Citations

Abstract Background Recent studies suggested that treating obesity and its comorbidities with glucagon-like peptide-1 (GLP-1) receptor agonists may improve outcomes in patients with heart failure with preserved ejection fraction (HFpEF). The randomized SUMMIT trial found that tirzepatide use was associated with a lower risk of heart failure (HF) events or cardiovascular death in adults with HFpEF and obesity compared with placebo. Purpose We aimed to examine whether tirzepatide use in clinical practice was associated with risks of HF events and all-cause mortality among adults with HFpEF and obesity. Methods This was a retrospective cohort study leveraging the Optum Labs Data Warehouse (OLDW), a de-identified administrative claims database of commercial and Medicare Advantage enrollees across the United States. We identified all adults with HFpEF and obesity from January 1, 2022, to December 31, 2024. Our primary exposure was tirzepatide use, and our primary outcome was a composite of a HF event (ED visits or hospitalization for HF) or mortality. Secondary outcomes included hospitalization for angina, atrial fibrillation or atrial flutter (AF/AFL), acute myocardial infarction (MI), cardiac arrest, and cardiogenic shock. Patients were followed from the index date, defined as the tirzepatide treatment start date after HFpEF diagnosis or pseudo-index date in tirzepatide non-users, to the end of enrollment or death using the intention-to-treat framework. Inverse probability of treatment weighting (IPTW) was used to balance groups. Fracture, conjunctivitis, ear infection, and fungal skin infection were used as falsification endpoints. Cox-proportional and Fine-Gray subdistribution hazard models were used to estimate a hazard ratio (HR) and subdistribution hazard ratio (SHR), respectively. Results Among our total cohort of 99,270 patients, the mean age was 73 years, 58,616 (59.1%) were female, 8,839 (8.9%) used tirzepatide, and the mean follow-up time was about 385 days. Patients using tirzepatide had a significantly lower risk of a HF event or mortality (HR=0.73; 95% confidence interval [CI]=0.66–0.80; p<0.001) compared to patients not using tirzepatide. Patients using tirzepatide had a lower risk of a HF event (SHR=0.80; 95% CI=0.73–0.88; p<0.001) and all-cause mortality (HR=0.48; 95% CI=0.38–0.60; p<0.001). Tirzepatide use was associated with lower risks of hospitalization for acute MI (SHR=0.67; 95% CI=0.52–0.85; p=0.001) and cardiogenic shock (SHR=0.56; 95% CI=0.38–0.83; p=0.003), but not angina, AF/AFL, or cardiac arrest (Figure 1). Conclusion Among adults with HFpEF and obesity, tirzepatide use in real-world clinical practice was associated with a lower risk of HF events, hospitalizations for acute cardiovascular disease, and all-cause mortality.For image description, please refer to the figure legend and surrounding text.

ImportanceIdentification of factors associated with variation in outpatient surgery may further quality improvement efforts to safely reduce postoperative hospital length of stay nationally.ObjectivesTo explore variation in the use of outpatient surgery, incorporating patient, geographic, and hospital factors.Design, Setting, and ParticipantsThis retrospective cross-sectional study used deidentified administrative claims data from OptumLabs Data Warehouse. Participants included adults who underwent 1 of 10 general, urological, or gynecological operations between January 1, 2015, and June 30, 2021, in the US. Patients who underwent combined procedures or reoperations or had at least 15 Elixhauser comorbidities were excluded. Data were analyzed from July 26 to December 16, 2023.ExposureInpatient or outpatient surgical procedures.Main Outcomes and MeasuresMultilevel logistic regression assessed variation in the use of outpatient surgery rates by hospital characteristics (bed size, presence of trainees, and rural referral center status) and hospital census division, adjusting for patient factors (age, sex, number of Elixhauser comorbidities, year, and rural-urban commuting area). This multilevel model allowed for the sources of variability to be quantitatively attributed to patient characteristics, geography, and hospital characteristics.ResultsA total of 330 424 (72.3%) of 456 954 included patients underwent outpatient surgery. The median age was 54 (IQR, 41-67) years, and of those with data available, most patients were female (268 692 of 414 193 [64.9%]). The likelihood of outpatient surgery varied significantly by hospital census division for all 10 operations (eg, MIS salpingo-oophorectomy range, 29.6%-58.8%; P < .001). Variation in hospital census division contributed most to outpatient surgery for 8 of 10 operations compared with other patient and hospital characteristics. Hospital census division contributed the greatest degree to the variation in outpatient simple mastectomy (20.6%) and the least to outpatient open ventral hernia repair (0.7%). Multivariable analysis showed that the odds of outpatient surgery for patients from metropolitan areas were higher for minimally invasive salpingo-oophorectomy (odds ratio [OR], 1.62; 95% CI, 1.34-1.95) and open ventral hernia repair (OR, 1.16; 95% CI, 1.09-1.24). Hospitals with 400 or more beds were independently associated with decreased odds of outpatient surgery compared with hospitals with 50 to 199 beds for 4 of 7 operations (MIS paraesophageal hernia repair [OR, 0.58; 95% CI, 0.47-0.71; P < .001]; MIS cholecystectomy [OR, 0.73; 95% CI, 0.68-0.78; P < .001]; open ventral hernia [OR, 0.51; 95% CI, 0.46-0.57; P < .001]; MIS ventral hernia repair [OR, 0.66; 95% CI, 0.56-0.77; P < .001]). The presence of a residency training program was independently associated with increased odds of outpatient surgery for simple mastectomy (OR, 1.35; 95% CI, 1.16-1.58; P < .001) and mastectomy with reconstruction (OR, 1.50; 95% CI, 1.27-1.77; P < .001) and decreased odds of outpatient surgery for minimally invasive cholecystectomy (OR, 0.96; 95% CI, 0.92-1.00; P = .04), open ventral hernia repair (OR, 0.93; 95% CI, 0.86-1.00; P = .04), and total thyroidectomy (OR, 0.84; 95% CI, 0.71-1.00; P = .04).Conclusions and RelevanceIn this cross-sectional study, significant variation existed in the use of outpatient surgery in the US and appeared to be driven primarily by hospital geography. Addressing these variations may improve the use of resources.

