Monitoring Pregnancies Exposed to Galcanezumab for Migraine in a United States Administrative Claims Database.

PURPOSE: Galcanezumab is a calcitonin gene-related peptide monoclonal antibody indicated for migraine prevention in adults. Due to the long half-life of galcanezumab and the prevalence of migraine in women of childbearing age, galcanezumab exposure may occur during pregnancy. However, real-world use and safety of galcanezumab during pregnancy has not been fully described. To help fill this gap, galcanezumab has two ongoing pregnancy safety studies, one of which is an insurance claims database study. METHODS: This database study is actively identifying and following pregnancies exposed to galcanezumab using commercial claims from the Healthcare Integrated Research Database (HIRD). Patient accrual is planned from September 2018 to June 2026, with a final study report planned for December 2027. This study requires 430 galcanezumab-exposed pregnancies with linked infants to reach power for comparative analysis of major congenital malformations. RESULTS: Recent monitoring of patient accrual, including data from 28 September 2018 to 31 January 2023, identified 207 galcanezumab-exposed pregnancies in women with migraine in the HIRD, of which 110 were live births and 73 of which were linked to an infant. This represents an annual accrual rate of approximately 17 pregnancies linked to infants, which is substantially lower than the 55 required annually to reach target size within current regulatory-committed study timelines. CONCLUSIONS: The accrual of a sufficient number of galcanezumab-exposed pregnancies represents a substantial, but not uncommon, barrier to conducting comparative analyses in pregnancy studies. Potential solutions that would allow for timely dissemination of important safety information to patients and providers may be available.

Applying machine learning approaches for predicting obesity risk using US health administrative claims database.

INTRODUCTION: Body mass index (BMI) is inadequately recorded in US administrative claims databases. We aimed to validate the sensitivity and positive predictive value (PPV) of BMI-related diagnosis codes using an electronic medical records (EMR) claims-linked database. Additionally, we applied machine learning (ML) to identify features in US claims databases to predict obesity status. RESEARCH DESIGN AND METHODS: This observational, retrospective analysis included 692 119 people ≥18 years of age, with ≥1 BMI reading in MarketScan Explorys Claims-EMR data (January 2013-December 2019). Claims-based obesity status was compared with EMR-based BMI (gold standard) to assess BMI-related diagnosis code sensitivity and PPV. Logistic regression (LR), penalized LR with L1 penalty (Least Absolute Shrinkage and Selection Operator), extreme gradient boosting (XGBoost) and random forest, with features drawn from insurance claims, were trained to predict obesity status (BMI≥30 kg/m2) from EMR as the gold standard. Model performance was compared using several metrics, including the area under the receiver operating characteristic curve. The best-performing model was applied to assess feature importance. Obesity risk scores were computed from the best model generated from the claims database and compared against the BMI recorded in the EMR. RESULTS: The PPV of diagnosis codes from claims alone remained high over the study period (85.4-89.2%); sensitivity was low (16.8-44.8%). XGBoost performed the best at predicting obesity with the highest area under the curve (AUC; 79.4%) and the lowest Brier score. The number of obesity diagnoses and obesity diagnoses from inpatient settings were the most important predictors of obesity. XGBoost showed an AUC of 74.1% when trained without an obesity diagnosis. CONCLUSIONS: Obesity prevalence is under-reported in claims databases. ML models, with or without explicit obesity, show promise in improving obesity prediction accuracy compared with obesity codes alone. Improved obesity status prediction may assist practitioners and payors to estimate the burden of obesity and investigate the potential unmet needs of current treatments.

Stroke Research Using Administrative Claims Database in Japan: A Narrative Review.

