Simple versus radical cholecystectomy and survival for pathologic stage T1B gallbladder cancer.

BACKGROUND: Radical cholecystectomy is recommended for T1B and greater gallbladder cancer, however, there are conflicting reports on the utility of extended resection for T1B disease. Herein, we characterize outcomes following simple and radical cholecystectomy for pathologic stage T1B gallbladder cancer. METHODS: The National Cancer Database (NCDB) was queried for patients with pathologic T1B gallbladder cancer diagnosed from 2004 to 2018. Patients were stratified by surgical management. Overall survival (OS) was compared with Kaplan-Meier and multivariable Cox proportional hazards methods. RESULTS: Altogether, 950 patients were identified with pathologic T1B gallbladder cancer: 187 (19.7 %) receiving simple and 763 (80.3 %) radical cholecystectomy. Median OS was 89.5 (95 % CI 62.5-137) and 91.4 (95 % CI 75.9-112) months for simple and radical cholecystectomy, respectively (log-rank p = 0.55). Receipt of simple cholecystectomy was not associated with greater hazard of mortality compared to radical cholecystectomy (HR 1.23, 95 % CI 0.95-1.59, p = 0.12). DISCUSSION: In this analysis, we report comparable outcomes with simple cholecystectomy among patients with pathologic T1B gallbladder cancer. These findings suggest that highly selected patients, such as those with R0 resection and imaging at low risk for residual disease and/or nodal metastasis, may not benefit from extended resection; however, radical cholecystectomy remains standard of care until prospective validation can be achieved.

Implications of missing data on reported breast cancer mortality.

BACKGROUND: National cancer registries are valuable tools to analyze patterns of care and clinical outcomes; yet, missing data may impact the accuracy and generalizability of these data. We sought to evaluate the association between missing data and overall survival (OS). METHODS: Using the NCDB (National Cancer Database) and SEER (Surveillance, Epidemiology, End Results Program), we assessed data missingness among patients diagnosed with invasive breast cancer from 2010 to 2014. Key variables included demographic (age, race, ethnicity, insurance, education, income), tumor (grade, ER, PR, HER2, TNM stages), and treatment (surgery in both databases; chemotherapy and radiation in NCDB). OS was compared between those with and without missing data using Cox proportional hazards models. RESULTS: Overall, 775,996 patients in the NCDB and 263,016 in SEER were identified; missing at least 1 key variable occurred for 29% and 13%, respectively. Of those, the overwhelming majority (NCDB 80%; SEER 88%) were missing tumor variables. When compared to patients with complete data, missingness was associated with a greater risk of death: NCDB HR 1.23 (99% CI 1.21-1.25) and SEER HR 2.11 (99% CI 2.05-2.18). Patients with complete tumor data had higher unadjusted OS estimates than that of the entire sample: NCDB 82.7% vs 81.8% and SEER 83.5% vs 81.7% for 5-year OS. CONCLUSIONS: Missingness of select variables is not uncommon within large national cancer registries and is associated with a worse OS. Exclusion of patients with missing variables may introduce unintended bias into analyses and result in findings that underestimate breast cancer mortality.

Comparing Survival After Resection, Ablation, and Radiation in Small Intrahepatic Cholangiocarcinoma.

BACKGROUND: Hepatectomy is the cornerstone of curative-intent treatment for intrahepatic cholangiocarcinoma (ICC). However, in patients unable to be resected, data comparing efficacy of alternatives including thermal ablation and radiation therapy (RT) remain limited. Herein, we compared survival between resection and other liver-directed therapies for small ICC within a national cancer registry. PATIENTS AND METHODS: Patients with clinical stage I-III ICC < 3 cm diagnosed 2010-2018 who underwent resection, ablation, or RT were identified in the National Cancer Database. Overall survival (OS) was compared using Kaplan-Meier and multivariable Cox proportional hazards methods. RESULTS: Of 545 patients, 297 (54.5%) underwent resection, 114 (20.9%) ablation, and 134 (24.6%) RT. Median OS was similar between resection and ablation [50.5 months, 95% confidence interval (CI) 37.5-73.9; 39.5 months, 95% CI 28.7-58.4, p = 0.14], both exceeding that of RT (20.9 months, 95% CI 14.1-28.3). RT patients had high rates of stage III disease (10.4% RT vs. 1.8% ablation vs. 11.8% resection, p < 0.001), but the lowest rates of chemotherapy utilization (9.0% RT vs. 15.8% ablation vs. 38.7% resection, p < 0.001). In multivariable analysis, resection and ablation were associated with reduced mortality compared with RT [hazard ratio (HR) 0.44, 95% CI 0.33-0.58 and HR 0.53, 95% CI 0.38-0.75, p < 0.001, respectively]. CONCLUSION: Resection and ablation were associated with improved survival in patients with ICC < 3 cm compared with RT. Acknowledging confounders, anatomic constraints of ablation, limitations of available data, and need for prospective study, these results favor ablation in small ICC where resection is not feasible.

