Radiotheranostics: a roadmap for future development.

Radiotheranostics, injectable radiopharmaceuticals with antitumour effects, have seen rapid development over the past decade. Although some formulations are already approved for human use, more radiopharmaceuticals will enter clinical practice in the next 5 years, potentially introducing new therapeutic choices for patients. Despite these advances, several challenges remain, including logistics, supply chain, regulatory issues, and education and training. By highlighting active developments in the field, this Review aims to alert practitioners to the value of radiotheranostics and to outline a roadmap for future development. Multidisciplinary approaches in clinical trial design and therapeutic administration will become essential to the continued progress of this evolving therapeutic approach.

Diffusion of Bevacizumab Across Oncology Practices: An Observational Study.

BACKGROUND: Technological advances can improve care and outcomes but are a primary driver of health care spending growth. Understanding diffusion and use of new oncology therapies is important, given substantial increases in prices and spending on such treatments. OBJECTIVES: Examine diffusion of bevacizumab, a novel (in 2004) and high-priced biologic cancer therapy, among US oncology practices during 2005-2012 and assess variation in use across practices. RESEARCH DESIGN: Population-based observational study. SETTING: A total of 2329 US practices providing cancer chemotherapy. PARTICIPANTS: Random 20% sample of 236,304 Medicare fee-for-service beneficiaries aged above 65 years in 2004-2012 undergoing infused chemotherapy for cancer. MEASURES: Diffusion of bevacizumab (cumulative time to first use and 10% use) in practices, variation in use across practices overall and by higher versus lower-value use. We used hierarchical models with practice random effects to estimate the between-practice variation in the probability of receiving bevacizumab and to identify factors associated with use. RESULTS: We observed relatively rapid diffusion of bevacizumab, particularly in independent practices and larger versus smaller practices. We observed substantial variation in use; the adjusted odds ratio (95% confidence interval) of bevacizumab use was 2.90 higher (2.73-3.08) for practices 1 SD above versus one standard deviation below the mean. Variation was less for higher-value [odds ratio=2.72 (2.56-2.89)] than lower-value uses [odds ratio=3.61 (3.21-4.06)]. CONCLUSIONS: Use of bevacizumab varied widely across oncology practices, particularly for lower-value indications. These findings suggest that interventions targeted to practices have potential for decreasing low-value use of high-cost cancer therapies.

External Factors That Influence the Practice of Radiology: Proceedings of the International Society for Strategic Studies in Radiology Meeting.

In both the United States and Europe, efforts to reduce soaring health care costs have led to intense scrutiny of both standard and innovative uses of imaging. Given that the United States spends a larger share of its gross domestic product on health care than any other nation and also has the most varied health care financing and delivery systems in the world, it has become an especially fertile environment for developing and testing approaches to controlling health care costs and value. This report focuses on recent reforms that have had a dampening effect on imaging use in the United States and provides a glimpse of obstacles that imaging practices may soon face or are already facing in other countries. On the basis of material presented at the 2015 meeting of the International Society for Strategic Studies in Radiology, this report outlines the effects of reforms aimed at (a) controlling imaging use, (b) controlling payer expense through changes in benefit design, and (c) controlling both costs and quality through "value-based" payment schemes. Reasons are considered for radiology practices on both sides of the Atlantic about why the emphasis needs to shift from providing a large volume of imaging services to increasing the value of imaging as manifested in clinical outcomes, patient satisfaction, and overall system savings. Options for facilitating the shift from volume to value are discussed, from the use of advanced management strategies that improve workflow to the creation of programs for patient engagement, the development of new clinical decision-making support tools, and the validation of clinically relevant imaging biomarkers. Radiologists in collaboration with industry must enhance their efforts to expand the performance of comparative effectiveness research to establish the value of these initiatives, while being mindful of the importance of minimizing conflicts of interest. © RSNA, 2017.

How Accountable Care Organizations Responded to Pediatric Incentives in the Alternative Quality Contract.

