Author Interviews, Primary Care, Vitamin K / 20.06.2016
Vitamin D Not A Panacea For Most Medical Conditions
MedicalResearch.com Interview with:
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Dr. Mike Allan[/caption]
Michael Allan, MD CCFP
Professor of Family Medicine and
Director of Evidence Based Medicine
Faculty of Medicine & Dentistry
University of Alberta
MedicalResearch.com: What is the background for this study?
Dr. Allan: A large volume of observational (lower-level) research links lower Vitamin D levels with a long list of health concerns. Other non-clinical studies show the biochemical and physiological actions of Vitamin D could impact many health states. These factors have led many clinicians and scientists to advocate strongly for Vitamin D supplementation. However, this type of research can draw false connections. Therefore, we must examine high-quality randomized studies to determine if Vitamin D supplement can help people live longer, have improved health or avoid negative health outcomes.
Dr. Mike Allan[/caption]
Michael Allan, MD CCFP
Professor of Family Medicine and
Director of Evidence Based Medicine
Faculty of Medicine & Dentistry
University of Alberta
MedicalResearch.com: What is the background for this study?
Dr. Allan: A large volume of observational (lower-level) research links lower Vitamin D levels with a long list of health concerns. Other non-clinical studies show the biochemical and physiological actions of Vitamin D could impact many health states. These factors have led many clinicians and scientists to advocate strongly for Vitamin D supplementation. However, this type of research can draw false connections. Therefore, we must examine high-quality randomized studies to determine if Vitamin D supplement can help people live longer, have improved health or avoid negative health outcomes.
Dr. Luca Passamonti[/caption]
MedicalResearch.com Interview with:
Dr. Luca Passamonti MD
Department of Clinical Neurosciences
University of Cambridge
MedicalResearch.com: What is the background for this study?
Dr. Passamonti: We wanted to study if the brain of young people with two different forms of conduct disorder (CD) (https://en.wikipedia.org/wiki/Conduct_disorder), a neuropsychiatric disease associated with severe and persistent antisocial behaviors (weapon use, aggression, fire-setting, stealing, fraudulent behavior), was different from that of young peers with no such abnormal behaviors.
There is already evidence that conduct disorder may have a biological basis (i.e., reduced levels of cortisol under stress) and brain alterations but a whole “map” of the brain in conduct disorder studying cortical thickness was never been done before.
Dr. Steven Woloshin[/caption]
Steven Woloshin, MD
Professor of The Dartmouth Institute
Professor of Medicine
Professor of Community and Family Medicine
New Hamphsire
MedicalResearch.com: What is the background for this study?
Dr. Woloshin: Drug companies are required by law to post results of trials used to support drug applications to the FDA on the clinicaltrials.gov website - but it is not clear whether posted results are complete and accurate. Recent studies attempting to validate posted results by comparing them to corresponding peer reviewed medical journal publications suggest that discrepancies are relatively common. But it is which source is more likely to be correct. We tried to validate posted results against an arguably better gold standard, the drug approval packages from the FDA (ie, the medical and statistical reviews posted on the drugs@fda.gov website). FDA reviews have an advantage over peer reviewed publications: unlike medical journal editors and peer reviewers, FDA has access to the individual participant data from the trials. This means FDA can see all the trials and all the outcomes (avoiding sleective publication) and it means FDA can independently reanalyze according to what they believe to be the best statistical practices (data can be analyzed in many ways - and different decisions, for example, how to account for missing data, can yield very different results).
Dr. Luisa Borrell[/caption]
Luisa N. Borrell, DDS, PhD
Professor
Department of Epidemiology & Biostatistics
Graduate School of Public Health & Health Policy
City University of New York
MedicalResearch.com: What is the background for this study?
Dr. Borrell: Racial/ethnic disparities in birth outcomes in the United States are well documented, with non-Hispanic Black women exhibiting the worst outcomes. Several hypotheses have been proposed as explanation to this finding such as the weathering hypothesis and cumulative or chronic experiences of social inequality and racism. However, these hypotheses have only accounted for the stress burden associated with the mother’s race/ethnicity, as her race/ethnicity has been the sole information used to determine the child’s race/ethnicity, ignoring the possible stress associated with the father’s race/ethnicity. We used NYC birth- and death-linked data from 2000 to 2010 to examine the added effect of paternal race/ethnicity on adverse birth outcomes (low birth weight [LBW], small for gestational age [SGA], preterm births, and infant mortality [IM]) among NYC women.
Dr. James Freeman[/caption]
Dr. James V. Freeman MD
Assistant professor of cardiology and
Assistant Clinical Professor of Nursing
Internal Medicine
Yale School of Medicine
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Freeman: Randomized trials of left atrial appendage (LAA) closure with the Watchman device have shown varying results, and its cost-effectiveness compared to anticoagulation has not been evaluated using all available contemporary trial data.
