Clinformatics DataMart Research Articles

890 Disparities in Supportive Care Utilization Among Neurosurgical Patients With Malignant Central Nervous System Tumors

INTRODUCTION: Patients with central nervous system (CNS) malignancies benefit from palliative care (PC) in addition to other supportive services, such as home health and social work. Guidelines also propose early PC for patients with advanced cancers. Racial disparities exist in healthcare access, and we introduce a novel construct, “provider patient racial diversity index” (provider pRDI), higher categories of which refer to higher proportions of non-white patients a provider sees as a measure of the provider’s exposure to racial diversity and cultural sensitivity. METHODS: Using Optum Clinformatics Datamart Database, all patients with at least one neurosurgery encounter, diagnosis of primary or secondary CNS malignancy, and no prior supportive services were included. Patient-level demographics were collated. Supportive services were defined based on provider categorization on individual claims. RESULTS: The cohort of 48,722 patients demonstrated significantly low rates of PC, home health, and social work services among racial minorities. However, patients who saw providers categorized into high provider pRDI categories were increasingly more likely to interface with supportive services and at an earlier point in their disease courses. Patient race did not impact supportive service spending, but higher provider pRDI was associated with monotonic increases in spending on PC. CONCLUSIONS: Neurosurgical patients with CNS malignancies from minority backgrounds are less likely to receive supportive services. Such effect is mitigated when they encounter at least one provider who scores highly in provider pRDI; patients receive supportive services earlier and demonstrate greater utilization. Our study highlights patient-level healthcare disparities and the need for provider-level intervention to address cultural sensitivity.

Increased risk of osteoarthritis in patients with atopic disease

ObjectivesTo determine the incidence of osteoarthrits (OA) in patients with atopic disease compared with matched non-exposed patients.MethodsWe conducted a retrospective cohort study with propensity score matching using claims data from...

Abstract P409: Estimating the Effect of Statewide Lockdown Orders on Rates of Acute Coronary Syndrome in the United States

Introduction: Initial statewide responses to the COVID-19 pandemic varied substantially in restrictions and duration. It is known that acute coronary syndrome (ACS) rates declined during the first wave of the COVID-19 pandemic. Whether statewide lockdowns were associated with overall and age-specific declines remains unknown. Hypotheses: 1) Statewide lockdown orders were associated with a reduction in ACS rates and 2) decline in rates of ACS were greater among older individuals. Methods: Individuals with a principal diagnosis of ACS, defined as unstable angina, non-ST elevation myocardial infarction (NSTEMI), and STEMI, were identified between January 2018 and September 2021 using ICD codes in Optum’s de-identified Clinformatics® Data Mart (CDM) Database. Multiple ACS claims from the same individual within 7-days were counted as a single event. Weekly, state-specific ACS rates were calculated by dividing the number of ACS events per week by the number of enrolled CDM members for the corresponding week. Lockdown dates were obtained from government issued orders. The 7-day case rates of COVID-19 were obtained for each state from the CDC COVID Data Tracker and modelled as per 1,000 cases. Generalized estimating equations were used to estimate the effect of statewide lockdowns on ACS rates overall and by age-stratified groups (<45, 45-64, 65-74, and ≥75 years). Results: Across all 50 US states, >17 million patients were enrolled in CDM on average each week (state median: 207,913; interquartile range: 73,510 - 509,593). The mean weekly ACS rate was 17.5 cases per 100,000 enrollees (SD: 10.2). Statewide lockdowns were associated with an 11% decrease in ACS rates (rate ratio [RR]: 0.89 [95% CI: 0.85, 0.94]) after controlling for 7-day case rates of COVID-19 and the peak enrollment month of January. In age-stratified analyses, statewide lockdowns were associated with significant decreases in ACS rates across all age groups: <45 (RR: 0.71 [95% CI: 0.56, 0.90]), 45-64 (RR: 0.80 [95% CI: 0.73, 0.87]), 65-74 (RR: 0.78 [95% CI: 0.69, 0.89]), ≥75 (RR: 0.77 [95% CI: 0.70, 0.84]). Per each 1,000-case increase in COVID-19 case rates, ACS rates declined 18% for those 45-64 (95% CI: 0.75, 0.91) but increased 29% for those 65-74 (95% CI: 1.09, 1.53). Conclusions: Statewide lockdowns were associated with a reduction in rates of ACS. The estimate decline in ACS rates were similar across age groups. Further study is needed to determine if ACS events were prevented by state lockdown periods or if the decline was due to other factors such as competing risks of death.

