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Compared with urban residents, rural Americans have seen slower declines in cancer deaths, have lower incidence but higher death rates from cancers that can be prevented through screening, have lower screening rates, are more likely to present with later-stage cancers, and have poorer cancer outcomes and lower survival. Rural health provider shortages and lack of cancer services may explain some disparities. The literature was reviewed to identify factors contributing to rural health care capacity shortages and propose policy recommendations for improving rural cancer care. Uncompensated care, unfavorable payer mix, and low patient volume impede rural physician recruitment and retainment. Students from rural areas are more likely to practice there but are less likely to attend medical school because of lower graduation rates, grades, and Medical College Admission Test (MCAT) scores versus urban students. The cancer care infrastructure is costly and financially challenging in rural areas with high proportions of uninsured and publicly insured patients. A lack of data on oncology providers and equipment impedes coordinated efforts to address rural shortages. Graduate Medical Education funding greatly favors large, urban, tertiary care teaching hospitals over residency training in rural, critical access and community-based hospitals and clinics. Policies have the potential to transform rural health care. This includes increasing advanced practice provider postgraduate oncology training opportunities and expanding the scope of practice; improving health workforce and services data collection and aggregation; transforming graduate medical education subsidies to support rural student recruitment and rural training opportunities; and expanding federal and state financial incentives and payments to support the rural cancer infrastructure.

Background Patient navigation is an increasingly widespread intervention to address the persistent, severe, and disproportionate breast cancer (BC) burden that African Americans (AA) face. Navigation may have more widespread effects than previously estimated due to patient-driven diffusion of BC information. Methods This pilot study examined the network effects of a randomized controlled trial via recruitment of navigated and non-navigated AA BC patients as well as their network members. We estimated study arm differences in patient BC promotion (i.e., number of individuals to whom BC patients promote BC screening) and network BC screening (i.e., % BC screening among network members). Results Among our sample of 100 AA BC patients, navigated patients promoted BC screening to more individuals than non-navigated patients. BC patients were more likely to promote BC screening to children and individuals with whom they communicated more frequently. Some models further suggested more network BC screening among "navigated" network members relative to "non-navigated" network members. Conclusions Navigated AA patients promoted BC screening more widely throughout their networks than non-navigated AA BC patients. There were also suggestive findings regarding increased BC screening among their network members. Our pilot study highlights the potential for social network analysis to improve the precision of intervention effect estimates and to inform future innovations (e.g., integrating navigation and network-based interventions) with multilevel effects on cancer health disparities.

PURPOSE: More than half of patients with head and neck squamous cell carcinoma (HNSCC) experience a delay initiating guideline-adherent postoperative radiation therapy (PORT), contributing to excess mortality and racial disparities in survival. However, interventions to improve the delivery of timely, equitable PORT among patients with HNSCC are lacking. This study (1) describes the development of NDURE (Navigation for Disparities and Untimely Radiation thErapy), a navigation-based multilevel intervention (MLI) to improve guideline-adherent PORT and (2) evaluates its feasibility, acceptability, and preliminary efficacy. METHODS: NDURE was developed using the six steps of intervention mapping (IM). Subsequently, NDURE was evaluated by enrolling consecutive patients with locally advanced HNSCC undergoing surgery and PORT (n = 15) into a single-arm clinical trial with a mixed-methods approach to process evaluation. RESULTS: NDURE is a navigation-based MLI targeting barriers to timely, guideline-adherent PORT at the patient, healthcare team, and organizational levels. NDURE is delivered via three in-person navigation sessions anchored to case identification and surgical care transitions. Intervention components include the following: (1) patient education, (2) travel support, (3) a standardized process for initiating the discussion of expectations for PORT, (4) PORT care plans, (5) referral tracking and follow-up, and (6) organizational restructuring. NDURE was feasible, as judged by accrual (88% of eligible patients [100% Blacks] enrolled) and dropout (n = 0). One hundred percent of patients reported moderate or strong agreement that NDURE helped solve challenges starting PORT; 86% were highly likely to recommend NDURE. The rate of timely, guideline-adherent PORT was 86% overall and 100% for Black patients. CONCLUSION: NDURE is a navigation-based MLI that is feasible, is acceptable, and has the potential to improve the timely, equitable, guideline-adherent PORT.

African American (AA) women experience much greater mortality due to breast cancer (BC) than non-Latino Whites (NLW). Clinical patient navigation is an evidence-based strategy used by healthcare institutions to improve AA women's breast cancer outcomes. While empirical research has demonstrated the potential effect of navigation interventions for individuals, the population-level impact of navigation on screening, diagnostic completion, and stage at diagnosis has not been assessed. An agent-based model (ABM), representing 50-74-year-old AA women and parameterized with locally sourced data from Chicago, is developed to simulate screening mammography, diagnostic resolution, and stage at diagnosis of cancer. The ABM simulated three counterfactual scenarios: (1) a control setting without any navigation that represents the "standard of care"; (2) a clinical navigation scenario, where agents receive navigation from hospital-affiliated staff; and (3) a setting with network navigation, where agents receive clinical navigation and/or social network navigation (i.e., receiving support from clinically navigated agents for breast cancer care). In the control setting, the mean population-level screening mammography rate was 46.3% (95% CI: 46.2%, 46.4%), the diagnostic completion rate was 80.2% (95% CI: 79.9%, 80.5%), and the mean early cancer diagnosis rate was 65.9% (95% CI: 65.1%, 66.7%). Simulation results suggest that network navigation may lead up to a 13% increase in screening completion rate, 7.8% increase in diagnostic resolution rate, and a 4.9% increase in early-stage diagnoses at the population-level. Results suggest that systems science methods can be useful in the adoption of clinical and network navigation policies to reduce breast cancer disparities.

It is not known whether implementation of Medicaid expansion under the Patient Protection and Affordable Care Act (ACA) was associated with improvements in the outcomes among racial and ethnic minority adults at risk of diabetes-related major amputations.To explore the association of early Medicaid expansion with outcomes of diabetic foot ulcerations (DFUs).This cohort study included hospitalizations for DFUs among African American, Asian and Pacific Islander, American Indian or Alaska Native, and Hispanic adults as well as adults with another minority racial or ethnic identification aged 20 to 64 years. Data were collected from the State Inpatient Databases for 19 states and the District of Columbia for 2013 to the third quarter of 2015. The analysis was performed on December 4, 2019, and updated on November 9, 2021.States were categorized into early-adopter states (expansion by January 2014) and nonadopter states.Poisson regression was performed to examine the associations of state type, time, and their combined association with the proportional changes of major amputation rate per year per 100 000 population.Among the 115 071 hospitalizations among racial and ethnic minority adults with DFUs (64% of sample aged 50 to 64 years; 35%, female; 61%, African American; 25%, Hispanic; 14%, other racial and ethnic minority group), there were 36 829 hospitalizations (32%) for Medicaid beneficiaries and 10 500 hospitalizations (9%) for uninsured patients. Hospitalizations increased 3% (95% CI, 1% to 5%) in early-adopter states and increased 8% (95% CI, 6% to 10%) in nonadopter states after expansion, a significant difference (P for interaction .001). Although there was no change in the amputation rate (0.08%; 95% CI, -6% to 7%) in early-adopter states after expansion, there was a 9% (95% CI, 3% to 16%) increase in nonadopter states, a significant change (P = .04). For uninsured adults, the amputation rate decreased 33% (95% CI, 10% to 50%) in early-adopter states and did not change (12%; 95% CI, -10% to 38%) in nonadopter states after expansion, a significant difference (P = .006). There was no difference in the change of amputation rate among Medicaid beneficiaries between state types after expansion.This study found a relative improvement in the major amputation rate among African American, Hispanic, and other racial and ethnic minority adults in early-expansion states compared with nonexpansion states, which could be because of the recruitment of at-risk uninsured adults into the Medicaid program during the first 2 years of ACA implementation. Future study is required to evaluate the long-term association of Medicaid expansion and the rates of amputation.