AIMS: Although administrative claims databases have recently been used for clinical research in Japan, no detailed description of their utilization in stroke research is available. We reviewed stroke studies using the Diagnosis Procedure Combination (DPC), the National Database of Health Insurance Claims and Specific Health Checkups (NDB), and several commercial databases sourced from social health insurance associations, focusing on their applications and limitations. METHODS: Original articles on stroke published by April 2024 using the DPC, NDB, and commercial databases were identified in Ovid MEDLINE. The characteristics of each database were compared in terms of comprehensiveness, traceability, baseline information, and outcome assessment in stroke research. RESULTS: A total of 114 studies were included (83 for DPC, 6 for NDB, and 25 for commercial databases). The number of stroke studies using administrative databases in Japan is still approximately 10 per year, although there is a slowly increasing trend. The DPC database was utilized for short-term outcome studies because of its detailed baseline and outcome information, although the inability to track patients once they changed facilities limits their use in long-term studies. The NDB database is potentially useful for long-term studies because of its comprehensiveness and traceability, but difficulties in data access restrict its usage. The most commonly used commercial database utilizes baseline information on lifestyle and blood test data, although the lack of coverage for those over 75 years old may limit its generalizability. CONCLUSIONS: Administrative claims databases are beginning to be used in stroke research in Japan but are not yet fully utilized. Researchers need to understand their applications and limitations.

Montelukast as a repurposable additive drug for standard-efficacy multiple sclerosis treatment: Emulating clinical trials with retrospective administrative health claims data.

BACKGROUND: Effective and safe treatment options for multiple sclerosis (MS) are still needed. Montelukast, a leukotriene receptor antagonist (LTRA) currently indicated for asthma or allergic rhinitis, may provide an additional therapeutic approach. OBJECTIVE: The study aimed to evaluate the effects of montelukast on the relapses of people with MS (pwMS). METHODS: In this retrospective case-control study, two independent longitudinal claims datasets were used to emulate randomized clinical trials (RCTs). We identified pwMS aged 18-65 years, on MS disease-modifying therapies concomitantly, in de-identified claims from Optum's Clinformatics® Data Mart (CDM) and IQVIA PharMetrics® Plus for Academics. Cases included 483 pwMS on montelukast and with medication adherence in CDM and 208 in PharMetrics Plus for Academics. We randomly sampled controls from 35,330 pwMS without montelukast prescriptions in CDM and 10,128 in PharMetrics Plus for Academics. Relapses were measured over a 2-year period through inpatient hospitalization and corticosteroid claims. A doubly robust causal inference model estimated the effects of montelukast, adjusting for confounders and censored patients. RESULTS: pwMS treated with montelukast demonstrated a statistically significant 23.6% reduction in relapses compared to non-users in 67.3% of emulated RCTs. CONCLUSION: Real-world evidence suggested that montelukast reduces MS relapses, warranting future clinical trials and further research on LTRAs' potential mechanism in MS.

Validating methods used to identify non-adherence adverse drug events in Canadian administrative health data.

AIMS: Medication non-adherence is a type of adverse drug event that can lead to untreated and exacerbated chronic illness, and that drives healthcare utilization. Research using medication claims data has attempted to identify instances of medication non-adherence using the proportion of days covered or by examining gaps between medication refills. We sought to validate these measures compared to a gold standard diagnosis of non-adherence made in hospital. METHODS: This was a retrospective analysis of adverse drug events diagnosed during three prospective cohorts in British Columbia between 2008 and 2015 (n = 976). We linked prospectively identified adverse drug events to medication claims data to examine the sensitivity and specificity of typical non-adherence measures. RESULTS: The sensitivity of the non-adherence measures ranged from 22.4% to 37.5%, with a proportion of days covered threshold of 95% performing the best; the non-persistence measures had sensitivities ranging from 10.4% to 58.3%. While a 7-day gap was most sensitive, it classified 61.2% of the sample as non-adherent, whereas only 19.6% were diagnosed as such in hospital. CONCLUSIONS: The methods used to identify non-adherence in administrative databases are not accurate when compared to a gold standard diagnosis by healthcare providers. Research that has relied on administrative data to identify non-adherent patients both underestimates the magnitude of the problem and may label patients as non-adherent who were in fact adherent.

Healthcare utilization and costs among patients with chronic migraine, episodic migraine, and tension-type headache enrolled in commercial insurance plans.

