Healthcare resource utilization and costs in patients with a newly confirmed diagnosis of lupus nephritis in the United States over a 5-year follow-up period.

BACKGROUND: We aimed to describe healthcare resource utilization (HCRU) and healthcare costs in patients with newly confirmed lupus nephritis (LN) in the United States over a 5-year follow-up period. METHODS: This retrospective, longitudinal cohort study (GSK Study 214102) utilized administrative claims data to identify individuals with a newly confirmed diagnosis of LN between August 01, 2011, and July 31, 2018, based on LN-specific International Classification of Diseases diagnosis codes. Index was the date of first LN-related diagnosis code claim. HCRU, healthcare costs, and incidence of systemic lupus erythematosus (SLE) flares were reported annually among eligible patients with at least 5 years continuous enrollment post-index. RESULTS: Of 2,159 patients with a newly confirmed diagnosis of LN meeting inclusion and exclusion criteria, 335 had at least 5 years continuous enrollment post-index. HCRU was greatest in the first year post-LN diagnosis across all categories (inpatient admission, emergency room [ER] visits, ambulatory visits, and pharmacy use), and trended lower, though remained substantial, in the 5-year follow-up period. Among patients with LN and HCRU, the mean (standard deviation [SD]) number of ER visits and inpatient admissions were 3.7 (4.6) and 1.8 (1.5), respectively, in Year 1, which generally remained stable in Years 2-5; the mean (SD) number of ambulatory visits and pharmacy fills were 35.8 (25.1) and 62.9 (43.8), respectively, in Year 1, and remained similar for Years 2-5. Most patients (≥ 91.6%) had ≥ 1 SLE flare in each of the 5 years of follow-up. The proportion of patients who experienced a severe SLE flare was higher in Year 1 (31.6%) than subsequent years (14.3-18.5%). Total costs (medical and pharmacy; mean [SD]) were higher in Year 1 ($44,205 [71,532]) than subsequent years ($29,444 [52,310]-$32,222 [58,216]), driven mainly by inpatient admissions (Year 1: $21,181 [58,886]; subsequent years: $7,406 [23,331]-$9,389 [29,283]). CONCLUSIONS: Patients with a newly confirmed diagnosis of LN have substantial HCRU and healthcare costs, particularly in the year post-diagnosis, largely driven by inpatient costs. This highlights the need for improved disease management to prevent renal damage, improve patient outcomes, and reduce costs among patients with renal involvement.

Diagnostic testing managed by hematopathology specialty and other laboratories: costs and patient diagnostic outcomes.

BACKGROUND: Successful management of patients with hematologic malignancies depends upon accurate and timely diagnosis, which frequently requires integration and interpretation of multiple tests. Our retrospective analysis compared diagnostic uncertainty, resource utilization, and costs for patients with diagnostic bone marrow (BM) tests managed by commercial laboratories. METHODS: Patients with BM biopsies and suspected hematologic cancer/condition were identified from claims (2005-2011) within a large US health plan (coverage ≥6 pre- and ≥3-months post-biopsy). Cohorts defined by laboratories performing BM morphologic assessment/directing testing sequence: Genoptix (GX, specialty hematology-testing laboratory), large commercial laboratories (LL), other laboratories (OL). One-year post-biopsy changes in diagnosis or treatments, tests performed, and diagnostic/treatment medical costs (measured as per-patient-per-month [PPPM]) were examined. RESULTS: The study population included 1,387 GX, 4,162 LL, and 19,115 OL patients with suspected hematologic malignancy/disease and BM morphology assessment. GX had lower diagnostic uncertainty measured between 2 time periods by diagnostic stability (no conditions the same; 6.16% GX, 8.04% LL, 9.73% OL; p < 0.001) and changes (≥1 condition different; 7.88% GX, 11.19% LL, and 14.08% OL; p < 0.001), fewer repeat BM biopsies, and fewer chemotherapy changes (30-days and 60-days post-initiation). One-year PPPM costs adjusted for patient characteristics differences were $8,202 GX, $7,711 LL, and $10,302 OL (p < 0.05); adjusted PPPM costs (excluding testing period) were $6,019 GX, $6,649 LL, and $7,801 OL (p < 0.05). CONCLUSIONS: Our data suggests that a hematopathology specialty laboratory may result in earlier final diagnosis, fewer subsequent diagnosis changes, reduced need for follow-on testing requiring repeat biopsy procedures, and may result in lower downstream healthcare costs. Further evaluations using medical chart abstractions or registries will be valuable.

