Author Interviews, Cancer Research, JAMA / 21.03.2019

MedicalResearch.com Interview with: Peter R. Dixon, MD Department of Otolaryngology-Head & Neck Surgery Institute of Health Policy, Management and Evaluation University of Toronto Toronto, Ontario, Canada  MedicalResearch.com: What is the background for this study? Response: The word ‘cancer’ is often associated with an aggressive and lethal disease. Innovations in screening and diagnostic tests detect some ‘cancers’ that -- even if left untreated -- pose very low-risk of any symptoms, progression, or mortality. Still, many of these low-risk cancers are treated aggressively and those treatments can have harmful consequences and side-effects. We were interested in determining how influential the word ‘cancer’ is in decisions made by patients about low-risk malignant neoplasms relative to other labels for the same disease. (more…)
Aging, Author Interviews, Circadian Rhythm / 21.03.2019

MedicalResearch.com Interview with: Adrian Bejan PhD ( MIT 1971, 1972, 1975 ) J.A. Jones Distinguished Professor Duke University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Among the most common human perceptions is that time passes faster as an individual becomes older. The days become shorter, and so do the years. We all have stories of this kind, from the long days of childhood and the never-ending class hours in elementary school, to days, months and years that now pass in a blur. Why does it feel that the time passes faster as we get older? What is the physical basis for the impression that some days are slower than others? Why do we tend to focus on the unusual (the surprise), not on the ever present? This new article unveils the physics basis for these common observations. The reason is that the measurable ‘clock time’ is not the same as the time perceived by the human mind. The ‘mind time’ is a sequence of images, i.e. reflections of nature that are fed by stimuli from sensory organs. The rate at which changes in mental images are perceived decreases with age, because of several physical features that change with age: saccades frequency, body size, pathways degradation, etc. The misalignment between mental-image time and clock time serves to unite the voluminous observations of this phenomenon in the literature with the constructal law of evolution everywhere, as physics. (more…)
Author Interviews, Gender Differences, Mental Health Research, OBGYNE, Psychological Science / 20.03.2019

MedicalResearch.com Interview with Haley Kranstuber Horstman, Ph.D. Department of Communication University of Missouri MedicalResearch.com: What is the background for this study? Response: Miscarriage is a prevalent health concern, with one in five pregnancies ending in miscarriage, which is a pregnancy loss before 20 weeks’ gestation. Past research has shown that women who have miscarried often suffer mental health effects such as heightened grief, depression, loneliness, and suicidality. Although much of the research on coping with miscarriage has focused on women’s health, many miscarriages occur within romantic relationships and affect the non-miscarrying partner as well. Women in heterosexual marriages report that their husband is often their top support-provider. Past research has shown that husbands suffer with mental health effects after a miscarriage, sometimes for even longer than their wives, but are not often supported in their grief because miscarriage is a “woman’s issue” and they feel uncomfortable talking about it. (more…)
Author Interviews, Blood Pressure - Hypertension, NEJM, Race/Ethnic Diversity / 20.03.2019

MedicalResearch.com Interview with: Dike B. Ojji, M.D., Ph.D, FWACP, FACP Department of Medicine Faculty of Clinical Sciences University of Abuja MedicalResearch.com: What is the background for this study? Response: We decided to do this research because there were no large RCTs before now that have compared the efficacy of contemporary combination therapies among any black populations in spite of the high burden of hypertension and its complications (such as heart failure, cerebrovascular accident and chronic kidney) in this population, and also the fact that majority require 2 or more medications to control their blood pressure. (more…)
Author Interviews, Erectile Dysfunction, Heart Disease / 20.03.2019

MedicalResearch.com Interview with: Jagat Narula, MD, PhD Philip J. and Harriet L. Goodhart Professor of Medicine (Cardiology) Associate Dean for Global Health Director of the Cardiovascular Imaging Program Mount Sinai Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Atherosclerosis has been linked to causing erectile dysfunction (ED) in the majority of patients with this cardiovascular condition, but researchers have not had the means of demonstrating atherosclerosis in penile arteries until now.  This unique study uses advanced imaging to detect how strong the association actually is.  For the first time, researchers have used advanced imaging of penile arteries to show a link between atherosclerosis and erectile dysfunction (ED). (more…)
Author Interviews, Heart Disease, JACC, Technology / 20.03.2019

