Publication Type
April Total
Articles
120
Editorial Material
6
Reviews
10
Total Publications Fiscal Year to Date:
Total
136
1,356
Publications in Top Quartile Journals 83 out of 136 (61.0%)
All rights reserved. Contents are the property of the authors and/or journals cited. Cover Image from “α-Galactosidase A-deficient rats accumulate glycosphingolipids and develop cardiorenal phenotypes of Fabry disease”
Ryan Spellecy, PhD Ursula von der Ruhr Professor of Bioethics Professor, Institute for Health and Equity Center for Bioethics and Medical Humanities Medical College of Wisconsin
I am a bioethicist who works primarily in research ethics. Just as physicians get ideas for research from their clinical practice, I get ideas for research from my work on the IRB. I have primarily worked on how to improve informed consent for research, which as a bioethicist, I see as an issue of respect for persons, or making sure that we respect the integrity of people deciding whether or not to enroll in a research study. I also study how to apply research ethics to community-based settings.
“Easy-to-Read Informed Consent Form for Hematopoietic Cell Transplantation Clinical Trials: Results from the Blood and Marrow Transplant Clinical Trials Network 1205 Study” Spellecy R, Tarima S, Denzen E, et al. Biol Blood Marrow Transplant. 2018;24(10):2145-2151. We tested a novel consent form template (ETRIC) in numerous blood and marrow transplant studies to learn if it was better (improved understanding, satisfaction, decreased anxiety and the time it takes for people to find information on the consent form) than the standard consent template. We developed ETRIC based on proven strategies to improve understanding and readability. We did not find that the ETRIC was better, although research participants, study staff, PIs and IRB staff all reported that they preferred ETRIC. We also found that many research participants decide whether to participate in research before they receive the consent form, or really don’t read it at all. This may not only explain why ETRIC was not better, but also suggest that efforts to improve informed consent, not just the paper but the entire process, should focus on aspects of the process other than the forms, particularly for cancer studies. Table 3: Themes related to barriers and facilitators to use of ETRIC format identified on evaluation study Interview Domain
Themes
Willingness to utilize and acceptability of ETRIC form
• •
Researchers and IRB’s are generally comfortable in using the ETRIC (two-column) form Local IRB-related factors can influence use of ETRIC form (e.g., flexibility in incorporating local IRB-specific language, challenges in having several consent formats within an institution, feedback and comfort level of IRB members)
Perceived value of ETRIC form
• • •
Formatting and layout enhancements will help research participants better locate information Will help health professionals and IRBs better explain trial (e.g., objectives, risks, benefits) to research participants ETRIC form will meet institutional standards for informed consent
Perceived barriers to implementation of ETRIC form
• •
•
Some center factors may hinder its use (e.g., length of consent form, local IRB and legal requirements, ability to use specific institutional language) Barriers specific to use by research participants (e.g., need for more graphics, consent length, use of plain language that is specific for hematopoietic cell transplantation) Barriers specific to use by health professionals and IRBs (e.g., consent length, duplication/redundancy of information, not familiar with two-column format, use of specific language) Failure to meet institutional standards (e.g., preference for single column format, IRB requirements around specific consent sections)
Previous experience with alternative consent forms
• • •
Variability in how participants review consent documents Variability in awareness of ETRIC form Variability in previous experience with using alternative consent forms
Educational resources for implementing ETRIC
•
Educational resources on ETRIC form will generally be helpful for research participants, research personnel, and IRBs
•
ETRIC – Easy-to-read informed consent; IRB – Institutional Review Board
Thomas W. Carver, MD Associate Professor Trauma and Critical Care Department of Surgery Medical College of Wisconsin
I joined the MCW faculty in 2013 following my Surgical Critical Care fellowship. My clinical focus is Trauma, Emergency General Surgery, and Surgical Critical Care. In addition to my clinical roles, I serve as the Medical Director of the Surgical Intensive Care Unit and am an Associate Program Director for the General Surgery Residency. My clinical interests have focused on thoracic trauma and the management of chest wall injuries, including the role of protocols to guide chest trauma management, the role of bedside functional studies following thoracic trauma, and quality of life after trauma. I have received grant funding to study the role of ketamine in chest trauma and have industry funding to further study the role of thoracic irrigation in the management of hemothoraces.
“Ketamine Infusion for Pain Control in Adult Patients with Multiple Rib Fractures: Results of a Randomized Control Trial” Carver TW, Kugler NW, Juul J. J Trauma Acute Care Surg. 2019;86(2):181-188. Our paper presents the results of the first randomized, double-blinded controlled trial of low dose ketamine (LDK) for the treatment of pain in patients with ≥3 rib fractures. This trial was pragmatically designed to include not just patients with isolated rib fractures, but the multiply injured population typically seen in trauma centers. While no difference was noted in pain scores or oral morphine equivalents (OME) within the entire cohort at 12, 24, or 48 hours, LDK significantly reduced OME utilization in severely injured patients (ISS >15), which suggests that our findings are related to the patients’ cumulative injuries. LDK may result in decreased opioid consumption within a group of severely injured patients, but additional studies are necessary to confirm this finding. Table 2. NPS and OMEs in All Subjects
Figure 2. Total OME in subset of ISS.
