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.

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.

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.

Ischaemic symptoms, quality of care and mortality during myocardial infarction.

OBJECTIVE: To study in myocardial infarction (MI) whether documentation of ischaemic symptoms is associated with quality of care and outcomes, and to compare patient reports of ischaemic symptoms during interviews with chart documentation. DESIGN: Observational acute MI study from 2003 to 2004 (Prospective Registry Evaluating Myocardial Infarction: Event and Recovery). SETTING: 19 diverse US hospitals. PATIENTS: 2094 consecutive patients with MI (10 911 patients screened; 3953 patients were eligible and enrolled) with both positive cardiac enzymes and other evidence of infarction (eg, symptoms, electrocardiographic changes). Transferred patients and those with confounding non-cardiac comorbidity were not included (n = 1859). MAIN OUTCOME MEASURES: Quality of care indicators and adjusted in-hospital survival. RESULTS: The records of 10% of all patients with MI (217/2094) contained no documented ischaemic symptoms at presentation. Patients without documented symptoms were less likely (p<0.05) to receive aspirin (89% vs 96%) or beta-blockers (77% vs 90%) within 24 hours, reperfusion therapy for ST-elevation MI (7% vs 58%) or to survive their hospitalisation (adjusted odds ratio = 3.2, 95% CI 1.8 to 5.8). Survivors without documented symptoms were also less likely (p<0.05) to be discharged with aspirin (87% vs 93%), beta-blockers (81% vs 91%), ACE/ARB (67% vs 80%), or smoking cessation counselling (46% vs 66%). In the subset of 1356 (65%) interviewed patients, most of those without documented ischaemic symptoms (75%) reported presenting symptoms consistent with ischaemia. CONCLUSIONS: Failure to document patients' presenting MI symptoms is associated with poorer quality of care from admission to discharge, and higher in-hospital mortality. Symptom recognition may represent an important opportunity to improve the quality of MI care.

Impact of obesity on disease-specific health status after percutaneous coronary intervention in coronary disease patients.

OBJECTIVE: Several investigators have focused on obesity as a specific risk factor for mortality in patients undergoing bypass surgery, but few have examined it as a risk factor among patients undergoing percutaneous coronary interventions (PCI). In addition, none have evaluated the impact of obesity on post-PCI quality of life or disease-specific health status. This study examined whether obesity is a risk factor for poor quality of life or diminished health status 12-months postprocedure among a large cohort of PCI patients. RESEARCH METHODS AND PROCEDURES: A total of 1631 consecutive PCI patients were enrolled into the study and classified as underweight (BMI <20 kg/m2), normal weight range (BMI >/=20 and <25 kg/m2), overweight (BMI >/=25 and <30 kg/m2), class I obese (BMI >/=30 kg/m2), or class II and III obese (BMI >/=35 kg/m2). The 12-month postprocedure outcomes included need for repeat procedure, survival, quality of life and health status, assessed using the Seattle Angina Questionnaire (SAQ) and the Short Form-12. RESULTS: Obese patients with and without a history of revascularization were significantly younger than overweight, normal weight range, or underweight patients at the time of PCI. However, obese patients demonstrated similar long-term recovery and improved disease-specific health status and quality of life when compared to patients in the normal weight range after PCI. In addition, mortality and risk for repeat procedure was similar to those patients in the normal weight range patients at 12-months postrevascularization. Underweight patients who had no previous history of revascularization reported lower quality of life (F=3.02; P=0.018) and poorer physical functioning (F=2.82; P=0.024) than other BMI groups. CONCLUSION: Obese patients presenting for revascularization were younger when compared to patients in the normal weight range, regardless of previous history of revascularization. However, weight status was not a significant predictor of differences in long-term disease-specific health status, quality of life, repeat procedures, or survival. Underweight patients demonstrated less improvement in quality of life and physical functioning than other BMI groups.

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.

Electronic collection of health-related quality of life data: validity, time benefits, and patient preference.

This study sought to validate World Wide Web-compliant software tools used to collect health-related quality of life (HRQOL) data, relative to pencil-and-paper collection. The RAND-36 general health survey and the Seattle Angina questionnaire (SAQ), a disease-specific functional status measure for patients with coronary artery disease, were each administered in paper and electronic format to 55 consecutive patients visiting the cardiology outpatient clinic of a public hospital. All eight sub-scale scores of the RAND-36 (interclass correlation coefficient range = 0.54-0.75, p < 0.01) and all five domains of the SAQ (interclass correlation coefficient range = 0.84-0.90, p < 0.01) collected using the software were significantly correlated with those collected using the paper version of questionnaires. Computer literacy, educational level, age, sex, and race were not significantly associated with the ability to successfully complete the computer-assisted questionnaire. Eighty-two percent of patients preferred the computer-assisted administration to paper, and 89% reported that they would feel comfortable using the software in the future without any technical assistance. This pilot study suggests that HRQOL measures can be reliably collected using software operating over the World Wide Web. Data collected in this manner are valid and of comparable quality to self-reported, HRQOL data obtained via paper survey.

