Urgent versus elective surgical disparities among American Indian and Alaska Native patients.

BACKGROUND: American Indian and Alaska Native (AIAN) health issues are understudied despite documentation of lower-than-average life expectancy. Urgent surgery is associated with higher rates of postsurgical complications and postoperative death. We assess whether American Indian and Alaska Native (AIAN) patients in Washington State are at greater risk of requiring urgent rather than elective surgery compared with non-Hispanic Whites (NHW). METHODS: We accessed data for the period 2009-2014 from the Washington State Comprehensive Hospital Abstract Reporting System (CHARS) database, which captures all statewide hospital admissions, to examine three common surgeries that are performed both urgently and electively: hip replacements, aortic valve replacements, and spinal fusions. We extracted patient race, age, insurance status, comorbidity, admission type, and procedures performed. We then constructed multivariable logistic regression models to identify factors associated with use of urgent surgical care. RESULTS: AIAN patients had lower mean age at surgery for all three surgeries compared with NHW patients. AIAN patients were at higher risk for urgent surgery for hip replacements (OR = 1.49, 95% CI 1.19-1.88), spinal fusions (OR = 1.39, 95% CI 1.04-1.87), and aortic valve replacements (OR = 2.06, 95% CI 1.12-3.80). CONCLUSION: AIAN patients were more likely to undergo urgent hip replacement, spinal fusion, and aortic valve replacement than NHW patients. AIAN patients underwent urgent surgery at younger ages. Medicaid insurance conferred higher risks for urgent surgery across all surgeries studied. Further research is warranted to more clearly identify the factors contributing to disparities among AIAN patients undergoing urgent surgery.

Study Protocol for the Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence (SISTER) study: a community engaged national randomized trial.

Aim: Social isolation in cancer patients is correlated with prognosis and is a potential mediator of treatment completion. Black women with endometrial cancer (EC) are at increased risk for social isolation when compared with White patients. We developed the Social Interventions for Support during Treatment for Endometrial Cancer and Recurrence (SISTER) study to compare and evaluate interventions to address social isolation among Black women with high-risk EC in USA. The primary objective of the SISTER study is to determine whether virtual support interventions improve treatment completion compared with Enhanced Usual Care. Secondary objectives include comparing effectiveness virtual evidence-based interventions and evaluating barriers and facilitators to social support delivery. Patients & methods: This is a multi-site prospective, open-label, community-engaged randomized controlled trial, consisting of three intervention arms: enhanced usual care, facilitated support group and one-to-one peer support. Primary outcome will be measured using relative dose. Qualitative semi-structured interviews will be conducted with a subset of participants to contextualize the relative degree or lack thereof of social isolation, over time. Data analysis: Primary analysis will be based on an intent-to-treat analysis. Multivariable analysis will be performed to determine the effect of the intervention on the primary and secondary outcomes of interest, relative dose and social isolation score. Semi-structured interviews will be qualitatively analyzed using inductive and deductive approaches of content analysis. Discussion/conclusion: Endometrial cancer mortality disproportionately affects Black women, and social isolation contributes to this disparity. The SISTER study aims to identify whether and to what extent differing social support vehicles improve key outcomes for Black women in the United States with high-risk EC. Clinical Trial Registration: NCT04930159 (ClinicalTrials.gov).

Isolating the Drivers of Racial Inequities in Prostate Cancer Treatment.

BACKGROUND: Black individuals in the United States are less likely than White individuals to receive curative therapies despite a 2-fold higher risk of prostate cancer death. While research has described treatment inequities, few studies have investigated underlying causes. METHODS: We analyzed a cohort of 40,137 Medicare beneficiaries (66 and older) linked to the Surveillance Epidemiology and End Results (SEER) cancer registry who had clinically significant, non-metastatic (cT1-4N0M0, grade group 2-5) prostate cancer (diagnosed 2010-2015). Using the Kitagawa-Oaxaca-Blinder decomposition, we assessed the contributions of patient health and health care delivery on the racial difference in localized prostate cancer treatments (radical prostatectomy or radiation). Patient health consisted of comorbid diagnoses, tumor characteristics, SEER site, diagnosis year, and age. Health care delivery was captured as a prediction model with these health variables as predictors of treatment, reflecting current treatment patterns. RESULTS: A total of 72.1% and 78.6% of Black and White patients received definitive treatment, respectively, a difference of 6.5 percentage points. An estimated 15% [95% confidence interval (CI): 6-24] of this treatment difference was explained by measured differences in patient health, leaving the remaining estimated 85% (95% CI: 74-94) attributable to a potentially broad range of health care delivery factors. Limitations included insufficient data to explore how specific health care delivery factors, including structural racism and social determinants, impact differential treatment. CONCLUSIONS: Our results show the inadequacy of patient health differences as an explanation of the treatment inequity. IMPACT: Investing in studies and interventions that support equitable health care delivery for Black individuals with prostate cancer will contribute to improved outcomes.

