Search

Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are novel oral anti-hyperglycemic drugs that demonstrate cardiovascular and metabolic benefits for patients with type 2 diabetes (T2D), heart failure (HF), and chronic kidney disease (CKD). There is limited knowledge of real-world data to predict adherence to SGLT-2i in an ambulatory setting. The study aims to predict SGLT-2i adherence in patients with T2D and/or HF and/or CKD by building a prediction model using electronic prescription claims data presented within EPIC datasets. This is a retrospective study of 174 adult patients prescribed SGLT-2i at UC San Diego Health ambulatory pharmacies between 1 January 2020 to 30 April 2021. Adherence was measured by the proportion of days covered (PDC). R packages were used to identify regression and non-linear regression predictive models to predict adherence. Age, gender, race/ethnicity, hemoglobin A1c, and insurance plan were included in the model. Diabetes control based on hemoglobin A1c (HbA1c) and the glomerular filtration rate (GFR) was also evaluated using Welch t-test with a p-value of 0.05. The best predictive model for measuring adherence was the simple decision tree. It had the highest area under the curve (AUC) of 74% and accuracy of 82%. The model accounted for 21 variables with the main node predictors, including glycated hemoglobin, age, gender, and insurance plan payment amount. The adherence rate was inversely proportional to HbA1c and directly proportional to the plan payment amount. As for secondary outcomes, HbA1c values from baseline till 90 days post-treatment duration were consistently higher in the non-compliant group: 7.4% vs. 9.6%, p < 0.001 for the PDC ≥ 0.80 and PDC < 0.80, respectively. Baseline eGFR was 55.18 mL/min/1.73m2 vs. 54.23 mL/min/m2 at 90 days. The mean eGFR at the end of the study (minimum of 90 days of treatment) was statistically different between the groups: 53.1 vs. 59.6 mL/min/1.73 m2, p < 0.001 for the PDC ≥ 0.80 and PDC < 0.80, respectively. Adherence predictive models will help clinicians to tailor regimens based on non-adherence risk scores.

ObjectivePrevious studies have shown that treatment of obstructive sleep apnea (OSA) with positive airway pressure (PAP) therapy in patients with depression may improve depression symptoms and response to antidepressant therapy. We investigated the association between PAP therapy adherence, self-harm events, healthcare resource utilization (HCRU), and costs over 2 years in a national sample of patients with pre-existing depression and newly diagnosed comorbid OSA.MethodsAdministrative claims data were linked to objective PAP therapy usage. Inverse probability treatment weighting was used to compare outcomes over 2 years across PAP adherence levels. The predicted numbers of emergency room (ER) visits and hospitalizations by adherence level were assessed using risk-adjusted generalized linear models.Results37,459 patients were included. Relative to non-adherent patients, consistently adherent patients had fewer self-harm events (0.04 vs 0.05, p

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]

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. 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). 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. 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. [ABSTRACT FROM AUTHOR]

Objective Data Sources and Study Setting Study Design Data Collection/Extraction Methods Principal Findings Conclusions To determine the feasibility of integrating Medicare Advantage (MA) admissions into the Centers for Medicare & Medicaid Services (CMS) hospital outcome measures through combining Medicare Advantage Organization (MAO) encounter‐ and hospital‐submitted inpatient claims.Beneficiary enrollment data and inpatient claims from the Integrated Data Repository for 2018 Medicare discharges.We examined timeliness of MA claims, compared diagnosis and procedure codes for admissions with claims submitted both by the hospital and the MAO (overlapping claims), and compared demographic characteristics and principal diagnosis codes for admissions with overlapping claims versus admissions with a single claim.We combined hospital‐ and MAO‐submitted claims to capture MA admissions from all hospitals and identified overlapping claims. For admissions with only an MAO‐submitted claim, we used provider history data to match the National Provider Identifier on the claim to the CMS Certification Number used for reporting purposes in CMS outcome measures.After removing void and duplicate claims, identifying overlapped claims between the hospital‐ and MAO‐submitted datasets, restricting claims to acute care and critical access hospitals, and bundling same admission claims, we identified 5,078,611 MA admissions. Of these, 76.1% were submitted by both the hospital and MAO, 14.2% were submitted only by MAOs, and 9.7% were submitted only by hospitals. Nearly all (96.6%) hospital‐submitted claims were submitted within 3 months after a one‐year performance period, versus 85.2% of MAO‐submitted claims. Among the 3,864,524 admissions with overlapping claims, 98.9% shared the same principal diagnosis code between the two datasets, and 97.5% shared the same first procedure code.Inpatient MA data are feasible for use in CMS claims‐based hospital outcome measures. We recommend prioritizing hospital‐submitted over MAO‐submitted claims for analyses. Monitoring, data audits, and ongoing policies to improve the quality of MA data are important approaches to address potential missing data and errors. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Purpose: In this study, we assess how the first and second waves of the COVID-19 pandemic influenced the suicide risk of patients with severe mental disorders in Germany. Methods: We analyzed German health insurance claims data to compare the suicide risk of patients with severe mental disorders before and during the pandemic. We included n = 690,845 patients between October 2019 and March 2020 and n = 693,457 patients the corresponding period of the previous year and applied entropy balancing to adjust for confounding covariates. Given that the cause of death was unknown, we defined potential suicides as deaths of patients with a history of intentional self-harm whose passing could not be explained by COVID-19. Potential suicides were tracked in both cohorts over one year and compared using logistic regression. Results: 128 potential suicides were identified in the period during and 101 before the pandemic. This corresponded to a significant increase in the risk for potential suicide of 27.4% compared to the control period (β = 0.24, z = 1.82, p < 0.05). Conclusion: The noticeable increase in the risk for potential suicide for patients with severe pre-existing mental disorders emphasizes the call for additional efforts to prevent suicide and to help patients cope with their mental illness in the aftermath of the COVID-19 crisis. [ABSTRACT FROM AUTHOR]

Jenna Wong,1– 3 Xiaojuan Li,1,2 David E Arterburn,4 Dongdong Li,1,2 Elizabeth Messenger-Jones,1 Rui Wang,1,2 Sengwee Toh1,2 1Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, MA, USA; 2Department of Population Medicine, Harvard Medical School, Boston, MA, USA; 3Optum Labs Visiting Fellow, Eden Prairie, MN, USA; 4Kaiser Permanente Washington Health Research Institute, Seattle, WA, USACorrespondence: Jenna Wong, Department of Population Medicine, Harvard Medical School & Harvard Pilgrim Health Care Institute, 401 Park Drive, Suite 401 East, Boston, MA, 02215, USA, Tel +1 617 867-4513, Fax +1 617 867-427, Email jenna_wong@hphci.harvard.eduBackground: Lack of body mass index (BMI) measurements limits the utility of claims data for bariatric surgery research, but pre-operative BMI may be imputed due to existence of weight-related diagnosis codes and BMI-related reimbursement requirements. We used a machine learning pipeline to create a claims-based scoring system to predict pre-operative BMI, as documented in the electronic health record (EHR), among patients undergoing a new bariatric surgery.Methods: Using the Optum Labs Data Warehouse, containing linked de-identified claims and EHR data for commercial or Medicare Advantage enrollees, we identified adults undergoing a new bariatric surgery between January 2011 and June 2018 with a BMI measurement in linked EHR data ≤ 30 days before the index surgery (n=3226). We constructed predictors from claims data and applied a machine learning pipeline to create a scoring system for pre-operative BMI, the B3S3. We evaluated the B3S3 and a simple linear regression model (benchmark) in test patients whose index surgery occurred concurrent (2011– 2017) or prospective (2018) to the training data.Results: The machine learning pipeline yielded a final scoring system that included weight-related diagnosis codes, age, and number of days hospitalized and distinct drugs dispensed in the past 6 months. In concurrent test data, the B3S3 had excellent performance (R2 0.862, 95% confidence interval [CI] 0.815– 0.898) and calibration. The benchmark algorithm had good performance (R2 0.750, 95% CI 0.686– 0.799) and calibration but both aspects were inferior to the B3S3. Findings in prospective test data were similar.Conclusion: The B3S3 is an accessible tool that researchers can use with claims data to obtain granular and accurate predicted values of pre-operative BMI, which may enhance confounding control and investigation of effect modification by baseline obesity levels in bariatric surgery studies utilizing claims data.Plain Language Summary: Pre-operative BMI is an important potential confounder in comparative effectiveness studies of bariatric surgeries.Claims data lack clinical measurements, but insurance reimbursement requirements for bariatric surgery often result in pre-operative BMI being coded in claims data.We used a machine learning pipeline to create a model, the B3S3, to predict pre-operative BMI, as documented in the EHR, among bariatric surgery patients based on the presence of certain weight-related diagnosis codes and other patient characteristics derived from claims data.Researchers can easily use the B3S3 with claims data to obtain granular and accurate predicted values of pre-operative BMI among bariatric surgery patients.Keywords: bariatric surgery, body mass index, confounding variable, comparative effectiveness research, administrative claims, supervised machine learning

