Penn Evidence-Based Literature Review (PEBLR)

Summarized highlights from contemporary literature in surgical and allied disciplines for general surgery residents.

Health Policy

US Nonprofit Hospitals Have Widely Varying Criteria To Decide Who Qualifies For Free And Discounted Charity Care
Messac L, Janke AT, Rogers LH, Fonfield I, Walker J, et al. Health Aff (Millwood). 2024 Nov;43(11):1569-1577
Contributor: Russell Simons

Brief Synopsis

Synopsis: This retrospective cross-sectional study examines the significant variability in charity care provided by private, non-profit hospitals in the United States. While non-profit hospitals have a legal obligation to deliver free or discounted care, there are no uniform requirements for implementation. The authors conclude that the wide range of eligibility criteria and the existence of opaque or burdensome application processes exacerbate the problems charity care is meant to alleviate.

Summary: A 2022 survey estimates that approximately 100 million Americans carry medical debt, 80% of which is held by households with zero or negative net worth. Hospital charity care, also known as financial assistance, is both a legal obligation of non-profit hospitals (tied to their tax-exempt status) and a policy strategy (outlined in the Affordable Care Act) to improve access to care for low-income patients. Importantly, there are no federal requirements governing how non-profit hospitals implement charity care or how much hospital revenue must be spent on financial assistance. Twenty states (CA, CO, DE, GA, IL, IN, KS, ME, MD, NV, NJ, NY, OH, OR, RI, SC, TN, VA, WA) have set mandatory minimums regarding the amount of money that must be spent on such care.

Using a novel data source of financial assistance policies from 2,989 private, non-profit hospitals in 2021, the authors examined state- and national-level income limits for free and discounted care as compared to state median income levels. Additionally, the authors reported the frequency of requirements related to residency, insurance status, assets, minimum hospital bill amounts, citizenship, and other documents needed to qualify for charity care.
The authors found that the median cutoffs used by hospitals for the provision of free and discounted care were 200% and 400% of the 2021 federal poverty line (FPL; $12,880 for one individual or $26,500 for a family of four). Cutoff marks for free care ranged from 41% to 600% of the FPL. When corrected for state median incomes, these cutoffs were revealed to be most generous among hospitals on the West Coast and in the South. Approximately 54% of hospitals investigate assets when determining eligibility, with variable exclusions of life necessities such as residences, retirement savings, and vehicles. A majority have document requirements (e.g., tax forms, pay stubs). Nearly one in ten required proof of citizenship, and one in five required proof of in-state residency. Charity care policies also appeared to be regressively responsive to demand within their respective markets—hospitals with poorer and more uninsured payer mixes tended to have more restrictive income eligibility requirements.

Limitations of the study include the over-representation of large hospital systems in the sample, thereby limiting generalizability. Analysis was further limited by the inability to detail specific discounts applied by hospitals when a patient qualified for charity care.

Bottom Line: This study confirmed wide variability in policies regarding charity care as provided by private, non-profit hospitals in the U.S. There are no federal guidelines for charity care, and, as of 2023, only twenty states provide state-level guidance. Consequently, there is significant potential for disparate provision of charity care to vulnerable, low-income Americans.

The financial assistance policy and application process for the University of Pennsylvania Health System can be found on the hospital’s website

Pediatric Surgery

Anastomotic Leak and its Implications: A Multicenter Analysis of “Type C” Esophageal Atresia/Tracheoesophageal fistulae (EA/TEF)
Datta A, Murthy K, Zaniletti I, Guner Y, Padula MA, et al. J Pediatr Surg. 2024 Oct 18;60(2):162015
Contributor: Val Luks

Brief Synopsis

Synopsis: This retrospective cohort study assessed clinical and demographic factors associated with esophageal anastomotic leaks in infants undergoing type C esophageal atresia with tracheoesophageal fistula (EA/TEF) repair, as well as the impact of such leaks on length of stay (LOS). The study found that thoracoscopic repair, male sex, staged repair, and the presence of a ventricular septal defect (VSD) were associated with a higher risk of leaks, and leaks were linked to increased hospital LOS.

Summary: Esophageal atresia with tracheoesophageal fistula (EA/TEF) occurs in 1 in every 4,000 live births. The majority of these cases (90%) are amenable to primary repair, generally undertaken soon after birth. Variations exist in the repair approach and technique, but one of the more serious complications overall is an anastomotic leak, occurring in up to 20% of patients. This study sought to identify risk factors for anastomotic leaks and the implications for patient care.