Tumor size and survival in intrahepatic cholangiocarcinoma treated with surgical resection or ablation.

OBJECTIVES: We performed a retrospective analysis within a national cancer registry on outcomes following resection or ablation for intrahepatic cholangiocarcinoma (iCCA). METHODS: The National Cancer Database was queried for patients with clinical stage I-III iCCA diagnosed during 2010-2018, who underwent resection or ablation. Overall survival (OS) was compared with Kaplan-Meier and multivariable Cox proportional hazards methods. RESULTS: Of 2140 patients, 1877 (87.7%) underwent resection and 263 (12.3%) underwent ablation, with median tumor sizes of 5.5 and 3 cm, respectively. Overall, resection was associated with greater median OS (41.2 months (95% confidence interval [95% CI]: 37.6-46.2) vs. 28 months (95% CI: 15.9-28.6) on univariable analysis (p < 0.0001). There was no significant difference on multivariable analysis (p = 0.42); however, there was a significant interaction between tumor size and management. On subgroup analysis of patients with tumors <3 cm, there was no difference in OS between resection versus ablation. However, ablation was associated with increased mortality for tumors ≥3 cm. CONCLUSION: Although resection is associated with improved OS for tumors ≥3 cm, we observed no difference in survival between management strategies for tumors < 3 cm. Ablation may be an alternative therapeutic strategy for small iCCA, particularly in patients at risk for high surgical morbidity.

A Multidimensional Bioinformatic Platform for the Study of Human Response to Surgery.

OBJECTIVE: To design and establish a prospective biospecimen repository that integrates multi-omics assays with clinical data to study mechanisms of controlled injury and healing. BACKGROUND: Elective surgery is an opportunity to understand both the systemic and focal responses accompanying controlled and well-characterized injury to the human body. The overarching goal of this ongoing project is to define stereotypical responses to surgical injury, with the translational purpose of identifying targetable pathways involved in healing and resilience, and variations indicative of aberrant peri-operative outcomes. METHODS: Clinical data from the electronic medical record combined with large-scale biological data sets derived from blood, urine, fecal matter, and tissue samples are collected prospectively through the peri-operative period on patients undergoing 14 surgeries chosen to represent a range of injury locations and intensities. Specimens are subjected to genomic, transcriptomic, proteomic, and metabolomic assays to describe their genetic, metabolic, immunologic, and microbiome profiles, providing a multidimensional landscape of the human response to injury. RESULTS: The highly multiplexed data generated includes changes in over 28,000 mRNA transcripts, 100 plasma metabolites, 200 urine metabolites, and 400 proteins over the longitudinal course of surgery and recovery. In our initial pilot dataset, we demonstrate the feasibility of collecting high quality multi-omic data at pre- and postoperative time points and are already seeing evidence of physiologic perturbation between timepoints. CONCLUSIONS: This repository allows for longitudinal, state-of-the-art geno-mic, transcriptomic, proteomic, metabolomic, immunologic, and clinical data collection and provides a rich and stable infrastructure on which to fuel further biomedical discovery.

Patterns and Impact of Fragmented Care in Stage II and III Gastric Cancer.

