National Estimates of the Participation of Patients With Cancer in Clinical Research Studies Based on Commission on Cancer Accreditation Data.

PURPOSE: National estimates of cancer clinical trial participation are nearly two decades old and have focused solely on enrollment to treatment trials, which does not reflect the willingness of patients to contribute to other elements of clinical research. We determined inclusive, contemporary estimates of clinical trial participation for adults with cancer using a national sample of data from the Commission on Cancer (CoC). METHODS: The data were obtained from accreditation information submitted by the 1,200 CoC programs, which represent more than 70% of all cancer cases diagnosed in the United States each year. Deidentified, institution-level aggregate counts of annual enrollment to treatment, biorepository, diagnostic, economic, genetic, prevention, quality-of-life (QOL), and registry studies were examined. Overall, study-type estimates for the period 2013-2017 were estimated. Multiple imputation by chained equations was used to account for missing data, with summary estimates calculated separately by type of program (eg, National Cancer Institute [NCI]-designated cancer centers) and pooled. RESULTS: The overall estimated patient participation rate to cancer treatment trials was 7.1%. Patients with cancer participated in a wide variety of other studies, including biorepository (12.9%), registry (7.3%), genetic (3.6%), QOL (2.8%), diagnostic (2.5%), and economic (2.4%) studies. Treatment trial enrollment was 21.6% at NCI-designated comprehensive cancer centers, 5.4% at academic (non-NCI-designated) comprehensive cancer programs, 5.7% at integrated network cancer programs, and 4.1% at community programs. One in five patients (21.9%) participated in one or more cancer clinical research studies. CONCLUSION: In a first-time use of national accreditation information from the CoC, enrollment to cancer treatment trials was 7.1%, higher than historical estimates of <5%. Patients participated in a diverse set of other study types. Contributions of adult patients with cancer to clinical research is more common than previously understood.

Comparing Smoking Cessation Interventions among Underserved Patients Referred for Lung Cancer Screening: A Pragmatic Trial Protocol.

Smoking burdens are greatest among underserved patients. Lung cancer screening (LCS) reduces mortality among individuals at risk for smoking-associated lung cancer. Although LCS programs must offer smoking cessation support, the interventions that best promote cessation among underserved patients in this setting are unknown. This stakeholder-engaged, pragmatic randomized clinical trial will compare the effectiveness of four interventions promoting smoking cessation among underserved patients referred for LCS. By using an additive study design, all four arms provide standard "ask-advise-refer" care. Arm 2 adds free or subsidized pharmacologic cessation aids, arm 3 adds financial incentives up to $600 for cessation, and arm 4 adds a mobile device-delivered episodic future thinking tool to promote attention to long-term health goals. We hypothesize that smoking abstinence rates will be higher with the addition of each intervention when compared with arm 1. We will enroll 3,200 adults with LCS orders at four U.S. health systems. Eligible patients include those who smoke at least one cigarette daily and self-identify as a member of an underserved group (i.e., is Black or Latinx, is a rural resident, completed a high school education or less, and/or has a household income <200% of the federal poverty line). The primary outcome is biochemically confirmed smoking abstinence sustained through 6 months. Secondary outcomes include abstinence sustained through 12 months, other smoking-related clinical outcomes, and patient-reported outcomes. This pragmatic randomized clinical trial will identify the most effective smoking cessation strategies that LCS programs can implement to reduce smoking burdens affecting underserved populations. Clinical trial registered with clinicaltrials.gov (NCT04798664). Date of registration: March 12, 2021. Date of trial launch: May 17, 2021.

Initial Assessment of the Effect of ProvenCare on Lung Cancer Surgical Quality.

