US Health System Research Articles

Managing the challenges of paying for gene therapy: strategies for market action and policy reform in the United States.

Gene therapies delivered through a single administration have revolutionized treatment possibilities for many patients living with serious or fatal conditions such as spinal muscular atrophy, hemophilia and sickle cell disease. However, shadowing the excitement about the transformational potential of many gene therapies has been widespread concern about the combination of uncertainty in the durability of their benefits over the long term and the short-term financial shock of high prices. As the healthcare payment ecosystem prepares for the growing number of gene therapies entering the market, three key interconnected challenges must be addressed: determining a fair price, managing clinical uncertainty and managing short-term budget impacts. This paper identifies specific policy reforms and market-based tools to help the US health system address these challenges to achieve more equitable and affordable access for patients to the growing number of gene therapies expected to be approved in the coming years.

DISP-19. ETHNIC DISPARITIES IN METASTASIS PATTERNS AND TREATMENT UTILIZATION AMONG METASTATIC BREAST CANCER PATIENTS WITH BRAIN METASTASIS: A RETROSPECTIVE ANALYSIS OF US HEALTH SYSTEMS DATA (2019-2023)

Abstract INTRODUCTION The treatment landscape for metastatic breast cancer (MBC) with brain metastasis (BM) has evolved due to novel therapies. However, outcomes remain poor and vary among groups. This study investigated ethnic disparities in metastasis (mets) patterns and treatment use among MBCBM patients (pts). METHODS We analyzed deidentified data from seven US health systems in the Guardian Research Network from December 2019 to December 2023. Pts with MBC were categorized by IHC scores: hormone receptor+/HER2-, HER2-low (IHC 1+ or 2+ with negative FISH), HER2 positive, and Triple Negative (TNBC). We used descriptive and comparative statistical analysis. RESULTS Of 421 MBC pts, 200 (47.5%) had HER2+, 167 (39.7%) had HR+/HER2-, and 54 (12.8%) had TNBC. 159 (37.7%) were reclassified as HER2-low, primarily from HR+/HER2- (127; 76.0%) and TNBC (32; 59.3%). Bone mets developed in 29.6% of pts, more prevalent in HER2+ (39.5%), TNBC (25.9%), and HR+/HER2- (19.1%) groups. Non-Hispanics showed higher BM prevalence (74.4% vs. 25.6%). HR+/HER2- BM pts had higher bone mets (71.88%) than HER2+ BM (65.82%). TNBC BM pts had the highest rate of liver mets (57.1%). HER2-low BM pts showed mets across liver (40%), lung (34.29%), and bone (68.57%). In the HER2+ BM group, non-Hispanics had higher liver (40.13% vs. 32.35%) and bone mets (69.08% vs. 52.94%) than Hispanics. In TNBC BM group, Hispanics had higher liver mets (66.67% vs. 35%), while non-Hispanics had higher lung mets (32.5% vs. 11.11%). Both ethnic groups in HR+/HER2- category had high bone mets (78.95% vs. 73.33%). There were disparities in the use of CDK4/6 inhibitors, ICIs, and mTOR inhibitors, with Hispanics frequently using them. CONCLUSION HR+/HER2- BM pts were most affected by bone mets, followed by HER2+ BM. TNBC BM pts predominantly had liver mets. Non-Hispanics had higher BM prevalence. Hispanics frequently used ICIs, CDK4/6 and mTOR inhibitors, which were more frequently used by Hispanics. Further research should explore these disparities in mets patterns, treatment choices, and responses.

Effectiveness of mailed outreach and patient navigation to promote HCC screening process completion: a multicentre pragmatic randomised clinical trial

BackgroundHepatocellular carcinoma (HCC) is plagued by failures across the cancer care continuum, leading to frequent late-stage diagnoses and high mortality. We evaluated the effectiveness of mailed outreach invitations plus patient...