Abstract Background This study was designed to identify factors associated with at least one emergency department (ED) visit and those associated without consultation by a general practitioner or paediatrician (GPP) before ED visit. Levels of annual consumption of healthcare services as a function of the number of ED visit were reported. Methods This retrospective study focused on children

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]

Background and Aims: The economic impact of managing patients with hepatitis C virus (HCV) infection remains unknown. This study aimed to assess the economic burden of chronic HCV infection from a national health insurance perspective and the impact of direct‐acting antivirals (DAAs) using nationwide real‐world data. Methods: Patients with chronic HCV infection were identified from the French Health Insurance Claims Databases (SNDS) and matched for age and sex to the general population. Health resource utilization and reimbursements were summarized according to healthcare expenditure items from 2012 to 2021. The economic burden attributable to chronic HCV infection was evaluated over a 10‐year period. Finally, the impact of DAAs was estimated using economic data derived from the SNDS. Results: A total of 145 187 patients with chronic HCV infection were identified. Among the patients eligible for DAA therapy, 81.5% had received DAA by the end of 2021. Over a 10‐year period, managing patients with chronic HCV infection resulted in an additional cost of €9.71 billion (95% confidence interval [CI]: €9.66–€9.78 billion) or €9191 (95% CI: €9134–€9252) per patient per year compared to the general population. After DAA therapy, patients with chronic HCV infection had a higher economic burden than the general population, with an additional cost of €5781 (95% CI: €5540–€6028) per patient at the fifth‐year post‐DAA therapy. Conclusions: A significant economic burden persists among patients with HCV infection after DAA treatment. The high proportion of patients not treated with DAA therapy supports reinforcing policies for universal access. [ABSTRACT FROM AUTHOR]

Purpose: Carfilzomib, commonly used for relapsed/refractory multiple myeloma (RRMM), has been associated with various adverse events in randomized controlled trials (RCTs). However, real-world safety data for a more diverse population are needed, as carfilzomib received expedited approval. This study aimed to evaluate carfilzomib’s safety in Korea by comparing new users of KRd (carfilzomib, lenalidomide, and dexamethasone) to Rd (lenalidomide and dexamethasone) using a nationwide administrative claims database. Methods: The retrospective cohort study utilized target trial emulation, focusing on adverse events in various organ systems similar to the ASPIRE trial. Results: This study included 4,580 RRMM patients between 2007 and 2020, and the KRd group showed significantly higher risks of hematologic adverse events (anemia, neutropenia, thrombocytopenia) and some non-hematologic adverse events (cough, hypokalemia, constipation, hypertension, heart failure) compared to the Rd group. Among non-hematologic adverse events, cardiovascular events (heart failure [HR 2.04; 95% CI 1.24–3.35], hypertension [HR 1.58; 95% CI 1.15–2.17]) had the highest risk in the KRd group. Conclusion: The safety profile of carfilzomib in Korean patients was similar to previous RCTs. Therefore, caution should be exercised when using carfilzomib in Asian individuals with RRMM due to the increased risk of cardiovascular adverse events. [ABSTRACT FROM AUTHOR]

Purpose: Major lockdowns were imposed in Germany from March until May 2020 and from December 2020 until May 2021. We studied the influence of these lockdowns, the strain on intensive care units and the strictness of COVID-19-related containment strategies on the utilization of mental health care among patients with severe mental disorders. Methods: We used health insurance claims data to identify n = 736,972 patients with severe mental disorders shortly before the pandemic and n = 735,816 patients a year earlier. We applied entropy balancing to adjust for baseline differences by district. For a 12-month follow-up, we modeled monthly changes in utilization through meta-analytic models using both the COVID-19 stringency index and intensive care unit cases per 100,000 inhabitants as predictors. Our outcomes were changes in psychiatric hospital days and time treated by outpatient psychiatrists. Results: Psychiatric hospital days declined by at least 7.7% in all calender month during the pandemic. Peak reduction rates were observed in April (− 27.9%), May (− 22.3%) 2020 and January 2021 (− 18.3%). Utilization changes were associated with the stringency index and the second lockdown. Time treated by psychiatrists was shorter in April (− 16.2%) and May (− 11.5%) 2020 and in January 2021 (− 10.5%), which was partially offset by higher utilization in June and September 2020. These utilization changes were associated with the stringency index and the strain on intensive care units during both lockdowns. Conclusion: Hospitals did not maintain the level of utilization during the pandemic, while outpatient psychiatrists adapted more quickly, presumably due to digital and telemedical care. [ABSTRACT FROM AUTHOR]

BACKGROUND: The Motor Vehicle Accident (MVA) Fund Botswana compensates claimants who lose their incomes due to road traffic accidents. In Botswana, road traffic accidents are becoming more frequent, and the MVA Fund is experiencing escalating claims. We describe the demographic characteristics of loss of income (LOI) claimants of the MVA Fund Botswana. We assess whether demographic characteristics are related to return to work (RTW). OBJECTIVE: We retrospectively reviewed records of MVA Fund claimants and extracted demographic information. We investigated the demographic profile and the relationship between demographic information and RTW. METHODS: We reviewed 432 LOI claims received by MVA Fund from January 1, 2015 to December 31, 2020. We descriptively analysed the demographic profiles of claimants. We used a univariate analysis and multivariate logistic regression to determine the association between independent demographic variables and the dependent variable, RTW. RESULTS: MVA Fund claimants were on average 37-years-old. Claimants were mostly from low-income socio-economic backgrounds. RTW was significantly associated with injury severity, type of injury, and having a RTW plan offer. The final predictors of RTW, using logistic regression, were time away from work and severity of injury. CONCLUSION: In Botswana, claimants who had severe injuries and who stayed away from work for longer were less likely to RTW. The MVA Fund Botswana must recognise the demographic profiles of claimants which are likely to influence RTW. [ABSTRACT FROM AUTHOR]

