Are care experiences associated with survival among cancer patients? An analysis of the SEER-CAHPS data resource.

PURPOSE: Cancer patients' care experiences encompass the range of interactions with the health care system and are an important indicator of care quality, which may influence survival outcomes. This study evaluates relationships between care experiences and survival using a large, nationally representative sample of cancer patients. METHODS: We used linked SEER (Surveillance Epidemiology and End Results)-CAHPS (Consumer Assessment of Healthcare Providers and Systems) data to identify people diagnosed 8/2006-12/2013, focusing on 10 solid tumor cancer sites with the highest mortality rates among those > 65. CAHPS measures included 5 global ratings and 3 composite scores. We used survey-weighted Cox proportional hazard models comparing survival time for those who had lower (0-8) vs higher ratings (9-10) and lower (0-89) vs higher (90-100) composite scores, adjusting for case-mix and additional covariates. RESULTS: We identified 2,263 eligible people; 26% died by 5-year post-survey completion or end of follow-up (12/31/2017). We found lower Prescription Drug Plan (PDP) ratings were significantly associated with lower mortality (adjusted HR = 0.67, p = 0.03). Lower Getting Needed Care scores were also significantly associated with lower mortality (adjusted HR = 0.79, p = 0.04). For other care experience measures, general health status, cancer stage, and comorbidities were more predictive of survival (p < .05). CONCLUSIONS: Except for PDP and Getting Needed Care, survival was similar for those with worse versus better care experiences. Patients with poorer cancer prognoses may perceive better services from their drug plan and more responsive care from clinical providers compared to those with better prognoses. Further research is needed examining processes underlying perceptions of care experiences and survival.

The influence of formal and informal policies and practices on health care innovation implementation: A mixed-methods analysis.

BACKGROUND: The implementation science literature has contributed important insights regarding the influence of formal policies and practices on health care innovation implementation, whereas informal implementation policies and practices have garnered little attention. The broader literature suggests that informal implementation policies and practices could also influence innovation use. PURPOSE: We used the Organizational Theory of Innovation Implementation to further understand the role of formal and informal implementation policies and practices as determinants of implementation effectiveness. We examined their role within the context of initiatives to increase palliative care consultation in inpatient oncology. METHODS: We used a case study design in two organizational settings within one academic medical center: medical and gynecologic oncology. We completed semistructured interviews with medical (n = 12) and gynecologic (n = 10) oncology clinicians using questions based on organizational theory. Quantitative data assessed implementation effectiveness, defined as aggregated palliative care consult rates within oncology services from 2010 to 2016. Four palliative care clinicians were interviewed to gain additional implementation context insights. RESULTS: Medical oncology employed multiple formal policies and practices including training and clinician prompting to support palliative care consultation and a top-down approach, yet most clinicians were unaware of the policies and practices, contributing to a weak implementation climate. In contrast, gynecologic oncology employed one formal policy (written guideline of criteria for initiating a consult) but also relied on informal policies and practices, such as spontaneous feedback and communication; they adopted a bottom-up approach, contributing to broader clinician awareness and strong implementation climate. Both services exhibited variable, increasing consult rates over time. PRACTICE IMPLICATIONS: Informal policies and practices may compensate or substitute for formal policies and practices under certain conditions (e.g., smaller health care organizations). Further research is needed to investigate the role of formal and informal policies and practices in shaping a strong and sustainable implementation climate and subsequent effective innovation implementation.

The Relationship Between Cancer Survivors' Socioeconomic Status and Reports of Follow-up Care Discussions with Providers.

Socioeconomically disadvantaged cancer survivors are less likely to have adequate follow-up care. In this study, we examined whether socioeconomically disadvantaged survivors are at risk for not having follow-up care discussions with providers, a critical determinant of access to follow-up care and desirable health outcomes. Using the 2011 Medical Expenditure Panel Survey and Experiences with Cancer Survivorship Supplement, we used a binary logit model with sample weights to examine associations between 1320 cancer survivors' socioeconomic status (SES) and reports of follow-up care discussions with providers, controlling for clinical and demographic characteristics. The multivariable model indicated survivors with incomes ≤200 % Federal Poverty Level (FPL) had a lower probability of reporting a follow-up care discussion than survivors with incomes >400 % FPL (p < 0.05). Survivors with less than high school education had a lower probability of reporting a discussion than survivors who had a college education or greater (p < 0.05). However, even after controlling for income, survivors with financial hardship had a greater probability of reporting a discussion than survivors with no financial hardship (p < 0.05). Insurance status was not a significant predictor of reporting a discussion (p > 0.05). Socioeconomically disadvantaged cancer survivors are at risk for not having follow-up care discussions with providers, particularly those who report lower income and education. The development of educational interventions targeting provider communication with socioeconomically disadvantaged cancer survivors, and survivors' understanding of the benefits of follow-up care discussions, may promote access to these services. Future research assessing mechanisms underlying relationships between survivors' SES indicators and reports of follow-up care discussions with providers is also warranted.

