Publications
PREMIER Registry |
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The Prospective Registry Evaluating Myocardial Infarction: Events and Recovery (PREMIER)--Evaluating the impact of myocardial infarction on patient outcomes Am Heart J 151:589-97, 2006 0 Comments 168 Downloads |
Background More information on the longitudinal care and outcomes of patients after myocardial infarction (MI) is needed to further improve the quality of MI care. The PREMIER study was designed to meet this need. Methods Patients with MI were prospectively screened and enrolled from 19 US centers between January 1, 2003, and June 28, 2004. Consenting patients had detailed chart abstractions of their medical history and processes of inpatient care, supplemented with a detailed, patient-centered interview. Centralized follow-up at 1, 6, and 12 months is being conducted to quantify patients’ postdischarge care and outcomes, with a focus on their health status (symptoms, function, and quality of life). In 2003, detailed chart abstractions, devoid of all personal health information, were collected for patients eligible but not enrolled in PREMIER. Results Of 10911 patients screened, 3953 were eligible and 2498 enrolled into PREMIER. Few clinically significant differences between the total MI population and those enrolled into PREMIER were observed. Adherence to accepted processes of quality care, such as aspirin and h-blockers on admission (96% and 91) or discharge (96 and 93), was high. One-month follow-up rates were high, with only 9 of patients being lost to follow-up. Conclusion PREMIER is a novel registry with detailed insights into patients’ sociodemographic, clinical, and health status characteristics, as well as detailed monitoring of their inpatient and outpatient processes of care. Ultimately, PREMIER will describe patients’ health status outcomes and identify determinants of these outcomes as an important step toward improving MI care. |
Seattle Angina Questionnaire |
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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 J Clin Epidemiol 51(7): 569-575, 1998. 0 Comments 128 Downloads |
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. |
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Electronic collection of health-related quality of life data: validity, time benefits, and patient preference Quality of Life Research 10: 15-22, 2001 0 Comments 30 Downloads |
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 coronay 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 correlated 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. |
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Effect of PCI on Quality of Life in Patients with Stable Coronary Disease N Engl J Med 2008;359:677-87 0 Comments 2 Downloads |
Background It has not been clearly established whether percutaneous coronary intervention (PCI) can provide an incremental benefit in quality of life over that provided by optimal medical therapy among patients with chronic coronary artery disease. Methods We randomly assigned 2287 patients with stable coronary disease to PCI plus optimal medical therapy or to optimal medical therapy alone. We assessed angina-specific health status (with the use of the Seattle Angina Questionnaire) and overall physical and mental function (with the use of the RAND 36-item health survey [RAND-36]). Results At baseline, 22% of the patients were free of angina. At 3 months, 53% of the patients in the PCI group and 42% in the medical-therapy group were angina-free (P<0.001). Baseline mean (±SD) Seattle Angina Questionnaire scores (which range from 0 to 100, with higher scores indicating better health status) were 66±25 for physical limitations, 54±32 for angina stability, 69±26 for angina frequency, 87±16 for treatment satisfaction, and 51±25 for quality of life. By 3 months, these scores had increased in the PCI group, as compared with the medical-therapy group, to 76±24 versus 72±23 for physical limitation (P = 0.004), 77±28 versus 73±27 for angina stability (P = 0.002), 85±22 versus 80±23 for angina frequency (P<0.001), 92±12 versus 90±14 for treatment satisfaction (P<0.001), and 73±22 versus 68±23 for quality of life (P<0.001). In general, patients had an incremental benefit from PCI for 6 to 24 months; patients with more severe angina had a greater benefit from PCI. Similar incremental benefits from PCI were seen in some but not all RAND-36 domains. By 36 months, there was no significant difference in health status between the treatment groups. Conclusions Among patients with stable angina, both those treated with PCI and those treated with optimal medical therapy alone had marked improvements in health status during follow-up. The PCI group had small, but significant, incremental benefits that disappeared by 36 months. (ClinicalTrials.gov number, NCT00007657.) |
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Efficacy of Percutaneous Coronary Intervention on Health Related Quality of Life in Optimally-Treated Stable Coronary Patients - Electronic Supplement N Engl J Med 2008;359:677-87 (electronic supplement) 0 Comments 2 Downloads |
Provides details of definitions of clinically-significant changes for each of the Seattle Angina Questionnaire scales. |
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Development and Evaluation of the Seattle Angina Questionnaire: A New Functional Status Measure for Coronary Artery Disease J Am Coll Cardiol 25(2): 333-41, 1995 3 Comments 583 Downloads |