Abstract Background Hospital‐at‐home programs (HaH) in the United States have evolved to include a virtual‐hybrid delivery model, where all physician encounters are virtual and partnered with a home care team. Objective To examine whether a virtual hybrid HaH program enabled by technology has similar clinical outcomes to traditional brick‐and‐mortar (B&M) hospital care. Methods We conducted a pragmatic trial at three hospitals, randomizing 1150 acutely ill patients requiring hospital care between July 10, 2023, and October 31, 2023 one‐to‐one into two groups: intervention (HaH) and control (B&M). The primary analysis was an intention‐to‐treat non‐inferiority analysis of the primary outcome, which was a composite of 30‐day all‐cause mortality and unplanned readmissions. Secondary outcomes included 30‐day readmission, all‐cause mortality, and patient experience. Results The mean age was 67.8 (standard deviation [SD] 16.3) years, and 52.2% were female. The primary outcome occurred in 99 (17.3%) HaH patients and 114 (19.8%) B&M patients (odds ratio [OR] 0.85, 95% confidence interval [CI] 0.63–1.14, p = .28), meeting the non‐inferiority criterion. Thirty‐day unplanned readmission occurred in 84 (14.7%) HaH patients and 101 (17.5%) B&M patients (OR 0.81, 95% CI 0.59–1.11, p = .19). Thirty‐day all‐cause mortality occurred in 25 (4.4%) HaH patients and 19 (3.3%) B&M patients (OR 1.34, 95% CI 0.73–2.46, p = .35). No HaH patients died while receiving their hospital care at home. HaH program was associated with a higher likelihood of patients reporting feeling extremely comfortable or very comfortable (84.4% HaH; 60.9% B&M, p = .001). Conclusion A hybrid HaH model is a safe and comfortable alternative to traditional B&M hospital care.

ABSTRACTIntroduction/AimsHealthcare utilization and costs in myotonic dystrophy (DM) are not well understood. This study describes the burden of DM and its associated costs.MethodsWe performed a retrospective study using data from a large U.S. administrative claims database to identify commercially insured individuals with DM and compared healthcare utilization and cost with a matched cohort. Analyses were performed between the cohorts with ≥ 3 years of insured follow‐up.ResultsWe identified 1182 DM individuals with coverage at least 3 year prior and 3 years following an index DM diagnosis from January 1, 2009 to December 31, 2018. Compared to controls, DM individuals were 3.7 times more likely to be hospitalized (p < 0.0001), 2.4 times more likely to visit an emergency department (p < 0.0001), and had twice as many outpatient visits (p < 0.0001) in the first year post‐diagnosis, with similar utilization at 2‐ and 3‐years post‐diagnosis. Annual mean costs were 3.9 times higher for health plan paid costs (p < 0.0001) and 2.6 times higher for patient‐paid costs (p < 0.0001) for DM individuals than controls in the first year post‐diagnosis, with similar costs at 2‐ and 3‐years post‐diagnosis. Factors associated with higher costs included the need for durable medical equipment, including gait aids or respiratory support devices.DiscussionIndividuals with DM experience significantly higher healthcare utilization and associated healthcare costs than controls of similar age, sex, race, and census region. The findings show the high clinical and economic burden of DM, highlighting the importance of improving cost‐effective care delivery in this population.

