Patient Access Research Articles

Exploring breast cancer screening fear through a psychosocial lens.

Breast cancer screening is crucial for early detection and treatment. Yet, underutilization persists due to various psychosocial factors. This manuscript delves into the multifaceted fears that hinder screening adherence. The literature provides a framework categorizing breast cancer screening fears into generalized cancer fear, fear of screening components, and fear of screening outcomes. In this review, we explore fear of screening components (concerns regarding radiation, discomfort, and pain) and fear of screening outcomes (disability and mortality apprehension, treatment fears, obligation anxiety, and financial concerns) as undesirable, and potentially addressable, aspects of breast cancer screening fear. False-positive results exacerbate these anxieties, prolonging distress and impacting patients' lives beyond the screening process. Addressing these concerns requires reframing current screening approaches to prioritize patient comfort, cultural sensitivity, and accessibility. To address current psychosocial challenges in breast cancer screening, this manuscript advocates for modifying breast cancer screening methods to improve adherence and patient well-being.

Defining the "ideal state": A primer on critical care pharmacy practice models.

In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Critical care pharmacists (CCPs) have been clearly established as value-added members of the interprofessional team, and their contributions positively impact patient outcomes in the intensive care unit (ICU). Despite this, not every critically ill patient in the US receives care from a CCP and the model through which CCPs practice is variable, which has important implications. The purpose of this primer is to review current CCP models and discuss elements of the optimal CCP practice model. Current CCP practice models are defined, including the drug processing and dispensing model, clinical pharmacy specialist model, integrated pharmacy generalist model, and hybrid model, as well as unit-based vs service-based models. The optimal CCP practice model considers the Triple Domain of CCP workload, which includes direct patient care, indirect patient care, and professional service. Elements of the ideal CCP practice model including 24/7/365 CCP services, unit- vs service-based models, prescriptive authority, operational support, and CCP-to-patient ratio are discussed. Other vital elements include protected offline time, use of appropriate workload metrics, development of career ladders, opportunities for professional development, and providing wellness resources. The ideal CCP practice model must also be considered through the lens of the patient and medical team, the CCP, the institution, and professional organizations. Strategies for optimizing current CCP practice models are provided, and application of optimal CCP practice model elements is explored through 5 case studies. The optimal CCP practice model includes multiple elements and incorporates the viewpoints of patients, providers, CCPs, institutions, and professional organizations; this model will increase access of all ICU patients to CCPs, enhance the scope of CCP cognitive services, and ensure the economic sustainability of CCP practice while establishing CCP involvement in activities outside of patient care and in professional service.

ASO Author Reflections: Improving Patient Access to Autologous Breast Reconstruction.

ASO Author Reflections: Improving Patient Access to Autologous Breast Reconstruction.

Development of a Scoring Rubric Assessing Medical Students' Explanations of Pathology Reports.

With increasing availability of immediate patient access to pathology reports, it is imperative that all physicians be equipped to discuss pathology reports with their patients. No validated measures exist to assess how pathology report findings are communicated during patient encounters. To pilot a scoring rubric evaluating medical students' communication of pathology reports to standardized patients. The rubric was iteratively developed using the Pathology Competencies for Medical Education and Accreditation Council for Graduate Medical Education pathology residency milestones. After a brief training, third- and fourth-year medical students completed 2 standardized patient encounters, presenting simulated benign and malignant pathology reports. Encounters were video recorded and scored by 2 pathologists to calculate overall and item-specific interrater reliability. All students recognized the need for pathology report teaching, which was lacking in their medical curriculum. Interrater agreement was high for malignant report scores (intraclass correlation coefficient, 0.65) but negligible for benign reports (intraclass correlation coefficient, 0). On malignant reports, most items demonstrated good interrater agreement, except for discussing the block (cassette) summary, explaining the purpose of the pathology report, and acknowledging uncertainty. Participating students (N = 9) felt the training was valuable given their limited prior exposure to pathology reports. This pilot study demonstrates the feasibility of using a structured rubric to assess the communication of pathology reports to patients. Our findings also provide a scalable example of training on pathology report communication, which can be incorporated in the undergraduate medical curriculum to equip more physicians to facilitate patients' understanding of their pathology reports.

