Change in Patient Enrollment After Site Principal Investigator Turnover in Surgical Clinical Trials.

This cohort study examines the association of principal investigator (PI) turnover with patient enrollment in surgical clinical trials.

Association of social determinants of health-related diagnosis codes with postoperative outcomes.

BACKGROUND: The association of an individual's social determinants of health-related problems with surgical outcomes has not been well-characterized. The objective of this study was to determine whether documentation of social determinants of a health-related diagnosis code (Z code) is associated with postoperative outcomes. METHODS: This retrospective cohort study included surgical cases from a single institution's national surgical quality improvement program (NSQIP) clinical registry from October 2015 to December 2021. The primary predictor of interest was documentation of a Z code for social determinants of health-related problems. The primary outcome was 30-day postoperative morbidity. Secondary outcomes included postoperative length of stay, disposition, and 30-day postoperative mortality, reoperation, and readmission. Multivariable regression models were fit to evaluate the association between the documentation of a Z code and outcomes. RESULTS: Of 10,739 surgical cases, 348 patients (3.2%) had a documented social determinants of health-related Z code. In multivariable analysis, documentation of a Z code was associated with increased odds of morbidity (20.7% vs. 9.9%; adjusted odds ratio [aOR], 1.88; 95% confidence interval [CI], 1.39-2.53), length of stay (median, 3 vs. 1 day; incidence rate ratio, 1.49; 95% CI, 1.33-1.67), odds of disposition to a location other than home (11.3% vs. 3.9%; aOR, 2.86; 95% CI, 1.89-4.33), and odds of readmission (15.3% vs. 6.1%; aOR, 1.99; 95% CI, 1.45-2.73). CONCLUSIONS: Social determinants of health-related problems evaluated using Z codes were associated with worse postoperative outcomes. Improved documentation of social determinants of health-related problems among surgical patients may facilitate improved risk stratification, perioperative planning, and clinical outcomes.

Pediatric Surgeon Perceptions on Operating Room Environmental Stewardship and Current Institutional Climate-Smart Actions.

BACKGROUND: Operating rooms generate significant greenhouse gas emissions. Our objective was to assess current institutional climate-smart actions and pediatric surgeon perceptions regarding environmental stewardship efforts in the operating room. METHODS: A survey was distributed to members of the American Pediatric Surgical Association in June 2022. The survey was piloted among ten general surgery residents and two professional society cohorts of pediatric surgeons. Comparisons were made by demographic and practice characteristics. RESULTS: Survey response rate was 15.9% (n = 160/1009) and included surgeons predominantly from urban (n = 93/122, 76.2%) and academic (n = 84/122, 68.9%) institutions. Only 9.8% (n = 12/122) of pediatric surgeons were currently involved in operating room environmental initiatives. The most common climate-smart actions were reusable materials and equipment (n = 120/159, 75.5%) and reprocessing of medical devices (n = 111/160, 69.4%). Most surgeons either strongly agreed (n = 48/121, 39.7%) or agreed (n = 62/121, 51.2%) that incorporation of environmental stewardship practices at work was important. Surgeons identified reusable materials/equipment (extremely important: n = 61/129, 47.3%, important: n = 38/129, 29.5%) and recycling (extremely important: n = 68/129, 52.7%, important: n = 29/129, 22.5%) as the most important climate-smart actions. Commonly perceived barriers were financial (extremely likely: n = 47/123, 38.2%, likely: n = 50/123, 40.7%) and staff resistance to change (extremely likely: n = 29/123, 23.6%, likely: n = 60/123, 48.8%). Regional differences included low adoption of energy efficiency strategies among respondents from southern states (n = 0/26, p = 0.01) despite high perceived importance relative to other regions (median: 5, IQR: 4-5 vs median: 4, IQR 4-5, p = 0.04). CONCLUSIONS: While most pediatric surgeons agreed that environmental stewardship was important, less than 10% are currently involved in initiatives at their institutions. Opportunities exist for surgical leadership surrounding implementation of climate-smart actions. LEVEL OF EVIDENCE: Level III.

A mixed-method approach to generate and deliver rapid-cycle evaluation feedback: lessons learned from a multicenter implementation trial in pediatric surgery.

