US Health Care Research Articles

The role of artificial intelligence and machine learning in optimizing U.S. healthcare supply chain management

This paper aims to review the role of Artificial Intelligence and Machine Learning in managing the healthcare supply chain in the United States. Healthcare supply chains face several challenges such as fragmentation, lack of real-time visibility, and inventory management issues. However, there are solutions with the help of AI and machine learning, including the availability of predictive analytics to improve demand forecasting, optimization algorithms for inventory and logistics, and automated quality control. Application areas demand forecasting, supplier selection, logistics optimization, quality control, and real-time tracking. The applications of AI in healthcare supply chains have the potential to improve the healthcare supply chain in terms of reduced costs, increased efficiency, optimized decision-making, and better patient outcomes. However, the implementation experience has shown several challenges such as data quality, privacy concerns, regulatory compliance, and workforce adaptation within organizations. Successful implementations in various health organizations in the US give valuable insights into how AI could be well implemented. The future presents several opportunities for supply chain optimization with the rise of blockchain and Internet of Things (IoT) integration. For healthcare supply chains to adopt AI, organizations should have specific AI plans, start with pilot projects in high-impact areas, invest in data infrastructure, and ensure strong leadership support. As AI becomes increasingly critical for competitive advantage, it has the potential to create more resilient, efficient, and patient-centric supply chains in the US healthcare system.

Brodalumab: Six-Year US Pharmacovigilance Report.

Brodalumab is a human interleukin-17 receptorA antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. In the USA, brodalumab has a boxed warning regarding suicidal ideation and behavior and is only available under a Risk Evaluation and Mitigation Strategy, but no causal association has been established. To assess long-term safety of brodalumab, we summarize pharmacovigilance data from 6years of real-world clinical practice. Crude adverse event (AE) reporting rates per 100 patients were calculated for common AEs and AEs of special interest reported to Ortho Dermatologics by US patients and healthcare providers from August 15, 2017 through August 14, 2023. Brodalumab exposure was estimated as time from the first to last prescription-dispensing authorization dates. Adverse events were defined by Medical Dictionary for Regulatory Activities v26.0 Preferred Terms and standardized MedDRA queries. Data were collected from 5138 US patients (estimated exposure of 6900 patient-years). Over 6years, 13 cases of adjudicated major adverse cardiovascular events were reported (0.25 events/100 patients). The rate of serious infections was 2.20 events/100 patients. Since the 5-year report, there was one new case of Candida infection and a serious fungal infection of the elbow. Among 57 reported malignancies affecting 49 patients, 4 were deemed possibly related to brodalumab. One new case of indeterminate inflammatory bowel disease unrelated to brodalumab was reported. No new suicide attempts were reported in year6, and there were no completed suicides throughout 6years. Pharmacovigilance data throughout 6years are consistent with the safety profile of brodalumab established in clinical trials and previous US pharmacovigilance reports, with no completed suicides and a low fungal infection rate.

Safety and efficacy of outpatient intravenous diuresis in decompensated heart failure: a systematic review

IntroductionHeart failure (HF) burdens the US healthcare system, with annual costs exceeding $30 billion. Outpatient intravenous (OP IV) diuresis in clinic or home settings may potentially improve outcomes and reduce costs, though limited data exists. This systematic review evaluates the safety, efficacy, and outcomes of OP IV diuresis in managing decompensated HF as a hospitalization alternative.MethodsFollowing PRISMA 2020 guidelines, this systematic review used MeSH terms in MEDLINE, SCOPUS, CINAHL Complete, and Cochrane Central. From 16 selected studies, 15 were single-center; 6 prospective, 9 retrospective; and 1 was a randomized trial comparing OP IV diuresis to oral home regimen. Demographics, visit data, and outcomes were collected, and 30-day outcomes were compared to inpatient IV (IP IV) diuresis from 2021 Medicare HF hospitalizations.ResultsThe review included 1,590 unique patients treated with OP IV diuretics, with a mean age of 70 ± 6 years, 69.7% male, and 74.8% NYHA III-IV. Minimal adverse post-diuresis events such as hypokalemia, hypotension, and worsening renal function occurred (4.5%, 0.7%, and 2.3% respectively). Post-visit mean weight loss was −2.2 ± 1.1 kg. The 30-day readmission rate for OP IV diuresis was significantly lower than IP IV diuresis (20.0% vs. 22.6%; p = 0.0.401), and 30-day mortality was also lower (5.6% vs. 10.7%; p = 0.003).DiscussionOP IV diuresis is a safe and effective treatment for decompensated HF with minimal risk of adverse events. Data demonstrate reduced 30-day readmission, mortality rates, cost. These findings highlight the potential of OP IV diuresis as an enhanced alternative HF care; however, further randomized control trials are needed to evaluate long-term outcomes.