B7-H3-Targeting Chimeric Antigen Receptors Epstein Barr Virus Specific T Cells Provides a Tumor Agnostic Off-The-Shelf Therapy Against B7-H3 Positive Solid Tumors.

Encouraged by our observations of pronounced B7-H3 protein over-expression in many human solid tumors compared to healthy tissues, we focused on targeting B7-H3 with CAR T cells. We utilized a nanobody as the t B7-H3 targeting domain in our CAR construct to circumvent the stability issues associated with scFv-based domains. In efforts to expand patient access to CAR T cell therapy, we engineered our nanobody-based CAR into human Epstein-Barr Virus Specific T Cells (EBVSTs), offering a readily available off-the-shelf treatment. B7H3.CAR-armored EBVSTs demonstrated potent in vitro and in vivo activities against multiple B7-H3-positive human tumor cell lines and patient-derived xenograft models. Murine T cells expressing a murine equivalent of our B7H3.CAR exhibited no life-threatening toxicities in immunocompetent mice bearing syngeneic tumors. Further in vitro evaluation revealed that while human T, B and NK cells were unaffected by B7H3.CAR EBVSTs, monocytes were targeted due to upregulation of B7-H3. Such targeting of myeloid cells, which are key mediators of cytokine release syndrome (CRS), contributed to a low incidence of CRS in humanized mice after B7H3.CAR EBVST treatment. Notably, we showed that B7H3.CAR EBVSTs can target B7-H3 expressing myeloid-derived suppressor cells (MDSCs), thereby mitigating MDSC-driven immune suppression. In summary, our data demonstrate that our nanobody-based B7H3.CAR EBVSTs are effective as an off-the-shelf therapy for B7-H3 positive solid tumors. These cells also offer an avenue to modulate the immunosuppressive tumor microenvironment, highlighting their promising clinical potential in targeting solid tumors.

Analyzing the Benefits and Costs of the Safe Step Act on Patients, Physicians, and Insurers

Pharmaceutical expenditures in the United States, particularly in dermatology, have grown rapidly, driven by expensive topical and biologic treatments. Insurers are employing cost-containing strategies such as step therapy, which mandates the use of lower-cost treatments before more expensive medications. The bipartisan Safe Step Act aims to enhance step therapy policies by introducing a transparent process for requesting exceptions and reasonable timelines for the process. However, there is limited analysis on how the Safe Step Act would affect the healthcare environment. We examine the policies of the Safe Step Act and existing literature on prior authorizations and discuss how the bill could affect patients, physicians, and insurers. While the act could expedite access to necessary medications and prevent irreversible harm to patients from delaying efficacious treatment, it falls short in relieving the administrative burdens on dermatology clinics. Although there is no ideal solution for managing healthcare costs, measures like step therapy encourage cost-effective treatments and optimizing care for the population. Curtailing step therapy with the exemptions process of the Safe Step Act might streamline patient access to treatments but could impede cost-containment strategies, weaken the bargaining power of insurers, and result in higher insurance premiums.

Effect of passive leg raising on the cross-sectional area of the right internal jugular vein in patients with obesity: a randomised controlled trial protocol

BackgroundVenous access in patients with obesity presents significant challenges. The success of central venous catheterisation largely depends on the cross-sectional area (CSA) of the internal jugular vein (IJV). While techniques...

Healhub Hospital Management Excellance

Healhub revolutionizes hospital management, offering seamless integration for administrators, doctors, and patients. Admins authenticate doctors, ensuring a secure platform. Verified doctors manage appointments and schedules, upload reports, and review patient feedback. Patients register and access departmental treatment options, browse doctor listings, and receive appointment updates. Healhub facilitates efficient communication and enhances patient-doctor interaction, improving healthcare delivery. One of Healhub's key features is its focus on enhancing communication and interaction between patients and doctors. Through the platform, patients can communicate with their healthcare providers, ask questions, and receive timely responses, leading to improved health outcomes and overall patient well-being with its intuitive functionalities and stringent security measures, Healhub sets a new standard for hospital operations. By fostering excellence in patient care and optimizing workflows, Healhub is at the forefront of transforming healthcare delivery. With intuitive functionalities and stringent security measures, Healhub streamlines hospital operations, fostering excellence in patient care.