Integrating baseline health status data collection into the process of care.

BACKGROUND: Health status data are an increasingly important component of outcomes assessment and can be used to facilitate quality assessment and improvement efforts. An enormous challenge to the use of health status data among hospitalized patients, however, is collecting baseline data at the time of treatment, an essential component for risk-adjusting subsequent outcomes. The Mid America Heart Institute of Saint Luke's Hospital (Kansas City, Mo), attempted to integrate the collection of health status assessments within the process of performing coronary revascularization. THE DATA COLLECTION STRATEGY: The data collection strategy was developed for each admission portalelective outpatients (admissions for same-day procedures), inpatients, and emergent cases. Health status data were collected on all patients with coronary artery disease who were receiving a percutaneous coronary intervention or coronary artery bypass graft with no disruption to physician scheduling or nursing staff. RESULTS: In general, patients were agreeable to completing the health status survey. Despite initial efforts to educate the hospital staff about the goal and purpose of health status assessment, staff members who were unaware of the uses of these data seemed to minimize their value. Providing examples of how to use these data relative to the staff member's specific occupational role facilitated buy-in for this project. EPILOGUE: After the pilot study, which lasted until June 1999, data were continually collected for 18 months, through August 2000, even with the cessation of external grant funding for this project. Baseline data collection finally stopped, primarily because of a failure to accommodate data collection into the routine flow of patient care by existing nursing staff.

Testing the effectiveness of converting patients to long-acting antianginal medications: The Quality of Life in Angina Research Trial (QUART).

OBJECTIVE: Our purpose was to test the hypothesis that converting patients with stable angina to long-acting antianginal medications would improve their functional status, symptom control, treatment satisfaction, and quality of life. METHODS AND RESULTS: A single-blind randomized trial of 100 patients with stable coronary artery disease was performed in the outpatient clinic of a Veterans Affairs Health System. Outpatients with chronic stable angina taking at least 2 antianginal medications were studied. Patients were randomized to one of two treatments: optimal adjustment of their usual antianginal medications or conversion to solely long-acting medications (long-acting diltiazem +/- nitroglycerin patches +/- atenolol) with subsequent optimization. The primary outcome was the 3-month change in Seattle Angina Questionnaire scores. Although no differences in physical limitation scores were noted, patients randomized to receive long-acting medications had improved symptom control (3-month improvement in anginal stability [19.1 vs 5.6, P =.02] and anginal frequency [17.8 vs 5.5, P =.006]), more treatment satisfaction (3-month improvement of 8.2 vs 3.0, P =.057), and better quality of life (3-month improvement of 11.2 vs 5.6, P =.09) compared with patients whose pretrial medications were optimized. The improvement in symptom control was statistically significant. CONCLUSION: Converting patients with chronic, stable angina to long-acting antianginal medications resulted in substantial improvements in symptom control with a trend toward better treatment satisfaction and quality of life.

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.

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.

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.

Association between depression and worse disease-specific functional status in outpatients with coronary artery disease.

BACKGROUND: The objective of this study was to determine if depression is associated with worse disease-specific functional status in patients with coronary artery disease. The study was designed as a cross-sectional survey and 3-month longitudinal cohort. METHODS AND RESULTS: The study took place in outpatient clinics of 3 Veterans Administration hospitals. All 7282 enrollees were surveyed and 4560 (62.6%) returned baseline questionnaires, including a screening instrument for depression. Thirty-nine percent (n = 1793) reported evidence of coronary artery disease and 1282 patients (71.5%) returned the Seattle Angina Questionnaire; 1025 patients (80%) completed a subsequent 3-month series of instruments. Main outcome measures used were the Seattle Angina Questionnaire, a valid, reliable, and responsive disease-specific functional status measure for patients with coronary disease, and the Mental Health Inventory, a mental health screening instrument from the Short Form-36. Mental Health Inventory evidence of depression was associated with significantly worse disease-specific functional status. Depressed patients had more physical limitation (mean difference in Seattle Angina Questionnaire score = 16.9, P <.001), more frequent angina (mean difference in Seattle Angina Questionnaire score = 9.5, P <.001), less satisfaction with their treatment for coronary artery disease (mean difference in Seattle Angina Questionnaire score = 9.9, P <.001), and lower perceived quality of life (mean difference in Seattle Angina Questionnaire score = 16.3, P <.001) than nondepressed patients. Frequency of depressive symptoms demonstrated an inverse relation with cardiac-specific functional status and when patients' depression status changed over time, so did their cardiac-specific health status. CONCLUSIONS: Depression is associated with significantly more physical limitation, more frequent angina, less treatment satisfaction, and lower perceived quality of life in outpatients with coronary artery disease.

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.

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.