What to Expect When Switching to a Biosimilar: A US Healthcare Professional’s Perspective

Abstract Biologics are medications made up of large, complex molecules that are manufactured in living tissues or cells and can be used to treat autoimmune conditions such as inflammatory bowel disease. Biosimilars are biologics that are highly similar to an approved biologic medicine. Biosimilars cost less for manufacturers to make than the original biologic (known as the reference product) and can help more people have access to treatment. Insurance companies in the United States may require a patient to switch their treatment from a reference product to a biosimilar to help decrease the cost of treatment. In this article, a physician assistant and a pharmacist discuss the patient experience when a patient is switched to a biosimilar. The most common questions patients have when being switched are around the safety and effectiveness of biosimilars. The authors explain that all biosimilars must go through a rigorous process mandated by the US Food and Drug Administration to prove they have the same side effects and effectiveness as the biologics on which they are based. It is important for healthcare professionals to proactively educate patients who are being switched about biosimilars. Advance practice providers, physicians, and pharmacists should work with patients to answer their questions to enable them to feel comfortable starting or switching to a biosimilar.

Clinical and economic outcomes with rivaroxaban versus warfarin in patients with nonvalvular atrial fibrillation and obstructive sleep apnea: retrospective analysis of US healthcare claims.

Atrial fibrillation (AF) and obstructive sleep apnea (OSA) are often comorbid and associated with increased risk of cardiovascular events such as stroke. We evaluated the effectiveness, safety, healthcare resource utilization, and costs of rivaroxaban versus warfarin in patients with nonvalvular AF (NVAF) and comorbid OSA. We used the IQVIA PharMetrics® Plus adjudicated claims database to evaluate patients with NVAF, OSA, and moderate-to-severe stroke risk who initiated rivaroxaban or warfarin between November 2011 and December 2022. We adjusted for potential confounders with propensity score overlap weighting. Primary endpoints were evaluated based on intent-to-treat (ITT) and on-treatment follow-up to compare stroke or systemic embolism risk, major bleeding risk, all-cause healthcare resource utilization (inpatient hospitalizations, emergency department visits, outpatient visits, and pharmacy fills), and costs (per patient per year [PPPY]) by treatment cohort. In total, 14,765 patients were included (9133 received rivaroxaban; 5632 received warfarin). Rivaroxaban significantly reduced stroke or systemic embolism versus warfarin by 26% (ITT-hazard ratio, 0.74 [95% CI 0.60-0.91]; P = 0.004) and 30% (on-treatment-hazard ratio, 0.70 [95% CI 0.55-0.89]; P = 0.004). Major bleeding was not significantly different between rivaroxaban and warfarin in either analysis. All-cause healthcare resource utilization was significantly reduced with rivaroxaban versus warfarin, leading to significantly reduced PPPY costs. Among patients with NVAF and OSA, rivaroxaban was associated with a significant reduction in stroke or systemic embolism risk versus warfarin with no difference in major bleeding. Rivaroxaban significantly reduced healthcare resource utilization and costs compared with warfarin, providing support for the use of rivaroxaban in this population.

