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Background Using observational data to assess the relative effectiveness of alternative cancer treatments is limited by patient selection into treatment, which often biases interpretation of outcomes. We evaluated methods for addressing confounding in treatment and survival of patients with early-stage prostate cancer in observational data and compared findings with those from a benchmark randomized clinical trial. Methods We selected 14302 early-stage prostate cancer patients who were aged 66-74 years and had been treated with radical prostatectomy or conservative management from linked Surveillance, Epidemiology, and End Results--Medicare data from January 1, 1995, through December 31, 2003. Eligibility criteria were similar to those from a clinical trial used to benchmark our analyses. Survival was measured through December 31, 2007, by use of Cox proportional hazards models. We compared results from the benchmark trial with results from models with observational data by use of traditional multivariable survival analysis, propensity score adjustment, and instrumental variable analysis. Results Prostate cancer patients receiving conservative management were more likely to be older, nonwhite, and single and to have more advanced disease than patients receiving radical prostatectomy. In a multivariable survival analysis, conservative management was associated with greater risk of prostate cancer-specific mortality (hazard ratio [HR] = 1.59, 95% confidence interval [CI] = 1.27 to 2.00) and all-cause mortality (HR = 1.47, 95% CI = 1.35 to 1.59) than radical prostatectomy. Propensity score adjustments resulted in similar patient characteristics across treatment groups, although survival results were similar to traditional multivariable survival analyses. Results for the same comparison from the instrumental variable approach, which theoretically equalizes both observed and unobserved patient characteristics across treatment groups, differed from the traditional multivariable and propensity score results but were consistent with findings from the subset of elderly patient with early-stage disease in the trial (ie, conservative management vs radical prostatectomy: for prostate cancer-specific mortality, HR = 0.73, 95% CI = 0.08 to 6.73; for all-cause mortality, HR = 1.09, 95% CI = 0.46 to 2.59). Conclusion Instrumental variable analysis may be a useful technique in comparative effectiveness studies of cancer treatments if an acceptable instrument can be identified. J Natl Cancer Inst 2010;102:1780-1793 DOI: 10.1093/jnci/djq393

Background: Cervical cancer screening guidelines were substantially revised in 2002 and 2003. Little information is available about primary care physicians' current Papanicolaou (Pap) test screening practices, including initiation, frequency, and stopping. Objective: To assess current Pap test screening practices in the United States. Design: Cross-sectional survey. Setting: Nationally representative sample of physicians during 2006 to 2007. Participants: 1212 primary care physicians. Measurements: The survey included questions about physician and practice characteristics and recommendations for Pap screening presented as clinical vignettes describing women by age and by sexual and screening histories. A composite measure--guideline-consistent recommendations--was created by using responses to vignettes in which major guidelines were uniform. Results: Most physicians reported providing Pap tests to their eligible patients (91.0% [95% CI, 89.0% to 92.6%]). Among Pap test providers (n = 1114), screening practices, including number of tests ordered or performed, use of patient reminder systems, and cytology method used, varied by physician specialty (P < 0.001). Although most Pap test providers reported that screening guidelines were very influential in their clinical practice, few had guideline-consistent recommendations for starting and stopping Pap screening across multiple vignettes (22.3% [CI, 19.9% to 25.0%]). Guideline-consistent recommendations varied by specialty (obstetrics/gynecology, 16.4%; internal medicine, 27.5%; and family or general practice, 21.1%). Compared with obstetricians/gynecologists, internal medicine specialists and family or general practice specialists were more likely to have guideline-consistent screening recommendations (odds ratio, 1.98 [CI, 1.22 to 3.23] and 1.45 [CI, 0.99 to 2.13], respectively) in multivariate analysis. Limitation: Physician self-report may reflect idealized rather than actual practice. Conclusion: Primary care physicians' recommendations for Pap test screening are not consistent with screening guidelines, reflecting overuse of screening. Implementation of effective interventions that focus on potentially modifiable physician and practice factors is needed to improve screening practice. Primary Funding Source: National Cancer Institute, Centers for Disease Control and Prevention, and Agency for Healthcare Research and Quality.

