Associations of Healthcare Affordability, Availability, and Accessibility with Quality Treatment Metrics in Patients with Ovarian Cancer.

BACKGROUND: Differential access to quality care is associated with racial disparities in ovarian cancer survival. Few studies have examined the association of multiple healthcare access (HCA) dimensions with racial disparities in quality treatment metrics, that is, primary debulking surgery performed by a gynecologic oncologist and initiation of guideline-recommended systemic therapy. METHODS: We analyzed data for patients with ovarian cancer diagnosed from 2008 to 2015 in the Surveillance, Epidemiology, and End Results-Medicare database. We defined HCA dimensions as affordability, availability, and accessibility. Modified Poisson regressions with sandwich error estimation were used to estimate the relative risk (RR) for quality treatment. RESULTS: The study cohort was 7% NH-Black, 6% Hispanic, and 87% NH-White. Overall, 29% of patients received surgery and 68% initiated systemic therapy. After adjusting for clinical variables, NH-Black patients were less likely to receive surgery [RR, 0.83; 95% confidence interval (CI), 0.70-0.98]; the observed association was attenuated after adjusting for healthcare affordability, accessibility, and availability (RR, 0.91; 95% CI, 0.77-1.08). Dual enrollment in Medicaid and Medicare compared with Medicare only was associated with lower likelihood of receiving surgery (RR, 0.86; 95% CI, 0.76-0.97) and systemic therapy (RR, 0.94; 95% CI, 0.92-0.97). Receiving treatment at a facility in the highest quartile of ovarian cancer surgical volume was associated with higher likelihood of surgery (RR, 1.12; 95% CI, 1.04-1.21). CONCLUSIONS: Racial differences were observed in ovarian cancer treatment quality and were partly explained by multiple HCA dimensions. IMPACT: Strategies to mitigate racial disparities in ovarian cancer treatment quality must focus on multiple HCA dimensions. Additional dimensions, acceptability and accommodation, may also be key to addressing disparities.

Ovarian Cancer Epidemiology, Healthcare Access and Disparities (ORCHiD): methodology for a population-based study of black, Hispanic and white patients with ovarian cancer.

INTRODUCTION: Less than 40% of patients with ovarian cancer (OC) in the USA receive stage-appropriate guideline-adherent surgery and chemotherapy. Black patients with cancer report greater depression, pain and fatigue than white patients. Lack of access to healthcare likely contributes to low treatment rates and racial differences in outcomes. The Ovarian Cancer Epidemiology, Healthcare Access and Disparities study aims to characterise healthcare access (HCA) across five specific dimensions-Availability, Affordability, Accessibility, Accommodation and Acceptability-among black, Hispanic and white patients with OC, evaluate the impact of HCA on quality of treatment, supportive care and survival, and explore biological mechanisms that may contribute to OC disparities. METHODS AND ANALYSIS: We will use the Surveillance Epidemiology and Ends Results dataset linked with Medicare claims data from 9744 patients with OC ages 65 years and older. We will recruit 1641 patients with OC (413 black, 299 Hispanic and 929 white) from cancer registries in nine US states. We will examine HCA dimensions in relation to three main outcomes: (1) receipt of quality, guideline adherent initial treatment and supportive care, (2) quality of life based on patient-reported outcomes and (3) survival. We will obtain saliva and vaginal microbiome samples to examine prognostic biomarkers. We will use hierarchical regression models to estimate the impact of HCA dimensions across patient, neighbourhood, provider and hospital levels, with random effects to account for clustering. Multilevel structural equation models will estimate the total, direct and indirect effects of race on treatment mediated through HCA dimensions. ETHICS AND DISSEMINATION: Result dissemination will occur through presentations at national meetings and in collaboration with collaborators, community partners and colleagues across othercancer centres. We will disclose findings to key stakeholders, including scientists, providers and community members. This study has been approved by the Duke Institutional Review Board (Pro00101872). Safety considerations include protection of patient privacy. All disseminated data will be deidentified and summarised.

Radiation therapy at the end of life: a population-based study examining palliative treatment intensity.

