Author Interviews, Cancer Research, Genentech, Leukemia / 25.03.2019

MedicalResearch.com Interview with: [caption id="attachment_48117" align="alignleft" width="200"]Nancy Valente, M.D.VP of Global Hematology DevelopmentGenentech Dr. Valente[/caption] Nancy Valente, M.D. VP of Global Hematology Development Genentech Dr. Valenta discusses the announcement of the submission by Genentech of a supplemental New Drug Application to the FDA for Venclexta plus Gazyva for people with previously untreated chronic lymphocytic leukemia  with co-existing medical conditions. MedicalResearch.com: What is the background for this study? What are the main findings of the Phase III CLL14 study?  Response: We completed the submission of a supplemental New Drug Application (sNDA) to the FDA for Venclexta® (venetoclax) in combination with Gazyva® (obinutuzumab) in people with previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions. CLL is the most common form of adult leukemia and more than 20,000 new cases will be diagnosed in the U.S. this year. The sNDA is based on data from the Phase III CLL14 study, which evaluated fixed-duration Venclexta in combination with Gazyva in people with previously untreated CLL. Results showed this chemotherapy-free combination can help people with previously untreated CLL live significantly longer without their disease worsening (progression-free survival; PFS) compared to standard-of-care Gazyva plus chlorambucil. The FDA is reviewing our application under the Real-Time Oncology Review (RTOR) pilot program, which is exploring a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. 
Author Interviews, Gender Differences, JAMA, Pediatrics / 25.03.2019

MedicalResearch.com Interview with: Dr. David Klein MD MPH Associate Program Director National Capital Consortium (NCC) Family Medicine Residency Fort Belvoir Community Hospital Dr. Elizabeth Hisle-Gorman MSW, PhD Assistant Professor, Uniformed Services University  MedicalResearch.com: What is the background for this study?  Response: Our study, “Transgender Children and Adolescents Receiving Care in the U.S. Military Healthcare System: A Descriptive Study,” sought to analyze the number of military dependent children and adolescents who have a transgender or gender-diverse identity and receive medical care in the Military Health System (MHS), recognizing that the number has been increasing, but not knowing to what extent. Ultimately, in studying this data, we hoped to document the needs of transgender children in military families to support provision of adequate and appropriate high-quality care.
Author Interviews, Health Care Systems, JAMA / 24.03.2019

MedicalResearch.com Interview with: [caption id="attachment_48108" align="alignleft" width="160"]Maryam Guiahi, MDAssociate Professor, Ob/GynSchool of MedicineUniversity of Colorado Dr. Guiahi[/caption] Maryam Guiahi, MD Associate Professor, Ob/Gyn School of Medicine University of Colorado  MedicalResearch.com: What is the background for this study? Response: The United States Conference of Catholic Bishops expects providers in Catholic Health Care Facilities to follow the Ethical and Religious Directives for Catholic Health Care Services, which places limits on reproductive and end-of-life care. Prior research has demonstrated that many patients do not anticipate religious health care restrictions, yet often face conflicts in care. We were interested in whether Catholic hospitals disclose their religious affiliation and explain to patients how this affiliation may impact the care they are offered.
Author Interviews, Depression, Dermatology / 24.03.2019

MedicalResearch.com Interview with: [caption id="attachment_24142" align="alignleft" width="128"]Dr. Jonathan L. Silverberg MD PhD MPH Assistant Professor in Dermatology Medical Social Sciences and Preventive Medicine Northwestern University, Chicago, Illinois Dr. Jonathan Silverberg[/caption] Dr. Jonathan L. Silverberg MD PhD MPH Assistant Professor in Dermatology Medical Social Sciences and Preventive Medicine Northwestern, Chicago, Illinois MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Atopic Dermatitis is characterized by chronic and often severe and debilitating itch, skin pain, sleep disturbances, skin lesions and multiple comorbid health conditions. The signs, symptoms and comorbidities of atopic dermatitis can lead to significant psychosocial distress and mental health burden We performed a cross-sectional, population-based study of 2893 US adults. We found that adults with atopic dermatitis had more severe symptoms scores for anxiety and depression (Hospital Anxiety and Depression anxiety). Adults with atopic dermatitis also had higher prevalences of anxiety and depression. Mean symptom scores and prevalences of anxiety and depression were even higher in adults with moderate and severe atopic dermatitis compared to those with mild atopic dermatitis. All respondents with severe PO-SCORAD, POEM and PO-SCORAD-itch scores had elevated anxiety and depression scores. Many adults with atopic dermatitis that had elevated anxiety and depression scores reported no diagnosis of anxiety or depression. 
Author Interviews, Endocrinology, Genetic Research / 24.03.2019