DISP-06. THE IMPACT OF SOCIAL DETERMINANTS OF HEALTH ON TREATMENT DELAYS FOR GLIOBLASTOMA

Abstract Social determinants of health (SDOH) contribute to treatment delays for a variety of diseases. However, the impact of SDOH on delays in treatment for glioblastoma (GBM) is not well established. Utilizing the Truveta database, which includes electronic health records, claims, linked SDOH data, and medication dispense data for a collective of US health systems, we evaluated individuals diagnosed with GBM from 1/1/2018-5/16/2024 who received either surgery, radiation, or temozolomide. Univariable and multivariable logistic regression modeling was performed to assess the odds of experiencing a delay in surgery (>7 days after diagnosis), radiation (>30 days after diagnosis), or temozolomide (>30 days after diagnosis). Adjusted odds ratios (aOR) and 95% confidence intervals (95% CI) are reported. Models were assessed for demographic (sex, age, race) and SDOH factors (education, income, social support, transportation, housing stability). At the univariable level, college attendance and single-member household were associated with delays in surgery but were not significant in the multivariable model. Individuals diagnosed with GBM at ages of 45-64 and 65+ were less likely to experience delays in surgery than individuals ages 18-44 (45-64 aOR (95%CI): 0.58(0.38-0.89), 65+ aOR (95%CI): 0.42(0.25-0.71)). Additionally, individuals with an estimated yearly income of $60,001-$120,000 were 61% more likely to experience delays in surgery compared to individuals with an estimated income of <$40,000 (aOR (95%CI): 1.61(1.16-2.24)). In univariable analyses, male sex, age at diagnosis of 18-44, college attendance, and an estimated income >$120,000 were associated with delays in radiation. However, no significant factors were associated with delays in radiation after adjustment. Individuals ages 45-64 and 65+ were less likely to encounter delays in temozolomide than individuals ages 18-44 (45-64 aOR (95%CI): 0.64(0.46-0.88), 65+ aOR (95%CI): 0.62(0.43-0.91)). Understanding how SDOH impact treatment patterns provides vital insight on diverse factors that impact patient care.

Lipoprotein (a) Testing in Patients With Atherosclerotic Cardiovascular Disease in 5 Large US Health Systems.

Lipoprotein (a) is an independent risk factor for atherosclerotic cardiovascular disease. However, lipoprotein (a) testing remains variable and it is unclear what factors influence testing and if testing changes clinical management. A retrospective study using electronic medical record data from 5 health systems identified an atherosclerotic cardiovascular disease cohort divided into those with and without a lipoprotein (a) test between 2019 and 2021. Baseline characteristics and lipid-lowering therapy patterns were assessed. Multivariable regression modeling was used to determine factors associated with lipoprotein (a) testing. Among 595 684 patients with atherosclerotic cardiovascular disease, only 2587 (0.4%) were tested for lipoprotein (a). Those who were older or Black individuals were less likely to have lipoprotein (a) testing, while those with familial hypercholesterolemia, ischemic stroke/transient ischemic attack, peripheral artery disease, prior lipid-lowering therapy, or low-density lipoprotein cholesterol ≥130 mg/dL were more likely to be tested. Those with a lipoprotein (a) test, regardless of the lipoprotein (a) value, were more frequently initiated on any statin therapy (30.3% versus 10.6%, P < 0.001), ezetimibe (7.65% versus 0.8%, P < 0.001), or proprotein convertase substilisin/kexin type 9 inhibitor (6.7% versus 0.3%, P < 0.001) compared with those without a test. Those with an elevated lipoprotein (a) level more frequently initiated ezetimibe (11.5% versus 5.9%, P < 0.001) or proprotein convertase substilisin/kexin type 9 inhibitor (10.9% versus 4.8%, P < 0.001). Lipoprotein (a) testing in patients with atherosclerotic cardiovascular disease is infrequent, with evidence of disparities among older or Black individuals. Testing for lipoprotein (a), regardless of level, is associated with greater initiation of any lipid-lowering therapy, while elevated lipoprotein (a) is associated with greater initiation of nonstatin lipid-lowering therapy. There is a critical need for multidisciplinary and inclusive approaches to raise awareness for lipoprotein (a) testing, and its implications on management.

Widespread Adoption of Precision Anticancer Therapies After Implementation of Pathologist-Directed Comprehensive Genomic Profiling Across a Large US Health System.

Precision therapies and immunotherapies have revolutionized cancer care, with novel genomic biomarker-associated therapies being introduced into clinical practice rapidly, resulting in notable gains in patient survival. Despite this, there is significant variability in the utilization of tumor molecular profiling that spans the timing of test ordering, comprehensiveness of gene panels, and clinical decision support through therapy and trial recommendations. To standardize testing, we designed a pathologist-directed test ordering system at the time of diagnosis using a 523-gene DNA/RNA hybrid comprehensive genomic profiling (CGP) panel and extensive clinical decision support tools. To comprehensively characterize the clinical impact of this protocol, we developed a novel natural language processing (NLP)-based approach to extract clinical features from physician chart notes. We assessed test actionability rates, therapy choice, and outcomes across a set of 3,216 patients with advanced cancer. We observed 49% of patients had at least one actionable genomic biomarker-driven-approved and/or guideline-recommended targeted or immunotherapy (IO) and 53% of patients would have been eligible for a precision therapy clinical trial from three large basket trials. When assessing CGP versus an in silico 50-gene panel, 67% of tumors compared with 33% harbored actionable alterations including clinical trials. Among patients with 6 months or more of follow-up, over 52% received a targeted therapy (TT) or IO, versus 32% who received conventional chemotherapy alone. Furthermore, patients receiving TT had significantly improved overall survival compared with patients receiving chemotherapy alone (P < .001). Overall, these data represent a major shift in standard clinical practice toward molecularly guided treatments (targeted and immunotherapies) over conventional systemic chemotherapy. As guidelines continue to evolve and more precision therapeutics gain approval, we expect this gap to continue to widen.