Patient navigation is an increasingly widespread intervention to address the persistent, severe, and disproportionate breast cancer (BC) burden that African Americans (AA) face. Navigation may have more widespread effects than previously estimated due to patient-driven diffusion of BC information.This pilot study examined the network effects of a randomized controlled trial via recruitment of navigated and non-navigated AA BC patients as well as their network members. We estimated study arm differences in patient BC promotion (i.e., number of individuals to whom BC patients promote BC screening) and network BC screening (i.e., % BC screening among network members).Among our sample of 100 AA BC patients, navigated patients promoted BC screening to more individuals than non-navigated patients. BC patients were more likely to promote BC screening to children and individuals with whom they communicated more frequently. Some models further suggested more network BC screening among "navigated" network members relative to "non-navigated" network members.Navigated AA patients promoted BC screening more widely throughout their networks than non-navigated AA BC patients. There were also suggestive findings regarding increased BC screening among their network members. Our pilot study highlights the potential for social network analysis to improve the precision of intervention effect estimates and to inform future innovations (e.g., integrating navigation and network-based interventions) with multilevel effects on cancer health disparities.

ObjectivesPrior research has reported an increased risk of fatality for patients with cancer, but most studies investigated the risk by comparing cancer to non-cancer patients among COVID-19 infections, where cancer might have contributed to the increased risk. This study is to understand COVID-19’s imposed HR of fatality while controlling for covariates, such as age, sex, metastasis status and cancer type.MethodsWe conducted survival analyses of 4606 cancer patients with COVID-19 test results from 16 March to 11 October 2020 in UK Biobank and estimated the overall HR of fatality with and without COVID-19 infection. We also examined the HRs of 13 specific cancer types with at least 100 patients using a stratified analysis.ResultsCOVID-19 resulted in an overall HR of 7.76 (95% CI 5.78 to 10.40, p−10) by following 4606 patients with cancer for 21 days after the tests. The HR varied among cancer type, with over a 10-fold increase in fatality rate (false discovery rate ≤0.02) for melanoma, haematological malignancies, uterine cancer and kidney cancer. Although COVID-19 imposed a higher risk for localised versus distant metastasis cancers, those of distant metastases yielded higher overall fatality rates due to their multiplicative effects.DiscussionThe results confirmed prior reports for the increased risk of fatality for patients with COVID-19 plus hematological malignancies and demonstrated similar findings of COVID-19 on melanoma, uterine, and kidney cancers.ConclusionThe results highlight the heightened risk that COVID-19 imposes on localised and haematological cancer patients and the necessity to vaccinate uninfected patients with cancer promptly, particularly for the cancer types most influenced by COVID-19. Results also suggest the importance of timely care for patients with localised cancer, whether they are infected by COVID-19 or not.

IntroductionPrior research has reported an increased risk of fatality for cancer patients, but most studies investigated the risk by comparing cancer patients to non-cancer patients among COVID-19 infections. Only a few studies have compared the impact of a COVID-19 infection to non-infection with matched cancer patients and types.Methods & MaterialsWe conducted survival analyses of 4,606 cancer patients with COVID-19 test results from March 16 to October 11, 2020 in UK Biobank and estimated the overall hazard ratio of fatality with and without COVID-19 infection. We also examined the hazard ratios of thirteen specific cancer types with at least 100 patients.ResultsCOVID-19 resulted in an overall hazard ratio of 7.76 (95% CI: [5.78, 10.40], p−10) by studying the survival rate of 4,606 cancer patients for 21-days after the tests. The hazard ratio was shown to vary among cancer type, with over a 10-fold increase in fatality rate (false discovery rate≤0.02) for melanoma, hematologic malignancies, uterine cancer, and kidney cancer using a stratified analysis on each of the cancer types. Although COVID-19 imposed a higher risk for localized cancers compared to distant metastasis ones, those of distant metastasis yielded higher fatality rates due to their multiplicative effects.ConclusionThe results highlight the importance of timely care for localized and hematological cancer patients and the necessity to vaccinate uninfected patients as soon as possible, particularly for the cancer types influenced most by COVID-19.

The COVID-19 pandemic has resulted in substantial morbidity and mortality and challenged public health agencies and healthcare systems worldwide. In the U.S., physical distancing orders and other restrictions have had severe economic and societal consequences. Populations already vulnerable in the United States have experienced worse COVID-19 health outcomes. The World Health Organization has made recommendations to engage at risk populations and communicate accurate information about risk and prevention; to conduct contract tracing; and to support those affected by COVID-19. This Commentary highlights the ways in which an existing and cost-effective, but underutilized workforce, community health workers and non-clinical patient navigators, should be deployed to address the COVID-19 pandemic. Community health workers and non-clinical patient navigators have skills in community engagement and health communication and are able to gain the trust of vulnerable communities. Furthermore, many community health workers and non-clinical patient navigators have skills in assisting community members with meeting basic needs and with navigating public health and healthcare systems. Members of this workforce are more than prepared to conduct contact tracing. State, local, tribal, and territorial public health agencies and healthcare systems should be collaborating with national, state, and local organizations that represent and employ CHWs/non-clinical patient navigators to determine how to better mobilize this workforce to address the COVID-19 pandemic. Furthermore, Congress, the Centers for Medicare & Medicaid Services (CMS), and individual states need to adopt policies to sustainably fund their critically needed services in the long term.

