Efficacy and Safety of the Melphalan/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma: Results from an Open-Label, Single-Arm, Multicenter Phase 3 Study.

BACKGROUND: Uveal melanoma (UM) has a poor prognosis once liver metastases occur. The melphalan/Hepatic Delivery System (melphalan/HDS) is a drug/device combination used for liver-directed treatment of metastatic UM (mUM) patients. The purpose of the FOCUS study was to assess the efficacy and safety of melphalan/HDS in patients with unresectable mUM. METHODS: Eligible patients with mUM received treatment with melphalan (3.0 mg/kg ideal body weight) once every 6 to 8 weeks for a maximum of six cycles. The primary end point was the objective response rate (ORR). The secondary end points included duration of response (DOR), overall survival (OS), and progression-free survival (PFS). RESULTS: The study enrolled 102 patients with mUM. Treatment was attempted in 95 patients, and 91 patients received treatment. In the treated population (n = 91), the ORR was 36.3 % (95 % confidence interval [CI], 26.44-47.01), including 7.7 % of patients with a complete response. Thus, the study met its primary end point because the lower bound of the 95 % CI for ORR exceeded the upper bound (8.3 %) from the benchmark meta-analysis. The median DOR was 14 months, and the median OS was 20.5 months, with an OS of 80 % at 1 year. The median PFS was 9 months, with a PFS of 65 % at 6 months. The most common serious treatment-emergent adverse events were thrombocytopenia (15.8 %) and neutropenia (10.5 %), treated mostly on an outpatient basis with observation. No treatment-related deaths were observed. CONCLUSION: Treatment with melphalan/HDS provides a clinically meaningful response rate and demonstrates a favorable benefit-risk profile in patients with unresectable mUM (study funded by Delcath; ClinicalTrials.gov identifier: NCT02678572; EudraCT no. 2015-000417-44).

Reporting time toxicity in prospective cancer clinical trials: A scoping review.

PURPOSE: This review aimed to assess the measurement and reporting of time toxicity (i.e., time spent receiving care) within prospective oncologic studies. METHODS: On July 23, 2023, PubMed, Scopus, and Embase were queried for prospective or randomized controlled trials (RCT) from 1984 to 2023 that reported time toxicity as a primary or secondary outcome for oncologic treatments or interventions. Secondary analyses of RCTs were included if they reported time toxicity. The included studies were then evaluated for how they reported and defined time toxicity. RESULTS: The initial query identified 883 records, with 10 studies (3 RCTs, 2 prospective cohort studies, and 5 secondary analyses of RCTs) meeting the final inclusion criteria. Treatment interventions included surgery (n = 5), systemic therapies (n = 4), and specialized palliative care (n = 1). The metric "days alive and out of the hospital" was used by 80% (n = 4) of the surgical studies. Three of the surgical studies did not include time spent receiving ambulatory care within the calculation of time toxicity. "Time spent at home" was assessed by three studies (30%), each using different definitions. The five secondary analyses from RCTs used more comprehensive metrics that included time spent receiving both inpatient and ambulatory care. CONCLUSIONS: Time toxicity is infrequently reported within oncologic clinical trials, with no standardized definition, metric, or methodology. Further research is needed to identify best practices in the measurement and reporting of time toxicity to develop strategies that can be implemented to reduce its burden on patients seeking cancer care.

Care fragmentation in hepatopancreatic surgery and postoperative outcomes.