MedicalResearch.com Interview with: Annapoorna Kini, MD Zena and Michael A Wiener Professor of Medicine Director of the Cardiac Catheterization Laboratory Mount Sinai Heart at Mount Sinai Hospital MedicalResearch.com: What is the background for this study?  
  • Expanding indication and use of Transcatheter aortic valve replacement (TAVR) poses a unique problem of coronary access after valve implantation.
  • Troubleshooting tools and techniques have been published but are not available at the fingertips of the user at all the times.
  • We tried to address this unique problem with an innovative educational mobile application (app) called "TAVRcathAID".
(more…)
Author Interviews, Biomarkers, OBGYNE / 20.03.2019

MedicalResearch.com Interview with: Dr. Kara Rood MD Maternal-fetal Medicine Physician The Ohio State University Wexner Medical Center MedicalResearch.com: What is the background for this study? What are the main findings?  Response: This is a simple, rapid, non-invasive test for early recognition of preeclampsia.  MedicalResearch.com: What should readers take away from your report? Response: Aid in timely diagnosis to help provide closer observations to pregnancies with complicated by preeclampsia, to prevent the devastating adverse pregnancies outcomes for mom's and babies that can occur when pregnancies become complicated by preeclampsia. (more…)
Addiction, Author Interviews, CDC, Emory / 20.03.2019

MedicalResearch.com Interview with: CDR Andrew Geller, MD Medical Officer, Medication Safety Program Division of Healthcare Quality Promotion, CDC Atlanta GA 30329 MedicalResearch.com: What is the background for this study? Response: There has been a lot of recent attention on drug overdoses in the United States, particularly fatal overdoses which involve opioids. But the overall frequency with which patients end up in the emergency department (ED) due to nonmedical use of medications across the US is unknown.
  • Nonmedical use refers to a spectrum of circumstances, including intentionally using more medication than is recommended in an attempt to treat a health condition (therapeutic misuse) to using medication to attain euphoria or get “high” (abuse).
With this analysis, we wanted to focus on the acute harms to individual patients from nonmedical use of all medications, in order to help target prevention efforts.
  • Specifically, we used data from a nationally-representative sample of hospital EDs to identify the medications with the highest numbers of emergency visits for harms following nonmedical use of medications and to identify the patient groups with the highest risks. 
(more…)
Author Interviews, Orthopedics, Pain Research / 19.03.2019

MedicalResearch.com Interview with: Geoffrey Westrich, MD Director of Research Adult Reconstruction and Joint Replacement Service Hospital for Special Surgery NYC  MedicalResearch.com: What is the background for this study? Response: Recent mortality trends in the U.S. associated with opioid use disorders have brought to the forefront of national debate the desirability of minimizing the use of potentially addictive pain management therapies.  Pain management after hip replacement surgery is an important part of patient care, and  opioids are frequently given as a major part of postoperative pain management. At the same time, multimodal analgesia, the administration of anesthetic agents and medications agents targeting multiple pain pathways, has seen increased popularity in pain management after hip replacement surgery.  At Hospital for Special Surgery (HSS), the multimodal protocol entails the use of several different anesthetic agents and medications both during and after surgery to control pain, minimize the use of opioids and reduce side effects. The use of non-opioid analgesics such as acetaminophen allows for a reduction in opioid administration after surgery [1]. Acetaminophen, commonly known as Tylenol, has traditionally been administered orally, but more recently an intravenous (IV) preparation has become available.  IV acetaminophen after major orthopedic surgery was shown to provide effective analgesia and reduce morphine administration by 33%, compared to placebo [2]. Unless a patient is unable to take acetaminophen, it is commonly used as part of the multimodal protocol due to its efficacy and minimal contraindications. Although intravenous (IV) acetaminophen presents pharmacokinetic benefits, such as increasing both serum blood and cerebrospinal fluid levels more rapidly, there is limited analysis of its potential clinical advantages compared to oral acetaminophen.  We hypothesized that there could be a reduction in pain with activity, opioid usage, or opioid- related side effects among patients receiving IV acetaminophen compared to oral acetaminophen following hip replacement surgery  (more…)
Author Interviews, Fertility, OBGYNE / 19.03.2019

