Optum's De-identified Clinformatics Research Articles

Provider imaging practices and outcomes of advanced colorectal cancer

PurposeTo explore the real-world utilization of computerized tomography (CT) in patients with advanced colorectal cancer (CRC) and the associated outcomes. MethodsUsing Optum's de-identified Clinformatics® Data Mart Database (2008–2016), we identified patients with CRC receiving combination of chemotherapies (fluoropyrimidines with either oxaliplatin or irinotecan, or capecitabine with either oxaliplatin or irinotecan) combined with bevacizumab as the initial treatment, and its starting date was registered as the index date. End of treatment was defined by the presence of a gap in therapy > 60 days or treatment switch. We assessed the CT scan utilization during the period between 60 days pre-index and 30 days post-end of treatment. Cox regressions were performed to assess the impact of intensity of follow-up CT scans, measured by time to the first scan from the index date, on likelihood of treatment switch and survival. ResultsAmong included 4,810 patients, the median (standard deviation) time to the first follow-up scan was 57 (45) days. The mean and median number of CT scans was 4 and 3, respectively. An earlier follow-up scan was associated with significantly greater chance of treatment switch (hazard ratio = 0.99 for each day of delay, P < 0.01), and greater likelihood of death (hazard ratio = 0.99 for each day of delay, P < 0.01). Conclusion: More intense follow-up increased the likelihood of treatment switch, yet it was not associated with better survival outcome. Further analysis in populations with longer follow-up period is warranted to elucidate the link between CT scan utilization and outcomes.

Clinical Characteristics of Atherosclerotic Cardiovascular Disease Patients and Familial Hypercholesterolemia Patients: A Database Analysis in the US. †

Lead Author's Financial Disclosures Divyagiri Seshagiri is an employee of Novartis Pharma AG, Basel, Switzerland. Study Funding None. Background/Synopsis Despite current lipid-lowering treatments (LLT), patients with atherosclerotic cardiovascular disease (ASCVD) do not reach the current guidelines recommended LDL-C goal. Objective/Purpose To describe the clinical characteristics of patients with atherosclerotic cardiovascular disease with hypercholesterolemia (ASCVD-H) and familial hypercholesterolemia (FH) in the United States (US). Methods This retrospective non-interventional study included patients from Optum's de-identified Clinformatics Data Mart database (2007-2019) in the US. Hypercholesterolemia was defined if patients had a recorded diagnosis, were prescribed LLT or had LDL-C levels of ≥70 mg/dL for ASCVD or ≥100mg/dL for FH, anytime within 6 months before and 3 months after index date. Index date was first ASCVD encounter or FH diagnosis during the identification period (1/07/2015-31/12/2018). Results 1,817,577 patients with ASCVD-H (50% females) and 66,277 patients with FH (53.6% females) with a mean (SD) age of 71 (11) years and 63 (18) years, respectively, were included. Use of statins was reported in 60% (ASCVD-H) and 49% (FH) patients at index, while 38% (ASCVD-H) and 48% (FH) patients received no LLT at index. Only 39% (ASCVD-H) and 43% (FH) patients receiving statins had LDL-C measurements within 6 months before and 3 months after index date. Higher proportion of male patients had controlled LDL-C levels than female patients across both cohorts (Table 1). Conclusions About 60% of ASCVD-H and FH patients did not have LDL-C measurements. More than one third of ASCVD-H patients and almost half of FH patients received no LLT. A substantial proportion of patients remain uncontrolled with LDL-C levels ≥70 mg/dL despite receiving LLT. Divyagiri Seshagiri is an employee of Novartis Pharma AG, Basel, Switzerland.

Accuracy of identifying diagnosis of moderate to severe chronic kidney disease in administrative claims data.

Prior validation studies of claims-based definitions of chronic kidney disease (CKD) using ICD-9 codes reported overall low sensitivity, high specificity, and variable but reasonable PPV. No studies to date have evaluated the accuracy of ICD-10 codes to identify a US patient population with CKD. We assessed the accuracy of claims-based algorithms to identify adults with CKD Stages 3-5 compared with laboratory values in a subset (~40%) of a US commercial insurance claims database (Optum's de-identified Clinformatics® Data Mart Database). We calculated the positive predictive value (PPV) of one or two ICD-9 (2012-2014) or ICD-10 (2016-2018) codes for CKD compared with a lab-based estimated glomerular filtration rate (eGFR) occurring within prespecified windows (±90 days, ±180 days, ±365 days) of the ICD-based CKD code(s). The study population ranged between 104 774 and 161 305 patients (ICD-9 cohorts) and between 285 520 and 373 220 patients (ICD-10 cohorts). The mean age was 74.4 years (ICD-9) and 75.6 years (ICD-10) and the median eGFR was 48 ml/min/1.73 m2 . The algorithm of two CKD codes compared with a lab value ±90 days of the first code achieved the highest PPV (PPV 86.36% [ICD-9] and 86.07% [ICD-10]). Overall, ICD-10 based codes had comparable PPVs to ICD-9 based codes and all ICD-10 based algorithms had PPVs >80%. The algorithm of one CKD code compared with laboratory value ±180 days maintained the PPV above 80% but still retained a large number of patients (PPV 80.32% [ICD-9] and 81.56% [ICD-10]). An ICD-10-based definition of CKD identified with sufficient accuracy a patient population with CKD Stages 3-5. Our findings suggest that claims databases could be used for future real-world research studies in patients with CKD Stages 3-5.