BACKGROUND: Practice fragmentation in surgery may be associated with poor quality of care. We sought to define the association between fragmented practice and outcomes in hepatopancreatic surgery relative to surgeon volume and sex. METHODS: Medicare beneficiaries who underwent hepatopancreatic surgery between 2016 and 2021 were identified. Multivariable analysis was performed to determine provider sex-based differences in the rate of fragmented practice relative to the achievement of a textbook outcome and health care expenditures after adjusting for procedure-specific case volume. RESULTS: Among 37,416 patients, almost one-half were female (n = 18,333, 49.0%) with the majority treated by male surgeons (n = 33,697, 90.8%). Female surgeons were more likely to have a greater rate of fragmented practice (females: n = 242, 84.9% vs males: n = 1,487, 78.4%, P = .003; odds ratio 2.66, 95% confidence interval 2.33-3.03, P < .001). Patients treated by high rate of fragmented practice surgeons had increased odds of postoperative complications (odds ratio 1.40, 95% confidence interval 1.28-1.54), extended length-of-stay (odds ratio 1.52, 95% confidence interval 1.38-1.68), 90-day-mortality (odds ratio 1.49, 95% confidence interval 1.28-1.72), and lower odds of achieving a textbook outcome (odds ratio 0.76, 95% confidence interval 0.71-0.83). This association persisted independent of surgeon-specific volume (textbook outcome, high vs low rate of fragmented practice: high-volume surgeon, odds ratio 0.53, 95% confidence interval 0.31-0.91, P = .021 vs. low-volume surgeon, odds ratio 0.76, 95% confidence interval 0.69-0.82, P < .001). Among patients treated by male surgeons, a high rate of fragmented practice was associated with reduced odds of achieving a textbook outcome (male surgeons: odds ratio 0.76, 95% confidence interval 0.70-0.82, P < .001; female surgeons: odds ratio 0.81, 95% confidence interval 0.63-1.05, P = .110). Treatment by surgeons with higher fragmented practice was associated with higher expenditures (index expenditure: percentage difference 9.87, 95% confidence interval, 7.42-12.36; P < .05). CONCLUSION: A high rate of fragmented practice adversely affected postoperative outcomes and healthcare expenditures even among high-volume surgeons with the impact varying based on surgeon sex.

Graduate medical education success coaching for residents and fellows: a single-institution real-world experience.

While coaching has been employed as a success strategy in many areas such as athletics and business for decades, its use is relatively new in the medical field despite evidence of its benefits. Implementation and engagement regarding coaching in graduate medical education (GME) for residents and fellows is particularly scarce. We report our three-year experience of a GME success coaching program that aims to help trainees reach their full potential by addressing various areas of medical knowledge, clinical skills, efficiency, interpersonal skills and communication, professionalism, and mental health and well-being. The majority of participants (87%) were identified by themselves, their program director, and/or the GME coaches to have more than one area of need. The majority (79%) of referrals were identified by the coaches to have additional needs to the reasons for referral. We provide a framework for implementation of a GME coaching program and propose that coaching in GME may provide an additional safe environment for learners to reveal areas of concerns or difficulty that otherwise would not be disclosed and/or addressed.

Prophylactic defunctioning stomas improve clinical outcomes of anastomotic leak following rectal cancer resections: An analysis of the US Rectal Cancer Consortium.

PURPOSE: Anastomotic leak (AL) is a complication of low anterior resection (LAR) that results in substantial morbidity. There is immense interest in evaluating immediate postoperative and long-term oncologic outcomes in patients who undergo diverting loop ileostomies (DLI). The purpose of this study is to understand the relationship between fecal diversion, AL, and oncologic outcomes. METHODS: This is a retrospective multicenter cohort study using patient data obtained from the US Rectal Cancer Consortium database compiled from six academic institutions. The study population included patients with rectal adenocarcinoma undergoing LAR. The primary outcome was the incidence of AL among patients who did or did not receive DLI during LAR. Secondary outcomes included risk factors for AL, receipt of adjuvant therapy, 3-year overall survival, and 3-year recurrence. RESULTS: Of 815 patients, 38 (4.7%) suffered AL after LAR. Patients with AL were more likely to be male, have unintentional preoperative weight loss, and are less likely to undergo DLI. On multivariable analysis, DLI remained protective against AL (p < 0.001). Diverted patients were less likely to undergo future surgical procedures including additional ostomy creation, completion proctectomy, or pelvic washout for AL. Subgroup analysis of 456 patients with locally advanced disease showed that DLI was correlated with increased receipt of adjuvant therapy for patients with and without AL on univariate analysis (SHR:1.59; [95% CI 1.19-2.14]; p = 0.002), but significance was not met in multivariate models. CONCLUSION: Lack of DLI and preoperative weight loss was associated with anastomotic leak. Fecal diversion may improve the timely initiation of adjuvant oncologic therapy. The long-term outcomes following routine diverting stomas warrant further study.

Measuring Chief Resident Skill and Entrustment Progression in An Operative Coaching Program: Four Years' Experience.