MedicalResearch.com Interview with: [caption id="attachment_48099" align="alignleft" width="200"]Emily J. Gallagher, MDAssistant Professor of MedicineEndocrinology, Diabetes and Bone DiseaseIcahn School of Medicine at Mount Sinai  Dr. Gallagher[/caption] Emily J. Gallagher, MD Assistant Professor of Medicine Endocrinology, Diabetes and Bone Disease Icahn School of Medicine at Mount Sinai  MedicalResearch.com: What is the background for this study? Response: Multiple Endocrine Neoplasia Syndrome Type 2 (MEN2) is an inherited endocrine disorder characterized by the development of pheochromocytoma, medullary thyroid carcinoma (MTC) and parathyroid tumors. It occurs due to activating missense variants in the RET gene. The estimated prevalence of MEN2 is 1 per 30,000 in the general population. Through a collaboration between The Center for Genomic Health, the Charles Bronfman Institute for Personalized Medicine, and the Division of Endocrinology at Mount Sinai, our aim was to investigate the prevalence and clinical manifestations of pathogenic RET variants in the multi-ethnic BioMe Biobank. The BioMe Biobank is an electronic health record-linked biobank with exome sequencing data available for more than 30,000 patients recruited across The Mount Sinai Health System.
Allergies, Author Interviews, Brigham & Women's - Harvard, Pharmacology / 23.03.2019

MedicalResearch.com Interview with: [caption id="attachment_48094" align="alignleft" width="128"]Daniel Reker, PhDKoch Institute for Integrative Cancer ResearchMassachusetts Institute of Technology Dr. Reker[/caption] Daniel Reker, PhD Koch Institute for Integrative Cancer Research Massachusetts Institute of Technology MedicalResearch.com: What is the background for this study? Response: We started thinking more about this topic following a clinical experience five years ago that Dr. Traverso was involved in where a patient suffering form Celiac disease received a prescription of a drug which potentially had gluten. This experience really opened our eyes for how little we knew about the inactive ingredients and how clinical workflows do not currently accommodate for such scenarios. We therefore set up a large scale analysis to better understand the complexity of the inactive ingredient portion in a medication as well as how frequently critical ingredients are included that could potential affect sensitive patients.
Author Interviews, Clots - Coagulation, Duke, Heart Disease, NEJM / 21.03.2019

MedicalResearch.com Interview with: [caption id="attachment_20394" align="alignleft" width="200"]Renato D. Lopes MD, MHS, PhD Duke University Medical Center Duke Clinical Research Institute Durham, NC 27705 Dr. Renato Lopes[/caption] 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.
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.
Author Interviews, Dermatology, Environmental Risks, FDA / 21.03.2019

