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Administrative claims databases often do not capture date or fact of death, so studies using these data may inappropriately treat death as a censoring event—equivalent to other withdrawal reasons—rather than a competing event. We examined 1-, 3-, and 5-year inverse-probability-of-treatment weighted cumulative risks of a composite cardiovascular outcome among 34 527 initiators of telmisartan (exposure) and ramipril (referent), who were aged ≥55 years, in Optum (United States) claims data from 2003 to 2020. Differences in cumulative risks of the cardiovascular endpoint due to censoring of death (cause-specific), as compared with treating death as a competing event (subdistribution), increased with greater follow-up time and older age, where event and mortality risks were higher. Among ramipril users, 5-year cause-specific and subdistribution cumulative risk estimates per 100, respectively, were 16.4 (95% CI, 15.3-17.5) and 16.2 (95% CI, 15.1-17.3) among ages 55-64 (difference = 0.2) and were 43.2 (95% CI, 41.3-45.2) and 39.7 (95% CI, 37.9-41.4) among ages ≥75 (difference = 3.6). Plasmode simulation results demonstrated the differences in cause-specific versus subdistribution cumulative risks to increase with increasing mortality rate. We suggest researchers consider the cohort's baseline mortality risk when deciding whether real-world data with incomplete death information can be used without concern. This article is part of a Special Collection on Pharmacoepidemiology. [ABSTRACT FROM AUTHOR]

Positive airway pressure (PAP) therapy is first-line therapy for OSA, but consistent use is required for it to be effective. Previous studies have used Medicare fee-for-service claims data (eg, device, equipment charges) as a proxy for PAP adherence to assess its effects. However, this approach has not been validated in a US commercially insured population, where coverage rules are not standardized. In a commercially insured population in the United States, how well do claims-based algorithms for defining PAP adherence correspond with objective PAP device usage? Deidentified administrative claims data of commercially insured patients (aged 18-64 years) with OSA were linked to objective PAP therapy usage data from cloud-connected devices. Adherence was defined based on device use (using an extension of Centers for Medicare & Medicaid Services 90-day compliance criteria) and from claims-based algorithms to compare usage metrics and identify potential misclassifications. The final sample included 213,341 patients. Based on device usage, 48% were adherent in the first year. Based on claims, between 10% and 84% of patients were identified as adherent (accuracy, sensitivity, and specificity ranges: 53%-68%, 12%-95%, and 26%-92%, respectively). Relative to patients who were claims-adherent, patients who were device-adherent had consistently higher usage across all metrics (mean, 339.9 vs 260.0-290.0 days of use; 6.6 vs 5.1-5.6 d/wk; 6.4 vs 4.6-5.2 h/d). Consistent PAP users were frequently identified by claims-based algorithms as nonadherent, whereas many inconsistent users were classified by claims-based algorithms as adherent. In aggregate US commercial data with nonstandardized PAP coverage rules, concordance between existing claims-based definitions and objective PAP use was low. Caution is warranted when applying existing claims-based algorithms to commercial populations. [Display omitted] [ABSTRACT FROM AUTHOR]

Although current guidelines recommend that nearly all patients with chronic hepatitis C virus (HCV) infection receive treatment, a substantial proportion remain untreated. We conducted an administrative claims analysis to provide real‐world data on treatment patterns and characteristics of treated versus untreated patients among individuals with HCV in the United States. Adults with an HCV diagnosis from 01 July 2016 through 30 September 2020 and continuous health plan enrolment for 12 months before and ≥1 month after the diagnosis date were identified in the Optum Research Database. Descriptive and multivariable analyses were conducted to evaluate the association between patient characteristics and the rate of treatment. Of 24,374 patients identified with HCV, only 30% initiated treatment during follow‐up. Factors associated with increased rate of treatment included younger age versus age 75+ (hazard ratio [HR] 1.50–1.83 depending on age group), commercial versus Medicare insurance (HR 1.32), and diagnosis by a specialist versus a primary care physician (HR 2.56 and 2.62 for gastroenterology and infectious disease or hepatology, respectively) (p <.01 for all). Several baseline comorbidities were associated with decreased rate of treatment, including psychiatric disorders (HR 0.87), drug use disorders (HR 0.85) and cirrhosis (HR 0.42) (p <.01 for all). These findings highlight existing HCV treatment inequities, particularly among older patients and those with psychiatric disorders, substance use disorders or chronic comorbidities. Targeted efforts to increase treatment uptake in these populations could mitigate a considerable future burden of HCV‐related morbidity, mortality and healthcare costs. [ABSTRACT FROM AUTHOR]

Opioid use disorder (OUD) is a chronic disease requiring long-term treatment and is associated with opioid overdose and increased risk of mortality. However, existing randomized clinical trials focused on short-term treatment engagement and detoxification rather than overdose or mortality risk due to limited follow-up time and ethical considerations. We used a hypothetical trial framework to conduct a retrospective cohort study to assess the effectiveness of time-varying buprenorphine-naloxone on opioid overdose and death. We identified 58,835 insured adult patients with OUD diagnosis in the US, 2010–2017. We fit a marginal structural model using inverse probability weighting methods to account for measured baseline and time-varying confounders, as well as selection bias due to possibly differential loss-to-follow-up. We found that receipt of buprenorphine-naloxone was associated with reduced risk of opioid overdose (hazard ratio (HR) = 0.66, 95% confidence interval (CI): 0.49, 0.91), death (HR = 0.24, 95% CI: 0.08, 0.75), and overdose or death (HR = 0.58, 95% CI: 0.40, 0.84). The E-value for death was 7.8, which was larger than the upper 95% CI of the association between each measured baseline variable and all-cause death, which implies that the unmeasured confounding itself may not explain away the estimated effect of treatment on the endpoint of all-cause mortality. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic, along with disruptions to routine medical care, brought renewed urgency to public health messaging about the importance of influenza vaccination. This retrospective cohort study used a database of linked claims and electronic medical record data to evaluate clinical and demographic characteristics and influenza vaccination history associated with changes in influenza vaccine uptake following the start of the COVID-19 pandemic. Influenza vaccine uptake was examined in six seasons (2015–2016 through 2020–2021). Individuals were grouped by vaccination history in the five seasons before 2020–2021. Characteristics of 2020–2021 vaccinated vs. unvaccinated individuals were compared, stratified by vaccination history. Overall influenza vaccination uptake was highest in 2020–2021 (35.4%), following a trend of increasing uptake since 2016–2017 (31.4%). Uptake in 2020–2021 was observed in all age groups except ≥65 years, and the increase was particularly notable in individuals <18 years. In the previous five seasons, individuals ≤17 and >65 years, White, and Asian individuals were most likely, while 18-to-49-year-olds and those with fewer comorbidities were least likely, to be consistently vaccinated. Influenza vaccination status in 2020–2021 aligned with vaccination history; few differences in patient characteristics (age, comorbidities, state of residence) were observed when stratified by vaccination history. [ABSTRACT FROM AUTHOR]

Background: For the two-thirds of patients with epilepsy who achieve seizure remission on antiseizure medications (ASMs), patients and clinicians must weigh the pros and cons of long-term ASM treatment. However, little work has evaluated how often ASM discontinuation occurs in practice. We describe the incidence of and predictors for sustained ASM fill gaps to measure discontinuation in individuals potentially eligible for ASM withdrawal.Methods: This was a retrospective cohort of Medicare beneficiaries. We included patients with epilepsy by requiring International Classification of Diseases codes for epilepsy/convulsions plus at least one ASM prescription each year 2014-2016, and no acute visit for epilepsy 2014-2015 (i.e., potentially eligible for ASM discontinuation). The main outcome was the first day of a gap in ASM supply (30, 90, 180, or 360 days with no pills) in 2016-2018. We displayed cumulative incidence functions and identified predictors using Cox regressions.Results: Among 21,819 beneficiaries, 5191 (24%) had a 30-day gap, 1753 (8%) had a 90-day gap, 803 (4%) had a 180-day gap, and 381 (2%) had a 360-day gap. Predictors increasing the chance of a 180-day gap included number of unique medications in 2015 (hazard ratio [HR] 1.03 per medication, 95% confidence interval [CI] 1.01-1.05) and epileptologist prescribing physician (≥25% of that physician's visits for epilepsy; HR 2.37, 95% CI 1.39-4.03). Predictors decreasing the chance of a 180-day gap included Medicaid dual eligibility (HR 0.75, 95% CI 0.60-0.95), number of unique ASMs in 2015 (e.g., 2 versus 1: HR 0.37, 95% CI 0.30-0.45), and greater baseline adherence (> 80% versus ≤80% of days in 2015 with ASM pill supply: HR 0.38, 95% CI 0.32-0.44).Conclusions: Sustained ASM gaps were rarer than current guidelines may suggest. Future work should further explore barriers and enablers of ASM discontinuation to understand the optimal discontinuation rate. [ABSTRACT FROM AUTHOR]

Health care providers are increasingly using clinical measures derived from electronic health records (EHRs) for risk stratification and predictive modeling. EHR-specific data elements such as prescriptions, laboratory results, and vital signs have been shown to improve risk prediction models. In this study, the value of EHR-based blood pressure (BP) values was assessed in predicting health care costs (ie, total, medical, and pharmacy) and key utilization end points (ie, hospitalization, emergency department use, and being among the highest utilizers). The study population included 37,451 patients of a large integrated delivery system in the mid-western United States with complete EHR data files, who were 18–64 years old, had continuous insurance at an affiliated health plan, and had eligible BP records. Both EHRs and insurance claims of the study population were used to extract the predictors (ie, demographics, diagnosis, and BP values) and outcomes (ie, costs and utilizations). Predictors were extracted from 2012 data, whereas concurrent and prospective outcomes were extracted from 2012 to 2013 data. Three base models (BMs) were constructed to predict each of the outcomes. The first BM no. 1 used demographics. The second BM no. 2 added the Charlson comorbidity index to BM no. 1, whereas the third BM no. 3 added the Adjusted Clinical Group Dx-PM case-mix score to BM no. 1. BP was specified as means, ranges, and classes. Adding BP ranges to BM no. 1 and BM no. 2 showed the greatest improvements when predicting costs and utilization. More specifically, adjusted R2 and area under the curve of BM no. 2 improved by 32.9% and 14.1% when BP ranges were added to predict concurrent total cost and hospitalization, respectively. The effect of BP measures on improving the risk stratification models was diminished when predicting prospective outcomes after adding the measures to BM no. 3 (ie, the more comprehensive diagnostic model), specifically when represented as BP means. Given the increasing availability of BP information, this research suggests that these data should be integrated into provider-based population health analytic activities. Future research should focus on subpopulations that benefit the most from incorporating vital signs such as BP measures in risk stratification models. [ABSTRACT FROM AUTHOR]