OBJECTIVE: From 2009 to 2010, 12 accountable care organizations (ACOs) entered into the alternative quality contract (AQC), BlueCross BlueShield of Massachusetts's global payment arrangement. The AQC included 6 outpatient pediatric quality measures among 64 total measures tied to pay-for-performance bonuses and incorporated pediatric populations in their global budgets. We characterized the pediatric infrastructure of these adult-oriented ACOs and obtained leaders' perspectives on their ACOs' response to pediatric incentives. METHODS: We used Massachusetts Health Quality Partners and American Hospital Association Survey data to characterize ACOs' pediatric infrastructure as extremely limited, basic, and substantial on the basis of the extent of pediatric primary care, outpatient specialist, and inpatient services. After ACOs had 16 to 43 months of experience with the AQC, we interviewed 22 leaders to gain insight into how organizations made changes to improve pediatric care quality, tried to reduce pediatric spending, and addressed care for children with special health care needs. RESULTS: ACOs' pediatric infrastructure ranged from extremely limited (eg, no general pediatricians in their primary care workforce) to substantial (eg, 42% of workforce was general pediatricians). Most leaders reported intensifying their pediatric quality improvement efforts and witnessing changes in quality metrics; most also investigated pediatric spending patterns but struggled to change patients' utilization patterns. All reported that the AQC did little to incentivize care for children with special health care needs and that future incentive programs should include this population. CONCLUSIONS: Although ACOs involved in the AQC were adult-oriented, most augmented their pediatric quality improvement and spending reduction efforts when faced with pediatric incentives.

Comparing a medical records-based and a claims-based index for measuring comorbidity in patients with lung or colon cancer.

OBJECTIVE: Ascertaining comorbid conditions in cancer patients is important for research and clinical quality measurement, and is particularly important for understanding care and outcomes for older patients and those with multi-morbidity. We compared the medical records-based ACE-27 index and the claims-based Charlson index in predicting receipt of therapy and survival for lung and colon cancer patients. MATERIALS AND METHODS: We calculated the Charlson index using administrative data and the ACE-27 score using medical records for Veterans Affairs patients diagnosed with stage I/II non-small cell lung or stage III colon cancer from January 2003 to December 2004. We compared the proportion of patients identified by each index as having any comorbidity. We used multivariable logistic regression to ascertain the predictive power of each index regarding delivery of guideline-recommended therapies and two-year survival, comparing the c-statistic and the Akaike information criterion (AIC). RESULTS: Overall, 97.2% of lung and 90.9% of colon cancer patients had any comorbidity according to the ACE-27 index, versus 59.5% and 49.7%, respectively, according to the Charlson. Multivariable models including the ACE-27 index outperformed Charlson-based models when assessing receipt of guideline-recommended therapies, with higher c-statistics and lower AICs. Neither index was clearly superior in prediction of two-year survival. CONCLUSIONS: The ACE-27 index measured using medical records captured more comorbidity and outperformed the Charlson index measured using administrative data for predicting receipt of guideline-recommended therapies, demonstrating the potential value of more detailed comorbidity data. However, the two indices had relatively similar performance when predicting survival.

Using Health Care Utilization and Publication Patterns to Characterize the Research Portfolio and to Plan Future Research Investments.

OBJECTIVE: Government funders of biomedical research are under increasing pressure to demonstrate societal benefits of their investments. A number of published studies attempted to correlate research funding levels with the societal burden for various diseases, with mixed results. We examined whether research funded by the Department of Veterans Affairs (VA) is well aligned with current and projected veterans' health needs. The organizational structure of the VA makes it a particularly suitable setting for examining these questions. METHODS: We used the publication patterns and dollar expenditures of VA-funded researchers to characterize the VA research portfolio by disease. We used health care utilization data from the VA for the same diseases to define veterans' health needs. We then measured the level of correlation between the two and identified disease groups that were under- or over-represented in the research portfolio relative to disease expenditures. Finally, we used historic health care utilization trends combined with demographic projections to identify diseases and conditions that are increasing in costs and/or patient volume and consequently represent potential targets for future research investments. RESULTS: We found a significant correlation between research volume/expenditures and health utilization. Some disease groups were slightly under- or over-represented, but these deviations were relatively small. Diseases and conditions with the increasing utilization trend at the VA included hypertension, hypercholesterolemia, diabetes, hearing loss, sleeping disorders, complications of pregnancy, and several mental disorders. CONCLUSIONS: Research investments at the VA are well aligned with veteran health needs. The VA can continue to meet these needs by supporting research on the diseases and conditions with a growing number of patients, costs of care, or both. Our approach can be used by other funders of disease research to characterize their portfolios and to plan research investments.

