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Showing papers by "Claudia S. Moy published in 2007"


Journal ArticleDOI
01 Sep 2007-Stroke
TL;DR: Individuals with clinically consistent symptoms but no stroke diagnosis have a lower quality of life than those without symptoms, and the difference in physical functioning is substantial with a smaller decline in mental functioning.
Abstract: Background and Purpose— Stroke symptoms in the absence of recognized stroke are common, but potential associated dysfunctions have not been described. Methods— We assessed quality-of-life measures using the Physical and Mental Component Summary scores of the Short Form 12 (PCS-12 and MCS-12) in the REasons for Geographic And Racial Differences in Stroke (REGARDS) cohort. Differences in mean PCS-12 and MCS-12 scores were assessed among participant groups symptoms-free (n=16 090); history of stroke symptoms but free of stroke/transient ischemic attack (n=3404); history of stroke (n=1491); and history of transient ischemic attack (n=818). Results— Participants with symptoms (but no diagnosis) had average PCS-12 scores 5.5 (95% CI: 5.2 to 5.9) points lower than those without symptoms, a difference similar to transient ischemic attack (6.0; 95% CI: 5.3 to 6.7) and over one half the effect of stroke (8.4; 95% CI: 8.0 to 9.0). MCS-12 scores were 2.7 (95% CI: 2.4 to 3.0) points lower for those with symptoms, −0.5...

46 citations


Journal ArticleDOI
TL;DR: Representatives from several DHHS agencies and institutes will discuss their need for better instruments within their discipline and describe current or future initiatives for exploring the benefits of these technologies.
Abstract: Many of the Institutes, Agencies and Centers that make up the US Department of Health and Human Services (DHHS) have recognized the need for better instrumentation in health outcomes research, and provide support, both internally and externally, for research utilizing advances in measurement theory and computer technology (informatics). In this paper, representatives from several DHHS agencies and institutes will discuss their need for better instruments within their discipline and describe current or future initiatives for exploring the benefits of these technologies. Together, the perspectives underscore the importance of developing valid, precise, and efficient measures to capture the full burden of disease and treatment on patients. Initiatives, like the Patient-Reported Outcomes Measurement Information System (PROMIS) to create health-related quality of life item banks, represent a trans-DHHS effort to develop a standard set of measures for informing decision making in clinical research, practice, and health policy.

41 citations


Journal ArticleDOI
TL;DR: The Albumin in Acute Stroke trial, a phase 3 randomised, double-blinded, placebo-controlled clinical trial was initiated to evaluate the efficacy of high-dose albumin compared to saline control within 5 h of ischaemic stroke onset.
Abstract: Stroke is a serious global illness. Human albumin has emerged as a putative therapy for ischaemic stroke based on strong evidence from animal models. Following confirmation of the safety and feasibility of high-dose albumin treatment for acute ischaemic stroke in a pilot study, the Albumin in Acute Stroke trial, a phase 3 randomised, double-blinded, placebo-controlled clinical trial was initiated to evaluate the efficacy of high-dose albumin compared to saline control within 5 h of ischaemic stroke onset. Methods: The trial will enrol 1800 patients in two cohorts – a thrombolytic and a nonthrombolytic arm. High-dose (2 g/kg) human albumin will be administered in a 2-h straight intravenous infusion to ischaemic stroke patients, within 5 h of symptom onset. The primary outcome will be an NIH stroke scale score of 0–1 or a modified Rankin scale score of 0–1 at 90 days. Safety outcomes will include the incidence of congestive heart failure after study drug administration. Results: Enrolment opened at 40 sites...

26 citations