Introduction: Standard economic evaluation methods may underestimate the value of health equity interventions by focusing exclusively on program costs and direct effects on participants' health. Yet, these interventions have spillover effects – wherein participants transition from being intervention recipients to becoming health advocates for their social networks. Consequently, interventions may improve the health of participants and other community members who are not directly connected with interventions. This study demonstrates the utility of incorporating spillover effects by comparing incremental cost-effectiveness ratios via a patient navigation intervention to promote mammography screening among African American (AA) women. Specifically, we compare the relative costs and cost-effectiveness when including mammography uptake of: (1) AA intervention participants (egos) only versus (2) AA intervention participants (egos) and their screening eligible social network members (alters). Methods: Our study draws from two studies: (1) an individual randomized trial to test the efficacy of patient navigation on mammography uptake (Patient Navigation in Medically Underserved Areas [PNMUA]) and (2) an observational ancillary study to test the effects of PNMUA on breast cancer survivor egos and their alters (Offering AA Survivors Increased Support [OASIS]). Overall, we used a healthcare system perspective. For 2021 cost data, we collected data from study records and expense reports. For effects data, we used: (1) medical record data for egos' mammography uptake, (2) self-report data from egos regarding their alters' mammography uptake, and (3) self-report data from alters about their own mammography uptake. We consequently computed incremental cost-effectiveness ratios (ICERs), using different data sources, to assess the impact of estimating spillover effects on economic evaluation of patient navigation. Results: Total cost of the intervention was $196,601. The greatest expense were breast cancer navigators' salaries and fringe rates ($126,745). In PNMUA, more navigated vs. non-navigated egos obtained biennial mammograms (45% vs. 39%). In terms of spillover effects, more navigation arm alters obtained biennial mammograms compared to alters in the non-navigated arm (ego self-report: n=1296 vs 949; alter self-report: n=1521 vs. 1195). Navigation had lower value when only incorporating participants' mammography uptake ($3,277 per each additional woman screened) versus when incorporating spillover effects ($2,027-$2,114 per each additional woman screened). Conclusion: Our results suggest breast cancer navigation programs may be more valuable when including spillover effects. This case study provides insight with real-world applicability into integrating spillover effects into economic evaluation. Our methods offer a new avenue for improved cost and effect estimates of health equity interventions, which may be useful for assessing future resource allocation in healthcare practice and policy. Citation Format: Nyahne Bergeron, Veronica Fitzpatrick, Carl Asche, Karriem S. Watson, Aditya S. Khanna, Bridgette Hempstead, Elizabeth A. Calhoun, Jean McDougall, Yamilé Molina. The value of estimating spillover effects in health equity interventions: A case study to promote mammogram uptake among African American women and their social networks [abstract]. In: Proceedings of the AACR Virtual Conference: 14th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2021 Oct 6-8. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr PO-208.

Given the momentum in adopting patient navigation into cancer care, there is a need to understand the contribution of specific navigator activities to improved clinical outcomes. A mixed-methods study combined direct observations of patient navigators within the Patient Navigation Research Program and outcome data from the trial. We correlated the frequency of navigator tasks with the outcome of rate of diagnostic resolution within 365 days among patients who received the intervention relative to controls. A focused content analysis examined those tasks with the strongest correlations between navigator tasks and patient outcomes. Navigating directly with specific patients (r = 0.679), working with clinical providers to facilitate patient care (r = 0.643), and performing tasks not directly related to their diagnostic evaluation for patients were positively associated with more timely diagnosis (r = 0.714). Using medical records for non-navigation tasks had a negative association (r = -0.643). Content analysis revealed service provision directed at specific patients improved care while systems-focused activities did not.

As part of the Patient Navigation Research Program, we examined the effect of patient navigation versus usual care on timely diagnostic follow-up, defined as clinical management for women with cervical abnormalities within accepted time frames.Participants from four Patient Navigation Research Program centers were divided into low- and high-risk abnormality groups and analyzed separately. Low-risk participants (n = 2088) were those who enrolled with an initial Pap test finding of atypical squamous cells of undetermined significance (ASCUS) with a positive high-risk human papillomavirus (HPV) serotype, atypical glandular cells, or low-grade squamous intraepithelial lesion (LGSIL). High-risk participants were those with an initial finding of high-grade squamous intraepithelial lesion (HGSIL) (n = 229). A dichotomous outcome of timely diagnostic follow-up within 180 days was used for the low-risk abnormality group and timely diagnostic follow-up within 60 days for the high-risk group, consistent with treatment guidelines. A logistic mixed-effects regression model was used to evaluate the intervention effect using a random effect for study arm within an institution. A backward selection process was used for multivariable model building, considering the impact of each predictor on the intervention effect.Low-risk women in the patient navigation arm showed an improvement in the odds of timely diagnostic follow-up across all racial groups, but statistically significant effects were only observed in non-English-speaking Hispanics (OR 5.88, 95% CI 2.81-12.29). No effect was observed among high-risk women.These results suggest that patient navigation can improve timely diagnostic follow-up among women with low-risk cervical abnormalities, particularly in non-English-speaking Hispanic women.

Limited socioeconomic resources contribute to high readmission rates at minority serving institutions (MSIs). A better understanding of patient-level factors and need for patient navigators could inform approaches to enhance care transitions tailored to these vulnerable patient populations. We sought to understand the perspectives of patients and their caregivers about hospital to home transitions from an MSI, as well as their attitudes about patient navigators to facilitate care transitions. We conducted qualitative research using focus groups (FGs)-five disease-specific patient FGs and two caregiver FGs, including 23 patients and 10 caregivers. Findings support the need for additional services to address: (1) gaps in the hospital discharge; (2) socioeconomic resources; (3) access to post-discharge care; (4) patient's health care seeking behaviors; (5) patient anxiety; (6) self-management education; and (7) social supports for patients and caregivers. While caregivers uniformly expressed interest in patient navigators, support for navigators among patients was more variable.

Background: Enrollment of early-stage lung cancer patients to randomized trials has historically been challenging. The STARS Trial enrolled 36 of 1,030 intended patients from 28 sites, while the ROSEL Trial recruited 22 of 960 intended patients from 10 sites. Unfortunately, evidence shows African Americans with early-stage NSCLC are significantly less likely than their European American counterparts to undergo resection and may also be less likely to participate in lung cancer trials as well. Purpose: The purpose of this research is to describe interim recruitment results from an NIMHD-funded, NCI NCORP-based patient navigation trial conducted with African Americans with early-stage, probable/proven non-small cell lung cancer (NSCLC). Design: The protocol-driven, barriers-focused patient navigation intervention is being conducted in the context of a two-arm cluster-randomized trial testing the effectiveness of the intervention in increasing rates of lung-directed curative-intent therapy (surgery and SBRT) in African Americans with Stage I-II NSCLC. The 2 study arms consist of the protocol-driven, intensive navigation intervention vs. usual care. The trial includes 20 study sites in 11 US states. Specific activities to enhance recruitment in the present trial include reaching out to referring physicians (e.g., primary care, pulmonologists, radiologists) to increase referrals of African American patients to the participating NCORP sites, and partnering with the leaders of community engagement activities at the sites to raise community-level awareness of the trial. Results/Conclusions: To date, 200 African American patients have been recruited and the trial is now on target to meet its expected accrual goal of 222 patients. The majority of potential participants were ineligible due to receipt of surgical resection or radiation therapy prior to enrollment (24%), not having been told that they had probable/proven NSCLC prior to study contact (22%), or a previous history of lung cancer (10%). The median age of the 200 participants is 65 years (range 40-86 years). Most are unmarried (70%) and have a high school diploma or less (71%). The number of enrolled-to-date African American participants in this ongoing trial exceeds the total number of participants recruited to the STARS Trial or to the ROSEL Trial. Citation Format: Marvella E. Ford, Debbie C. Bryant, Kathleen B. Cartmell, Katherine Sterba, Dana R. Burshell, Elizabeth G. Hill, Joanne Kim, Allan De Toma, Kendrea D. Knight, Ta'Myiah Reed, Kathryn Weaver, Elizabeth Calhoun, Nestor F. Esnaola. Challenges and successes in recruiting African Americans with early-stage, non-small cell lung cancer to an NIMHD-funded, NCORP-based patient navigation trial [abstract]. In: Proceedings of the Eleventh AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2018 Nov 2-5; New Orleans, LA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl):Abstract nr A085.