Racial disparities in cancer care in the Veterans Affairs health care system and the role of site of care.

OBJECTIVES: We assessed cancer care disparities within the Veterans Affairs (VA) health care system and whether between-hospital differences explained disparities. METHODS: We linked VA cancer registry data with VA and Medicare administrative data and examined 20 cancer-related quality measures among Black and White veterans diagnosed with colorectal (n = 12,897), lung (n = 25,608), or prostate (n = 38,202) cancer from 2001 to 2004. We used logistic regression to assess racial disparities for each measure and hospital fixed-effects models to determine whether disparities were attributable to between- or within-hospital differences. RESULTS: Compared with Whites, Blacks had lower rates of early-stage colon cancer diagnosis (adjusted odds ratio [AOR] = 0.80; 95% confidence interval [CI] = 0.72, 0.90), curative surgery for stage I, II, or III rectal cancer (AOR = 0.57; 95% CI = 0.41, 0.78), 3-year survival for colon cancer (AOR = 0.75; 95% CI = 0.62, 0.89) and rectal cancer (AOR = 0.61; 95% CI = 0.42, 0.87), curative surgery for early-stage lung cancer (AOR = 0.50; 95% CI = 0.41, 0.60), 3-dimensional conformal or intensity-modulated radiation (3-D CRT/IMRT; AOR = 0.53; 95% CI = 0.47, 0.59), and potent antiemetics for highly emetogenic chemotherapy (AOR = 0.87; 95% CI = 0.78, 0.98). Adjustment for hospital fixed-effects minimally influenced racial gaps except for 3-D CRT/IMRT (AOR = 0.75; 95% CI = 0.65, 0.87) and potent antiemetics (AOR = 0.95; 95% CI = 0.82, 1.10). CONCLUSIONS: Disparities in VA cancer care were observed for 7 of 20 measures and were primarily attributable to within-hospital differences.

Two-year impact of the alternative quality contract on pediatric health care quality and spending.

OBJECTIVE: To examine the 2-year effect of Blue Cross Blue Shield of Massachusetts' global budget arrangement, the Alternative Quality Contract (AQC), on pediatric quality and spending for children with special health care needs (CSHCN) and non-CSHCN. METHODS: Using a difference-in-differences approach, we compared quality and spending trends for 126,975 unique 0- to 21-year-olds receiving care from AQC groups with 415,331 propensity-matched patients receiving care from non-AQC groups; 23% of enrollees were CSHCN. We compared quality and spending pre (2006-2008) and post (2009-2010) AQC implementation, adjusting analyses for age, gender, health risk score, and secular trends. Pediatric outcome measures included 4 preventive and 2 acute care measures tied to pay-for-performance (P4P), 3 asthma and 2 attention-deficit/hyperactivity disorder quality measures not tied to P4P, and average total annual medical spending. RESULTS: During the first 2 years of the AQC, pediatric care quality tied to P4P increased by +1.8% for CSHCN (P < .001) and +1.2% for non-CSHCN (P < .001) for AQC versus non-AQC groups; quality measures not tied to P4P showed no significant changes. Average total annual medical spending was ~5 times greater for CSHCN than non-CSHCN; there was no significant impact of the AQC on spending trends for children. CONCLUSIONS: During the first 2 years of the contract, the AQC had a small but significant positive effect on pediatric preventive care quality tied to P4P; this effect was greater for CSHCN than non-CSHCN. However, it did not significantly influence (positively or negatively) CSHCN measures not tied to P4P or affect per capita spending for either group.

Tumor boards and the quality of cancer care.