Digital Youth and Family Engagement Program for Adolescents Who Receive Outpatient Mental Health Services: Qualitative Evaluation.

Incidents of depression, anxiety, and suicidal ideation among adolescents have increased in recent years. Mental health interventions tailored to adolescents and families need to consider mechanisms for increasing enrollment and sustaining program engagement. A telephone-based, health coach intervention for adolescents and families was implemented at a Southeastern US health system with the goals of improving psychiatric appointment attendance, medication adherence, reduction in emergency department visits, and assisting with crisis management ("Youth and Family Engagement" [YFE] program). This study aims to explore patients' and parents' perceptions of a mental health program and the factors that impact enrollment and sustained engagement. Semistructured interviews were conducted with adolescent patients (n=9, 56%), parents (n=11, 92%), and clinicians who placed patient referrals (n=6, 100%). Interviews were in English (participants: 19/26, 73%) or Spanish (parents: 7/11, 64%), depending upon participants' preference. Interviews explored perceptions of the YFE program, experiences working with health coaches, suggestions for program changes, and program goals. The data were analyzed using inductive coding methodologies, with thematic analysis used to organize emergent themes. Two qualitatively trained researchers, one bilingual in English and Spanish, facilitated all data collection and collaboratively performed data analysis. The YFE program's structure was often mentioned as promoting engagement, with telephone appointments and health coaches' ability to accommodate inflexible work or school schedules alleviating participation barriers. Skills learned from health coaches were frequently referenced, with adolescents generally citing internal processes, such as positive thinking and mindfulness. Parents discussed behaviors relative to their children, such as improvements with discipline, setting boundaries, and improved parent-child communication. Many participants discussed the importance of health coaches assisting families in navigating social systems, such as accessing resources (eg, housing) and navigating school processes (eg, individualized educational plans), with clinicians suggesting an increased emphasis on adolescents' nutrition and engagement in primary care. Spanish-speaking parents highlighted numerous advantages of working with bilingual health coaches, emphasizing both enhanced communication and cultural understanding. They specifically noted the coaches' ability to grasp their lived experiences and challenges as immigrants in the United States, which significantly enriched their participation in the program. Prioritizing convenient engagement for adolescents and families may be important for sustained program participation, as inflexible schedules and competing priorities pose barriers to traditional appointments. Future programs should carefully consider health coach-participant relationships, specifically cultural competency, providing services in native languages, and assisting families with wraparound care, as these may be crucial to sustained engagement.

Autism Diagnosis Among US Children and Adults, 2011-2022

An improved understanding of autism spectrum disorder (ASD) prevalence over time and across the lifespan can inform health care service delivery for the growing population of autistic children and adults. To describe trends in the prevalence of ASD diagnoses using electronic records data from a large network of health systems in the US. This cross-sectional study examined annual diagnosis rates in health records of patients in US health systems from January 1, 2011, to December 31, 2022. Eligible individuals were included in the study sample for a given calendar year if they were enrolled in a participating health system for at least 10 months out of the year. Data were extracted from 12 sites participating in the Mental Health Research Network, a consortium of research centers embedded within large, diverse health care systems. Diagnoses of ASD were ascertained using International Classification of Diseases, Ninth Revision (ICD-9) and International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) revision codes. Annual diagnosis rates were calculated as the number of unique members diagnosed, divided by the total members enrolled. A total of 12 264 003 members were enrolled in 2022 (2 359 359 children aged 0 to 17 years [19.2%]; 6 400 222 female [52.2%]; 93 002 American Indian or Alaska Native [0.8%], 1 711 950 Asian [14.0%], 952 287 Black or African American [7.8%], 2 971 355 Hispanic [24.2%], 166 144 Native Hawaiian or Pacific Islander [1.4%], and 6 462 298 White [52.7%]). The ASD diagnosis rate was greatest among 5-to-8-year-olds throughout the study period and increased by 175% among the full sample, from 2.3 per 1000 in 2011 to 6.3 per 1000 in 2022. The greatest relative increase in diagnosis rate from 2011 to 2022 occurred among 26-to-34-year-olds (450%) and increases were greater for female vs male individuals among children (305% [estimated annual percentage change (EAPC), 13.62 percentage points; 95% CI, 12.49-14.75 percentage points] vs 185% [EAPC, 9.63 percentage points; 95% CI, 8.54-10.72 percentage points], respectively) and adults (315% [EAPC, 13.73 percentage points; 95% CI, 12.61-14.86 percentage points] vs 215% [EAPC, 10.33 percentage points; 95% CI, 9.24-11.43 percentage points]). Relative increases were greater in racial and ethnic minority groups compared with White individuals among children, but not adults. In this cross-sectional study of children and adults in the US, ASD diagnosis rates increased substantially between 2011 and 2022, particularly among young adults, female children and adults, and children from some racial or ethnic minority groups. Diagnosis prevalence trends generated using health system data can inform the allocation of resources to meet the service needs of this growing, medically complex population.