BACKGROUND: To examine factors associated with the use of radiation therapy (RT) at the end of life in patients with breast, prostate, or colorectal cancer. METHODS: Using data from the Surveillance, Epidemiology, and End Results (SEER) - Medicare database, patients were over age 65 and diagnosed between January 1, 2004 and December 31, 2011 with any stage of cancer when the cause of death, as defined by SEER, was cancer; or with stage 4 cancer, who died of any cause. We employed multiple logistic regression models to identify patient and health systems factors associated with palliative radiation use. RESULTS: 50% of patients received RT in the last 6 months of life. RT was used less frequently in older patients and in non-Hispanic white patients. Similar patterns were observed in the last 14 days of life. Chemotherapy use in the last 6 months of life was strongly correlated with receiving RT in the last 6 months (OR 2.72, 95% CI: 2.59-2.88) and last 14 days of life (OR 1.55, 95% CI: 1.40-1.66). Patients receiving RT accrued more emergency department visits, radiographic exams and physician visits (all comparisons p < 0.0001). CONCLUSIONS: Among patients with breast, colorectal, and prostate cancer, palliative RT use was common. End-of-life RT correlated with end-of-life chemotherapy use, including in the last 14 days of life, when treatment may cause increased treatment burden without improved quality of life. Research is needed optimize the role and timing of RT in palliative care.

Did changes in drug reimbursement after the medicare modernization act affect chemotherapy prescribing?

PURPOSE: The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) decreased fee-for-service (FFS) payments for outpatient chemotherapy. We assessed how this policy affected chemotherapy in FFS settings versus in integrated health networks (IHNs). PATIENTS AND METHODS: We examined 5,831 chemotherapy regimens for 3,613 patients from 2003 to 2006 with colorectal cancer (CRC) or lung cancers in the Cancer Care Outcomes Research Surveillance Consortium. Patients were from four geographically defined regions, seven large health maintenance organizations, and 15 Veterans Affairs Medical Centers. The outcome of interest was receipt of chemotherapy that included at least one drug for which reimbursement declined after the MMA. RESULTS: The odds of receiving an MMA-affected drug were lower in the post-MMA era: the odds ratio (OR) was 0.73 (95% CI, 0.59 to 0.89). Important differences across cancers were detected: for CRC, the OR was 0.65 (95% CI, 0.46 to 0.92); for non-small-cell lung cancer (NSCLC), the OR was 1.60 (95% CI, 1.09 to 2.35); and for small-cell lung cancer, the OR was 0.63 (95% CI, 0.34 to 1.16). After the MMA, FFS patients were less likely to receive MMA-affected drugs: OR, 0.73 (95% CI, 0.59 to 0.89). No pre- versus post-MMA difference in the use of MMA-affected drugs was detected among IHN patients: OR, 1.01 (95% CI, 0.66 to 1.56). Patients with CRC were less likely to receive an MMA-affected drug in both FFS and IHN settings in the post- versus pre-MMA era, whereas patients with NSCLC were the opposite: OR, 1.60 (95% CI, 1.09 to 2.35) for FFS and 6.33 (95% CI, 2.09 to 19.11) for IHNs post- versus pre-MMA. CONCLUSION: Changes in reimbursement after the passage of MMA appear to have had less of an impact on prescribing patterns in FFS settings than the introduction of new drugs and clinical evidence as well as other factors driving adoption of new practice patterns.

Stereotactic body radiation therapy versus intensity-modulated radiation therapy for prostate cancer: comparison of toxicity.

