Baseline Quality-of-Life of Caregivers of Patients With Heart Failure Prior to Advanced Therapies: Findings From the Sustaining Quality of Life of the Aged: Transplant or Mechanical Support (SUSTAIN-IT) Study.

BACKGROUND: We compared health-related quality of life (HRQOL), depressive symptoms, anxiety, and burden in caregivers of older patients with heart failure based on the intended therapy goal of the patient: awaiting heart transplantation (HT) with or without mechanical circulatory support (MCS) or prior to long-term MCS; and we identified factors associated with HRQOL. METHODS: Caregivers (n = 281) recruited from 13 HT and MCS programs in the United States completed measures of HRQOL (EQ-5D-3L), depressive symptoms (PHQ-8), anxiety (STAI-state), and burden (Oberst Caregiving Burden Scale). Analyses included ANOVA, Kruskal-Wallis tests, χ2 tests, and linear regression. RESULTS: The majority of caregivers were female, white spouses with ≤ 2 comorbidities, median [Q1,Q3] age = 62 [57.8, 67.0] years. Caregivers (HT with MCS = 87, HT without MCS = 98, long-term MCS = 96) reported similarly high baseline HRQOL (EQ-5D-3L visual analog scale median score = 90; P = 0.67 for all groups) and low levels of depressive symptoms. STAI-state median scores were higher in the long-term MCS group vs the HT groups with and without MCS, (38 vs 32 vs 31; P < 0.001), respectively. Burden (task: time spent/difficulty) differed significantly among groups. Caregiver factors (number of comorbidities, diabetes and higher anxiety levels) were significantly associated with worse caregiver HRQOL, R2 = 26%. CONCLUSIONS: Recognizing caregiver-specific factors, including comorbidities and anxiety, associated with the HRQOL of caregivers of these older patients with advanced HF may guide support strategies.

Clinical outcomes associated with proton pump inhibitor use among clopidogrel-treated patients within CYP2C19 genotype groups following acute myocardial infarction.

We examined clinical outcomes with proton pump inhibitors (PPI) use within CYP2C19 genotype groups during clopidogrel treatment following acute myocardial infarction (AMI). 2062 patients were genotyped for CYP2C19*2 and *17 variants in TRIUMPH. 12 month clinical outcomes were analyzed among patients discharged on clopidogrel within CYP2C19*2 carrier, CYP2C19*17 carrier, and CYP2C19*1 homozygote genotype groups. PPI use was not associated with a difference in mortality. Among clopidogrel-treated Caucasians following AMI, PPI use was associated with a significantly higher rate of cardiac rehospitalization (HR 1.62, 95% CI 1.19-2.19; P=0.002) compared with no PPI use. PPI users who were carriers of the CYP2C19*17 variant experienced significantly higher rates of cardiac rehospitalization (HR 2.05, 95% CI 1.26-3.33; P=0.003), carriers of the CYP2C19*2 variant had a trend toward increased 1-year cardiac rehospitalization (HR 1.69, 95% CI 0.95-2.99; P=0.07), while no significant differences were observed among CYP2C19*1 homozygotes. These results indicate that the risks associated with PPI use among clopidogrel-treated Caucasian post-MI patients are impacted by CYP2C19 genotype, and suggest knowledge of genotype may be useful for personalizing PPI use among patients following AMI to reduce rehospitalization.

Peripheral artery questionnaire improves ankle brachial index screening in symptomatic patients with peripheral artery disease.

AIM: The peripheral artery questionnaire (PAQ) is a disease-specific health status measure of patients with peripheral artery disease (PAD). Whether the PAQ scores are associated with a PAD diagnosis among patients with symptoms suspicious for PAD is unknown and could help increase the pretest probability of ankle brachial index (ABI) screening among patients with suspicious symptoms. METHODS: The PAQ was completed by 567 patients evaluated for potential intermittent claudication at six tertiary centres. Demographics, medical history, physical examination findings and the PAQ domain scores were compared with ABI. A diagnostic threshold < 0.90 for a PAD diagnosis was assessed with a ROC of PAQ scores. The correlation between the PAQ Summary Score and ABI was also calculated. RESULTS: The PAQ Summary Score was significantly lower in patients with low ABI as compared with those having a normal ABI (37.6 ± 19.0 vs. 70.1 ± 22.7, p < 0.001). The PAQ Summary Score and ABI were highly correlated (r = 0.56, p < 0.001) and the optimal PAQ Summary Score for predicting low ABI was 50.3 (AUC = 0.86, sensitivity 80.3%, specificity 78.3%). CONCLUSIONS: The PAQ Summary Score was associated with an increased likelihood of PAD in patients with suspected PAD symptoms, and a low summary score (≤ 50.3) was an optimal threshold for predicting PAD among patients referred for ABI.