Prevalence and predictors for postpartum sleep disorders: a nationwide analysis

Objective To describe the prevalence and predictors of postpartum sleep disorders. Design A retrospective cohort study. Setting Postpartum. Population Commercially insured women delivering in California (USA) between 2011 and 2014. Methods Using the Optum Clinformatics Datamart Database. Main outcome measures Prevalence of a postpartum sleep disorder diagnosis with and without a depression diagnosis up to 12 months following hospital discharge for inpatient delivery. We also identified predictors of a postpartum sleep disorder diagnosis using multivariable logistic regression. Results We identified 3535 (1.9%) women with a postpartum sleep disorder diagnosis. The prevalence of sleep disorder diagnoses was insomnia (1.3%), sleep apnea (0.25%), and other sleep disorder (0.25%). The odds of a postpartum sleep disorder were highest among women with a history of drug abuse (adjusted odds ratio (aOR): 2.70, 95% confidence interval (CI): 1.79–4.09); a stillbirth delivery (aOR: 2.15, 95% CI: 1.53–3.01); and chronic hypertension (aOR: 1.82; 95% CI: 1.57–2.11). A comorbid diagnosis of a postpartum sleep disorder and depression occurred in 1182 women (0.6%). These women accounted for 33.4% of all women with a postpartum sleep disorder. The strongest predictors of a comorbid diagnosis were a history of drug abuse (aOR: 4.13; 95% CI: 2.37–7.21) and a stillbirth delivery (aOR: 2.93; 95% CI: 1.74–4.92). Conclusions Postpartum sleep disorders are underdiagnosed conditions, with only 2% of postpartum women in this cohort receiving a sleep diagnosis using International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes. Insomnia was the most common disorder and one-third of women diagnosed with a postpartum sleep disorder had a co-morbid diagnosis of depression. Future studies are needed to improve the screening and diagnostic accuracy of postpartum sleep disorders.

Comparison of clinical and economic burden of pulmonary arterial hypertension patients with and without connective tissue disease treated with macitentan

Abstract Introduction Patients with pulmonary arterial hypertension (PAH) and connective tissue disease (CTD) have a poorer prognosis than those diagnosed with other PAH etiologies. Purpose To compare the clinical and economic burden among PAH patients with and without CTD (PAH-CTD/PAH non-CTD) treated with macitentan. Methods This retrospective study used the Optum Clinformatics DataMart to identify PAH-CTD and PAH non-CTD patients aged ≥18 years and prescribed macitentan from 01JAN2015–30JUN2019. The index date was the date of the first macitentan claim. Patients had to have ≥12 months of continuous enrollment before index and were followed until earliest of macitentan discontinuation, health plan disenrollment, death, or study end. Patients in the PAH-CTD cohort had to have a claim for a CTD condition at any time during the 12-month baseline period. Patients with a baseline claim for any PAH medication, chronic thromboembolic pulmonary hypertension, prior atrial septostomy or lung transplant were excluded. Descriptive analysis comprised means, standard deviations, medians, and interquartile ranges for continuous variables and frequencies and percentages for categorical variables. Multivariable analyses (Cox proportional hazards and generalized linear models) adjusting for baseline characteristics were used to compare time to PAH-related and all-cause hospitalization, disease progression (death, lung transplant, atrial septostomy or addition of intravenous/subcutaneous prostanoids), and PAH- and all-cause related medical (inpatient and outpatient) costs between the two cohorts with PAH non-CTD as reference. Results The analysis included 203 PAH-CTD and 750 PAH non-CTD patients treated with macitentan. Versus PAH non-CTD, PAH-CTD patients were younger, had proportionately more females, and lower Charlson Comorbidity Index (CCI) scores (Table). The proportion of patients with a baseline hospitalization, length of stay and inpatient costs were similar across groups. There were no significant differences observed in time to PAH-related hospitalization (hazard ratio [HR]=0.99; p=0.910), all-cause hospitalization (HR=1.13; p=0.195), or disease progression (HR=1.00; p-value=0.973) for the PAH-CTD cohort (PAH non-CTD as reference). All-cause medical costs were similar between the cohorts ($3,836 per patient per month [PPPM] for PAH CTD vs $3,521 PPPM for PAH non-CTD, p=0.362). PAH-CTD patients incurred higher mean PAH-related medical costs vs PAH non-CTD ($2,806 PPPM vs $1,961 PPPM, p=0.047). Conclusion The study suggests that risk of all-cause and PAH-related hospitalization and disease progression did not differ for PAH-CTD and PAH non-CTD patients. Treatment with macitentan in the real world appears to confer similar clinical benefits in both PAH-CTD and PAH non-CTD groups. All-cause costs did not differ between the two cohorts but PAH-related costs were significantly higher in PAH-CTD patients suggesting an incremental burden associated with CTD. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Janssen Scientific Affairs, LLC