In the United States, racial/ethnic minority, rural, and low-income populations continue to experience suboptimal access to and quality of health care despite decades of recognition of health disparities and policy mandates to eliminate them. Many health care interventions that were designed to achieve health equity fall short because of gaps in knowledge and translation. We discuss these gaps and highlight innovative interventions that help address them, focusing on cardiovascular disease and cancer. We also provide recommendations for advancing the field of health equity and informing the implementation and evaluation of policies that target health disparities through improved access to care and quality of care.

Objectives One of the aims of the Chicago Cancer Navigation Project (CCNP) is to reduce the interval of time between abnormal breast cancer screening and definitive diagnosis in patients who are navigated as compared to usual care. In this article, we investigate the extent to which total costs of breast cancer navigation can be offset by survival benefits and savings in lifetime breast cancer-attributable costs. Methods Data sources for the cost-effectiveness analysis include data from published literature, secondary data from the NCI's Surveillance Epidemiology and End Results (SEER) program, and primary data from the CCNP. Results If women enrolled in CCNP receive breast cancer diagnosis earlier by 6 months as compared to usual care, then navigation is borderline cost-effective for $95,625 per life-year saved. Results from sensitivity analyses suggest that the cost-effectiveness of navigation is sensitive to: the interval of time between screening and diagnosis, percent increase in number of women who receive cancer diagnosis and treatment, women's age, and the positive predictive value of a mammogram. Conclusions In planning cost-effective navigation programs, special considerations should be made regarding the characteristics of the disease, program participants, and the initial screening test that determines program eligibility.

Background: Enrollment of early-stage lung cancer patients to randomized trials has historically been challenging. The STARS Trial enrolled 36 of 1,030 intended patients from 28 sites, while the ROSEL Trial recruited 22 of 960 intended patients from 10 sites. Unfortunately, evidence shows African Americans with early-stage non-small cell lung cancer (NSCLC) are significantly less likely than their European American counterparts to undergo resection and may also be less likely to participate in lung cancer trials as well. Purpose: The purpose of this research is to describe interim recruitment results from an NIMHD-funded, NCI NCORP-based patient navigation trial conducted with African Americans with early-stage, probable/proven NSCLC. Design: The protocol-driven, barriers-focused patient navigation intervention is being conducted in the context of a two-arm cluster-randomized trial testing the effectiveness of the intervention in increasing rates of lung-directed curative-intent therapy (surgery and SBRT) in African Americans with Stage I-II NSCLC. The two study arms consist of the protocol-driven, intensive navigation intervention vs. usual care. The trial includes 24 study sites in 13 U.S. states. Specific activities to enhance recruitment in the present trial include reaching out to referring physicians (e.g., primary care, pulmonologists, radiologists) to increase referrals of African American patients to the participating NCORP sites, and partnering with the leaders of community-engagement activities at the sites to raise community-level awareness of the trial. Results/Conclusions: To date, 90 African American patients have been recruited and the trial is now on target to meet its expected accrual goal of 200 patients. The majority of potential participants were ineligible due to receipt of surgical resection or radiation therapy prior to enrollment (27%), not having been told that they had probable/proven NSCLC prior to study contact (32%), or a previous history of lung cancer (10%). Only 13 potential participants have refused trial participation. The median age of the 90 participants is 66 years (range 51-86 years). Most are unmarried (64%) and have a high school diploma or less (73%). Only 10 of the participants (24%) have no comorbidities. The number of enrolled-to-date African American participants in this ongoing trial exceeds the total number of participants recruited to the STARS Trial or to the ROSEL Trial. Citation Format: Marvella E. Ford, Debbie C. Bryant. Kathleen B. Cartmell, Katherine Sterba, Dana R. Burshell, Elizabeth G. Hill, Allan De Toma, Kendrea D. Knight, Kathryn Weaver Elizabeth Calhoun, Nestor F. Esnaola. Interim Recruitment Outcomes in an NCORP-Based Patient Navigation Trial for African Americans with Early Stage Lung Cancer [abstract]. In: Proceedings of the Tenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2017 Sep 25-28; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2018;27(7 Suppl):Abstract nr A23.

Challenges arise when people contemplate cancer screening. They multiply when tests suggest a threatening disease and indicate the need for follow-up investigations. And the challenges expand dramatically when such investigations reveal cancer, as people become “patients” in the complex realm of referrals, consultants, examinations, decisions, and often arduous treatment regimens. Individuals who are socially and economically disadvantaged may find cancer care all the more problematic (Baquet et al. 2005). These people are at substantial risk of receiving inadequate care at each step of the cancer care continuum: screening, diagnostic follow-up of suspicious results, treatment when cancer is diagnosed, and survivorship surveillance. Moreover, the systems of care available to them, such as “safety net” institutions, are often beset with inefficiencies. Patient navigation has emerged in the past decade in response to these widely recognized disparities in cancer care. Health care advocates, policy makers, and innovative health care organizations have called for the adoption of patient navigation to assist patients and remedy inefficiencies in the provision of timely care (Freeman 2006; Jandorf et al. 2006;). As a result, patient navigation services have proliferated rapidly in recent years. Research to date supports the promise of patient navigation for reducing cancer disparities (Gabram et al. 2008). Currently, a large, multisite cooperative study of patient navigation is being conducted. The National Cancer Institute's Patient Navigation Research Program (PNRP) is designed to evaluate the effectiveness of navigation in improving timeliness of care (i.e., time to follow-up of abnormal screening results and to completion of treatment when cancer is diagnosed) and patient satisfaction (Freund et al. 2008). The nine cooperating studies of the PNRP provide a laboratory for characterizing the actual work of patient navigators and linking variation in their activities to patient outcomes. The first step in such an effort is to design procedures for systematically observing navigators' activities. This paper reports on the development of a protocol for observing what navigators actually do.

Background: Despite current recommendations for women to be screened for breast cancer with mammography every 1 to 2 years, less than half of all newly diagnosed breast cancers are initially detected through screening mammography. Prompt medical attention to a new breast symptom can result in earlier stage at diagnosis, yet many patients delay seeking medical care after becoming aware of a breast symptom. Methods: In a population-based study of breast cancer, we examined factors potentially associated with patient delay in seeking health care for a breast symptom among 436 symptomatic urban breast cancer patients (146 white, 197 black, and 95 Hispanic). Race/ethnicity, socioeconomic status, health care access and utilization, and misconceptions about the meaning of breast lumps were the key independent variables. Results: Sixteen percent of patients reported delaying more than 3 months before seeking medical advice about breast symptoms. Misconceptions about breast lumps and lacking a regular provider, health insurance, and recent preventive care were all associated with prolonged patient delay (P < 0.005 for all). Misconceptions were much more common among ethnic minorities and women of lower socioeconomic status. Conclusion: Reducing patient delay and disparities in delay will require educating women about the importance of getting breast lumps evaluated in a timely manner and providing greater access to regular health care. Cancer Epidemiol Biomarkers Prev; 19(3); 640–7

Objective To describe self-reported practice patterns of PCPs for the diagnosis, treatment, and management of men with CP/CPPS. Methods 556 PCPs in Boston, Chicago, and Los Angeles were presented a vignette, which described a man with typical CP/CPPS symptoms, followed by questions about CP/CPPS. Results The response rate was 52%. Only 62 percent of respondents reported ever seeing a patient like the one described in the vignette. Fully 16% of respondents were “not at all” familiar with CP/CPPS, and 48% were “not at all” familiar with the NIH classification scheme for prostatitis. PCPs reported practice patterns regarding diagnosis and treatment of CP/CPPS, which are not supported by evidence. Conclusions Although studies suggest that CP/CPPS is common, many PCPs reported little or no familiarity, important knowledge deficits, and limited experience in managing men with this syndrome.