BACKGROUND: Rapid-cycle feedback loops provide timely information and actionable feedback to healthcare organizations to accelerate implementation of interventions. We aimed to (1) describe a mixed-method approach for generating and delivering rapid-cycle feedback and (2) explore key lessons learned while implementing an enhanced recovery protocol (ERP) across 18 pediatric surgery centers. METHODS: All centers are members of the Pediatric Surgery Research Collaborative (PedSRC, www.pedsrc.org ), participating in the ENhanced Recovery In CHildren Undergoing Surgery (ENRICH-US) trial. To assess implementation efforts, we conducted a mixed-method sequential explanatory study, administering surveys and follow-up interviews with each center's implementation team 6 and 12 months following implementation. Along with detailed notetaking and iterative discussion within our team, we used these data to generate and deliver a center-specific implementation report card to each center. Report cards used a traffic light approach to quickly visualize implementation status (green = excellent; yellow = needs improvement; red = needs significant improvement) and summarized strengths and opportunities at each timepoint. RESULTS: We identified several benefits, challenges, and practical considerations for assessing implementation and using rapid-cycle feedback among pediatric surgery centers. Regarding potential benefits, this approach enabled us to quickly understand variation in implementation and corresponding needs across centers. It allowed us to efficiently provide actionable feedback to centers about implementation. Engaging consistently with center-specific implementation teams also helped facilitate partnerships between centers and the research team. Regarding potential challenges, research teams must still allocate substantial resources to provide feedback rapidly. Additionally, discussions and consensus are needed across team members about the content of center-specific feedback. Practical considerations include carefully balancing timeliness and comprehensiveness when delivering rapid-cycle feedback. In pediatric surgery, moreover, it is essential to actively engage all key stakeholders (including physicians, nurses, patients, caregivers, etc.) and adopt an iterative, reflexive approach in providing feedback. CONCLUSION: From a methodological perspective, we identified three key lessons: (1) using a rapid, mixed method evaluation approach is feasible in pediatric surgery and (2) can be beneficial, particularly in quickly understanding variation in implementation across centers; however, (3) there is a need to address several methodological challenges and considerations, particularly in balancing the timeliness and comprehensiveness of feedback. TRIAL REGISTRATION: NIH National Library of Medicine Clinical Trials. CLINICALTRIALS: gov Identifier: NCT04060303. Registered August 7, 2019, https://clinicaltrials.gov/ct2/show/NCT04060303.

Operating Room Recycling: Opportunities to Reduce Carbon Emissions Without Increases in Cost.

BACKGROUND: The healthcare industry is a major contributor to greenhouse gas emissions. Within the hospital, operating rooms are responsible for the largest proportion of emissions due to high resource utilization and waste generation. Our aim was to generate estimates of greenhouse gas emissions avoided and cost implications following implementation of a recycling program across operating rooms at our freestanding children's hospital. METHODS: Data were collected from three commonly performed pediatric surgical procedures: circumcision, laparoscopic inguinal hernia repair, and laparoscopic gastrostomy tube placement. Five cases of each procedure were observed. Recyclable paper and plastic waste was weighed. Emission equivalencies were determined using the Environmental Protection Agency Greenhouse Gas Equivalencies Calculator. Institutional cost of waste disposal was $66.25 United States Dollars (USD)/ton for recyclable waste and $67.00 USD/ton for solid waste. RESULTS: The proportion of recyclable waste ranged from 23.3% for circumcision to 29.5% for laparoscopic gastrostomy tube placement. The amount of waste redirected from landfill to a recycling stream could result in annual avoidance of 58,500 to 91,500 kg carbon dioxide equivalent emissions, or 6583 to 10,296 gallons of gasoline. Establishing a recycling program would not require additional cost and could lead to modest cost savings (range $15 to 24 USD/year). CONCLUSIONS: Incorporation of recycling into operating rooms has the potential to reduce greenhouse gas emissions without increased cost. Clinicians and hospital administrators should consider operating room recycling programs as they work towards improved environmental stewardship. LEVEL OF EVIDENCE: Level VI - evidence form a single descriptive or qualitative study.

Addressing pediatric surgical health inequities through quality improvement efforts.

Concepts of healthcare quality and health equity should be inextricably linked but are often pursued separately. Quality improvement (QI) can serve as a powerful means to eliminate health inequities by adopting an equity-focused lens to diagnose and address baseline disparities among pediatric populations using targeted interventions. QI and pediatric surgery practitioners should integrate concepts of equity at every stage of formulating a QI project including conceptualization, planning, and execution. Early adaptation of an equity conscious perspective using QI methodology can prevent exacerbation of preexisting disparities while improving overall outcomes.

Disparities in Utilization of Same-Day Discharge Following Appendectomy in Children.

