28 results on '"E. Mann"'
Search Results
2. Pharmacy Benefit Manager Market Concentration for Prescriptions Filled at US Retail Pharmacies.
- Author
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Qato DM, Chen Y, and Van Nuys K
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- Humans, Drug Prescriptions statistics & numerical data, Drug Prescriptions economics, Insurance, Pharmaceutical Services, Prescription Drugs economics, United States, Medicare Part D economics, Medicare Part D statistics & numerical data, Medicaid economics, Medicaid statistics & numerical data, Pharmacies economics, Pharmacies statistics & numerical data
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- 2024
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3. Mediators of racial and ethnic inequities in clinical trial participation among patients with cancer, 2011-2023.
- Author
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Guadamuz JS, Wang X, Altomare I, Camelo Castillo W, Sarkar S, Mamtani R, and Calip GS
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- Adult, Aged, Female, Humans, Male, Middle Aged, Black or African American, Ethnicity, Healthcare Disparities ethnology, Healthcare Disparities statistics & numerical data, Hispanic or Latino, Neighborhood Characteristics statistics & numerical data, Patient Participation statistics & numerical data, Patient Selection, Racial Groups, Retrospective Studies, Social Marginalization, United States, White, Clinical Trials as Topic statistics & numerical data, Neoplasms ethnology, Neoplasms therapy, Proportional Hazards Models, Social Determinants of Health ethnology
- Abstract
Background: Although racially and ethnically minoritized populations are less likely to participate in cancer trials, it is unknown whether social determinants of health (SDOH) explain these inequities. Here we identify SDOH factors that contribute to racial and ethnic inequities in clinical trial participation among patients with 22 common cancers., Methods: This retrospective cohort study used electronic health record data (2011-2023) linked to neighborhood (US Census tract) data from multiple sources. Patients were followed from diagnosis to clinical study drug receipt (proxy for trial participation), death, or last recorded activity. Associations were assessed using Cox proportional hazards models adjusted for clinical factors (year of diagnosis, age, sex, performance status, disease stage, cancer type). To elucidate which area-level SDOH underlie racial and ethnic inequities, mediation analysis was performed using nonlinear multiple additive regression tree models., Results: This study included 250 105 patients (64.7% non-Latinx White, 8.9% non-Latinx Black, 5.2% Latinx). Black and Latinx patients were more likely to live in economically or socially marginalized areas (eg, disproportionately minoritized [measure of segregation], limited English proficiency, low vehicle ownership) than White patients. Black (3.7%; hazard ratio = 0.55, 95% confidence interval [CI] = 0.52 to 0.60) and Latinx patients (4.4%; hazard ratio = 0.63, 95% CI = 0.58 to 0.69) were less likely to participate in trials than White patients (6.3%). Fewer patients in economically or socially marginalized neighborhoods participated in trials. Mediators explained 62.2% (95% CI = 49.5% to 74.8%) of participation inequities between Black and White patients; area-level SDOH-including segregation (29.9%, 95% CI = 21.2% to 38.6%) and vehicle ownership (11.6%, 95% CI = 7.0% to 16.1%)-were the most important mediators. Similarly, Latinx-White participation inequities were mediated (65.1%, 95% CI = 49.8% to 80.3%) by area-level SDOH, such as segregation (39.8%, 95% CI = 28.3% to 51.3%), limited English proficiency (11.6%, 95% CI = 2.8% to 20.4%), and vehicle ownership (9.6%, 95% CI = 5.8% to 13.5%)., Conclusions: To improve racial and ethnic diversity in cancer trials, efforts to address barriers related to adverse neighborhood SDOH factors are necessary., (© The Author(s) 2024. Published by Oxford University Press.)
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- 2024
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4. Disparate Patient Advocacy When Facing Unaffordable and Problematic Medical Bills.
- Author
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Duffy EL, Frasco MA, and Trish E
- Subjects
- Humans, Retrospective Studies, Male, Female, Adult, Middle Aged, United States, Health Expenditures statistics & numerical data, Surveys and Questionnaires, Financing, Personal, Patient Advocacy economics
- Abstract
Importance: People in the US face high out-of-pocket medical expenses, yielding financial strain and debt., Objective: To understand how households respond to medical bills they disagree with or cannot afford., Design, Setting, and Participants: A retrospective cohort study was carried out using a survey fielded between August 14 and October 14, 2023. The study included a random sample of adult (aged ≥18 years) survey respondents from the Understanding America Study (UAS). Participant responses were weighted to be nationally representative. The analysis took place from November 3, 2023, through January 8, 2024., Main Outcomes and Measures: Respondents reported if their household received a medical bill that they could not afford or did not agree with in the prior 12 months, and if anyone contacted the billing office regarding their concerns. Those who did reach out were asked about their experience and those who did not were asked why., Results: The survey was sent to 1233 UAS panelists, of which 1135 completed the survey, a 92.1% cooperation rate. Overall, 1 in 5 of the 1135 respondents received a medical bill that they disagreed with or could not afford. Leading bill sources were physician offices (66 [34.6%]), emergency room or urgent care (22 [19.9%]), and hospitals (31 [15.3%]), and 136 respondents (61.5%) contacted the billing office to address their concern. A more extroverted and less agreeable personality increased likelihood of reaching out. Respondents without a college degree, lower financial literacy, and the uninsured were less likely to contact a billing office. Among those who did not reach out, 55 (86.1%) reported that they did not think it would make a difference. Of those who reached out, 37 (25.7%) achieved bill corrections, better understanding (16 [18.2%]), payment plans (18 [15.5%]), price drop (17 [15.2%]), financial assistance (10 [8.1%]), and/or bill cancellation (6 [7.3%]), while 32 (21.8%) said that the issue was unresolved and 23.8% reported no change. These outcomes aligned well with respondents' billing concerns with financial relief for 75.8% of respondents reaching out about an unaffordable bill, bill corrections for 73.7% of those who thought there was mistake, and a price drop for 61.8% of those who negotiated., Conclusions and Relevance: This cross-sectional survey of a representative sample of patients in the US found that most respondents who self-advocated achieved bill corrections and payment relief. Differences in self-advocacy may be exacerbating socioeconomic inequalities in medical debt burden, as those with less education, lower financial literacy, and the uninsured were less likely to self-advocate. Policies that streamline the administrative burden or shift it from patients to the billing clinician may counter these disparities.