BACKGROUND: ProvenCare is a joint initiative of the American College of Surgeons Commission on Cancer, Geisinger, and The Society of Thoracic Surgeons (STS) to standardize evidence-based practices in the delivery of surgical lung cancer care. This study compares outcomes of ProvenCare patients with the STS Database. METHODS: Best practice elements were agreed on through expert consensus meetings. ProvenCare elements were used to direct care. Compliance was monitored while clinical outcomes were collected within the STS General Thoracic Surgery Database (GTSD). ProvenCare patient outcomes were compared with outcomes in all other STS GTSD patients. Univariable and multivariable logistic regression models compared morbidity and mortality. RESULTS: A total of 2026 patients at 23 ProvenCare hospitals were compared with 71 565 control patients at 311 hospitals from 2010 to 2016. ProvenCare patients were more likely to receive guideline-recommended staging evaluations and more likely to have mediastinal staging performed during resection (63.4% vs 49.4%; P < .001). There was no difference in 30-day mortality (1.4% vs 1.3% lobectomy [P = .84]; 3.4% vs 2.0% all other resections [P = .054]) or STS indicator complications (10.8% vs 9.9% lobectomy [P = .21]; 9.2% vs 9.4% all other resections [P = .92]). When controlling for patient-level clinical and demographic risk factors, the likelihood of perioperative morbidity and mortality was not significantly different (odds ratio [OR], 1.07 [95% CI, 0.77-1.47] lobectomy; OR, 0.97 [95% CI, 0.62-1.50] all other resections). CONCLUSIONS: Variability in preoperative evaluation of patients with lung cancer represents an opportunity to improve quality of care. ProvenCare increased use of guideline-recommended preoperative processes, which may improve cancer outcomes and survival, without resulting in differences in short-term surgical outcomes.

Trends in Patient Volume by Hospital Type and the Association of These Trends With Time to Cancer Treatment Initiation.

Importance: Increasing demand for cancer care may be outpacing the capacity of hospitals to provide timely treatment, particularly at referral centers such as National Cancer Institute (NCI)-designated and academic centers. Whether the rate of patient volume growth has strained hospital capacity to provide timely treatment is unknown. Objective: To evaluate trends in patient volume by hospital type and the association between a hospital's annual patient volume growth and time to treatment initiation (TTI) for patients with cancer. Design, Setting, and Participants: This retrospective, hospital-level, cross-sectional study used longitudinal data from the National Cancer Database from January 1, 2007, to December 31, 2016. Adult patients older than 40 years who had received a diagnosis of 1 of the 10 most common incident cancers and initiated their treatment at a Commission on Cancer-accredited hospital were included. Data were analyzed between December 19, 2019, and March 27, 2020. Exposures: The mean annual rate of patient volume growth at a hospital. Main Outcomes and Measures: The main outcome was TTI, defined as the number of days between diagnosis and the first cancer treatment. The association between a hospital's mean annual rate of patient volume growth and TTI was assessed using a linear mixed-effects model containing a patient volume × time interaction. The mean annual change in TTI over the study period by hospital type was estimated by including a hospital type × time interaction term. Results: The study sample included 4 218 577 patients (mean [SD] age, 65.0 [11.4] years; 56.6% women) treated at 1351 hospitals. From 2007 to 2016, patient volume increased 40% at NCI centers, 25% at academic centers, and 8% at community hospitals. In 2007, the mean TTI was longer at NCI and academic centers than at community hospitals (NCI: 50 days [95% CI, 48-52 days]; academic: 43 days [95% CI, 42-44 days]; community: 37 days [95% CI, 36-37 days]); however, the mean annual increase in TTI was greater at community hospitals (0.56 days; 95% CI, 0.49-0.62 days) than at NCI centers (-0.73 days; 95% CI, -0.95 to -0.51 days) and academic centers (0.14 days; 95% CI, 0.03-0.26 days). An annual volume growth rate of 100 patients, a level observed at less than 1% of hospitals, was associated with a mean increase in TTI of 0.24 days (95% CI, 0.18-0.29 days). Conclusions and Relevance: In this cross-sectional study, from 2007 to 2016, across the studied cancer types, patients increasingly initiated their cancer treatment at NCI and academic centers. Although increases in patient volume at these centers outpaced that at community hospitals, faster growth was not associated with clinically meaningful treatment delays.