Healthcare Resource Utilization and Associated Costs in Patients With Systemic Lupus Erythematosus Diagnosed With Lupus Nephritis.

BACKGROUND: Lupus nephritis (LN) is among the most severe organ manifestations of systemic lupus erythematosus (SLE), affecting between 31% and 48% of patients, usually within five years of SLE diagnosis. SLE without LN is associated with a high economic burden on the healthcare system, and although data are limited, several studies have shown that SLE with LN could increase this burden.  Aim: We aimed to compare the economic burden of LN versus SLE without LN among patients managed in routine clinical practices in the USA and describe the clinical course of these patients. MATERIALS AND METHODS: This was a retrospective observational study of patients with commercial or Medicare Advantage health insurance. It included 2310 patients with LN and 2310 matched patients who had SLE without LN; each patient was followed for 12 months after diagnosis (the patient's index date). Outcome measures included healthcare resource utilization (HCRU), direct healthcare costs, and SLE clinical manifestations.  Results: In all healthcare settings, the mean (SD) use of all-cause healthcare resources was significantly higher in the LN versus SLE without LN cohort, including the mean number of ambulatory visits (53.9 (55.1) vs 33.0 (26.0)), emergency room visits (2.9 (7.9) vs 1.6 (3.3)), inpatient stays (0.9 (1.5) vs 0.3 (0.8)), and pharmacy fills (65.0 (48.3) vs 51.2 (42.6)) (all p<0.001). Total all-cause costs per patient in the LN cohort were also significantly higher compared with the SLE without LN cohort ($50,975 (86,281) vs $26,262 (52,720), p<0.001), including costs for inpatient stays and outpatient visits. Clinically, a significantly higher proportion of patients with LN experienced moderate or severe SLE flares compared with the SLE without LN cohort (p<0.001), which may explain the difference in HCRU and healthcare costs. CONCLUSION: All-cause HCRU and costs were higher for patients with LN than for matched patients with SLE without LN, highlighting the economic burden associated with LN.

Hemoglobin A1c outcomes and health care resource use in type 2 diabetes mellitus patients treated with combination oral antidiabetic drugs through step therapy and loose-dose and fixed-dose combinations.

PURPOSE: To compare outcomes of type 2 diabetes mellitus (T2DM) patients initiating therapy with FDC vs. those with loose-dose combination (LDC) or step therapy (ST) in a managed care population. DESIGN: A retrospective claims database analysis. METHODOLOGY: Treatment-naive T2DM patients who were continuously enrolled in a health plan during 2006-2009 were studied. Eligible patients were assigned to FDC, LDC, or ST cohorts. Glycated hemoglobin goal attainment (HbA1c < 7%) was assessed using the American Diabetes Association (ADA) treatment guidelines. Health care resources use and costs, including inpatient, emergency room (ER), and ambulatoryvisits, were measured during the 12 months after therapy initiation. All-cause and diabetes-related use and costs were assessed. PRINCIPAL FINDINGS: 21,048 patients met study criteria (FDC n = 8,416, ST n = 8,407, LDC n = 4,225), and 1,926 of these patients had HbA1c results. FDC patients had lower rates of post-index all-cause inpatient stays and ER visits compared with the other cohorts. FDC patients had lower average counts of diabetes-related ambulatory visits (2.7) compared with ST (3.7; p < 0.001) and LDC (3.2; p < 0.001) and significantly lower average post-index all-cause and diabetes-related costs compared with the other cohorts, with average all-cause costs for FDC, ST, and LDC of $8,445, $10,515, and $9,688, respectively, and diabe-tes-related costs of $1,641, $2,099, and $1,900, respectively. FDC patients had higher rates of achieving HbA1c goal (61%) compared to ST (48%; p < 0.001) or LDC (52%; p = 0.015). Differences in outcomes remained following multivariate analyses. CONCLUSION: Treatment with FDC was associated with lower health care resources use and costs and better likelihood of HbA1c goal attainment.

Racial and ethnic disparity in clinical outcomes among patients with confirmed COVID-19 infection in a large US electronic health record database.