Abstract 10805: Income and Antiplatelet Adherence Following Acute Coronary Syndrome: An Administrative Claims Analysis

Introduction: Income and social resources are associated with cardiovascular health and outcomes. We examined income and medication adherence following acute coronary syndromes (ACS). We hypothesized that following percutaneous coronary intervention (PCI), individuals with lower income would have lower adherence to antiplatelet agents than higher income referents. Methods: We employed administrative claims of commercially insured and Medicare Advantage beneficiaries (Optum's de-identified Clinformatics® Data Mart Database) with incident ST- and non-ST elevation myocardial infarction from 2017-19. We collected data on age, sex, race, education, and covariates (medications, healthcare visits, insurance type, copay, antiplatelet type, and Elixhauser Comorbidity Index conditions). We compared antiplatelet adherence, measured with proportion of days covered (PDC) using up to 12 months of pharmacy claims, across income categories (&lt;$40K; $40-49K; $50-59K; $60-74K; $75-99K; and ≥$100K). Our multivariable-adjusted regression models determined odds of non-adherence (PDC&lt;80%) with the highest income category as referent. Results: Our dataset included 31,272 individuals (age 72.5 ±11.9, 34.3% women, 22.6% non-White) who presented with ACS and underwent PCI. We observed graded, decreased antiplatelet adherence across income categories (Figure): rates of PDC≥80% decreased with successively lower income, from 84.3% (≥$100K) to 73.1% (&lt;$40K). Individuals with income &lt;$40K had 1.6-fold higher odds of non-adherence (95% CI, 1.43-1.75) compared to those with income ≥$100K after multivariable adjustment. Conclusions: Lower income is associated with lower adherence to antiplatelet agents following PCI for ACS. These results support consideration of income and long-term barriers to medication access as part of strategies to address adherence.

Impact of Dosing Frequency of Oral Oncolytics on Refill Adherence Among Patients with Hematological Malignancies

Background: With advances in oral oncolytics for hematologic malignancies, it is important to consider dosing frequency and treatment (tx) adherence, as prior data have shown poor adherence to oral cancer medications may result in inferior tx outcomes (Huang WC, Expert Rev Anticancer Ther, 2016; Muluneh B, J Oncol Pract, 2018). There is limited evidence regarding the impact of dosing frequency on tx adherence among patients with hematological malignancies treated with oral oncolytics. The objective of this study was to characterize real-world demographic and clinical characteristics, and compare refill adherence, among patients with hematological malignancies receiving once-daily (QD) versus twice-daily (BID) oral oncolytics.Methods: This retrospective cohort study used multi-year (2012-2020) commercial claims data from Optum's de-identified Clinformatics ® Data Mart Database and included adults (≥18 yr) with a diagnosis of a hematological malignancy identified using ICD-9-CM and ICD-10-CM codes. The exposure of interest was receipt of an oral oncolytic, and the date of the first observed oral oncolytic (QD or BID) was considered the index date. All patients were required to have continuous health plan enrollment for ≥6 mo prior and ≥6 mo after the index date. The 6-mo period prior to the index date was considered the baseline period for determining patient demographics, clinical characteristics, and prior medication use. To minimize the effect of the differences in observable baseline patient characteristics between the QD and BID groups on refill adherence, 1:1 propensity score (PS) matching was used. Tx refill adherence to QD and BID oral oncolytics was measured using two established metrics: proportion of days covered (PDC) and medication possession ratio (MPR). PDC, a conservative measure of refill adherence, was considered for primary analysis as it measures total days of drug coverage within a pre-specified follow-up period; whereas MPR which was included for sensitivity analysis, measures total drug supplied within the pre-specified follow-up period. PDC and MPR were measured at pre-defined time periods of 3 and 6 mo, and from the index date until the end of the follow-up period (variable-length follow-up). Patients with drug coverage for ≥80% (PDC or MPR ≥0.8) of pre-defined time periods were considered tx refill adherent.Results: The study identified 5,874 adults with hematological malignancies, of whom 4,938 (84.1%) received QD oral oncolytics and 936 (15.9%) received BID oral oncolytics. Before 1:1 PS matching, there were significant differences between the two groups in terms of mean age (67.5 yr QD vs 61.6 yr BID, P<0.001), insurance type (Medicare, 65.4% QD vs 46.8% BID, P<0.001), being previously untreated (67.6% QD vs 63.7% BID, P=0.019), and Charlson's comorbidity score (mean: 1.61 QD vs 1.44 BID, P<0.001). After 1:1 PS matching, demographics, baseline comorbidities, cancer histology, and line of therapy were well-balanced. The matched cohort comprised 936 patients receiving QD oral oncolytics and 936 patients receiving BID oral oncolytics. Table 1 summarizes refill adherence among patients with hematological malignancies receiving QD versus BID oral oncolytics. The proportion of patients with ≥80% of drug coverage during follow-up was higher for QD versus BID recipients at 3 mo: numerically higher by PDC (70.8% vs 66.9%, P=0.065) and statistically significantly higher by MPR (72% vs 67.8%, P=0.049). The proportion of adherent patients was significantly higher for QD vs BID for both PDC and MPR at 6 mo (PDC: 62% vs 56.8%, P=0.024; MPR: 62.7% vs 57.5%, P=0.021) and at variable-length follow-up (PDC: 82.4% QD vs 77.7% BID, P=0.011; MPR: 84.9% QD vs 80.9%, P=0.020). These results suggest QD dosing is associated with improved tx adherence to oral hematological oncolytics compared to BID dosing.Conclusions: This study demonstrates significantly higher refill adherence in patients receiving QD versus BID oral hematological oncolytics at 6 mo and variable-length follow-up, highlighting the potential benefit of dosing convenience in improving adherence to oral oncolytics in the real-world setting. As suboptimal tx adherence may result in reduced tx effectiveness, real-world characterization of refill adherence rates of oral oncolytics can better inform on tx effectiveness outside of a controlled clinical trial environment. [Display omitted] DisclosuresChallagulla: Pharmacyclics LLC, an AbbVie Company: Current Employment; AbbVie: Current equity holder in publicly-traded company. Kebede: Pharmacyclics LLC, an AbbVie Company: Consultancy; ObsEva: Other. Rege: Pharmacyclics LLC, an AbbVie Company (paid to institution): Consultancy. Volodarsky: AbbVie: Current equity holder in publicly-traded company; Pharmacyclics LLC, an AbbVie Company: Current Employment. Osei-Bonsu: AbbVie: Current equity holder in publicly-traded company; Pharmacyclics LLC, an AbbVie Company: Current Employment. Karve: AbbVie: Current Employment, Current equity holder in publicly-traded company.

