Predictive nomogram for 28-day mortality risk in mitral valve disorder patients in the intensive care unit: A comprehensive assessment from the MIMIC-III database.

BACKGROUND: Mitral valve disorder (MVD) stands as the most prevalent valvular heart disease. Presently, a comprehensive clinical index to predict mortality in MVD remains elusive. The aim of our study is to construct and assess a nomogram for predicting the 28-day mortality risk of MVD patients. METHODS: Patients diagnosed with MVD were identified via ICD-9 code from the MIMIC-III database. Independent risk factors were identified utilizing the LASSO method and multivariate logistic regression to construct a nomogram model aimed at predicting the 28-day mortality risk. The nomogram's performance was assessed through various metrics including the area under the curve (AUC), calibration curves, Hosmer-Lemeshow test, integrated discriminant improvement (IDI), net reclassification improvement (NRI), and decision curve analysis (DCA). RESULTS: The study encompassed a total of 2771 patients diagnosed with MVD. Logistic regression analysis identified several independent risk factors: age, anion gap, creatinine, glucose, blood urea nitrogen level (BUN), urine output, systolic blood pressure (SBP), respiratory rate, saturation of peripheral oxygen (SpO2), Glasgow Coma Scale score (GCS), and metastatic cancer. These factors were found to independently influence the 28-day mortality risk among patients with MVD. The calibration curve demonstrated adequate calibration of the nomogram. Furthermore, the nomogram exhibited favorable discrimination in both the training and validation cohorts. The calculations of IDI, NRI, and DCA analyses demonstrate that the nomogram model provides a greater net benefit compared to the Simplified Acute Physiology Score II (SAPSII), Acute Physiology Score III (APSIII), and Sequential Organ Failure Assessment (SOFA) scoring systems. CONCLUSION: This study successfully identified independent risk factors for 28-day mortality in patients with MVD. Additionally, a nomogram model was developed to predict mortality, offering potential assistance in enhancing the prognosis for MVD patients. It's helpful in persuading patients to receive early interventional catheterization treatment, for example, transcatheter mitral valve replacement (TMVR), transcatheter mitral valve implantation (TMVI).

National trends in prescription drug expenditures and projections for 2021.

PURPOSE: To report historical patterns of pharmaceutical expenditures, to identify factors that may influence future spending, and to predict growth in drug spending in 2021 in the United States, with a focus on the nonfederal hospital and clinic sectors. METHODS: Historical patterns were assessed by examining data on drug purchases from manufacturers using the IQVIA National Sales Perspectives database. Factors that may influence drug spending in hospitals and clinics in 2021 were reviewed-including new drug approvals, patent expirations, and potential new policies or legislation. Focused analyses were conducted for biosimilars, cancer drugs, generics, coronavirus disease 2019 (COVID-19) pandemic influence, and specialty drugs. For nonfederal hospitals, clinics, and overall (all sectors), estimates of growth of pharmaceutical expenditures in 2021 were based on a combination of quantitative analyses and expert opinion. RESULTS: In 2020, overall pharmaceutical expenditures in the United States grew 4.9% compared to 2019, for a total of $535.3 billion. Utilization (a 2.9% increase) and new drugs (a 1.8% increase) drove this increase, with price changes having minimal influence (a 0.3% increase). Adalimumab was the top drug in 2020, followed by apixaban and insulin glargine. Drug expenditures were $35.3 billion (a 4.6% decrease) and $98.4 billion (an 8.1% increase) in nonfederal hospitals and clinics, respectively. In clinics, growth was driven by new products and increased utilization, whereas in hospitals the decrease in expenditures was driven by reduced utilization. Several new drugs that will influence spending are expected to be approved in 2021. Specialty and cancer drugs will continue to drive expenditures along with the evolution of the COVID-19 pandemic. CONCLUSION: For 2021, we expect overall prescription drug spending to rise by 4% to 6%, whereas in clinics and hospitals we anticipate increases of 7% to 9% and 3% to 5%, respectively, compared to 2020. These national estimates of future pharmaceutical expenditure growth may not be representative of any particular health system because of the myriad of local factors that influence actual spending.

Burden of Infective Endocarditis in Homeless Patients in the United States: A National Perspective.