Sarcoidosis incidence after mTOR inhibitor treatment

ObjectiveMechanistic target of rapamycin (mTOR) inhibitors are effective in animal models of granulomatous disease, but their benefit in sarcoidosis patients is unknown. We evaluated the incidence of sarcoidosis in patients treated with mTOR inhibitors versus calcineurin inhibitors. MethodsThis was a cohort study using the Optum Clinformatics® Data Mart (CDM) Database (2003–2019), IBM® MarketScan® Research Database (2006–2016), and Danish health and administrative registries (1996–2018). Patients aged ≥18 years with ≥1 year continuous enrollment before and after kidney, liver, heart, or lung transplant treated with an mTOR inhibitor or calcineurin inhibitor were included. Patients diagnosed with sarcoidosis before, or up to 90 days after, transplant were excluded. The incidence of sarcoidosis by treatment group was calculated. ResultsIn the Optum CDM/IBM MarketScan cohort, 1,898 patients were treated with an mTOR inhibitor (mean age 49 years; 34% female) and 9,894 patients were treated with a calcineurin inhibitor (mean age 50 years; 37% female). The mean follow-up in the mTOR inhibitor group was 1.1 years, with no incident sarcoidosis diagnosed. In the calcineurin inhibitor group, the mean follow-up was 2.2 years, with 12 incident sarcoidosis cases diagnosed. In the Danish cohort, 230 patients were treated with an mTOR inhibitor (mean age 49; 45% female), with no incident sarcoidosis diagnosed. There were 3,411 patients treated with a calcineurin inhibitor (mean age 45; 40% female), with 10 incident cases of sarcoidosis diagnosed. ConclusionsThis study indicates a potential protective effect of mTOR inhibitor treatment compared with calcineurin inhibitor treatment against the development of sarcoidosis.

Operative Versus Nonoperative Management of Unstable Spine Fractures in the Elderly: Outcomes and Mortality.

Retrospective cohort study. To assess outcomes and mortality in elderly patients following unstable spine fractures depending on treatment modality. Operative management of unstable spine fractures in the elderly remains controversial due to increased risk of perioperative complications. Mortality rates after operative versus nonoperative treatment of these injuries have not been well-characterized. Patients aged above 65 with unstable spine fractures without neurologic injury from 2015 to 2021 were identified from the Clinformatics ® Data Mart (CDM) Database. Demographics, complications, and mortality were collected. Multivariable logistic regression was used to adjust for the effect of baseline characteristics on mortality following unstable fracture diagnosis. Of the 3688 patients included, 1330 (36.1%) underwent operative management and 2358 (63.9%) nonoperative. At baseline, nonoperative patients were older, female, had higher Elixhauser comorbidity scores, and were more likely to have a cervical fracture. Operative patients had a longer length of stay in the hospital compared with nonoperative patients (9.7 vs. 7.7 days; P <0.001). Although patients in the operative group had higher rates of readmission at 30, 60, 90, and 120 days after diagnosis ( P <0.01), they had lower mortality rates up to five years after injury. After adjusting for covariates, nonoperative patients had a 60% greater risk of mortality compared with operative patients (hazard ratio: 1.60, 95% confidence interval: 1.40-1.78, P <0.001). After propensity score matching, operative patients age 65 to 85 had greater survivorship compared with their nonoperative counterparts. Elderly patients with an unstable spine fracture who undergo surgery experience lower mortality rates up to five years postdiagnosis compared with patients who received nonoperative management, despite higher hospital readmission rates and an overall perioperative complication rate of 37.3%. Operating on elderly patients with unstable spine fractures may outweigh the risks and should be considered as a viable treatment option in appropriately selected patients.

Nationwide Trends in Contralateral Prophylactic Mastectomies: An Analysis of 55,060 Unilateral Breast Cancer Patients.

Background:The effects of recent initiatives to better educate unilateral breast cancer (UBC) patients about contralateral prophylactic mastectomy (CPM) have not been fully examined. The purpose of this study was to update and examine recent annual CPM trends by evaluating 2015–2020 data from a large administrative claims database. We also sought to determine if there were any variations in trends among different age groups and reconstructive modalities.Methods:Patients diagnosed with UBC between 2015 and 2019 were identified in Optum Clinformatics DataMart. Patients were then categorized by age group, whether they underwent CPM, whether they underwent breast reconstruction (BR), timing of any BR (immediate or delayed), and type of BR (implant-based or autologous).Results:Of 55,060 patients who were diagnosed with UBC, 2625 (4.8%) underwent CPM. After a slight decline from 2015 to 2016, the CPM rate among UBC patients increased significantly from 3.4% in 2016 to 6.8% in 2019. Although this upward trend remained consistent across all age groups examined, younger UBC patients represented a significantly higher and faster growing percentage of those undergoing CPM. BR rates among those who underwent CPM also increased between 2015 and 2019, with implant-based and immediate BR becoming more heavily favored over autologous and delayed BR.Conclusions:CPM rates continued to rise between 2016 and 2019 and younger women represented a substantially higher and faster growing percentage of UBC patients undergoing CPM than older women. In addition, implant-based and immediate BR are becoming more heavily favored over autologous and delayed BR.

Modifiers of and Disparities in Palliative and Supportive Care Timing and Utilization among Neurosurgical Patients with Malignant Central Nervous System Tumors.