OBJECTIVE: Operative coaching (OC) may facilitate improvement of surgery residents' competencies by optimizing learning and teaching. We investigated how residents' operative skills and prospective entrustment (PE) progress throughout the chief year in our OC program, how OC is perceived by participants, and how OC may facilitate learning and teaching. DESIGN, SETTING, AND PARTICIPANTS: This is a mixed-methods study conducted within the Ohio State University Wexner Medical Center General Surgery residency. Validated performance evaluations with procedural-specific skill, general skill (GS), step-specific guidance required (SSG) (an autonomy measure), and PE measures completed by chiefs, faculty coaches, and attending surgeons from 7/2018 to 6/2022 were reviewed. We also interviewed OC participants to understand their experience. Descriptive statistical and qualitative content analysis were applied. RESULTS: 441 evaluations from 147 OC cases completed by 22 chiefs, 5 faculty coaches, and 24 attendings were included. Overall, resident GS (p = 0.036), SSG (p = 0.023), and PE (p = 0.002) significantly improved throughout the year. PE significantly correlated (all p < 0.0001) with SSG (r = 0.73), followed by procedural-specific skill (r = 0.59), then GS (r = 0.57). On average, chiefs underestimated their surgical skills while attendings overestimated autonomy they permitted to residents. Chiefs, coaches, and attendings reached consensus on chiefs' PE upon graduation. Five graduated chiefs and 5 attendings were interviewed. Chiefs described OC as effective in improving their self-regulated learning and particularly valued 3 OC elements: neutral authentic feedback, third-party real-time observation, and actionable feedback. Attendings noted OC promoted their engagement in skills assessment and teaching. CONCLUSIONS: Our findings suggest chief residents' skills, autonomy, and PE progress steadily along their OC journey. Despite differences in residents', coaches', and attendings' perceptions of skill, measures of autonomy reliably correlate with entrustment. OC promotes resident learning, faculty teaching, and assessment of resident skills, autonomy, and PE in the OR.

Management of Intrahepatic Cholangiocarcinoma: A Narrative Review.

The management of resectable intrahepatic cholangiocarcinoma remains a challenge due to the high risk of recurrence. Numerous clinical trials have identified effective systemic therapies for advanced biliary tract cancer; however, fewer trials have evaluated systemic therapies in the perioperative period. The objective of this review is to summarize the current recommendations regarding the diagnosis, surgical resection, and systemic therapy for anatomically resectable intrahepatic cholangiocarcinoma. Our review demonstrates that surgical resection with microscopic negative margins and lymphadenectomy remains the cornerstone of treatment. High-level evidence regarding specific systemic therapies for use in resectable intrahepatic cholangiocarcinoma remains sparse, as most of the evidence is extrapolated from trials involving heterogeneous tumor populations. Targeted therapies are an evolving practice for intrahepatic cholangiocarcinoma with most evidence coming from phase II trials. Future research is required to evaluate the use of neoadjuvant therapy for patients with resectable and borderline resectable disease.

Recurrence following Resection of Intraductal Papillary Mucinous Neoplasms: A Systematic Review to Guide Surveillance.

Patients who undergo resection for non-invasive IPMN are at risk for long-term recurrence. Further evidence is needed to identify evidence-based surveillance strategies based on the risk of recurrence. We performed a systematic review of the current literature regarding recurrence patterns following resection of non-invasive IPMN to summarize evidence-based recommendations for surveillance. Among the 61 studies reviewed, a total of 8779 patients underwent resection for non-invasive IPMN. The pooled overall median follow-up time was 49.5 months (IQR: 38.5-57.7) and ranged between 14.1 months and 114 months. The overall median recurrence rate for patients with resected non-invasive IPMN was 8.8% (IQR: 5.0, 15.6) and ranged from 0% to 27.6%. Among the 33 studies reporting the time to recurrence, the overall median time to recurrence was 24 months (IQR: 17, 46). Existing literature on recurrence rates and post-resection surveillance strategies for patients with resected non-invasive IPMN varies greatly. Patients with resected non-invasive IPMN appear to be at risk for long-term recurrence and should undergo routine surveillance.

Online artificial intelligence platforms and their applicability to gastrointestinal surgical operations.