Background: Epidemiologic studies have demonstrated that the incidence of heart failure varies by race and ethnicity, with the highest incidence occurring in blacks. However, whether these racial and ethnic variations extend to commercially insured populations and whether differences in early outcomes after diagnosis exist requires further exploration. Methods: We utilized administrative claims data from a large U.S. commercial insurance database to retrospectively identify privately insured and Medicare Advantage patients who were diagnosed with heart failure between 2006 and 2014. Published claims-based algorithms were used to identify patients with incident HF and categorize reasons for hospitalization after diagnosis. Results: Among 148,827 patients with incident heart failure (mean age 72.2 years, 51% women), 70% were white, 15% black, 6% Hispanic, 3% Asian and 6% had unknown race/ ethnicity. The incidence of heart failure during the study period was 3.7 per 1000 person-years and was highest among blacks, followed by whites, Hispanics and Asians (9.9, 3.6, 2.5, and 2.0 per 1000 person-years, respectively). In total, 37% of patients were hospitalized at least once in the first year after diagnosis for a total of 93,358 hospitalizations. HF was the most common reason for hospitalization (13% of all hospitalizations), followed by arrhythmia (5%), sepsis (5%), pneumonia (4%), COPD (3%) and acute renal failure (3%). Reasons for hospitalization were similar across racial and ethnic groups. The rate of hospitalizations was highest the first month after diagnosis and then gradually declined. Black patients had the highest rates of hospitalization, while Asians had the lowest (Figure). Conclusions: Even among a commercially insured population that likely have fewer barriers to care, black patients had a higher incidence of HF and higher rates of hospitalization after initial diagnosis compared with other racial and ethnic groups.

ObjectivesRacial disparities are pervasive in access to pediatric surgery. The goal of this study was to test the hypotheses that, compared with White children, non‐White and Hispanic children: (1) were less likely to attend evaluations by otolaryngologists after a diagnosis of otitis media (OM) eligible for surgical referral, and (2) these children were less likely to receive tympanostomy tube (TT) after surgical consultation.MethodsThe OptumLabs Data Warehouse is a de‐identified claims database of privately insured enrollees. Guidelines on the management of OMs suggest that children should be evaluated for surgery if they have recurrent acute OM or chronic OM with effusion. A cohort of children who were diagnosed with OM were constructed. For Hypothesis 1, the primary outcome was otolaryngology office visit within 6 months of a diagnosis of recurrent or chronic OM. For Hypothesis 2, the outcome was TT placement within 6 months following the otolaryngology office visit. Cox regression models were used to determine the relationship between race/ethnicity and the primary outcomes.ResultsAmong 187,776 children with OMs, 72,774 (38.8%) had otolaryngology visits. In a multivariate Cox model, the hazard ratios of attending otolaryngology visit for Black, Hispanic, and Asian children were 0.93 (95% CI,0.90, 0.96), 0.86 (0.83, 0.88), and 0.74 (0.71, 0.77), compared with White children. Among the children evaluated by otolaryngologists, 46,554 (63.97%) received TT. Black, Hispanic, and Asian children with recurrent acute OM had lower likelihood of receiving TT.ConclusionsRacial disparities in attending otolaryngology office visit contributed to the disparities in receiving TT.Quality of EvidenceLevel 3 Laryngoscope, 134:3846–3852, 2024

