Measuring Costs of Cardiovascular Disease Prevention for Patients with Familial Hypercholesterolemia in Administrative Claims Data.

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.

Improving Billing and Collections in a High-Volume Pediatric Surgery Practice: Denials-Based Approach.

BACKGROUND: Despite minimal coding and billing training, surgeons are frequently tasked with both in clinical practice. This often results in denials for reimbursement based on incorrect or insufficient documentation, and reduced collections for work performed. We sought to evaluate how to correct these deficits while improving reimbursement for the most frequently rejected procedures at a high-volume academic center. STUDY DESIGN: Hospital billing data were analyzed for a 4-year period (2018 to 2021) to determine the CPT code denials with the largest overall cost. The denials were then stratified according to payor, reason for denial, and preventability. Assigned ICD-10 codes were categorized based on specificity as related to the procedure. The distribution of denials according to ICD-10 specificity was evaluated using the chi-square test. RESULTS: A total of 8,833 denials representing $11,009,108 in billing were noted during the study period. The CPT code 44970 (laparoscopic appendectomy) was the code associated with the largest financial impact, representing 12.8% of the total denied amount ($1.41M). Of the 823 denials for CPT 44970, 93.3% were associated with nonspecific ICD-10 codes, whereas only 42.0% had been associated with procedure-specific ICD-10 codes. Of the patients with nonspecific codes, 80.7% of denials were due to criteria that could be remedied with supplemental information or timely filing, representing $1,059,968 in collections. CONCLUSIONS: This is the first study to systematically evaluate a pathway for using denial data to improve collections for work performed at a high-volume academic pediatric surgery practice. Using this methodology, targets for improvement in coding and/or documentation can be identified to improve the financial performance of a surgical department. This study also provides evidence that association with nonspecific diagnostic codes is correlated with initial denial of payment by insurance companies.

Improved Prediction of Body Mass Index in Real-World Administrative Healthcare Claims Databases.

INTRODUCTION: To continue closing the gap between the predictive modeling and its real-world application, we report a new data-to-prediction pipeline that advanced the state-of-the-art predictive performance of body mass index (BMI) classifications by integrating siloed claims databases via a common data model. METHODS: This study adapted the ensemble-based methodology of the baseline prediction model and focused on removing the silos in the claims databases. We applied the Super Learner machine learning algorithm (SLA) to learn a combined dataset consisting of 50% data from the Optum Date of Death database and 50% data from the IBM MarketScan Commercial Claims and Encounters (CCAE), and omitted the commonly used one-hot-encoding step and used multi-categorical variables directly in the feature engineering process. These developments were then optimized via a standard cross-validation scheme and the performance was evaluated on a holdout test set. RESULTS: Sociodemographic and clinical characteristics were used with (denoted as SLA1) and without (denoted as SLA2) baseline BMI values to predict BMI classifications (≥ 30, ≥ 35, and ≥ 40 kg/m2). Although the newly implemented SLA1 performed similarly to the previous model, with the area under the receiver operating characteristic curve (ROC AUC) being approximately 88% for all BMI classifications, specificity ranging from 90% to 96%, and accuracy ranging from 88% to 93%. The new SLA2 achieved consistently better performance on all metrics across all BMI classes. In particular, the new SLA2 achieved 77-79% in ROC AUC, increasing from the previously reported level (73%). Its specificity improved to the range of 76-90% from 71-86%. Its accuracy improved to the range of 77-86% from 73-80%. Its recall (i.e., sensitivity) improved to the range of 64-78% from 60-76%. CONCLUSIONS: This study demonstrates dramatic improvements in the prediction of BMI across classifications using integrated databases in a common data model for the generation of real-world evidence.

Identification of pregnancies and infants within a US commercial healthcare administrative claims database.