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

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

The Longitudinal Implementation Strategy Tracking System (LISTS): feasibility, usability, and pilot testing of a novel method.

BACKGROUND: Systematic approaches are needed to accurately characterize the dynamic use of implementation strategies and how they change over time. We describe the development and preliminary evaluation of the Longitudinal Implementation Strategy Tracking System (LISTS), a novel methodology to document and characterize implementation strategies use over time. METHODS: The development and initial evaluation of the LISTS method was conducted within the Improving the Management of SymPtoms during And following Cancer Treatment (IMPACT) Research Consortium (supported by funding provided through the NCI Cancer MoonshotSM). The IMPACT Consortium includes a coordinating center and three hybrid effectiveness-implementation studies testing routine symptom surveillance and integration of symptom management interventions in ambulatory oncology care settings. LISTS was created to increase the precision and reliability of dynamic changes in implementation strategy use over time. It includes three components: (1) a strategy assessment, (2) a data capture platform, and (3) a User's Guide. An iterative process between implementation researchers and practitioners was used to develop, pilot test, and refine the LISTS method prior to evaluating its use in three stepped-wedge trials within the IMPACT Consortium. The LISTS method was used with research and practice teams for approximately 12 months and subsequently we evaluated its feasibility, acceptability, and usability using established instruments and novel questions developed specifically for this study. RESULTS: Initial evaluation of LISTS indicates that it is a feasible and acceptable method, with content validity, for characterizing and tracking the use of implementation strategies over time. Users of LISTS highlighted several opportunities for improving the method for use in future and more diverse implementation studies. CONCLUSIONS: The LISTS method was developed collaboratively between researchers and practitioners to fill a research gap in systematically tracking implementation strategy use and modifications in research studies and other implementation efforts. Preliminary feedback from LISTS users indicate it is feasible and usable. Potential future developments include additional features, fewer data elements, and interoperability with alternative data entry platforms. LISTS offers a systematic method that encourages the use of common data elements to support data analysis across sites and synthesis across studies. Future research is needed to further adapt, refine, and evaluate the LISTS method in studies with employ diverse study designs and address varying delivery settings, health conditions, and intervention types.

External validity of the cardiovascular health study: a comparison with the Medicare population.

BACKGROUND: The Cardiovascular Health Study (CHS), a population-based prospective cohort study, has been used to identify major risk factors associated with cardiovascular disease and stroke in the elderly. OBJECTIVE: To assess the external validity of the CHS. RESEARCH DESIGN: Comparison of the CHS cohort to a national cohort of Medicare beneficiaries and to Medicare beneficiaries residing in the CHS geographic regions. SUBJECTS: CHS participants and a 5% sample of Medicare beneficiaries. MEASURES: Demographic and administrative characteristics, comorbid conditions, resource use, and mortality. RESULTS: Compared with both Medicare cohorts, the CHS cohort was older and included more men and African American participants. CHS participants were more likely to be enrolled in Medicare managed care than beneficiaries in the national Medicare cohort. Compared with the Medicare cohorts, mortality in the CHS was more than 40% lower at 1 year, approximately 25% lower at 5 years, and approximately 15% lower at 10 years. There were minimal differences in comorbid conditions and health care resource use. CONCLUSION: The CHS cohort is comparable with the Medicare population, particularly with regard to comorbid conditions and resource use, but had lower mortality. The difference in mortality may reflect the CHS recruitment strategy or volunteer bias. These findings suggest it may not be appropriate to project absolute rates of disease and outcomes based on CHS data to the entire Medicare population. However, there is no reason to expect that the relative risks associated with physiologic processes identified by CHS data would differ for nonparticipants.

The impact of two triggered palliative care consultation approaches on consult implementation in oncology.