BACKGROUND: Optimal management of stage II/III gastric cancer requires multidisciplinary care, often necessitating treatment at more than one facility. We aimed to determine patterns of "fragmented" care and its impact on outcomes, including concordance with National Comprehensive Cancer Network (NCCN) guidelines and overall survival. METHODS: The 2006-2016 National Cancer Database was queried for patients with clinical stage II/III gastric adenocarcinoma who received preoperative therapy in addition to surgery. Patients were stratified based on whether surgery and chemotherapy/chemoradiation were performed at one versus multiple facilities (termed "coordinated" and "fragmented" care, respectively). Multivariable logistic regression was performed to identify factors associated with fragmented care. Survival was compared using Kaplan-Meier and Cox proportional hazards methods. RESULTS: Overall, 2033 patients met study criteria: 1043 (51.3%) received coordinated care and 990 (48.7%) fragmented care. There was no significant difference in time to surgery or pathologic upstaging by care structure. On adjusted analysis, factors associated with receipt of fragmented care included increasing age and distance traveled to the treating facility. Factors associated with coordinated care included metropolitan residence and treatment at academic and high-volume centers. Fragmented care was associated with a reduction in guideline-preferred perioperative chemotherapy (odds ratio [OR] 0.78, 95% confidence interval [CI] 0.63-0.97, p = 0.02) and increased mortality (HR 1.16, 95% CI 1.00-1.34, p = 0.05). CONCLUSIONS: For patients with stage II/III gastric cancer, fragmented care is associated with inferior outcomes, including a reduction in preferred perioperative treatment and survival. Further work is needed to ensure equitable outcomes among patients as complex cancer care becomes more regionalized.

Identifying Modifiable and Non-modifiable Risk Factors of Readmission and Short-Term Mortality in Chondrosarcoma: A National Cancer Database Study.

BACKGROUND: Limited data are available to inform the risk of readmission and short-term mortality in musculoskeletal oncology. The goal of this study was to identify factors independently associated with 30-day readmission and 90-day mortality following surgical resection of chondrosarcoma. METHODS: We retrospectively reviewed 6653 patients following surgical resection of primary chondrosarcoma in the National Cancer Database (2004-2017). Both demographic and clinicopathologic variables were assessed for correlation with readmission and short-term mortality utilizing univariate and multivariate logistic regression modeling. RESULTS: Of 220 readmissions (3.26%), risk factors independently associated with an increased risk of unplanned 30-day readmission included Charlson-Deyo Comorbidity Index (CDCC) (odds ratio [OR] 1.31; p = 0.027), increasing American Joint Committee on Cancer (AJCC) stage (OR 1.31; p = 0.004), undergoing major amputation (OR 2.38; p = 0.001), and axial skeletal location (OR 1.51; p = 0.028). A total of 137 patients died within 90 days of surgery (2.25%). Risk factors associated with increased mortality included the CDCC (OR 1.60; p = 0.001), increasing age (OR 1.06; p < 0.001), having Medicaid insurance status (OR 3.453; p = 0.005), living in a zip code with a higher educational attainment (OR 1.59; p = 0.003), increasing AJCC stage (OR 2.32; p < 0.001), longer postoperative length of stay (OR 1.015; p = 0.033), and positive surgical margins (OR 2.75; p = 0.001). Although a majority of the cohort did not receive radiation therapy (88.8%), receiving radiotherapy (OR 0.132; p = 0.010) was associated with a decreased risk of short-term mortality. CONCLUSIONS: Several tumor, treatment, and patient factors can help inform the risk of readmission and short-term mortality in patients with surgically treated chondrosarcoma.

Review of Religious Variables in Advance Care Planning for End-of-Life Care: Consideration of Faith as a New Construct.

Religion and spirituality have long been considered important social determinants of human health, and there exists an extensive body of research to support such. End-of-life (EOL) may raise complex questions for individuals about religious and spiritual (R/S) values guiding advance care planning (ACP) and EOL care decisions, including the provision of spiritual care. This commentary will review the history and current national trends of ACP activities for EOL, principally within the United States. It will describe the relationship of religious variables and the attributes of selected research instruments used to study religious variables on ACP and EOL preferences. The review also summarizes unique ACP challenges for patients with neurocognitive disorders and severe mental illness. Findings disclose that higher levels of religiosity, reliance on religious coping, conservative faith traditions, and "belief in God's control over life's length and divine intervention have lower levels of ACP and more intensive EOL care preferences, although the provision of spiritual spiritual care at EOL mitigates intensive EOL care. Based upon the curated evidence, we propose an epistemological justification to consider "faith" as a separately defined religious variable in future ACP and EOL research. This review is relevant to geriatric psychiatrists and gerontological health care professionals, as they may be part of multidisciplinary palliative care teams; provide longitudinal care to patients with neurocognitive disorders and severe mental illness; and may provide diagnostic, emotional, and therapeutic services for patients and families who may struggle with EOL care decisions.