Circumferential Resection Margin as a Hospital Quality Assessment Tool for Rectal Cancer Surgery.

BACKGROUND: Circumferential resection margin (CRM) status is an important predictor of outcomes after rectal cancer operation, and is influenced not only by operative technique, but also by incorporation of a multidisciplinary treatment strategy. This study sought to develop a risk-adjusted quality metric based on CRM status to assess hospital-level performance for rectal cancer operation. STUDY DESIGN: We conducted a retrospective observational cohort study of 58,374 patients with resected stage I to III rectal cancer within 1,303 hospitals who were identified from the National Cancer Database (2010 to 2015). The number of observed cases with a positive CRM (≤ 1 mm) was divided by the risk-adjusted expected number of cases with positive CRM to form the observed-to-expected (O/E) ratio. Secondary endpoint was overall survival. RESULTS: The overall rate of CRM positivity was 15.9%. Based on the O/E ratio for 1,139 hospitals, 147 (12.9%) and 103 (9.0%) were significantly worse and better performers, respectively. The majority of hospitals (n = 570) performed as expected. Positive CRMs using criteria of 0 mm and 0.1 to 1 mm were associated with a significantly shorter 5-year overall survival of 49% and 63.5% (hazard ratio 1.67; 95% CI, 1.57 to 1.76 and hazard ratio 1.19; 95% CI, 1.12 to 1.26) than negative CRM > 1 mm of 74.1% (all p < 0.001). CONCLUSIONS: CRM-based O/E ratio is a robust hospital-based quality measure for rectal cancer operation. It allows facilities to compare their performance with that of centers of similar characteristics and helps identify underperforming, at-risk, and high-performing centers. National quality-improvement initiatives for rectal cancer should focus on ensuring high-quality data collection and providing ready access to risk-adjusted comparative metrics.

Using the National Cancer Database for Outcomes Research: A Review.

Importance: The National Cancer Database (NCDB), a joint quality improvement initiative of the American College of Surgeons Commission on Cancer and the American Cancer Society, has created a shared research file that has changed the study of cancer care in the United States. A thorough understanding of the nuances, strengths, and limitations of the database by both readers and investigators is of critical importance. This review describes the use of the NCDB to study cancer care, with a focus on the advantages of using the database and important considerations that affect the interpretation of NCDB studies. Observations: The NCDB is one of the largest cancer registries in the world and has rapidly become one of the most commonly used data resources to study the care of cancer in the United States. The NCDB paints a comprehensive picture of cancer care, including a number of less commonly available details that enable subtle nuances of treatment to be studied. On the other hand, several potentially important patient and treatment attributes are not collected in the NCDB, which may affect the extent to which comparisons can be adjusted. Finally, the NCDB has undergone several significant changes during the past decade that may affect its completeness and the types of available data. Conclusions and Relevance: The NCDB offers a critically important perspective on cancer care in the United States. To capitalize on its strengths and adjust for its limitations, investigators and their audiences should familiarize themselves with the advantages and shortcomings of the NCDB, as well as its evolution over time.

External Validation of a Survival Nomogram for Non-Small Cell Lung Cancer Using the National Cancer Database.