Time to Next Treatment, Healthcare Resource Utilization, and Healthcare Costs Among Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Following First-Line Ibrutinib

Background: Ibrutinib is an oral once-daily Bruton's tyrosine kinase inhibitor (BTKi) and is the only targeted treatment that has demonstrated significant progression-free survival (PFS) and overall survival (OS) benefit in multiple phase 3 trials for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). With ibrutinib established as a preferred first-line (1L) treatment option, it is important to better understand the treatment sequence after 1L ibrutinib and the characteristics of patients who are treated with a second-line (2L) therapy. Using a real-world US administrative claims database, this study aimed to compare time to next treatment (TTNT), healthcare resource utilization (HRU), and healthcare costs between different 2L treatment regimens (cohorts) used after ibrutinib.Methods: Adults with CLL/SLL treated with 1L ibrutinib were identified in a US claims database (Optum's de-identified Clinformatics ® Data Mart Database; 02/12/2013-03/31/2020). Those receiving a 2L therapy were considered eligible for the study. Retreatment with ibrutinib, in-class switch to another BTKi, or treatment with anti-CD20 immunotherapy-only were not considered eligible 2L treatment options for this evaluation. The most commonly used treatment regimens were categorized into the following clinically-relevant treatment cohorts: 1) chemoimmunotherapy (CIT) or chemotherapy (CT)-only, and 2) venetoclax (VEN)- or idelalisib (IDELA)-based regimens (monotherapy or combination regimens). Comparisons of TTNT, HRU (inpatient admissions, outpatient visits, emergency room visits, other ancillary services), and per patient per month healthcare costs (inpatient admissions, outpatient visits, emergency room visits, other ancillary services, pharmacy) were evaluated based on the sum of the payer and patient paid amount during 2L treatment. Comparisons were adjusted using multivariate regression including confounders observed in the baseline period and during 1L ibrutinib therapy. For costs and HRU, 95% confidence intervals and p-values were obtained from 499 bootstrap resamples.Results: A total of 132 CLL/SLL patients who received ibrutinib as a 1L treatment and had a subsequent eligible 2L therapy were included; mean age was 74 years old, 64% were male. Eligible patients received 2L CIT/CT-only (63/132, 48%), or VEN/IDELA-based regimens (69/132, 52%). TTNT was significantly longer for 2L VEN/IDELA-based regimens than for CIT/CT (hazard ratio at 12 months: 0.37; P=0.0337) (Figure 1). The number of outpatient visits for antineoplastic drug administration was significantly lower for patients receiving 2L VEN/IDELA-based regimens compared to CIT/CT (rate ratio=0.44; P=0.004). Total mean monthly healthcare cost (includes CLL/SLL and non-CLL/SLL-related medical/pharmacy costs) was $1,754 higher, but not significantly different (P=0.593), for patients receiving VEN/IDELA-based regimens compared with CIT/CT (Figure 2). Total mean monthly medical cost (non-pharmacy) was significantly lower ($-5,202; P=0.036) for patients receiving VEN/IDELA-based regimens compared to CIT/CT (Figure 2).Conclusions: This study demonstrates that VEN/IDELA-based regimens may be a more viable treatment option post-1L ibrutinib use for CLL/SLL patients compared to CIT/CT. When compared to 2L CIT/CT, use of VEN/IDELA-based regimens post-1L ibrutinib use was associated with significantly longer TTNT and lower medical costs, signifying reduced disease burden to the patients and lessened burden to the healthcare system. These findings also suggest that treatment convenience associated with 2L oral targeted regimens may play an important role in improving treatment outcomes. These results support the need for evaluating treatment sequencing strategies in the real-world setting to further improve clinical outcomes and reduce the burden of total cost of care for patients with CLL/SLL. [Display omitted] DisclosuresChallagulla: Pharmacyclics LLC, an AbbVie Company: Current Employment; AbbVie: Current equity holder in publicly-traded company. Emond: Janssen: Consultancy; Novartis: Consultancy; Pfizer: Consultancy; Pharmacyclics LLC, an AbbVie Company: Consultancy; GlaxoSmithKline: Consultancy. Volodarsky: Pharmacyclics LLC, an AbbVie Company: Current Employment; AbbVie: Current equity holder in publicly-traded company. Young: AbbVie: Current equity holder in publicly-traded company; Pharmacyclics LLC, an AbbVie Company: Current Employment. Manceur: AbbVie: Consultancy; Actelion, part of the Janssen Pharmaceutical Companies of Johnson & Johnson: Consultancy; Bristol-Myers Squibb: Consultancy; Daiichi-Sankyo: Consultancy; Janssen: Consultancy; Novartis: Consultancy; Pharmacyclics LLC, an AbbVie Company: Consultancy. Karve: AbbVie: Current Employment, Current equity holder in publicly-traded company.

Initial maintenance therapy adherence among older adults with asthma-COPD overlap.

