Generalized Safety and Efficacy of Simplified Intravenous Thrombolysis Treatment (SMART) Criteria in Acute Ischemic Stroke: The MULTI SMART Study.

BACKGROUND: Common intravenous recombinant tissue plasminogen activator (IV rt-PA) exclusion criteria may substantially limit the use of thrombolysis. Preliminary data have shown that the SMART (Simplified Management of Acute stroke using Revised Treatment) criteria greatly expand patient eligibility by reducing thrombolysis exclusions, but they have not been assessed on a large scale. We evaluated the safety and efficacy of general adoption of SMART thrombolysis criteria to a large regional stroke network. METHODS: Retrospective analysis of consecutive patients who received IV thrombolysis within a regional stroke network was performed. Patients were divided into those receiving thrombolysis locally versus at an outside hospital. The primary outcome was modified Rankin Scale score (≤1) at discharge and the main safety outcome was symptomatic intracranial hemorrhage (sICH) rate. RESULTS: There were 539 consecutive patients, and 50.5% received thrombolysis at an outside facility. Ninety percent of the patients possessed common conventional IV rt-PA contraindications. There were no significant differences between local and network treated patients in favorable outcome (45.4% versus 37.4%; odds ratio [OR], .72; P > .09), mortality (9% versus 14%; OR, 1.6; P > .07), or sICH rate (2.6% versus 5.1%; OR, 2.0; P = .13). Multivariate analysis showed no association between receiving IV rt-PA at an outlying spoke hospital and higher rate of sICH or worse outcome at discharge. CONCLUSIONS: Generalized application of SMART criteria is safe and effective. Widespread application of these criteria could substantially increase the proportion of patients who might qualify for treatment.

Hearing Impairment in Relation to Severity of Diabetes in a Veteran Cohort.

OBJECTIVE: Type 2 diabetes is epidemic among veterans, approaching three times the prevalence of the general population. Diabetes leads to devastating complications of vascular and neurologic malfunction and appears to impair auditory function. Hearing loss prevention is a major health-related initiative in the Veterans Health Administration. Thus, this research sought to identify, and quantify with effect sizes, differences in hearing, speech recognition, and hearing-related quality of life (QOL) measures associated with diabetes and to determine whether well-controlled diabetes diminishes the differences. DESIGN: The authors examined selected cross-sectional data from the baseline (initial) visit of a longitudinal study of Veterans with and without type 2 diabetes designed to assess the possible differences in age-related trajectories of peripheral and central auditory function between the two groups. In addition, the diabetes group was divided into subgroups on the basis of medical diagnosis of diabetes and current glycated hemoglobin (HbA1c) as a metric of disease severity and control. Outcome measures were pure-tone thresholds, word recognition using sentences presented in noise or time-compressed, and an inventory assessing the self-perceived impact of hearing loss on QOL. Data were analyzed from 130 Veterans ages 24 to 73 (mean 48) years with well-controlled (controlled) diabetes, poorly controlled (uncontrolled) diabetes, prediabetes, and no diabetes. Regression was used to identify any group differences in age, noise exposure history, and other sociodemographic factors, and multiple regression was used to model each outcome variable, adjusting for potential confounders. Results were evaluated in relation to diabetes duration, use of insulin (yes, no), and presence of selected diabetes complications (neuropathy and retinopathy). RESULTS: Compared with nondiabetics, Veterans with uncontrolled diabetes had significant differences in hearing at speech frequencies, including poorer hearing by 3 to 3.5 dB for thresholds at 250 Hz and in a clinical pure-tone average, respectively. Compared with nondiabetic controls, individuals with uncontrolled diabetes also significantly more frequently reported that their hearing adversely impacted QOL on one of the three subscales (ability to adapt). Despite this, although they also had slightly poorer mean scores on both word recognition tasks performed, these differences did not reach statistical significance and all subjects performed well on these tasks. Compared with Veterans with controlled diabetes, those with uncontrolled disease tended to have had diabetes longer, be insulin-dependent, and have a greater prevalence of diabetic retinopathy. Results are generally comparable with the literature with regard to the magnitude of threshold differences and the prevalence of hearing impairment but extend prior work by providing threshold difference and hearing loss prevalence effect sizes by category of diabetes control and by including additional functional measures. CONCLUSIONS: In a cohort of Veterans with type 2 diabetes and relatively good hearing, significant effects of disease severity were found for hearing thresholds at a subset of frequencies and for one of the three QOL subscales. Significant differences were concentrated among those with poorly controlled diabetes based on current HbA1c. Results provide evidence that the observed hearing dysfunction in type 2 diabetes might be prevented or delayed through tight metabolic control. Findings need to be corroborated using longitudinal assessments.