Changing trends in Black-White racial differences in surgical menopause: a population-based study.

BACKGROUND: Bilateral oophorectomy before menopause, or surgical menopause, is associated with negative health outcomes, including an increased risk for stroke and other cardiovascular outcomes; however, surgical menopause also dramatically reduces ovarian cancer incidence and mortality rates. Because there are competing positive and negative sequelae associated with surgical menopause, clinical guidelines have not been definitive. Previous research indicates that White women have higher rates of surgical menopause than other racial groups. However, previous studies may have underestimated the rates of surgical menopause among Black women. Furthermore, clinical practice has changed dramatically in the past 15 years, and there are no population-based studies in which more recent data were used. Tracking actual racial differences among women with surgical menopause is important for ensuring equity in gynecologic care. OBJECTIVE: This population-based surveillance study evaluated racial differences in the rates of surgical menopause in all inpatient and outpatient settings in a large, racially diverse US state with historically high rates of hysterectomy. STUDY DESIGN: We evaluated all inpatient and outpatient surgeries in North Carolina from 2011 to 2014 for patients aged between 20 and 44 years. Surgical menopause was defined as a bilateral oophorectomy, with or without an accompanying hysterectomy, among North Carolina residents. International Classification of Diseases, Ninth Revision, and Current Procedural Terminology codes were used to identify inpatient and outpatient procedures, respectively, and diagnostic indications. We estimated age-, race-, and ethnicity-specific rates of surgical menopause using county-specific population estimates based on the 2010 United States census. We used Poisson regression with deviance-adjusted residuals to estimate the incidence rate ratios in the entire state population. We tested changes in surgery rates over time (reference year, 2011), differences by setting (reference, inpatient), and differences by race and ethnicity (reference, non-Hispanic White). We then described the surgery rates between non-Hispanic White and non-Hispanic Black patients. RESULTS: Between 2011 and 2014, 11,502 surgical menopause procedures for benign indications were performed in North Carolina among reproductive-aged residents. Most (95%) of these surgeries occurred concomitant with a hysterectomy. Over the 4-year study period, there was a 39% reduction in inpatient surgeries (incidence rate ratio, 0.61) and a 100% increase in outpatient surgeries (incidence rate ratio, 2.0). Restricting the analysis to surgeries among non-Hispanic White and Black patients, the increase in outpatient surgeries was significantly higher among non-Hispanic Black women (P<.01) for year-race interaction (reference, 2011 and non-Hispanic White). The overall rates of bilateral oophorectomy for non-Hispanic Black women rose more quickly than for non-Hispanic White women (P<.01). In 2011, the rate of surgical menopause was greater among White women than among Black women (17.7 vs 13.2 per 10,000 women). By 2014, the racial trends were reversed (rate, 24.8 per 10,000 for non-Hispanic White women and 28.4 per 10,000 for non-Hispanic Black women). CONCLUSION: Our findings suggest that the rates of surgical menopause increased in North Carolina in the early 2010s, especially among non-Hispanic Black women. By 2014, the rates of surgical menopause among non-Hispanic Black women had surpassed that of non-Hispanic White women. Given the long-term health consequences associated with surgical menopause, we propose potential drivers for the racially-patterned increases in the application of bilateral oophorectomy before the age of 45 years.

The Missouri Physician and Health Professional Wellness Program: A Comprehensive Resource for Physician Wellness.

Burnout is just one of many ways that physicians unintentionally become impaired. This article reviews the relevant literature and issues facing physician wellness and presents information about the Missouri Physician and Health Professional Wellness Program sponsored by the Missouri Association of Osteopathic Physicians (MAOPS) and Capital Region Medical Center in Jefferson City, Missouri. Considerations for when to reach out in addition to information on some of the program's preventative services are provided.

Factors influencing prostate cancer treatment decisions for African American and white men.