OBJECTIVE: To quantify and compare healthcare utilization and costs for patients with chronic migraine (CM), episodic migraine (EM), and tension-type headache (TTH) enrolled in US commercial health plans. METHODS: This retrospective cohort study used the Optum Clinformatics® Data Mart database from January 2015 to December 2018. Adult patients with a diagnosis of EM, CM or TTH and at least 12 months of continuous enrollment before and after diagnosis were included. Inverse probability of treatment weighting was used to adjust for baseline differences among the three groups. Patient demographic and clinical characteristics at baseline, and healthcare utilization and costs during follow-up, were described and compared between the three groups. RESULTS: A total of 45,849 patients were included: 8955 with CM, 31,961 with EM, and 4933 with TTH. The total all-cause annual direct medical costs of patients with CM ($17,878) were 1.38 times higher (95% CI: 1.31-1.44) than those with EM ($12,986), and 2.26 times higher (95% CI: 2.08-2.47) than those with TTH ($7902). The annual migraine/TTH-related costs of patients with CM ($1869) were 4.19 times higher (95% CI: 3.92-4.48) than those with EM ($446), and 11.90 times (95% CI: 10.59-13.52) higher than those with TTH ($157). In the adjusted analyses, for all service categories (emergency department, inpatient, outpatient, and prescriptions), the expected costs in the migraine groups were higher than in the TTH group (all p < 0.001), while controlling for covariates. Main findings were consistent in both weighted and unweighted samples, and with both unadjusted and adjusted analyses. CONCLUSION: This study provides an updated assessment of healthcare utilization and expenditures for adult patients with primary headache disorders. Compared to TTH, migraine is associated with higher resource use and direct medical costs, especially for those with a chronic condition. Future studies are needed to understand the indirect medical costs (productivity loss) and humanistic burden (quality of life) between migraine and TTH.

Reclamos de los usuarios externos en un hospital general del Perú / Complaints from external users in a general hospital of Peru

RESUMEN Introducción: los reclamos de los usuarios externos son oportunidades de mejora; su gestión adecuada permite alcanzar los resultados sanitarios finales. Objetivos: evaluar las características de los reclamos de los usuarios externos en un hospital general del Perú. Materiales y métodos: estudio descriptivo retrospectivo de los reclamos recibidos en la Plataforma de Atención al Usuario en Salud durante el año 2019, en un hospital general de Ica, Perú. Del Libro de Reclamaciones en Salud se elaboró una base de datos. Se calcularon medidas de frecuencia absolutas, relativas y promedios. Resultados: se tuvo un total de 993 reclamos. El 11,5 % de ellos fueron registrados en el Libro de Reclamaciones en Salud. El departamento más quejado fue el de Estadística, con 29,8 %. Respecto al personal quejado, el 46,4 % fue el administrativo, el 28,8 % los médicos, el 10,4 % las enfermeras, y el 14,4 % otros profesionales. Las causas de los reclamos fueron problemas de gestión (82,7 %), problemas en las relaciones proveedor-paciente (11,3 %) y problemas clínicos (6,0 %). El tiempo transcurrido para dar respuesta al usuario fue en promedio 20,5 días. Conclusiones: solo el 11,5 % de los pacientes insatisfechos que acuden a la Plataforma de Atención al Usuario en Salud, hacen uso del Libro de Reclamaciones en Salud. Las causas más frecuentes de reclamos son las relacionadas con la gestión, principalmente por problemas de demora en la atención y de acceso a los servicios.

ABSTRACT Introduction: claims from external users are opportunities for improvement; its proper management enables the attainment of final health outcomes. Objective: to evaluate the characteristics of external users claims in a general hospital in Peru. Materials and methods: a retrospective descriptive study of the claims received on the Healthcare User Care Platform in 2019, in a general hospital of Ica, Peru. A database was developed from the Health Claims Book. Absolute, relative, and average frequency measurements were calculated. Results: a total of 993 complaints were filed. 11.5 % of them were registered in the Health Claims Book. The most complained department was that of Statistics, with 29.8 %. With regard to the members of staff staff complained, 46.4 % were administrative workers, 28.8 % doctors, 10.4 % nurses and 14.4 % other professionals. The causes of the complaints were management problems (82.7 %), problems in provider-patient relationships (11.3 %) and clinical problems (6.0 %). The elapsed time to respond to the user was on average 20.5 days. Conclusions: only 11.5 % of dissatisfied patients who access the Healthcare User Attention Platform make use of the Health Claims Book. The most frequent causes of complaints are those related to management, mainly due to problems of delayed care and access to services.