Saurabh Chhabra, MD, MS Assistant Professor of Medicine Division of Hematology/Oncology Department of Medicine Medical College of Wisconsin Scientific Director, Center for International Blood and Marrow Transplant Research
I am an Assistant Professor and a member of the Blood and Marrow Transplant & Cellular Therapy Program at Froedtert & MCW. I am also the Scientific Director of the Regimen-Related Toxicity Working Committee of the Center for International Blood and Marrow Transplant Research (CIBMTR). My clinical research is focused on the use of allogeneic hematopoietic cell transplantation and making it a safer treatment option for hematologic malignancies. I have been a principal investigator of several retrospective and prospective studies examining the efficacy of different prophylactic and therapeutic regimens against Graft-versus-HostDisease, a common complication after allogeneic transplant.
“Comparative Analysis of Calcineurin Inhibitor-Based Methotrexate and Mycophenolate Mofetil-Containing Regimens for Prevention of Graft-versusHost Disease after Reduced-Intensity Conditioning Allogeneic Transplantation� Chhabra S, Liu Y, Hemmer MT, et al. Biol Blood Marrow Transplant. 2019;25(1): 73-85. Calcineurin inhibitors such as tacrolimus (TAC) or cyclosporine (CYSP), in combination with methotrexate (MTX) or mycophenolate mofetil (MMF) have been used for GVHD prophylaxis after allogeneic transplant. We evaluated 1564 adult recipients of reduced-intensity conditioning transplant (2000-2013) receiving CYSP/TAC with MTX or MMF for GVHD prophylaxis using the CIBMTR database. Primary outcomes were acute and chronic GVHD and overall survival. For patients with unrelated donor, MMF-CYSP was associated with increased acute GVHD risk (vs. MTX-TAC) and MMFTAC (vs. MTX-TAC) led to higher non-relapse mortality, but there was no difference in chronic GVHD, disease-free and overall survival. For those with related donor, no difference was found in any outcome among the regimens. The results of the study suggested MMF-CYSP was inferior to MTXbased regimens for GVHD prevention in unrelated donor transplants. Figure 1.
Figure 3.
Adjusted curves for cumulative incidence of grade II-IV acute GVHD in matched sibling and unrelated donors using one of four GVHD prophylaxis regimens: MTX-TAC, MMF-TAC, MTX-CYSP, MMF-CYSP.
Adjusted curves for overall survival after reduced-intensity conditioning allogeneic transplant using one of the four GVHD prophylaxis regimens: MTX-TAC, MMF-TAC, MTX-CYSP, MMF-CYSP.
Ben Weston, MD, MPH Assistant Professor Division of EMS Medicine Department of Emergency Medicine Medical College of Wisconsin
I serve as Medical Director for Kenosha Fire Department and the Assistant Director of Medical Services for Milwaukee County. I am the Director of Mass Gathering and Event Medicine, having provided medical direction and oversight for events including NFL, NBA, MLB, Indycar, and USA Triathlon as well as other concerts and competitive sporting events. I am also the Assistant Program Director for the ACGME Emergency Medical Services Fellowship Program. I practice clinically in the emergency department at Froedtert Hospital. I received my baccalaureate degree at Lawrence University, my medical degree and master of public health from the University of Wisconsin School of Medicine and Public Health, and completed my emergency medicine residency at Hennepin County Medical Center. I am dual board-certified in Emergency Medicine as well as Emergency Medical Services by the American Board of Emergency Medicine after completing my Emergency Medical Services Fellowship at MCW. My research interests include prehospital care, resuscitation, and public health surveillance.
â&#x20AC;&#x153;Self-Assessment Feedback Form Improves Quality of Out-of-Hospital CPRâ&#x20AC;? Weston BW, Jasti J, Mena M, et al. Prehosp Emerg Care. 2018;17:1-8. Various continuous quality improvement (CQI) approaches have been used to improve quality of cardiopulmonary resuscitation (CPR) delivered at the scene of out-of-hospital cardiac arrest. We evaluated a post-event, self-assessment, CQI feedback form to determine its impact on delivery of CPR quality metrics. This before/after retrospective review evaluated data from a CQI program in a midsized urban emergency medical services (EMS) system using CPR quality metrics in adult patients with nontraumatic out-of-hospital cardiac arrest. Two nine-month periods, one before and one after implementation of the feedback form were evaluated. The feedback form was distributed to all EMS providers involved in the resuscitation within 72 hours for self-review. A total of 439 encounters before and 621 encounters after were evaluated including basic life support (BLS) and advanced life support (ALS) providers. The Before Group consisted of 408 patients while the After Group consisted of 556 patients. Overall, combining BLS and ALS Figure 1. CPR Feedback Form encounters, improvements were noted in chest compression depth (5.0 cm vs 5.5 cm; p<0.001), rate (109.6/min vs 114.8/min; p<0.001), fraction (79.2% vs 86.4%; p<0.001), and preshock pause (18.8 sec vs 11.8 sec; p<0.001). Goal achievement also improved in chest compression depth (48.5% vs 66.6%; p<0.001), fraction (68.1% vs 91.0%; p<0.001), and preshock pause (24.1% vs 59.5%; p<0.001).