BACKGROUND: Despite the widespread use of tumor boards, few data on their effects on cancer care exist. We assessed whether the presence of a tumor board, either general or cancer specific, was associated with recommended cancer care, outcomes, or use in the Veterans Affairs (VA) health system. METHODS: We surveyed 138 VA medical centers about the presence of tumor boards and linked cancer registry and administrative data to assess receipt of stage-specific recommended care, survival, or use for patients with colorectal, lung, prostate, hematologic, and breast cancers diagnosed in the period from 2001 to 2004 and followed through 2005. We used multivariable logistic regression to assess associations of tumor boards with the measures, adjusting for patient sociodemographic and clinical characteristics. All statistical tests were two-sided. RESULTS: Most facilities (75%) had at least one tumor board, and many had several cancer-specific tumor boards. Presence of a tumor board was associated with only seven of 27 measures assessed (all P < .05), and several associations were not in expected directions. Rates of some recommended care (eg, white blood cell growth factors with cyclophosphamide, adriamycin, vincristine, and prednisone in diffuse large B-cell lymphoma) were lower in centers with hematologic-specialized tumor boards (39.4%) than in centers with general tumor boards (61.3%) or no tumor boards (56.4%; P = .002). Only one of 27 measures was statistically significantly associated with tumor boards after applying a Bonferroni correction for multiple comparisons. CONCLUSIONS: We observed little association of multidisciplinary tumor boards with measures of use, quality, or survival. This may reflect no effect or an effect that varies by structural and functional components and participants' expertise.

Area-level variations in cancer care and outcomes.

BACKGROUND: : Substantial regional variations in health-care spending exist across the United States; yet, care and outcomes are not better in higher-spending areas. Most studies have focused on care in fee-for-service Medicare; whether spillover effects exist in settings without financial incentives for more care is unknown. OBJECTIVE: : We studied care for cancer patients in fee-for-service Medicare and the Veterans Health Administration (VA) to understand whether processes and outcomes of care vary with area-level Medicare spending. DESIGN: : An observational study using logistic regression to assess care by area-level measures of Medicare spending. SUBJECTS: : Patients with lung, colorectal, or prostate cancers diagnosed during 2001-2004 in Surveillance, Epidemiology, and End Results (SEER) areas or the VA. The SEER cohort included fee-for-service Medicare patients aged older than 65 years. MEASURES: : Recommended and preference-sensitive cancer care and mortality. RESULTS: : In fee-for-service Medicare, higher-spending areas had higher rates of recommended care (curative surgery and adjuvant chemotherapy for early-stage non-small-cell lung cancer and chemotherapy for stage III colon cancer) and preference-sensitive care (chemotherapy for stage IV lung and colon cancer and primary treatment of local/regional prostate cancer) and had lower lung cancer mortality. In the VA, we observed minimal variation in care by area-level Medicare spending. DISCUSSION: : Our findings suggest that intensity of care for Medicare beneficiaries is not driving variations in VA care, despite some overlap in physician networks. Although the Dartmouth Atlas work has been of unprecedented importance in demonstrating variations in Medicare spending, new measures may be needed to better understand variations in other populations.

Survival of older patients with cancer in the Veterans Health Administration versus fee-for-service Medicare.