BACKGROUND: Earlier studies have shown disparate cardiovascular care in homeless patients. Limited data exist on burden of infective endocarditis (IE) in homeless patients and in this study, we aimed to analyze it using a nationally representative United States population sample. METHODS: Data were extracted from National Inpatient Sample database from January 2000 to December 2017. Patients with endocarditis were sampled using International Classification of Diseases, 9th Revision, Clinical Modification codes of 421.0, 421.1 or 421.9 and International Classification of Diseases, 10th Revision, Clinical Modification codes of I33.0 or I33.9. Homeless patients were identified using codes of V60 and Z59. Linear regression was used for trend analysis and logistic regression was utilized to identify predictors of mortality. 1:1 propensity score (PS) matching was also done to balance confounders and outcomes were assessed in both unmatched and matched cohorts. RESULTS: We found an increase in proportion of homeless patients admitted with endocarditis from 0.2% in year 2000 to 2.4% in year 2017. Mortality was not statistically significant in PS matched homeless and non-homeless cohorts (4.7% vs 6.6%, p = 0.072). There was a trend towards increased mortality in homeless endocarditis patients over our study years with lower utilization of valvular surgeries. Advanced age, alcohol abuse and admission to large hospitals were independently associated with mortality in homeless endocarditis patients. CONCLUSION: Homeless patients have rising trend of IE and IE related mortality and also found to have low utilization of life saving valvular surgeries when compared to general population.

Neighborhood Socioeconomic Status and Stroke Incidence: A Systematic Review.

OBJECTIVE: To summarize overall patterns of the impact of neighborhood socioeconomic status (nSES) on stroke incidence and uncover potential gaps in the literature, we conducted a systematic review of studies examining the association between nSES and stroke incidence, independent of individual SES. METHODS: Four electronic databases and reference lists of included articles were searched, and corresponding authors were contacted to locate additional studies. A keyword search strategy included the 3 broad domains of neighborhood, SES, and stroke. Eight studies met our inclusion criteria (e.g., nSES as an exposure, individual SES as a covariate, and stroke incidence as an outcome). We coded study methodology and findings across the 8 studies. RESULTS: The results provide evidence for the overall nSES and stroke incidence association in Sweden and Japan, but not within the United States. Findings were inconclusive when examining the nSES-stroke incidence association stratified by race. We found evidence for the mediating role of biological factors in the nSES-stroke incidence association. CONCLUSIONS: Higher neighborhood disadvantage was found to be associated with higher stroke risk, but it was not significant in all the studies. The relationship between nSES and stroke risk within different racial groups in the United States was inconclusive. Inconsistencies may be driven by differences in covariate adjustment (e.g., individual-level sociodemographic characteristics and neighborhood-level racial composition). Additional research is needed to investigate potential intermediate and modifiable factors of the association between nSES and stroke incidence, which could serve as intervention points.

Mind the brain gap: The worldwide distribution of neuroimaging research on adolescent depression.

Adolescents comprise one fourth of the world's population, with about 90% of them living in low- and middle-income countries (LMICs). The incidence of depression markedly increases during adolescence, making the disorder a leading cause of disease-related disability in this age group. However, most research on adolescent depression has been performed in high-income countries (HICs). To ascertain the extent to which this disparity operates in neuroimaging research, a systematic review of the literature was performed. A total of 148 studies were identified, with neuroimaging data available for 4,729 adolescents with depression. When stratified by income group, 122 (82%) studies originated from HICs, while 26 (18%) were conducted in LMICs, for a total of 3,705 and 1,024 adolescents with depression respectively. A positive Spearman rank correlation was observed between country per capita income and sample size (rs=0.673, p = 0.023). Our results support the previous reports showing a large disparity between the number of studies and the adolescent population per world region. Future research comparing neuroimaging findings across populations from HICs and LMICs may provide unique insights to enhance our understanding of the neurobiological processes underlying the development of depression.

Industry-Sponsored Research Payments in Neurosurgery-Analysis of the Open Payments Database From 2014 to 2018.