To examine the impact of initial maintenance therapy (IMT) type (inhaled corticosteroid [ICS] vs fixed-dose combination of ICS and long-acting β agonist [ICS/LABA]) on trajectories of adherence among older adults (≥ 65 years) with coexisting asthma and chronic obstructive pulmonary disease (COPD), known as asthma-COPD overlap (ACO). We used a longitudinal, retrospective cohort design. This study used a cohort of older adults with ACO using longitudinal data from a 10% sample of Optum's Deidentified Clinformatics Data Mart. We adopted group-based trajectory modeling to identify medication adherence trajectories over 12 months. Multinomial logistic regressions were used to evaluate the unadjusted and adjusted associations of IMT medication and adherence trajectory categories. All analyses accounted for treatment option selection bias with inverse probability treatment weighting. Of 1555 individuals, 73% of the sample used ICS/LABA for IMT. Four medication adherence trajectories were observed regardless of regimen: (1) persistent high adherence (12.0%), (2) progression to high adherence (20.8%), (3) progression to low adherence (10.5%), and (4) persistent low adherence (56.7%). Those who were initiated on ICS/LABA were less likely to have persistent low adherence (unadjusted odds ratio [OR], 0.44; 95% CI, 0.29-0.67) compared with those initiated on ICS monotherapy when "persistent high adherence" was used as the reference group. The relationship remained significant in adjusted regressions (adjusted OR, 0.38; 95% CI, 0.24-0.59). Real-world evidence suggests that using ICS/LABA for IMT may decrease the likelihood of persistent low adherence over time among older adults with ACO compared with ICS monotherapy.

Suboptimal adherence to daily growth hormone in a US real-world study: an unmet need in the treatment of pediatric growth hormone deficiency

Objective To evaluate adherence to, and discontinuation of, somatropin treatment over 4 years in a US population-based study of children with pediatric growth hormone deficiency (pGHD). Methods A retrospective cohort analysis of commercially insured patients ≥3 and <16 years, diagnosed with pGHD, newly treated with somatropin was conducted using Optum De-identified Clinformatics Data Mart. Index date was defined as the first prescription for somatropin between 01 July 2002 and 30 September 2019. Five non-exclusive patient cohorts were identified (>3, 12, 24, 36, and 48 months of post-index continuous enrollment). Suboptimal adherence was defined as medication possession ratio <80%. Discontinuation was defined as the date at which a gap of >60 days between somatropin fills first occurred. Cox proportional hazards regression was used to evaluate time to discontinuation. Results In the 12-month cohort (n = 3091), mean age was 11.3 ± 2.9 years, 75.9% were male, 70.9% white, 9.4% Hispanic, 3.6% Asian, and 3.1% black. The proportion with suboptimal adherence at months 12 and 48 was 19.6% and 35.9%, respectively. Discontinuation occurred in 42.2% of patients. The rate of discontinuation (HR [95% CI]) was higher for age ≥10 (1.74 [1.53–1.98]), females (1.35 [1.21–1.50]), black and Hispanic race/ethnicity (1.50 [1.18–1.90] and 1.27 [1.09–1.49] compared to White) and obesity (1.69 [1.19–2.40]). Conclusion Suboptimal adherence increases with treatment duration, and risk of discontinuation is associated with age, female gender, black or Hispanic race/ethnicity, and obesity. Strategies that facilitate adherence among children at risk of discontinuation may improve clinical outcomes.

Trends in initiation of GLP-1 RA in patients with type 2 diabetes during 2014–2019: a US database study

Abstract Background/Introduction Evidence of cardiovascular (CV) benefit of certain glucagon-like peptide 1 receptor agonists (GLP-1 RAs) from CV outcomes trials (CVOTs) resulted in updates to international guidelines and label indications in patients with type 2 diabetes (T2D) at high CV risk. Purpose To evaluate the impact of new evidence, we investigated the incidence of new GLP-1 RA use and trends in prescriber and patient characteristics over a 5-year period encompassing key CVOT publications and an updated label indication. Methods Data from consecutive cross-sectional cohorts of patients with T2D and no GLP-1 RA prescription for ≥1 year prior to the start date, corresponding to each year between 2014 and 2019, were extracted retrospectively from US Optum's de-identified Clinformatics® Data Mart Database (2004–2020). For each year, incidence of new GLP-1 RA use, overall and according to prescriber speciality and the proportion of patients with atherosclerotic CV disease (ASCVD) among the new users were evaluated. Speciality was categorised using prescriber information within the database, while ASCVD was identified with ICD-9 CM or 10 CM codes reported prior to GLP-1 RA prescription or year-start date. Results During the study period, 2,966,970 eligible patients with T2D were identified, 108,541 of whom were new users of GLP-1 RAs. Overall incidence of new GLP-1 RA use increased each year, with a 3-fold increase in prescriptions from 727 to 2045 per 100,000 patient years between 2014 and 2019 (Figure a). Among new GLP-1 RA users, mean age was 60.1 years, increasing from 56.8 to 61.7 years. Mean HbA1c was 8.6% and was stable over time. Further analysis of new GLP-1 RA prescriptions identified family medicine as the greatest contributor to the absolute increase in incidence between 2014 and 2019, comprising nearly 40% of total prescriptions each year, whereas cardiology contributed the least, at &amp;lt;1% each year. The overall proportion of patients with ASCVD among those newly initiated on a GLP-1 RA and those initiated by a cardiology specialist increased after 2015, from 30.8–44.3% and 45.2–57.9% in 2019, respectively (Figure b). However, this increase in the proportion of patients with ASCVD was also observed among the total population of patients with T2D without new GLP-1 RA use (Figure b). Conclusion New use of GLP-1 RAs in patients with T2D increased in absolute terms between 2014 and 2019. Interestingly, the proportion of patients with ASCVD among those newly initiating the class has not changed relative to non-GLP-1 RA users over time, highlighting a gap in adoption of CVOT data in clinical practice by all specialities and the potential opportunity to further reduce CV risk in these patients. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Novo Nordisk

Risk for Post-Colonoscopy Irritable Bowel Syndrome in Patients With and Without Antibiotic Exposure: A Retrospective Cohort Study