PURPOSE BMT CTN 1102 was a phase III trial comparing reduced-intensity allogeneic hematopoietic cell transplantation (RIC alloHCT) to standard of care for persons with intermediate- or high-risk myelodysplastic syndrome (MDS). We report results of a cost-effectiveness analysis conducted alongside the clinical trial. METHODS Three hundred eighty-four patients received HCT (n = 260) or standard of care (n = 124) according to availability of a human leukocyte antigen–matched donor. Cost-effectiveness was calculated from US commercial and Medicare perspectives over a 20-year time horizon. Health care utilization and costs were estimated using propensity score–matched cohorts of HCT recipients in the OptumLabs Data Warehouse (age 50-64 years) and Medicare (age 65 years and older). EuroQol 5 Dimension (EQ-5D) surveys of trial participants were used to derive health state utilities. RESULTS Extrapolated 20-year overall survival for those age 50-64 years was 29% for HCT (n = 105) versus 13% for usual care (n = 44) and 31% for HCT (n = 155) versus 12% for non-HCT (n = 80) for those age 65 years and older. HCT was more effective (+2.36 quality-adjusted life-years [QALYs] for age 50-64 years and +2.92 QALYs for age 65 years and older) and more costly (+$452,242 in US dollars (USD) for age 50-64 years and +$233,214 USD for age 65 years and older) than usual care, with incremental cost-effectiveness ratios of $191,487 (USD)/QALY and $79,834 (USD)/QALY, respectively. For persons age 50-64 years, there was a 29% chance that HCT was cost-effective using a willingness-to-pay (WTP) threshold of $150K (USD)/QALY and 51% at a $200K (USD)/QALY. For persons age 65 years and older, the probability was 100% at a WTP >$150K (USD)/QALY. CONCLUSION Among patients age 65 years and older with high-risk MDS, RIC HCT is a high-value strategy. For those age 50-64 years, HCT is a lower-value strategy but has similar cost-effectiveness to other therapies commonly used in oncology.

Introduction The Blood and Marrow Transplant Clinical Trials Network 1102 study (BMT CTN 1102, NCT02016781) was a multicenter, biologic assignment trial, where patients aged 50-75 with intermediate-2 or high risk de novo myelodysplastic syndrome (MDS) were assigned to reduced-intensity allogeneic hematopoietic cell transplantation (alloHCT) or best supportive care (non-alloHCT) based on donor availability. A parallel economic evaluation was performed alongside BMT CTN 1102. Here, we report on the financial impact of the treatment protocol on patients using a prospective cost diary study conducted within the trial. Methods BMT CTN 1102 enrollees were offered the option to participate in the parallel cost diary study at the same time of primary study enrollment. The cost diary survey instrument, comprised of 19 questions, covered the domains of out-of-pocket (OOP) costs of healthcare and financial hardship indicators. Surveys were distributed at 1- (1M), 7- (7M), and 19-months (19M) after enrollment. Study participants were grouped by actual treatment received, rather than group assignment. Responses were analyzed using univariate Fisher's exact and Wilcoxon rank sum tests for association. Results Out of 216 enrollee invitations, 138 patients (64%) returned at least one survey. Total completed surveys at the 1M, 7M, and 19M timepoints were 103 (39%), 93 (35%), and 71 (27%), respectively. 50 (36%) completed only one survey, while 41 (39%) completed surveys at all three timepoints. Of all respondents, median age was 67.7 years (IQR: 64.8-70.3), 88 (64%) were male, 128 (93%) white, and 126 (91%) were non-Hispanic. Among respondents of the 1M, 7M and 19M surveys, 82 (80%), 78 (84%), 65 (92%) received alloHCT, respectively. Mean OOP costs by category are presented in Table 1. While alloHCT patients experienced higher OOP costs compared to non-alloHCT patients across all categories (outpatient services, prescription medications, and accommodations for healthcare), none of the comparisons were statistically significant. However, total OOP costs were significantly higher among alloHCT patients at 1 and 7 months (mean over past 30 days, 1M: $889 vs. $217, p=0.046; 7M: $678 vs. $349, p=0.03; 19M: $328 vs. $103, p=0.15). Financial hardship indicators are presented in Table 2. While alloHCT patients experienced greater financial hardship compared to non-alloHCT patients across all categories (mobilized reserve funds, borrowed money to pay for care, developed debt due to care), none of the comparisons were statistically significant. However, alloHCT patients were significantly more likely to experience at least one of these factors of financial hardship at 7 months (1M: 38% vs. 19%, p=0.13; 7M: 42% vs. 13%; p=0.04; 19M: 37% vs. 0%, p=0.08). Discussion Patients with MDS who received alloHCT incurred substantially more OOP costs overall compared to patients who did not receive alloHCT, most notably for accommodations related to alloHCT. Similarly, alloHCT patients were more likely to develop financial hardship, including mobilizing reserve funds, borrowing money, and developing debt. These findings demonstrate that treatment-related OOP expenditures associated with alloHCT are substantial and may pose significant burdens for some populations receiving alloHCT. Financial navigation and assistance, which have been shown to help patients address cost burden in solid tumor settings, should be considered for MDS patients prior to alloHCT. Small final sample sizes limited our analyses significantly; further research into OOP costs and financial hardship among larger cohorts of alloHCT patients are necessary to confirm these findings. Acknowledgement Support for this study was provided by grants #U10HL069294 and #U24HL138660 to the Blood and Marrow Transplant Clinical Trials Network from the National Heart, Lung, and Blood Institute and the National Cancer Institute. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.