by
Eunice Abdul Remane Jethá;
Catherine Lynch;
Debra Houry;
Maria Alexandra Rodrigues;
Christine Keyes;
Baltazar Chilundo;
David Wright;
Scott M. Sasser
Background: Family violence (FV) is a global health problem that not only impacts the victim, but the family unit, local community and society at large. Objective: To quantitatively and qualitatively evaluate the treatment and follow up provided to victims of violence amongst immediate and extended family units who presented to three health centers in Mozambique for care following violence. Methods: We conducted a verbally-administered survey to self-disclosed victims of FV who presented to one of three health units, each at a different level of service, in Mozambique for treatment of their injuries. Data were entered into SPSS (SPSS, version 13.0) and analyzed for frequencies. Qualitative short answer data were transcribed during the interview, coded and analyzed prior to translation by the principal investigator. Results: One thousand two hundred and six assault victims presented for care during the eight-week study period, of which 216 disclosed the relationship of the assailant, including 92 who were victims of FV. Almost all patients (90%) waited less than one hour to be seen, with most patients (67%) waiting less than 30 minutes. Most patients did not require laboratory or radiographic diagnostics at the primary (70%) and secondary (93%) health facilities, while 44% of patients received a radiograph at the tertiary care center. Among all three hospitals, only 10% were transferred to a higher level of care, 14% were not given any form of follow up or referral information, while 13% required a specialist evaluation. No victims were referred for psychological follow-up or support. Qualitative data revealed that some patients did not disclose violence as the etiology, because they believed the physician was unable to address or treat the violence-related issues and/or had limited time to discuss. Conclusion: Healthcare services for treating the physical injuries of victims of FV were timely and rarely required advanced levels of medical care, but there were no psychological services or follow-up referrals for violence victims. The healthcare environment at all three surveyed health centers in Mozambique does not encourage disclosure or self-report of FV. Policies and strategies need to be implemented to encourage patient disclosure of FV and provide more health system-initiated victim resources.
The sex hormone progesterone has been shown to improve outcomes in animal models of a number of neurologic diseases, including traumatic brain injury, ischemia, spinal cord injury, peripheral nerve injury, demyelinating disease, neuromuscular disorders, and seizures. Evidence suggests it exerts its neuroprotective effects through several pathways, including reducing edema, improving neuronal survival, and modulating inflammation and apoptosis. In this review, we summarize the functional outcomes and pathophysiologic mechanisms attributed to progesterone treatment in neurologic disease. We then comment on the breadth of evidence for the use of progesterone in each neurologic disease family. Finally, we provide support for further human studies using progesterone to treat several neurologic diseases.
Repetitive head impacts (RHI) are a growing concern due to their possible neurocognitive effects, with research showing a season of RHI produce white matter (WM) changes seen on neuroimaging. We conducted a secondary analysis of diffusion tensor imaging (DTI) data for 28 contact athletes to compare WM changes. We collected pre-season and post-season DTI scans for each subject, approximately 3 months apart. We collected helmet data for the athletes, which we correlated with DTI data. We adapted the SPatial REgression Analysis of DTI (SPREAD) algorithm to conduct subject-specific longitudinal DTI analysis, and developed global inferential tools using functional norms and a novel robust p value combination test.
At the individual level, most detected injured regions (93.3%) were associated with decreased FA values. Using meta-analysis techniques to combine injured regions across subjects, we found the combined injured region at the group level occupied the entire WM skeleton, suggesting the WM damage location is subject-specific. Several subject-specific functional summaries of SPREAD-detected WM change, e.g., the L∞ norm, significantly correlated with helmet impact measures, e.g. cumulative unweighted rotational acceleration (adjusted p = 0.0049), time between hits rotational acceleration (adjusted p value 0.0101), and time until DTI rotational acceleration (adjusted p = 0.0084), suggesting RHIs lead to WM changes.
