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1.  Crowd-out and Exposure Effects of Physical Comorbidities on Mental Health Care Use: Implications for Racial–Ethnic Disparities in Access 
Health Services Research  2011;46(4):1259-1280.
Objectives
In disparities models, researchers adjust for differences in “clinical need,” including indicators of comorbidities. We reconsider this practice, assessing (1) if and how having a comorbidity changes the likelihood of recognition and treatment of mental illness; and (2) differences in mental health care disparities estimates with and without adjustment for comorbidities.
Data
Longitudinal data from 2000 to 2007 Medical Expenditure Panel Survey (n = 11,083) split into pre and postperiods for white, Latino, and black adults with probable need for mental health care.
Study Design
First, we tested a crowd-out effect (comorbidities decrease initiation of mental health care after a primary care provider [PCP] visit) using logistic regression models and an exposure effect (comorbidities cause more PCP visits, increasing initiation of mental health care) using instrumental variable methods. Second, we assessed the impact of adjustment for comorbidities on disparity estimates.
Principal Findings
We found no evidence of a crowd-out effect but strong evidence for an exposure effect. Number of postperiod visits positively predicted initiation of mental health care. Adjusting for racial/ethnic differences in comorbidities increased black–white disparities and decreased Latino–white disparities.
Conclusions
Positive exposure findings suggest that intensive follow-up programs shown to reduce disparities in chronic-care management may have additional indirect effects on reducing mental health care disparities.
doi:10.1111/j.1475-6773.2011.01253.x
PMCID: PMC3130831  PMID: 21413984
Access/demand/utilization of services; mental health; racial/ethnic differences in health and health care
2.  The Comprehensive Care Project: Measuring Physician Performance in Ambulatory Practice 
Health Services Research  2010;45(6 Pt 2):1912-1933.
Objective
To investigate the feasibility, reliability, and validity of comprehensively assessing physician-level performance in ambulatory practice.
Data Sources/Study Setting
Ambulatory-based general internists in 13 states participated in the assessment.
Study Design
We assessed physician-level performance, adjusted for patient factors, on 46 individual measures, an overall composite measure, and composite measures for chronic, acute, and preventive care. Between- versus within-physician variation was quantified by intraclass correlation coefficients (ICC). External validity was assessed by correlating performance on a certification exam.
Data Collection/Extraction Methods
Medical records for 236 physicians were audited for seven chronic and four acute care conditions, and six age- and gender-appropriate preventive services.
Principal Findings
Performance on the individual and composite measures varied substantially within (range 5–86 percent compliance on 46 measures) and between physicians (ICC range 0.12–0.88). Reliabilities for the composite measures were robust: 0.88 for chronic care and 0.87 for preventive services. Higher certification exam scores were associated with better performance on the overall (r = 0.19; p <.01), chronic care (r = 0.14, p = .04), and preventive services composites (r = 0.17, p = .01).
Conclusions
Our results suggest that reliable and valid comprehensive assessment of the quality of chronic and preventive care can be achieved by creating composite measures and by sampling feasible numbers of patients for each condition.
doi:10.1111/j.1475-6773.2010.01160.x
PMCID: PMC3029848  PMID: 20819110
Comprehensive assessment; quality of care; primary care; composite measures
3.  Crowd-out and Exposure Effects of Physical Comorbidities on Mental Health Care Use: Implications for Racial-Ethnic Disparities in Access 
Health services research  2011;46(4):1259-1280.
Objectives
In disparities models, researchers adjust for differences in “clinical need,” including indicators of comorbidities. We reconsider this practice, assessing 1) if and how having a comorbidity changes the likelihood of recognition and treatment of mental illness; and 2) differences in mental health (MH) care disparities estimates with and without adjustment for comorbidities.
Data
Longitudinal data from the 2000-2007 Medical Expenditure Panel Survey (n=11,083) split into pre- and post-periods for White, Latino, and Black adults with probable need for MH care.
Study Design
First, we tested a crowd-out effect (comorbidities decrease initiation of MH care after a PCP visit) using logistic regression models and an exposure effect (comorbidities cause more PCP visits, increasing initiation of MH care) using instrumental variable methods. Second, we assessed the impact of adjustment for comorbidities on disparity estimates.
Principal Findings
We found no evidence of a crowd-out effect but strong evidence for an exposure effect. Number of post-period visits positively predicted initiation of MH care. Adjusting for racial/ethnic differences in comorbidities increased Black-White disparities and decreased Latino-White disparities.