Previous studies have shown that treatment of obstructive sleep apnea (OSA) with positive airway pressure (PAP) therapy in patients with depression may improve depression symptoms and response to antidepressant therapy. We investigated the association between PAP therapy adherence, self-harm events, healthcare resource utilization (HCRU), and costs over 2 years in a national sample of patients with pre-existing depression and newly diagnosed comorbid OSA. Administrative claims data were linked to objective PAP therapy usage. Inverse probability treatment weighting was used to compare outcomes over 2 years across PAP adherence levels. The predicted numbers of emergency room (ER) visits and hospitalizations by adherence level were assessed using risk-adjusted generalized linear models. 37,459 patients were included. Relative to non-adherent patients, consistently adherent patients had fewer self-harm events (0.04 vs 0.05, p < 0.001) after 1 year, and significantly (all p < 0.001) fewer ER visits (0.66 vs 0.86) and all-cause hospitalizations (0.13 vs 0.17), and lower total ($11,847 vs $11,955), inpatient hospitalization ($1634 vs $2274), and ER visit ($760 vs $1006) costs per patient in the second year of PAP therapy. Consistently adherent patients showed lower risk for hospitalizations and ER visits. Using observational claims data, we were unable to assess clinical characteristics including sleep, sleepiness, and daytime symptoms, or important social determinants of health. We were limited in assessing care received outside of the included health plans. Consistent adherence to PAP therapy over 2 years was associated with improved HCRU outcomes for patients with pre-existing depression newly diagnosed with comorbid OSA. • Obstructive sleep apnea is highly comorbid in patients with depression. • Positive airway pressure therapy treats obstructive sleep apnea. • Adherence to positive airway pressure therapy reduces occurrence of self-harm. • Adherence to positive airway pressure therapy reduces healthcare use over two years. [ABSTRACT FROM AUTHOR]

Background: This study was designed to identify factors associated with at least one emergency department (ED) visit and those associated without consultation by a general practitioner or paediatrician (GPP) before ED visit. Levels of annual consumption of healthcare services as a function of the number of ED visit were reported. Methods: This retrospective study focused on children < 18 years of age living in mainland France and followed for one-year after their birth or birthday in 2018. Children were selected from the national health data system, which includes data on healthcare reimbursements, long-term chronic diseases (LTD) eligible for 100% reimbursement, and individual complementary universal insurance (CMUc) status granted to households with a low annual income. Adjusted odds ratios (OR) were estimated using multivariate logistic regression. Results: There were 13.211 million children included (94.2% of children; girls 48.8%). At least one annual ED visit was found for 24% (1: 16%, 2: 5%, 3 or more: 3%) and 14% of visits led to hospitalization. Factors significantly associated with at least one ED visit were being a girl (47.1%; OR = 0.92), age < 1 year (9.1%; OR = 2.85), CMUc (22.7%, OR = 1.45), an ED in the commune of residence (33.3%, OR = 1.15), type 1 diabetes (0.25%; OR = 2.4), epilepsy (0.28%; OR = 2.1), and asthma (0.39%; OR = 2.0). At least one annual short stay hospitalisation (SSH) was found for 8.8% children of which 3.4% after an ED visit. A GPP visit the three days before or the day of the ED visit was found for 19% of children (< 1 year: 29%, 14–17 years: 13%). It was 30% when the ED was followed by SSH and 17% when not. Significant factors associated with the absence of a GPP visit were being a girl (OR = 0.9), age (1 year OR = 1.4, 14–17 years OR = 3.5), presence of an ED in the commune of residence (OR = 1.12), epilepsy LTD (OR = 1.1). Conclusion: The low level of visits to GPP prior to a visit to the ED and the associated factors are the elements to be taken into account for appropriate policies to limit ED overcrowding. The same applies to factors associated with a visit to the ED, in order to limit daily variations. [ABSTRACT FROM AUTHOR]

Introduction: Familial hypercholesterolemia is a common genetic condition that significantly increases an individual's risk of cardiovascular events such as heart attack, stroke, and cardiac death and is a candidate for population-wide screening programs. Economic analyses of strategies to identify and treat familial hypercholesterolemia are limited by a lack of real-world cost estimates for screening services and medications for reducing cardiovascular risk in this population. Methods: We estimated the cost of lipid panel testing in patients with hyperlipidemia and the cost of statins, ezetimibe, and PCKS9 inhibitors in patients with familial hypercholesterolemia from a commercial claims database and report costs and charges per panel and prescription by days' supply. Results: The mean cost for a 90-day supply for statins was $183.33, 2.3 times the mean cost for a 30-day supply at $79.35. PCSK9 inhibitors generated the highest mean costs among medications used by patients with familial hypercholesterolemia. Conclusions: Lipid testing and lipid-lowering medications for cardiovascular disease prevention generate substantial real-world costs which can be used to improve cost-effectiveness models of familial hypercholesterolemia screening and care management. [ABSTRACT FROM AUTHOR]

Abstract Background Ultrasound enhancing agents (UEAs) are an invaluable adjunct to stress and transthoracic echocardiography (STE) to improve left ventricular visualization. Despite multiple single center studies evaluating UEA use, investigation into the rates, sources of variation, and outcomes of UEA use on a national level in the United States (US) has been limited by lack of validation of UEA codes for claims analyses. Methods We conducted a retrospective cross-sectional study, 2019–2022, using linked multicenter electronic medical record (EMR) data from > 30 health systems linked to all-payor claims data representing > 90% of the US population. Individuals receiving STE in both EMR and claims data on the same day during the study window were included. UEA receipt as identified by presence of a Current Procedural Terminology (CPT) or National Drug Code (NDC) for UEA use within 1-day of the index STE event. We evaluated the performance of claims to identify UEA use, using EMR data as the gold standard, stratified by inpatient and outpatient status. Results Amongst 54,525 individuals receiving STE in both EMR and claims data, 12,853 (23.6%) had a UEA claim in EMR, 10,461 (19.2%) had a UEA claim in claims, and 9140 (16.8%) had a UEA claim in both within the 1-day window. The sensitivity, specificity, accuracy, positive, and negative predictive values for UEA claims were 71.1%, 96.8%, 90.8%, 87.4%. and 91.6% respectively. However, amongst inpatients, the sensitivity of UEA claims was substantially lower (6.8%) compared to outpatients (79.7%). Conclusions While the overall accuracy of claims to identify UEA use was high, there was substantial under-capture of UEA use by claims amongst inpatients. These results call into question published rates of UEA use amongst inpatients in studies using administrative claims, and highlight ongoing need to improve inpatient coding for UEA use.

Background: Ultrasound enhancing agents (UEAs) are an invaluable adjunct to stress and transthoracic echocardiography (STE) to improve left ventricular visualization. Despite multiple single center studies evaluating UEA use, investigation into the rates, sources of variation, and outcomes of UEA use on a national level in the United States (US) has been limited by lack of validation of UEA codes for claims analyses. Methods: We conducted a retrospective cross-sectional study, 2019–2022, using linked multicenter electronic medical record (EMR) data from > 30 health systems linked to all-payor claims data representing > 90% of the US population. Individuals receiving STE in both EMR and claims data on the same day during the study window were included. UEA receipt as identified by presence of a Current Procedural Terminology (CPT) or National Drug Code (NDC) for UEA use within 1-day of the index STE event. We evaluated the performance of claims to identify UEA use, using EMR data as the gold standard, stratified by inpatient and outpatient status. Results: Amongst 54,525 individuals receiving STE in both EMR and claims data, 12,853 (23.6%) had a UEA claim in EMR, 10,461 (19.2%) had a UEA claim in claims, and 9140 (16.8%) had a UEA claim in both within the 1-day window. The sensitivity, specificity, accuracy, positive, and negative predictive values for UEA claims were 71.1%, 96.8%, 90.8%, 87.4%. and 91.6% respectively. However, amongst inpatients, the sensitivity of UEA claims was substantially lower (6.8%) compared to outpatients (79.7%). Conclusions: While the overall accuracy of claims to identify UEA use was high, there was substantial under-capture of UEA use by claims amongst inpatients. These results call into question published rates of UEA use amongst inpatients in studies using administrative claims, and highlight ongoing need to improve inpatient coding for UEA use. [ABSTRACT FROM AUTHOR]