PURPOSE: Stereotactic body radiation therapy (SBRT) is a technically demanding prostate cancer treatment that may be less expensive than intensity-modulated radiation therapy (IMRT). Because SBRT may deliver a greater biologic dose of radiation than IMRT, toxicity could be increased. Studies comparing treatment cost to the Medicare program and toxicity are needed. METHODS: We performed a retrospective study by using a national sample of Medicare beneficiaries age ≥ 66 years who received SBRT or IMRT as primary treatment for prostate cancer from 2008 to 2011. Each SBRT patient was matched to two IMRT patients with similar follow-up (6, 12, or 24 months). We calculated the cost of radiation therapy treatment to the Medicare program and toxicity as measured by Medicare claims; we used a random effects model to compare genitourinary (GU), GI, and other toxicity between matched patients. RESULTS: The study sample consisted of 1,335 SBRT patients matched to 2,670 IMRT patients. The mean treatment cost was $13,645 for SBRT versus $21,023 for IMRT. In the 6 months after treatment initiation, 15.6% of SBRT versus 12.6% of IMRT patients experienced GU toxicity (odds ratio [OR], 1.29; 95% CI, 1.05 to 1.53; P = .009). At 24 months after treatment initiation, 43.9% of SBRT versus 36.3% of IMRT patients had GU toxicity (OR, 1.38; 95% CI, 1.12 to 1.63; P = .001). The increase in GU toxicity was due to claims indicative of urethritis, urinary incontinence, and/or obstruction. CONCLUSION: Although SBRT was associated with lower treatment costs, there appears to be a greater rate of GU toxicity for patients undergoing SBRT compared with IMRT, and prospective correlation with randomized trials is needed.

Medical oncologists' perceptions of financial incentives in cancer care.

PURPOSE: The cost of cancer care continues to increase at an unprecedented rate. Concerns have been raised about financial incentives associated with the chemotherapy concession in oncology practices and their impact on treatment recommendations. METHODS: The objective of this study was to measure the physician-reported effects of prescribing chemotherapy or growth factors or making referrals to other cancer specialists, hospice, or hospital admissions on medical oncologists' income. US medical oncologists involved in the care of a population-based cohort of patients with lung or colorectal cancer from the Cancer Care Outcomes Research and Surveillance (CanCORS) study were surveyed regarding their perceptions of the impact of prescribing practices or referrals on their income. RESULTS: Although most oncologists reported that their incomes would be unaffected, compared with salaried oncologists, physicians in fee-for-service practice, and those paid a salary with productivity incentives were more likely to report that their income would increase from administering chemotherapy (odds ratios [ORs], 7.05 and 7.52, respectively; both P < .001) or administering growth factors (ORs, 5.60 and 6.03, respectively; both P < .001). CONCLUSION: A substantial proportion of oncologists who are not paid a fixed salary report that their incomes increase when they administer chemotherapy and growth factors. Further research is needed to understand the impact of these financial incentives on both the quality and cost of care.

Proton versus intensity-modulated radiotherapy for prostate cancer: patterns of care and early toxicity.

BACKGROUND: Proton radiotherapy (PRT) is an emerging treatment for prostate cancer despite limited knowledge of clinical benefit or potential harms compared with other types of radiotherapy. We therefore compared patterns of PRT use, cost, and early toxicity among Medicare beneficiaries with prostate cancer with those of intensity-modulated radiotherapy (IMRT). METHODS: We performed a retrospective study of all Medicare beneficiaries aged greater than or equal to 66 years who received PRT or IMRT for prostate cancer during 2008 and/or 2009. We used multivariable logistic regression to identify factors associated with receipt of PRT. To assess toxicity, each PRT patient was matched with two IMRT patients with similar clinical and sociodemographic characteristics. The main outcome measures were receipt of PRT or IMRT, Medicare reimbursement for each treatment, and early genitourinary, gastrointestinal, and other toxicity. All statistical tests were two-sided. RESULTS: We identified 27,647 men; 553 (2%) received PRT and 27,094 (98%) received IMRT. Patients receiving PRT were younger, healthier, and from more affluent areas than patients receiving IMRT. Median Medicare reimbursement was $32,428 for PRT and $18,575 for IMRT. Although PRT was associated with a statistically significant reduction in genitourinary toxicity at 6 months compared with IMRT (5.9% vs 9.5%; odds ratio [OR] = 0.60, 95% confidence interval [CI] = 0.38 to 0.96, P = .03), at 12 months post-treatment there was no difference in genitourinary toxicity (18.8% vs 17.5%; OR = 1.08, 95% CI = 0.76 to 1.54, P = .66). There was no statistically significant difference in gastrointestinal or other toxicity at 6 months or 12 months post-treatment. CONCLUSIONS: Although PRT is substantially more costly than IMRT, there was no difference in toxicity in a comprehensive cohort of Medicare beneficiaries with prostate cancer at 12 months post-treatment.