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- 2024
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5. Prescription Fills for Semaglutide Products by Payment Method.
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Scannell C, Romley J, Myerson R, Goldman D, and Qato DM
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- Humans, United States, Diabetes Mellitus, Type 2 drug therapy, Diabetes Mellitus, Type 2 economics, Glucagon-Like Peptides therapeutic use, Glucagon-Like Peptides economics, Hypoglycemic Agents economics, Hypoglycemic Agents therapeutic use
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- 2024
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6. Can Generalized Cost-Effectiveness Analysis Leverage Meaningful Use of Novel Value Elements in Pharmacoeconomics to Inform Medicare Drug Price Negotiation?
- Author
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Padula WV and Kolchinsky P
- Subjects
- Humans, Negotiating, Technology Assessment, Biomedical, United States, Cost-Effectiveness Analysis, Drug Costs, Economics, Pharmaceutical, Medicare economics, Quality-Adjusted Life Years
- Abstract
Objectives: Decision makers considering using cost-effectiveness analysis (CEA) to inform health-technology assessment must contend with documented and controversial shortfalls of CEA, including its assumption of disease severity independence and static pricing. ISPOR has recently introduced novel value elements besides direct healthcare cost and effectiveness for the patient, and these should be captured in CEA. Although novel value elements advance our understanding of "what" should be measured (value of hope, severity of disease, health equity, etc), there is limited direction on "how" to measure them in conventional CEA. Furthermore, with Medicare empowered to set drug prices under the Inflation Reduction Act, it is not clear what role CEA might have on where prices are set, given objections to the quality-adjusted life year in conventional approaches., Methods: We critically reviewed the evidence for expanding conventional CEA methods to a more generalized approach of generalized CEA (GCEA)., Results: GCEA accounts for methods that address objections to the quality-adjusted life year and incorporate novel value elements. Although GCEA offers advantages, it also requires further research to develop "off-the-shelf" resources to help inform, for example, maximum fair price in the context of Medicare drug price negotiation., Conclusions: Should a shift toward GCEA reveal that the societal value of novel medicines exceeds their market-based costs, which will raise the key question of what market failure Medicare negotiation is meant to solve, if any, and therefore what the appropriate role of such negotiation might be to maximize the value society might garner from the development of novel medicines., Competing Interests: Author Disclosures Author disclosure forms can be accessed below in the Supplemental Material section., (Copyright © 2024. Published by Elsevier Inc.)
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- 2024
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7. Comparative Effectiveness of Placental Allografts in the Treatment of Diabetic Lower Extremity Ulcers and Venous Leg Ulcers in U.S. Medicare Beneficiaries: A Retrospective Observational Cohort Study Using Real-World Evidence.
- Author
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Padula WV, Ramanathan S, Cohen BG, Rogan G, and Armstrong DG
- Subjects
- Humans, Female, United States, Retrospective Studies, Male, Aged, Pregnancy, Allografts, Varicose Ulcer therapy, Aged, 80 and over, Amputation, Surgical statistics & numerical data, Cohort Studies, Leg Ulcer, Medicare, Placenta, Diabetic Foot
- Abstract
Objective: To compare the effectiveness of cellular tissue products (CTP) versus standard care in U.S. Medicare beneficiaries with diabetic lower extremity ulcers (DLEUs) or venous leg ulcers (VLUs). Approach: We performed a retrospective cohort study using real-world evidence from U.S. Medicare claims for DLEUs or VLUs between 2016 and 2020. There were three cohorts evaluated: viable cryopreserved placental membrane (vCPM) or viable lyopreserved placental membrane (vLPM); other CTP; and standard care. Claims were collapsed into episodes of care. Univariate and bivariate statistics were used to examine the frequency distribution of demographics and clinical variables. Multivariable zero-inflated binomial regressions were used to evaluate mortality and recurrence trends. Logistic regression compared three adverse outcomes (AOs): amputation; 1-year mortality; and wound recurrence. Results: There were 333,362 DLEU episodes among 261,101 beneficiaries, and 122,012 VLU episodes among 80,415 beneficiaries. DLEU treatment with vLPM was associated with reduced 1-year mortality (-26%), reduced recurrence (-91%), and reduced AOs (-71%). VLU treatment with vCPM or vLPM was associated with reduced 1-year mortality (-23%), reduced recurrence (-80%), and 66.77% reduction in AOs. These allografts were also associated with a 49% and 73% reduced risk of recurrence in DLEU and VLU, respectively, compared with other CTPs. Finally, vCPM or vLPM were associated with noninferior prevention of AOs related to amputation, mortality, and recurrence (95% CI: 0.69-1.14). Conclusions: DLEUs and VLUs treated with vCPM and vLPM allografts are associated with lowered 1-year mortality, wound recurrence, and AOs in DLEUs and VLUs compared with standard care. Decision makers weighing coverage of placental allografts should consider these added short- and long-term clinical benefits relative to costly management and high mortality of Medicare's most frequent wounds.
- Published
- 2024
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8. Shingles Vaccination in Medicare Part D After Inflation Reduction Act Elimination of Cost Sharing.
- Author
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Qato DM, Romley JA, Myerson R, Goldman D, and Fendrick AM
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- Aged, Humans, United States, Vaccination economics, Vaccination legislation & jurisprudence, Cost Sharing economics, Herpes Zoster prevention & control, Herpes Zoster Vaccine economics, Medicare Part D economics, Medicare Part D legislation & jurisprudence
- Published
- 2024
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9. Medication persistence and its impact on type 2 diabetes.