Background: There is limited consensus on the optimal time to initiate supervised physical rehabilitation after a rotator cuff repair (RCR). We examined whether timing of initiating supervised physical rehabilitation was associated with repeat RCR or development of adhesive capsulitis within 12 months postoperatively in an observational cohort of commercially insured adults., Methods: This retrospective cohort study used the IBM MarketScan Commercial Claims and Encounters Database. We included adults aged 18-64 who underwent a unilateral outpatient RCR between 2017 and 2020 and initiated supervised physical rehabilitation 1-90 days postoperatively. Multivariable logistic regression models examined the adjusted association between time of initiating supervised physical rehabilitation (1-13, 14-27, 28-41, and 42-90 days postoperatively) and each of the primary outcomes: repeat RCR and capsulitis. In a sensitivity analysis, time to rehabilitation was alternatively categorized using a data-driven approach of quartiles (1-7, 8-16, 17-30, and 31-90 days postoperatively). We report adjusted odds ratios (OR)., Results: Among 33,841 patients (86.7% arthroscopic index RCR), the median time between index RCR and rehabilitation initiation was 16 days (interquartile range 7-30), with 39.9% initiating rehabilitation at 1-13 days. Additionally, 2.2% underwent repeat RCR within 12 months, and 12-month capsulitis was identified in 1.9% of patients. There were no significant associations between timing of initiating rehabilitation and 12-month repeat RCR (OR 0.85-0.93, P = .18-.49) or 12-month capsulitis (OR 0.83-0.94, P = .22-.63). Lack of associations between timing and outcomes was supported in sensitivity analyses., Conclusions: Timing of initiating rehabilitation was not significantly associated with adverse outcomes after RCR. The finding of no increased odds of repeat RCR or capsulitis with the earliest timing may support earlier initiation of rehabilitation to accelerate return to daily activities. Findings should be replicated in another dataset of similarly-aged patients., (Copyright © 2024 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.)

Background: Telehealth can be defined as using remote technologies to provide health care. It may increase access to care among people with sickle cell disease (SCD). This study examined (1) telehealth use, (2) characteristics of telehealth use, and (3) differences between telehealth users and nonusers among people with SCD during the COVID-19 pandemic. Methods: This was a retrospective analysis of Medicaid claims among four states [California (CA), Georgia (GA), Michigan (MI), Tennessee (TN)] participating in the Sickle Cell Data Collection program. Study participants were individuals ≥1 year old with SCD enrolled in Medicaid September 2019-December 2020. Telehealth encounters during the pandemic were characterized by provider specialty. Health care utilization was compared between those who did (users) and did not (nonusers) use telehealth, stratified by before and during the pandemic. Results: A total of 8,681 individuals with SCD (1,638 CA; 3,612 GA; 1,880 MI; and 1,551 TN) were included. The proportion of individuals with SCD that accessed telehealth during the pandemic varied across states from 29% in TN to 80% in CA. During the pandemic, there was a total of 21,632 telehealth encounters across 3,647 users. In two states (MI and GA), over a third of telehealth encounters were with behavioral health providers. Telehealth users had a higher average number of health care encounters during the pandemic: emergency department (pooled mean = 2.6 for users vs. 1.5 for nonusers), inpatient (1.2 for users vs. 0.6 for nonusers), and outpatient encounters (6.0 for users vs. 3.3 for nonusers). Conclusions: Telehealth was frequently used at the beginning of the COVID-19 pandemic by people with SCD. Future research should focus on the context, facilitators, and barriers of its implementation in this population.

Aims: To examine healthcare utilization and costs in a US Medicare population diagnosed with Huntington's disease (HD). Methods: This was a retrospective matched cohort study using Medicare fee-for-service (FFS) claims data using 2013-2017 Research Identifiable Files. Medicare beneficiaries diagnosed with HD based on the presence of at least one medical claim with an International Classification of Diseases, Ninth or Tenth Revision, Clinical Modification (ICD-9/10-CM) diagnosis code for HD (ICD-9-CM: 333.4; ICD-10-CM: G10) during the identification period (2014-2016). Beneficiaries without HD were drawn from a 5% random sample of Medicare beneficiaries and 1:1 matched to those with HD for comparison. All-cause and HD-related (any utilization related to HD diagnosis or symptoms associated with HD) healthcare utilization and costs were reported. Results: We identified 3,688 matched pairs of beneficiaries with and without HD. Of those with HD, 1,922 (52.1%) were late-stage, 916 (24.8%) were middle-stage, and 850 (23.1%) were early-stage. Mean [SD] annual total healthcare costs were higher for HD beneficiaries than beneficiaries without HD ($41,631 [57,393] vs. $17,222 [31,218], p<.001) and were primarily driven by outpatient pharmacy costs ($19,182 [45,469] vs. $4,318 [11,553], p<.001). In the stratified analysis, total healthcare costs were highest among beneficiaries with late-stage HD (mean [SD] cost: $20,475 [$41,122] for early-stage vs. $29,733 [$44,977] for middle-stage vs. $56,657 [$64,185] for late-stage; p<.001). Limitations: Results are not generalizable to beneficiaries enrolled in other non-FFS Medicare plans. Administrative claims are intended for billing purposes, not research, and may not capture all symptoms, comorbidities, and other adverse events. Conclusions: This original, comprehensive analysis of healthcare utilization and economic burden among Medicare beneficiaries with HD found that healthcare needs and associated costs are substantially higher among Medicare beneficiaries who are diagnosed with HD compared to beneficiaries without HD. [ABSTRACT FROM AUTHOR]

Background: Various methodologies have been reported to assess the real-world epidemiology of amyotrophic lateral sclerosis (ALS) in the United States. The aim of this study was to estimate the prevalence, incidence, and geographical distribution of ALS using administrative claims data and to model future trends in ALS epidemiology. Methods: We performed a retrospective analysis of deidentified administrative claims data for >100 million patients, using 2 separate databases (IBM MarketScan Research Databases and Symphony Health Integrated DataVerse [IDV]), to identify patients with ALS. We evaluated disease prevalence, annual incidence, age- and population-controlled geographical distribution, and expected future trends. Results: From 2013 to 2017, we identified 7,316 and 35,208 ALS patients from the MarketScan databases and IDV, respectively. Average annual incidence estimates were 1.48 and 1.37 per 100,000 and point prevalence estimates were 6.85 and 5.16 per 100,000 and in the United States for the MarketScan databases and IDV, respectively. Predictive modeling estimates are reported out to the year 2060 and demonstrate an increasing trend in both incident and prevalent cases. Conclusions: This study provides incidence and prevalence estimates as well as geographical distribution for what the authors believe to be the largest ALS population studied to date. By using 2 separate administrative claims data sets, confidence in our estimates is increased. Future projections based on either database demonstrate an increase in ALS cases, which has also been seen in other large-scale ALS studies. These results can be used to help improve the allocation of healthcare resources in the future. [ABSTRACT FROM AUTHOR]

aimed to characterize the treated United States of America (US) adult asthma population, including those experiencing exacerbations, in terms of socio-demographics, clinical characteristics, and healthcare resource utilization (HRU). Patients and Methods: A retrospective cohort of asthma patients aged ≥ 18 years on 01 January 2014 with ≥ 1 ICD-9 asthma code (493.xx) enrolled in a US healthcare claims database during 2013– 2014. Patients who had ≥ 2 asthma medication dispensings during 2013 (baseline), including ≥ 1 in the 90-day period before index date, were classified according to NHLBI step. Patients with chronic obstructive pulmonary disease, cystic fibrosis, or lung cancer diagnoses were excluded. Demographics, comorbidities, clinical characteristics, and HRU were described during baseline. Exacerbations and HRU were described during 2014 (follow-up period). Results: In total, 72,156 patients were included; 10,590 (14.7%) had ≥ 1 exacerbation during follow-up. Approximately 44% of patients were classified as NHLBI Steps 1– 2, 41% as Steps 3– 4, and 11% as Steps 5– 6. Exacerbation frequency increased with step (Steps 1, 2, and 3: 12– 14%; Steps 4, 5, and 6: 16– 26%). Compared with the overall population during baseline, patients with an exacerbation had similar demographics, but differences were observed for comorbid allergic rhinitis (46.4% vs 40.1%, respectively), blood eosinophil counts ≥ 300 cells/μL (45.5% vs 39.6%, respectively), and asthma-related healthcare encounters (62.9% vs 52.4%, respectively). Overall, asthma-related HRU during follow-up increased with NHLBI step. Conclusion: Exacerbations were observed among patients classified at each NHLBI step and were more frequent with increasing step. Exacerbations and asthma-related HRU highlight the continued unmet need in the treated US asthma population. [ABSTRACT FROM AUTHOR]

Acquired thrombotic thrombocytopenic purpura (aTTP) is a rare hematologic disorder that can lead to serious life-threatening medical complications. The aim of this study was to describe aTTP-related hospital resource utilization, cost, complications, and overall survival among US Medicare and non-Medicare populations following aTTP episodes prior to the US approval of caplacizumab. This retrospective study utilized administrative claims data for Medicare Fee-for-Service (FFS) beneficiaries (100% sample) and a sample of commercial, managed Medicaid [MM], Medicare Advantage [MA] plan members from the Inovalon MORE2 Registry. aTTP patients ages 18+ were identified between 2010 and 2018 using a published validated algorithm: ≥1 hospitalization for thrombotic microangiopathy + therapeutic plasma exchange (TPE). 2,279 patients were identified; 65.2% were enrolled in Medicare FFS, 13.6% in commercial, 15.7% in MM, and 5.4% in MA. Mean hospitalization days for aTTP index episode ranged between 12 and 17 days; ∼60% of patients required intensive care. Mean payments for index hospitalization varied by payer [Medicare FFS: $29,024; MA: $12,860; commercial: $9,996 and MM: $10,470]. Among FFS patients, 15.7% died during initial hospitalization and 21.0% died within first 30 days of the event. During follow-up, 11.6–19.6% experienced aTTP-related exacerbation. Incidence rate of relapse and complications per 100 person-years was 5.6 [Medicare FFS: 3.6; MA: 8.7; commercial: 10.4 and MM: 14.7] and 16.7 [FFS: 15.5; MA: 20.5; commercial: 21.7 and MM: 19.1], respectively. Among Medicare patients with and without aTTP, mortality risk was 2.9 (95 % CI: 2.4–3.4) times higher for aTTP vs. non-aTTP patients. This is the first real-world study evaluating burden of illness among aTTP patients in the US across payer types. Despite being treated with TPE, patients with aTTP have lower survival rates in comparison to a matched cohort without aTTP. These findings highlight the need for more effective and novel therapies to reduce disease burden for this population. In US Medicare and managed care populations with aTTP between 2010 and 2018, aTTP can lead to significant utilization of ICU services due to clinical complications, and/or relapse following hospital discharge. Despite treatment with therapeutic plasma exchange, acute mortality remains high (15.7%) indicating the need for more effective and novel treatments. [ABSTRACT FROM AUTHOR]