Background A model that predicts the economic benefit of reduced cancer mortality provides critical information for allocating scarce resources to the interventions with the greatest benefits. Methods We developed models using the human capital approach, which relies on earnings as a measure of productivity, to estimate the value of productivity lost as a result of cancer mortality. The base model aggregated age- and sex-specific data from four primary sources: 1) the US Bureau of the Census, 2) US death certificate data for 1999-2003, 3) cohort life tables from the Berkeley Mortality Database for 1900-2000, and 4) the Bureau of Labor Statistics Current Population Survey. In a model that included costs of caregiving and household work, data from the National Human Activity Pattern Survey and the Caregiving in the U.S. study were used. Sensitivity analyses were performed using six types of cancer assuming a 1% decline in cancer mortality rates. The values of forgone earnings for employed individuals and imputed forgone earnings for informal caregiving were then estimated for the years 2000-2020. Results The annual productivity cost from cancer mortality in the base model was approximately $115.8 billion in 2000; the projected value was $147.6 billion for 2020. Death from lung cancer accounted for more than 27% of productivity costs. A 1% annual reduction in lung, colorectal, breast, leukemia, pancreatic, and brain cancer mortality lowered productivity costs by $814 million per year. Including imputed earnings lost due to caregiving and household activity increased the base model total productivity cost to $232.4 billion in 2000 and to $308 billion in 2020. Conclusions Investments in programs that target the cancers with high incidence and/or cancers that occur in younger, working-age individuals are likely to yield the greatest reductions in productivity losses to society.

Background Value-of-life methods are increasingly used in policy analyses of the economic burden of disease. The purpose of this study was to estimate and project the value of life lost from cancer deaths in the United States. Methods We estimated and projected US age-specific mortality rates for all cancers and for 16 types of cancer in men and 18 cancers in women in the years 2000-2020 and applied them to US population projections to estimate the number of deaths in each year. Cohort life tables were used to calculate the remaining life expectancy in the absence of cancer deaths--the person-years of life lost (PYLL). We used a willingness-to-pay approach in which the value of life lost due to cancer death was calculated by multiplying PYLL by an estimate of the value of 1 year of life ($150000). We performed sensitivity analyses for female breast, colorectal, lung, and prostate cancers using varying assumptions about future cancer mortality rates through the year 2020. Results The value of life lost from all cancer deaths in the year 2000 was $960.6 billion; lung cancer alone represented more than 25% of this value. Projections for the year 2020 with current cancer mortality rates showed a 53% increase in the total value of life lost ($1472.5 billion). Projected annual decreases of cancer mortality rates of 2% reduced the expected value of life lost in the year 2020 from $121.0 billion to $80.7 billion for breast cancer, $140.1 billion to $93.5 billion for colorectal cancer, from $433.4 billion to $289.4 billion for lung cancer, and from $58.4 billion to $39.0 billion for prostate cancer. Conclusions Estimated value of life lost due to cancer deaths in the United States is substantial and expected to increase dramatically, even if mortality rates remain constant, because of expected population changes. These estimates and projections may help target investments in cancer control strategies to tumor sites that are likely to result in the greatest burden of disease and to interventions that are the most cost-effective.