MedicalResearch.com Interview with: Prof. Daniel R Brison PhD, FRCPath Scientific Director Department of Reproductive Medicine Manchester University NHS Foundation Trust Old St. Mary's Hospital Manchester U.K and Catherine M Castillo PhD Maternal & Fetal Health Research Centre Division of Developmental Biology and Medicine School of Medical Sciences, Faculty of Biology, Medicine and Health The University of Manchester  MedicalResearch.com: What is the background for this study? What are the main findings? Response: IVF conceived children have been known to have poorer birth outcomes when compared to spontaneously conceived children. Even when excluding twins and triplets, which result from more complicated pregnancies, IVF singletons have an increased risk of low birth weight and being born small for “dates” (length of gestation).  This is important as studies carried out in non-IVF children show that low birth weight is associated with slightly higher risk of disease in later life. We knew from the literature that birth outcomes differed within the IVF population depending on the type of treatment used; for example, singletons conceived from frozen/thawed embryos are born with higher average birth weights when compared to their fresh embryo conceived counterparts. Our research team wanted to investigate whether IVF practices and technologies per se (which have advanced quite rapidly over the years since 1978 when the first IVF baby was conceived) were associated with differences in singleton birth weight. In attempting to quantify historical changes in laboratory practice going back as far as we could, we discovered that our outcome of interest – birth weight – had indeed increased notably throughout the time period covered by the available data. Besides observing an increase in birth weight of almost 180g over the study period (when accounting for child gender, gestational age and maternal parity), we also observed that frozen embryo transfer was associated with higher birth weight, and spontaneous fetal reduction and longer duration of infertility were associated with lower average birth weight. (more…)
Author Interviews, Heart Disease, JAMA / 19.03.2019

MedicalResearch.com Interview with: Dr. Carina Blomström-Lundqvist, MD Professor of Cardiology Department of Cardioloy Institution of Medical Science Uppsala, Sweden MedicalResearch.com: What is the background for this study?   Response: While all previous trials comparing atrial fibrillation (AF) ablation and antiarrhythmic drugs to our best knowledge have evaluated the efficacy of these treatments in terms of atrial fibrillation (AF) recurrences (with an AF episode of 30 seconds duration as standard primary endpoint) we wanted to use quality of Life (QoL) - general health - as primary endpoint, since the indication for treatment is improving QoL. This was important since, despite the fact that the indication for treatment is to improve (QoL) and reduce symptom, all prior trials have used 30 seconds AF episodes as standard primary endpoint, which if occurred it would be defined as a failed treatment. We also wanted to assess effects on various clinical outcome events. We know from registries such as ORBIT AF registry that around 60 % of AF patients have symptoms resulting in repeated hospitalisation visits in at least 30-40% of patients annually, and that only around 5 % of the AF population are being referred for AF ablation. Previous trials have used intermittent 24 hours Holter recordings whioch does not give the true AF burden (% of time in AF). We therefore also wanted to assess and compare treatments effects on true AF burden by implanting an implantable cardiac monitor (ICM) which continuosly records the heart rhythm. We would then be able to prove that improvement in QoL was directly related to a reduction in AF burden and that treatment differences in QoL was related to a difference in reduction in AF burden. We also wanted to study an AF population in their early AF disease state so that we could offer atrial fibrillation ablation to a broader AF population before their atria have become remodelled and too damaged for a pulmonary vein isolation to be effective.  (more…)
Author Interviews, Heart Disease / 19.03.2019