Background: Low rates of HIV pre-exposure prophylaxis (PrEP) prescribing contribute to the disproportionate burden of HIV in the United States. Among adolescent and young adults (AYA) with opioid use disorder, HIV testing and PrEP co-prescription rates are poorly characterized., Methods: We performed a retrospective analysis involving deidentified data from Philadelphia's Medicaid beneficiaries ages 16-29 years who were prescribed medication for opioid use disorder (MOUD) from 2015 to 2020 and continuously Medicaid-enrolled for ≥6 months prior to that prescription. After identifying the presence of a qualifying diagnosis signifying a PrEP indication, we examined the outcome of appropriate PrEP co-prescriptions and HIV testing using generalized estimating equations (GEE) modeling., Results: We identified 795 AYA Medicaid beneficiaries with 1269 qualified treatment episodes. We calculated a PrEP prescribing rate of 29.47 per 1000 person-years among AYA receiving MOUD. The HIV testing rate was 63.47 per 1000 person-years among AYA receiving MOUD. GEE modeling revealed that individuals receiving methadone were more likely (aOR=2.62, 95% CI=1.06-6.49) to receive HIV testing within 6 months after a PrEP-qualifying diagnosis compared to those receiving other MOUD medications. Those who only saw outpatient behavioral health providers were less likely (aOR=0.48, 95% CI=0.24-0.99) to have received an HIV test within 6 months after the PrEP-qualifying diagnosis compared to those receiving inpatient behavioral health services., Conclusions: Co-prescription of PrEP and HIV testing among AYA receiving MOUD was rare in this large urban publicly insured population. Interventions are needed to increase HIV prevention services for this key population of AYA at risk for HIV infection., Competing Interests: Declaration of Competing Interest None of the authors have any financial conflict to disclose., (Copyright © 2024. Published by Elsevier B.V.)

Study Objectives: The aims of this study were to characterize obstructive sleep apnea (OSA) care pathways among commercially insured individuals in the United States and to investigate between-groups differences in population, care delivery, and economic aspects., Methods: We identified adults with OSA using a large, national administrative claims database (January 1, 2016-February 28, 2020). Inclusion criteria included a diagnostic sleep test on or within ≤ 12 months of OSA diagnosis (index date) and 12 months of continuous enrollment before and after the index date. Exclusion criteria included prior OSA treatment or central sleep apnea. OSA care pathways were identified using sleep testing health care procedural health care common procedure coding system/current procedural terminology codes then selected for analysis if they were experienced by ≥ 3% of the population and assessed for baseline demographic/clinical characteristics that were also used for model adjustment. Primary outcome was positive airway pressure initiation rate; secondary outcomes were time from first sleep test to initiation of positive airway pressure, sleep test costs, and health care resource utilization. Associations between pathway type and time to treatment initiation were assessed using generalized linear models., Results: Of 86,827 adults with OSA, 92.1% received care in 1 of 5 care pathways that met criteria: home sleep apnea testing (HSAT; 30.8%), polysomnography (PSG; 23.6%), PSG-Titration (19.8%), Split-night (14.8%), and HSAT-Titration (3.2%). Pathways had significantly different demographic and clinical characteristics. HSAT-Titration had the highest positive airway pressure initiation rate (84.6%) and PSG the lowest (34.4%). After adjustments, time to treatment initiation was significantly associated with pathway ( P < .0001); Split-night had shortest duration (median, 28 days), followed by HSAT (36), PSG (37), PSG-Titration (58), and HSAT-Titration (75). HSAT had the lowest sleep test costs and health care resource utilization., Conclusions: Distinct OSA care pathways exist and are associated with differences in population, care delivery, and economic aspects., Citation: Wickwire EM, Zhang X, Munson SH, et al. The OSA patient journey: pathways for diagnosis and treatment among commercially insured individuals in the United States. J Clin Sleep Med . 2024;20(4):505-514., (© 2024 American Academy of Sleep Medicine.)

Objective To conduct a retrospective analysis of sequential cross-sectional data of opioid prescribing practices in patients with no prior history of opioid use. Methods Individuals filling an oral opioid prescription who had 1 year of prior observation were identified from four different administrative claims databases for the period between January 1, 2002, and December 31, 2018: IBM MarketScan® Commercial Database (CCAE), Multi-State Medicaid Database (MDCD), Medicare Supplemental Data base (MDCR), and Optum© De-Identified Clinformatics® Data Mart Database. Outcomes included incidence of new opioid use and characteristics of patients' first opioid prescription, including dispensed morphine milligram equivalent (MME) per day, total MME dispensed, total MME ≥300, and days' supply of prescription for ≤3 or ≥30 days. Results There were 40,600,696 new opioid users identified. The incidence of new opioid use in the past 17 years ranged from 6% to 11% within the two commercially insured databases. Incidence decreased over time in MDCD and was consistently higher in MDCR. Total MME dispensed decreased in MDCD and increased in CCAE, with no major changes in the other databases. The proportion of patients receiving ≥30-day prescriptions decreased and the proportion of patients receiving ≤3-day prescriptions increased in MDCD, while ≥30-day prescriptions in the Optum database dramatically increased (low of 3.0% in 2003 to peak of 16.9% in 2017). Conclusions Opioid prescribing practices varied across different populations of insured individuals during the past 17 years. The most substantial changes in opioid prescriptions over time have occurred in MDCD, with reductions in use across multiple metrics. [ABSTRACT FROM AUTHOR]

Background: The treatment landscape for multiple sclerosis (MS) is quickly evolving. Understanding real-world treatment patterns of patients is necessary to identifying potential gaps in care.Methods: Patients with incident MS were identified from a large national claims database during 1/1/2014-6/30/2019. Patients had ≥2 diagnoses for MS or an inpatient hospitalization with a primary diagnosis of MS. Patients were required to have enrollment in the database ≥1 year prior to and ≥ 1 year following their first MS diagnosis. Treatment sequences were captured for all available disease modifying therapies (DMTs) during all available follow-up. Presence of comorbid conditions were captured during the one year prior to and following (and including) the index date; absolute change in prevalence from the pre- to post-index periods was calculated.Results: We identified 5691 patients with incident MS. Common comorbidities included physical symptoms (e.g., pain, weakness, fatigue), mental health conditions (anxiety, depression), and cardiovascular/metabolic conditions (hypertension, hyperlipidemia, diabetes, obesity). Just 1994 (35.0%) of patients received a DMT at any time during follow-up. Of those receiving a DMT, 28.2% went on to receive a second line of therapy, 5.8% received a third, and just 0.9% went on to a fourth line. Use of more than one DMT concomitantly occurred in just 1.8% of all treated patients. Glatiramer and dimethyl fumarate were by far the most common first-line treatments received accounting for nearly 62% of patients receiving a DMT.Conclusion: Approximately two-thirds of patients newly diagnosed with MS did not receive a DMT and the disease is accompanied by a significant comorbid burden. [ABSTRACT FROM AUTHOR]

A retrospective analysis of administrative claims data from a large U.S. health insurer was performed to study a potential association between oral antibiotic use during early childhood and occurrence of later gastrointestinal (GI) symptoms in children with autism spectrum disorder (ASD). Among 3253 children with ASD, 37.0% had a GI-related diagnosis during the last 2 years of their 5-year health coverage enrollment period, compared to 20.0% of 278,370 children from the general population without an ASD diagnosis. Greater numbers of oral antibiotic fills during the first 3 years of enrollment were found to significantly increase the hazard rate of having a later GI-related diagnosis (adjusted hazard ratio 1.48; 95% confidence interval 1.34, 1.63) in children both with and without ASD. [ABSTRACT FROM AUTHOR]

Few studies have assessed the risk of adverse pregnancy outcomes in women with multiple sclerosis (MS). We used 2 large US administrative databases, the Truven Health MarketScan Database (2011–2015; Truven Health Analytics Inc. Ann Arbor, Michigan) and the Nationwide Inpatient Sample (2007–2011), to identify delivery cohorts. MS and pregnancy outcomes (infections, cesarean delivery, preterm delivery, poor fetal growth, preeclampsia, chorioamnionitis, postpartum hemorrhage, stillbirth, and infant malformations) were identified during pregnancy and at delivery. We calculated adjusted risk ratios according to MS status and relapse(s) in the year before delivery. Among over 5 million pregnancies, we identified 3,875 pregnancies in women with MS. Women with MS had an increased risk of infections during pregnancy (Truven Health: adjusted risk ratio (aRR) = 1.22, 95% confidence interval (CI): 1.16, 1.27) and preterm delivery (Truven Health: aRR = 1.19 (95% CI: 1.04, 1.35); Nationwide Inpatient Sample: aRR = 1.30 (95% CI: 1.16, 1.44)). The risks of other outcomes were similar for women with and without MS. In the Truven Health database, risk ratios for the pregnancy outcomes in women experiencing relapses versus those without relapses were between 0.9 and 1.4, and confidence intervals overlapped the null. Overall, women with MS had an increased risk of infections and preterm delivery; however, their risks for other adverse pregnancy outcomes were not elevated. Disease activity before delivery was not a strong predictor of outcomes. [ABSTRACT FROM AUTHOR]