Age differences in trajectories of depressive, anxiety, and burnout symptoms in a population with a high likelihood of persistent occupational distress.

OBJECTIVES: Work in occupations with higher levels of occupational stress can bring mental health costs. Many older adults worldwide are continuing to work past traditional retirement age, raising the question whether older adults experience depression, anxiety, or burnout at the same or greater levels as younger workers, and whether there are differences by age in these levels over time. DESIGN/SETTING/PARTICIPANTS: Longitudinal survey of 1161 currently employed US clergy followed every 6-12 months for up to 66 months. MEASUREMENTS: Depression was measured with the 8-item Patient Health Questionnaire (PHQ-8). Anxiety was measured using the anxiety component of the Hospital Anxiety and Depression Scale (HADS). Burnout symptoms were assessed using the three components of the Maslach Burnout Inventory: emotional exhaustion (EE), depersonalization (DP), and sense of personal accomplishment (PA). RESULTS: Older participants had lower scores of depression, anxiety, EE, and DP and higher levels of PA over time compared to younger adults. Levels of EE decreased for older working adults, while not significantly changing over time for those younger. DP symptoms decreased over time among those 55 years or older but increased among those 25-54 years. CONCLUSIONS: Older working adults may have higher levels of resilience and be able to balance personal life with their occupation as well as may engage in certain behaviors that increase social support and, for clergy, spiritual well-being that may decrease stress in a way that allows these older adults to appear to tolerate working longer without poorer mental health outcomes.

Surgical resection is associated with improved long-term survival of patients with resectable pancreatic head cancer compared to multiagent chemotherapy.

BACKGROUND: Standard of care for resectable pancreatic cancer is a combination of surgical resection (SR) and multiagent chemotherapy (MCT). We aim to determine whether SR or MCT is associated with superior survival for patients receiving only single-modality therapy. METHODS: Patients with stage I-IIb pancreatic head adenocarcinoma who received either MCT or SR were identified in the NCDB (2013-2015). Following a piecewise approach to estimating hazards over the course of follow-up, conditional overall survival (OS) at 30, 60, and 90 days after treatment initiation was estimated using landmark analyses. RESULTS: 3103 patients received MCT alone (60.3%) and 2043 underwent SR alone (39.7%). SR had an OS disadvantage at 30 (HR 3.99, 95% CI 3.12-5.11) and 60 days (HR 1.85, 95% CI 1.4-2.45), but an OS advantage after 90 days (HR 0.59, 95% CI 0.55-0.64). In a landmark analysis conditioned on 90 days survival post treatment initiation, median OS was improved for SR (17.0 vs. 12.2 months, p < 0.0001); SR improved 3-year OS by 21.3% (p < 0.05), despite patients being older (median 72 vs. 67 years, p < 0.0001) with higher Charlson-Deyo comorbidity scores (≥2: 11.2 vs. 8.6%, p = 0.006). CONCLUSION: For patients with resectable pancreatic cancer, SR is associated with superior long-term survival compared to MCT.

Impact of Postoperative Chemotherapy on the Survival of Patients with High-Grade Gastroenteropancreatic Neuroendocrine Carcinoma.