MedicalResearch.com Interview with: Mandeep R. Mehra, MD, MSc, FRCP (London) The William Harvey Distinguished Chair in Advanced Cardiovascular Medicine Medical Director, Heart and Vascular Center Brigham and Women’s Hospital Executive Director Center for Advanced Heart Disease Brigham and Women’s Hospital Professor of Medicine, Harvard Medical School  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The MOMENTUM 3 trial is the largest study of LVAD therapy in Advanced Heart Failure with over 1000 randomized patients followed to at least 2 years. This trial tested a novel fully magnetically levitated LVAD, the HeartMate 3 pump against a mechanical bearing containing LVAD, the HeartMate II pump in patients suffering from advanced heart failure (85% of whom were on continuous intravenous Inotropic therapy or IABP device at the time of randomization). While LVADs have improved survival for such patients, the morbidity has remained excessive due to serious complication as a result of problems with hemocompatibility. The principal concerns revolve around complications of pump thrombosis requiring surgical replacement, strokes and bleeding events, especially gastrointestinal bleeding. The trial has previously reported two interim analyses which suggested signals for superiority on pump replacement and even a decrease in ischemic stroke. This final full report concludes convincingly that all three domains of hemocompatibility related adverse events are reduced with the novel LVAD with near elimination of pump thrombosis, halving of strokes of any kind and any severity and a marked decrease in bleeding complications. (more…)
Author Interviews, Heart Disease, Infections, Opiods / 18.03.2019

MedicalResearch.com Interview with: Serena Day, MD Ohio State University  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The idea for this research came from my own observations of patients that I was caring for in the hospital first as an Internal Medicine Resident and now as a senior Cardiology Fellow. I did my residency here at Ohio State and noticed a marked increase in the number of patients with endocarditis that we were caring for just in my short time here as a trainee. Over 5 years, we saw an increase of 436% in intravenous drug use related endocarditis. How this disease is treated as changed as well. It used to be that if a patient was a good surgical candidate, we would offer a replacement valve. Now, we see that these patient's have such a high rate of recurrent intravenous drug use and reinfection of their heart valves that we now treat with antibiotics only rather than surgery. In many cases, the infection never goes away because we can't offer definitive therapy with surgery due to their high relapse and reinfection rates of nearly 50%. (more…)
Author Interviews, Clots - Coagulation, Heart Disease / 18.03.2019

MedicalResearch.com Interview with: Stavros V. Konstantinides, MD, PhD, FESC, FRCP(Glasg) Professor, Clinical Trials, and Medical Director Center for Thrombosis and Hemostasis (CTH) Johannes Gutenberg University Mainz Mainz, Germany MedicalResearch.com: What is the background for this study? What are the main findings? Response: Acute pulmonary embolism (PE) is the third most frequent acute cardiovascular syndrome. It encompasses a wide spectrum of clinical symptoms and severity, ranging from massive, immediately life-threatening PE with hemodynamic collapse to the low-risk, stable patient with very few symptoms. These latter patients with acute low-risk PE may qualify for early discharge from hospital (e.g., within 48 hours) and continuation of treatment at home. This is a very promising strategy, because it may not only increase patient satisfaction and quality of life, but also help to reduce hospital-related complications and costs. However, it needed to be clearly determined, and tested in a prospective management trial, who are the appropriate candidates for an effective and safe home treatment approach. To this date, trials suggesting favorable clinical outcomes with home treatment of PE are small and date back to the era of vitamin K antagonists. Direct oral anticoagulants permitting a single drug treatment of PE are more promising in this regard, as they may make an early transition from hospital to ambulatory care both safer and more convenient. The international Home Treatment of Pulmonary Embolism (HoT-PE) phase 4 management trial tested the efficacy and safety of early discharge and ambulatory anticoagulation treatment with the direct factor Xa inhibitor rivaroxaban in patients with acute low-risk PE. Patients were identified on the basis of
  • clinical criteria or PE severity, comorbidity, and contraindications; and
  • the absence of right heart failure or intracardiac thrombi on cardiac imaging. Early termination of the study was possible following the prespecified interim analysis, which was performed after recruitment and 3-month evaluation of 525 patients (50% of the planned trial population). At the interim analysis, the primary efficacy outcome of symptomatic recurrent venous thromboembolism or PE-related death occurred in only 3 (0.6%) patients (compared to an estimated 1.7% rate based on historical data). This rate was sufficiently low to reject the primary hypothesis as predefined in the statistical analysis plan. None of the recurrent events was nonfatal.Major bleeding occurred in 6 (1.2%) patients of the safety population. The study could therefore be terminated early for efficacy. 
(more…)
Accidents & Violence, Author Interviews, Heart Disease, Inflammation, JACC, Lipids / 18.03.2019