MedicalResearch.com Interview with: [caption id="attachment_48076" align="alignleft" width="200"]Anna Benevente Anna Benevente[/caption] Anna Benevente Director of product, labeling, and ingredient review at Registrar Corp (registrarcorp.com), an FDA consulting firm that helps companies comply with FDA regulations. She has been assisting companies with U.S. FDA regulations since 2009. She and her team have researched thousands of products to determine whether they meet FDA requirements for compliance. In February 2019, the U.S. Food and Drug Administration (FDA) published a proposed rule to put into effect a final monograph for over-the-counter (OTC) sunscreen drug products.  If finalized, the rule will update conditions under which OTC sunscreen products may be marketed in the United States.  Given the effect this rule could have on the pharmaceutical and cosmetic industries, MedicalResearch.com sat down with Anna Benevente, Director of Product, Labeling, and Ingredient Review at FDA consulting firm Registrar Corp, to dig deeper into the article they recently published on the rule. MedicalResearch.com:  What is the background for this announcement? Response:  FDA issues monographs for specific types of over-the-counter (OTC) drug products, which establish conditions under which a drug may be marketed without FDA approval of a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The conditions that are established by the monograph include the active ingredients that have been deemed generally recognized as safe and effective (GRASE) and statements that must appear on the labeling in the form of a Drug Facts panel. Sunscreens have never had an effective final monograph.  Instead, they have been largely regulated under enforcement discretion since 2001, when FDA issued a stay on a final monograph for OTC sunscreen drug products. The Sunscreen Innovation Act (SIA) of 2014 calls for FDA to establish a final monograph for OTC sunscreen by November 26, 2019. If finalized, the rule proposed in February would lift the stay on the final monograph and amend certain regulations for OTC sunscreen drug products. MedicalResearch.com:  What is enforcement discretion? Response: FDA rulemaking can take a considerable amount of time.  During this process, FDA may issue guidance or an enforcement policy that specifies stipulations under which the Agency permits the marketing of certain products in the absence of codified regulations.  While these documents are not legally-binding, they often outline provisions where FDA states that the Agency does not intend to take regulatory action.  These provisions are often incorporated into an FDA rule, as we are seeing in the case of this new rule for sunscreen. MedicalResearch.com:  Would you explain what GRASE ingredients are? Response: When FDA establishes a monograph for an OTC drug product, the Agency reviews scientific data on ingredients used for that product and classifies them into three categories: Category I: The ingredient is generally recognized as safe and effective for its intended use. Category II: The ingredient is not generally recognized as safe and effective for its intended use.  This ingredient may be not safe as a whole, may be not be safe for the specific intended use, or may not be effective for the specific intended use relative to its health risk. Category III: There is insufficient scientific data to determine whether the ingredient is safe and effective for its intended use. While a monograph is still in the rulemaking stage, FDA permits the marketing of products formulated with active ingredients that are deemed Category I or Category III. At this time, industry may submit data to support a Category I designation for a Category III ingredient. When the final monograph is published, FDA no longer uses the terms "Category I", "Category II", and "Category III."  Those ingredients that were deemed Category I become "monograph conditions," while Category II and III ingredients become "nonmonograph conditions" and may not be marketed after the compliance date identified in the final rule. Q: What are the main products that would require a label change? Response:The statement of identity for all sunscreen products would be required to list the sunscreen active ingredients in alphabetical order followed by “Sunscreen” and the product’s dosage form (e.g. “Titanium Dioxide, Zinc Oxide Sunscreen Lotion”).  Additionally, the rule proposes formatting changes to sunscreen labels that would make SPF, broad spectrum, and water resistance statements more prominent. The rule would require all products over 15 SPF to satisfy broad spectrum testing requirements and the associated labeling requirements for broad spectrum products.  Products under 15 SPF that do not satisfy broad spectrum requirements would be required to include “*See Skin Cancer/Skin Aging Alert” next to the SPF value as a reference to the warning required under 21 CFR 201.327(d)(2).
Author Interviews, Infections, Schizophrenia / 21.03.2019

MedicalResearch.com Interview with: [caption id="attachment_48055" align="alignleft" width="200"]Bartonella - Wikipedia image Bartonella - Wikipedia image[/caption] Dr. Ed Breitschwerdt, DVM, DACVIM Melanie S. Steele Distinguished Professor of Internal Medicine NC State MedicalResearch.com: What is the background for this case report?  Can you briefly explain the signs/symptoms of a Bartonella infection? Response: Bartonella henselae is a bacteria most commonly associated with cat scratch disease, which until recently was thought to be a short-lived (or self-limiting) infection. There are now at least 40 different known species of Bartonella, 13 of which have been found to infect human beings. The ability to find and diagnose Bartonella infection in animals and humans – it is notorious for “hiding” in the linings of blood vessels – has led to its identification in patients with a host of chronic illnesses ranging from migraines to seizures to rheumatoid illnesses, some of which the medical community previously hadn’t been able to attribute to a specific cause. Evolving data suggests a role for these bacteria in a spectrum of cardiovascular, neurological and rheumatological diseases. Specific symptoms or diseases that have been reported with neurobartonellosis previously include encephalitis, headaches, migraines, demyelinating polyneuropathy, neuroretinitis and transverse myelitis. Documentation of Bartonella henselae blood stream infection in a boy diagnosed with Schizophrenia and Pediatric Acute-onset Neuropsychiatric Syndrome (PANS) extends the spectrum of symptomatology associated with neurobartonellosis.
Author Interviews, Brigham & Women's - Harvard, Critical Care - Intensive Care - ICUs, End of Life Care, JAMA / 21.03.2019

