Baylor Research Institute

Roden-Foreman, J. W., M. M. Bennett, E. E. Rainey, J. S. Garrett, M. B. Powers and A. M. Warren (2017). “Secondary traumatic stress in emergency medicine clinicians.” Cogn Behav Ther: 1-11.

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Previously called Secondary Traumatic Stress (STS), secondary exposure to trauma is now considered a valid DSM-5 Criterion A stressor for posttraumatic stress disorder (PTSD). Previous studies have found high rates of STS in clinicians who treat traumatically injured patients. However, little research has examined STS among Emergency Medicine (EM) physicians and advanced practice providers (APPs). The current study enrolled EM providers (N = 118) working in one of 10 hospitals to examine risk factors, protective factors, and the prevalence of STS in this understudied population. Most of the participants were physicians (72.9%), Caucasian (85.6%), and male (70.3%) with mean age of 39.7 (SD = 8.9). Overall, 12.7% of the sample screened positive for STS with clinical levels of intrusion, arousal, and avoidance symptom clusters, and 33.9% had at least one symptom cluster at clinical levels. Low resilience and a history of personal trauma were positively associated with positive STS screens and STS severity scores. Borderline significance suggested that female gender and spending >/=10% of one’s time with trauma patients could be additional risk factors. Findings suggest that resilience-building interventions may be beneficial.

Lindner, P., A. Miloff, W. Hamilton, L. Reuterskiold, G. Andersson, M. B. Powers and P. Carlbring (2017). “Creating state of the art, next-generation Virtual Reality exposure therapies for anxiety disorders using consumer hardware platforms: design considerations and future directions.” Cogn Behav Ther: 1-17.

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Decades of research and more than 20 randomized controlled trials show that Virtual Reality exposure therapy (VRET) is effective in reducing fear and anxiety. Unfortunately, few providers or patients have had access to the costly and technical equipment previously required. Recent technological advances in the form of consumer Virtual Reality (VR) systems (e.g. Oculus Rift and Samsung Gear), however, now make widespread use of VRET in clinical settings and as self-help applications possible. In this literature review, we detail the current state of VR technology and discuss important therapeutic considerations in designing self-help and clinician-led VRETs, such as platform choice, exposure progression design, inhibitory learning strategies, stimuli tailoring, gamification, virtual social learning and more. We illustrate how these therapeutic components can be incorporated and utilized in VRET applications, taking full advantage of the unique capabilities of virtual environments, and showcase some of these features by describing the development of a consumer-ready, gamified self-help VRET application for low-cost commercially available VR hardware. We also raise and discuss challenges in the planning, development, evaluation, and dissemination of VRET applications, including the need for more high-quality research. We conclude by discussing how new technology (e.g. eye-tracking) can be incorporated into future VRETs and how widespread use of VRET self-help applications will enable collection of naturalistic “Big Data” that promises to inform learning theory and behavioral therapy in general.

Hughes, D. A., K. Nicholls, S. P. Shankar, G. Sunder-Plassmann, D. Koeller, K. Nedd, G. Vockley, T. Hamazaki, R. Lachmann, T. Ohashi, I. Olivotto, N. Sakai, P. Deegan, D. Dimmock, F. Eyskens, D. P. Germain, O. Goker-Alpan, E. Hachulla, A. Jovanovic, C. M. Lourenco, I. Narita, M. Thomas, W. R. Wilcox, D. G. Bichet, R. Schiffmann, E. Ludington, C. Viereck, J. Kirk, J. Yu, F. Johnson, P. Boudes, E. R. Benjamin, D. J. Lockhart, C. Barlow, N. Skuban, J. P. Castelli, J. Barth and U. Feldt-Rasmussen (2017). “Oral pharmacological chaperone migalastat compared with enzyme replacement therapy in fabry disease: 18-month results from the randomised phase iii attract study.” J Med Genet 54(4): 288-296.

