Cardiovascular Risk Factors and Disparities in Management of Embolic Stroke: A Western Sydney Perspective.

BACKGROUND: Ischaemic stroke remains one of the leading causes of death and disability worldwide. The population of Western Sydney has a unique demographic with lower socioeconomic status and a culturally and linguistically diverse population. This study aims to investigate the demographics and cardiovascular risk factors of patients in Western Sydney, focusing on the prevalence and profile of cardioembolic (CE) strokes and embolic strokes of undetermined source (ESUS). METHOD: Prospective data were collected in 463 patients with ischaemic stroke presenting to a tertiary centre in Western Sydney, who underwent predischarge transthoracic echocardiography. Patients with haemorrhagic strokes or unclear stroke diagnosis were excluded. Analysis of stroke subtype (CE, ESUS, or non-embolic) and clinical characteristics was performed based on age, gender, and prior atrial fibrillation (AF) prevalence. RESULTS: Of the 463 patients, 147 (32%) had CE strokes, and 147 (32%) had ESUS. Cardioembolic (CE) strokes were associated with older age (≥65 years) and a history of congestive cardiac failure. Older patients had higher rates of hypertension, ischaemic heart disease, AF, and congestive heart failure. History of AF was present in 67 patients (14.5%); however, only 51% received anticoagulation before admission despite a low bleeding risk. The transthoracic echocardiography characteristics of ESUS/non-embolic strokes differed from those of CE strokes; 20% of patients with ESUS had an enlarged left atrium, suggesting a subset of patients with ESUS with a left atrial myopathy. CONCLUSIONS: Patients with ischaemic stroke in Western Sydney have a high prevalence of cardiovascular risk factors which were often undertreated. Half of the patients with prior AF did not receive anticoagulation despite low bleeding risk, indicating a gap in optimal stroke prevention. There were distinct echocardiographic characteristics among stroke subtypes. Further analysis of left atrium parameters may provide greater insights into the pathogenesis and prevention of embolic strokes.

Diabetes and Dyslipidemia Screening in Pediatric Practice.

The incidence of diabetes and hyperlipidemia are increasing at rapid rates in children. These conditions are associated with increased risk of macrovascular and microvascular complications causing major morbidity and mortality later in life. Early diagnosis and treatment can reduce the lifelong risk of complications from these diseases, exemplifying the importance of screening in the pediatric population. The following article presents a summary of the current guidelines for diabetes and hyperlipidemia screening in pediatric patients.

Assessing acutely ill children in general practice using the National PEWS and LqSOFA clinical scores: a retrospective cohort study.

BACKGROUND: Clinical tools are needed in general practice to help identify seriously ill children. The Liverpool quick Sequential Organ Failure Assessment (LqSOFA) was validated in an Emergency Department and performed well. The National Paediatric Early Warning score (PEWS) has been introduced in hospitals throughout England with hopes for implementation in general practice. AIM: To validate the LqSOFA and National PEWS in general practice. DESIGN/SETTING: Secondary analysis of 6,703 children <5 years presenting to 225 general practices in England and Wales with acute illnesses, linked to hospital data. METHOD: Variables from the LqSOFA and National PEWS were mapped onto study data to calculate score totals. A primary outcome of admission within two days of GP consultation was used to calculate sensitivity, specificity, negative predictive values (NPV), positive predictive values (PPV) and area-under-the-curve (AUC). RESULTS: 104/6,703 children were hospitalised within two days (pre-test probability 1.6%). The sensitivity of the LqSOFA was 30.6% (95% confidence interval 21.8% - 41.0%), with a specificity of 84.7% (83.7% - 85.6%), PPV of 3.0% (2.1% - 4.4%), NPV of 98.7% (98.4% - 99.0%), and AUC of 0.58 (0.53 - 0.63). The sensitivity of the National PEWS was 81.0% (71.0% - 88.1%), with a specificity of 32.5% (31.2% - 33.8%); PPV of 1.9% (1.5% - 2.5%); NPV of 99.1% (98.4% - 99.4%) and AUC of 0.66 (0.59 - 0.72). CONCLUSION: Although the NPVs appear useful, due to low pre-test probabilities rather than discriminative ability, neither tool accurately identified hospitalisations. Unconsidered use by GPs could result in unsustainable referrals.