PURPOSE: The Veterans Health Administration (VHA) provides high-quality preventive chronic care and cancer care, but few studies have documented improved patient outcomes that result from this high-quality care. We compared the survival rates of older patients with cancer in the VHA and fee-for-service (FFS) Medicare and examined whether differences in the stage at diagnosis, receipt of guideline-recommended therapies, and unmeasured characteristics explain survival differences. PATIENTS AND METHODS: We used propensity-score methods to compare all-cause and cancer-specific survival rates for men older than age 65 years who were diagnosed or received their first course of treatment for colorectal, lung, lymphoma, or multiple myeloma in VHA hospitals from 2001 to 2004 to similar FFS-Medicare enrollees diagnosed in Surveillance, Epidemiology, and End Results (SEER) areas in the same time frame. We examined the role of unmeasured factors by using sensitivity analyses. RESULTS: VHA patients versus similar FFS SEER-Medicare patients had higher survival rates of colon cancer (adjusted hazard ratio [HR], 0.87; 95% CI, 0.82 to 0.93) and non-small-cell lung cancer (NSCLC; HR, 0.91; 95% CI, 0.88 to 0.95) and similar survival rates of rectal cancer (HR, 1.05; 95% CI, 0.95 to 1.16), small-cell lung cancer (HR, 0.99; 95% CI, 0.93 to 1.05), diffuse large-B-cell lymphoma (HR, 1.02; 95% CI, 0.89 to 1.18), and multiple myeloma (HR, 0.92; 95% CI, 0.83 to 1.03). The diagnosis of VHA patients at earlier stages explained much of the survival advantages for colon cancer and NSCLC. Sensitivity analyses suggested that additional adjustment for the severity of comorbid disease or performance status could have substantial effects on estimated differences. CONCLUSION: The survival rate for older men with cancer in the VHA was better than or equivalent to the survival rate for similar FFS-Medicare beneficiaries. The VHA provision of high-quality care, particularly preventive care, can result in improved patient outcomes.

Understanding variation in primary prostate cancer treatment within the Veterans Health Administration.

OBJECTIVE: To examine the variation in prostate cancer treatment in the Veterans Health Administration (VHA)--a national, integrated delivery system. We also compared the care for older men in the VHA with that in fee-for-service Medicare. METHODS: We used data from the Veterans Affairs Central Cancer Registry linked with administrative data and Surveillance, Epidemiology, and End Results-Medicare data to identify men with local or regional prostate cancer diagnosed during 2001 to 2004. We used multinomial logistic and hierarchical regression models to examine the patient, tumor, and facility characteristics associated with treatment in the VHA and, among older patients, used propensity score methods to compare primary therapy between the VHA and fee-for-service Medicare. RESULTS: The rates of radical prostatectomy and radiotherapy varied substantially across VHA facilities. Among the VHA patients, older age, black race/ethnicity, and greater comorbidity were associated with receiving neither radical prostatectomy nor radiotherapy. Facilities with more black patients with prostate cancer had lower rates of radical prostatectomy, and those with less availability of external beam radiotherapy had lower radiotherapy rates. The adjusted rates of radiotherapy (39.7% vs 52.0%) and radical prostatectomy (12.1% vs 15.8%) were lower and the rates of receiving neither treatment greater (48.2% vs 32.2%) in the VHA versus fee-for-service Medicare (P < .001). CONCLUSIONS: In the VHA, the treatment rates varied substantially across facilities, and black men received less aggressive prostate cancer treatment than white men, suggesting factors other than patient preferences influence the treatment decisions. Also, primary prostate cancer therapy for older men is less aggressive in the VHA than in fee-for-service Medicare.

Location of cancer surgery for older veterans with cancer.

OBJECTIVE: Many veterans undergo cancer surgery outside of the Veterans Health Administration (VHA). We assessed to what extent these patients obtained care in the VHA before surgery. DATA SOURCES: VHA-Medicare data, VHA administrative data, and Veterans Affairs Central Cancer Registry data. STUDY DESIGN: We identified patients aged ≥65 years in the VHA-Medicare cohort who underwent lung or colon cancer resection outside the VHA and assessed VHA visits in the year before surgery. PRINCIPAL FINDINGS: Over 60% of patients in the VHA-Medicare cohort who received lung or colon cancer surgeries outside the VHA did not receive any care in VHA before surgery. CONCLUSIONS: Veterans' receipt of major cancer surgery outside the VHA probably reflects usual private sector care among veterans who are infrequent VHA users.

Improved outcomes associated with higher surgery rates for older patients with early stage nonsmall cell lung cancer.