BACKGROUND: The Open Payments Database (OPD) started in 2013 to combat financial conflicts of interest between physicians and medical industry. OBJECTIVE: To evaluate the first 5 yr of the OPD regarding industry-sponsored research funding (ISRF) in neurosurgery. METHODS: The Open Payments Research Payments dataset was examined from 2014 to 2018 for payments where the clinical primary investigator identified their specialty as neurosurgery. RESULTS: Between 2014 and 2018, a $106.77 million in ISRF was made to 731 neurosurgeons. Fewer than 11% of neurosurgeons received ISRF yearly. The average received $140 000 in total but the median received $30,000. This was because the highest paid neurosurgeon received $3.56 million. A greater proportion ISRF was made to neurosurgeons affiliated with teaching institutions when compared to other specialties (26.74% vs 20.89%, P = .0021). The proportion of the total value of ISRF distributed to neurosurgery declined from 0.43% of payments to all specialties in 2014 to 0.37% in 2018 (P < .001), but no steady decline was observed from year to year. CONCLUSION: ISRF to neurosurgeons comprises a small percentage of research payments made to medical research by industry sponsors. Although a greater percentage of payments are made to neurosurgeons in teaching institutions compared to other specialties, the majority is given to neurosurgeons not affiliated with a teaching institution. A significant percentage of ISRF is given to a small percentage of neurosurgeons. There may be opportunities for more neurosurgeons to engage in industry-sponsored research to advance our field as long as full and complete disclosures can always be made.

Profiles of decent work: General trends and group differences.

Recent trends in the labor market-marked by instability and insecurity-have further ignited a discourse on the significance of decent work in people's lives. Scholars have mostly studied the multidimensional decent work construct using the composite scores of the Decent Work Scale (DWS; Duffy et al., 2017). However, there may be different combinations of decent work beyond the simple continuum of composite scores. Thus, we employed latent profile analysis to identify profiles of decent work using the 5 subscales of the DWS as indicators. As a result, 5 different groups with distinct profiles emerged: (a) average, (b) low health care, (c) indecent work, (d) only health care, and (e) decent work. Subsequent analyses comparing each group on demographics (gender, employment, education), theoretical predictors (economic constraints, marginalization, work volition), and theoretical outcomes (job satisfaction, life satisfaction) revealed notable differences across the 5 groups. Implications, limitations, and future directions of the results are discussed. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Demographic and socioeconomic disparities of benign and malignant spinal meningiomas in the United States.

INTRODUCTION: Spinal meningiomas constitute the majority of primary spinal neoplasms, yet their pathogenesis remains elusive. By investigating the distribution of these tumors across sociodemographic variables can provide direction in etiology elucidation and healthcare disparity identification. METHODS: To investigate benign and malignant spinal meningioma incidences (per 100,000) with respect to sex, age, income, residence, and race/ethnicity, we queried the largest American administrative dataset (1997-2016), the National (Nationwide) Inpatient Sample (NIS), which surveys 20% of United States (US) discharges. RESULTS: Annual national incidence was 0.62 for benign tumors and 0.056 for malignant. For benign meningiomas, females had an incidence of 0.81, larger (P=0.000004) than males at 0.40; yet for malignant meningiomas, males had a larger (P=0.006) incidence at 0.062 than females at 0.053. Amongst age groups, peak incidence was largest for those 65-84 years old (2.03) in the benign group, but 45-64 years old (0.083) for the malignant group. For benign and malignant meningiomas respectively, individuals with middle/high income had an incidence of 0.67 and 0.060, larger (P=0.000008; P=0.04) than the 0.48 and 0.046 of low income patients. Incidences were statistically similar (P=0.2) across patient residence communities. Examining race/ethnicity (P=0.000003) for benign meningiomas, incidences for Whites, Asian/Pacific Islanders, Hispanics, and Blacks were as follows, respectively: 0.83, 0.42, 0.28, 0.15. CONCLUSIONS: Across sociodemographic strata, healthcare inequalities were identified with regards to spinal meningiomas. For benign spinal meningiomas, incidence was greatest for patients who were female, 65-84 years old, middle/high income, living in rural communities, White, and Asian/Pacific Islander. Meanwhile, for malignant spinal meningiomas incidence was greatest for males, those 45-65 years old, and middle/high income.

Trends in Morbidity and Mortality Following Colectomy Among Patients with Ulcerative Colitis in the Biologic Era (2002-2013): A Study Using the National Inpatient Sample.