BACKGROUND: Prostate cancer racial disparities in mortality outcomes are the largest in all of oncology, and less aggressive treatment received by African American (AA) patients versus white patients is likely a contributing factor. However, the reasons underlying the differences in treatment are unclear. METHODS: This study examined a prospective, population-based cohort of 1170 men with newly diagnosed nonmetastatic prostate cancer enrolled from 2011 to 2013 before treatment throughout North Carolina. By phone survey, each participant was asked to rate the aggressiveness of his cancer, and his response was compared to the actual diagnosis based on a medical record review. Participants were also asked to rate the importance of 10 factors for their treatment decision-making process. RESULTS: Among AA and white patients with low-risk cancer (according to National Comprehensive Cancer Network guidelines), 78% to 80% perceived their cancers to be "not very aggressive." However, among high-risk patients, 54% of AA patients considered their cancers to be "not very aggressive," whereas 24% of white patients did (P < .001). Although both AA and white patients indicated that a cure was a very important decision-making factor, AAs were significantly more likely to consider cost, treatment time, and recovery time as very important. In a multivariable analysis, perceived cancer aggressiveness and cure as the most important factor were significantly associated with receiving any aggressive treatment and were associated with surgery (vs radiation). After adjustments for these factors and sociodemographic factors, race was not significantly associated with the treatment received. CONCLUSIONS: Racial differences in perceived cancer aggressiveness and factors important in treatment decision making provide novel insights into reasons for the known racial disparities in prostate cancer as well as potential targets for interventions to reduce these disparities.

Implementing a small media intervention to increase colorectal cancer screening in primary care clinics.

Colorectal cancer (CRC) is one of the most common cancers in the USA. In 2017, an estimated 135,420 people were diagnosed with CRC and 50,260 people died from CRC. Several screening modalities are recommended by the United States Preventive Services Task Force (USPSTF), including annual stool tests that are usually completed at home and under-used compared with colonoscopy despite stated patient preferences for an alternative to colonoscopy. The Community Preventive Services Task Force recommends use of small media interventions (SMIs) to increase CRC screening and calls for a greater understanding of its independent impact on screening participation. This study tested whether a SMI increased the likelihood of participant return of a USPSTF recommended Fecal Immunochemical Test (FIT). In total, 804 individuals participated in a two-group, prospective randomized controlled trial. Descriptive statistics with chi-square tests compared differences in participant characteristics and return rates. Multivariable log-binomial modeling estimated combined effects of patient characteristics with FIT return rates. No differences in return rates were observed overall or by participant characteristics other than the year of enrollment. A multivariable model controlling for all covariates, found gender, insurance type, and regular place for healthcare to be significantly associated with return rates. Receipt of the SMI did not independently increase overall return rates but it may have improved the ease of completing the FIT by some participants, particularly women, those with insurance, and those with a regular place for healthcare.

Total Medicare Costs Associated With Diagnosis and Treatment of Prostate Cancer in Elderly Men.

Importance: Localized prostate cancer diagnosis and treatment among elderly men who are not likely to benefit represents a potential source of low-value health care services. Objective: To quantify the costs to the Medicare program associated with detection and treatment of prostate cancer among elderly men in the United States. Design, Setting, and Participants: This nationwide, population-based, retrospective cohort study uses the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database to identify men 70 years or older diagnosed with localized prostate cancer between 2004 and 2007 and to ascertain Medicare costs associated with diagnosis and workup, treatment, follow-up, and morbidity management of the disease. National Medicare costs were estimated using per-person costs, stage-adjusted prostate cancer incidence rates by age from SEER 2007 through 2011, and 2010 Census population estimates by age. Main Outcomes and Measures: Estimated costs to the Medicare program overall, and in each (mutually exclusive) category related to diagnosis and workup, treatment, follow-up, and morbidity management. Results: This nationwide, population-based, retrospective cohort study included 49 692 men with nonmetastatic prostate cancer from the SEER-Medicare database (all participants were 70 years or older; 25 981 [52.3%] were 76 years or older). The median per-patient cost within 3 years after prostate cancer diagnosis was $14 453 (interquartile range [IQR], $4887-$27 899). The majority of this cost was attributable to treatment costs (median, $10 558; IQR, $1990-$23 718). Patients with a Gleason score of 6 or lower who pursued initial conservative management (no treatment within 12 months of diagnosis) had a 3-year median total cost of $1914 per patient. The estimated total 3-year cost to the Medicare program associated with the annual detection of prostate cancer in men 70 years or older is approximately $1.2 billion. Increasing active surveillance use in those with Gleason score of 6 or lower could reduce this cost by $320 million. Conclusions and Relevance: There is substantial cost to the Medicare program associated with the diagnosis and treatment of localized prostate cancer among elderly men in the United States, despite the fact that these men are unlikely to die of prostate cancer. The majority of costs are related to treatment. Reducing provision of low-value health care services among this patient population could result in significant health care savings.