BACKGROUND: The internet is a common source of health information for patients. Interactive online artificial intelligence (AI) may be a more reliable source of health-related information than traditional search engines. This study aimed to assess the quality and perceived utility of chat-based AI responses related to 3 common gastrointestinal (GI) surgical procedures. METHODS: A survey of 24 questions covering general perioperative information on cholecystectomy, pancreaticoduodenectomy (PD), and colectomy was created. Each question was posed to Chat Generative Pre-trained Transformer (ChatGPT) in June 2023, and the generated responses were recorded. The quality and perceived utility of responses were independently and subjectively graded by expert respondents specific to each surgical field. Grades were classified as "poor," "fair," "good," "very good," or "excellent." RESULTS: Among the 45 respondents (general surgeon [n = 13], surgical oncologist [n = 18], colorectal surgeon [n = 13], and transplant surgeon [n = 1]), most practiced at an academic facility (95.6%). Respondents had been in practice for a mean of 12.3 years (general surgeon, 14.5 ± 7.2; surgical oncologist, 12.1 ± 8.2; colorectal surgeon, 10.2 ± 8.0) and performed a mean 53 index operations annually (cholecystectomy, 47 ± 28; PD, 28 ± 27; colectomy, 81 ± 44). Overall, the most commonly assigned quality grade was "fair" or "good" for most responses (n = 622/1080, 57.6%). Most of the 1080 total utility grades were "fair" (n = 279, 25.8%) or "good" (n = 344, 31.9%), whereas only 129 utility grades (11.9%) were "poor." Of note, ChatGPT responses related to cholecystectomy (45.3% ["very good"/"excellent"] vs 18.1% ["poor"/"fair"]) were deemed to be better quality than AI responses about PD (18.9% ["very good"/"excellent"] vs 46.9% ["poor"/"fair"]) or colectomy (31.4% ["very good"/"excellent"] vs 38.3% ["poor"/"fair"]). Overall, only 20.0% of the experts deemed ChatGPT to be an accurate source of information, whereas 15.6% of the experts found it unreliable. Moreover, 1 in 3 surgeons deemed ChatGPT responses as not likely to reduce patient-physician correspondence (31.1%) or not comparable to in-person surgeon responses (35.6%). CONCLUSIONS: Although a potential resource for patient education, ChatGPT responses to common GI perioperative questions were deemed to be of only modest quality and utility to patients. In addition, the relative quality of AI responses varied markedly on the basis of procedure type.

Patient Perceptions of Care Coordination during Neoadjuvant Therapy for Gastrointestinal Cancers: A Mixed Methods Analysis.

PURPOSE: Effective cancer care coordination (CCC) is an integral component of health care delivery and critical to achieving optimal oncologic outcomes. Neoadjuvant therapy (NT), the delivery of multimodality therapy prior to surgery, is inherently complex and multidisciplinary, but CCC during NT is poorly understood. The objective of this study was to characterize patient perceptions of CCC during NT using a mixed methods approach. METHODS: This study is a cross-sectional analysis of patients with gastrointestinal cancers receiving NT who participated in a prospective longitudinal cohort study evaluating their real-time experience using a customized smartphone application. Patients completed the Cancer Care Coordination Questionnaire for Patients (CCCQ-P), a 20-item validated measure of care coordination quality, six weeks after initiating NT. Items were scored on a 5-point Likert scale, and subsections on communication (13 questions) and navigation (7 questions) were calculated with higher scores signifying better CCC. Univariate linear regression was used to calculate the impact of fragmented care and other factors on perceived CCC. Semi-structured interviews were conducted among a convenience sample of patients (n = 5); transcribed interviews were then coded using an inductive approach. RESULTS: Among 82 participants, mean age was 61 years old, 68% were male, and mean number of comorbidities was 1.68. Overall (mean 76.6 out of 100), communication subsection (48.6 out of 65), and navigation subsection (28.0 out of 35) CCCQ-P scores suggested overall positive perceptions of care coordination. Qualitative analysis of patient interviews highlighted the need for coordination among physicians before communicating the plan to patients as well as the importance of providers communicating plans in verbal and written form. CONCLUSIONS: Successful completion of NT requires significant care coordination between patients and healthcare professionals. Yet, in this cross-sectional analysis of patients on a prospective cohort study, patient perceptions of CCC during NT were overall positive. Future research should focus on optimizing other aspects of care delivery in order to improve outcomes of NT.

Association of omental pedicled flap with anastomotic leak following low anterior resection for rectal cancer.