PURPOSE: Health care insurance claims databases are becoming a more common data source for studies of medication safety during pregnancy. While pregnancies have historically been identified in such databases by pregnancy outcomes, International Classification of Diseases, 10th revision Clinical Modification (ICD-10-CM) Z3A codes denoting weeks of gestation provide more granular information on pregnancies and pregnancy periods (i.e., start and end dates). The purpose of this study was to develop a process that uses Z3A codes to identify pregnancies, pregnancy periods, and links infants within a commercial health insurance claims database. METHODS: We identified pregnancies, gestation periods, pregnancy outcomes, and linked infants within the US-based Optum Research Database between 2015 and 2020 via a series of algorithms utilizing diagnosis and procedure codes on claims. The diagnosis and procedure codes included ICD-10-CM codes, Current Procedural Terminology (CPT) codes, and Healthcare Common Procedure Coding System (HCPCS) codes. RESULTS: We identified 1 030 874 pregnancies among 841 196 women of reproductive age. Of pregnancies with livebirth outcomes, 84% were successfully linked to infants. The prevalence of pregnancy outcomes (livebirth, stillbirth, ectopic, molar, and abortion) was similar to national estimates. CONCLUSIONS: This process provides an opportunity to study drug safety and care patterns during pregnancy and may be replicated in other claims databases containing ICD-10-CM, CPT, and HCPCS codes. Work is underway to validate and refine the various algorithms.

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.

Real-World Data of Palbociclib in Combination With Endocrine Therapy for the Treatment of Metastatic Breast Cancer in Men.

This report examined the benefits and risks of palbociclib plus endocrine therapy (ET) in men with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC). Palbociclib was evaluated using three independent data sources: real-world data from pharmacy and medical claims, a de-identified real-world data source derived from electronic health records (EHRs), and a global safety database. From medical and pharmacy records, 1,139 men with MBC were identified; in the first-line setting, median duration of treatment was longer with palbociclib plus ET (n = 37, 8.5 months, 95% confidence interval (CI), 4.4-13.0) than ET alone (n = 214, 4.3 months, 95% CI, 3.0-5.7) and specifically, was longer with palbociclib plus letrozole (n = 26, 9.4 months, 95% CI, 4.4-14.0) than letrozole alone (n = 63, 3.0 months, 95% CI, 1.8-4.8). In the EHR-derived database, 59 men received treatment for MBC; real-world response across all lines of therapy in the metastatic setting was reported in 4 of 12 patients (33.3%) in the palbociclib plus ET group vs. 1 of 8 (12.5%) patients in the ET group. Review of the global safety database did not identify any new safety signals in palbociclib-treated men. Real-world data indicated that men with MBC benefit from palbociclib plus ET, with a safety profile consistent with previous observations in women with MBC. Collective data on palbociclib in women and men in this report, including clinical trial data, real-world data, and a well-established risk/benefit profile, led to US approval of an expansion of the palbociclib indication to include men with MBC.

Longitudinal Data Discontinuity in Electronic Health Records and Consequences for Medication Effectiveness Studies.

Electronic health record (EHR) discontinuity (i.e., receiving care outside of the study EHR system), can lead to information bias in EHR-based real-world evidence (RWE) studies. An algorithm has been previously developed to identify patients with high EHR-continuity. We sought to assess whether applying this algorithm to patient selection for inclusion can reduce bias caused by data-discontinuity in four RWE examples. Among Medicare beneficiaries aged >=65 years from 2007 to 2014, we established 4 cohorts assessing drug effects on short-term or long-term outcomes, respectively. We linked claims data with two US EHR systems and calculated %bias of the multivariable-adjusted effect estimates based on only EHR vs. linked EHR-claims data because the linked data capture medical information recorded outside of the study EHR. Our study cohort included 77,288 patients in system 1 and 60,309 in system 2. We found the subcohort in the lowest quartile of EHR-continuity captured 72-81% of the short-term and only 21-31% of the long-term outcome events, leading to %bias of 6-99% for the short-term and 62-112% for the long-term outcome examples. This trend appeared to be more pronounced in the example using a nonuser comparison rather than an active comparison. We did not find significant treatment effect heterogeneity by EHR-continuity for most subgroups across empirical examples. In EHR-based RWE studies, investigators may consider excluding patients with low algorithm-predicted EHR-continuity as the EHR data capture relatively few of their actual outcomes, and treatment effect estimates in these patients may be unreliable.

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.

Angiotensin-Converting Enzyme Inhibitors Used Concomitantly with Insulin Secretagogues and the Risk of Serious Hypoglycemia.

