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Lavery L.A.,Southwestern University | Fulmer J.,River City Clinical Research | Shebetka K.A.,Clinical Trials of Texas | Regulski M.,Ocean County Foot and Ankle | And 15 more authors.
International Wound Journal | Year: 2014

In a randomised, controlled study, we compared the efficacy of Grafix®, a human viable wound matrix (hVWM) (N = 50), to standard wound care (n = 47) to heal diabetic foot ulcers (DFUs). The primary endpoint was the proportion of patients with complete wound closure by 12 weeks. Secondary endpoints included the time to wound closure, adverse events and wound closure in the crossover phase. The proportion of patients who achieved complete wound closure was significantly higher in patients who received Grafix (62%) compared with controls (21%, P = 0·0001). The median time to healing was 42 days in Grafix patients compared with 69·5 days in controls (P = 0·019). There were fewer Grafix patients with adverse events (44% versus 66%, P = 0·031) and fewer Grafix patients with wound-related infections (18% versus 36·2%, P = 0·044). Among the study subjects that healed, ulcers remained closed in 82·1% of patients (23 of 28 patients) in the Grafix group versus 70% (7 of 10 patients) in the control group (P = 0·419). Treatment with Grafix significantly improved DFU healing compared with standard wound therapy. Importantly, Grafix also reduced DFU-related complications. The results of this well-controlled study showed that Grafix is a safe and more effective therapy for treating DFUs than standard wound therapy. © 2014 The Authors. Source


Rizzo A.,University of Southern California | Hartholt A.,University of Southern California | Rothbaum B.,Emory University | Difede J.,Cornell College | And 7 more authors.
Studies in Health Technology and Informatics | Year: 2014

The stressful experiences that have been characteristic of the combat environments in Iraq and Afghanistan have produced significant numbers of returning service members at risk for developing posttraumatic stress disorder and other psychosocial/behavioral health conditions. This paper describes a set of projects that are expanding the content for inclusion in a newly updated 'Virtual Iraq/Afghanistan' Virtual Reality system for the delivery of exposure therapy (VRET) for PTSD with Service Members and Veterans. In addition to the complete rebuilding of this VRET system using the latest version of the Unity Game Engine, the system's content and functionality has been expanded to now support the use of VRET with combat medics/corpsmen and persons who have experienced military sexual trauma (MST). The focus of this paper is to present the rationale and general overview of the progress on these projects that will provide new relevant and customizable options for conducting VRET with a wider range of trauma experiences. © 2014 The authors and IOS Press. All rights reserved. Source


Hamilton A.B.,University of California at Los Angeles | Hamilton A.B.,Greater Los Angeles Healthcare Center | Cohen A.N.,University of California at Los Angeles | Cohen A.N.,Greater Los Angeles Healthcare Center | And 8 more authors.
Health Services Research | Year: 2013

Objective Study a quality improvement approach for implementing evidence-based employment services at specialty mental health clinics. Data Sources/Study Setting Semistructured interviews with clinicians and administrators before, during, and after implementation. Qualitative field notes, structured baseline and follow-up interviews with patients, semistructured interviews with patients after implementation, and administrative data. Study Design Site-level controlled trial at four implementation and four control sites. Hybrid implementation-effectiveness study with mixed methods intervention evaluation design. Data Collection/Extraction Methods Site visits, in-person and telephone interviews, patient surveys, patient self-assessment. A total of 801 patients completed baseline surveys and 53 clinicians and other clinical key stakeholders completed longitudinal qualitative interviews. Principal Findings At baseline, sites varied in the availability, utilization, and quality of supported employment. Each site needed quality improvement for this service, though for differing reasons, with some needing development of the service itself and others needing increased service capacity. Improvements in knowledge, attitudes, beliefs, and referral behaviors were evident in mid- and postimplementation interviews, though some barriers persisted. Half of patients expressed an interest in working at baseline. Patients at implementation sites were 2.3 times more likely to receive employment services during the study year. Those who had a service visit were more likely to be employed at follow-up than those who did not. Conclusions Studies of implementation and effectiveness require mixed methods to both enhance implementation in real time and provide context for interpretation of complex results. In this study, a quality improvement approach resulted in superior patient-level outcomes and improved clinician knowledge, attitudes, and behaviors, in the context of substantial variation among sites. © Health Research and Educational Trust. Source

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