Author Interviews, Brigham & Women's - Harvard, Ebola, Global Health, Lancet / 28.03.2019

MedicalResearch.com Interview with: Patrick Vinck, PhD Research Director, Harvard Humanitarian Initiative Assistant Professor, Global Health and Population T.H. Chan Harvard School of Public Health; Emergency Medicine Harvard Medical School Lead Investigator, Brigham & Women's Hospital  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The second worst epidemic of Ebola on record is currently unfolding in the eastern part of the Democratic Republic of the Congo. Whether or not safe practices are implemented to prevent the spread of the epidemic is influenced by the behavior of individuals at-risk of contracting the Ebola Virus Disease (EVD) - Will they follow the recommendations of health professionals? Will they report suspected cases and deaths? Will they seek treatment from health professionals? Will they accept vaccines and adopt preventive behaviors? We find that belief in misinformation about Ebola is widespread and trust in authorities is generally low, likely as a result of decades of violence and poor governance and, more recently, the politicization of the Ebola response. Our analysis shows that trust and (mis-)information influence adherence to risk avoidance behavior and acceptance of vaccination. (more…)
Accidents & Violence, Author Interviews, Emergency Care, NEJM, University Texas / 27.03.2019

MedicalResearch.com Interview with: Jeffrey Howard, PhD Assistant Professor Department of Kinesiology, Health and Nutrition University of Texas at San Antonio San Antonio, TX 78249 MedicalResearch.com: What is the background for this study? Response:  There is a saying that “the only winner in war is medicine”, which is the first sentence in the article.  The point of that quote is that many medical advances over the last 500 years or more have been learned or propagated as a result of war. With that as the backdrop, the purpose of our study was to provide a more comprehensive assessment of the trauma system than previous work.  We accomplished this by compiling the most complete data to-date on the conflicts, using data from both Afghanistan and Iraq, and analyzing multiple interventions/policy changes simultaneously rather than in isolation.  Previous work had focused primarily on single interventions and within more narrow timeframes.  We wanted to expand the scope to include multiple interventions and encompass the entirety of the conflicts through the end of 2017.  (more…)
Author Interviews, Duke, Endocrinology, Environmental Risks, Thyroid Disease, Weight Research / 27.03.2019

MedicalResearch.com Interview with: Christopher D. Kassotis, Ph.D. NRSA Postdoctoral Research Scholar Stapleton Lab Duke University Nicholas School of the Environment Durham, NC 27708  MedicalResearch.com: What is the background for this study? What are the main findings?
  • So this was something that Heather Stapleton had been curious about for years, as she's been one of several researchers characterizing the hundreds of chemicals that have been measured in indoor house dust. Before I came to Duke, one of her PhD students had measured the ability of many common indoor contaminants to activate the peroxisome proliferator activated receptor gamma (PPARg). The majority of these chemicals did, often quite well, which led to them testing indoor house dust extracts, also finding that the majority of dust extracts were also able to do so at very low levels. As PPARg is often considered the master regulator of fat cell development, the next obvious question was whether these common contaminants (and house dust) could promote fat cell development in cell models. My first work at Duke evaluated a suite of common indoor contaminants, finding that many of these chemicals could promote fat cell development, and that low levels of house dust extracts did as well.
  • We next explored this more systematically in a group of adults involved in a thyroid cancer cohort (this was just recently published in Science of the Total Environment: https://www.sciencedirect.com/science/article/pii/S0048969719307715?dgcid=author
  • In this study we evaluated the extent to which house dust extracts could promote fat cell development in a common cell model, and associated this with the metabolic health of adults living in these homes. We found that the greater extent of fat cell development was associated with significantly greater thyroid stimulating hormone concentrations (control residents only, with no evidence of thyroid dysfunction) and lower free triiodothyronine (T3) and thyroxine (T4). We further found a significant and positive association between extent of fat cell development and the body mass index (BMI) of all adults in the study. So this suggested that the indoor environment might play a role in the BMI and metabolic health of residents, and we next wondered if this would be more pronounced in children, who may be exposed to these contaminants during a critical window of development.
  • The next step, for our current work, was to substantiate these effects in a larger group of households, each with children.
  • Our major conclusions thus far have been that ~80% of house dust extracts promote significant fat cell development in a cell model - either via development from precursor cells into mature fat cells, measured via accumulation of lipids into the cells, or via the proliferation of those precursor fat cells. We also reported positive correlations of fat cell development with the concentrations of 70 different contaminants in the dust from these homes, suggesting that mixtures of contaminants are likely all acting weakly to produce these effects in combination. We’ve also begun to assess the other chemicals present in dust - chemistry can be either targeted (measuring concentrations of specific known chemicals in a sample), or non-targeted, where you try and determine the identity of the other chemicals in a sample. This has greater utility for identifying many more chemicals, though you will often not get chemical concentrations from this, nor absolute confirmed identification - just varying degrees of certainty based on evidence. Thus far we report approximately 35,000 chemicals in house dust samples across this study, and differential analyses have begun to pick out the few (less than 10 in each case) chemicals most differentially expressed between samples that exhibit high degrees of fat cell development in the lab vs inactive samples, for example, or which are differentially present in the homes of children categorized as obese or overweight. We are now working to confirm identity of these select contaminants that are more likely to be causative factors in the results we have observed.
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Author Interviews, Brigham & Women's - Harvard, Dermatology, Heart Disease, JAMA / 27.03.2019