MedicalResearch.com Interview with: Dr. George Dangas MD PhD Professor of Medicine, Cardiology Mount Sinai Health System MedicalResearch.com: What is the background for this study? Response: Widespread use of statins targeted to decrease levels of low density lipoprotein cholesterol (LDL-C) below 70mg/dL are recommended by guidelines. However, residual cholesterol risk may only be one part of the residual risk equation. Indeed, Biological inflammation has long been known as a pathophysiological mechanism of atherosclerosis and the recent CANTOS trial opened new therapeutic perspective by demonstrating that inflammation modulation via selective interleukin-1β inhibition could result in improved diagnosis in patients with coronary artery disease. However, the prevalence and impact of a residual inflammatory biological syndrome in patients with controlled cholesterol risk is unclear. (more…)
Author Interviews, Opiods, Orthopedics / 18.03.2019

MedicalResearch.com Interview with: Paul Cagle, Jr. MD Assistant Professor of Orthopedic Surgery Icahn School of Medicine at Mount Sinai MedicalResearch.com: What is the background for this study? What are the main findings ie What are some of the significant comorbidities?  Response: In this study our goal was to better understand what medical issues (medical comorbidities) can cause trouble or issue for patients with a proximal humerus fracture (shoulder fracture).  To tackle this issue we used a large national sample of patients and sorted our the different medical issues the patients had. We found that patients with increased medical issues had longer hospital stays and higher use of opioid medications (pain medications). (more…)
Author Interviews, Biomarkers, BMJ, Heart Disease / 18.03.2019

MedicalResearch.com Interview with: Prof. Nick Curzen  BM(Hons) PhD FRCP Professor of Interventional Cardiology/Consultant Cardiologist University Hospital Southampton Southampton MedicalResearch.com: What is the background for this study? Response: The commonest blood test now used to assess whether a patient has had a heart attack or not is called high sensitivity troponin (hs trop).  The test is supplied with an Upper Limit of Normal, which is based upon results from relatively healthy people.  When doctors take the hs trop, they then use this ULN to decide if the patient had has a heart attack. This study set out to see what the hs trop level is in a large number of patients attending the hospital for any reason, either inpatient or outpatient, in most of whom there was no clinical suspicion of heart attack at all.  We therefore took hs trop measurements on 20,000 consecutive patients attending our hospital and having a blood sample for any reason.  (more…)
Author Interviews / 18.03.2019

MedicalResearch.com Interview with: Darwin Chen, MD Assistant Professor of Orthopedic Surgery Icahn School of Medicine at Mount Sinai MedicalResearch.com: What is the background for this study? What are the main findings? Response: Periprosthetic joint infection unfortunately remains a leading cause of total knee arthroplasty failure. One method of mitigating the risk of PJI is to use antibiotic loaded bone cement in a prophylactic fashion. While the use of antibiotic cement makes inherent sense, the decision is not as simple as it seems. There are potential side effects such as renal damage, antibiotic hypersensitivity, and antibiotic resistance. Antibiotics decrease the mechanical strength of cement fixation, which may impact component loosening. Additionally, antibiotic cement is significantly more expensive than standard cement, driving up cost. Currently there is no consensus on if antibiotic cement truly reduces infection risk and there are many conflicting studies. The purpose of our study is the use a large national database to evaluate real world utilization patterns of antibiotic cement, and assess outcomes, complications, and cost associated with antibiotic cement usage. Our hypothesis was that antibiotic cement is associated with a decreased risk of infection and no increased risk of systemic complications.  (more…)
Author Interviews, Opiods, Orthopedics, Surgical Research / 18.03.2019

MedicalResearch.com Interview with: Dr. Alexis Colvin, MD Associate Professor of Orthopedic Surgery Icahn School of Medicine at Mount Sinai  MedicalResearch.com: What is the background for this study? Response: 40% of all opioid overdose deaths involve a prescription opioid and orthopaedic surgeons are the 3rd highest prescribers of opioids.  Set guidelines for post surgery opioid prescriptions have not been established.  Arthroscopic knee meniscectomy is one of the most common orthopaedic procedures.  The purpose of this study was to determine how many opioids were being prescribed  among a group of six sports fellowship trained orthopaedic surgeons versus how many patients were actually using. (more…)
Author Interviews, Education, Health Care Systems / 14.03.2019