Homebound status among older adult home care recipients in Ontario, Canada.

BACKGROUND: Homebound status is associated with an increased risk of morbidity and mortality in older adults, yet little is known about homebound older adults in Canada. Our objectives were to describe time trends in the prevalence of homebound status among community-dwelling long-term home care recipients and the characteristics associated with homebound status. METHODS: This was a retrospective cross-sectional and cohort study using linked health administrative data in Canada's most populous province, Ontario. We included adults aged 65 years and older who received at least one long-term home care assessment from 2006 to 2017 (N = 666,514). Homebound individuals were those who exited the home an average of 0-1 days/week over the previous 30 days; not homebound comparators exited the home 2-7 days per week. We compared baseline characteristics between groups and estimated the association between these characteristics and homebound status at baseline and over time. RESULTS: From 2006 to 2017, the annual proportion of long-term home care recipients who were homebound increased from 48% to 65%. At first assessment, 50% of the cohort (331,836 of 666,514) were homebound. Among those with a 4-12 month repeat assessment, homebound status persisted over time for 80%, and developed anew in 24%. Dependency on others for locomotion, use of an assistive device, poor access to dwelling, older age, and female sex were most strongly associated with homebound status at baseline, as well as its development and persistence over time. CONCLUSIONS: We found that half of Ontario older adult long-stay home care clients were homebound at the time of their first assessment, and that the prevalence of homebound status among home care recipients rose steadily from 2006 to 2017. This informs further research and policy development to ensure the adequacy of supports for older homebound persons.

Racial disparities in the utilization of parathyroidectomy among patients with primary hyperparathyroidism: Evidence from a nationwide analysis of Medicare claims.

BACKGROUND: Among patients with primary hyperparathyroidism, parathyroidectomy offers a chance of cure and mitigation of disease-related complications. The impact of race/ethnicity on referral and utilization of parathyroidectomy has not been fully explored. METHODS: Population-based, retrospective cohort study using 100% Medicare claims from beneficiaries with primary hyperparathyroidism from 2006 to 2016. Associations of race/ethnicity with disease severity, surgeon evaluation, and subsequent parathyroidectomy were analyzed using adjusted multivariable logistic regression models. RESULTS: Among 210,206 beneficiaries with primary hyperparathyroidism, 63,136 (30.0%) underwent parathyroidectomy within 1 year of diagnosis. Black patients were more likely than other races/ethnicities to have stage 3 chronic kidney disease (10.8%) but had lower prevalence of osteoporosis and nephrolithiasis compared to White patients, Black and Hispanic patients were more likely to have been hospitalized for primary hyperparathyroidism-associated conditions (White 4.8%, Black 8.1%, Hispanic 5.8%; P < .001). Patients who were White and met operative criteria were more likely to undergo parathyroidectomy than Black, Hispanic, or Asian patients (White 30.5%, Black 23.0%, Hispanic 21.4%, Asian 18.7%; P < .001). Black and Hispanic patients had lower adjusted odds of being evaluated by a surgeon (odds ratios 0.71 [95% confidence interval 0.69-0.74], 0.68 [95% confidence interval 0.61-0.74], respectively) and undergoing parathyroidectomy if evaluated by a surgeon (odds ratios 0.72 [95% confidence interval 0.68-0.77], 0.82 [95% confidence interval 0.67-0.99]). Asian race was associated with lower adjusted odds of being evaluated by a surgeon (odds ratio 0.64 [95% confidence interval 0.57-0.71]), but no difference in odds of parathyroidectomy. CONCLUSION: Racial/ethnic disparities exist in the management of primary hyperparathyroidism among older adults. Determining the factors that account for this disparity require urgent attention to achieve parity in the management of primary hyperparathyroidism.

Changing patterns of use of implantable cardiac monitors from 2011 to 2018 for a large commercially-insured U.S. population.