Interruptions in bladder cancer care during the COVID-19 public health emergency.

BACKGROUND: Academic and community urology centers participating in a pragmatic clinical trial in non-muscle-invasive bladder cancer completed monthly surveys assessing restrictions in aspects of bladder cancer care due to the COVID-19 Public Health Emergency. Our objective was to describe pandemic-related restrictions on bladder cancer care. METHODS: We invited 32 sites participating in a multicenter pragmatic bladder cancer trial to complete monthly surveys distributed through REDCap beginning in May 2020. These surveys queried sites on whether they were experiencing restrictions in the use of elective surgery, transurethral resection of bladder tumors (TURBT), radical cystectomy, office cystoscopy, and intravesical bacillus Calmette-Guerin (BCG) availability. Responses were collated with descriptive statistics. RESULTS: Of 32 eligible sites, 21 sites had at least a 50% monthly response rate over the study period and were included in the analysis. Elective surgery was paused at 76% of sites in May 2020, 48% of sites in January 2021, and 52% of sites in January 2022. Over those same periods, coinciding with COVID-19 incidence waves, TURBT was restricted at 10%, 14%, and 14% of sites, respectively, radical cystectomy was restricted at 10%, 14%, and 19% of sites, respectively, and cystoscopy was restricted at 33%, 0%, and 10% of sites, respectively. CONCLUSIONS: Bladder cancer care was minimally restricted compared with more pronounced restrictions seen in general elective surgeries during the COVID-19 pandemic.

Prostate cancer screening in African American men: a review of the evidence.

BACKGROUND: Prostate cancer is the most diagnosed cancer in African American men, yet prostate cancer screening regimens in this group are poorly guided by existing evidence, given underrepresentation of African American men in prostate cancer screening trials. It is critical to optimize prostate cancer screening and early detection in this high-risk group because underdiagnosis may lead to later-stage cancers at diagnosis and higher mortality while overdiagnosis may lead to unnecessary treatment. METHODS: We performed a review of the literature related to prostate cancer screening and early detection specific to African American men to summarize the existing evidence available to guide health-care practice. RESULTS: Limited evidence from observational and modeling studies suggests that African American men should be screened for prostate cancer. Consideration should be given to initiating screening of African American men at younger ages (eg, 45-50 years) and at more frequent intervals relative to other racial groups in the United States. Screening intervals can be optimized by using a baseline prostate-specific antigen measurement in midlife. Finally, no evidence has indicated that African American men would benefit from screening beyond 75 years of age; in fact, this group may experience higher rates of overdiagnosis at older ages. CONCLUSIONS: The evidence base for prostate cancer screening in African American men is limited by the lack of large, randomized studies. Our literature search supported the need for African American men to be screened for prostate cancer, for initiating screening at younger ages (45-50 years), and perhaps screening at more frequent intervals relative to men of other racial groups in the United States.

Interstate Telemedicine for Urologic Cancer Care.

PURPOSE: US states eased licensing restrictions on telemedicine during the COVID-19 pandemic, allowing interstate use. As waivers expire, optimal uses of telemedicine must be assessed to inform policy, legislation, and clinical care. We assessed whether telemedicine visits provided the same patient experience as in-person visits, stratified by in- vs out-of-state residence, and examined the financial burden. MATERIALS AND METHODS: Patients seen in person and via telemedicine for urologic cancer care at a major regional cancer center received a survey after their first appointment (August 2019-June 2022) on satisfaction with care, perceptions of communication during their visit, travel time, travel costs, and days of work missed. RESULTS: Surveys were completed for 1058 patient visits (N = 178 in-person, N = 880 telemedicine). Satisfaction rates were high for all visit types, both interstate and in-state care (mean score 60.1-60.8 [maximum 63], P > .05). More patients convening interstate telemedicine would repeat that modality (71%) than interstate in-person care (61%) or in-state telemedicine (57%). Patients receiving interstate care had significantly higher travel costs (median estimated visit costs $200, IQR $0-$800 vs median $0, IQR $0-$20 for in-state care, P < .001); 55% of patients receiving interstate in-person care required plane travel and 60% required a hotel stay. CONCLUSIONS: Telemedicine appointments may increase access for rural-residing patients with cancer. Satisfaction outcomes among patients with urologic cancer receiving interstate care were similar to those of patients cared for in state; costs were markedly lower. Extending interstate exemptions beyond COVID-19 licensing waivers would permit continued delivery of high-quality urologic cancer care to rural-residing patients.

