Impact of an online decision support tool for ductal carcinoma in situ (DCIS) using a pre-post design (AFT-25).

BACKGROUND: The heterogeneous biology of ductal carcinoma in situ (DCIS), as well as the variable outcomes, in the setting of numerous treatment options have led to prognostic uncertainty. Consequently, making treatment decisions is challenging and necessitates involved communication between patient and provider about the risks and benefits. We developed and investigated an interactive decision support tool (DST) designed to improve communication of treatment options and related long-term risks for individuals diagnosed with DCIS. FINDINGS: The DST was developed for use by individuals aged > 40 years with DCIS and is based on a disease simulation model that integrates empirical data and clinical characteristics to predict patient-specific impacts of six DCIS treatment choices. Personalized risk predictions for each treatment option were communicated using icon arrays and percentages for each outcome. Users of the DST were asked before and after interacting with the DST about: (1) awareness of DCIS treatment options, (2) willingness to consider these options, (3) knowledge of risks associated with DCIS, and (4) helpfulness of the DST. Data were collected from January 2019 to April 2022. Users' median estimated risk of dying from DCIS in 10 years decreased from 9% pre-tool to 3% post-tool (p < 0.0001). 76% (n = 101/132) found the tool helpful. CONCLUSIONS: Information about DCIS treatment options and related risk predictions was effectively communicated, and a large majority participants found the DST to be helpful. Successfully informing patients about their treatment options and how their individual risks affect those options is a critical step in the decision-making process. CLINICALTRIALS: gov Identifier NCT02926911.

Use of Fundamentals of Laparoscopic Surgery Testing to Assess Gynecologic Surgeons: A Retrospective Cohort Study of 10-Years Experience.

STUDY OBJECTIVE: To compare the Fundamentals of Laparoscopic Surgery (FLS) exam scores between obstetrics and gynecology (OBGYN) and general surgery (GS) providers. DESIGN: This is a retrospective cohort study at a single institution from July 2007 to May 2018. Categorical and continuous variables were analyzed with χ2 test, t test, and Wilcoxon rank sum test. SETTING: Beth Israel Deaconess Medical Center (BIDMC), Boston, MA, a tertiary care academic medical center. PATIENTS: All providers who took the FLS exam at the Carl J. Shapiro Simulation and Skills Center at BIDMC. INTERVENTIONS: FLS certification. MEASUREMENTS AND MAIN RESULTS: A total of 205 BIDMC trainees and faculty took the FLS exam between July 2007 and May 2018, of which 176 were identified to be OBGYN or GS providers. The FLS certification pass rate was high for both specialties (97.0% OBGYN vs 96.1% sGS, p = .76). When comparing all providers, no significant difference was found in the mean manual skill test scores between surgical specialties (594.9 OBGYN vs 601.0 GS, p = .59); whereas, a significant difference was noted in the mean cognitive scores, with GS providers scoring higher than OBGYN providers (533.8 OBGYN vs 583.4 GS, p <.001). However, when adjusting for several variables in a multivariate linear regression model, surgical specialty was not a predictor for cognitive scores. In the multivariate analysis, age, sex, and test year were predictors for cognitive scores, with higher scores associated with younger age, male sex, and advancing calendar year. None of the variables were significant predictors of manual scores. CONCLUSION: Both OBGYN and GS providers had extremely high FLS pass rates. In the multivariate analysis, surgical specialty was not a predictor for higher FLS test scores for either manual or cognitive test scores. Although OBGYN residency programs offer fewer years of training, OBGYN trainees demonstrate the capacity to perform well on the FLS exam.

Cost and Utilization of Lung Cancer End-of-Life Care Among Racial-Ethnic Minority Groups in the United States.

BACKGROUND: The end-of-life period is a crucial time in lung cancer care. To have a better understanding of the racial-ethnic disparities in health care expenditures, access, and quality, we evaluated these disparities specifically in the end-of-life period for patients with lung cancer in the U.S. MATERIALS AND METHODS: We used the Surveillance, Epidemiology, and End Results (SEER)-Medicare database to analyze characteristics of lung cancer care among those diagnosed between the years 2000 and 2011. Linear and logistic regression models were constructed to measure racial-ethnic disparities in end-of-life care cost and utilization among non-Hispanic (NH) Asian, NH black, Hispanic, and NH white patients while controlling for other risk factors such as age, sex, and SEER geographic region. RESULTS: Total costs and hospital utilization were, on average, greater among racial-ethnic minorities compared with NH white patients in the last month of life. Among patients with NSCLC, the relative total costs were 1.27 (95% confidence interval [CI], 1.21-1.33) for NH black patients, 1.36 (95% CI, 1.25-1.49) for NH Asian patients, and 1.21 (95% CI, 1.07-1.38) for Hispanic patients. Additionally, the odds of being admitted to a hospital for NH black, NH Asian, and Hispanic patients were 1.22 (95% CI, 1.15-1.30), 1.47 (95% CI, 1.32-1.63), and 1.18 (95% CI, 1.01-1.38) times that of NH white patients, respectively. Similar results were found for patients with SCLC. CONCLUSION: Minority patients with lung cancer have significantly higher end-of-life medical expenditures than NH white patients, which may be explained by a greater intensity of care in the end-of-life period. IMPLICATIONS FOR PRACTICE: This study investigated racial-ethnic disparities in the cost and utilization of medical care among lung cancer patients during the end-of-life period. Compared with non-Hispanic white patients, racial-ethnic minority patients were more likely to receive intensive care in their final month of life and had statistically significantly higher end-of-life care costs. The findings of this study may lead to a better understanding of the racial-ethnic disparities in end-of-life care, which can better inform future end-of-life interventions and help health care providers develop less intensive and more equitable care, such as culturally competent advanced care planning programs, for all patients.