INTRODUCTION: Studies show palliative care delivered concurrently with cancer treatment improves outcomes, yet palliative care integration with inpatient oncology is underused. A promising approach to improve integration is a triggered palliative care consultation (TPCC). This study evaluated the impact of two TPCC approaches on consistency and quality of consult implementation, operationalized as uptake and timeliness, on solid tumor medical and gynecologic oncology services at an academic hospital. METHODS: The study timeframe was 2010-2016. TPCC in gynecologic oncology began in 2014 and was supported by a single strategy (written guideline); TPCC in medical oncology began in 2015 and was supported by multiple strategies (e.g. training, chart review). Palliative care consult information was chart abstracted and linked to hospital encounter data. We compared the effect of a single strategy vs. usual care, and multiple strategies vs. a single strategy on implementation. Difference-in-differences modified Poisson regression models evaluated whether implementation differed after TPCC; we estimated adjusted relative risk (aRR), controlling for patient demographic and clinical characteristics. RESULTS: Overall, 8.8% of medical oncology and 11.0% of gynecologic oncology inpatient encounters involved palliative care consultation. In regression analyses, TPCC supported by a single strategy in gynecologic oncology was associated with greater uptake vs. usual care (aRR: 1.45, p < .05), and TPCC supported by multiple strategies in medical oncology was associated with greater uptake vs. a single strategy (aRR: 2.34, p < .001). CONCLUSION: Across two inpatient oncology services, TPCC supported by multiple strategies had the greatest impact on uptake. How strategies affect sustained use of palliative care consults remains to be investigated.

Association between the Medicare Modernization Act of 2003 and patient wait times and travel distance for chemotherapy.

CONTEXT: The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) altered reimbursements for outpatient chemotherapy drugs and drug administration services. Anecdotal reports suggest that these adjustments may have negatively affected access to chemotherapy for Medicare beneficiaries. OBJECTIVE: To compare patient wait times and travel distances for chemotherapy before and after the enactment of the MMA. DESIGN, SETTING, AND PATIENTS: Analysis of a nationally representative 5% sample of claims from the Centers for Medicare & Medicaid Services for the period 2003 through 2006. Patients were Medicare beneficiaries with incident breast cancer, colorectal cancer, leukemia, lung cancer, or lymphoma who received chemotherapy in inpatient hospital, institutional outpatient, or physician office settings. MAIN OUTCOME MEASURES: Days from incident diagnosis to first chemotherapy visit and distance traveled for treatment, controlling for age, sex, race/ethnicity, cancer type, geographic region, comorbid conditions, and year of diagnosis and treatment. RESULTS: There were 5082 incident cases of breast cancer, colorectal cancer, leukemia, lung cancer, or lymphoma in 2003; 5379 cases in 2004; 5116 cases in 2005; and 5288 cases in 2006. Approximately 70% of patients received treatment in physician office settings in each year. Although the distribution of treatment settings in 2004 and 2005 was not significantly different from 2003 (P = .24 and P = .72, respectively), there was a small but significant change from 2003 to 2006 (P = .02). The proportion of patients receiving chemotherapy in inpatient settings decreased from 10.2% in 2003 to 8.8% in 2006 (P = .03), and the proportion in institutional outpatient settings increased from 21.1% to 22.5% (P = .004). The proportion in physician offices remained at 68.7% (P = .29). The median time from diagnosis to initial chemotherapy visit was 28 days in 2003, 27 days in 2004, 29 days in 2005, and 28 days in 2006. In multivariate analyses, average wait times for chemotherapy were 1.96 days longer in 2005 than in 2003 (95% confidence interval [CI], 0.11-3.80 days; P = .04) but not significantly different in 2006 (0.88 days; 95% CI, -0.96 to 2.71 days; P = .35). Median travel distance was 7 miles (11.2 km) in 2003 and 8 miles (12.8 km) in 2004 through 2006. After adjustment, average travel distance remained slightly longer in 2004 (1.47 miles [2.35 km]; 95% CI, 0.87-2.07 miles [1.39-3.31 km]; P < .001), 2005 (1.19 miles [1.90 km]; 95% CI, 0.58-1.80 miles [0.93-2.88 km]; P < .001), and 2006 (1.30 miles [2.08 km]; 95% CI, 0.69-1.90 miles [1.10-3.04 km]; P < .001) compared with 2003. CONCLUSION: There have not been major changes in travel distance and patient wait times for chemotherapy in the Medicare population since 2003, the year before MMA-related changes in reimbursement.

Inpatient Palliative Care Consultation and 30-Day Readmissions in Oncology.

