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1.
Am J Epidemiol ; 2024 Jun 24.
Artículo en Inglés | MEDLINE | ID: mdl-38918039

RESUMEN

There is a dearth of safety data on maternal outcomes after perinatal medication exposure. Data-mining for unexpected adverse event occurrence in existing datasets is a potentially useful approach. One method, the Poisson tree-based scan statistic (TBSS), assumes that the expected outcome counts, based on incidence of outcomes in the control group, are estimated without error. This assumption may be difficult to satisfy with a small control group. Our simulation study evaluated the effect of imprecise incidence proportions from the control group on TBSS' ability to identify maternal outcomes in pregnancy research. We simulated base case analyses with "true" expected incidence proportions and compared these to imprecise incidence proportions derived from sparse control samples. We varied parameters impacting Type I error and statistical power (exposure group size, outcome's incidence proportion, and effect size). We found that imprecise incidence proportions generated by a small control group resulted in inaccurate alerting, inflation of Type I error, and removal of very rare outcomes for TBSS analysis due to "zero" background counts. Ideally, the control size should be at least several times larger than the exposure size to limit the number of false positive alerts and retain statistical power for true alerts.

2.
Drug Saf ; 2024 Jun 28.
Artículo en Inglés | MEDLINE | ID: mdl-38940904

RESUMEN

While many pregnant individuals use prescription medications, evidence supporting product safety during pregnancy is often inadequate. Existing electronic healthcare data sources provide large, diverse samples of health plan members to allow for the study of medical product utilization during pregnancy, as well as pregnancy, maternal, and infant outcomes. The Sentinel System is a national medical product surveillance system that includes administrative claims and electronic health record databases from large national and regional health insurers. In addition to these data sources, Sentinel develops and maintains a sizeable selection of analytic tools to facilitate epidemiologic analyses in a way that protects patient privacy and health system autonomy. In this article, we provide an overview of Sentinel System infrastructure, including the Mother-Infant Linkage Table, parameterizable analytic tools, and algorithms to estimate gestational age and identify pregnancy outcomes. We also describe past and future Sentinel work that contributes to our understanding of the way medical products are used and the safety of these products during pregnancy.

3.
Clin Epidemiol ; 16: 329-343, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38798915

RESUMEN

Objective: Partially observed confounder data pose challenges to the statistical analysis of electronic health records (EHR) and systematic assessments of potentially underlying missingness mechanisms are lacking. We aimed to provide a principled approach to empirically characterize missing data processes and investigate performance of analytic methods. Methods: Three empirical sub-cohorts of diabetic SGLT2 or DPP4-inhibitor initiators with complete information on HbA1c, BMI and smoking as confounders of interest (COI) formed the basis of data simulation under a plasmode framework. A true null treatment effect, including the COI in the outcome generation model, and four missingness mechanisms for the COI were simulated: completely at random (MCAR), at random (MAR), and two not at random (MNAR) mechanisms, where missingness was dependent on an unmeasured confounder and on the value of the COI itself. We evaluated the ability of three groups of diagnostics to differentiate between mechanisms: 1)-differences in characteristics between patients with or without the observed COI (using averaged standardized mean differences [ASMD]), 2)-predictive ability of the missingness indicator based on observed covariates, and 3)-association of the missingness indicator with the outcome. We then compared analytic methods including "complete case", inverse probability weighting, single and multiple imputation in their ability to recover true treatment effects. Results: The diagnostics successfully identified characteristic patterns of simulated missingness mechanisms. For MAR, but not MCAR, the patient characteristics showed substantial differences (median ASMD 0.20 vs 0.05) and consequently, discrimination of the prediction models for missingness was also higher (0.59 vs 0.50). For MNAR, but not MAR or MCAR, missingness was significantly associated with the outcome even in models adjusting for other observed covariates. Comparing analytic methods, multiple imputation using a random forest algorithm resulted in the lowest root-mean-squared-error. Conclusion: Principled diagnostics provided reliable insights into missingness mechanisms. When assumptions allow, multiple imputation with nonparametric models could help reduce bias.