ABSTRACT: Implantable cardiac monitors (ICMs) provide long-term electrocardiographic monitoring for a number of indications. However, frequencies of use by indication and temporal changes have not been characterized on a national scale. We sought to characterize overall use and changes between 2011 and 2018. We used generalized linear models to characterize the incidence rate per 1,000,000 patient-quarters at risk and an autoregressive integrated moving average model to account for autocorrelation in this time series data. We studied commercially-insured patients and their insured dependents in the IBM MarketScan Commercial Database who had an ICM placed. We described the characteristics of individuals who received ICMs and the frequency of placements into 3 guideline concordance groups. We estimated the mean change per quarter in ICM placements (mean quarterly change in incidence rate per 1,000,000 patient-quarters at risk) for quarter (Q)1 2011 through Q1 2014, Q1 2014 to Q2 2014, and Q2 2014 through Q4 2018 for each guideline concordance group. The most common indications for categorizable ICM placement were syncope (24%), atrial fibrillation (11%), and stroke (11%). For each of the 3 guideline concordance groups except guideline unaddressed inpatient ICM placements, there was a significant increase in use either during the Q1 2014 to Q2 2014 or the Q2 2014 through Q4 2018 periods. A significant portion of ICM placements were for indications that lack strong evidence, such as established atrial fibrillation. The incidence of ICM placement for most of the indications and settings increased after miniaturization and technical improvements.

Prevalence, Incidence, and Risk of Progression of Asymptomatic Pancreatic Cysts in Large Sample Real-world Data.

OBJECTIVES: Using large-sample, real-world administrative claims data, we evaluated the prevalence of putatively asymptomatic pancreatic cysts, the historical growth in their incident diagnosis, and their risk of malignant progression. METHODS: Data were sourced from IBM MarketScan administrative claims databases of more than 200 million patients. Period prevalence was assessed using 700,000 individuals without conditions that predispose to pancreatic cyst. The standardized cumulative incidence was compared with the cross-sectional abdominal imaging rate from 2010-2017. The risk of progression to pancreatic cancer for 14,279 newly diagnosed patients with a cyst was estimated using Kaplan-Meier analysis. RESULTS: Standardized prevalence increased exponentially with age and was 1.84% (95% confidence interval, 1.80%-1.87%) for patients older than 45. Standardized incidence nearly doubled from 2010-2017 (6.3 to 11.4 per 10,000), whereas the imaging rate changed from only 8.0% to 9.4%. The cumulative risk of pancreatic cancer at 7 years was 3.0% (95% confidence interval, 2.4%-3.5%), increasing linearly (R2 = 0.991) with an annual progression risk of 0.47%. CONCLUSIONS: Using large-sample data, we show a significant burden of asymptomatic pancreatic cysts, with an annual risk of progression to cancer of 0.47% for 7 years. Rapid growth in cyst diagnosis over the last decade far outpaced increases in the imaging rate.

Implementation Status of Liver Function Tests for Monitoring Benzbromarone-Induced Hepatotoxicity: An Epidemiological Survey Using the Japanese Claims Database.

A major adverse effect of benzbromarone is hepatotoxicity. Therefore, periodic liver function tests are required at least for the first 6 months of benzbromarone administration. However, it is not clear whether the relevant blood tests are implemented appropriately. Here, we performed a cross-sectional survey of the implementation status of liver function tests in patients who were newly prescribed benzbromarone, using the Japanese large claims database. Male patients who were newly prescribed benzbromarone from January 2010 to December 2016 were included. We targeted patients who continued benzbromarone during the observation period (up to 180 d from the start of administration). The primary endpoint was the proportion of patients in whom periodic liver function tests were implemented. A periodic liver function test was defined as one or more liver function tests performed during both 1-90 and 91-180 d of initial benzbromarone administration. We labeled the tests as a "periodic test" or "non-periodic test" based on whether periodic liver function tests were performed or not, respectively. Furthermore, factors influencing non-periodic test were analyzed. Periodic testing was implemented only in 28.7% of patients. Additionally, factors such as number of hospital beds ≤19 (compared to 100-199 beds) and duration of the first prescription of benzbromarone were associated with non-periodic testing. Our study revealed that periodic liver function tests are not performed sufficiently in Japan. Thus, clinicians prescribing benzbromarone should be educated about the test. Our blood-test-based approach should be applied to other drugs and countries in future research.