BACKGROUND AND OBJECTIVES: Anastomotic leak following colorectal anastomosis adversely impacts short-term, oncologic, and quality-of-life outcomes. This study aimed to assess the impact of omental pedicled flap (OPF) on anastomotic leak among patients undergoing low anastomotic resection (LAR) for rectal cancer using a multi-institutional database. METHODS: Adult rectal cancer patients in the US Rectal Cancer Consortium, who underwent a LAR for stage I-III rectal cancer with or without an OPF were included. Patients with missing data for surgery type and OPF use were excluded from the analysis. The primary outcome was the development of anastomotic leaks. Multivariable logistic regression was used to determine the association. RESULTS: A total of 853 patients met the inclusion criteria and OPF was used in 106 (12.4%) patients. There was no difference in age, sex, or tumor stage of patients who underwent OPF versus those who did not. OPF use was not associated with an anastomotic leak (p = 0.82), or operative blood loss (p = 0.54) but was associated with an increase in the operative duration [ß = 21.42 (95% confidence interval = 1.16, 41.67) p = 0.04]. CONCLUSIONS: Among patients undergoing LAR for rectal cancer, OPF use was associated with an increase in operative duration without any impact on the rate of anastomotic leak.

Intracystic injection of large surface area microparticle paclitaxel for chemoablation of intraductal papillary mucinous neoplasms: Insights from an expanded access protocol.

AIMS: A novel large surface area microparticle paclitaxel (LSAM-PTX) has unique properties of long retention in cystic spaces while maintaining high drug concentration. We prospectively evaluated the safety and response of EUS-guided fine needle injection (EUS-FNI) of LSAM-PTX to chemoablate branch duct (BD)-IPMNs. METHODS: Subjects diagnosed with BD-IPMNs exhibiting at least one worrisome criteria and considered non-surgical were enrolled in a multicenter clinical trial (NCT03188991) and subsequently included in an Expanded Access Protocol (EAP) where they received EUS-FNI of LSAM-PTX (15 mg/mL). RESULTS: Six BD-IPMNs measuring (mean ± SD) 3.18 ± 0.76 cm in diameter among 5 subjects (mean age: 66 years) were treated by EUS-FNI of LSAM-PTX. A mean of 4 doses of LSAM-PTX (mean dose/cyst: 73 ± 31 mg) were administered, and subjects were followed for up to 32 months. The mean volume reduction/cyst ranged from 42 to 89% (9.58 ± 5.1 ml to 2.2 ± 1.1 ml (p = 0.016)). The mean surface area reduction ranged from 31 to 83% (21.9 ± 8.7 cm2 to 5.7 ± 2.5 cm2 (p = 0.009)). Higher dosing-frequency of EUS-FNI of LSAM-PTX significantly correlated with a reduction in cyst volume (R2 = 0.87, p = 0.03) and surface area (R2 = 0.83, p = 0.04). Comparing pre- and post-ablation samples, molecular analysis of the cyst fluid revealed a loss of IPMN-associated mutations in 5 cases (83.3%), while reemergence was observed in 1 case and persistence in 1 case. Intracystic changes (fibrosis/calcification) were observed in 83.3% (n = 5). One subject developed mild acute pancreatitis (1 of 22 EUS-FNIs of LSAM-PTX). CONCLUSION: In this EAP, EUS-FNI of LSAM-PTX into BD-IPMNs was safe and resulted in volume and surface area reduction, morphological changes, and loss of pathogenic mutations.

Association of Racial and Economic Privilege on Postoperative Outcomes Among Medicare Beneficiaries.