4.
Clin Epidemiol ; 16: 71-89, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38357585

RESUMEN

Purpose: Few studies have examined how the absolute risk of thromboembolism with COVID-19 has evolved over time across different countries. Researchers from the European Medicines Agency, Health Canada, and the United States (US) Food and Drug Administration established a collaboration to evaluate the absolute risk of arterial (ATE) and venous thromboembolism (VTE) in the 90 days after diagnosis of COVID-19 in the ambulatory (eg, outpatient, emergency department, nursing facility) setting from seven countries across North America (Canada, US) and Europe (England, Germany, Italy, Netherlands, and Spain) within periods before and during COVID-19 vaccine availability. Patients and Methods: We conducted cohort studies of patients initially diagnosed with COVID-19 in the ambulatory setting from the seven specified countries. Patients were followed for 90 days after COVID-19 diagnosis. The primary outcomes were ATE and VTE over 90 days from diagnosis date. We measured country-level estimates of 90-day absolute risk (with 95% confidence intervals) of ATE and VTE. Results: The seven cohorts included 1,061,565 patients initially diagnosed with COVID-19 in the ambulatory setting before COVID-19 vaccines were available (through November 2020). The 90-day absolute risk of ATE during this period ranged from 0.11% (0.09-0.13%) in Canada to 1.01% (0.97-1.05%) in the US, and the 90-day absolute risk of VTE ranged from 0.23% (0.21-0.26%) in Canada to 0.84% (0.80-0.89%) in England. The seven cohorts included 3,544,062 patients with COVID-19 during vaccine availability (beginning December 2020). The 90-day absolute risk of ATE during this period ranged from 0.06% (0.06-0.07%) in England to 1.04% (1.01-1.06%) in the US, and the 90-day absolute risk of VTE ranged from 0.25% (0.24-0.26%) in England to 1.02% (0.99-1.04%) in the US. Conclusion: There was heterogeneity by country in 90-day absolute risk of ATE and VTE after ambulatory COVID-19 diagnosis both before and during COVID-19 vaccine availability.

5.
JAMIA Open ; 7(1): ooae008, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38304248

RESUMEN

Objectives: Partially observed confounder data pose a major challenge in statistical analyses aimed to inform causal inference using electronic health records (EHRs). While analytic approaches such as imputation are available, assumptions on underlying missingness patterns and mechanisms must be verified. We aimed to develop a toolkit to streamline missing data diagnostics to guide choice of analytic approaches based on meeting necessary assumptions. Materials and methods: We developed the smdi (structural missing data investigations) R package based on results of a previous simulation study which considered structural assumptions of common missing data mechanisms in EHR. Results: smdi enables users to run principled missing data investigations on partially observed confounders and implement functions to visualize, describe, and infer potential missingness patterns and mechanisms based on observed data. Conclusions: The smdi R package is freely available on CRAN and can provide valuable insights into underlying missingness patterns and mechanisms and thereby help improve the robustness of real-world evidence studies.

6.
Int J Numer Method Biomed Eng ; 39(12): e3766, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37551449

RESUMEN

Vertex models have been extensively used for simulating the evolution of multicellular systems, and have given rise to important global properties concerning their macroscopic rheology or jamming transitions. These models are based on the definition of an energy functional, which fully determines the cellular response and conclusions. While two-dimensional vertex models have been widely employed, three-dimensional models are far more scarce, mainly due to the large amount of configurations that they may adopt and the complex geometrical transitions they undergo. We here investigate the shape of single and two-cells configurations as a function of the energy terms, and we study the dependence of the final shape on the model parameters: namely the exponent of the term penalising cell-cell adhesion and surface contractility. In single cell analysis, we deduce analytically the radius and limit values of the contractility for linear and quadratic surface energy terms, in 2D and 3D. In two-cells systems, symmetrical and asymmetrical, we deduce the evolution of the aspect ratio and the relative radius. While in functionals with linear surface terms yield the same aspect ratio in 2D and 3D, the configurations when using quadratic surface terms are distinct. We relate our results with well-known solutions from capillarity theory, and verify our analytical findings with a three-dimensional vertex model.