Introduction: In addition to the considerable patient and societal burdens, the financial burdens of ankylosing spondylitis (AS) are substantial. Understanding both all-cause and AS-specific direct costs in patients with AS is important if we are to understand the financial impact on patients with AS and payers in the United States. This study assessed both all-cause and AS-specific healthcare utilization and direct costs in US patients with AS using administrative claims data.Methods: Adults aged ≥ 18 years enrolled in the MarketScan® Commercial and Medicare databases with ≥ 1 inpatient or ≥ 2 non-rule-out outpatient diagnoses of AS between January 1, 2013, and December 31, 2013, were included. Patients had continuous enrollment with medical and pharmacy benefits for ≥ 12 months before and after the index date (first diagnosis). Non-AS controls were matched up to 5:1 to patients with AS on age, geographic region, index calendar year, and sex. All-cause and AS-specific healthcare utilization and direct costs were measured during the follow-up period and reported as per patient per year.Results: Patients with AS (N = 6679) had significantly higher rates of total all-cause inpatient admission (12% vs 6%), emergency department visits (23% vs 15%), nonhospital-based outpatient visits (100% vs 84%), hospital-based outpatient visits (68% vs 46%), other outpatient services (97% vs 81%), and medication use (97% vs 82%) compared with matched controls (N = 19,951). Patients with AS had approximately tenfold higher median total healthcare costs than matched controls ($24,978 vs $2139 per patient per year), largely driven by increased outpatient and pharmacy costs; P < 0.05 for all comparisons. The median (IQR) total AS-specific healthcare costs were $10,250 ($774, $28,824).Conclusion: In this analysis of claims data, increased outpatient and pharmacy costs were key contributors to higher all-cause total healthcare costs in US patients with AS.Funding: Novartis Pharmaceuticals Corporation, East Hanover, NJ. [ABSTRACT FROM AUTHOR]

Purpose: Despite the rise in opioid-related hospitalizations, there has been little research regarding opioid-related healthcare utilization. The objective of this study was to estimate the mean adjusted hospital costs, payments, and length of stay (LOS) for opioid-related visits for the nation and each of the nine US census regions. Methods: An observational study of retrospective claims data from the Vizient health system database was conducted. Eligible visits had a principal diagnosis of opioid use or dependence defined by ICD, ninth and tenth revision (ICD-9/10), and occurred between January 2014 and June 2017. Separate regression models for inpatient and outpatient visits were generated to estimate the adjusted costs, payments, and LOS for opioid-related visits. Results: A total of 193,614 (32,713 inpatient and 160,901 outpatient) visits met the inclusion criteria. The overall adjusted mean cost, payment, and LOS for an inpatient opioid-related visit were $4,383 (range between regions: $2,894–$5,835), $6,689 (range between regions: $4,038–$9,001), and 4.35 days (range between regions: 3.8–5.7 days), respectively. The overall adjusted mean cost and payment for an outpatient opioid-related visit were $533 (range between regions: $395–$802) and $374 (range between regions: $187–$574), respectively. Opioid-related hospital costs, payments, and LOS varied across the US. Data on the regional variation and national averages are necessary for hospitals to benchmark their services and more effectively manage this population. Conclusion: Future research should examine intraregion utilization to understand the effect of prices and level of services. [ABSTRACT FROM AUTHOR]

Purpose: To assess accuracy of administrative claims prescription fill-based estimates of glucocorticoid use and dose, and approximate bias from glucocorticoid exposure misclassification., Methods: We identified adults with rheumatoid arthritis with linked Medicare and CorEvitas registry data. An algorithm identifying glucocorticoid use and average dose over 90 days from Medicare prescription fills was compared to physician-reported measures from a CorEvitas visit during the same period, using weighted kappa to compare doses (none, ≤5 mg, 5-10 mg, >10 mg/day). A deterministic sensitivity analysis examined the effect of exposure misclassification on estimated glucocorticoid-associated infection risk from a prior study., Results: We identified 621 observations among 494 patients. Prescription fills identified glucocorticoid use in 41.9% of observations versus 31.1% identified by CorEvitas physician-report. For glucocorticoid use (yes/no), prescription fills had sensitivity 88.1% (95% CI 82.7-92.3), specificity 79.0% (74.8-82.7), PPV 65.4% (59.3-71.2), NPV 93.6% (90.6-95.9), and 81.8% agreement with CorEvitas, with kappa 0.61 (moderate to substantial agreement). There was 89.5% agreement between prescription fills and physician-reported doses, with weighted kappa 0.56 (moderate agreement). Applying these results to a prior Medicare study evaluating glucocorticoid-associated infection risk [risk ratio 1.44 (95% CI 1.41-1.48)] led to an externally adjusted risk ratio of 1.74 when accounting for exposure misclassification, representing -17% bias in infection risk estimate., Conclusions: This study supports the use of claims data to estimate glucocorticoid use and dose, but investigators should account for exposure misclassification, which may lead to underestimates of glucocorticoid risks. Our results could be applied to adjust risk estimates in other studies that use prescription fills to estimate glucocorticoid use., (© 2023 John Wiley & Sons Ltd.)

Purpose: To develop and validate an algorithm to estimate probability of ever smoking using administrative claims., Methods: Using population-based samples of Medicare-aged individuals (121,278 Behavioral Risk Factor Surveillance System survey respondents and 207,885 Medicare beneficiaries), we developed a logistic regression model to predict probability of ever smoking from demographic and claims data. We applied the model in 1,657,266 additional Medicare beneficiaries and calculated area under the receiver operating characteristic curve (AUC) using presence or absence of a tobacco-specific diagnosis or procedure code as our "gold standard." We used these "gold standard" and lung/laryngeal cancer codes to over-ride predicted probability as 100%. We calculated Spearman's rho between probability from this full algorithm and smoking assessed in prior Parkinson disease studies, by substituting our observed and prior ("true") smoking-Parkinson disease odds ratios into the attenuation equation., Results: The predictive model contained 23 variables, including basic demographics, high alcohol consumption, asthma, cardiovascular disease and associated risk factors, selected cancers, and indicators of routine medical usage. The AUC was 67.6% (95% confidence interval 67.5%-67.7%) comparing smoking probability to tobacco-specific diagnosis or procedure codes. Spearman's rho for the full algorithm was 0.82., Conclusions: Ever smoking might be approximated in administrative data for use as a continuous, probabilistic variable in epidemiologic analyses., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Brad A. Racette and Susan Searles Nielsen report financial support was provided by the Paula and Rodger Riney Foundation. Susan Searles Nielsen, Brad A. Racette, and Alejandra Camacho-Soto report a relationship with Michael J Fox Foundation for Parkinson’s Research that includes: funding grants., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: It has been estimated that more than 30% of health care spending in the United States is wasteful, and that low-value care, which drives up costs unnecessarily while increasing patient risk, is a significant component of wasteful spending.Objectives: To address the need for an ability to measure the magnitude of low-value care nationwide, identify the clinical services that are the greatest contributors to waste, and track progress toward eliminating low-value use of these services. Such an ability could provide valuable input to the efforts of policymakers and health systems to improve efficiency.Methods and Results: We reviewed existing methods that could contribute to measuring low-value care and developed an integrated framework that combines multiple methods to comprehensively estimate and track the magnitude and principal sources of clinical waste. We also identified a process and needed research for implementing the framework.Conclusions: A comprehensive methodology for measuring and tracking low-value care in the United States would provide an important contribution toward reducing waste. Implementation of the framework described in this article appears feasible, and the proposed research program will allow moving incrementally toward full implementation while providing a near-term capability for measuring low-value care that can be enhanced over time. [ABSTRACT FROM AUTHOR]

Objectives: Describe the operating characteristics of a proposed set of revenue center codes to correctly identify ICU stays among hospitalized patients.Design: Retrospective cohort study. We report the operating characteristics of all ICU-related revenue center codes for intensive and coronary care, excluding nursery, intermediate, and incremental care, to identify ICU stays. We use a classification and regression tree model to further refine identification of ICU stays using administrative data. The gold standard for classifying ICU admission was an electronic patient location tracking system.Setting: The University of Pennsylvania Health System in Philadelphia, PA, United States.Patients: All adult inpatient hospital admissions between July 1, 2013, and June 30, 2015.Interventions: None.Measurements and Main Results: Among 127,680 hospital admissions, the proposed combination of revenue center codes had 94.6% sensitivity (95% CI, 94.3-94.9%) and 96.1% specificity (95% CI, 96.0-96.3%) for correctly identifying hospital admissions with an ICU stay. The classification and regression tree algorithm had 92.3% sensitivity (95% CI, 91.6-93.1%) and 97.4% specificity (95% CI, 97.2-97.6%), with an overall improved accuracy (χ = 398; p < 0.001).Conclusions: Use of the proposed combination of revenue center codes has excellent sensitivity and specificity for identifying true ICU admission. A classification and regression tree algorithm with additional administrative variables offers further improvements to accuracy. [ABSTRACT FROM AUTHOR]

Background: This study evaluated the characteristics, healthcare resource utilization (HCRU), and costs, from the payer perspective, of hepatorenal syndrome (HRS) patients covered by commercial and Medicare insurance. Mortality was assessed as a secondary outcome.Methods: Patients were identified from claims databases of commercially insured patients (OptumHealth Care Solutions Inc.) in 1998-2014 and Medicare beneficiaries in 2009-2013 (5% Standard Analytic Files). At the time of their first inpatient admission ("index date") with an HRS diagnosis (ICD-9 code 572.4), commercially insured patients must be aged 18-64 and Medicare patients must be aged 65 and older.Results: A total of 784 commercially insured and 1061 Medicare HRS patients met the sample selection criteria. Patients were disproportionately male (commercial: 63.0%; Medicare: 57.9%) with a mean age of 54.1 among commercially insured and 74.1 among Medicare patients. Within the first 30 days, the average hospital length of stay (LOS) was 12.3 days among commercially insured and 10.8 days among Medicare patients. Based on Kaplan-Meier analyses, 36% of commercially insured and 26% of Medicare patients were readmitted within the next 30 days. During follow-up, many patients received dialysis (commercial: 33.0%; Medicare: 22.1%) or liver transplant (commercial: 10.7%; Medicare: 1.6%). Average costs within the 90 day follow-up were $157,665 for commercially insured and $48,322 for Medicare patients, with 68.3% and 78.3% of the costs incurred within the first 30 days. The primary cost driver was inpatient visits (commercial: 90.3% of costs; Medicare: 83.1% of costs), with differences between the populations consistent with lower mortality, higher dialysis rates, and higher transplant rates (both liver and kidney) among the commercially insured. Using US population and prevalence statistics, these results suggest that HRS imposes an annual total direct medical cost burden of approximately $3.0-$3.8 billion to payers over the period.Conclusions: HRS imposes a significant economic burden. [ABSTRACT FROM AUTHOR]