The influence of near-infrared therapy on arteriovenous fistula patency in haemodialysis patients: A multicentre, randomised, controlled clinical trial.

Arteriovenous fistula (AVF) is the preferred vascular access for patients undergoing haemodialysis (HD). AVF malfunction remains a major clinical problem and is a significant independent risk factor for death. Although far-infrared (FIR) therapy has been shown to reduce complications and improve the patency rate of AVFs in various studies, it has been cautiously recommended by the Kidney Disease Outcome Quality Initiative (KDOQI) guidelines for AVF care due to insufficient evidence. Therefore, it is necessary to identify more effective methods for preventing AVF dysfunction. Many in vitro studies and few clinical studies have examined the effects of near-infrared (NIR) therapy on the vasculature. This study will examine the effects of NIR therapy on AVF. A randomised, controlled, open-label, multicentre trial will compare the effect of NIR on AVF patency after 1 year of therapy with that of a control group of patients with existing AVF. One group of patients received NIR treatment above their AVFs, whereas the control group received regular care. The primary outcome is the primary fistula patency rate within 12 months. In addition, acute changes in inflammatory, vasodilatory and haemodynamic parameters after a single treatment in the first 40 participants will be examined. This study was registered in the Clinical Trials Registry (ChiCTR2300071305) at https://register.clinicaltrials.gov/. This study will explore the long-term and acute effects of NIR on AVFs. The study findings will provide information that can be used to develop new technical support for the prevention of AVF dysfunction in patients undergoing haemodialysis.

Factors Associated With Increased Substance Use Disorder Care in VA PTSD Specialty Outpatient Treatment

Objective: Substance use disorders (SUDs) commonly co-occur with posttraumatic stress disorder (PTSD). Understanding PTSD clinics that serve higher percentages of patients with PTSD/SUD is crucial for improving SUD care in clinics with lower percentages of such patients. This study examined the differences between Veterans Affairs (VA) PTSD treatment sites with higher percentages ("High%") and lower percentages ("Low%") of patients with PTSD/SUD as well as exploring the roles of the PTSD/SUD specialists. Methods: The study collected quantitative and qualitative data from 18 clinic directors and 21 specialists from 33 VA PTSD specialty outpatient clinics from 2014 to 2016. The clinics were chosen from the top and bottom quartiles based on two criteria: (1) the percentage of patients with PTSD/SUD and (2) the percentage of patients with PTSD/SUD who completed at least three SUD visits within the first month of their SUD treatment. The interviews sought to identify distinguishing characteristics between the High% and Low% clinics in terms of treatment access and practices for patients with PTSD/SUD. Results: More of the High% clinics reported providing evidence-based, patient-centered, and integrated/concurrent PTSD/SUD treatment and had staff members with more up-to-date knowledge and skills than the Low% clinics. We also found the roles of the PTSD/SUD specialists were demanding and confusing, leading to high turnover rates. Conclusions: The two groups of PTSD clinics differed in three key factors: Resources, knowledge and skills of staff members, and local policies. Future research should focus on addressing resource limitations, knowledge gaps, and local policy disparities in Low% clinics. By emulating the practices of High% clinics, VA PTSD clinics can improve SUD care for patients with PTSD/SUD.