Conclusions
Positive exposure findings suggest that intensive follow-up programs shown to reduce disparities in chronic care management may have additional indirect effects on reducing MH care disparities.
doi:10.1111/j.1475-6773.2011.01253.x
PMCID: PMC3130831  PMID: 21413984
4.  WHAT IS EVIDENCE? 
Statistics in medicine  2010;29(19):1985-1997.
SUMMARY
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.
doi:10.1002/sim.3933
PMCID: PMC2917254  PMID: 20683888
evidentiary evaluation; multiple outcomes and comparisons; hierarchical Bayesian models; Bayes factors; posterior predictive probability
5.  Myocardial infarction and quality of care 
doi:10.1503/cmaj.081438
PMCID: PMC2565734  PMID: 18936445
6.  Characteristics of Medical Practices in Three Developed Managed Care Markets 
Health Services Research  2005;40(3):675-696.
Objective
To describe physician practices, ranging from solo and two-physician practices to large medical groups, in three geographically diverse parts of the country with strong managed care presences.
Data Sources/Study Design
Surveys of medical practices in three managed care markets conducted in 2000–2001.
Study Design
We administered questionnaires to all medical practices affiliated with two large health plans in Boston, MA, and Portland, OR, and to all practices providing primary care for cardiovascular disease patients admitted to five large hospitals in Minneapolis, MN. We offer data on how physician practices are structured under managed care in these geographically diverse regions of the country with a focus on the structural characteristics, financial arrangements, and care management strategies adopted by practices.
Data Collection
A two-staged survey consisting of an initial telephone survey that was undertaken using CATI (computerized assisted telephone interviewing) techniques followed by written modules triggered by specific responses to the telephone survey.
Principal Findings
We interviewed 468 practices encompassing 668 distinct sites of care (overall response rate 72 percent). Practices had an average of 13.9 member physicians (range: 1–125). Most (80.1 percent) medium- (four to nine physicians) and large-size (10 or more physicians) groups regularly scheduled meetings to discuss resource utilization and referrals. Almost 90 percent of the practices reported that these meetings occurred at least once per month. The predominant method for paying practices was via fee-for-service payments. Most other payments were in the form of capitation. Overall, 75 percent of physician practices compensated physicians based on productivity, but there was substantial variation related to practice size. Nonetheless, of the practices that did not use straight productivity methods (45 percent of medium-sized practices and 54 percent of large practices), most used arrangements consisting of combinations of salary and productivity formulas.
Conclusions
We found diversity in the characteristics and capabilities of medical practices in these three markets with high managed care involvement. Financial practices of most practices are geared towards rewarding productivity, and care management practices and capabilities such as electronic medical records remain underdeveloped.
doi:10.1111/j.1475-6773.2005.00380.x
PMCID: PMC1361163  PMID: 15960686
Physician groups; managed care; financial incentives
7.  Impact of Cardiac Service Availability on Case-Selection for Angiography and Survival Associated with Angiography 
Health Services Research  2003;38(1 Pt 1):21-40.
Objective
To examine whether availability of cardiac services at the admitting hospital affects case-selection for angiography and one-year survival following angiography, within groups of patients who have similar clinical need for angiography according to published criteria.
Study Setting
Elderly Medicare beneficiaries (37,788) discharged with a diagnosis of acute myocardial infarction (AMI) from hospitals in seven U.S. states between February 1994 and July 1995. We focused on patients who were eligible to receive angiography 12 or more hours after symptom onset.
Data Collection
Data were abstracted from patient's medical records, Medicare National Claims Standard Analytic Files, Health Care Financing Administration (HCFA) Provider of Service File and Health Insurance Master File.
Methods
Admitting hospitals were classified as offering no cardiac services, angiography only, or revascularization. Case-selection differences across these three types of hospitals were examined by comparing relative risk of receiving angiography for various patient and hospital characteristics. Relative differences in one-year survival rate, comparing patients who received angiography to those who did not, were estimated within each hospital type and clinical need category (necessary, appropriate, or uncertain) after matching on propensity to receive angiography.
Principal Findings
Compared to patients for whom angiography was deemed necessary, the relative risk of receiving angiography among those for whom it was deemed of uncertain benefit was 0.58, 0.79, and 0.92 (p-value of homogeneity test < 0.001) at hospitals offering no cardiac services, angiography only, and revascularization, respectively. There was no significant difference in survival following angiography across hospital types, overall as well as within clinical need categories.
Conclusions
Despite increased case selection at hospitals with on-site cardiac services, there was no evidence of increase in the survival rate associated with angiography use at these hospitals.
doi:10.1111/1475-6773.00103
PMCID: PMC1360872  PMID: 12650379
Coronary angiography; practice guidelines; classification trees; survival
8.  Integrating Risk Adjustment and Enrollee Premiums in Health Plan Payment 
Journal of health economics  2013;32(6):10.1016/j.jhealeco.2013.05.002.