Application of a digital quality measure for cancer diagnosis in Epic Cosmos.

Missed and delayed cancer diagnoses are common, harmful, and often preventable. We previously validated a digital quality measure (dQM) of emergency presentation (EP) of lung cancer in 2 US health systems. This study aimed to apply the dQM to a new national electronic health record (EHR) database and examine demographic associations. We applied the dQM (emergency encounter followed by new lung cancer diagnosis within 30 days) to Epic Cosmos, a deidentified database covering 184 million US patients. We examined dQM associations with sociodemographic factors. The overall EP rate was 19.6%. EP rate was higher in Black vs White patients (24% vs 19%, P < .001) and patients with younger age, higher social vulnerability, lower-income ZIP code, and self-reported transport difficulties. We successfully applied a dQM based on cancer EP to the largest US EHR database. This dQM could be a marker for sociodemographic vulnerabilities in cancer diagnosis.

Impacts of age and BMI on vancomycin model choice in a Bayesian software: Lessons from a very large multi-site retrospective study.

Model-informed precision dosing (MIPD) optimizes drug doses based on pharmacokinetic (PK) model predictions, necessitating careful selection of models tailored to patient characteristics. This study evaluates the predictive performance of various vancomycin PK models across diverse age and BMI categories, drawing insights from a large multi-site database. Adults receiving vancomycin intravenous therapy at United States health systems between January 1, 2022, and December 31, 2023, were included. Patient demographics, vancomycin administration records, and therapeutic drug monitoring levels (TDMs) were collected from the InsightRX database. Age and body mass index (BMI)-based subgroups were formed to assess model performance, with predictions made iteratively. The optimal model for each age-BMI subgroup was chosen based on predefined criteria: models were filtered for mean percentage error (MPE) ≤ 20% and normalized root mean squared error (RMSE) < 8 mg/L, and then the most accurate among them was selected. A total of 384,876 treatment courses across 155 US health systems were analyzed, contributing 841,604 TDMs. Eleven models were compared, showing varying accuracy across age-BMI categories (41%-73%), with higher accuracy observed once TDMs were available for Bayesian estimates of individual PK parameters. Models performed more poorly in younger adults compared to older adults, and the optimal model differed depending on age-BMI categories and prediction methods. Notably, in the a priori period, the Colin model performed best in adults aged 18-64 years across most BMI categories; the Goti/Tong model performed best in the older, non-obese adults; and the Hughes model performed best in many of the obese categories. Our study identifies specific vancomycin PK models that demonstrate superior predictions across age-BMI categories in MIPD applications. Our findings underscore the importance of tailored model selection for vancomycin management, especially highlighting the need for improved models in younger adult patients. Further research into the clinical implications of model performance is warranted to enhance patient care outcomes.

Real-world exploration of LDL-cholesterol management in patients with atherosclerotic cardiovascular disease