- Author
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Choe JH, Xuan S, Goldenberg A, Matian J, McCombs J, and Kim RE
- Subjects
- Adult, Humans, Aged, United States, Retrospective Studies, Medication Adherence, Health Care Costs, Hypoglycemic Agents therapeutic use, Diabetes Mellitus, Type 2, Medicare Part C
- Abstract
Objectives: Medication persistence in type 2 diabetes (T2D) is a critical factor for preventing adverse clinical events. We assessed persistence among newly treated patients with T2D and documented the impact of persistence on clinical outcomes and costs., Study Design: Retrospective study of Optum Clinformatics Data Mart commercial and Medicare Advantage enrollees from 2007 to 2020., Methods: We identified adult patients who initiated antidiabetic treatments. Patients were required to have at least 1 treatment-free year prior to their first T2D prescription. Persistence was measured as the duration of continuous therapy until a 60-day gap in drug availability appeared in any antidiabetic therapy. Factors associated with duration were documented, focusing on the initial class(es) of T2D drugs. The impact of treatment duration on the risk of hospitalization and on total health care costs was also examined., Results: A total of 673,265 patients were included, with a median follow-up of 7 years. Only 22% of patients maintained continuous treatment, of whom 10% added a second medication. A 1-month increase in duration was associated with reduced risk of hospitalization due to stroke by 0.54% (95% CI, 0.46%-0.60%), acute myocardial infarction by 0.51% (95% CI, 0.44%-0.57%), and all-cause hospitalization by 0.36% (95% CI, 0.34%-0.37%). A 1-month increase in duration was associated with a year-to-year decrease in medical costs of $51 (95% CI, -$54 to -$48) and an increase in year-to-year drug costs of $14 (95% CI, $13-$14)., Conclusions: Our findings show low persistence among patients with T2D and emphasize the importance of medication persistence, which is associated with cost savings and lower risk of hospitalizations.
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- 2024
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10. Cost-effectiveness of nirsevimab and palivizumab for respiratory syncytial virus prophylaxis in preterm infants 29-34 6/7 weeks' gestation in the United States.
- Author
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Yu T, Padula WV, Yieh L, and Gong CL
- Subjects
- Infant, Infant, Newborn, Humans, United States, Pregnancy, Female, Palivizumab therapeutic use, Cost-Benefit Analysis, Gestational Age, Antiviral Agents therapeutic use, Respiratory Syncytial Viruses, Hospitalization, Infant, Premature, Respiratory Syncytial Virus Infections prevention & control, Antibodies, Monoclonal, Humanized
- Abstract
Background: Respiratory syncytial virus (RSV) hospitalizations have increased since the 2014 guideline update recommended against the use of palivizumab for preterm infants born ≥29 0/7 weeks' gestational age (GA) without additional risk factors. A novel drug candidate, nirsevimab, has been developed for this population. We analyzed the cost-effectiveness of palivizumab/nirsevimab vs. no prophylaxis in this population., Methods: A hybrid-Markov model predicted the RSV clinical course in the first year of life and sequelae in the subsequent four years for preterm infants from the healthcare and societal perspectives. Model parameters were derived from the literature. We calculated costs and quality-adjusted life-years (QALYs) to produce an incremental cost-effectiveness ratio (ICER) evaluated at a willingness-to-pay threshold of $150,000/QALY. Sensitivity analyses assessed model robustness. A threshold analysis examined nirsevimab pricing uncertainty., Results: Compared to no prophylaxis, palivizumab costs $9572 and $9584 more from the healthcare and societal perspectives, respectively, with 0.0019 QALYs gained per patient over five years, resulting in ICERs >$5 million per QALY from each perspective. Results were robust to parameter uncertainties; probabilistic sensitivity analysis revealed that no prophylaxis had a 100% probability of being cost-effective. The threshold analysis suggested that nirsevimab is not cost-effective when compared to no prophylaxis if the price exceeds $1962 from a societal perspective., Conclusion: Palivizumab is dominated by no prophylaxis for preterm infants 29 0/7-34 6/7 weeks' GA with no additional risk factors. Relevant stakeholders should consider alternatives to palivizumab for this population that are both effective and economical., Competing Interests: Conflict of interest T. Yu reported receiving personal fees from AbbVie outside the submitted work., (Copyright © 2024 Taiwan Pediatric Association. Published by Elsevier B.V. All rights reserved.)
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- 2024
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11. Changes in HIV Pre-exposure Prophylaxis (PrEP) Coverage at State and County Level During the COVID-19 Pandemic in the United States.
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Fallahi M, Guadamuz JS, Shooshtari A, and Qato DM
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- Humans, United States epidemiology, Pandemics prevention & control, New York, HIV Infections epidemiology, HIV Infections prevention & control, Pre-Exposure Prophylaxis, COVID-19 epidemiology, COVID-19 prevention & control
- Abstract
This study quantifies the prevalence and trends in weekly PrEP coverage at the national, state and county-level, before and during the COVID-19 pandemic in the United States.We estimated weekly PrEP coverage using longitudinal individual-level pharmacy claims from IQVIA LRx for a cohort of PrEP users (N = 287,493) ages 16 to 85 years between December 29th, 2019 and November 8th, 2020. Weekly PrEP coverage was defined as PrEP use among individuals at high risk for HIV. We conducted an interrupted time series analysis to quantify changes in weekly PrEP coverage before (December 29th, 2019 - March 8th, 2020) and during (March 29th - November 8th, 2020) the COVID-19 pandemic at the national, state and county-level by county characteristics, specifically by EHE priority jurisdiction, racial/ethnic composition, and urbanity. Nationally, weekly PrEP coverage among individuals ages 16 to 85 at high risk for HIV declined by 11.5% (from 11.0% before to 9.5% during the pandemic; t = 8.02,p < 0.01). Weekly PrEP coverage declined in all states and most counties yet varied substantially across states and counties. Geographic disparities in weekly PrEP coverage were also observed between urban EHE priority counties with significantly lower rates in counties with ≥ 50% Black/Latinx population when compared to their counterparts (7.9% vs. 11.2%; t = 18.91,p < 0.01);these disparities were most pronounced in California and New York. Weekly PrEP coverage was much lower than the 25% annual coverage reported by the Centers for Disease Control and geographic disparities observed within states likely contribute to the persistent racial/ethnic disparities in new HIV diagnoses observed within those states., (© 2023. The Author(s).)