Protocol of the Comparison of Intravesical Therapy and Surgery as Treatment Options (CISTO) study: a pragmatic, prospective multicenter observational cohort study of recurrent high-grade non-muscle invasive bladder cancer.

BACKGROUND: Bladder cancer poses a significant public health burden, with high recurrence and progression rates in patients with non-muscle-invasive bladder cancer (NMIBC). Current treatment options include bladder-sparing therapies (BST) and radical cystectomy, both with associated risks and benefits. However, evidence supporting optimal management decisions for patients with recurrent high-grade NMIBC remains limited, leading to uncertainty for patients and clinicians. The CISTO (Comparison of Intravesical Therapy and Surgery as Treatment Options) Study aims to address this critical knowledge gap by comparing outcomes between patients undergoing BST and radical cystectomy. METHODS: The CISTO Study is a pragmatic, prospective observational cohort trial across 36 academic and community urology practices in the US. The study will enroll 572 patients with a diagnosis of recurrent high-grade NMIBC who select management with either BST or radical cystectomy. The primary outcome is health-related quality of life (QOL) at 12 months as measured with the EORTC-QLQ-C30. Secondary outcomes include bladder cancer-specific QOL, progression-free survival, cancer-specific survival, and financial toxicity. The study will also assess patient preferences for treatment outcomes. Statistical analyses will employ targeted maximum likelihood estimation (TMLE) to address treatment selection bias and confounding by indication. DISCUSSION: The CISTO Study is powered to detect clinically important differences in QOL and cancer-specific survival between the two treatment approaches. By including a diverse patient population, the study also aims to assess outcomes across the following patient characteristics: age, gender, race, burden of comorbid health conditions, cancer severity, caregiver status, social determinants of health, and rurality. Treatment outcomes may also vary by patient preferences, health literacy, and baseline QOL. The CISTO Study will fill a crucial evidence gap in the management of recurrent high-grade NMIBC, providing evidence-based guidance for patients and clinicians in choosing between BST and radical cystectomy. The CISTO study will provide an evidence-based approach to identifying the right treatment for the right patient at the right time in the challenging clinical setting of recurrent high-grade NMIBC. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03933826. Registered on May 1, 2019.

Inequities in Definitive Treatment for Localized Prostate Cancer Among Those With Clinically Significant Mental Health Disorders.

INTRODUCTION: Patients with mental health disorders are at risk for receiving inequitable cancer treatment, likely resulting from various structural, social, and health-related factors. This study aims to assess the relationship between mental health disorders and the use of definitive treatment in a population-based cohort of those with localized, clinically significant prostate cancer. METHODS: We conducted a cohort study analysis in SEER (Surveillance, Epidemiology, and End Results)-Medicare (2004-2015). History of a mental health disorder was defined as presence of specific ICD (International Classification of Diseases)-9 or ICD-10 diagnostic codes in the 2 years preceding cancer diagnosis. Descriptive statistics were performed using Wilcoxon rank-sum and χ2 testing. Multivariable logistic regression was used to evaluate the relationship between mental health disorders and definitive treatment utilization (defined as surgery or radiation). RESULTS: Of 101,042 individuals with prostate cancer, 7,945 (7.8%) had a diagnosis of a mental health disorder. They were more likely to be unpartnered, have a lower socioeconomic status, and less likely to receive definitive treatment (61.8% vs 68.2%, P < .001). Definitive treatment rates were >66%, 62.8%, 60.3%, 58.2%, 54.3%, and 48.1% for post-traumatic stress disorder, depressive disorder, bipolar disorder, anxiety disorder, substance abuse disorder, and schizophrenia, respectively. After adjusting for age, race and ethnicity, marital status and socioeconomic status, history of a mental health disorder was associated with decreased odds of receiving definitive treatment (OR 0.74, 95% CI 0.66-0.83). CONCLUSIONS: Individuals with mental health disorders and prostate cancer represent a vulnerable population; careful attention to clinical and social needs is required to support appropriate use of beneficial treatments.