Prevalence and predictors of persistent health status impairment in patients referred to a vascular clinic with intermittent claudication.

BACKGROUND: The goal of treatment for lower extremity peripheral artery disease is often to improve health status. Factors associated with failure to improve are unknown. METHODS: Health status was assessed with the Peripheral Artery Questionnaire (PAQ) at baseline and 2 years in 344 patients referred to vascular clinics. Improvement was defined as an increase of ≥5 points on the PAQ Summary Score. Multivariable logistic regression identified patient and treatment characteristics associated with impaired baseline health status, and predictors of no improvement (<5 points). RESULTS: Older age, bilateral symptoms, female sex and prior revascularization were associated with impaired baseline health status. At 2 years 36% reported unimproved health status. Factors associated with no improvement were older age (Odds Ratio 1.67/decade, CI 1.28, 2.19), better baseline health status (OR 1.40/10-points, CI 1.24, 1.59), beta blocker use (OR 2.53, CI 1.37, 4.68), prior stroke (OR 4.12, CI 1.33, 12.77) and bilateral claudication (OR 1.79, CI 1.07, 2.99). SUMMARY: Older patients, women, and those with bilateral symptoms or prior revascularization have worse health status at vascular referral. Over 1/3 of patients' health status did not improve over 2 years; older patients and those with bilateral or milder symptoms, prior stroke or using beta blockers were less likely to improve.

Further validation of the peripheral artery questionnaire: results from a peripheral vascular surgery survey in the Netherlands.

OBJECTIVES: Peripheral arterial disease (PAD) is associated with adverse cardiovascular events and can significantly impair patients' health status. Recently, marked methodological improvements in the measurement of PAD patients' health status have been made. The Peripheral Artery Questionnaire (PAQ) was specifically developed for this purpose. We validated a Dutch version of the PAQ in a large sample of PAD patients. DESIGN: Cross-sectional study. METHODS: The Dutch PAQ was completed by 465 PAD patients (70% men, mean age 65+/-10 years) participating in the Euro Heart Survey Programme. Principal components analysis and reliability analyses were performed. Convergent validity was documented by comparing the PAQ with EQ-5D scales. RESULTS: Three factors were discerned; Physical Function, Perceived Disability, and Treatment Satisfaction (factor loadings between 0.50 and 0.90). Cronbach's alpha values were excellent (mean alpha=0.94). Shared variance of the PAQ domains with EQ-5D scales ranged from 3 to 50%. CONCLUSIONS: The Dutch PAQ proved to have good measurement qualities; assessment of Physical Function, Perceived Disability, and Treatment Satisfaction facilitates the monitoring of patients' perceived health in clinical research and practice. Measuring disease-specific health status in a reliable way becomes essential in times were a wide array of treatment options are available for PAD patients.

Multiple differences between patients who initiate fish oil supplementation post-myocardial infarction and those who do not: the TRIUMPH Study.

The utility of fish oil supplements (FOS) in patients who survive an acute myocardial infarction (MI) remains controversial, with randomized trials showing less benefit than observational studies would suggest. The differences in the characteristics of MI patients who use FOS in routine clinical care are unknown but may help explain this discrepancy. We used data from a 24-site registry study in which extensive information was available on 4340 MI patients at admission and 1, 6, and 12 months postdischarge. After excluding those using FOS at admission (n = 651), those who died before the 1-month follow-up visit (n = 63), and those with missing data at 1 month (n = 1228), 2398 remained. Of them, 377 (16%) started FOS within 1 month of their MI. We analyzed 53 patient characteristics associated with FOS use. We observed differences (P < .001) in 20 demographic, socioeconomic, treatment, disease severity, and health status domains. The FOS users were more likely than nonusers to be white, married, financially secure, highly educated, and eating fish. They also had a higher ejection fraction at discharge, were more likely to have had in-hospital percutaneous coronary interventions, and were more likely to have participated in cardiac rehabilitation programs. The FOS users were less likely to have a history of diabetes, alcohol abuse, stroke, MI, and angina. In conclusion, post-MI patients who initiate FOS within 1 month of discharge in routine clinical practice differ substantially from those who do not. These differences are strongly associated with a better post-MI prognosis and may illuminate several sources of unmeasured confounding in observational studies.

Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure.

OBJECTIVES: To create a valid, sensitive, disease-specific health status measure for patients with congestive heart failure (CHF). BACKGROUND: Quantifying health status is becoming increasingly important for CHF. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a new, self-administered, 23-item questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. METHODS: To establish the performance characteristics of the KCCQ, two distinct patient cohorts were recruited: 70 stable and 59 decompensated CHF patients with ejection fractions of <40. Upon entry into the study, patients were administered the KCCQ, the Minnesota Living with Heart Failure Questionnaire and the Short Form-36 (SF-36). Questionnaires were repeated three months later. RESULTS: Convergent validity of each KCCQ domain was documented by comparison with available criterion standards (r = 0.46 to 0.74; p < 0.001 for all). Among those with stable CHF who remained stable by predefined criteria (n = 39), minimal changes in KCCQ domains were detected over three months of observation (mean change = 0.8 to 4.0 points, p = NS for all). In contrast, large changes in score were observed among patients whose decompensated CHF improved three months later (n = 39; mean change = 15.4 to 40.4 points, p < 0.01 for all). The sensitivity of the KCCQwas substantially greater than that of the Minnesota Living with Heart Failure and the SF-36 questionnaires. CONCLUSIONS: The KCCQis a valid, reliable and responsive health status measure for patients with CHF and may serve as a clinically meaningful outcome in cardiovascular research, patient management and quality assessment.

Length of hospital stay after acute myocardial infarction in the Myocardial Infarction Triage and Intervention (MITI) Project registry.

OBJECTIVES: This study sought to identify current trends in length of stay in patients with an acute myocardial infarction and to evaluate which demographic, clinical, procedural and hospital-related factors explain the variation and reduction in length of stay observed during the study period. BACKGROUND: Hospital length of stay is an important contribution to cost of care. Previous studies of length of stay after acute myocardial infarction have been performed largely on administrative data bases and do not reflect current practice patterns. METHODS: We used univariate and multivariate models to evaluate which demographic, clinical and administrative factors influenced length of stay in 11,932 patients with acute myocardial infarction admitted to 19 Seattle-area hospitals between 1988 and 1994. RESULTS: Length of hospital stay decreased from (mean +/- SD) 8.5 +/- 8.2 to 6.0 +/- 5.8 days during the study period. Demographic and clinical characteristics known at the time of admission explained only 6% of variation in length of stay, whereas hospital complications, procedure use and type of admitting hospital explained an additional 27% of variation. The use of primary angioplasty and early diagnostic coronary angiography predicted a shorter length of stay; however, none of the measured variables explained the 29% reduction in length of stay that occurred between 1988 and 1994. CONCLUSIONS: Although hospital complications, procedure use and hospital characteristics are important predictors of length of hospital stay, none of these factors explains the 29% reduction in length of stay observed in postmyocardial infarction patients between 1988 and 1994. It is likely that unmeasured economic and administrative factors play important roles in influencing hospital length of stay.

Development and evaluation of the Seattle Angina Questionnaire: a new functional status measure for coronary artery disease.

OBJECTIVES: This study sought to establish the validity, reproducibility and responsiveness of the Seattle Angina Questionnaire, a 19-item self-administered questionnaire measuring five dimensions of coronary artery disease: physical limitation, anginal stability, anginal frequency, treatment satisfaction and disease perception. BACKGROUND: Assessing the functional status of patients is becoming increasingly important in both clinical research and quality assurance programs. No current functional status measure quantifies all of the important domains affected by coronary artery disease. METHODS: Cross-sectional or serial administration of the Seattle Angina Questionnaire was carried out in four groups of patients: 70 undergoing exercise treadmill testing, 58 undergoing coronary angioplasty, 160 with initially stable coronary artery disease and an additional 84 with coronary artery disease. Evidence of validity was sought by comparing the questionnaire's five scales with the duration of exercise treadmill tests, physician diagnoses, nitroglycerin refills and other validated instruments. Reproducibility and responsiveness were assessed by comparing serial responses over a 3-month interval. RESULTS: All five scales correlated significantly with other measures of diagnosis and patient function (r = 0.31 to 0.70, p < or = 0.001). Questionnaire responses of patients with stable coronary artery disease did not change over 3 months. The questionnaire was sensitive to both dramatic clinical change, as seen after successful coronary angioplasty, and to more subtle clinical change, as seen among outpatients with initially stable coronary artery disease. CONCLUSIONS: The Seattle Angina Questionnaire is a valid and reliable instrument that measures five clinically important dimensions of health in patients with coronary artery disease. It is sensitive to clinical change and should be a valuable measure of outcome in cardiovascular research.