Physician self-reported treatment of brain metastases according to patients' clinical and demographic factors and physician practice setting.

BACKGROUND: Limited data guide radiotherapy choices for patients with brain metastases. This survey aimed to identify patient, physician, and practice setting variables associated with reported preferences for different treatment techniques. METHOD: 277 members of the American Society for Radiation Oncology (6% of surveyed physicians) completed a survey regarding treatment preferences for 21 hypothetical patients with brain metastases. Treatment choices included combinations of whole brain radiation therapy (WBRT), stereotactic radiosurgery (SRS), and surgery. Vignettes varied histology, extracranial disease status, Karnofsky Performance Status (KPS), presence of neurologic deficits, lesion size and number. Multivariate generalized estimating equation regression models were used to estimate odds ratios. RESULTS: For a hypothetical patient with 3 lesions or 8 lesions, 21% and 91% of physicians, respectively, chose WBRT alone, compared with 1% selecting WBRT alone for a patient with 1 lesion. 51% chose WBRT alone for a patient with active extracranial disease or KPS=50%. 40% chose SRS alone for an 80 year-old patient with 1 lesion, compared to 29% for a 55 year-old patient. Multivariate modeling detailed factors associated with SRS use, including availability of SRS within one's practice (OR 2.22, 95% CI 1.46-3.37). CONCLUSIONS: Poor prognostic factors, such as advanced age, poor performance status, or active extracranial disease, correspond with an increase in physicians' reported preference for using WBRT. When controlling for clinical factors, equipment access was independently associated with choice of SRS. The large variability in preferences suggests that more information about the relative harms and benefits of these options is needed to guide decision-making.

Use of colony-stimulating factors with chemotherapy: opportunities for cost savings and improved outcomes.

Myeloid colony-stimulating factors (CSFs) decrease the risk of febrile neutropenia (FN) from high-risk chemotherapy regimens administered to patients at 20% or greater risk of FN, but little is known about their use in clinical practice. We evaluated CSF use in a multiregional population-based cohort of lung and colorectal cancer patients (N = 1849). Only 17% (95% confidence interval [CI] = 8% to 26%) patients treated with high-risk chemotherapy regimens received CSFs, compared with 18% (95% CI = 16% to 20%) and 10% (95% CI = 8% to 12%) of patients treated with intermediate- (10%-20% risk of FN) and low-risk (<10% risk of FN) chemotherapy regimens, respectively. Using a generalized estimating equation model, we found that enrollment in a health maintenance organization (HMO) was strongly associated with a lower adjusted odds of discretionary CSF use, compared with non-HMO patients (odds ratio = 0.44, 95% CI = 0.32 to 0.60, P < .001). All statistical tests were two-sided. Overall, 96% (95% CI = 93% to 98%) of CSFs were administered in scenarios where CSF therapy is not recommended by evidence-based guidelines. This finding suggests that policies to decrease CSF use in patients at lower or intermediate risk of FN may yield substantial cost savings without compromising patient outcomes.

A population-based assessment of specialty physician involvement in cancer clinical trials.