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- 2024
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12. Risk of contralateral breast cancer among Asian/Pacific Islander women in the United States.
- Author
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Huang HC, Guadamuz JS, Hoskins KF, Ko NY, and Calip GS
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- Female, Humans, Asian statistics & numerical data, Hawaii, Native Hawaiian or Other Pacific Islander statistics & numerical data, Retrospective Studies, United States epidemiology, Adolescent, Young Adult, Adult, Breast Neoplasms epidemiology, Breast Neoplasms ethnology, Breast Neoplasms etiology
- Abstract
Purpose: While breast cancer studies often aggregate Asian/Pacific Islander (API) women, as a single group or exclude them, this population is heterogeneous in terms of genetic background, environmental exposures, and health-related behaviors, potentially resulting in different cancer outcomes. Our purpose was to evaluate risks of contralateral breast cancer (CBC) among subgroups of API women with breast cancer., Methods: We conducted a retrospective cohort study of women ages 18 + years diagnosed with stage I-III breast cancer between 2000 and 2016 in the Surveillance, Epidemiology and End Results registries. API subgroups included Chinese, Japanese, Filipina, Native Hawaiian, Korean, Vietnamese, Indian/Pakistani, and other API women. Asynchronous CBC was defined as breast cancer diagnosed in the opposite breast 12 + months after first primary unilateral breast cancer. Multivariable-adjusted subdistribution hazard ratios (SHR) and 95% confidence intervals (CI) were estimated and stratified by API subgroups., Results: From a cohort of 44,362 API women with breast cancer, 25% were Filipina, 18% were Chinese, 14% were Japanese, and 8% were Indian/Pakistani. API women as an aggregate group had increased risk of CBC (SHR 1.15, 95% CI 1.08-1.22) compared to NHW women, among whom Chinese (SHR 1.23, 95% CI 1.08-1.40), Filipina (SHR 1.37, 95% CI 1.23-1.52), and Native Hawaiian (SHR 1.69, 95% CI 1.37-2.08) women had greater risks., Conclusion: Aggregating or excluding API patients from breast cancer studies ignores their heterogeneous health outcomes. To advance cancer health equity among API women, future research should examine inequities within the API population to design interventions that can adequately address their unique differences., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
- Published
- 2024
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13. Estimating the cost of inappropriate antibiotic prophylaxis prior to dental procedures.
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Gong CL, Duong A, and Zangwill KM
- Subjects
- Humans, United States, Antibiotic Prophylaxis adverse effects, Anti-Bacterial Agents therapeutic use, Amoxicillin, Dentistry, Endocarditis, Bacterial, Endocarditis etiology, Endocarditis prevention & control
- Abstract
Inappropriate dental antibiotic prescriptions to prevent infective endocarditis in the United States results in ∼$31 million in excess costs to the healthcare system and patients. This includes out-of-pocket costs ($20.5 million), drug costs ($2.69 million) and adverse event costs (eg, Clostridioides difficile and hypersensitivity) of $5.82 million (amoxicillin), $1.99 million (clindamycin), and $380,849 (cephalexin).
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- 2023
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14. The AACP Academic Affairs Committee's Final 2022 Curricular Outcomes and Entrustable Professional Activities (COEPA) for Pharmacy Graduates to Replace 2013 CAPE and 2016 EPAs.
- Author
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Medina MS, Farland MZ, Conry JM, Culhane N, Kennedy DR, Lockman K, Malcom DR, Mirzaian E, Vyas D, Stolte S, Steinkopf M, and Ragucci KR
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- Humans, United States, Curriculum, Clinical Competence, Competency-Based Education, Education, Pharmacy, Pharmacy, Pharmaceutical Services, Pharmacies
- Abstract
The American Association of Colleges of Pharmacy (AACP) Academic Affairs Committee was charged with revising both the 2013 Center for the Advancement of Pharmacy Education (CAPE) Educational Outcomes (EOs) and the 2016 Entrustable Professional Activities (EPAs). The Committee changed the document name from the CAPE outcomes to COEPA, (Curricular Outcomes and Entrustable Professional Activities) since the EOs and EPAs would now be housed together. A draft of the COEPA EOs and EPAs was released at the AACP July 2022 Annual meeting. After receiving additional stakeholder feedback during and after the meeting, the Committee made additional revisions. The final COEPA document was submitted to and approved by the AACP Board of Directors in November 2022. This COEPA document contains the final version of the 2022 EOs and EPAs. The revised EOs have been reduced to 3 domains and 12 subdomains (from 4 domains and 15 subdomains previously in CAPE 2013) and the revised EPAs have been reduced from 15 to 13 activities., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Melissa Medina and Daniel Malcom are Associate Editors for AJPE., (Copyright © 2023 American Association of Colleges of Pharmacy. Published by Elsevier Inc. All rights reserved.)
- Published
- 2023
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15. Envisioning the Future of Student Success: Report of the 2022-2023 AACP Student Affairs Standing Committee.
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Robinson ET, Cochrane ZR, Akiyode O, Chahine EB, Culhane JM, Do DP, Franson KL, Minze MG, and Ross LJ
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- Humans, United States, Curriculum, Schools, Pharmacy, Education, Pharmacy, Pharmacy, Pharmaceutical Services, Students, Pharmacy
- Abstract
Over the past several years, traditional metrics have indicated declining student success within colleges and schools of pharmacy. Though students may be less well-prepared for professional school than in years past, once candidates are admitted to our institutions, we have a responsibility to effectively support their progression through the program. The 2022-2023 Student Affairs Committee was convened to evaluate and advance the construct of student success within Doctor of Pharmacy programs. The Student Affairs Committee was charged with identifying environmental factors affecting the ability of pharmacy students to be successful; determining how colleges and schools of pharmacy are currently meeting needs related to student progress; conducting a literature review to determine what academic support measures minimize attrition; and developing innovative suggestions and recommendations that better support student success. To accomplish this work, we conducted an extensive literature review and synthesis of evidence, engaged in professional networking across the Academy, and administered a wide-ranging student success survey to all colleges and schools of pharmacy. In this report, we explore the complex and interacting systems that affect learning behavior and academic success and offer a novel, comprehensive description of how the Academy is currently responding to challenges of academic and student success. Additionally, we envision the future of student success, offering 7 recommendations to the American Association of Colleges of Pharmacy and 5 suggestions to members of the Academy to advance this vision., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 American Association of Colleges of Pharmacy. Published by Elsevier Inc. All rights reserved.)