Patients with primary or secondary central nervous system (CNS) malignancies benefit from utilization of palliative care (PC) in addition to other supportive services, such as home health and social work. Guidelines propose early initiation of PC for patients with advanced cancers. We analyzed a cohort of privately insured patients with malignant brain or spinal tumors derived from the Optum Clinformatics Datamart Database to investigate health disparities in access to and utilization of supportive services. We introduce a novel construct, "provider patient racial diversity index" (provider pRDI), which is a measure of the proportion of non-white minority patients a provider encounters to approximate a provider's patient demographics and suggest a provider's cultural sensitivity and exposure to diversity. Our analysis demonstrates low rates of PC, home health, and social work services among racial minority patients. Notably, Hispanic patients had low likelihood of engaging with all three categories of supportive services. However, patients who saw providers categorized into high provider pRDI (categories II and III) were increasingly more likely to interface with supportive care services and at an earlier point in their disease courses. This study suggests that prospective studies that examine potential interventions at the provider level, including diversity training, are needed.

MP21-16 DEMOGRAPHICS AND INCIDENTAL DIAGNOSES OF MEN WITH PRIAPISM

You have accessJournal of UrologyCME1 May 2022MP21-16 DEMOGRAPHICS AND INCIDENTAL DIAGNOSES OF MEN WITH PRIAPISM Evan Mulloy, Shufeng Li, and Michael Eisenberg Evan MulloyEvan Mulloy More articles by this author , Shufeng LiShufeng Li More articles by this author , and Michael EisenbergMichael Eisenberg More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002554.16AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Priapism is a painful, debilitating condition that burdens sexually active men. While the sequelae of priapism including recurrent priapism episodes, erectile dysfunction, or Peyronie’s disease are well known, the association with other health conditions are unknown. We therefore sought to define other health conditions diagnosed in men in the year after a priapism episode. METHODS: Using Optum® de-identified Clinformatics Datamart (SES view), a large commercial claims data warehouse, we evaluated all men (age >=18) with a diagnosis of priapism from 2003-2020 and matched them to a cohort of men with another urologic male penile disorder (i.e. erectile dysfunction (ED)). Demographic and geographic patient information was obtained. We identified incident disease (e.g. heart disease, embolism, thromobosis, cerebrovascular disease, cancer, endocrine disorders, immune disorders, inflammatory disorders). Follow up time was calculated from the index date until the incident diagnosis or end of enrollment time. Analyses were adjusted for age, year of diagnosis, race, education, income, geographic region, and visits per year. RESULTS: 9,004 men with priapism were matched (2:1) to 17,403 men with ED. The average age of men was 50.6 years old. The racial distribution for men with priapism was 65% White, 12% Black, 10% Hispanic, 10% Other, and 1% Asian. Overall, 3% of men with a history of priapism subsequently develop venous thrombosis/embolism compared to 2.2% of controls. After multivariable adjustment, men with history of priapism had a higher risk of embolism (HR 1.21, 95% CI 1.04-1.42). When examining pulmonary embolism specifically, 1.3% of men with priapism developed PE compared to 0.88% of controls. After adjustment, the risk remained elevated for men with a history of priapism (HR 1.30, 1.02-1.65). Incident cerebrovascular disease was also more likely in men with a history of priapism (HR 1.11, 1.01-1.21). In contrast, cancers (HR 0.87, 0.82-0.92) and endocrine disorders (HR 0.94, 0.89-0.998) were less common. Given the association with sickle cell anemia and thrombotic disease, we performed a sensitivity analysis after excluding men with sickle cell anemia were excluded from the analysis with similar interpretation. CONCLUSIONS: Men with priapism, even in the absence of sickle cell anemia, may be at increased risk for venous thrombotic/embolic events. Future studies should be performed to determine if additional evaluation or follow up of men with priapism is warranted beyond examination for sexual dysfunction. Source of Funding: N/A © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e333 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Evan Mulloy More articles by this author Shufeng Li More articles by this author Michael Eisenberg More articles by this author Expand All Advertisement PDF DownloadLoading ...

The Association Between Sustained HbA1c Control and Long-Term Complications Among Individuals with Type 2 Diabetes: A Retrospective Study.

IntroductionThe prevalence of type 2 diabetes (T2D) represents a rising burden in the US and worldwide, with the condition shown to be associated with relatively large human and economic costs. Part of the reason for such high costs associated with T2D is that the condition is often accompanied by additional health-related complications. The goal of this research is to examine the association between glycemic control and diabetes-related complications for individuals with T2D.MethodsThe Optum Clinformatics® Data Mart (CDM) database from 2007 to 2020 was used to identify adults with T2D. Individuals were classified as having sustained glycemic control (all hemoglobin A1c [HbA1c] < 7%) or poor glycemic control (all HbA1c ≥ 7%) over the 5-year post-period, and diabetes-related complications were identified based upon the Diabetes Complications Severity Index. Multivariable analyses examined the association between sustained glycemic control and diagnosis of a diabetes-related complication in the post-period.ResultsMaintaining HbA1c < 7% over the 5-year post-period, compared to maintaining HbA1c ≥ 7%, was associated with reduced odds of the diabetes-related complications of cardiovascular disease (odds ratio [OR] = 0.76, 95% confidence interval [CI] 0.61–0.94), metabolic disease (OR = 0.37, 95% CI 0.22–0.600), neuropathy (OR = 0.62, 95% CI 0.45–0.84), nephropathy (OR = 0.81, 95% CI 0.69–0.94), and peripheral vascular disease (OR = 0.52, 95% CI 0.33–0.83). There was no statistically significant association between sustained glycemic control and cerebrovascular disease.ConclusionsSustained glycemic control was found to be associated with significant reductions in the odds of being diagnosed with diabetes-related complications over a 5-year post-period.