Real-world evaluation of costs of illness for pneumonia in adult patients in Dubai-A claims database study.

BACKGROUND: Pneumonia is a significant cause of morbidity and mortality among adults globally. This retrospective cohort analysis assessed the pneumonia burden and related healthcare resource utilization and costs in the at-risk (low, medium, and high-risk) adult patients in Dubai, United Arab Emirates (UAE). METHODS: The claims data from January 1, 2014 to June 30, 2019 were extracted from the Dubai Real-World Claims Database for patients, aged ≥18 year, having at least 1 pneumonia claim. Data for the inpatient, outpatient and emergency visits were assessed for 12-months, before (pre-index) and after (follow-up) a pneumonia episode. Healthcare costs were calculated based on dollar value of 2020. RESULTS: Total 48,562 records of eligible patients were analyzed (mean age = 39.9 years; low [62.1%], medium [36.2%] and high [1.7%] risk cohorts). Mean all-cause healthcare costs were approximately >45% higher in the follow-up period (1,947 USD/patient) versus pre-index period (1,327 USD/patient). During follow-up period, the mean annual pneumonia incidence rate was 1.3 episodes, with a similar pattern across all cohorts. Overall, mean claims and costs (USD) per patient (all-cause) were highest in the high-risk cohort in the follow-up period (claims: overall, 11.6; high-risk, 22.0; medium-risk, 13.9; low-risk, 9.9; costs: high-risk, 14,184; medium-risk, 2,240; low-risk, 1,388). Similarly, the mean pneumonia-related costs (USD) per patient were highest for the high-risk cohort (overall: 1,305; high-risk, 10,207; medium-risk, 1,283; low-risk, 882), however, the claims were similar across cohorts (claims/patient: overall: 2.0; high-risk, 1.9; medium-risk, 2.2; low-risk, 1.9). Most all-cause and pneumonia-related costs were due to inpatient visits (4,901 and 4,818 USD respectively), while outpatient (1,232 and 166 USD respectively) and emergency visits (347 and 206 USD respectively) contributed significantly lesser. CONCLUSIONS: Pneumonia imposes a significant healthcare burden in the UAE, especially in the high-risk patients with severe comorbidities. These findings would guide clinicians and policy makers to make informed decisions.

Trends in the use of cervical cancer screening tests in a large medical claims database, United States, 2013-2019.

OBJECTIVE: To examine trends in the use of cervical cancer screening tests during 2013-2019 among commercially insured women. METHODS: The study population included women of all ages with continuous enrollment each year in the IBM MarketScan commercial or Medicare supplemental databases and without known history of cervical cancer or precancer (range = 6.9-9.8 million women per year). Annual cervical cancer screening test use was examined by three modalities: cytology alone, cytology plus HPV testing (cotesting), and HPV testing alone. Trends were assessed using 2-sided Poisson regression. RESULTS: Use of cytology alone decreased from 34.2% in 2013 to 26.4% in 2019 among women aged 21-29 years (P < .0001). Among women aged 30-64 years, use of cytology alone decreased from 18.9% in 2013 to 8.6% in 2019 (P < .0001), whereas cotesting use increased from 14.9% in 2013 to 19.3% in 2019 (P < .0001). Annual test use for HPV testing alone was below 0.5% in all age groups throughout the study period. Annually, 8.7%-13.6% of women aged 18-20 years received cervical cancer screening. There were persistent differences in screening test use by metropolitan residence and census regions despite similar temporal trends. CONCLUSIONS: Temporal changes in the use of cervical cancer screening tests among commercially insured women track changes in clinical guidelines. Screening test use among individuals younger than 21 years shows that many young women are inappropriately screened for cervical cancer.

Comparison of the Safety and Effectiveness of Four Direct Oral Anticoagulants in Japanese Patients with Nonvalvular Atrial Fibrillation Using Real-World Data.