US Hospital Service Availability and New 340B Program Participation

The US 340B Drug Pricing Program enables eligible hospitals to receive substantial discounts on outpatient drugs to improve hospitals' financial sustainability and maintain access to care for patients who have low income and/or are uninsured. However, it is unclear whether hospitals use program savings to subsidize access as intended. To evaluate whether the 340B program is associated with improvements in access to hospital-based services and to test whether the association varies by hospital ownership. Difference-in-differences and cohort analysis from 2010 to 2019. Never and newly participating 340B general, acute, nonfederal hospitals in the US using data from the American Hospital Association's Annual Survey of Hospitals merged with hospital and market characteristics. Data were analyzed from January 1, 2023, to January 31, 2024. New enrollment in 340B between 2012 and 2018. Total number of unprofitable service lines, ie, substance use, psychiatric (inpatient and outpatient), burn clinic, and obstetrics services; and profitable services, ie, cardiac surgery and orthopedic, oncologic, neurologic, and neonatal intensive services. The study sample comprised a total of 2152 hospitals, 1074 newly participating and 1078 not participating in the 340B program. Participating hospitals were more likely than nonparticipating hospitals to be critical access and teaching hospitals, have higher Medicaid shares, and be located in rural areas and in Medicaid expansion states. At public hospitals, participation in the 340B program was associated with a significant increase in total unprofitable services (0.21; 95% CI, 0.04 to 0.38; P = .02) and marginal increases in substance use (5.4 percentage points [pp]; 95% CI, -0.8 pp to 11.6 pp; P = .09) and inpatient psychiatric (6.5 pp; 95% CI, -0.7 pp to 13.7 pp; P = .09) services. Among nonprofit hospitals, there was no significant association between 340B and service offerings (profitable and unprofitable) except for an increase in oncologic services (2.5 pp; 95% CI, 0.0 pp to 5.0 pp; P = .05). The finding of the cohort study indicate that participation in the 340B program was associated with an increase in unprofitable services among newly participating public hospitals. Nonprofit hospitals were largely unaffected. These findings suggest that public hospitals responded to 340B savings by improving patient access, whereas nonprofits did not. This heterogeneous response should be considered when evaluating the eligibility criteria for the 340B program and how it affects social welfare.

Incomes to Outcomes: A Global Assessment of Disparities in Cleft and Craniofacial Treatment.

Recent investigations focused on health equity have enumerated widespread disparities in cleft and craniofacial care. This review introduces a structured framework to aggregate findings and direct future research. Systematic review was performed to identify studies assessing health disparities based on race/ethnicity, payor type, income, geography, and education in cleft and craniofacial surgery in high-income countries (HICs) and low/middle-income countries (LMICs). Case reports and systematic reviews were excluded. Meta-analysis was conducted using fixed-effect models for disparities described in three or more studies. N/A. Patients with cleft lip/palate, craniosynostosis, craniofacial syndromes, and craniofacial trauma. N/A. One hundred forty-seven articles were included (80% cleft, 20% craniofacial; 48% HIC-based). Studies in HICs predominantly described disparities (77%,) and in LMICs focused on reducing disparities (42%). Level II-IV evidence replicated delays in cleft repair, alveolar bone grafting, and cranial vault remodeling for non-White and publicly insured patients in HICs (Grades A-B). Grade B-D evidence from LMICs suggested efficacy of community-based speech therapy and remote patient navigation programs. Meta-analysis demonstrated that Black patients underwent craniosynostosis surgery 2.8 months later than White patients (P < .001) and were less likely to undergo minimally-invasive surgery (OR 0.36, P = .002). Delays in cleft and craniofacial surgical treatment are consistently identified with high-level evidence among non-White and publicly-insured families in HICs. Multiple tactics to facilitate patient access and adapt multi-disciplinary case in austere settings are reported from LMICs. Future efforts including those sharing tactics among HICs and LMICs hold promise to help mitigate barriers to care.

Evaluating feedback from an implementation advisory board to assess the rollout of a postpartum patient navigation program

BackgroundPatient navigation is an individualized intervention to facilitate comprehensive care which has not yet been fully implemented in obstetric or postpartum care.MethodsWe aimed to develop and evaluate a mechanism to incorporate feedback regarding implementation of postpartum patient navigation for low-income birthing individuals at an urban academic medical center. This study analyzed the role of an Implementation Advisory Board (IAB) in supporting an ongoing randomized trial of postpartum navigation. Over the first 24 months of the trial, the IAB included 11 rotating obstetricians, one clinic resource coordinator, one administrative leader, two obstetric nurses, one primary care physician, one social worker, and one medical assistant. Members completed serial surveys regarding program implementation, effects on patient care, and areas for improvement. Quarterly IAB meetings offered opportunities for additional feedback. Survey responses and meeting notes were analyzed using the constant comparative method and further interpreted within the Exploration, Preparation, Implementation, Sustainment (EPIS) Framework.ResultsMembers of the IAB returned 37 surveys and participated in five meetings over 24 months. Survey analysis revealed four themes among the inner context: reduced clinician burden, connection of care teams, communication strategies, and clinic workflow. Bridging factors included improved patient access to care, improved follow-up, and adding social context to care. Innovation factors included availability of navigators, importance of consistent communication, and adaptation over time. Meeting notes highlighted the importance of bidirectional feedback regarding implementation, and members expressed positive opinions regarding navigators’ effects on patient care, integration into clinic workflow, and responsiveness to feedback. IAB members initially suggested changes to improve implementation; later survey responses demonstrated successful program adaptations.ConclusionsMembers of an implementation advisory board provided key insights into the implementation of postpartum patient navigation that may be useful to promote dissemination of navigation and establish avenues for the engagement of implementing partners in other innovations.Trial registrationClinicalTrials.gov, NCT03922334. Registered April 19, 2019. The results here do not present the results of the primary trial, which is ongoing.