Laboratory studies have demonstrated that antibiotic use in conjunction with bowel purgatives causes alterations to the gut microbiota. Because gut microbiota changes may be a trigger for the development of irritable bowel syndrome (IBS), we sought to assess whether individuals who undergo bowel cleansing for colonoscopy and have concurrent antibiotic exposure develop IBS at higher rates than individuals who undergo colonoscopy without antibiotic exposure. We used data from Optum's de-identified Clinformatics Data Mart Database in the United States to study a cohort of 50- to 55-year-olds who underwent screening colonoscopy. Individuals exposed to antibiotics within 14 days of colonoscopy were propensity-score matched to individuals who were not exposed to antibiotics around colonoscopy. The primary outcome was a new IBS diagnosis, and the composite outcome was a new claim for IBS, IBS medications, or IBS symptoms. The association of antibiotic exposure and the outcomes was calculated using Cox proportional hazards regression. There were 408,714 individuals who met criteria for the screening colonoscopy cohort. Of these, 24,617 (6.0%) were exposed to antibiotics around the time of colonoscopy, and they were propensity-score matched to 24,617 individuals not exposed to antibiotics. There was no statistically significant association between antibiotic use and IBS (hazard ratio, 1.11; 95% confidence interval, 0.89-1.39), but there was a weak association between antibiotic use and the composite outcome (hazard ratio, 1.12; 95% confidence interval, 1.02-1.24; number needed to harm, 94). Individuals concurrently exposed to antibiotics and bowel purgative had slightly higher rates of surrogate IBS outcomes compared with matched controls who did not receive antibiotics concurrently with bowel purgative.

PD50-01 PROSTERIA: A CLAIMS-BASED STUDY OF DEMOGRAPHIC AND TEMPORAL TRENDS IN FREQUENT PROSTATE SPECIFIC ANTIGEN TESTING

You have accessJournal of UrologyProstate Cancer: Detection & Screening V (PD50)1 Sep 2021PD50-01 PROSTERIA: A CLAIMS-BASED STUDY OF DEMOGRAPHIC AND TEMPORAL TRENDS IN FREQUENT PROSTATE SPECIFIC ANTIGEN TESTING Dylan Peterson, Shufeng Li, Hriday Bhambhvani, James Brooks, and Michael Eisenberg Dylan PetersonDylan Peterson More articles by this author , Shufeng LiShufeng Li More articles by this author , Hriday BhambhvaniHriday Bhambhvani More articles by this author , James BrooksJames Brooks More articles by this author , and Michael EisenbergMichael Eisenberg More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002072.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: While there is disagreement between professional medical organizations about which patients should undergo Prostate Specific Antigen (PSA) screening, there are no guidelines that recommend PSA screening more often than annually. Despite this, there are patients who have their PSA tested more frequently, which we have termed “Prosteria”. We aimed to characterize patient demographic and temporal trends of frequent PSA testing. METHODS: Adult men with at least three PSA tests and two or more years of continuous insurance enrollment in the Optum De-identified Clinformatics® Data Mart were included in this study. Men were censored at the end of their insurance enrollment or 30 days prior to a diagnosis of prostate cancer, prostatitis, or UTI. PSA tests were excluded if they occurred within 30 days of a prior PSA test. “High frequency PSA testing” was defined as an average of one or more PSA tests every 9 months. Multivariable logistic regression evaluated associations between demographic features and PSA testing frequency. RESULTS: 9,547,876 PSA tests obtained between January 2003 and June 2019 on 1,996,472 men were included. While 55% of men were tested less than annually, 19% of men underwent high frequency testing. The distribution of time between PSA tests was notable for spikes around 90, 180, and 365 days. Patients were less likely to undergo high frequency testing if they were White (OR: 0.73, 95% CI: [0.72, 0.73]), educated (OR: 0.91, 95% CI: [0.91, 0.92]), and younger (OR: 0.98 per year, 95% CI: [0.97-0.98]). However, a U-shaped distribution was observed with men aged 55-65 being less likely to undergo high frequency testing than younger or older men. Of men with PSA levels available, men with high frequency testing had higher average PSA values (1.99 (SD: 1.94) vs 1.31 (SD: 1.30); p < 0.001). Over the study period, the proportion of patients getting high frequency testing increased at a rate of 1.17% per year (figure). CONCLUSIONS: In this large cohort study, high-frequency PSA testing was common, increasing over time, and significantly associated with demographic characteristics. Future work will investigate variations between ordering providers based on geographic region and specialty, as well as the impact of screening frequency on rates of prostate biopsy, cancer detection and treatment. Source of Funding: None © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e851-e851 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Dylan Peterson More articles by this author Shufeng Li More articles by this author Hriday Bhambhvani More articles by this author James Brooks More articles by this author Michael Eisenberg More articles by this author Expand All Advertisement Loading ...

Substantial gaps in evaluation and treatment of patients with hepatitis B in the US