Asunto(s)
Modelos Biológicos , Adhesión Celular , Reología
7.
Ann Epidemiol ; 86: 80-89.e2, 2023 10.
Artículo en Inglés | MEDLINE | ID: mdl-37479122

RESUMEN

PURPOSE: The U.S. Food and Drug Administration's Sentinel System is a national medical product safety surveillance system consisting of a large multisite distributed database of administrative claims supplemented by electronic health-care record data. The program seeks to improve data capture of race and ethnicity for pharmacoepidemiology studies. METHODS: We conducted a narrative literature review of published research on data augmentation and imputation methods to improve race and ethnicity capture in U.S. health-care systems databases. We focused on methods with limited (five-digit ZIP codes only) or full patient identifiers available to link to external sources of self-reported data. We organized the literature by themes: (1) variation in data capture of self-reported data, (2) data augmentation from external sources of self-reported data, and (3) imputation methods, including Bayesian analysis and multiple regression. RESULTS: Researchers reduced data missingness with high validity for Asian, Black, White, and Pacific Islander racial groups and Hispanic ethnicity. Native American and multiracial groups were difficult to validate due to relatively small sample sizes. CONCLUSIONS: Limitations on accessible self-reported data for validation will dictate methods to improve race and ethnicity data capture. We recommend methods leveraging multiple sources that account for variations in geography, age, and sex.


Asunto(s)
Bases de Datos Factuales , Etnicidad , Farmacoepidemiología , Grupos Raciales , Humanos , Teorema de Bayes , Estados Unidos , United States Food and Drug Administration
8.
Drug Saf ; 46(8): 725-742, 2023 08.
Artículo en Inglés | MEDLINE | ID: mdl-37340238

RESUMEN

INTRODUCTION: Pharmacovigilance programs protect patient health and safety by identifying adverse event signals through postmarketing surveillance of claims data and spontaneous reports. Electronic health records (EHRs) provide new opportunities to address limitations of traditional approaches and promote discovery-oriented pharmacovigilance. METHODS: To evaluate the current state of EHR-based medication safety signal identification, we conducted a scoping literature review of studies aimed at identifying safety signals from routinely collected patient-level EHR data. We extracted information on study design, EHR data elements utilized, analytic methods employed, drugs and outcomes evaluated, and key statistical and data analysis choices. RESULTS: We identified 81 eligible studies. Disproportionality methods were the predominant analytic approach, followed by data mining and regression. Variability in study design makes direct comparisons difficult. Studies varied widely in terms of data, confounding adjustment, and statistical considerations. CONCLUSION: Despite broad interest in utilizing EHRs for safety signal identification, current efforts fail to leverage the full breadth and depth of available data or to rigorously control for confounding. The development of best practices and application of common data models would promote the expansion of EHR-based pharmacovigilance.


Asunto(s)
Sistemas de Registro de Reacción Adversa a Medicamentos , Registros Electrónicos de Salud , Humanos , Farmacovigilancia , Minería de Datos
9.
Vaccines (Basel) ; 10(11)2022 Nov 10.
Artículo en Inglés | MEDLINE | ID: mdl-36366404

RESUMEN

Since the authorization of the first COVID-19 vaccines in December 2020, multiple studies using real-world data (RWD) have been published to assess their effectiveness/safety profile. This systematic review aimed to characterize the methods and outcomes of studies using RWD for assessment of COVID-19 vaccines, four months after vaccine approval. MEDLINE and EMBASE were searched to identify published studies until 6 May 2021. Two independent researchers selected relevant publications and extracted data from included studies. The risk of bias was assessed using New-Castle Ottawa tools. After screening 1086 studies, 15 were included. Out of the 15 studies, 12 (80%) followed a cohort design, 8 (53%) were based on USA data, 7 (47%) assessed health care professionals, and 14 articles (93%) assessed the BNT162b2 vaccine. Data sources included institutional databases, electronic health records, and patient-generated data. The primary endpoint mainly described was SARS-CoV-2-infection. Hospitalization and mortality were assessed in 2 studies. For the comparability domain, six studies (40%) had a high risk of bias. A few months after the beginning of COVID-19 vaccination, Real-world Evidence (RWE) provided timely safety surveillance and comparative effectiveness with findings that showed similar findings to Randomized control trial (RCT). Most of the initiatives assessed BNT162b2 and were conducted in the USA and used healthcare workers' data.

