Abstract 188: Comparison of Physician- and Patient-Assessed Impressions of Treatment Efficacy: Insights from the TERISA Clinical Trial
BACKGROUND: Physicians typically rely on their qualitative interpretation of patients’ symptoms to evaluate the efficacy of antianginal therapy. However, the accuracy of this approach has not been examined.
METHODS: Using data from the international multicenter TERISA clinical trial of patients with type 2 diabetes, CAD, and stable angina, we compared the physician’s assessment of change with patient-reported changes in angina. Physicians were asked to complete a well-validated visual analog scale (PGAVAS) at baseline and after 8 weeks of treatment. The PGAVAS asks the physician to rate the disease activity of their patient on a scale of 0 (“very good”) to 100 (“very bad”). A clinically important change in PGAVAS was defined as 8.5 points (i.e., half the baseline SD; a moderate change by Cohen’s effect size). Change from baseline in PGAVAS was compared with change from baseline in angina frequency (AF) as measured by an electronic daily diary. Among patients with an improvement in AF of ≥ 1 weekly episode, multivariable logistic regression examined predictors of physician recognition of change.
RESULTS: Among 927 patients in TERISA, 892 (96%) had PGAVAS scores at baseline and at 8 weeks. Of the 605 patients with improvement in AF of ≥ 1 episode, 291 (48%) were recognized by the physician as improved (per the PGAVAS). Comparatively, of the 287 patients with unchanged or worsened AF, 197 (69%) were believed to be unchanged or worse by the physician. Overall, 45% of physicians’ assessments were discordant with their patients’ symptoms. There was a significant but poor correlation between the change in PGAVAS and change in patient-reported AF (Figure; r = 0.15). In multivariable regression, the degree of change in AF was significantly associated with physician recognition of change, with each 1 episode reduction in weekly AF associated with a 12% increased odds of physician recognition (95% CI 1.05-1.20). Age, sex, geography, and baseline AF were not associated with recognition.
CONCLUSION: In TERISA, physicians were limited in their ability to recognize significant improvement in patients’ angina, although greater patient change was associated with greater physician recognition. These data suggest that patient-reported outcomes may provide added value to physicians in monitoring their patients’ angina and health status.
Author Disclosures: P. Yue: A. Employment; Significant; Employee of Gilead Sciences, Inc.; active stockholder. Y. Li: None. A. Olmsted: A. Employment; Significant; Employee and stockholder of Gilead Sciences, Inc. M. Kosiborod: B. Research Grant; Significant; Gilead Sciences, American Heart Association, Medtronic Minimed, Genentech, Sanofi-Aventis, Glumetrics, Maquet. G. Consultant/Advisory Board; Modest; Gilead Sciences, Genentech, AstraZeneca, Abbvie, F Hoffmann-La Roche, Medtronic Minimed. B. Chaitman: B. Research Grant; Significant; NHLBI. C. Other Research Support; Significant; Gilead Sciences. D. Speakers; Modest; Gilead Sciences. E. Honoraria; Modest; Gilead Sciences. G. Consultant/Advisory Board; Modest; Gilead Sciences, Merck, Pfizer, Forest Pharmaceuticals, Sanofi-Aventis, Roche, Takeda, Eli Lilly. L. Belardinelli: A. Employment; Significant; Employee and stockholder of Gilead Sciences, Inc. J.A. Spertus: B. Research Grant; Significant; NHLBI, ACCF, AHA, PCORI, Gilead Sciences, Amorcyte, Genentech, Eli Lilly. G. Consultant/Advisory Board; Modest; Gilead Sciences, Genentech, Amgen, United Healthcare. G. Consultant/Advisory Board; Significant; Board Member, Health Outcomes Sciences. H. Other; Significant; Copyright holder for SAQ, Copyright holder for KCCQ, Copyright holder for PAQ. S.V. Arnold: B. Research Grant; Significant; Gilead Sciences, Genentech, Sanofi-Aventis.
- © 2014 by American Heart Association, Inc.