In two important health policy contexts – private plans in Medicare and the new state-run “Exchanges” created as part of the Affordable Care Act (ACA) – plan payments come from two sources: risk-adjusted payments from a Regulator and premiums charged to individual enrollees. This paper derives principles for integrating risk-adjusted payments and premium policy in individual health insurance markets based on fitting total plan payments to health plan costs per person as closely as possible. A least squares regression including both health status and variables used in premiums reveals the weights a Regulator should put on risk adjusters when markets determine premiums. We apply the methods to an Exchange-eligible population drawn from the Medical Expenditure Panel Survey (MEPS).
doi:10.1016/j.jhealeco.2013.05.002
PMCID: PMC3855655  PMID: 24308878
9.  Patient-Clinician Ethnic Concordance and Communication in Mental Health Intake Visits 
Patient education and counseling  2013;93(2):188-196.
Objective
This study examines how communication patterns vary across racial and ethnic patient-clinician dyads in mental health intake sessions and its relation to continuance in treatment, defined as attending the next scheduled appointment.
Methods
Observational study of communication patterns among ethnically/racially concordant and discordant patient-clinician dyads. Primary analysis included 93 patients with 38 clinicians in race/ethnic concordant and discordant dyads. Communication was coded using the Roter Interaction Analysis System (RIAS) and the Working Alliance Inventory Observer (WAI-O) bond scale; continuance in care was derived from chart reviews.
Results
Latino concordant dyad patients were more verbally dominant (p<.05), engaged in more patient-centered communication (p<.05) and scored higher on the (WAI-O) bond scale (all p<.05) than other groups. Latino patients had higher continuance rates than other patients in models that adjusted for non-communication variables. When communication, global affect, and therapeutic process variables were adjusted for, differences were reversed and white dyad patients had higher continuance in care rates than other dyad patients.
Conclusion
Communication patterns seem to explain the role of ethnic concordance for continuance in care.
Practice Implications
Improve intercultural communication in cross cultural encounters appears significant for retaining minorities in care.
doi:10.1016/j.pec.2013.07.001
PMCID: PMC3800470  PMID: 23896127
Concordance; Patient-Clinician Communication; RIAS; Therapeutic Alliance
10.  The Effects of Parity on Mental Health and Substance Use Disorder Spending and Utilization: Does Diagnosis Matter? 
The American journal of psychiatry  2013;170(2):180-187.
Objective
The Mental Health Parity and Addiction Equity Act (MHPAEA) requires insurance parity for mental health/substance use disorder (MH/SUD) and general medical services. Prior research found that parity did not increase MH/SUD spending and lowered out-of-pocket spending. Whether parity’s effects differ by diagnosis is unknown. We examine this question in the context of parity implementation in the Federal Employees Health Benefit (FEHB) Program.
Methods
Using administrative data and a difference-in-difference design, we compared MH/SUD treatment use and spending before (2000) and after (2002) parity for FEHB enrollees diagnosed in 1999 with bipolar disorder, major depression, or adjustment disorder (N=19,094) to that for a national sample of privately-insured individuals unaffected by the policy (N=10,521). Separate models were fit for each diagnostic group.
Results
The parity directive resulted in total spending that was unchanged among MH/SUD users with bipolar disorder and major depression but decreased for adjustment disorder (−$114 [95% CI:−$193,−$41]). Out-of-pocket spending decreased by a comparable amount for all three diagnoses (range: −$78 to −$86). Total annual utilization (e.g., medication management visits, psychotropic prescriptions, and MH/SUD hospitalization bed days) remained unchanged across all diagnoses. Annual psychotherapy visits decreased significantly only for individuals with adjustment disorders (−12%[−17.0%,−6.1%]).
Conclusions
While parity implemented in the context of managed care improved financial protection for individuals in all three diagnostic groups, the policy differentially affected spending and psychotherapy utilization across groups. There was some evidence that resources were preferentially preserved for diagnoses typically more severe/chronic and reduced for diagnoses that are expected to be less so.