The study utilized the Children’s Hospital Neonatal Database, which captures inpatient clinical data from infants admitted to level IV NICUs (the highest level of care for the most complex infants). From 2021-2023, 629 babies with EA/TEF were identified. After excluding those without a Type C fistula, those with long-gap atresia, and those who did not undergo anastomosis, 365 infants were included from 36 hospitals. Anastomotic leaks were identified clinically or radiographically in 15% of patients.

On multivariate analysis, patients born male, small for gestational age, and with a concurrent VSD were at higher risk of developing an anastomotic leak. In this cohort, 78% of patients underwent an open thoracotomy approach to repair with a leak rate of 12%. The remaining 22% of patients had a minimally invasive thoracoscopic approach with a leak rate of 22%. Patients with a staged approach (fistula ligation followed by atresia repair) also had a much higher leak rate (28% vs. 14%), likely related to a combination of patient factors, difficult anastomosis, and a re-operative field. Only 9% of patients with a leak underwent reoperation. Patients with a leak unsurprisingly had a longer LOS, increased duration of central lines, longer PN use, and an increased need for esophageal dilation while inpatient. Mortality was 8% in the leak group and 4% in the non-leak group.

After adjusting for patient comorbidities (SGA, birthweight, VSD, male gender, surgical approach), the study found that the magnitude of the leak's contribution to LOS was greatly diminished, suggesting that the leak itself may not always be the main driver of hospital stay. However, this patient population requires significant longitudinal care with high rates of readmissions and complications, so the importance of LOS in the index hospitalization is unclear. Additional outcome measures, such as the likelihood of stricture or timing to stricture after a leak, may have more clinical impact in examining this patient population.

Notable in this study is the increased leak rate after thoracoscopic EA/TEF repair. Other similar studies have not found differences in outcomes based on open versus minimally invasive approaches. This may be partially due to patient selection, as thoracoscopic patients are often of greater weight and gestational age, but it may also reflect differences in surgeon or center volume. In this study, the range of EA/TEF cases at each hospital was 1-28 over the two-year period, with a median case volume of 8. The study found a 15-fold variation in LOS between centers independent of leaks, highlighting significant practice differences between institutions. There is an opportunity to identify high-performing centers and establish best practice guidelines for managing these complex patients. 

Bottom line: The study suggests that specific clinical and surgical factors increase the likelihood of esophageal anastomotic leaks and prolong hospital stays in infants undergoing type C EA/TEF repair. Identifying and mitigating these risk factors and sharing best practices across centers may improve patient outcomes and support better parental counseling.

Transplant Surgery

Liver transplantation plus chemotherapy versus chemotherapy alone in patients with permanently unresectable colorectal liver metastases (TransMet): results from a multicentre, open-label, prospective, randomised controlled trial
Adam R, Piedvache C, Chiche L, et al. The Lancet. 2024;404(10458):1107-1118
Contributor: Nic Muñoz

Brief Synopsis

Synopsis: TRANSMET is a multi-center, randomized controlled trial that assessed overall survival in patients with unresectable colorectal liver metastases (uCRLMs) who were assigned to either chemotherapy alone or liver transplantation combined with chemotherapy. The study demonstrated improved survival in patients who underwent liver transplantation along with chemotherapy.

Summary: Historically, surgical resection combined with chemotherapy has been the best treatment for patients with CRLMs, offering up to a 40% five-year survival rate. However, fewer than 30% of patients with CRLMs are eligible for resection. Liver transplantation for uCRLMs was first offered in the 1980s but initially showed poor five-year survival rates. With recent advancements in chemotherapy agents, improved detection of colorectal metastases, and better immunosuppression regimens, two trials out of Norway investigated liver transplantation in carefully selected patients with uCRLMs who had responded to chemotherapy, showing promising results.

The TRANSMET study is the first randomized controlled trial to prospectively compare liver transplantation plus adjuvant chemotherapy with standard chemotherapy for patients deemed to have uCRLMs. This multi-center, open-label, prospective randomized trial took place in 20 tertiary centers across Europe. Patients aged 18-65 were eligible if they were BRAF wild-type, had primary-resected colorectal cancer, demonstrated disease stability for at least 3 months with up to 3 lines of chemotherapy, had a CEA level of less than 80 ng/mL or a reduction of 50%, showed no evidence of extrahepatic disease on CT and PET-CT, and were deemed unresectable by an independent panel. In the liver transplant group, a special prioritization process ensured transplantation within 2 months of the last chemotherapy cycle to reduce the risk of disease progression.