130 Development of an Integrated Risk Scale for Prediction of Shunt Placement After Neonatal Intraventricular Hemorrhage

INTRODUCTION: Neonatal intraventricular hemorrhage (IVH) is a major source of mortality and morbidity in infants, particularly following premature birth. Even after the acute phase, post-hemorrhagic hydrocephalus is a long-term complication, frequently requiring permanent ventriculoperitoneal shunt placement (VPS). Currently, there are no risk classification methods integrating the constellation of clinical data to predict short- and long-term prognosis in neonatal IVH. METHODS: Neonates with IVH were identified from the Optum Clinformatics DataMart administrative claims database using ICD-9/10 codes. Matched maternal-childbirth characteristics were obtained. Primary endpoints were short-term (30-day) mortality and long-term VPS placement. Classification of short-term mortality risk was evaluated using five different machine learning approaches and the best-performing method was validated using a withheld validation subset. Prediction of long-term shunt risk was performed using a multivariable Cox regression model with stepwise variable selection, which was subsequently converted to an easily applied integer risk scale. RESULTS: A total of 5,926 neonate-maternal pairs were included. Empiric 30-day neonatal mortality risk was 10.9% across all IVH grades and highest among grade IV IVH (34.3%). Among those surviving beyond 30 days, actuarial 12-month risk of shunt placement was 5.4% across all IVH grades and 31.3% for grade IV IVH. The optimal short-term risk classifier was a random forest model achieving an AUROC of 0.882 with important predictors ranging from gestational age to diverse comorbid medical conditions. The final multivariable Cox regression model for long-term shunt risk stratification following stepwise feature selection included IVH grade, respiratory distress syndrome, disseminated intravascular coagulation, and maternal preeclampsia/eclampsia. An integer risk scale termed the Shunt Prediction After IVH in Neonates (SPAIN) scale was developed from these four features which, evaluated on withheld validation cases, demonstrated improved risk stratification compared to IVH grade alone (Harrell’s concordance index 0.869 vs 0.852). CONCLUSION: We developed an integrated risk classification approach to anticipate short-term mortality and long-term shunt risk. Application of such approaches may improve outcome prognostication and identification of higher risk individuals warranting careful surveillance and early intervention.

BRCA testing and testing results among women 18–65 years old

Since the 1990 s discovery of BRCA1 and BRCA2 pathogenic variants in breast or ovarian cancer patients, genetic testing has been recommended as part of a targeted, individualized approach for cancer prevention and treatment in eligible individuals. The aim of this study was to assess trends in BRCA test rates and results among adult women aged 18 to 65 in the US between 2007 and 2017. Using Clinformatics© Data Mart (CDM) Electronic Health Records, we included 223,211 women 18–65 years old with documented BRCA testing results from 1/1/2007–9/30/2017. Positive results indicated the presence of pathogenic variantss. BRCA test rates increased significantly from 34 per 100,000 women in 2007 to 488 per 100,000 women in 2016 (APC 30.8, 95% confidence interval 26.6–35.1). Documented positive results decreased from 86.1% in 2007 to 78.0% in 2017(APC −0.6, 95% confidence interval −1.4–0.2). From 2007 to 2017, decreasing trends in the rates of documented positive results were observed among all three age groups (18–39, 40–54, and 55–65 years; largest in 40–54 group). In 2015–2017, women with positive test results were less likely to be non–Hispanic Whites, cancer patients, or living in the Northeast or an area with average household income ≥$50,000. Between 2007 and 2017, increasing use of BRCA testing for cancer prevention and treatment occurred, correlating to the observed decreasing documented positive test rate. The utilization of testing and corresponding test results differed significantly across races/ethnicities, suggestive of a divergent application of the same testing criteria.

Cardiovascular outcomes associated with prescription of sodium-glucose co-transporter-2 inhibitors versus dipeptidyl peptidase-4 inhibitors in patients with diabetes and chronic kidney disease.

