Author Interviews, Opiods, Orthopedics, Surgical Research / 18.03.2019

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

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

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

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

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

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

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

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

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

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

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

MedicalResearch.com Interview with: Bo Chawes, MD, PhD, DMSc Associate Professor C‌openhagen Prospective Studies on Asthma in Childhood H‌erlev and G‌entofte H‌ospital U‌niversity of C‌openhagen MedicalResearch.com: What is the background for this study? What are the main findings? Response: There has been a global surge in vitamin D deficiency happening in parallel with an increase in prevalence of childhood asthma, which suggests that low maternal vitamin D levels during pregnancy may increase asthma risk in the child. Due to that we conducted a randomized double-blinded controlled trial within the Danish COPSAC2010 cohort (www.copsac.com) of 7-fold (2,800 IU/d) vs. standard dose (400 IU/d) of vitamin D supplementation from pregnancy week 24 aiming to reduce offspring asthma risk. At age 3, we observed a non-significant 24% reduced risk of recurrent asthma-like symptoms, ie. recurrent wheeze, in the high-dose vitamin D group. In the current study, we followed 545 of the 581 children in the study till age 6, where an asthma diagnosis can be established and observed no effect of the high-dose vitamin D supplement on the child's risk of asthma.  (more…)
Author Interviews, Cost of Health Care, Gastrointestinal Disease, Opiods / 12.03.2019

MedicalResearch.com Interview with: Howard Franklin, MD, MBA Vice President of Medical Affairs and Strategy Salix Pharmaceuticals MedicalResearch.com: What is opioid-induced constipation? Response: Opioid-induced constipation (OIC) is a side effect in as many as 80 percent of chronic pain patients on opioids. OIC is unlikely to improve over time without treatment and can lead to suffering and discomfort. More importantly, the insufficient treatment of OIC can have negative implications for patients, both those on opioid therapy for chronic non-cancer pain as well as advanced illness, and for hospitals.  (more…)
Alcohol, Author Interviews, JAMA, Weight Research / 12.03.2019

MedicalResearch.com Interview with: Alice R Carter MSc Doctor of Philosophy Student MRC Integrative Epidemiology Unit Population Health Science, Bristol Medical School University of Bristol MedicalResearch.com: What is the background for this study?   Response: Higher body mass index and alcohol intake have been shown to increase the risk of liver disease. Some studies have looked at their combined effect by comparing the risk of liver disease between individuals with both high BMI and high alcohol intake and individuals with low BMI and low alcohol intake. However, these studies have produced mixed results. Some possible reasons for that are errors in self-reported BMI and alcohol intake, other factors confounding the association of BMI & alcohol intake with liver disease risk and changes in lifestyle that individuals with ill health may have been advised to adopt. One way to overcome these limitations is to use a technique called Mendelian randomisation. This method uses genetic differences between individuals that influence their characteristics (e.g. their body mass and how much alcohol they drink) to help understand whether these characteristics are causally related to diseases. Our study used this method to explore the joint effects of BMI and alcohol consumption on liver disease and biomarkers of liver injury.  (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, Diabetes, Pharmaceutical Companies, Weight Research / 12.03.2019

WeightControl.com Interview with: Dr. Lynn Kramer, MD FAAN VP and Chief Clinical Officer & Chief Medical Office Eisai Co., Ltd WeightControl.com: What is the background for this announcement? Response: On February 25th, Eisai announced that the U.S. Food and Drug Administration (FDA) accepted its supplemental New Drug Application to potentially update the label for BELVIQ® (lorcaserin HCI) CIV 10 mg twice-daily/BELVIQ XR (lorcaserin HCI) CIV once daily to include long-term efficacy and safety data from CAMELLIA-TIMI 61, a clinical trial of BELVIQ in 12,000 overweight and obese patients with cardiovascular (CV) disease and/or multiple CV risk factors such as type 2 diabetes mellitus (T2DM). (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…)
Abbvie, Author Interviews, Dermatology, Immunotherapy / 11.03.2019