Psychometric development and validation of the Hospital Resilience Index

BackgroundThroughout the past decades, the United States healthcare system has seen increased efforts to promote continuity of operations in response to external or internal stressors. There is no marker to characterize this facet of health system resilience. The two databases which may contain the most relevant data are the American Hospital Association (AHA) annual survey, which gathers over 1000 data points from more than 6000 hospitals, and the RAND corporation, which provides information on the financial health and viability of hospitals and health care systems. In that sense, AHA focuses more on organizational and practice issues, while RAND will cover more economic factors. Our study aimed to develop and psychometrically validate a new Hospital Resilience Index (HRI).MethodsWe took the AHA and RAND databases as primary data sources, and defined hospital closure as the main negative outcome indicating failed resilience. We performed descriptive statistics, and regression analysis of the databases.ResultsOur findings show that a combination of eleven variables is strongly associated with the likelihood of hospital closure. These factors mirror smaller hospital size, lack of ancillary functions, staffing structure of the hospital, size of facilities, number of surgeries performed, Medicare discharges, operating expenses, and medical school affiliation as a teaching hospital. We further classified hospitals with a low HRI (< 25) or high HRI (> 25). In this setup, we found that both hospitals with a low HRI and hospitals that would subsequently close were characterized by smaller patient census, smaller numbers of surgeries, fewer beds, a smaller staff, and a lower operating margin.ConclusionsTogether, these factors would point to a higher resilience to external stressors in larger, more expanded hospitals and healthcare systems, offering a broad range of services, and having a higher operating margin. The higher tiers of the healthcare system therefore seem to have more resilience, but the recent Covid-19 pandemic exhibited how much all tiers in the system are needed to respond to extraordinary crises such as pandemics or large natural disasters. Future research should seek to determine whether tracking the HRI over time may be a tool to identify hospitals at risk of closure.

Cost-effectiveness analysis of additional local prostate radio therapy in metastatic prostate cancer from a medicare perspective

BackgroundMetastatic prostate cancer remains a therapeutic challenge. Based on data of the STAMPEDE trial, patients with a low metastatic burden showed prolonged failure-free and overall survival when treated with prostate radio therapy (RT) in addition to standard of care (SOC). The objective of this study was to determine the cost-effectiveness of additional prostate RT compared to SOC alone for following subgroups: non-regional lymph node (NRLN) metastases, up to three bone metastases and four or more bone metastases.MethodsA partitioned survival model was implemented with clinical data from STAMPEDE trial. Analyses were performed from a United States healthcare system perspective. Costs for treatment and adverse events were derived from Medicare coverage. Utilities for health states were derived from public databases and literature. Outcome measurements included incremental costs, effectiveness, and cost-effectiveness ratio. The willingness-to-pay threshold was set to USD 100,000 per quality-adjusted life year (QALY).ResultsAdditional RT led to 0.92 incremental QALYs with increased costs of USD 26,098 with an incremental cost-effectiveness ratio (ICER) of USD 28,452/QALY for patients with only NRLN metastases and 3.83 incremental QALYs with increased costs of USD 153,490 with an ICER of USD 40,032/QALY for patients with up to three bone metastases. Sensitivity analysis showed robustness of the model regarding various parameters. In probabilistic sensitivity analysis using Monte Carlo simulation with 10,000 iterations, additional RT was found as the cost-effective strategy in over 96% for both subgroups iterations at a willingness-to-pay threshold of USD 100,000/QALYs.ConclusionsAdditional RT is cost-effective in patients with only NRLN metastases and up to three metastases compared to SOC.

Advanced Data Analytics and Machine Learning Driven Fraud Detection and Data Loss Prevention for Automated Incident Response in the US Healthcare Corporations

Fraud detection and data loss prevention are critical challenges facing US healthcare corporations as they strive to safeguard sensitive patient information and comply with stringent data protection regulations. The integration of advanced data analytics and machine learning has emerged as a powerful approach to enhance the efficiency and accuracy of detecting fraudulent activities and preventing data breaches. This study explores the application of machine learning-driven solutions in automating incident response for healthcare data security. The research begins by examining the current landscape of data analytics and machine learning in fraud detection, emphasizing the limitations of traditional methods. Through an extensive literature review and analysis of case studies within the US healthcare industry, the paper identifies key areas where advanced technologies can bridge existing gaps. The methods section outlines the data collection process, the machine learning algorithms implemented, and the evaluation metrics used to measure model performance. Results demonstrate the enhanced detection accuracy and prompt response capabilities of machine learning models compared to conventional techniques. The discussion delves into the implications of these findings, showcasing the transformative potential of automated incident response systems in reducing response times and mitigating data loss risks. Although promising, the study acknowledges limitations in data variability and model generalizability, suggesting avenues for further research. The paper concludes with strategic recommendations for adopting machine learning solutions in healthcare security protocols. By highlighting best practices and policy recommendations, this research aims to provide a roadmap for healthcare corporations seeking to strengthen their data protection frameworks. The insights presented underscore the pivotal role of advanced data analytics and machine learning in fortifying healthcare data security against evolving cyber threats.