The influence of clinical risk factors on the use of angiography and revascularization after acute myocardial infarction. Myocardial Infarction Triage and Intervention Project Investigators.

BACKGROUND: Coronary revascularization provides the greatest survival advantage in those patients with the greatest mortality risk. This study examines the relationship between variables that predict mortality and the use of angiography and revascularization after acute myocardial infarction. METHODS: Study of 4823 survivors of acute myocardial infarction, who underwent angiography between 6 hours and 5 days of admission, to determine the relationship between factors that predict mortality and the use of angiography (n = 2274), angioplasty (n = 692), and bypass surgery (n = 469). RESULTS: Except for recurrent angina, clinical factors that predict higher mortality were associated with a lower use of angiography (the multivariable adjusted odds ratio was 0.47 for older age, 0.85 for a history of infarction, 0.50 for patients not receiving thrombolytic medications, 0.64 for new heart failure, and 2.75 for recurrent angina [P < .001 for all factors]). A similar relationship was observed among patients selected for angioplasty (the odds ratio was 0.51 for an ejection fraction of < 40%, 0.72 for those patients not receiving thrombolytic medications, 0.74 for a history of infarction, and 1.94 for recurrent angina [P < .001 for all factors]). In contrast, patients with unfavorable prognostic profiles were much more likely to undergo coronary bypass surgery (the odds ratio was 1.46 for recurrent angina, 1.28 for older age groups, 2.23 for new heart failure, 1.28 for patients not receiving thrombolytic medications, and 1.46 for a history of infarction [P < .001 for all factors]). CONCLUSIONS: These data suggest that aside from symptoms of recurrent angina, the use of angiography and angioplasty is not driven by mortality risk stratification. In contrast, bypass surgery is preferentially performed in patients at increased risk for mortality.

Transmyocardial CO(2) laser revascularization improves symptoms, function, and quality of life: 12-month results from a randomized controlled trial.

PURPOSE: To describe differences in health status (symptoms, physical function, and quality of life) between continued medical management and transmyocardial revascularization with a carbon dioxide laser in patients with severe, symptomatic, inoperable coronary artery disease. SUBJECTS AND METHODS: This prospective, multicenter trial randomized 98 patients to transmyocardial revascularization and 99 to continued medical therapy. Health status was assessed with the Seattle Angina Questionnaire and the Short Form-36 at baseline and at 3, 6, and 12 months. A new analytic technique, the benefit statistic, was developed to facilitate interpretability of disease-specific health status assessments over time. RESULTS: Of the 99 patients assigned to medical therapy, 59 (60%) subsequently underwent transmyocardial revascularization. By an intention-to-treat analysis, patients initially randomized to transmyocardial revascularization had 44% of their angina eliminated versus 21% for the medical treatment group (difference = 23%; 95% confidence interval [CI], 11% to 34%). Differences in the benefits of transmyocardial revascularization on physical limitations (33% vs 11% in the medical arm [difference = 23%; 95% CI, 15% to 31%]) and quality of life (47% vs 20% in the medical arm [difference = 26%; 95% CI, 18% to 35%]) were similarly large. These benefits were apparent at 3 months and sustained throughout the 1 year of follow-up. An efficacy analysis that excluded patients who crossed over from the medical treatment to transmyocardial revascularization arm suggested greater treatment benefits. CONCLUSIONS: Transmyocardial revascularization may offer a valuable palliative alternative to patients with severe limitations in health status for whom no standard revascularization options exist.

Five-year prospective study of the effects of anxiety and depression in patients with coronary artery disease.

Anxiety and depression have significant and widespread effects on daily function and symptoms of patients with coronary artery disease over a 5-year period. This may partially explain why results of treadmill stress testing and angiography poorly predict the daily functioning of patients with coronary artery disease.

Monitoring the quality of life in patients with coronary artery disease.