BACKGROUND: Clinical trials are critical for evaluating new cancer therapies, but few adult patients participate in them. Physicians have an important role in facilitating patient participation in clinical trials. We examined the characteristics of specialty physicians who participate in clinical trials by enrolling or referring patients, the types of trials in which they participate, and factors associated with physicians who report greater involvement in clinical trials. METHODS: We analyzed data from the Cancer Care Outcomes Research and Surveillance Consortium. The study included 1533 specialty physicians who cared for colorectal and lung cancer patients (496 medical oncologists, 228 radiation oncologists, and 809 surgeons) and completed a survey conducted during 2005-2006 (response rate = 61.0%). Descriptive statistics were used to characterize physicians' personal and practice characteristics, and regression models were used to examine associations between these characteristics and physician participation in clinical trials. All statistical tests were two-sided. RESULTS: A total of 87.8% of medical oncologists, 66.1% of radiation oncologists, and 35.0% of surgeons reported referring or enrolling one or more patients in clinical trials during the previous 12 months. The mean number of patients referred or enrolled by these physicians was 17.2 (95% confidence interval [CI] = 15.5 to 18.9) for medical oncologists, 9.5 (95% CI = 7.7 to 11.3) for radiation oncologists, and 12.2 (95% CI = 9.8 to 14.6) for surgeons (P < .001). Specialty type, involvement in teaching, and affiliation with a Community Clinical Oncology Program (CCOP) and/or a National Cancer Institute-designated cancer center were associated with physician trial participation and enrolling more patients (all Ps < .05). Two-thirds of physicians with a CCOP or National Cancer Institute-designated cancer center affiliation reported participating in trials. CONCLUSIONS: Features of specialty physicians' practice environments are associated with their trial participation, but many physicians at CCOPs and cancer centers do not participate.

Patient recruitment methods to evaluate treatment decision making for localized prostate cancer.

OBJECTIVE: To examine methods for identifying and recruiting prostate cancer patients prior to initiating treatment to gain insight into the treatment decision process and avoid recall bias. STUDY DESIGN AND SETTING: One recruitment strategy involved providers and nursing staff approaching patients in community and academic urology clinics. The second recruitment strategy used electronic pathology reports to identify newly diagnosed cases in real time in an integrated health system. Our recruitment goal was to have patients complete the survey about the decision-making process prior to initiating therapy. RESULTS: The two recruitment methods yielded different response rates. Of the 226 eligible participants approached in urology clinics, 187 (83%) returned a completed baseline survey. Of the 1177 surveys mailed to potentially eligible participants at KPNC, 617 (52%) returned a completed baseline survey. The number of surveys completed prior to treatment was 125 (67%) for the clinic recruitment approach and 437 (71%) for the electronic medical record approach. Younger participants and patients with less aggressive clinical characteristics were more likely to complete the survey before initiating treatment. Other patient demographic and clinical factors were not associated with the timing of survey return. CONCLUSIONS: Recruiting newly diagnosed patients prior to initiating treatment is feasible with both approach methods. The use of electronic medical records to identify subjects was more cost efficient, although it results in a lower response rate.

Impact of cancer on health-related quality of life of older Americans.

BACKGROUND: The impact of cancer on health-related quality of life (HRQOL) is poorly understood because of the lack of baseline HRQOL status before cancer diagnosis. To our knowledge, this is the first population-based study to quantify the nature and extent of HRQOL changes from before to after cancer diagnosis for nine types of cancer patients and to compare their health with individuals without cancer. METHODS: The Surveillance, Epidemiology, and End Results cancer registry data were linked with the Medicare Health Outcomes Survey (MHOS) data; data were collected from Medicare beneficiaries who were aged 65 years and older from 1998 through 2003. Cancer patients (n = 1432; with prostate, breast, colorectal, lung, bladder, endometrial, or kidney cancers; melanoma; or non-Hodgkin lymphoma [NHL]) were selected whose first cancer diagnosis occurred between their baseline and follow-up MHOS assessments. Control subjects without cancer (n = 7160) were matched to cancer patients by use of propensity scores that were estimated from demographics and comorbid medical conditions. Analysis of covariance models were used to estimate changes in HRQOL as assessed with the Medical Outcomes Study Short Form-36 survey (mean score = 50, SD = 10). All statistical tests were two-sided. RESULTS: Patients with all cancer types (except melanoma and endometrial cancer) reported statistically significant declines in physical health (mean scores: prostate cancer = -3.4, 95% confidence interval [CI] = -2.5 to -4.2; breast cancer = -3.5, 95% CI = -2.5 to -4.5; bladder cancer = -4.3, 95% CI = -2.5 to -6.1; colorectal cancer = -4.4, 95% CI = -3.3 to -5.5; kidney cancer = -5.7, 95% CI = -3.2 to -8.2; NHL = -6.7, 95% CI = -4.4 to -9.1; and lung cancer = -7.5, 95% CI = -5.9 to -9.2) compared with the control subjects (mean score = -1.8, 95% CI = -1.6 to -2.0) (all P < .05). However, only lung (mean score = -5.4, 95% CI = -3.5 to -7.2), colorectal (mean score = -3.5, 95% CI = -2.2 to -4.7), and prostate (mean score = -2.8, 95% CI = -1.8 to -3.7) cancer patients showed statistically significant decreases in mental health relative to the mean change of the control subjects (mean score = -1.2, 95% CI = -0.9 to -1.4) (all P < .05). CONCLUSION: These findings provide validation of the specific deleterious effects of cancer on HRQOL and an evidence base for future research and clinical interventions aimed at understanding and remediating these effects.

