Biomedical subjects

Michael Frankel

Publications and source records attributed to Michael Frankel.

6 recordsLinked to original sources

PubMed2006

Designing a sustainable national registry for stroke quality improvement.

Several studies have shown wide variations in the delivery of hospital-based care to patients with acute ischemic stroke. The findings of these studies suggest that recommendations drawn from published evidence-based or consensus-based guidelines are implemented inconsistently. Although rates of adherence to stroke quality indicators can be increased through the use of targeted quality improvement (QI) efforts, stroke QI programs are still in their infancy. Current stroke QI programs are often highly variable and poorly coordinated, rely on differing definitions of key data elements and/or indicators, and are challenging to implement and sustain in resource-constrained healthcare environments. Key barriers to long-term success of these programs include inadequate funding at the local and national level, lack of infrastructure to support electronic data capture for QI as part of the process of patient care, lack of a single clearinghouse for uniform data definitions and performance indicator descriptions, competing survey instruments to monitor hospitalized stroke care, and constraints on inpatient and post-discharge data collection imposed by the new Federal Health Insurance Portability and Accountability Act Privacy Rule. In addition, the competing needs of registry activities (e.g., complete case ascertainment) versus QI efforts (e.g., incremental tests of change) must be balanced. Potential solutions include: (1) financial incentives to healthcare providers and institutions for participation in QI initiatives; (2) financial incentives to healthcare providers and institutions for measurable improvements in care; (3) mandatory data reporting on key measures of stroke care; and (4) promotion of active and sustainable collaborations among key stakeholders including healthcare providers (e.g., physicians, nurses), healthcare organizations (e.g., hospitals, physicians' groups), quality improvement organizations, health payers and insurers, public health departments, and state and federal health agencies to create a single national stroke registry for stroke QI.

Acute Disease↗

PubMed2006

ProTECT: a randomized clinical trial of progesterone for acute traumatic brain injury.

STUDY OBJECTIVE: Laboratory evidence indicates that progesterone has potent neuroprotective effects. We conducted a pilot clinical trial to assess the safety and potential benefit of administering progesterone to patients with acute traumatic brain injury. METHODS: This phase II, randomized, double-blind, placebo-controlled trial was conducted at an urban Level I trauma center. One hundred adult trauma patients who arrived within 11 hours of injury with a postresuscitation Glasgow Coma Scale score of 4 to 12 were enrolled with proxy consent. Subjects were randomized on a 4:1 basis to receive either intravenous progesterone or placebo. Blinded observers assessed patients daily for the occurrence of adverse events and signs of recovery. Neurologic outcome was assessed 30 days postinjury. The primary safety measures were differences in adverse event rates and 30-day mortality. The primary measure of benefit was the dichotomized Glasgow Outcome Scale-Extended 30 days postinjury. RESULTS: Seventy-seven patients received progesterone; 23 received placebo. The groups had similar demographic and clinical characteristics. Laboratory and physiologic characteristics were similar at enrollment and throughout treatment. No serious adverse events were attributed to progesterone. Adverse and serious adverse event rates were similar in both groups, except that patients randomized to progesterone had a lower 30-day mortality rate than controls (rate ratio 0.43; 95% confidence interval 0.18 to 0.99). Thirty days postinjury, the majority of severe traumatic brain injury survivors in both groups had relatively poor Glasgow Outcome Scale-Extended and Disability Rating Scale scores. However, moderate traumatic brain injury survivors who received progesterone were more likely to have a moderate to good outcome than those randomized to placebo. CONCLUSION: In this small study, progesterone caused no discernible harm and showed possible signs of benefit.

Accidents, Traffic↗

PubMed2006

The Paul Coverdell National Acute Stroke Registry: initial results from four prototypes.

BACKGROUND: This paper summarizes the experiences of the Paul Coverdell National Acute Stroke Registry first four prototype registries in Georgia (GA), Massachusetts (MA), Michigan (MI), and Ohio (OH), and includes information on their sampling design, case ascertainment, and data collection methods, as well as some key findings. METHODS: Using a combination of different sampling methods, each prototype obtained a representative statewide sample of hospitals. Acute stroke admissions were identified through prospective (MA, MI) or retrospective (GA, OH) methods. A common set of case definitions and data elements were used by each registry. Weighted site-specific frequencies and 95% confidence intervals were generated for each outcome. A summary estimate, representing a weighted average of the four site-specific estimates, was also calculated. RESULTS: Of the total 6867 admissions, 1487 (21.6%) were from the GA registry, 1206 (17.6%) from MA, 2566 (37.4%) from MI, and 1608 (23.4%) from the OH prototype. Just less than 60% of admissions were ischemic strokes (site-specific estimates ranged from 52% to 70%), with transient ischemic attack (18.5%) and intracerebral hemorrhage (8.8%) making up most of the remainder. Twenty-one percent of patients admitted were younger than 60 years of age, and 55.3% were women. The proportion of black subjects varied from 7.1% (MI) to 30.6% (GA). Twenty-three percent of admissions arrived at the emergency department within 3 hours of onset. Overall 4.5% of ischemic stroke admissions were treated with recombinant tissue plasminogen activator; site-specific treatment rates were 3.0% (GA), 3.2% (OH), 3.4% (MI), and 8.5% (MA). Only a small minority of treated patients (range, 10.8% [OH] to 19.6% [MI]) received recombinant tissue plasminogen activator within the recommended 1 hour door-to-needle time. A minority of eligible subjects were screened for dysphagia (45.4%), underwent lipid testing (33.6%), or received smoking-cessation counseling (21.4%). In contrast, compliance with antithrombotic treatments at discharge was high (91.5%). CONCLUSIONS: A minority of acute stroke patients are treated according to established guidelines. Quality improvement interventions, targeted primarily at the healthcare systems level, are needed to improve acute stroke care in the United States.

