongoing efforts are needed to address the stigma, discrimination, and financial disincentives that may introduce barriers to the healthcare system, and to facilitate access to high-quality, consistent primary care services for chronic pain patients and those with OUD. [ABSTRACT FROM AUTHOR]

Introduction:  Treatment guidelines for hepatoblastoma discourage nonanatomic liver resections. However, the evidence for this is inadequate and comes from a study performed almost two decades ago which additionally contained inherent limitations. This study aimed to assess the feasibility and oncologic outcomes of nonanatomic resections (NAR) performed in diligently selected patients and compare the results with anatomic resections (AR).Materials and Methods:  A total of 120 patients who underwent liver resections for hepatoblastoma between January 2008 and July 2019 were reviewed. Feasibility of NAR was based on postchemotherapy relations to vessels, site of the lesion, and possibility of achieving negative resection margins.Results:  AR was performed in 95 patients and 25 had NAR. The NAR cohort had similar International Childhood Liver Tumors Strategy Group (SIOPEL) risk group distribution. Blood loss and operative times were lower in patients undergoing NAR. No differences were noted between the two groups concerning postoperative morbidity and hospitalization. There were no pathologic positive margins or local recurrences in the NAR patients. Relapse free (RFS) and overall survival (OS) was similar in the two groups (p = 0.54 and 0.96, respectively). Subgroup analysis of only posttreatment extent of tumor (POSTTEXT) I and II patients also showed no difference in RFS or OS for the two groups with a persistent significant difference in operative times and blood loss.Conclusion:  NAR is feasible with clear margins in carefully selected patients. It is not associated with more complications and outcomes are not inferior to AR. NAR is associated with lesser blood loss and operative time. [ABSTRACT FROM AUTHOR]

Background: Deep spinal infection is a devastating complication after epidural injection. This study aimed to investigate the incidence of deep spinal infection primarily after outpatient single-shot epidural injection for pain. Secondarily, this study assessed the national trends of the procedure and risk factors for said infection.Methods: Using South Korea's National Health Insurance Service sample cohort database, the 10-yr national trend of single-shot epidural injections for pain and the incidence rate of deep spinal infection after the procedure with its risk factors were determined. New-onset deep spinal infections were defined as those occurring within 90 days of the most recent outpatient single-shot epidural injection for pain, needing hospitalization for at least 1 night, and receiving at least a 4-week course of antibiotics.Results: The number of outpatient single-shot epidural injections per 1,000 persons in pain practice doubled from 40.8 in 2006 to 84.4 in 2015 in South Korea. Among the 501,509 injections performed between 2007 and 2015, 52 cases of deep spinal infections were detected within 90 days postprocedurally (0.01% per injection). In multivariable analysis, age of 65 yr or more (odds ratio, 2.91; 95% CI, 1.62 to 5.5; P = 0.001), living in a rural area (odds ratio, 2.85; 95% CI, 1.57 to 5.0; P < 0.001), complicated diabetes (odds ratio, 3.18; 95% CI, 1.30 to 6.7; P = 0.005), multiple epidural injections (three times or more) within the previous 90 days (odds ratio, 2.34; 95% CI, 1.22 to 4.2; P = 0.007), and recent use of immunosuppressants (odds ratio, 2.90; 95% CI, 1.00 to 6.7; P = 0.025) were significant risk factors of the infection postprocedurally.Conclusions: The incidence of deep spinal infection after outpatient single-shot epidural injections for pain is very rare within 90 days of the procedure (0.01%). The data identify high-risk patients and procedure characteristics that may inform healthcare provider decision-making.Editor’s Perspective: [ABSTRACT FROM AUTHOR]

Introduction: This retrospective analysis aimed to characterize patients with migraine initiating erenumab and the shifting or trend of patient characteristics over time in a real-world setting.Methods: Adult patients with at least one erenumab written prescription/administration between May 1, 2018 and September 30, 2019 were identified from the Optum De-identified Electronic Health Record (EHR) database (index date = date of the first erenumab prescription/administration). Patient demographics and characteristics, acute and preventive medications used prior to initiation of erenumab, and the initial prescriber specialty were examined. In addition, the shifting or trends of patient characteristics over time were analyzed among subgroups of patients based on when they initiated erenumab.Results: A total of 14,774 eligible patients who met inclusion and exclusion criteria were included in the analysis. Most patients were female (86.4%), average age 46.3 (standard deviation [SD] = 13.1) years, Caucasian (88.7%), non-Hispanic (91.8%), and commercially insured (59.8%) at the index date. During the 12-month pre-index period, commonly observed selected comorbid conditions included anxiety (30.6%), depression (28.2%), and cardiovascular diseases (26.4%), and the mean (SD) Elixhauser comorbidity score was 1.7 (5.5). The most common provider specialty at erenumab initiation was neurologist/headache specialist (46.5%). Over time, there was a decrease in mean baseline Elixhauser comorbidity score at erenumab initiation, an increase in general practitioners prescribing initial erenumab, and increased utilization in patients with less severe migraine overall (a proxy of the declining trend in chronic migraine and triptan use).Conclusion: Early use of erenumab post approval focused on patients with more severe disease and a high comorbidity index rating. Over time, utilization of this preventive medication occurred in a broader population of patients with migraine, with increased use by general practitioners and those outside of headache centers. [ABSTRACT FROM AUTHOR]

Background: Interventional studies are the fundamental method for obtaining answers to clinical questions. However, these studies are sometimes difficult to conduct because of insufficient financial or human resources or the rarity of the disease in question. One means of addressing these issues is to conduct a non-interventional observational study using electronic health record (EHR) databases as the data source, although how best to evaluate the suitability of an EHR database when planning a study remains to be clarified. The aim of the present study is to identify and characterize the data sources that have been used for conducting non-interventional observational studies in Japan and propose a flow diagram to help researchers determine the most appropriate EHR database for their study goals.Methods: We compiled a list of published articles reporting observational studies conducted in Japan by searching PubMed for relevant articles published in the last 3 years and by searching database providers' publication lists related to studies using their databases. For each article, we reviewed the abstract and/or full text to obtain information about data source, target disease or therapeutic area, number of patients, and study design (prospective or retrospective). We then characterized the identified EHR databases.Results: In Japan, non-interventional observational studies have been mostly conducted using data stored locally at individual medical institutions (663/1511) or collected from several collaborating medical institutions (315/1511). Whereas the studies conducted with large-scale integrated databases (330/1511) were mostly retrospective (73.6%), 27.5% of the single-center studies, 47.6% of the multi-center studies, and 73.7% of the post-marketing surveillance studies, identified in the present study, were conducted prospectively. We used our findings to develop an assessment flow diagram to assist researchers in evaluating and choosing the most suitable EHR database for their study goals.Conclusions: Our analysis revealed that the non-interventional observational studies were conducted using data stored local at individual medical institutions or collected from collaborating medical institutions in Japan. Disease registries, disease databases, and large-scale databases would enable researchers to conduct studies with large sample sizes to provide robust data from which strong inferences could be drawn. [ABSTRACT FROM AUTHOR]