Improving access to gene therapies: a holistic view of current challenges and future policy solutions in the United States.

Gene therapies hold the promise of delivering groundbreaking improvements in health outcomes for previously intractable diseases.These therapies possess unique characteristics that differ from traditional small molecule or biologic treatments, posing new challenges for healthcare stakeholders. While previous analyses have predominantly focused on the payment challenges associated with emerging gene therapies, a more holistic examination reveals numerous obstacles that currently hinder optimal patient access. In the United States (US), these include production and distribution issues, logistical and treatment administration challenges and coverage and reimbursement limitations imposed by US healthcare payers. Several opportunities exist to address these challenges and improve patient access, including the use of appropriate value assessment methods, the development of innovative payment solutions, the removal of inappropriate access barriers imposed by payers and improving education and awareness regarding treatment availability, benefits and risks. Moving forward, we must collectively strive for comprehensive policy and market solutions that are sensitive to the uniqueness of gene therapies to ensure their full potential is realized and these treatments are made available to those in need.

The Impact of COVID-19 on Diverse Communities During the Pandemic: A Case for Culturally Competent Intervention Strategies

Providing access to adequate and culturally competent healthcare in the United States has been an ongoing challenge with healthcare access barriers impacting the quality of care received by racially and ethnically diverse populations. Despite the preventative measures taken to halt the spread of the COVID-19 pandemic, vulnerable populations and diverse communities were disproportionately represented in COVID-19 transmission and mortality rates. Through a review of the available literature and a quantitative analysis of COVID-19 surveillance data, this study addresses how culturally competent intervention strategies impacted COVID-19 mortality and fatality rates. This paper discusses how community leadership addressed vaccine distribution gaps and delayed government responses for diverse populations were addressed by the community leadership and provides examples of culturally competent solutions to healthcare emergencies. This cross-sectional study contributes to the current literature by exploring the impact of culturally competent healthcare interventions in North Carolina during the COVID-19 pandemic and makes the case for culturally competent practices to reduce the impact on diverse populations.

American health system problems and potential solutions

Abstract. The United States healthcare system indicates a paradox. It becomes famous for advances while plagues for significant challenges. This paper will emphasize the situation of the American health system, focus on its complexity and find out the potential factors. The burden stands out as a prominent characteristic of the US healthcare system. Despite its wealth, the US spends a disproportionate amount of its GDP on healthcare, surpassing other nations significantly. This financial strain affects individuals, families, insurers, healthcare facilities, and government budgets. The system lacks universal coverage and operates as a mixed system, combining publicly financed programs like Medicare and Medicaid with privately financed market coverage. One of the main challenges is the absence of price controls, leading to inflated healthcare costs compared to other countries. The US relies on individual insurers to negotiate prices, increasing prescription medication and medical services expenses. This model incentivizes innovation but burdens American consumers with subsidizing healthcare costs globally. The complexity and much broader structural problems intertwine, involving dispersive payment systems, for-profit markets and ultimately expensive management costs. All these factors push the price of American health soring, even persistent increasing through decades. Thus, this paper will have potential solutions by price negotiation and regulation, improving price transparency and easing price-setting. In addition, this paper will also analyze the effects of stakeholders due to these solutions. Generally, solving the issues of the US healthcare system requires a nuanced understanding of its intricacies and a concerted effort to promote affordability, accessibility, and quality of care for all Americans.

A Different View of the Issue: Seeing Disability Through the Lens of Diversity and Inclusivity in Healthcare in the United States

ABSTRACT Advocacy for diversity, inclusion and equity within healthcare continues to be an issue of importance and attention nationally. However, definitions of diversity often do not include people with disability. This commentary describes barriers to healthcare utilization experienced by people with disabilities in the United States (U.S.) and presents a rationale to refocus disability through this lens of diversity, equity, and inclusion within the U.S. systems of care. Bringing light to the ongoing challenges and inequities faced by our patients with disability is an essential first step toward improved inclusivity, leading to improved welfare of persons with disability as a whole.