BackgroundAlthough guidelines recommend low-density lipoprotein cholesterol (LDL-C) to be <70mg/dL in patients with atherosclerotic cardiovascular disease (ASCVD), the rate of achieving this goal remains suboptimal. We sought to understand real world contemporary practice patterns of LDL-C management in patients with ASCVD, and whether LDL-C testing influenced management across US health systems. MethodsA retrospective cohort study utilizing electronic medical record data from five health systems participating in the CardioHealth Alliance was performed on patients with an LDL-C measurement in 2021 and prior ASCVD. Multivariable regression modeling was used to determine the relationship of clinical factors with achievement of guideline directed LDL-C target. Changes in lipid lowering therapy (LLT) after LDL-C testing were also described. ResultsAmong 216,074 patients with ASCVD, 129,886 (60.1%) had uncontrolled LDL-C (i.e. ≥70 mg/dL). Compared with participants with controlled LDL-C (<70mg/dL), those with uncontrolled LDL-C were more frequently female (50.9% vs 35.1%), or Black (13.7% vs. 10.3%), and less commonly had coronary artery disease as the form of vascular disease (73.0% vs. 83.5% %), heart failure (21.3% vs. 29.1% %), diabetes (34.1% vs. 48.2%), atrial fibrillation (19.3% vs. 26.1%), or chronic kidney disease (25.1% vs. 32.2%). In multivariable analyses, the factors most strongly associated with failure to achieve LDL-C control were female sex (RR 1.13 [95% CI 1.12-1.14] p <0.001) and Black race (1.15 [1.14-1.17] p <0.001). Among the 53,957 (41.5%) of those with uncontrolled LDL-C ≥70 mg/dL not on lipid lowering therapy (LLT) at baseline, only 21% were initiated on any LLT within 6 months of the uncontrolled LDL-C value. ConclusionsWithin five diverse large health systems in the CardioHealth Alliance, more than half of the patients with ASCVD had uncontrolled LDL-C with significant disparities based on sex and race at baseline. The vast majority were not initiated on any lipid lowering therapy within 6 months of an elevated test result indicating persistent gaps in care that will likely worsen health inequities in outcomes. This highlights the urgent need for implementation efforts to improve equitable care.

Clinical Adjudication of Outpatient Complications Reported in the U.S. News and World Report’s Urology Rankings

ObjectivesTo assess whether the US News and World Report (USNWR) Urology specialty ranking methodology accurately captures and classifies complications following elective outpatient urology procedures. MethodsWe conducted electronic health record chart review of n=80 elective, outpatient urology procedures with complications from 2019-2023 across four hospitals in our integrated US health system. We used the Solventum AM-PPC software and USNWR methodology to determine eligibility and measure complications. For each complication identified by the software, we assessed: 1.) Whether the procedure was performed by a urologist; 2.) Whether the adjudicator agreed with the complication type; and 3.) Whether the complication was a clinically-related sequelae of the index procedure. We reported Clavien-Dindo severity of each complication. Results: Our adjudication agreed on complication type in 62/80 (78%) complications, and 64/80 (80%) complications were clinically related to the index urology procedure. Combined, 57/80 (71%) complications were concordant on both complication type and clinical relatedness. However, 38/80 (48%) index procedures were conducted by interventional radiologists, not urologists. Furthermore, 11/80 (13.8%) complications were false positive urinary tract infections (UTIs). ConclusionsThe USNWR methodology for elective outpatient urology procedural complications showed reasonable clinical validity but detected several false positive UTIs. Further, USNWR should clarify the extent to which procedures performed by interventional radiologists belong in urology rankings.

Use of electronic health records to characterize patients with uncontrolled hypertension in two large health system networks

BackgroundImproving hypertension control is a public health priority. However, consistent identification of uncontrolled hypertension using computable definitions in electronic health records (EHR) across health systems remains uncertain.MethodsIn this retrospective cohort study, we applied two computable definitions to the EHR data to identify patients with controlled and uncontrolled hypertension and to evaluate differences in characteristics, treatment, and clinical outcomes between these patient populations. We included adult patients (≥ 18 years) with hypertension (based on either ICD-10 codes of hypertension or two elevated blood pressure [BP] measurements) receiving ambulatory care within Yale-New Haven Health System (YNHHS; a large US health system) and OneFlorida Clinical Research Consortium (OneFlorida; a Clinical Research Network comprised of 16 health systems) between October 2015 and December 2018. We identified patients with controlled and uncontrolled hypertension based on either a single BP measurement from a randomly selected visit or all BP measurements recorded between hypertension identification and the randomly selected visit).ResultsOverall, 253,207 and 182,827 adults at YNHHS and OneFlorida were identified as having hypertension. Of these patients, 83.1% at YNHHS and 76.8% at OneFlorida were identified using ICD-10-CM codes, whereas 16.9% and 23.2%, respectively, were identified using elevated BP measurements (≥ 140/90 mmHg). A total of 24.1% of patients at YNHHS and 21.6% at OneFlorida had both diagnosis code for hypertension and elevated blood pressure measurements. Uncontrolled hypertension was observed among 32.5% and 43.7% of patients at YNHHS and OneFlorida, respectively. Uncontrolled hypertension was disproportionately higher among Black patients when compared with White patients (38.9% versus 31.5% in YNHHS; p < 0.001; 49.7% versus 41.2% in OneFlorida; p < 0.001). Medication prescription for hypertension management was more common in patients with uncontrolled hypertension when compared with those with controlled hypertension (overall treatment rate: 39.3% versus 37.3% in YNHHS; p = 0.04; 42.2% versus 34.8% in OneFlorida; p < 0.001). Patients with controlled and uncontrolled hypertension had similar incidence rates of deaths, CVD events, and healthcare visits at 3, 6, 12, and 24 months. The two computable definitions generated consistent results.ConclusionsWhile the current EHR systems are not fully optimized for disease surveillance and stratification, our findings illustrate the potential of leveraging EHR data to conduct digital population surveillance in the realm of hypertension management.

