Elevated Uric Acid Prevalence and Clinical Outcomes in Patients with Heart Failure with Preserved Ejection Fraction: Insights from RELAX.

PURPOSE: We aimed to 1) describe characteristics of patients with heart failure with preserved ejection fraction (HFpEF) enrolled in RELAX stratified by normal or elevated baseline serum uric acid (sUA) level; 2) evaluate the association between sUA level and surrogate clinical measures; and 3) assess associations between changes in sUA level over time and changes in surrogate clinical measures. METHODS: We analyzed 212 patients with HFpEF and normal or elevated (>6 mg/dL) baseline sUA measurements from the RELAX trial. Variables examined included clinical characteristics, cardiopulmonary exercise testing, 6-minute walk testing, quality of life, echocardiography, and serum biomarker testing. Baseline characteristics between groups were compared and scatter plots with quadratic regression lines and linear regression modeling were used to assess the relationship between baseline sUA and clinical measures. Kaplan-Meier curves were used to describe composite death or cardiovascular/renal hospitalization. RESULTS: The prevalence of elevated baseline sUA was 68.9%. Patients with elevated sUA had more baseline comorbidities and poorer functional status on cardiopulmonary exercise testing than those without. After adjustment, significant associations between baseline sUA levels and cystatin C, N-terminal pro B-type natriuretic peptide, high-sensitivity troponin I, and high-sensitivity C-reactive protein were identified. Higher baseline sUA was also associated with worsening peak VO2, 6-minute walk testing, and left ventricular mass. No significant association was found between baseline sUA levels and the composite of death or cardiovascular/renal hospitalization at 24 weeks. CONCLUSION: sUA is an important marker of comorbidities and functional status in patients with HFpEF. Clinical trials of sUA-lowering therapies in patients with HFpEF are promising.

Comparative effectiveness of hysterectomy versus myomectomy on one-year health-related quality of life in women with uterine fibroids.

OBJECTIVE: To compare long-term health-related quality of life (HRQOL) 1 year after hysterectomy or myomectomy for treatment of uterine fibroids (UFs) and to determine whether route of procedure, race, or age affected improvements in HRQOL. DESIGN: Prospective cohort study. SETTING: Eight clinical sites throughout the United States. PATIENT(S): A total of 1,113 premenopausal women with UFs who underwent hysterectomy or myomectomy as part of Comparing Options for Management: Patient-Centered Results for Uterine Fibroids. INTERVENTION(S): None. MAIN OUTCOME MEASURE (S): Self-reported HRQOL measures including Uterine Fibroid Symptom Quality of Life, the European QOL 5 Dimension Health Questionnaire, and the visual analog scale at baseline and 1-year after hysterectomy or myomectomy. RESULT (S): Hysterectomy patients were older with a longer history of symptomatic UF compared with myomectomy patients. There were no differences in baseline HRQOL. After adjustment for baseline differences between groups, compared with myomectomy, patients' HRQOL (95% confidence interval [CI], 5.4, 17.2) and symptom severity (95% CI, -16.3, -8.8) were significantly improved with hysterectomy. When stratified across race/ethnicity and age, hysterectomy had higher HRQOL scores compared with myomectomy. There was little difference in HRQOL (95% CI, 0.1 [-9.5, 9.6]) or symptom severity (95% CI, -3.4 [-10, 3.2]) between abdominal hysterectomy and abdominal myomectomy. CONCLUSION (S): HRQOL improved in all women 1 year after hysterectomy or myomectomy. Hysterectomy patients reported higher HRQOL summary scores compared with myomectomy patients. When stratified by route, minimally invasive hysterectomy had better HRQOL scores than minimally invasive myomectomy. There was little difference in scores with abdominal approaches.

Short-Term Health-Related Quality of Life After Hysterectomy Compared With Myomectomy for Symptomatic Leiomyomas.