Acute Disease↗

PubMed2005

Acute stroke care in the US: results from 4 pilot prototypes of the Paul Coverdell National Acute Stroke Registry.

BACKGROUND AND PURPOSE: The Paul Coverdell National Acute Stroke Registry is being developed to improve the quality of acute stroke care. This article describes key features of acute stroke care from 4 prototype registries in Georgia (Ga), Massachusetts (Mass), Michigan (Mich), and Ohio. METHODS: Each prototype developed its own sampling scheme to obtain a representative sample of hospitals. Acute stroke admissions were identified using prospective (Mass, Mich) or retrospective (Ga, Ohio) methods. All prototypes used a common set of case definitions and data elements. Weighted site-specific frequencies were generated for each outcome. RESULTS: A total of 6867 admissions from 98 hospitals were included; the majority were ischemic strokes (range, 52% to 70%) with transient ischemic attack and intracerebral hemorrhage comprising the bulk of the remainder. Between 19% and 26% of admissions were younger than age 60 years, and between 52% and 58% were female. Black subjects varied from 7.1% (Mich) to 30.6% (Ga). Between 20% and 25% of admissions arrived at the emergency department within 3 hours of onset. Treatment with recombinant tissue plasminogen activator (rtPA) was administered to between 3.0% (Ga) and 8.5% (Mass) of ischemic stroke admissions. Of 118 subjects treated with intravenous rtPA, <20% received it within 60 minutes of arrival. Compliance with secondary prevention practices was poorest for smoking cessation counseling and best for antithrombotics. CONCLUSIONS: A minority of acute stroke patients are treated according to established guidelines. Quality improvement interventions, targeted primarily at the health care systems level, are needed to improve acute stroke care in the United States.

Adolescent↗

PubMed2004

Association of outcome with early stroke treatment: pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroke trials.

BACKGROUND: Quick administration of intravenous recombinant tissue plasminogen activator (rt-PA) after stroke improved outcomes in previous trials. We aimed to analyse combined data for individual patients to confirm the importance of rapid treatment. METHODS: We pooled common data elements from six randomised placebo-controlled trials of intravenous rt-PA. Using multivariable logistic regression we assessed the relation of the interval from stroke onset to start of treatment (OTT) on favourable 3-month outcome and on the occurrence of clinically relevant parenchymal haemorrhage. FINDINGS: Treatment was started within 360 min of onset of stroke in 2775 patients randomly allocated to rt-PA or placebo. Median age was 68 years, median baseline National Institute of Health Stroke Scale (NIHSS) 11, and median OTT 243 min. Odds of a favourable 3-month outcome increased as OTT decreased (p=0.005). Odds were 2.8 (95% CI 1.8-4.5) for 0-90 min, 1.6 (1.1-2.2) for 91-180 min, 1.4 (1.1-1.9) for 181-270 min, and 1.2 (0.9-1.5) for 271-360 min in favour of the rt-PA group. The hazard ratio for death adjusted for baseline NIHSS was not different from 1.0 for the 0-90, 91-180, and 181-270 min intervals; for 271-360 min it was 1.45 (1.02-2.07). Haemorrhage was seen in 82 (5.9%) rt-PA patients and 15 (1.1%) controls (p<0.0001). Haemorrhage was not associated with OTT but was with rt-PA treatment (p=0.0001) and age (p=0.0002). INTERPRETATION: The sooner that rt-PA is given to stroke patients, the greater the benefit, especially if started within 90 min. Our results suggest a potential benefit beyond 3 h, but this potential might come with some risks.

Aged↗

PubMed2003

The Ischemic Stroke Genetics Study (ISGS) Protocol.

BACKGROUND: The molecular basis for the genetic risk of ischemic stroke is likely to be multigenic and influenced by environmental factors. Several small case-control studies have suggested associations between ischemic stroke and polymorphisms of genes that code for coagulation cascade proteins and platelet receptors. Our aim is to investigate potential associations between hemostatic gene polymorphisms and ischemic stroke, with particular emphasis on detailed characterization of the phenotype. METHODS/DESIGN: The Ischemic Stroke Genetic Study is a prospective, multicenter genetic association study in adults with recent first-ever ischemic stroke confirmed with computed tomography or magnetic resonance imaging. Patients are evaluated at academic medical centers in the United States and compared with sex- and age-matched controls. Stroke subtypes are determined by central blinded adjudication using standardized, validated mechanistic and syndromic classification systems. The panel of genes to be tested for polymorphisms includes beta-fibrinogen and platelet glycoprotein Ia, Iba, and IIb/IIIa. Immortalized cell lines are created to allow for time- and cost-efficient testing of additional candidate genes in the future. DISCUSSION: The study is designed to minimize survival bias and to allow for exploring associations between specific polymorphisms and individual subtypes of ischemic stroke. The data set will also permit the study of genetic determinants of stroke outcome. Having cell lines will permit testing of future candidate risk factor genes.

Academic Medical Centers↗