Abstract PO4-14-02: Enhancing Informative Outcomes with Liquid Biopsy in a Real-World Population of Patients with Advanced Breast Cancer: Analysis of the SOLTI-1903 HOPE Study

Abstract Background: The integration of next-generation sequencing (NGS) into routine clinical practice is often hindered by financial and logistical challenges, resulting in diagnostic and therapeutic disparities among patients. Addressing these issues, the SOLTI-1903 HOPE study (NCT04497285) seeks to evaluate the feasibility of implementing a molecular screening program that actively involves patients with advanced breast cancer (ABC) in the management of their disease. By empowering patients, this study aims to gain a comprehensive understanding of the genomic landscape of ABC and to facilitate patient access to matched targeted therapies in Spain Methods: In the SOLTI-1903 HOPE study, a patient-centric approach was adopted, allowing patients living anywhere in Spain, and diagnosed with ABC, to actively lead their inclusion, participation, and follow-up using a digital tool (DT). Patients signed an informant consent, and then provided clinical information and underwent a liquid biopsy (LBx) using the Guardant360 panel at a local laboratory. LBx samples could be obtained at the moment of progressive disease (PD), when a new line of treatment was started &amp;lt; 8 weeks before extraction (PT), or during treatment with stable disease o partial response lasting more than 8 weeks (SD/PR). Clinical and molecular findings were evaluated by a Molecular Advisory Board (MAB), which generated a comprehensive report explaining the observed alterations and listing potentially beneficial matched targeted treatments. The primary endpoint of this subanalysis was to compare the genomic outcomes between LBx samples obtained at SD and those obtained at PD or PT. In the study, tissue samples were also collected and analysed by Foundation but this analysis will be reported in other communications. Results: From October 2020 to May 2023, a total of 273 blood samples were obtained from 253 patients diagnosed with ABC, with the majority being HR+/HER2- (81%), followed by HER2-positive (13%) and triple-negative (6%). Mean turnaround time was 10.9 days from blood collection to final result. Despite nearly 40% of patients being SD or PR, in 79.9% of the LBx (n=218), one or more genomic alterations were detected, and among these, 74.0% (n=202) were classified as pathogenic. Among the 74 genes analyzed by the Guardant360 panel, 8 genes were classified as tiers I-III according to the ESCAT levels of clinical relevance. In 150 LBx samples (54.9%), one or more pathogenic alterations were associated with ESCAT levels I-III, while only the remaining 52 LBx samples (19.1%) with pathogenic alterations were not associated with any ESCAT levels I-III. Among the analyzed LBx samples, a total of 928 distinct gene alterations were identified. Of these, 650 alterations (70.1%) were classified as pathogenic, while 278 (29.9%) were categorized as variants of unknown significance or lacked a reported impact. Notably, 25% (n=323) of the pathogenic gene alterations were further classified as ESCAT I-III. Out of the 273 LBx samples, 140 were obtained at PD, 30 at PT, and 103 at SD/PR. Circulating tumor DNA (ctDNA) was detected in 91.4% of PD samples, 86.7% of PT samples, and 62.1% of SD/PR samples (p&amp;lt; 0.001). Alterations classified as ESCAT levels I-III were observed in 70% of PD samples, 60% of PT samples, and 33% of SD/PR samples (p&amp;lt; 0.001). In 20 patients, LBx was repeated, with 16 of them having the first LBx obtained during SD/PR and the second LBx collected during PD or PT. The detection rate of ctDNA increased significantly from 18.7% (n=3) to 87.5% (n=14) (p&amp;lt; 0.001). The number of LBx samples with ESCAT levels I-III alterations also showed a significant increase from 12.5% (n=2) to 68.7% (n=11) (p=0.0032). Conclusions: Our findings highlight the importance of obtaining LBx samples during disease progression -compared to SD/PR- to gain greater genomic informativeness and better guide personalized treatment approaches for patients with advanced breast cancer. Citation Format: Tomás Pascual, Elia Seguí, Ruben Olivera-Salguero, Juan Miguel Cejalvo, Mafalda Oliveira, Pablo Tolosa, Maria Vidal, Marcos Malumbres, Joaquín Gavilá, Cristina Saura, Sonia Pernas, Rafael López, Mireia Margelí, Judith Balmaña, Montserrat Muñoz, Isabel Blancas, Valentina Boni, Eva Ciruelos, Elena Galve, Antonia Perelló, Rodrigo Sánchez-Bayona, Susana De La Cruz, Miguel De La Hoya, Aura Blanch-Torras, Rosana Sposito, Jordi Canes, Helena Masanas, Rosa Olmos, Margarita Forns, Maria José Prieto, Ana Casas, Aleix Prat. Enhancing Informative Outcomes with Liquid Biopsy in a Real-World Population of Patients with Advanced Breast Cancer: Analysis of the SOLTI-1903 HOPE Study [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-14-02.