10.
Am J Prev Med ; 63(4): 496-504, 2022 10.
Artículo en Inglés | MEDLINE | ID: mdl-35680481

RESUMEN

INTRODUCTION: This study identifies mental health, tobacco prevention, alcohol/beer, food/beverage, pharmaceutical, and other health-related advertisements across Spanish- and English-language TV networks owned by the same parent media company in the U.S. as commercial determinants of health disparities for Latino populations and/or viewers of Spanish-language TV. METHODS: A 3-week composite sample of Telemundo and National Broadcasting Company prime-time TV owned by the same parent media company was randomly drawn from March 31, 2021 to June 12, 2021 in Houston, Texas. A total of 1,593 health-related advertisements were yielded for systematic content analysis. Analyses included intercoder reliability, descriptive and bivariate analysis, and rate ratio and rate difference calculations. RESULTS: Telemundo had significantly more health-adverse and fewer health-beneficial advertisements than National Broadcasting Company. Telemundo broadcasted about 11 more alcohol (95% CI=9.1, 12.5) and 5 more unhealthy/noncore food/beverages (95% CI=2.0, 7.2) advertisements per hour of TV advertisement programming than the National Broadcasting Company. Telemundo also broadcasted about 1 fewer mental health/tobacco prevention (95% CI= -0.9, -0.2), 3 fewer healthy/core food/beverages (95% CI= -1.5, -4.3), and 4 fewer pharmaceutical (95% CI= -2.4, -5.7) advertisements per hour of advertisement programming than the National Broadcasting Company. CONCLUSIONS: Overall greater health-adverse and fewer health-beneficial advertisements are broadcasted on Spanish-language than on English-language TV. Unchecked corporate marketing strategies may serve as a commercial determinant of health disparities for Latino populations by Spanish-language TV.


Asunto(s)
Publicidad , Televisión , Humanos , Bebidas , Alimentos , Hispánicos o Latinos , Preparaciones Farmacéuticas , Reproducibilidad de los Resultados , Disparidades en el Estado de Salud , Promoción de la Salud
11.
Proc (Bayl Univ Med Cent) ; 35(4): 437-440, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35754610

RESUMEN

The value of self-monitoring blood glucose (SMBG) in patients with non-insulin-treated type 2 diabetes (NITT2DM) has been debated; however, the practice remains common. Patient perception of SMBG has been documented in several qualitative studies. However, the literature is lacking on the perceived value of SMBG by providers. This study used a structured questionnaire to evaluate and compare the perceived value, recommended frequency, and utility of SMBG in patients with NITT2DM by primary care providers (PCPs) and endocrinologists. A total of 70 PCPs and 14 endocrinologists completed the questionnaire. The results suggest that PCPs and endocrinologists find the practice of SMBG valuable in NITT2DM and believe it promotes behavioral changes in their patients. However, endocrinologists tend to recommend more frequent SMBG and find SMBG values more useful in making medication decisions. Conversely, PCPs tend to find the hemoglobin A1c more valuable than SMBG in making medication adjustments.