BACKGROUND: Total abdominal colectomy (TAC) is a treatment modality of last recourse for patients with severe and/or refractory ulcerative colitis (UC). The goal of this study is to evaluate temporal trends and treatment outcomes following TAC among hospitalized UC patients in the biologic era. METHODS: We queried the National Inpatient Sample (NIS) to identify patients older than 18 years with a primary diagnosis of ulcerative colitis (UC) who underwent TAC between 2002 and 2013. We evaluated postoperative morbidity and mortality as outcomes of interest. Logistic regression was used to explore factors associated with postoperative morbidity and mortality after TAC. RESULTS: A weighted total of 307,799 UC hospitalizations were identified. Of these, 27,853 (9%) resulted in TAC. Between 2002 and 2013, hospitalizations for UC increased by over 70%; however, TAC rates dropped significantly from 111.1 to 77.1 colectomies per 1000 UC admissions. Overall, 2.2% of patients died after TAC. Mortality rates after TAC decreased from 3.5% in 2002 to 1.4% in 2013. Conversely, morbidity rates were stable throughout the study period. UC patients with emergent admissions, higher comorbidity scores and who had TAC in low volume colectomy hospitals had poorer outcomes. Regardless of admission type, outcomes were worse if TAC was performed more than 24 h after admission. CONCLUSIONS: Despite increased hospitalizations for UC, rates of TAC have declined during the post-biologic era. For UC patients who undergo TAC, mortality has declined significantly while morbidity remains stable. Older age, race, emergent admissions and delayed surgery are predictive factors of both postoperative morbidity and mortality.

Association of Neurosurgical Work Relative Value Units with Objective Markers of Operative Complexity.

OBJECTIVE: Relative value units (RVUs) form the backbone of health care service reimbursement calculation in the United States. However, it remains unclear how well RVUs align with objective measures of procedural complexity within neurosurgery. METHODS: The 2018 American College of Surgeons National Surgical Quality Improvement Program database was queried for neurosurgical procedures with >50 patients, using Current Procedural Terminology (CPT) codes. Length of stay (LOS), operative time, mortality, and readmission and reoperation rates were collected for each code and a univariate correlation analysis was performed, with significant predictors entered into a multivariate logistic regression model, which generated predicted work RVUs, which were compared with actual RVUs to identify undervalued and overvalued procedures. RESULTS: Among 64 CPT codes, LOS, operative time, mortality, readmission, and reoperation were significant independent predictors of work RVUs and together explained 76% of RVU variance in a multivariate model (R2 = 0.76). Using a difference of >1.5 standard deviations from the mean, procedures associated with greater than predicted RVU included surgery for intracranial carotid circulation aneurysms (CPTs 61697 and 61700; residual RVU = 12.94 and 15.07, respectively), and infratemporal preauricular approaches to middle cranial fossa (CPT 61590; residual RVU = 15.39). Conversely, laminectomy/foraminotomy for decompression of additional spinal cord, cauda equina, and/or nerve root segments (CPT 63048; residual RVU = -21.30), transtemporal craniotomy for cerebellopontine angle tumor resection (CPT 61526; residual RVU = -9.95), and brachial plexus neuroplasty (CPT 64713; residual RVU = -11.29) were associated with lower than predicted RVU. CONCLUSIONS: Work RVUs for neurosurgical procedures are largely predictive of objective measures of surgical complexity, with few notable exceptions.

Association Between Social Determinants of Health and Postoperative Outcomes in Patients Undergoing Single-Level Lumbar Fusions: A Matched Analysis.