BACKGROUNDMolecular characterization of prostate cancer (PCa) has revealed distinct subclasses based on underlying genomic alterations occurring early in the natural history of the disease. However, how these early alterations influence subsequent molecular events and the course of the disease over its long natural history remains unclear.METHODSWe explored the molecular and clinical progression of different genomic subtypes of PCa using distinct tumor lineage models based on human genomic and transcriptomic data. We developed transcriptional classifiers, and defined "early" and "late" categories of molecular subclasses from 8,158 PCa patients. Molecular subclasses were correlated with clinical outcomes and pathologic characteristics using Kaplan-Meier and logistic regression analyses.RESULTSWe identified PTEN and CHD1 alterations as subtype-specific late progression events specifically in ERG-overexpressing (ERG+) and SPOP-mutant tumors, respectively, and 2 distinct progression models consisting of ERG/PTEN (normal to ERG+ to PTEN-deleted) and SPOP/CHD1 (normal to SPOP-mutated to CHD1-deleted) with shared early tumorigenesis but distinct pathways toward progression. We found that within ERG+ and SPOP-mutant subtypes, late events were associated with worse prognosis. Importantly, the clinical and pathologic features associated with distinct late events at radical prostatectomy were strikingly different; PTEN deletions were associated with increased locoregional stage, while CHD1 deletions were only associated with increased grade, despite equivalent metastatic potential.CONCLUSIONThese findings suggest a paradigm in which specific subtypes of PCa follow distinct pathways of progression, at both the molecular and clinical levels. Therefore, the interpretation of common clinical parameters such as locoregional tumor stage may be influenced by the underlying tumor lineage, and potentially influence management decisions.FUNDINGProstate Cancer Foundation, National Cancer Institute, Urology Care Foundation, Damon Runyon Cancer Research Foundation, US Department of Defense, and the AIRC Foundation. [ABSTRACT FROM AUTHOR]

Background: While health-related social needs (HRSN) are known to compromise health, work to date has not clearly demonstrated the relationship between clinically acknowledged social needs, via ICD-10 Z-codes, and readmission.Objective: Assess the rate of 30-, 60-, and 90-day readmission by the level of ICD-10-identified social need. In addition, we examined the associations between demographics, social need, hospital characteristics, and comorbidities on 30-day readmission.Design: Retrospective study using the 2017 Nationwide Readmission Database PARTICIPANTS: We identified 5 domains of HRSN from ICD-10 diagnosis codes including employment, family, housing, psychosocial, and socioeconomic status (SES) and identified how many and which an individual was coded with during the year.Main Measures: The proportion of patients with 30-, 60-, and 90-day readmission stratified by the number of HRSN domains with a multivariable logistic regression to examine the relationship between the number/type of and readmission adjusting for sex, age, payer, hospital characteristics, functional limitations, and comorbidities.Key Results: From 13,217,506 patients, only 2.4% had at least one HRSN diagnosis. Among patients without HRSN, 11.5% had a 30-day readmission, compared to 27.0% of those with 1 domain, increasing to 63.5% for patients with codes in 5 domains. Similar trends were observed for 60- and 90-day readmission; 78.7% of patients with documented HRSN in all 5 domains were hospitalized again within 90 days. The adjusted odds ratio for readmission for individuals with all 5 domains was 12.55 (95% CI: 9.04, 17.43). Housing and employment emerged as two of the most commonly documented HRSN, as well as having the largest adjusted odds ratio.Conclusions: There is a dose-response relationship between the number of HRSN diagnoses and hospital readmission. This work calls attention to the need to develop interventions to reduce readmissions for those at social risk and demonstrates the significance of ICD-10 Z-codes in health outcomes studies. [ABSTRACT FROM AUTHOR]

Background: To analyse and interpret gait patterns in pathological paediatric populations, accurate determination of the timing of specific gait events (e.g. initial contract - IC, or toe-off - TO) is essential. As currently used clinical identification methods are generally subjective, time-consuming, or limited to steps with force platform data, several techniques have been proposed based on processing of marker kinematics. However, until now, validation and standardization of these methods for use in diverse gait patterns remains lacking.Research Questions: 1) What is the accuracy of available kinematics-based identification algorithms in determining the timing of IC and TO for diverse gait signatures? 2) Does automatic identification affect interpretation of spatio-temporal parameters?.Methods: 3D kinematic and kinetic data of 90 children were retrospectively analysed from a clinical gait database. Participants were classified into 3 gait categories: group A (toe-walkers), B (flat IC) and C (heel IC). Five kinematic algorithms (one modified) were implemented for two different foot marker configurations for both IC and TO and compared with clinical (visual and force-plate) identification using Bland-Altman analysis. The best-performing algorithm-marker configuration was used to compute spatio-temporal parameters (STP) of all gait trials. To establish whether the error associated with this configuration would affect clinical interpretation, the bias and limits of agreement were determined and compared against inter-trial variability established using visual identification.Results: Sagittal velocity of the heel (Group C) or toe marker configurations (Group A and B) was the most reliable indicator of IC, while the sagittal velocity of the hallux marker configuration performed best for TO. Biases for walking speed, stride time and stride length were within the respective inter-trial variability values.Significance: Automatic identification of gait events was dependent on algorithm-marker configuration, and best results were obtained when optimized towards specific gait patterns. Our data suggest that correct selection of automatic gait event detection approach will ensure that misinterpretation of STPs is avoided. [ABSTRACT FROM AUTHOR]

Background: The Pareto principle states that the majority of any effect comes from a minority of the causes. This property is widely used in quality improvement science.Research Question: Among patients requiring mechanical ventilation (MV), are there subgroups according to MV duration that may serve as potential nodes for high-value interventions aimed at reducing costs without compromising quality?Study Design and Methods: This multicenter retrospective cohort study included approximately 780 hospitals in the Premier Research Database (2014-2018). Patients receiving MV were identified by using International Classification of Diseases, Ninth Revision, Clinical Modification, and International Classification of Diseases, Tenth Revision, codes. They were then divided into quintiles according to MV duration; their hospital costs, post-MV onset length of stay (LOS), ICU LOS, and cumulative post-MV onset hospital days per quintile were compared.Results: A total of 691,961 patients were included in the analysis. Median [interquartile range] duration of MV in days by quintile was as follows: quintile 1 (Q1), 1 [1, 1]; Q2, 2 [2, 2]; Q3, 3 [3, 3]; Q4, 6 [6, 7]; and Q5, 13 [10, 19]. Median [interquartile range] post-MV onset LOS (Q1, 2 [0, 5]; Q5, 17 [12, 26]) and hospital costs (Q1, $15,671 [$9,180, $27,901]; Q5, $70,133 [$47,136, $108,032]) rose from Q1 through Q5. Patients in Q5 consumed 47.7% of all post-MV initiation hospital days among all patients requiring MV, and the mean per-patient hospital costs in Q5 exceeded the sum of costs incurred by Q1 to Q3. Adjusted marginal mean (95% CI) hospital costs rose exponentially from Q1 through Q5: Q2 vs Q1, $3,976 ($3,354, $4,598); Q3 vs Q2, $5,532 ($5,103, $5,961); Q4 vs Q3, $11,705 ($11,071, $12,339); and Q5 vs Q4, $26,416 ($25,215, $27,616).Interpretation: Patients undergoing MV in the highest quintiles according to duration of MV consume a disproportionate amount of resources, as evidenced by MV duration, hospital LOS, and costs, making them a potential target for streamlining MV care. [ABSTRACT FROM AUTHOR]

Study Design: Retrospective analysis of data from the National Surgical Quality Improvement Program (NSQIP).Objective: We sought to compare the short-term outcomes of laminectomy with/without fusion for single-level lumbar degenerative spondylolisthesis (DS).Summary Of Background Data: Lumbar DS is a common cause of low back and radicular pain. Controversy remains over the safety and efficacy of fusion in addition to standard decompressive surgery.Methods: Patients with lumbar DS who underwent laminectomy alone or laminectomy plus posterolateral fusion at a single level were identified from the 2012-2017 NSQIP database. Outcomes included 30-day mortality, major complication, reoperation, readmission, as well as operative duration, need for blood transfusion, length of stay (LOS), and discharge destination. Outcomes were compared between treatment groups by multivariable regression, adjusting for age, sex, and comorbidities (modified Frailty Index). Effect sizes were reported by adjusted odds ratio (aOR) or mean difference (aMD).Results: The study cohort consisted of 1804 patients; of these, 802 underwent laminectomy alone and 1002 laminectomy plus fusion. On both unadjusted and adjusted analyses, there was no difference in 30-day mortality, major complications, reoperation, or readmission. However, laminectomy plus fusion was associated with longer operative time (170.0 vs. 152.7 minutes; aMD 16.00 minutes, P < 0.001), longer hospital LOS (3.2 vs. 2.5 days; aMD 0.68, P < 0.001), more frequent need for intra- or postoperative blood transfusion (6.8% vs. 3.1%; aOR 2.24, P = 0.001), and less frequent discharge home (80.7% vs. 89.2%; aOR 0.46, P < 0.001).Conclusion: We found single-level laminectomy plus fusion for lumbar DS to have a comparable short-term safety profile to laminectomy alone. However, fusion was associated with longer operative time and LOS, higher risk of blood transfusion, and greater need for inpatient rehabilitation. These factors should be recognized by clinicians and discussed with patients in the context of their values when weighing surgical treatment of lumbar DS.Level of Evidence: 3. [ABSTRACT FROM AUTHOR]