MedicalResearch.com Interview with: Joanna Paladino, MD Director of Implementation, Serious Illness Care Program | Ariadne Labs Brigham and Women's Hospital | Harvard T.H. Chan School of Public Health Palliative Care | Dana-Farber Cancer Institute Instructor | Harvard Medical School and Dr. Rachelle Bernacki MD MS Director of Quality Initiatives Psychosocial Oncology and Palliative Care Senior Physician, Assistant Professor of Medicine Harvard Medical School Dr. Paladino's responses: MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Paladino: People living with serious illness face many difficult decisions over the course of their medical care. These decisions, and the care patients receive, should be guided by what matters most to patients, including their personal values, priorities, and wishes. These conversations don’t often happen in clinical practice or do so very late in the course of illness, leaving patients exposed to getting care they don’t want. Doctors and nurses want to have these important discussions, but there are real challenges, including insufficient training and uncertainties about when and how to start the conversation. We designed an intervention with clinical tools, clinician training, and systems-changes to address these challenges. When tested in a randomized clinical trial in oncology, we found that the intervention led to more, earlier, and better conversations between oncology clinicians and their patients with life-limiting cancer. These findings demonstrate that it is possible to ensure reliable, timely, and patient-centered serious illness conversations in an outpatient oncology practice.
Author Interviews, Urinary Tract Infections / 21.03.2019

MedicalResearch.com Interview with: [caption id="attachment_48040" align="alignleft" width="130"]Prof. Lindsay E NicolleDepartment of Internal Medicine, School of MedicineRady Faculty of Health SciencesUniversity of Manitoba, Winnipeg, Canada  Dr. Nicolle[/caption] Prof. Lindsay E Nicolle Department of Internal Medicine, School of Medicine Rady Faculty of Health Sciences University of Manitoba, Winnipeg, Canada  MedicalResearch.com: What is the background for these updated guidelines? What are the main recommendations? Response: The guideline updates the guideline previously published in 2005. There is some new information published in the interim, but the recommendations from the earlier guideline have not changed. In addition, some populations not included in the 2005 guideline are addressed in the update. These include children, transplant recipients, and patients undergoing elective surgery with prosthesis implantation.
Author Interviews, Cancer Research, JAMA / 21.03.2019

MedicalResearch.com Interview with: [caption id="attachment_48037" align="alignleft" width="150"]Peter R. Dixon, MDDepartment of Otolaryngology-Head & Neck SurgeryInstitute of Health Policy, Management and EvaluationUniversity of TorontoToronto, Ontario, Canada  Dr. DIxon[/caption] 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.
Aging, Author Interviews, Circadian Rhythm / 21.03.2019

MedicalResearch.com Interview with: [caption id="attachment_48030" align="alignleft" width="200"]Adrian Bejan PhD ( MIT 1971, 1972, 1975 )J.A. Jones Distinguished Professor Duke University Dr. Bejan[/caption] 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.
Author Interviews, Gender Differences, Mental Health Research, OBGYNE, Psychological Science / 20.03.2019

MedicalResearch.com Interview with [caption id="attachment_48025" align="alignleft" width="150"]Haley Kranstuber Horstman, Ph.D.Department of CommunicationUniversity of Missouri Dr. Kranstuber Horstman[/caption] 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.
Author Interviews, Blood Pressure - Hypertension, NEJM, Race/Ethnic Diversity / 20.03.2019