To determine the association with cardiovascular (CV) outcomes of sodium-glucose co-transporter-2 (SGLT-2) inhibitors compared with dipeptidyl peptidase-4 (DPP-4) inhibitors in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). We conducted a population-based cohort study of new users of SGLT-2 inhibitors and DPP-4 inhibitors with T2D and CKD using data from Optum Clinformatics DataMart. We assembled three cohorts: T2D/no CKD, T2D/CKD 1-2, and T2D/CKD 3a. The study outcomes were (a) time to first heart failure (HF) hospitalization and (b) time to a composite CV endpoint comprised of non-fatal myocardial infarction (MI) or stroke. After inverse probability of treatment weighting, we used proportional hazards regression to estimate hazard ratios (HR) and 95% confidence intervals (CI). New users of SGLT-2 inhibitors versus DPP-4 inhibitors had lower risks of HF hospitalization in the T2D/no CKD (HR, 0.76; 95% CI, 0.70, 0.82) and T2D/CKD 1-2 (HR, 0.63; 95% CI, 0.48, 0.84) cohorts, but no significant association was present in the T2D/CKD 3a cohort. Compared with prescription of DPP-4 inhibitors, SGLT-2 inhibitors were associated with lower risks of non-fatal MI or stroke of 23% (HR, 0.77; 95% CI, 0.70, 0.85) in the T2D/no CKD cohort, but no significant associations were present in the T2D/CKD 1-2 and T2D/CKD 3a cohorts. Incident prescription of SGLT-2 inhibitors was associated with lower risks of HF hospitalization but not with non-fatal MI or stroke despite suggesting benefit, relative to prescription of DPP-4 inhibitor across different stages of CKD.

Acute Bacterial Infections and Longitudinal Risk of Readmissions and Mortality in Patients Hospitalized with Heart Failure.

Aims: Infections are associated with worse short-term outcomes in patients with heart failure (HF). However, acute infections may have lasting pathophysiologic effects that adversely influence HF outcomes after discharge. Our objective was to describe the impact of acute bacterial infections on longitudinal outcomes of patients hospitalized with a primary diagnosis of HF. Methods and Results: This paper is based on a retrospective cohort study of patients hospitalized with a primary diagnosis of HF with or without a secondary diagnosis of acute bacterial infection in Optum Clinformatics DataMart from 2010–2015. Primary outcomes were 30 and 180-day hospital readmissions and mortality, intensive care unit admission, length of hospital stay, and total hospital charge, compared between those with or without an acute infection. Cohorts were compared after inverse probability of treatment weighting. Multivariable logistic regression was used to examine relationship to outcomes. Of 121,783 patients hospitalized with a primary diagnosis of HF, 27,947 (23%) had a diagnosis of acute infection. After weighting, 30-day hospital readmissions [17.1% vs. 15.7%, OR 1.11 (1.07–1.15), p < 0.001] and 180-day hospital readmissions [39.6% vs. 38.7%, OR 1.04 (1.01–1.07), p = 0.006] were modestly greater in those with an acute infection versus those without. Thirty-day [5.5% vs. 4.3%, OR 1.29 (1.21–1.38), p < 0.001] and 180-day mortality [10.7% vs. 9.4%, OR 1.16 (1.11–1.22), p < 0.001], length of stay (7.1 ± 7.0 days vs. 5.7 ± 5.8 days, p < 0.001), and total hospital charges (USD 62,200 ± 770 vs. USD 51,100 ± 436, p < 0.001) were higher in patients with an infection. Conclusions: The development of an acute bacterial infection in patients hospitalized for HF was associated with an increase in morbidity and mortality after discharge.

Yellow fever vaccine usage in the United States and risk of neurotropic and viscerotropic disease: A retrospective cohort study using three healthcare databases

BackgroundYellow fever (YF) vaccines are highly effective and have a well-established safety profile despite the risk of rare serious adverse events (SAEs), vaccine-associated neurotropic (YEL-AND) and viscerotropic disease (YEL-AVD). This study aimed to describe US civilian YF vaccine usage, the population characteristics and pre-existing immunosuppressive medical conditions among those vaccinated, and to provide updated risk estimates of neurotropic and viscerotropic disease post-vaccination. MethodsA retrospective cohort study was conducted using de-identified patient information from Optum Electronic Healthcare Record (EHR) (2007–2019), Optum Clinformatics Data Mart (CDM) (2004–2019) and IBM MarketScan (2007–2019) databases. YF vaccine recipients were identified using relevant vaccination and procedural codes. Demographic characteristics and pre-existing medical conditions were described. Incidence proportions with 95% confidence intervals (CI) of neurotropic and viscerotropic diseases occurring ≤ 30 days post-vaccination, after exclusion of unlikely cases based on current clinical guidelines of YEL-AND and YEL-AVD, were calculated. ResultsA total of 92,205, 46,539 and 125,235 YF vaccine recipients were retrieved from Optum EHR, Optum CDM and IBM MarketScan databases, respectively. The majority of vaccine recipients were aged < 60 years (highest proportion aged 18–29 years) with a higher proportion of females overall. Few vaccine recipients (<1%) had conditions predisposing them to immunosuppression. Four non-fatal cases of neurotropic disease and zero cases of viscerotropic disease were identified. The incidence proportion of post-vaccination neurotropic disease was 1.41 (95% CI: 0.15–6.61) and 3.04 (95% CI: 0.86–8.11) per 100,000 vaccine recipients in Optum EHR and IBM MarketScan, respectively, with no events identified in Optum CDM. ConclusionsThis study provides updated insights into current YF vaccine usage in US civilian recipients and supports the safety profile of YF vaccines in US practice. The low frequency of pre-existing immunosuppressive medical conditions among vaccine recipients suggests good adherence to vaccination guidelines by healthcare practitioners. The risk of developing neurotropic and viscerotropic disease post-vaccination remains rare.