Correlates of improved outcomes in patients with COVID-19 treated in US emergency departments

BackgroundThe COVID-19 pandemic was managed in part by the rapid development of vaccines, diagnostics, and therapeutics including antiviral agents and advances in emergency airway and ventilatory management. The impact of these therapeutic advances on clinically pertinent metrics of emergency care have not been well-studied. MethodsWe abstracted data from emergency department (ED) visits made to 21 US health systems during the first two years of the pandemic, from February 1, 2020 to January 31, 2022. These health systems were participants in the NIH-supported COVID EHR Cohort, in which the University of Wisconsin served as the coordinating site. Limited patient-level data files were submitted monthly. Data elements included demographic and clinical variables, as well as standard measures of ED outcomes including 72-h returns, 72-h returns leading to readmission, and in-hospital mortality. Multivariable models were fitted to identify correlates of each of the dependent variables. A test for trend was used to detect changes in outcomes over time. ResultsDuring the two-year period, 150,357 individuals aged 18 years or older visited the ED. The median age was 45.4 years (IQR 27), 58.1 % were female, 49 % were White, 18.3 % Hispanic/Latino, and 45 % were publicly insured or uninsured. The prevalence of 72-h ED returns, readmissions, and in-hospital mortality significantly declined across the two-year period. SARS-CoV-2 vaccination was associated with reduced ED returns and mortality. Therapeutic agents were associated with increased mortality risk but were likely confounded by unmeasured covariates. ConclusionsOperational and clinical outcomes of ED-based treatment of individuals with COVID-19 improved in the first two years of the pandemic. This improvement is likely multifactorial and includes the development and deployment of SARS-CoV-2-specific vaccines, therapeutic agents, and improved healthcare delivery in the ED and elsewhere addressing management of airway and ventilatory status, as well as increased innate immunity in the general population.

Survival Outcomes Among Patients With Hepatocellular Carcinoma in a Large Integrated US Health System

Hepatocellular carcinoma (HCC) is the leading oncologic cause of death among patients with cirrhosis, but large studies examining mortality trends are lacking. To evaluate survival among patients with HCC in one of the largest integrated health care systems in the US. This retrospective cohort study included 3441 adult patients who received a diagnosis of HCC between January 1, 2006, and December 31, 2019, with end of follow-up on December 31, 2020. The study period was further categorized as era 1, defined as 2006 to 2012, and era 2, defined as 2013 to 2019. Statistical analysis was conducted from January 2021 to June 2024. Patient demographic characteristics and disease factors. All-cause and HCC-specific mortality were used as primary end points, and survival probabilities were estimated using the Kaplan-Meier method. Cox proportional hazards regression analyses were adjusted for age at diagnosis, sex, race and ethnicity, cause of disease, Barcelona Clinic Liver Cancer (BCLC) stage, alpha-fetoprotein level, and treatment type. Of 3441 patients with HCC, 2581 (75.0%) were men, and the median age was 65 years (IQR, 58-73 years). A total of 1195 patients (34.7%) received curative treatment, 1374 (39.9%) received noncurative treatment, and 872 (25.3%) received no treatment. During the study period, 2500 patients (72.7%) experienced all-cause mortality, and 1809 (52.6%) had HCC-specific mortality. In multivariable analysis, being 70 years of age or older (adjusted hazard ratio [AHR], 1.39; 95% CI, 1.22-1.59), male sex (AHR, 1.20; 95% CI, 1.07-1.35), BCLC stage C or D (AHR, 2.40; 95% CI, 2.15-2.67), increasing alpha-fetoprotein level (vs <20 ng/mL; 20-99 ng/mL: AHR, 1.20; 95% CI, 1.04-1.38; ≥1000 ng/mL: AHR, 2.84; 95% CI, 2.45-3.25), noncurative treatment (AHR, 2.51; 95% CI, 2.16-2.90), and no treatment (AHR, 3.15; 95% CI, 2.64-3.76) were associated with higher all-cause mortality, while Asian or Other Pacific Islander race and ethnicity (vs non-Hispanic White; AHR, 0.76; 95% CI, 0.65-0.88) was associated with lower all-cause mortality. Survival improved in diagnosis era 2 (2013-2019; n = 2007) compared with diagnosis era 1 (2006-2012; n = 1434). This large, racially and ethnically diverse cohort study of patients with HCC found improving survival over time, especially among individuals with early-stage HCC receiving potentially curative treatments. This study highlights the importance of surveillance for detection of HCC at early stages, particularly among groups at risk for poorer outcomes.