MedicalResearch.com Interview with: [caption id="attachment_48022" align="alignleft" width="133"]Dike B. Ojji, M.D., Ph.D, FWACP, FACPDepartment of MedicineFaculty of Clinical SciencesUniversity of Abuja Dr. Ojji[/caption] 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.
Author Interviews, Erectile Dysfunction, Heart Disease / 20.03.2019

MedicalResearch.com Interview with: [caption id="attachment_48010" align="alignleft" width="130"]Jagat Narula, MD, PhDPhilip J. and Harriet L. Goodhart Professor of Medicine (Cardiology)Associate Dean for Global HealthDirector of the Cardiovascular Imaging ProgramMount Sinai Medical Center Dr. Narula[/caption] 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).
Author Interviews, Heart Disease, JACC, Technology / 20.03.2019

MedicalResearch.com Interview with: [caption id="attachment_48004" align="alignleft" width="130"]Annapoorna Kini, MDZena and Michael A Wiener Professor of MedicineDirector of the Cardiac Catheterization LaboratoryMount Sinai Heart at Mount Sinai Hospital Dr. Kini[/caption] 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".
Author Interviews, Biomarkers, OBGYNE / 20.03.2019

MedicalResearch.com Interview with: [caption id="attachment_48001" align="alignleft" width="125"]Dr. Kara Rood MDMaternal-fetal Medicine PhysicianThe Ohio State University Wexner Medical Center Dr. Rood[/caption] 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.
Addiction, Author Interviews, CDC, Emory / 20.03.2019

[caption id="attachment_48017" align="alignleft" width="145"]CDR Andrew Geller, MDMedical Officer, Medication Safety ProgramDivision of Healthcare Quality Promotion,CDCAtlanta GA 30329 Dr. Geller[/caption] 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. 
Author Interviews, Orthopedics, Pain Research / 19.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47992" align="alignleft" width="122"]Geoffrey Westrich, MDDirector of ResearchAdult Reconstruction and Joint Replacement ServiceHospital for Special SurgeryNYC Dr. Westrich[/caption] 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 
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.
Author Interviews, Heart Disease, JAMA / 19.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47952" align="alignleft" width="167"]Dr. Carina Blomström-Lundqvist, MDProfessor of CardiologyDepartment of CardioloyInstitution of Medical ScienceUppsala, Sweden Dr. Blomström-Lundqvist[/caption] 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. 
Author Interviews, Heart Disease / 19.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47945" align="alignleft" width="200"]Mandeep R. Mehra, MD, MSc, FRCP (London)The William Harvey Distinguished Chair in Advanced Cardiovascular MedicineMedical Director, Heart and Vascular Center, Brigham and Women’s HospitalExecutive Director, Center for Advanced Heart DiseaseBrigham and Women’s HospitalProfessor of Medicine, Harvard Medical School Dr. Mehra[/caption] 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.
Author Interviews, Heart Disease, Infections, Opiods / 18.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47941" align="alignleft" width="200"]Serena Day, MDOhio State University. Dr. Serena Day[/caption] 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%.
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 [caption id="attachment_47749" align="alignleft" width="200"]Stavros V. Konstantinides, MD, PhD, FESC, FRCP(Glasg)Professor, Clinical Trials, and Medical DirectorCenter for Thrombosis and Hemostasis (CTH)Johannes Gutenberg University MainzMainz, Germany Dr. Konstantinides[/caption] 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. 
Accidents & Violence, Author Interviews, Heart Disease, Inflammation, JACC, Lipids / 18.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47835" align="alignleft" width="200"]Dr. George Dangas MD PhDProfessor of Medicine, CardiologyMount Sinai Health System Dr. Dangas[/caption] 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.
Author Interviews, Opiods, Orthopedics / 18.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47877" align="alignleft" width="130"]Paul Cagle, Jr. MDAssistant Professor of Orthopedic SurgeryIcahn School of Medicine at Mount Sinai Dr. Cagle[/caption] 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).
Author Interviews, Biomarkers, BMJ, Heart Disease / 18.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47901" align="alignleft" width="158"]Prof. Nick Curzen  BM(Hons) PhD FRCPProfessor of Interventional Cardiology/Consultant CardiologistUniversity Hospital SouthamptonSouthampton Prof. Curzen[/caption] 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.