Background. Giardiasis, the most common enteric parasitic infection in the United States, causes an estimated 1.2 million episodes of illness annually. Published clinical recommendations include readily available Giardia-specific diagnostic testing and antiparasitic drugs. We investigated sequences of giardiasis diagnostic and treatment events using MarketScan, a large health insurance claims database. Methods. We created a longitudinal cohort of 2995 persons diagnosed with giardiasis (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] code 007.1) from 2006 to 2010, and analyzed claims occurring 90 days before to 90 days after initial diagnosis. We evaluated differences in number and sequence of visits, diagnostic tests, and prescriptions by age group (children 1-17 years, adults 18-64 years) using Χ2 tests and data visualization software. Results. Among 2995 patients (212 433 claims), 18% had a Giardia-specific test followed by or concurrent with an effective antiparasitic drug, without ineffective antibiotics. Almost two-thirds of patients had an antiparasitic and 27% had an antibiotic during the study window. Compared with children, adults more often had ≥3 visits before diagnosis (19% vs 15%; P = .02). Adults were also less likely to have a Giardia-specific diagnostic test (48% vs 58%; P < .001) and more likely to have an antibiotic prescription (28% vs 25%; P = .04). When Giardia-specific tests and antiparasitic and antibiotic prescriptions were examined, pediatric clinical event sequences most frequently began with a Giardia-specific test, whereas adult sequences most frequently began with an antiparasitic prescription. Conclusions. Giardiasis care infrequently follows all aspects of clinical recommendations. Multiple differences between pediatric and adult care, despite age-agnostic recommendations, suggest opportunities for provider education or tailored guidance. [ABSTRACT FROM AUTHOR]

Background Frailty is rarely assessed in clinical trials of patients who receive dual antiplatelet therapy (DAPT) after percutaneous coronary intervention. This study investigated whether frailty defined using claims data is associated with outcomes following percutaneous coronary intervention, and if there is a differential association in patients receiving standard versus extended duration DAPT. Methods and Results Patients ≥65 years of age in the DAPT (Dual Antiplatelet Therapy) Study, a randomized trial comparing 30 versus 12 months of DAPT following percutaneous coronary intervention, had data linked to Medicare claims (n=1326), and a previously validated claims-based index was used to define frailty. Net adverse clinical events, a composite of all-cause mortality, myocardial infarction, stroke, and major bleeding, were compared between frail and nonfrail patients. Patients defined as frail using claims data (12.0% of the cohort) had higher incidence of net adverse clinical events (23.1%) compared with nonfrail patients (10.7%; P <0.001) at 18-month follow-up and increased risk after multivariable adjustment (adjusted hazard ratio [HR], 2.24 [95% CI, 1.38-3.63]). There were no differences in effects of extended duration DAPT on net adverse clinical events for frail (HR, 1.42 [95% CI, 0.73-2.75]) and nonfrail patients (HR, 1.18 [95% CI, 0.83-1.68]; interaction P =0.61), although analyses were underpowered. Bleeding was highest among frail patients who received extended duration DAPT. Conclusions Among older patients in the DAPT Study, claims-defined frailty was associated with higher net adverse clinical events. Effects of extended duration DAPT were not different for frail patients, although comparisons were underpowered. Further investigation of how frailty influences ischemic and bleeding risks with DAPT are warranted. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT00977938.

Objectives: Lead migration (LM) after spinal cord stimulation (SCS) implantation surgery is the most common device-related complication. Our study of lead and implantable pulse generator (IPG) migration using a large administrative claims data base aims to understand rates, risk factors, and outcomes after SCS implantation., Materials and Methods: This retrospective cohort study used the IBM® MarketScan® (Armonk, NY) Commercial and Medicare Supplemental Databases from 2016 to 2018. Adult patients who underwent SCS surgical procedures with at least 90 days of follow-up were identified using Current Procedural Terminology (CPT®) codes. Patients with LM and IPG migration after SCS surgery were identified using the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10 CM) codes. Patients who underwent revision surgery after SCS implantation were identified using the CPT codes and ICD-10 CM codes. In addition, patient characteristics associated with LM or IPG migration, the temporal relationship of migration diagnosis, and revision surgery were evaluated in the cohort. Continuous outcomes were compared between groups using the two-sample Student t-test. The Fisher exact test was used to compare categorical outcomes between groups., Results: A total of 7322 patients (64.4% percutaneous SCS) underwent SCS surgery during the study period. A total of 141 patients (1.9%) had LM or IPG migration. Of those, 116 patients (1.6%) had LM only; 18 patients (0.2%) had IPG migration; and seven patients (0.1%) had LM and IPG migration. The mean duration for migration diagnosis after initial SCS implantation was 168 (±163.1) days. The mean duration to revision surgery after the migration diagnosis was 12.3 (±35.2) days only. Most patients with migration (105, 74.5%) underwent revision surgery. Only younger age (p = 0.02) was associated with migration in this study., Conclusions: LM and pulse generator migration that required revision surgery occurred in a small proportion of patients who underwent SCS surgical procedures., (Copyright © 2022 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.)

Background: To address the impact of using multiple sources of data in the United States Medicare Current Beneficiary Survey (MCBS) compared to using only one source of data to identify those with neuropsychiatric diagnoses. Methods: Our data source was the 2010 MCBS with associated Medicare claims files (N = 14, 672 beneficiaries). The MCBS uses a stratified multistage probability sample design to select a nationally representative sample of Medicare beneficiaries. We excluded those participants in Medicare Health Maintenance Organizations (n = 3894) and performed a cross-sectional analysis. We classified neuropsychiatric conditions according to four broad categories: intellectual/developmental disorders, neurological conditions affecting the central nervous system (Neuro-CNS), dementia, and psychiatric conditions. To account for different baseline prevalence differences of the categories we calculated the relative increase in prevalence that occurred from adding information from claims in addition to the absolute increase to allow comparison among categories. Results: The estimated proportion of the sample with neuropsychiatric disorders increased to 50.0 (both sources) compared to 38.9 (health survey only) and 33.2 (claims only) with an overlap between sources of only 44.1 %. Augmenting health survey data with claims led to an increase in estimated percentage of intellectual/developmental disorders, psychiatric disorders, Neuro-CNS disorders and dementia of 1.3, 5.9, 11.5 and 3.8 respectively. In the community sample, the largest relative increases were seen for dementia (147.6 %) and Neuro-CNS disorders (87.4 %). With the exception of dementia, larger relative increases were seen in the facility sample with the greatest being for intellectual/developmental disorders (121.5 %) and Neuro-CNS disorders (93.8 %). Conclusions: The magnitude of potentially underestimated sample proportions using health survey only data varied strikingly according to the category of diagnosis and setting. Augmentation of survey data with claims appears essential particularly when attempting to estimate proportion of the sample affected by conditions that cause cognitive impairment which may affect ability to self-report. Augmenting proxy survey data with claims data also appears to be essential when ascertaining proportion of the facility-dwelling sample affected by neuropsychiatric disorders. [ABSTRACT FROM AUTHOR]

Objectives: The objective of this study was to assess the reliability the Social Security Administration Death Master File (SSADMF) for evaluating mortality in comparative peripheral vascular device studies., Methods: We leveraged 2 versions of an administrative claims data set that were identical except for the source of mortality data. The SSADMF was the primary source of mortality records in one version. The SSADMF was combined with mortality from Medicare beneficiary records in the other. Our study was set in the context of a comparative effectiveness analysis of recent Food and Drug Administration interest involving peripheral paclitaxel-coated devices. Mortality of patients with Medicare Advantage insurance coverage from 2015 to 2018 who underwent femoropopliteal artery revascularization with a drug-coated device (DCD) or non-DCD was assessed through 2019. Covariate differences between treatment groups were adjusted by inverse propensity treatment weighting. The hazard ratio of DCD to non-DCD mortality was estimated using Cox regression., Results: The cumulative incidences of mortality differed substantially between versions of the data. Nevertheless, we could not reject the null hypothesis that the hazard ratios of the SSADMF (1.05; 95% confidence interval 0.95-1.17) and the Master Beneficiary Summary File/SSADMF (1.03; 95% confidence interval 0.96-1.11) were the same (P = .63)., Conclusions: The SSADMF is a common source of mortality records in the United States that can be linked to real-world data sources but is known to underreport mortality rates. We find that the SSADMF provides a reliable source of all-cause mortality for a comparative study assessing the safety of peripheral vascular devices., (Copyright © 2022. Published by Elsevier Inc.)

Aims: To provide more recent estimates of healthcare utilization and costs in Huntington's disease (HD) in the Medicaid population., Materials and Methods: This retrospective analysis used administrative claims data for HD beneficiaries (≥1 HD claim; ICD-9-CM 333.4) from Medicaid Analytic eXtract data files from 1 January 2010-31 December 2014. The date of the first HD claim during the identification period (1 January 2011-31 December 2013) was assigned as the index date. If a beneficiary had multiple HD claims during the identification period, one was randomly chosen as the index date. Beneficiaries were required to be continuously enrolled in fee-for-service plans during the 1-year pre-index and post-index periods. Medicaid beneficiaries without HD were drawn from a 100% random sample and matched (3:1) to those with HD. Beneficiaries were classified by disease stage (early/middle/late). All-cause and HD-related (any utilization related to HD diagnosis or symptoms associated with HD) healthcare utilization and costs were reported., Results: A total of 1,785 beneficiaries without HD were matched to 595 beneficiaries with HD (139 early-, 78 middle-, and 378 late-stage). The mean (SD) annual total costs were higher for beneficiaries with HD than beneficiaries without HD ($73,087 [$75,140] vs. $26,834 [$47,659], p  <.001) and driven by inpatient costs ($45,190 [$48,185] vs. $13,808 [$39,596], p  <.001). Total healthcare costs were highest among beneficiaries with late-stage HD (mean [SD] cost: $22,797 [$31,683] for early-stage HD vs. $55,294 [$129,290] for middle-stage HD vs. $95,251 [$60,197] for late-stage HD; p  <.001)., Limitations: Administrative claims are intended for billing purposes and subject to coding errors. This study did not address functional status, which may provide further insight to late-stage and end-of-life burden of HD, and indirect costs., Conclusions: Medicaid beneficiaries with HD have higher acute healthcare utilization and costs compared to beneficiaries without HD, which tend to increase with disease progression, indicating that HD beneficiaries at later disease stages have greater burden.