Responding to a Community's Concern: A Comparison of Breast Cancer Characteristics and Initial Treatment in Three Selected North Carolina Counties.

BACKGROUND A 2007 national report identified North Carolina's Edgecombe County as having among the highest breast cancer incidence and mortality rates nationally, motivating the initiation of a task force and other local efforts to address the problem. The goal of this study is to examine county breast cancer characteristics before and after the report, including whether geographic variation may mask racial disparities in this majority African American community.METHOD With guidance from community partners, breast cancer cases from 2000 to 2012 in Edgecombe, Nash, and Orange Counties (N = 2,641) were obtained from the North Carolina Central Cancer Registry. Bivariate and trend analyses of tumor and treatment characteristics were examined by county and race.RESULTS Women in Edgecombe and Nash Counties were diagnosed with more advanced stage, higher grade tumors. African Americans in Edgecombe and Nash Counties were diagnosed with advanced disease more often than African Americans in Orange County. Average time-to-treatment was well within guideline recommendations. Incidence and mortality rates appear to have declined, with variation in measures of racial differences over time.LIMITATIONS Changes in coding standards across the observation period required reliance on coarse measures that may partially mute useful findings.CONCLUSIONS Racial disparities remain a concern in North Carolina; however, they appear to be less profound than in the 2007 national report. The portentous statistics in the report represent an all-time high, after which some, but not all, measures reflect positive change amidst ongoing local efforts to improve breast cancer knowledge and care.

For U.S. Black women, shift of hysterectomy to outpatient settings may have lagged behind White women: a claims-based analysis, 2011-2013.

BACKGROUND: Hysterectomy is among the most common surgeries performed on U.S. women. For benign conditions, minimally invasive hysterectomy is recommended, whenever permitted by clinical indication and previous surgery history. No study has examined whether the use of less invasive hysterectomy spread more slowly for Black women. METHODS: We used the hysterectomy that occurs in outpatient settings as a proxy for minimally invasive hysterectomy. Using claims-based surgery data and census denominators, we calculated age-standardized rates of all hysterectomies in North Carolina from 2011 to 2013. Study participants were 41,899 women (64.6% non-Hispanic White, 28.3% non-Hispanic Black) who underwent hysterectomy for non-malignant indications. We fit Poisson models to determine whether changes in outpatient hysterectomy rates differed by Black-White race. We employed a difference-in-difference approach to control for racial differences in the severity of clinical indication. Further, we restricted to one state to minimize confounding from geographic differences in where Black and White women live. RESULTS: From 2011 to 2013, the overall hysterectomy rate decreased from 42.3 per 10,000 women (n = 14,648) to 37.9 per 10,000 (n = 13,241) (p < 0.0001). Most hysterectomy (67.6%) occurred in outpatient settings. The inpatient rate decreased 35.2% (p < 0.0001), to 10.3 per 10,000, while the outpatient rate increased 4.6% (p < 0.01), to 27.5 per 10,000. From 2011 to 2013, Black women's outpatient rate increased 22% (p < 0.0001): from 25.8 per 10,000 to 31.5. In contrast, among White women, outpatient rates remained stable (p = 0.79): at 28.3 per 10,000 in 2013. CONCLUSIONS: Rapid increases in outpatient hysterectomy among Black women compared to stable rates among White women indicate a race-specific catch-up phenomenon in the spread of minimally invasive hysterectomy. These results are consistent with the hypothesis that minimally invasive hysterectomy may have been adopted more slowly for Black women than their White counterparts after its introduction in the early 2000s. The persistently high rates of hysterectomy among young Black women and potentially slower adoption of minimally invasive procedures among these women highlight a potential racial disparity in women's healthcare.

Peer Connect for African American breast cancer survivors and caregivers: a train-the-trainer approach for peer support.