Repeat CT Performed Within One Month of CT Conducted in the Emergency Department for Abdominal Pain: A Secondary Analysis of Data From a Prospective Multicenter Study.

OBJECTIVE: The purpose of this study is to determine both the frequency of repeat CT performed within 1 month after a patient visits the emergency department (ED) and undergoes CT evaluation for abdominal pain and the frequency of worsened or new CT-based diagnoses. SUBJECTS AND METHODS: Secondary analysis was performed on data collected during a prospective multicenter study. The parent study included patients who underwent CT in the ED for abdominal pain between 2012 and 2014, and these patients constituted the study group of the present analysis. The proportion of patients who underwent (in any setting) repeat abdominal CT within 1 month of the index CT examination was calculated. For each of these patients, results of the index and repeat CT scans were compared by an independent panel and categorized as follows: no change (group 1); same process, improved (group 2); same process, worse (group 3); or different process (group 4). The proportion of patients in groups 1 and 2 versus groups 3 and 4 was calculated, and patient and ED physician characteristics were compared. RESULTS: The parent study included 544 patients (246 of whom were men [45%]; mean patient age, 49.4 years). Of those 544 patients, 53 (10%; 95% CI, 7.5-13%) underwent repeat abdominal CT. Patients' CT comparisons were categorized as follows: group 1 for 43% of patients (23/53), group 2 for 26% (14/53), group 3 for 15% (8/53), and group 4 for 15% (8/53). New or worse findings were present in 30% of patients (16/53) (95% CI, 19-44%). When patients with findings in groups 1 and 2 were compared to patients with findings in groups 3 and 4, no significant difference was noted in patient age (p = 0.25) or sex (p = 0.76), the number of days between scans (p = 0.98), and the diagnostic confidence of the ED physician after the index CT scan was obtained (p = 0.33). CONCLUSION: Short-term, repeat abdominal CT was performed for 10% of patients who underwent CT in the ED for abdominal pain, and it yielded new or worse findings for 30% of those patients.

Progression to pancreatic ductal adenocarcinoma from pancreatic intraepithelial neoplasia: Results of a simulation model.

OBJECTIVES: To gain insight into the natural history and carcinogenesis pathway of Pancreatic Intraepithelial Neoplasia (PanIN) lesions by building a calibrated simulation model of PanIN progression to pancreatic ductal adenocarcinoma (PDAC) METHODS: We revised a previously validated simulation model of solid PDAC, calibrating the model to fit data from the National Cancer Institute's Surveillance, Epidemiology, and End Results program and published literature on PanIN prevalence by age. We estimated the likelihood of progression from PanIN states (1, 2, and 3) to PDAC and the time between PanIN onset and PDAC (dwell time). We evaluated a hypothetical intervention to test for and treat PanIN 3 lesions to estimate the potential benefits from PanIN detection. RESULTS: We estimated the lifetime probability of progressing from PanIN 1 to PDAC to be 1.5% (men), 1.3% (women). Progression from PanIN 1 to PDAC took 33.6 years and 35.3 years, respectively, and from PanIN 3 to PDAC took 11.3 years and 12.3 years. A hypothetical test for PanIN 3 detection and treatment could provide a maximum, average life expectancy gain of 40 days. CONCLUSIONS: Our modeling analysis estimates PanINs have a relatively indolent course to PDAC, supporting the feasibility of potential future early detection strategies.

Survival Disparities by Race and Ethnicity in Early Esophageal Cancer.