MedicalResearch.com Interview with: Seoyoung C. Kim, MD, ScD, MSCE Director, Program in Rheumatologic, Immunologic, and Musculoskeletal PharmacoEpidemiology Associate Professor of Medicine Division of Pharmacoepidemiology & Pharmacoeconomics Division of Rheumatology, Immunology and Allergy Brigham and Women's Hospital Harvard Medical School MedicalResearch.com: What is the background for this study? Response: Given a high cardiovascular (CV) risk among patients with psoriasis and psoriatic arthritis, it is important to have more information with regard to potential effect of different treatment agents on CV risk. As the number of treatment options for psoriasis and psoriatic arthritis has been rising over the few decades, it is even more crucial to have high-quality evidence on comparative safety of different treatment options so physicians and patients can choose an agent based on the benefit-risk profile of each drug they are considering. (more…)
Author Interviews, Brigham & Women's - Harvard, Flu - Influenza, Heart Disease, JAMA / 27.03.2019

MedicalResearch.com Interview with: Sonja Kytomaa MA Research Associate Brigham and Women’s Hospital Scott D. Solomon, MD The Edward D. Frohlich Distinguished Chair Professor of Medicine Harvard Medical School Senior Physician Brigham and Women’s Hospital International Associate Editor, European Heart Journal   MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Influenza is associated with an increased risk of cardiovascular events, yet few studies have explored the temporal association between influenza activity and hospitalizations, especially due to heart failure (HF). Our aim with this study was to explore the temporal association between influenza activity and hospitalizations for HF and myocardial infarction (MI) in the general population. We related the number of MI and HF hospitalizations by month, which were sampled from 4 US communities and adjudicated in the surveillance component of the Atherosclerosis Risk in Communities (ARIC) study, to monthly influenza-like illness activity, as reported by the Centers for Disease Control and Prevention. We found that a 5% increase in influenza activity was associated with a 24% increase in HF hospitalizations rates, while overall influenza was not significantly associated with MI hospitalizations. Influenza activity in the months before hospitalization was not associated with either outcome. (more…)
Author Interviews, Cost of Health Care, UCLA / 27.03.2019

MedicalResearch.com Interview with: John N. Mafi, MD, MPH Division of General Internal Medicine and Health Services Research Department of Medicine David Geffen School of Medicine at UCLA RAND Health, RAND Corporation MedicalResearch.com: What is the background for this study? What types of services are low-value in this setting?  Response: For decades we have known that offering routine preoperative testing for patients undergoing cataract surgery provides limited value, yet low-value preoperative testing persists at very high rates, even at Los Angeles County Department of Health Services, one of the largest safety net health systems in the United States. (more…)
Author Interviews, JAMA, Karolinski Institute, Pediatrics / 26.03.2019

MedicalResearch.com Interview with: Mikael Norman, MD, PhD, Professor Karolinska Institutet & Karolinska University Hospital Stockholm, Sweden  MedicalResearch.com: What is the background for this study? Response: So far, preterm birth has been difficult to predict and prevent. In particular, extremely preterm birth has continued to be an issue in terms of optimal care before and after birth, costs and long term health outcomes. Therefore, studies on how the management and outcome varies over time in these patients are important. (more…)
Author Interviews, Autism, Social Issues, University of Pittsburgh, Vaccine Studies / 26.03.2019