12.
Proc Biol Sci ; 289(1975): 20220621, 2022 05 25.
Artículo en Inglés | MEDLINE | ID: mdl-35582804

RESUMEN

Movement-induced forces are critical to correct joint formation, but it is unclear how cells sense and respond to these mechanical cues. To study the role of mechanical stimuli in the shaping of the joint, we combined experiments on regenerating axolotl (Ambystoma mexicanum) forelimbs with a poroelastic model of bone rudiment growth. Animals either regrew forelimbs normally (control) or were injected with a transient receptor potential vanilloid 4 (TRPV4) agonist during joint morphogenesis. We quantified growth and shape in regrown humeri from whole-mount light sheet fluorescence images of the regenerated limbs. Results revealed significant differences in morphology and cell proliferation between groups, indicating that TRPV4 desensitization has an effect on joint shape. To link TRPV4 desensitization with impaired mechanosensitivity, we developed a finite element model of a regenerating humerus. Local tissue growth was the sum of a biological contribution proportional to chondrocyte density, which was constant, and a mechanical contribution proportional to fluid pressure. Computational predictions of growth agreed with experimental outcomes of joint shape, suggesting that interstitial pressure driven from cyclic mechanical stimuli promotes local tissue growth. Predictive computational models informed by experimental findings allow us to explore potential physical mechanisms involved in tissue growth to advance our understanding of the mechanobiology of joint morphogenesis.


Asunto(s)
Ambystoma mexicanum , Urodelos , Animales , Miembro Anterior/anatomía & histología , Morfogénesis , Canales Catiónicos TRPV
13.
Dev Cell ; 57(7): 867-882.e5, 2022 04 11.
Artículo en Inglés | MEDLINE | ID: mdl-35413236

RESUMEN

During development, organs reach precise shapes and sizes. Organ morphology is not always obtained through growth; a classic counterexample is the condensation of the nervous system during Drosophila embryogenesis. The mechanics underlying such condensation remain poorly understood. Here, we characterize the condensation of the embryonic ventral nerve cord (VNC) at both subcellular and tissue scales. This analysis reveals that condensation is not a unidirectional continuous process but instead occurs through oscillatory contractions. The VNC mechanical properties spatially and temporally vary, and forces along its longitudinal axis are spatially heterogeneous. We demonstrate that the process of VNC condensation is dependent on the coordinated mechanical activities of neurons and glia. These outcomes are consistent with a viscoelastic model of condensation, which incorporates time delays and effective frictional interactions. In summary, we have defined the progressive mechanics driving VNC condensation, providing insights into how a highly viscous tissue can autonomously change shape and size.


Asunto(s)
Drosophila , Neuroglía , Animales , Desarrollo Embrionario , Neuronas
14.
J Med Educ Curric Dev ; 8: 23821205211044590, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34869902

RESUMEN

BACKGROUND: Active learning (AL) is recognized as a valuable learning strategy. OBJECTIVE: Using a conceptual framework, the objective of this study was to conduct a faculty self- and needs assessment to determine the extent to which the faculty at one college of pharmacy perceived they already carried out AL, describe faculty challenges, and evaluate faculty examples of AL techniques. METHODS: A 19-question survey was administered in July 2017 to all 50 college faculty. Survey question types included multiple-choice single- or multiple-answer questions and open-ended questions. For validity, Medina's conceptual framework of 4 key elements for the effective administration of AL was used. For reliability, the draft survey questions were reviewed multiple times and revised accordingly. RESULTS: Thirty-five faculty members, 70%, completed the survey in full. The majority of the faculty perceived that they carried out 3 of the 4 key elements during lectures: activate prior knowledge (74%), involve the majority of students (89%), and provide feedback (91%). However, only 37% stated they promoted metacognition, another key element. Our qualitative analysis identified (1) faculty had misconceptions about most of Medina's conceptual framework elements, (2) challenges to AL implementation included: need for more technology training, perception that AL requires cutting course material, beliefs that AL does not work, and fear of poor evaluations with AL implementation, and (3) suggestions to improve AL included: faculty development, training students on the importance of AL, and integrating AL throughout the curriculum. CONCLUSIONS: Although most faculties indicated they integrated AL in their teaching, faculty misconceptions, and beliefs suggest the need for long-term faculty and organizational development using strategies aligned with or seeking to change the beliefs of the faculty and college system.