Abstract 4135712: Mortality and Cardiovascular Complications Associated with Weight Loss Drugs among Breast Cancer Females Under Cardiotoxic Therapies: A Real-World Populational Study in the United States

Background: Obesity is an adverse prognostic factor for breast cancer (BC). While liraglutide and semaglutide, derived from antidiabetic glucagon-like peptide-1 receptor agonists (GLP1RA), are established weight loss drugs known for their cardiovascular safety in the general obese population, their safety in BC patients undergoing cardiotoxic antineoplastic therapies remains less understood. Objective: To investigate the mortality and cardiovascular outcomes related to GLP1RA used for weight loss among the highly susceptible BC females. Methods: This retrospective cohort study was based on the TrinetX network, comprising real-time health records from over 60 US healthcare organizations. The study population included obese females (≥18 years old) who received at least three prescriptions of either exclusive GLP1RA (liraglutide or semaglutide) or non-GLP1RA weight loss drugs (phentermine, bupropion-naltrexone, orlistat) upon BC diagnosis between 01/01/2015 and 01/01/2022. The index date was the initiation of systemic anti-cancer treatment, including chemotherapy (anthracycline, taxane, or cyclophosphamide), and/or anti-HER2 agents (trastuzumab, pertuzumab, or lapatinib). We used 1:1 propensity score-matching (PSM) to balance demographics, BMI, comorbidities, concurrent medications for cardiovascular diseases and metabolic disorders, BC receptor status and prior treatment, and levels of serum cholesterol (LDL, HDL) and hemoglobin A1c. Cox regression models were applied to compute hazard ratios (HR) and 95% confidence intervals (CIs). Follow-up continued until 05/24/2024, or until adverse cardiovascular events or death occurred. Results: Among 380 PSM-balanced pairs, the GLP1RA group (mean age: 57.6±11) showed significantly lower risks of all-cause mortality (HR 0.593, 95% CI 0.457-0.77), acute heart failure (HR 0.496, 95% CI 0.286-0.859), angina pectoris (HR 0.566, 95% CI 0.343-0.936), and acute stroke (HR 0.661, 95% CI 0.46-0.951) than the non-GLP1RA group (mean age: 57.5±12). Otherwise, no significant difference was shown in acute myocardial infarction (HR 0.787, 95% CI 0.495-1.251), pulmonary hypertension (HR 0.777, 95% CI 0.55-1.099), or arrhythmias (HR 0.829, 95% CI 0.566-1.215). Conclusion: Compared to non-GLP1RA weight loss agents, GLP1RA offers better survival and cardiovascular protection for BC patients undergoing cardiotoxic therapies. Future studies are warranted to validate the safety of these weight loss drugs during the BC treatment continuum.

Cost-effectiveness of midomafetamine-assisted therapy (MDMA-AT) in chronic and treatment-resistant post-traumatic stress disorder of moderate or higher severity: A health-economic model.

To explore the cost-effectiveness of midomafetamine-assisted therapy (MDMA-AT) compared to placebo with therapy (PT) in US healthcare settings. A health state-transition model was used to analyze the cost-effectiveness of MDMA-AT for treating patients with chronic PTSD of moderate or higher severity. Both treatment arms consisted of 3 preparation (90-min), 3 interventional (8-h), and 9 integration (90-min) sessions, lasting ~4 months total. All sessions included psychotherapy, with interventional also including MDMA or placebo. After receiving treatment, patients were distributed across health states of No PTSD (not meeting PTSD diagnostic criteria), Non-Severe PTSD (treatment responders), Severe PTSD (treatment non-responders), and death. Each state had unique healthcare costs and utilities sourced from real-world data analysis and patient data from MDMA-AT clinical trials (including long-term follow-up). The base-case analysis considered the payer's perspective with a 5-year horizon, 3.5% annual cost and effect discounts, and an assumed MDMA medication price of $12,000 per session. Trial-derived utilities and US life tables mortality data were used to calculate quality-adjusted life years (QALY). The main outcome was an incremental cost-effectiveness ratio (ICER) with a $150,000 willingness-to-pay (WTP) threshold. The base-case ICER was $83,845 per QALY. Total direct costs were $64,745 in the MDMA-AT and $33,132 in the PT arms ($31,613 increment). The costs of intervention were $48,376 for MDMA-AT and $12,376 for PT. The highest MDMA medication cost to fit under the WTP threshold was $20,314 per session. Costs related to PTSD healthcare visits and other PTSD treatments were lower with MDMA-AT than PT (-$2,511 and -$1,877 increments, respectively). Utility benefits were higher in MDMA-AT than PT, with 3.691 and 3.314 QALYs generated over 5 years, respectively (0.377 QALY increment). These data suggest MDMA-AT may be a cost-effective treatment compared to PT for patients with chronic PTSD of moderate or higher severity.