doi:10.1176/appi.ajp.2012.12030392
PMCID: PMC4169195  PMID: 23377639
11.  Developing an African youth psychosocial assessment: an application of item response theory 
This study aimed to refine a dimensional scale for measuring psychosocial adjustment in African youth using item response theory (IRT). A 60-item scale derived from qualitative data was administered to 667 war-affected adolescents (55% female). Exploratory factor analysis (EFA) determined the dimensionality of items based on goodness-of-fit indices. Items with loadings less than 0.4 were dropped. Confirmatory factor analysis (CFA) was used to confirm the scale's dimensionality found under the EFA. Item discrimination and difficulty were estimated using a graded response model for each subscale using weighted least squares means and variances. Predictive validity was examined through correlations between IRT scores (θ) for each subscale and ratings of functional impairment. All models were assessed using goodness-of-fit and comparative fit indices. Fisher's Information curves examined item precision at different underlying ranges of each trait. Original scale items were optimized and reconfigured into an empirically-robust 41-item scale, the African Youth Psychosocial Assessment (AYPA). Refined subscales assess internalizing and externalizing problems, prosocial attitudes/behaviors and somatic complaints without medical cause. The AYPA is a refined dimensional assessment of emotional and behavioral problems in African youth with good psychometric properties. Validation studies in other cultures are recommended.
doi:10.1002/mpr.1420
PMCID: PMC4098666  PMID: 24478113
psychometric measurement; children and adolescents; Africa; Uganda; mental health assessment; item response theory (IRT)
12.  Characteristics and Outcomes of Patients Receiving New and Replacement Implantable Cardioverter-Defibrillators: Results from the NCDR® 
Circulation. Cardiovascular quality and outcomes  2013;6(4):10.1161/CIRCOUTCOMES.111.000054.
Background
Little is known regarding the clinical features, procedural risks, or survival of patients receiving replacement versus new implantable cardioverter-defibrillators (ICDs).
Methods and Results
Entries in the National Cardiovascular Data Registry (NCDR®) ICD Registry™ from 2005 through 2010 were eligible for (N=463,978). Baseline demographic, clinical information, and procedural variables were compared between new (N = 359,993; 77.6%) and replacement (N = 103,985; 22.4%) ICD patients, and entered into a propsensity match model to determine adjusted survival rates. Replacement ICD patients were older (70.7 versus 67.5 years) and more likely to have atrial fibrillation (41.8% vs. 31.4%, P<0.001) and ventricular tachycardia (60.5% vs. 33.9%, P<0.001) compared with new ICD patients. Median battery life was only 4.6 years (25–75% IQR 3.7–5.8) for all replaced devices, 5.8 (25–75% IQR 4.2–7.5) for single-chamber, 5.1 (25–75% IQR 4.1–6.1) for dual-chamber, and 3.9 (25–75% IQR 3.2–4.6) years for biventricular devices. Replacement ICD patients had lower rates of index admission complications (0.9% vs 3.2%, P<0.001) but greater risk for death compared with new ICD patients in unadjusted analysis (HR 1.18, 95%CI 1.16 – 1.20, P<0.0001) and after propensity score matching (HR 1.28, 95% CI 1.25 to 1.30, P < 0.0001).
Conclusions
Patients receiving replacement ICDs are older and are at greater risk for death compared to those receiving initial ICD implants. The battery life of initial ICDs is shorter than previously reported.
doi:10.1161/CIRCOUTCOMES.111.000054
PMCID: PMC3839636  PMID: 23759471
implantable cardioverter-defibrillators; death; sudden; defibrillation
13.  Protocol for the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) retrospective study of coronary catheterisation and percutaneous coronary intervention 
BMJ Open  2014;4(3):e004595.
Introduction
During the past decade, the volume of percutaneous coronary intervention (PCI) in China has risen by more than 20-fold. Yet little is known about patterns of care and outcomes across hospitals, regions and time during this period of rising cardiovascular disease and dynamic change in the Chinese healthcare system.
Methods and analysis
Using the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) research network, the Retrospective Study of Coronary Catheterisation and Percutaneous Coronary Intervention (China PEACE-Retrospective CathPCI Study) will examine a nationally representative sample of 11 900 patients who underwent coronary catheterisation or PCI at 55 Chinese hospitals during 2001, 2006 and 2011. We selected patients and study sites using a two-stage cluster sampling design with simple random sampling stratified within economical-geographical strata. A central coordinating centre will monitor data quality at the stages of case ascertainment, medical record abstraction and data management. We will examine patient characteristics, diagnostic testing patterns, procedural treatments and in-hospital outcomes, including death, complications of treatment and costs of hospitalisation. We will additionally characterise variation in treatments and outcomes by patient characteristics, hospital, region and study year.
Ethics and dissemination
The China PEACE collaboration is designed to translate research into improved care for patients. The study protocol was approved by the central ethics committee at the China National Center for Cardiovascular Diseases (NCCD) and collaborating hospitals. Findings will be shared with participating hospitals, policymakers and the academic community to promote quality monitoring, quality improvement and the efficient allocation and use of coronary catheterisation and PCI in China.
