The National Cancer Database Conforms to the Standardized Framework for Registry and Data Quality.

BACKGROUND: Standardization of procedures for data abstraction by cancer registries is fundamental for cancer surveillance, clinical and policy decision-making, hospital benchmarking, and research efforts. The objective of the current study was to evaluate adherence to the four components (completeness, comparability, timeliness, and validity) defined by Bray and Parkin that determine registries' ability to carry out these activities to the hospital-based National Cancer Database (NCDB). METHODS: Tbis study used data from U.S. Cancer Statistics, the official federal cancer statistics and joint effort between the Centers for Disease Control and Prevention (CDC) and the National Cancer Institute (NCI), which includes data from National Program of Cancer Registries (NPCR) and Surveillance, Epidemiology, and End Results (SEER) to evaluate NCDB completeness between 2016 and 2020. The study evaluated comparability of case identification and coding procedures. It used Commission on Cancer (CoC) standards from 2022 to assess timeliness and validity. RESULTS: Completeness was demonstrated with a total of 6,828,507 cases identified within the NCDB, representing 73.7% of all cancer cases nationwide. Comparability was followed using standardized and international guidelines on coding and classification procedures. For timeliness, hospital compliance with timely data submission was 92.7%. Validity criteria for re-abstracting, recording, and reliability procedures across hospitals demonstrated 94.2% compliance. Additionally, data validity was shown by a 99.1% compliance with histologic verification standards, a 93.6% assessment of pathologic synoptic reporting, and a 99.1% internal consistency of staff credentials. CONCLUSION: The NCDB is characterized by a high level of case completeness and comparability with uniform standards for data collection, and by hospitals with high compliance, timely data submission, and high rates of compliance with validity standards for registry and data quality evaluation.

Association of pathologic factors with postoperative venous thromboembolism after gastrointestinal cancer surgery.

BACKGROUND: Venous thromboembolism (VTE) chemoprophylaxis is the standard of care after gastrointestinal (GI) cancer surgery; however, variation in risk based on pathologic factors (eg, stage and histology) is unclear. This study aimed to evaluate the association of pathologic factors with VTE after GI cancer surgery. METHODS: The American College of Surgeons National Surgical Quality Improvement Program procedure targeted datasets were queried for patients who underwent colorectal, pancreatic, primary hepatic, and esophageal cancer surgery between 2017 and 2020. Disease-specific and pathologic factors associated with postoperative VTE were evaluated using multivariable logistic regression. RESULTS: Among 70,934 patients who underwent GI cancer surgery, the incidence rates of 30-day postoperative VTE were 3.3% for pancreatic cancer, 3.2% for esophageal cancer, 2.7% for primary hepatic, and 1.3% for colorectal cancer. T stage was associated with VTE for colorectal cancer (T4 vs T1; odds ratio [OR], 1.79; 95% CI, 1.24-2.60), pancreatic cancer (all T stages vs T1; P < .05), and primary hepatic cancer (T4 vs T1; OR, 2.80; 95% CI, 1.55-5.08). N stage was associated with VTE for colorectal cancer (N2 vs N0; OR, 1.33; 95% CI, 1.04-1.68) and pancreatic cancer (N2 vs N0; OR, 1.36; 95% CI, 1.03-1.81). M stage was associated with VTE for colorectal cancer (OR, 1.47; 95% CI, 1.17-1.85) and esophageal cancer (OR, 2.54; 95% CI, 1.24-5.19). Histologic subtype was not associated with VTE, except for pancreatic neuroendocrine tumors vs adenocarcinoma (OR, 1.34; 95% CI, 1.03-1.74). CONCLUSION: Pathologic factors were associated with higher 30-day VTE risk after GI cancer surgery. Acknowledging the association of pathologic factors on VTE is an important first step to considering a more tailored approach to chemoprophylaxis.

Survival Among Patients With High-Risk Gastrointestinal Cancers During the COVID-19 Pandemic.