Abstract PO2-09-10: Addressing Breast Cancer Disparities: Co-Creating Digital Interventions with Patients, Navigators &amp; the Community to Address Social Determinants of Health in the Memphis Statistical Area

Abstract Background: The Memphis Statistical Area, which covers counties in Arkansas, Mississippi, and Tennessee, leads in disparities in mortality rates between Black breast cancer patients compared to White counterparts1. Urban Health Education &amp; Support Services (UHESS), in partnership with RabbleHealth, and West Cancer Center &amp; Research Institute (WCCRI), initiated a solutions-oriented, community-based scalable initiative in January 2023 to measurably address social determinants of health (SDOH), which often drive cancer inequities that disproportionately impact individuals of marginalized communities. By leveraging a community-driven, co-creation sustainable approach, the team sought to measurably improve breast cancer equality utilizing digital enablement and the knowledge of local breast cancer survivors and leading healthcare professionals, including navigators. Methods: A four-phase approach was leveraged to 1. improve access to locally available breast cancer services in communities that are traditionally underserved and 2. measure the public health impact against root causes of breast inequities (i.e., care pathway metrics), and 3. create a repeatable, scalable model to expand to other underserved communities. In Phase 1, UHESS leveraged the Mid-South Regional Breast Cancer Coalition, which convenes ten local breast cancer patient advocacy organizations, to recruit focus groups for co-creation throughout all phases of the initiative. The working group consisted of eight representatives from a variety of Memphis-based cancer organizations, faith-based organizations, navigator programs, and WCCRI. This phase centered around establishing trust with the local patient advocacy community. In Phase 2, an initial patient survey was circulated to identify key resources that reduce health inequities and barriers to access. Human-centered design facilitators supported a series of Listen &amp; Learn workshops with patients to convey root causes of gaps in access to relevant services and with navigators to understand professional needs of navigators and scale the ability improve patient access to resources. To co-create a solution, facilitated patient and navigator workshops were held in Phase 3 to gather patient-centric user experience and design enhancements for a digital patient engagement app. These requirements as well as navigator-defined metrics needs were digitized and organized by SDoH. Phase 4, the Deploy &amp; Measure phase, will begin in September of 2023 and the community-based deployment model focuses on three drivers including: (a) embedding within navigator workflow, (b) activating faith-based organizations, and (c) leveraging societies. Health equity performance data will be analyzed weekly to rapidly target those ZIP codes with the greatest need. Results: Co-design efforts included over 50 members of the Greater Memphis community and final initiative results will be presented at the meeting. Planning for further research regarding community impact and model scalability is already underway. Conclusion: By leveraging a community-driven, co-creation sustainable approach, this model enables a better way to measurably improve breast cancer equality utilizing digital enablement and the knowledge of local breast cancer survivors and leading healthcare professionals, including navigators. Initiative Funding Acknowledgements: Gilead Life Sciences &amp; Blue Cross Blue Shield of Tennessee Foundation 1. Vidal G, Bursac Z, Miranda-Carboni G, White-Means S, Starlard-Davenport A. Racial disparities in survival outcomes by breast tumor subtype among African American women in Memphis, Tennessee. Cancer Med. 2017 Jul;6(7):1776-1786. doi: 10.1002/cam4.1117. Epub 2017 Jun 14. PMID: 28612435; PMCID: PMC5504313. Citation Format: Gregory Vidal, Stacey Tinianov, Aubrey Kelly, Andrea Curry, Carla Baker. Addressing Breast Cancer Disparities: Co-Creating Digital Interventions with Patients, Navigators &amp; the Community to Address Social Determinants of Health in the Memphis Statistical Area [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-09-10.

