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Subglottic Secretion Aspiration In The Prevention Of Ventilator-Associated Pneumonia: A Review Of The Literature., Rachel Scherzer

Jefferson Hospital Staff Papers and Presentations

Ventilator-associated pneumonia is a common nosocomial infection that results in both negative patient outcomes and increased health care costs. Recently, many efforts have been targeted at ventilator-associated pneumonia prevention, including the practice of subglottic secretion aspiration. Six randomized control studies examining the effectiveness of subglottic secretion aspiration in the prevention of ventilator-associated pneumonia were reviewed for this article. Results consistently show that subglottic secretion aspiration significantly reduces the incidence of ventilator-associated pneumonia in a variety of patient populations. Despite these findings, this practice is limited in clinical settings. This clinical practice should be implemented in individuals requiring mechanical ventilation to …

Wild-Type And Mutant Sod1 Share An Aberrant Conformation And A Common Pathogenic Pathway In Als., Daryl A Bosco, Gerardo Morfini, N Murat Karabacak, Yuyu Song, Francois Gros-Louis, Piera Pasinelli, Holly Goolsby, Benjamin A Fontaine, Nathan Lemay, Diane Mckenna-Yasek, Matthew P Frosch, Jeffrey N Agar, Jean-Pierre Julien, Scott T Brady, Robert H Brown

Farber Institute for Neuroscience Faculty Papers

Many mutations confer one or more toxic function(s) on copper/zinc superoxide dismutase 1 (SOD1) that impair motor neuron viability and cause familial amyotrophic lateral sclerosis (FALS). Using a conformation-specific antibody that detects misfolded SOD1 (C4F6), we found that oxidized wild-type SOD1 and mutant SOD1 share a conformational epitope that is not present in normal wild-type SOD1. In a subset of human sporadic ALS (SALS) cases, motor neurons in the lumbosacral spinal cord were markedly C4F6 immunoreactive, indicating that an aberrant wild-type SOD1 species was present. Recombinant, oxidized wild-type SOD1 and wild-type SOD1 immunopurified from SALS tissues inhibited kinesin-based fast axonal …

Automated Classification Of Breast Pathology Using Local Measures Of Broadband Reflectance, Ashley M. Laughney, Venkataramanan Krishnaswamy, Pilar Beatriz Garcia-Allende, Olga M. Conde, Wendy A. Wells, Keith D. Paulsen, Brian W. Pogue

Dartmouth Scholarship

We demonstrate that morphological features pertinent to a tissue's pathology may be ascertained from localized measures of broadband reflectance, with a mesoscopic resolution (100-μm lateral spot size) that permits scanning of an entire margin for residual disease. The technical aspects and optimization of a k-nearest neighbor classifier for automated diagnosis of pathologies are presented, and its efficacy is validated in 29 breast tissue specimens. When discriminating between benign and malignant pathologies, a sensitivity and specificity of 91 and 77% was achieved. Furthermore, detailed subtissue-type analysis was performed to consider how diverse pathologies influence scattering response and overall classification efficacy. The …

Image Guided Near-Infrared Spectroscopy Of Breast Tissue In Vivo Using Boundary Element Method, Subhadra Srinivasan, Colin M. Carpenter, Hamid R. Ghadyani, Senate J. Taka, Peter A. Kaufman, Roberta M. Diflorio-Alexander, Wendy A. Wells, Brian W. Pogue, Keith D. Paulsen

Dartmouth Scholarship

We demonstrate quantitative functional imaging using image-guided near-infrared spectroscopy (IG-NIRS) implemented with the boundary element method (BEM) for reconstructing 3-D optical property estimates in breast tissue in vivo. A multimodality MRI-NIR system was used to collect measurements of light reflectance from breast tissue. The BEM was used to model light propagation in 3-D based only on surface discretization in order to reconstruct quantitative values of total hemoglobin (HbT), oxygen saturation, water, and scatter. The technique was validated in experimental measurements from heterogeneous breast-shaped phantoms with known values and applied to a total of seven subjects comprising six healthy individuals …

Should We Be Concerned About Jejunoileal Atresia During Repair Of Duodenal Atresia?, Shawn D. St Peter, Danny C. Little, Katherine A. Barsness, Daniel R. Copeland, Casey M. Calkins, Suzanne Yoder, Steve S. Rothenberg, Saleem Islam, Kuojen Tsao, Daniel J. Ostlie

Manuscripts, Articles, Book Chapters and Other Papers

INTRODUCTION: During repair for duodenal atresia, it has been emphasized that inspection of the small bowel to identify a second atresia is required. The laparoscopic approach for repair of duodenal atresia has been criticized for its limitation to perform this step. Given that duodenal atresia and jejunoileal atresias do not share common embryologic origins, we question the validity of this concern. Therefore, we conducted a multicenter retrospective review of duodenal atresia patients to quantify the incidence of jejunoileal atresia in this population.