MedicalResearch.com Interview with: Anne Robinson, Pharm D Executive Scientific Director AbbVie MedicalResearch.com: What is the background for the risankizumab data presented at the American Academy of Dermatology 2019 Annual Meeting? Response: Abstracts presented by AbbVie at the American Academy of Dermatology (AAD) 2019 Annual Meeting highlight additional data from the Phase 3 clinical trial program evaluating the safety and efficacy of risankizumab, an investigational interleukin-23 (IL-23) inhibitor. The registrational program for risankizumab evaluated more than 2,000 adult patients with moderate to severe plaque psoriasis across four pivotal studies. (more…)
Author Interviews, Diabetes, Nutrition, Salt-Sodium, Weight Research / 09.03.2019

MedicalResearch.com Interview with: Megan A McCrory, PhD, FTOS Research Associate Professor Dept of Health Sciences Sargent College of Health and Rehabilitation Sciences Boston University 02215 MedicalResearch.com: What is the background for this study? Response: The prevalence of overweight and obesity has increased in the US, along with documented increases in portion size in the food supply. Fast food is popular, making up about 11% of adult daily calorie intake in the US, and over 1/3 of U.S. adults eat at fast food establishments on any given day. We therefore sought to examine changes in portion size, calories, and selected nutrients in fast-food entree, side, and dessert menu items across the years 1986, 1991, and 2016. (more…)
Author Interviews, Depression, Nutrition, Supplements, Weight Research / 08.03.2019

MedicalResearch.com Interview with: Prof. Marjolein Visser PhD Professor of Healthy Aging Head section Nutrition and Health Department of Health Sciences, Vrije Universiteit Amsterdam Amsterdam Public Health research institute MedicalResearch.com: What is the background for this study? What are the main findings? Response: More than 40 million Europeans experience a major depressive disorder. One in ten men, and one in five women suffer from clinical depression at least once during their lifetime. Depression is one of the most prevalent and disabling disorders in the EU. Given the increasing prevalence of depression, more people are actively searching for ways to decrease their risk through lifestyle modification, but are often overwhelmed by confusing and contradictory information. The MooDFOOD prevention trial is the largest randomized clinical trial to study the effects of nutritional strategies on the prevention of major depressive disorder. Over 1000 overweight or obese participants identified as being at elevated risk for depression but who were not currently depressed, from four European countries -the Netherlands, the United Kingdom, Germany and Spain, took part in the study. Participants were randomized to either take nutritional supplements containing folic acid, vitamin D, zinc, selenium or to a pill placebo, and half of participants also received a behavioral lifestyle intervention intended to change dietary behaviors and patterns. (more…)
Author Interviews, Diabetes, Statins / 08.03.2019

MedicalResearch.com Interview with: Fariba Ahmadizar, PharmD, MSc, PhD Department of Epidemiology Erasmus University Medical Centre Rotterdam, the Netherlands MedicalResearch.com: What is the background for this study? Response: Several observational studies and trials have already reported an increased risk of incident type 2 diabetes in subjects treated with statins; however, most of them lack details, meaning that there were limited studies on the association of statin use with glycemic traits. Studies on this association underestimated type 2 diabetes incident cases due to including either questionnaire-based data, short follow-up time or lack of a direct comparison between different statin types, dosages and duration of use with respect to diabetes-related outcomes. (more…)
Author Interviews, Pediatrics / 08.03.2019

MedicalResearch.com Interview with: Prof. Angela Morgan PhD NHMRC Practitioner Fellow and Leads the Speech and Language Group Murdoch Children's Research Institute MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Approximately 5% of school-aged children have a communication impairment that affects speech, language, or both. There are many subtypes of speech sound disorders, but the most severe is  (CAS), which impacts sequencing of speech movements. Childhood apraxia of speech  occurs in around 1 in 1000 children. In persistent cases of CAS, speech cannot easily be understood throughout life. Although CAS is rare, unravelling its neurobiological causes is likely to identify brain networks crucial to more common and less severe forms of speech disorders. Here we provide comprehensive speech and neuroimaging data on a large novel family where one parent and 11 children presented with features of childhood apraxia of speech. Brain MRI scanning revealed changes in core parts of the brain responsible for speech production. Even though CAS manifests as a problem with talking, we found disruptions in an underlying pathway of the brain normally associated with language (the meaning and grammar of what we say), rather than speech production. Our findings identify disruption of the dorsal language stream as a novel finding in developmental speech disorders. Overall, our data confirm the early role of this stream in auditory-to-articulation transformations.  (more…)
Author Interviews, Blood Pressure - Hypertension, Heart Disease, Sleep Disorders / 07.03.2019