BACKGROUND: Racial and ethnic minority groups have been disproportionately affected by the US coronavirus disease 2019 (COVID-19) pandemic; however, nationwide data on COVID-19 outcomes stratified by race/ethnicity and adjusted for clinical characteristics are sparse. This study analyzed the impacts of race/ethnicity on outcomes among US patients with COVID-19. METHODS: This was a retrospective observational study of patients with a confirmed COVID-19 diagnosis in the electronic health record from 01 February 2020 through 14 September 2020. Index encounter site, hospitalization, and mortality were assessed by race/ethnicity (Hispanic, non-Hispanic Black [Black], non-Hispanic White [White], non-Hispanic Asian [Asian], or Other/unknown). Associations between racial/ethnic categories and study outcomes adjusted for patient characteristics were evaluated using logistic regression. FINDINGS: Among 202,908 patients with confirmed COVID-19, patients from racial/ethnic minority groups were more likely than White patients to be hospitalized on initial presentation (Hispanic: adjusted odds ratio 1·690, 95% CI 1·620-1·763; Black: 1·810, 1·743-1·880; Asian: 1·503, 1·381-1·636) and during follow-up (Hispanic: 1·700, 1·638-1·764; Black: 1·578, 1·526-1·633; Asian: 1·391, 1·288-1·501). Among hospitalized patients, adjusted mortality risk was lower for Black patients (0·881, 0·809-0·959) but higher for Asian patients (1·205, 1·000-1·452). INTERPRETATION: Racial/ethnic minority patients with COVID-19 had more severe disease on initial presentation than White patients. Increased mortality risk was attenuated by hospitalization among Black patients but not Asian patients, indicating that outcome disparities may be mediated by distinct factors for different groups. In addition to enacting policies to facilitate equitable access to COVID-19-related care, further analyses of disaggregated population-level COVID-19 data are needed.

T1DBase: integration and presentation of complex data for type 1 diabetes research.

T1DBase (http://T1DBase.org) [Smink et al. (2005) Nucleic Acids Res., 33, D544-D549; Burren et al. (2004) Hum. Genomics, 1, 98-109] is a public website and database that supports the type 1 diabetes (T1D) research community. T1DBase provides a consolidated T1D-oriented view of the complex data world that now confronts medical researchers and enables scientists to navigate from information they know to information that is new to them. Overview pages for genes and markers summarize information for these elements. The Gene Dossier summarizes information for a list of genes. GBrowse [Stein et al. (2002) Genome Res., 10, 1599-1610] displays genes and other features in their genomic context, and Cytoscape [Shannon et al. (2003) Genome Res., 13, 2498-2504] shows genes in the context of interacting proteins and genes. The Beta Cell Gene Atlas shows gene expression in beta cells, islets, and related cell types and lines, and the Tissue Expression Viewer shows expression across other tissues. The Microarray Viewer shows expression from more than 20 array experiments. The Beta Cell Gene Expression Bank contains manually curated gene and pathway annotations for genes expressed in beta cells. T1DMart is a query tool for markers and genotypes. PosterPages are 'home pages' about specific topics or datasets. The key challenge, now and in the future, is to provide powerful informatics capabilities to T1D scientists in a form they can use to enhance their research.

Inhaled Corticosteroid-Containing Treatment Escalation and Outcomes for Patients with Asthma in a U.S. Health Care Organization.