Background: Osteoarthritis (OA) is a leading cause of chronic pain and disability. Prior studies have documented racial disparities in the clinical management of OA. The objective of this study was to assess the racial variations in the economic burden of osteoarthritis within the Medicaid population., Methods: We conducted a retrospective observational study using the MarketScan Multi-State Medicaid database (2012-2019). Newly diagnosed, adult, knee and/or hip OA patients were identified and followed for 24 months. Demographic and clinical characteristics were collected at baseline; outcomes, including OA treatments and healthcare resource use (HCRU) and expenditures, were assessed during the 24-month follow-up. We compared baseline patient characteristics, use of OA treatments, and HCRU and costs in OA patients by race (White vs. Black; White vs. Other) and evaluated racial differences in healthcare costs while controlling for underlying differences. The multivariable models controlled for age, sex, population density, health plan type, presence of non-knee/hip OA, cardiovascular disease, low back pain, musculoskeletal pain, presence of moderate to severe OA, and any pre-diagnosis costs., Results: The cohort was 56.7% White, 39.9% Black and 3.4% of Other race (American Indian/Alaska Native, Hispanic, Asian, Native Hawaiian/Other Pacific Islander, two or more races and other). Most patients (93.8%) had pharmacologic treatment for OA. Inpatient admission during the 24-month follow-up period was lowest among Black patients (25.8%, p  < .001 White vs. Black). In multivariable-adjusted models, mean all-cause expenditures were significantly higher in Black patients ($25,974) compared to White patients ($22,913, p  < .001). There were no significant differences between White patients and patients of Other race ($22,352)., Conclusions: The higher expenditures among Black patients were despite a lower rate of inpatient admission in Black patients and comparable length and number of hospitalizations in Black and White patients, suggesting that other unmeasured factors may be driving the increased costs among Black OA patients.

Administrative claims provide a rich data source for retrospective studies of real-world clinical practice, yet some important data may be inconsistent or unavailable. This study explored factors influencing discontinuation of thrombopoietin receptor agonists (TPO-RAs) among patients with immune thrombocytopenia (ITP), by adding medical chart abstraction for additional details. Adult (≥ 18 years) patients with continuous commercial or Medicare Advantage with Part D health insurance coverage were included. Inclusion criteria were ≥ 1 claim for eltrombopag or romiplostim and ≥ 2 diagnoses of ITP between December 31, 2017, and January 1, 2020. Providers were asked to provide access to medical charts for abstraction. The analyses included only patients who discontinued TPO-RA and described patient characteristics, treatment patterns, platelet values, and reasons for discontinuation. Among 207 ITP patients treated with a TPO-RA, 137 (66%) discontinued treatment during the observation period. The mean TPO-RA treatment duration was 185 days. Mean platelet count at the time of discontinuation was 197 × 10 9 /L. The most common reason for discontinuation was improvement of the patient's condition (42%). Other reasons included worsening of ITP/lack of response (12%), adverse events (12%), and cost-related or social reasons (23%). No reason was reported for 10%. Notably 26% of patients who discontinued remained off all ITP therapy for the remainder of the study, with a mean treatment-free period of 262 days. These results emphasize that some patients with ITP are able to discontinue TPO-RA therapy and achieve durable treatment-free periods., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Objective: Estimate the annual cost of care in the 5 years following a cancer diagnosis for 17 invasive cancer types, by stage at diagnosis., Methods: We used 2012-2016 data from the Surveillance, Epidemiology, and End Results (SEER) registry-Medicare claims database to examine cost of care among Medicare beneficiaries with a confirmed cancer diagnosis based on International Classification of Diseases for Oncology, Third Edition histology codes reported in SEER. Beneficiaries contributed to the annual cost calculations (Years 1-5) using their observed time after diagnosis. Beneficiaries were continuously enrolled in fee-for-service Medicare Parts A/B and Part D during follow-up. Total, inpatient, outpatient, and pharmacy cancer-related service costs were calculated., Results: From 2012 to 2016, we identified 597,778 Medicare beneficiaries with incident cancer diagnosis within 5 years (Stage I, II, III, and IV: 32.6%, 33.4%, 15.9%, and 18.0%, respectively). In Year 1, mean (standard deviation) total costs for Stage I diagnoses varied from $7640 ($17,378) (prostate) to $94,636 ($117,636) (pancreas). Total costs increased by stage and reached $58,783 ($92,344) (prostate) to $156,982 ($175,009) (stomach) for Stage IV diagnoses in Year 1. Costs in Year 1 were significantly higher for Stage IV diagnoses than for earlier stages across all cancer types. In Years 2-5, total costs were lower than in Year 1 but continued to increase by stage., Conclusions: Beneficiaries diagnosed at later stages of cancer have higher costs of care (up to 7 times as much) than those diagnosed at earlier stages. Earlier cancer diagnosis may lead to more efficient treatment and decreased management cost.

Objective (study Question): Advanced practice registered nurses (APRNs) play an increased role in mental illness treatment. Health services research that uses claims to study mental health is often limited because behavioral health nurse practitioners (i.e., APRNs who specialize in mental illness, also known as psychiatric mental health APRNs) cannot be easily identified in claims data. We describe two methodologies to identify behavioral health APRNs in administrative claims. DATA SOURCES/STUDY SETTING (W/ HOSPITAL/INSTITUTION SETTING ANONYMIZED): We use 2010-2018 claims from the traditional Medicare fee-for-service program along with 2010-2019 commercial claims and Medicare Advantage data from the OptumLabs Data Warehouse (OLDW). Self-reported specialty data from the National Plan & Provider Enumeration System (NPPES) were used for validation., Study Design: For each APRN, we calculated the percentage of visit diagnoses and of prescriptions in each database that were for mental health and classified those with ≥80% as behavioral health APRNs. We validated our definition with NPPES self-reported specialty for Medicare data., Data Collection/extraction Methods: Not applicable., Principal Findings: Among APRNs with 10+ visits, 10,978 (8.1%) in Medicare and 9829 (11.7%) in commercial claims data met our visit-based criteria as behavioral health APRNs. Among APRNs with 10+ prescriptions, 8160 (6.2%) in Medicare and 16,538 (9.0%) in commercial claims data met our prescription-based criteria as behavioral health APRNs. Among the APRNs who self-reported they were behavioral health APRNs, 92.8% and 90.5% met our visit-based and prescription-based criteria, respectively., Conclusions: We present and validate two methods of identifying behavioral health APRNs in claims that can be used by other researchers., (© 2022 Health Research and Educational Trust.)

Real-world evidence on the comparative effectiveness and safety of abaloparatide versus teriparatide in women with osteoporosis may help inform treatment decisions. Following 18 months of treatment, abaloparatide was comparable to teriparatide for prevention of nonvertebral fractures, resulted in a 22% risk reduction for hip fractures, and demonstrated similar cardiovascular safety. Osteoporotic fracture risk can be reduced with anabolic or antiresorptive medications. In addition to efficacy and safety data from controlled clinical trials, real-world evidence on comparative effectiveness and safety may help inform treatment decisions., Introduction: The real-world effectiveness of abaloparatide versus teriparatide on nonvertebral fracture (NVF) incidence and cardiovascular safety during the 19-month period after treatment initiation were evaluated (NCT04974723)., Methods: Anonymized US patient claims data from Symphony Health, Integrated Dataverse (IDV)®, May 1, 2017 to July 31, 2019, included women aged ≥ 50 years with ≥ 1 prescription of abaloparatide or teriparatide and no prior anabolic therapy. Most were enrolled in commercial and Medicare health plans. Index was the date of the initial prescription dispensed during the identification period. In 1:1 propensity score matched cohorts, time to first NVF following index date, major adverse cardiovascular events (MACE), and MACE + heart failure (HF) were compared between cohorts using a Cox proportional hazards model., Results: Propensity score matching yielded 11,616 patients per cohort. Overall median age (interquartile range) was 67 (61, 75) years, and 25.6% had a fracture history. Over 19 months, 335 patients on abaloparatide and 375 on teriparatide had a NVF (hazard ratio [95% confidence interval]: 0.89 [0.77, 1.03]), and 121 and 154 patients, respectively, had a hip fracture [HR (95% CI): 0.78 (0.62, 1.00)]. The MACE and MACE + HF rates were similar between cohorts., Conclusions: Following 18 months of treatment, abaloparatide was comparable to teriparatide for prevention of NVF and similar cardiovascular safety was demonstrated between cohorts., (© 2022. The Author(s).)

Background: Based on a literature search, there are limited data on the economic burden of systemic lupus erythematosus (SLE), particularly in patients with lupus nephritis. Objective: The objective of this study was to compare health care resource utilization and direct medical care costs over a period of 12 months in patients with a history of SLE with or without nephritis. Methods: Patients aged ≥18 years with ≥1 claim for an immunosuppressive/disease-modifying antirheumatic drug, antimalarial agent, NSAID/cyclooxygenase-2 inhibitor, or other SLE-related treatment (eg, opioid and combination analgesic, antianxiety agent, antihyperlipidemic agent, antihypertensive agent, bisphosphonate, vitamin D) dated between January 1, 2007, and December 31, 2007, were identified using a nationally representative, US commercial insurance claims database. The date of the first dispensation of the treatment represented the index date. Patients were required to have ≥2 claims containing a diagnosis of SLE during a 6-month preindex period through 3 months postindex and to have continuous health plan enrollment for 6 months before and 12 months after the index date. Patients with ≥1 claim containing a diagnosis of nephritis during the preindex period were identified. Health care resource utilization and direct medical care cost data were assessed over a period of 12 months; paid amounts were used as a proxy for costs and were expressed in year-2008 US dollars. Results: A total of 15,590 patients with SLE were identified (13,828 women, 1762 men; mean age, 48 years); 1068 (6.9%) had a history of nephritis. The mean age of patients with SLE without nephritis was significantly greater compared with the group with nephritis (47.9 vs 46.5 years, respectively; P < 0.001), and a greater proportion of this group were women (89.0% vs 84.7%; P < 0.001). Over a period of 12 months, 30.3% of patients with nephritis were hospitalized compared with 13.6% of those without nephritis (P < 0.001); the mean lengths of hospital stays were 16.52 and 9.69 days (P < 0.001) in patients with and without nephritis, respectively. Patients with nephritis also underwent more outpatient laboratory tests (mean, 64.42 vs 30.96; P < 0.001) and had a significantly higher mean number of intravenous infusions (mean, 1.7 vs 1.1; P < 0.001), and total 12-month follow-up costs were significantly greater in patients with nephritis compared with those without nephritis (mean, $30,652 vs $12,029; P < 0.001). Costs associated with inpatient and outpatient care were 252% and 146% higher in patients with SLE with nephritis, respectively. Outpatient costs were associated with approximately half of the total costs in patients with or without nephritis; pharmacy costs accounted for 20% of the total costs in patients with SLE and nephritis and 27% of total costs among those without nephritis. Significantly higher costs also were found in patients with nephritis when only SLE-related costs were assessed and after differences in patient characteristics and comorbidities were adjusted through multivariate analyses (all, P < 0.05). Conclusions: The present data analysis found that patients with SLE with nephritis consumed significantly more health care resources, with >2.5-fold the costs, compared with those without nephritis. The majority (84%) of added costs were attributable to inpatient hospitalizations and outpatient services, and 16% were attributable to pharmacy services. [Copyright &y& Elsevier]