INTRODUCTION: Disparities in the delivery of pediatric surgical care exist for racial and ethnic minority groups. Utilization of same-day discharge (SDD) following appendectomy for acute, uncomplicated appendicitis is increasing; however, rates among diverse populations have not been explored to evaluate equitable care delivery and healthcare utilization. Our objective was to determine whether race and ethnicity are associated with rates of SDD and postdischarge healthcare utilization. We hypothesized that racial and ethnic minority groups would have lower rates of SDD. METHODS: This retrospective cohort study used data from the 2015-2019 American College of Surgeons National Surgical Quality Improvement Program-Pediatric clinical registry and included children who underwent appendectomy. Patients with complicated appendicitis were excluded. Primary exposure was racial or ethnic group. The primary outcome was SDD, and secondary outcomes included postdischarge emergency department visits and hospital readmissions. RESULTS: Of 37,579 simple appendicitis patients, SDD after appendectomy occurred in 10,012 (26.6%). On multivariable analysis, Black or African American race was associated with lower likelihood of SDD (adjusted odds ratio [aOR]: 0.85; 95% confidence interval [95% CI]:0.79-0.92; P < 0.0001). Hispanic ethnicity was associated with higher likelihood of SDD (aOR: 1.19; 95% CI: 1.12-1.25; P < 0.0001). Likelihood of postoperative emergency department visits was higher in Black or African American patients (aOR: 1.36; 95% CI: 1.14-1.62; P < 0.001) and Hispanic patients (aOR: 1.37; 95% CI: 1.12-1.58; P < 0.0001). Hospital readmission rates were similar across groups. CONCLUSIONS: Rates of SDD following appendectomy vary among racial and ethnic groups. Interventions to achieve equitable healthcare delivery including SDD after appendectomy are needed.

Comparative analysis of two porcine kidney decellularization methods for maintenance of functional vascular architectures.

Kidney transplantation is currently the only definitive solution for the treatment of end-stage renal disease (ESRD), however transplantation is severely limited by the shortage of available donor kidneys. Recent progress in whole organ engineering based on decellularization/recellularization techniques has enabled pre-clinical in vivo studies using small animal models; however, these in vivo studies have been limited to short-term assessments. We previously developed a decellularization system that effectively removes cellular components from porcine kidneys. While functional re-endothelialization on the porcine whole kidney scaffold was able to improve vascular patency, as compared to the kidney scaffold only, the duration of patency lasted only a few hours. In this study, we hypothesized that significant damage in the microvasculatures within the kidney scaffold resulted in the cessation of blood flow, and that thorough investigation is necessary to accurately evaluate the vascular integrity of the kidney scaffolds. Two decellularization protocols [sodium dodecyl sulfate (SDS) with DNase (SDS + DNase) or Triton X-100 with SDS (TRX + SDS)] were used to evaluate and optimize the levels of vascular integrity within the kidney scaffold. Results from vascular analysis studies using vascular corrosion casting and angiograms demonstrated that the TRX + SDS method was able to better maintain intact and functional microvascular architectures such as glomeruli within the acellular matrices than that by the SDS + DNase treatment. Importantly, in vitro blood perfusion of the re-endothelialized kidney construct revealed improved vascular function of the scaffold by TRX + SDS treatment compared with the SDS + DNase. Our results suggest that the optimized TRX + SDS decellularization method preserves kidney-specific microvasculatures and may contribute to long-term vascular patency following implantation. STATEMENT OF SIGNIFICANCE: Kidney transplantation is the only curative therapy for patients with end-stage renal disease (ESRD). However, in the United States, the supply of donor kidneys meets less than one-fifth of the demand; and those patients that receive a donor kidney need life-long immunosuppressive therapy to avoid organ rejection. In the last two decades, regenerative medicine and tissue engineering have emerged as an attractive alternative to overcome these limitations. In 2013, Song et al. published the first experimental orthotopic transplantation of a bioengineering kidney in rodents. In this study, they demonstrated evidences of kidney tissue regeneration and partial function restoration. Despite these initial promising results, there are still many challenges to achieve long-term blood perfusion without graft thrombosis. In this paper, we demonstrated that perfusion of detergents through the renal artery of porcine kidneys damages the glomeruli microarchitecture as well as peritubular capillaries. Modifying dynamic parameters such as flow rate, detergent concentration, and decellularization time, we were able to establish an optimized decellularization protocol with no evidences of disruption of glomeruli microarchitecture. As a proof of concept, we recellularized the kidney scaffolds with endothelial cells and in vitro perfused whole porcine blood successfully for 24 h with no evidences of thrombosis.

Bioengineered transplantable porcine livers with re-endothelialized vasculature.

Donor shortage remains a continued challenge in liver transplantation. Recent advances in tissue engineering have provided the possibility of creating functional liver tissues as an alternative to donor organ transplantation. Small bioengineered liver constructs have been developed, however a major challenge in achieving functional bioengineered liver in vivo is the establishment of a functional vasculature within the scaffolds. Our overall goal is to bioengineer intact livers, suitable for transplantation, using acellular porcine liver scaffolds. We developed an effective method for reestablishing the vascular network within decellularized liver scaffolds by conjugating anti-endothelial cell antibodies to maximize coverage of the vessel walls with endothelial cells. This procedure resulted in uniform endothelial attachment throughout the liver vasculature extending to the capillary bed of the liver scaffold and greatly reduced platelet adhesion upon blood perfusion in vitro. The re-endothelialized livers, when transplanted to recipient pigs, were able to withstand physiological blood flow and maintained for up to 24 h. This study demonstrates, for the first time, that vascularized bioengineered livers, of clinically relevant size, can be transplanted and maintained in vivo, and represents the first step towards generating engineered livers for transplantation to patients with end-stage liver failure.