Project SATURN– a real-world evidence data collaboration with existing European datasets in Osteogenesis Imperfecta to support future therapies

Regulatory marketing authorisation is not enough to ensure patient access to new medicinal products. Health Technology Assessment bodies may require data on effectiveness, relative effectiveness, and cost-effectiveness. Healthcare systems may require data on clinical utility, savings, and budget impact. Furthermore, the exact requirements of these bodies vary country by country and sometimes even region to region, resulting in a patchwork of different data requirements to achieve effective, reimbursed patient access to new therapies. In addition, clinicians require data to make informed clinical management decisions. This requirement is of key importance in rare diseases where there is often limited data and clinical experience at the time of regulatory approval.This paper describes an innovative initiative that is called Project SATURN: Systematic Accumulation of Treatment practices and Utilization, Real world evidence, and Natural history data for the rare disease Osteogenesis Imperfecta. The objective of this project is to generate a common core dataset by utilising existing data sources to meet the needs of the various stakeholders and avoiding fragmentation through multiple approaches (e.g., a series of individual national requests/approaches, and unconnected with the regulators’ potential requirements). It is expected that such an approach will reduce the time for patient access to life-changing medications. Whilst Project SATURN applies to Osteogenesis Imperfecta, it is anticipated that the principles could also be applied to other rare diseases and reduce the time for patient access to new medications.

Abstract PO1-17-03: Real-world evidence of Trastuzumab biosimilars in HER2-positive breast cancer: Evaluating utilization, efficacy, and safety in Taiwan

Abstract Purpose Biosimilars have emerged as a promising alternative to reference biologic products for the treatment of cancers and immunological diseases. With regard to breast cancer, trastuzumab, a reference monoclonal antibody biologic, has been the standard of care for early and advanced HER2-positive breast cancer since 1998. Trastuzumab biosimilars, which provide comparable efficacy at a lower cost, have the potential to reduce financial burden on patients and healthcare systems and improve patient access to HER2-targeted therapy. This study aimed to evaluate the utilization, efficacy, and safety of trastuzumab biosimilars in HER2-positive breast cancer patients at Kaohsiung Veterans General Hospital. Methods A total of 113 HER2-positive breast cancer patients were enrolled between February 2020 and December 2022 and treated with trastuzumab biosimilars (OGIVRI®, trastuzumab-dkst). Of these, 44 were in the neoadjuvant group, 27 in the adjuvant group, and 42 in the metastatic group. Clinical outcomes were evaluated, including pathological complete response (pCR) rate in the neoadjuvant group, objective response rate (ORR) and clinical benefit rate (CBR) in the metastatic group, and safety profile in all groups. Results In the neoadjuvant group, 18 out of 44 evaluable patients achieved pathological complete response after surgery, resulting in a pCR rate of 40.90%. In the metastatic group , the ORR was 57.14% and the CBR was 90.47%. Furthermore, in the metastatic group, treatment with dual blockade using biosimilars resulted in an better ORR of 62.96%. No adverse events of cardiac toxicity were reported in any group. In the adjuvant group, longer follow-up is needed to assess efficacy. Conclusions Our real-world experience suggests that trastuzumab biosimilars are a safe and cost-effective alternative to reference trastuzumab in the treatment of HER2-positive breast cancer. Biosimilar trastuzumab demonstrated efficacy in the neoadjuvant setting, while dual blockade with biosimilars resulted in better disease control in the metastatic setting. Further follow-up is necessary to evaluate the efficacy of trastuzumab biosimilars in the adjuvant setting. Citation Format: Yi-Hung Lo, Yen-Dun Tzeng. Real-world evidence of Trastuzumab biosimilars in HER2-positive breast cancer: Evaluating utilization, efficacy, and safety in Taiwan [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-17-03.

