Publications About the SAQ, KCCQ, and PAQ

The Seattle Angina Questionnaire, Kansas City Cardiomyopathy Questionnaire, and Peripheral Artery Questionnaire have been in widespread use in clinical trials, longitudinal clinical registries, and routine clinical practice for over a decade. Their development, validation, and use have been thoroughly documented in peer-reviewed scientific literature. We present here a brief synopsis of the work backing these instruments.

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Over the years since Dr. John Spertus developed the Seattle Angina Questionnaire, Kansas City Cardiomyopathy Questionnaire, and Peripheral Artery Questionnaire, these health-related quality-of-life measures have been extensively used in scientific research within academia and industry.

To date (as of this writing in March 2011), the KCCQ has been used in nearly 1400 studies involving nearly 120,000 patients; the SAQ has been used in 600 studies of 113,000 patients, and the PAQ in 28 studies of 10,000 patients. These studies and ongoing operational programs are being conducted by nearly every pharmaceutical company and device manufacturer that exists as well as most university medical centers.

Distribution of these instruments is handled through CV Outcomes, a nonprofit research organization formed by Dr. Spertus to conduct large-scale clinical investigations. Much more information is available there about these measures — particularly in their publications section. You should explore that site to learn more, but we provide some of the more important abstracts of these publications here along with links by which you can download the papers themselves.

Development and Evaluation of the Seattle Angina Questionnaire: A New Functional Status Measure for Coronary Artery Disease

Spertus JA, Winder JA, Dewhurst TA, Deyo RA, Prodzinski J, McDonell M, Fihn SD
J Am Coll Cardiol 25(2): 333-41, 1995

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.

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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

Dougherty CM, Dewhurst T, Nichol WP, Spertus JA
J Clin Epidemiol 51(7): 569-575, 1998.

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

Bliven BD, Kaufman SE, Spertus JA
Quality of Life Research 10: 15-22, 2001

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

Weintraub WS, Spertus JA, Kolm P, Maron DJ, Zhang Z, Jurkovitz C, Zhang W, Hartigan PM, Lewis C, Veledar E, Bowen J, Dunbar SB, Deaton C, Kaufman S, O’Rourke RA, Goeree R, Barnett PG, Teo KK, Boden WE, for the COURAGE Trial Research Group
N Engl J Med 2008;359:677-87

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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Development and Evaluation of the Kansas City Cardiomyopathy Questionnaire: A New Health Status Measure for Heart Failure

Green CP, Porter CB, Bresnahan DR, Spertus JA
J Am Coll Cardiol 35(5): 1245-55, 2000

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

Spertus JA, Peterson ED, Conard MW, Heidenreich PA, Krumholz HM, Jones P, McCullough PA, Pina I, Tooley J, Weintraub WS, Rumsfeld JS
Am Heart J 150:707-15, 2005.

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.

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The Peripheral Artery Questionnaire: A new disease-specific health status measure for patients with peripheral arterial disease

Spertus J, Jones P, Poler S, Rocha-Singh K
Am Heart J 147: 301-8, 2004

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.

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Created: March 26, 2011 16:57; Last updated: March 26, 2011 17:00