PURPOSE: Survival nomograms offer individualized predictions using a more diverse set of factors than traditional staging measures, including the American Joint Committee on Cancer Tumor Node Metastasis (AJCC TNM) Staging System. A nomogram predicting overall survival (OS) for resected, non-metastatic non-small cell lung cancer (NSCLC) has been previously derived from Asian patients. The present study aims to determine the nomogram's predictive capability in the US using the National Cancer Database (NCDB). METHODS: This was a retrospective review of adults with resected, non-metastatic NSCLC entered into the NCDB between 2004 and 2012. Concordance indices and calibration plots analyzed discrimination and calibration, respectively. Multivariate analysis was also used. RESULTS: A total of 57,313 patients were included in this study. The predominant histologies were adenocarcinoma (48.2%) and squamous cell carcinoma (31.3%), and patients were diagnosed with stage I-A (38.3%), stage I-B (22.7%), stage II-A (14.2%), stage II-B (11.5%), and stage III-A (13.3%). Median OS was 74 months. 1-, 3- and 5-year OS rates were 89.8% [95% confidence interval (CI) 89.5-90.0%], 71.1% (95% CI 70.7-71.6%), and 55.7% (95% CI 54.7-56.6%), respectively. The nomogram's concordance index (C-index) was 0.804 (95% CI 0.792-0.817). AJCC TNM staging demonstrated higher discrimination (C-index 0.833, 95% CI 0.821-0.840). CONCLUSIONS: The nomogram's individualized estimates accurately predicted survival in this patient collective, demonstrating higher discrimination in this population than in the developer's cohorts. However, the generalized survival estimates provided by traditional staging demonstrated superior predictive capability; therefore, AJCC TNM staging should remain the gold standard for the prognostication of resected NSCLC in the US.

Esophagectomy: Comparison of Short-Term Outcomes between Single-versus Two-Team Approach.

Literature about combining expertise of two specialties in esophageal cancer surgery is limited. We present the experience at a single institute comparing single-team (ST) versus two-team (TT) approach combining thoracic and abdominal surgeons. This is a retrospective study from a single tertiary care center. Data were collected from electronic medical records. Patients undergoing esophagectomy for esophageal cancer from November 2006 until August 2014 were included. The primary outcome measured was 30-day postoperative morbidity, secondary outcomes measured were operative time, intraoperative blood loss, and 30-day mortality. Results are reported as mean with an interquartile range. Forty-nine patients underwent esophagectomy by an ST and 51 patients by TT. Patient demographics, tumor characteristics, stage, pathology, and use of neoadjuvant therapy were comparable between groups. Charlson comorbidity index was significantly higher in TT group [3 (2, 4) vs 2 (2, 3), P = 0.02]. The TT group had a significantly shorter operative time compared to the ST group [304 (252,376) minutes vs 438 (375, 494] minutes, P < 0.0001). Intraoperative blood loss was 300 (200, 550) mL for the TT group and 250 (200,400) mL for the ST group (P = 0.29). There was no difference in 30-day postoperative morbidity (68.6% for TT, 59.2% for ST, P = 0.32) and mortality (2% each, P = 1) between the two groups. In conclusion, the operative time by the TT approach was significantly shorter than the ST approach with comparable postoperative morbidity and mortality. Long-term follow-up is needed to study this approach's effect on long-term survival.

Non-intubated video-assisted thoracic surgery in patients aged 80 years and older.

BACKGROUND: Video-assisted thoracic surgery (VATS) is routinely performed with general anesthesia and double-lumen endotracheal intubation, but this technique may stress an elderly patient's functional reserve. We chose to study the safety and efficacy of non-intubated VATS, utilizing local anesthesia, sedation, and spontaneous ventilation in the elderly. METHODS: The medical records of all patients aged 80 years and older who underwent VATS under local anesthesia and sedation during the time period 6/1/2002 to 6/1/2010 at Geisinger Health System (Pennsylvania, USA) and 10/1/2011 to 12/31/2014 at Sinai Hospital (Maryland, USA) were retrospectively reviewed. Unsuccessful attempts at this technique were eligible for inclusion but there were none. No patient was excluded based on comorbidity. RESULTS: A total of 96 patients ranging in age from 80 to 104 years underwent 102 non-intubated VATS procedures: pleural biopsy/effusion drainage with or without talc 73, drainage of empyema 17, evacuate hemothorax 4, pericardial window 3, lung biopsy 2, treat chylothorax 2, treat pneumothorax 1. No patient required intubation or conversion to thoracotomy. No patient required a subsequent procedure or biopsy. Complications occurred in three patients (3.1% morbidity): cerebrovascular accident, pulmonary embolism, prolonged air leak. One 94-year-old patient died from overanticoagulation and two 84-year-old patients died of their advanced lung cancers (3.1% morbidity). CONCLUSIONS: Non-intubated VATS utilizing local anesthesia and sedation in the elderly is well tolerated and safe for a number of indications.