BACKGROUND: Although surgery offers the greatest chance of a cure for patients with early stage nonsmall cell lung cancer (NSCLC), older and sicker patients often fail to undergo resection. The benefits of surgery in older patients and patients with multiple comorbidities are uncertain. METHODS: The authors identified a national cohort of 17,638 Medicare beneficiaries aged ≥66 years living in Surveillance, Epidemiology, and End Results (SEER) areas who were diagnosed with stage I or II NSCLC during 2001 to 2005. Areas with high and low rates of curative surgery for early stage lung cancer were compared to estimate the effectiveness of surgery in older and sicker patients. Logistic regression models were used to assess mortality according to the quintile of area-level surgery rates, adjusting for potential confounders. RESULTS: Less than 63% of patients underwent surgery in low-surgery areas, whereas >79% underwent surgery in high-surgery areas. High-surgery areas operated on more patients of advanced age and patients with chronic obstructive pulmonary disease than low-surgery areas. The adjusted all-cause 1 year mortality was 18% in high-surgery areas versus 22.8% in low-surgery areas (adjusted odds ratio [OR], 0.89; 95% confidence interval [CI], 0.86-0.93) for each 10% increase in the surgery rate).The 1-year lung-cancer-specific mortality similarly was lower in high-surgery areas (12%) versus low-surgery areas (16.9%; adjusted OR, 0.86; 95% CI, 0.82-0.91) for each 10% increase in the surgery rate. CONCLUSIONS: Higher rates of surgery for stage I/II NSCLC were associated with improved survival, even when older patients and sicker patients underwent resection. The authors concluded that more work is needed to identify and reduce barriers to surgery for early stage NSCLC.

Reasons for underuse of recommended therapies for colorectal and lung cancer in the Veterans Health Administration.

BACKGROUND: Many studies have documented low rates of effective cancer therapies, particularly in older or minority populations. However, little is known about why effective therapies are underused in these populations. METHODS: The authors examined medical records of 584 patients with cancer diagnosed or treated in Department of Veterans Affairs facilities to assess reasons for lack of 1) surgery for stage I/II nonsmall cell lung cancer, 2) surgery for stage I/II/III rectal cancer, 3) adjuvant radiation therapy for stage II/III rectal cancer, and 4) adjuvant chemotherapy for stage III colon cancer. They also assessed differences in reasons for underuse by patient age and race. RESULTS: Across the 4 guideline-recommended treatments, 92% to 99% of eligible patients were referred to the appropriate cancer specialist; however, therapy was recommended in only 74% to 92% of eligible cases. Poor health was cited in the medical record as the reason for lack of therapy in 15% to 61% of underuse cases; patient refusal explained 26% to 58% of underuse cases. African American patients were more likely to refuse surgery. Older patients were more likely to refuse treatments. CONCLUSIONS: Recommendation against therapy was a primary factor in underuse of effective therapies in older and sicker patients. Patients' refusal of therapy contributed to age and racial disparities in care. Improved data on the effectiveness of cancer therapies in community populations and interventions aimed at improved communication of known risks and benefits of therapy to cancer patients could be effective tools to reduce underuse and lingering disparities in care.

Quality of care for older patients with cancer in the Veterans Health Administration versus the private sector: a cohort study.

BACKGROUND: The Veterans Health Administration (VHA) is the largest integrated health care system in the United States. Studies suggest that the VHA provides better preventive care and care for some chronic illnesses than does the private sector. OBJECTIVE: To assess the quality of cancer care for older patients provided by the VHA versus fee-for-service Medicare. DESIGN: Observational study of patients with cancer that was diagnosed between 2001 and 2004 who were followed through 2005. SETTING: VHA and non-VHA hospitals and office-based practices. PATIENTS: Men older than 65 years with incident colorectal, lung, or prostate cancer; lymphoma; or multiple myeloma. MEASUREMENTS: Rates of processes of care for colorectal, lung, or prostate cancer; lymphoma; or multiple myeloma. Rates were adjusted by using propensity score weighting. RESULTS: Compared with the fee-for-service Medicare population, the VHA population received diagnoses of colon (P < 0.001) and rectal (P = 0.007) cancer at earlier stages and had higher adjusted rates of curative surgery for colon cancer (92.7% vs. 90.5%; P < 0.010), standard chemotherapy for diffuse large B-cell non-Hodgkin lymphoma (71.1% vs. 59.3%; P < 0.001), and bisphosphonate therapy for multiple myeloma (62.1% vs. 50.4%; P < 0.001). The VHA population had lower adjusted rates of 3-dimensional conformal or intensity-modulated radiation therapy for prostate cancer treated with external-beam radiation therapy (61.6% vs. 86.0%; P < 0.001). Adjusted rates were similar for 9 other measures. Sensitivity analyses suggest that if patients with cancer in the VHA system have more severe comorbid illness than other patients, rates for most indicators would be higher in the VHA population than in the fee-for-service Medicare population. LIMITATION: This study included only older men and did not include information about performance status, severity of comorbid illness, or patient preferences. CONCLUSION: Care for older men with cancer in the VHA system was generally similar to or better than care for fee-for-service Medicare beneficiaries, although adoption of some expensive new technologies may be delayed in the VHA system. PRIMARY FUNDING SOURCE: Department of Veterans Affairs.

