Lei Xuan

Predicting Risk of Perioperative Death and Stroke After Carotid Endarterectomy in Asymptomatic Patients Derivation and Validation of a Clinical Risk Score

Background and Purpose— National guidelines on carotid endarterectomy (CEA) for asymptomatic patients state that the procedure should be performed with a ≤3% risk of perioperative death or stroke. We developed and validated a multivariate model of risk of death or stroke within 30 days of CEA for asymptomatic disease and a related clinical prediction rule. Methods— We analyzed asymptomatic cases in a population-based cohort of CEAs performed in Medicare beneficiaries in New York State. Medical records were abstracted for sociodemographics, neurologic history, disease severity, diagnostic imaging data, comorbidities, and deaths and strokes within 30 days of surgery. We used multivariate logistic regression to identify independent predictors of perioperative death or stroke. The CEA-8 clinical risk score was derived from the final model. Results— Among the 6553 patients, the mean age was 74 years, 55% were male, 62% had coronary artery disease, and 22% had a history of distant stroke or transient ischemic attack. The perioperative rate of death or stroke was 3.0%. Multivariable predictors of perioperative events were female sex (odds ratio [OR]=1.5; 95% CI, 1.1 to 1.9), nonwhite race (OR=1.8; 95% CI, 1.1 to 2.9), severe disability (OR=3.7; 95% CI, 1.8 to 7.7), congestive heart failure (OR=1.6; 95% CI, 1.1 to 2.4), coronary artery disease (OR=1.6; 95% CI, 1.2 to 2.2), valvular heart disease (OR=1.5; 95% CI, 1.1 to 2.3), a distant history of stroke or transient ischemic attack (OR=1.5; 95% CI, 1.1 to 2.0), and a nonoperated stenosis ≥50% (OR=1.8; 95% CI, 1.3 to 2.3). The CEA-8 risk score stratified patients with a predicted probability of death or stroke rate from 0.6% to 9.6%. Conclusions— Several sociodemographic, neurologic severity, and comorbidity factors predicted the risk of perioperative death or stroke in asymptomatic patients. The CEA-8 risk score can help clinicians calculate a predicted probability of complications for an individual patient to help inform the decision about revascularization.

Impact of Prior Cancer on Eligibility for Lung Cancer Clinical Trials

BACKGROUND In oncology clinical trials, the assumption that a prior cancer diagnosis could interfere with study conduct or outcomes results in frequent exclusion of such patients. We determined the prevalence and characteristics of this practice in lung cancer clinical trials and estimated impact on trial accrual. METHODS We reviewed lung cancer clinical trials sponsored or endorsed by the Eastern Oncology Cooperative Group for exclusion criteria related to a prior cancer diagnosis. We estimated prevalence of prior primary cancer diagnoses among lung cancer patients using Surveillance Epidemiology and End Results (SEER)-Medicare linked data. We assessed the association between trial characteristics and prior cancer exclusion using chi-square analysis. All statistical tests were two-sided. RESULTS Fifty-one clinical trials (target enrollment 13072 patients) were included. Forty-one (80%) excluded patients with a prior cancer diagnosis as follows: any prior (14%), within five years (43%), within two or three years (7%), or active cancer (16%). In SEER-Medicare data (n = 210509), 56% of prior cancers were diagnosed within five years before the lung cancer diagnosis. Across trials, the estimated number and proportion of patients excluded because of prior cancer ranged from 0-207 and 0%-18%. Prior cancer was excluded in 94% of trials with survival primary endpoints and 73% of trials with nonsurvival primary endpoints (P = .06). CONCLUSIONS A substantial proportion of patients are reflexively excluded from lung cancer clinical trials because of prior cancer. This inclusion criterion is applied widely across studies, including more than two-thirds of trials with nonsurvival endpoints. More research is needed to understand the basis and ramifications of this exclusion policy.

Residential racial segregation and mortality among black, white, and Hispanic urban breast cancer patients in Texas, 1995 to 2009.