OBJECTIVE: To compare short-term health-related quality of life (HRQOL) 6-12 weeks after hysterectomy or myomectomy for the treatment of symptomatic leiomyomas. METHODS: We conducted a prospective comparative effectiveness analysis of data. In an existing multisite registry, we compared 6-12-week postsurgical HRQOL using the disease-specific Uterine Fibroid Symptom Quality of Life and the generic EuroQoL 5-Dimension Health Questionnaire, in women from the ages of 18-54 years with documented leiomyomas undergoing hysterectomy or myomectomy. Propensity score weighting was used to adjust for confounding, and analyses were also stratified by route of surgery. RESULTS: A total of 1,295 patients (727 with hysterectomy and 568 with myomectomy) enrolled from registry initiation in November 2015 until June 2018 met inclusion criteria. At baseline, leiomyoma-specific HRQOL (44.0±25.4 and 50.2±25.3, P<.01), symptom severity (60.7±23.6 and 51.7±24.6, P<.01), and generic HRQOL (69.3±20.4 and. 73.4±18.9, P<.01) were significantly different between the hysterectomy compared with myomectomy groups, respectively. Differences were eliminated by propensity adjustment. Substantial improvement in HRQOL measures were seen in both groups at 6-12 weeks, with the mean propensity-adjusted symptom severity score 4 points lower in hysterectomy patients (mean difference -4.6; 95% CI -7.0 to -2.3), compared with myomectomy patients. Hysterectomy patients had better scores on the concern and self-consciousness subscales compared with myomectomy patients. When stratified by surgical route, these two subscale findings were similar between minimally invasive hysterectomy and minimally invasive myomectomy. Symptom severity scores did not differ after abdominal myomectomy compared with abdominal hysterectomy, but subscale scores on activity and energy/mood were higher with myomectomy. CONCLUSION: Both hysterectomy and myomectomy were associated with substantial improvement in HRQOL at short-term follow-up, with small but statistically significant differences in symptom severity and certain subscales. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02260752.

The Comparing Options for Management: PAtient-centered REsults for Uterine Fibroids (COMPARE-UF) registry: rationale and design.

BACKGROUND: Uterine fibroids are common in premenopausal women, yet comparative effectiveness research on uterine fibroid treatments is rare. OBJECTIVE: The purpose of this study was to design and establish a uterine fibroid registry based in the United States to provide comparative effectiveness data regarding uterine fibroid treatment. STUDY DESIGN: We report here the design and initial recruitment for the Comparing Options for Management: Patient-centered REsults for Uterine Fibroids (COMPARE-UF) registry (Clinicaltrials.gov, NCT02260752), funded by the Agency for Healthcare Research and Quality in collaboration with the Patient-Centered Outcomes Research Institute. COMPARE-UF was designed to help answer critical questions about treatment options for women with symptomatic uterine fibroids. Women who undergo a procedure for uterine fibroids (hysterectomy, myomectomy [abdominal, hysteroscopic, vaginal, and laparoscopic/robotic], endometrial ablation, radiofrequency fibroid ablation, uterine artery embolization, magnetic resonance-guided focused ultrasound, or progestin-releasing intrauterine device insertion) at 1 of the COMPARE-UF sites are invited to participate in a prospective registry with 3 years follow up for postprocedural outcomes. Enrolled participants provide annual follow-up evaluation through an online portal or through traditional phone contact. A central data abstraction center provides information obtained from imaging, operative or procedural notes, and pathology reports. Women with uterine fibroids and other stakeholders are a key part of the COMPARE-UF registry and participate at all points from study design to dissemination of results. RESULTS: We built a network of 9 clinical sites across the United States with expertise in the care of women with uterine fibroids to capture geographic, racial, ethnic, and procedural diversity. Of the initial 2031 women who were enrolled in COMPARE-UF, 42% are self-identified as black or African American, and 40% are ≤40 years old, with 16% of participants <35 years old. Women who undergo myomectomy comprise the largest treatment group at 46% of all procedures, with laparoscopic or robotic myomectomy comprising the largest subset of myomectomies at 19% of all procedures. Hysterectomy is the second most common treatment within the registry at 38%. CONCLUSION: In response to priorities that were identified by our patient stakeholders, the initial aims within COMPARE-UF will address how different procedures that are used to treat uterine fibroids compare in terms of long-lasting symptom relief, potential for recurrence, medical complications, improvement in quality of life and sexual function, age at menopause, and fertility and pregnancy outcomes. COMPARE-UF will generate evidence on the comparative effectiveness of different procedural options for uterine fibroids and help patients and their caregivers make informed decisions that best meet an individual patient's short- and long-term preferences. Building on this infrastructure, the COMPARE-UF team of investigators and stakeholders, including patients, collaborate to identify future priorities for expanding the registry, such as assessing the efficacy of medical therapies for uterine fibroids. COMPARE-UF results will be disseminated directly to patients, providers, and other stakeholders by traditional academic pathways and by innovative methods that include a variety of social media platforms. Given demographic differences among women who undergo different uterine fibroid treatments, the assessment of comparative effectiveness for this disease through clinical trials will remain difficult. Therefore, this registry provides optimized evidence to help patients and their providers better understand the pros and cons of different treatment options so that they can make more informed decisions.