METHODS: After institutional review board approval (IRB #07-12-187X), a retrospective review was conducted on all patients who have …

Plant Phenolics: Extraction, Analysis And Their Antioxidant And Anticancer Properties, Jin Dai, Russell J. Mumper

Pharmaceutical Sciences Faculty Publications

Phenolics are broadly distributed in the plant kingdom and are the most abundant secondary metabolites of plants. Plant polyphenols have drawn increasing attention due to their potent antioxidant properties and their marked effects in the prevention of various oxidative stress associated diseases such as cancer. In the last few years, the identification and development of phenolic compounds or extracts from different plants has become a major area of health- and medical-related research. This review provides an updated and comprehensive overview on phenolic extraction, purification, analysis and quantification as well as their antioxidant properties. Furthermore, the anticancer effects of phenolics in-vitro …

Limitations Of The Knee Society Score In Evaluating Outcomes Following Revision Total Knee Arthroplasty., Elie Ghanem, Ian Pawasarat, Adam Lindsay, Lauren May, Khalid Azzam, Ashish Joshi, Javad Parvizi

Department of Orthopaedic Surgery Faculty Papers

BACKGROUND: Traditionally, the results of revision total knee arthroplasty have been determined with use of surgeon-based measures such as the Knee Society rating system. Recently, outcome and quality-of-life measures have shifted toward a greater emphasis on patient-based evaluation. The aim of our study was to determine the validity and responsiveness of the Knee Society rating system compared with the Short Form-36 health survey (SF-36), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and a four-question 4-point Likert scale satisfaction questionnaire following revision total knee arthroplasty.

METHODS: A total of 152 patients underwent revision total knee arthroplasty at our institution, between …

Differential Regulation Of P53 Function By The N-Terminal Δnp53 And Δ113p53 Isoforms In Zebrafish Embryos., William R Davidson, Csaba Kari, Qing Ren, Borbala Daroczi, Adam P Dicker, Ulrich Rodeck

Department of Radiation Oncology Faculty Papers

BACKGROUND: The p53 protein family coordinates stress responses of cells and organisms. Alternative promoter usage and/or splicing of p53 mRNA gives rise to at least nine mammalian p53 proteins with distinct N- and C-termini which are differentially expressed in normal and malignant cells. The human N-terminal p53 variants contain either the full-length (FL), or a truncated (ΔN/Δ40) or no transactivation domain (Δ133) altogether. The functional consequences of coexpression of the different p53 isoforms are poorly defined. Here we investigated functional aspects of the zebrafish ΔNp53 ortholog in the context of FLp53 and the zebrafish Δ133p53 ortholog (Δ113p53) coexpressed in the …

Patient-Orientated Longitudinal Study Of Multiple Sclerosis In South West England (The South West Impact Of Multiple Sclerosis Project, Swims) 1: Protocol And Baseline Characteristics Of Cohort., John P. Zajicek, Wendy M. Ingram, Jane Vickery, Siobhan Creanor, Dave E. Wright, Jeremy C. Hobart

Peninsula Medical School

BACKGROUND: There is a need for greater understanding of the impact of multiple sclerosis (MS) from the perspective of individuals with the condition. The South West Impact of MS Project (SWIMS) has been designed to improve understanding of disease impact using a patient-centred approach. The purpose is to (1) develop improved measurement instruments for clinical trials, (2) evaluate longitudinal performance of a variety of patient-reported outcome measures, (3) develop prognostic predictors for use in individualising drug treatment for patients, particularly early on in the disease course. METHODS: This is a patient-centred, prospective, longitudinal study of multiple sclerosis and clinically isolated …

Differential Effects Of Mindful Breathing, Progressive Muscle Relaxation, And Loving-Kindness Meditation On Decentering And Negative Reactions To Repetitive Thoughts., Greg Feldman, Jeffrey M. Greeson, Joanna Senville