Neuropsychiatric Comorbidities and Psychotropic Medication Use in Medicare Beneficiaries With Dementia by Sex and Race.

BACKGROUND: Neuropsychiatric symptoms affect the majority of dementia patients. Past studies report high rates of potentially inappropriate prescribing of psychotropic medications in this population. We investigate differences in neuropsychiatric diagnoses and psychotropic medication prescribing in a local US cohort by sex and race. METHODS: We utilize Medicare claims and prescription fill records in a cohort of 100% Medicare North and South Carolina beneficiaries ages 50 and above for the year 2017 with a dementia diagnosis. We identify dementia and quantify diagnosis of anxiety, depression and psychosis using validated coding algorithms. We search Medicare claims for antianxiety, antidepressant and antipsychotic medications to determine prescriptions filled. RESULTS: Anxiety and depression were diagnosed at higher rates in White patients; psychosis at higher rates in Black patients. (P < .001) Females were diagnosed with anxiety, depression and psychosis at higher rates than males (P < .001) and filled more antianxiety and antidepressant medications than males. (P < .001) Black and Other race patients filled more antipsychotic medications for anxiety, depression and psychosis than White patients. (P < .001) Antidepressants were prescribed at higher rates than antianxiety or antipsychotic medications across all patients and diagnoses. Of patients with no neuropsychiatric diagnosis, 11.4% were prescribed an antianxiety medication, 22.8% prescribed an antidepressant and 7.6% prescribed an antipsychotic. CONCLUSIONS: The high fill rate of antianxiety (benzodiazepine) medications in dementia patients, especially females is a concern. Patients are prescribed psychotropic medications at high rates. This practice may represent potentially inappropriate prescribing. Patient/caregiver education with innovative community outreach and care delivery models may help decrease medication use.

Health Expenditures After Bariatric Surgery: A Retrospective Cohort Study.

OBJECTIVE: Bariatric surgery leads to substantial improvements in weight and weight-related conditions, but prior literature on post-surgical health expenditures is equivocal. In a retrospective cohort study, we compared expenditures between surgical and matched non-surgical patients. SUMMARY BACKGROUND DATA AND METHODS: In a retrospective study, total, outpatient, inpatient and medication expenditures 3 years before and 5.5 years after surgery were compared between 22,698 bariatric surgery (n=7,127 RYGB, 15,571 sleeve gastrectomy) patients from 2012-2019 and 66,769 matched non-surgical patients, using generalized estimating equations. We also compared expenditures between patients receiving the two leading surgical procedures in weighted analyses. RESULTS: Surgical and non-surgical cohorts were well matched, 80-81% female, with mean body mass index (BMI) of 44, and mean age of 47 (RYGB) and 44 (SG) years. Estimated total expenditures were similar between surgical and non-surgical groups 3 years before surgery ($27 difference, 95% confidence interval (CI): -42, 102)), increased 6 months prior to surgery for surgical patients, and decreased below pre-period levels for both groups after 3-5.5 years to become similar (difference at 5.5 y=-$61, 95% CI: -166, 52). Long-term outpatient expenditures were similar between groups. Surgical patients' lower long-term medication expenditures ($314 lower at 5.5 y, 95% CI: -419, -208) were offset by a higher risk of hospitalization. Total expenditures were similar between RYGB and SG patients 3.5 to 5.5 years after surgery. CONCLUSIONS: Bariatric surgery translated into lower medication expenditures than matched controls, but not lower overall long-term expenditures. Expenditure trends appear similar for the two leading bariatric operations.

A Quantitative Bias Analysis Approach to Informative Presence Bias in Electronic Health Records.