Abstract 4128599: Facility-level Variation Underlying Low Inferior Vena Cava Filter Retrieval in the United States

Background: Inferior vena cava (IVC) filters are commonly implanted in patients with venous thromboembolism (VTE) who are unable to receive anticoagulation, to protect against clot migration to the heart. With prolonged implantation, IVC filters are associated with complications: device fracture, migration, penetration into adjacent organs and worsened VTE. Two Federal Drug Administration advisories and multi-society guidelines have emphasized the importance of timely retrieval but national retrieval rates remain low (&lt;30%). Aims: To quantify hospital-level variation in IVC filter retrieval , describe time-based retrieval rates and examine factors associated with retrieval. Methods: IVC Filter implantation for all patients &gt;= 18 years was identified in the 2016-2020 inpatient and outpatient 100% limited data set Medicare files using claims codes. Hospital information for the implanting facility was cross-linked from the American Hospital Association and Healthcare Cost Report Information System files, including identifying information, teaching status, census location, operating margin and % uncompensated care. IVC filter retrieval rates and time to retrieval from implantation was calculated. Bayesian hospital profiling methods were used to quantify 1-year retrieval rate for all U.S. facilities, adjusting for patient factors – demographics, diagnostic indications and comorbidities. Results: Among Medicare beneficiaries, there were 140,481 IVC Filter implantations across 2,850 facilities. Excluding patients who died within 90 days of implantation (25.7%), retrieval rates at 3 months, 1 year and anytime were 7.9%, 18.7% and 20.0% respectively. IVC Filter retrieval within 1 year varied significantly at the facility-level, from 0-100% . Focusing on facilities with at least 13 IVC filter implantations each year (top 25%ile volume), 1-year retrieval ranged from 0 to 74.5%. Higher 1-year retrieval was seen among higher implantation volume (12.4% bottom quartile, 20.5% top quartile), teaching (21.1% teaching vs. 16.9% nonteaching) and non-safety net (21.1% low uncompensated care, 15.0% high uncompensated care) hospitals. Retrieval rates did not vary significantly by hospital operating margin or rurality. Conclusion(s): There is low overall IVC filter retrieval in the United States with large underlying facility-level variation. Focused examination of high-performing facilities could yield insights on how to improve device retrieval nationally.

Abstract 4123530: Disparities in Hypertension Treatment Intensification among Adults in a Large United States Healthcare System