Registration details
http://www.clinicaltrials.gov (NCT01624896).
doi:10.1136/bmjopen-2013-004595
PMCID: PMC3948460  PMID: 24607563
Catheterization; Angiography; Angioplasty; China
14.  Parity and Out-of-Pocket Spending for Children With High Mental Health or Substance Abuse Expenditures 
Pediatrics  2013;131(3):e903-e911.
OBJECTIVE:
The Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act required health plans to provide mental health and substance use disorder (MH/SUD) benefits on par with medical benefits beginning in 2010. Previous research found that parity significantly lowered average out-of-pocket (OOP) spending on MH/SUD treatment of children. No evidence is available on how parity affects OOP spending by families of children with the highest MH/SUD treatment expenditures.
METHODS:
We used a difference-in-differences study design to examine whether parity reduced families’ (1) share of total MH/SUD treatment expenditures paid OOP or (2) average OOP spending among children whose total MH/SUD expenditures met or exceeded the 90th percentile. By using claims data, we compared changes 2 years before (1999–2000) and 2 years after (2001–2002) the Federal Employees Health Benefits Program implemented parity to a contemporaneous group of health plans that did not implement parity over the same 4-year period. We examined those enrolled in the Federal Employees Health Benefits Program because their parity directive is similar to and served as a model for the new federal parity law.
RESULTS:
Parity led to statistically significant annual declines in the share of total MH/SUD treatment expenditures paid OOP (−5%, 95% confidence interval: −6% to −4%) and average OOP spending on MH/SUD treatment (−$178, 95% confidence interval: −257 to −97).
CONCLUSIONS:
This study provides the first empirical evidence that parity reduces the share and level of OOP spending by families of children with the highest MH/SUD treatment expenditures; however, these spending reductions were smaller than anticipated and unlikely to meaningfully improve families’ financial protection.
doi:10.1542/peds.2012-1491
PMCID: PMC3581843  PMID: 23420919
mental health; substance use disorder; parity; insurance
15.  The Effect of Race-Ethnicity and Geography on Adoption of Innovations in the Treatment of Schizophrenia 
Objective
This study evaluated the effect of race-ethnicity and geography on the adoption of a pharmacological innovation (long-acting injectable risperidone, LAIR) among Medicaid beneficiaries with schizophrenia, and also evaluated the contribution of geographic location to observed racial-ethnic disparities.
Methods
Data source was a claims dataset from the Florida Medicaid program for the 2.5 year period that followed the launch of LAIR in the US market. Study participants were beneficiaries with schizophrenia who had filled at least 1 antipsychotic prescription during the study period. Outcome variable was any use of LAIR; model variables were need indicators and random effects for 11 Medicaid areas, multi-county units used by the Medicaid program to administer benefits. Adjusted probability of use of LAIR for blacks and Latinos versus whites was estimated with logistic regression models.
Results
The study cohort included 13,992 Medicaid beneficiaries: 25% blacks, 37% Latinos, and 38% whites. Unadjusted probability of LAIR use was lower for Latinos than whites and it varied across the state’s geographic areas. Adjustment for need confirmed the unadjusted finding of a Latino-white disparity (OR = .58, 95% CI = .49–.70). While the inclusion of geographic location in the model eliminated the Latino-white disparity, doing so confirmed the unadjusted finding of geographic variation in adoption.
Conclusions
Within a state Medicaid program, the initial finding of a Latino-white adoption disparity was driven by geographic disparities in adoption rates and the geographic concentration of Latinos in a low-adoption area. Possible contributors and implications of these results are discussed.
doi:10.1176/appi.ps.201100408
PMCID: PMC3666934  PMID: 23026838
16.  Economic Grand Rounds 
The impact of parity coverage on the quantity of behavioral health services used by enrollees and on the prices of these services was examined in a set of Federal Employees Health Benefit (FEHB) Program plans. After parity implementation, the quantity of services used in the FEHB plans declined in five service categories, compared with plans that did not have parity coverage. The decline was significant for all service types except inpatient care. Because a previous study of the FEHB Program found that total spending on behavioral health services did not increase after parity implementation, it can be inferred that average prices must have increased over the period. The finding of a decline in service use and increase in prices provides an empirical window on what might be expected after implementation of the federal parity law and the parity requirement under the health care reform law.
doi:10.1176/appi.ps.20120p107
PMCID: PMC3773179  PMID: 22302324
18.  Association of Single vs. Dual Chamber ICDs with Mortality, Readmissions and Complications among Patients Receiving an ICD for Primary Prevention 
Importance
Randomized trials of implantable cardioverter defibrillators (ICDs) for primary prevention predominantly employed single chamber devices. In clinical practice, patients often receive dual chamber ICDs, even without clear indications for pacing. The outcomes of dual versus single chamber devices are uncertain.