The authors investigated whether residential segregation (the degree to which racial/ethnic groups live separately from one another in a geographic area) 1) was associated with mortality among urban women with breast cancer, 2) explained racial/ethnic disparities in mortality, and 3) whether its association with mortality varied by race/ethnicity.

National trends in incidence rates of hospitalization for stroke in children with sickle cell disease

The success of primary stroke prevention for children with sickle cell disease (SCD) throughout the United States is unknown. Therefore, we aimed to generate national incidence rates of hospitalization for stroke in children with sickle cell disease (SCD) before and after publication of the Stroke Prevention Trial in Sickle Cell Anemia (STOP trial) in 1998.

Hospitalization for invasive pneumococcal disease in a national sample of children with sickle cell disease before and after PCV7 licensure.

To estimate national hospitalization rates for invasive pneumococcal disease (IPD) in children with sickle cell disease (SCD) before and after the 2000 licensure of the heptavalent pneumococcal conjugate vaccine (PCV7).

Modestly Increased Use of Colonoscopy When Copayments Are Waived

BACKGROUND & AIMS Colorectal cancer (CRC) screening with colonoscopy often requires expensive copayments from patients. The 2010 Patient Protection and Affordable Care Act mandated elimination of copayments for CRC screening, including colonoscopy, but little is known about the effects of copayment elimination on use. The University of Texas employee, retiree, and dependent health plan instituted and promoted a waiver of copayments for screening colonoscopies in fiscal year (FY) 2009; we examined the effects of removing cost sharing on colonoscopy use. METHODS We conducted a retrospective cohort study of 59,855 beneficiaries of the University of Texas employee, retiree, and dependent health plan, associated with 16 University of Texas health and nonhealth campuses, ages 50-64 years at any point in FYs 2002-2009 (267,191 person-years of follow-up evaluation). The primary outcome was colonoscopy incidence among individuals with no prior colonoscopy. We compared the age- and sex-standardized incidence ratios for colonoscopy in FY 2009 (after the copayment waiver) with the expected incidence for FY 2009, based on secular trends from years before the waiver. RESULTS The annual incidence of colonoscopy increased to 9.5% after the copayment was waived, compared with an expected incidence of 8.0% (standardized incidence ratio, 1.18; 95% confidence interval, 1.14-1.23; P < .001). After adjusting for age, sex, and beneficiary status, the copayment waiver remained significantly associated with greater use of colonoscopy, with an adjusted hazard ratio of 1.19 (95% confidence interval, 1.12-1.26). CONCLUSIONS Waiving copayments for colonoscopy screening results in a statistically significant, but modest (1.5%), increase in use. Additional strategies beyond removing financial disincentives are needed to increase use of CRC screening.

Communication About Advance Directives and End-of-Life Care Options Among Internal Medicine Residents.

Background: Despite increasing awareness about the importance of discussing end-of-life (EOL) care options with terminally ill patients and families, many physicians remain uncomfortable with these discussions. Objective: The objective of the study was to examine perceptions of and comfort with EOL care discussions among a group of internal medicine residents and the extent to which comfort with these discussions has improved over time. Methods: In 2013, internal medicine residents at a large academic medical center were asked to participate in an on-line survey that assessed their attitudes and experiences with discussing EOL care with terminally-ill patients. These results were compared to data from a similar survey residents in the same program completed in 2006. Results: Eighty-three (50%) residents completed the 2013 survey. About half (52%) felt strongly that they were able to have open, honest discussions with patients and families, while 71% felt conflicted about whether CPR was in the patient’s best interest. About half (53%) felt strongly that it was okay for them to tell a patient/family member whether or not CPR was a good idea for them. Compared to 2006 respondents, the 2013 cohort felt they had more lectures about EOL communication, and had watched an attending have an EOL discussion more often. Conclusions: Modest improvements were made over time in trainees’ exposure to EOL discussions; however, many residents remain uncomfortable and conflicted with having EOL care discussions with their patients. More effective training approaches in EOL communication are needed to train the next generation of internists.