Importance: Prior reports demonstrated that patients with cancer experienced worse outcomes from pandemic-related stressors and COVID-19 infection. Patients with certain malignant neoplasms, such as high-risk gastrointestinal (HRGI) cancers, may have been particularly affected. Objective: To evaluate disruptions in care and outcomes among patients with HRGI cancers during the COVID-19 pandemic, assessing for signs of long-term changes in populations and survival. Design, Setting, and Participants: This retrospective cohort study used data from the National Cancer Database to identify patients with HRGI cancer (esophageal, gastric, primary liver, or pancreatic) diagnosed between January 1, 2018, and December 31, 2020. Data were analyzed between August 23 and September 4, 2023. Main Outcome and Measures: Trends in monthly new cases and proportions by stage in 2020 were compared with the prior 2 years. Kaplan-Meier curves and Cox regression were used to assess 1-year mortality in 2020 compared with 2018 to 2019. Proportional monthly trends and multivariable logistic regression were used to evaluate 30-day and 90-day mortality in 2020 compared with prior years. Results: Of the 156 937 patients included in this study, 54 994 (35.0%) were aged 60 to 69 years and 100 050 (63.8%) were men. There was a substantial decrease in newly diagnosed HRGI cancers in March to May 2020, which returned to prepandemic levels by July 2020. For stage, there was a proportional decrease in the diagnosis of stage I (-3.9%) and stage II (-2.3%) disease, with an increase in stage IV disease (7.1%) during the early months of the pandemic. Despite a slight decrease in 1-year survival rates in 2020 (50.7% in 2018 and 2019 vs 47.4% in 2020), survival curves remained unchanged between years (all P > .05). After adjusting for confounders, diagnosis in 2020 was not associated with increased 1-year mortality compared with 2018 to 2019 (hazard ratio, 0.99; 95% CI, 0.97-1.01). The rates of 30-day (2.1% in 2018, 2.0% in 2019, and 2.1% in 2020) and 90-day (4.3% in 2018, 4.4% in 2019, and 4.6% in 2020) operative mortality also remained similar. Conclusions and Relevance: In this retrospective cohort study, a period of underdiagnosis and increase in stage IV disease was observed for HRGI cancers during the pandemic; however, there was no change in 1-year survival or operative mortality. These results demonstrate the risks associated with gaps in care and the tremendous efforts of the cancer community to ensure quality care delivery during the pandemic. Future research should investigate long-term survival changes among all cancer types as additional follow-up data are accrued.

Safety and feasibility of establishing an adjuvant hepatic artery infusion program.

BACKGROUND: Hepatic artery infusion (HAI) is less frequently used in the adjuvant setting for resectable colorectal liver metastasis (CRLM) due to concerns regarding toxicity. Our objective was to evaluate the safety and feasibility of establishing an adjuvant HAI program. METHODS: Patients who underwent HAI pump placement between January 2019 and February 2023 for CRLM were identified. Complications and HAI delivery were compared between patients who received HAI in the unresectable and adjuvant settings. RESULTS: Of 51 patients, 23 received HAI for unresectable CRLM and 28 in the adjuvant setting. Patients with unresectable CRLM more commonly had bilobar disease (n = 23/23 vs n = 18/28, p < 0.01) and more preoperative liver metastases (median 10 [IQR 6-15] vs 4 [IQR 3-7], p < 0.01). Biliary sclerosis was the most common complication (n = 2/23 vs n = 4/28); however, there were no differences in postoperative or HAI-specific complications. In the most recent two years, 0 patients in the unresectable group vs 2 patients in the adjuvant group developed biliary sclerosis. All patients were initiated on HAI with no difference in treatment times or dose reductions. CONCLUSION: Adjuvant HAI is safe and feasible for patients with resectable CRLM. HAI programs can carefully consider including patients with resectable CRLM if managed by an experienced multidisciplinary team with quality assurance controls in place.

Barriers and Facilitators to End-of-Life Care Delivery in ICUs: A Qualitative Study.