Background: Although femoral retroversion has been linked to the onset of slipped capital femoral epiphysis (SCFE), and may result from a rotation of the femoral epiphysis around the epiphyseal tubercle leading to femoral retroversion, femoral version has rarely been described in patients with SCFE. Furthermore, the prevalence of actual femoral retroversion and the effect of different measurement methods on femoral version angles has yet to be studied in SCFE.Questions/purposes: (1) Do femoral version and the prevalence of femoral retroversion differ between hips with SCFE and the asymptomatic contralateral side? (2) How do the mean femoral version angles and the prevalence of femoral retroversion change depending on the measurement method used? (3) What is the interobserver reliability and intraobserver reproducibility of these measurement methods?Methods: For this retrospective, controlled, single-center study, we reviewed our institutional database for patients who were treated for unilateral SCFE and who had undergone a pelvic CT scan. During the period in question, the general indication for obtaining a CT scan was to define the surgical strategy based on the assessment of deformity severity in patients with newly diagnosed SCFE or with previous in situ fixation. After applying prespecified inclusion and exclusion criteria, we included 79 patients. The mean age was 15 ± 4 years, 48% (38 of 79) of the patients were male, and 56% (44 of 79) were obese (defined as a BMI > 95th percentile (mean BMI 34 ± 9 kg/m2). One radiology resident (6 years of experience) measured femoral version of the entire study group using five different methods. Femoral neck version was measured as the orientation of the femoral neck. Further measurement methods included the femoral head's center and differed regarding the level of landmarks for the proximal femoral reference axis. From proximal to distal, this included the most-proximal methods (Lee et al. and Reikerås et al.) and most-distal methods (Tomczak et al. and Murphy et al.). Most proximally (Lee et al. method), we used the most cephalic junction of the greater trochanter as the landmark and, most distally, we used the center base of the femoral neck superior to the lesser trochanter (Murphy et al.). The orientation of the distal femoral condyles served as the distal reference axis for all five measurement methods. All five methods were compared side-by-side (involved versus uninvolved hip), and comparisons among all five methods were performed using paired t-tests. The prevalence of femoral retroversion (< 0°) was compared using a chi-square test. A subset of patients was measured twice by the first observer and by a second orthopaedic resident (2 years of experience) to assess intraobserver reproducibility and interobserver reliability; for this assessment, we used intraclass correlation coefficients.Results: The mean femoral neck version was lower in hips with SCFE than in the contralateral side (-2° ± 13° versus 7° ± 11°; p < 0.001). This yielded a mean side-by side difference of -8° ± 11° (95% CI -11° to -6°; p < 0.001) and a higher prevalence of femoral retroversion in hips with SCFE (58% [95% CI 47% to 69%]; p < 0.001) than on the contralateral side (29% [95% CI 19% to 39%]). These differences between hips with SCFE and the contralateral side were higher and ranged from -17° ± 11° (95% CI -20° to -15°; p < 0.001) based on the method of Tomczak et al. to -22° ± 13° (95% CI -25° to -19°; p < 0.001) according to the method of Murphy et al. The mean overall femoral version angles increased for hips with SCFE using more-distal landmarks compared with more-proximal landmarks. The prevalence of femoral retroversion was higher in hips with SCFE for the proximal methods of Lee et al. and Reikerås et al. (91% [95% CI 85% to 97%] and 84% [95% CI 76% to 92%], respectively) than for the distal measurement methods of Tomczak et al. and Murphy et al. (47% [95% CI 36% to 58%] and 60% [95% CI 49% to 71%], respectively [all p < 0.001]). We detected mean differences ranging from -19° to 4° (all p < 0.005) for 8 of 10 pairwise comparisons in hips with SCFE. Among these, the greatest differences were between the most-proximal methods and the more-distal methods, with a mean difference of -19° ± 7° (95% CI -21° to -18°; p < 0.001), comparing the methods of Lee et al. and Tomczak et al. In hips with SCFE, we found excellent agreement (intraclass correlation coefficient [ICC] > 0.80) for intraobserver reproducibility (reader 1, ICC 0.93 to 0.96) and interobserver reliability (ICC 0.95 to 0.98) for all five measurement methods. Analogously, we found excellent agreement (ICC > 0.80) for intraobserver reproducibility (reader 1, range 0.91 to 0.96) and interobserver reliability (range 0.89 to 0.98) for all five measurement methods in healthy contralateral hips.Conclusion: We showed that femoral neck version is asymmetrically decreased in unilateral SCFE, and that differences increase when including the femoral head's center. Thus, to assess the full extent of an SCFE deformity, femoral version measurements should consider the position of the displaced epiphysis. The prevalence of femoral retroversion was high in patients with SCFE and increased when using proximal anatomic landmarks. Since the range of femoral version angles was wide, femoral version cannot be predicted in a given hip and must be assessed individually. Based on these findings, we believe it is worthwhile to add evaluation of femoral version to the diagnostic workup of children with SCFE. Doing so may better inform surgeons as they contemplate when to use isolated offset correction or to perform an additional femoral osteotomy for SCFE correction based on the severity of the slip and the rotational deformity. To facilitate communication among physicians and for the design of future studies, we recommend consistently reporting the applied measurement technique.Level Of Evidence: Level III, prognostic study. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the association between adherence to antimalarials and type 2 diabetes mellitus (DM) in patients with systemic lupus erythematosus (SLE).Methods: Using administrative health databases in British Columbia, Canada, we conducted a retrospective, longitudinal cohort study of patients with incident SLE and incident antimalarial use. We established antimalarial drug courses by defining a new course when a 90-day gap is exceeded between refills and we calculated proportion of days covered (PDC) for each course. We categorized medication taking as: 1) adherent (PDC ≥0.90), 2) nonadherent (0 < PDC < 0.90), and 3) discontinuer (no drug). Type 2 DM outcomes were based on outpatient or inpatient visits, or antidiabetic medication use. We used multivariable Cox proportional hazards models with time-dependent variables.Results: Over a median of 4.62 years of follow-up in our incident cohort of 1,498 patients with SLE (90.8% women), we recorded 140 incident cases of type 2 DM. Multivariable hazard ratios were 0.61 (95% confidence interval [95% CI] 0.40-0.93) for adherent and 0.78 (95% CI 0.50-1.22) for nonadherent, respectively, as compared to discontinuers.Conclusion: Our findings of a protective effect of adherence to antimalarials in preventing type 2 DM provides further support for the importance of adherence to antimalarials to obtain the benefits of therapy. [ABSTRACT FROM AUTHOR]