What is evidence?

The assumption that comparative effectiveness research will provide timely, relevant evidence rests on changing the current framework for assembling evidence. In this commentary, we provide the background of how coverage decisions for new medical technologies are currently made in the United States. We focus on the statistical issues regarding how to use the ensemble of information for inferring comparative effectiveness. It is clear a paradigm shift in how clinical information is integrated in real-world settings to establish effectiveness is required.

GRACE principles: recognizing high-quality observational studies of comparative effectiveness.

Nonrandomized comparative effectiveness studies contribute to clinical and biologic understanding of treatments by themselves, via subsequent confirmation in a more targeted randomized clinical trial, or through advances in basic science. Although methodological challenges and a lack of accepted principles to assess the quality of nonrandomized studies of comparative effectiveness have limited the practical use of these investigations, even imperfect studies can contribute useful information if they are thoughtfully designed, well conducted, carefully analyzed, and reported in a manner that addresses concerns from skeptical readers and reviewers. The GRACE (Good Research for Comparative Effectiveness) principles have been developed to help healthcare providers, researchers, journal readers, and editors evaluate the quality inherent in observational research studies of comparative effectiveness. The GRACE principles were developed by experienced academic and private sector researchers and were vetted over several years through presentation, critique, and consensus building among outcomes researchers, pharmacoepidemiologists, and other medical scientists and via formal review by the International Society of Pharmacoepidemiology. In contrast to other documents that guide systematic review and reporting, the GRACE principles are high-level concepts about good practice for nonrandomized comparative effectiveness research. The GRACE principles comprise a series of questions to guide evaluation. No scoring system is provided or encouraged, as interpretation of these observational studies requires weighing of all available evidence, tempered by judgment regarding the applicability of the studies to routine care.

End-of-life care for older cancer patients in the Veterans Health Administration versus the private sector.

BACKGROUND: Treatment of older cancer patients at the end of life has become increasingly aggressive, despite the absence of evidence for better outcomes. We compared aggressiveness of end-of-life care of older metastatic cancer patients treated in the Veterans Health Administration (VHA) and those under fee-for-service Medicare arrangements. METHODS: Using propensity score methods, we matched 2913 male veterans who were diagnosed with stage IV lung or colorectal cancer in 2001-2002 and died before 2006 with 2913 similar men enrolled in fee-for-service Medicare living in Surveillance, Epidemiology, and End Result (SEER) areas. We assessed chemotherapy within 14 days of death, intensive care unit (ICU) admissions within 30 days of death, and >1 emergency room visit within 30 days of death. RESULTS: Among matched cohorts, men treated in the VHA were less likely than men in the private sector to receive chemotherapy within 14 days of death (4.6% vs 7.5%, P<.001), be admitted to an ICU within 30 days of death (12.5% vs 19.7%, P<.001), or have >1 emergency room visit within 30 days of death (13.1 vs 14.7, P=.09). CONCLUSIONS: Older men with metastatic lung or colorectal cancer treated in the VHA healthcare system received less aggressive end-of-life care than similar men in fee-for-service Medicare. This may result from the absence of financial incentives for more intensive care in the VHA or because this integrated delivery system is better structured to limit potentially overly aggressive care. Additional studies are needed to assess whether men undergoing less aggressive end-of-life care also experience better outcomes.