OBJECTIVES: To understand frontline ICU clinician's perceptions of end-of-life care delivery in the ICU. DESIGN: Qualitative observational cross-sectional study. SETTING: Seven ICUs across three hospitals in an integrated academic health system. SUBJECTS: ICU clinicians (physicians [critical care, palliative care], advanced practice providers, nurses, social workers, chaplains). INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: In total, 27 semi-structured interviews were conducted, recorded, and transcribed. The research team reviewed all transcripts inductively to develop a codebook. Thematic analysis was conducted through coding, category formulation, and sorting for data reduction to identify central themes. Deductive reasoning facilitated data category formulation and thematic structuring anchored on the Systems Engineering Initiative for Patient Safety model identified that work systems (people, environment, tools, tasks) lead to processes and outcomes. Four themes were barriers or facilitators to end-of-life care. First, work system barriers delayed end-of-life care communication among clinicians as well as between clinicians and families. For example, over-reliance on palliative care people in handling end-of-life discussions prevented timely end-of-life care discussions with families. Second, clinician-level variability existed in end-of-life communication tasks. For example, end-of-life care discussions varied greatly in process and outcomes depending on the clinician leading the conversation. Third, clinician-family-patient priorities or treatment goals were misaligned. Conversely, regular discussion and joint decisions facilitated higher familial confidence in end-of-life care delivery process. These detailed discussions between care teams aligned priorities and led to fewer situations where patients/families received conflicting information. Fourth, clinician moral distress occurred from providing nonbeneficial care. Interviewees reported standardized end-of-life care discussion process incorporated by the people in the work system including patient, family, and clinicians were foundational to delivering end-of-life care that reduced both patient and family suffering, as well as clinician moral distress. CONCLUSIONS: Standardized work system communication tasks may improve end-of life discussion processes between clinicians and families.

Access, Outcomes, and Costs Associated with Surgery for Malignancy Among People Experiencing Homelessness.

BACKGROUND: Little is known about surgery for malignancy among people experiencing homelessness (PEH). Poor healthcare access may lead to delayed diagnosis and need for unplanned surgery. This study aimed to (1) characterize access to care among PEH, (2) evaluate postoperative outcomes, and (3) assess costs associated with surgery for malignancy among PEH. METHODS: This was a retrospective cohort study of patients in the Healthcare Cost and Utilization Project (HCUP) who underwent surgery in Florida, New York, or Massachusetts for gastrointestinal or lung cancer from 2016 to 2017. PEH were identified using HCUP's "Homeless" variable and ICD-10 code Z59. Multivariable regression models controlling patient and hospital variables evaluated associations between homelessness and postoperative morbidity, length of stay (LOS), 30-day readmission, and hospitalization costs. RESULTS: Of 67,034 patients at 566 hospitals, 98 (0.2%) were PEH. Most PEH (44.9%) underwent surgery for colorectal cancer. PEH more frequently underwent unplanned surgery than housed patients (65.3% vs 23.7%, odds ratio (OR) 5.17, 95% confidence interval (CI) 3.00-8.92) and less often were treated at cancer centers (66.0% vs 76.2%, p=0.02). Morbidity rates were similar between groups (20.4% vs 14.5%, p=0.10). However, PEH demonstrated higher odds of facility discharge (OR 5.89, 95% CI 3.50-9.78) and readmission (OR 1.81, 95% CI 1.07-3.05) as well as 67.7% longer adjusted LOS (95% CI 42.0-98.2%). Adjusted costs were 32.7% higher (95% CI 14.5-53.9%) among PEH. CONCLUSIONS: PEH demonstrated increased odds of unplanned surgery, longer LOS, and increased costs. These results underscore a need for improved access to oncologic care for PEH.

Comparison of perioperative and histopathologic outcomes among neoadjuvant treatment strategies for locoregional gastric cancer.