BACKGROUND: This study aimed to determine whether postoperative chemotherapy is associated with a survival benefit for patients with poorly differentiated neuroendocrine carcinoma (NEC) of the stomach, small bowel, or pancreas. METHODS: Patients were identified in the National Cancer Database (NCDB) between 2004 and 2014. Inverse probability of treatment weighting (IPTW) was used to reduce selection bias. To compare the overall survival (OS) of patients in different treatment groups, IPTW-adjusted Kaplan-Meier curves and Cox proportional hazards models were used. RESULTS: The inclusion criteria were met by 759 patients. The diagnosis was NEC of the stomach for 195 patients (25.7%), NEC of the small intestine for 278 patients (36.6%), and NEC of the pancreas for 286 patients (37.7%). Overall, 213 patients (28.1%) received postoperative chemotherapy after curative resection. For the patients who received chemotherapy, IPTW-adjusted survival showed no OS benefit. However, subgroup analysis demonstrated improved OS with observation (OB) for patients with NEC of the small intestine (hazard ratio [HR], 1.436; 95% confidence interval [CI] 1.13-1.823; P = 0.003), T3 or T4 primary tumor (HR, 1.258; 95% CI 1.08-1.465; P = 0.003), node-positive disease (HR, 1.238; 95% CI 1.040-1.475; P = 0.0165), or positive resection margin (HR, 1.4283; 95% CI 1.02-2.00; P = 0.038). CONCLUSIONS: In this national database analysis, postoperative chemotherapy was not associated with improved survival for patients with poorly differentiated gastroenteropancreatic (GEP) NECs. These findings highlight the need for continued efforts to understand better which patients in this high-risk population will benefit from additional systemic therapy and the need for continued development of more effective therapies for these patients.

Identifying Modifiable and Non-modifiable Risk Factors of Readmission and Short-Term Mortality in Osteosarcoma: A National Cancer Database Study.

BACKGROUND: There are limited data to inform risk of readmission and short-term mortality in musculoskeletal oncology. The goal of this study was to identify factors independently associated with 30-day readmission and 90-day mortality following surgical resection of osteosarcoma. METHODS: We retrospectively reviewed patients (n = 5293) following surgical resection of primary osteosarcoma in the National Cancer Database (2004-2015). Univariate and multivariate methods were used to correlate variables with readmission and short-term mortality. RESULTS: Of 210 readmissions (3.97%), risk factors independently associated with unplanned 30-day readmission included comorbidity burden (odds ratio [OR] 2.4, p = 0.042), Medicare insurance (OR 1.9, p = 0.021), and axial skeleton location (OR 1.5, p = 0.029). A total of 91 patients died within 90 days of their surgery (1.84%). Risk factors independently associated with mortality included age (hazard ratio 1.1, p < 0.001), increasing comorbidity burden (OR 6.6, p = 0.001), higher grade (OR 1.7, p = 0.007), increasing tumor size (OR 2.2, p = 0.03), metastatic disease at presentation (OR 8.5, p < 0.001), and amputation (OR 2.0, p = 0.04). Chemotherapy was associated with a decreased risk of short-term mortality (p < 0.001). CONCLUSIONS: Several trends were clear: insurance status, tumor location and comorbidity burden were independently associated with readmission rates, while age, amputation, grade, tumor size, metastatic disease, and comorbidity burden were independently associated with short-term mortality.

Percutaneous Gastrojejunostomy Tube Insertion in Patients with Surgical Gastrojejunal Anastomoses: Analysis of Success Rates and Durability.

Patients with a gastrojejunal anastomosis pose challenging anatomy for percutaneous gastrojejunostomy (GJ)-tube placement. A retrospective review of 24 patients (mean age 67.8 years, 13 males) with GJ anastomoses who underwent attempted GJ tube placement revealed infeasible placement in 6 patients (25%) due to an inadequate window for puncture. When a gastric puncture was achieved, GJ tube insertion was technically successful in 83% (15/18) of attempts, resulting in an overall technical success rate of 63% (15/24). The most common tube-related complication was the migration of the jejunal limb into the stomach, which occurred in 40% (6/15) of successful cases. No major procedure related complications were encountered.

Empiric nasogastric decompression after pancreaticoduodenectomy is not necessary.