Introduction: The COVID-19 pandemic has led to a decrease in demand for medical services in Japan, but the utilization of telehealth, which the Japanese government has recently promoted, has seen a temporary increase. This study aims to analyze the trend of telehealth utilization and changes in patient characteristics following the policy response to COVID-19. Methods: This retrospective study analyzed data from 26,152 adult patients who used telehealth for the first time between April 2019 and April 2021 in Mie Prefecture, Japan. An interrupted time series analysis was conducted to evaluate changes in the number of first-time patients before and after April 2020. Results: The number of telehealth users increased by 111.87% after April 2020, but the trend showed a declining slope thereafter. Patient characteristics and disease types showed different trends. The percentage of patients choosing a hospital over a clinic increased for the first time. Conclusions: After the policy response to COVID-19, the number of first-time telehealth users overall increased immediately, but gradually showed a declining trend. However, some diseases have shown both an immediate increase and a continued upward trend in telehealth utilization. Patients with these diseases may be candidates for adopting telehealth services in clinical settings. [ABSTRACT FROM AUTHOR]

Purpose: Treatment for HER2-low [defined as ImmunoHistoChemistry (IHC) 1 + or 2 + and negative/normal in Situ Hybridization (ISH)] breast cancer patients is rapidly evolving, yet we lack critical information about the HER2-low population. Methods: We conducted a retrospective cohort study of women aged 18 years or older diagnosed with breast cancer between 2010 and 2016 in North Carolina. Analyses were conducted for the overall cohort and a stage IV sub-cohort. We examined demographic and clinical characteristics, and characterized prevalence of HER2-low disease and healthcare utilization. We estimated adjusted rate ratios for the association between HER2 classifications and utilization outcomes, and hazard ratios for 3-year all cause mortality (stage IV only). Results: The overall and stage IV cohorts included 12,965 and 635 patients, respectively. HER2-low patients represented more than half of both cohorts (59% overall, 53% stage IV). HER2-low patients were more likely than IHC 0 patients to have hormone receptor (HR)-positive disease. In the stage IV cohort, HER2-low patients were more likely to be Black (26% vs. 16% IHC 0, p = 0.0159). In both cohorts, rates of hospitalizations were slightly higher among HER2-low patients. There were no survival differences between HER2-low and IHC 0 among stage IV patients. Conclusion: New treatment options for HER2-low breast cancer may have potential for significant impact at the population level particularly for patients with stage IV disease. In light of racial differences between HER2-low and IHC 0 patients observed in our cohort, research- and practice-based efforts to ensure equitable adoption of new treatment guidelines for patients with HER2-low metastatic breast cancer will be essential. [ABSTRACT FROM AUTHOR]

Purpose: Describe patient characteristics and pregnancy outcomes among all pregnant patients, and additionally describe infant outcomes among the subset with linked infants in the Maternal Outcomes Masterset (MOM). Methods: We used closed claims within the MOM data to identify publicly and privately insured patients at the first record of pregnancy January 1, 2018–December 1, 2021, with ≥180 days baseline enrollment. We described characteristics during baseline and follow‐up (until an observed pregnancy endpoint, disenrollment, or 42‐week maximum). We described maternal and infant characteristics overall and by infant linkage and contextualized them within national statistics. Results: Among the 1 438 861 pregnant patients meeting the study criteria, the most common pregnancy endpoint recorded was live birth (42%) followed by spontaneous abortion (14%). Among 602 721 patients with a live birth, 99% had a week‐specific gestational age recorded and 35% had at least one linked infant. Patients with infant linkage and sufficient follow‐up (N = 155 621) had similar baseline comorbidities, pregnancy complications, and gestational age at delivery as those without any linkage. However, more patients with linkage had commercial coverage (70% vs. 31%), and were therefore older (50% vs. 31% aged ≥30 years) and more likely to have an unknown race (57% vs. 34%). Conclusions: In this large sample of pregnant patients, maternal and infant characteristics generally align with national statistics, providing confidence in the use of this data source for pregnancy research. Further, confirmation that the subset of patients with infant linkage is similar to the overall pregnancy cohort provides assurance that this subset can be considered representative. [ABSTRACT FROM AUTHOR]

Abstract Background Recently, real‐world data have been recognized to have a significant role for research and quality improvement worldwide. The decision on the existence or nonexistence of postoperative complications is complex in clinical practice. This multicenter validation study aimed to evaluate the accuracy of identification of patients who underwent gastrointestinal (GI) cancer surgery and extraction of postoperative complications from Japanese administrative claims data. Methods We compared data extracted from both the Diagnosis Procedure Combination (DPC) and chart review of patients who underwent GI cancer surgery from April 2016 to March 2019. Using data of 658 patients at Kyoto University Hospital, we developed algorithms for the extraction of patients and postoperative complications requiring interventions, which included an invasive procedure, reoperation, mechanical ventilation, hemodialysis, intensive care unit management, and in‐hospital mortality. The accuracy of the algorithms was externally validated using the data of 1708 patients at two other hospitals. Results In the overall validation set, 1694 of 1708 eligible patients were correctly extracted by DPC (sensitivity 0.992 and positive predictive value 0.992). All postoperative complications requiring interventions had a sensitivity of >0.798 and a specificity of almost 1.000. The overall sensitivity and specificity of Clavien–Dindo ≥grade IIIb complications was 1.000 and 0.995, respectively. Conclusion Patients undergoing GI cancer surgery and postoperative complications requiring interventions can be accurately identified using the real‐world data. This multicenter external validation study may contribute to future research on hospital quality improvement or to a large‐scale comparison study among nationwide hospitals using real‐world data.

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. [ABSTRACT FROM AUTHOR]

Background: Recently, real‐world data have been recognized to have a significant role for research and quality improvement worldwide. The decision on the existence or nonexistence of postoperative complications is complex in clinical practice. This multicenter validation study aimed to evaluate the accuracy of identification of patients who underwent gastrointestinal (GI) cancer surgery and extraction of postoperative complications from Japanese administrative claims data. Methods: We compared data extracted from both the Diagnosis Procedure Combination (DPC) and chart review of patients who underwent GI cancer surgery from April 2016 to March 2019. Using data of 658 patients at Kyoto University Hospital, we developed algorithms for the extraction of patients and postoperative complications requiring interventions, which included an invasive procedure, reoperation, mechanical ventilation, hemodialysis, intensive care unit management, and in‐hospital mortality. The accuracy of the algorithms was externally validated using the data of 1708 patients at two other hospitals. Results: In the overall validation set, 1694 of 1708 eligible patients were correctly extracted by DPC (sensitivity 0.992 and positive predictive value 0.992). All postoperative complications requiring interventions had a sensitivity of >0.798 and a specificity of almost 1.000. The overall sensitivity and specificity of Clavien–Dindo ≥grade IIIb complications was 1.000 and 0.995, respectively. Conclusion: Patients undergoing GI cancer surgery and postoperative complications requiring interventions can be accurately identified using the real‐world data. This multicenter external validation study may contribute to future research on hospital quality improvement or to a large‐scale comparison study among nationwide hospitals using real‐world data. [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]