Racial/Ethnic differences in process of care and outcomes among patients hospitalized with intracerebral hemorrhage.

BACKGROUND AND PURPOSE: Although racial/ethnic differences in care are pervasive in many areas of medicine, little is known whether intracerebral hemorrhage (ICH) care processes or outcomes differ by race/ethnicity. METHODS: We analyzed 123 623 patients with ICH (83 216 white, 22 147 black, 10 519 Hispanic, and 7741 Asian) hospitalized at 1199 Get With The Guidelines-Stroke hospitals between 2003 and 2012. Multivariable logistic regression with generalized estimating equation was used to evaluate the association among race, stroke performance measures, and in-hospital outcomes. RESULTS: Relative to white patients, black, Hispanic, and Asian patients were significantly younger, but more frequently had more severe stroke (median National Institutes of Health Stroke Scale, 9, 10, 10, and 11, respectively; P<0.001). After adjustment for both patient and hospital-level characteristics, black patients were more likely to receive deep venous thrombosis prophylaxis, rehabilitation assessment, dysphagia screening, and stroke education, but less likely to have door to computed tomographic time ≤25 minutes and smoking cessation counseling than whites. Both Hispanic and Asian patients had higher odds of dysphagia screening but lower odds of smoking cessation counseling. In-hospital all-cause mortality was lower for blacks (23.0%), Hispanics (22.8%), and Asians (25.3%) than for white patients (27.6%). After risk adjustment, all minority groups had lower odds of death, of receiving comfort measures only or of being discharged to hospice. In contrast, they were more likely to exceed the median length of stay when compared with white patients. CONCLUSIONS: Although individual quality indicators in ICH varied by race/ethnicity, black, Hispanic, and Asian patients with ICH had lower risk-adjusted in-hospital mortality than white patients with ICH.

Patterns of stress testing and diagnostic catheterization after coronary stenting in 250 350 medicare beneficiaries.

BACKGROUND: Patterns of noninvasive stress test (ST) and invasive coronary angiography (CA) utilization after percutaneous coronary intervention (PCI) are not well described in older populations. METHODS AND RESULTS: We linked National Cardiovascular Data Registry CathPCI Registry data with longitudinal Medicare claims data for 250 350 patients undergoing PCI from 2005 to 2007 and described subsequent testing and outcomes. Between 60 days post-PCI and end of follow-up (median 24 months), 49% (n=122 894) received ST first, 10% (n=25 512) underwent invasive CA first, and 41% (n=101 944) had no testing. Several clinical risk factors at time of index PCI were associated with decreased likelihood of downstream testing (ST or CA, P<0.05 for all), including older age (hazard ratio [HR] 0.784 per 10-year increase), male sex (HR 0.946), heart failure (HR 0.925), diabetes mellitus (HR 0.954), smoking (HR 0.804), and renal failure (HR 0.880). Fifteen percent of patients with ST first proceeded to subsequent CA within 90 days of testing (n=18 472/122 894) [corrected]; of these, 48% (n=8831) underwent revascularization within 90 days, compared with 53% (n=13 316) of CA first patients (P<0.0001). CONCLUSIONS: In this descriptive analysis, ST and invasive CA were common in older patients after PCI. Paradoxically, patients with higher risk features at baseline were less likely to undergo post-PCI testing. The revascularization yield was low on patients referred for ST after PCI, with only 7% [corrected] undergoing revascularization within 90 days.