The Seattle Angina Questionnaire is a 19-item self-administered questionnaire measuring five dimensions of coronary artery disease: physical limitation, anginal stability, anginal frequency, treatment satisfaction and disease perception. 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. All five scales correlated significantly with other measures of diagnosis and patient functions (r = 0.31 to 0.70, p< 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. 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. |
Kansas City Cardiomyopathy Questionnaire |
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Prognostic Value of Health Status in Patients With Heart Failure After Acute Myocardial Infarction Circulation 110: 546-51, 2004. 0 Comments 41 Downloads |
Background Disease-specific health status instruments such as the Kansas City Cardiomyopathy Questionnaire (KCCQ) can quantify symptoms, functional limitations, and quality of life in patients with heart failure. Understanding the relationship between KCCQ scores and prognosis may assist clinicians in both interpreting KCCQ scores and stratifying Methods and Results We examined the prognostic value of the KCCQ in a prospective, international cohort of 1516 patients with heart failure after a recent acute myocardial infarction. We focused on the relationship between the KCCQ overall score (KCCQ-os), measured at the first outpatient visit (4 weeks after enrollment), and subsequent 1-year cardiovascular mortality or hospitalization (n=258, 20.3). KCCQ-os was strongly associated with subsequent cardiovascular events in that those with a score 75 had an 84 1-year event-free survival compared with 59% for those with a score <25 (P<0.001). After demographic and other clinical characteristics were controlled for in multivariable models, KCCQ-os remained strongly associated with outcome (hazard ratio, 2.02; 95% CI, 1.24 to 3.27 for KCCQ-os <25; P<0.001). Conclusions In outpatients with heart failure complicating an acute myocardial infarction, KCCQ-os is strongly associated with subsequent 1-year cardiovascular mortality and hospitalization. Use of the KCCQ in outpatient clinical practice can both quantify patients’ health status and provide insight into their prognosis. |
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Health Status Identifies Heart Failure Outpatients at Risk for Hospitalization or Death JACC 47(4): 752-6, 2006. 0 Comments 58 Downloads |
Objectives We tested the hypothesis that one health status measure, the Kansas City Cardiomyopathy Questionnaire (KCCQ), provides prognostic information independent of other clinical data in outpatients with heart failure (HF). Background Health status measures are used to describe a patient’s clinical condition and have been shown to predict mortality in some populations. Their prognostic value may be particularly useful among patients with HF for identifying candidates for disease management in whom increased care may reduce hospitalizations and prevent death. Methods We evaluated 505 HF patients from 13 outpatient clinics who had an ejection fraction 40% using the KCCQ summary score. Proportional hazards regression was used to evaluate the association between the KCCQ summary score (range, 0 to 100; higher scores indicate better health status) and the primary outcome of death or HF admission, adjusting for baseline patient characteristics, 6-min walk distance, and B-type natriuretic peptide (BNP). Results The mean age was 61 years, 76% of patients were male, 51% had an ischemic HF etiology, and 5% were New York Heart Association functional class IV. At 12 months, among the 9% of patients with a KCCQ score <25, 37% had been admitted for HF and 20% had died, compared with 7% (HF admissions) and 5% (death) of those with a KCCQ score ≥75 (33% of patients, p <0.0001 for both comparisons). In sequential multivariable models adjusting for clinical variables, 6-min walk, and BNP levels, the KCCQ score remained significantly associated with survival free of HF hospitalization. Conclusions A low KCCQ score is an independent predictor of poor prognosis in outpatients with HF. |
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Development and Evaluation of the Kansas City Cardiomyopathy Questionnaire: A New Health Status Measure for Heart Failure J Am Coll Cardiol 35(5): 1245-55, 2000 0 Comments 588 Downloads |
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. 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. 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 KCCQ was substantially greater than that of the Minnesota Living with Heart Failure and the SF-36 questionnaires. The KCCQ is 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. |
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Monitoring clinical changes in patients with heart failure: A comparison of methods Am Heart J 150:707-15, 2005. 0 Comments 183 Downloads |