College of Science & Mathematics Departmental Research

Decentering has been proposed as a potential mechanism of mindfulness-based interventions but has received limited empirical examination to date in experimental studies comparing mindfulness meditation to active comparison conditions. In the present study, we compared the immediate effects of mindful breathing (MB) to two alternative stress-management techniques: progressive muscle relaxation (PMR) and loving-kindness meditation (LKM) to test whether decentering is unique to mindfulness meditation or common across approaches. Novice meditators (190 female undergraduates) were randomly assigned to complete one of three 15-min stress-management exercises (MB, PMR, or LKM) presented by audio recording. Immediately after the exercise, participants completed measures of …

The Pathways To Mental Health Care Of First-Episode Psychosis Patients: A Systematic Review., Kelly K. Anderson, Rebecca Fuhrer, Ashok K. Malla

Epidemiology and Biostatistics Publications

BACKGROUND: Although there is agreement on the association between delay in treatment of psychosis and outcome, less is known regarding the pathways to care of patients suffering from a first psychotic episode. Pathways are complex, involve a diverse range of contacts, and are likely to influence delay in treatment. We conducted a systematic review on the nature and determinants of the pathway to care of patients experiencing a first psychotic episode.

METHOD: We searched four databases (Medline, HealthStar, EMBASE, PsycINFO) to identify articles published between 1985 and 2009. We manually searched reference lists and relevant journals and used forward citation …

Assessment Of Tobacco Dependence Curricula In U.S. Dental Hygiene Programs, Joan M. Davis, Anne Koerber

Journal Articles

Tobacco dependence education (TDE) continues to be a vital component of dental hygiene curricula-made even more important by the fact that tobacco cessation in adults in the United States has stagnated over the past ten years. This study was undertaken to assess the salient characteristics of TDE in U.S. dental hygiene programs. A fifty-one question survey was mailed to the program directors of all 283 accredited dental hygiene programs during the 2007-08 school year (this number does not include the programs in Illinois, which were excluded since they had participated in a previous study). A total of 187 schools returned …

End-Of-Life Care For Hospitalized Patients With Lung Cancer: Utilization Of A Palliative Care Service., Barbara Reville, M.S., Achpn, Marshal N Miller, B.S., Richard W Toner, M.S., Joanne Reifsnyder, Ph.D., Achpn

Department of Family & Community Medicine Faculty Papers

PURPOSE: High symptom burden and hospital mortality among patients with lung cancer argues for early palliative care intervention. Patient characteristics and discharge dispositions in hospitalized patients with lung cancer receiving usual care were compared to those referred to a new palliative care service.

METHODS: A retrospective database review of all lung cancer discharges receiving usual care (UC) and palliative care service (PCS) consultation was conducted. Demographics, length of stay, discharge disposition, and mortality were described and compared. Palliative Performance Scale scores were described according to discharge disposition in the PCS group. Disposition of all patients receiving either chemotherapy or surgery …

Alterations In Multiple Measures Of White Matter Integrity In Normal Women At High Risk For Alzheimer's Disease, Brian T. Gold, David K. Powell, Anders H. Andersen, Charles D. Smith

Neuroscience Faculty Publications

There is evidence that disruption of white matter (WM) microstructure is an early event in the course of Alzheimer's disease (AD). However, the neurobiological bases of WM microstructural declines in presymptomatic AD are unknown. In the present study we address this issue using a multimodal imaging approach to the study of presymptomatic AD. Participants were 37 high-risk (both family history of dementia and one or more APOE4 alleles) women and 20 low-risk (neither family history nor APOE4) women. Groups were matched for age, education, neuropsychological performance, and vascular factors that could affect white matter. Whole-brain analyses of diffusion tensor imaging …

Leg Ulcers In Sickle Cell Disease., Caterina P Minniti, James Eckman, Paola Sebastiani, Martin H Steinberg, Samir K. Ballas

Department of Medicine Faculty Papers

Sickle cell disease is a single amino acid molecular disorder of hemoglobin leading to its pathological polymerization, red cell rigidity that causes poor microvascular blood flow, with consequent tissue ischemia and infarction. The manifestations of this disease are protean.Among them, leg ulcers represent a particularly disabling and chronic complication, often associated with a more severe clinical course.Despite the fact that this complication has been recognized since the early times of SCD, there has been little improvement in the efficacy of its management and clinical outcome over the past 100 years. Recently, vasculopathic abnormalities involving abnormal vascular tone and activated, adhesive …