INTRODUCTION: Social determinants of health can play an important role in patient health. Privilege is a right, benefit, advantage, or opportunity that can positively affect all social determinants of health. We sought to assess variations in the prevalence of privilege among patient populations and define the association of privilege on postoperative surgical outcomes. METHODS: Medicare beneficiaries who underwent elective coronary artery bypass grafting, abdominal aortic aneurysm repair, total hip arthroplasty, total knee arthroplasty, colectomy, and lung resection were identified. The Index of Concentration of Extremes (ICE), a validated metric of both social spatial polarization and privilege was calculated and merged with county-level data obtained from the American Community Survey. Textbook outcome (TO) was defined as absence of postoperative complications, extended length of stay, 90-day mortality, and 90-day readmission. Multivariable regression analysis was performed to assess the relationship between ICE and TO. RESULTS: Among 1,885,889 Medicare beneficiaries who met inclusion criteria, 655,980 (34.8%) individuals resided in areas with the highest privilege (i.e., White, high-income homogeneity), whereas 221,314 (11.7%) individuals resided in areas of the lowest privilege (i.e., Black, low-income homogeneity). The overall incidence of TO was 66.2% (n = 1,247,558). On multivariable regression, residence in the most advantaged neighbourhoods was associated with a lower chance of surgical complications (odds ratio [OR] 0.90, 95% confidence interval [CI] 0.88-0.91), a prolonged length of stay (OR 0.81, 95% CI 0.79-82), 90-day readmission (OR 0.94, 95% CI 0.92-0.95), and 90-day mortality (OR 0.71, 95% CI 0.68-0.74) (all P < 0.001). Residence in the most privileged areas was associated with 19% increased odds of achieving TO (OR 1.19, 95% CI 1.18-1.21), as well as a 6% reduction in Medicare expenditures versus individuals in the least privileged counties (OR 0.94, 95% CI 0.94-0.94) (both P < 0.001). CONCLUSIONS: Privilege, based on the ICE joint measure of racial/ethnic and economic spatial concentration, was strongly associated with the likelihood to achieve an "optimal" TO following surgery. As healthcare is a basic human right, privilege should not be associated with disparities in surgical care.

Variation in Hospital Mortality After Complex Cancer Surgery: Patient, Volume, Hospital or Social Determinants?

INTRODUCTION: We sought to define the individual contributions of patient characteristics (PCs), hospital characteristics (HCs), case volume (CV), and social determinants of health (SDoH) on in-hospital mortality (IHM) after complex cancer surgery. METHODS: The California Department of Health Care Access and Information database identified patients who underwent esophagectomy (ES), pneumonectomy (PN), pancreatectomy (PD), or proctectomy (PR) for a malignant diagnosis between 2010 and 2020. Multi-level multivariable regression was performed to assess the proportion of variance explained by PCs, HCs, CV and SDoH on IHM. RESULTS: A total of 52,838 patients underwent cancer surgery (ES: n = 2,700, 5.1%; PN: n = 30,822, 58.3%; PD: n = 7530, 14.3%; PR: n = 11,786, 22.3%) across 294 hospitals. The IHM for the overall cohort was 1.7% and varied from 4.4% for ES to 0.8% for PR. On multivariable regression, PCs contributed the most to the variance in IHM (overall: 32.0%; ES: 21.6%; PN: 28.0%; PD: 20.3%; PR: 39.9%). Among the overall cohort, CV contributed 2.4%, HCs contributed 1.3%, and SDoH contributed 1.2% to the variation in IHM. CV was the second highest contributor to IHM among ES (5.3%), PN (5.3%), and PD (5.9%); however, HCs were a more important contributor among patients who underwent PR (8.0%). The unexplained variance in IHM was highest among ES (72.4%), followed by the PD (67.5%) and PN (64.6%) patient groups. CONCLUSIONS: PCs are the greatest underlying contributor to variations in IHM following cancer surgery. These data highlight the need to focus on optimizing patients and exploring unexplained sources of IHM to improve quality of surgical care.

Association of surgeon-patient sex concordance with postoperative outcomes following complex cancer surgery.

BACKGROUND AND OBJECTIVES: Sex concordance may impact the therapeutic relationship and provider-patient interactions. We sought to define the association of surgeon-patient sex concordance on postoperative patient outcomes following complex cancer surgery. METHODS: Patients who underwent surgery for lung, breast, hepato-pancreato-biliary, or colorectal cancer between 2014 and 2020 were identified from the Medicare Standard Analytic Files. The impact of surgeon-patient sex concordance or discordance on achieving an optimal postoperative textbook outcome (TO) was assessed using multivariable logistic regression. RESULTS: Among 495 628 patients, 241 938 (48.8%) patients were sex concordant with their surgeon while 253 690 (51.2%) patients were sex discordant. Sex discordance between surgeon and patient was associated with a decreased likelihood to achieve a postoperative TO (odds ratio [OR]: 0.95, 95% CI: 0.93-0.97; p < 0.001). Sex discordance was associated with a higher risk of complications (OR: 1.05, 95% CI: 1.03-1.07; p < 0.001) and 90-day mortality (OR: 1.05, 95% CI: 1.01-1.09; p = 0.011). Of note, male patients treated by female surgeons (OR: 0.96, 95% CI: 0.93-0.99; p = 0.017) had a similar lower likelihood to achieve a TO as female patients treated by male surgeons (OR: 0.90, 95% CI: 0.86-0.93; p < 0.001). CONCLUSIONS: Sex discordance was associated with a reduced likelihood of achieving an "optimal" postoperative course following complex cancer surgery.