STUDY DESIGN: Retrospective cohort. OBJECTIVE: The aim of this study was to analyze association between social determinants of health (SDH) disparity on postoperative complication rates, and 30-day and 90-day all-cause readmission in patients undergoing single-level lumbar fusions. SUMMARY OF BACKGROUND DATA: Decreasing postoperative complication rates is of great interest to surgeons and healthcare systems. Postoperative complications are associated with poor convalescence, inferior patient reported outcomes measures, and increased health care resource utilization. Better understanding of the association between Social Determinants of Health (SDH) on postoperative outcomes maybe helpful to decrease postoperative complication rates. METHODS: MARINER 2020, an all-payer claims database, was utilized to identify patients undergoing single-level lumbar fusions between 2010 and 2018. The primary outcomes were the rates of any postoperative complication, symptomatic pseudarthrosis, need for revision surgery, or 30-day and 90-day all-cause readmission. RESULTS: The exact matched population analyzed in this study contained 16,560 patients (8280 [50.0%] patients undergoing single-level lumbar fusion with an SDH disparity; 8280 [50.0%] patients undergoing single-level lumbar fusion without a disparity). Both patient groups were balanced at baseline. The rate of symptomatic pseudarthrosis (1.0% vs. 0.6%, P < 0.05) or any postoperative complication (16.3% vs. 10.4%, P < 0.05) in the matched analysis was higher in the disparity group. The presence of a disparity was associated with 70% increased odds of developing any complication (OR 1.7, 95% CI 1.53-1.84) or symptomatic pseudarthrosis (OR 1.7, 95% CI 1.17-2.37). Unadjusted and adjusted sensitivity analyses yielded similar results as the primary analysis. CONCLUSION: Social Determinants of Health affect outcomes in spine surgery patients and are associated with an increased risk of developing postoperative complications following lumbar spine fusion.Level of Evidence: 3.

Indication-based analysis of patient outcomes following deep brain stimulation surgery.

BACKGROUND: While considered a safe operation, deep brain stimulation (DBS) has been associated with various morbidities. We assessed differences in postsurgical complication rates in patients undergoing the most common types of neurostimulation surgery. METHODS: The National Readmission Database (NRD) was queried to identify patients undergoing neurostimulation placement with the diagnosis of Parkinson disease (PD), epilepsy, dystonia, or essential tremor (ET). Demographics and complications, including infection, pneumonia, and neurostimulator revision, were queried for each cohort and compiled. Readmissions were assessed in 30-, 90-, and 180-day intervals. We implemented nearest-neighbor propensity score matching to control for demographic and sample size differences between groups. RESULTS: We identified 3230 patients with Parkinson disease, 1289 with essential tremor, 965 with epilepsy, and 221 with dystonia. Following propensity score matching, 221 patients remained in each cohort. Readmission rates 30-days after hospital discharge for PD patients (15.5 %) were significantly greater than those for ET (7.8 %) and seizure patients (4.4 %). Pneumonia was reported for PD (1.6 %), seizure (3.3 %) and dystonia (1.7 %) patients but not individuals ET. No PD patients were readmitted at 30-days due to dysphagia while individuals treated for ET (6.5 %), seizure (1.6 %) and dystonia (5.2 %) were. DBS-revision surgery was performed for 11.48 % of PD, 6.52 % of ET, 1.64 % of seizure and 6.90 % of dystonia patients within 30-days of hospital discharge. CONCLUSION: 30-day readmission rates vary significantly between indications, with patients receiving DBS for PD having the highest rates. Further longitudinal studies are required to describe drivers of variation in postoperative outcomes following DBS surgery for different indications.

Risk Factors Associated with 90-Day Readmissions Following Occipitocervical Fusion-A Nationwide Readmissions Database Study.

BACKGROUND: Occipitocervical fusion (OCF) procedures are increasing due to an aging population and the prevalence of trauma, rheumatoid arthritis, and tumors. Reoperation rates and readmission risk factors for cervical fusions have been established, but in relation to OCF they have not been explored. This study investigates the patterns of readmissions and complications following OCF using a national database. METHODS: The 2016 U.S. Nationwide Readmissions Database was used for sample collection. Adults (>18 years) who underwent OCF were identified using the 2016 ICD-10 coding system, and we examined the readmission rates (30-day and 90-day) and reoperation rates. RESULTS: Between January and September 2016, a total of 477 patients underwent OCF; the 30-day and 90-day readmission rates were 10.4% and 22.4%, respectively. The 90-day reoperation rate related to the index surgery was 5.7%. Mean age (68.58 years) was significantly greater in the readmitted group versus nonreadmitted group (61.76 years) (P < 0.001). The readmitted group had a significantly higher Charlson Comorbidity Index and Elixhauser Comorbidity Index (5.00 and 2.41, respectively) than the nonreadmitted group (3.25 and 1.15, respectively; P < 0.001). Nonelective OCF showed a higher readmission rate (29.18%) versus elective OCF (12.23%) (P < 0.001). Medicare and Medicaid patients showed the highest rates of readmission (27.27% and 20.41%, respectively). Readmitted patients had higher total health care costs. CONCLUSIONS: Nonelective OCF was found to have a readmission rate of almost 2½× that of elective OCF. Understanding risk factors associated with OCF will help with operative planning and patient optimization.