Background Although monitoring the clinical status of patients with heart failure rests at the core of clinical medicine, the ability of different techniques to reflect clinical change has not been evaluated. This study sought to describe changes in various measures of disease status associated with gradations of clinical change. Methods A prospective, 14-center cohort of 476 outpatients was assessed at baseline and 6 F 2 weeks to compare changes in 7 heart failure measures with clinically observed change. Measures included health status instruments (theKansas City Cardiomyopathy Questionnaire [KCCQ], Short Form-12, and EQ-5D), physician-assessed functional class (New York Heart Association [NYHA]), an exercise test (6-minute walk), patient weight, and a biomarker (B-type natriuretic peptide). Cardiologists, blinded to all measures except weight and NYHA, categorized clinical change ranging from large deterioration to large improvement. Results The KCCQ, NYHA, and 6-minute walk test were most sensitive to clinical change. For patients with large, moderate, and small deteriorations, the KCCQ decreased by 25±16, 17±14, and 5.3±11 points, respectively. For patients with small, moderate, and large improvements, the KCCQ increased by 5.7±16, 10.5±16, and 22.3±16 points, respectively ( P<.01 for all compared with the no change group). New York Heart Association and 6-minute walk distance were significantly different for those with moderate and large changes ( P<.05) but neither revealed a difference between those with small versus no clinical deterioration. The KCCQ had the highest c statistic for monitoring individual patients, followed by NYHA and 6-minute walk. Conclusion The KCCQ, followed by the NYHA and the 6-minute walk test, most accurately reflected clinical change in patients with heart failure. |
Peripheral Artery Questionnaire |
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The Peripheral Artery Questionnaire: A new disease-specific health status measure for patients with peripheral arterial disease Am Heart J 147: 301-8, 2004 0 Comments 132 Downloads |
Background The most common indication for treating patients with peripheral arterial disease is to improve their health status: their symptoms, function, and quality of life. Quantifying health status requires a valid, reproducible, and sensitive disease-specific measure. The Peripheral Artery Questionnaire (PAQ) is a 20-item questionnaire developed to meet this need by quantifying patients’ physical limitations, symptoms, social function, treatment satisfaction, and quality of life. Methods Psychometric and clinical properties of the PAQ were evaluated in a prospective cohort study of 44 patients undergoing elective percutaneous peripheral revascularization. To establish reproducibility, 2 assessments were performed 2 weeks apart and before revascularization. The change in scores before and 6 weeks after revascularization were used to determine the instruments’ responsiveness and were compared with the Short Form-36 and the Walking Impairment Questionnaire. A series of cross-sectional analyses were performed to establish the construct validity of the PAQ. Results The 7 domains of the PAQ were internally reliable, with Cronbach alpha = 0.80 to 0.94. The test-retest reliability analyses revealed insignificant mean changes of 0.6 to 2.3 points (P = not significant for all). Conversely, the change after revascularization ranged from 13.7 to 41.9 points (P ≤ .001 for all), reflecting substantial sensitivity of the PAQ to clinical improvement. The PAQ Summary Scale was the most sensitive of all scales tested. Construct validity was established by demonstrating correlations with other measures of patient health status. Conclusions The PAQ is a valid, reliable, and responsive disease-specific measure for patients with peripheral arterial disease. It may prove to be a useful end point in clinical trials and a potential aid in disease management. |
Determinants of Health Status after Acute Coronary Syndromes |
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Predictors of Quality of Life following Acute Coronary Syndromes Am J Cardiol 88: 781-4, 2001 0 Comments 186 Downloads |
Noncardiac factors are the strongest predictors of Health-related Quality of life after Acute Coronary Syndromes, and certain noncardiac co-morbidities, especially depression, lend themselves to treatment that subsequently may improve quality of life. Revascularization may also lead to better quality of life after Acute Coronary Syndromes. |
Correlates of Health Status |
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Disease-Specific Health Status After Stent-Assisted Percutaneous Coronary Intervention and Coronary Artery Bypass Surgery -- One-Year Results From the Stent or Surgery Trial Circulation 108: 1694-1700, 2003. 0 Comments 51 Downloads |
Background Functional status and quality of life are important outcomes in the evaluation of revascularization approaches for symptomatic coronary artery disease. Few data are available regarding the comparative improvement in disease-specific health status after CABG versus percutaneous coronary intervention (PCI) in the era of coronary stenting. Methods and Results Cardiac-specific health status was evaluated at baseline and at 6 and 12 months after intervention with the Seattle Angina Questionnaire (SAQ) in patients randomized to stent-assisted PCI (n=488) versus CABG (n=500) in the Stent or Surgery trial. Scores for physical limitation, angina frequency, and quality of life improved significantly for both treatment groups at 6 months (range of improvement from 13.6 to 34.7 points) and 12 months (14.3 to 38.2 points; all P<0.001). CABG patients had greater improvement than those assigned to PCI, although the magnitude of the difference decreased over time (difference at 6 months, 4.03 to 6.48 points; 12 months, 2.05 to 2.93 points). A component of this reduction is accounted for by PCI-arm patients who required repeat intervention. Conclusions Both CABG and stent-assisted PCI dramatically improved cardiac-related health status in patients with multivessel disease at 6- and 12-month follow-up. During the first postprocedure year, patients’ angina burden and physical limitations were alleviated to a greater extent with CABG. |