First implemented in 1990, patient navigation interventions are emerging today as an approach to reduce cancer disparities. However, there is lack of consensus about how patient navigation is defined, what patient navigators do, and what their qualifications should be. Little is known about the efficacy and cost-effectiveness of patient navigation. For this review, the authors conducted a qualitative synthesis of published literature on cancer patient navigation. By using the keywords 'navigator' or 'navigation' and 'cancer,' 45 articles were identified in the PubMed database and from reference searches that were published or in press through October 2007. Sixteen studies provided data on the efficacy of navigation in improving timeliness and receipt of cancer screening, diagnostic follow-up care, and treatment. Patient navigation services were defined and differentiated from other outreach services. Overall, there was evidence of some degree of efficacy for patient navigation in increasing participation in cancer screening and adherence to diagnostic follow-up care after the detection of an abnormality. The reported increases in screening ranged from 10.8% to 17.1%, and increases in adherence to diagnostic follow-up care ranged from 21% to 29.2% compared with control patients. There was less evidence regarding the efficacy of patient navigation in reducing either late-stage cancer diagnosis or delays in the initiation of cancer treatment or improving outcomes during cancer survivorship. There were methodological limitations in most studies, such as a lack of control groups, small sample sizes, and contamination with other interventions. Although cancer-related patient navigation interventions are being adopted increasingly across the United States and Canada, further research will be necessary to evaluate their efficacy and cost-effectiveness in improving cancer care.

Most patients who are treated with standard chemotherapy regimens report adverse events—including fatigue, nausea, diarrhea, and pain—during treatment [1,2], but the incidence of chemotherapy-related adverse events and their effect on doctors and nurses have been underestimated. A community study in 12,239 women with breast cancer that was conducted in 2006 found that serious chemotherapy-related adverse events were more common than had been reported in large clinical trials and led to more healthcare expenditures than had been estimated [3]. The occurrence of adverse events increases the likelihood that patients will not complete their treatment [4–7]. Febrile neutropenia, for example, is not directly linked to survival but can lead to life-threatening infections [8,9] and chemotherapy dose reductions and delays, which can compromise survival [10–13]. Furthermore, quality of life may be compromised in patients with cancer who have chemotherapy-induced neutropenia [14], fatigue or anemia [15–17], nausea or vomiting [18,19], or weight loss [20]. Research in physician-patient communication has shown that effective communication and active patient participation in making decisions about treatments can influence a patient's satisfaction, quality of life, and treatment outcome [21–26]. In particular, verbal and nonverbal communication between physicians and patients can affect a patient's satisfaction [27,28], adherence [29], and quality of life [30,31]. Insufficient communication or miscommunication may compromise a patient's ability to participate in making decisions about treatment [21]. This study examines patients' perceptions of the physician-patient relationship and communication about cancer-related issues, particularly adverse events. We also performed an exploratory assessment of differences in race concerning patients' perceptions about physician-patient communication about cancer-related topics and patients' understanding of these topics.

OBJECTIVES To assess the direct medical costs, medication, and procedure use associated with interstitial cystitis (IC) in women in the Kaiser Permanente Northwest (KPNW) managed care population. METHODS The KPNW electronic medical record was used to identify women diagnosed with IC (n = 239). Each of these patients was matched with three controls according to age and duration in the health plan. Health plan cost accounting data were used to determine the inpatient, outpatient, and pharmacy costs for 1998 to 2003. An analysis of the prescription medication use and cystoscopic and urodynamic procedures commonly associated with IC was also performed. To evaluate for co-morbidities, an automated risk-adjustment model linked to 28 chronic medical conditions was applied to the administrative data sets from both groups. RESULTS The mean duration from the date of IC diagnosis to the end of the study period was 36.6 months (range 1.4 to 60). The mean yearly costs were 2.4-fold greater for the patients than for the controls ($7100 versus $2994), and the median yearly costs were 3.8-fold greater ($5000 versus $1304). These cost differences were predominantly due to outpatient and pharmacy expenses. Medication and procedure use were significantly greater for the patients than for the controls. These findings were consistent across risk-adjustment model categories, which suggest that the observed cost differences are IC specific. CONCLUSIONS The direct per-person costs of IC are high, with average yearly costs approximately $4000 greater than for the age-matched controls. This cost differential is an underestimate, because the costs preceding the diagnosis, the use of alternative therapies, indirect costs, and the costs of those with IC that is not diagnosed were not included.

Given the wide variety of lower urinary tract symptoms caused by benign prostatic hyperplasia, we ascertained the impact on quality of life for 5 domains of benign prostatic hyperplasia/lower urinary tract symptoms progression. In addition, with the increasing number of patients using alternative therapies to alleviate bother from benign prostatic hyperplasia/lower urinary tract symptoms, we investigated whether utility scores differed between phytotherapy users and nonusers.Using an office based population 40 consecutive patients were identified as surgically naïve with benign prostatic hyperplasia/lower urinary tract symptoms based on the American Urological Association Symptom Index. A trained interviewer administered 2 surveys to the patients, that is a time trade-off questionnaire assessing the health states of urinary retention, urinary tract infection, incontinence, erectile dysfunction and ejaculatory dysfunction, as well as an alternative therapy questionnaire. Patient chart reviews were conducted to collect clinical parameters (age, American Urological Association Symptom Index, erectile dysfunction complaints, prostate specific antigen, quality of life, etc). Two-tailed student t tests were then performed to compare groups. Patients were stratified as phytotherapy users and phytotherapy nonusers.The time trade-off scores of the participants for urinary retention, urinary tract infection, incontinence, erectile dysfunction and ejaculatory dysfunction were 0.61 +/- 0.33, 0.57 +/- 0.34, 0.66 +/- 0.32, 0.73 +/- 0.31 and 0.71 +/- 0.32, respectively. Of the 17 patients having used phytotherapy for lower urinary tract symptoms, 9 were actively using alpha-blockers, 1 was on 5alpha-reductase inhibitor alone, and 2 were using alpha-blockers and 5alpha-reductase inhibitors. Of the 23 patients not having used phytotherapy, 5 were using alpha-blockers alone, and 6 were using alpha-blockers and 5alpha-reductase inhibitors. Patients who reported having used phytotherapy for lower urinary tract symptoms had lower scores in all 5 health states, statistically significant for urinary retention (0.49 +/- 0.37 vs 0.71 +/- 0.26, p0.05), erectile dysfunction (0.60 +/- 0.39 vs 0.82 +/- 0.20, p0.05) and ejaculatory dysfunction (0.55 +/- 0.39 vs 0.82 +/- 0.19, p0.05). These 2 patient populations did not differ significantly with respect to the clinical parameters of age, American Urological Association Symptom Index, erectile dysfunction, prostate specific antigen or quality of life.This study is the first to demonstrate time trade-off utilities in a benign prostatic hyperplasia/lower urinary tract symptoms group by the 5 domains of disease progression. We have shown that benign prostatic hyperplasia/lower urinary tract symptoms patients who have used phytotherapy have markedly lower utility scores than those patients not having used phytotherapy despite comparable clinical parameters. These results have important implications for clinical trial design and health economics.