Vertebroplasty and kyphoplasty in the USA from 2004 to 2017: national inpatient trends, regional variations, associated diagnoses, and outcomes.

BACKGROUND: To explore the national inpatient trends, regional variations, associated diagnoses, and outcomes of vertebral augmentation (vertebroplasty and kyphoplasty) in the USA from 2004 to 2017. METHODS: Data from the National Inpatient Sample were used to study hospitalization records for percutaneous vertebroplasty and kyphoplasty. Longitudinal projections of trends and outcomes, including mortality, post-procedural complications, length of stay, disposition, and total hospital charges were analyzed. RESULTS: Following a period of decreased utilization from 2008 to 2012, hospitalizations for vertebroplasty and kyphoplasty plateaued after 2013. Total hospital charges and overall financial burden of hospitalizations for vertebroplasty and kyphoplasty increased to a peak of $1.9 billion (range $1.7-$2.2 billion) in 2017. Overall, 8% of procedures were performed in patients with a history of malignancy. In multivariable modeling, lung cancer (adjusted OR (aOR) 2.6 (range 1.4-5.1)) and prostate cancer (aOR 3.4 (range 1.2-9.4)) were associated with a higher risk of mortality. The New England region had the lowest frequency of routine disposition (14.1±1.1%) and the lowest average hospital charges ($47 885±$1351). In contrast, 34.0±0.8% had routine disposition in the West Central South region, and average hospital charges were as high as $99 836±$2259 in the Pacific region. The Mountain region had the lowest number of procedures (5365±272) and the highest mortality rate (1.2±0.3%). CONCLUSION: National inpatient trends of vertebroplasty and kyphoplasty utilization remained stable after a period of decline from 2008 to 2012, while the financial burden of hospitalizations increased. Despite recent improvements in outcomes, significant regional variations persisted across the USA.

Changes in hemoglobin levels with age and altitude in preschool-aged children in Peru: the assessment of two individual-based national databases.

According to the World Health Organization, the cutoff hemoglobin (Hb) value for defining anemia is 11 g/dL in preschool-aged children, and Hb measurements should be corrected above an altitude of 1000 meters. This study sought to determine the altitude at which the Hb value increases compared with that at sea level, Hb changes with age and region in Peru, the prevalence of anemia according to three different models used to correct Hb for altitude, and the association of the Hb value with stunting. Two individual-based Peruvian national databases were analyzed. Hb increased from an altitude of 375 meters. Hb concentration was lower at younger ages and higher at older ages. The increase in Hb with increasing altitude was lower in southern Peru. Implementing the different models for Hb measurement correction resulted in a higher and lower prevalence of anemia at altitudes >2500 and <2500 m, respectively, using the CDC adjustment. In children aged 6-23 months, the rate of stunting was lower in those with an Hb level of 10-12 g/dL (including mild anemia). In conclusion, the adjustment of Hb values for altitude should be considered before 1000 m and reference ranges should be adjusted to smaller groups of children instead of the same reference range for children aged 6-59 months.

Global Safety Database Summary of COVID-19-Related Drug Utilization-Safety Surveillance: A Sponsor's Perspective.