15.
J Math Biol ; 83(6-7): 71, 2021 12 06.
Artículo en Inglés | MEDLINE | ID: mdl-34870766

RESUMEN

Cells and tissues exhibit sustained oscillatory deformations during remodelling, migration or embryogenesis. Although it has been shown that these oscillations correlate with intracellular biochemical signalling, the role of these oscillations is as yet unclear, and whether they may trigger drastic cell reorganisation events or instabilities remains unknown. Here, we present a rheological model that incorporates elastic, viscous and frictional components, and that is able to generate oscillatory response through a delay adaptive process of the rest-length. We analyse its stability as a function of the model parameters and deduce analytical bounds of the stable domain. While increasing values of the delay and remodelling rate render the model unstable, we also show that increasing friction with the substrate destabilises the oscillatory response. This fact was unexpected and still needs to be verified experimentally. Furthermore, we numerically verify that the extension of the model with non-linear deformation measures is able to generate sustained oscillations converging towards a limit cycle. We interpret this sustained regime in terms of non-linear time varying stiffness parameters that alternate between stable and unstable regions of the linear model. We also note that this limit cycle is not present in the linear model. We study the phase diagram and the bifurcations of the non-linear model, based on our conclusions on the linear one. Such dynamic analysis of the delay visco-elastic model in the presence of friction is absent in the literature for both linear and non-linear rheologies. Our work also shows how increasing values of some parameters such as delay and friction decrease its stability, while other parameters such as stiffness stabilise the oscillatory response.


Asunto(s)
Fricción , Modelos Lineales , Reología , Viscosidad
16.
Curr Pharm Teach Learn ; 13(11): 1510-1516, 2021 11.
Artículo en Inglés | MEDLINE | ID: mdl-34799067

RESUMEN

INTRODUCTION: In today's workforce, non-technical skills (NTS) are essential in determining an employee's ability to fit into an organization. However, it is unknown whether pharmacy students consider these skills essential to their future work or believe they are sufficiently trained. Therefore, this study evaluated student perceptions of the value of NTS as a pharmacist and their satisfaction with NTS training. METHODS: A 45-item survey was distributed to 111 fourth-year pharmacy students at Texas A&M College of Pharmacy in March 2019. Given the diverse nature of NTS, this study collected student perceptions about the 2016 Accreditation Council for Pharmacy Education Standard 4 Key Elements: self-awareness, leadership, innovation, and professionalism. Results were analyzed utilizing descriptive statistics. RESULTS: Approximately 84% (n = 93) of students completed the survey. More students perceived professionalism as an important skill to have, followed by leadership, self-awareness, and innovation. Similar results were shown with students' satisfaction with NTS training. Also, results highlighted that students' satisfaction level with their NTS training and their belief regarding their strengths relied on two factors: the number of advanced pharmacy practice experiences (APPEs) where NTS training occurred and the amount of time spent practicing the NTS. CONCLUSION: These data add to the existing literature to support NTS training in experiential pharmacy education. While APPEs should not be the only setting where these skills are practiced in the curriculum, our study's findings may further guide curricular priorities and assessment strategies for NTS in the experiential setting.


Asunto(s)
Educación en Farmacia , Servicios Farmacéuticos , Farmacia , Estudiantes de Farmacia , Curriculum , Humanos
17.
Sci Adv ; 7(42): eabg6467, 2021 Oct 15.
Artículo en Inglés | MEDLINE | ID: mdl-34644109

RESUMEN

The loss of epithelial homeostasis and the disruption of normal tissue morphology are hallmarks of tumor development. Here, we ask how the uniform activation oncogene RAS affects the morphology and tissue mechanics in a normal epithelium. We found that inducible induction of HRAS in confined epithelial monolayers on soft substrates drives a morphological transformation of a 2D monolayer into a compact 3D cell aggregate. This transformation was initiated by the loss of monolayer integrity and formation of two distinct cell layers with differential cell-cell junctions, cell-substrate adhesion, and tensional states. Computational modeling revealed how adhesion and active peripheral tension induces inherent mechanical instability in the system, which drives the 2D-to-3D morphological transformation. Consistent with this, removal of epithelial tension through the inhibition of actomyosin contractility halted the process. These findings reveal the mechanisms by which oncogene activation within an epithelium can induce mechanical instability to drive morphological tissue transformation.