Background: There are racial/ethnic and socioeconomic status (SES) disparities in hypertension control, even in populations with regular care. It is unclear if clinical inertia by clinicians contributes to these disparities. Objectives: To quantify racial/ethnic and SES disparities in treatment intensification (TI) among adults with hypertension. Methods: We performed a retrospective cohort study using electronic health records from Johns Hopkins primary care practices from January 2018 to December 2022. We included non-Hispanic Black (Black) and non-Hispanic White (White) adults with at least 2 elevated blood pressure readings (&gt;=140/90 mm Hg) in the 12 months prior to the index primary care visit and a diagnosis of essential hypertension. We excluded patients with diagnoses of end-stage renal disease, liver disease, dementia, and metastatic solid tumor. Patients could contribute multiple index visits. We measured SES using the national Area Deprivation Index, which comprises 17 neighborhood-level SES indicators, and dichotomized the population into high and low median SES groups. We defined TI as a change in antihypertensive class or dose increase within 14 days of the index visit. We balanced covariates reflecting clinical need at the index visit (age, sex, blood pressure readings, cardiometabolic comorbidities, body mass index) and the index visit’s calendar time across racial/ethnic and SES groups using inverse probability weighting. We estimated annual race/ethnic and SES specific TI rates and risk difference measures of disparity with 95% confidence intervals (CI) using a clustered bootstrap. Results: The cohort included 25,287 patients (11,800 Black, 13,487 White) with 79,898 eligible visits. Black patients were more often younger, female, and residing in low SES areas compared to White patients. In 2018, TI rates for Black patients (37%, 95% CI: 36-38%) were slightly lower than rates for White patients (39%, 95% CI: 38-40%). In 2022, the disparity persisted, with the Black patients’ TI rate lower by 3% (95% CI: -5%, -1%). Similarly, low SES patients had lower TI rates than high SES patients by 2% to 3% over the study period. Conclusion: Black patients and those from low SES consistently had modestly lower rates of TI compared to White patients and those from high SES. It will be important to identify the drivers and clinical implications of these treatment disparities.

INNV-38. 3 DAYS-ON-1 DAY-OFF FRACTIONATED USE PROTOCOL FOR IMPROVED COMPLIANCE AND PREVENTATIVE SKIN SAFETY FOR USE OF TUMOR TREATING FIELDS: PRACTICE IMPROVEMENT STRATEGY IN NEURO-ONCOLOGY

Abstract BACKGROUND Compassionate care delivery requires that providers understand patient values and adopt practices aimed to improve the quality of extended survival. Many brain tumor clinical trials measure survival outcomes based on therapeutic interventions, but often fail to anticipate patient noncompliance and the provider’s ability to communicate the plan. Tumor Treating Fields (TTFields) is an FDA-approved locoregional, noninvasive therapy worn on the scalp to treat glioblastoma (GBM). When worn, TTFields therapy disrupts cancer cell viability and delays tumor progression but is complicated by mild-moderate skin irritation and real-world inconvenience of the unclear recommendation to wear the device an average of “≥18 hours/day or 75% of the time”. We simplified the physician instructions to encourage patient compliance and skin safety on TTFields. METHODS Adults with GBM were provided an easy-to-follow flow chart and advised across multiple centers to follow the 3-days-on (72 hours) and 1-day-off (16–24 hours) TTFields therapy use schedule and given skin-specific wound prevention guidance (cleansing selenium-based shampoo and reparative skin-barrier moisturizing) during the ‘off day’. We evaluated the ease to explain the 3-on-1-off schedule, patient adherence, and the presence and severity of skin AEs during follow-up visits. REAL-WORLD PRACTICE OUTCOMES Seventy-six patients received TTFields therapy using the 3-on-1-off protocol between 2015 and 2021 at two US healthcare centers. The median age was 57 years (range 25–81). The mean time on TTFields therapy was 73 weeks. Skin AEs occurred in 5% of patients on the 3-on-1-off protocol, as compared to 16% and 52% reported on EF-11 (NCT00379470) and EF-14 (NCT00916409) GBM studies, respectively. Majority of AEs were mild, and no patients discontinued TTFields therapy or modified electrode placement due to skin AEs while on the 3-on-1-off protocol. CONCLUSION We report real-world data confirming a practice improvement for patient compliance using a novel 3-on-1-off protocol which minimizes skin AEs and treatment interruptions to improves patient outcomes. An ounce of prevention is worth a pound of cure.

Strengthening healthcare providers’ leadership capabilities, interprofessional collaboration, and systems thinking: a conceptualization of the Clinical Scholars program impact