Objective
Compare outcomes of single and dual chamber ICDs for primary prevention of sudden cardiac death.
Design, Setting, and Participants
Retrospective cohort study. Admissions in the National Cardiovascular Data Registry’s (NCDR®) ICD Registry™ from 2006–2009 that could be linked to CMS fee for service Medicare claims data were identified. Patients were included if they received an ICD for primary prevention and did not have a documented indication for pacing.
Main Outcome Measures
Adjusted risks of 1-year mortality, all-cause readmission, HF readmission and device-related complications within 90 days were estimated with propensity-score matching based on patient, clinician and hospital factors.
Results
Among 32,034 patients, 38% (n=12,246) received a single chamber device and 62% (n=19,788) received a dual chamber device. In a propensity-matched cohort, rates of complications were lower for single chamber devices (3.5% vs. 4.7%; p<0.001; risk difference −1.20; 95% CI −1.72, −0.69), but device type was not significantly associated with mortality or hospitalization outcomes (unadjusted rate 9.9% vs. 9.8%; HR 0.99, 95% CI 0.91–1.07; p=0.792 for 1-year mortality; unadjusted rate 43.9% vs. 44.8%; HR 1.00, 95% CI 0.97–1.04; p=0.821 for 1-year all-cause hospitalization; unadjusted rate 14.7% vs. 15.4%; HR 1.05, 95% CI 0.99–1.12; p=0.189 for 1-year HF hospitalization).
Conclusions and Relevance
Among patients receiving an ICD for primary prevention without indications for pacing, the use of a dual chamber device compared with a single chamber device was associated with a higher risk of device-related complications but not with different risks for mortality or hospitalization. Further studies should be performed to determine if other benefits of dual chamber devices exist, such as reduced device therapy or improved quality of life, to justify their use in this context.
doi:10.1001/jama.2013.4982
PMCID: PMC3752924  PMID: 23677314
19.  VASCULAR CLOSURE DEVICE FAILURE IN CONTEMPORARY PRACTICE 
Objectives
To assess the frequency and predictors of vascular closure device (VCD) deployment failure, and its association with vascular complications of three commonly used VCDs.
Background
VCDs are commonly used following percutaneous coronary intervention (PCI) on the basis of studies demonstrating reduced time to ambulation, increased patient comfort, and possible reduction in vascular complications as compared to manual compression. However, limited data are available on the frequency and predictors of VCD failure, and the association of deployment failure with vascular complications.
Methods
From a de-identified dataset provided by Massachusetts Department of Health, 23,813 consecutive interventional coronary procedures that used either a collagen plug-based (n=18,533) or nitinol clip-based (n=2,284) or suture-based (n=2,996) VCD between 06/2005 and 12/2007 were identified. We defined VCD failure as unsuccessful deployment or failure to achieve immediate access site hemostasis.
Results
Among 23,813 procedures, VCD failed in 781 (3.3%) procedures (2.1% of collagen plug-based, 6.1% of suture-based, 9.5% of nitinol clip-based). Patients with VCD failure had excess risk of ‘any’ (7.7% versus 2.8%; P<0.001), major (3.3% versus 0.8%; P<0.001), or minor (5.8% versus 2.1%; P<0.001) vascular complications compared with successful VCD deployment. In a propensity-score adjusted analysis, when compared with collagen plug-based VCD (Reference OR =1.0), nitinol clip-based VCD had 2-fold increased risk (OR 2.0, 95% CI: 1.8–2.3, p<0.001) and suture-based VCD had 1.25-fold increased risk (OR 1.25, 95% CI: 1.2–1.3, p<0.001) for VCD failure. VCD failure was a significant predictor of subsequent vascular complications for both collagen plug-based VCD and nitinol clip-based VCD, but not for suture-based VCD.
Conclusion
VCD failure rates vary depending upon the types of VCD used and are associated with significantly higher vascular complications as compared to deployment successes.
doi:10.1016/j.jcin.2012.05.005
PMCID: PMC3427601  PMID: 22917455
Angio-Seal; complications; Perclose; StarClose; vascular closure device
20.  Mortality and Readmission at Safety Net and Non-Safety Net Hospitals for Three Common Medical Conditions 
Health affairs (Project Hope)  2012;31(8):1739-1748.