Comparison of cancer diagnosis and treatment in Medicare fee-for-service and managed care plans.

OBJECTIVE: To compare the Medicare managed care (MC) and fee-for-service (FFS) sectors on stage at diagnosis and treatment patterns for prostate, female breast, and colorectal cancers, and to examine patterns across MC plans. DATA: Surveillance, Epidemiology, and End Results-Medicare linked data. METHODS: Among cases diagnosed at ages 65-79 between 1998 and 2002, we selected all MC enrollees (n = 42,467) and beneficiaries in FFS (n = 82,998) who resided in the same counties. MC and FFS samples were compared using logistic regression, adjusting for demographic, geographic, and clinical covariates. RESULTS: The percentage of late stage cases was similar in MC and FFS for prostate and colorectal cancers; there were slightly fewer late stage breast cancer cases in MC after adjustment (7.3% vs. 8.5%, P < 0.001). Within MC, radical prostatectomy was performed less frequently for clinically localized prostate cancer (18.3% vs. 22.4%, P < 0.0001), and 12 or more lymph nodes were examined less often for resected colon cancer cases (40.9% vs. 43.0%, P < 0.05). Treatment patterns for early stage breast cancer were similar in MC and FFS. Analyses of treatment patterns at the individual plan level revealed significant variation among plans, as well as within the FFS sector, for all 3 types of cancer. CONCLUSIONS: On average, there are few significant differences in cancer diagnosis and treatment between MC and FFS. Such comparisons, however, mask the wide variability among MC plans, as well as FFS providers. Observed variation in patterns of care may be related to patient selection, but can potentially lead to outcome differences. These findings support the need for quality measures to evaluate plan practices and performance.

Trends in treatment costs for localized prostate cancer: the healthy screenee effect.

OBJECTIVE: We sought to obtain estimates of trends in initial treatment costs during the prostate-specific antigen (PSA) era that account for the changing patient case-mix associated with screening. SUBJECTS: We used reimbursement claims for Medicare-eligible subjects diagnosed with nonmetastatic prostate cancer between 1991 and 1999. Patients were grouped by initial treatment, with 17,846 receiving radical prostatectomy (RP), 25,933 receiving external beam radiotherapy (XRT), and 4525 receiving brachytherapy (BT). METHODS: Cancer-attributable costs were computed by subtracting noncancer costs from total Medicare reimbursements among newly diagnosed cancer patients. Noncancer costs were estimated in 2 ways: (1) average costs among age-matched, cancer-free control subjects (control method) and (2) projections based on claims from subjects before diagnosis (prediagnosis method). Adjusted annual percent change in cancer-attributable costs was calculated using multivariate generalized linear models. RESULTS: Noncancer costs increased at a much lower rate among men prior to diagnosis (3.8% annually) than among the general Medicare population (10.9%). The 2 approaches yielded different results; RP costs declined by 2.4% annually (prediagnosis method) versus 6.2% (control method); XRT costs declined by 1.5% versus 5.8%; and BT costs declined by 4.1% versus 8.3%. CONCLUSIONS: Because of self-selection of PSA screening, men diagnosed with prostate cancer today are now healthier overall than men in the general population and are considerably healthier than men diagnosed previously. Estimates of cancer-attributable costs that do not account for this healthy selection effect are likely to be biased. Declines in cancer-attributable treatment costs are evident even after accounting for a healthy screenee effect, suggesting that there has been a real reduction in cancer treatment costs.

