MedicalResearch.com Interview with:
Dr. Leung
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.
MedicalResearch.com Interview with:
Dr. Robert Avram
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. Continue reading
MedicalResearch.com Interview with:
Dr. Chawes
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.
MedicalResearch.com Interview with:
Dr. Franklin
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.
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. Continue reading
MedicalResearch.com Interview with:
Dr. Gyamfi-Bannerman
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). Continue reading
WeightControl.com Interview with:
Dr. Kramer
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).
MedicalResearch.com Interview with:
Dr. Rhee
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. Continue reading
MedicalResearch.com Interview with:
Dr. Robinson
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. Continue reading
MedicalResearch.com Interview with:
Dr. McCrory
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.
MedicalResearch.com Interview with:
Dr. Visser
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.
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.
MedicalResearch.com Interview with:
Prof. Morgan
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. Continue reading
MedicalResearch.com Interview with:
Dr. Kallistratos
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. Continue reading
MedicalResearch.com Interview with:
Dr. Hart
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. Continue reading
MedicalResearch.com Interview with:
Dr. Mikkola
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. Continue reading
MedicalResearch.com Interview with:
Dr. Silber
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.
MedicalResearch.com Interview with:
Dr. Garmendia
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. Continue reading
MedicalResearch.com Interview with:
Dr. Jun Ma
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.
MedicalResearch.com Interview with:
Dr. Del Rosso
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?
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. Continue reading
MedicalResearch.com Interview with:
Dr. Hassanpour
Saeed Hassanpour, PhD
Assistant Professor
Departments of Biomedical Data Science,
Computer Science, and Epidemiology
Geisel School of Medicine at Dartmouth
Lebanon, NH 03756
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Lung cancer is the deadliest cancer for both men and women in the western world. The most common form, lung adenocarcinoma, requires pathologist’s visual examination of resection slides to determine grade and treatment. However, this is a hard and tedious task. Using new technologies in artificial intelligence and deep learning, we trained a deep neural network to classify lung adenocarcinoma subtypes on histopathology slides and found that it performed on par with three practicing pathologists. Continue reading
MedicalResearch.com Interview with:
Charlotte Skriver, PhD student, MSc
Danish Cancer Society Research Center
Statistics & Pharmacoepidemiology
Danish Cancer Society
Copenhagen
MedicalResearch.com: What is the background for this study?
Response: The drug aspirin is widely used due to its established protection against cardiovascular diseases. Increasing evidence also supports an effect of aspirin use on reducing the risk of and mortality from colorectal cancer and possibly other cancer types. Recent studies have suggested that aspirin use after a diagnosis of prostate cancer may improve the prognosis.
We examined whether use of low-dose aspirin was associated with survival after prostate cancer in a nationwide study of prostate cancer patients in Denmark.
MedicalResearch.com Interview with:
Dr. Barnes
Geoffrey Barnes, MD, MSc
Assistant Professor
Vascular and Cardiovascular Medicine
University of Michigan
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Both aspirin and warfarin are commonly used medications meant to prevent thrombotic complications, but might increase rates of bleeding complications.
We used a multi-center anticoagulation collaborative to explore how often patients being treated with warfarin were also taking aspirin but without a clear indication. We found that more than one-third (37.5%) of warfarin-treated patients without a clear reason for aspirin therapy were receiving aspirin. And these patients on both warfarin and aspirin experienced higher rates of bleeding and emergency department visits for bleeding than the patients taking warfarin alone. There were no differences in the rate of thrombotic events between the patients taking warfarin alone or those taking warfarin plus aspirin. Continue reading
MedicalResearch.com Interview with:
Dr. Khorasani
Hooman Khorasani, M.D.
Cosmetic Surgeon & Mohs Skin Cancer Surgeon
Icahn School of Medicine at Mt. Sinai
MedicalResearch.com: What is the background for this study?
Response: Lipomas are tumors composed of mature fat cells located just beneath the skin surface. They are the most common soft tissue tumor and are estimated to occur in 1% of the population. These benign tumors are more common in overweight individuals, diabetics, patients with elevated serum cholesterol, and those suffering from familial multiple lipomatosis. Most of these tumors are treated for cosmetic reasons; however, large lipomas can also cause significant functional impairment. Traditional treatment includes surgical removal and / or liposuction.
Deoxycholic acid is a member of the bile acid family that assists in the breakdown of fat. We investigated the use of deoxycholic acid injections to reduce the size of large lipomas prior to surgical removal.