BACKGROUND: The aim of the present study was to evaluate the impact of routine NGT decompression after PD on postoperative outcomes in the era of an enhanced recovery after surgery (ERAS) protocol. MATERIALS AND METHODS: A retrospective review of all patients undergoing PD between January 2015 and October 2017 at our institution was performed comparing routine post-operative NGT decompression versus omission. The incidence of delayed gastric emptying, post-operative pancreatic fistula, hospital length of stay, operative time, 30-day readmission rate as well the time to first oral intake were evaluated. RESULTS: Out of 149 patients who underwent PD, 65 maintained post-operative NGT decompression while post-operative NGT decompression was omitted in 84 patients. No differences were noted in delayed gastric emptying rates (both p>0.05). The median length of stay (9 days for NGT group versus 8.5 days for no NGT group) and 30-day readmission rates (13.8% versus 15.5%, respectively) were similar (p=0.781). Compared with patients who had routine post-operative NGT placed, those who had omission of a post-operative NGT had a lower need for reinsertion, shorter time to PO intake, and a lower likelihood of extended length of stay. CONCLUSIONS: In the era of ERAS protocols, we observed no association between routine post-operative NGT decompression after PD and improved postoperative outcomes.

Is There a Role for Surgery in Patients with Neuroendocrine Tumors of the Esophagus? A Contemporary View from the NCDB.

BACKGROUND: Esophageal neuroendocrine tumors (eNETs) are exceedingly rare, aggressive and have a poor prognosis. Treatment guidelines are ill-defined and mainly based on evidence from case reports and analogous experiences drawn from similar disease sites. METHODS: The NCDB was reviewed for histologically confirmed stage I-III, primary eNETs from 2006 to 2014. Patients were grouped into whether or not they underwent primary tumor resection. Univariate, multivariable, and full bipartite propensity score (PS) adjusted Cox regression analyses were used to assess overall and relative survival differences. RESULTS: A total of 250 patients were identified. Mean age was 65.0 (standard deviation [SD] 11.9) years, and 174 (69.6%) patients were male. Most patients had stage III disease (n = 136, 54.4%), and the most common type of NET was small cell eNET (n = 111, 44.4%). Chemotherapy was used in 186 (74.4%), radiation therapy in 178 (71.2%), and oncological resection was performed in 69 (27.6%) patients. Crude 2-year survival rates were higher in the operated (57.3%) compared with the nonoperated group (35.2%; p < 0.001). The survival benefit held true after multivariable adjustment (hazard ratio [HR] 0.47, 95% confidence interval [CI] 0.32-0.69, p < 0.001). After full bipartite PS adjustment analysis, survival was longer for patients who received a surgical resection compared with those who did not (HR 0.48, 95% CI 0.31-0.75, p = 0.003) with a corresponding 2-year overall survival rate of 63.3% (95% CI 52.0-77.2) versus 38.8% (95% CI 30.9-48.8), respectively. CONCLUSIONS: Multimodal treatment that includes surgery is associated with better overall survival for eNETs. Additional research is needed to more definitively identify patients who benefit from esophagectomy and to establish an appropriate treatment algorithm.

Limb salvage versus amputation in patients with osteosarcoma of the extremities: an update in the modern era using the National Cancer Database.

BACKGROUND: Historically, amputation was the primary surgical treatment for osteosarcoma of the extremities; however, with advancements in surgical techniques and chemotherapies limb salvage has replaced amputation as the dominant treatment paradigm. This study assessed the type of surgical resection chosen for osteosarcoma patients in the twenty-first century. METHODS: Utilizing the largest registry of primary osteosarcoma, the National Cancer Database (NCDB), we retrospectively analyzed patients with high grade osteosarcoma of the extremities from 2004 through 2015. Differences between patients undergoing amputation and patients undergoing limb salvage are described. Unadjusted five-year overall survival between patients who received limb salvage and amputation was assessed utilizing Kaplan Meier curves. A multivariate Cox proportional hazard model and propensity matched analysis was used to determine the variables independently correlated with survival. RESULTS: From a total of 2442 patients, 1855 underwent limb salvage and 587 underwent amputation. Patients undergoing amputation were more likely to be older, male, uninsured, and live in zip codes associated with lower income. Patients undergoing amputation were also more likely to have larger tumors, more comorbid conditions, and metastatic disease at presentation. After controlling for confounders, limb salvage was associated with a significant survival benefit over amputation (HR: 0.70; p < 0.001). Although this may well reflect underlying biases impacting choice of treatment, this survival benefit remained significant after propensity matched analysis of all significantly different independent variables (HR: 0.71; p < 0.01). CONCLUSION: Among patients in the NCDB, amputation for osteosarcoma is associated with advanced age, advanced stage, larger tumors, greater comorbidities, and lower income. Limb salvage is associated with a significant survival benefit, even when controlling for significant confounding variables and differences between cohorts.