ObjectiveTo investigate the use of repurposed and adjuvant drugs in patients admitted to hospital with covid-19 across three continents.DesignMultinational network cohort study.SettingHospital electronic health records from the United States, Spain, and China, and nationwide claims data from South Korea.Participants303 264 patients admitted to hospital with covid-19 from January 2020 to December 2020.Main outcome measuresPrescriptions or dispensations of any drug on or 30 days after the date of hospital admission for covid-19.ResultsOf the 303 264 patients included, 290 131 were from the US, 7599 from South Korea, 5230 from Spain, and 304 from China. 3455 drugs were identified. Common repurposed drugs were hydroxychloroquine (used in from

BACKGROUND: The National Comprehensive Cancer Network and American Society of Clinical Oncology recommend consideration of the use of echocardiography 6 to 12 months after completion of anthracycline-based chemotherapy in at-risk populations. Assessment of BNP (B-type natriuretic peptide) has also been suggested by the American College of Cardiology/American Heart Association/Heart Failure Society of America for the identification of Stage A (at risk) heart failure patients. The real-world frequency of the use of these tests in patients after receipt of anthracycline therapy, however, has not been studied previously. METHODS AND RESULTS: In this retrospective study, using administrative claims data from the OptumLabs Data Warehouse, we identified 31 447 breast cancer and lymphoma patients (age ≥18 years) who were treated with an anthracycline in the United States between January 1, 2008 and January 31, 2018. Continuous medical and pharmacy coverage was required for at least 6 months before the initial anthracycline dose and 12 months after the final dose. Only 36.1% of patients had any type of cardiac surveillance (echocardiography, BNP, or cardiac imaging) in the year following completion of anthracycline therapy (29.7% echocardiography). Surveillance rate increased from 37.5% in 2008 to 42.7% in 2018 (25.6% in 2008 to 40.5% echocardiography in 2018). Lymphoma patients had a lower likelihood of any surveillance compared with patients with breast cancer (odds ratio, 0.79 [95% CI, 0.74-0.85]; P50% rate of surveillance. CONCLUSIONS: The majority of survivors of breast cancer and lymphoma who have received anthracycline-based chemotherapy do not undergo cardiac surveillance after treatment, including those with a history of cardiovascular comorbidities, such as heart failure.

Abstract Background We aimed to evaluate the factors associated with baloxavir prescription in Japanese hospitals using a health insurance claim-based database (MDV analyzer), during the 2018/2019 and 2019/2020 influenza seasons. The MDV analyzer contains anonymized claims data from approximately 420 Diagnosis Procedure Combination hospitals, and does not contain data from clinics. Methods Data were collected for influenza patients treated with anti-influenza drugs during the 2018/2019 and 2019/2020 influenza seasons. Multivariate analysis was used to identify factors associated with baloxavir prescription. Results During the study period, 322,063 influenza patients were included for analyses. In multivariate analysis, children, female sex, inpatient, hospital bed capacity, and private hospitals were negatively associated with baloxavir prescription. Compared to elderly patients, the adjusted odds ratio (OR) for baloxavir prescription was 0.612 (95% confidence interval (CI), 0.587–0.637) in children aged 6–11 years, and 0.119 (95% CI, 0.111–0.128) in children aged 0–5 years. Compared to small hospitals (bed capacity, 20–299), the adjusted OR for baloxavir prescription was 0.559 (95% CI, 0.540–0.578) in large hospitals (bed capacity, ≥ 500). Conclusion Children, female sex, inpatient, hospital bed capacity, and private hospitals were negatively associated with baloxavir prescription.

Abstract Background There is limited evidence on the clinical and economic benefit of achieving disease control in psoriatic arthritis (PsA) and ankylosing spondylitis (AS), thus we aimed to assess the impact of disease control on healthcare resource use (HCRU) and direct medical costs among US patients with PsA or AS over 1 year. Methods Data were derived from the US OM1 PsA/AS registries (PsA: 1/2013–12/2020; AS: 01/2013–4/2021) and the Optum Insight Clinformatics® Data Mart to identify adult patients with PsA or AS. Two cohorts were created: with disease control and without disease control. Disease control was defined as modified Disease Activity Index for Psoriatic Arthritis (DAPSA28) ≤ 4 for PsA and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

Abstract Background Dystrophic epidermolysis bullosa (DEB) is a serious, ultra-rare, genetic blistering disease that requires a multidisciplinary care team and lifelong, proactive disease management. To organize and optimize care, we comprehensively examined diagnoses, healthcare use, and annual costs in patients with DEB across all healthcare settings. Methods A retrospective study was performed using electronic health record (EHR) data from Optum Clinical Database (January 1, 2016, through June 30, 2020). Patients with an epidermolysis bullosa (EB) diagnosis between July 1, 2016, and December 31, 2019, with ≥ 6 months of baseline and 12 months of follow-up activity were included. Patients were stratified by EB type: recessive DEB (RDEB), dominant DEB (DDEB), DEB (type unknown), and EB unspecified. Demographics, comorbid conditions, and healthcare resource utilization were identified from EHR data. Cost of bandages and total medical costs (US$) were identified from linked claims data. Results A total of 412 patients were included, classified as having DDEB (n = 17), RDEB (n = 85), DEB (type unknown; n = 45), and EB unspecified (n = 265). Mean age was 38.4 years, and 41.7% had commercial insurance coverage. The most common comorbidities were mental health disorders, malnutrition, and constipation. Rates of cutaneous squamous cell carcinoma ranged from 0% (DDEB) to 4.4% (RDEB). Prescriptions included antibiotics (56.6%), pain medications (48.3%), and itch medications (50.7%). On average, patients had 19.7 ambulatory visits during the 12-month follow-up, 22.8% had an emergency department visit, and 23.8% had an inpatient stay. Direct medical costs among patients with claims data (n = 92) ranged from $22,179 for EB unspecified to $48,419 for DEB (type unknown). Conclusions This study demonstrated the range of comorbidities, multiple healthcare visits and prescription medications, and treatment costs during 1 year of follow-up for patients with DEB. The results underscore that the clinical and economic burden of DEB is substantial and primarily driven by supportive and palliative strategies to manage sequelae of this disease, highlighting the unmet need for treatments that instead directly address the underlying pathology of this disease.

Abstract 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.

Purpose: To estimate survival of acetabular fracture repair by tracking patients across healthcare encounters. We hypothesized that hip survival estimated this way would be lower than reported by single-surgeon or single-center series not capturing censored reoperations. Methods: Retrospective health insurance administrative database cohort study. All claimed healthcare encounters for employer-sponsored health insurance beneficiaries aged 18−65 years without pre-existing hip pathology with a newly diagnosed acetabular fracture were identified between October 1, 2015, through December 31, 2018. The intervention was open reduction internal fixation of acetabular fracture during index admission. The primary outcome was survival of the acetabular fracture repair to subsequent reoperation by arthroscopy, arthrotomy for drainage of infection, implant removal, revision acetabular fixation, hip arthroplasty, hip resection, or arthrodesis. Results: 38 reoperation procedures on the fractured acetabulum in 852 patients occurred within 2 years (incidence 4.5%). Total hip arthroplasty (2.5%) and revision internal fixation (1.5%) accounted for most early reoperations. Multivariable Cox regression identified an association between reoperation and increasing patient age (hazard ratio = 1.4 per decade, p < 0.01). The prevalence of any mental health condition was 29%. Conclusions: Non-elderly adults with employer-sponsored insurance who sustain acetabular fractures have a greater burden of mental health disease than similarly insured patients without these injuries. Survival of the native acetabulum after fracture fixation exceeded 95% at 2 years and decreased with increasing patient age. Level of evidence: Level III, Prognostic Study. [ABSTRACT FROM AUTHOR]