MedicalResearch.com Interview with: Nicholas A. Rattray, Ph.D. Research Scientist/Investigator VA HSR&D Center for Health Information and Communication Implementation Core, Precision Monitoring to Transform Care (PRISM) QUERI Richard L. Roudebush Veterans Affairs Medical Center Indiana University Center for Health Services & Outcomes Research Regenstrief Institute, Inc. Indianapolis, Indiana on behalf of study co-authors re: Rattray NA, Flanagan ME, Militello LG, Barach P, Franks Z, Ebright P, Rehman SU, Gordon HS, Frankel RM MedicalResearch.com: What is the background for this study? What are the main findings?  Response: End-of-shift handoffs pose a substantial patient safety risk. The transition of care from one doctor to another has been associated with delays in diagnosis and treatment, duplication of tests or treatment and patient discomfort, inappropriate care, medication errors and longer hospital stays with more laboratory testing. Handoff education varies widely in medical schools and residency training programs. Although there have been efforts to improve transfers of care, they have not shown meaningful improvement. Led for the last decade by Richard Frankel, Ph.D., a senior health scientist at Regenstrief Institute and Indiana University and professor at Indiana University School of Medicine, our team has studied how health practitioners communicate during end-of-shift handoffs. In this current study, funded by VA Health Services and Research Development, we conducted interviews with 35 internal medicine and surgery residents at three VA medical centers about a recent handoff and analyzed the responses. Our team also video-recorded and analyzed more than 150 handoffs. Published in the Journal of General Internal Medicine, this study explains how the person receiving the handoff can affect the interaction. Medical residents said they changed their delivery based on the doctor or resident who was taking over (i.e., training level, preference for fewer details, day or night shift). We found that handoff communication involves a complex combination of socio-technical information where residents balance relational factors against content and risk. It is not a mechanistic process of merely transferring clinical data but rather is based on learned habits of communication that are context-sensitive and variable, what we refer to as “recipient design”. In another paper led by Laura Militello, we focus on how residents cognitively prepare for handoffs. In the paper published in The Joint Commission Journal of Quality and Patient Safety®, researchers detailed the tasks involved in cognitively preparing for handoffs. A third paper, published in BMC Medical Education, reports on the limited training that physicians receive during their residency. Residents said they were only partially prepared for enacting handoffs as interns, and clinical experience and enacting handoffs actually taught them the most.   (more…)
Author Interviews, BMJ, CT Scanning, Lung Cancer, University of Pittsburgh / 14.03.2019

MedicalResearch.com Interview with: Panayiotis (Takis) Benos, Ph.D. Professor and Vice Chair for Academic Affairs Department of Computational and Systems Biology Associate Director, Integrative Systems Biology Program Department of Computational and Systems Biology, SOM and Departments of Biomedical Informatics and Computer Science University of Pittsburgh    MedicalResearch.com: What is the background for this study? What are the main findings? Response: Low-dose computed tomography (LDCT) scans is the main method used for early lung cancer diagnosis.  Early lung cancer diagnosis significantly reduces mortality.  LDCT scans identify nodules in the lungs of 24% of the people in the high-risk population, but 96% of these nodules are benign.  Currently there is no accurate way to discriminate benign from malignant nodules and hence all people with identified nodules are subjected to follow up screens or biopsies.  This increases healthcare costs and creates more anxiety for these individuals.  By analyzing a compendium of low-dose computed tomography scan data together with demographics and other clinical variables we were able to develop a predictor that offers a promising solution to this problem.  (more…)
Anesthesiology, Author Interviews, Dermatology, JAMA, NYU, Pediatrics / 14.03.2019

MedicalResearch.com Interview with: Roy G. Geronemus, M.D. Director, Laser & Skin Surgery Center of New York Clinical Professor of Dermatology New York University Medical Center New York, NY 10016 MedicalResearch.com: What is the background for this study? What are the main findings?  Response: We made the observation in clinical practice that port wine stain birthmarks can be safely and effectively treated in early infancy without the need for general anesthesia. This observation is particularly important because of the FDA warnings regarding multiple exposures to general anesthesia under the age of 3 and the potential impact on neurocognitive development as these patients require multiple treatments. (more…)
Author Interviews, Genetic Research, Heart Disease, Lipids, NEJM, Statins / 13.03.2019