Accurate outcome and exposure ascertainment in electronic health record (EHR) data, referred to as EHR phenotyping, relies on the completeness and accuracy of EHR data for each individual. However, some individuals, such as those with a greater comorbidity burden, visit the health care system more frequently and thus have more complete data, compared with others. Ignoring such dependence of exposure and outcome misclassification on visit frequency can bias estimates of associations in EHR analysis. We developed a framework for describing the structure of outcome and exposure misclassification due to informative visit processes in EHR data and assessed the utility of a quantitative bias analysis approach to adjusting for bias induced by informative visit patterns. Using simulations, we found that this method produced unbiased estimates across all informative visit structures, if the phenotype sensitivity and specificity were correctly specified. We applied this method in an example where the association between diabetes and progression-free survival in metastatic breast cancer patients may be subject to informative presence bias. The quantitative bias analysis approach allowed us to evaluate robustness of results to informative presence bias and indicated that findings were unlikely to change across a range of plausible values for phenotype sensitivity and specificity. Researchers using EHR data should carefully consider the informative visit structure reflected in their data and use appropriate approaches such as the quantitative bias analysis approach described here to evaluate robustness of study findings.

Left atrial shape as a marker of atrial myopathy in embolic stroke of undetermined source.

AIMS: Embolic Stroke of Undetermined Source (ESUS) results in significant morbidity. A left atrial (LA) myopathy is implicated in a proportion of these patients. We hypothesized that LA shape varies by cause of stroke (cardioembolic versus ESUS). METHODS AND RESULTS: 236 ischemic stroke, atrial fibrillation (AF) patients and controls were recruited prospectively. AF was classified as paroxysmal (PAF) or persistent AF (PersAF). Stroke patients comprised cardioembolic stroke (CE) secondary to AF and ESUS. There were 81 AF (47 PAF, 34 PersAF), 50 ESUS, 57 CE patients (subdivided into CE with PAF (CEpaf) and CE with PersAF (CEpers) and 48 controls. Echocardiographic parameters including LA volume, function, and shape/sphericity (3D LA-sphericity and 2D-derived LA-circularity, ellipticity, sphericity and eccentricity indices) were evaluated. Increased LA volume and sphericity with LA dysfunction was present in CE, AF and ESUS groups compared to controls. K-means cluster analysis demonstrated a spectrum of LA myopathy with controls at the lowest and CEpers and PersAF at the upper extremes, with ESUS, PAF and CEpaf being similar and falling between these extremes. After adjusting for age, sex and left ventricular (LV) and LA parameters, LA sphericity markers differentiated ESUS from controls (p < 0.01). CONCLUSIONS: Alterations in LA shape are present in ESUS, AF and CE patients, particularly increased spherical remodelling. The novel markers of LA sphericity proposed may identify LA myopathy in ESUS patients and potentially guide management for secondary prevention.

Racial Disparities in Low-Value Care in the Last Year of Life for Medicare Beneficiaries With Neurodegenerative Disease.

Background and Objectives: There are racial disparities in health care services received by patients with neurodegenerative diseases, but little is known about disparities in the last year of life, specifically in high-value and low-value care utilization. This study evaluated racial disparities in the utilization of high-value and low-value care in the last year of life among Medicare beneficiaries with dementia or Parkinson disease. Methods: This was a retrospective, population-based cohort analysis using data from North and South Carolina fee-for-service Medicare claims between 2013 and 2017. We created a decedent cohort of beneficiaries aged 50 years or older at diagnosis with dementia or Parkinson disease. Specific low-value utilization outcomes were selected from the Choosing Wisely initiative, including cancer screening, peripheral artery stenting, and feeding tube placement in the last year of life. Low-value outcomes included hospitalization, emergency department visits, neuroimaging services, and number of days receiving skilled nursing. High-value outcomes included receipt of occupational and physical therapy, hospice care, and medications indicated for dementia and/or Parkinson disease. Results: Among 70,650 decedents, 13,753 were Black, 55,765 were White, 93.1% had dementia, and 7.7% had Parkinson disease. Adjusting for age, sex, Medicaid dual enrollment status, rural vs urban location, state (NC and SC), and comorbidities, Black decedents were more likely to receive low-value care including colorectal cancer screening (adjusted hazard ratio [aHR] 1.46 [1.32-1.61]), peripheral artery stenting (aHR 1.72 [1.43-2.08]), and feeding tube placement (aHR 2.96 [2.70-3.24]) and less likely to receive physical therapy (aHR 0.73 [0.64-0.85)], dementia medications (aHR 0.90 [0.86-0.95]), or Parkinson disease medications (aHR 0.88 [0.75-1.02]) within the last year of life. Black decedents were more likely to be hospitalized (aHR 1.28 [1.25-1.32]), more likely to be admitted to skilled nursing (aHR 1.09 [1.05-1.13]), and less likely to be admitted to hospice (aHR 0.82 [0.79-0.85]) than White decedents. Discussion: We found racial disparities in care utilization among patients with neurodegenerative disease in the last year of life, such that Black decedents were more likely to receive specific low-value care services and less likely to receive high-value supportive care than White decedents, even after adjusting for health status and socioeconomic factors.