Background Despite reports of increases in the cost of cancer treatment, little is known about how costs of cancer treatment have changed over time and what services have contributed to the increases. Methods We used data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database for 306709 persons aged 65 and older and diagnosed with breast, lung, colorectal, or prostate cancer between 1991 and 2002 to assess the number of patients assigned to initial cancer care, from 2 months before diagnosis to 12 months after diagnosis, and mean annual Medicare payments for this care according to cancer type and type of treatment. Mutually exclusive treatment categories were cancer-related surgery, chemotherapy, radiation therapy, and other hospitalizations during the period of initial cancer care. Linear regression models were used to assess temporal trends in the percentage of patients receiving treatment and costs for those treated. We extrapolated our results based on the SEER data to the US Medicare population to estimate national Medicare payments by cancer site and treatment category. All statistical tests were two-sided. Results For patients diagnosed in 2002, Medicare paid an average of $39891 for initial care for each lung cancer patient, $41 134 for each colorectal cancer patient, and $20964 for each breast cancer patient, corresponding to inflation-adjusted increases from 1991 of $7139, $5345, and $4189, respectively. During the same interval, the mean Medicare payment for initial care for prostate cancer declined by $196 to $18261 in 2002. Costs for any hospitalization accounted for the largest portion of payments for all cancers. Chemotherapy use increased markedly for all cancers between 1991 and 2002, as did radiation therapy use (except for colorectal cancers). Total 2002 Medicare payments for initial care for these four cancers exceeded $6.7 billion, with colorectal and lung cancers being the most costly overall. Conclusions The statistically significant increase in costs of initial cancer treatment reflects more patients receiving surgery and adjuvant therapy and rising prices for these treatments. These trends are likely to continue in the near future, although more efficient targeting of costly therapies could mitigate the overall economic impact of this trend.

Background Timely estimates of the costs of care for cancer patients are an important element in the formulation of national cancer programs and policies. We estimated net costs of care for elderly cancer patients in the United States for the 18 most prevalent cancers and for all other tumor sites combined. Methods We used Surveillance, Epidemiology, and End Results-Medicare files to identify 718907 cancer patients and 1 623651 noncancer control subjects. Within each tumor site, noncancer control subjects were matched to patients by sex, age group, geographic location, and phase of care (ie, initial, continuing, and last year of life). Costs of care were estimated for each phase by use of Medicare claims data from January 1, 1999, through December 31, 2003. Per-patient net costs of care were applied to the 5-year survival of cancer patients by phase of care to estimate 5-year costs of care and extrapolated to the elderly US Medicare population diagnosed with cancer in 2004. Results Across tumor sites, mean net costs of care were highest in the initial and last year of life phases of care and lowest in the continuing phase. Mean 5-year net costs varied widely, from less than $20000 for patients with breast cancer or melanoma of the skin to more than $40000 for patients with brain or other nervous system, esophageal, gastric, or ovarian cancers or lymphoma. For elderly cancer patients diagnosed in 2004, aggregate 5-year net costs of care to Medicare were estimated to be approximately $21.1 billion. Costs to Medicare were highest for lung, colorectal, and prostate cancers, reflecting underlying incidence, stage distribution at diagnosis, survival, and phase-specific costs for these tumor sites. Conclusions The costs of cancer care to Medicare are substantial and vary by tumor site, phase of care, stage at diagnosis, and survival.

Background: For many diseases, specialized care (i.e., care rendered by a specialist) has been associated with superior-quality care (i.e., better outcomes). We examined associations between physician specialty and outcomes in a population-based cohort of elderly ovarian cancer surgery patients. Methods: We analyzed the Medicare claims, by physician specialty, of all women aged 65 years or older who underwent surgery for pathologically confirmed invasive epithelial ovarian cancer between January 1, 1992, and December 31, 1999, while living in an area monitored by the Surveillance, Epidemiology, and End Results (SEER) program to assess important care processes (i.e., the appropriate extent of surgery and use of adjuvant chemotherapy) and outcomes (i.e., surgical complications, ostomy rates, and survival). All statistical tests were two-sided. Results: Among 3067 ovarian cancer patients who underwent surgery, 1017 patients (33%) were treated by a gynecologic oncologist, 1377 patients (45%) by a general gynecologist, and 673 patients (22%) by a general surgeon. Among patients with stage I or II disease, those treated by a gynecologic oncologist (60%) were more likely to undergo lymph node dissection than those treated by a general gynecologist (36%) or a general surgeon (16%). Patients with stage III or IV disease were more likely to undergo a debulking procedure if the initial surgery was performed by a gynecologic oncologist (58%) than by a general gynecologist (51%) or a general surgeon (40%; P