INTRODUCTION: Evidence-based clinical data on coronavirus disease 2019 (COVID-19) pharmacotherapies are scarce. OBJECTIVE: This study documented and characterized COVID-19 cases reported in individuals receiving treatment with Pfizer pharmaceutical products and cases that reported use of Pfizer pharmaceutical products for COVID-19 treatment. METHODS: This retrospective observational review leveraged the Pfizer safety database containing adverse event data collected in association with use of Pfizer products between 1 October, 2019, and 25 June, 2020; the database includes worldwide adverse event data from various sources. Selected Medical Dictionary for Drug Regulatory Activities (MedDRA®) Preferred Terms and subsequent clinical review were used to characterize COVID-19 cases. RESULTS: Over 1500 relevant cases were identified over an 8-month period. In cases that reported COVID-19, immunosuppressant/immunomodulating agents, followed by anticoagulant/antithrombic agents and corticosteroids, were the most frequently reported agents. The frequent reporting of immunosuppressant/immunomodulating agents among cases of COVID-19 suggests increased vulnerability to infection among treated patients, either because of immunosuppressive effects of certain agents or the nature of the underlying treated condition. In cases involving off-label pharmacotherapy use for the treatment of COVID-19-related conditions, the most frequently reported therapeutic classes included antibiotics, antimalarial agents, antivirals/antiretroviral agents, immunosuppressant/immunomodulating agents, corticosteroids, anticoagulants, and immunoglobulin/interferons. The most frequently reported pharmacotherapeutic agents were azithromycin and chloroquine/hydroxychloroquine, followed by lopinavir-ritonavir, ceftriaxone, and tofacitinib. The most frequently reported clinical adverse events associated with azithromycin (as sole therapy or combined with chloroquine/hydroxychloroquine) include electrocardiogram QT prolonged, drug interaction, hepatitis, diarrhea, and hepatitis acute. Regarding cardiac-related events, 19% (120/645) of azithromycin cases reported events associated with QT prolongation/torsade de pointes (which included seven fatal cardiac events). The most frequently reported clinical adverse events associated with other commonly used agents are also presented. CONCLUSIONS: This pharmacovigilance surveillance study provides a unique characterization of cases in which a broad range of pharmaceutical products was reported in relation to COVID-19.

The Impact of Obesity on Risk Factors for Adverse Outcomes in Patients Undergoing Elective Posterior Lumbar Spine Fusion.

STUDY DESIGN: Retrospective case-control study. OBJECTIVE: The aim of this study was to determine the influence of obesity on risk factors for adverse outcome after lumbar spine fusion (LSF). SUMMARY OF BACKGROUND DATA: Obesity is risk factor for complications after LSF and poses unique challenges regarding optimization of care. Nonetheless, this patient population is not well-studied. METHODS: Adult patients undergoing LSF were identified the State Inpatient Database. Patients were identified as obese or nonobese using ICD-9 codes. Outcome variables were 90-day readmission, major medical complication, infection, and revision rates. Data were queried for demographics, comorbidities, surgery characteristics, and outcome variables. Logistic multivariate regression was utilized, serially testing interactions between obesity and other independent variables in separate models for each outcome. The Benjamini-Hochberg procedure was used to adjust statistical significance for multiple comparisons. RESULTS: A total of 262,153 patients were included: 31,062 obese and 231, 091 nonobese. For major complications, obese patients had lower odds ratios (ORs) versus nonobese patients for cerebrovascular accident, diabetes with chronic complications, age ≥65, congestive heart failure, history of myocardial infarction, renal disease, chronic pulmonary disease, Medicare/Medicaid payor, more than two levels fused, transforaminal/posterior lumbar interbody fusion, and female sex, and higher OR for non-White race. For readmission, obese patients had lower OR for age ≥65, history of MI, renal disease, and mental health disease, and higher OR for female sex. For revision, obese patients had higher OR for female sex and TLIF/PLIF. For infection, obese patients had lower OR for diabetes with and without chronic complications, and higher OR for female sex. CONCLUSION: Many medical comorbidities have less impact in obese patients than nonobese patients in predicting adverse outcomes despite increased rates of adverse outcomes in obese patients. These findings reflect the impact of obesity as an independent risk factor and have important implications for preoperative optimization.Level of Evidence: 3.

Trends Associated with Hemorrhoids in Japan: Data Mining of Medical Information Datasets and the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB) Open Data Japan.