Association of COVID-19 Vaccination With Risk of Medically Attended Postacute Sequelae of COVID-19 During the Ancestral, Alpha, Delta, and Omicron Variant Eras.

Uncertainty exists regarding the effectiveness of COVID-19 vaccine to prevent postacute sequelae of COVID-19 (PASC) following a breakthrough infection. While most studies based on symptom surveys found an association between preinfection vaccination status and PASC symptoms, studies of medically attended PASC are less common and have reported conflicting findings. In this retrospective cohort of patients with an initial SARS-CoV-2 infection who were continually empaneled for primary care in a large US health system, the electronic health record was queried for preinfection vaccination status, demographics, comorbidity index, and diagnosed conditions. Multivariable logistic regression was used to model the outcome of a medically attended PASC diagnosis within 6 months of SARS-CoV-2 infection. Likelihood ratio tests were used to assess the interaction between vaccination status and prevalent variant at the time of infection and between vaccination status and hospitalization for SARS-CoV-2 infection. During the observation period, 6.9% of patients experienced medically attended and diagnosed PASC. A diagnosis of PASC was associated with older age, female sex, hospitalization for the initial infection, and an increased severity-weighted comorbidity index and was inversely associated with infection during the Omicron period. No difference in the development of diagnosed PASC was observed between unvaccinated patients and those vaccinated with either 2 doses of an mRNA vaccine or >2 doses. We found no association between vaccination status at the time of infection and development of medically diagnosed PASC. Vaccine remains an important measure to prevent SARS-CoV-2 infection and severity. Further research is needed to identify effective measures to prevent and treat PASC.

Housing Instability Screening and Referral Programs: A Scoping Review

Housing instability in the United States is a critical social determinant of health, influencing health outcomes and health care utilization. This scoping review aimed to analyze literature on US health system screening and response programs addressing housing instability, highlighting methodologies, geographic and demographic variations, and policy implications. Adhering to PRISMA-ScR guidelines, the review included studies focusing on US health systems that screen and refer for housing instability. Major scholarly databases, including PubMed and Scopus, were queried. Screening and response program characteristics, methodologies, and outcomes were characterized. Thirty studies published between 2003 and 2023 were included in this study. Included studies were primarily cross-sectional (26.7%) or quality improvement (20.0%), among 9 other designs. Screening programs were predominantly implemented in academic hospital systems (46.7%) and in the Northeast (63.3%). Of the 25 adult population studies, 68.0% were in outpatient settings, and of the 23 studies providing detailed information on their process, 52.2% used electronic health record entry. Of the 22 studies that describe their screening tool, 15 used institution-specific tools, and only 4 of the remaining 7 studies used identical tools. Of the 20 studies that described their response to positive screenings, 13 provided patients with a paper or electronic referral to a collaborating community partner, while only 6 aided the patient in connecting with community resources. This study found significant variability in screening and response programs for housing instability among US health care providers. A lack of standardized definitions and methodologies hampers effective comparison and implementation of these programs. Future research should focus on standardizing screening methods and measurement of interventions and outcomes to address housing instability.

Hospital–Skilled Nursing Facility Integration and Participation in a Bundled Payment Initiative