The present study established the psychometric properties of the Functional Assessment of Cancer Therapy-Neutropenia (FACT-N), a self-report instrument to assess neutropenia-specific concerns and health-related quality of life (HRQL), in a sample of adults 65 years of age and older.Participants were undergoing chemotherapy for lung, breast, or ovarian cancer or non-Hodgkin's lymphoma (n = 852) and were randomly assigned to receive pegfilgrastim beginning with cycle 1 (primary prophylaxis) or pegfilgrastim subsequent to cycle 1 at their clinicians' discretion (usual care). Participants completed a self-report assessment on day 1 of each cycle (up to six cycles) and at the expected nadir of the white blood cell count of each cycle. Using factor analysis, three subscales were identified in the 19-item FACT-N subscale: Malaise, Worry, and Flu-like symptoms.The FACT-N and each of the subscales were sensitive to the presence of neutropenia although did not correlate with the absolute neutrophil count (ANC). While ANC is a marker of the impact of chemotherapy on the myeloid precursors of the bone marrow and is correlated with risk of febrile neutropenia, however the constellation of symptoms and patient experience vary throughout the period of neutropenia as the ANC first declines and then recovers. The 19-item neutropenia subscale can be used alone; however, evidence supporting reliability and validity was most robust for aggregate scores from the FACT-N and the Trial Outcome Index-Neutropenia (TOI-N).Understanding the impact of neutropenia on HRQL through the availability of a validated self-report measure will, ideally, lead to interventions to reduce the burden associated with cancer and its treatments.

While cancer chemotherapy-related febrile neutropenia affects patients' activities and medical expenditures, few studies have reported on the total costs of this condition. Here, we evaluate the feasibility of obtaining detailed and comprehensive cost information on patients who experience febrile neutropenia during cancer chemotherapy treatment.Community oncology cancer patients who experienced chemotherapy-associated febrile neutropenia recorded information about use of medical care, tests, devices, medications, and lost productivity. Direct cost estimates were derived from Medicare Physician Fee Schedules and cost-to-charge ratios. Indirect cost estimates were based on modified Labor Force, Employment, and Earnings data for employed patients and wages earned by paid caregivers. Multivariate regression models evaluated predictors of higher direct, indirect, and total costs.Outpatients' mean direct and indirect costs were 5,704 dollars and 1,201 dollars (lymphoma), 1,094 dollars and 1,530 dollars (breast cancer), and 1,329 dollars and 1,325 dollars (lung cancer and myeloma), respectively. The mean direct and indirect costs were three- to tenfold and 1.5- to threefold greater for inpatients, respectively. Factors associated with higher direct costs of care included diagnosis of lymphoma and inpatient care; higher indirect costs, male versus female gender; higher total costs, lymphoma diagnosis and inpatient care.Estimation of the total costs of cancer-related neutropenia is feasible. Indirect costs appear to account for as much as half of the total supportive care costs when febrile neutropenia is managed in the outpatient setting and about one fifth of the total supportive care costs in the inpatient setting.

This article assessed the impact of knowledge of breast cancer and type and intensity of participation in a church-based breast cancer education program and other factors on mammography screening among African Americans and Latinas. Logistic regression was used to assess the impact of these factors on self-reported mammography utilization. Passive participation in church-sponsored activities, measured by breast cancer information that was heard, seen, or read, was found to be significantly associated with the likelihood of mammography use among African Americans. Moreover, African Americans who reported hearing, seeing, or reading about mammograms at their churches four or more times were 15 times more likely to report mammography use within the past year than were those who encountered information only once. Messages from pastors and church bulletin announcements were the most significant predictors. An increase in knowledge was not associated with higher mammography use. For Latinas, none of the hypothesized knowledge or participation variables was found to be significant. The results suggest that faith-based breast cancer programs can be effective by adopting tailored strategies to raise awareness about the importance of early detection.

Numerous studies have been performed to identify potential risk factors for CP/CPPS and IC. However, few studies have been done to identify predictors of disease severity.A total of 174 men with CP/CPPS and 111 women with IC completed questionnaires to quantify symptom severity and identify demographic, medical and psychosocial characteristics. Symptom severity was assessed with the National Institutes of Health CPSI in men, and the O'Leary-Sant ICSI and problem index in women. Univariate and multivariate analyses were performed to identify characteristics predictive of worse symptoms.The mean National Institutes of Health CPSI score in men was 15.32, and the mean O'Leary-Sant ICSI and problem index in women was 19.17. The most commonly reported comorbidities were allergies, sinusitis, erectile dysfunction and irritable bowel syndrome in men, and allergies, urinary incontinence, sinusitis and irritable bowel syndrome in women. In the 2 sexes self-reported urinary frequency and urgency, worse depression scores and lower education level were independent predictors of worse symptom severity. In men additional independent predictors were self-reported pelvic pain, fibromyalgia and previous heart attack, and in women an additional independent predictor was postmenopausal status.There are several common medical conditions associated with urological pelvic pain syndromes in men and women. Few of them were predictive of symptoms severity in this analysis. Self-reported pelvic pain symptoms, education and depression severity were the factors most strongly predictive of symptom severity in patients with CP/CPPS and IC.

Objectives: The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) was developed to assess symptoms and quality of life in men with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). We assessed the responsiveness of the NIH-CPSI to change over time and defined thresholds for changes perceptible to patients. Methods: We studied 174 men with CP/CPPS who participated in a placebo-controlled randomized clinical trial. Changes from baseline to six weeks in the NIH-CPSI total score and pain, urinary, and quality of life subscores were compared to a global response assessment (GRA). Effect sizes and Guyatt statistics were calculated to evaluate responsiveness; 95% confidence intervals were produced using bootstrapping. Results: All scores decreased over time with the largest decrease in subjects who reported on the GRA that they were markedly improved. The NIH-CPSI total, pain, and quality of life scores were highly responsive in the improved groups; the urinary score showed minimal responsiveness. There was no evidence of responsiveness among those subjects who worsened on the trial. ROC curves identified a 6-point decline in the NIH-CPSI total score as the optimal threshold to predict treatment response. Conclusions: The NIH-CPSI total score and pain and quality of life subscores are responsive to change over␣time.