Background: The increasing proportion of elderly patients being treated for abdominal aortic aneurysm (AAA) in the endovascular era is controversial.Objectives: This study compared 30-day outcomes of endovascular aortic repair (EVAR) in nonagenarians (NAs) with non-nonagenarians (NNAs).Methods: This retrospective analysis of the American College of Surgeons National Surgical Quality Improvement Program database included EVAR procedures performed from 2011 to 2017. Multivariate logistic regression in the unadjusted cohort, followed by propensity-score matching (PSM), was performed. Primary outcomes were 30-day mortality and 30-day major adverse events.Results: A total of 12,267 patients were included (365 NAs). Ruptured aneurysms accounted for 6.7% (n = 819): 15.7% (n = 57) in NAs versus 6.5% (n = 762) in NNAs (p < 0.001). Mean aneurysm diameter was 6.5 ± 1.8 cm in NAs versus 5.8 ± 1.7 cm in NNAs (p < 0.001). The unadjusted 30-day mortality was 9.9% in NA versus 2.2% in NNAs (p < 0.001). Multivariate analysis revealed age ≥90 years (odds ratio [OR]: 3.36), male sex (OR: 1.78), functional status (OR: 4.22), pre-operative ventilator dependency (OR: 3.80), bleeding disorders (OR: 1.52), dialysis (OR: 2.56), and ruptured aneurysms (OR: 17.21) as independent predictors of mortality. After PSM, no differences in 30-day mortality (intact AAA [iAAA]: 5.3% NA vs. 3% NNA [p = 0.15]; ruptured AAA [rAAA]: 38% NA vs. 28.6% NNA [p = 0.32]) or 30-day major adverse events (iAAA: 7% NA vs. 4.6% NNA [p = 0.22]; rAAA: 28% NA vs. 36.7% NNA [p = 0.35]) were observed.Conclusions: Age was identified as an independent predictor of 30-day mortality after EVAR on multivariate analysis. However, no differences were found after PSM, suggesting that being ≥90 years of age but with similar comorbidities to younger patients is not associated with a higher short-term mortality after EVAR. Age ≥90 years alone should not exclude patients from EVAR, and tailored indications and carefully balanced risk assessment are advised. [ABSTRACT FROM AUTHOR]

Background: Recent clinical trials support adding ovarian suppression (OS) to oral endocrine therapy (ET) for premenopausal women with early breast cancer. The adoption of OS among real-world populations and the impact of OS on ET adherence have not been evaluated.Methods: This study examined a retrospective, observational cohort of women under the age of 50 years with incident early breast cancer from 2001 to 2016. The IBM MarketScan Commercial insurance claims database was used to identify new users of ET with or without OS and to track discontinuation of or adherence to ET. In all, 21,948 women filled at least 1 prescription for ET within 12 months of their diagnosis after a washout period of 12 months with no prior claims. Patients who received an aromatase inhibitor without a synchronous OS drug were excluded.Results: Use of OS increased over time and reached 11.3% in 2016. In an unadjusted analysis, 40.2% of ET+OS users discontinued ET early, whereas 48.8% of tamoxifen-alone users did. In adjusted analyses, ET+OS users had a similar likelihood of discontinuing ET in comparison with tamoxifen-alone users (hazard ratio, 0.92; 95% confidence interval, 0.83-1.03). Approximately 30% of women had low adherence over the first year of use. The likelihood of high adherence was similar, regardless of OS exposure.Conclusions: The use of OS among young, commercially insured patients with breast cancer increased over time in agreement with recent clinical trial results but remained relatively low. Nonadherence to ET was common, but the use of OS was not associated with lower adherence to ET in this observational, nonrandomized cohort. These findings may reassure oncologists that use of OS does not endanger ET adherence, although prospective studies are needed for confirmation. [ABSTRACT FROM AUTHOR]

Study Design: Longitudinal.Objectives: To evaluate whether the rate of patients who report low health-related quality of life (HRQOL) scores at 2 years following surgical correction of adolescent idiopathic scoliosis (AIS) improves by 5 years postoperatively.Summary Of Background Data: HRQOL scores are dependent upon a number of factors and even in instances of good surgical correction of a spinal deformity, are not guaranteed to be high postoperatively. Understanding how a low HRQOL score varies over the postoperative period can help surgeons more effectively counsel patients and temper expectations.Methods: A multicenter database was reviewed for patients with both 2 and 5-year follow-up after spinal fusion and instrumentation for AIS. From a cohort of 916 patients, 52 patients with low HRQOL scores at their 2-year follow-up were identified and reevaluated at 5-year follow-up. A low HRQOL outcome was defined as having SRS-22 domain or total scores less than 2 standard deviations below the mean score. Reoperations were also evaluated to determine if they were associated with HRQOL scores.Results: Of those patients with low SRS-22 HRQOL scores at 2 years postoperatively, improvements were seen in all SRS-22 domains and total scores at the 5-year time point. The greatest change was seen in the satisfaction category where 41 patients showed improvement. The rate of reoperations during this period did not significantly impact patient-reported outcomes.Conclusions: Having a low HRQOL score 2 years after surgery for AIS does not guarantee a low score 5 years after surgery. Promisingly, most patients demonstrate some improvement in all domains for patient-reported SRS-22 scores at 5-year compared to 2-year follow-up. Understanding the longer term postoperative evolution in patient-reported outcomes may help surgeons to effectively manage and counsel patients who are dissatisfied in the short term.Level of Evidence: 3. [ABSTRACT FROM AUTHOR]

Objectives: New versions of balloon-expandable and self-expandable valves for transcatheter aortic valve replacement (TAVR) have been developed, but few studies have examined the outcomes associated with these devices using national-level data. This study aimed to elucidate the clinical and economic outcomes of TAVR for aortic stenosis in Japan through an analysis of real-world data.Methods: This retrospective cohort study was performed using data from patients with aortic stenosis who had undergone transfemoral TAVR with Edwards SAPIEN 3, Medtronic CoreValve, or Medtronic Evolut R valves throughout Japan from April 2016 to March 2018. Pacemaker implantation, mortality, and health expenditure were examined for each valve type during hospitalization and at 1 month, 3 months, 6 months, and 1 year. Generalized linear regression models and Cox proportional hazards models were used to examine the associations between the valve types and outcomes.Results: We analyzed 7244 TAVR cases (SAPIEN 3: 5276, CoreValve: 418, and Evolut R: 1550) across 145 hospitals. The adjusted 1-year expenditures for SAPIEN 3, CoreValve, and Evolut R were $79 402, $76 125, and $75 527, respectively; SAPIEN 3 was significantly more expensive than the other valves (P < .05). The pacemaker implantation hazard ratios (95% confidence intervals) for CoreValve and Evolut R were significantly higher (P < .001) than SAPIEN 3 at 2.61 (2.07-3.27) and 1.80 (1.53-2.12), respectively. The mortality hazard ratios (95% confidence intervals) for CoreValve and Evolut R were not significant at 1.11 (0.84-1.46) and 1.22 (0.97-1.54), respectively.Conclusions: SAPIEN 3 users had generally lower pacemaker implantation and mortality but higher expenditures than CoreValve and Evolut R users. [ABSTRACT FROM AUTHOR]

Background: Institutional-level disparities in non-small cell lung cancer (NSCLC) survival may be driven by reversible differences in care-delivery processes. We quantified the impact of differences in readily identifiable quality metrics on long-term survival disparities in resected NSCLC.Research Question: How do reversible differences in oncologic quality of care contribute to institutional-level disparities in early-stage NSCLC survival?Study Design and Methods: We retrospectively analyzed patients in the National Cancer Data Base who underwent NSCLC resection from 2004 through 2015 within institutions categorized as Community, Comprehensive Community, Integrated Network, Academic, and National Cancer Institute (NCI)-Designated Cancer Programs. We estimated percentages and adjusted ORs for six potentially avoidable poor-quality markers: incomplete resection, nonexamination of lymph nodes, nonanatomic resection, non-evidence-based use of adjuvant chemotherapy, non-evidence-based use of adjuvant radiation therapy, and 60-day postoperative mortality. By sequentially eliminating patients with poor-quality markers and calculating adjusted hazard ratios, we quantified their overall survival impact.Results: Of 169,775 patients, 7%, 46%, 10%, 24%, and 12% underwent surgery at Community, Comprehensive Community, Integrated Network, Academic, and NCI-Designated Cancer Programs, with 5-year overall survival rates of 52%, 56%, 58%, 60% and 66%, respectively. After the sequential elimination process, using NCI-Designated Cancer Centers as a reference, the adjusted hazard ratio for 5-year overall survival changed from 1.47 (95% CI, 1.41-1.53), 1.29 (95% CI, 1.25-1.33), 1.18 (95% CI, 1.14-1.23), and 1.20 (95% CI, 1.16-1.24) for Community, Comprehensive Community, Integrated Networks, and Academic Cancer Programs to 1.35 (95% CI, 1.28-1.42), 1.22 (95% CI, 1.17-1.26), 1.16 (95% CI, 1.11-1.22), and 1.17 (95% CI, 1.12-1.21), respectively (P < .001 for all comparisons with NCI-designated programs). Differences in quality of surgical resection and postoperative care accounted for 11% to 26% of the interinstitutional survival disparities.Interpretation: Targeting six readily identified poor-quality markers narrowed, but did not eliminate, institutional survival disparities. The greatest impact was in community programs. Residual factors driving persistent institution-level long-term NSCLC survival disparities must be characterized to eliminate them. [ABSTRACT FROM AUTHOR]