Racial disparities in breast cancer survivorship are a major concern nationally. How survivors cope with cancer and re-frame their lives is a critical part of survivorship. Community-academic research partnerships may facilitate access to much-needed psychosocial support for African American survivors and caregivers in rural areas, but drivers of successful intervention implementation are not well understood. The purpose of this study was to describe the training and evaluation of Community Coaches and Guides (i.e., peer supporters) using the Peer Connect program for African American breast cancer survivors and caregivers. Community engagement strategies were used to implement the training component of Peer Connect, an evidence-based program grounded in the Diffusion of Innovation Theory utilizing motivational interviewing techniques (MI) and a "train-the-trainer" model. Quantitative and qualitative methods examined implementation outcomes of feasibility, MI fidelity, and acceptability-precursor outcomes that must be achieved before examining intervention impact vis-à-vis changes in support care. Training was feasible to implement and replicable by the trained Community Coaches. Beyond feasibility and replicability, success was modest regarding MI fidelity. Benefits (e.g., serving as role models and having safe sources of support) and lessons learned (e.g., need for additional quality control) were identified as both facilitators and barriers to implementation and as factors that could impact the effectiveness of community-engaged programs to improve survivorship outcomes. Peer Connect, like other programs that employ community-engagement strategies, holds promise to meet the psychosocial support needs of diverse rural cancer survivor populations.

Association Between Choice of Radical Prostatectomy, External Beam Radiotherapy, Brachytherapy, or Active Surveillance and Patient-Reported Quality of Life Among Men With Localized Prostate Cancer.

Importance: Patients diagnosed with localized prostate cancer have to decide among treatment strategies that may differ in their likelihood of adverse effects. Objective: To compare quality of life (QOL) after radical prostatectomy, external beam radiotherapy, and brachytherapy vs active surveillance. Design, Setting, and Participants: Population-based prospective cohort of 1141 men (57% participation among eligible men) with newly diagnosed prostate cancer were enrolled from January 2011 through June 2013 in collaboration with the North Carolina Central Cancer Registry. Median time from diagnosis to enrollment was 5 weeks, and all men were enrolled with written informed consent prior to treatment. Final follow-up date for current analysis was September 9, 2015. Exposures: Treatment with radical prostatectomy, external beam radiotherapy, brachytherapy, or active surveillance. Main Outcomes and Measures: Quality of life using the validated instrument Prostate Cancer Symptom Indices was assessed at baseline (pretreatment) and 3, 12, and 24 months after treatment. The instrument contains 4 domains-sexual dysfunction, urinary obstruction and irritation, urinary incontinence, and bowel problems-each scored from 0 (no dysfunction) to 100 (maximum dysfunction). Propensity-weighted mean domain scores were compared between each treatment group vs active surveillance at each time point. Results: Of 1141 enrolled men, 314 pursued active surveillance (27.5%), 469 radical prostatectomy (41.1%), 249 external beam radiotherapy (21.8%), and 109 brachytherapy (9.6%). After propensity weighting, median age was 66 to 67 years across groups, and 77% to 80% of participants were white. Across groups, propensity-weighted mean baseline scores were 41.8 to 46.4 for sexual dysfunction, 20.8 to 22.8 for urinary obstruction and irritation, 9.7 to 10.5 for urinary incontinence, and 5.7 to 6.1 for bowel problems. Compared with active surveillance, mean sexual dysfunction scores worsened by 3 months for patients who received radical prostatectomy (36.2 [95% CI, 30.4-42.0]), external beam radiotherapy (13.9 [95% CI, 6.7-21.2]), and brachytherapy (17.1 [95% CI, 7.8-26.6]). Compared with active surveillance at 3 months, worsened urinary incontinence was associated with radical prostatectomy (33.6 [95% CI, 27.8-39.2]); acute worsening of urinary obstruction and irritation with external beam radiotherapy (11.7 [95% CI, 8.7-14.8]) and brachytherapy (20.5 [95% CI, 15.1-25.9]); and worsened bowel symptoms with external beam radiotherapy (4.9 [95% CI, 2.4-7.4]). By 24 months, mean scores between treatment groups vs active surveillance were not significantly different in most domains. Conclusions and Relevance: In this cohort of men with localized prostate cancer, each treatment strategy was associated with distinct patterns of adverse effects over 2 years. These findings can be used to promote treatment decisions that incorporate individual preferences.