Purpose: To determine the accuracy of International Classification of Diseases‐ Tenth Revision (ICD‐10) diagnosis codes for rheumatoid arthritis (RA) serostatus using a U.S. claims database (Optum Clinformatics Data Mart, Optum) and to compare the results to a previous validation study performed in IBM Marketscan Research Database (sensitivity 73%, positive predictive value, PPV, 84%). Methods: In Optum (01/01/2016–03/31/2020) linked with laboratory results, we selected RA patients based on ≥2 ICD‐10 diagnosis codes for RA (M05 or M06) and at least one dispensing of RA treatments. We included individuals with at least one laboratory result for rheumatoid factor (RF) or anti‐cyclic citrullinated peptide (CCP) performed 365 days prior to and including the cohort entry date. An individual was "seropositive" if at least one of the 2 diagnosis codes used to define RA status was M05. "Seronegative" patients were required to have only M06. Secondary analyses were performed using subsets of M05 and M06 diagnosis codes. We calculated the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and kappa of M05 and M06 against the prespecified reference standard laboratory data. Results: We identified 14 490 adult RA patients who had at least 1 RF or anti‐CCP result. The number of patients identified for each reference standard definition ranged from 3315 (reference standard definition: high + anti‐CCP) to 13 636 (any + RF). PPV for seropositive RA, M05, was 77.1%. The PPV of M06 for seronegative RA was 61.6%. When we applied more restricted definitions of M05 and M06, the PPV for seropositive RA increased to 79.2%. The PPV for seronegative RA also notably increased to 89.5%. Conclusion: ICD‐10 codes (M05 and M06) can help identify RA serostatus in claims data, but their limitations should be acknowledged. The PPVs for seropositive and seronegative RA found in the Optum database were lower than those found in MarketScan, perhaps related to database variability or differing patient characteristics and clinical practice. When more restricted definitions of M05 and M06 were used, the PPVs for seropositive and seronegative RA improved to 79.2% and 89.5%, respectively. [ABSTRACT FROM AUTHOR]

Background: A prehospital delay from symptom onset to hospital arrival resulted in stroke-related complications or in-hospital deaths in acute stroke patients. We aimed to investigate trends in prehospital visits as a cause of prehospital delay using data from the Korean Health Insurance Service. Methods: This nationwide, population-based, retrospective cohort study included 524,524 newly-diagnosed stroke patients admitted via the emergency departments of secondary and tertiary hospitals. We obtained the prehospital visits rate from 2010 to 2019 and identified the related characteristics. Results: Prehospital visits were observed in 111,465 patients (21.3%). The prehospital visits rate decreased from 25.1% in 2010 to 17.8% in 2019, but the number of patients increased from 11,255 cases in 2010 to 11,747 cases in 2019. Fortunately, the rate of delayed admission for more than one day decreased from 26.7% to 21.3%. However, 10.4% of patients were diagnosed more than two days later. Young, females, or patients with higher income status and living in low urbanization areas exhibited a higher rate of prehospital visits. Conclusions: Prehospital visits in Korean stroke patients decreased from 25.1% in 2010 to 17.8% in 2019. However, more than 10,000 patients still visited other medical institutions before admission to treatment. [ABSTRACT FROM AUTHOR]

Background Widespread implementation of immune checkpoint inhibitors (ICI) and targeted therapies for metastatic melanoma has led to a decline in melanoma-related mortality but increased healthcare costs. We aimed to determine how healthcare utilization varied by systemic, non-adjuvant melanoma treatment from 2016 to 2020. Patients and Methods Adults with presumed stage IV metastatic melanoma receiving systemic therapy from 2016 to 2020 were identified in Optum, a nationwide commercial claims database. Treatment groups were nivolumab, pembrolizumab, ipilimumab+nivolumab (combination-ICI), or BRAF+MEK inhibitor (BRAFi+MEKi) therapy. Outcomes included hospitalizations, days hospitalized, emergency room (ER) visits, outpatient visits, and healthcare costs per patient per month (pppm). Multivariable regression models were used to analyze whether cost and utilization outcomes varied by treatment group, with nivolumab as reference. Results Among 2018 adult patients with metastatic melanoma identified, mean (SD) age was 67 (15) years. From 2016 to 2020, nivolumab surpassed pembrolizumab as the most prescribed systemic melanoma therapy while combination-ICI and BRAFi+MEKi therapies remained stable. Relative to nivolumab, all other therapies were associated with increased total healthcare costs (combination-ICI: β = $47 600 pppm, 95%CI $42 200-$53 100; BRAFi+MEKi: β = $3810, 95%CI $365-$7260; pembrolizumab: β = $6450, 95%CI $4420-$8480). Combination-ICI and BRAFi+MEKi therapies were associated with more inpatient hospital days. Conclusions Amid the evolving landscape of systemic therapy for advanced melanoma, nivolumab monotherapy emerged as the most used and least costly systemic treatment from 2016 to 2020. Its sharp increase in use in 2018 and lower costs relative to pembrolizumab may in part be due to earlier adoption of less frequent dosing intervals. [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

Background and objectiveEarly detection methods for pancreatic cancer are lacking. We aimed to develop a prediction model for pancreatic cancer based on changes in health captured by healthcare claims data.MethodsWe conducted a case-control study on 29,646 Medicare-enrolled patients aged 68 years and above with pancreatic ductal adenocarcinoma (PDAC) reported to the Surveillance Epidemiology an End Results (SEER) tumor registries program in 2004-2011 and 88,938 age and sex-matched controls. We developed a prediction model using multivariable logistic regression on Medicare claims for 16 risk factors and pre-diagnostic symptoms of PDAC present within 15 months prior to PDAC diagnosis. Claims within 3 months of PDAC diagnosis were excluded in sensitivity analyses. We evaluated the discriminatory power of the model with the area under the receiver operating curve (AUC) and performed cross-validation by bootstrapping.ResultsThe prediction model on all cases and controls reached AUC of 0.68. Excluding the final 3 months of claims lowered the AUC to 0.58. Among new-onset diabetes patients, the prediction model reached AUC of 0.73, which decreased to 0.63 when claims from the final 3 months were excluded. Performance measures of the prediction models was confirmed by internal validation using the bootstrap method.ConclusionModels based on healthcare claims for clinical risk factors, symptoms and signs of pancreatic cancer are limited in classifying those who go on to diagnosis of pancreatic cancer and those who do not, especially when excluding claims that immediately precede the diagnosis of PDAC.

OBJECTIVE: To examine the effects of provider choice policies on workers compensation medical and indemnity costs. DATA SOURCES/STUDY SETTING: Pooled cross-sectional analysis of administrative claims records for workers with work-related injuries primarily in 2007-2010 across 25 states (n = 4,489,729). STUDY DESIGN: We used linear and quantile regression analyses to evaluate differences in claim costs (medical and indemnity) based on whether policies give employers or injured workers control over the choice of provider. PRINCIPAL FINDINGS: We find no difference in average medical costs by provider choice policies, although a distributional analysis indicates higher developed medical costs for the costliest back injury cases in states where workers control provider choice. The evidence for indemnity costs is similar, although the point estimates also indicate (statistically insignificantly) higher average costs when policies give workers more control of the choice of provider. CONCLUSIONS: Our nuanced evidence suggests that policymakers seeking to reduce workers compensation costs may need to focus on the highest cost cases in states where policy gives workers more control over the choice of provider, rather than the simpler and broader issue of whether policy gives workers or employers more control.