Impact of minimally invasive gastrectomy on use of and time to adjuvant chemotherapy for gastric adenocarcinoma.

BACKGROUND: Chemotherapy improves outcomes in patients with resectable gastric cancer. Minimally invasive gastrectomy (MIS) rates are increasing, though the impact of MIS on postoperative chemotherapy remains uncertain. This study examines the impact of MIS vs open gastrectomy (OG) on utilization of adjuvant chemotherapy for high-risk gastric cancer. METHODS: Patients in the National Cancer Database who underwent resection for high-risk gastric adenocarcinoma between 2010 and 2015 were included. Patients were stratified by surgical approach (MIS vs OG) and analyzed using multivariable regression modeling. Primary endpoints were utilization of and time to initiation of adjuvant chemotherapy. RESULTS: Overall, 23 071 patients were included; 16 595 (71.9%) underwent OG and 6476 (28.1%) underwent MIS. After adjusting for patient and tumor characteristics, MIS was not associated with increased use of adjuvant chemotherapy (odds ratio [OR]: 1.027, 95% confidence interval [CI]: 0.95 to 1.11, P = .50), and time to initiation of chemotherapy was similar (-2% change, 95% CI: -5% to +1%, P = .27). MIS was associated with shorter hospital stays (-1 day). Thirty-day readmission rates, 90-day mortality, and overall survival were similar between groups. CONCLUSIONS: In this study, while MIS for gastric adenocarcinoma was associated with shorter hospital stays and comparable survival, it was not associated with improved utilization or time to initiation of adjuvant chemotherapy.

Defining a textbook surgical outcome for patients undergoing surgical resection of intermediate and high-grade soft tissue sarcomas of the extremities.

BACKGROUND: Quality measures for the surgical management soft tissue sarcoma of the extremity are limited. The purpose of this study was to define a textbook surgical outcome (TO) for soft tissue sarcoma of the extremities (STS-E) and to examine its associations with hospital volume and overall survival. METHODS: All patients in the National Cancer Database undergoing resection of primary STS-E between 2004 and 2015 were identified. The primary outcome was a TO, defined as: hospital length of stay (LOS) <75th percentile, survival >90 days from the date of surgery, no readmission within 30 days of discharge, and negative surgical margins (R0 resection). RESULTS: Overall, 7658 patients met criteria for inclusion; a TO was achieved in 4291 (56%) patients. Of patients who did not achieve TOs, 51.9% (n = 1748) had an extended LOS, and 47.3% (n = 1591) did not have negative margins. Older age, more medical comorbidities, and non-white or black race were independently associated with not receiving a TO (P = .034). With respect to tumor and treatment characteristics, larger tumor size, lower extremity location and higher grade were independently associated with not receiving a TO (P < .001). Hospital volume was not associated with a TO. TOs conferred a significant survival benefit (hazrds ratio = 0.71 [0.65-0.78], P < .001). A TO was associated with a 27.5% longer survival time (P < .001). CONCLUSIONS: This study defined a TO in intermediate and high-grade STS-E and demonstrated that this outcome measure is associated with overall survival. Facility volume was not associated with a TO.

Equalization of four cardiovascular risk algorithms after systematic recalibration: individual-participant meta-analysis of 86 prospective studies.