BACKGROUND: Survival outcome disparities among esophageal cancer patients exist, but are not fully understood. AIMS: We used the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database to determine whether survival differences among racial/ethnic patient populations persist after adjusting for demographic and clinical characteristics. METHODS: Our study included T1-3N0M0 adenocarcinoma and squamous cell cancer patients diagnosed between 2003 and 2011. We compared survival among two racial/ethnic patient subgroups using Cox proportional hazards methods, adjusting for age, sex, histology, marital status, socioeconomics, SEER region, comorbidities, T stage, tumor location, diagnosis year, and treatment received. RESULTS: Among 2025 patients, 87.9% were White and 12.1% were Nonwhite. Median survival was 18.7 months for Whites vs 13.8 months for Nonwhites (p = 0.01). In the unadjusted model, Nonwhite patients had higher risk of mortality (HR = 1.29, 95% CI 1.11-1.49, p < 0.0001) when compared to White patients; however, in the Cox regression adjusted model there was no significant difference (HR = 0.94, 95% CI 0.80-1.10, p = 0.44). Surgery, chemotherapy, younger age, lower T stage, and lower Charlson comorbidity score were significant predictors in the full adjusted model. CONCLUSIONS: Differences in mortality risk by race/ethnicity appear to be largely explained by additional factors. In particular, associations were seen in surgery and T stage. Further research is needed to understand potential mechanisms underlying the differences and to better target patients who can benefit from treatment options.

Cost Effectiveness of Screening Patients With Gastroesophageal Reflux Disease for Barrett's Esophagus With a Minimally Invasive Cell Sampling Device.

BACKGROUND & AIMS: It is important to identify patients with Barrett's esophagus (BE), the precursor to esophageal adenocarcinoma (EAC). Patients with BE usually are identified by endoscopy, which is expensive. The Cytosponge, which collects tissue from the esophagus noninvasively, could be a cost-effective tool for screening individuals with gastroesophageal reflux disease (GERD) who are at increased risk for BE. We developed a model to analyze the cost effectiveness of using the Cytosponge in first-line screening of patients with GERD for BE with endoscopic confirmation, compared with endoscopy screening only. METHODS: We incorporated data from a large clinical trial of Cytosponge performance into 2 validated microsimulation models of EAC progression (the esophageal adenocarcinoma model from Massachusetts General Hospital and the microsimulation screening analysis model from Erasmus University Medical Center). The models were calibrated for US Surveillance, Epidemiology and End Results data on EAC incidence and mortality. In each model, we simulated the effect of a 1-time screen for BE in male patients with GERD, 60 years of age, using endoscopy alone or Cytosponge collection of tissue, and analysis for the level of trefoil factor 3 with endoscopic confirmation of positive results. For each strategy we recorded the number of cases of EAC that developed, the number of EAC cases detected with screening by Cytosponge only or by subsequent targeted surveillance, and the number of endoscopies needed. In addition, we recorded the cumulative costs (including indirect costs) incurred and quality-adjusted years of life lived within each strategy, discounted at a rate of 3% per year, and computed incremental cost-effectiveness ratios (ICERs) among the 3 strategies. RESULTS: According to the models, screening patients with GERD by Cytosponge with follow-up confirmation of positive results by endoscopy would reduce the cost of screening by 27% to 29% compared with screening by endoscopy, but led to 1.8 to 5.5 (per 1000 patients) fewer quality-adjusted life years. The ICERs for Cytosponge screening compared with no screening ranged from $26,358 to $33,307. For screening patients by endoscopy compared with Cytosponge the ICERs ranged from $107,583 to $330,361. These results were sensitive to Cytosponge cost within a plausible range of values. CONCLUSIONS: In a comparative modeling analysis of screening strategies for BE in patients with GERD, we found Cytosponge screening with endoscopic confirmation to be a cost-effective strategy. The greatest benefit was achieved by endoscopic screening, but with an unfavorable cost margin.

The Impact of a Prior Diagnosis of Barrett's Esophagus on Esophageal Adenocarcinoma Survival.

OBJECTIVES: Endoscopic surveillance of patients with Barrett's Esophagus (BE) is recommended to detect esophageal adenocarcinoma (EAC) and its dysplasia precursors, but survival benefits are unclear. Using Surveillance, Epidemiology, and End Results (SEER) and linked Medicare data, we sought to determine the impact of a prior BE diagnosis on survival in patients with EAC. METHODS: Our analysis focused on patients over age 65 with primary EAC diagnosed in a SEER region from 2000-2011 and enrolled in Medicare. We identified patients with preexisting BE prior to EAC diagnosis and compared this group to EAC patients without a prior BE diagnosis. A Cox Proportional Hazards model compared survival and included variables such as age, sex, cancer stage, treatment, and medical comorbidities. RESULTS: Among 4,978 SEER-Medicare patients identified with EAC, 577 (12%) had preexisting BE; 4,401 (88%) did not. BE patients had overall lower stage (28.5% stage I vs. 12.8% stage IV) than those without preexisting BE (16.4% stage I vs. 30.6% stage IV). Overall survival was better among patients in the BE group (hazard ratio (HR), 0.56; 95% confidence interval (CI), 0.50-0.61); this benefit persisted in the adjusted model (HR, 0.72; 95%, 0.65-0.80). After adjusting for lead-time bias, the HRs attenuated to the null, with an unadjusted HR of 0.96 (95% CI: 0.86-1.05, P=0.39) and adjusted HR of 0.99 (CI: 0.89-1.10, P=0.92). CONCLUSIONS: Survival outcomes in patients with a BE diagnosis prior to EAC were statistically better in both the unadjusted and adjusted Cox proportional hazards model. However, this benefit appears to be predominantly lead-time and length-time bias.