S100a1: A Multifaceted Therapeutic Target In Cardiovascular Disease., David Rohde, Julia Ritterhoff, Mirko Voelkers, Hugo A Katus, Thomas G Parker, Patrick Most

Department of Medicine Faculty Papers

Cardiovascular disease is the leading cause of death worldwide, showing a dramatically growing prevalence. It is still associated with a poor clinical prognosis, indicating insufficient long-term treatment success of currently available therapeutic strategies. Investigations of the pathomechanisms underlying cardiovascular disorders uncovered the Ca(2+) binding protein S100A1 as a critical regulator of both cardiac performance and vascular biology. In cardiomyocytes, S100A1 was found to interact with both the sarcoplasmic reticulum ATPase (SERCA2a) and the ryanodine receptor 2 (RyR2), resulting in substantially improved Ca(2+) handling and contractile performance. Additionally, S100A1 has been described to target the cardiac sarcomere and mitochondria, leading to …

Are Roadside Pedestrian Injury Patterns Predictable In A Densely Populated, Urban Setting?, Niels D. Martin, Daniel J. Grabo, Lili Tang, Jacqueline Sullivan, Kris R. Kaulback, Michael S. Weinstein, Gary A. Lindenbaum, Murray J. Cohen

Department of Surgery Faculty Papers

BACKGROUND: Roadside pedestrian injuries represent a significant portion of trauma team activations, especially at urban trauma centers. Patient demographics and severity of injury vary greatly in this patient population. Herein, we hypothesize that injury patterns may be predictable, especially with respect to age.

MATERIALS AND METHODS: All patients with roadside pedestrian injuries evaluated at our urban, level one trauma center from January 2006 through December 2008 were retrospectively reviewed. Data were collected from the institutional trauma registry. Age was used as an independent variable and compared with injury type, substance abuse, discharge setting, and mortality.

RESULTS: There were 226 roadside …

The Mir-15/107 Group Of Microrna Genes: Evolutionary Biology, Cellular Functions, And Roles In Human Diseases, John R. Finnerty, Wang-Xia Wang, Sébastien S. Hébert, Bernard R. Wilfred, Guogen Mao, Peter T. Nelson

Pathology and Laboratory Medicine Faculty Publications

The miR-15/107 group of microRNA (miRNA) gene is increasingly appreciated to serve key functions in humans. These miRNAs regulate gene expression involved in cell division, metabolism, stress response, and angiogenesis in vertebrate species. The miR-15/107 group has also been implicated in human cancers, cardiovascular disease and neurodegenerative disease, including Alzheimer's disease. Here we provide an overview of the following: (1) the evolution of miR-15/107 group member genes; (2) the expression levels of miRNAs in mammalian tissues; (3) evidence for overlapping gene-regulatory functions by different miRNAs; (4) the normal biochemical pathways regulated by miR-15/107 group miRNAs; and (5) the roles played …

Microrna-21 Dysregulates The Expression Of Mef2c In Neurons In Monkey And Human Siv/Hiv Neurological Disease., Sowmya V. Yelamanchili, A Datta Chaudhuri, L N. Chen, Huangui Xiong, Howard S. Fox

Journal Articles: Pharmacology & Experimental Neuroscience

MicroRNAs (miRNAs) play important roles in regulating a plethora of physiological and pathophysiogical processes including neurodegeneration. In both HIV associated dementia in humans and its monkey model SIV encephalitis we find miR-21, a miRNA largely known for its link to oncogenesis, to be significantly upregulated in the brain. In situ hybridization of the diseased brain sections revealed induction of miR-21 in neurons. MiR-21 can be induced in neurons by prolonged N-methyl-D-aspartic acid receptor stimulation, an excitotoxic process active in HIV and other neurodegenerative diseases. Introduction of miR-21 into human neurons leads to pathological functional defects. Furthermore, we show that miR-21 …

The Armadillo Repeat Protein Pf16 Is Essential For Flagellar Structure And Function In Plasmodium Male Gametes, Ursula Straschil, Arthur M. Talman, David J. P. Ferguson, Karen A. Bunting, Zhengyao Xu, Elizabeth Bailes, Robert E. Sinden, Anthony A. Holder, Elizabeth F. Smith