BackgroundHealthcare provider leadership programs represent an intervention opportunity to support advancement of the national system of care and an evaluation of their program impacts is needed. Between 2016 and 2023, the Robert Wood Johnson Foundation (RWJF) funded Clinical Scholars (CS), a three-year equity-centered leadership training program for US healthcare providers. CS recruited participants (referred to as Fellows) in cohorts and engaged them as members of interprofessional teams to transform their careers and the health of their communities. The aim of this study was to evaluate Fellows’ perspectives on the success of CS, specifically the program elements and their importance for community well-being and sustainability.MethodsWe used the mixed methods group concept mapping (GCM) approach to evaluate Fellows’ perspectives on program success. First, we conducted the qualitative phases of brainstorming, sorting, and rating with Fellows. Secondly, we conducted the quantitative phases using multi-dimensional scaling and hierarchical cluster analysis and integrated the sorting and rating information from each Fellow to develop a series of concept maps. Finally, we conducted the interpretation phase to synthesize findings. Fellows (N = 177) across five cohorts were invited to participate in the study.ResultsFifty-seven Fellows (32%) completed one or more GCM phases. A conceptual map emerged, consisting of seven thematic clusters, which showed that program value could be attributed to the following elements: “Resources”, “Wicked Problem Impact Project (WPIP) Support”, “Curriculum”, “Thinking Bigger”, “Leadership Training”, “Networking”, and “Teamwork.” The pattern match showed that all seven clusters were highly rated by Fellows across the Community Well-being Impact and Sustainability domains.ConclusionStudy findings support the value of the RWJF-CS program strategy of long-term investment in the development of healthcare leaders with applied skills in interprofessional collaboration who will be prepared to continue addressing complex, multi-faceted challenges in the system of care.

Patient Health Record Protection Beyond the Health Insurance Portability and Accountability Act: Mixed Methods Study.

The security and privacy of health care information are crucial for maintaining the societal value of health care as a public good. However, governance over electronic health care data has proven inefficient, despite robust enforcement efforts. Both federal (HIPAA [Health Insurance Portability and Accountability Act]) and state regulations, along with the ombudsman rule, have not effectively reduced the frequency or impact of data breaches in the US health care system. While legal frameworks have bolstered data security, recent years have seen a concerning increase in breach incidents. This paper investigates common breach types and proposes best practices derived from the data as potential solutions. The primary aim of this study is to analyze health care and hospital breach data, comparing it against HIPAA compliance levels across states (spatial analysis) and the impact of the Omnibus Rule over time (temporal analysis). The goal is to establish guidelines for best practices in handling sensitive information within hospitals and clinical environments. The study used data from the Department of Health and Human Services on reported breaches, assessing the severity and impact of each breach type. We then analyzed secondary data to examine whether HIPAA's storage and retention rule amendments have influenced security and privacy incidents across all 50 states. Finally, we conducted a qualitative analysis of textual data from vulnerability and breach reports to identify actionable best practices for health care settings. Our findings indicate that hacking or IT incidents have the most significant impact on the number of individuals affected, highlighting this as a primary breach category. The overall difference-in-differences trend reveals no significant reduction in breach rates (P=.50), despite state-level regulations exceeding HIPAA requirements and the introduction of the ombudsman rule. This persistence in breach trends implies that even strengthened protections and additional guidelines have not effectively curbed the rising number of affected individuals. Through qualitative analysis, we identified 15 unique values and associated best practices from industry standards. Combining quantitative and qualitative insights, we propose the "SecureSphere framework" to enhance data security in health care institutions. This framework presents key security values structured in concentric circles: core values at the center and peripheral values around them. The core values include employee management, policy, procedures, and IT management. Peripheral values encompass the remaining security attributes that support these core elements. This structured approach provides a comprehensive security strategy for protecting patient health information and is designed to help health care organizations develop sustainable practices for data security.

Advanced Disease Detection and Personalized Medicine: Integrated Data Approaches for Enhanced Parkinson's Disease and Breast Cancer Detection and Treatment in the USA

This present study focuses on integrating data-driven approaches into personalized medicine for better detection and treatment of Parkinson's disease and breast cancer through the US healthcare system. The deeper integration of genomics, clinical records, and patient self-reported data with machine learning algorithms will enhance early disease detection and optimization of treatment pathways. The results show that, more precisely, Random Forest and XGBoost machine learning models hold great promise for considerably improving diagnostic precision and predictive power. This realization opens a door for precision medicine-tailored health services according to the peculiarities of individual patients, which would improve treatment outcomes and encourage preventive healthcare. In addition, this approach aligns with the latest US efforts in precision medicine and contributes to evidence-based transformation in healthcare practice.