MedicalResearch.com Interview with: Dr Manolis S Kallistratos MD, PhD, FESC,EHS Asklepeion General Hospital Greece  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Lifestyle changes represent the cornerstone of treatment of arterial hypertension. Alcohol and salt reduction may decrease blood pressure levels by 2 to 8 mmHg. In our study 60 minutes of midday sleep decrease 24 hours systolic blood pressure levels by up to 3 mmHg in well controlled hypertensives. That is an effect as potent as other well-established life style changes. The magnitude of blood pressure decrease might seem small, but a drop in blood pressure as small as 2 mmHg can reduce the risk of cardiovascular events by up to 10 percent.  (more…)
Author Interviews, Cost of Health Care, Kidney Disease, Medicare, Transplantation / 07.03.2019

MedicalResearch.com Interview with: Allyson Hart MD MS Department of Medicine, Hennepin Healthcare, University of Minnesota Minneapolis, Minnesota MedicalResearch.com: What is the background for this study? What are the main findings? Response: Kidney transplantation confers profound survival, quality of life, and cost benefits over dialysis for the treatment of end-stage kidney disease. Kidney transplant recipients under 65 years of age qualify for Medicare coverage following transplantation, but coverage ends after three years for patients who are not disabled. We studied 78,861 Medicare-covered kidney transplant recipients under the age of 65, and found that failure of the transplanted kidney was 990 percent to 1630 percent higher for recipients who lost Medicare coverage before this three-year time point compared with recipients who lost Medicare on time. Those who lost coverage after 3 years had a lesser, but still very marked, increased risk of kidney failure. Recipients who lost coverage before or after the three-year time point also filled immunosuppressive medications at a significantly lower rate than those who lost coverage on time. (more…)
Alzheimer's - Dementia, Author Interviews, BMJ, Hormone Therapy / 07.03.2019

MedicalResearch.com Interview with: Tomi Mikkola MD Associate Professor Helsinki University Hospital Department of Obstetrics and Gynecology Helsinki, Finland MedicalResearch.com: What is the background for this study? What are the main findings? Response: In Finland we have perhaps the most comprehensive and reliable medical registers in the world. Thus, with my research group I have conducted various large studies evaluating association of postmenopausal hormone therapy use and various major diseases (see e.g. the references in the B;MJ paper). There has been various smaller studies indicating that hormone therapy might be protective for all kinds of dementias, also Alzheimer’s disease. However, we have quite recently shown that hormone therapy seems to lower the mortality risk of vascular dementia but not Alzheimer’s disease (Mikkola TS et al. J Clin Endocrinol Metab 2017;102:870-7). Now in this upcoming BMJ-paper we report in a very large case-control study (83 688 women with Alzheimer’s disease and same number of control women without the disease) that systemic hormone therapy was associated with a 9-17% increased risk of Alzheimer’s disease. Furthermore, this risk increase is particularly in women using hormone therapy long, for more than 10 years. This was somewhat surprising finding, but it underlines the fact that mechanisms behind Alzheimer’s disease are likely quite different than in vascular dementia, where the risk factors are similar as in cardiovascular disease. We have also shown how hormone therapy protects against cardiovascular disease, particularly in women who initiate hormone therapy soon after menopause. (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…)
Author Interviews, Depression, OBGYNE, Weight Research / 05.03.2019