We used a Markov decision model to estimate lifetime quality-adjusted survival, costs, and cost-effectiveness of LAA closure with Watchman, compared directly with warfarin and indirectly with dabigatran, using data from the long-term (mean 3.8 year) follow-up of PROTECT AF and PREVAIL randomized trials. Using data from PROTECT AF, the incremental cost-effectiveness ratios (ICER) compared to warfarin and dabigatran were $20,486 and $23,422 per quality adjusted life year (QALY), respectively. Using data from PREVAIL, LAA closure was dominated by warfarin and dabigatran, meaning that it was less effective (8.44, 8.54, and 8.59 QALYs, respectively) and more costly.
Dr. Sahil Agrawal[/caption]
Sahil Agrawal MD, MD
Heart and Vascular Center
St. Luke’s University Health Network
Bethlehem, PA 18015
MedicalResearch.com: What is the background for this study?
Dr. Agrawal: Patients admitted on a weekend have previously been known to have poorer outcomes compared to patients admitted on weekdays for various acute illnesses. With the advent of early fibrinolytic therapy and subsequently, emergent primary percutaneous coronary interventions (PCI), such discrepancies in outcomes have been largely resolved for ST-segment elevation myocardial infarctions (STEMI). In contrast, treatment of non-ST segment elevation myocardial infarction (NSTEMI) has remained less stringent such that invasive coronary angiography and potential intervention is often delayed for those presenting on a weekend rather than a week day. According to current ACC/AHA guidelines for NSTEMI, an early invasive strategy (EIS) is the preferred method of management unless barred by presence of contraindications (comorbid conditions) or patients’ preference. We were interested in investigating differences in utilization of EIS between patients admitted on a weekend versus those admitted on a weekday for an NSTEMI, and to evaluate the impact of such differences on in-hospital mortality in such patients.
Dr. Ian Kronish[/caption]
Ian Kronish, MD, MPH
Florence Irving Assistant Professor of Medicine
Center for Behavioral Cardiovascular Health
Columbia University Medical Center
MedicalResearch.com: What is the background for this study?
Dr. Kronish: Prior studies have shown that adherence to statins is suboptimal both in patients prescribed statins for primary prevention and in high-risk patients who are prescribed statins to prevent recurrent events. But, to our knowledge, prior studies had not examined the impact of a hospitalization for a myocardial infarction (MI) on subsequent adherence to statins. We wondered whether the hospitalization would serve as a wake-up call that led patients to become more adherent after the MI. At the same time, we were concerned that the physical and psychological distress that arises after a hospitalization for an MI may lead to a decline in statin adherence.
Prof. David Halon[/caption]
Prof. David A. Halon MB ChB, FACC, FESC
Associate Professor of Clinical Medicine
Technion, Israel Institute of Technology.
Director, Interventional Cardiology
Lady Davis Carmel Medical Center
Haifa, Israel
MedicalResearch.com: What is the background for this study?
Prof. Halon: Type 2 diabetics are well known to have more cardiovascular events than non-diabetics but even among diabetics this risk is heterogeneous and some remain at very low risk. It remains uncertain if additional diagnostic modalities over and above clinical risk scores may be helpful in defining which diabetics are at high risk for an adverse event. We performed a study using cardiac CT angiography (CCTA) in 630 type 2 diabetics 55-74 years of age with no history of coronary artery disease to examine if CTA findings would have additional prognostic value over traditional risk scores for cardiovascular or microvascular based events over 7.5 years of follow-up.
Dr. Mari Videman[/caption]
Mari Videman
Senior Consultant in Child Neurology
BABA Center
Children’s Hospital, Helsinki University Hospital
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Depression and anxiety are common during pregnancy, and up to 5% of all pregnant women are treated with serotonin uptake inhibitors (SRI). It is now known that SRIs do not cause major malformations in humans, however recent animal studies have suggested that fetal early SRI exposure may cause changes in brain microstructure and neuronal signaling. Prior human studies have shown that fetal SRI exposure leads to transient postnatal adaptation syndrome, as well as to an increased risk of developing childhood depression.
We used electroencephalography (EEG) and advanced computational methods to assess both the local and global cortical function of the newborn brain. We found that several aspects of newborn brain activity are affected by exposuse to SRI during pregnancy. Most importantly, the communication between brain hemispheres, and the synchronization between cortical rhythms were weaker in the SRI-exposed newborns. These changes were most likely related to SRI exposure, because they did not correlate with the psychiatric symptoms of the mothers.