Safety net hospitals remain under financial strain, possibly affecting quality of care, and face uncertain financial consequences under the Patient Protection and Affordable Care Act. We compared risk-standardized mortality and readmission rates among fee-for-service Medicare beneficiaries admitted for acute myocardial infarction, heart failure, or pneumonia to urban hospitals within metropolitan statistical areas containing at least one safety net and non-safety net hospital. There was substantial variation in both mortality and readmission rates among safety-net and non-safety net hospitals for all three conditions, although safety-net hospitals had marginally worse outcomes. Herein we discuss the clinical and policy implications of these findings.
doi:10.1377/hlthaff.2011.1028
PMCID: PMC3527010  PMID: 22869652
Safety net hospitals; Vulnerable Populations; Quality of Care
21.  The Effect of Race-Ethnicity on Clozapine Outcomes among Medicaid Beneficiaries with Schizophrenia 
Objective
Effectiveness trials have confirmed the superiority of clozapine in the treatment of schizophrenia, but little is known about whether the drug’s superiority holds across racial-ethnic groups. This study examined the effect of race-ethnicity on the effectiveness of clozapine relative to other antipsychotics among patients in maintenance antipsychotic treatment.
Methods
Black, Latino, and white Florida Medicaid beneficiaries with schizophrenia receiving maintenance treatment with clozapine or other antipsychotic medications during 7/1/00-6/30/05 were identified. Cox proportional hazard regression models were used to estimate associations of clozapine, race-ethnicity, and their interaction, with time to discontinuation for any cause, our primary measure of effectiveness.
Results
The study cohort included 20,122 episodes of treatment with clozapine (3.7%) and other antipsychotics (96.3%), with 23% black and 36% Latino. Unadjusted analyses suggested that Latinos continue on clozapine longer than whites, while they and blacks discontinue other antipsychotics sooner than whites. Adjusted analyses using 749 propensity score matched sets of clozapine and other antipsychotic users indicated that risk of discontinuation was lower for clozapine users (RR = .45, 95% CI = .39 – .52), an effect that was not moderated by race-ethnicity. Times to discontinuation were longer for clozapine users. Overall risk of antipsychotic discontinuation was higher for blacks (RR =1.56, CI = 1.27 – 1.91), and Latinos (RR = 1.23, CI = 1.02 – 1.48).
Conclusions
This study confirmed clozapine’s superior effectiveness and did not find evidence that race-ethnicity modifies this effect. These findings heighten the need for efforts to increase clozapine use, particularly among minority groups.
doi:10.1176/appi.ps.201200041
PMCID: PMC3713199  PMID: 23242347
22.  National and regional trends in heart failure hospitalization and mortality rates for Medicare beneficiaries: 1998–2008 
Context
Whether recent declines in ischemic heart disease and its risk factors have been accompanied by declines in heart failure (HF) hospitalization and mortality is not known.
Objective
To examine changes in HF hospitalization rate and 1-year mortality rate in the U.S., nationally and by state/territory.
Design, Setting, and Participants
55,097,390 fee-for-service Medicare beneficiaries hospitalized between 1998 and 2008 in acute care hospitals in the U.S. and Puerto Rico admitted with a principal discharge diagnosis code for HF.
Main Outcome Measures
Changes in patient demographics and comorbidities, HF hospitalization rates, and 1-year mortality rates.
Results
The HF hospitalization rate adjusted for age, sex, and race declined from 2,845 per 100,000 person-years in 1998 to 2,007 per 100,000 person-years in 2008 (p<0.001), a relative decline of 29.5%. Age-adjusted HF-hospitalization rates declined over the study period for all race-sex categories. Black men had the lowest rate of decline (4,142 to 3,201 per 100,000 person-years) among all race-sex categories which persisted after adjusting for age (incidence rate ratio=0.81, 95% confidence interval [CI] 0.79 to 0.84). HF hospitalization rates declined significantly faster than the national mean in 16 states, and significantly slower in 3 states. Risk-adjusted 1-year mortality fell from 31.7% in 1999 to 29.6% in 2008 (p<0.001), a relative decline of 6.6%. 1-year mortality rates declined significantly in 4 states, but increased in 5 states.