Role of CT in the Diagnosis of Nonspecific Abdominal Pain: A Multicenter Analysis.

OBJECTIVE: The objective of our study was to determine whether specific patient and physician factors-known before CT-are associated with a diagnosis of nonspecific abdominal pain (NSAP) after CT in the emergency department (ED). MATERIALS AND METHODS: We analyzed data originally collected in a prospective multicenter study. In the parent study, we identified ED patients referred to CT for evaluation of abdominal pain. We surveyed their physicians before and after CT to identify changes in leading diagnoses, diagnostic confidence, and admission decisions. In the current study, we conducted a multiple regression analysis to identify whether the following were associated with a post-CT diagnosis of NSAP: patient age; patient sex; physicians' years of experience; physicians' pre-CT diagnostic confidence; and physicians' pre-CT admission decision if CT had not been available. We analyzed patients with and those without a pre-CT diagnosis of NSAP separately. For the sensitivity analysis, we excluded patients with different physicians before and after CT. RESULTS: In total, 544 patients were included: 10% (52/544) with a pre-CT diagnosis of NSAP and 90% (492/544) with a pre-CT diagnosis other than NSAP. The leading diagnoses changed after CT in a large proportion of patients with a pre-CT diagnosis of NSAP (38%, 20/52). In regression analysis, we found that physicians' pre-CT diagnostic confidence was inversely associated with a post-CT diagnosis of NSAP in patients with a pre-CT diagnosis other than NSAP (p = 0.0001). No other associations were significant in both primary and sensitivity analyses. CONCLUSION: With the exception of physicians' pre-CT diagnostic confidence, the factors evaluated were not associated with a post-CT diagnosis of NSAP.

Comparative effectiveness of adjuvant chemoradiotherapy after gastrectomy among older patients with gastric adenocarcinoma: a SEER-Medicare study.

BACKGROUND: Since the INT-0116 trial reported a survival advantage, postoperative chemoradiotherapy (CRT) has been a care standard for US patients in whom gastric adenocarcinoma has been diagnosed. We sought to estimate the association between treatment and survival among the older US Medicare population. METHODS: This is a retrospective cohort study of Medicare beneficiaries aged 65-79 years with stage IB-III gastric adenocarcinoma diagnosed between 2002 and 2009 in a Surveillance, Epidemiology, and End Results region. Patients were categorized on the basis of treatment: (1) gastrectomy only and (2) gastrectomy plus adjuvant CRT. We examined factors associated with receipt of adjuvant CRT, including stage at diagnosis, comorbidity, and tumor subtype. Overall survival was measured from 90 days after gastrectomy until death or the censoring date of December 31, 2010. RESULTS: Of the 1519 patients who underwent gastrectomy, 41.7% received adjuvant CRT. Factors associated with adjuvant CRT included age younger than 75 years at cancer diagnosis and stage II or stage III cancer. The median overall survival from the time of gastrectomy was 25.1 months (interquartile range 43.7 months) for gastrectomy only and 26.9 months (interquartile range 40.9 months) for adjuvant CRT. Multivariable and propensity-score-stratified models demonstrated a survival benefit associated with adjuvant CRT [hazard ratio (HR) 0.58; 95% confidence interval (CI) 0.50-0.67], although the magnitude was greater for stage II tumors (HR 0.50; 95% CI 0.39-0.61) and stage III tumors (HR 0.58; 95% CI 0.45-0.73) than for stage IB tumors (HR 1.02; 95% CI 0.71-1.45). CONCLUSIONS: Adjuvant CRT, in conjunction with gastrectomy, was associated with a survival benefit among older patients with stage II or stage III tumors.

Changes in Physician Decision Making after CT: A Prospective Multicenter Study in Primary Care Settings.