The occurrence of HBV-associated liver complications is reduced by antiviral therapy. However, prior studies using local institutional cohorts have suggested that evaluation and treatment are suboptimal. We aimed to determine the proportion of patients with chronic HBV infection who received adequate evaluation, were treatment eligible, and received antiviral treatment using a large, nationwide cohort. This retrospective analysis utilized claims data of approximately 73 million enrollees across the US from Optum's de-identified Clinformatics® Data Mart Database, 2003-2019. Adults observed for ≥6 months before and after an index diagnosis of chronic HBV infection were identified via ICD-9/ICD-10 codes, with the diagnosis confirmed by positive HBsAg, HBeAg or HBV DNA PCR. We included 12,608 eligible patients in the study analysis (mean age 45.7 years, 52.1% male, 54.6% Asian, 18.1% Caucasian, 10.5% African American). About half of the cohort (n= 6,559, 52.3%) did not have a complete laboratory evaluation (defined as having HBeAg, HBV DNA, and ALT tests) and only 72.4% (n= 9,129) had an "adequate" evaluation (at least HBV DNA and ALT) during the entire study period. Of those with an adequate evaluation, 11.2% were treatment eligible by AASLD criteria and 13.9% by EASL criteria; 60.4% of AASLD eligible patients and 54.3% of EASL eligible patients received treatment within 12 months from becoming eligible. Half of patients with chronic HBV infection in the US with private insurance did not have a complete laboratory assessment. Over one-third of treatment-eligible patients did not receive antiviral therapy. Patients who visited a specialist had a higher chance of receiving adequate evaluation and treatment. Urgent intervention is needed to identify and address the barriers to optimal care. In this study, we used a national database that includes laboratory data in addition to medical and pharmacy claims data to assess the current real-world management of chronic HBV infection in the US. Among the 12,608 patients with chronic HBV infection included in our study, 52.3% never had a complete laboratory evaluation and only 73% had an adequate evaluation. Among those who were treatment eligible according to major society guidelines, only 60.4% and 54.3% received treatment within 12 months, respectively.

High-risk Opioid Prescribing Associated with Postoperative New Persistent Opioid Use in Adolescents and Young Adults.

In this study, we explored which postoperative opioid prescribing practices were associated with persistent opioid use among adolescents and young adults. Approximately 5% of adolescents and young adults develop postoperative new persistent opioid use. The impact of physician prescribing practices on persistent use among young patients is unknown. We identified opioid-naïve patients aged 13 to 21 who underwent 1 of 13 procedures (2008-2016) and filled a perioperative opioid prescription using commercial insurance claims (Optum Deidentified Clinformatics Data Mart Database). Persistent use was defined as ≥ 1 opioid prescription fill 91 to 180 days after surgery. High-risk opioid prescribing included overlapping opioid prescriptions, co-prescribed benzodiazepines, high daily prescribed dosage, long-acting formulations, and multiple prescribers. Logistic regression modeled persistent use as a function of exposure to high-risk prescribing, adjusted for patient demographics, procedure, and comorbidities. High-risk opioid prescribing practices increased from 34.9% to 43.5% over the study period; the largest increase was in co-prescribed benzodiazepines (24.1%-33.4%). High-risk opioid prescribing was associated with persistent use (aOR 1.235 [1.12,1.36]). Receipt of prescriptions from multiple opioid prescribers was individually associated with persistent use (aOR 1.288 [1.16,1.44]). The majority of opioid prescriptions to patients with persistent use beyond the postoperative period were from nonsurgical prescribers (79.6%). High-risk opioid prescribing practices, particularly receiving prescriptions from multiple prescribers across specialties, were associated with a significant increase in adolescent and young adult patients' risk of persistent opioid use. Prescription drug monitoring programs may help identify young patients at risk of persistent opioid use.

Management of Patients with Metastatic Castration-Sensitive Prostate Cancer in the Real-World Setting in the United States

Purpose:This study provides a contemporary assessment of the treatment patterns, health care resource utilization (HRU) and costs among metastatic castration-sensitive prostate cancer (mCSPC) patients in the U.S.Materials and Methods:Adults with mCSPC were selected from Optum's de-identified Clinformatics® Data Mart Database (Commercial insurance/Medicare Advantage [COM/MA]; January 1, 2014–July 31, 2019) or Medicare Fee-for-Service (FFS; January 1, 2014–December 31, 2017). The index date was the first metastatic disease diagnosis date on/after the first prostate cancer diagnosis (without prior evidence of castration resistance). Patients were observed for 12 months pre-index (baseline) through their mCSPC period (from index until castration resistance or followup end). First-line (1L) mCSPC therapy was assessed during the mCSPC period; all-cause HRU and health plan-paid costs per-patient-per-year (PPPY) were measured during baseline and mCSPC periods.Results:Among 6,517 COM/MA and 13,324 Medicare-FFS mCSPC patients over ∼10 months (median mCSPC period), 38% and 48% remained untreated/deferred treatment, and 45% and 46% received 1L androgen deprivation therapy (ADT) monotherapy, respectively. 1L abiraterone acetate and docetaxel were used among 7% and 6% of COM/MA and 1% and 2% of Medicare-FFS patients, respectively. HRU increased from baseline to mCSPC period, resulting in increased health plan-paid costs from $21,201 to $108,767 in COM/MA and from $16,819 to $69,639 PPPY in Medicare-FFS.Conclusions:This study highlights the limited use of newer therapies that improve survival in men with mCSPC in the U.S. HRU and costs increased substantially after onset of metastasis. Given the emergence of newer effective mCSPC therapies, further evaluation of future real-world mCSPC treatment patterns and outcomes is warranted.

Diagnostic delay and characterization of the clinical prodrome in AL amyloidosis among 1523 US adults diagnosed between 2001 and 2019.

Light-chain (AL) amyloidosis is a multisystem disorder with a high early mortality and diagnostic delays of >1year from symptom onset. This retrospective observational study sought to characterize the clinical prodrome and diagnostic delay to inform early detection. We identified 1523 adults with newly diagnosed AL amyloidosis in the Optum de-identified Clinformatics® Datamart US healthcare claims database as those with ≥2 new diagnosis codes for AL or other amyloidosis in 90days with ≥1 multiple myeloma treatment within 730days, excluding patients with prior hereditary or secondary amyloidosis and Familial Mediterranean Fever. We considered 34 signs/symptoms using diagnosis codes in all observable time on or before AL amyloidosis diagnosis. Sign/symptom prevalence was compared to that of 1:4 matched population controls. The overlap and sequence of signs/symptoms and the median time from first sign/symptom to AL amyloidosis diagnosis were explored. Healthcare utilization was summarized. The most common individual AL amyloidosis signs/symptoms were malaise/fatigue (61%) and dyspnea (59%). Cardiac signs/symptoms were observed in 77% of patients, followed by renal (62%) and neurologic (59%) signs/symptoms. Multisystem involvement (≥3 systems) was present in 54%. Monoclonal gammopathy was detected in 29% before diagnosis. Median time from symptom onset to AL amyloidosis diagnosis was 2.7years. Healthcare utilization was high between first AL amyloidosis signs/symptoms and diagnosis, with 50% visiting ≥5 physician types. AL amyloidosis patients have a lengthy and complex clinical prodrome. Novel approaches to early diagnosis are needed to improve outcomes.