Conclusions
The overall HF hospitalization rate declined substantially from 1998 to 2008, but at a lower rate for black men. The overall 1-year mortality rate declined slightly over the past decade, but remains high. Changes in HF hospitalization and 1-year mortality rates were uneven across states.
doi:10.1001/jama.2011.1474
PMCID: PMC3688069  PMID: 22009099
heart failure; hospitalization; mortality; epidemiology
23.  Meta-Analysis of Rare Binary Adverse Event Data 
We examine the use of fixed-effects and random-effects moment-based meta-analytic methods for analysis of binary adverse event data. Special attention is paid to the case of rare adverse events which are commonly encountered in routine practice. We study estimation of model parameters and between-study heterogeneity. In addition, we examine traditional approaches to hypothesis testing of the average treatment effect and detection of the heterogeneity of treatment effect across studies. We derive three new methods, simple (unweighted) average treatment effect estimator, a new heterogeneity estimator, and a parametric bootstrapping test for heterogeneity. We then study the statistical properties of both the traditional and new methods via simulation. We find that in general, moment-based estimators of combined treatment effects and heterogeneity are biased and the degree of bias is proportional to the rarity of the event under study. The new methods eliminate much, but not all of this bias. The various estimators and hypothesis testing methods are then compared and contrasted using an example dataset on treatment of stable coronary artery disease.
doi:10.1080/01621459.2012.664484
PMCID: PMC3665366  PMID: 23734068
24.  Racial and Ethnic Service Use Disparities Among Homeless Adults With Severe Mental Illnesses Receiving ACT 
Objective
Case management–based interventions aimed at improving quality of care have the potential to narrow racial and ethnic disparities among people with chronic illnesses. The aim of this study was to assess the equity effects of assertive community treatment (ACT), an evidence-based case management intervention, among homeless adults with severe mental illness.
Methods
This study used baseline, three-, and 12-month data for 6,829 black, Latino, and white adults who received ACT services through the ACCESS study (Access to Community Care and Effective Services and Support). Zero-inflated Poisson random regression models were used to estimate the adjusted probability of use of outpatient psychiatric services and, among service users, the intensity of use. Odds ratios and rate ratios (RRs) were computed to assess disparities at baseline and over time.
Results
No disparities were found in probability of use at baseline or over time. Compared with white users, baseline intensity of use was lower for black users (RR=.89; 95% confidence interval [CI]=.83–.96) and Latino users (RR=.65; CI=.52–.81]). Intensity did not change over time for whites, but it did for black and Latino users. Intensity increased for blacks between baseline and three months (RR=1.11, CI=1.06–1.17]) and baseline and 12 months (RR=1.17, CI=1.11–1.22]). Intensity of use dropped for Latinos between baseline and three months (RR=.83, CI=.70–.98).
Conclusions
Receipt of ACT was associated with a reduction in service use disparities for blacks but not for Latinos. Findings suggest that ACT’s equity effects differ depending on race-ethnicity.
doi:10.1176/appi.ps.62.6.598
PMCID: PMC3648808  PMID: 21632726
25.  Relationship of Hospital Performance with Readmission and Mortality Rates for Patients Hospitalized with Acute Myocardial Infarction, Heart Failure, or Pneumonia 
Context
The Centers for Medicare & Medicaid Services publicly reports hospital 30-day all-cause risk-standardized mortality rates (RSMRs) and 30-day all-cause risk-standardized readmission rates (RSRRs) for acute myocardial infarction (AMI), heart failure (HF), and pneumonia. The relationship between hospital performance as measured by RSMRs and RSRRs has not been well characterized.
Objective
We determined the relationship between hospital RSMRs and RSRRs overall, and within subgroups defined by hospital characteristics.
Design, Setting, and Participants
We studied Medicare fee-for-service beneficiaries discharged with AMI, HF, or pneumonia between July 1, 2005 and June 30, 2008. We quantified the correlation between hospital RSMRs and RSRRs using weighted linear correlation; evaluated correlations in groups defined by hospital characteristics; and determined the proportion of hospitals with better and worse performance on both measures.
Main Outcome Measures
Hospital 30-day RSMRs and RSRRs.
Results
The analyses included 4506 hospitals for AMI; 4767 hospitals for HF; and 4811 hospitals for pneumonia. The mean RSMRs and RSRRs were 16.60% and 19.94% for AMI; 11.17% and 24.56% for HF; and 11.64% and 18.22% for pneumonia. The correlations (95% confidence intervals [CIs]) between RSMRs and RSRRs were 0.03 (95% CI: −0.002, 0.06) for AMI, −0.17 (95% CI: −0.20, −0.14) for HF, and 0.002 (95% CI: −0.03, 0.03) for pneumonia. The results were similar for subgroups defined by hospital characteristics. Although there was a significant negative linear relationship between RSMRs and RSRRs for HF, the shared variance between them was only 2.90% (r2 = 0.029).
Conclusions
Our findings do not support concerns that hospitals with lower RSMRs will necessarily have higher RSRRs. The rates are not associated for patients admitted with an AMI or pneumonia and only weakly associated, within a certain range, for patients admitted with HF.
doi:10.1001/jama.2013.333
PMCID: PMC3621028  PMID: 23403683

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