Objectives: Assess the impact of heterogeneity among established sepsis criteria (Sepsis-1, Sepsis-3, Centers for Disease Control and Prevention Adult Sepsis Event, and Centers for Medicare and Medicaid severe sepsis core measure 1) through the comparison of corresponding sepsis cohorts.Design: Retrospective analysis of data extracted from electronic health record.Setting: Single, tertiary-care center in St. Louis, MO.Patients: Adult, nonsurgical inpatients admitted between January 1, 2012, and January 6, 2018.Interventions: None.Measurements and Main Results: In the electronic health record data, 286,759 encounters met inclusion criteria across the study period. Application of established sepsis criteria yielded cohorts varying in prevalence: Centers for Disease Control and Prevention Adult Sepsis Event (4.4%), Centers for Medicare and Medicaid severe sepsis core measure 1 (4.8%), International Classification of Disease code (7.2%), Sepsis-3 (7.5%), and Sepsis-1 (11.3%). Between the two modern established criteria, Sepsis-3 (n = 21,550) and Centers for Disease Control and Prevention Adult Sepsis Event (n = 12,494), the size of the overlap was 7,763. The sepsis cohorts also varied in time from admission to sepsis onset (hr): Sepsis-1 (2.9), Sepsis-3 (4.1), Centers for Disease Control and Prevention Adult Sepsis Event (4.6), and Centers for Medicare and Medicaid severe sepsis core measure 1 (7.6); sepsis discharge International Classification of Disease code rate: Sepsis-1 (37.4%), Sepsis-3 (40.1%), Centers for Medicare and Medicaid severe sepsis core measure 1 (48.5%), and Centers for Disease Control and Prevention Adult Sepsis Event (54.5%); and inhospital mortality rate: Sepsis-1 (13.6%), Sepsis-3 (18.8%), International Classification of Disease code (20.4%), Centers for Medicare and Medicaid severe sepsis core measure 1 (22.5%), and Centers for Disease Control and Prevention Adult Sepsis Event (24.1%).Conclusions: The application of commonly used sepsis definitions on a single population produced sepsis cohorts with low agreement, significantly different baseline demographics, and clinical outcomes. [ABSTRACT FROM AUTHOR]

Study Design: Retrospective review of a multi-institutional data registry.Objective: The authors sought to determine the association between age and complications & patient-reported outcomes (PRO) in patients undergoing multilevel transforaminal interbody lumbar fusion (MTLIF).Summary Of Background Data: Elderly patients undergoing MTLIF are considered high risk. However, data on complications and PRO are lacking. Additionally, safety of multilevel lumbar fusion in the elderly remains uncertain.Methods: Patients ≥50-year-old who underwent MTLIF for degenerative lumbar spine conditions were analyzed. Ninety-day complications and PROs (baseline, 90-d, 1-y, 2-y) were queried using the MSSIC database. PROs were measured by back & leg visual analog scale (VAS), Patient-reported Outcomes Measurement Information System (PROMIS), EuroQol-5D (EQ-5D), and North American Spine Society (NASS) Patient Satisfaction Index. Univariate analyses were used to compare among elderly and complication cohorts. Generalized estimating equation (GEE) was used to identify predictors of complications and PROs.Results: A total of 3120 patients analyzed with 961 (31%) ≥ 70-y-o and 2159 (69%) between 50-69. A higher proportion of elderly experienced postoperative complications (P = .003) including urinary retention (P = <.001) and urinary tract infection (P = .002). Multivariate analysis demonstrated that age was not independently associated with complications. Number of operative levels was associated with any (P = .001) and minor (P = .002) complication. Incurring a complication was independently associated with worse leg VAS and PROMIS scores (P = <.001). Preoperative independent ambulation was independently associated with improved PROMIS, and EQ5D (P = <.001). Within the elderly, preoperative independent ambulation and lower BMI were associated with improved PROMIS (P = <.001). Complications had no significant effect on PROs in the elderly.Conclusions: Age was not associated with complications nor predictive of functional outcomes in patients who underwent MTLIF. Age alone, therefore, may not be an appropriate surrogate for risk. Furthermore, baseline preoperative independent ambulation was associated with better clinical outcomes and should be considered during preoperative surgical counseling.Level of Evidence: 3. [ABSTRACT FROM AUTHOR]

Purpose: This study evaluated Japanese patients' adherence to first-line therapy and physicians' compliance with the guidelines (GLs) for glaucoma in daily practice. Methods: This retrospective, noninterventional cohort study used a Japanese health care/pharmacy claims database from 2011 to 2016. We compared adherence based on the primary outcomes assessed as proportion of days covered (PDC) and persistence between patients who received first-line monotherapy followed by second-line fixed-combination therapy (GL-compliant cohort) and those who received first-line fixed-combination therapy (GL-noncompliant cohort). Furthermore, we explored treatment patterns, glaucoma consultation, and key factors associated with GL noncompliance. Results: Among 11,666 patients who received first-line therapy, 1,183 (10.1%) and 542 (4.6%) were in the GL-compliant and GL-noncompliant cohorts, respectively. Prostaglandin (70.7%) and subsequent prostaglandin/β blocker (BB) (20.9%) within 12 months were most used by the GL-compliant cohort. Prostaglandin/BB (48.9%) and carbonic anhydrase inhibitor/BB (51.1%) were prescribed for the GL-noncompliant cohort. The mean PDC [standard deviation (SD)], persistence rate (95% confidence interval), and consultation (SD) over 12 months were 60.9% (34.0), 16.0% (14.0-18.1), and 5.23 (3.21) times, respectively, in the GL-compliant cohort and 59.7% (35.8), 22.0% (18.6-25.5), and 4.76 (3.19) times, respectively, in the GL-noncompliant cohort. No significant differences were observed between the 2 cohorts. No clinically relevant factor associated with GL noncompliance was found. Conclusions: Around 5% of patients were prescribed a fixed-combination eye drop as first-line therapy not in accordance with GLs. The similarity of adherence and persistence between the 2 cohorts indicates that first-line fixed-combination therapy could be considered for glaucoma treatment. [ABSTRACT FROM AUTHOR]