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- 2023
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16. Factors Associated with Biosimilar Exclusions and Step Therapy Restrictions Among US Commercial Health Plans.
- Author
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Yu T, Jin S, Li C, Chambers JD, and Hlávka JP
- Subjects
- Child, Humans, United States, Biosimilar Pharmaceuticals therapeutic use, Pharmacy
- Abstract
Background: Biosimilars have been introduced with the goal of competing with high-priced biologic therapies, yet their adoption has been slower than expected and resulted in limited efficiency gains. We aimed to explore factors associated with biosimilar coverage relative to their reference products by commercial plans in the United States (US)., Methods and Data: We identified 1181 coverage decisions for 19 commercially available biosimilars, corresponding to 7 reference products and 28 indications from the Tufts Medical Center Specialty Drug Evidence and Coverage database. We also drew on the Tufts Medical Center Cost-Effectiveness Analysis Registry for cost-effectiveness evidence, and the Merative™ Micromedex
® RED BOOK® for list prices. We summarized the coverage restrictiveness as a binary variable based on whether the product is covered by the health plan, and if covered, the difference of payers' line of therapy between the biosimilar and its reference product. We used a multivariate logistic regression to examine the association between coverage restrictiveness and a number of potential drivers of coverage., Results: Compared with reference products, health plans imposed coverage exclusions or step therapy restrictions on biosimilars in 229 (19.4%) decisions. Plans were more likely to restrict biosimilar coverage for the pediatric population (odds ratio [OR] 11.558, 95% confidence interval [CI] 3.906-34.203), in diseases with US prevalence higher than 1,000,000 (OR 2.067, 95% CI 1.060-4.029), and if the plan did not contract with one of the three major pharmacy benefit managers (OR 1.683, 95% CI 1.129-2.507). Compared with the reference product, plans were less likely to impose restrictions on the biosimilar-indication pairs if the biosimilar was indicated for cancer treatments (OR 0.019, 95% CI 0.008-0.041), if the product was the first biosimilar (OR 0.225, 95% CI 0.118-0.429), if the biosimilar had two competitors (reference product included; OR 0.060, 95% CI 0.006-0.586), if the biosimilar could generate annual list price savings of more than $15,000 per patient (OR 0.171, 95% CI 0.057-0.514), if the biosimilar's reference product was restricted by the plan (OR 0.065, 95% CI 0.038-0.109), or if a cost-effectiveness measure was not available (OR 0.066, 95% CI 0.023-0.186)., Conclusion: Our study offered novel insights on the factors associated with biosimilar coverage by commercial health plans in the US relative to their reference products. Cancer treatment, pediatric population, and coverage restriction of the reference products are some of the most significant factors that are associated with biosimilar coverage decisions., (© 2023. The Author(s).)- Published
- 2023
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17. "Beyond just the four walls of the clinic": The roles of health systems caring for refugee, immigrant and migrant communities in the United States.
- Author
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Abudiab S, de Acosta D, Shafaq S, Yun K, Thomas C, Fredkove W, Garcia Y, Hoffman SJ, Karim S, Mann E, Yu K, Smith MK, Coker T, and Dawson-Hahn E
- Subjects
- Humans, United States, Pandemics, Qualitative Research, Refugees, Transients and Migrants, COVID-19 epidemiology
- Abstract
This article is part of the Research Topic 'Health Systems Recovery in the Context of COVID-19 and Protracted Conflict'., Introduction: Refugee, immigrant and migrant (hereafter referred to as "immigrant") communities have been inequitably affected by the COVID-19 pandemic. There is little data to help us understand the perspectives of health systems on their role, in collaboration with public health and community-based organizations, in addressing inequities for immigrant populations. This study will address that knowledge gap., Methods: This qualitative study used semi-structured video interviews of 20 leaders and providers from health systems who cared for immigrant communities during the pandemic. Interviewees were from across the US with interviews conducted between November 2020-March 2021. Data was analyzed using thematic analysis methods., Results: Twenty individuals representing health systems participated with 14 (70%) community health centers, three (15%) county hospitals and three (15%) academic systems represented. The majority [16 health systems (80%)] cared specifically for immigrant communities while 14 (70%) partnered with refugee communities, and two (10%) partnered with migrant farm workers. We identified six themes (with subthemes) that represent roles health systems performed with clinical and public health implications. Two foundational themes were the roles health systems had building and maintaining trust and establishing intentionality in working with communities. On the patient-facing side, health systems played a role in developing communication strategies and reducing barriers to care and support . On the organizational side, health systems collaborated with public health and community-based organizations, in optimizing pre-existing systems and adapting roles to evolving needs throughout the pandemic., Conclusion: Health systems should focus on building trusting relationships, acting intentionally, and partnering with community-based organizations and public health to handle COVID-19 and future pandemics in effective and impactful ways that center disparately affected communities. These findings have implications to mitigate disparities in current and future infectious disease outbreaks for immigrant communities who remain an essential and growing population in the US., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Abudiab, de Acosta, Shafaq, Yun, Thomas, Fredkove, Garcia, Hoffman, Karim, Mann, Yu, Smith, Coker and Dawson-Hahn.)
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- 2023
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18. Potentially Inappropriate Medication Use in Community-Dwelling Older Adults Living with Dementia.