Hemorrhoids are a common anorectal disease. Epidemiological studies on medication trends and risk factors using information from real-world databases are rare. Our objective was to analyze the relationship between hemorrhoid treatment prescription trends and several risk factors using the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB) Open Data Japan and related medical information datasets. We calculated the standardized prescription ratio (SPR) based on the 2nd NDB Open Data Japan from 2015. The correlation coefficients between the SPR of antihemorrhoidals and those of "antispasmodics," "antiarrhythmic agents," "antidiarrheals, intestinal regulators," "purgatives and clysters," "hypnotics and sedatives, antianxietics," "psychotropic agents," and "opium alkaloids preparations" were 0.7474, 0.7366, 0.7184, 0.6501, 0.6320, 0.4571, and 0.4542, respectively. The correlation coefficient between the SPR of antihemorrhoidals and those of "average annual temperature," "percentage of people who were smokers," and "percentage of people who drank regularly" were -0.7204, 0.6002, and 0.3537, respectively. The results of cluster analysis revealed that Hokkaido and Tohoku regions tended to have low average annual temperature values and high percentage of people who were smokers and had comparatively high SPRs of "antispasmodics," "antiarrhythmic agents," "antidiarrheals, intestinal regulators," "purgatives and clysters," "hypnotics and sedatives, antianxietics," "psychotropic agents," and "opium alkaloids preparations." Antihemorrhoidals are frequently used in Hokkaido and Tohoku, Japan; thus, it is important for these prefectural governments to focus on these factors when taking measures regarding health promotion.

Prescription of Colchicine with Other Dangerous Concomitant Medications: A Nation-Wide Survey Using the Japanese Claims Database.

The anti-inflammatory agent colchicine may cause toxic effects such as rhabdomyolysis, pancytopenia, and acute respiratory distress syndrome in cases of overdose and when patients have renal or liver impairment. As colchicine is a substrate for CYP3A4 and P-glycoprotein (P-gp), drug-drug interactions are important factors that cause fatal colchicine-related side effects. Thus, we conducted a nation-wide survey to determine the status of inappropriate colchicine prescriptions in Japan. Patients prescribed the regular use of colchicine from April 2014 to March 2017 were identified using the Japanese large health insurance claims database. As the primary endpoint, we evaluated the concomitant prescription proportions of strong CYP3A4 and/or P-gp inhibitors classified as "contraindications for co-administration" with colchicine in patients with renal or liver impairment. We defined these cases as "inappropriate colchicine prescriptions." Additionally, factors affecting inappropriate colchicine prescriptions were analyzed. Among the 3302 enrolled patients, 43 (1.30%) were inappropriately prescribed colchicine. Of these 43 patients, 11 had baseline renal and/or liver impairment. By multiple regression analysis, the primary diseases "gout" and "Behçet's disease" were extracted as independent factors for inappropriate colchicine prescriptions with odds ratios of 0.40 (95% confidence interval: 0.19-0.84) and 4.93 (95% confidence interval: 2.12-11.5), respectively. We found that approximately 1% of patients had important colchicine interactions. Particularly, Behçet's disease was a risk factor for inappropriate prescriptions, with approximately 25% of patients showing renal and/or liver impairment (classified as "contraindications for co-administration"). These findings may be useful for medical professionals who prescribe colchicine therapy.

Utilization of treatment by Medicaid enrollees with opioid use disorder and co-occurring substance use disorders.

BACKGROUND: Multiple substance use is common among adults who misuse opioids. Adverse consequences of drugs are more severe among multisubstance users than among single drug users. This study sought to determine whether adults with opioid use disorder (OUD) and at least one other substance use disorder (SUD) are less likely than adults with OUD only to receive certain services. METHODS: We conducted a retrospective longitudinal study using the IBM® MarketScan® Multi-State Medicaid Database. We used logistic regression to measure associations between clinical characteristics and service utilization. The sample included non-Medicare-eligible adults aged 18-64 years with at least one claim in 2016 with a primary diagnosis of OUD who were continuously enrolled in Medicaid in 2016 and 2017. RESULTS: Of the 58,745 Medicaid enrollees with an initial OUD diagnosis in 2016, 29,267 had one or more additional SUD diagnoses. In the year following diagnosis, these adults were less likely than adults with OUD only to receive OUD medication treatment (OR = 0.88, p < .0001). This was true for all specifically diagnosed co-occurring SUDS. Adults with OUD and a co-occurring SUD, however, were more likely than those with OUD only to use any type of high-intensity services. CONCLUSIONS: Adults with OUD and at least one co-occurring SUD received more intensive services, which may reflect severity and lack of OUD medication treatment before misuse escalation. Programs should account for barriers to connecting these individuals to appropriate OUD treatment.