BACKGROUND AND OBJECTIVES: Neoadjuvant chemotherapy (NAC) and chemoradiation (NCRT) have demonstrated improved survival for gastric cancer. However, the optimal neoadjuvant treatment remains unclear. We sought to evaluate perioperative and histopathologic outcomes among neoadjuvant treatments for locoregional gastric cancer. METHODS: The National Cancer Database queried patients who received NAC or NCRT followed by resection for T2-T4 and/or node-positive gastric cancer (2006-2018). Logistic and Poisson regression assessed perioperative (30-day readmission, 30- and 90-day mortality, length of stay [LOS]) and histopathologic outcomes (pathologic complete response [PCR], margin status, and negative pathologic lymph nodes [ypN0]). Kaplan-Meier methods and Cox regression assessed overall survival (OS). RESULTS: Of 9831 patients, 4221 (42.9%) received NAC and 5610 (57.1%) NCRT. There were no differences in perioperative outcomes, apart from patients treated with NCRT exhibiting increased LOS (incidence rate ratio 1.09, 95% confidence interval [CI] 1.03-1.16). Patients who received NCRT were more likely to achieve PCR, margin-negative resection, and ypN0 (all p < 0.05). Median OS was 36.8 months for NAC and 33.6 months for NCRT (p < 0.001). NCRT independently predicted worse OS (vs. NAC, hazard ratio 1.10, 95% CI 1.03-1.18). CONCLUSION: NCRT was associated with better histologic tumor response although NAC was associated with improved OS. Better understanding prognostication through histologic assessment following neoadjuvant therapy is needed.

Data-driven optimization of version 9 American Joint Committee on Cancer staging system for anal cancer.

INTRODUCTION: The American Joint Committee on Cancer (AJCC) staging system undergoes periodic revisions to maintain contemporary survival outcomes related to stage. Recently, the AJCC has developed a novel, systematic approach incorporating survival data to refine stage groupings. The objective of this study was to demonstrate data-driven optimization of the version 9 AJCC staging system for anal cancer assessed through a defined validation approach. METHODS: The National Cancer Database was queried for patients diagnosed with anal cancer in 2012 through 2017. Kaplan-Meier methods analyzed 5-year survival by individual clinical T category, N category, M category, and overall stage. Cox proportional hazards models validated overall survival of the revised TNM stage groupings. RESULTS: Overall, 24,328 cases of anal cancer were included. Evaluation of the 8th edition AJCC stage groups demonstrated a lack of hierarchical prognostic order. Survival at 5 years for stage I was 84.4%, 77.4% for stage IIA, and 63.7% for stage IIB; however, stage IIIA disease demonstrated a 73.0% survival, followed by 58.4% for stage IIIB, 59.9% for stage IIIC, and 22.5% for stage IV (p <.001). Thus, stage IIB was redefined as T1-2N1M0, whereas Stage IIIA was redefined as T3N0-1M0. Reevaluation of 5-year survival based on data-informed stage groupings now demonstrates hierarchical prognostic order and validated via Cox proportional hazards models. CONCLUSION: The 8th edition AJCC survival data demonstrated a lack of hierarchical prognostic order and informed revised stage groupings in the version 9 AJCC staging system for anal cancer. Thus, a validated data-driven optimization approach can be implemented for staging revisions across all disease sites moving forward.

Alterations in Cancer Treatment During the First Year of the COVID-19 Pandemic in the US.