Serious hypoglycemia is a major adverse event associated with insulin secretagogues. Previous studies have suggested a potential relationship between angiotensin-converting enzyme inhibitors (ACEIs) used with sulfonylureas and serious hypoglycemia, and widely used drug compendia warn of this potential drug-drug interaction. We investigated the association between serious hypoglycemia and concomitant use of ACEIs in patients receiving insulin secretagogues, using the self-controlled case series design and Medicaid claims data from 5 US states linked to Medicare claims from 1999-2011. The exposure of interest was active prescription for ACEIs during insulin secretagogue or metformin (negative control object drug) episodes. The outcome was hospital presentation for serious hypoglycemia, identified by discharge diagnosis codes in inpatient and emergency department claims (positive predictive value ~ 78-89%). We calculated confounder-adjusted rate ratios (RRs) and 95% confidence internals (CIs) of outcome occurrence during ACEI-exposed vs. ACEI-unexposed time using conditional Poisson regression. The RRs for ACEIs were not statistically elevated during observation time of glipizide (RR, 1.06; CI, 0.98-1.15), glyburide (RR, 1.05; CI, 0.96-1.15), repaglinide (RR, 1.15; CI, 0.94-1.41), or metformin (RR, 1.02; CI, 0.97-1.06); but was modestly elevated with glimepiride (RR, 1.23; CI, 1.11-1.37) and modestly reduced with nateglinide (RR, 0.73; CI, 0.56-0.96). The overall pattern of results do not suggest that ACEIs used with insulin secretagogues were associated with increased rates of serious hypoglycemia, with the possible exception of glimepiride.

Comparative Safety of Dipeptidyl Peptidase-4 Inhibitors and Sudden Cardiac Arrest and Ventricular Arrhythmia: Population-Based Cohort Studies.

In vivo studies suggest that arrhythmia risk may be greater with less selective dipeptidyl peptidase-4 inhibitors, but evidence from population-based studies is missing. We aimed to compare saxagliptin, sitagliptin, and linagliptin with regard to risk of sudden cardiac arrest (SCA)/ventricular arrhythmia (VA). We conducted high-dimensional propensity score (hdPS) matched, new-user cohort studies. We analyzed Medicaid and Optum Clinformatics separately. We identified new users of saxagliptin, sitagliptin (both databases), and linagliptin (Optum only). We defined SCA/VA outcomes using emergency department and inpatient diagnoses. We identified and then controlled for confounders via a data-adaptive, hdPS approach. We generated marginal hazard ratios (HRs) via Cox proportional hazards regression using a robust variance estimator while adjusting for calendar year. We identified the following matched comparisons: saxagliptin vs. sitagliptin (23,895 vs. 96,972) in Medicaid, saxagliptin vs. sitagliptin (48,388 vs. 117,383) in Optum, and linagliptin vs. sitagliptin (36,820 vs. 78,701) in Optum. In Medicaid, use of saxagliptin (vs. sitagliptin) was associated with an increased rate of SCA/VA (adjusted HR (aHR), 2.01, 95% confidence interval (CI) 1.24-3.25). However, in Optum data, this finding was not present (aHR, 0.79, 95% CI 0.41-1.51). Further, we found no association between linagliptin (vs. sitagliptin) and SCA/VA (aHR, 0.65, 95% CI 0.36-1.17). We found discordant results regarding the association between SCA/VA with saxagliptin compared with sitagliptin in two independent datasets. It remains unclear whether these findings are due to heterogeneity of treatment effect in the different populations, chance, or unmeasured confounding.

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.

Epidemiology, Etiology, and Treatment of Gastroparesis: Real-World Evidence From a Large US National Claims Database.

BACKGROUND & AIMS: Although gastroparesis carries a considerable health care and patient burden, associated epidemiological data are limited. To provide new real-world evidence for gastroparesis, we estimated disease prevalence, and investigated patient demographics and disease etiology in a large US claims database. METHODS: This retrospective, cross-sectional analysis used de-identified, longitudinal patient-level enrollment and billing data for adults from the Optum Clinformatics Data Mart database, a large US national administrative health insurance claims database. Prevalence was age-, sex-, and geographical region-standardized using the 2018 US census. Descriptive analyses of demographic and clinical variables and underlying disease etiologies were performed. RESULTS: The overall standardized prevalence of gastroparesis was 267.7 (95% confidence interval [CI] 264.8-270.7) per 100,000 US adults, whereas prevalence of "definite" gastroparesis (individuals diagnosed within 3 months of gastric emptying scintigraphy testing with persistent symptoms for more than 3 months) was 21.5 (95% CI 20.6-22.4) per 100,000 persons. Patients with gastroparesis had an overall Charlson Comorbidity Index score of 4.2, indicating substantial comorbidity burden. The most frequently documented comorbidities were chronic pulmonary disease (46.4%), diabetes with chronic complication (37.3%), and peripheral vascular disease (30.4%). Patients most commonly had a diabetic etiology (57.4%; type 1, 5.7% and type 2, 51.7%), followed by postsurgical (15.0%), drug-induced (11.8%), and idiopathic (11.3%) etiologies. CONCLUSIONS: New evidence is provided regarding the prevalence, patient demographics, and etiology of gastroparesis in the US general population. Wider availability of reliable objective gastric emptying measures and further education of medical professionals in recognizing and diagnosing gastroparesis would benefit future studies and improve understanding of disease epidemiology.

