Author Interviews, Brain Injury, JAMA / 16.09.2020

MedicalResearch.com Interview with: Susan Rowell MD, MBA, MCR Associate Professor, Department of Surgery Division of Trauma, Acute & Critical Care Surgery Duke University School of Medicine Durham, NC 27710 MedicalResearch.com: What is the background for this study? Response: Tranexamic acid (TXA) has been increasingly used in trauma patients since publication of the CRASH-2 trial in 2010 demonstrated a survival benefit for patients at risk for traumatic hemorrhage. Subsequently, it was shown that the earlier TXA was administered, the better the outcome. There had been several small studies suggesting that TXA may also be beneficial in patients with traumatic brain injury (TBI), however, an adequate prospective randomized trial was needed. In this trial we randomized over 1000 patients with moderate and severe TBI as early as possible after injury (by paramedics in the prehospital setting an average of 42 minutes after injury) to either a 1-gram TXA bolus followed by a 1-gram 8-hour TXA infusion (the dose typically used for trauma patients), a 2-gram TXA bolus only (a logistically easier route of administration requiring no maintenance infusion), or placebo only. (more…)
Author Interviews, Diabetes, Duke, Telemedicine / 15.06.2020

MedicalResearch.com Interview with: Matthew J. Crowley, MD Core Investigator, Durham Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT) Affiliated Investigator, VA Office of Rural Health Staff Physician, Endocrinology Section, Durham VA Health Care System Elizabeth Kobe, BS Medical Student Durham VA Health Care System Duke University School of Medicine MedicalResearch.com: What is the background for this study? With whom were the telehealth sessions performed? (MDs, PAs, Dieticians etc). Response: Diabetes management in rural populations is especially challenging due to limited access to specialty care and self-management programs. Telehealth is a potential strategy for extending high-quality diabetes care to rural areas. The Veterans Health Administration (VHA) has a robust Home Telehealth (HT) system that is currently used for telemonitoring patient blood glucose values. In order to address the challenges of managing diabetes in rural areas in a clinically feasible manner, we strategically designed an intensive diabetes management intervention – Advanced Comprehensive Diabetes Care (ACDC) – for delivery using existing VHA HT infrastructure and clinical staffing. ACDC is a 6-month telehealth intervention that combines telemonitoring with module-based self-management support and medication management. ACDC is delivered entirely by existing clinical staff (a clinical HT nurse and a medication manager (typically a PharmD)) through bimonthly, 30-minute calls. Our initial randomized controlled trial found that ACDC improved HbA1c by a clinically and statistically significant  -1.0% relative to usual care at 6 months, while also improving blood pressure and diabetes self-care. Our goal with the present work was to improve diabetes care in clinical practice for rural Veterans whose type 2 diabetes remained uncontrolled despite receiving available services. To this end, we partnered with the VA Office of Rural Health to implement ACDC into VA sites across the country with large rural populations.  (more…)
Aging, Author Interviews, JAMA / 27.02.2020

MedicalResearch.com Interview with: Dr. Konstantin G. Arbeev, PhD Associate Research Professor Biodemography of Aging Research Unit (BARU) Social Science Research Institute (SSRI) Duke University Dr. Abraham Aviv, MD Department Pediatrics Director, The Center of Human Development and Aging Rutgers New Jersey Medical School MedicalResearch.com: What is the background for this study? Response: A body of research has shown that having comparatively short leukocyte telomere length (LTL) is associated with increased risk of death in adults.    (more…)
Author Interviews, Blood Pressure - Hypertension, Duke, Pediatrics / 22.01.2020

MedicalResearch.com Interview with: Yuichiro Yano MD Assistant Professor in Family Medicine and Community Health Duke University  MedicalResearch.com: What is the background for this study? Response: The blood pressure (BP) guideline in the US recommend using an “average” of multiple BP measurements over time for screening for and management of high BP in young adults. While it is well known that BP varies across visits, that “variability” (i.e., visit-to-visit blood pressure variability) is dismissed as a random fluctuation in the clinical setting. Little is known regarding the clinical relevance of visit-to-visit blood pressure variability over time in young adults. (more…)
Author Interviews, Environmental Risks, JAMA, Smoking / 17.09.2019

MedicalResearch.com Interview with: Sairam Jabba, Ph.D Senior Research Associate Department of Anesthesiology Duke University Durham, NC 27710 MedicalResearch.com: What is the background for this study? Response: Pulegone is a potential carcinogen contained in several mint oils. Due to its carcinogenic properties, FDA banned pulegone last year as a food additive. Previous chemical analytical studies from CDC have demonstrated that several mint/menthol-flavored e-cigarette liquids and snuff tobacco products contain pulegone in significant amounts. FDA currently does not regulate pulegone in e-cigarettes and snuff products and the health risk associated with it for the users is not well understood.  (more…)
Author Interviews, Blood Pressure - Hypertension, Duke, Heart Disease, JAMA, Race/Ethnic Diversity / 14.08.2019

MedicalResearch.com Interview with: Yuichiro Yano MD Assistant Professor in Family Medicine and Community Health Duke University  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: African Americans are disproportionally affected by hypertension-related cardiovascular disease compared with other racial/ethnic groups in the United States and have higher blood pressure levels inside and outside the clinic than whites and Asians. However, little is known, among African Americans, regarding whether higher mean blood pressure measured outside of the clinic setting on 24-hour ambulatory blood pressure monitoring is associated with an increased risk for cardiovascular disease events, independent of blood pressure measured in the clinic setting. (more…)
Author Interviews, Dermatology, Duke / 15.07.2019