Prevalence of physician recommendation and patient completion of colorectal cancer screening was investigated among Federally Qualified Health Centers (FQHC) serving low-income neighborhoods in Chicago. Medical records of 3,416 patients receiving primary care services at 1 of 31 FQHCs were randomly chosen for review. In all, 642 patients were identified by age and family history as eligible for colorectal cancer screening and included in this study. Patient demographic information and colorectal cancer screening history were collected. The physician screening recommendation rate was 9.2% (n=59); 7.0% (n=45) of patients were determined to have been appropriately screened for colorectal cancer, primarily by Fecal Occult Blood Test (94.1%, n=43). Among patients who received a recommendation from their physician, 76.2% had completed a screening test. Older patients were more likely than their younger counterparts to have received a recommendation from their physician (p

For the past six years, the Chicago-area faith-based Reach Out Consortium has mobilized low-income uninsured and underinsured African American women and Latinas to seek screening for breast and cervical cancer. The funding history for this program illustrates how funds for a small community-based program were leveraged into a broader program, and that grew to serve low-income women across the state. Further, as the program reached more and more uninsured women, community activism led to a further state investment in services for the uninsured. Program sustainability and expansion depended on a combination of public and private competitive grants and grassroots advocacy.

We calculated the prevalence of symptoms typically associated with interstitial cystitis (IC) in men and women in a managed care population in the Pacific Northwest.International Classification of Diseases-9 based queries of the Kaiser Permanente Northwest, Portland, Oregon database were used to identify subjects with IC exclusion criteria, who were excluded from further analysis. A total of 10,000 questionnaires, including 5,000 for women and 5,000 for men, were mailed to subjects with codes indicating bladder symptoms and to those with none of the codes. The questionnaires included questions about the presence of IC symptoms and the O'Leary-Sant interstitial cystitis questionnaire. IC symptoms were defined in 2 ways, that is as 1) pelvic pain at least 3 months in duration plus urgency or frequency at least 3 months in duration and 2) the same criteria plus pain increasing as the bladder fills and/or pain relieved by urination.The prevalence of IC symptoms according to definitions 1 and 2 was 11.2% and 6.2% in women, and 4.6% and 2.3% in men, respectively. Symptoms were long-standing (duration greater than 1 year in 80% of cases) and bothersome (severity score 5 or greater in greater than 50%). Mean O'Leary-Sant interstitial cystitis questionnaire scores were 15.94 in subjects with definition 1 IC symptoms, 18.97 in those with definition 2 IC symptoms and 6.69 in those with no IC symptoms (p0.001). Symptoms were most common and most severe in subjects previously diagnosed with IC.The prevalence of IC symptoms is 30 to 50-fold higher in women and 60 to 100-fold higher in men than the prevalence of a coded physician diagnosis of IC in the same population. Although these findings are not conclusive, they imply that IC may be significantly under diagnosed.

Purpose: We describe temporal trends in hospitalizations, outpatient visits and the treatment of female urinary incontinence (UI), and estimated the costs of incontinence using national databases. Materials and Methods: The analytic methods used to generate these results have been described previously. Results: The rate of hospitalization with a primary diagnosis of UI decreased from 51/100,000 women in 1994 to 44/100,000 in 2000 and mean length of stay decreased from 3.1 days to 2.1. In contrast, outpatient visits for UI more than doubled during the same period from 845/100,000 women to 1,845/100,000. Rates of inpatient surgical treatment for UI decreased slightly from 1994 to 2000, while ambulatory surgical center visit rates for Medicare beneficiaries 65 years or older more than doubled from 60/100,000 in 1992 to 142/100,000 in 1998. Medical expenditures for UI increased substantially during the 1990s, almost doubling from $128.1 million in 1992 to $234.4 million in 1998 for Medicare beneficiaries 65 years or older. This increase was due almost entirely to increased outpatient costs, which increased from $25.4 million or 9.1% of total costs in 1992 to $329 million or 27.3% of total costs in 2000 in this group. Conclusions: While existing national databases generally capture only the minority of incontinent women with UI who seek and receive care for UI, they are useful for documenting treads in service use and surgical treatments, and estimating economic impact. This data can be helpful when formulating public policy and designing observational and clinical studies.

Purpose: We quantified and describe the demographics and economic burden of male urinary incontinence in the United States of America.Materials and Methods: The analytic methods used to gen...

Purpose: Benign prostatic hyperplasia (BPH), the most common benign neoplasm in American men, is a chronic condition that is associated with progressive lower urinary tract symptoms and affects almost 3 of 4 men during the seventh decade of life. Approximately 6.5 million of the 27 million white men who are 50 to 79 years old in the United States in 2000 were estimated to meet the criteria for discussing treatment. Materials and Methods: The analytical methods used to generate these results have been described previously. Results: In 2000 approximately 4.5 million visits were made to physician offices to for a primary diagnosis of BPH and almost 8 million visits were made with a primary or secondary diagnosis of BPH. In the same year approximately 87,400 prostatectomies for BPH were performed in inpatients in nonfederal hospitals in the United States. While the number of outpatient visits for BPH increased consistently during the 1990s, there was a dramatic decrease in the use of transurethral prostatectomy, inpatient hospitalization and length of hospital stay for this condition. These trends reflect the changing face of medical management for BPH, ie increasing use of pharmacological agents and minimally invasive therapies. In 2000 the direct cost of BPH treatment was estimated to be $1.1 billion exclusive of outpatient pharmaceuticals. Conclusions: Given the impact that BPH has on quality of life and health care cost in millions of American men, additional research into risk factors, diagnostic and therapeutic resource use, and effectiveness and cost benefit of therapies are warranted.

We quantified the burden of urolithiasis in the United States by identifying trends in the use of health care resources and estimating the economic impact of the disease.The analytical methods used to generate these results have been described previously.The rate of national inpatient hospitalizations for a diagnosis of urolithiasis decreased by 15% and hospital length of stay decreased from 2.6 to 2.2 days between 1994 and 2000. Rates of hospitalization were 2.5 to 3-fold higher for Medicare beneficiaries with little change between 1992 and 1998. Almost 2 million outpatient visits for a primary diagnosis of urolithiasis were recorded in 2000. Hospital outpatient visits increased by 40% between 1994 and 2000 and physician office visits increased by 43% between 1992 and 2000. In the Medicare population hospital outpatient and office visits increased by 29% and 41%, respectively, between 1992 and 1998. The distribution of surgical procedures remained relatively stable through the 1990s. Shock wave lithotripsy was the most commonly performed procedure, followed closely by ureteroscopy. Overall the total estimated annual expenditure for individuals with claims for a diagnosis of urolithiasis was almost $2.1 billion in 2000, representing a 50% increase since 1994.The cost of urolithiasis is estimated at almost $2 billion annually and it appears to be increasing with time despite a shift in inpatient to outpatient treatment and the emergence of minimally invasive treatment modalities, perhaps because the prevalence of stone disease is increasing.