18.
Drugs Aging ; 38(8): 713-723, 2021 08.
Artículo en Inglés | MEDLINE | ID: mdl-34235644

RESUMEN

BACKGROUND AND OBJECTIVE: The decision to initiate anticoagulation in older adults with atrial fibrillation is complicated by the benefit of ischemic stroke prevention vs the risk of falls resulting in major bleeds. The objective of this study was to assess the impact of different treatments including direct oral anticoagulants on quality-adjusted life-years (QALYs) in patients aged 75 years and older with atrial fibrillation in the context of falls. METHODS: A Markov decision process was constructed for older patients with atrial fibrillation taking no anti-thrombotic, aspirin, warfarin, rivaroxaban, and apixaban. Input probabilities for clinical events were estimated from the available literature. One-way and two-way sensitivity analyses were performed by measuring the impact of varying input probabilities of clinical events on QALY outcomes. RESULTS: The base-case scenario estimated that older adults treated with no anti-thrombotic, aspirin, warfarin, rivaroxaban, and apixaban had QALYs of 8.03, 8.69, 10.38, 11.02, and 11.56, respectively. The sensitivity analysis estimated that an older adult would need to fall over 45 (rivaroxaban) and 458 (apixaban) times per year for the QALY of a direct oral anticoagulant to be lower than that of aspirin. CONCLUSIONS: Older adults with atrial fibrillation benefit from stroke protection of anticoagulants, especially direct oral anticoagulants, even if they are at high risk of falls. Clinicians should not consider fall risk as a deciding factor for withholding anticoagulation in this population of patients.


Asunto(s)
Fibrilación Atrial , Accidente Cerebrovascular , Anciano , Anticoagulantes/efectos adversos , Fibrilación Atrial/complicaciones , Fibrilación Atrial/tratamiento farmacológico , Análisis Costo-Beneficio , Técnicas de Apoyo para la Decisión , Humanos , Piridonas , Años de Vida Ajustados por Calidad de Vida , Rivaroxabán , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control
19.
J Manag Care Spec Pharm ; 27(6): 714-723, 2021 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-34057388

RESUMEN

BACKGROUND: Asthma is one of the leading chronic disease states in pediatric patients in Texas. Pharmacy-led interventions such as targeted asthma education, scheduled consultations, and monitoring have shown success in improving asthma outcomes. However, no studies have evaluated the impact of the pharmaceutical care incentive (PCI) programs on Texas Medicaid pediatric beneficiaries. OBJECTIVES: To (1) describe the prevalence of asthma medication utilization and persistent asthma among Medicaid pediatric patients in Texas Health Service Region 11 (HSR 11) and (2) describe the prevalence and impact of PCI program interventions offered by pharmacists to Medicaid pediatric patients or their caregivers at the point-of-service in their medication utilization and asthma medication ratio (AMR). METHODS: This study used a 2-year longitudinal assessment of Medicaid pharmacy claims for beneficiaries aged between 0 and 18 years, with continuous enrollment, and at least 1 asthma medication claim during 2018 and 2019. The prevalence of asthma medication utilization during the study period was described. Also, the prevalence of PCI interventions among beneficiaries with at least 1 asthma medication was described. The prevalence of PCI interventions was also estimated for beneficiaries with persistent asthma. The AMR for beneficiaries with persistent asthma was calculated and compared for those with and without at least 1 PCI intervention. RESULTS: 22,051 beneficiaries with continuous enrollment between the ages of 0 and 18 years and with at least 1 pharmacy claim for an asthma medication during the study period were included. The overall prevalence of asthma medication utilization was 14.55%. 374 (1.70%) beneficiaries with at least 1 asthma medication received at least 1 asthma PCI intervention. Among beneficiaries that received at least 1 asthma PCI intervention, 158 (42.25%) were on rescue medication only; 4 (1.07%) were on maintenance medication only; and 212 (56.68%) were on rescue and maintenance medications. The overall prevalence of persistent asthma was 4.86%. 52 (0.76%) persistent asthma cases received at least 1 asthma PCI intervention after the index date. The overall unadjusted mean AMR (SD) for the 6,885 beneficiaries with persistent asthma was 0.50 (0.19). The adjusted AMR (SD) among beneficiaries with persistent asthma was reported at 0.530 (0.026) for beneficiaries who received at least 1 PCI intervention and 0.483 (0.002) for beneficiaries who did not receive a PCI intervention (P = 0.066). Beneficiaries with persistent asthma generated 64.35% of the total asthma pharmacy claims during 2019. CONCLUSIONS: Despite a high utilization of asthma medications among Medicaid pediatric beneficiaries, pharmacists servicing this group are underusing the PCI program interventions. An increase in the AMR among patients with persistent asthma receiving PCI interventions was observed when compared with those without PCI interventions. However, the difference was not statistically significant. Subsequent studies should include larger groups of beneficiaries receiving PCI interventions to establish the effect of PCI interventions on AMR before widespread implementation. DISCLOSURES: This research project was supported by the Global Institute for Hispanic Health (GIHH) through research grant M1803961. The authors have nothing to disclose. A part of this study was presented as a poster at the AMCP 2020 Virtual Annual Meeting and Exposition Meeting, April 21-24, 2020.