ProvenCare lung cancer: a multi-institutional improvement collaborative.

Geisinger's ProvenCare™ Program (for elective coronary artery bypass surgery, total hip replacement, and others) has shown that the principles of reliability science, facilitated by a robust electronic health record and institutional commitment, allow the re-engineering of complicated clinical processes. This eliminates unwarranted variation and promotes the completion of evidence-based elements of care. It has not been established that ProvenCare can be generalized to other institutions. Now, under the auspices of the American College of Surgeons Commission on Cancer, ProvenCare has been adapted to a multi-institutional collaborative for the care of the patient with resectable lung cancer.

Video-assisted thoracic surgery utilizing local anesthesia and sedation: 384 consecutive cases.

BACKGROUND: Video-assisted thoracic surgery (VATS) is usually performed with general anesthesia and endotracheal intubation. There are risks to such anesthesia and some operations may not require general anesthesia or intubation. We elected to study the safety and efficacy of VATS utilizing local anesthesia, sedation, and spontaneous ventilation. METHODS: The medical records of all patients undergoing VATS utilizing local anesthesia and sedation at our system's three hospitals between June 1, 2002 and June 1, 2009 were retrospectively reviewed. The authors or residents under supervision performed all procedures. Unsuccessful attempts at this technique were eligible for inclusion but there were none. No patient was excluded based on age or comorbidity. All procedures were performed in the operating room with patients in full lateral position; no patient had endotracheal intubation or epidural or nerve block analgesia. RESULTS: Three hundred fifty-three patients ranging in age from 21 to 100 years (mean 67 years) underwent 384 VATS operations: pleural biopsy-drainage with or without talc, 244; drainage of empyema, 74; lung biopsy, 40; evacuate hemothorax, 13; pericardial window, 7; drain lung abscess, 2; treat chylothorax, 2; treat pneumothorax, 1; and biopsy mediastinal mass, 1. No patient required intubation or conversion to thoracotomy. No patient required a subsequent biopsy for diagnosis; two patients required a subsequent procedure for empyema. There were 10 complications: cerebrovascular accident, 2; atrial fibrillation, 2; persistent air leak, 2; empyema, transient renal failure, transient respiratory failure, and urinary tract infection, 1 each. There were no deaths due to operation; within 30 days 9 patients died from underlying disease and 1 from overanticoagulation. CONCLUSIONS: Video-assisted thoracic surgery utilizing local anesthesia-sedation is well tolerated, safe, and valuable for an increasing number of indications.

Infection after endoscopic ultrasound-guided aspiration of mediastinal cysts.

Foregut duplication cysts are rare congenital anomalies of enteric origin that arise during early embryonic development. They are usually incidentally found on routine imaging studies. The diagnosis can usually be made by computed tomography (CT) and endoscopic ultrasound (EUS) appearance. On CT, cyst attenuation values usually measure 0+/-20 Hounsfield units (HU). Higher HU is possible with hemorrhage, proteinaceous material or septations. At EUS, characteristic location and anechoic as well as hypoechoic but not necessarily anechoic appearance may be suggestive of a foregut duplication cyst. EUS-guided fine needle aspiration (FNA) has been thought to provide a safe, minimally invasive approach to establish the diagnosis. The purpose of this report is to highlight the potential for infectious risk of EUS-FNA for these cysts, and to suggest CT and EUS features that can suggest this diagnosis without FNA. Three patients who underwent EUS-FNA for diagnosis of incidental mediastinal lesions developed cyst infection despite accepted techniques including prophylactic antibiotics. Combined CT and EUS appearance may be sufficient in making this diagnosis without FNA. IV antibiotics may not be completely protective against infectious complications of FNA of mediastinal duplication cysts.