Reduced institutional postacute care has been associated with savings in alternative payment models. However, organizations may avoid voluntary participation if participation could threaten their own revenues. To characterize the association between hospital-skilled nursing facility (SNF) integration and participation in Medicare's Bundled Payments for Care Improvement Advanced (BPCI-A) program. This is a cross-sectional analysis of hospital participation in BPCI-A beginning with its launch in 2018. Each SNF-integrated hospital was matched with 2 nonintegrated hospitals for each of 4 episode-specific analyses. Fifteen hospital-level variables were used for matching: beds, case mix index, days, area SNF beds, metropolitan location, ownership, region, system membership, and teaching status. Hospitals were also matched on episode-specific volume, target price, and the interaction of target price and case mix. Episode-specific logistic models were estimated regressing hospital participation on integration and the previously listed variables. The marginal effect of integration on participation was then calculated. Analysis took place from August 2022 to May 2024. Hospital-SNF integration, as defined by common ownership and referral patterns and identified using cost reports, Medicare claims, and Provider Enrollment, Chain, and Ownership System records. Additional sources included records of target prices and participation, the Area Health Resources File, and the Compendium of US Health Systems. Participation in BPCI-A. In total, 1524 hospitals met criteria for inclusion in the hip and femur (HFP) analysis, 1825 were included in the major joint replacement of the lower extremity (MJRLE) analysis, 2018 were included in the sepsis analysis, and 1564, were included in the stroke-specific analysis. Across episodes, 191 HFP-eligible hospitals (12.5% of HFP-eligible hospitals), 302 MJRLE-eligible hospitals (16.5%), 327 sepsis-eligible hospitals (16.2%), and 185 sepsis-eligible hospitals (11.8%) were SNF integrated. In total, 79 hospitals (5.2%) participated in the HFP episode, 128 (7.0%) participated in the MJRLE episode, 204 (10.1%) participated in the sepsis episode, and 141 (9.0%) participated in the stroke episode. Integration was associated with a 4.7-percentage point decrease (95% CI, 2.4 to 6.9 percentage points) in participation in the MJRLE episode. There was no association between integration and participation for HFP (0.5-percentage point increase in participation moving from nonintegrated to integrated; 95% CI, -2.9 to 3.8 percentage points), sepsis (1.0-percentage point increase; 95% CI, -2.2 to 4.2 percentage points), and stroke (0.3-percentage point decrease; 95% CI, -3.1 to 3.8 percentage points). In this cross-sectional study, there was an uneven association between hospital-SNF integration and participation in Medicare's BPCI-A program. Other factors may be more consistent determinants of selection into voluntary payment reform.

How adoption of new pharmaceuticals can impact US health system reimbursement under alternative payment models: An economic model measuring the impact of sotagliflozin among patients with heart failure and diabetes.

Heart failure (HF) is among the leading causes of death in the United States. Further, patients hospitalized because of HF with comorbid diabetes mellitus (DM) are at a significantly increased risk of death and rehospitalization. Results from the SOLOIST-WHF trial show that sotagliflozin lowered rates of readmission among hospitalized patients with HF and comorbid DM. However, it is unclear what the economic impact of the use of sotagliflozin would be on hospitals and health systems, particularly in an age where provider reimbursement is increasingly tied to value. To quantify the 1-year financial impact on US provider health systems of adopting sotagliflozin relative to standard of care (SoC) across different alternative payment models. This study created a 3-part decision tree model to quantify the financial impact of using sotagliflozin to treat patients hospitalized with HF in a US hospital setting. The model first estimated the clinical and economic outcomes of health systems with current SoC (no sotagliflozin) to treat US patients hospitalized for HF with comorbid DM. Then, using the results from the SOLOIST trial, the changes in clinical and economic outcomes with sotagliflozin adoption were modeled. Finally, the differences in health care utilization between sotagliflozin and SoC arms were translated to differences in health system reimbursement in the context of 3 common alternative payment models (APMs) in addition to the baseline fee-for-service (FFS) model: FFS with the Hospital Readmissions Reduction Program, the Bundled Payments for Care Improvement-Advanced program, and Accountable Care Organizations. A typical community hospital would have 83.4 patients per year on average with an index HF hospitalization with comorbid DM. The model predicted that sotagliflozin would reduce the probability of hospitalization, emergency department visits, and deaths by 29.3%, 38.5%, and 17.8%, respectively, compared with SoC. For hospitals not participating in APM programs, sotagliflozin resulted in a net loss of $92.94 per person ($7,754 per health system). Conversely, when accounting for provider health system participation in APMs, sotagliflozin adoption increased financial returns by $4,720 per person ($305,604 per health system) under the Hospital Readmissions Reduction Program, $1,200 per person ($100,106 per health system) for the Bundled Payments for Care Improvement-Advanced program, and $1,078 per person ($31,029 per health system) for Accountable Care Organizations. Based on the national average composition of APM reimbursement, sotagliflozin adoption resulted in a $1,576 increase in margin per patient with HF ($105,454 per health system). Although sotagliflozin adoption reduced health system revenue in an FFS payment model, it led to a net positive financial impact after accounting for APM bonus payments.

Evolving role of the health system CIO: perspectives from 33 health systems

ObjectivesThis study explores the evolving position of the health system chief information officer (CIO) by identifying new core roles for success.MethodsAn advisory board of industry executives and system leaders guided...