Trends in Testosterone Therapy use in Prostate Cancer Survivors in the United States

BackgroundPhysician prescribing patterns surrounding the use of testosterone therapy (TTh) in men with a history of prostate cancer (CaP) is not well described. AimTo characterize the demographics and usage patterns of testosterone therapy in men with a history of prostate cancer in the United States. MethodsThis was a retrospective review using Optum's De-identified Clinformatics Data Mart database. Administrative diagnosis, procedural, pharmacy, and laboratory codes were used to identify male subjects 40 years and older with prostate cancer treated with surgery or radiation between 2003 and 2018 who went on to receive TTh. Demographic and clinical factors are identified. Temporal trends in TTh usage were reported. OutcomesThe main outcomes were rates of testosterone prescriptions in men with treated prostate cancer and associated laboratory values such as Prostate Specific Antigen (PSA) and testosterone levels before TTh. Results126,374 men completed treatment for CaP during the study period (42,515 surgery, 75,186 radiation, 8,673 both). Of these, 3,074 men (2.4%) received testosterone after CaP treatment. Men who received testosterone were younger, more likely to have erectile dysfunction, depressive disorder, and lower pretreatment PSA values compared to men who did not receive. Median PSA levels before TTh initiation were 0 – 0.2 depending on CaP treatment modality and median total testosterone level was <300 ng/dL. TTh began an average of 1.5 years after radical prostatectomy and 2.6 years after radiation treatment. We observed an increase in TTh after CaP from the beginning of the study period until it peaked in 2013 at 4.9%. After 2013, rates decreased annually until a plateau of approximately 1.8% of men. Approximately a third of men did not have testosterone labs checked before initiation of TTh. Clinical ImplicationsThese findings provide insight into trends in testosterone prescriptions in men after prostate cancer treatment and may aid in clinical decision-making, as well as areas for improvement in cancer survivorship care. Strengths and LimitationsStrengths include the large sample size, length of data coverage, and real-world analysis of testosterone prescribing patterns across the United States. Limitations include the reliance on insurance claims data, the retrospective study design, and lack of additional relevant clinical variables that may impact decision making regarding TTh. ConclusionNational trends in testosterone prescriptions for men with treated prostate cancer suggest that many men are treated with TTh after prostate cancer therapy with patterns of indications and monitoring consistent with the general population.Chen T, Li S, Eisenberg M. Trends in Testosterone Therapy use in Prostate Cancer Survivors in the United States. J Sex Med 2021;18:1346–1353.

Development and validation of a claims-based model to identify patients at risk of chronic thromboembolic pulmonary hypertension following acute pulmonary embolism

Objective Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare disease that often follows pulmonary embolism (PE). Screening for CTEPH is challenging, often delaying diagnosis and worsening prognosis. Predictive risk models for CTEPH could help identify at-risk patients, but existing models require multiple clinical inputs. We developed and validated a predictive risk model for CTEPH using health insurance claims that can be used by payers/quality-of-care organizations to screen patients post-PE. Methods Adult patients newly diagnosed with acute PE (index date) were identified from the Optum De-identified Clinformatics Extended DataMart (January 2007–March 2018; development set) and IBM MarketScan (January 2008–June 2019; validation set) databases. Predictors were identified 12 months before or on the index PE. Risk of “likely CTEPH” was assessed post-PE based on CTEPH-related diagnoses and procedures since the CTEPH diagnosis code (ICD-10-CM: I27.24) was not available until 1 October 2017. Stepwise variable selection was used to build the model using the development set; model validation was subsequently conducted using the validation set. Results The development set included 93,428 patients, of whom 11,878 (12.7%) developed likely CTEPH. Older age (odds ratios [OR] = 1.16–1.49), female (OR = 1.09), unprovoked PE (i.e. without thrombotic factors; OR = 1.14), hypertension (OR = 1.07), osteoarthritis (OR = 1.08), diabetes (OR = 1.07), chronic obstructive pulmonary disease (OR = 1.11), obesity (OR = 1.21) were associated with higher odds of likely CTEPH, and oral anticoagulants with lower odds (OR= 0.50, all p < .01). C-statistic was 0.77 in the development and validation sets. Conclusion A claims-based risk model reliably predicted the risk of CTEPH post-PE and could be used to identify high-risk patients who may benefit from focused monitoring.

Chemotherapy-induced peripheral neuropathy increases nontraumatic fracture risk in breast cancer survivors.