Purpose To determine the effect of computed tomography (CT) results on physician decision making in three common clinical scenarios in primary care. Materials and Methods This research was approved by the institutional review board (IRB) and was HIPAA compliant. All physicians consented to participate with an opt-in or opt-out mechanism; patient consent was waived with IRB approval. In this prospective multicenter observational study, outpatients referred by primary care providers (PCPs) for CT evaluation of abdominal pain, hematuria, or weight loss were identified. Prior to CT, PCPs were surveyed to elicit their leading diagnosis, confidence in that diagnosis (confidence range, 0%-100%), a rule-out diagnosis, and a management plan if CT were not available. Surveys were repeated after CT. Study measures were the proportion of patients in whom leading diagnoses and management changed (PCP management vs specialist referral vs emergency department transfer), median changes in diagnostic confidence, and the proportion of patients in whom CT addressed rule-out diagnoses. Regression analyses were used to identify associations between study measures and site and participant characteristics. Specifically, logistic regression analysis was used for binary study measures (change in leading diagnosis, change in management), and linear regression analysis was used for the continuous study measure (change in diagnostic confidence). Accrual began on September 5, 2012, and ended on June 28, 2014. Results In total, 91 PCPs completed pre- and post-CT surveys in 373 patients. In patients with abdominal pain, hematuria, or weight loss, leading diagnoses changed after CT in 53% (131 of 246), 49% (36 of 73), and 57% (27 of 47) of patients, respectively. Management changed in 35% (86 of 248), 27% (20 of 74), and 54% (26 of 48) of patients, respectively. Median absolute changes in diagnostic confidence were substantial and significant (+20%, +20%, and +19%, respectively; P ≤ .001 for all); median confidence after CT was high (90%, 88%, and 80%, respectively). PCPs reported CT was helpful in confirming or excluding rule-out diagnoses in 98% (184 of 187), 97% (59 of 61), and 97% (33 of 34) of patients, respectively. Significant associations between primary measures and site and participant characteristics were not identified. Conclusion Changes in PCP leading diagnoses and management after CT were common, and diagnostic confidence increased substantially. © RSNA, 2016 Online supplemental material is available for this article.

CT in the Emergency Department: A Real-Time Study of Changes in Physician Decision Making.

PURPOSE: To determine how physicians' diagnoses, diagnostic uncertainty, and management decisions are affected by the results of computed tomography (CT) in emergency department settings. MATERIALS AND METHODS: This study was approved by the institutional review board and compliant with HIPAA. Data were collected between July 12, 2012, and January 13, 2014. The requirement to obtain patient consent was waived. In this prospective, four-center study, patients presenting to the emergency department who were referred for CT with abdominal pain, chest pain and/or dyspnea, or headache were identified. Physicians were surveyed before and after CT to determine the leading diagnosis, diagnostic confidence (on a scale of 0% to 100%), alternative "rule out" diagnosis, and management decisions. Primary measures were the proportion of patients for whom the leading diagnosis or admission decision changed and median changes in diagnostic confidence. Secondary measures addressed alternative diagnoses and return-to-care visits (eg, to emergency department) at 1-month follow-up. Regression analysis was used to identify associations between primary measures and site and participant characteristics. RESULTS: Both surveys were completed for 1280 patients by 245 physicians. The leading diagnosis changed in 235 of 460 patients with abdominal pain (51%), 163 of 387 with chest pain and/or dyspnea (42%), and 103 of 433 with headache (24%). Pre-CT diagnostic confidence was inversely associated with the likelihood of a diagnostic change (P < .0001). Median changes in confidence were substantial (increases of 25%, 20%, and 13%, respectively, for patients with abdominal pain, chest pain and/or dyspnea, and headache; P < .0001); median post-CT confidence was high (95% for all three groups). CT helped confirm or exclude at least 95% of alternative diagnoses. Admission decisions changed in 116 of 457 patients with abdominal pain (25%), 72 of 387 with chest pain and/or dyspnea (19%), and 81 of 426 with headache (19%). During follow-up, 70 of 450 patients with abdominal pain (15%), 53 of 387 with chest pain and/or dyspnea (14%), and 49 of 433 with headache (11%) returned for the same indication. In general, changes in leading diagnosis, diagnostic confidence, and admission decisions were not well explained with site or participant characteristics. CONCLUSION: Physicians' diagnoses and admission decisions changed frequently after CT, and diagnostic uncertainty was alleviated.

Screening for Nonalcoholic Steatohepatitis in Individuals with Type 2 Diabetes: A Cost-Effectiveness Analysis.

BACKGROUND AND AIM: Individuals with type 2 diabetes are at heightened risk for nonalcoholic fatty liver disease, which gives rise to nonalcoholic steatohepatitis (NASH) and cirrhosis. Yet, current guidelines do not recommend screening for NASH among these high-risk patients. Using a simulation model, we assessed the effectiveness and cost-effectiveness of screening diabetic patients for NASH. METHODS: A Markov model was constructed to compare two management strategies for 50-year-olds with diabetes. In the No Screening strategy, patients do not undergo screening, although NASH may be diagnosed incidentally over their lifetime. In the NASH Screening strategy, all patients receive a one-time screening ultrasound. Individuals with fatty infiltration on ultrasound then have a liver biopsy, and those found to have NASH receive medical therapy, which decreases progression to cirrhosis. Endpoints evaluated included quality-adjusted life years (QALYs) gained, costs, and incremental cost-effectiveness ratios (ICERs). RESULTS: Screening for NASH decreased the number of individuals who developed cirrhosis by 12.9 % and resulted in an 11.9 % decrease in liver-related deaths. However, screening resulted in 0.02 fewer QALYs, due to the disutility associated with treatment, and was therefore dominated by the No Screening strategy. When the model excluded this quality-of-life decrement, screening became cost-effective, at an ICER of $42,134 per QALY. CONCLUSIONS: Screening for NASH may improve liver-related outcomes, but is not cost-effective at present, due to side effects of therapy. As better tolerated treatments for NASH become available, even with modest efficacy, screening for NASH will become cost-effective.