How Should We Manage Antimicrobial Resistance in Resource-Limited Settings?

Patients living in low- and middle-income countries (LMICs) shoulder the greatest burden of infections caused by antimicrobial-resistant pathogens. Speedy access to appropriate broad-spectrum antimicrobials significantly improves health outcomes and reduces transmission of antimicrobial-resistant pathogens, but persons living in LMICs have compromised access to these antimicrobials. This article considers how inequities in microbiology diagnostics, antimicrobial access, and antimicrobial affordability influence outcomes for patients infected with antimicrobial-resistant pathogens who live in resource-limited settings.

The impact of national health insurance on the cost of auricular reconstruction with skin expansion for microtia in China: A single-center retrospective study based on 1290 surgeries

BackgroundCongenital microtia presents challenges that encompass physical disabilities and psychosocial distress. It is reported that people with low income have a higher possibility of giving birth to babies with congenital malformations. At the end of June 2023, auricular reconstruction was partially incorporated into national health insurance in our hospital. MethodsBriefly, 1290 surgeries, including stage-I and stage-II auricular reconstruction with tissue expansion were performed in 2023, involving 779 patients. Patient data, including age, sex, length of stay, residence, and costs, were retrieved from the electronic medical record system. The final cost before and after health insurance coverage, as well as the medical insurance reimbursement ratio in each province and municipality were statistically analyzed. ResultsFollowing insurance coverage, a significant increase in the number of surgeries was observed (514 [39.84%] vs. 776 [60.16%], χ2 = 45.99, p = 0.000), with notable reductions in out-of-pocket costs for unilateral and bilateral stage-I and -II auricular reconstructions ($3915.01 vs. $6645.28, p < 0.05; $11546.80 vs. $5198.08, p < 0.05). Disparities in reimbursement rates across regions were evident, but showed no correlation to the local GDP per capita. There was a positive correlation between the length of stay and inpatient cost. Patient’s age was not related to the inpatient cost, but to the length of stay. ConclusionThe health insurance coverage for microtia treatment significantly alleviated financial burdens on the patients’ family and increased the number of auricular reconstruction surgeries. These findings underscore the critical role of insurance coverage in enhancing healthcare accessibility and affordability for patients with congenital microtia.

Barriers to liver transplant referral in safety net settings: A national provider survey.

Safety net systems care for patients with a high burden of liver disease, yet experience many barriers to liver transplant (LT) referral. This study aimed to assess safety net providers' perspectives on barriers to LT referrals in the United States (US). We conducted a nationwide anonymous online survey of self-identified safety net gastroenterologists and hepatologists from March through November 2022. This 27-item survey was disseminated via e-mail, society platforms, and social media. Survey sections included practice characteristics, transplant referral practices, perceived multilevel barriers to referral, potential solutions, and respondent characteristics. 50 complete surveys were included in analysis. 60.0% of respondents self-identified as White, 54.0% male. 90.0% practiced in an urban setting, 82.0% in tertiary medical centers, and 16.0% in community settings with all four US regions represented. Perceived patient-level barriers ranked as most significant, followed by practice-level, then provider-level barriers. Patient-level barriers such as lack of insurance (72.0%), finances (66.0%), social support (66.0%), and stable housing/transportation (64.0%) were ranked as significant barriers to referral, while medical mistrust and lack of interest were not. Limited access to financial services (36.0%) and addiction/mental health resources (34.0%) were considered important practice-level barriers. Few reported existing access to patient navigators (12.0%), and patient navigation was ranked as most likely to improve referral practices, followed by an expedited/expanded pathway for insurance coverage for LT. In this national survey, safety net providers reported highest barriers to LT referral at the patient- and practice-level. These data can inform development of multilevel interventions in safety net settings to enhance equity in LT access for vulnerable patients.