PurposeCancer ascertainment using large-scale electronic health records is a challenge. Our aim was to propose and apply a structured approach for evaluating multiple candidate approaches for cancer ascertainment using colorectal cancer (CRC) ascertainment within the US Department of Veterans Affairs (VA) as a use case.MethodsThe proposed approach for evaluating cancer ascertainment strategies includes assessment of individual strategy performance, comparison of agreement across strategies, and review of discordant diagnoses. We applied this approach to compare three strategies for CRC ascertainment within the VA: administrative claims data consisting of International Classification of Diseases, Ninth Revision (ICD9) diagnosis codes; the VA Central Cancer Registry (VACCR); and the newly accessible Oncology Domain, consisting of cases abstracted by local cancer registrars. The study sample consisted of 1,839,043 veterans with index colonoscopy performed from 1999 to 2014. Strategy-specific performance was estimated based on manual record review of 100 candidate CRC cases and 100 colonoscopy controls. Strategies were further compared using Cohen's κ and focused review of discordant CRC diagnoses.ResultsA total of 92,197 individuals met at least one CRC definition. All three strategies had high sensitivity and specificity for incident CRC. However, the ICD9-based strategy demonstrated poor positive predictive value (58%). VACCR and Oncology Domain had almost perfect agreement with each other (κ, 0.87) but only moderate agreement with ICD9-based diagnoses (κ, 0.51 and 0.57, respectively). Among discordant cases reviewed, 15% of ICD9-positive but VACCR- or Oncology Domain-negative cases had incident CRC.ConclusionEvaluating novel strategies for identifying cancer requires a structured approach, including validation against manual record review, agreement among candidate strategies, and focused review of discordant findings. Without careful assessment of ascertainment methods, analyses may be subject to bias and limited in clinical impact.

Real-world evidence in multiple sclerosis (MS) is limited by the availability of data elements in individual real-world datasets. We introduce a novel, growing database which links administrative claims and medical records from an MS patient management system, allowing for the complete capture of patient profiles. Using the AOK PLUS sickness fund and the Multiple Sclerosis Documentation System MSDS3D from the Center of Clinical Neuroscience (ZKN) in Germany, a linked MS-specific database was developed (MSDS-AOK PLUS). Patients treated at ZKN and insured by AOK PLUS were recruited and asked for informed consent. For linkage, insurance IDs were mapped to registry IDs. After the deletion of insurance IDs, an anonymized dataset was provided to a university-affiliate, IPAM e.V., for further research applications. The dataset combines a complete record of patient diagnoses, treatment, healthcare resource use, and costs (AOK PLUS), with detailed clinical parameters including functional performance and patient-reported outcomes (MSDS3D). The dataset currently captures 500 patients; however, is actively expanding. To demonstrate its potential, we present a use case describing characteristics, treatment, resource use, and costs of a patient subsample. By linking administrative claims to clinical information in medical charts, the novel MSDS-AOK PLUS database can increase the quality and scope of real-world studies in MS. [ABSTRACT FROM AUTHOR]

Background: There is limited evidence on the clinical and economic benefit of achieving disease control in psoriatic arthritis (PsA) and ankylosing spondylitis (AS), thus we aimed to assess the impact of disease control on healthcare resource use (HCRU) and direct medical costs among US patients with PsA or AS over 1 year. Methods: Data were derived from the US OM1 PsA/AS registries (PsA: 1/2013–12/2020; AS: 01/2013–4/2021) and the Optum Insight Clinformatics® Data Mart to identify adult patients with PsA or AS. Two cohorts were created: with disease control and without disease control. Disease control was defined as modified Disease Activity Index for Psoriatic Arthritis (DAPSA28) ≤ 4 for PsA and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) < 4 for AS. Outcomes were all-cause inpatient, outpatient, and emergency department (ED) visits and associated costs over a 1-year follow-up period. Mean costs per person per year (PPPY) were assessed descriptively and adjusted odds ratios (aOR) with 95% confidence intervals (CI) were estimated for the likelihood of HCRU by logistic regression. Results: The study included 1235 PsA (with disease control: N = 217; without: N = 1018) and 581 AS patients (with disease control: N = 342; without: N = 239). Patients without disease control were more likely to have an inpatient (aOR [95% CI]; PsA: 3.0 [0.9, 10.1]; AS: 7.7 [2.3, 25.1]) or ED (PsA: 1.6 [0.6, 4.2]; AS: 3.5 [1.5, 8.3]) visit than those with disease control. Those without disease control, vs. those with disease control, had greater PPPY costs associated with inpatient (PsA: $1550 vs. $443), outpatient (PsA: $1789 vs. $1327; AS: $2498 vs. $2023), and ED (PsA: $114 vs. $57; AS: $316 vs. $50) visits. Conclusions: Findings from this study demonstrate lower disease activity among patients with PsA and AS is associated with less HCRU and lower costs over the following year. [ABSTRACT FROM AUTHOR]

Ranking antidepressants according to their acceptability (i.e., a combination of both efficacy and tolerability) in the general population may help choosing the best first-line medication. This study aimed to replicate the results of a proof-of-concept study ranking anti-depressants according to the proportion of filled prescription sequences consistent with a continuation of the first treatment versus those consistent with a change. We used a nationwide cohort from the French national health data system (SNDS) to support the use of this method as a widely available tool to rank antidepressant treatments in real life settings. About 1.2 million people were identified as new antidepressant users in the SNDS in 2011. The outcome was clinical acceptability as measured by the continuation/failure ratio over the six-month period following the introduction of the first-line treatment. Continuation was defined as at least two refills of the same treatment. Failure was defined as a psychiatric hospitalization, death or at least one filled prescription of another antidepressant, an antipsychotic medication, or a mood-stabilizer. Adjusted Odds Ratios (aOR) and 95% Confidence Interval (CI) were computed through multivariable binary logistic regressions. We ranked antidepressant medications according to clinical acceptability. Escitalopram again was the most acceptable option, and the five following antidepressants were the same as in the replication sample of the proof-of-concept study, in order Fluoxetine, Paroxetine, Sertraline, Citalopram and Venlafaxine with aOR (95% CI) for continuation ranging from 0.79 (0.77–0.81) to 0.66 (0.64–0.67). The present study provides evidence that filled prescription sequences is a widely available, robust and reproductible tool to rank antidepressant treatments in real life settings. [ABSTRACT FROM AUTHOR]

BACKGROUND: Novel agents approved for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), including acalabrutinib, duvelisib, ibrutinib, idelalisib, and venetoclax, have been shown to improve survival, but they may also be associated with cardiovascular (CV) events, which can increase the total costs to the healthcare system. OBJECTIVE: To analyze the prevalence of CV events and the real-world healthcare costs associated with such events in patients with CLL/SLL who received a novel agent. METHODS: In this retrospective, observational study we compared the healthcare costs between patients with CLL/SLL who were receiving one of the novel agents and either had or did not have a claim for a CV event during the first year of treatment, using IBM MarketScan Commercial and Medicare US claims data. Patients were divided into 2 cohorts, a CV disease (CVD) cohort and a no-CVD cohort, based on the presence or absence of CV events. Patients aged =18 years with CLL/SLL who received one of the novel agents between November 2013 and November 2019 and had continuous health insurance for 6 months before initiating treatment with the novel agent were included in the analysis. All-cause healthcare costs were calculated per patient per month (PPPM) and annually for a variable-length follow-up period. RESULTS: Of 1886 patients with CLL/SLL who received novel agents for a median follow-up of 12 months, 27.7% had claims for a CV event that occurred at a mean of 103 days after novel agent initiation. Almost half (47.1%) of the CVD cohort had a CV event before a novel agent initiation. Allcause annual healthcare costs were $216,573 in the CVD cohort and $184,055 in the no-CVD cohort (P <.001). The main drivers for total healthcare costs differed in the pre- and post-CV event periods, with PPPM cost contributions from pharmacy (75% vs 39%, respectively), outpatient services (18% vs 22%, respectively), and hospitalization (8% vs 39%, respectively). CONCLUSION: The total healthcare costs for patients with CLL/SLL were higher for those who had a CV event than for patients without a CV event. To avoid early discontinuation of highly effective treatments, and to reduce the total healthcare costs for patients, it is important to reduce CV events in patients with CLL/SLL. [ABSTRACT FROM AUTHOR]