Evaluating the caregiver experience during neoadjuvant therapy for pancreatic ductal adenocarcinoma.

INTRODUCTION: Neoadjuvant therapy (NT) is increasingly recommended for patients with localized pancreatic ductal adenocarcinoma (PDAC). Recent research has highlighted the significant treatment burden that patients experience during NT, but caregiver well-being during NT is poorly understood. METHODS: A cross-sectional mixed-methods analysis of primary caregivers of patients with localized PDAC receiving NT was undertaken. All patients completed the Caregiver Quality of Life Index-Cancer (CQOLC) survey, while semi-structured interviews were conducted among a convenience sample of participants. RESULTS: Among 28 caregivers, the mean age was 60.1 years, and most were patient spouses/significant others (71.4%). Patients had resectable (18%), borderline resectable (46%), or locally advanced (36%) PDAC with a mean treatment duration of 2.9 months at the time of their caregiver's enrollment. Most caregivers felt that they received adequate emotional/psychosocial support (80%) and understood the rationale for NT (93%). A majority (60%) reported that caregiving responsibilities impacted their daily lives and required a decrease in their work hours, leading to financial challenges (47%). While overall QOL was moderate (mean 83 ± 21.1, range 0-140), "emotional burden" (47.3 ± 20.9), and "positive adaption" (57.3 ± 13.9) were the lowest ranked CQOLC subsection scores. DISCUSSION: Caregivers of patients with PDAC undergoing NT experience significant emotional symptoms and impact on their daily lives. Assessing caregiver needs and providing resources during NT should be a priority.

Mediators of racial disparities in postoperative outcomes among patients undergoing complex surgery.

BACKGROUND: This study sought to quantify the direct and indirect effects of race on postoperative outcomes after complex surgery. METHODS: Medicare patients who underwent abdominal aortic aneurysm (AAA) repair, coronary artery bypass grafting (CABG), lung resection or colectomy were identified (2014-2018). Generalized structural equation modelling was utilized to quantify the direct and indirect effects of race on Textbook outcome (TO). RESULTS: Among 930,033 patients, 46.8% of patients achieved a TO, with Black patients less likely to achieve a TO (referent: White; Black: OR 0.72, 95% CI 0.70-0.73). Notably, 32.3% of the disparities in TO were attributable to race itself, while 67.7% was explained by other factors. Specifically, residential segregation accounted for 39.4% of the lower TO rates among Black patients, while 21.0% was attributable to a high comorbidity burden. CONCLUSIONS: These data highlight the need to target structural racism as a policy priority to promote a more equitable healthcare system.

Quality of Life and Real-time Patient Experience During Neoadjuvant Therapy: A Prospective Cohort Study.

OBJECTIVE: To use a customized smartphone application to prospectively measure QOL and the real-time patient experience during neoadjuvant therapy (NT). BACKGROUND: NT is increasingly used for patients with localized gastrointestinal (GI) cancers. There is little data assessing patient experience and quality of life (QOL) during NT for GI cancers. METHODS: Patients with GI cancers receiving NT were instructed on using a customized smartphone application through which the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire, a validated measure of health-related QOL, was administered at baseline, every 30 days, and at the completion of NT. Participants also tracked their moods and symptoms and used free-text journaling functionalities in the application. Mean overall and subsection health-related QOL scores were calculated during NT. RESULTS: Among 104 enrolled patients, the mean age was 60.5 ± 11.5 years and 55% were males. Common cancer diagnoses were colorectal (40%), pancreatic (37%), and esophageal (15%). Mean overall FACT-G scores did not change during NT ( P = 0.987). While functional well-being scores were consistently the lowest and social well-being scores the highest, FACT subscores similarly did not change during NT (all P > 0.01). The most common symptoms reported during NT were fatigue, insomnia, and anxiety (39.3%, 34.5%, and 28.3% of patient entries, respectively). Qualitative analysis of free-text journaling entries identified anxiety, fear, and frustration as the most common themes, but also the importance of social support systems and confidence in health care providers. CONCLUSIONS: While patient symptom burden remains high, results of this prospective cohort study suggest QOL is maintained during NT for localized GI cancers.