MedicalResearch.com Interview with: Beth Hoffman, B.Sc., graduate student University of Pittsburgh Graduate School of Public Health Research Assistant, University of Pittsburgh Center for Research on Media, Technology and Health MedicalResearch.com: What is the background for this study? What are the main findings? Response: Vaccine refusal is a public health crisis - low vaccination rates are leading to outbreaks of deadly vaccine-preventable diseases. In 2017, Kids Plus Pediatrics, a Pittsburgh-based pediatric practice, posted a video on its Facebook pagef eaturing its practitioners encouraging HPV vaccination to prevent cancer. Nearly a month after the video posted, it caught the attention of multiple anti-vaccination groups and, in an eight-day period, garnered thousands of anti-vaccination comments. Our team analyzed the profiles of a randomly selected sample of 197 commenters in the hopes that this crisis may be stemmed if we can better understand and communicate with vaccine-hesitant parents. We determined that, although Kids Plus Pediatrics is an independent practice caring for patients in the Pittsburgh region, the commenters in the sample were spread across 36 states and eight countries. By delving into the messages that each commenter had publicly posted in the previous two years, we also found that they clustered into four distinct subgroups:
  • “trust,” which emphasized suspicion of the scientific community and concerns about personal liberty;
  • “alternatives,” which focused on chemicals in vaccines and the use of homeopathic remedies instead of vaccination;
  • “safety,” which focused on perceived risks and concerns about vaccination being immoral; and
  • “conspiracy,” which suggested that the government and other entities hide information that this subgroup believes to be facts, including that the polio virus does not exist. 
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Author Interviews, JAMA, Pediatrics, Stanford, Technology / 26.03.2019

MedicalResearch.com Interview with: Dennis P. Wall, PhD Associate Professor Departments of Pediatrics, Psychiatry (by courtesy) and Biomedical Data Science Stanford University  MedicalResearch.com: What did we already know about the potential for apps and wearables to help kids with autism improve their social skills, and how do the current study findings add to our understanding? What’s new/surprising here and why does it matter for children and families?  Response: We have clinically tested apps/AI for diagnosis (e.g.  https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002705) in a number of studies. This RCT is a third phase of a phased approach to establish feasibility and engagement through in-lab and at-home codesign with families with children with autism. This stepwise process is quite important to bring a wearable form of therapy running AI into the homes in a way that is clinically effective. What’s new here, aside from being a first in the field, is the rigorous statistical approach we take with an intent-to-treat style of analysis. This approach ensures that the effect of the changes are adjusted to ensure that any significance observed is due to the treatment.  Thus, with this, it is surprising and encouraging to see an effect on the VABS socialization sub-scale. This supports the hypothesis that the intervention has a true treatment effect and increases the social acuity of the child. With it being a home format for intervention that can operate with or without a clinical practitioner, it increases options and can help bridge gaps in access to care, such as when on waiting lists or if the care process is inconsistent.   (more…)
Author Interviews, Dermatology, JAMA, Pediatrics, Sleep Disorders, UCSF / 26.03.2019

MedicalResearch.com Interview with: Dr. Katrina Abuabara, MD, MA, MSCE Department of Dermatology Program for Clinical Research, University of California, San Francisco MedicalResearch.com: What is the background for this study? Response: The wellbeing and development of children is strongly influenced by parents’ physical and psychosocial health. Parents of children with chronic illness, in particular, are susceptible to poor sleep, and previous studies have found major sleep impairments among parents of children with ventilator dependency and cystic fibrosis, but few studies have examined sleep patterns among parents of children with more common chronic illnesses like atopic dermatitis (also known as eczema). (more…)
Allergies, Author Interviews, Brigham & Women's - Harvard, Pharmacology / 23.03.2019

MedicalResearch.com Interview with: 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. (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…)
Author Interviews, Dermatology, Environmental Risks, FDA / 21.03.2019

MedicalResearch.com Interview with: 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). (more…)
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. (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. 
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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, 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, 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, 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…)
Author Interviews, Columbia, Nutrition, OBGYNE, Pediatrics / 12.03.2019

MedicalResearch.com Interview with: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of Women's Health in Obstetrics and Gynecology Director, Maternal-Fetal Medicine Fellowship Program Co-Director, CUMC Preterm Birth Prevention Center Columbia University MedicalResearch.com: What is the background for this study? What are the main findings? Response: In 2016 our group published the findings of the Antenatal Late Preterm Steroids (ALPS) trial in the NEJM.  We found that administration of antenatal corticosteroids to women at high risk for delivery from 34-36 weeks decreased breathing problems in their neonates.  This treatment had been traditionally only given at less than 34 weeks. The current paper is a cost analysis of that trial.  We found that the treatment was also cost effective.  From a cost perspective treatment was both low cost and highly effective (the options are low cost, low effect/low cost/high effect, high cost/low effect, high cost/high effect).  (more…)
Author Interviews, Brigham & Women's - Harvard, Critical Care - Intensive Care - ICUs, Infections, JAMA / 12.03.2019