Real-World Evaluation of the Treatment Landscape for Chronic Lymphocytic Leukemia

Introduction:The treatment paradigm of chronic lymphocytic leukemia (CLL) has changed significantly with the introduction of targeted oral therapies, including Bruton's tyrosine kinase inhibitors (BTKis) and B-cell lymphoma 2 inhibitors (Bcl-2is). As more therapies enter the clinic, real-world data (RWD) are important to understand changes in the CLL treatment landscape and describe treatment patterns, to guide decisions on treatment strategies.Methods:This retrospective analysis used 2 RWD sources. Patients (pts) diagnosed with CLL and treated with chemotherapy, CD20 monoclonal antibodies (mAbs), BTKis, or Bcl-2is were studied in the Optum Clinformatics® Data Mart (CDM), a de-identified US administrative claims database. Pts in the CDM analysis received at least 1 prescription for or administration of a treatment of interest between 2016 and 2020 Q2, and a diagnosis of CLL within 12 months (mo) of treatment start. Cross-sectional annual cohorts were used to understand changes in treatment mix over time, and longitudinal cohorts were formed to identify treatment patterns. Medication adherence was assessed with persistence at 12 mo using a 60-day gap and proportion of days covered (PDC) at 12 mo. Electronic health records from oncology practices were extracted through December 2020 from the COTA real-world evidence database. Adults diagnosed with CLL/small lymphocytic lymphoma and treated with BTKis and/or Bcl-2is were included. Treatment discontinuation was assessed using physician-documented treatment dates and reasons for discontinuation, and overall duration of treatment with targeted therapy was assessed using Kaplan-Meier analysis.Results:In CDM, annual treatment rate among pts diagnosed with CLL increased from 16% (1788/10911) in 2016 to 26% (2441/9349) in 2020. The proportion of pts treated with BTKis and Bcl-2is increased from 40% (2016) to 65% (2020) and <1% (2016) to 13% (2020), respectively; corresponding decreases in the use of chemotherapies and CD20 mAbs were observed (Figure 1A). In pts initiating BTKis, most pts were not previously treated (937/1438; 65%); the most common initial regimens were BTKi monotherapy (mono) (1367/1438; 95%) and BTKi + CD20 mAb (54/1438; 4%). Few pts switched from BTKi mono to CD20 mAb mono (43/1367; 3%) or added CD20 mAb to BTKi mono (44/1367; 3%) within 12 mo. In pts initiating Bcl-2is, most received prior treatment (169/198; 85%); most common regimens were Bcl-2i mono (159/198; 80%), Bcl-2i + CD20 mAb (31/198; 16%), and Bcl-2i + BTKi (8/198; 4%). Among pts initiating Bcl-2i mono, 30% (48/159) added CD20 mAb within 12 mo; among pts initiating Bcl-2i + CD20 mAb, 94% (29/31) switched to Bcl-2i mono within 12 mo. Persistence at 12 mo was similar for BTKis (899/1438; 63%) and Bcl-2is (120/198; 61%) and mean (SD) PDC was similar for BTKis 0.69 (0.31) and Bcl-2is 0.68 (0.29). In COTA, 469 pts treated with BTKis and/orBcl-2is were included. More pts initiated BTKis as first-line (1L) (185/449; 41%) compared with Bcl-2is (13/109; 12%). Among pts initiating targeted therapy as 1L, most pts (81%; 149/185) initiated BTKi mono. Discontinuation rates were high for pts receiving BTKis (62%; 279/449) and Bcl-2is (61%; 67/109). Among BTKi discontinuers, toxicity (54%; 150/279) was the most common reason for discontinuation, followed by disease progression (12%; 34/279) (Figure 1B). Among Bcl-2i discontinuers, toxicity (36%; 24/67) was the most common reason for discontinuation, followed by completion of regimen (30%; 20/67) (Figure 1C). Median duration of treatment was 777 days (95% CI: 632-920) for the BTKis group and 639 days (95% CI: 335-755) for the Bcl-2is group. Median treatment duration in days was comparable between mono and combination regimens in both BTKis (782 vs. 809) and Bcl-2is (747 vs. 718) groups.Conclusions:RWD show standard of care shifted from chemoimmunotherapy to targeted therapies. Pts receiving targeted therapies had high rates of discontinuation, most commonly due to toxicity. Most targeted regimens were mono; more BTKi pts were treatment naive compared to Bcl-2i pts. Slow adoption of fixed-duration therapy with the Bcl-2i combination regimen was observed. The duration of Bcl-2i mono was comparable to that of the Bcl-2i combination regimens, and a high number of pts initiating combo regimens continued on mono regimens in contrast to regimens studied in randomized controlled trials. [Display omitted] DisclosuresSmith: Novartis: Current Employment; Pfizer: Ended employment in the past 24 months. Owusu: Novartis: Current Employment; Roche: Ended employment in the past 24 months. Wormser: Roche: Current equity holder in publicly-traded company; Novartis: Current Employment, Current equity holder in publicly-traded company. Woo: Novartis: Current Employment, Current equity holder in publicly-traded company.