Background: Watch and wait is a novel management strategy in patients with rectal cancer who have a clinical complete response after neoadjuvant chemoradiotherapy. Surveillance of these patients is generally intensive, because local regrowth (with the potential for salvage) occurs in 25% of patients, and distant metastases occur in 10% of patients. It is unclear for how long these patients should be followed up. To address this issue, we did conditional survival modelling using the International Watch & Wait Database (IWWD), which is a large-scale registry of patients with a clinical complete response after neoadjuvant chemotherapy who have been managed by a watch-and-wait strategy.Methods: We did a retrospective, multicentre registry study using a dataset from the IWWD, which includes data from 47 clinics across 15 countries. We selected patients (aged ≥18 years) with rectal cancer who had a clinical complete response after neoadjuvant chemotherapy, and who were subsequently managed by a watch-and-wait strategy between Nov 25, 1991, and Dec 31, 2015. Patients who had not achieved a clinical complete response or who had undergone any surgical procedure were excluded. The criteria used for defining a clinical complete response and the specific surveillance strategies were at the discretion of each participating centre. We used conditional survival modelling to estimate the probability of patients remaining free of local regrowth or distant metastasis for an additional 2 years after sustaining a clinical complete response or being distant metastasis-free for 1, 3, and 5 years from the date of the decision to commence watch and wait. The primary outcomes were conditional local regrowth-free survival at 3 years, and conditional distant metastasis-free survival at 5 years.Findings: We identified 793 patients in the IWWD with clinical complete response who had been managed by a watch-and-wait strategy. Median follow-up was 55·2 months (IQR 36·0-75·6). The probability of remaining free from local regrowth for an additional 2 years if a patient had a sustained clinical complete response for 1 year was 88·1% (95% CI 85·8-90·9), for 3 years was 97·3% (95·2-98·6), and for 5 years was 98·6% (97·6-100·0). The probably of remaining free from distant metastasis for a further 2 years in patients who had a clinical complete response without distant metastasis for 1 year was 93·8% (92·3-95·9), for 3 years was 97·8% (96·6-99·3), and for 5 years was 96·6% (94·0-98·9).Interpretation: These results suggest that the intensity of active surveillance in patients with rectal cancer managed by a watch-and-wait approach could be reduced if they achieve and maintain a clinical complete response within the first 3 years of starting this approach.Funding: European Registration of Cancer Care, financed by the European Society of Surgical Oncology, the Champalimaud Foundation Lisbon, the Bas Mulder Award, granted by the Alpe d'HuZes Foundation and the Dutch Cancer Society, the European Research Council Advanced Grant, and the National Institute of Health and Research Manchester Biomedical Research Centre. [ABSTRACT FROM AUTHOR]

Background: Early cholecystectomy (E-CCY; 8 weeks or less) after percutaneous cholecystostomy tube (PCT) placement has been associated with increased postoperative complications, but this finding has not been validated at a national level and PCT-related complications and interventions (PCT-RCIs) were not evaluated.Study Design: Adults with PCT for acute cholecystitis subsequently undergoing CCY were identified within the Nationwide Readmission Database (2010-2015) and our institution (2017-2019). Adjusted relative risks (aRRs) of postoperative complications were estimated using Poisson regression comparing E-CCY with delayed cholecystectomy (D-CCY; more than 8 weeks) within the nationwide cohort. Institutional PCT-RCIs, operative data, and postoperative outcomes were compared between E-CCY and D-CCY using chi-square and Kruskal-Wallis tests.Results: Of 6,145 patients from the Nationwide Readmission Database, 32.9% were D-CCY. Risk-adjusted analysis identified no differences between E-CCY and D-CCY in complications (aRR 0.98; 95% CI, 0.89 to 1.07), mortality (aRR 0.88; 95% CI, 0.43 to 1.81), or 30-day readmissions (aRR 1.04; 95% CI, 0.85 to 1.27). Risk-adjusted analyses assessing the association of time to interval cholecystectomy (IC) with morbidity indicated an increased risk of surgical complications in the first month after PCT placement (aRR 1.17; 95% CI, 1.08 to 1.33). In the institutional cohort (E-CCY, n = 23; D-CCY, n = 45), there were no statistically significant differences found in estimated blood loss, length of stay, and postoperative complications. There were increased PCT-RCIs in the D-CCY group (26.9% E-CCY vs 69% D-CCY; p < 0.01) based on our unadjusted analysis.Conclusions: Increased operative complications when IC is performed within 1 month of PCT placement and increased PCT-RCIs when IC is performed 8 weeks after PCT placement suggest that the most favorable timing for IC is between 4 and 8 weeks after PCT placement. [ABSTRACT FROM AUTHOR]

Objectives: The epidemiology of chronic critical illness is not well known. We aimed to estimate the prevalence, mortality, and costs associated with chronic critical illness in Japan.Design: A nationwide inpatient administrative database study in Japan from April 2011 to March 2018.Setting: Six hundred seventy-nine acute-care hospitals with ICU beds in Japan.Patients: Adult patients who met our definition for chronic critical illness: one of six eligible clinical conditions (prolonged acute mechanical ventilation, tracheotomy, stroke, traumatic brain injury, sepsis, and severe wound) plus at least 8 consecutive days in an ICU.Interventions: None.Measurements and Main Results: Among 2,395,016 ICU admissions during the study period, 216,434 (9.0%) met the definition for chronic critical illness. The most common eligible condition was prolonged acute mechanical ventilation (73.9%), followed by sepsis (50.6%), tracheostomy (23.8%), and stroke (22.8%). Overall inhospital mortality was 28.6%. The overall age-specific population prevalence was 42.0 per 100,000. The age-specific population prevalence steadily increased with age, reaching 109.6 per 100,000 in persons aged greater than 85 years. With extrapolation to national estimates in Japan, there were 47,729 chronic critical illness cases in 2011 and the number remained similar at 46,494 cases in 2017. Hospitalization costs increased gradually, rising from U.S.$2.3 billion in 2011 to U.S.$2.7 billion in 2017. Inhospital mortality decreased from 30.6% to 28.2%, whereas the proportion of patients with total/severe dependence increased from 29.6% to 33.2% and the proportion of patients with decreased consciousness at discharge increased from 18.7% to 19.6%.Conclusions: Using a nationwide inpatient database in Japan, we found substantial clinical and economic burdens of chronic critical illness in Japan. Chronic critical illness was particularly common in elderly people. Although inhospital mortality of chronic critical illness patients continues to decrease, costs and patients with dependence for activities of daily living or decreased consciousness at discharge are increasing. [ABSTRACT FROM AUTHOR]

Purpose: This work aimed to evaluate genotype-phenotype associations in individuals carrying germline variants of transmembrane protein 127 gene (TMEM127), a poorly known gene that confers susceptibility to pheochromocytoma (PHEO) and paraganglioma (PGL).Design: Data were collected from a registry of probands with TMEM127 variants, published reports, and public databases.Main Outcome Analysis: Clinical, genetic, and functional associations were determined.Results: The cohort comprised 110 index patients (111 variants) with a mean age of 45 years (range, 21-84 years). Females were predominant (76 vs 34, P < .001). Most patients had PHEO (n = 94; 85.5%), although PGL (n = 10; 9%) and renal cell carcinoma (RCC, n = 6; 5.4%) were also detected, either alone or in combination with PHEO. One-third of the cases had multiple tumors, and known family history was reported in 15.4%. Metastatic PHEO/PGL was rare (2.8%). Epinephrine alone, or combined with norepinephrine, accounted for 82% of the catecholamine profiles of PHEO/PGLs. Most variants (n = 63) occurred only once and 13 were recurrent (2-12 times). Although nontruncating variants were less frequent than truncating changes overall, they were predominant in non-PHEO clinical presentations (36% PHEO-only vs 69% other, P < .001) and clustered disproportionately within transmembrane regions (P < .01), underscoring the relevance of these domains for TMEM127 function. Integration of clinical and previous experimental data supported classification of variants into 4 groups based on mutation type, localization, and predicted disruption.Conclusions: Patients with TMEM127 variants often resemble sporadic nonmetastatic PHEOs. PGL and RCC may also co-occur, although their causal link requires further evaluation. We propose a new classification to predict variant pathogenicity and assist with carrier surveillance. [ABSTRACT FROM AUTHOR]