Patient-centered outcomes of telehealth for the care of rural-residing patients with urologic cancer.

BACKGROUND: Patients residing in rural areas with urologic cancers confront significant obstacles in obtaining oncologic care. In the Pacific Northwest, a sizeable portion of the population lives in a rural county. Telehealth offers a potential access solution. METHODS: Patients receiving urologic care through telehealth or an in-person appointment at the Fred Hutchinson Cancer Center in Seattle, Washington, were surveyed to assess appointment-related satisfaction and travel costs. Patients' residences were classified as rural or urban based on their self-reported ZIP code. Median patient satisfaction scores and appointment-related travel costs were compared by rural versus urban residence within telehealth and in-person appointment groups using Wilcoxon signed-rank or χ2 testing. RESULTS: A total of 1091 patients seen for urologic cancer care between June 2019 and April 2022 were included, 28.7% of which resided in a rural county. Patients were mostly non-Hispanic White (75%) and covered by Medicare (58%). Among rural-residing patients, telehealth and in-person appointment groups had the same median satisfaction score (61; interquartile ratio, 58, 63). More rural-residing than urban-residing patients in the telehealth appointment groups strongly agreed that "Considering the cost and time commitment of my appointment, I would choose to meet with my provider in this setting in the future" (67% vs. 58%, p = .03). Rural-residing patients with in-person appointments carried a higher financial burden than those with telehealth appointments (medians, $80 vs. $0; p <.001). CONCLUSIONS: Appointment-related costs are high among rural-residing patients traveling for urologic oncologic care. Telehealth provides an affordable solution that does not compromise patient satisfaction.

A Patient-Centered Approach to Research Prioritization in Prostate Cancer.

PURPOSE: Research priorities are often set by expert clinicians and researchers. We sought to apply an established process in patient-centered research to engage survivors and their caregivers in prioritizing research topics in prostate cancer. MATERIALS AND METHODS: A prostate cancer patient survey network, formed in partnership with Us TOO and the National Alliance of State Prostate Cancer Coalitions, engaged in a series of mixed-methods studies to prioritize comparative effectiveness research questions. This was accomplished through an iterative process that included 2 survey rounds and multidisciplinary working groups. RESULTS: There were 591 and 706 survey respondents in the first and second rounds, respectively, with most having had localized prostate cancer (58.1%). Survey participants represented 45 states in the U.S. Five of the top 11 prioritized research questions related to treatment decision making and/or survivorship care. The following had the highest overall importance ratings: What is the comparative effectiveness of different 1) strategies to improve counseling regarding the side effects of prostate cancer treatment, 2) tools for decision making in localized prostate cancer and 3) sequences of treatments for metastatic prostate cancer? CONCLUSIONS: We present a unique, patient-centered list of prioritized research questions among prostate cancer patients and their caregivers. These research questions may inform funding decisions for organizations that support research, and should be considered as priorities for clinicians, researchers and institutions conducting prostate cancer research. Prostate cancer is a common disease that affects 1 in 9 men over their lifetime. Researchers usually identify questions to study without asking men with prostate cancer. We asked survivors of prostate cancer and their caregivers to help us. They identified research questions and topics that are important to them. Researchers can focus on this list of questions to help men with prostate cancer. Groups who pay for research studies can make these questions their priority.

Patient and public involvement in the design and conduct of a large, pragmatic observational trial to investigate recurrent, high-risk non-muscle-invasive bladder cancer.

BACKGROUND: Patient-centered approaches to research design are particularly important for diseases with complex treatment decision-making, such as recurrent, high-grade non-muscle-invasive bladder cancer (NMIBC). The objective of this article is to describe patient and public involvement (PPI) in designing a large, pragmatic observational trial and to articulate barriers, challenges, and lessons learned for future design. METHODS: Through multistakeholder involvement, a large, pragmatic observational trial was designed to investigate the outcomes of high-risk, recurrent NMIBC, and it was titled Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer (CISTO). CISTO's design used the Guidance for Reporting Involvement of Patients and the Public 2 reporting checklist for PPI and built on prior engagement infrastructure in partnership with the Bladder Cancer Advocacy Network. RESULTS: CISTO's PPI began with research prioritization to identify the highest priority questions facing patients with NMIBC. A pragmatic observational study design was selected and refined through stakeholder input. PPI included patients and caregivers organized into an advocate advisory board and clinicians, researchers, payers, and industry representatives organized into an external advisory board. An engagement plan was created to define the stages of PPI and the level and nature of the involvement of each group. PPI was measured quantitatively and qualitatively through evaluation surveys and iterative feedback from board members, with changes made for continuous improvement. CONCLUSIONS: Through intentional PPI, CISTO aims to produce pragmatic and generalizable results that will allow patients to make informed decisions for recurrent, high-risk NMIBC based on their personal experiences. LAY SUMMARY: Involving patients and other stakeholders in research ensures that it reflects the outcomes that matter most to them. This is especially important when research focuses on conditions in which patients face difficult decisions about treatment options. This article describes the key role that stakeholders played in shaping the Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer (CISTO) study. It compares treatments for recurrent noninvasive bladder cancer and describes how stakeholders were engaged to design and develop the study and the practices that supported their involvement.