MedicalResearch.com Interview with: Chanu Rhee, MD,MPH Assistant Professor of Population Medicine Harvard Medical School / Harvard Pilgrim Health Care Institute Assistant Hospital Epidemiologist Brigham and Women’s Hospital  MedicalResearch.com: What is the background for this study? Response: Sepsis is the body’s reaction to a serious infection that results a cascade of inflammation in the body and organ dysfunction, such as low blood pressure, confusion, or failure of the lungs, kidneys, or liver.   Sepsis is a major cause of death, disability, and cost in the U.S. and around the world.  Growing recognition of this problem has led to numerous sepsis performance improvement initiatives in hospitals around the country.  Some of these efforts have also been catalyzed by high-profile tragic cases of missed sepsis leading to death, which may have contributed to a perception that most sepsis deaths are preventable if doctors and hospitals were only better at recognizing it. However, the extent to which sepsis-related deaths might be preventable with better hospital-based care is unknown.  In my own experience as a critical care physician, a lot of sepsis patients we treat are extremely sick and even when they receive timely and optimal medical care, many do not survive.  This led myself and my colleagues to conduct this study to better understand what types of patients are dying from sepsis and how preventable these deaths might be.  (more…)
Author Interviews, Education, Health Care Systems, Outcomes & Safety, University of Pennsylvania / 07.03.2019

MedicalResearch.com Interview with: Jeffrey H. Silber, MD, PhD Director, Center for Outcomes Research Nancy Abramson Wolfson Endowed Chair Health Services Research Children's Hospital of Philadelphia Professor of Pediatrics, Anesthesiology and Critical Care Perelman School of Medicine, University of Pennsylvania Professor of Health Care Management Wharton School, University of Pennsylvania  MedicalResearch.com: What is the background for this study? Response: This was a year-long randomized trial that involved 63 internal medicine residency programs from around the US.  In 2015-2016, about half of the programs were randomized to follow the existing rules about resident duty hours that included restrictions on the lengths of shifts and the rest time required between shifts (the standard arm of the trial) and the other half of the programs didn’t have those shift length or rest period rules (the flexible arm of the trial).  We measured what happened to the patients cared for in those programs (the safety study), and other studies examined how much sleep the residents received, and how alert they were at the end of shifts (the sleep study), and previously we published on the educational outcomes of the interns. To measure the impact on patient outcomes when allowing program directors the ability to use a flexible shift length for their interns, we compared patient outcomes after the flexible regimen went into place to outcomes the year before in the same program. We did the same comparison for the standard arm. Then we compared the difference between these comparisons. Comparing before and after the implementation of the trial within the same program allowed us to be more confident that a particularly strong or weak program, or a program with especially sick or healthy patients, would not throw off the results of the study. The trial was designed to determine, with 95% confidence, if the flexible arm did not do more than 1% worse than the standard arm. If this were true for the flexible arm, we could say the flexible regimen was “non-inferior” to the standard regimen. (more…)
Author Interviews, FDA, JAMA / 06.03.2019

MedicalResearch.com Interview with: Craig Alexander Garmendia, PhD Office of Bioresearch Monitoring Operations Office of Regulatory Affairs US Food and Drug Administration Miami, Florida MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Clinical trials under the U.S. Food and Drug Administration’s (FDA) purview have been shown to suffer from falsified data. While the FDA warns researchers when falsified data are discovered, these data still make their way into medical literature. In this novel study, Dr. Garmendia and colleagues conducted a systematic review to examine the effects of publications containing falsified data on meta-analyses using sensitivity analyses. Almost half of all meta-analyses had conclusions altered by publications containing falsified data, while nearly one-third of all analyses had considerable changes in outcomes. (more…)
AACR, Author Interviews, Biomarkers, MD Anderson / 05.03.2019