Incorporating Acute Conditions into Risk-Adjustment for Provider Profiling: The Case of the US News and World Report Best Hospitals Rankings Methodology.

Several years ago, the US News and World Report changed their risk-adjustment methodology, now relying almost exclusively on chronic conditions for risk adjustment. The impacts of adding selected acute conditions like pneumonia, sepsis, and electrolyte disorders ("augmented") to their current risk models ("base") for 4 specialties-cardiology, neurology, oncology, and pulmonology-on estimates of hospital performance are reported here. In the augmented models, many acute conditions were associated with substantial risks of mortality. Compared to the base models, the discrimination and calibration of the augmented models for all specialties were improved. While estimated hospital performance was highly correlated between the 2 models, the inclusion of acute conditions in risk-adjustment models meaningfully improved the predictive ability of those models and had noticeable effects on hospital performance estimates. Measures or conditions that address disease severity should always be included when risk-adjusting hospitalization outcomes, especially if the goal is provider profiling.

Altered left atrial metrics in patients with cryptogenic stroke: A systematic review and meta-analysis.

BACKGROUND: There is no defined cause for cryptogenic stroke/embolic stroke of undetermined source (CS-ESUS). As atrial fibrillation (AF) develops in a significant proportion of these patients, it has been suggested that left atrial (LA) myopathy may predispose to CS-ESUS. We investigated alterations in echocardiographic measures of LA size and function in patients with CS-ESUS. METHODS: A systematic literature review and meta-analysis was performed. PubMed, EMBASE, Cochrane Library, Web of Science and SCOPUS were searched for articles published between 1 January 1990 and 10 February 2023. All observational studies of adult CS-ESUS patients with LA volume or function measurements performed by transthoracic echocardiogram were included. Individual random effects meta-analyses were performed on LA measurements in the CS-ESUS patients using subgroup analysis of comparator groups. RESULTS: We included 29 articles with 3927 CS-ESUS patients. Analysis of weighted mean differences showed CS-ESUS patients had altered LA structure and function parameters, with a larger maximum indexed LA volume, reduced LA emptying fraction and/or LA reservoir strain, compared to healthy controls and noncardioembolic stroke patients. Conversely, CS-ESUS patients had a smaller left atrium with better function, compared to cardioembolic stroke patients and CS-ESUS patients who subsequently developed atrial fibrillation. CONCLUSIONS: LA volume and function are altered in CS-ESUS patients compared to healthy controls and other stroke aetiologies. An underlying atrial myopathy in a subset of CS-ESUS patients may be involved in both thrombogenesis and dysrhythmia (specifically AF). While LA functional assessment is not currently recommended following stroke, it may offer an opportunity for recurrent stroke risk stratification.

TBCRC 039: a phase II study of preoperative ruxolitinib with or without paclitaxel for triple-negative inflammatory breast cancer.