Importance: The COVID-19 pandemic created challenges to the evaluation and treatment of cancer, and abrupt resource diversion toward patients with COVID-19 put cancer treatment on hold for many patients. Previous reports have shown substantial declines in cancer screening and diagnoses in 2020; however, the extent to which the delivery of cancer care was altered remains unclear. Objective: To assess alterations in cancer treatment in the US during the first year of the COVID-19 pandemic. Design, Setting, and Participants: This retrospective cohort study used data from the National Cancer Database (NCDB) on patients older than 18 years with newly diagnosed cancer from January 1, 2018, to December 31, 2020. Main Outcomes and Measures: The main outcomes were accessibility (time to treatment, travel distance, and multi-institutional care), availability (proportional changes in cancer treatment between years), and utilization (reductions by treatment modality, hospital type) of cancer treatment in 2020 compared with 2018 to 2019. Autoregressive models forecasted expected findings for 2020 based on observations from prior years. Results: Of 1 229 654 patients identified in the NCDB in 2020, 1 074 225 were treated for cancer, representing a 16.8% reduction from what was expected. Patients were predominately female (53.8%), with a median age of 66 years (IQR, 57-74 years), similar to demographics in 2018 and 2019. Median time between diagnosis and treatment was 26 days (IQR, 0-36 days) in 2020, and median travel distance for care was 11.1 miles (IQR, 5.0-25.3 miles), similar to 2018 and 2019. In 2020, fewer patients traveled longer distances (20.2% reduction of patients traveling >35 miles). The proportions of patients treated with chemotherapy (32.0%), radiation (29.5%), and surgery (57.1%) were similar to those in 2018 and 2019. Overall, 146 805 fewer patients than expected underwent surgery, 80 480 fewer received radiation, and 68 014 fewer received chemotherapy. Academic hospitals experienced the greatest reduction in cancer surgery and treatment, with a decrease of approximately 484 patients (-19.0%) per hospital compared with 99 patients (-12.6%) at community hospitals and 110 patients (-12.8%) at integrated networks. Conclusions and Relevance: This study found that among patients diagnosed with cancer in 2020, access and availability of treatment remained intact; however, reductions in treated patients varied across treatment modalities and were greater at academic hospitals than at community hospitals and integrated networks compared with expected values. These results suggest the resilience of cancer service lines and frame the economic losses from reductions in cancer treatment during the pandemic.

Evaluation of Nationwide Trends in Nodal Sampling Guideline Adherence for Gastric Cancer: 2005-2017.

INTRODUCTION: Surgical resection is the primary curative treatment for localized gastric cancer. A multitude of research supports surgical nodal sampling guidelines. Though there are known disparities in adherence to nodal sampling, it is unclear how hospital program-level disparities have changed over time. The purpose of this study is to evaluate trends in program-level disparities in adherence to gastric cancer nodal sampling guidelines. METHODS: Patients who underwent resection of gastric cancer from 2005 to 2017 were identified in the National Cancer Database. Patients treated at academic programs were compared to those treated at nonacademic programs, and rates and trends of adherence to nodal sampling guidelines (defined as ≥15 lymph nodes) were determined. Adjusted multivariable analysis was used to determine likelihood of nodal sampling adherence while controlling for sociodemographic, clinical, hospital, and travel distance characteristics. RESULTS: A total of 55,421 patients were included with 27,201 (49.1%) of patients meeting adherence criteria for lymph node sampling. Academic programs treated 44.4% of the total cohort. Overall, lymph node sampling criteria were met in 59.2% of patients treated at high-volume academic programs and 37.0% of patients treated at low-volume nonacademic programs (incidence rate ratios 0.67, 95% confidence interval 0.63-0.72 versus high-volume academic programs). Adherence rates improved from 2005 to 2017 for both low-volume nonacademic programs (27.8% in 2005 to 50.1% in 2017) and high-volume academic programs (46.0% in 2005 to 69.8% in 2017, P < 0.001). CONCLUSIONS: Though adherence rates have improved from 2005 to 2017, high-volume academic programs were more likely to adhere to lymph node sampling guidelines for gastric cancer.

Autonomy Maps: Building a Shared Mental Model for Progressive Resident Operative Autonomy on the Road to Entrustable Professional Activities (EPAs).

Our residents expressed dissatisfaction with operative autonomy and faculty feedback regarding technical skills. They reported variability among faculty regarding allowed operative autonomy. Our goals were to establish a shared mental model among residents and faculty regarding intraoperative performance expectations. We asked faculty to assign a level of expected autonomy (Zwisch scale) for various steps of common procedures according to the resident post-graduate year. Through an iterative process, the maps were standardized across service lines. The resulting "Autonomy Maps" were distributed to the faculty and residents. We held educational sessions and set expectations for use. Selected benchmarks were incorporated into resident end-of-rotation assessment forms. Initial operative case mapping identified variability in faculty expectations for a given post-graduate year and procedure. Residents reported improved satisfaction with understanding expectations regarding operative performance. Establishing autonomy benchmarks facilitated more specific feedback regarding residents' technical skills. Faculty expectations for resident operative autonomy are variable. Autonomy Maps provide structure for a shared mental model between faculty and residents for progressive operative autonomy and serve as a framework for expectations that improve resident satisfaction. Case-specific technical benchmarks are useful tools for assessing residents' technical milestones.