Background: We aimed to evaluate the factors associated with baloxavir prescription in Japanese hospitals using a health insurance claim-based database (MDV analyzer), during the 2018/2019 and 2019/2020 influenza seasons. The MDV analyzer contains anonymized claims data from approximately 420 Diagnosis Procedure Combination hospitals, and does not contain data from clinics. Methods: Data were collected for influenza patients treated with anti-influenza drugs during the 2018/2019 and 2019/2020 influenza seasons. Multivariate analysis was used to identify factors associated with baloxavir prescription. Results: During the study period, 322,063 influenza patients were included for analyses. In multivariate analysis, children, female sex, inpatient, hospital bed capacity, and private hospitals were negatively associated with baloxavir prescription. Compared to elderly patients, the adjusted odds ratio (OR) for baloxavir prescription was 0.612 (95% confidence interval (CI), 0.587–0.637) in children aged 6–11 years, and 0.119 (95% CI, 0.111–0.128) in children aged 0–5 years. Compared to small hospitals (bed capacity, 20–299), the adjusted OR for baloxavir prescription was 0.559 (95% CI, 0.540–0.578) in large hospitals (bed capacity, ≥ 500). Conclusion: Children, female sex, inpatient, hospital bed capacity, and private hospitals were negatively associated with baloxavir prescription. [ABSTRACT FROM AUTHOR]

The excess cancer mortality in persons with severe mental illness (SMI) has been well documented, and research suggests that it may be influenced by care-related factors. Our objective was to assess breast cancer care pathways in women with SMI in France, using an exhaustive population-based data-linkage study with a matched case-control design. The cases were 1346 women with incident breast cancer in 2013/2014 and preexisting SMI who were matched with three controls without SMI presenting similar demographics, initial breast cancer type, and year of incidence. We compared cancer care pathways and their quality for cases and controls, using a consensual set of indicators covering diagnosis, treatment, follow-up, and mortality (until 2017). After adjusting for covariates, cases had lower odds to undergo the main diagnostic tests, lumpectomy, adjuvant chemotherapy, and radiotherapy, as well as hormone therapy, but higher odds for mastectomy. Suboptimal quality in cancer pathways was observed for both groups, but to a higher extent for cases, especially for not receiving timely care after diagnosis and post-treatment follow-up. Breast cancer mortality, considering competing risks of deaths, was significantly elevated in women with SMI. These findings highlight disparities in cancer care pathways for individuals with SMI, as well as specific aspects of the care continuum which could benefit from targeted actions to reach equity of outcomes. [ABSTRACT FROM AUTHOR]

Introduction: Prevention, identification, analysis and reduction of adverse events (AEs) are all activities designed to increase safety of care in the clinical setting. Closed claims reviews are a strategy that allows to identify patient safety issues. This study analyzes adverse events resulting in malpractice lawsuits against anesthesiologists affiliated to an insurance fund in Colombia between 2013-2019. Objective: To analyze adverse events in closed medicolegal lawsuits against anesthesiologists affiliated to an insurance fund between 2013-2019. Methods: Cross-sectional observational study. Convenience sampling was used, including all closed claims in which anesthesiologists affiliated to an insurance fund in Colombia were sued during the observation period. Variables associated with the occurrence of AEs were analyzed. Results: Overall, 71 claims were analyzed, of which 33.5% were due to anesthesia-related AEs. Adverse events were found more frequently among ASA I-II patients (78.9%), and in surgical procedures (95.8%). The highest number of adverse events occurred in plastic surgery (29.6%); the event with the highest proportion was patient death (43.7%). Flaws in clinical records and failure to comply with the standards were found in a substantial number of cases. Conclusions: When compared with a previously published study in the same population, an increase in ethical, disciplinary and administrative claims was found, driven by events not directly related to anesthesia. Most of the anesthesia-related events occurred in the operating room during surgical procedures in patients and procedures categorized as low risk, and most of them were preventable. [ABSTRACT FROM AUTHOR]

Among children younger than 18 years, the prevalence of long-term chronic diseases (LTDs) is not well known in France, nor the frequency of the use of healthcare services. This nationwide observational study focused on both topics over a 1-year period following the birth or birthday of French children in 2018 and compared the LTD status and use of healthcare. We selected children living in mainland France from the national health data system (SNDS). It includes data concerning the LTD status, which guarantees 100% reimbursement for related healthcare expenditures. We calculated the median and interquartile range (IQR) for the prevalence of LTDs and the rate of children using healthcare services at least once during the year. We included 13.211 million children (51.2% boys), of whom 4% had at least one LTD (boys: 4.6%, girls: 3.3%). Mental and behavioral disorders were the most frequent cause (1.6%). At least one visit to a general practitioner (GP) or pediatrician was found for 88% of children (median: 3, IQR: 2–6): 98% for children under 1 year of age and 81% for children aged 14–17 years. A pediatrician was visited by 17% of children, another specialist by 39%, a dentist by 37%, with peaks of about 60% at the ages of 6, 9, and 12 years; 8% visited a nurse and 7% visited a physiotherapist. At least one emergency department visit was recorded for 24% of children (42% <1 year) and one short-stay hospitalization (SSH) for 9%. Regional variations were observed. Children with LTDs more frequently used all services, such as specialist visits (50% vs. 40%), ED visits (32% vs. 23%), SSHs (26% vs. 8% and 15% vs. 4.0% for one night or more), and psychiatric hospital admissions (5% vs. 0.1%). Most children saw a GP or pediatrician during the year and children with an LTD showed more frequent use. Nevertheless, outpatient visits appeared to be underutilized with respect to recommendations or free-of-charge prevention visits, such as for dentists. More detailed studies are required to identify factors associated with the use of healthcare services in France, for example, studies including the deprivation index and regional variations. [ABSTRACT FROM AUTHOR]

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. 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. 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). 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. [ABSTRACT FROM AUTHOR]

Background: Acquired hemophilia A (AHA) is a rare disorder, and clinical practices for treating AHA have not been fully clarified in Japan. Objectives: This study aims to investigate the epidemiology of AHA and real-world treatment practices in Japan. Patients/methods: This observational study was based on a health administrative database of hospitalized patients diagnosed with AHA who were treated with immunosuppressants. Results: The study included 214 males and 124 females (mean age 75.7 years). The most frequently used bypassing agent was recombinant activated factor VII. The predominant choice of immunosuppressant for first-line treatment was steroid monotherapy. Median days from the index date to the start of rehabilitation was 65.0 for cardiovascular, 35.5 for respiratory and 23.0 for locomotor. The proportion of patients with an activities of daily living (ADL) score < 70 points was high at both first admission and final discharge (47.4% and 38.8%). The percentage of deaths during hospitalization was 18.6%. Conclusions: This study clarified the treatment patterns and clinical outcomes of AHA in a large population in Japan. This was the first study showing ADL score distribution and time to rehabilitation. Further investigation is needed to develop better clinical practices for treatment of AHA. [ABSTRACT FROM AUTHOR]