Direct oral anticoagulants (DOACs) are widely used for the prevention of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). However, the differences in safety and effectiveness among four DOACs, dabigatran, rivaroxaban, apixaban, and edoxaban, in Japanese patients have not been clarified. Therefore, we conducted a retrospective cohort study to directly compare the safety and effectiveness among the four DOACs using the Japan Medical Data Center (JMDC) claims database. We identified 3823 patients with NVAF who started receiving a DOAC between March 2011 and June 2017. The safety outcome was major bleeding (a composite outcome of intracranial, gastrointestinal, respiratory, or renal/urinary tract bleeding) and the effectiveness outcome was the composite of ischemic stroke including transient ischemic attack (TIA) or systemic embolism. We constructed a Cox proportional hazard model to calculate the hazard ratio (HR) for all four DOAC combinations. The risk of major bleeding was significantly lower in the dabigatran group than in the apixaban group (HR, 0.55; 95% confidence interval (CI), 0.31-0.93; p = 0.03). In contrast, there was no significant difference in the risk of major bleeding among the other DOACs. In the composite risk of ischemic stroke including TIA or systemic embolism, there was no significant difference among the four DOACs. This study suggested that in the current use of DOACs in Japanese patients with NVAF, dabigatran had a significantly lower risk of major bleeding than apixaban, but there was no significant difference in effectiveness among the four DOACs.

The effect of data aggregation on estimations of nurse staffing and patient outcomes.

OBJECTIVE: To examine how estimates of the association between nurse staffing and patient length of stay (LOS) change with data aggregation over varying time periods and settings, and statistical controls for unobserved heterogeneity. DATA SOURCES/STUDY SETTING: Longitudinal secondary data from October 2002 to September 2006 for 215 intensive care units and 438 general acute care units at 143 facilities in the Veterans Affairs (VA) health care system. RESEARCH DESIGN: This retrospective observational study used unit-level panel data to analyze the association between nurse staffing and LOS. This association was measured over both a month-long and a year-long period, with and without fixed effects. DATA COLLECTION: We used VA administrative data to obtain patient data on the severity of illness and LOS, as well as labor hours and wages for each unit by month. PRINCIPAL FINDINGS: Overall, shorter LOS was associated with higher nurse staffing hours and lower proportions of hours provided by licensed professional nurses (LPNs), unlicensed personnel, and contract staff. Estimates of the association between nurse staffing and LOS changed in magnitude when aggregating data over years instead of months, in different settings, and when controlling for unobserved heterogeneity. CONCLUSIONS: Estimating the association between nurse staffing and LOS is contingent on the time period of analysis and specific methodology. In future studies, researchers should be aware of these differences when exploring nurse staffing and patient outcomes.

Acute myocardial infarction: Development and application of an ICD-10-CM-based algorithm to a large U.S. healthcare claims-based database.

BACKGROUND: Healthcare administrative claims data hold value for monitoring drug safety and assessing drug effectiveness. The U.S. Food and Drug Administration Biologics Effectiveness and Safety Initiative (BEST) is expanding its analytical capacity by developing claims-based definitions-referred to as algorithms-for populations and outcomes of interest. Acute myocardial infarction (AMI) was of interest due to its potential association with select biologics and the lack of an externally validated International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) algorithm. OBJECTIVE: Develop and apply an ICD-10-CM-based algorithm in a U.S. administrative claims database to identify and characterize AMI populations. METHODS: A comprehensive literature review was conducted to identify validated AMI algorithms. Building on prior published methodology and consistent application of ICD-9-CM codes, an ICD-10-CM algorithm was developed via forward-backward mapping using General Equivalence Mappings and refined with clinical input. An AMI population was then identified in the IBM® MarketScan® Research Databases and characterized using descriptive statistics. RESULTS AND DISCUSSION: Between 2014-2017, 2.83-3.16 individuals/1,000 enrollees/year received ≥1 AMI diagnosis in any healthcare setting. The 2015 transition to ICD-10-CM did not result in a substantial change in the proportion of patients identified. Average patient age at first AMI diagnosis was 64.9 years, and 61.4% of individuals were male. Unspecified chest pain, hypertension, and coronary atherosclerosis of native coronary vessel/artery were most commonly reported within one day of AMI diagnosis. Electrocardiograms were the most common medical procedure and beta-blockers were the most commonly ordered cardiac medication in the one day before to 14 days following AMI diagnosis. The mean length of inpatient stay was 5.6 days (median 3 days; standard deviation 7.9 days). Findings from this ICD-10-CM-based AMI study were internally consistent with ICD-9-CM-based findings and externally consistent with ICD-9-CM-based studies, suggesting that this algorithm is ready for validation in future studies.