MedicalResearch.com Interview with: Jun Ma, MD, PhD, FAHA, FABMR Professor and Associate Head of Research Department of Medicine Director, Center for Health Behavior Research The University of Illinois at Chicago MedicalResearch.com: What is the background for this study? What are the main findings? Response: Obesity and depression are major public health problems. Obesity affects 40% of United States (US) adults. About 20% in US women and 13% in men experience major depressive disorder at some point in their lifetime and, additionally, many adults have elevated depressive symptoms that do not meet clinical diagnostic criteria but can nevertheless negatively affect their health and quality of life. Obesity and depression share common risk factors, such as poor diet and lack of exercise, and cause other health problems, such as diabetes and cardiovascular disease. People with obesity are at increased risk of being depressed and, likewise, people with depression are at increased risk of being obese. Consequently, obesity and depression often co-occur. To date, there has been no integrated therapy to effectively treat patients affected by both conditions at the same time. The RAINBOW randomized clinical trial addressed this gap. The main finding from the trial is that, among adult patients with obesity and depression, a collaborative care intervention integrating behavioral weight loss treatment, problem-solving therapy, and as-needed antidepressant medications significantly improve weight loss and depressive symptoms over one year compared with usual care, which patients received through their primary care physicians.  (more…)
Author Interviews, Dermatology, Pharmaceutical Companies / 05.03.2019

MedicalResearch.com Interview with: Dr. James Q. Del Rosso, D.O., FAOCD, Dermatologist Research Director and Principal Investigator Del Rosso Dermatology Research Center, Las Vegas, NV Galderma Consultant MedicalResearch.com: What is the background for this study? What are the main findings?
  • The ANSWER study, a 12-week, randomized, multicenter, Phase 4, Phase 3b in Canada and Europe clinical trial, is the first study of its kind to compare the efficacy and safety of combination therapy with Oracea® (doxycycline, USP) 40 mg Capsules + Soolantra® (ivermectin) Cream, 1% versus Soolantra® (ivermectin) Cream, 1% monotherapy in 273 adults with severe papulopustular rosacea (IGA 4) at clinical trial sites in the United States, Canada and Europe (Czech Republic, Poland, Hungary and Germany).
  • Results showed the combination therapy with Oracea Capsules + Soolantra Cream was well tolerated and effective with a faster onset of action than Soolantra Cream given as monotherapy. Key highlights of the study include:
  • The mean reduction in percentage of inflammatory lesions from baseline to Week 12 was significant with combination therapy compared to monotherapy (80.29% vs. 73.56%, respectively; p=0.032).
  • 5 times as many patients taking combination therapy achieved 100% clearance of inflammatory lesions by Week 12 compared with monotherapy (17.8% vs. 7.2%, respectively; p=0.006).
  • Over 2 times as many patients taking combination therapy achieved 100% clear (IGA 0) by Week 12 compared with monotherapy (11.9% vs. 5.1%, respectively; p=0.043).
  • Combination therapy was generally well tolerated and no discontinuation of treatments due to side effects.
(more…)
Author Interviews, Diabetes, Exercise - Fitness, JAMA, Lifestyle & Health, Weight Research / 05.03.2019

MedicalResearch.com Interview with: Giuseppe Pugliese, MD, PhD for the Italian Diabetes and Exercise Study 2 (IDES_2) Investigators Department of Clinical and Molecular Medicine ‘‘La Sapienza’’ University Diabetes Unit, Sant’Andrea University Hospital Rome, Italy MedicalResearch.com: What is the background for this study? Response: There is a growing epidemic of obesity and type 2 diabetes worldwide, which are causally related to the increasing prevalence of “physical inactivity”, i.e., an insufficient amount of moderate-to-vigorous physical activity according to current guidelines, and “sedentariness”, i.e., too many hours, especially if uninterrupted, spent in a sitting or reclined position.  These two unhealthy behaviors exert their detrimental effects independently of each other and are very common among people suffering from type 2 diabetes, who would therefore benefit from increasing physical activity and reducing sedentary time, as recommended by current guidelines. However, such a behavior change is generally difficult for a number of internal and external barriers and requires behavioral interventions targeting both physical activity and sedentary habits.  Unfortunately, there is no definitive evidence that this is indeed feasible and, particularly, that, if adopted, change in behavior can be maintained in the long term.  (more…)