Use of post-discharge heparin prophylaxis and the risk of venous thromboembolism and bleeding following bariatric surgery.

INTRODUCTION: Venous thromboembolism (VTE) is a significant cause of morbidity and mortality after bariatric surgery. Roughly 80% of VTEs occur post-discharge. The frequency of post-discharge heparin (PDH) prophylaxis use is unknown, and evidence about benefits and risks is limited. We aimed to determine the rate of use of PDH prophylaxis and evaluate its relationship with VTE and bleeding events. METHODS: Using the Truven Health MarketScan® database, we performed a retrospective cohort study (2007-2015) of adult patients who underwent sleeve gastrectomy or gastric bypass. We determined PDH prophylaxis from outpatient pharmacy claims, and post-discharge 90-day VTE and bleeding events from outpatient and inpatient claims. We used propensity score-adjusted regression models to mitigate confounding bias. RESULTS: Among 43,493 patients (median age 45 years; 78% women; 77% laparoscopic gastric bypass, 17% laparoscopic sleeve gastrectomy, 6% open gastric bypass), 6% received PDH prophylaxis. Overall, 224 patients (0.52%) experienced VTEs, and 806 patients (1.85%) experienced bleeding. The unadjusted VTE rate did not differ between patients who did and did not receive PDH prophylaxis (0.39% vs. 0.52%, respectively; p = 0.347). The unadjusted bleeding rate was higher for the PDH prophylaxis group (2.74% vs. 1.80%, p < 0.001). In our adjusted analysis, a 23% lower risk of VTE in the PDH prophylaxis group was not statistically significant (odds ratio [OR] 0.77, 95% confidence interval [CI] 0.41 to 1.46), whereas the 47% higher risk of bleeding was statistically significant (OR 1.47, 95% CI 1.14 to 1.88). CONCLUSIONS: PDH prophylaxis after bariatric surgery is uncommon. In our analysis, use was not associated with a lower VTE risk but was associated with a higher bleeding risk.

Practice Patterns for Women With Overactive Bladder Syndrome: Time Between Medications and Third-Line Treatments.

OBJECTIVE: The aims of this study are to determine how long it takes female patients with overactive bladder (OAB) to receive third-line treatment after starting OAB medications and identify factors associated with increased time. METHODS: This was a retrospective observational cohort study of adult female patients with OAB who received third-line treatment between 2013 and 2015 using insurance claims databases. Primary outcome was time between first OAB medication and first third-line treatment. Additional variables were patient demographics, diagnostic tests, and medical comorbidities. RESULTS: Of 3232 patients included in this study, 48.8% underwent sacral neuromodulation, 31.6% percutaneous tibial nerve stimulation, and 23% intradetrusor onabotulinumtoxin A injections. Twenty-one percent of patients filled medication prescriptions for 3 or more antimuscarinic medications, 30.4% took mirabegron, and 32.3% had advanced diagnostic tests suggestive of a specialist evaluation prior to starting medications. Median time to third-line treatment was 37.7 (interquartile range, 14.9, 16.3) months. Adjusted linear regression model revealed 2 predominant predictors of time to third-line treatments: each antimuscarinic medication trial was associated with 5.3 (95% confidence interval, 4.4-6.3) more months before third-line treatment (P < 0.001), and advanced diagnostic evaluations prior to starting medications were associated with 28.2 (95% confidence interval, 21-35) fewer months before third-line treatment (P < 0.001). CONCLUSIONS: Women with OAB who undergo third-line therapy do so on average more than 3 years after starting medications. Time to third-line treatment is largely driven by the number of antimuscarinic medications tried and timing of diagnostic evaluation by a specialist. Based on these results, we suggest providers consider limiting antimuscarinic trials to 2 medications prior to moving on to other treatment options.