by
David N. Hager;
Michael H. Hooper;
Gordon R. Bernard;
Laurence Busse;
E. Wesley Ely;
Alpha A. Fowler;
David F. Gaieski;
Alex Hall;
Jeremiah S. Hinson;
James C. Jackson;
Gabor D. Kelen;
Mark Levine;
Christopher J. Lindsell;
Richard E. Malone;
Anna McGlothlin;
Richard E. Rothman;
Kert Viele;
David Wright;
Jonathan Sevransky;
Gregory Martin
Background: Sepsis accounts for 30% to 50% of all in-hospital deaths in the United States. Other than antibiotics and source control, management strategies are largely supportive with fluid resuscitation and respiratory, renal, and circulatory support. Intravenous vitamin C in conjunction with thiamine and hydrocortisone has recently been suggested to improve outcomes in patients with sepsis in a single-center before-and-after study. However, before this therapeutic strategy is adopted, a rigorous assessment of its efficacy is needed. Methods: The Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) trial is a prospective, multi-center, double-blind, adaptive sample size, randomized, placebo-controlled trial. It will enroll patients with sepsis causing respiratory or circulatory compromise or both. Patients will be randomly assigned (1:1) to receive intravenous vitamin C (1.5 g), thiamine (100 mg), and hydrocortisone (50 mg) every 6 h or matching placebos until a total of 16 administrations have been completed or intensive care unit discharge occurs (whichever is first). Patients randomly assigned to the comparator group are permitted to receive open-label stress-dose steroids at the discretion of the treating clinical team. The primary outcome is consecutive days free of ventilator and vasopressor support (VVFDs) in the 30 days following randomization. The key secondary outcome is mortality at 30 days. Sample size will be determined adaptively by using interim analyses with pre-stated stopping rules to allow the early recognition of a large mortality benefit if one exists and to refocus on the more sensitive outcome of VVFDs if an early large mortality benefit is not observed. Discussion: VICTAS is a large, multi-center, double-blind, adaptive sample size, randomized, placebo-controlled trial that will test the efficacy of vitamin C, thiamine, and hydrocortisone as a combined therapy in patients with respiratory or circulatory dysfunction (or both) resulting from sepsis. Because the components of this therapy are inexpensive and readily available and have very favorable risk profiles, demonstrated efficacy would have immediate implications for the management of sepsis worldwide.
by
Christopher J. Lindsell;
Anna McGlothlin;
Samuel Nwosu;
Todd W. Rice;
Alex Hall;
Gordon R. Bernard;
Laurence Busse;
E. Wesley Ely;
Alpha A. Fowler;
David F. Gaieski;
Jeremiah S. Hinson;
Michael H. Hooper;
James C. Jackson;
Gabor D. Kelen;
Mark Levine;
Gregory Martin;
Richard E. Rothman;
Jonathan Sevransky;
Kert Viele;
David Wright;
David N. Hager
BACKGROUND: Observational research suggests that combined therapy with Vitamin C, thiamine and hydrocortisone may reduce mortality in patients with septic shock. METHODS AND DESIGN: The Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) trial is a multicenter, double-blind, adaptive sample size, randomized, placebo-controlled trial designed to test the efficacy of combination therapy with vitamin C (1.5 g), thiamine (100 mg), and hydrocortisone (50 mg) given every 6 h for up to 16 doses in patients with respiratory or circulatory dysfunction (or both) resulting from sepsis. The primary outcome is ventilator- and vasopressor-free days with mortality as the key secondary outcome. Recruitment began in August 2018 and is ongoing; 501 participants have been enrolled to date, with a planned maximum sample size of 2000. The Data and Safety Monitoring Board reviewed interim results at N = 200, 300, 400 and 500, and has recommended continuing recruitment. The next interim analysis will occur when N = 1000. This update presents the statistical analysis plan. Specifically, we provide definitions for key treatment and outcome variables, and for intent-to-treat, per-protocol, and safety analysis datasets. We describe the planned descriptive analyses, the main analysis of the primary end point, our approach to secondary and exploratory analyses, and handling of missing data. Our goal is to provide enough detail that our approach could be replicated by an independent study group, thereby enhancing the transparency of the study. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03509350. Registered on 26 April 2018.
Ocular fundus examination is a critical part of the physical examination in patients with severely elevated blood pressure (BP), which is defined by the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7) as a BP exceeding 180/120 mm Hg. Indeed, the presence or absence of severe, grade III/IV hypertensive retinopathy helps differentiate hypertensive emergencies requiring intensive care from less severe hypertensive urgencies. As a secondary analysis in the Fundus photography versus Ophthalmoscopy Trial Outcomes in the Emergency Department (FOTO-ED) study, we sought to explore potential risk factors, in particular BP, for the presence of ocular fundus abnormalities relevant to the care of emergency department (ED) patients. We found evidence of acute end-organ ocular damage at lower blood pressures than the JNC7 criteria.
Objectives
Examination of the ocular fundus is imperative in many acute medical and neurologic conditions, but direct ophthalmoscopy by non-ophthalmologists is underutilized, poorly performed, and difficult without pharmacologic pupillary dilation. The objective was to examine the feasibility of non-mydriatic fundus photography as a clinical alternative to direct ophthalmoscopy by emergency physicians (EPs).