Of the 157 patients assessed for the trial, 47 were randomized to each group, with 36/47 receiving liver transplants in the treatment group and 38/47 receiving ongoing chemotherapy in the control group. Baseline demographics and disease characteristics were similar in both groups, with the majority having synchronous metastasis and over 10 tumors, with the largest tumor diameter averaging ~5 cm. Of the nine patients in the treatment group who did not receive a transplant, five had progression of intra- or extra-hepatic disease, three had intraoperative discovery of extrahepatic disease, and one was found to have another malignancy. Among transplant recipients, 34% experienced severe morbidity, 8% required re-transplantation, and the mortality rate was 3% within 3 months. In the intention-to-treat analysis, the five-year overall survival rate was 56.6% for the liver transplant and chemotherapy group versus 12.6% for the chemotherapy-alone group. The per-protocol analysis showed a five-year overall survival rate of 73.2% for liver transplantation compared to 9.3% for chemotherapy alone. Progression-free survival was 17.4 months in the liver transplantation plus chemotherapy group versus 6.4 months in the chemotherapy-alone group.

Limitations of this study include patient selection bias (highly selective patient group), the complexity of treatment (liver transplants are not widely available), and statistical power constraints due to the small sample size of the study.

Bottom line: Liver transplantation combined with chemotherapy may improve survival for patients with uCRLMs. However, there remain questions about appropriate patient selection protocols to ensure good outcomes, the role of hepatic artery infusion pumps, and the availability of liver allografts (use of extended criteria grafts, machine perfusion, and living donor liver transplant), among other questions for future study. 

Trauma Surgery

Emergency Medicaid Enrollment After Traumatic Injury Predicts Long-term Healthcare Utilization
Haddad DN, Eisinger E, Hatchimonji JS, Chen AT, Ramadan OI, et al. J. Trauma Acute Care Surg. (2024) doi:10.1097/ta.0000000000004403
Contributor: Joe Kern

Brief Synopsis

Synopsis: This study investigates healthcare utilization among traumatically injured patients who were retroactively enrolled in Medicaid. The study examines subsequent utilization patterns compared to patients who remained uninsured and those who were enrolled prior to their injury. The findings reveal that while insurance enrollment improves access to care, it does not independently address broader social and health challenges.

Summary: Emergency Medicaid enrollment allows hospitals to enroll eligible patients in insurance during their hospitalization and opens a path to permanent insurance. This offers potential benefits to both patients and health systems, enabling patients to seek and pay for care and allowing health systems to receive payment for previously unreimbursed care. The present study examines the impact of emergency Medicaid enrollment on health care utilization in trauma patients.

This single-center, retrospective cohort study was conducted in Philadelphia, comparing health care utilization between three groups: retroactively insured (RI) patients, patients with pre-existing Medicaid insurance (MI), and patients who remained uninsured (UI) throughout their hospitalization. The study analyzed data from 2017 to 2024 for patients aged 18 to 64. Using the institutional trauma registry and electronic medical records, researchers examined emergency department (ED) visits, hospital admissions, and clinic appointments at 30 days and 12 months post-injury. The authors also evaluated patient-reported outcomes (PROs) between these groups.

The study demonstrated that the health-seeking behaviors of RI patients differed from those of UI patients and began to resemble the health-seeking behaviors of patients with pre-existing Medicaid insurance. Compared to UI patients, RI patients were more likely to utilize health care services; they had higher rates of ED visits, hospital readmissions, specialist visits, and visits to their primary care provider within 30 days and 12 months. Compared to the MI group, RI patients were less likely to utilize health care services. It is also noteworthy that, compared to MI and UI patients, RI patients had higher rates of penetrating injuries and were more likely to require operative interventions. However, PROs at 6 months showed no significant differences in physical function or anxiety between the groups.

This study provides important context for understanding the health-seeking behaviors of a vulnerable patient population. The findings demonstrate that insurance enrollment changes how patients utilize healthcare but may not fully address the needs of this patient population. There was some selection bias in this study, as RI patients were inherently different from UI patients; however, MI patients more closely resembled RI patients, so comparisons between those groups may be less skewed. By nature of being a retrospective single-center study, this research does not evaluate healthcare utilization at other regional health systems, limiting the ability to generalize its findings. Lastly, only 11.3% of patients in this study completed the PROs, limiting the ability to fully understand the downstream impact of insurance enrollment on patient-reported health outcomes.

Bottom Line: Emergency Medicaid enrollment provides traumatically injured patients with an opportunity to obtain insurance and improves their ability to access post-acute care. Insurance enrollment alone does not sufficiently address barriers to care and access but may serve as an important step in improving post-acute care for traumatically injured patients.

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