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BACKGROUND: Fabry disease is an X-linked lysosomal storage disorder caused by GLA mutations, resulting in alpha-galactosidase (alpha-Gal) deficiency and accumulation of lysosomal substrates. Migalastat, an oral pharmacological chaperone being developed as an alternative to intravenous enzyme replacement therapy (ERT), stabilises specific mutant (amenable) forms of alpha-Gal to facilitate normal lysosomal trafficking. METHODS: The main objective of the 18-month, randomised, active-controlled ATTRACT study was to assess the effects of migalastat on renal function in patients with Fabry disease previously treated with ERT. Effects on heart, disease substrate, patient-reported outcomes (PROs) and safety were also assessed. RESULTS: Fifty-seven adults (56% female) receiving ERT (88% had multiorgan disease) were randomised (1.5:1), based on a preliminary cell-based assay of responsiveness to migalastat, to receive 18 months open-label migalastat or remain on ERT. Four patients had non-amenable mutant forms of alpha-Gal based on the validated cell-based assay conducted after treatment initiation and were excluded from primary efficacy analyses only. Migalastat and ERT had similar effects on renal function. Left ventricular mass index decreased significantly with migalastat treatment (-6.6 g/m2 (-11.0 to -2.2)); there was no significant change with ERT. Predefined renal, cardiac or cerebrovascular events occurred in 29% and 44% of patients in the migalastat and ERT groups, respectively. Plasma globotriaosylsphingosine remained low and stable following the switch from ERT to migalastat. PROs were comparable between groups. Migalastat was generally safe and well tolerated. CONCLUSIONS: Migalastat offers promise as a first-in-class oral monotherapy alternative treatment to intravenous ERT for patients with Fabry disease and amenable mutations.

Havrdova, E., G. Giovannoni, R. Gold, R. J. Fox, L. Kappos, J. T. Phillips, M. Okwuokenye and J. L. Marantz (2017). “Effect of delayed-release dimethyl fumarate on no evidence of disease activity in relapsing-remitting multiple sclerosis: Integrated analysis of the phase iii define and confirm studies.” Eur J Neurol: 2017 Mar [Epub ahead of print].

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BACKGROUND AND PURPOSE: Significant effects on clinical/neuroradiological disease activity have been reported in patients with relapsing-remitting multiple sclerosis treated with delayed-release dimethyl fumarate (DMF) in phase III DEFINE/CONFIRM trials. We conducted a post hoc analysis of integrated data from DEFINE/CONFIRM to evaluate the effect of DMF on achieving no evidence of disease activity (NEDA) in patients with relapsing-remitting multiple sclerosis. METHODS: The analysis included patients randomized to DMF 240 mg twice daily, placebo or glatiramer acetate (CONFIRM only) for

McCullough, P. A., J. Zhang and C. Ronco (2017). “Volume expansion and contrast-induced acute kidney injury.” Lancet: 2017 Feb [Epub ahead of print].

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There is an ever-increasing population at risk of being exposed to intravascular iodinated contrast because of the increasingly popular practice of imaging techniques in medicine and surgery. Despite efforts to improve the safety of these agents, there has been no fundamental improvement in contrast product development since the introduction of iso-osmolar contrast more than 20 years ago.1; 2 ; 3 Thus, clinicians have focused on strategies to decrease the risk of contrast-induced acute kidney injury by limiting contrast volume, giving adjuvant agents, and providing supportive care once the renal damage has occurred. It has been suggested that intravascular volume expansion with isotonic crystalloid solution can decrease the incidence and the severity of contrast-induced acute kidney injury.4 This approach is attractive because the short-term administration of intravenous fluid results in an increase in renal blood flow, glomerular filtration, and increased volume of urine flow through the tubular segments of the nephron. Forced diuresis has been associated with a lesser rise in serum creatinine especially when higher rates (>150 ml/h) of urine flow have been achieved.5