Avaliação e processos de subjetivação na atenção básica à saúde: avaliação e subjetivação / La evaluación y los procesos de subjetivación en la atención primaria de salud: evaluación y subjetivación / Evaluation and processes of subjectivation at the primary health care: evaluation and subjectivation

RESUMO Desde a redemocratização no Brasil, o tema da subjetividade tem sido um componente importante na discussão e na formulação das políticas públicas no país. Existe um grande embate na literatura em torno dos méritos e dos prejuízos decorrentes dos processos de avaliação. O objetivo desta pesquisa é investigar os efeitos das práticas avaliativas nos processos de subjetivação vividos por profissionais das equipes de Saúde da Família na Atenção Básica, em um distrito sanitário do município de Belo Horizonte. Buscamos também compreender os efeitos da avaliação na subjetividade dos profissionais envolvidos. Realizamos 16 entrevistas semiestruturadas com os profissionais e gestores de duas Unidades Básicas de Saúde. Fizemos uma análise temática das entrevistas em três eixos: os ganhos desencadeados pelas práticas de avaliação, os seus aspectos problemáticos e os processos de subjetivação decorrentes das avaliações. Os ganhos que as avaliações permitiram foram: detectar as falhas no trabalho e redirecionar as atividades; melhorar o atendimento à população e modificar o comportamento com os colegas e em relação ao trabalho. As críticas se direcionaram aos indicadores dos instrumentos, aos processos de avaliação, à dificuldade de colocar em prática os resultados obtidos e ao não cumprimento dos acordos por parte dos gestores municipais. Os processos de subjetivação promovidos pelas avaliações foram por um lado a reflexão em relação ao trabalho e aos colegas, produzindo mudanças de atitudes, e por outro os sentimentos de medo, culpa e frustração em relação ao processo de avaliação, seus resultados e consequências.

RESUMEN Hay un embate en la literatura en torno a los méritos y los perjuicios derivados de los procesos de evaluación. Esta pesquisa investiga los efectos de las prácticas evaluativas en los procesos de subjetivación vividos por los profesionales de los Equipos de Salud de la Familia en la Atención Básica, en un distrito sanitario del municipio de Belo Horizonte. También buscamos comprender los efectos de la evaluación sobre la subjetividad de los profesionales involucrados. Realizamos 16 entrevistas semiestructuradas con los profesionales y gestores de dos Unidades Básicas de Salud. Hicimos un análisis temático de las entrevistas en tres ejes: las ganancias desencadenadas por las prácticas de evaluación, sus aspectos problemáticos y los procesos de subjetivación derivados de las evaluaciones. Las ganancias fueron: detectar los fallos en el trabajo y reorientar las actividades; mejorar la atención a la población y modificar el comportamiento con los colegas y con relación al trabajo. Las críticas se dirigieron a los indicadores de los instrumentos, a los procesos de evaluación, a la dificultad de poner en práctica los resultados obtenidos y al incumplimiento de los acuerdos por parte de los gestores municipales. Los procesos de subjetivación promovidos por las evaluaciones fueron, por un lado, la reflexión con relación al trabajo y a los colegas, lo que produjo cambios de actitudes, y, por otro lado, los sentimientos de miedo, culpa y frustración con relación al proceso de evaluación, sus resultados y consecuencias.

ABSTRACT This study aimed to investigate the effects of evaluation practices in the processes of subjectivation experienced by professionals from Family Health Teams in Primary Health Care, in a health district in the municipality of Belo Horizonte, state of Minas Gerais. We also sought to understand the effects of evaluation on the subjectivity of the professionals involved. We conducted 16 semi-structured interviews with professionals and managers of two Basic Health Units. A thematic analysis of the interviews was carried out in three axes: the gains triggered by the evaluation practices, their problematic aspects and the subjectivation processes resulting from the assessments. The gains that the evaluations allowed were: detecting work failures and redirecting activities; improve service to the population and change behavior with coworkers and in relation to work. Criticism was directed towards the instruments' indicators, the evaluation processes, the difficulty of putting into practice the results obtained and the non-compliance with the agreements by the municipal managers. The subjectivation processes promoted by the evaluations were, on the one hand, the self-reflection in relation to work and coworkers, producing changes in attitudes, and, on the other, the feelings of fear, guilt and frustration regarding evaluation process, its results and consequences.