BACKGROUND: Prior research indicates that hospice and palliative care delivered in outpatient settings are associated with reduced hospital readmissions for cancer patients. However, little is known about how inpatient palliative care affects readmissions in oncology. OBJECTIVE: To examine associations among inpatient palliative care consultation, hospice use (discharge), and 30-day readmissions among patients with solid tumor cancers. METHODS: We identified all live discharges from a large tertiary cancer hospital between 2010 and 2016. Palliative care consult data were abstracted from medical charts and linked to hospital encounter data. Propensity scores were used to match palliative care consult to usual care encounters. Modified Poisson regression models estimated adjusted relative risk (aRR) and 95% confidence intervals (CI) of 30-day readmissions and hospice discharge. We compared predicted probabilities of readmission for palliative care consultation with hospice discharge, without hospice discharge, and usual care. RESULTS: Of 8085 eligible encounters, 753 involved a palliative care consult. The likelihood of having a 30-day readmission did not differ between palliative care consult and usual care groups (p > 0.05). However, the palliative care consult group was more likely than usual care to have a hospice discharge (aRR = 4.09, 95% CI: 3.07-5.44). The predicted probability of 30-day readmission was lower when palliative care consultation was combined with hospice discharge compared to usual care or consultation with discharge to nonhospice postacute care (p < 0.001). CONCLUSIONS: The effect of inpatient palliative care on readmissions in oncology is largely driven by hospice enrollment. Strategies that combine palliative care consultation with hospice discharge may decrease hospital readmissions and improve cancer care quality.

Elaborating on theory with middle managers' experience implementing healthcare innovations in practice.

BACKGROUND: The theory of middle managers' role in implementing healthcare innovations hypothesized that middle managers influence implementation effectiveness by fulfilling the following four roles: diffusing information, synthesizing information, mediating between strategy and day-to-day activities, and selling innovation implementation. The theory also suggested several activities in which middle managers might engage to fulfill the four roles. The extent to which the theory aligns with middle managers' experience in practice is unclear. We surveyed middle managers (n = 63) who attended a nursing innovation summit to (1) assess alignment between the theory and middle managers' experience in practice and (2) elaborate on the theory with examples from middle managers' experience overseeing innovation implementation in practice. FINDINGS: Middle managers rated all of the theory's hypothesized four roles as "extremely important" but ranked diffusing and synthesizing information as the most important and selling innovation implementation as the least important. They reported engaging in several activities that were consistent with the theory's hypothesized roles and activities such as diffusing information via meetings and training. They also reported engaging in activities not described in the theory such as appraising employee performance. CONCLUSIONS: Middle managers' experience aligned well with the theory and expanded definitions of the roles and activities that it hypothesized. Future studies should assess the relationship between hypothesized roles and the effectiveness with which innovations are implemented in practice. If evidence supports the theory, the theory should be leveraged to promote the fulfillment of hypothesized roles among middle managers, doing so may promote innovation implementation.

Guidelines for the use of survivorship care plans: a systematic quality appraisal using the AGREE II instrument.

BACKGROUND: Survivorship care plans (SCPs) are written treatment summaries and follow-up care plans that are intended to facilitate communication and coordination of care among survivors, cancer care providers, and primary care providers. A growing number of guidelines for the use of SCPs exist, yet SCP use in the United States remains limited. Limited use of SCPs may be due to poor quality of these guidelines. The purpose of the study was to evaluate the quality of guidelines for SCP use, tools that are intended to promote evidence-based medicine. METHODS: We conducted a comprehensive search of the literature using MEDLINE/PubMed, EMBASE (Excerpta Medica Database), and CINAHL (Cumulative Index to Nursing and Allied Health Literature) published through April 2014, in addition to grey literature sources and bibliographic and expert reviews. Guideline quality was assessed using the AGREE II instrument (Appraisal of Guidelines for Research and Evaluation, 2nd edition), a tool developed by an international group of scientists to advance the quality of clinical practice guidelines. To promote consistency with extant studies using the AGREE II instrument and to clearly and unambiguously identify potentially useful guidelines for SCP use, we also summarized AGREE II scores by strongly recommending, recommending, or not recommending the guidelines that we evaluated. RESULTS: Of 128 documents screened, we included 16 guidelines for evaluation. We did not strongly recommend any of the 16 guidelines that we evaluated; we recommended 5 and we did not recommend 11. Overall, guidelines scored highest on clarity of presentation (i.e., guideline language, structure, and format): Guidelines were generally unambiguous in their recommendations that SCPs should be used. Guidelines scored lowest on applicability (i.e., barriers and facilitators to implementation, implementation strategies, and resource implications of applying the guideline): Few guidelines discussed facilitators and barriers to guideline application; advice and tools for implementing guidelines were vague; and none explicitly discussed resource implications of implementing the guidelines. CONCLUSIONS: Guidelines often advocated survivorship care plan use without justification or suggestions for implementation. Improved guideline quality may promote survivorship care plan use.