BACKGROUND: Asthma is a common disorder that affects approximately 8% of the U.S. POPULATION: Treatment guidelines indicate inhaled corticosteroids (ICS) as the mainstay treatment, yet poor asthma control is common among ICS-treated patients. Treatment escalation (ICS dose increase and other controller therapy add-ons) is used to manage symptoms. Real-world studies of postescalation outcomes may inform treatment decisions. OBJECTIVES: To (a) describe characteristics and treatment patterns among asthma patients who escalated treatment and (b) assess outcomes (exacerbations, uncontrolled asthma, and health care resource utilization [HCRU]) after escalation. METHODS: The study cohort was identified from a large U.S. administrative claims database via ICD-9-CM codes for asthma (493.xx on ≥ 2 dates) and initiation (defining index date) of long-term (> 1 fill) ICS-containing treatment between January 1, 2009, and September 30, 2014. One year of continuous enrollment was required before and after the index date. Escalation was defined as ≥ 1 of the following: ICS dose increase; a switch between ICS, long-acting beta-2 agonists (LABA), or leukotriene modifiers (LTRM) to a different ICS, LABA, or LTRM; or add-on of controller medications (e.g., antibody biologic). Escalation patterns were examined. Rates of exacerbation (defined by inpatient admission, emergency department [ED] visit, or office visit with a pharmacy claim for an oral corticosteroid [OCS] within 7 days) and occurrence of uncontrolled asthma (defined by > 4 fills for a short-acting beta agonist [SABA] in a 1-year period, ≥ 1 OCS fill, or ≥ 1 asthma-related ED visit or inpatient admission) were calculated. Per-patient-per-year (PPPY) HCRU was estimated. RESULTS: Among 35,126 patients (mean [SD] age 38 [16] years) who initiated long-term ICS-containing treatment, 5,044 (14%) patients escalated their index regimens at 136 (105) days post-index (i.e., pre-escalation period). The most frequent changes, alone or in combination, included ICS dose increase (68%) or LABA (27%) or LTRM (25%) add-ons. Before escalation, the exacerbation rate was 1.60 (5.10) PPPY, and 1,108 (22%) patients experienced exacerbation. During the postescalation period of 251.6 (138.9) days, the exacerbation rate was 0.75 (2.9) PPPY, and 1,038 (21%) patients experienced exacerbation. A majority (> 85%) of exacerbations in the periods before and after escalation were associated with an office visit plus an OCS pharmacy claim within 7 days. Uncontrolled asthma was experienced by 41.5% and 41.0% of patients before and after escalation, respectively. Ambulatory care visits were common before (mean [SD] 24.0 [26.7] all-cause and 8.5 [13.4] asthma-related PPPY) and after escalation (19.3 [21.3] all-cause and 4.6 [8.1] asthma-related PPPY). CONCLUSIONS: Among asthma patients who initiated a long-term ICS-containing regimen, approximately 14% escalated therapy within a year of initiation. Yet, 21% of those patients had ≥ 1 exacerbation, and 41% of patients had uncontrolled asthma within 1 year after treatment escalation. The results demonstrate an unmet need among asthma patients who escalated their ICS-containing treatment. DISCLOSURES: This study was sponsored and funded by Boehringer-Ingelheim, which contracted with Optum to conduct the research. The sponsor collaborated with Optum on the preparation, writing, revision, and approval of the manuscript. Bengston, Cao, Hulbert, Wolbeck, Elliott, and Buikema are employees of Optum. Yu and Wang are employed by Boehringer-Ingelheim. Study concept and design were contributed by Bengston, Yu, and Wang. Cao, Hulbert, and Wolbeck collected the data, and data analysis was performed by Bengston, Yu, and Wang. The manuscript was written by Bengston, along with Yu and Wang, and revised by Bengston, Yu, and Wang, along with the other authors.

Improving endoscopy completion: effectiveness of an interactive voice response system.

OBJECTIVE: To test whether an interactive voice response (IVR) system phone call was equally effective as a nurse-delivered phone call at educating and preparing patients for flexible sigmoidoscopy (FS) and colonoscopy examinations. STUDY DESIGN: Three-arm randomized controlled trial. METHODS: The trial included patients with upcoming FS or colonoscopy appointments to test the equivalence of an IVR system to nurse-delivered phone calls in reducing appointment nonattendance and inadequate preparation for an examination. Message timing and satisfaction with the intervention were assessed. The 3 study conditions included the following: nurse phone call 7 days before the procedure, IVR system call 7 days before the procedure, and IVR system call 3 days before the procedure. All calls included an appointment reminder, information about preparation for the examination, and encouragement to prepare for and attend the examination. RESULTS: A total of 3610 patients were eligible for the study; of these, 1229 (34%) were scheduled for FS and 2381 (66%) for colonoscopy. There were no statistically significant differences across the 3 study arms in appointment attendance or adherence to preparation instructions. Significantly more patients in IVR conditions reported neutral perceptions about the phone calls, and more patients receiving nurse calls reported very positive perceptions about the phone calls. CONCLUSION: An IVR system call is as effective as a nurse phone call for ensuring that patients attend appointments and are adequately prepared for endoscopy examinations.