Personalizing annual lung cancer screening for patients with chronic obstructive pulmonary disease: A decision analysis.

BACKGROUND: Lung cancer screening with annual chest computed tomography (CT) is recommended for current and former smokers with a ≥30-pack-year smoking history. Patients with chronic obstructive pulmonary disease (COPD) are at increased risk of developing lung cancer and may benefit from screening at lower pack-year thresholds. METHODS: We used a previously validated simulation model to compare the health benefits of lung cancer screening in current and former smokers ages 55-80 with ≥30 pack-years with hypothetical programs using lower pack-year thresholds for individuals with COPD (≥20, ≥10, and ≥1 pack-years). Calibration targets for COPD prevalence and associated lung cancer risk were derived using the Framingham Offspring Study limited data set. We performed sensitivity analyses to evaluate the stability of results across different rates of adherence to screening, increased competing mortality risk from COPD, and increased surgical ineligibility in individuals with COPD. The primary outcome was projected life expectancy. RESULTS: Programs using lower pack-year thresholds for individuals with COPD yielded the highest life expectancy gains for a given number of screens. Highest life expectancy was achieved when lowering the pack-year threshold to ≥1 pack-year for individuals with COPD, which dominated all other screening strategies. These results were stable across different adherence rates to screening and increases in competing mortality risk for COPD and surgical ineligibility. CONCLUSIONS: Current and former smokers with COPD may disproportionately benefit from lung cancer screening. A lower pack-year threshold for screening eligibility may benefit this high-risk patient population.

Incidence and predictors of adenocarcinoma following endoscopic ablation of Barrett's esophagus.

BACKGROUND: The rate and risk factors of recurrent or metachronous adenocarcinoma following endoscopic ablation therapy in patients with Barrett's esophagus (BE) have not been specifically reported. AIM: The aim of this study was to determine the incidence and predictors of adenocarcinoma after ablation therapy for BE high-grade dysplasia (HGD) or intramucosal carcinoma (IMC). METHODS: This is a single center, retrospective review of prospectively collected data on consecutive cases of endoscopic ablation for BE. A total of 223 patients with BE (HGD or IMC) were treated by ablation between 1996 and 2011. Primary outcome measures were recurrence and new development of adenocarcinoma after ablation. Recurrence was defined as the presence of adenocarcinoma following the absence of adenocarcinoma in biopsy samples from two consecutive surveillance endoscopies. Logistic regression analysis was performed to assess predictors of adenocarcinoma after ablation. RESULTS: One hundred and eighty-three patients were included in the final analysis, and 40 patients were excluded: 22 for palliative ablation, eight lost to follow-up, five for residual carcinoma and five for postoperative state. Median follow-up was 39 months. Recurrence or new development of adenocarcinoma was found in 20 patients (11 %) and the median time to recurrence/development of adenocarcinoma was 11.5 months. Independent predictors of recurrent or metachronous adenocarcinoma were hiatal hernia size ≥ 4 cm (odds ratio 3.649, P = 0.0233) and histology (HGD/adenocarcinoma) after first ablation (odds ratio 4.141, P = 0.0065). CONCLUSIONS: Adenocarcinoma after endoscopic therapy for HGD or IMC in BE is associated with large hiatal hernia and histology status after initial ablation therapy.

Assessing Patient Readiness for an Electronic Patient-Reported Outcome-Based Symptom Management Intervention in a Multisite Study.

PURPOSE: While the use of electronic patient-reported outcomes (ePROs) in routine clinical practice is increasing, barriers to patient engagement limit adoption. Studies have focused on technology access as a key barrier, yet other characteristics may also confound readiness to use ePROs including patients' confidence in using technology and confidence in asking clinicians questions. METHODS: To assess readiness to use ePROs, adult patients from six US-based health systems who started a new oncology treatment or underwent a cancer-directed surgery were invited to complete a survey that assessed access to and confidence in the use of technology, ease of asking clinicians questions about health, and symptom management self-efficacy. Multivariable ordinal logistic regression models were fit to assess the association between technology confidence, ease of asking questions, and symptom management self-efficacy. RESULTS: We contacted 3,212 individuals, and 1,043 (33%) responded. The median age was 63 years, 68% were female, and 75% reported having access to patient portals. Over 80% had two or more electronic devices. Most patients reported high technology confidence, higher ease of asking clinicians questions, and high symptom management self-efficacy (n = 692; 66%). Patients with high technology confidence also reported higher ease of asking nurses about their health (adjusted odds ratio [AOR], 4.58 [95% CI, 2.36 to 8.87]; P ≤ .001). Those who reported higher ease of asking nurses questions were more likely to report higher confidence in managing symptoms (AOR, 30.54 [95% CI, 12.91 to 72.30]; P ≤ .001). CONCLUSION: Patient readiness to use ePROs likely depends on multiple factors, including technology and communication confidence, and symptom management self-efficacy. Future studies should assess interventions to address these factors.