Do palliative care interventions reduce emergency department visits among patients with cancer at the end of life? A systematic review.

BACKGROUND: Frequent emergency department (ED) visits are an indicator of poor quality of cancer care. Coordination of care through the use of palliative care teams may limit aggressive care and improve outcomes for patients with cancer at the end of life. OBJECTIVES: To systematically review the literature to determine whether palliative care interventions implemented in the hospital, home, or outpatient clinic are more effective than usual care in reducing ED visits among patients with cancer at the end of life. ELIGIBILITY CRITERIA: PubMed, EMBASE, and CINAHL databases were searched from database inception to May 7, 2014. Only randomized/non-randomized controlled trials (RCTs) and observational studies examining the effect of palliative care interventions on ED visits among adult patients with cancer with advanced disease were considered. DATA EXTRACTION AND DATA SYNTHESIS: Data were abstracted from the articles that met all the inclusion criteria. A second reviewer independently abstracted data from 2 articles and discrepancies were resolved. From 464 abstracts, 2 RCTs, 10 observational studies, and 1 non-RCT/quasi-experimental study were included. Overall there is limited evidence to support the use of palliative care interventions to reduce ED visits, although studies examining effect of hospice care and those conducted outside of the United States reported a statistically significant reduction in ED visits. CONCLUSIONS: Evidence regarding whether palliative care interventions implemented in the hospital, home or outpatient clinic are more effective than usual care at reducing ED visits is not strongly substantiated based on the literature reviewed. Improvements in the quality of reporting for studies examining the effect of palliative care interventions on ED use are needed.

Treatment patterns for neovascular age-related macular degeneration: analysis of 284 380 medicare beneficiaries.

PURPOSE: To examine trends in the treatment of newly diagnosed neovascular age-related macular degeneration (AMD). DESIGN: Retrospective cohort study. METHODS: Among 284 380 Medicare beneficiaries with a new diagnosis between 2006 and 2008, we used the cumulative incidence function to estimate procedure rates and the mean frequency function to estimate the cumulative mean number of intravitreous injections. We used Cox log-binomial regression to estimate predictors of the use of vascular endothelial growth factor (VEGF) antagonists within 1 year after diagnosis. Discontinuation of anti-VEGF therapy was defined by absence of treatment for 12 months. Discontinuation rates were calculated using the Kaplan-Meier method. RESULTS: The proportion of patients receiving anti-VEGF therapy increased from 60.3% to 72.7%, photodynamic therapy decreased from 12.8% to 5.3%, and thermal laser treatment decreased from 5.5% to 3.2%. Black patients (hazard ratio, 0.77; 95% confidence interval, 0.75-0.79) and patients of other/unknown race (0.83; 0.81-0.84) were less likely than white patients to receive anti-VEGF therapy. Patients with dementia were less likely to receive anti-VEGF therapy (0.88; 0.88-0.89). Among patients who received anti-VEGF therapy, the mean number of injections within 1 year of the first injection was 4.3 per treated eye. Anti-VEGF therapy was discontinued in 53.6% of eyes within 1 year, and in 61.7% of eyes within 18 months. CONCLUSIONS: Treatment of new neovascular AMD changed significantly between 2006 and 2008, most notably in the increasing use of anti-VEGF therapies. However, few patients treated with anti-VEGF medications received monthly injections, and discontinuation rates were high.

Use of guideline-recommended therapies for heart failure in the Medicare population.