To study end-of-life care of a representative sample of older people using qualitative interpretation of administrative claims by clinicians and to explore whether this method yields insights into patient care, including continuity, errors, and cause of death.Random, stratified sampling of decedents and all their Medicare-covered healthcare claims in the 3 years before death from a 5% sample of elderly fee-for-service beneficiaries, condensation of all claims into a chronological clinical summary, and abstraction by two independent clinicians using a standardized form.United States.One hundred Medicare fee-for-service older people without disability or end-stage renal disease entitlement who died in 1996 to 1999 and had at least 36 months of continuous Part A and Part B enrollment before death.Qualitative narrative of the patient's medical course; clinician assessment of care continuity and apparent medical errors; cause, trajectory, and place of death.The qualitative narratives developed by the independent abstracters were highly concordant. Clinicians felt that 75% of cases lacked continuity of care that could have improved the quality of life and the way the person died, and 13% of cases had a medical error identified by both abstracters. Abstracters disagreed about assignment of a single cause of death in 28% of cases, and abstracters and the computer algorithm disagreed in 43% of cases.Qualitative claims analysis illuminated many problems in the care of chronically ill older people at the end of life and suggested that traditional vital statistics assignation of a single cause of death may distort policy priorities. This novel approach to claims review is feasible and deserves further study. [ABSTRACT FROM AUTHOR]

Background: Medications for opioid use disorder (MOUDs), including methadone, buprenorphine and naltrexone, are associated with lower death rates and improved quality of life for people in recovery from opioid use disorder (OUD). Less is known about each MOUD modality's association with treatment retention and the contribution of behavioral health therapy (BHT). The objectives of the current study were to estimate the association between MOUD type and treatment retention and determine whether BHT was associated with length of time retained., Methods: We investigated the time from initiation to discontinuation from MOUD by medication type and exposure to BHT using statewide Medicaid Claims data (N = 81,752). We estimated covariate adjusted hazard ratios (AHR) using a Cox proportional hazards model., Results: Compared to methadone, buprenorphine was associated with a higher risk of discontinuation at the time of initiation (AHR = 2.41, 95% CI = 2.28-2.55), however that difference decreased over one year of maintained retention (AHR = 1.44, 95% CI = 1.37-1.50). Compared to methadone and buprenorphine, naltrexone was associated with a higher risk of discontinuation at the time of initiation (naltrexone vs. methadone AHR = 2.49, 95% CI = 2.30-2.65; naltrexone vs. buprenorphine AHR 1.03, 95% CI = 1.00-1.07), and that relative risk increased over the course of one year of retention (naltrexone vs. methadone AHR = 3.85, 95% CI = 3.63-4.09; naltrexone vs. buprenorphine AHR = 2.67, 95% CI = 2.54-2.81). In general, independent of MOUD type, exposure to BHT during MOUD treatment was associated with a lower risk of discontinuation (AHR = 0.94, 95% CI = 0.92-0.96). However, BHT during the treatment episode was not associated with retention in the adolescent/young adult and pregnant women subpopulations., Discussion: From the standpoint of early success, methadone was associated with the lowest risk of treatment discontinuation. While buprenorphine and naltrexone were associated with similar risks at the beginning of treatment, the relative discontinuation risk for buprenorphine was less than half that of naltrexone at one year of retention. In general, BHT with MOUD was associated with a lower risk of treatment discontinuation., (Copyright © 2021. Published by Elsevier Inc.)

Aim: Vagus nerve stimulation (VNS), responsive neurostimulation (RNS), and deep brain stimulation (DBS) all are options for drug-resistant epilepsy (DRE). However, little is known about how the choice of neurostimulation impacts subsequent healthcare costs., Materials and Methods: We used a large US healthcare claims database to identify all patients with epilepsy who underwent neurostimulation between 2012 and 2019. Eligible patients were identified and stratified based on procedure received (VNS vs. RNS/DBS). VNS patients were matched by propensity scoring to RNS/DBS patients. Use and cost of healthcare resources and pharmacotherapy were ascertained over the 24-month period following neurostimulation, incorporating all-cause and epilepsy-related measures. Disease-related care was defined based on diagnoses of claims for medical care and relevant pharmacotherapies., Results: Seven hundred and ninety-two patients met all selection criteria. VNS patients were younger, were prescribed a higher pre-index mean number of anti-seizure medications (ASMs), and had higher pre-index levels of use and cost of epilepsy-related healthcare services. We propensity matched 148 VNS patients to an equal number of RNS/DBS patients. One year following index date (inclusive), mean total all-cause healthcare costs were 50% lower among VNS patients than RNS/DBS patients, and mean epilepsy-related costs were 55% lower; corresponding decreases at the two-year mark were 41% and 48%, respectively., Limitations: Some clinical variables, such as seizure frequency and severity, quality of life, and functional status were unavailable in the database, precluding our ability to comprehensively assess differences between devices. Administrative claims data are subject to billing code errors, inaccuracies, and missing data, resulting in possible misclassification and/or unmeasured confounding., Conclusions: After matching, VNS was associated with significantly lower all-cause and epilepsy-related costs for the two-year period following implantation. All-cause and epilepsy-related costs remained statistically significantly lower for VNS even after costs of implantation were excluded.

Background Community-acquired pneumonia (CAP) develops in persons outside of a healthcare facility and is associated with significant morbidity and mortality. Estimating the incidence of CAP is challenging because it lacks a standardized case definition and because study designs and selection criteria vary. Reconciling these differences across studies is critical for understanding the true burden of CAP which, in turn, informs prevention strategies, including vaccination. Methods We performed a systemic literature review of studies describing the incidence of hospitalized CAP among adults in the United States. Specifically, we examined the impact of the following study characteristics on estimates of incidence: (i) study population, (ii) study type and data source, and (iii) diagnostic criteria for pneumonia. Results After review of 8361 articles as of January 31, 2019, we identified 26 studies which contained 39 unique CAP estimates. Among adults ≥65 years of age, annual rates of hospitalized CAP ranged from 847 to 3,500 per 100,000 persons with median = 1,830. Rates were lower in studies that excluded patients with healthcare-associated (but community-onset) pneumonia (HCAP; median = 2,003 vs. 1,286; P =.02) or immunocompromising conditions (median = 1,895 vs. 1,409; P =.29). Rates of CAP were also lower in studies that used more restrictive criteria for diagnosing pneumonia (e.g. pneumonia coded in any diagnosis position [median = 2,246] vs. pneumonia coded in the first position only [median = 1,375] in studies of administrative claims; P = 0.03). For adults <65 years of age, annual rates of CAP were lower (range = 89 to 1,024 per 100,000; median = 210). Conclusion CAP causes a significant disease burden among adults, particularly among those ≥65 years of age where the incidence of hospitalization is approximately 2,000 per 100,000 annually. Commonly-applied exclusion criteria (e.g. persons with HCAP or immunocompromising conditions) or restrictive case definitions (e.g. only including pneumonias coded in the primary diagnosis position) have led to systematic underestimation of CAP incidence in many previous studies. Understanding the true burden of adult CAP is critical for highlighting the ongoing need for expanded prevention programs, including vaccination. Disclosures All authors: No reported disclosures. [ABSTRACT FROM AUTHOR]

Background: Adverse health impacts of cystic fibrosis (CF) can be present in children before respiratory complications are observed. Children with CF show progressive health decline, with increasing lung function decline in adolescence. This study aims to quantify the healthcare resource utilization (HCRU) and costs attributable to CF by comparing children with CF with the general pediatric population., Methods: This retrospective, cross-sectional, observational study compared HCRU and costs among children with CF in the US with demographically similar children without CF (comparison group) over a 12-month period using administrative claims data spanning 2010-2017. Analyses were conducted by insurance type (commercially insured [COM] and Medicaid insured [MED]) and stratified by age (<2 years, 2 to <6 years, 6 to <12 years, and 12-17 years)., Results: Children with CF (2831 COM and 1896 MED) were matched to children in the comparison group (8493 COM and 5688 MED). Higher prevalence of comorbidities was seen in children with CF versus the comparison group across all ages. Across all ages, HCRU attributable to CF was substantial (higher hospitalization rates, more outpatient and emergency room visits, and greater use of prescription medications), and there were higher associated costs (all p values < .05), in COM and MED populations. HCRU and costs attributable to CF were highest for children aged 12-17 years., Conclusions: Substantial HCRU and costs are evident among children with CF across all ages, starting as young as infancy, with highest HCRU and costs among adolescents. Effective treatments from an early age are needed for children with CF., (© 2021 The Authors. Genetic Epidemiology Published by Wiley Periodicals LLC.)