Comparison of Patient Report and Medical Records of Comorbidities: Results From a Population-Based Cohort of Patients With Prostate Cancer.

IMPORTANCE: The comorbid conditions of patients with cancer affect treatment decisions, which in turn affect survival and health-related quality-of-life outcomes. Comparative effectiveness research studies must account for these conditions via medical record abstraction or patient report. OBJECTIVE: To examine the agreement between medical records and patient reports in assessing comorbidities. DESIGN, SETTING, AND PARTICIPANTS: Patient-reported information and medical records were prospectively collected as part of the North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study, a population-based cohort of 881 patients with newly diagnosed localized prostate cancer enrolled in the North Carolina Central Cancer Registry from January 1, 2011, through June 30, 2013. The presence or absence of 20 medical conditions was compared based on patient report vs abstraction of medical records. MAIN OUTCOMES AND MEASURES: Agreement between patient reports and medical records for each condition was assessed using the κ statistic. Subgroup analyses examined differences in κ statistics based on age, race, marital status, educational level, and income. Logistic regression models for each condition examined factors associated with higher agreement. RESULTS: A total of 881 patients participated in the study (median age, 65 years; age range, 41-80 years; 633 white [71.9%]). In 16 of 20 conditions, there was agreement between patient reports and medical records for more than 90% of patients; agreement was lowest for hyperlipidemia (68%; κ = 0.36) and arthritis (66%; κ = 0.14). On multivariable analysis, older age (≥70 years old) was significantly associated with lower agreement for myocardial infarction (odds ratio [OR], 0.31; 95% CI, 0.12-0.80), cerebrovascular disease (OR, 0.10; 95% CI, 0.01-0.78), coronary artery disease (OR, 0.37; 95% CI, 0.20-0.67), arrhythmia (OR, 0.44; 95% CI, 0.25-0.79), and kidney disease (OR, 0.18; 95% CI, 0.06-0.52). Race and educational level were not significantly associated with κ in 18 of 19 modeled conditions. CONCLUSIONS AND RELEVANCE: Overall, patient reporting provides information similar to medical record abstraction without significant differences by patient race or educational level. Use of patient reports, which are less costly than medical record audits, is a reasonable approach for observational comparative effectiveness research.

Using Procedure Codes to Define Radiation Toxicity in Administrative Data: The Devil is in the Details.

BACKGROUND: Systematic coding systems are used to define clinically meaningful outcomes when leveraging administrative claims data for research. How and when these codes are applied within a research study can have implications for the study validity and their specificity can vary significantly depending on treatment received. SUBJECTS: Data are from the Surveillance, Epidemiology, and End Results-Medicare linked dataset. STUDY DESIGN: We use propensity score methods in a retrospective cohort of prostate cancer patients first examined in a recently published radiation oncology comparative effectiveness study. RESULTS: With the narrowly defined outcome definition, the toxicity event outcome rate ratio was 0.88 per 100 person-years (95% confidence interval, 0.71-1.08). With the broadly defined outcome, the rate ratio was comparable, with 0.89 per 100 person-years (95% confidence interval, 0.76-1.04), although individual event rates were doubled. Some evidence of surveillance bias was suggested by a higher rate of endoscopic procedures the first year of follow-up in patients who received proton therapy compared with those receiving intensity-modulated radiation treatment (11.15 vs. 8.90, respectively). CONCLUSIONS: This study demonstrates the risk of introducing bias through subjective application of procedure codes. Careful consideration is required when using procedure codes to define outcomes in administrative data.

Are Small Reimbursement Changes Enough to Change Cancer Care? Reimbursement Variation in Prostate Cancer Treatment.