MedicalResearch.com Interview with: Brian A Ference, MD, MPhil, MSc, FACC, FESC Professor and Director of Research in Translational Therapeutics Executive Director, Centre for Naturally Randomized Trials Strangeways Research Laboratory University of Cambridge Cambridge, UK MedicalResearch.com: What is the background for this study? Response: Bempedoic acid is a novel therapy currently in development that lowers LDL-C by inhibiting ATP-citrate lyase, an enzyme in the same cholesterol biosynthesis pathway as HMG-CoA reductase (the target of stains).  However, whether lowering LDL-C by inhibiting ATP-citrate lyase will reduce the risk of cardiovascular events to the same extent as lowering LDL-C by inhibiting HMG-CoA reductase with a statin is unknown. We conducted a “naturally randomized trial” using Mendelian randomization in more than 650,000 participants who experienced more than 100,000 cardiovascular events to evaluate the potential clinical benefit of lowering LDL-C by inhibiting ATP-citrate lyase as compared to lowering LDL-C by inhibiting HMG-CoA reductase. (more…)
Author Interviews, Brigham & Women's - Harvard, NEJM, Opiods / 13.03.2019

MedicalResearch.com Interview with: Wenjia Zhu, PhD. Marshall J. Seidman Fellow Department of Health Care Policy Harvard Medical School  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The current opioid epidemic continues to cause deaths and tremendous suffering in the United States, driven in large part by overuse of prescription opioids. Of special concern are new opioid prescriptions, i.e. opioids given to patients who have not used opioids before, which research tells us are an important gateway to long-term opioid use, misuse, overdoes and death. Recently, in their efforts to curb over prescribing of opioids, the CDC issued guidelines (December 2015 in draft form; March 2016 in final version) to encourage opioid prescribers to limit the use, duration and dose of opioids, particularly opioids to first-time users. Despite these, little is known about the prescribing of opioids to first-time users on a national scale, particularly among commercially insured patients. In this study, we examined national monthly trends in the rate at which opioid therapy was started among commercially insured patients. Using administrative claims from Blue Cross Blue Shield Association commercial insurers from 2012 to 2017, we analyzed more than 86 million commercially insured patients across the United States. (more…)
Author Interviews, Infections, NEJM / 13.03.2019

MedicalResearch.com Interview with: Susan Swindells MBBS Professor and Medical Director, HIV Clinic Department of Internal Medicine University of Nebraska Medical Center Omaha, NE MedicalResearch.com: What is the background for this study? What are the main findings?  Response: More than one quarter of the world’s population is infected with tuberculosis (TB), and there is effective treatment for this but only a small fraction of those eligible actually receive it.   TB is the leading cause of death for people with HIV infection, globally.  One of the major problems with currently available treatments for TB infection is that they take too long, and people just stop taking them after a while.  We identified an ultra-short course of treatment (only one month) and tested it against the conventional 6-month course of treatment. Our main findings were that the new short course was just as effective as the standard 6 month course, more patients taking the short course completed their treatment, and had less adverse effects.  (more…)
Author Interviews, Heart Disease, Imperial College, Lipids, NEJM, Statins / 13.03.2019

MedicalResearch.com Interview with: Prof. Kosh Ray, MB ChB, MD, MPhil Faculty of Medicine, School of Public Health Chair in Public Health (Clinical) Imperial College London MedicalResearch.com: What is the background for this study? What are the main findings? Response: Bempedoic acid is the first in class of a new therapy for lowering LDL cholesterol. This is the largest and longest study to date with this therapy and involved about 2200 pts with patients with either established cardiovascular disease or familial hypercholestrolaemia and in whom LDL was > 70mg/dl or 1.8 mmol/L despite maximally tolerated statins. %0% were on high intensity statins and the majority of the rest on moderate intensity. The aim was to show long term safety 1 year and efficacy at 24 weeks and at 1 year.  (more…)
Author Interviews, Cancer Research, NEJM / 13.03.2019