Mass spectrometry-detected MGUS is associated with obesity and other novel modifiable risk factors in a high-risk population.

ABSTRACT: Monoclonal gammopathy of undetermined significance (MGUS) is a premalignant condition of multiple myeloma with few known risk factors. The emergence of mass spectrometry (MS) for the detection of MGUS has provided new opportunities to evaluate its risk factors. In total, 2628 individuals at elevated risk for multiple myeloma were enrolled in a screening study and completed an exposure survey (PROMISE trial). Participant samples were screened by MS, and monoclonal proteins (M-proteins) with concentrations of ≥0.2 g/L were categorized as MS-MGUS. Multivariable logistic models evaluated associations between exposures and MS outcomes. Compared with normal weight (body mass index [BMI] of 18.5 to <25 kg/m2), obesity (BMI of ≥30 kg/m2) was associated with MS-MGUS, adjusting for age, sex, Black race, education, and income (odds ratio [OR], 1.73; 95% confidence interval [CI], 1.21-2.47; P = .003). High physical activity (≥73.5 metabolic equivalent of task (MET)-hours per week vs <10.5 MET-hours per week) had a decreased likelihood of MS-MGUS (OR, 0.45, 95% CI, 0.24-0.80; P = .009), whereas heavy smoking and short sleep had increased likelihood of MS-MGUS (>30 pack-years vs never smoker: OR, 2.19; 95% CI, 1.24-3.74; P = .005, and sleep <6 vs ≥6 hours per day: OR, 2.11; 95% CI, 1.26-3.42; P = .003). In the analysis of all MS-detected monoclonal gammopathies, which are inclusive of M-proteins with concentrations of <0.2 g/L, elevated BMI and smoking were associated with all MS-positive cases. Findings suggest MS-detected monoclonal gammopathies are associated with a broader range of modifiable risk factors than what has been previously identified. This trial was registered at www.clinicaltrials.gov as #NCT03689595.

Hypofractionated vs Conventionally Fractionated Postmastectomy Radiation After Implant-Based Reconstruction: A Randomized Clinical Trial.

Importance: Postmastectomy radiation therapy (PMRT) improves local-regional disease control and patient survival. Hypofractionation (HF) regimens have comparable efficacy and complication rates with improved quality of life compared with conventional fractionation (CF) schedules. However, the use of HF after mastectomy in patients undergoing breast reconstruction has not been prospectively examined. Objective: To compare HF and CF PMRT outcomes after implant-based reconstruction. Design, Setting, and Participants: This randomized clinical trial assessed patients 18 years or older undergoing mastectomy and immediate expander or implant reconstruction for breast cancer (Tis, TX, or T1-3) and unilateral PMRT from March 8, 2018, to November 3, 2021 (median [range] follow-up, 40.4 [15.4-63.0] months), at 16 US cancer centers or hospitals. Analyses were conducted between September and December 2023. Interventions: Patients were randomized 1:1 to HF or CF PMRT. Chest wall doses were 4256 cGy for 16 fractions for HF and 5000 cGy for 25 fractions for CF. Chest wall toxic effects were defined as a grade 3 or higher adverse event. Main Outcomes and Measures: The primary outcome was the change in physical well-being (PWB) domain of the Functional Assessment of Cancer Therapy-Breast (FACT-B) quality-of-life assessment tool at 6 months after starting PMRT, controlling for age. Secondary outcomes included toxic effects and cancer recurrence. Results: Of 400 women (201 in the CF arm and 199 in the HF arm; median [range] age, 47 [23-79] years), 330 patients had PWB scores at baseline and at 6 months. There was no difference in the change in PWB between the study arms (estimate, 0.13; 95% CI, -0.86 to 1.11; P = .80), but there was a significant interaction between age group and study arm (P = .03 for interaction). Patients younger than 45 years had higher 6-month absolute PWB scores if treated with HF rather than CF regimens (23.6 [95% CI, 22.7-24.6] vs 22.0 [95% CI, 20.7-23.3]; P = .047) and reported being less bothered by adverse effects (mean [SD], 3.0 [0.9] in the HF arm and 2.6 [1.2] in the CF arm; P = .02) or nausea (mean [SD], 3.8 [0.4] in the HF arm and 3.6 [0.8] in the CF arm; P = .04). In the as-treated cohort, there were 23 distant (11 in the HF arm and 12 in the CF arm) and 2 local-regional (1 in the HF arm and 1 in the CF arm) recurrences. Chest wall toxic effects occurred in 39 patients (20 in the HF arm and 19 in the CF arm) at a median (IQR) of 7.2 (1.8-12.9) months. Fractionation was not associated with chest wall toxic effects on multivariate analysis (HF arm: hazard ratio, 1.02; 95% CI, 0.52-2.00; P = .95). Fewer patients undergoing HF vs CF regimens had a treatment break (5 [2.7%] vs 15 [7.7%]; P = .03) or required unpaid time off from work (17 [8.5%] vs 34 [16.9%]; P = .02). Conclusions and Relevance: In this randomized clinical trial, the HF regimen did not significantly improve change in PWB compared with the CF regimen. These data add to the increasing experience with HF PMRT in patients with implant-based reconstruction. Trial Registration: ClinicalTrials.gov Identifier: NCT03422003.