Potential unintended financial consequences of pay-for-performance on the quality of care for minority patients.

OBJECTIVES: The purpose of this study was to determine whether pay-for-performance (PFP) increases existing racial care disparities. BACKGROUND: Medicare's PFP program provides financial rewards to hospitals whose care performance ranks in the highest quintile relative to peers and reduces funding to hospitals that rank in the lowest quintile. Pay-for-performance is designed to improve care but may disproportionately penalize hospitals caring for large minority populations. METHODS: Using Medicare data, 3449 US hospitals were ranked by performance on PFP process measures for acute myocardial infarction (AMI), community-acquired pneumonia (CAP), and heart failure (HF). These rankings were compared with the percentage of African American (AA) patients in a center. We determined the eligibility for financial bonus (highest quintile ranking) or penalty (lowest quintile) among centers treating large AA populations (> or = 20%) versus not after adjusting for hospital facility (catheterization, percutaneous coronary intervention, surgery), academic status, number of hospital beds, location, patient volume, and region. RESULTS: The percentage of AA patients treated by a center was inversely associated with performance for AMI and CAP (P < .01) but not HF (P = .06). Relative to hospitals with < 20% AA, those with > or = 20% AA were less likely eligible for financial bonuses and more likely to face penalties: for AMI, adjusted odds ratio (OR) 0.7 (95% CI 0.5-1.0) and 1.8 (1.4-2.4), respectively; for CAP, OR 0.5 (95% CI 0.3-0.6) and 2.3 (1.8-2.9), respectively; for HF, OR 1.0 (95% CI 0.7-1.2) and 1.2 (0.9-1.5), respectively. CONCLUSIONS: Hospitals with large minority populations may be at financial risk under PFP. Thus, PFP may worsen existing racial care disparities.

Pay for performance, quality of care, and outcomes in acute myocardial infarction.

CONTEXT: Pay for performance has been promoted as a tool for improving quality of care. In 2003, the Centers for Medicare & Medicaid Services (CMS) launched the largest pay-for-performance pilot project to date in the United States, including indicators for acute myocardial infarction. OBJECTIVE: To determine if pay for performance was associated with either improved processes of care and outcomes or unintended consequences for acute myocardial infarction at hospitals participating in the CMS pilot project. DESIGN, SETTING, AND PARTICIPANTS: An observational, patient-level analysis of 105,383 patients with acute non-ST-segment elevation myocardial infarction enrolled in the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the American College of Cardiology/American Heart Association (ACC/AHA) Guidelines (CRUSADE) national quality-improvement initiative. Patients were treated between July 1, 2003, and June 30, 2006, at 54 hospitals in the CMS program and 446 control hospitals. MAIN OUTCOME MEASURES: The differences in the use of ACC/AHA class I guideline recommended therapies and in-hospital mortality between pay for performance and control hospitals. RESULTS: Among treatments subject to financial incentives, there was a slightly higher rate of improvement for 2 of 6 targeted therapies at pay-for-performance vs control hospitals (odds ratio [OR] comparing adherence scores from 2003 through 2006 at half-year intervals for aspirin at discharge, 1.31; 95% confidence interval [CI], 1.18-1.46 vs OR, 1.17; 95% CI, 1.12-1.21; P = .04) and for smoking cessation counseling (OR, 1.50; 95% CI, 1.29-1.73 vs OR, 1.28; 95% CI, 1.22-1.35; P = .05). There was no significant difference in a composite measure of the 6 CMS rewarded therapies between the 2 hospital groups (change in odds per half-year period of receiving CMS therapies: OR, 1.23; 95% CI, 1.15-1.30 vs OR, 1.17; 95% CI, 1.14-1.20; P = .16). For composite measures of acute myocardial infarction treatments not subject to incentives, rates of improvement were not significantly different (OR, 1.09; 95% CI, 1.05-1.14 vs OR, 1.08; 95% CI, 1.06-1.09; P = .49). Overall, there was no evidence that improvements in in-hospital mortality were incrementally greater at pay-for-performance sites (change in odds of in-hospital death per half-year period, 0.91; 95% CI, 0.84-0.99 vs 0.97; 95% CI, 0.94-0.99; P = .21). CONCLUSIONS: Among hospitals participating in a voluntary quality-improvement initiative, the pay-for-performance program was not associated with a significant incremental improvement in quality of care or outcomes for acute myocardial infarction. Conversely, we did not find evidence that pay for performance had an adverse association with improvement in processes of care that were not subject to financial incentives. Additional studies of pay for performance are needed to determine its optimal role in quality-improvement initiatives.