PURPOSE: The Centers for Medicare and Medicaid Services recently initiated small reimbursement adjustments to improve the value of care delivered under fee-for-service. To estimate the degree to which reimbursement influences physician decision making, we examined utilization of gonadotropin-releasing hormone (GnRH) agonists among urologists as Part B drug reimbursement varied in a fee-for-service environment. METHODS: We analyzed treatment patterns of urologists treating 15,128 men included in SEER-linked Medicare claims who were diagnosed with localized prostate cancer between January 1, 2000, and December 31, 2003. We calculated a reimbursement generosity index to measure differences in GnRH agonist reimbursement among regional Medicare carriers and over time. We used multilevel analysis to control for patient and provider characteristics. RESULTS: Among urologists treating early-stage and lower grade prostate cancer, variation in reimbursement was not associated with overuse of GnRH agonists from 2000 to 2003, a period of guideline stability (odds ratio, 1.00; 95% CI, 0.99 to 1.00). CONCLUSION: Small differences in androgen-deprivation therapy reimbursement generosity were not associated with differential use. Fee-for-service reimbursement changes currently being implemented to improve quality in fee-for-service Medicare may not affect patterns of cancer care.

Enrollment and Racial Disparities in Cancer Treatment Clinical Trials in North Carolina.

BACKGROUND: Clinical trials provide access to innovative, high-quality cancer treatment. Simultaneously, broad access helps to ensure that trials include heterogeneous patient populations, which improves the generalizability of findings and the development of interventions that are effective for diverse populations. We provide updated data describing enrollment into cancer treatment trials in North Carolina. METHODS: For the period 1996-2009, person-level data regarding cancer clinical trial enrollment and cancer incidence were obtained from the North Carolina Central Cancer Registry and the National Cancer Institute (NCI). Enrollment rates were estimated as the ratio of trial enrollment to cancer incidence for race, sex, and year for each county, Area Health Education Center region, and the state overall. Enrollment rates for common cancers are presented. RESULTS: From 1996 to 2009, North Carolina NCI treatment trial enrollment rates were 2.4% and 2.2% for white patients and minority patients, respectively. From 2007 to 2009, rates were 3.8% for white women, 3.5% for minority women, 1.3% for white men, and 1.0% for minority men; there was greater enrollment among more urban populations (2.4%) than among the most rural populations (1.5%). LIMITATIONS: This study is limited to NCI-sponsored treatment trials in North Carolina. Policies governing collection of original data necessitate a delay in data availability. CONCLUSIONS: Effort is needed to ensure trial access and enrollment among all North Carolina populations. Specifically, we identified racial and sex disparities, particularly for certain cancers (eg, breast cancer). Programs in North Carolina and across the nation can use the methods we employed to assess their success in broadening clinical trial enrollment to include diverse populations.

Racial Differences in Diffusion of Intensity-Modulated Radiation Therapy for Localized Prostate Cancer.

Intensity-modulated radiation therapy (IMRT), an innovative treatment option for prostate cancer, has rapidly diffused over the past decade. To inform our understanding of racial disparities in prostate cancer treatment and outcomes, this study compared diffusion of IMRT in African American (AA) and Caucasian American (CA) prostate cancer patients during the early years of IMRT diffusion using the Surveillance, Epidemiology and End Results (SEER)-Medicare linked database. A retrospective cohort of 947 AA and 10,028 CA patients diagnosed with localized prostate cancer from 2002 through 2006, who were treated with either IMRT or non-IMRT as primary treatment within 1 year of diagnoses was constructed. Logistic regression was used to examine potential differences in diffusion of IMRT in AA and CA patients, while adjusting for socioeconomic and clinical covariates. A significantly smaller proportion of AA compared with CA patients received IMRT for localized prostate cancer (45% vs. 53%, p < .0001). Racial differences were apparent in multivariable analysis though did not achieve statistical significance, as time and factors associated with race (socioeconomic, geographic, and tumor related factors) explained the preponderance of variance in use of IMRT. Further research examining improved access to innovative cancer treatment and technologies is essential to reducing racial disparities in cancer care.

Comparative Effectiveness of Oxaliplatin Versus 5-flourouricil in Older Adults: An Instrumental Variable Analysis.