An Examination of End-of-Life Care in a Safety Net Hospital System: A Decade in Review

Objectives. To examine patterns of use of end-of-life care in patients receiving treatment at a large, urban safety-net hospital from 2000 to 2010. Methods. Data from the Parkland Hospital palliative care database, which tracked all consults for this period, were analyzed. Logistic regression was used to identify predictors of hospice use, and Cox proportional hazards modeling to examine survival. Results. There were 5,083 palliative care consults over the study period. More patients were Black (41%) or White (31%), and younger than 65 years old (75%). Cancer patients or those who received palliative care services longer were more likely to receive hospice; those who had no form of health care assistance were less likely. There were no racial/ethnic differences in hospice use. Conclusion. In this cohort, there were no racial/ethnic disparities in hospice use. Those who had no form of health care assistance were less likely to receive hospice.

Prior cancer does not adversely affect survival in locally advanced lung cancer: A national SEER-medicare analysis

INTRODUCTION Management of locally advanced non-small cell lung cancer is among the most highly contested areas in thoracic oncology. In this population, a history of prior cancer frequently results in exclusion from clinical trials and may influence therapeutic decisions. We therefore determined prevalence and prognostic impact of prior cancer among these patients. MATERIALS AND METHODS We identified patients>65years of age diagnosed 1992-2009 with locally advanced lung cancer in the Surveillance, Epidemiology, and End Results-Medicare linked dataset. We characterized prior cancer by prevalence, type, stage, and timing. We compared all-cause and lung cancer-specific survival between patients with and without prior cancer using propensity score-adjusted Cox regression. RESULTS 51,542 locally advanced lung cancer patients were included; 15.8% had a history of prior cancer. Prostate (25%), gastrointestinal (17%), breast (16%), and other genitourinary (15%) were the most common types of prior cancer, and 76% percent of prior cancers were localized or in situ stage. Approximately half (54%) of prior cancers were diagnosed within 5 years of the index lung cancer date. Patients with prior cancer had similar (propensity-score adjusted hazard ratio [HR] 0.96; 95% CI, 0.94-0.99; P=0.005) and improved lung cancer-specific (HR 0.84; 95% CI, 0.81-0.86; P<0.001) survival compared to patients with no prior cancer. CONCLUSIONS For patients with locally advanced lung cancer, prior cancer does not adversely impact clinical outcomes. Patients with locally advanced lung cancer and a history of prior cancer should not be excluded from clinical trials, and should be offered aggressive, potentially curative therapies if otherwise appropriate.

Revisiting a longstanding clinical trial exclusion criterion: impact of prior cancer in early-stage lung cancer

Background:Early-stage lung cancer represents a key focus of numerous multicenter clinical trials, but common exclusion criteria such as a prior cancer diagnosis may limit enrollment. We examined the prevalence and prognostic impact of a prior cancer diagnosis among patients with early-stage lung cancer.Methods:We identified patients>65 years of age with early-stage lung cancer diagnosed 1996–2009 in the Surveillance, Epidemiology, and End Results-Medicare linked database. Prior cancers were characterized by type, stage, and timing with respect to the lung cancer diagnosis. All-cause and lung cancer specific-survival rates were compared between patients with and without prior cancer using Cox regression analyses and propensity scores.Results:Among 42,910 patients with early-stage lung cancer, one-fifth (21%) had a prior cancer. The most common prior cancers were prostate (21%), breast (18%), gastrointestinal (17%), and other genitourinary (15%). Most prior cancers were localized, and 61% were diagnosed within 5 years of the lung cancer diagnosis. There was no difference in all-cause survival between patients with and without prior cancer (hazard ratio [HR] 1.01; P=0.52). Lung cancer specific survival was improved among patients with prior cancer (HR 0.79; P<0.001).Conclusions:A prior cancer history may exclude a substantial proportion of patients with early-stage lung cancer from enrollment in clinical trials. Without adverse effect on clinical outcomes, inclusion of patients age >65 years with prior cancer in clinical trials should be considered to improve study accrual, completion rates, and generalizability.