MedicalResearch.com Interview with: Luis Garza, M.D., Ph.D. Associate Professor of Dermatology Johns Hopkins University School of Medicine. MedicalResearch.com: What is the background for this study? What are the main findings? Response: We wanted to find out what might stimulate regeneration in mice and humans. We find that in both species during wounding, released “loose” dsRNA induces production of retinoic acid that stimulates regeneration. (more…)
Author Interviews, Clots - Coagulation, Duke, Genetic Research, Heart Disease, JAMA / 30.05.2019

MedicalResearch.com Interview with: Thomas J. Povsic, MD, PhD Interventional Cardiologist Duke Clinical Research Institute Duke University School of Medicine Durham, North Carolina  MedicalResearch.com: What is the background for this study?  Response: The background for this study is that it is unknown how mandatory reporting of CYP2C19 metabolizer status affects how doctors treat patients or to what degree provision of this information would affect choice of a P2Y12 inhibitor within a clinical trial. As part of the GEMINI-ACS trial, all patients underwent CYP2C19 metabolizer testing.  This trial enrolled patients with a recent acute coronary syndrome and randomized them to aspirin or a low dose of rivaroxaban.  All patients were also to be treated with ticagrelor or clopidogrel, which was at the discretion of the investigator.  Investigators were given information regarding the CYP2C19 metabolizer status about a week after randomization.  Importantly prior to randomization, all investigators were asked how they expected to use this information, and then we followed what they actually did. (more…)
Allergies, Author Interviews, Dermatology, Heart Disease, JAMA / 03.04.2019

MedicalResearch.com Interview with: Amber Reck Atwater, M.D. Dermatology Residency Program Director Associate Professor of Dermatology Director, Contact Dermatitis Clinic Duke Dermatology  MedicalResearch.com: What is the background for this study? What are the main findings? Response: We completed an evaluation of our Duke Dermatology patients who underwent patch testing for possible allergy to their cardiac devices - pacemakers and defibrillators. From March 1, 2012 to September 15, 2017 we saw 11 patients with suspected allergy to their devices.  Concern for allergy, skin eruption, skin symptoms, and concern for infection were common. 73% of patients had erythema at their implant scars; pruritus and pain were also noted.  Six of our patients had relevant reactions, and the most common allergies were metals, silicone and rubber accelerators.  (more…)
Author Interviews, Clots - Coagulation, Duke, Heart Disease, NEJM / 21.03.2019

MedicalResearch.com Interview with: Renato D. Lopes MD, MHS, PhD Professor of Medicine Division of Cardiology Duke University Medical Center Duke Clinical Research Institute MedicalResearch.com: What is the background for this study? What are the main findings? Response: In patients with acute coronary syndromes (ACS), approximately 20% to 30% of those with nonvalvular atrial fibrillation (NVAF) have concomitant coronary artery disease (CAD), and 5 to 10% of patients who undergo PCI have NVAF. These patients often receive both antiplatelet therapy and oral anticoagulants; and how best to combine these agents to minimize bleeding risk without compromising protection against thrombosis is an important unanswered question. Analysis of results for bleeding indicated no significant interaction between the two randomization factors permitting independent analysis of results for the two key comparisons. The first showed that apixaban was both non-inferior and significantly superior to VKA for the primary outcome with a 31% reduction in the relative risk for bleeding. Aspirin significantly increased the relative risk for bleeding versus placebo by 89%. Results for the composite of death and hospitalization showed that apixaban resulted in a relative risk reduction of 17%, primarily driven by a reduction in all cause hospitalization. There was no significant difference between results for aspirin versus placebo for this outcome. Analysis of the composite of death and ischemic events indicated no significant differences in results for apixaban versus VKA or aspirin versus placebo. (more…)
Author Interviews, Duke, Heart Disease, JAMA / 21.03.2019

MedicalResearch.com Interview with: Renato D. Lopes MD, MHS, PhD Professor of Medicine Division of Cardiology Duke University Medical Center Duke Clinical Research Institute Alexander C. Fanaroff, MD, MHS Division of Cardiology and Duke Clinical Research Institute Duke University, Durham, North Carolina MedicalResearch.com: What is the background for this study? What are the main findings? Response: About ten years ago, a group of researchers examined the evidence supporting guideline recommendations in cardiology for the first time. Quite surprisingly, they found that only 11% of recommendations in American College of Cardiology/American Heart Association (ACC/AHA) guidelines were supported by evidence from randomized controlled trials, the highest level of evidence. The researchers called for greater collaboration among investigators and funders in identifying key research questions, development of streamlined clinical trial methods, and expansion of funding for clinical research. Over the past 10 years, some of these steps have been taken, but it is unclear how the evidence supporting guideline recommendations has changed. We therefore analyzed the 51 current cardiovascular guideline documents -- 26 from the ACC/AHA and 25 from the European Society of Cardiology (ESC) -- including 6,329 recommendations. Overall, 8.5% of recommendations in ACC/AHA guidelines and 14.3% of recommendations in ESC guidelines were supported by evidence from randomized controlled trials. When looking specifically at guidelines that have been updated, we found no significant changes in the proportion of recommendations supported by evidence from randomized controlled trials. (more…)