BACKGROUND: Oxaliplatin was rapidly adopted for treatment of stage III colon cancer after FDA approval in November 2004, thus providing an opportunity to use calendar time as an instrumental variable in nonexperimental comparative effectiveness research. Assuming instrument validity, instrumental variable analyses account for unmeasured confounding and are particularly valuable in sub-populations of unresolved effectiveness, such as older individuals. METHODS: We examined stage III colon cancer patients ages 65+ years initiating chemotherapy between 2003 and 2008 using US population-based cancer registry data linked with Medicare claims (N = 3,660). Risk differences for all-cause mortality were derived from Kaplan-Meier survival curves. We examined instrumental variable strength and compared risk differences with propensity score estimates. RESULTS: Calendar time greatly affected oxaliplatin receipt. The calendar time instrument compared patients treated from January 2003 through September 2004 (N = 1,449) with those treated from March 2005 through May 2007 (N = 1,432), resulting in 54% compliance. The 1-, 2-, and 3-year local average treatment effect of the risk differences per 100 patients in the "compliers" (95% confidence intervals) were -4.6 (-8.2, -0.44), -6.3 (-12, -0.16), and -9.2 (-15, -2.5), respectively. Corresponding propensity score-matched results were -1.9 (-4.0, 0.2), -3.4 (-6.2, -0.05), and -4.3 (-7.5, -0.96). CONCLUSIONS: Instrumental variable and propensity score analyses both indicate better survival among patients treated with oxaliplatin. As these results are based on different populations and assumptions, the instrumental variable analysis adds to evidence of oxaliplatin's effectiveness in older adults, who bear the greatest burden of colon cancer yet were underrepresented in clinical trials. In nonexperimental comparative effectiveness research of rapidly emerging therapies, the potential to use calendar time as an instrumental variable is worth consideration.

Perceptions of Cancer Clinical Research Among African American Men in North Carolina.

ACKNOWLEDGEMENTS: The authors are grateful to the men and women who participated in our Focus Groups and shared with us their very personal cancer experience. Their insight is valuable, and will inform and improve cancer care for future generations. The authors thank the Greensboro area Community Research Advocates - especially April Durr, Elvira Mebane, Marie McAdoo, Kathy Norcott, and Cindy Taylor - who assisted in the conduct of the study, including interpretation of results. They also thank Gratia Wright of First Research Group for her expertise in moderating and executing all of the focus groups, and Lindsey Haynes-Maslow for her assistance in responding to reviewer comments. The study was funded as a part of the Carolina Community Network program, funded by a grant from the National Cancer Institute (U01-CA114629). This study was reviewed and approved by the Institutional Review Board (IRB) at the University of North Carolina at Chapel Hill. OBJECTIVE: The problem of cancer health disparities is substantial. Clinical trials are widely advocated as a means of reducing disparities and bringing state-of-the-art care to the broader community, where most cancer care is delivered. This study sought to develop a better understanding of why disproportionately few African American men enroll in clinical trials given their substantial cancer burden. DESIGN: This study applied community-based participatory research (CBPR) methods to design and conduct four focus groups of African American male cancer survivors and their caregivers in North Carolina. RESULTS: Among major themes, participants expressed confusion about the relationship between clinical trials, treatment, and research: signifying patient confusion and misinterpretation of common clinical trial terminology. Social norms including gender barriers and generational differences remain problematic; participants often reported that men do not talk about health issues, are unwilling to go to the doctor, and exhibit misapprehension and distrust regarding trials. Participants perceived this misunderstanding as detrimental to community health and expressed the need for more clarity in clinical trials information and a more fundamental social openness and communication about cancer detection and treatment. CONCLUSION: Findings indicate the importance of clinical trial education in both traditional provider referral to trials and also in general patient navigation. To dispel pervasive misapprehension regarding placebos, clinical trial information should emphasize the role of standard care in modern cancer treatment trials. Many participants described willingness to participate in a trial upon physician recommendation, suggesting merit in improving patient-physician communication through culturally competent terminology and trial referral systems.

Design of the North Carolina Prostate Cancer Comparative Effectiveness and Survivorship Study (NC ProCESS).

