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Biomedical subjects

John J Smith

Publications and source records attributed to John J Smith.

15 recordsLinked to original sources
PubMed2006

An outline for public registration of clinical trials evaluating medical devices.

Public registration of clinical trials is fundamentally important to the integrity of the medical device development process. In addition to fulfilling obligations to those study volunteers, a complete record of trial results provides the general public, clinical community, and medical device manufacturers with a more accurate understanding as to how a specific therapeutic should be used. Although the issues associated with public disclosure of clinical trials are similar to the pharmaceutical industries, the iterative nature of device development introduces differences in what type of information needs to be disclosed during development and commercialization. The Second Dartmouth Device Development Symposium (3D2) held in October 2004 brought together thought leaders representing many of the stakeholders associated with medical device development. This consensus document arising from the proceedings of the 3D2 is offered to provide background to these issues and recommend pathways to implementation of device trial registration.

Clinical Trials as Topic↗
PubMed2004

Facilitated percutaneous coronary intervention versus primary percutaneous coronary intervention: design and rationale of the Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events (FINESSE) trial.

BACKGROUND: Percutaneous coronary intervention (PCI) has emerged as the strategy of choice in reestablishing effective flow in occluded infarct-related arteries in patients with acute myocardial infarction (MI) if it can be administered in a timely fashion. Patients who enter the catheterization laboratory with Thrombolysis In Myocardial Infarction (TIMI) grade 3 blood flow in the infarct-related vessel have better clinical outcomes than patients presenting with impaired flow. We hypothesize that a strategy of early pharmacologic reperfusion therapy with abciximab alone or in conjunction with reduced-dose reteplase, followed by PCI will improve the outcome of patients eligible for primary PCI. STUDY DESIGN: The Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events (FINESSE) study is a 3000-patient, prospective, multicenter, randomized, double-blind, placebo-controlled trial. The study is designed to compare the efficacy and safety of early administration of reduced-dose reteplase and abciximab combination therapy or abciximab alone followed by PCI with abciximab alone administered just before PCI for acute MI. Patients will be randomized to one of these 2 facilitated PCI treatments or primary PCI in a 1:1:1 fashion. The primary efficacy end point of FINESSE is the composite of all-cause mortality or post-MI complications within 90 days of randomization. The primary safety outcome assessment will be Thrombolysis In Myocardial Infarction (TIMI) major bleeding. CONCLUSIONS: The FINESSE study will answer important questions regarding the efficacy and safety of "upstream" medical therapy followed by planned intervention for patients with ST-elevation MI, potentially expanding the population eligible for a primary PCI approach. This study will also provide insight as to which facilitated regimen (reteplase/abciximab combination therapy or abciximab monotherapy) provides the best balance of efficacy and safety.

Abciximab↗
PubMed2004

Reteplase monotherapy and reteplase/abciximab combination therapy in peripheral arterial occlusive disease: results from the RELAX trial.

PURPOSE: The safety and efficacy of increasing doses of intraarterial reteplase monotherapy and reteplase/abciximab combination therapy were examined in patients with acute peripheral arterial occlusive disease (PAOD). The primary endpoint of this analysis was major bleeding as defined by the Thrombolysis in Myocardial Infarction (TIMI) investigators. MATERIALS AND METHODS: The RELAX trial was a prospective, dose-escalating safety trial of reteplase monotherapy (0.1, 0.2, 0.5, or 1.0 U/h) and reteplase/abciximab combination therapy (0.25-mg/kg bolus and 0.125 micro g/kg/min abciximab in addition to each reteplase regimen) for patients with acute or subacute clinical deterioration of PAOD. Reteplase was administered intraarterially to 74 patients; 38 patients were also administered intravenous abciximab for the duration of reteplase infusion. Protocol-specified angiograms were obtained at 6 and 20 hours or for clinical need. Each angiogram was assessed for volume of thrombus dissolved and for arterial patency. The primary safety endpoint (TIMI major bleeding) was assessed at discharge and at day 7. Clinical endpoints were assessed at discharge and at days 30 and 90. RESULTS: Major bleeding occurred with similar frequency in patients treated with and without abciximab (15% of the pooled patients receiving reteplase monotherapy and 20% of patients receiving reteplase/abciximab combination therapy). There were no intracranial hemorrhagic events in the 74 patients. Reteplase doses of at least 0.2 U/hour were effective at dissolving thrombus and restoring patency. There was no clear dose-response relationship for reteplase. However, the addition of abciximab reduced the occurrence of distal embolic events requiring intervention (5% vs. 31%; P =.014). CONCLUSIONS: Over the range of reteplase doses studied for peripheral arterial thrombolysis, there were no significant differences in safety or efficacy. However, the addition of intravenous abciximab to reteplase was associated with a decreased rate of distal embolic events without a significant increase in the risk of hemorrhagic complications. Further investigation is needed to define the role of abciximab in catheter-directed thrombolysis with reteplase for PAOD.

Abciximab↗
PubMed2003

Biomarkers in imaging: realizing radiology's future.

Modern pharmaceuticals and medical devices have provided substantial benefits to patients throughout the world. These benefits come at a high and increasing cost, with development of the typical pharmaceutical requiring 12 years and hundreds of millions of dollars before gaining U.S. Food and Drug Administration marketing approval. Appropriate use of imaging biomarkers--defined as anatomic, physiologic, biochemical, or molecular parameters detectable with imaging methods used to establish the presence or severity of disease--offer the prospect of smaller, less expensive, and more efficient preclinical studies and clinical trials. Scientists, government regulators, and industry have all recognized the potential of biomarkers in imaging. Although real, this promise can only be realized with the rigorous application of science to their use. Success is most likely when (a) the presence of an imaging marker is closely linked with the presence of a target disease; (b) detection and/or measurement of the biomarker is accurate, reproducible, and feasible over time; and (c) measured changes are closely linked to success or failure of the therapeutic effect of the product being evaluated. By applying this paradigm to the array of imaging modalities, the radiology community is poised to become a major force in preclinical and clinical evaluations of new medical treatments.

Biomarkers↗
PubMed2002

Retropubic surgery for stress urinary incontinence.

More than 150 surgical techniques have been proposed in the literature for treating stress urinary incontinence. Many of the original published approaches were vaginal, but through the years the literature has expanded to include needle suspension, pubovaginal slings, and retropubic procedures. In this chapter, we focus on retropubic approaches for the treatment of SUI and discuss the physiology, indications, technical details and the complications of these procedures.

Female↗
PubMed2002

Hospital outpatient prospective payment under Medicare: understanding the system and its implications.

The newly implemented Medicare hospital outpatient prospective payment system provides fixed prospectively determined reimbursement for technical and other nonphysician services provided to beneficiaries in the hospital outpatient setting. As such, it represents the latest attempt by the federal government to control health care costs through prospective bundled payment systems such as the well-known Medicare diagnosis-related group system for hospital inpatients. The new system is complex, however, with several discrete reimbursement mechanisms possible for the same service. This complexity, in concert with the major change in outpatient reimbursement that the system represents, creates considerable uncertainty for radiologists and for medicine in general. It is incumbent on the radiology community to understand and assess the hospital outpatient prospective payment system and to work with the Centers for Medicare and Medicaid Services to minimize any potential negative effects on the profession and on patients.

Ambulatory Care↗