Evaluating Knowledge, Attitudes, and Beliefs About Lung Cancer Screening Using Crowdsourcing.

BACKGROUND: Lung cancer screening, despite its proven mortality benefit, remains vastly underutilized. Previous studies examined knowledge, attitudes, and beliefs to better understand the reasons underlying the low screening rates. These investigations may have limited generalizability because of traditional participant recruitment strategies and examining only subpopulations eligible for screening. The current study used crowdsourcing to recruit a broader population to assess these factors in a potentially more general population. METHODS: A 31-item survey was developed to assess knowledge, attitudes, and beliefs regarding screening among individuals considered high risk for lung cancer by the United States Preventive Services Task Force. Amazon's crowdsourcing platform (Mechanical Turk) was used to recruit subjects. RESULTS: Among the 240 respondents who qualified for the study, 106 (44%) reported knowledge of a screening test for lung cancer. However, only 36 (35%) correctly identified low-dose CT scanning as the appropriate test. A total of 222 respondents (93%) reported believing that early detection of lung cancer has the potential to save lives, and 165 (69%) were willing to undergo lung cancer screening if it was recommended by their physician. Multivariable regression analysis found that knowledge of lung cancer screening, smoking status, chronic pulmonary disease, and belief in the efficacy of early detection of lung cancer were associated with willingness to screen. CONCLUSIONS: Although a minority of individuals at high risk for lung cancer are aware of screening, the majority believe that early detection saves lives and would pursue screening if recommended by their primary care physician. Health systems may increase screening rates by improving patient and physician awareness of lung cancer screening.

Analysis of the Completely Dry Rate Over Time After Mid-urethral Sling in a Real-world Clinical Setting.

OBJECTIVE: To improve patient counseling regarding mid-urethral slings (MUS), we performed an analysis of MUS patients dry at initial follow-up to evaluate probability of remaining dry over time, and analyzed clinical factors potentially influencing the probability of remaining dry. METHODS: A retrospective review of our prospectively-collected institutional database identified patients who underwent retropubic MUS (RMUS) or transobturator MUS (TMUS) between January 2001 and March 2016 and were completely dry, defined as an answer of "not at all" to UDI-6 question 3, at first follow-up within 1.5 years of surgery. Proportion remaining dry over time was estimated by Kaplan-Meier. Associated factors were evaluated using Cox proportional hazards modeling. Proportion with urge urinary incontinence at time of sling failure was assessed. RESULTS: Of 1102 patients undergoing MUS, 38.4% returned questionnaires and 47.5% of these were completely dry at initial follow-up (139 RMUS, 62 TMUS). Probability (95% CI, n = total patients) of remaining dry after RMUS at 3, 5, and 10 years was 72% (64%-81%, n = 70), 60% (51%-70%, n = 51), and 26% (18%-43%, n = 17). Probability estimates for TMUS at 3 and 5 years were 74% (62%-88%, n = 27) and 50% (35%-70%, n = 14). Obesity (Hazard ratio 2.22, P = .003) and age (Hazard ratio 1.043, P < .001) were associated with lower probability of remaining dry after RMUS. Of patients no longer completely dry at last follow-up, 72% RMUS and 75% TMUS had urge urinary incontinence. CONCLUSION: In our real-world cohort, patients who are dry within the first 1.5 years following MUS have ≥50% chance of remaining dry for 4 more years.

Role of bleeding recognition and evaluation in Black-White disparities in endometrial cancer.

BACKGROUND: Advanced stage at diagnosis is an independent, unexplained contributor to racial disparity in endometrial cancer. OBJECTIVE: We sought to investigate whether, prior to diagnosis, provider recognition of the cardinal symptom of endometrial cancer, postmenopausal bleeding, differs by patient race. STUDY DESIGN: Black and White women diagnosed with endometrial cancer (2001 through 2011) from Surveillance, Epidemiology, and End Results-Medicare who had at least 2 years of claims prior to diagnosis were identified. Bleeding diagnoses along with procedures done prior to diagnosis were captured via claims data. Multinomial logistic regression was used to evaluate the association of race with diagnostic workup and multivariate models built to determine the association of appropriate diagnostic procedures with stage at diagnosis. RESULTS: In all, 4354 White and 537 Black women diagnosed with endometrial cancer were included. Compared to White women, Black women were less likely to have guideline-concordant care: postmenopausal bleeding and appropriate diagnostic evaluation (70% vs 79%, P < .001), with adjusted relative risk ratios of 1.12-1.73 for different nonguideline-concordant pathways: bleeding without diagnostic procedures, alternative bleeding descriptions, and neither bleeding nor procedures. These pathways were associated with higher odds of advanced stage at diagnosis (adjusted odds ratio, 1.90-2.88). CONCLUSION: The lack of recognition and evaluation of postmenopausal bleeding is associated with advanced stage at diagnosis in endometrial cancer. Older Black women are at highest risk for the most aggressive histology types, yet they are less likely to have guideline-concordant evaluation of vaginal bleeding. Efforts aimed at improving recognition-among patients and providers-of postmenopausal bleeding in Black women could substantially reduce disparities in endometrial cancer.