Is early too early? Effect of shorter stays after bypass surgery.

BACKGROUND: Postoperative stays after coronary artery bypass graft surgery (CABG) decreased substantially in the 1990s. Although shorter stays offer clinical benefits, premature discharge could increase adverse events and offset initial savings. This study examined the effect of early discharge after CABG on readmission/death and cost within 60 days of discharge home. Variability in hospitals' tendencies for early discharge and adverse outcomes was also explored. METHODS: Analyses were based on clinical and claims data for 55,889 New York CABG patients discharged home 1995 to 1998. Early discharge was defined as a postoperative stay below the 15th percentile for patients with similar risk. The likelihood of early discharge and its effect on readmission/death were examined using hierarchical logistic regression, accounting for patient risk and within-hospital correlation. The correlation between early discharge and adverse outcomes at the hospital level was assessed. The effect of early discharge on subsequent inpatient, outpatient, skilled nursing, and home health costs was examined in the Medicare subset. RESULTS: Overall, 17% of patients were discharged early, with increasing prevalence over time. The tendency to discharge early varied widely among hospitals (2% to 42% of patients). We found no association between hospitals' tendencies for early discharge and adverse outcomes. Lower postdischarge costs among patients discharged early (mean = 3,491 dollars versus 5,246 dollars for typical stays) resulted in average cumulative savings of 6,309 dollars. CONCLUSIONS: Patients selected for earlier discharge after CABG did not have increased adverse event rates or higher costs. Variation among hospitals in early discharge suggests that more efficient patient management could be achieved at some hospitals.

Trends in postoperative length of stay after bypass surgery.

BACKGROUND: Although single-site studies have reported reductions in coronary artery bypass graft (CABG) surgery length of stay (LOS) over the last 15 years, less information is available regarding overall temporal trends and interhospital variability. This study examined trends in postoperative LOS, associated rates of transfer at discharge and variation among hospitals in LOS at CABG hospitals in New York State. METHODS: Trends in postoperative LOS and transfers at discharge for 105,842 CABG patients treated in 30 hospitals in New York between 1992 and 1998 were first described graphically. Mixed models were then used to assess temporal trends and interhospital variability in LOS, accounting for differences in patient risk and within-hospital correlation in outcomes. Clinical and LOS data were obtained from the Cardiac Surgery Reporting System. Additional information was extracted from the New York Statewide Planning and Research Cooperative System. RESULTS: Postoperative LOS decreased 30% between 1992 and 1998 after adjusting for patient risk. A concurrent increase in the probability of nonacute patient transfers occurred over time, with the most pronounced increase in patients with stays exceeding 5 days. Underlying the downward trend in LOS was substantial interhospital variability that peaked in 1994 and remained significant in 1998. Stays were longer at hospitals located in New York City. CONCLUSIONS: The downward shift in LOS observed in the 1990s was achieved in part by an increase in nonacute care transfers, reflecting a shift in care setting. After decreasing trends in postoperative stays tapered off, significant variability among hospitals remained.