Background: Opioid prescription drug abuse is increasingly becoming a concern beyond the United States. Little is known regarding nurse practitioners' opioid prescribing patterns or settings. Aim: To examine nurse practitioners' opioid prescription patterns. Methods: We conducted a retrospective cross‐sectional descriptive study of the 2016 Medicare Part D Prescriber Public Use File and analysed the association between the number of nurse practitioners and the number of opioid prescriptions. We conducted Web searches on the top 1% of prescribers to obtain the specialty areas in which nurse practitioners worked. Results: There was no significant correlation between the prevalence of nurse practitioners and the opioid prescription rates among the states in the United States. Most nurse practitioners do not prescribe opioids. Opioid prescription is highly concentrated among nurse practitioners, as 1% of nurse practitioners account for one third of opioids prescribed by nurse practitioners. Most of the top 1% opioid prescribers practice in specialty care with board‐certified pain medicine physicians. Conclusions: The prevalence of nurse practitioners is not likely a significant contributing factor to the opioid epidemic. Rather than increased scrutiny of opioid prescribing, a better approach to curb the opioid crisis might be to facilitate collaboration among physicians, nurse practitioners and patients. SUMMARY STATEMENT: What is already known about this topic? Opioid prescription drug abuse is increasingly becoming a concern beyond the United States.Little is known regarding nurse practitioners' (NPs') opioid prescribing patterns or settings.What this paper adds? There is no significant correlation between prevalence of NPs and total amount of opioid prescriptions.Most NPs do not prescribe opioids; opioid prescription is highly concentrated in a small portion of NPs.Many of the top 1% opioid prescribing NPs do not work in primary care but in specialty care with pain management physicians.The implications of this paper: Promoting the NP profession could help curb the opioid crisis as most NPs do not prescribe opioids.To combat the opioid crisis, policies should encourage collaborative patient care where physicians work with NPs synergistically.There may be countries where these results could help design NP prescribing policies. [ABSTRACT FROM AUTHOR]

Objective: To study whether the growth trajectory of the first, second, and third trimester, birth, and 5 years of age differs between children born following fresh embryo transfer (fresh ET), frozen-thawed embryo transfer (FET), and children born after natural conception (NC).Design: Historical cohort study of children. The analysis compared cross-sectional and longitudinal differences in measurement between individuals stratified by method of conception.Setting: Not applicable.Patients: Participants were born between 1997 and 2012 by NC (n = 65,683), fresh ET (n = 576), and FET (n = 179). Data were available for method of conception and fetal, maternal, and neonatal characteristics and measurements at 5 years.Intervention (s): None MAIN OUTCOME MEASURE(S): Size at first, second, and third trimester, birth, and 5 years.Result(s): In the longitudinal model, first trimester crown-rump length was significantly longer after fresh ET compared to NC. Second trimester head size was larger after fresh ET and after FET compared to NC. Birth weight was lower after fresh ET conception compared to FET. At 5 years of age, children conceived by fresh ET and FET were no heavier than peers conceived by NC.Conclusion(s): Individuals conceived by in vitro fertilization have significantly different antenatal growth trajectories during the first and second trimester compared to those conceived by NC, and differences persist at birth for weight and head size. The relevance of these different growth trajectories remains uncertain, and larger prospective studies are required. [ABSTRACT FROM AUTHOR]

Objective: To study the impact of both controlled ovarian hyperstimulation (COH) length and total gonadotropin (GN) dose individually and in concert on live birth rates (LBR) in both fresh and freeze-all in vitro fertilization embryo transfer (IVF-ET) cycles.Design: Historical cohort study.Setting: Not applicable.Patient(s): The U.S. national database from the Society of Assisted Reproductive Technology Clinic Outcome Reporting System from 2014 to 2015 was used to identify patients undergoing autologous GN stimulation IVF cycles with the use of GnRH antagonist-based suppression protocols where a single embryo transfer was performed as part of a fresh IVF-ET cycle (fresh, n = 14,866) or the first frozen embryo transfer after a freeze-all cycle (frozen, n = 2,964), and not including preimplantation genetic testing cycles. The patients' demographic and cycle characteristics, duration of COH, total GN dose, and pregnancy outcomes were extracted. Binomial regression models estimated trend and relative risk of live birth with respect to days of stimulation and total GN dose singularly, and after adjustment for a priori confounders including age, parity, body mass index, diagnosis, and maximum follicle-stimulating hormone in both fresh and frozen embryo transfer cycles. Both days of stimulation and total GN dose were then added to the multivariate model to show whether they were independently associated with LBR.Intervention(s): Not applicable.Main Outcome Measure(s): Live birth rate.Results: In both fresh and frozen cycles, length of COH was significantly associated with total GN dose. On univariate analysis, LBR decreased significantly with increasing length of stimulation and increasing total GN dose in both fresh and frozen cycles. On multivariable analysis including both days of stimulation and total GN dose, days of stimulation was no longer significantly correlated with LBR, whereas total GN dose remained significantly correlated with LBR in fresh cycles only. When total GN doses ranging from <2,000 IU through 5,000 IU to >5,000 IU were compared, a significant improvement in live birth rate was noted with lower total GN doses. Specifically, GN doses <2,000 IU had a 27% higher rate of live birth compared with GN dose >5,000 IU. For GN dose groups up to 4,000 IU, the estimated effect on LBR was similar. There was a marginal improvement (13%) in LBR with GN doses of 4,000 IU to 5,000 IU compared with >5,000 IU. When the multivariate model was applied to the frozen cycles, neither total GN dose nor days of stimulation was significantly associated with LBR.Conclusions: High total GN dose but not prolonged COH is associated with decreasing LBRs in fresh cycles, whereas neither factor significantly affects LBR in frozen cycles. Consideration should be given to minimizing the total GN dose when possible in fresh autologous cycles, either by decreasing the daily dose or by limiting the length of stimulation to improve LBRs. In freeze-all cycles, the use of higher GN doses does not seem to adversely affect the LBR of the first frozen embryo transfer. High total GN dose likely exerts a negative impact on the endometrium and/or oocyte/embryo unrelated to the length of stimulation. The differential effect of total GN dose on LBR in fresh and frozen cycles may imply a greater impact exerted on the endometrium rather than the oocyte. [ABSTRACT FROM AUTHOR]

Objectives: The influence of different forms of treatment limitation on mortality rate in the ICU is not known despite the common use of the latter as a quality indicator. The aim of the present study was to assess the prevalence of treatment limitation and its influence on ICU mortality rate. Primary outcomes were prevalence of treatment limitation and its influence on severity-adjusted ICU mortality rate. Secondary outcomes included the association of limitation with age, sex, type of admission, diagnostic group, treatment intensity, and length of ICU stay.Design: Retrospective, observational study.Setting: All Swiss adult ICUs.Interventions: None.Patients: A total of 166,764 patients were admitted to an ICU in 2016 and 2017. Of these, 9139 were excluded because of readmission or invalid coding.Measurements and Main Results: Of 157,625 ICU patients, 20,916 (13.3%) had a fully defined treatment limitation. Among this group, treatment limitation was defined upon ICU admission in 12,854 (61%), the decision to limit treatment was based on the patient's advance directives in 9,951 (48%), and in 15,341 (73%), there was a decision to deliberately withhold certain treatment modalities. The mortality odds ratio for the group with a treatment limitation, considering relevant cofactors, was 18.1 (95% CI 16.8-19.4).Conclusions: Every seventh patient in a Swiss ICU has some kind of treatment limitation, and this most probably affects the severity-adjusted mortality rate. Thus, mortality data as a quality indicator or benchmark in intensive care can only meaningfully be interpreted if existence, grade, cause, and time of treatment limitation are taken into account. [ABSTRACT FROM AUTHOR]