The North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS) was designed in collaboration with stakeholders to compare the effectiveness of different treatment options for localized prostate cancer. Using the Rapid Case Ascertainment system of the North Carolina Central Cancer Registry, 1,419 patients (57% of eligible) with newly-diagnosed localized prostate cancer were enrolled from January 2011 to June 2013, on average 5 weeks after diagnosis. All participants were enrolled prior to treatment and this population-based cohort is sociodemographically diverse. Prospective follow-up continues to collect data on treatments received, disease control, survival and patient-reported outcomes. This study highlights several important considerations regarding stakeholder involvement, study design and generalizability regarding comparative effectiveness research in prostate cancer.

Provider-based research networks and diffusion of surgical technologies among patients with early-stage kidney cancer.

BACKGROUND: Provider-based research networks such as the National Cancer Institute's Community Clinical Oncology Program (CCOP) have been shown to facilitate the translation of evidence-based cancer care into clinical practice. This study compared the utilization of laparoscopy and partial nephrectomy among patients with early-stage kidney cancer according to their exposure to CCOP-affiliated providers. METHODS: With linked Surveillance, Epidemiology, and End Results-Medicare data, patients with T1aN0M0 kidney cancer who had been treated with nephrectomy from 2000 to 2007 were identified. For each patient, the receipt of care from a CCOP physician or hospital and treatment with laparoscopy or partial nephrectomy were determined. Adjusted for patient characteristics (eg, age, sex, and marital status) and other organizational features (eg, community hospital and National Cancer Institute-designated cancer center), multivariate logistic regression was used to estimate the association between each surgical innovation and CCOP affiliation. RESULTS: During the study interval, 1578 patients (26.8%) were treated by a provider with a CCOP affiliation. Trends in the utilization of laparoscopy and partial nephrectomy remained similar between affiliated and nonaffiliated providers (P ≥ .05). With adjustments for patient characteristics, organizational features, and clustering, no association was noted between CCOP affiliation and the use of laparoscopy (odds ratio [OR], 1.11; 95% confidence interval [CI], 0.81-1.53) or partial nephrectomy (OR, 1.04; 95% CI, 0.82-1.32) despite the more frequent receipt of these treatments in academic settings (P < .05). CONCLUSIONS: At a population level, patients treated by providers affiliated with CCOP were no more likely to receive at least 1 of 2 surgical innovations for treatment of their kidney cancer, indicating perhaps a more limited scope to provider-based research networks as they pertain to translational efforts in cancer care.

Provider-based research networks may improve early access to innovative colon cancer treatment for African Americans treated in the community.

BACKGROUND: African American (AA) patients with colon cancer (CC) experience worse outcomes than whites partly due to differential treatment. The National Cancer Institute's Community Clinical Oncology Program (CCOP), a provider-based research network, adopts and diffuses innovative CC treatments quickly. The authors hypothesized that CCOP participation would lessen racial differences in the receipt of oxaliplatin, an innovative treatment for CC, among patients with stage III CC in the community. METHODS: Using Surveillance, Epidemiology, and End Results (SEER)-Medicare data, the authors performed a population-based retrospective cohort study of AA and white individuals aged ≥66 years who were diagnosed with AJCC stage III CC from 2003 through 2005. Generalized estimating equations were used to calculate the odds of receiving an oxaliplatin-containing regimen. Predicted probabilities of oxaliplatin receipt for race-CCOP combinations were calculated. The absolute difference in oxaliplatin receipt between races was estimated using the interaction contrast ratio. RESULTS: Of 2971 included individuals, 36% received oxaliplatin, 29.5% were CCOP-affiliated, and 7.6% were AA. On multivariate analysis, early diffusion of oxaliplatin was not found to be associated with race or CCOP participation. The probability of receiving oxaliplatin for AAs participating in a CCOP (0.46) was nearly double that of AAs who were not participating in a CCOP (0.25; P <.05). For white individuals, the probabilities of receiving oxaliplatin did not differ by CCOP participation. For oxaliplatin receipt, the joint effects assessment suggested a greater benefit of CCOP participation among AAs (interaction contrast ratio, 1.7). CONCLUSIONS: Among older patients with stage III CC, there is a differential impact of race on oxaliplatin receipt depending on CCOP participation. AAs treated by CCOPs were more likely to receive oxaliplatin than AAs treated elsewhere. Provider-based research networks may facilitate early access to innovative treatment for AAs with stage III CC.