Racial disparity in primary and adjuvant treatment for nonmetastatic prostate cancer: SEER-Medicare trends 1991 to 1999.

OBJECTIVES: To assess trends in the initial care of nonmetastatic prostate cancer, including the use of primary and adjuvant androgen deprivation therapy (ADT), using population-based treatment claims from 1991 to 1999. METHODS: We used a database linking the Surveillance, Epidemiology, and End Results (SEER) registry with Medicare claims to extract treatment information for 90,128 men aged 65 years and older, who were newly diagnosed with nonmetastatic prostate cancer. RESULTS: The use of aggressive therapy has increased among white men over time; but aggressive therapy has recently declined among African-American men. Accounting for age, grade, socioeconomic status, and comorbidity, African-American men were 26% less likely to receive aggressive therapy than white men (odds ratio 0.74; 95% confidence interval 0.70 to 0.79). The use of ADT has increased substantially in both the primary and the adjuvant settings. By 1999, 45.6% of white men and 35.8% of African-American men who selected conservative management received primary ADT; among men treated with external beam radiotherapy, the proportion receiving adjuvant ADT was 53.7% for white men and 42.4% for African-American men (P <0.001). CONCLUSIONS: Racial differences in the use of aggressive and conservative therapies are increasing. ADT is becoming a widely adopted component of initial treatment for localized prostate cancer. It is crucial to understand the impact of treatment patterns, including the increased use of ADT, on patient survival, morbidity, and costs of care.

Race/ethnicity and the intensity of medical monitoring under 'watchful waiting' for prostate cancer.

BACKGROUND: Previous studies have found that racial/ethnic minority patients with prostate cancer are more frequently managed with "watchful waiting." Little, however, is known about the medical care received among men managed with watchful waiting. We examine the type and intensity of medical monitoring received by African American, Hispanic, and white patients with prostate cancer managed with "watchful waiting" in fee-for-service systems. METHODS: Surveillance Epidemiology and End Results-Medicare data for men diagnosed with prostate cancer 1994-1996 were used in this study. Men were determined to have initially received watchful waiting if they did not receive surgery, radiation, or hormone treatment within the first 7 months of diagnosis. Crosstabulations, multivariate logistic, and Cox regressions were used to examine the association between clinical and sociodemographic variables and the receipt of a primary care, urology visit, prostate-specific antigen test, or bone scan. RESULTS: In general, Hispanic and African American men received less medical monitoring and had longer median times from diagnosis to receipt of a medical monitoring visit or procedure than white men. Furthermore, nearly 6% of African American, 5% of Hispanic, and 1% of white men did not have any medical monitoring visits or procedures during the 60-month follow-up period (P<0.001). Differences in observed clinical or sociodemographic characteristics did not explain variations in medical monitoring. CONCLUSION: Regular medical monitoring is considered by most medical authorities to be a necessary component of management with watchful waiting. The disproportionately low receipt of medical monitoring visits and procedures observed for African American and Hispanic men managed with watchful waiting in this study suggest that there are racial/ethnic disparities in the receipt of appropriate prostate cancer management.

Incremental treatment costs in national cancer institute-sponsored clinical trials.