BACKGROUND: Patients with inflammatory breast cancer (IBC) have overall poor clinical outcomes, with triple-negative IBC (TN-IBC) being associated with the worst survival, warranting the investigation of novel therapies. Preclinical studies implied that ruxolitinib (RUX), a JAK1/2 inhibitor, may be an effective therapy for TN-IBC. METHODS: We conducted a randomized phase II study with nested window-of-opportunity in TN-IBC. Treatment-naïve patients received a 7-day run-in of RUX alone or RUX plus paclitaxel (PAC). After the run-in, those who received RUX alone proceeded to neoadjuvant therapy with either RUX + PAC or PAC alone for 12 weeks; those who had received RUX + PAC continued treatment for 12 weeks. All patients subsequently received 4 cycles of doxorubicin plus cyclophosphamide prior to surgery. Research tumor biopsies were performed at baseline (pre-run-in) and after run-in therapy. Tumors were evaluated for phosphorylated STAT3 (pSTAT3) by immunostaining, and a subset was also analyzed by RNA-seq. The primary endpoint was the percent of pSTAT3-positive pre-run-in tumors that became pSTAT3-negative. Secondary endpoints included pathologic complete response (pCR). RESULTS: Overall, 23 patients were enrolled, of whom 21 completed preoperative therapy. Two patients achieved pCR (8.7%). pSTAT3 and IL-6/JAK/STAT3 signaling decreased in post-run-in biopsies of RUX-treated samples, while sustained treatment with RUX + PAC upregulated IL-6/JAK/STAT3 signaling compared to RUX alone. Both treatments decreased GZMB+ T cells implying immune suppression. RUX alone effectively inhibited JAK/STAT3 signaling but its combination with PAC led to incomplete inhibition. The immune suppressive effects of RUX alone and in combination may negate its growth inhibitory effects on cancer cells. CONCLUSION: In summary, the use of RUX in TN-IBC was associated with a decrease in pSTAT3 levels despite lack of clinical benefit. Cancer cell-specific-targeting of JAK2/STAT3 or combinations with immunotherapy may be required for further evaluation of JAK2/STAT3 signaling as a cancer therapeutic target. TRIAL REGISTRATION: www. CLINICALTRIALS: gov , NCT02876302. Registered 23 August 2016.

Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial-Efficacy and Biomarker Discovery.

PURPOSE: The neutralizing peptibody trebananib prevents angiopoietin-1 and angiopoietin-2 from binding with Tie2 receptors, inhibiting angiogenesis and proliferation. Trebananib was combined with paclitaxel±trastuzumab in the I-SPY2 breast cancer trial. PATIENTS AND METHODS: I-SPY2, a phase II neoadjuvant trial, adaptively randomizes patients with high-risk, early-stage breast cancer to one of several experimental therapies or control based on receptor subtypes as defined by hormone receptor (HR) and HER2 status and MammaPrint risk (MP1, MP2). The primary endpoint is pathologic complete response (pCR). A therapy "graduates" if/when it achieves 85% Bayesian probability of success in a phase III trial within a given subtype. Patients received weekly paclitaxel (plus trastuzumab if HER2-positive) without (control) or with weekly intravenous trebananib, followed by doxorubicin/cyclophosphamide and surgery. Pathway-specific biomarkers were assessed for response prediction. RESULTS: There were 134 participants randomized to trebananib and 133 to control. Although trebananib did not graduate in any signature [phase III probabilities: Hazard ratio (HR)-negative (78%), HR-negative/HER2-positive (74%), HR-negative/HER2-negative (77%), and MP2 (79%)], it demonstrated high probability of superior pCR rates over control (92%-99%) among these subtypes. Trebananib improved 3-year event-free survival (HR 0.67), with no significant increase in adverse events. Activation levels of the Tie2 receptor and downstream signaling partners predicted trebananib response in HER2-positive disease; high expression of a CD8 T-cell gene signature predicted response in HR-negative/HER2-negative disease. CONCLUSIONS: The angiopoietin (Ang)/Tie2 axis inhibitor trebananib combined with standard neoadjuvant therapy increased estimated pCR rates across HR-negative and MP2 subtypes, with probabilities of superiority >90%. Further study of Ang/Tie2 receptor axis inhibitors in validated, biomarker-predicted sensitive subtypes is warranted.

Race, Gene Expression Signatures, and Clinical Outcomes of Patients With High-Risk Early Breast Cancer.