Background: Strong associations between provider (i.e., hospital or surgeon) procedure volumes and patient outcomes have been demonstrated for many types of cancer operation. We performed a population-based cohort study to examine these associations for ovarian cancer resections. Methods: We used the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database to identify 2952 patients aged 65 years or older who had surgery for a primary ovarian cancer diagnosed from 1992 through 1999. Hospital- and surgeon-specific procedure volumes were ascertained based on the number of claims submitted during the 8-year study period. Primary outcome measures were mortality at 60 days and 2 years after surgery, and overall survival. Length of hospital stay was also examined. Patient age at diagnosis, race, marital status, comorbid illness, cancer stage, and median income and population density in the area of residence were used to adjust for differences in case mix. All P values are two-sided. Results: Neither hospital- nor surgeon-specific procedure volume was statistically significantly associated with 60-day mortality following primary ovarian cancer resection. However, differences by hospital volume were seen with 2-year mortality; patients treated at the low-, intermediate-, and high-volume hospitals had 2-year mortality rates of 45.2% (95% confidence interval [CI]= 42.1% to 48.4%), 41.1% (95% CI = 38.1% to 44.3%), and 40.4% (95% CI = 37.4% to 43.4%), respectively. The inverse association between hospital procedure volume and 2-year mortality was statistically significant both before (P = .011) and after (P = .006) case-mix adjustment but not after adjustment for surgeon volume. Two-year mortality for patients treated by low-, intermediate-, and high-volume surgeons was 43.2% (95% CI = 40.7% to 45.8%), 42.9% (95% CI = 39.5% to 46.4%), and 39.5% (95% CI = 36.0% to 43.2%), respectively; there was no association between 2-year mortality and surgeon procedure volume, with or without case-mix adjustment. After case-mix adjustment, neither hospital volume (P = .031) nor surgeon volume (P = .062) was strongly associated with overall survival. Conclusion: Hospital- and surgeon-specific procedure volumes are not strong predictors of survival outcomes following surgery for ovarian cancer among women aged 65 years or older.

Background: Population trends in aging and improved cancer survival are likely to result in increased cancer prevalence in the United States, but few estimates of the burden of illness among cancer survivors are currently available. The purpose of this study was to estimate the burden of illness in cancer survivors in a national, population-based sample. Methods: A total of 1823 cancer survivors and 5469 age-, sex-, and educational attainment-matched control subjects were identified from the 2000 National Health Interview Survey. Multiple measures of burden, including utility, a summary measure of health, and days lost from work, were compared using two-sided tests of statistical significance for the two groups overall and for subgroups stratified by tumor site and time since diagnosis. Results: Compared with matched control subjects, cancer survivors had poorer outcomes across all burden measures (P

Objective. To utilize health services research techniques in developing an episode of care using an administrative data set. This method is demonstrated for an episodic clinical condition, migraine. Data Sources. Medicaid administrative data set of 3,372 patients with a diagnosis of migraine (ICD-9-CM 346.0, 346.1) in the state of Pennsylvania between May 1990 and March 1992. Study Design. The duration of a migraine episode was measured by assessing the magnitude of resource utilization and the proportion of patients with charges in the period after the index migraine as compared to the period before the index migraine. A confidence interval (CI) was developed around each measure using bootstrap techniques. Data Collection Methods. All charge data were extracted daily for a 113-day observation period surrounding each index migraine in order to observe the duration of impact of a migraine diagnosis on resource utilization. Principal Findings. The lower limits of both the 95% and 99% CIs for the difference in charges are greater than 0 for three weeks. The lower limits of both Cis for the difference in the proportion of patients with charges are above 0 for six weeks. Conclusions. Our analysis demonstrates that a health services research framework can be used to define an episode of care for a chronic disease category such as migraine. This method can be used to evaluate episodes of care for clinical studies of limited or episodic conditions and to complement clinical expertise in developing time horizons for clinical trials. Key Words. Migraine therapy, clinical trials, cost-effectiveness analysis, episode of care, episode of illness, economic evaluation, Prospective economic evaluations of new medical technologies are rapidly becoming standard practice in the pharmaceutical industry. Economic evaluation is designed to inform healthcare decision makers about the economic benefits of [...]