ABSTRACTChemotherapy is a common treatment for breast cancer (BrCa) and can cause chemotherapy‐induced peripheral neuropathy (CIPN). CIPN contributes to falls, and is thus a potential risk factor for nontraumatic fractures (NTFx); yet, the effect of CIPN on NTFx risk has not been examined for BrCa survivors. We therefore investigated the association between CIPN and NTFx in BrCa survivors. Data were extracted from Optum's Deidentified Clinformatics® Data Mart Database years 2010–2015 in this retrospective cohort study. Among women, three groups were derived based on BrCa and CIPN status: BrCa+/CIPN+ (primary group of interest), BrCa+/CIPN− (first comparison group), and BrCa−/CIPN− (second comparison group). After propensity score matching the comparison groups to BrCa+/CIPN+ at a ratio of 1:11 (BrCa:control) for demographics, osteoporosis, glucocorticoid medication, comorbidities, and cancer‐related variables for BrCa+/CIPN−, 1‐year incidence rate (IR) of NTFx was determined for each group. The incident rate ratio (IRR) determined if the IR for NTFx was different for BrCa+/CIPN+ compared to BrCa+/CIPN− and BrCa−/CIPN−. Cox proportional hazards regression models estimated the hazard ratios (HRs) after adjusting for covariates that were unable to be matched for. The crude IR (95% confidence interval [CI]) of NTFx was 4.54 (2.32–6.77) for BrCa+/CIPN+ (n = 359), 2.53 (2.03–3.04) for BrCa+/CIPN− (n = 3949), and 1.76 (1.35–2.18) for BrCa−/CIPN− (n = 3949). The crude IRR of NTFx was significantly elevated for BrCa+/CIPN+ as compared to BrCa+/CIPN− (IRR = 1.80; 95% CI, 1.06–3.05) and BrCa−/CIPN− (IRR = 2.58; 95% CI, 1.50–4.44). The elevated rate of NTFx for BrCa+/CIPN+ remained unchanged after adjusting for aromatase inhibitors compared to BrCa+/CIPN− (HR = 1.79; 95% CI, 1.06–3.04). Female BrCa survivors have an increased 1‐year IR of NTFx after the onset of CIPN, suggesting that CIPN is an additive burden on NTFx risk among BrCa survivors. © 2021 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.

The Association Between Hemoglobin A1c Levels and Inflatable Penile Prosthesis Infection: Analysis of US Insurance Claims Data

BackgroundThe association between elevated hemoglobin A1c (HbA1c) levels and the risk of postoperative infection after penile prosthesis surgery remains controversial. AimTo examine the association between HbA1c levels and penile implant infections in men undergoing inflatable penile prosthesis (IPP) surgery for erectile dysfunction using a large insurance claims database. MethodsThis was a retrospective review using Optum's de-identified Clinformatics Data Mart Database. Male subjects 18 years and older with available laboratory data undergoing IPP insertion between 2003 and 2018 were included. Administrative diagnosis and procedural codes were used to assess subsequent penile implant revision surgery status for either infectious or noninfectious causes. Associated conditions were controlled for such as smoking status, hyperlipidemia, hypertension, obesity status, and Peyronie's disease. OutcomesThe main outcomes were risk of revision for infection and time to revision. ResultsA total of 2,363 individuals underwent initial IPP insertion and had available HbA1c data with a mean HbA1c of 6.9%. The overall IPP infection revision rate was 3.9% and the highest rate of 12.1% was seen in the highest HbA1c group (>10%). After adjusting for demographic and health factors, a higher HbA1c level was associated with a higher risk of revision for infection, with every 1 point increase in HbA1c conferring an increased risk of infection requiring revision by 29% (95% CI 17–42%). When infections did occur, they happened sooner in men with HbA1c > 10.0% with an average of 1.3 months vs 3.5 months in the HbA1c < 6.0% group. Clinical ImplicationsThese findings provide insight into the potential relationship between HbA1c levels and postoperative risk of infection after penile prosthesis surgery and may aid in clinical decision-making. Strengths and LimitationsStrengths include the large sample size, length of data coverage, and real-world analysis of surgeries done across the United States. Limitations include the reliance on insurance claims data, the retrospective study design, and lack of additional relevant clinical variables that may impact infection rates. ConclusionsWhile the overall risk of penile prosthesis infection remains modest, the current report notes an increased risk of infection for diabetic men with poor glycemic control.Chen T, Li S, Eisenberg ML. The Association Between Hemoglobin A1c Levels and Inflatable Penile Prosthesis Infection: Analysis of US Insurance Claims Data. J Sex Med 2021;18:1104–1109.

Critical periods of bone health across the lifespan for individuals with cerebral palsy: Informing clinical guidelines for fracture prevention and monitoring.

Skeletal fragility is a major burden for individuals with cerebral palsy (CP), but little is known clinically about when to prevent fractures or monitor bone health for this population. Critical periods of bone health (CPBH) are important windows for intervention to augment bone growth or mitigate bone loss. However, CPBH from the general population may not align with the needs or timing of skeletal fragility for individuals with CP. The objective of this study was to identify discrepancies when evaluating individuals with CP using CPBH across the lifespan from the general population, and propose new CP-specific CPBH. Data from 2016 administrative claims databases were used, including the Optum's De-identified Clinformatics® Data Mart Database and a random 20% sample of the Medicare fee-for-service database from the Centers for Medicare and Medicaid Services. Sex-stratified fracture prevalence was compared between individuals with and without CP across the lifespan starting at 2years of age using age groups to capture important stages of development and 3-4-year age bands in adulthood (up to >80years). Sex-specific CPBH from the general population included: rapid bone accrual, peak bone mass, menopause, and elderly. There were 23,861 individuals with CP and 9,976,161 individuals without CP. CPBH from the general population did not align with the timing of skeletal fragility for CP. For example, fractures were rare and decreased throughout the CPBH of peak bone mass for males without CP, but males with CP had a greater relative fracture risk (2.9-5.6-fold higher) and a substantially increased rate of fracture (CP-slope 14× higher than non-CP-slope). For females with CP, fracture risk was increased by 18-21years, with additional inflection points (e.g., decade before menopause and again by 57-60years). For males with CP, fracture risk in mid-life exhibited a pattern similar to elderly males without CP. This study identified discrepancies in evaluating fracture risk for individuals with CP if using established CPBH from the general population. We therefore propose new CP- and sex-specific CPBH for fracture monitoring and prevention.