Importance: There has been little consideration of genomic risk of recurrence by breast cancer subtype despite evidence of racial disparities in breast cancer outcomes. Objective: To evaluate associations between clinical trial end points, namely pathologic complete response (pCR) and distant recurrence-free survival (DRFS), and race and examine whether gene expression signatures are associated with outcomes by race. Design, Setting, and Participants: This retrospective cohort study used data from the Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging and Molecular Analysis 2 (I-SPY 2) multicenter clinical trial of neoadjuvant chemotherapy with novel agents and combinations for patients with previously untreated stage II/III breast cancer. Analyses were conducted of associations between race and short- and long-term outcomes, overall and by receptor subtypes, and their association with 28 expression biomarkers. The trial enrolled 990 female patients between March 30, 2010, and November 5, 2016, with a primary tumor size of 2.5 cm or greater and clinical or molecular high risk based on MammaPrint or hormone receptor (HR)-negative/ERBB2 (formerly HER2 or HER2/neu)-positive subtyping across 9 arms. This data analysis was performed between June 10, 2021, and October 20, 2022. Exposure: Race, tumor receptor subtypes, and genomic biomarker expression of early breast cancer. Main Outcomes and Measures: The primary outcomes were pCR and DRFS assessed by race, overall, and by tumor subtype using logistic regression and Cox proportional hazards regression models. The interaction between 28 expression biomarkers and race, considering pCR and DRFS overall and within subtypes, was also evaluated. Results: The analytic sample included 974 participants (excluding 16 self-reporting as American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander, or multiple races due to small sample sizes), including 68 Asian (7%), 120 Black (12%), and 786 White (81%) patients. Median (range) age at diagnosis was 47 (25-71) years for Asian, 49 (25-77) for Black, and 49 (23-73) years for White patients. The pCR rates were 32% (n = 22) for Asian, 30% for Black (n = 36), and 32% for White (n = 255) patients (P = .87). Black patients with HR-positive/ERBB2-negative tumors not achieving pCR had significantly worse DRFS than their White counterparts (hazard ratio, 2.28; 95% CI, 1.24-4.21; P = .01), with 5-year DRFS rates of 55% (n = 32) and 77% (n = 247), respectively. Black patients with HR-positive/ERBB2-negative tumors, compared with White patients, had higher expression of an interferon signature (mean [SD], 0.39 [0.87] and -0.10 [0.99]; P = .007) and, compared with Asian patients, had a higher mitotic score (mean [SD], 0.07 [1.08] and -0.69 [1.06]; P = .01) and lower estrogen receptor/progesterone receptor signature (mean [SD], 0.31 [0.90] and 1.08 [0.95]; P = .008). A transforming growth factor ß signature had a significant association with race relative to pCR and DRFS, with a higher signature associated with lower pCR and worse DRFS outcomes among Black patients only. Conclusions and Relevance: The findings show that women with early high-risk breast cancer who achieve pCR have similarly good outcomes regardless of race, but Black women with HR-positive/ERBB2-negative tumors without pCR may have worse DRFS than White women, highlighting the need to develop and test novel biomarker-informed therapies in diverse populations.

Reducing Stress after Trauma (ReSeT): study protocol for a randomized, controlled trial of an online psychoeducational program and video therapy sessions for children hospitalized after trauma.

BACKGROUND: Post-traumatic stress symptoms develop in a quarter to half of injured children affecting their longer-term psychologic and physical health. Evidence-based care exists for post-traumatic stress; however, it is not readily available in some communities. We have developed an eHealth program consisting of online, interactive educational modules and telehealth therapist support based in trauma-focused cognitive behavioral therapy, the Reducing Stress after Trauma (ReSeT) program. We hypothesize that children with post-traumatic stress who participate in ReSeT will have fewer symptoms compared to the usual care control group. METHODS: This is a randomized controlled trial to test the effectiveness of the ReSeT intervention in reducing symptoms of post-traumatic stress compared to a usual care control group. One hundred and six children ages 8-17 years, who were admitted to hospital following an injury, with post-traumatic stress symptoms at 4 weeks post-injury, will be recruited and randomized from the four participating trauma centers. The outcomes compared across groups will be post-traumatic stress symptoms at 10 weeks (primary outcome) controlling for baseline symptoms and at 6 months post-randomization (secondary outcome). DISCUSSION: ReSeT is an evidence-based program designed to reduce post-traumatic stress symptoms among injured children using an eHealth platform. Currently, the American College of Surgeons standards suggest that trauma programs identify and treat patients at high risk for mental health needs in the trauma system. If effectiveness is demonstrated, ReSeT could help increase access to evidence-based care for children with post-traumatic stress within the trauma system. TRIAL REGISTRATION: ClinicalTrials.gov NCT04838977. 8 April 2021.