Asunto(s)
Asma/tratamiento farmacológico , Enfermedad Crónica , Motivación , Servicios Farmacéuticos , Niño , Preescolar , Femenino , Humanos , Estudios Longitudinales , Masculino , Estados Unidos
20.
P R Health Sci J ; 40(1): 19-25, 2021 03.
Artículo en Inglés | MEDLINE | ID: mdl-33876914

RESUMEN

OBJECTIVE: Evaluate the appropriateness of acetaminophen dosing by caregivers seeking care for their children/wards at the emergency department of a pediatric hospital. METHODS: Design: Cross-sectional descriptive study. Setting: The emergency department of the University Pediatric Hospital in San Juan, Puerto Rico. Participants: Eighty-eight caregivers who had, in the past 24 hours, administered a known quantity of acetaminophen to a pediatric patient under their care and were visiting the emergency room with that patient. Intervention: The caregivers were interviewed by the investigators, using a standardized questionnaire. Main outcome measures: The appropriateness of the acetaminophen doses administered by caregivers. The product's dosage form and strength, measurement device used (if any), and demographic data (of the caregiver and child) were also collected. Doses of 10 to 15 mg/kg of acetaminophen were considered appropriate. RESULTS: Overall, 45% of the caregivers had administered an inappropriate dose. Of these, 70% were subtherapeutic and 30% were supratherapeutic. Although 74% of the caregivers knew their child's/ward's weight, only 50% had used it to determine the dose. Caregivers with previous experience (as caregivers) were most likely to have administered an inappropriate dose (P = 0.03). Physicians were the source most consulted (40%) by caregivers, followed by the product's label (35%). Only 9% of the caregivers consulted a pharmacist for dosing recommendations. CONCLUSION: Nearly half of all the caregivers administered an incorrect acetaminophen dose, suggesting that there is a need for better caregiver education. Due to their accessibility at the point of sale of OTC medications and pharmacotherapy knowledge, pharmacists could have an active role in promoting the safe and effective use of acetaminophen.


Asunto(s)
Acetaminofén/administración & dosificación , Cuidadores , Servicio de Urgencia en Hospital/estadística & datos numéricos , Fiebre/tratamiento farmacológico , Medicamentos sin Prescripción/administración & dosificación , Acetaminofén/efectos adversos , Adulto , Analgésicos no Narcóticos/administración & dosificación , Niño , Preescolar , Estudios Transversales , Cálculo de Dosificación de Drogas , Femenino , Hospitales Pediátricos , Hospitales Universitarios , Humanos , Lactante , Masculino , Puerto Rico , Autocuidado
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