AIMS: There is debate about the optimum algorithm for cardiovascular disease (CVD) risk estimation. We conducted head-to-head comparisons of four algorithms recommended by primary prevention guidelines, before and after 'recalibration', a method that adapts risk algorithms to take account of differences in the risk characteristics of the populations being studied. METHODS AND RESULTS: Using individual-participant data on 360 737 participants without CVD at baseline in 86 prospective studies from 22 countries, we compared the Framingham risk score (FRS), Systematic COronary Risk Evaluation (SCORE), pooled cohort equations (PCE), and Reynolds risk score (RRS). We calculated measures of risk discrimination and calibration, and modelled clinical implications of initiating statin therapy in people judged to be at 'high' 10 year CVD risk. Original risk algorithms were recalibrated using the risk factor profile and CVD incidence of target populations. The four algorithms had similar risk discrimination. Before recalibration, FRS, SCORE, and PCE over-predicted CVD risk on average by 10%, 52%, and 41%, respectively, whereas RRS under-predicted by 10%. Original versions of algorithms classified 29-39% of individuals aged ≥40 years as high risk. By contrast, recalibration reduced this proportion to 22-24% for every algorithm. We estimated that to prevent one CVD event, it would be necessary to initiate statin therapy in 44-51 such individuals using original algorithms, in contrast to 37-39 individuals with recalibrated algorithms. CONCLUSION: Before recalibration, the clinical performance of four widely used CVD risk algorithms varied substantially. By contrast, simple recalibration nearly equalized their performance and improved modelled targeting of preventive action to clinical need.

Association Between Depressive Symptoms and Incident Cardiovascular Diseases.

Importance: It is uncertain whether depressive symptoms are independently associated with subsequent risk of cardiovascular diseases (CVDs). Objective: To characterize the association between depressive symptoms and CVD incidence across the spectrum of lower mood. Design, Setting, and Participants: A pooled analysis of individual-participant data from the Emerging Risk Factors Collaboration (ERFC; 162 036 participants; 21 cohorts; baseline surveys, 1960-2008; latest follow-up, March 2020) and the UK Biobank (401 219 participants; baseline surveys, 2006-2010; latest follow-up, March 2020). Eligible participants had information about self-reported depressive symptoms and no CVD history at baseline. Exposures: Depressive symptoms were recorded using validated instruments. ERFC scores were harmonized across studies to a scale representative of the Center for Epidemiological Studies Depression (CES-D) scale (range, 0-60; ≥16 indicates possible depressive disorder). The UK Biobank recorded the 2-item Patient Health Questionnaire 2 (PHQ-2; range, 0-6; ≥3 indicates possible depressive disorder). Main Outcomes and Measures: Primary outcomes were incident fatal or nonfatal coronary heart disease (CHD), stroke, and CVD (composite of the 2). Hazard ratios (HRs) per 1-SD higher log CES-D or PHQ-2 adjusted for age, sex, smoking, and diabetes were reported. Results: Among 162 036 participants from the ERFC (73%, women; mean age at baseline, 63 years [SD, 9 years]), 5078 CHD and 3932 stroke events were recorded (median follow-up, 9.5 years). Associations with CHD, stroke, and CVD were log linear. The HR per 1-SD higher depression score for CHD was 1.07 (95% CI, 1.03-1.11); stroke, 1.05 (95% CI, 1.01-1.10); and CVD, 1.06 (95% CI, 1.04-1.08). The corresponding incidence rates per 10 000 person-years of follow-up in the highest vs the lowest quintile of CES-D score (geometric mean CES-D score, 19 vs 1) were 36.3 vs 29.0 for CHD events, 28.0 vs 24.7 for stroke events, and 62.8 vs 53.5 for CVD events. Among 401 219 participants from the UK Biobank (55% were women, mean age at baseline, 56 years [SD, 8 years]), 4607 CHD and 3253 stroke events were recorded (median follow-up, 8.1 years). The HR per 1-SD higher depression score for CHD was 1.11 (95% CI, 1.08-1.14); stroke, 1.10 (95% CI, 1.06-1.14); and CVD, 1.10 (95% CI, 1.08-1.13). The corresponding incidence rates per 10 000 person-years of follow-up among individuals with PHQ-2 scores of 4 or higher vs 0 were 20.9 vs 14.2 for CHD events, 15.3 vs 10.2 for stroke events, and 36.2 vs 24.5 for CVD events. The magnitude and statistical significance of the HRs were not materially changed after adjustment for additional risk factors. Conclusions and Relevance: In a pooled analysis of 563 255 participants in 22 cohorts, baseline depressive symptoms were associated with CVD incidence, including at symptom levels lower than the threshold indicative of a depressive disorder. However, the magnitude of associations was modest.