Monitoring the outcomes of treatment and quantifying patients' functional status have assumed a prominent role in both clinical trials and quality assurance programs. Because patients with coronary artery disease (CAD) may have comorbid illnesses, and because generic health status questionnaires may not focus on symptoms and impairments unique to coronary disease, a generic measure of health status may not be sufficient to detect important changes in patients' CAD. The responsiveness to clinical change of the Seattle Angina Questionnaire (SAQ), a disease-specific measure for CAD, was compared with that of the Short Form-36, a generic measure of health status. Both questionnaires were serially administered, 3 months apart, to 45 patients undergoing coronary angioplasty and to 130 patients with stable CAD. Most scales of both questionnaires improved significantly after coronary angioplasty. The responsiveness statistics of the SAQ exceeded those of the Short Form-36. Among 130 patients with initially stable angina, 33 deteriorated, 79 remained stable, and 18 improved over 3 months of observation. Mean SAQ scores changed significantly and appropriately in each of these groups. In contrast, none of the Short Form-36 scales detected these more subtle changes. Although useful in assessing overall function, a generic health status measure, such as the Short Form-36, may not be responsive enough to detect important clinical changes in patients' CAD. A disease-specific instrument, such as the SAQ, can be an important and relevant outcome measure in clinical trials or quality assurance programs.

Economics, health-related quality of life, and cost-effectiveness methods for the TACTICS (Treat Angina With Aggrastat [tirofiban]] and Determine Cost of Therapy with Invasive or Conservative Strategy)-TIMI 18 trial.

Concern over escalating health care costs has led to increasing focus on economics and assessment of outcome measures for expensive forms of therapy. This is being investigated in the Treat Angina With Aggrastat [tirofiban] and Determine Cost of Therapy with Invasive or Conservative Strategy (TACTICS)-TIMI 18 trial, a randomized trial comparing outcome of patients with unstable angina or non-Q-wave myocardial infarction treated with tirofiban and then randomized to an invasive versus a conservative strategy. Hospital and professional costs initially and over 6 months, including outpatient costs, will be assessed. Hospital costs will be determined for patients in the United States from the UB92 formulation of the hospital bill, with costs derived from charges using departmental cost to charge ratios. Professional costs will be determined by accounting for professional services and then converted to resource units using the Resource Based Relative Value Scale and then to costs using the Medicare conversion factor. Follow-up resource consumption, including medications, testing and office visits, will be carefully measured with a Patient Economic Form, and converted to costs from the Medicare fee schedule. Health-related quality of life will be assessed with a specific instrument, the Seattle Angina Questionnaire, and a general instrument, the Health Utilities Index at baseline, 1, and 6 months. The Health Utilities Index will also be used to construct a utility. By knowing utility and survival, quality-adjusted life years will be determined. These measures will permit the performance of a cost-effectiveness analysis, with the cost-effectiveness of the invasive strategy defined and the difference in cost between the invasive and conservative strategies divided by the difference in quality-adjusted life years. The economic and health-related quality of life aspects of TACTICS-TIMI 18 are an integral part of the study design and will provide a comprehensive understanding of the impact of invasive versus conservative management strategies on a broad range of outcomes after hospitalization for unstable angina or non-Q-wave myocardial infarction.

Comparison of three quality of life instruments in stable angina pectoris: Seattle Angina Questionnaire, Short Form Health Survey (SF-36), and Quality of Life Index-Cardiac Version III.

Three instruments for the assessment of quality of life, the Seattle Angina Questionnaire (SAQ), the Short Form Health Survey (SF-36), and the Quality of Life Index-Cardiac Version III (QLI) were administered to 107 patients with stable angina pectoris in a longitudinal randomized trial comparing the use of alternative anginal medications in the management of chronic stable angina pectoris. This study demonstrated that differences in angina severity as measured by the Canadian Cardiovascular Society Classification (CCSC) were related to each of the SAQ subscales, to selected subscales of the SF-36, but not to the QLI. All quality of life (QOL) instruments demonstrated acceptable test-retest reliability when administered over a 2-week interval. Neither the SF-36 nor the QLI were discriminative of angina severity or sensitive to changes in CCSC angina classification. Both the SAQ and QLI detected changes in heart disease related QOL over time.

A new self-administered questionnaire to monitor health-related quality of life in patients with COPD. Ambulatory Care Quality Improvement Project (ACQUIP) Investigators.