- Author
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Bae-Shaaw YH, Shier V, Sood N, Seabury SA, and Joyce G
- Subjects
- Aged, Humans, United States epidemiology, Potentially Inappropriate Medication List, Inappropriate Prescribing, Independent Living, Medicare, Retrospective Studies, Antipsychotic Agents therapeutic use, Dementia drug therapy, Dementia epidemiology
- Abstract
Background: The Beers Criteria identifies potentially inappropriate medications (PIMs) that should be avoided in older adults living with dementia., Objective: The aim of this study was to provide estimates of the prevalence and persistence of PIM use among community-dwelling older adults living with dementia in 2011-2017., Methods: Medicare claims data were used to create an analytic dataset spanning from 2011 to 2017. The analysis included community-dwelling Medicare fee-for-service beneficiaries aged 65 and older who were enrolled in Medicare Part D plans, had diagnosis for dementia, and were alive for at least one calendar year. Dementia status was determined using Medicare Chronic Conditions Date Warehouse (CCW) Chronic Condition categories and Charlson Comorbidity Index. PIM use was defined as 2 or more prescription fills with at least 90 days of total days-supply in a calendar year. Descriptive statistics were used to report the prevalence and persistence of PIM use., Results: Of 1.6 million person-year observations included in the sample, 32.7% used one or more PIMs during a calendar year in 2011-2017. Breakdown by drug classes showed that 14.9% of the sample used anticholinergics, 14.0% used benzodiazepines, and 11.0% used antipsychotics. Conditional on any use, mean annual days-supply for all PIMs was 270.6 days (SD = 102.7). The mean annual days-supply for antipsychotic use was 302.7 days (SD = 131.2)., Conclusion: Significant proportion of community-dwelling older adults with dementia used one or more PIMs, often for extended periods of time. The antipsychotic use in the community-dwelling older adults with dementia remains as a significant problem.
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- 2023
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19. Contact Tracing and Exposure Investigation in Response to the First Case of Monkeypox Virus Infection in the United States During the 2022 Global Monkeypox Outbreak.
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Shenoy ES, Wright SB, Barbeau DN, Foster LA, King AD, Gordon PS, Mehrotra P, Pepe DE, Caroff DA, Kim LR, McGrath SE, Courtney A, Fahy M, Hooper DC, Macdonald K, Searle EF, Shearer JA, Zachary KC, Bouton L, Cumming M, Hopkins B, Jacoboski J, Mann E, Osborne M, Perez C, Schultz J, Scotland S, Traphagen E, Madoff LC, and Brown CM
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- Humans, United States, Monkeypox virus, Contact Tracing, Disease Outbreaks, Massachusetts, Mpox (monkeypox)
- Abstract
Background: In May 2022, the first case of monkeypox virus (MPXV) infection in the United States in the current global outbreak was identified. As part of the public health and health care facility response, a contact tracing and exposure investigation was done., Objective: To describe the contact tracing, exposure identification, risk stratification, administration of postexposure prophylaxis (PEP), and exposure period monitoring for contacts of the index patient, including evaluation of persons who developed symptoms possibly consistent with MPXV infection., Design: Contact tracing and exposure investigation., Setting: Multiple health care facilities and community settings in Massachusetts., Participants: Persons identified as contacts of the index patient., Intervention: Contact notification, risk stratification, and symptom monitoring; PEP administration in a subset of contacts., Measurements: Epidemiologic and clinical data collected through standard surveillance procedures at each facility and then aggregated and analyzed., Results: There were 37 community and 129 health care contacts identified, with 4 at high risk, 49 at intermediate risk, and 113 at low or uncertain risk. Fifteen health care contacts developed symptoms during the monitoring period. Three met criteria for MPXV testing, with negative results. Two community contacts developed symptoms. Neither met criteria for MPXV testing, and neither showed disease progression consistent with monkeypox. Among 4 persons with high-risk exposures offered PEP, 3 elected to receive PEP. Among 10 HCP with intermediate-risk exposures for which PEP was offered as part of informed clinical decision making, 2 elected to receive PEP. No transmissions were identified at the conclusion of the 21-day monitoring period, despite the delay in recognition of monkeypox in the index patient., Limitation: Descriptions of exposures are subject to recall bias, which affects risk stratification., Conclusion: In a contact tracing investigation involving 166 community and health care contacts of a patient with monkeypox, no secondary cases were identified., Primary Funding Source: None.
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- 2022
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20. Use of Point-of-Care Handheld Ultrasound for Splenomegaly in United States-Bound Refugees: A Novel Technology with Far-Reaching Implications.
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Kummer T, Medley AM, Klosovsky A, Mann E, Mburu P, Ekernas K, Bonass B, Stauffer JC, Walukaga S, Weinberg M, Dunlop SJ, and Stauffer WM
- Subjects
- Humans, United States, Splenomegaly diagnostic imaging, Point-of-Care Systems, Refugees
- Abstract
Ultrasound (US) is an invaluable clinical tool. New point-of-care US technology holds great promise for hard-to-reach and mobile populations such as refugees. The implementation of US in unique and challenging settings has been hindered by cost, fragility of equipment, need for uninterrupted electricity, training, and difficulty in sharing data/image files impeding quality assurance. The recent development of more flexible, durable, high-quality, low-cost, handheld US technology has offered increased potential to address many of these barriers. We describe a pilot program using a new point-of-care US technology to identify and monitor splenomegaly in United States-bound Congolese refugees. This experience and model may hold lessons for planning and development of similar approaches in other hard-to-reach mobile populations.
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- 2022
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21. " How can you advocate for something that is nonexistent? " (CM16-17) Power of community in a pandemic and the evolution of community-led response within a COVID-19 CICT and testing context.