MedicalResearch.com Interview with: Vassiliki Papadimitrakopoulou, MD Professor of Medicine Department of Thoracic/Head and Neck Medical Oncology MD Anderson Cancer Center in Houston MedicalResearch.com: What is the background for this study? What are the main findings? Response: 30% of patients with newly diagnosed advanced NSCLC can be treated successfully with targeted therapies, often yielding higher response rates than chemotherapy or immune checkpoint inhibitors. Selecting first-line therapy for patients with NSCLC requires assessment of an expanding list of guideline-recommended genomic biomarkers (EGFR, ALK, ROS1, BRAF, RET, MET amplification and exon 14 skipping, and ERBB2, with NTRK newly added) Standard-of-care (SOC) testing relies on tissue, which is limited by biopsy-related risks, specimen insufficiency, and lab processing duration, which hamper timely optimal treatment selection -          NILE is a large, prospective, multicenter, head-to-head study of SOC tissue-based genomic testing to plasma-based comprehensive cfDNA genomic testing (Guardant360®). For the four biomarkers with FDA approved therapies, up to 34% of patients were tested by SOC tissue testing versus 95% with cfDNA testing. NILE met its primary endpoint - cfDNA performed similar to tissue in the detection of guideline-recommended biomarkers and cfDNA results were delivered significantly faster than SOC tissue testing (median 9 days vs. 15 days).Using cfDNA testing first, 87% of patients with a guideline-recommended biomarker would have been detected, compared to 67% if SOC tissue testing was first. (more…)
Author Interviews, Columbia, Nutrition / 04.03.2019

MedicalResearch.com Interview with: Sonia Y. Angell, MD MPH Division of General Medicine Department of Medicine, Columbia University Irving Medical Center New York, NY   MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Trans fatty acid in the diet increases the incidence of coronary heart disease in the population. In 2006, a policy restricting restaurant use of trans fat went into effect in NYC. This study measured the change in trans fatty acid serum concentration among a representative sample of the NYC population between 2004 and 2013-2014, and whether the change varied by frequency of restaurant food dining. Overall, blood trans fatty acid serum concentration went down by 57%. Among people who dined out less than one time a week, it went down 51% and in those who dined out 4 or more times a week, it went down 61.6%.  In fact, in 2013-2014 there was no longer a significant increase in the serum trans fatty acid concentrations among those who ate restaurant foods frequently compared with those who ate out rarely.  (more…)
Author Interviews, Brigham & Women's - Harvard, Health Care Systems, JAMA, Mental Health Research / 04.03.2019

MedicalResearch.com Interview with: Mark S. Bauer, M.D. Professor of Psychiatry, Emeritus Harvard Medical School Center for Healthcare Organization and Implementation Research VA Boston Healthcare System-152M Boston, MA 02130 MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Collaborative Chronic Care Models (CCMs) have extensive evidence for their effectiveness in a wide variety of mental health conditions.  CCMs are frameworks of care that include several or all of the following six elements:  work role redesign for anticipatory, continuous care; self-management support for individuals in treatment; provider decision support; information system support for population-based and measurement-guided care; linkage to community resources; and organization and leadership support. However, evidence for Collaborative Chronic Care Model effectiveness comes almost exclusively from highly structured clinical trials.  Little is known about whether CCMs can be implemented in general clinical practice settings, and the implementation evidence that does exist derives primarily from studies of the CCM used in primary care settings to treat depression. We conducted a randomized, stepped wedge implementation trial using implementation facilitation to establish CCMs in general mental health teams in nine US Department of Veterans Affairs medical centers. We found that establishing Collaborative Chronic Care Models was associated with reduced mental health hospitalization rates and, for individuals with complex clinical presentations, improvements in mental health status.  Additionally, standardized assessment of team clinicians indicated that facilitation improved clinician role clarity and increased focus on team goals. (more…)
Alzheimer's - Dementia, Author Interviews, JAMA, Pharmacology, University of Pittsburgh / 01.03.2019

MedicalResearch.com Interview with: Alvaro San-Juan-Rodriguez, PharmD Pharmacoeconomics, Outcomes and Pharmacoanalytics Research Fellow Pharmacy and Therapeutics School of Pharmacy University of Pittsburgh MedicalResearch.com: What are the main findings? Response: Currently, there are 4 antidementia drugs approved by the FDA for the treatment of Alzheimer’s disease, including 3 acetylcholinesterase inhibitors (AChEIs)—donepezil, rivastigmine, and galantamine—and the N-methyl-D-aspartic receptor antagonist memantine. On the one hand, evidence about the effect of these drugs at delaying nursing home admission is still sparse and conflicting. On the other, all these antidementia medications have been associated with several cardiovascular side effects, such as bradycardia, ventricular tachycardia, syncope, QT interval prolongation, atrioventricular block or even myocardial infarction. In this study, we aimed to compare time to nursing home admission and time to cardiovascular side effects across all drug therapies available for the treatment of Alzheimer’s disease. In doing so, we used 2006-2014 medical and pharmacy claims data from Medicare Part D beneficiaries with a new diagnosis Alzheimer’s disease who initiated antidementia drug therapy. (more…)