Megan L. Schultz, MD, MA, FAAP Assistant Professor Pediatric Emergency Medicine Associate Director Global Health Pathway Children’s Hospital of Wisconsin Medical College of Wisconsin
I am a Pediatric Emergency Medicine physician at Children’s Hospital of Wisconsin. I went to medical school at the University of Wisconsin and got my Masters in Education at Johns Hopkins University. I completed pediatric residency at Massachusetts General Hospital and pediatric emergency fellowship at Medical College of Wisconsin. I am currently the Associate Director of the Global Health Pathway at MCW. My research interests lie at the intersection of medical education and global health, and my current research projects involve teaching procedural sedation to pediatric providers in Liberia and conducting a continentalwide survey of pediatric sedation practices in Africa.
“A Case of Toxic Breast-feeding?” Schultz ML, Kostic M, Kharasch S. Pediatr Emerg Care. 2019;35(1):e9-e10.
Opiates are frequently prescribed postpartum for pain relief after cesarean delivery, episiotomies, and headaches. It is estimated that greater than 30% of breast-feeding mothers in the United States are prescribed opiates for pain relief associated with childbirth. Many opiates are readily transferred to human milk, although life-threatening events are rare. We report a 6-day-old breast-feeding infant whose mother was taking hydromorphone for pain relief from a cesarean delivery and whose clinical course was suggestive of opiate toxicity. This case emphasizes the importance of thorough medication history taking in postpartum breast-feeding mothers whose infants may present with symptoms of opiate toxicity.
“Percutaneous Melody Valve Implantation in a Native Tricuspid Valve Following Failed Surgical Repair” Sumski CA, Bartz P, Gudausky T. Catheter Cardiovasc Interv. 2018;92(7):1334-1337. Disorders of the tricuspid valve can cause severe heart disease, leading to progressive exercise intolerance, right heart failure, and death. Increasingly, patients who have undergone tricuspid valve replacement have undergone transcatheter valve-in-valve replacement when their bioprosthetic valve deteriorates. Transcatheter valve replacement eliminates many of the risks of open cardiac surgery. To date, transcatheter valve replacements in the tricuspid and mitral valve positions have required a bioprosthetic valve or an annuloplasty ring to be present. We describe a case where a Melody valve was percutaneously implanted in a native tricuspid valve with severe stenosis following surgical repair.
Christopher A. Sumski, DO Pediatric Cardiology Fellow Instructor Department of Pediatrics
M. Bilal Abid, MD, MRCP (UK) Fellow Infectious Disease Department of Medicine
“Could the Menagerie of the Gut Microbiome Really Cure Cancer? Hope or Hype” Abid MB. J Immunother Cancer. 2019;7(1):92. The investigational scale of the gut microbiome is expanding rapidly. In 2018, the intersection of gut microbiota and immuno-oncology received much attention. While the impact of gut microbiota on the immune system was already established, the year received an exponential expansion of microbiome’s role in the immunotherapy setting. The microbiome research pipeline is ripe for large-scale, prospective trials. This manuscript provides a working knowledge of immune-based cancer treatments, heterogeneity in their responses and resistance mechanisms, relevant immunological and microbiological pathways and potential for the gut microbiome in enhancing the responses.
“Detecting PTSD in a Traumatically Injured Population: The Diagnostic Utility of the PTSD Checklist for DSM-5” Geier TJ, Hunt JC, Nelson LD, Brasel KJ, deRoon-Cassini TA. Depress Anxiety. 2019;36(2):170178. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) is a validated measure of DSM-5 PTSD severity. However, its diagnostic utility and optimal cut-scores had yet to be determined specifically among traumatically injured civilians. This investigation provided support for the PCL-5 in PTSD detection among injured patients six months after discharge. PCL-5 specificity and sensitivity suggest clinicians working with this population can feel confident in using this measure over more onerous structured interviews. This study signifies a move toward ensuring those experiencing mental health difficulties after traumatic injury are identified and connected to resources.
Timothy Geier, PhD Trauma and Health Psychology Fellow Division of Trauma and Acute Care Department of Surgery
James J. Miller, PhD Medical Student Medical Scientist Training Program Department of Biochemistry
“α-Galactosidase A-deficient rats accumulate glycosphingolipids and develop cardiorenal phenotypes of Fabry disease” Miller JJ, Aoki K, Mascari CA, et al. FASEB Journal. 2019;33(1):418-429. Patients with Fabry disease develop kidney and heart failure and have a shortened lifespan. This disease is caused by a lysosomal enzyme deficiency, which leads to the cellular accumulation of glycosphingolipids. However, the mechanisms of kidney and heart dysfunction remain poorly understood as mouse models do not recapitulate cardiorenal phenotypes. We generated a rat model of Fabry disease using CRISPR/Cas9 technology and observed that glycosphingolipids accumulate in kidney and heart. We showed that Fabry rats develop renal tubule dysfunction and mitral valve thickening. Thus, our work provides a foundation to better understand pathogenic mechanisms and develop treatments for Fabry disease.