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.

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.

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.

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.

Disruption of National Cancer Database Data Models in the First Year of the COVID-19 Pandemic.

Importance: Each year, the National Cancer Database (NCDB) collects and analyzes data used in reports to support research, quality measures, and Commission on Cancer program accreditation. Because data models used to generate these reports have been historically stable, year-to-year variances have been attributed to changes within the cancer program rather than data modeling. Cancer submissions in 2020 were anticipated to be significantly different from prior years because of the COVID-19 pandemic. This study involved a validation analysis of the variances in observed to expected 2020 NCDB cancer data in comparison with 2019 and 2018. Observations: The NCDB captured a total of 1 223 221 overall cancer cases in 2020, a decrease of 14.4% (Δ = -206 099) compared with 2019. The early months of the COVID-19 pandemic (March-May 2020) coincided with a nadir of cancer cases in April 2020 that did not recover to overall prepandemic levels through the remainder of 2020. In the early months of the COVID-19 pandemic, the proportion of early-stage disease decreased sharply overall, while the proportion of late-stage disease increased. However, differences in observed to expected stage distribution in 2020 varied by primary disease site. Statistically significant differences in the overall observed to expected proportions of race and ethnicity, sex, insurance type, geographic location, education, and income were identified, but consistent patterns were not evident. Conclusions and Relevance: Historically stable NCDB data models used for research, administrative, and quality improvement purposes were disrupted during the first year of the COVID-19 pandemic. NCDB data users will need to carefully interpret disease- and program-specific findings for years to come to account for pandemic year aberrations when running models that include 2020.

Compliance with Cancer Quality Measures Over Time and Their Association with Survival Outcomes: The Commission on Cancer's Experience with the Quality Measure Requiring at Least 12 Regional Lymph Nodes to be Removed and Analyzed with Colon Cancer Resections.

BACKGROUND: Many quality measures in cancer care are process measures. The rates of compliance for these measures over time have not been well described, and the relationships between measure compliance and survival are not well understood. METHODS: The National Cancer Database, representing cancer registry data from approximately 1500 Commission on Cancer (CoC) cancer programs, was queried to determine the rates of compliance, with the CoC's colon cancer quality measure requiring 12 regional lymph nodes be removed at resection. Data were assessed in 2003, before the measure was reported to programs, through 2015. Measure compliance and risk-adjusted survival were examined by hospital type. RESULTS: From 2003 to 2015, 544,018 cases of colon cancer were analyzed for number of nodes removed. In 2003, compliance was 52.8% and National Cancer Institute (NCI) centers had the highest compliance rate (69.0%), followed by academic cancer centers (61.9%), comprehensive community hospitals (50.9%), and community hospitals (44.0%). Between 2003 and 2015, compliance improved for all hospital types, although differences remained. Risk-adjusted survival in 2009 was better at NCI centers [hazard ratio (HR) 0.76] than at academic cancer centers (HR 0.90), which had better survivals than comprehensive community programs (HR 0.93) when compared with patients treated at community hospitals. CONCLUSION: After introduction of this quality measure, performance at CoC-accredited hospitals improved over the subsequent 13 years, and survival by hospital type paralleled measure compliance by hospital type. This demonstrated measurement may be associated with improvements in performance, and that there are differences in performance and outcome by hospital type.

Incident Cases Captured in the National Cancer Database Compared with Those in U.S. Population Based Central Cancer Registries in 2012-2014.

BACKGROUND: The National Cancer Database (NCDB) is a hospital-based cancer registry that includes diagnostic, staging, treatment, and outcomes data for newly diagnosed cancer patients in the United States. The NCDB data include 31 million records for patients diagnosed between 1985-2015. A Participant User File based on a subset of these data has been available to researchers at facilities accredited by the Commission on Cancer since 2010. This study aimed to compare the number of incident cancer cases in the NCDB with a national population cancer registry. METHODS: Incident cancer cases in the NCDB in 2012-2014 were compared with the number of cancer cases in the United States Cancer Statistics data for the 2012-2014 diagnosis years. Comparisons were made by primary site and other factors. RESULTS: In 2012-2014, the NCDB captured 72% of the cancer cases in the United States, which was slightly higher than the 67% and 69% reported respectively in two prior assessments. Among the top 10 major cancer sites, the highest coverage (80%) was found for breast cancer, and the lowest was found for melanoma of the skin (52%) and prostate (58%). Colon, bladder, and kidney and renal pelvis cancers had relatively high coverage of 71%, 70% and 78%, respectively, whereas lung and bronchus had slightly lower coverage (65%). CONCLUSIONS: The NCDB coverage of U.S. cancer cases has remained relatively high (72%), but differences remain by cancer site and other factors that should be taken into account by users of the NCDB data.