Recombinant granulocyte colony-stimulating factor (G-CSF) [filgrastim and lenograstim] and pegylated G-CSF (pegfilgrastim) have been shown to reduce the severity and duration of chemotherapy-associated febrile neutropenia (FN) when administered prophylactically to cancer patients receiving chemotherapeutic regimens. The American Society of Clinical Oncology (ASCO) evidence-based clinical guidelines published in 1994, 1996 and 1997 recommended primary prophylaxis with G-CSF for cancer patients. The 2000 ASCO update, with the same recommendation, highlights the importance of economic considerations in decision making for CSFs. This paper reviews the available cost-effectiveness evidence on the use of G-CSF as primary prophylaxis against FN in patients with small cell lung cancer (SCLC).Cost-effectiveness ratios from a healthcare payer perspective supported the use of filgrastim as primary prophylaxis for people with SCLC, on the basis of both clinical and economic benefits, treated with chemotherapeutic regimens that have an FN rate in the range of 40-60%. However, when indirect and patient out-of-pocket costs attributable to severe FN are included, available evidence suggests that the risk threshold may be reduced by more than half. Given that FN rates associated with chemotherapeutic regimens for SCLC are generally

We calculated the prevalence and incidence of physician diagnosed interstitial cystitis (IC) in men and women in a managed care population in the Pacific Northwest.A computer search of the Kaiser Permanente Northwest (Portland, Oregon) database was performed for January 1998 to May 2002. The prevalence of IC in patients 25 to 80 years old was calculated using the 4 definitions of 1) patients assigned a diagnosis of IC, 2) patients assigned a diagnosis of IC without any of the consensus IC exclusion criteria, 3) patients who had also had undergone cystoscopy and 4) patients who had specifically undergone cystoscopy with hydrodistention for IC. A second database search was performed 1 year later (May 2003) to identify incident cases of IC.The prevalence of IC was 197 per 100,000 women and 41 per 100,000 men for definition 1, 158 per 100,000 women and 28 per 100,000 men for definition 2, 99 per 100,000 women and 19 per 100,000 men for definition 3, and 45 per 100,000 women and 8 per 100,000 men for definition 4. Using definition 2 the 1-year incidence of IC was 21 per 100,000 women and 4 per 100,000 men. The female-to-male ratio for each estimate was 5:1.The prevalence and incidence of interstitial cystitis is significantly higher for women and men than previously published estimates. Men account for a higher proportion of patients with IC than has previously been recognized.

Objective The purpose of this study was to determine whether a knowledge of fetal fibronectin results affects patient treatment and health care costs. Study design Women between 24 and 34 weeks of gestation with a singleton pregnancy and preterm uterine contractions were eligible for enrollment. Once informed consent was given, a fetal fibronectin specimen was obtained, and women were assigned randomly into 2 groups. In 1 group, results of the fetal fibronectin test were available; in the other group, results were not available. The use of inpatient and outpatient health care resources subsequent to enrollment was ascertained through the use of medical records, hospital billing data, and patient interviews. This study was powered to allow the detection in the fetal fibronectin group of a 20% reduction in total health care–related costs. Results The 2 groups were similar with respect to maternal age, parity, race, cervical examination at admission, and estimated gestational age at enrollment and at delivery. Women who did not have fetal fibronectin results available were no different than those women who did with respect to initial length of labor and delivery observation (median, 4 hours vs 3 hours), hospital admission (28% vs 26%), tocolysis (18% vs 16%), cessation of work (27% vs 26%), or total health care–related costs (log mean ± SD, 7.6 ± 1.2 vs 7.5 ± 1.1). Conclusion In this study population, the use of fetal fibronectin did not affect physician behavior or health care costs related to preterm contractions.

Study Objectives. Previous studies have used direct hospital costs to determine the threshold at which the cost of prophylactic use of colony-stimulating factor (CSF) is offset by savings from the lower risk of hospitalization for febrile neutropenia. By conducting a survey of patients in whom febrile neutropenia had developed during treatment with chemotherapy, we sought to reassess these costs by including estimates of indirect costs associated with febrile neutropenia as well as new categories of direct costs that were not previously available. Costs were included in an existing cost-minimization model, and their effect on the risk threshold at which the prophylactic use of CSF becomes cost saving was determined. Patients. A sample survey of 26 patients with ovarian cancer who were treated with chemotherapy and developed febrile neutropenia. Intervention. Analysis of data from patients' questionnaires containing survey items on indirect costs and additional direct costs associated with febrile neutropenia. Measurements and Main Results. Estimates of indirect costs and other direct costs from the questionnaires were included in an existing cost-minimization model, and risk thresholds were recalculated. Before modification, the model showed cost neutrality for prophylactic use of CSF when the risk of hospitalization for febrile neutropenia was approximately 23%. Including previously excluded direct costs and indirect costs ranging from $1000–5000 attributable to severe neutropenia in the model lowered the risk threshold for hospitalization for febrile neutropenia at which the prophylactic use of CSF becomes cost neutral to between 22% and 18%. Conclusion. Including additional direct as well as indirect costs associated with chemotherapy-induced neutropenia permits a more realistic assessment of the possible effect of prophylactic use of CSF from a societal perspective. Despite the limited size of the survey, this study shows a cost-benefit rationale to support prophylactic use of CSF in a greater proportion of patients treated with chemotherapy.

Objective . Perceptions of the severity of chemotherapy-related toxicity differ among physicians, ovarian cancer patients, at-risk individuals, and persons in the general population. In this study, we elicited assessments of toxicity from women with ovarian cancer, women at increased risk of developing ovarian cancer, women in the general population, and gynecologic oncologists. Methods . Thirty-nine ovarian cancer patients, fifteen women at increased risk, thirty-nine women at baseline risk, and eleven gynecologic oncologists completed utility assessment surveys. Results . There was good face validity to the utility exercise as assessments of health states. Health states with toxicity were consistently associated with less favorable assessments than the health states with no toxicity. The ovarian cancer patients as a group and the women at risk for the development of ovarian cancer viewed health states with toxicity similarly and more favorably than women in the general population. However, patient assessments varied, with the most favorable assessment of life with toxicity being reported from individuals who had experienced such toxicity. Physician assessments of the impact of toxicity on overall health status were most similar to those obtained from patients who had experienced moderate to severe toxicity, and were more favorable than those elicited from patients who had not experienced any toxicity. Conclusions . Assessments of the impact of chemotherapy-related toxicity vary depending on the perspective of the individual responding to these questions. In discussing ovarian cancer treatments with at-risk women and the general population, concerns over treatment-related toxicity are likely to be greater than those expressed by persons who are more familiar with the actual occurrence of such events and therapeutic preferences may be affected as a result.

Objective To compare the perceptions of miscarriage and birth of a child with Down syndrome among pregnant women and to evaluate the implications of these preferences for the traditional 35-year old maternal age risk boundary. Methods An interviewer-administered survey was given to 186 pregnant women receiving antepartum care at a university hospital. Preferences, as reflected by utilities, for birth of a child with Down syndrome and pregnancy miscarriage, stratified by patient characteristics, were assessed. Results The utility for the birth of a child with Down syndrome decreased (p < 0.001) as clinical severity increased from mild (0.78) to severe (0.65). Miscarriage of a pregnancy had a mean utility of 0.76 ± 0.31. Women who desired prenatal diagnosis had a utility value for miscarriage (0.79 ± 0.28) that was significantly higher than for the birth of a child with Down syndrome of unknown severity (0.73 ± 0.27). In multivariable logistic regression, desire for prenatal diagnosis was the only factor associated with a preference of miscarriage over birth of an affected child (odds ratio 2.26, 95% confidence interval 1.03, 4.96). Conclusion Women who desire prenatal diagnosis do not perceive the birth of a child with Down syndrome and a pregnancy miscarriage to be equivalent health states. This finding calls into question the rationale of the 35-year-old maternal age criterion and suggests that actual patient preferences should be better incorporated into the decision to offer definitive prenatal diagnosis. Copyright © 2002 John Wiley & Sons, Ltd.