Patients with alcohol-related diagnoses at initial hospitalization are at high risk of 30-day readmission. Understanding risk factors for 30-day readmission among these patients may help to identify those who would benefit from efforts to reduce risk of readmission. The Nationwide Readmissions Database was used to estimate 30-day all-cause readmissions among United States patients with an alcohol-related index hospitalization and to evaluate risk factors and costs associated with these readmissions. Included patients were 18 years of age or older at initial hospitalization, had an alcohol-related primary diagnosis (based on ICD-9-CM codes), and were discharged between 2010 and 2015. They were followed for 30 days after initial hospitalization within the calendar year to identify all-cause readmissions. A logistic regression analysis assessed the association between risk factors and 30-day readmission. Average costs of initial admissions and readmissions were estimated. Among 113,931,723 adult index hospitalizations, 1,124,228 had alcohol-related diagnoses. Patients had a mean age of 49 years, 73% were male, and 45% had public insurance coverage. The annual rate of 30-day readmissions among patients with index alcohol-related hospitalizations increased from 119 readmissions per 1000 admissions in 2010 to 140 per 1000 in 2015, while the rate of readmissions among patients with all-cause hospitalizations declined from 103 to 98 per 1000. The regression analysis suggested that age, male sex, comorbid conditions, discharge against medical advice, admission to large and teaching hospitals, and Medicaid vs. non-Medicaid payment were all risk factors for 30-day readmission. Mean costs of initial alcohol-related hospitalizations were greater among those with a 30-day readmission than without a 30-day readmission, and the mean cost of 30-day readmission was even greater. Mitigating the upward trend in rates of readmission following alcohol-related initial hospitalizations may be addressed through better identification of high-risk patients who are admitted with an alcohol-related diagnosis and greater use of existing evidence-based psychosocial and pharmacotherapy treatment methods. [ABSTRACT FROM AUTHOR]

Background: Patients with a patient-reported penicillin allergy may be at greater risk for postoperative prosthetic joint infection (PJI) after total joint arthroplasty of the hip, knee, or shoulder. The increased risk of PJI in these patients has been attributed to these patients receiving a less-effective perioperative antibiotic. However, prior reports did not fully address the clinical characteristics of these unique patients, who may inherently be at greater risk of having a PJI, which may confound prior findings.Questions/purposes: After controlling for risk factors for PJI such as BMI, anxiety, depression, and other comorbidities, we asked: Are patients with a patient-reported penicillin allergy more likely to have a PJI after THA, TKA, or total shoulder arthroplasty than patients without such a reported allergy?Methods: We queried patient records from 2010 to 2017 from a nationwide administrative claims database of 122 million patients to adequately power an investigation comparing the 1-year incidence of PJI after TKA, total shoulder arthroplasty, and THA in patients with patient-reported penicillin allergy versus patients without a patient-reported penicillin allergy. Operative treatments for deep joint infection, identified by Current Procedural Terminology and ICD-9 and ICD-10 codes were used as a surrogate for PJI. Clinical characteristics such as age, sex, BMI, length of stay, and Charlson comorbidity index and specific comorbidities including alcohol abuse, anemia, anxiety, cardiac disease, diabetes, immunocompromised status, rheumatoid arthritis, depression, liver disease, chronic kidney disease, tobacco use, and peripheral vascular disease were queried for each study group. The odds of PJI within 1 year of THA, TKA, or total shoulder arthroplasty were compared using multiple logistic regression after adjusting for potential confounders.Results: After adjusting for potential confounding factors such as BMI, anxiety, depression and other comorbidities, we found that patient-reported penicillin allergy was independently associated with an increased odds of PJI after TKA (odds ratio 1.3 [95% confidence interval 1.1 to 1.4]; p < 0.01) and total shoulder arthroplasty (OR 3.9 [95% CI 2.7 to 5.4]; p < 0.01). However, patient-reported penicillin allergy was not independently associated with an increased odds of PJI after THA (OR 1.1 [95% CI 0.9 to 1.3]; p = 0.36) after controlling for the same risk factors.Conclusions: In this study, we found that patients with patient-reported penicillin allergy were at an increased risk for PJI after TKA and total shoulder arthroplasty, which we suspect-but cannot prove-is likely a function of those patients receiving a second-line antibiotic for presurgical prophylaxis. Since prior research has found that many patients listed in medical records as having a penicillin allergy are in fact not allergic to penicillin, we suggest that surgeons consider preoperative allergy testing, such as using an intraoperative test dose, to aid in choosing the most appropriate antibiotic choice before knee or shoulder arthroplasty and to amend patient medical records based on testing results. Future studies should determine whether this additional diagnostic maneuver is cost-effective.Level Of Evidence: Level III, therapeutic study. [ABSTRACT FROM AUTHOR]

Objective: Minimally invasive surgery (MIS) continues to gain traction as a feasible approach for the operative management of gastrointestinal (GI) malignancies. The aim of this study is to quantify national trends, perioperative and oncologic outcomes of MIS for the most common GI malignancies including the esophagus, stomach, pancreas, colon, and rectum. We hypothesize that with more widespread use of MIS techniques, perioperative outcomes and oncologic resection quality will remain preserved.Methods: The National Cancer Database (2010-2014) was utilized to assess perioperative outcomes and pathologic quality of MIS (robotic and laparoscopic) compared to open, in patients who underwent resection for cancers of the esophagus, stomach, pancreas, colon, and rectum. Multilevel logistic regression models were constructed to identify independent factors associated with postoperative and long-term outcomes.Results: Data from 11,023 esophageal, 30,664 gastric, 30,689 pancreas, 260,669 colon, and 52,239 rectal resections were analyzed. Although laparoscopy is the most prevalent MIS approach, the number of robotic resections increased nearly fourfold from 2010 to 2014 in all organ sites (increase by factor: esophagus: 3.8, stomach: 4.4, pancreas: 4.4, colon: 3.8 and rectum: 4). The number of laparoscopic resections increased at a slower rate (factor: 1.3-1.9), whereas the number of open resections decreased (factor: 0.67-0.77). Patients who underwent robotic-assisted resections were younger for stomach and colorectal resections and with lower Charlson Comorbidity Index across all sites. Patients who underwent robotic or laparoscopic resections had shorter hospitalizations, fewer readmissions (with the exception of rectal resections) and lower postoperative mortality at 90 days. Robotic-assisted resections had comparable negative margin resections and number of lymph nodes to laparoscopic and open resections across all sites.Conclusion: The utilization of robotic-assisted resections of GI cancers is rapidly increasing with more frequent use in younger and healthier patients. This study demonstrates that with the rising utilization of robotic-assisted resections, perioperative outcomes and oncologic safety have not been compromised. [ABSTRACT FROM AUTHOR]

Background: Minimally invasive resection of rectal cancer is controversial due to concerns of the oncologic efficacy and the difficulties of a laparoscopic total mesorectal excision (TME).Methods: Using the National Cancer Database (NCDB), for the period 2010-2015, perioperative outcomes and overall survival (OS) in patients with rectal cancer who underwent laparoscopic or robotic low anterior resection (LLAR or RLAR) were compared to open LAR (OLAR) after propensity score matching.Results: 26,047 patients underwent LAR: 4062 (16%) RLAR, 9236 (35%) LLAR, and 12,749 (49%) OLAR. Patient and clinical tumor characteristics were similar between groups after matching. The conversion rates among patients undergoing LLAR and RLAR were 15% and 8%, respectively. In matched OLAR and LLAR patients, longitudinal and circumferential resection margins (CRM) were positive in 5.4% and 3.2% (p < 0.001) and 5.5% and 4.1% (p < 0.001); length of stay was 6 and 5 days, (p < 0.001); readmission was required in 6.5% and 7.0% (p = 0.112); OS at 1, 3, and 5 years were 95.5%, 83.7%, and 72.0% and 95.9%, 86.3%, and 76.4%, respectively (p < 0.001). In matched OLAR and RLAR patients, longitudinal and CRM were positive in 5.4% and 3.2% (p < 0.001) and 5.5% and 3.9% (p < 0.001); length of stay was 6 and 5 days (p < 0.001); readmission was required in 6.1% and 7.9%, (p = 0.010); and OS at 1, 3, and 5 years were 96.2%, 86.5%, and 77.1% and 97.5%, 89.4%, and 79.7%, respectively (p = 0.001).Conclusions: In this national sample of propensity matched patients with rectal cancer who underwent open, laparoscopic, or robotic sphincter-saving rectal resection, only small differences in terms of resection margin status, length of stay, readmission, and overall survival were revealed. With acknowledgement of the limitations introduced by selection bias, our data indicate that each of the evaluated operative techniques results in acceptable outcomes for patients with rectal cancer. [ABSTRACT FROM AUTHOR]