Impact of Medicaid expansion on the multimodal treatment of biliary tract cancer.

INTRODUCTION: The impact of Medicaid expansion (ME) on the treatment of patients with cancer remains controversial, especially individuals requiring complex multidisciplinary care. We sought to evaluate the impact of Medicaid expansion (ME) on receipt of multimodal care, including surgical resection, for Stage I-III biliary tract cancer (BTC). METHODS: Patients diagnosed with BTC between 40 and 65 years of age were identified from the National Cancer Database and divided into pre- (2008-2012) and post- (2015-2018) ME cohorts. Difference-in-difference (DID) analysis was used to determine the impact of ME on the utilization of surgery and multimodal chemotherapy and/or radiotherapy treatment for BTC. RESULTS: Among 12,415 patients with BTC (extrahepatic, n = 5622, 45.3%; intrahepatic, n = 4352, 35.1%; gallbladder, n = 1944, 15.7%; overlapping, n = 497, 4.0%), 5835 (47.0%) and 6580 (53.0%) patients were diagnosed before versus after ME, respectively. Overall utilization of surgery (OR 1.13, 95% CI 1.02-1.26) and multimodality therapy (OR 1.13, 95% CI 1.01-1.27) increased in states that adopted ME. Utilization of surgery among uninsured/Medicaid patients in ME states increased relative to patients living in non-ME states (∆+10.1%, p = 0.01). Similarly, the use of multimodal treatment increased among uninsured/Medicaid patients living in ME versus non-ME states (∆+6.4%, p = 0.04); in contrast, there were no difference among patients with other insurance statuses (overall: ∆+1.5%, private: ∆-2.0%, other: ∆+3.9%, all p > 0.5). Uninsured/Medicaid patients with BTC who lived in a ME state had a lower risk of long-term death in the post-ME era (HR 0.81, 95% CI 0.67-0.98; p = 0.03). CONCLUSIONS: Implementation of ME positively impacted survival among patients who underwent surgical and multimodal treatment for Stage I-III BTC.

Short-course radiation with consolidation chemotherapy does not increase operative morbidity compared to long-course chemoradiation: A retrospective study of the US rectal cancer consortium.

BACKGROUND AND OBJECTIVES: Neoadjuvant short-course radiation and consolidation chemotherapy (SC TNT) remains less widely used for rectal cancer in the United States than long-course chemoradiation (LCRT). SC TNT may improve compliance and downstaging; however, a longer radiation-to-surgery interval may worsen pelvic fibrosis and morbidity with total mesorectal excision (TME). A single, US-center retrospective analysis has shown comparable risk of morbidity after neoadjuvant short-course radiation with consolidation chemotherapy (SC TNT) and long-course chemoradiation (LCRT). Validation by a multi-institutional study is needed. METHODS: The US Rectal Cancer Consortium database (2010-2018) was retrospectively reviewed for patients with nonmetastatic, rectal adenocarcinoma treated with neoadjuvant LCRT or SC TNT before TME. The primary endpoint was severe postoperative morbidity. Cohorts were compared by univariate analysis. Multivariable logistic regression modeled the odds of severe complication. RESULTS: Of 788 included patients, 151 (19%) received SC TNT and 637 (81%) LCRT. The SC TNT group had fewer distal tumors (33.8% vs. 50.2%, p < 0.0001) and more clinical node-positive disease (74.2% vs. 47.6%, p < 0.0001). The intraoperative complication rate was similar (SC TNT 5.3% vs. 4.4%, p = 0.65). There was no difference in overall postoperative morbidity (38.4% vs. 46.3%, p = 0.08). Severe morbidity was similar with low anterior resection (9.1% vs. 15.3%, p = 0.10) and abdominoperineal resection (24.4% vs. 29.7%, p = 0.49). SC TNT did not increase the odds of severe morbidity relative to LCRT on multivariable analysis (OR 0.64, 95% CI 0.37-1.10). CONCLUSIONS: SC TNT does not increase morbidity after TME for rectal cancer relative to LCRT. Concern for surgical complications should not discourage the use of SC TNT when aiming to increase the likelihood of complete clinical response.