Rates of Opioid Prescriptions Obtained After Mohs Surgery

To curtail the opioid epidemic, physicians have been advised to limit opioid prescriptions. To characterize the frequency and changes over time (2009-2020) of opioid prescriptions following Mohs micrographic surgery. This cross-sectional study using Optum Clinformatics DataMart (Optum CDM), a nationally representative insurance claims database, included patients aged 18 years and older who had Mohs micrographic surgery insurance claims in the Optum CDM database from 2009 to 2020. Data were analyzed from November 11, 2020, to March 30, 2021. Opioid prescription following Mohs surgery. The primary outcome was the proportion of patients who underwent Mohs surgery and obtained an opioid prescription within 2 days of surgery. Secondary outcomes included type and opioid quantity prescribed. Among 358 012 patients with Mohs micrographic surgery claims (mean [SD] age, 69 [13] years; 205 609 [57.4%] were men), the proportion of patients obtaining an opioid prescription after Mohs micrographic surgery increased from 2009 (34.6%) to 2011 (39.6%). This proportion then declined each year, reaching a low of 11.7% in 2020 (27.9% absolute decrease from 2011 to 2020). Hydrocodone, codeine, oxycodone, and tramadol were the 4 most commonly prescribed opioids. By 2020, hydrocodone was obtained less (2009: 47.5%; 2011: 67.1%; 2020: 45.4%; 21.7% absolute decrease from 2011 to 2020) and tramadol was obtained more (2009: 1.6%; 2020: 27.9%; 26.3% absolute increase from 2009 to 2020). In this cross-sectional study of Mohs micrographic surgery claims, patients obtained fewer postsurgery opioid prescriptions over the study period, suggesting responsiveness of patients and dermatologic surgeons to public health concerns regarding the opioid epidemic. During this decline, prescriptions for hydrocodone decreased and tramadol increased.

Computational drug repositioning of atorvastatin for ulcerative colitis.

ObjectiveUlcerative colitis (UC) is a chronic inflammatory disorder with limited effective therapeutic options for long-term treatment and disease maintenance. We hypothesized that a multi-cohort analysis of independent cohorts representing real-world heterogeneity of UC would identify a robust transcriptomic signature to improve identification of FDA-approved drugs that can be repurposed to treat patients with UC.Materials and MethodsWe performed a multi-cohort analysis of 272 colon biopsy transcriptome samples across 11 publicly available datasets to identify a robust UC disease gene signature. We compared the gene signature to in vitro transcriptomic profiles induced by 781 FDA-approved drugs to identify potential drug targets. We used a retrospective cohort study design modeled after a target trial to evaluate the protective effect of predicted drugs on colectomy risk in patients with UC from the Stanford Research Repository (STARR) database and Optum Clinformatics DataMart.ResultsAtorvastatin treatment had the highest inverse-correlation with the UC gene signature among non-oncolytic FDA-approved therapies. In both STARR (n = 827) and Optum (n = 7821), atorvastatin intake was significantly associated with a decreased risk of colectomy, a marker of treatment-refractory disease, compared to patients prescribed a comparator drug (STARR: HR = 0.47, P = .03; Optum: HR = 0.66, P = .03), irrespective of age and length of atorvastatin treatment.Discussion & ConclusionThese findings suggest that atorvastatin may serve as a novel therapeutic option for ameliorating disease in patients with UC. Importantly, we provide a systematic framework for integrating publicly available heterogeneous molecular data with clinical data at a large scale to repurpose existing FDA-approved drugs for a wide range of human diseases.

Immunomodulatory Medication Use in Newly Diagnosed Youth With Systemic Lupus Erythematosus.

To examine glucocorticoid-sparing immunomodulatory medication use in youth with systemic lupus erythematosus (SLE) during their first year of care. We conducted a retrospective cohort study using administrative claims for 2000 to 2013 from Clinformatics DataMart for youth ages 10-24 years with an incident diagnosis of SLE (≥3 International Classification of Diseases, Ninth Revision codes for SLE [710.0], each >30 days apart). We determined the proportion of subjects filling a prescription for immunomodulatory medications within 12 months of the first SLE code (index date). We used multivariable regression to examine associations between demographic/disease factors and time to prescription fill in the first year, and also between prescription fill at any time after the index date. We identified 532 youth with an incident SLE diagnosis, of which 413 (78%) had a glucocorticoid-sparing immunomodulatory prescription fill in the first year. Prescriptions for hydroxychloroquine and immunosuppressants were filled in the first year by 366 youth (69%) and by 182 (34%), respectively. Those with adult-onset (versus childhood-onset) disease were less likely to fill animmunomodulatorymedication by 12 months. No other statistically significant associations were found, although there was increasing likelihood of immunomodulatory medication fills with each subsequent calendar year. Among youth with newly diagnosed SLE, hydroxychloroquine use is prevalent although not universal, and prescription immunosuppressant use is notably low during the first year of care. Further research is needed to identify factors contributing to suboptimal immunomodulatory medication use during the first year of care.