Microsimulation model predicts survival benefit of radiofrequency ablation and stereotactic body radiotherapy versus radiotherapy for treating inoperable stage I non-small cell lung cancer.

OBJECTIVE: A subset of patients with stage IA and IB non-small cell lung cancer (NSCLC) is ineligible for surgical resection and undergoes radiation therapy. Radiofrequency ablation (RFA) and stereotactic body radiotherapy are newer potentially attractive alternative therapies. MATERIALS AND METHODS: We added RFA and stereotactic body radiotherapy treatment modules to a microsimulation model that simulates lung cancer's natural history, detection, and treatment. Natural history parameters were previously estimated via calibration against tumor registry data and cohort studies; the model was validated with screening study and cohort data. RFA model parameters were calibrated against 2-year survival from the Radiofrequency Ablation of Pulmonary Tumor Response Evaluation (RAPTURE) study, and stereotactic body radiotherapy model parameters were calibrated against 3-year survival from a phase 2 prospective trial. We simulated lifetime histories of identical patients with early-stage NSCLC who were ineligible for resection, who were treated with radiation therapy, RFA, or stereotactic body radiotherapy under a range of scenarios. From 5,000,000 simulated individuals, we selected a cohort of patients with stage I medically inoperable cancer for analysis (n = 2056 per treatment scenario). Main outcomes were life expectancy gains. RESULTS: RFA or stereotactic body radiotherapy treatment in patients with peripheral stage IA or IB NSCLC who were nonoperative candidates resulted in life expectancy gains of 1.71 and 1.46 life-years, respectively, compared with universal radiation therapy. A strategy where patients with central tumors underwent stereotactic body radiotherapy and those with peripheral tumors underwent RFA resulted in a gain of 2.02 life-years compared with universal radiation therapy. Findings were robust with respect to changes in model parameters. CONCLUSION: Microsimulation modeling results suggest that RFA and stereotactic body radiotherapy could provide life expectancy gains to patients with stage IA or IB NSCLC who are ineligible for resection.

Mental health disorders and survival among older patients with diffuse large B-cell lymphoma in the USA: a population-based study.

BACKGROUND: Mental health disorders can potentially decrease quality of life and survival in patients with cancer. Little is known about the survival implications of mental health disorders in patients with diffuse large B-cell lymphoma (DLBCL). We aimed to evaluate the effect of pre-existing depression, anxiety, or both on survival in a US cohort of older patients with DLBCL. METHODS: Using the Surveillance, Epidemiology, and End Results-Medicare (SEER-Medicare) database, we identified patients aged 67 years or older, diagnosed with DLBCL in the USA between Jan 1, 2001, and Dec 31, 2013. We used billing claims to identify patients with pre-existing depression, anxiety, or both before their DLBCL diagnosis. We compared 5-year overall survival and lymphoma-specific survival between these patients and those without pre-existing depression, anxiety, or both using Cox proportional analyses, adjusting for sociodemographic and clinical characteristics, including DLBCL stage, extranodal disease, and B symptoms. FINDINGS: Among 13 244 patients with DLBCL, 2094 (15·8%) had depression, anxiety, or both disorders; 6988 (52·8%) were female, and 12 468 (94·1%) were White. The median follow-up for the cohort was 2·0 years (IQR 0·4-6·9 years). 5-year overall survival was 27·0% (95% CI 25·1-28·9) for patients with these mental health disorders versus 37·4% (36·5-38·3) for those with no mental health disorder (hazard ratio [HR] 1·37, 95% CI 1·29-1·44). Although survival differences between mental health disorders were modest, those with depression alone had the worst survival compared with no mental health disorder (HR 1·37, 95% CI 1·28-1·47), followed by those with depression and anxiety (1·23, 1·08-1·41), and then anxiety alone (1·17, 1·06-1·29). Individuals with these pre-existing mental health disorders also had lower 5-year lymphoma-specific survival, with depression conferring the greatest effect (1·37, 1·26-1·49) followed by those with depression and anxiety (1·25, 1·07-1·47) and then anxiety alone (1·16, 1·03-1·31). INTERPRETATION: Pre-existing depression, anxiety, or both disorders present within 24 months before DLBCL diagnosis, worsens prognosis for patients with DLBCL. Our data underscore the need for universal and systematic mental health screening for this population, as mental health disorders are manageable, and improvements in this prevalent comorbidity might affect lymphoma-specific survival and overall survival. FUNDING: American Society of Hematology, National Cancer Institute, Alan J Hirschfield Award.