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Hoffman SJ, Garcia Y, Altamirano-Crosby J, Ortega SM, Yu K, Abudiab SM, de Acosta D, Fredkove WM, Karim S, Mann E, Thomas CM, Yun K, and Dawson-Hahn EE
- Subjects
- Ethnicity, Humans, Pandemics, United States, COVID-19 epidemiology, Refugees, Transients and Migrants
- Abstract
Formal and informal bilingual/bicultural organizations and networks form the backbone of support for refugee, immigrant, and migrant (RIM) communities in the United States. They are pivotal in mitigating barriers and inequities in social and structural determinants of health. These organizations and networks are situated within the communities they serve, and often are established and run by members of a community, to serve the community. In the United States, the COVID-19 pandemic surfaced and widened existing health inequities for some racial and ethnic communities. Our primary objectives were to: (1) describe the processes that underpinned the pivotal role of immigrant-serving community structures in developing and implementing culturally sustaining programming in the context of pandemic response, and (2) amplify the voices of community experts, as they shared experiences and perspectives around these humanistic and community-centered approaches. We applied a community case study approach to a national sample of RIM-serving community structures representing broad country/region-of-origin, cultural, and linguistic identities. Community engagement strategies utilized in the project period included engaging community partners to identify and facilitate connections, and consult on analysis and dissemination. The project team conducted 20 in-depth, semi-structured interviews with a purposive sample of community experts/community organizations. Sampling strategy was further informed by immigrant identity (i.e., characterization of status) and geography (i.e., United States Department of Health & Human Services, Office of Intergovernmental and External Affairs Regions). Through thematic analysis, results identified key contextual, process-, and impact-oriented themes inherent to community-led COVID-19 responses, that were situated within and around the public and health system response to the pandemic. As public health and health systems scrambled to address acute and unprecedented barriers to access, distribution of COVID-19-related health resources and services, and disparate health outcomes, community structures diligently and intentionally reimagined and reconceptualized their response to COVID-19, frequently in the setting of scarce resources. The grassroots response evolved as a counter-narrative to top-down equity processes, historically defined by systems and applied to the community., Competing Interests: Author JA-C was employed by WAGRO Foundation. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Hoffman, Garcia, Altamirano-Crosby, Ortega, Yu, Abudiab, de Acosta, Fredkove, Karim, Mann, Thomas, Yun and Dawson-Hahn.)
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- 2022
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22. Prospective Randomized Study Examining Preoperative Opioid Counseling on Postoperative Opioid Consumption after Upper Extremity Surgery.
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Vincent S, Paskey T, Critchlow E, Mann E, Chapman T, Abboudi J, Jones C, Kirkpatrick W, Namdari S, Hammoud S, and Ilyas AM
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- Counseling, Humans, Prospective Studies, United States, Upper Extremity surgery, Analgesics, Opioid therapeutic use, Pain, Postoperative drug therapy, Pain, Postoperative prevention & control
- Abstract
Background: Rates of opioid addiction and overdose continue to climb in the United States, increasing pressure on prescribers to identify solutions to decrease postoperative opioid consumption. Hand and upper extremity surgeries are high-volume surgeries with a predilection for inadvertent overprescribing. Recent investigations have shown that preoperative opioid counseling may decrease postoperative opioid consumption. In order to test this hypothesis, a prospective randomized trial was undertaken to determine the effect of preoperative opioid counseling on postoperative opioid consumption. Methods: Eligible patients undergoing outpatient upper extremity surgery were randomized to either receive preoperative opioid counseling or to receive no counseling. Surgeons were blinded to their patient's counseling status. Preoperatively, patient demographics, surgical and prescription details were recorded. Postoperatively, patients' pain experience including opioid consumption, pain levels, and satisfaction was recorded. Results: There were 131 total patients enrolled, with 62 in the counseling group and 69 in the control group. Patients receiving counseling consumed 11.8 pills compared to 17.4 pills in the control group ( P = .007), which translated to 93.7 Morphine Equivalent Units (MEU) in the counseling group compared to 143.2 MEU in the control group ( P = .01). There was no difference in pain scores at any time point between groups. Among all study patients a total of 3767 opioid pills were prescribed with approximately 50% left unused. Conclusion: Patients receiving preoperative counseling consumed significantly fewer opioids postoperatively. Inadvertant overprescribing remains high. Routine use of preoperative counseling should be implemented along with prescribing fewer opioids overall to prevent overprescribing.
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- 2022
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23. Impact of Shared Plans of Care on Healthcare Utilization by Children with Special Healthcare Needs and Mental Health Diagnoses.
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Mann E, Pyevich M, Eyck PT, and Scholz T
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- Child, Emergency Service, Hospital, Health Services Needs and Demand, Humans, Mental Health, Patient Acceptance of Health Care, Primary Health Care, United States, Child Health Services, Disabled Children
- Abstract
Objectives: We assessed how shared plans of care (SPoC), a care coordination tool, impact healthcare utilization of a cohort of children with special healthcare needs (CSHCN) and mental health conditions., Methods: Data, including emergency department (ED) visits, hospitalizations, and primary care visits, were collected through chart review of CSHCN. A Poisson generalized linear mixed model was used to analyze healthcare utilization data for CSHCN., Results: Our results showed a decrease in primary care visits, hospitalizations, and ED visits for CSHCN after SPoC implementation, though only primary care visits reached significance. Mental health care visits were specifically found to decrease by 39% following employment of SPoC., Conclusions for Practice: The use of SPoCs in CSHCN had a positive impact on healthcare utilization suggesting widespread use of this tool improved care coordination in this population.
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- 2021
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24. Nursing practice and global refugee migration: initial impressions from an Intergovernmental-Academic Partnership.