STUDY OBJECTIVE: To develop and validate a brief, computer-scannable, self-administered questionnaire to monitor health-related quality of life in patients with COPD. The Seattle Obstructive Lung Disease Questionnaire (SOLQ) consists of 29 items measuring four health dimensions: physical function, emotional function, coping skills, and treatment satisfaction. METHODS: A series of studies was performed to assess reliability, validity, and responsiveness. Internal consistency was measured using a cross-sectional survey of 203 COPD patients. Reproducibility was tested over a 4-month interval among 97 patients with self-reported stable conditions. To assess construct validity, SOLQ scales were correlated with corresponding Chronic Respiratory Disease Questionnaire (CRDQ) scales, the COPD Self-Efficacy Scale (CSES), percent predicted FEV1, and 6-min walk test. Treatment satisfaction scores of 920 subjects were correlated with a general measure of patient satisfaction. Baseline and follow-up scores of subjects were compared to assess treatment responsiveness. RESULTS: SOLQ scales were reliable (Cronbach's alpha 0.79 to 0.93, and intraclass correlation coefficients 0.64 to 0.87). Change in SOLQ scores correlated with corresponding CRDQ scales: dyspnea, r=0.42; emotional burden, r=0.49; mastery, r=0.36. Coping skills correlated highly with CSES, r=0.93. Treatment satisfaction correlation was r=0.54. Significant changes occurred in all three scales postintervention. CONCLUSION: The SOLQ is a reliable, valid, and responsive measure of physical and emotional function, coping skills, and treatment satisfaction. Brief, self-administered, and computer scannable, it is useful in monitoring long-term outcomes among large groups of COPD patients.

Washington State's model of physician leadership in cardiac outcomes reporting.

BACKGROUND: In 1993, the cardiac surgery community in Washington State opposed an effort by the state Health Care Authority (HCA) to identify "centers of excellence" for selective contracting of coronary artery bypass grafting (CABG) procedures, and proposed an alternate model that would create a statewide cardiac outcomes registry under physician governance to be used by all institutions for internal quality improvement activities. METHODS: A prospective pilot data collection effort, which examined preoperative and postoperative patient-reported health status, served as the basis for evaluating the capacity of a physician-led organization to develop a collaborative atmosphere and facilitate universal hospital participation. RESULTS: A surgical steering group met on a regular basis and reached consensus on governance issues, protocols for standardized data collection, and policies regarding data dissemination. All 14 centers that performed bypass surgery in the state participated. Patients who were surveyed reported statistically significant improvements in physical, emotional, and anginal-specific health status after bypass surgery. Baseline patient characteristics and longitudinal outcomes were compared across institutions. CONCLUSIONS: Based on the feasibility of this collaborative outcomes reporting program, the HCA revised its policy regarding selective contracting and has helped to support an ongoing physician-led and -governed cardiac outcomes reporting system that is particularly notable for the subsequent integration of both CABG surgery and catheterization-based procedures into one standardized registry.

Review of available instruments and methods for assessing quality of life in anti-anginal trials.

Collection of patient-centred health status is a method for quantifying patient outcome in the context of clinical trials for the treatment of coronary artery disease (CAD). Traditional clinical trial end-points, such as morbidity and mortality, fail to adequately measure the health-related outcomes of disease states for which death is a rare occurrence. Health-related quality of life (QOL) and functional status surveys allow measurement of the general, and/or disease-specific, health-related limitations experienced by patients. Measures of patient preference, in turn, quantify the effects these health-related limitations have on the overall value patients ascribe to their current health state. Together, these outcomes measures may provide a more accurate appraisal of the benefit conferred by treatment. Currently, selection of the appropriate outcomes measures and methodological approaches for a clinical trial is complicated by the lack of consensus on a single quality of life measure for use with patients with (CAD). This article outlines the use of QOL measures in anti-anginal trials done to date and summarises the approaches currently available for assessing QOL, including the differences between psychometric and preference-based techniques, and general and disease-specific health measures. In conclusion, a framework is provided for selecting the appropriate instruments and methodology in the context of the clinical trial.

Native aortic valve tissue systemic embolization complicating bacterial endocarditis.

Systemic embolic events are known complications of bacterial endocarditis. Embolization of prosthetic valves has previously been reported in the literature. We report a case of embolization of native aortic valve tissue to the popliteal artery as the presenting event in a patient with subacute bacterial endocarditis. To our knowledge, this rare complication has not been previously reported.

Outpatient nursing case management for cardiovascular disease.

Case management has been an effective treatment model for maintaining costs while preserving quality of care for vulnerable populations who are frequent care users. Nursing case management has been effective in improving health outcomes in chronically ill populations. Specifically, nurse practitioner care has been as effective, and in some areas, more effective in managing chronic health problems of patients than care provided by physicians. Cardiovascular disease is a chronic condition, often accompanied by long-term symptoms and disability, that is prevalent in the United States population. Outpatient nursing case management for chronic health problems associated with cardiovascular disease is posited as a model for a heavily used system that maintains quality of care in this group.