Linking Medicare-Medicaid Claims for Patient-Centered Outcomes Research Among Dual-Eligible Beneficiaries.

BACKGROUND: Evaluation of Medicare-Medicaid integration models' effects on patient-centered outcomes and costs requires multiple data sources and validated processes for linkage and reconciliation. OBJECTIVE: To describe the opportunities and limitations of linking state-specific Medicaid and Centers for Medicare & Medicaid Services administrative claims data to measure patient-centered outcomes for North Carolina dual-eligible beneficiaries. RESEARCH DESIGN: We developed systematic processes to (1) validate the beneficiary ID linkage using sex and date of birth in a beneficiary ID crosswalk, (2) verify dates of dual enrollment, and (3) reconcile Medicare-Medicaid claims data to support the development and use of patient-centered outcomes in linked data. PARTICIPANTS: North Carolina Medicaid beneficiaries with full Medicaid benefits and concurrent Medicare enrollment (FBDE) between 2014 and 2017. MEASURES: We identified need-based subgroups based on service use and eligibility program requirements. We calculated utilization and costs for Medicaid and Medicare, matched Medicaid claims to Medicare service categories where possible, and reported outcomes by the payer. Some services were covered only by Medicaid or Medicare, including Medicaid-only covered home and community-based services (HCBS). RESULTS: Of 498,030 potential dual enrollees, we verified the linkage and FBDE eligibility of 425,664 (85.5%) beneficiaries, including 281,174 adults enrolled in Medicaid and Medicare fee-for-service. The most common need-based subgroups were intensive behavioral health service users (26.2%) and HCBS users (10.8%) for adults under age 65, and HCBS users (20.6%) and nursing home residents (12.4%) for adults age 65 and over. Medicaid funded 42% and 49% of spending for adults under 65 and adults 65 and older, respectively. Adults under 65 had greater behavioral health service utilization but less skilled nursing facility, HCBS, and home health utilization compared with adults 65 and older. CONCLUSIONS: Linkage of Medicare-Medicaid data improves understanding of patient-centered outcomes among FBDE by combining Medicare-funded acute and ambulatory services with Medicaid-funded HCBS. Using linked Medicare-Medicaid data illustrates the diverse patient experience within FBDE beneficiaries, which is key to informing patient-centered outcomes, developing and evaluating integrated Medicare and Medicaid programs, and promoting health equity.

Long-term Participation and Functional Status in Children Who Experience Traumatic Brain Injury.

OBJECTIVE: To evaluate the effect of child and family factors on children's participation outcomes 2 to 3 years following traumatic brain injury (TBI). SETTING: Two level 1 pediatric trauma centers. PARTICIPANTS: Children aged 0 to 15 years with TBI at all severity levels or an orthopedic injury. DESIGN: Prospective cohort. MAIN MEASURES: Caregivers completed the Child and Adolescent Scale of Participation (CASP) at 2- and 3-year follow-ups. The CASP was categorized as more than 90 or 90 or less on a 100-point scale, with 90 or less representing the 10th percentile and below in this sample. Modified Poisson regression models were used to describe relative risk of the CASP at 90 or less at 2 to 3 years postinjury, adjusting for preinjury family environment variables and injury group. A secondary analysis only included children who were 31 months or older at injury (n = 441) to determine whether changes in functional outcome (Pediatric Injury Functional Outcome Scale, PIFOS) and executive functions (Behavior Rating Inventory of Executive Function, BRIEF) from preinjury to 1 year after injury predicted CASP scores at the 2- or 3-year follow-up. RESULTS: Seventy-eight percent (596/769) of children who had a completed preinjury survey had a completed CASP. In the adjusted model, children with severe TBI had a nearly 3 times higher risk (RR = 2.90; 95% CI, 1.43-5.87) of reduced participation than children with an orthopedic injury. In the secondary analysis, lower functional skills (5-point increase in 1-year postinjury PIFOS score) (RR = 1.36; 95% CI, 1.18-1.57) and less favorable family function (RR = 1.46; 95% CI, 1.02-2.10) were associated with reduced participation in both girls and boys. CONCLUSION: Participation in home, school, and community activities after TBI is related to multiple biopsychosocial factors. Participation-focused interventions are needed to reduce barriers to involvement and assist children and families to close the participation gap across settings.