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Bampoh V, Thongkhamkitcharoen M, Dicker S, Dalal W, Frerich E, Mann E, Porta C, Siddons N, Stauffer WM, and Hoffman SJ
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- Adult, Female, Humans, International Cooperation, Male, Middle Aged, United States, Emigration and Immigration, International Agencies statistics & numerical data, Nurse's Role psychology, Nursing Care psychology, Nursing Staff psychology, Nursing Staff statistics & numerical data, Refugees
- Abstract
Aim: This report from the field describes impressions of the initial impact of bilateral, multi-sectoral field-based activities undertaken to strengthen International Organization for Migration/United Nations Migration Agency and US-based nurses' capacity to address complex clinical, social and cultural challenges experienced by refugees in resettlement. Authors comment on the defined and thorough health assessment process that refugees go through prior to resettlement, and focus on the essential nursing role in the health assessment process and continuum of care. The development of the interdisciplinary and collaborative partnership is described as well as next steps to move the partnership forward., Background: In 2017, International Organization for Migration/United Nations Migration Agency and the University of Minnesota, guided by experts from the United States Centers for Disease Control and Prevention, began a unique bilateral Intergovernmental-Academic partnership to enhance the health care of refugees. A key component was to strengthen nursing care of refugees through the standardization of clinical practice and nursing leadership., Sources of Evidence: Listening sessions, direct interaction between International Organization for Migration/United Nations Migration Agency and US-based refugee resettlement stakeholders, patterns in resettlement., Conclusion and Implications for Nursing and Health Policy: The report highlights the potential public health impact of a bilateral and collaborative initiative that develops and bridges key points in the migration and health trajectory of people with refugee status. Separated by geography, context and scope of work, health professionals in different roles in varied worldwide settings with a spectrum of resources may not fully understand the work of each other. Project activities were a platform through which US-based and internationally based nurses established mutuality, reciprocity and equity as partners. By strengthening systems and resources, the partnership reinforces the abilities of nurses who engage in this important work, to optimize health and wellbeing of people with refugee status., (© 2020 International Council of Nurses.)
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- 2020
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25. Unrealized potential of the US military battlefield trauma system: DOW rate is higher in Iraq and Afghanistan than in Vietnam, but CFR and KIA rate are lower.
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Nessen SC, Gurney J, Rasmussen TE, Cap AP, Mann-Salinas E, Le TD, Shackelford S, Remick KN, Akers KS, Eastridge BJ, Jenkins D, Stockinger ZT, Murray CK, Gross KR, Seery J, Mabry R, and Holcomb JB
- Subjects
- Adult, Emergency Medical Services organization & administration, Emergency Medical Services statistics & numerical data, Female, History, 20th Century, History, 21st Century, Humans, Male, United States, War-Related Injuries history, War-Related Injuries therapy, Young Adult, Afghan Campaign 2001-, Iraq War, 2003-2011, Military Medicine history, Military Medicine organization & administration, Military Medicine statistics & numerical data, Vietnam Conflict, War-Related Injuries mortality
- Abstract
Level of Evidence: Observational/retrospective/historic controls, level IV.
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- 2018
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26. Factors associated with trauma patients' length of stay at Role 2 facilities in Afghanistan, October 2009 to September 2014.
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Staudt A, Gurney J, Valdez-Delgado K, Suresh M, Trevino J, Le T, Seery J, Shackelford S, Nessen S, and Mann-Salinas E
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- Adult, Female, Humans, Male, Retrospective Studies, United States, War-Related Injuries surgery, Young Adult, Afghan Campaign 2001-, Hospitals, Military statistics & numerical data, Length of Stay statistics & numerical data, War-Related Injuries therapy
- Abstract
Background: Understanding patients' length of stay at far-forward Role 2 surgical units may help to determine support needs, stabilization requirements, predeployment training, and necessity of increased care capability before or during transport to a higher level of care. The objectives of this study were to (1) evaluate the amount of time patients spent at Role 2 and (2) determine the factors associated with trauma patients' length of stay at Role 2., Methods: We conducted a secondary data analysis of the Joint Trauma System Role 2 Database. Logistic regression was used to determine factors associated with extended length of stay at Role 2., Results: There were 7,912 study patients, and the overall median (interquartile range) amount of time patients spent at Role 2 was 2.5 (1.2-5.5) hours. The adjusted odds ratio (aOR) of extended stay for civilian/other forces and non-US military patients were 1.2 (95% confidence interval [CI], 1.0-1.4) and 1.4 (95% CI, 1.2-1.7) times higher as compared with US military patients, respectively. The aOR of extended stay were higher for patients who received blood transfusions (aOR, 1.4; 95% CI, 1.2-1.6), surgical procedures (aOR, 1.6; 95% CI, 1.4-1.8), or did not use a tourniquet (aOR, 1.2; 95% CI, 1.0-1.5). As compared with those injured by an explosion, the adjusted odds of extended stay were 1.2 (95% CI, 1.0-1.4) times higher for patients injured by another mechanism. The odds of extended stay were lower (aOR, 0.3; 95% CI, 0.2-0.5) for patients who died and higher (aOR, 1.4; 95% CI, 1.2-1.6) for transferred patients as compared with patients who returned to duty., Conclusion: In this study, interventions, patient affiliation, discharge status, and injury mechanism were associated with length of stay at Role 2. Our study results will help inform training and current Role 2 logistic and personnel support needs., Level of Evidence: Prognostic, level III.
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- 2018
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27. Educating health professionals collaboratively for team-based primary care.
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Schuetz B, Mann E, and Everett W
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- Cooperative Behavior, Delivery of Health Care, Integrated standards, Diffusion of Innovation, Humans, Interprofessional Relations, Models, Organizational, Organizational Culture, United States, Delivery of Health Care, Integrated methods, Medical Staff education, Patient Care Team organization & administration, Primary Health Care organization & administration
- Abstract
Team-based primary care offers the potential to dramatically improve the quality and efficiency of care, but its broader adoption is hindered by an education system that trains health professions in silos. Collaborative models that educate multiple practitioners together are needed to create a new generation of health professionals able to work in efficiently functioning teams. Changes in professional cultures, organizational structures, clinical partnerships, admissions, accreditation, and funding models will be required to support the expansion of collaborative education effectively.
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- 2010
- Full Text
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28. The first American account of cerebrospinal meningitis.
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Danielson L and Mann E
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- Child, Child, Preschool, Female, History, 19th Century, Humans, Infant, Male, Meningitis, Meningococcal diagnosis, Periodicals as Topic, United States, Meningitis, Meningococcal history
- Published
- 1983
- Full Text
- View/download PDF
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