Recent trends in the care of patients with non-ST-segment elevation acute coronary syndromes: insights from the CRUSADE initiative.

BACKGROUND: The extent to which national health quality improvement initiatives have altered reported treatment gaps among patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS) is unknown. We sought to determine recent trends in adherence to guideline-based therapies for NSTE ACS. METHODS: We evaluated the treatment of patients with high-risk (positive cardiac markers and/or ischemic ST-segment changes) NSTE ACS enrolled in the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the ACC/AHA (American College of Cardiology/American Heart Association) Guidelines (CRUSADE) Quality Improvement Initiative from 2002 through 2004 (a total of 113 595 patients over 11 calendar quarters). We analyzed adherence to guideline-recommended therapies, including medications used in the acute care period (<24 hours after presentation), invasive procedures, in-hospital outcomes, and discharge therapies and interventions. RESULTS: The use of each class I guideline recommendation, as well as overall adherence to the guidelines, improved significantly (P<.001) during the study period. In the acute care setting, the use of antiplatelet agents increased by 5% and beta-blockers by 12%; at hospital discharge, the use of antiplatelet agents increased by 3% and beta-blockers by 8%. Heparin use in the acute care period increased by 6%, largely owing to a 9% increase in the use of low-molecular-weight heparin. Use of glycoprotein IIb/IIIa inhibitors in the acute care period also increased by more than 13%. At discharge, clopidogrel use increased by 22%, lipid-lowering agents by 11%, and angiotensin-converting enzyme inhibitors by 5%. While adherence improved, many patients still failed to receive 100% indicated treatments at the end of the study period. CONCLUSIONS: During the 4 years since the initial release of the ACC/AHA guidelines for NSTE ACS, adherence to class I recommendations has significantly improved among hospitals participating in CRUSADE. Still, further improvements are needed for optimal implementation of the these guidelines.

Frequency, predictors, and outcomes of drug-eluting stent utilization in patients with high-risk non-ST-segment elevation acute coronary syndromes.

Despite the established benefit of drug-eluting stents (DESs) in improving clinical and angiographic outcomes in pivotal, randomized trials, relatively little is known regarding the frequency and patterns of DES use in clinical practice. To characterize DES use in a broad, unselected high-risk non-ST-segment elevation acute coronary syndrome population, we evaluated the frequency, patterns, and predictors of DES use among patients in the Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the American College of Cardiology/American Heart Association Guidelines (CRUSADE) Quality Improvement Initiative who were selected to undergo percutaneous coronary intervention. Of 8,852 patients with high-risk non-ST-segment elevation acute coronary syndromes who underwent percutaneous revascularization at 262 hospitals between October 2003 and June 2004, 5,858 (66.2%) were treated with DESs and 2,994 (33.8%) were not. During a 9-month period, DES use increased considerably from 52.6% of cases in October 2003 to 78.5% in June 2004. Compared with the bare metal stent cohort, patients receiving DESs were more likely to be women and to have private insurance, but were less likely to present with positive cardiac markers or ST-segment depression. In adjusted analysis, death and recurrent infarction were significantly lower among the patients with a DES, yet early revascularization and treatment with guideline-recommended therapies were less frequent. In a multivariate model, significant (p <0.05) predictors of DES use included hyperlipidemia, elevated systolic blood pressure, private insurance, and treatment at a larger hospital. In conclusion, these findings not only identified differences in the selection and treatment of patients receiving bare metal stents versus DESs, but also demonstrated the increasing use of DESs in higher risk patients who have previously been excluded from randomized, pivotal trials.

Influence of clinical trial enrollment on the quality of care and outcomes for patients with non-ST-segment elevation acute coronary syndromes.