Challenges in Predicting Recurrence After Resection of Node-Negative Non-Small Cell Lung Cancer.

BACKGROUND: One in 5 patients with completely resected early-stage non-small cell lung cancer will recur within 2 years. Risk stratification may facilitate a personalized approach to the use of adjuvant therapy and surveillance imaging. We developed a prediction model for recurrence based on five clinical variables (tumor size and grade, visceral pleural and lymphovascular invasion, and sublobar resection), and tested the hypothesis that the addition of several new molecular markers of poor long-term outcome (vascular endothelial growth factor C; microRNA precursors 486 and 30d) would enhance prediction. METHODS: We performed a retrospective cohort study of patients with completely resected, node-negative non-small cell lung cancer from 2011 to 2014 (follow-up through 2016) using the Lung Cancer Biospecimen Resource Network. Cox regression was used to estimate the 2-year risk of recurrence. Our primary measure of model performance was the optimism-corrected C statistic. RESULTS: Among 173 patients (mean tumor size, 3.6 cm; 12% sublobar resection, 32% poorly differentiated, 16% lymphovascular invasion, 26% visceral pleural invasion), the 2-year recurrence rate was 23% (95% confidence interval, 17% to 31%). A prediction model using five known risk factors for recurrence performed only slightly better than chance in predicting recurrence (optimism-corrected C statistic, 0.54; 95% confidence interval, 0.51 to 0.68). The addition of biomarkers did not improve the model's ability to predict recurrence (corrected C statistic, 0.55; 95% confidence interval, 0.52 to 0.71). CONCLUSIONS: We were unable to predict lung cancer recurrence using a risk-prediction model based on five well-known clinical risk factors and several biomarkers. Further research should consider novel predictors of recurrence to stratify patients with completely resected early-stage non-small cell lung cancer according to their risk of recurrence.

Comparison of Outcomes of antibiotic Drugs and Appendectomy (CODA) trial: a protocol for the pragmatic randomised study of appendicitis treatment.

INTRODUCTION: Several European studies suggest that some patients with appendicitis can be treated safely with antibiotics. A portion of patients eventually undergo appendectomy within a year, with 10%-15% failing to respond in the initial period and a similar additional proportion with suspected recurrent episodes requiring appendectomy. Nearly all patients with appendicitis in the USA are still treated with surgery. A rigorous comparative effectiveness trial in the USA that is sufficiently large and pragmatic to incorporate usual variations in care and measures the patient experience is needed to determine whether antibiotics are as good as appendectomy. OBJECTIVES: The Comparing Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial for acute appendicitis aims to determine whether the antibiotic treatment strategy is non-inferior to appendectomy. METHODS/ANALYSIS: CODA is a randomised, pragmatic non-inferiority trial that aims to recruit 1552 English-speaking and Spanish-speaking adults with imaging-confirmed appendicitis. Participants are randomised to appendectomy or 10 days of antibiotics (including an option for complete outpatient therapy). A total of 500 patients who decline randomisation but consent to follow-up will be included in a parallel observational cohort. The primary analytic outcome is quality of life (measured by the EuroQol five dimension index) at 4 weeks. Clinical adverse events, rate of eventual appendectomy, decisional regret, return to work/school, work productivity and healthcare utilisation will be compared. Planned exploratory analyses will identify subpopulations that may have a differential risk of eventual appendectomy in the antibiotic treatment arm. ETHICS AND DISSEMINATION: This trial was approved by the University of Washington's Human Subjects Division. Results from this trial will be presented in international conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02800785.

A decision aid versus shared decision making for prostate cancer screening: results of a randomized, controlled trial.