Second international consensus report on gaps and opportunities for the clinical translation of precision diabetes medicine.

Precision medicine is part of the logical evolution of contemporary evidence-based medicine that seeks to reduce errors and optimize outcomes when making medical decisions and health recommendations. Diabetes affects hundreds of millions of people worldwide, many of whom will develop life-threatening complications and die prematurely. Precision medicine can potentially address this enormous problem by accounting for heterogeneity in the etiology, clinical presentation and pathogenesis of common forms of diabetes and risks of complications. This second international consensus report on precision diabetes medicine summarizes the findings from a systematic evidence review across the key pillars of precision medicine (prevention, diagnosis, treatment, prognosis) in four recognized forms of diabetes (monogenic, gestational, type 1, type 2). These reviews address key questions about the translation of precision medicine research into practice. Although not complete, owing to the vast literature on this topic, they revealed opportunities for the immediate or near-term clinical implementation of precision diabetes medicine; furthermore, we expose important gaps in knowledge, focusing on the need to obtain new clinically relevant evidence. Gaps include the need for common standards for clinical readiness, including consideration of cost-effectiveness, health equity, predictive accuracy, liability and accessibility. Key milestones are outlined for the broad clinical implementation of precision diabetes medicine.

Tracking the emergence of an organized use of space: A direct comparison of the spatial patterning within Middle and Upper Paleolithic open-air sites.

Although the 'organization of space' is said to be one of the defining characteristics of modern human behavior, the identification and documentation of such organization has proven to be elusive, especially as rendered in artifact patterning. Without directly comparing artifact patterns within multiple sites, there is no benchmark with which to conclude one site to be more or less 'organized' than another. We can objectively identify patterns within the distribution of archaeological materials, but the decision of whether that patterning constitutes as 'organized' is entirely subjective without a comparative model. In this paper, I present the results of a study in which the spatial distribution of artifacts within nine Middle and Upper Paleolithic sites in France are directly compared to one another, and discernible changes in patterning can be identified. The differences in spatial patterning between the Middle and Upper Paleolithic sites suggest that the organization of space likely became increasingly formalized into and throughout the Upper Paleolithic alongside other cultural norms of behavior. Though more sites are needed to thoroughly document this phenomenon, this study suggests that direct comparisons of spatial patterning have the potential to yield more objective results on the question of spatial organization.

Dementia and Parkinson's disease diagnoses in electronic health records vs. Medicare claims data: a study of 101,980 linked patients.

BACKGROUND: Medicare claims and electronic health record data are both commonly used for research and clinical practice improvement; however, it is not known how concordant diagnoses of neurodegenerative diseases (NDD, comprising dementia and Parkinson's disease) are in these data types. Therefore, our objective was to determine the sensitivity and specificity of neurodegenerative disease (NDD) diagnoses contained in structured electronic health record (EHR) data compared to Medicare claims data. METHODS: This was a retrospective cohort study of 101,980 unique patients seen at a large North Carolina health system between 2013-2017, which were linked to 100% North and South Carolina Medicare claims data, to evaluate the accuracy of diagnoses of neurodegenerative diseases in EHRs compared to Medicare claims data. Patients age > 50 who were enrolled in fee-for-service Medicare were included in the study. Patients were classified as having or not having NDD based on the presence of validated ICD-CM-9 or ICD-CM-10 codes associated with NDD or claims for prescription drugs used to treat NDD. EHR diagnoses were compared to Medicare claims diagnoses. RESULTS: The specificity of any EHR diagnosis of NDD was 99.0%; sensitivity was 61.3%. Positive predictive value and negative predictive value were 90.8% and 94.1% respectively. Specificity of an EHR diagnosis of dementia was 99.0%, and sensitivity was 56.1%. Specificity of an EHR diagnosis of PD was 99.7%, while sensitivity was 76.1%. CONCLUSIONS: More research is needed to investigate under-documentation of NDD in electronic health records relative to Medicare claims data, which has major implications for clinical practice (particularly patient safety) and research using real-world data.