In loco nursing practice inspection costs in a Brazilian setting / Costes de la inspección in loco de la supervisión de la práctica profesional de enfermería en una realidad brasileña / Custos da inspeção in loco da fiscalização do exercício profissional de Enfermagem em uma realidade brasileira

Abstract Objective: To identify the average direct cost related to the direct labor of the inspectors involved in the "in loco inspection" step of the inspection process carried out at the Headquarters of the Regional Nursing Council of São Paulo. Method: Quantitative, exploratory-descriptive research, in the form of a single case study. The non-probabilistic convenience sample consisted of records of initial and return "in loco inspections", carried out by inspectors working at the Headquarters of The Regional Nursing Council of São Paulo, from January 13, 2020 to March 13, 2020. Results: The average direct cost of initial in loco inspection (N = 182) corresponded to BRL 331.67 (SD = 140.32), ranging from BRL 115.80 to BRL 1071.15, and that of return in loco inspection (N = 98) to BRL 256.16 (SD = 130.90), ranging from BRL 77.20 to BRL 694.80. Time and cost variables analysis of initial and return in loco inspections showed an alpha significance level of 0.05, and it was possible to statistically state that the time (p ≤ 0.001) and the cost of initial in loco inspection (p ≤ 0.001) are higher than those for return in loco inspection. Conclusion: the cost of the step of "in loco inspection" will support the Nursing Council in the decision-making process aiming at allocating efficiency of human resources required in the inspection process.

RESUMEN Objetivo: Identificar el coste medio directo relacionado con la labor directa de los inspectores involucrados en la etapa de "inspección in loco" del proceso de inspección realizado en la Unidad Sede del Consejo Regional de Enfermería de São Paulo. Método: Investigación cuantitativa, exploratoria-descriptiva, en forma de estudio de caso único. La muestra de conveniencia no probabilística consistió en registros de "inspecciones in loco", iniciales y de retorno, realizadas por inspectores que trabajan en la Sede, desde el 13/01/2020 al 13/03/2020. Resultados: El coste medio directo de la inspección inicial (N = 182) correspondió a R$ 331,67 (DP = 140,32), con un rango de R$ 115,80 a R$ 1071,15, y el de la inspección de retorno (N = 98) a R$ 256,16 (DP = 130,90), oscilando entre R$ 77,20 y R$ 694,80. El análisis de las variables tiempo y coste de las inspecciones inicial y de retorno indicó un nivel de significancia alfa de 0.05, y fue posible afirmar estadísticamente que el tiempo (p ≤ 0.001) y el costo de la inspección inicial (p ≤ 0,001) son mayores que los de la inspección de retorno. Conclusión: el costo de la etapa de "inspección in loco" subsidiará el Consejo en el proceso de toma de decisiones buscando la eficiencia en la asignación de los recursos humanos requeridos en el proceso de inspección.

RESUMO Objetivo: Identificar o custo direto médio relativo à mão de obra direta dos fiscais envolvidos na etapa "inspeção in loco" do processo de fiscalização realizado na Unidade Sede do Conselho Regional de Enfermagem de São Paulo. Método: Pesquisa quantitativa, exploratório-descritiva, na modalidade de estudo de caso único. A amostra de conveniência, não probabilística, foi constituída por registros de "inspeções in loco", iniciais e de retorno, realizadas por fiscais atuantes na Unidade Sede, no período de 13/01/2020 a 13/03/2020. Resultados: O custo direto médio da inspeção in loco inicial (N = 182) correspondeu a R$ 331,67 (DP = 140,32), variando de R$ 115,80 a R$ 1071,15, e da inspeção in loco de retorno (N = 98) a R$ 256,16 (DP = 130,90), variando entre R$77,20 e R$ 694,80. A análise das variáveis tempo e custo das inspeções in loco iniciais e de retorno evidenciou nível de significância alfa de 0,05, sendo possível afirmar estatisticamente que o tempo (p ≤ 0,001) e o custo da inspeção in loco inicial (p ≤ 0,001) são maiores do que os da inspeção in loco de retorno. Conclusão: o custeio da etapa "inspeção in loco" subsidiará o Conselho no processo decisório visando à eficiência alocativa dos recursos humanos requeridos no processo de fiscalização.