Anticholinergic burden: First comprehensive analysis using claims data shows large variation by age and sex.

PURPOSE: The cumulative effect of medication inhibiting acetylcholine activity-also known as anticholinergic burden (AB)-can lead to functional and cognitive decline, falls, and death. Given that studies on the population prevalence of AB are rare, we aimed to describe it in a large and unselected population sample. METHODS: Using the German Pharmacoepidemiological Research Database (GePaRD) with claims data from ~20% of the German population we analyzed outpatient drug dispensations in 2016. Based on the Anticholinergic Cognitive Burden (ACB) scale, we classified persons into four categories and determined the cumulative AB as continuous variable. RESULTS: Among 16,470,946 persons (54% female), the prevalence of clinically relevant AB (ACB≥3) was 10% (women) and 7% (men). Below age 40 it was highest in persons ≤18 years (6% both sexes). At older ages (50-59 vs. 90-99 years), prevalence of ACB≥3 increased from 7% to 26% (men) and from 10% to 32% (women). Medication classes contributing to the cumulative AB differed by age: antihistamines, antibiotics, glucocorticoids (≤19 years), antidepressants (20-49 years), antidepressants, cardiovascular medication, antidiabetics (50-64 years), and additionally medication for urinary incontinence/overactive bladder (≥65 years). Medication dispensed by general physicians contributed most to the cumulative AB. CONCLUSION: Although a clinically relevant AB is particularly common in older persons, prevalence in younger age groups was up to 7%. Given the risks associated with AB in older persons, targeted interventions at the prescriber level are needed. Furthermore, risks associated with AB in younger persons should be explored.

Long-term care service mix in the Veterans Health Administration after home care expansion.

OBJECTIVE: To determine whether the Veterans Health Administration's (VHA) efforts to expand access to home- and community-based services (HCBS) after the 2001 Millennium Act significantly changed Veterans' utilization of institutional, paid home, and unpaid home care relative to a non-VHA user Medicare population that was not exposed to HCBS expansion efforts. DATA SOURCES: We used linkages between the Health and Retirement Study and VHA administrative data from 1998 until 2012. STUDY DESIGN: We conducted a retrospective-matched cohort study using coarsened exact matching to ensure balance on observable characteristics for VHA users (n = 943) and nonusers (n = 6106). We used a difference-in-differences approach with a person fixed-effects estimator. DATA COLLECTION/EXTRACTION METHODS: Individuals were eligible for inclusion in the analysis if they were age 65 or older and indicated that they were covered by Medicare insurance in 1998. Individuals were excluded if they were covered by Medicaid insurance at baseline. Individuals were considered exposed to VHA HCBS expansion efforts if they were enrolled in the VHA and used VHA services. PRINCIPAL FINDINGS: Theory predicts that an increase in the public allocation of HCBS will decrease the utilization of its substitutes (e.g., institutional care and unpaid caregiving). We found that after the Millennium Act was passed, there were no observed differences between VHA users and nonusers in the probability of using institutional long-term care (0.7% points, 95% CI: -0.009, 0.022) or in receiving paid help with activities of daily living (0.06% points, 95% CI: -0.011, 0.0125). VHA users received more hours of unpaid care post-Millennium Act (1.48, 95% CI: -0.232, 3.187), though this effect was not significant once we introduced controls for mental health. CONCLUSIONS: Our findings indicate that mandating access to HCBS services does not necessarily imply that access to these services will follow suit.