Purpose: An International Classification of Disease (ICD-10) Charlson Comorbidity Index (CCI) adaptation had not been previously developed and validated for United States (US) healthcare claims data. Many researchers use the Canadian adaption by Quan et al (2005), not validated in US data. We sought to evaluate the predictive validity of a US ICD-10 CCI adaptation in US claims and compare it with the Canadian standard., Methods: Diverse patient cohorts (rheumatoid arthritis, hip/knee replacement, lumbar spine surgery, acute myocardial infarction [AMI], stroke, pneumonia) in the IBM® MarketScan® Research Databases were linked with the IBM MarketScan Mortality file. Predictive performance was measured using c-statistics for binary outcomes (1-year and postoperative mortality, in-hospital complications) and root mean square prediction error (RMSE) for continuous outcomes (1-year all-cause medical costs, index hospitalization costs, length of stay [LOS]), after adjusting for age and sex. C-statistics were compared by the method of DeLong and colleagues (1988); RMSEs, by resampling., Results: C-statistics were generally high (≥ ~ 0.8) for mortality but lower for in-hospital complications (~0.6-0.7). RMSEs for costs and hospitalization LOS were relatively large and comparable to standard deviations. Results were similar overall between the US and Canadian adaptations, with relative differences typically <1%., Conclusions: This US-based coding adaptation and a previously published Canadian adaptation resulted in similar predictive ability for all outcomes evaluated but may have different construct validity (not evaluated in our study). We recommend using adaptations specific to the country of data origin based on good research practice., (© 2021 John Wiley & Sons Ltd.)

Background: Increasing doses of oral antiparkinson medications are indicated in advanced Parkinson's disease (PD), but little is known about sustainment of high-dose regimens., Objective: To investigate sustainment of high-dose oral medication regimens in Medicare beneficiaries with incident advanced PD., Methods: This retrospective cohort study utilized 100%fee-for-service Medicare claims from 2011-2013. We identified advanced PD using a pharmacy claims-based proxy and selected patients who initiated a new high-dose oral medication regimen (daily levodopa equivalent dose [LED] >1000 mg/day for ≥30 days) in 2012. In the following 12 months, we examined: 1) annual proportion of days covered (PDC)≥0.80 and 2) presence of a ≥ 90 day continuous gap at varying dosage thresholds: the initial >1000 mg/day, >800 mg/day, >500 mg/day, or >0 mg/day., Results: We identified 9,405 patients with advanced PD (mean age 77.4 [SD 6.8] years; 53%men). Only 5%maintained a regimen of >1000 mg/day at PDC ≥0.80; 75% had a ≥ 90-day gap in that dosage level. At a dosage threshold of >800 mg/day, 20% had a PDC ≥0.80 and 53% had a ≥ 90-day gap; at >500 mg/day, 56% had a PDC ≥0.80 and 19%had a ≥ 90-day gap; and at >0 mg/day (any dose), 76% had a PDC ≥0.80 and only 10%had a≥90-day gap., Conclusion: Few patients with advanced PD sustained a high-dose oral medication regimen in the year following initiation, but most sustained a substantially lower-dose regimen. Strategies to improve advanced PD treatment are needed.

Purpose: Our aim was to develop and validate a practical US healthcare claims algorithm for identifying incident lung cancer that improves on positive predictive value (PPV) and sensitivity observed in past studies., Methods: Patients newly diagnosed with lung cancer in Surveillance, Epidemiology, and End Results (SEER) (gold standard) were linked with Medicare claims. A 5% Medicare "other cancer" sample and noncancer sample served as controls. A split-sample validation approach was used. Rules-based, regression, and machine learning models for developing algorithms were explored. Algorithms were developed in the model building subset. Rules-based algorithms and those with the highest F scores were evaluated in the validation subset. F scores were compared for 1000 bootstrap samples. Misclassification was evaluated by calculating the odds of selection by the algorithm among true positives and true negatives., Results: A practical single-score algorithm derived from a logistic regression model had sensitivity = 78.22% and PPV = 78.50% (F score: 78.36). The algorithm was most likely to misclassify older patients (ages ≥80 years) or with missing data in the SEER registry, shorter follow-up time in Medicare (<3 months), insurance through Veterans Affairs, >1 cancer in SEER, or certain Charlson comorbidities (dementia, chronic pulmonary disease, liver disease, or myocardial infarction)., Conclusion: In this dataset, a practical point-based algorithm for identifying incident lung cancer demonstrated significant and substantial improvement (7.9% and 23.9% absolute improvement in sensitivity and PPV, respectively) compared with a current standard., (© 2020 John Wiley & Sons Ltd.)

Almost half of chronic obstructive pulmonary disease (COPD) exacerbations are estimated to be inaccurately reported by patients, inconsistently recorded in medical records, or not measured due to coding errors inherent to administrative claims. This retrospective observational study aimed to develop an algorithm capable of detecting acute COPD exacerbations (AECOPD) in healthcare claims and estimate costs associated with AECOPD over a 12-month period. Commercial and Medicare Advantage healthcare plan members (≥40 years old) with evidence of COPD were identified from US healthcare-claims database. To refine the algorithm detecting AECOPD in claims data, sensitivity and positive-predictive value calculations were performed to compare AECOPD identification in healthcare claims versus medical charts. Analyses were also performed to examine total exacerbation-related costs for events identified with the new claims algorithm plus events missed. The final algorithm had a sensitivity of 84.9%, with a positive-predictive value of 67.5%. Medical records were abstracted for 402 patients. In the overall sample of healthcare claims ( n  = 243,998), the algorithm detected ≥1 AECOPD event in 61.3% of patients. The mean cost per patient during an AECOPD episode, identified by the final algorithm, was USD 6,760 ( n  = 301), with an incremental average cost of USD 607 ( n  = 122) to 'unobserved' episodes (not reported in claims data) among the chart sample. After multivariate modeling, predicted yearly exacerbation costs translated to USD 1.12 billion per 100,000 patients (USD 12,000 per patient), with 35.76 million associated with unobserved exacerbations. While the final algorithm warrants further validation and study, these findings highlight unobserved AECOPD and their economic burden.

Objectives: The aim of this study was to evaluate the performance of administrative claims in ascertaining trial clinical events committee-adjudicated outcomes in the U.S. CoreValve studies., Background: Real-world data offer tremendous opportunity to improve outcome ascertainment in clinical trials. However, little is known about the validity of outcomes ascertained using real-world data to capture trial endpoints., Methods: Patients enrolled in 3 pivotal trials and 2 pre-market continued-access studies evaluating transcatheter aortic valve replacement were linked to Medicare fee-for-service inpatient claims. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and kappa agreement statistic of claims to detect clinical endpoints and procedural complications in trial patients were calculated., Results: Claims accurately identified trial-adjudicated deaths (sensitivity, specificity, PPV, and NPV all >99.6%; kappa 1.00). Claims had good performance in identifying trial-adjudicated permanent pacemaker implantation (sensitivity 92.2%, specificity 99.1%, PPV 96.1%, NPV 98.2%, kappa 0.93) and aortic valve reintervention (sensitivity 84.4%, specificity 99.6%, PPV 69.1%, NPV 99.8%, kappa 0.76). Claims had more modest performance in ascertaining trial-adjudicated myocardial infarction (sensitivity 63.6%, specificity 97.2%, PPV 29.9%, NPV 99.3%, kappa 0.39) and acute kidney injury (sensitivity 70.2%, specificity 85.4%, PPV 38.2%, NPV 95.7%, kappa 0.41) and the poorest performance for identifying trial-adjudicated bleeding events (sensitivity 86.4%, specificity 36.8%, PPV 35.0%, NPV 86.3%, kappa 0.16)., Conclusions: Compared with trial-adjudicated outcomes, claims data performed well in ascertaining death and outcomes with procedural billing codes and more modestly in identifying other outcomes. Claims may be cautiously and selectively used to augment data collection in future cardiovascular device trials., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Improved treatment approaches for ulcerative colitis (UC), including novel medications, might reduce the need for colectomy. We performed a retrospective cohort study of adult patients (age 18-64) with UC in the United States to examine time trends for colectomy and biologic use from 2007 to 2016., Methods: We estimated quarterly rates for colectomy and biologic use using the IQVIA Legacy PharMetrics Adjudicated Claims Database. We used interrupted time series methods with segmented regression to assess time trends with 95% confidence intervals (CIs) for biologic use and colectomy before and after the emergence of newly available biologic therapies in 2014., Results: Among 93,930 patients with UC, 2275 (2.4%) underwent colectomy from 2007 to 2016. Biologic use rates increased significantly from 2007 to 2016, from 131 per 1000 person-years in 2007 (95% CI, 121 to 140) to 589 per 1000 person-years in 2016 (95% CI, 575 to 604; P < 0.001). Colectomy rates decreased significantly between 2007 and 2016, from 7.8 per 1000 person-years (95% CI, 7.4 to 8.2) to 4.2 per 1000 person-years in 2016 (95% CI, 3.2 to 5.1; P < 0.001). An interruption in 2014 was associated with a positive trend deflection for biologic use (+72 treatments per 1000 person-years per year (95% CI, 61 to 83) and a negative trend deflection for colectomy (-0.76 per 1000 person-years per year; 95% CI, -1.47 to -0.05)., Conclusions: Among commercially insured patients in the United States from 2007 to 2016, biologic use rates increased, colectomy rates decreased, and both trends were impacted by the interruption in 2014. These findings suggest that new biologic therapies may have contributed to decreased colectomy rates., (© 2019 Crohn’s & Colitis Foundation. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Purpose: Studies of medication persistence in plaque psoriasis have shown inconsistent results, likely due to differing definitions of nonpersistence and of the permissible gap between refills. Also, medication persistence information for two recently approved drugs, apremilast and ixekizumab, is limited., Methods: We use the Truven Health MarketScan claims database to assess persistence for six drugs: adalimumab, apremilast, etanercept, ixekizumab, secukinumab, and ustekinumab. We define the permissible gap in three ways: 150 days for ustekinumab and 90 days for all other drugs (150/90 model); 120 days for all drugs (120 model); and twice the days' supply for all drugs (days' supply model). To estimate unadjusted persistence, we use Kaplan-Meier curves, and a proportional hazards model to estimate the adjusted risk of non-persistence., Results: Ustekinumab is most sensitive to changes in the definition of permissible gap, likely because of its longer maintenance dosing interval. Among targeted drug-experienced patients using ustekinumab, median persistence is 358 days (95% confidence interval: 343-371) in the 150/90 model and 189 days (179-199) in the days' supply model. Among targeted drug-experienced patients, median persistence in the days' supply model is longest for ixekizumab and secukinumab at 252 (217-301) and 222 (210-244) days, respectively. We also find that adjusted risk of nonpersistence increases by approximately 1% per year at treatment start., Conclusion: The definition of permissible gap meaningfully changes both absolute and ordinal estimates of medication persistence. Each definition has unique limitations, which should be considered when interpreting persistence data., (© 2020 John Wiley & Sons Ltd.)