BACKGROUND: Most information about the use of guideline-recommended therapies for heart failure reflects what occurred at discharge after an inpatient stay. HYPOTHESIS: Using a nationally representative, community-dwelling sample of elderly Medicare beneficiaries, we examined how the use of angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and beta-blockers has changed and factors associated with their use. METHODS: Using data from the Medicare Current Beneficiary Survey cost and use files matched with Medicare claims data, we identified beneficiaries for whom a diagnosis of heart failure was reported between January 1, 2000, and December 31, 2004. Data on medications prescribed during the year of cohort entry were based on patient self-report. We used multivariable logistic regression to explore relationships between the use of ACE inhibitors/ARBs and beta-blockers and patient demographic characteristics. RESULTS: From 2000 through 2004, the use of ARBs increased from 12% to 19%, and the use of beta-blockers increased from 30% to 41%. The use of ACE inhibitors remained constant at 45%. Beneficiaries who reported having prescription drug insurance coverage were 32% more likely than other beneficiaries to have filled a prescription for an ACE inhibitor or ARB and 26% more likely to have filled a prescription for a beta-blocker. CONCLUSIONS: Although the use of guideline-recommended therapies for heart failure has increased, it remains suboptimal.

Geographic variation in carotid revascularization among Medicare beneficiaries, 2003-2006.

BACKGROUND: Little is known about patterns in the use of carotid revascularization since a 2004 Medicare national coverage decision supporting carotid artery stenting. We examined geographic variation in and predictors of carotid endarterectomy and carotid stenting. METHODS: Analysis of claims from the Centers for Medicare & Medicaid Services from January 1, 2003, through December 31, 2006. Patients were 65 years or older and had undergone carotid endarterectomy or carotid stenting. The main outcome measures were annual age-adjusted rates of carotid endarterectomy and carotid stenting, factors associated with the use of carotid revascularization, and mortality rate at 30 days and 1 year. RESULTS: The rate of endarterectomy decreased from 3.2 per 1000 person-years in 2003 to 2.6 per 1000 person-years in 2006. After adjustment for demographic and clinical characteristics, there was significant geographic variation in the odds of carotid revascularization, with the East North Central region having the greatest odds of endarterectomy (odds ratio, 1.60; 95% confidence interval, 1.55-1.65) and stenting (1.61; 1.46-1.78) compared with New England. Prior endarterectomy (odds ratio, 3.06; 95% confidence interval, 2.65-3.53) and coronary artery disease (2.12; 2.03-2.21) were strong predictors of carotid stenting. In 2005, mortality was 1.2% at 30 days and 6.8% at 1 year for endarterectomy and 2.3% at 30 days and 10.3% at 1 year for stenting. CONCLUSIONS: Significant geographic variation exists for carotid endarterectomy and carotid stenting. Prior endarterectomy and coronary disease were associated with greater odds of carotid stenting.

Representativeness of a national heart failure quality-of-care registry: comparison of OPTIMIZE-HF and non-OPTIMIZE-HF Medicare patients.

BACKGROUND: Participation in clinical registries is nonrandom, so participants may differ in important ways from nonparticipants. The extent to which findings from clinical registries can be generalized to broader populations is unclear. METHODS AND RESULTS: We linked data from the Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients With Heart Failure (OPTIMIZE-HF) registry with 100% inpatient Medicare fee-for-service claims to identify matched and unmatched patients with heart failure. We evaluated differences in baseline characteristics and mortality, all-cause readmission, and cardiovascular readmission rates. We used Cox proportional hazards models to examine relationships between registry enrollment and outcomes, controlling for baseline characteristics. There were 25,245 OPTIMIZE-HF patients in the Medicare claims data and 929,161 Medicare beneficiaries with heart failure who were not enrolled in OPTIMIZE-HF. Although hospital characteristics differed, patient demographic characteristics and comorbid conditions were similar. In-hospital mortality for OPTIMIZE-HF and non-OPTIMIZE-HF patients was not significantly different (4.7% versus 4.5%; P=0.37); however, OPTIMIZE-HF patients had slightly higher 30-day (11.9% versus 11.2%; P<0.001) and 1-year unadjusted mortality (37.2% versus 35.7%; P<0.001). Controlling for other variables, OPTIMIZE-HF patients were similar to non-OPTIMIZE-HF patients for the hazard of mortality (hazard ratio, 1.02; 95% confidence interval, 0.98 to 1.06). There were small but significant decreases in all-cause (hazard ratio, 0.94; 95% CI, 0.92 to 0.97) and cardiovascular readmission (hazard ratio, 0.94; 95% CI, 0.91 to 0.98). CONCLUSIONS: Characteristics and outcomes of Medicare beneficiaries enrolled in OPTIMIZE-HF are similar to the broader Medicare population with heart failure, suggesting that findings from this clinical registry may be generalized.