Dartmouth Scholarship

Malaria, caused by the apicomplexan parasite Plasmodium, threatens 40% of the world's population. Transmission between vertebrate and insect hosts depends on the sexual stages of the life-cycle. The male gamete of Plasmodium parasite is the only developmental stage that possesses a flagellum. Very little is known about the identity or function of proteins in the parasite's flagellar biology. Here, we characterise a Plasmodium PF16 homologue using reverse genetics in the mouse malaria parasite Plasmodium berghei. PF16 is a conserved Armadillo-repeat protein that regulates flagellar structure and motility in organisms as diverse as green algae and mice. We show that …

Maintenance Of Activity And Eating Change After A Clinical Trial Of Tailored Newsletters With Older Rural Women., Susan Noble Walker, Carol H. Pullen, Patricia A. Hageman, Linda S. Boeckner, Melody A. Hertzog, Maureen K. Oberdorfer, Matthew J. Rutledge

Journal Articles: College of Nursing

BACKGROUND: In the Wellness for Women Project, a randomized-by-site 1-year controlled clinical trial, the efficacy of generic newsletters and newsletters tailored on Health Promotion Model behavior-specific cognitions, eating behavior, and activity behavior were compared among 225 women aged 50 to 69 years.

OBJECTIVES: The purpose of this study was to compare the maintenance of change in healthy eating and physical activity over the 12 months following the tailored versus generic mailed newsletter intervention.

METHODS: Outcomes at 18 and 24 months included behavioral markers and biomarkers of physical activity and eating. Data were analyzed using the multivariate approach to repeated measures …

Public Health Systems And Services Research: Bridging The Practice-Research Gap., F. Douglas Scutchfield, Cynthia D. Lamberth

Preventive Medicine and Environmental Health Faculty Publications

Public health practitioners understand the principles of evidence-based practice

and the science that should drive their efforts to improve the community’s

health through the implementation of science-driven public health programs.

However, the translation of research to practice still has numerous barriers.

This commentary provides suggestions to strengthen the link between research

and practice.

Quantitative Imaging Reveals Heterogeneous Growth Dynamics And Treatment-Dependent Residual Tumor Distributions In A Three-Dimensional Ovarian Cancer Model, Jonathan P. Celli, Imran Rizvi, Conor L. Evans, Adnan O. Abu-Yousif, Tayyaba Hasan

Dartmouth Scholarship

Three-dimensional tumor models have emerged as valuable in vitro research tools, though the power of such systems as quantitative reporters of tumor growth and treatment response has not been adequately explored. We introduce an approach combining a 3-D model of disseminated ovarian cancer with high-throughput processing of image data for quantification of growth characteristics and cytotoxic response. We developed custom MATLAB routines to analyze longitudinally acquired dark-field microscopy images containing thousands of 3-D nodules. These data reveal a reproducible bimodal log-normal size distribution. Growth behavior is driven by migration and assembly, causing an exponential decay in spatial density concomitant with …

Mip/Mtmr14 And Muscle Aging, Scott K. Powers, Michael B. Reid

Physiology Faculty Publications

No abstract.

Comparing Implementations Of Magnetic-Resonance-Guided Fluorescence Molecular Tomography For Diagnostic Classification Of Brain Tumors, Scott C. Davis, Kimberley S. Samkoe, Julia A. O’Hara, Summer L. Gibbs-Strauss, Keith D. Paulsen, Brian W. Pogue

Dartmouth Scholarship

Fluorescence molecular tomography (FMT) systems coupled to conventional imaging modalities such as magnetic resonance imaging (MRI) and computed tomography provide unique opportunities to combine data sets and improve image quality and content. Yet, the ideal approach to combine these complementary data is still not obvious. This preclinical study compares several methods for incorporating MRI spatial prior information into FMT imaging algorithms in the context of in vivo tissue diagnosis. Populations of mice inoculated with brain tumors that expressed either high or low levels of epidermal growth factor receptor (EGFR) were imaged using an EGF-bound near-infrared dye and a spectrometer-based MRI-FMT …

Noninvasive Fluorescence Monitoring Of Protoporphyrin Ix Production And Clinical Outcomes In Actinic Keratoses Following Short-Contact Application Of 5-Aminolevulinate, Christine B. Warren, Sara Lohser, Lauren C. Wene, Brian W. Pogue, Philip Bailin, Edward Maytin