Methods
Adult patients presenting to the emergency department (ED) with headache, acute focal neurologic deficit, diastolic blood pressure ≥ 120 mmHg, or acute visual change had ocular fundus photographs taken by nurse practitioners using a non-mydriatic fundus camera. Photographs were reviewed by a neuro-ophthalmologist within 24 hours for findings relevant to acute ED patient care. Nurse practitioners and patients rated ease, comfort, and speed of non-mydriatic fundus photography on a 10-point Likert scale (10 best). Timing of visit and photography were recorded by automated electronic systems.
Results
Three hundred fifty patients were enrolled. There were 1,734 photographs taken during 230 nurse practitioner shifts. Eighty-three percent of the 350 patients had at least one eye with a high quality photograph, while only 3% of patients had no photographs of diagnostic value. Mean ratings were ≥ 8.7 (standard deviation [SD] ≤ 1.9) for all measures. The median photography session lasted 1.9 minutes (interquartile range [IQR] 1.3 to 2.9 minutes), typically accounting for less that 0.5% of the patient’s total ED visit.
Conclusions
Non-mydriatic fundus photography taken by nurse practitioners is a feasible alternative to direct ophthalmoscopy in the ED. It is performed well by non-physician staff, is well-received by staff and patients, and requires a trivial amount of time to perform.
Examination of the ocular fundus is imperative in the diagnosis and treatment of many acute medical and neurologic conditions, but direct ophthalmoscopy is underused and difficult to perform without pharmacologic pupillary dilation. We believe that nonmydriatic ocular fundus photography (i.e., performed without pupillary dilation) represents a promising alternative to direct ophthalmoscopy, particularly in the emergency department, where limited training in ophthalmoscopy, increased demands on physicians' time, and underappreciation of the prognostic value of ocular fundus examination can place patients at risk for poor outcomes and expose their caregivers to medicolegal liability. The FOTO-ED (Fundus Photography vs. Ophthalmoscopy Trial Outcomes in the Emergency Department) study hypothesized that the use of nonmydriatic fundus photography in the emergency department would result in increased detection of abnormalities in the ocular fundus relevant to emergency-department care, a majority of which would be missed during routine clinical practice in the department.
Objective: Non-mydriatic fundus photography by non-ophthalmic trained personnel has recently been shown to be a potential alternative to direct ophthalmoscopy in the emergency department (ED). We evaluated the reliability of a novel quality rating scale and applied this scale to non-mydriatic fundus photographs taken during routine ED patient encounters to determine factors associated with diminished photograph quality.
Design: Prospective, cross-sectional
Participants: 350 patients enrolled in the Fundus photography vs. Ophthalmoscopy Trials Outcomes in the Emergency Department (FOTO-ED) study were photographed by nurse practitioners after <30 minutes of training followed by supervision.
Methods: Photographs of both eyes were graded for quality on two occasions by two neuro-ophthalmologists. Four regions were independently evaluated for quality: optic disc, macula, superior and inferior vascular arcades. Quality as a function of the number of photographs taken was evaluated by Kaplan-Meier analysis. Mixed effects ordinal logistic regression was used to evaluate for predictors of image quality while accounting for the repeated measures design.
Main Outcome Measure: Overall photographic quality (1–5 scale, 5 best).
Results: We evaluated 1734 photographs. Inter- and intra-observer agreements between neuro-ophthalmologists were very good (weighted kappa:0.84–0.87). Quality of the optic disc area was better than those of other retinal areas (p<0.002). Kaplan-Meier analysis showed that if a high-quality photograph of an eye was not obtained by the third attempt it was unlikely that one would be obtained at all. A 10 second increase in the inter-photograph interval before a total of forty seconds increased the odds of a one unit higher quality rating by 1.81 times (95%CI: 1.68–1.98), and a ten year increase in age decreased the odds by 0.76 times (95%CI: 0.69–0.85). Black patients had 0.42 times (95%CI: 0.28–0.63) the odds of a one unit higher quality rating compared to whites.
Conclusions: Our 5-point scale is a reliable measure of non-mydriatic photograph quality. The region of interest, interphotograph interval, age, and race are significant predictors of image quality for non-mydriatic photographs taken by nurse practitioners in the ED. Addressing these factors may have a direct impact on the successful implementation of non-mydriatic fundus photography into the ED.