BACKGROUND: Clinical trials provide evidence that is formulated into recommendations for practice guidelines, but it remains uncertain whether patients enrolled in trials are similar to those treated in routine practice and whether trial enrollment influences inhospital treatments and outcomes. METHODS: Using data from the CRUSADE quality improvement initiative, we evaluated predictors of trial enrollment, treatment patterns, and clinical outcomes among high-risk patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS) who were and were not enrolled in a clinical trial during hospitalization. RESULTS: Among 55,172 high-risk patients presenting with NSTE ACS at 443 US hospitals, 1397 (2.5%) patients were enrolled in a clinical trial during index hospitalization. Significant predictors of trial enrollment included male sex, lack of renal insufficiency, and absence of congestive heart failure on presentation. Acute (<24 hours) and discharge secondary prevention interventions recommended by the American College of Cardiology/American Heart Association guidelines for NSTE ACS were used more commonly in patients enrolled in clinical trials. Cardiac catheterization (84.5% vs 65.8%, P < .0001), percutaneous coronary intervention (48.2% vs 36.3%, P < .0001), and bypass surgery (19.1% vs 11.3%, P < .0001) were also performed more frequently in trial patients. The adjusted risk of inhospital mortality was similar in trial versus nontrial patients (odds ratio 0.86, 95% CI 0.60-1.24). CONCLUSIONS: Patients with NSTE ACS participating in clinical trials are more likely to receive beneficial therapies and interventions throughout hospitalization, but preferential recruitment of patients with lower-risk features may limit the external validity of trial results.

Willingness to participate in cardiac trials.

The elderly, women, and minorities are all less likely to be enrolled in randomized clinical trials (RCTs). Whether differential patient interest in RCTs contributes to these disparities is unclear. The authors surveyed 660 patients willingness to consider two potential cardiac RCTs of medical therapy vs. percutaneous coronary angioplasty or coronary artery bypass surgery, respectively. The cohorts mean age was 67 years (43% aged >or=70 years; 35% women; and 28% nonwhite). Compared with younger patients, those aged >or=70 years were equal or more likely to consider both the percutaneous coronary angioplasty (46% vs. 41%) and coronary artery bypass surgery RCTs (35% vs. 31%). Race also had no significant impact on trial enrollment, yet women were significantly less likely than men to participate in either RCT. In conclusion, patient willingness to consider RCT participation does not explain underenrollment of elderly and minority patients. Women, however, were more reluctant to consider RCTs, an area requiring further study.

Effect of cardiac rehabilitation on functional outcomes after coronary revascularization.

BACKGROUND: Current guidelines recommending cardiac rehabilitation (CR) after coronary revascularization are largely based on early studies that evaluated only a subset of the population and failed to assess the impact of CR on a patient's perception of their functional status. The main objective of this study was to evaluate the impact of CR in a diverse contemporary population on patient functional outcomes. METHODS: We studied the effect of CR on 6-month SF-36 Physical Functioning (PF) in 700 patients (mean age 67 +/- 11 years, 37% women) who underwent coronary bypass grafting or percutaneous intervention from August 1998 to July 2000. RESULTS: Overall CR participation was 24%. At baseline, CR participants had higher PF (mean 62.5 vs 52.5, P <.001). After adjusting for baseline clinical variables and PF score, CR was associated with significant improvement in 6-month PF (+5.0, 95% CI 1.0-9.0). This improvement was observed in all patient subgroups, but tended to be greater in magnitude in men versus women, patients aged <70 years versus > or =70 years, and patients with coronary bypass grafting versus patients with percutaneous intervention. CR participants also tended to be more likely to engage in regular exercise (63% vs 55%, P =.06) and modify their diet (82% vs 73%, P =.07). Rates of rehospitalization and repeat revascularization were similar among CR participants and nonparticipants. CONCLUSIONS: CR after coronary revascularization is associated with improved functional outcomes and adoption of secondary preventive measures. Innovative strategies to facilitate CR enrollment and tailoring programs to better address the needs of all patient subgroups would extend these benefits to more eligible patients.