CONTEXT: Concern about additional costs for direct patient care impedes efforts to enroll patients in clinical trials. But generalizable evidence substantiating these concerns is lacking. OBJECTIVE: To assess the additional cost of treating cancer patients in the National Cancer Institute (NCI)-sponsored clinical trials in the United States across a range of trial phases, treatment modalities, and patient care settings. DESIGN: Retrospective cost study using a multistage, stratified, random sample of patients enrolled in 1 of 35 active phase 3 trials or phase 1 or any phase 2 trials between October 1, 1998, and December 31, 1999. Unadjusted and adjusted costs were compared and related to trial phase, institution type, and vital status. SETTING AND PARTICIPANTS: A representative sample of 932 cancer patients enrolled in nonpediatric, NCI-sponsored clinical trials and 696 nonparticipants with a similar stage of disease not enrolled in a research protocol from 83 cancer clinical research institutions across the United States. MAIN OUTCOME MEASURES: Direct treatment costs as measured using a combination of medical records, telephone survey, and Medicare claims data. Administrative and other research costs were excluded. RESULTS: The incremental costs of direct care in trials were modest. Over approximately a 2.5-year period, adjusted costs were 6.5% higher for trial participants than nonparticipants (35,418 dollars vs 33,248 dollars; P =.11). Cost differences for phase 3 studies were 3.5% (P =.22), lower than for phase 1 or 2 trials (12.8%; P =.20). Trial participants who died had higher costs than nonparticipants who died (17.9%; 39,420 dollars vs 33,432 dollars, respectively; P =.15). CONCLUSIONS: Treatment costs for nonpediatric clinical trial participants are on average 6.5% higher than what they would be if patients did not enroll. This implies total incremental treatment costs for NCI-sponsored trials of 16 million dollars in 1999. Incremental costs were higher for patients who died and who were in early phase studies although these findings deserve further scrutiny. Overall, the additional treatment costs of an open reimbursement policy for government-sponsored cancer clinical trials appear minimal.

Measuring complications of cancer treatment using the SEER-Medicare data.

BACKGROUND: The linkage of SEER registry data with Medicare claims allows the longitudinal tracking of health care and outcomes for patients after a cancer diagnosis. One category of outcomes amenable to research using Medicare claims is complications of cancer treatments: the unintentional, adverse side effects or sequelae of interventions used to treat or palliate cancer patients. RESEARCH DESIGN: The authors review some of the methods and limitations of using Medicare claims to identify both acute and chronic complications of cancer treatments, and present an original analysis comparing survey-based and claims-based complications following radical prostatectomy for prostate cancer to illustrate some of the potential limitations inherent in using claims for this purpose. RESULTS: Utility of the Medicare claims for identifying postdischarge complications varies by the patient type, the initial treatment used, and any subsequent treatment of complications. For patients undergoing surgical interventions, Medicare claims can be used to identify most acute inpatient complications. However, claims data cannot be used as effectively in the long-term to capture chronic complications, particularly when the complication does not consistently prompt an intervention. CONCLUSION: Researchers who use the SEER-Medicare-linked database to assess long-term complications of cancer treatments should exercise caution when designing and interpreting studies. Ideally, for studies of most chronic complications of cancer care, validation studies similar to the one performed here would provide valuable additional evidence to assess the credibility of conclusions based on claims data.

Identifying cancer relapse using SEER-Medicare data.

INTRODUCTION: Tumor registries capture valid information at the time of cancer diagnosis, but often do not conduct longitudinal follow-up evaluations. However, investigators may be interested in questions relating to subsequent relapsed disease. Linking administrative data to registry data, as in the creation of the SEER (Surveillance, Epidemiology, and End Results) and Medicare data set, can provide the ability to infer the occurrence of relapse in selected situations. METHODS: The authors created different algorithms to detect relapse of acute myelogenous leukemia (AML). A retrospective cohort of patients with AML was identified, and both their billing data and medical records were obtained. The algorithms were then applied to the billing data, the results were compared with medical record review. RESULTS: Eighty-nine patients were identified, of whom 22 were treated for relapsed AML. The sensitivity of the best algorithm for detecting relapse was 86%, and the specificity 99%, with a positive predictive value of 95% and a negative predictive value of 96%. CONCLUSIONS: Identification of relapse from SEER-Medicare data using clinical algorithms is feasible for cancers where a majority of patients receive treatment for relapse, without a "watch and wait" strategy, and where that treatment is with a modality that can be detected in billing data (ie, intravenous chemotherapy, radiation, surgery, or all three). Optimal analytic situations are ones in which the investigator is mostly interested in positive predictive value, less interested in sensitivity, and wants to evaluate outcomes among those patients who receive treatment for their relapsed disease. However, the accuracy of such an approach for cancers other than AML has not yet been established.