MedicalResearch.com Interview with: Maud Jansen, MD | Resident Dermatology | PhD candidate Dermatologie, Maastricht MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Actinic keratosis is the most frequent premalignant skin disease in the white population and is caused by exposure to ultraviolet radiation. With a prevalence of 37.5% among whites 50 years of age or older, actinic keratosis is one of the most frequent reasons for patients to visit a dermatologist. If left untreated, actinic keratosis may develop into squamous cell carcinoma. Current guidelines provide no clear recommendations about which treatment approach is preferred. Currently, the choice of treatment often depends on the preferences of patients and their treating physicians. Evidence from randomized trials with direct comparison between treatments and with long-term follow-up is scarce. Frequently prescribed and studied field-directed treatment approaches are 5-fluorouracil cream, imiquimod cream, photodynamic therapy (PDT), and ingenol mebutate gel. We investigated the effectiveness of these four frequently used field-directed treatments (for multiple lesions in a continuous area). Over 600 patients in four different hospitals (Maastricht UMC+, Zuyderland (Heerlen), VieCuri (Venlo and Venray) en Catharina (Eindhoven)participated in the study. Patients were randomly assigned to one of the four treatments. The main result of our study was that we found that after 12 months of follow-up, 5% fluorouracil cream was the most effective treatment in the treatment of patients with multiple actinic keratosis lesions. Moreover, patient satisfaction and increase in health-related quality of life were highest in the 5-fluorouracil group. (more…)
Author Interviews, Blood Pressure - Hypertension, JAMA / 12.03.2019

MedicalResearch.com Interview with: Alexander A. Leung, MD, MPH Department of Community Health Sciences Department of Medicine University of Calgary Calgary, Alberta, Canada MedicalResearch.com: What is the background for this study? Response: The 2017 American College of Cardiology and American Heart Association (ACC/AHA) blood pressure guidelines redefined hypertension according to a blood pressure cutoff of ≥130/80 mm Hg, compared to the traditional cutoff of ≥140/90 mm Hg. (more…)
Author Interviews, Diabetes, Technology, UCSF / 12.03.2019

MedicalResearch.com Interview with: Robert Avram MD MSc Division of Cardiology University of California, San Francisco MedicalResearch.com: What is the background for this study? Would you briefly describe what is meant by Photoplethysmography? While analyzing the heart rate data as collected using smartphones apps in the Health-eHeart study, we noticed that diabetic patients had, on average, a higher ‘free-living’ heart rate than non-diabetic patients when adjusted from multiple factors. This pushed us to analyze the signal to see if there were other features that would help differentiate diabetes patients from non-diabetes patients. By identifying these features, we saw a huge opportunity to develop a screening tool for diabetes using deep learning and a smartphone camera and flash, in order to classify patients as having prevalent diabetes/no-diabetes. Photoplethysmography is the technique of measuring the difference in light absorption by the skin in order to detect blood volume changes in the microvasculature. Most modern mobile devices, including smartphones and many fitness trackers (Apple Wathc, FitBit), have the ability to acquire PPG waveforms, providing a unique opportunity to detect diabetes-related vascular changes at population-scale.  (more…)
Asthma, Author Interviews, JAMA, OBGYNE, Pediatrics, Vitamin D / 12.03.2019

MedicalResearch.com Interview with: Bo Chawes, MD, PhD, DMSc Associate Professor C‌openhagen Prospective Studies on Asthma in Childhood H‌erlev and G‌entofte H‌ospital U‌niversity of C‌openhagen MedicalResearch.com: What is the background for this study? What are the main findings? Response: There has been a global surge in vitamin D deficiency happening in parallel with an increase in prevalence of childhood asthma, which suggests that low maternal vitamin D levels during pregnancy may increase asthma risk in the child. Due to that we conducted a randomized double-blinded controlled trial within the Danish COPSAC2010 cohort (www.copsac.com) of 7-fold (2,800 IU/d) vs. standard dose (400 IU/d) of vitamin D supplementation from pregnancy week 24 aiming to reduce offspring asthma risk. At age 3, we observed a non-significant 24% reduced risk of recurrent asthma-like symptoms, ie. recurrent wheeze, in the high-dose vitamin D group. In the current study, we followed 545 of the 581 children in the study till age 6, where an asthma diagnosis can be established and observed no effect of the high-dose vitamin D supplement on the child's risk of asthma.  (more…)