INTRODUCTION: Shared decision making (SDM) is widely encouraged by both the American Urological Association and Choosing Wisely for prostate cancer screening. Implementation of SDM is challenging secondary to time constraints and competing patient priorities. One strategy to mitigate the difficulties in implementing SDM is to utilize a decision aid (DA). Here we evaluate whether a DA improves a patient's prostate cancer knowledge and affects prostate-specific antigen (PSA) screening rates. MATERIALS AND METHODS: Patients were randomized to usual care (UC), DA, or DA + SDM. Perception of quality of care was measured using the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey. Outcomes were stratified by long term provider relationship (LTPR, > 3 years) versus short term provider relationship (STPR, < 3 years). Knowledge of prostate cancer screening and the decision regarding screening were assessed. Groups were compared using ANOVA and logistic regression models. RESULTS: A total of 329 patients were randomized. Patients in the DA + SDM arm were significantly more likely to report discussing the implication of screening (33% DA + SDM, 22% UC, 16% DA, p = 0.0292) and answered significantly more knowledge questions correctly compared to the UC arm (5.03 versus 4.46, p = 0.046). However, those in the DA arm were significantly less likely to report that they always felt encouraged to discuss all health concerns (72% DA, 78% DA + SDM, 87% UC, p = 0.0285). Interestingly, STPR patients in the DA arm were significantly more likely to undergo PSA-based prostate cancer screening (41%) than the UC arm (8%, p = 0.019). This effect was not observed in the LTPR group. CONCLUSIONS: Providing patients a DA without a personal interaction resulted in a greater chance of undergoing PSA-based screening without improving knowledge about screening or understanding of the consequences of this decision. This effect was exacerbated by a shorter term provider relationship. With complex issues such as the decision to pursue PSA-based prostate cancer screening, tools cannot substitute for direct interaction with a trusted provider.

A prospective study of health-related quality-of-life outcomes for patients with low-risk prostate cancer managed by active surveillance or radiation therapy.

INTRODUCTION: Patients with low-risk prostate cancer (PCa) often have excellent oncologic outcomes. However, treatment with curative intent can lead to decrements in health-related quality of life (HRQoL). Patients treated with radical prostatectomy have been shown to suffer declines in urinary and sexual HRQoL as compared to those managed with active surveillance (AS). Similarly, patients treated with external-beam radiation therapy (EBRT) are hypothesized to experience greater declines in bowel HRQoL. As health-related quality-of-life (HRQoL) concerns are paramount when selecting among treatment options for low-risk PCa, this study examined HRQoL outcomes in men undergoing EBRT as compared to AS in a prospective, racially diverse cohort. METHODS: A prospective study of HRQoL in patients with PCa enrolled in the Center for Prostate Disease Research (CPDR) Multicenter National Database was initiated in 2007. The current study included patients diagnosed through April 2014. HRQoL was assessed with the Expanded Prostate Cancer Index Composite (EPIC) and the Medical Outcomes Study Short Form (SF-36). Temporal changes in HRQoL were compared for patients with low-risk PCa managed on AS vs. EBRT at baseline, 1-, 2-, and 3 years post-PCa diagnosis. Longitudinal patterns were modeled using linear regression models fitted with generalized estimating equations (GEE), adjusting for baseline HRQoL, demographic, and clinical patient characteristics. RESULTS: Of the 499 eligible patients with low-risk PCa, 103 (21%) selected AS and 60 (12%) were treated with EBRT. Demographic characteristics of the treatment groups were similar, though a greater proportion of patients in the EBRT group were African American (P = 0.0003). At baseline, both treatment groups reported comparable HRQoL. EBRT patients experienced significantly worse bowel function and bother at 1 year (adjusted mean score: 87 vs. 95, P = 0.001 and 89 vs. 95, P = 0.008, respectively) and 2 years (87 vs. 93, P = 0.007 and 87 vs. 96, P = 0.002, respectively) compared to patients managed on AS. In contrast to those on AS, more than half the number of patients who received EBRT experienced a decline in bowel function (52% vs. 17%, p=0.003) and bother (52% vs. 15%, P = 0.002) from baseline to 1 year. Patients who received EBRT were significantly more likely to experience a decrease in more than one functional domain (urinary, sexual, bowel, or hormonal) at 1 year when compared with those on AS (60% vs. 28%, P = 0.004). CONCLUSIONS: Patients receiving EBRT for low-risk prostate cancer suffer declines in bowel HRQoL. These declines are not experienced by patients on AS, suggesting that management of low-risk prostate cancer with AS may offer a means for preserving HRQoL following prostate cancer diagnosis.