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.

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.

Patients with stable coronary artery disease and type 2 diabetes but without prior myocardial infarction or stroke and THEMIS-like patients: real-world prevalence and risk of major outcomes from the SNDS French nationwide claims database.

AIM AND HYPOTHESES: The THEMIS randomized trial compared ticagrelor plus aspirin versus placebo plus aspirin for patients with stable coronary artery disease and type 2 diabetes mellitus (CAD-T2DM), and without prior myocardial infarction (MI) or stroke. The aim of the study was to quantify the size of the CAD-T2DM population without prior MI or stroke population in a real-world setting, and more specifically populations with similar THEMIS selection criteria (THEMIS-like and THEMIS-PCI-like populations), as well as their risk of major outcomes in current practice. METHODS: A 2-year follow-up cohort study included all CAD-T2DM without MI/stroke prevalent patients on January 1st, 2014 in the SNDS French nationwide claims database. The THEMIS-like population concerned those ≥ 50 years of age with similar THEMIS inclusion and exclusion criteria. Prevalence was standardized to the European population. The cumulative incidence function was used to estimate the incidence of clinical outcomes (MI, ischemic stroke, and major bleeding according to the TIMI classification) with death as competing risk, and the Kaplan-Meier estimate for all-cause death and a composite outcome of MI, stroke and all-cause death. RESULTS: From a population of about 50 million adults, the prevalence of CAD-T2DM without MI/stroke, THEMIS-like and THEMIS-PCI-like populations was respectively at 6.04, 1.50 and 0.27 per 1000 adults, with a mean age of 72.7, 72.3 and 70.9 years and less comorbidities and diabetic complications for the THEMIS-like and THEMIS-PCI-like population. The 2-year cumulative incidence was respectively 1.7%, 1.3% and 1.6% for MI, 1.7%, 1.5% and 1.4% for stroke, 4.8%, 3.1% and 2.9% for major bleeding, 13.6%, 9.7% and 6.8% for all-cause death, and 16.2%, 12.0% and 9.5% for the composite outcome. CONCLUSION: THEMIS-like prevalence was estimated at 1.50 per 1,000 adults, representing about a quarter of CAD-T2DM without MI/stroke patients, and 0.27 per 1000 adults for the THEMIS-PCI-like populations. In current French practice, the median age of both these populations was about 5-6 years older than in the THEMIS trial, with a 2-year incidence of major outcomes between two or four time above the ones of the placebo arm of the THEMIS trial using very close definitions. Registration No. EUPAS27402 ( http://www.ENCEPP.eu ).

Cardiovascular outcomes after initiating GLP-1 receptor agonist or basal insulin for the routine treatment of type 2 diabetes: a region-wide retrospective study.

AIM: We aimed to compare cardiovascular outcomes of patients with type 2 diabetes (T2D) who initiated GLP-1 receptor agonists (GLP-1RA) or basal insulin (BI) under routine care. METHODS: We accessed the administrative claims database of the Veneto Region (Italy) to identify new users of GLP-1RA or BI in 2014-2018. Propensity score matching (PSM) was implemented to obtain two cohorts of patients with superimposable characteristics. The primary endpoint was the 3-point major adverse cardiovascular events (3P-MACE). Secondary endpoints included 3P-MACE components, hospitalization for heart failure, revascularizations, and adverse events. RESULTS: From a background population of 5,242,201 citizens, 330,193 were identified as having diabetes. PSM produced two very well matched cohorts of 4063 patients each, who initiated GLP-1RA or BI after an average of 2.5 other diabetes drug classes. Patients were 63-year-old and only 15% had a baseline history of cardiovascular disease. During a median follow-up of 24 months in the intention-to-treat analysis, 3P-MACE occurred less frequently in the GLP-1RA cohort (HR versus BI 0.59; 95% CI 0.50-0.71; p < 0.001). All secondary cardiovascular endpoints were also significantly in favor of GLP-1RA. Results were confirmed in the as-treated approach and in several stratified analyses. According to the E-value, confounding by unmeasured variables were unlikely to entirely explain between-group differences in cardiovascular outcomes. CONCLUSIONS: Patients with T2D who initiated a GLP-1RA experienced far better cardiovascular outcomes than did matched patients who initiated a BI in the same healthcare system. These finding supports prioritization of GLP-1RA as the first injectable regimen for the management of T2D.