Survival outcomes used to validate version 9 of the American Joint Committee on Cancer staging system for appendiceal cancer.

The standard for cancer staging in the United States for all cancer sites, including primary carcinomas of the appendix, is the American Joint Committee on Cancer (AJCC) staging system. AJCC staging criteria undergo periodic revisions, led by a panel of site-specific experts, to maintain contemporary staging definitions through the evaluation of new evidence. Since its last revision, the AJCC has restructured its processes to include prospectively collected data because large data sets have become increasingly robust and available over time. Thus survival analyses using AJCC eighth edition staging criteria were used to inform stage group revisions in the version 9 AJCC staging system, including appendiceal cancer. Although the current AJCC staging definitions were maintained for appendiceal cancer, incorporating survival analysis into the version 9 staging system provided unique insight into the clinical challenges in staging rare malignancies. This article highlights the critical clinical components of the now published version 9 AJCC staging system for appendix cancer, which (1) justified the separation of three different histologies (non-mucinous, mucinous, signet-ring cell) in terms of prognostic variance, (2) demonstrated the clinical implications and challenges in staging heterogeneous and rare tumors, and (3) emphasized the influence of data limitations on survival analysis for low-grade appendiceal mucinous neoplasms.

Survival outcomes used to generate version 9 American Joint Committee on Cancer staging system for anal cancer.

The American Joint Committee on Cancer (AJCC) staging system for all cancer sites, including anal cancer, is the standard for cancer staging in the United States. The AJCC staging criteria are dynamic, and periodic updates are conducted to optimize AJCC staging definitions through a panel of experts charged with evaluating new evidence to implement changes. With greater availability of large data sets, the AJCC has since restructured and updated its processes, incorporating prospectively collected data to validate stage group revisions in the version 9 AJCC staging system, including anal cancer. Survival analysis using AJCC eighth edition staging guidelines revealed a lack of hierarchical order in which stage IIIA anal cancer was associated with a better prognosis than stage IIB disease, suggesting that, for anal cancer, tumor (T) category has a greater effect on survival than lymph node (N) category. Accordingly, version 9 stage groups have been appropriately adjusted to reflect contemporary long-term outcomes. This article highlights the changes to the now published AJCC staging system for anal cancer, which: (1) redefined stage IIB as T1-T2N1M0 disease, (2) redefined stage IIIA as T3N0-N1M0 disease, and (3) eliminated stage 0 disease from its guidelines altogether.

The inaccuracies of gastric adenocarcinoma clinical staging and its predictive factors.

INTRODUCTION: Accurate clinical staging (CS) of gastric adenocarcinoma is important to guide treatment planning. Our objectives were to (1) assess clinical to pathologic stage migration patterns for patients with gastric adenocarcinoma, (2) identify factors associated with inaccurate CS, and (3) evaluate the association of understaging with survival. METHODS: The National Cancer Database was queried for patients who underwent upfront resection for stage I-III gastric adenocarcinoma. Multivariable logistic regression was used to detect factors associated with inaccurate understaging. Kaplan-Meier analyses and cox proportional hazards regression were performed to assess overall survival (OS) for patients with inaccurate CS. RESULTS: Of 14 425 analyzed patients, 5781 (40.1%) patients were inaccurately staged. Factors associated with understaging included treatment at a Comprehensive Community Cancer Program, presence of lymphovascular invasion, moderate to poor differentiation, large tumor size, and T2 disease. Based on overall CS, median OS was 51.0 months for accurately staged patients and 29.5 months for understaged patients (<0.001). CONCLUSION: Clinical T-category, large tumor size, and worse histologic features lead to inaccurate CS for gastric adenocarcinoma, impacting OS. Improvements to staging parameters and diagnostic modalities focusing on these factors may improve prognostication.