Special topic

2001 Journal of the American College of Cardiology  
Health status meawres are being increasingly used as endpoints in clinical trials and observational studies. Validating these measures against "hard" clinical outcomes could improve their acceptability, enhance assessment of health care quality and assist in disease management. Methods: This study was part of the Ambulatory Care Quality Improvement Project, a randomized trial conducted from 1197.12199 in 6 Veterans Affairs medical centers. 5,558 outpatients with coronary artery disease (CAD)
more » ... e given the Seattle Angina Questionnaire (SAQ), a 19-i&m disease-specific health status instrument, and followed for up to 2 years. The prognostic ability of the SAQ was evaluated for survival and admission for acute coronary syndrome (ACS), both univariately and in multivariable models controlling for demographic and clinical factors. Results: In univariate analyses, SAQ Physical Limitation (PL) and Angina Frequency (AF) scores were highly predictive of mortality and ACS. Kaplan-M&r survival by PL score is shown in the figure (higher scores imply less limitation). Odds ratios (ORs) for lyear mortality for patients with PL scores of O-24, 25-49 and 50-74 were 6.2,2.5 and 1.6 versus those scoring 75-100 (p 2 pound weight gain or optional outpatient IV diuretics for > 5 pound weight gain to avert ernergency department(ED) visits or hospital admissions. 85% were placed on ace inhibitors and 48% were started on beta blocker therapy. Results: The mean age was 56 +I-14 years and 48% were female. Follow up was nine months +I-10 weeks. ED visits for this cohort were reduced by 60% as compared to historical control. Length of stay and hospital admissions were reduced by 68% and 72%, respectively with a cost savings estimated at $470,000. Summary: Implementation of a CHF disease management model applied to an indigent population was proven both feasible and cost effective, requiring no additional institutional expenditures, and resulting in fewer ED visits, fewer hospital admissions and reduced length of stay. Introduction: Cost-effectiveness(CE) analyses are becoming an increasingly important consideration in the design and implementation of clinical trials. Determining CE requires an assessment of patients' utilities (range = O-l where O=death and l=a state of perfect health). The gold standard for determining utilities is the Standard Gamble(SG), a complicated technique of eliciting patients' preferences (or willingness) to risk dying in order to be rid of their disease. The COURAGE trial, a 3,260 patient trial comparing optimal medical therapy +/-percutaneous coronary intervention, chose to explicitly mea?.ure patients' utilities with a computerized version of the SG. This analysis was conducted to see whether utilities could have been estimated from quality of life (QOL) questionnaires and whether the expense of explicitly measuring patient utilities was warranted. Methods and Results: Baseline data from the first 191 pts in COURAGE were analyzed to correlate QOL measures (the Seattle Angina Questionnaire(SAQ) and SF-36) with the SG. To facilitate interpretation, SAQ scores were grouped into the following ranges: O-24, 25-49, 50-74 and 75-100. No significant correlations were detected among SAQ scores and SG utilities. Whereas patients with the highest ranges of SAQ scores consis-
doi:10.1016/s0735-1097(01)80009-7 fatcat:hjtiufzafne4xphl7afpv5mkja