Dartmouth Scholarship

Topical 5-aminolevulinic acid (ALA) is widely used in photodynamic therapy (PDT) of actinic keratoses (AK), a type of premalignant skin lesion. However, the optimal time between ALA application and exposure to light has not been carefully investigated. Our objective is to study the kinetics of protoporphyrin IX (P_pIX) accumulation in AK after short contact ALA and relate this to erythemal responses. Using a noninvasive dosimeter, P_pIX fluorescence measurements (5 replicates) were taken at 20-min intervals for 2 h following ALA application, in 63 AK in 20 patients. Data were analyzed for maximal fluorescent signal obtained, kinetic …

Nona-Arginine Facilitates Delivery Of Quantum Dots Into Cells Via Multiple Pathways, Yi Xu, Betty Revon Liu, Han Jung Lee, Katie Shannon, Jeffrey G. Winiarz, Tien-Chun Wang, Huey-Jenn Chiang, Yue-Wern Huang

Biological Sciences Faculty Research & Creative Works

Semiconductor quantum dots (QDs) have recently been used to deliver and monitor biomolecules, such as drugs and proteins. However, QDs alone have a low efficiency of transport across the plasma membrane. In order to increase the efficiency, we used synthetic nona-arginine (SR9), a cell-penetrating peptide, to facilitate uptake. We found that SR9 increased the cellular uptake of QDs in a noncovalent binding manner between QDs and SR9. Further, we investigated mechanisms of QD/SR9 cellular internalization. Low temperature and metabolic inhibitors markedly inhibited the uptake of QD/SR9, indicating that internalization is an energy-dependent process. Results from both the pathway inhibitors and …

Efficacy Of Morning-Only Compared With Split-Dose Polyethylene Glycol Electrolyte Solution For Afternoon Colonoscopy: A Randomized Controlled Single-Blind Study., Rebecca Matro, Md, Anastasia Shnitser, Md, Maya Spodik, Md, Constantine Daskalakis, Sc.D, Leo Katz, Md, Alexandra Murtha, Ba, David Kastenberg, Md

Division of Internal Medicine Faculty Papers & Presentations

OBJECTIVES: Administering a purgative close to the time of colonoscopy is optimal for cleansing. The aim of this study was to compare the efficacy and tolerability of morning-only (AM-only) polyethylene glycol electrolyte solution (PEG-ELS) to split-dose (PM/AM) PEG-ELS for afternoon colonoscopy.

METHODS: This was a single-center, prospective, randomized, investigator-blinded, non-inferiority study comparing AM-only to PM/AM PEG-ELS for afternoon outpatient colonoscopy. The primary end point was whole colon prep adequacy. Tolerance and polyp detection were secondary outcomes.

RESULTS: Overall, 125 patients were randomized and 9 withdrew without taking any prep. Of 116 analyzed, 62 received AM-only prep and 54 received PM/AM …

The Intellectual And Moral Integrity Of Bioethics: Response To Commentaries On "A Case Study In Unethical Transgressive Bioethics: 'Letter Of Concern From Bioethicists' About The Prenatal Administration Of Dexamethasone"., Laurence B Mccullough, Frank A Chervenak, Robert L Brent, Benjamin Hippen

Department of Pediatrics Faculty Papers

In our target article we showed that the Letter of Concern (LoC) fails to meet accepted standards for presenting empirical data for the purpose of supplementing a normative claim and for argument-based normative ethics. The LoC fails to meet the standards of evidence-based reasoning by making false claims, failing to reference data that undermine its key premises, and misrepresenting and misinterpreting the scientific publications it selectively references. The LoC fails to meet the standards of argument-based reasoning by treating as settled matters what are, instead, ongoing controversies, offering “mere opinion” as a substitute for argument, and making contradictory claims. The …

A Case Study In Unethical Transgressive Bioethics: "Letter Of Concern From Bioethicists" About The Prenatal Administration Of Dexamethasone., Laurence B Mccullough, Frank A Chervenak, Robert L Brent, Benjamin Hippen

Department of Pediatrics Faculty Papers

On February 3, 2010, a "Letter of Concern from Bioethicists," organized by fetaldex.org, was sent to report suspected violations of the ethics of human subjects research in the off-label use of dexamethasone during pregnancy by Dr. Maria New. Copies of this letter were submitted to the FDA Office of Pediatric Therapeutics, the Department of Health and Human Services (DHHS) Office for Human Research Protections, and three universities where Dr. New has held or holds appointments. We provide a critical appraisal of the Letter of Concern and show that it makes false claims, misrepresents scientific publications and websites, fails to meet …