Profiles of Neurological Outcome Prediction Among Intensivists

Background  

Advances in intensive care medicine have increased survival rates of patients with critical neurological conditions. The focus of prognostication for such patients is therefore shifting from predicting chances of survival to meaningful neurological recovery. This study assessed the variability in long-term outcome predictions among physicians and aimed to identify factors that may account for this variability.     

FDA’S Perspectives on Cardiovascular Devices

The Food and Drug Administration (FDA) decision process for approving or clearing medical devices is often determined by a review of robust clinical data and extensive preclinical testing of the device. The mission statement for the Center for Devices and Radiological Health (CDRH) is to review the information provided by manufacturers so that it can promote and protect the health of the public by ensuring the safety and effectiveness of medical devices deemed appropriate for human use (Food, Drug & Cosmetic Act, §903(b)(1, 2(C)), December 31, 2004; accessed December 17, 2008 ). For high-risk devices, such as ventricular assist devices (VADs), mechanical heart valves, stents, cardiac resynchronization therapy (CRT) devices, pacemakers, and defibrillators, the determination is based on FDA’s review of extensive preclinical bench and animal testing followed by use of the device in a clinical trial in humans. These clinical trials allow the manufacturer to evaluate a device in the intended use population. FDA reviews the data from the clinical trial to determine if the device performed as predicted and the clinical benefits outweigh the risks. This article reviews the regulatory framework for different marketing applications related to cardiovascular devices and describes the process of obtaining approval to study a cardiovascular device in a U.S. clinical trial.     

Acquired Cutis Laxa in Childhood Sweet's Syndrome

Abstract:  In Sweet's syndrome, the essential features are the characteristic morphology of the lesions, their histologic appearance, the dramatic response to corticosteroids and the absence of scarring. We report an 8-month-old infant in whom Sweet's syndrome was diagnosed and who developed acquired cutis laxa in the skin lesions.     

Localized bullous pemphigoid in a patient with primary lymphoedema tarda

We report a case of localized bullous pemphigoid (BP) in a woman patient with primary lymphoedema tarda. There is only one previous case reported of localized pemphigoid in an area of lymphoedema, this being of the cicatricial variant. Slow circulation in the lymphatic vessels, increased capillary permeability with preferential localization of antibodies in the area, and potential cleavage of the epidermal junction due to increased hydrostatic pressure leading to autoimmunity, have all been advocated as possible pathogenic mechanisms. Nevertheless, we consider that the mechanism by which localized pemphigoid arises on lymphoedema remains elusive, based on a previous case of generalized BP sparing an area of postsurgical lymphoedema.     

A Systematic Review of the Effectiveness of Contrast Baths

Study DesignSystematic review.IntroductionContrast baths are used as an intervention in hand therapy, yet it is unclear which patients, if any, benefit from this intervention.Purpose of the StudyTo examine the nature and quality of the evidence regarding the use of contrast baths using a systematic review process.MethodsOf a total of 28 clinical research articles on contrast baths, from 1938 forward, ten met the inclusion criteria set by the authors.ResultsThese studies addressed the physiological changes of hot and cold on blood flow, intramuscular temperature, subcutaneous temperature, and the influence of room temperature and age. The subjects included normal/healthy volunteers and patients with a diagnosis of rheumatoid arthritis, diabetes, or foot/ankle injuries. The diversity of conditions, protocols, and outcomes limited the ability to make definitive conclusions on efficacy.ConclusionsThe contrast bath procedure may increase superficial blood flow and skin temperature, though the evidence on the impact on edema is conflicting. No relationship between physiologic effects and functional outcomes has been established.Level of Evidence: 2A     

The effect of ethanol intake on tendon healing: a histological and biomechanical study in a rat model

Introduction  

Ethanol has a suppressive effect on inflammation and the immune system, but the effect of ethanol on tendon healing in vivo has not been studied. The purpose of this study was to investigate the histological and biomechanical effects of ethanol intake on tendon healing in a rat tendon injury model.