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Report of the National Heart, Lung, and Blood Institute Working Group on Outcomes Research in Cardiovascular Disease Circulation 111: 3158-3166, 2005 0 Comments 96 Downloads |
The National Heart, Lung, and Blood Institute convened a working group on outcomes research in cardiovascular disease (CVD). The working group sought to provide guidance on research priorities in outcomes research related to CVD. For the purposes of this document, “outcomes research” is defined as investigative endeavors that generate knowledge to improve clinical decision making and healthcare delivery to optimize patient outcomes. The working group identified the following priority areas: (1) national surveillance projects for high-prevalence CV conditions; (2) patient-centered care; (3) translation of the best science into clinical practice; and (4) studies that place the cost of interventions in the context of their real-world effectiveness. Within each of these topics, the working group described examples of initiatives that could serve the Institute and the public. In addition, the group identified the following areas that are important to the field: (1) promotion of the use of existing data; (2) facilitation of collaborations with other federal agencies; (3) investigations into the basic science of outcomes research, with an emphasis on methodological advances; (4) strengthening of appropriate study sections with individuals who have expertise in outcomes research; and (5) expansion of opportunities to train new outcomes research investigators. The working group concluded that a dedicated investment in CV outcomes research could directly improve the care delivered in the United States. |
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Depressive Symptoms Are the Strongest Predictors of Short-Term Declines in Health Status in Patients With Heart Failure JACC 42:1811-7, 2003. 0 Comments 116 Downloads |
Objectives The purpose of this study was to assess whether depressive symptoms are independently associated with changes in heart failure (HF)-specific health status. Background Depression is common in patients with HF, but the impact of depressive symptoms on the health status of these patients over time is unknown. Methods We conducted a multicenter prospective cohort study of outpatients with HF. Data from 460 patients who completed a baseline Medical Outcomes Study-Depression Questionnaire and both a baseline and follow-up (6 ± 2 weeks) Kansas City Cardiomyopathy Questionnaire (KCCQ) were analyzed. The KCCQ measures HF-specific health status, including symptoms, physical and social function, and quality of life. Multivariable regression was used to evaluate depressive symptoms as a predictor of change in KCCQ scores, adjusting for baseline KCCQ scores and other patient variables. The primary outcome was change in KCCQ summary scores (range 0 to 100; higher scores indicate better health status; 5 points is a clinically meaningful change). Results Approximately 30% (139/460) of the patients had significant depressive symptoms at baseline. Depressed patients had markedly lower baseline KCCQ summary scores (beta = -19.6; p < 0.001). After adjustment for potential confounders, depressed patients were at risk for significant worsening of their HF symptoms, physical and social function, and quality of life (average change in KCCQ summary score = -7.1 points; p < 0.001). Depressive symptoms were the strongest predictor of decline in health status in the multivariable models. Conclusions Depressive symptoms are a strong predictor of short-term worsening of HF-specific health status. The recognition and treatment of depression may be an important component of HF care. |
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Health Status Predicts Long-Term Outcome in Outpatients With Coronary Disease Circulation 106: 43-49, 2002. 0 Comments 131 Downloads |
Background Although patient-reported health status measures have been used as endpoints in clinical trials, they are rarely used in other settings. Demonstrating that they independently predict mortality and hospitalizations among outpatients with coronary disease could emphasize their clinical value. Methods and Results This study evaluated the prognostic utility of the Seattle Angina Questionnaire (SAQ), a disease-specific health status measure for patients with coronary artery disease. Patients were enrolled in a prospective cohort study from 6 Veterans Affairs General Internal Medicine clinics. All patients reporting coronary artery disease who completed a SAQ and had one year of follow-up were analyzed (n=5,558). SAQ predictor variables were the physical limitation, angina stability, angina frequency and quality of life scores. The primary outcome was one-year all-cause mortality, and a secondary outcome was hospitalization for acute coronary syndrome (ACS). Lower SAQ scores were associated with increased risks of mortality and ACS admissions. Prognostic models controlling for demographic and clinical characteristics demonstrated significant independent mortality risk with lower SAQ physical limitation scores; odds ratios for mild, moderate and severe limitation were 1.5, 2.0 and 4.0 versus minimal limitation (p < 0.001). Odds ratios for mild, moderate and severe angina frequency were 0.8, 1.2 and 1.6 (p = 0.078). The odds ratios for ACS admission among those with mild, moderate and severe angina frequency were 1.4, 2.0 and 2.2 (p = 0.016). Conclusion SAQ scores are independently associated with 1-year mortality and acute coronary syndromes among outpatients with coronary disease and may serve a valuable role in the risk stratification of such patients. |