Dr. Kelli Komro[/caption]
Kelli A. Komro, MPH, PhD, Professor
Director of Graduate Studies
Behavioral Sciences and Health Education
Jointly Appointed, Epidemiology
Rollins School of Public Health
Emory University
Atlanta, GA 30322
MedicalResearch.com: What is the background for this study?
Dr. Komro: Epidemiologists have done a thorough job describing the income-health gradient, which shows a clear association between income and health. That is, as income increases, exposure to health risks and premature mortality decreases. Each step down on the income ladder decreases one’s health for many reasons related to material resources, physical environment exposures and social circumstances.
The income to health association begins at birth, and more than one in four women giving birth in the U.S. are below the poverty level, putting nearly 1 million babies at risk each year. Low-income mothers are more likely to give birth prematurely, to have low birth weight babies, and to suffer the death of their infant during the post-neonatal period (28 to 364 days old).
Given the importance of the income-health gradient, we set out to test the health effects of policies that are designed to increase economic security among low-income families. Our main question is: Do policies designed to reduce poverty and improve family economic security also improve health?
One relevant policy is minimum wage laws. A federal minimum wage was first enacted in 1938. The real value (in 2015 dollars) of the federal minimum wage reached a high of $10.85 in 1968. The current federal rate is $7.25. Many cities and states have passed minimum wage laws that are higher than the federal rate, and currently there is a range of minimum wage increases under active public and policymaker discussion.
Given that some states pass minimum wage standards and others do not, and that laws within states change over time, we took advantage of all the changes that have occurred to design a natural experiment. Our natural experiment examined the effects of state minimum wage laws on infant health.
Dr. Kathleen Fischer[/caption]
Kathleen Fischer, PhD
Department of Biology
UAB | University of Alabama Birmingham
Birmingham, AL
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Fischer: Aging is by far the greatest risk factor for most of the chronic, non-communicable diseases (e.g. cardiovascular disease, cancer, diabetes). By discovering the basic mechanisms responsible for aging we can find ways to extend healthy and productive life and reduce the burdens of chronic disease and disability experienced by individuals and society. Sex differences in longevity can provide novel insights into the basic biology of aging; however this aspect of aging has been largely ignored.
Demographic data show that women outlive men in every society during every historical period and in every geographic area. In spite of this robust survival advantage, women suffer far greater morbidity late in life—a phenomenon described as the morbidity-mortality paradox. It is not clear whether this is a general mammalian pattern or something unique to humans. Research on sex differences in aging and age-related diseases in humans and a range of species will be crucial if we are going to identify the basic mechanisms responsible for the patterns we observe.
Dr. Kate Merritt[/caption]
Kate Merritt PhD
Post-Doctoral Research Worker
NOC Study (Nitric Oxide in Cognition)
Institute of Psychiatry
De Crespigny Park
London
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Merritt: Research has indicated that levels of one of the main chemicals in the brain, glutamate, may be abnormal in schizophrenia. Almost sixty studies have measured glutamate levels in schizophrenia, however the findings are inconsistent, and it is thought that changes in glutamate levels may vary with the length or the severity of illness. This study therefore analysed all the published reports of glutamate in schizophrenia.
The main findings are that, overall, schizophrenia is associated with elevated glutamate in several brain regions; namely the medial temporal cortex, the basal ganglia and the thalamus. These changes also differed with the stage of illness; in the medial frontal cortex, glutamate was increased in people at risk for developing schizophrenia, but not in people who had been diagnosed with schizophrenia for several years, whereas in the medial temporal lobe the opposite pattern was detected.
Dr. Celeste Torio[/caption]
Celeste M. Torio, Ph.D., M.P.H
Scientific Review Officer
AHRQ
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Torio: Hospital care expenditures constitute the largest single component of health care spending. These expenses are of significant concern to policymakers because of their impact on governments, consumers and insurers.
MedicalResearch.com: What are the main findings?
• Aggregate hospital costs for 35.6 million hospital stays totaled $381.4 billion in 2013.
• Septicemia, osteoarthritis, newborn infants, complication of device, and acute myocardial infarction are the five most expensive conditions, and account for 1/5 of the total aggregate costs for hospitalizations.
• Sixty-three percent of aggregate hospital costs were covered by Medicare and Medicaid, while 28 percent were covered by private insurance and 5 percent were covered by the uninsured.
Dr. Leland McClure[/caption]
Leland McClure, PhD
Director in Medical Affairs for Quest Diagnostics
Fellow of the American Board of Forensic Toxicology
MedicalResearch.com: What is the background for this study?
Dr. McClure: Quest Diagnostics is the leading provider of diagnostic information services, providing clinical lab testing to about one in three American adults each year. As a result, we've amassed the largest private clinical laboratory database in the United States, based on 20 billion data points from lab testing. Quest uses this data (in de-identified, HIPAA compliant form) to perform research -- called Quest Diagnostics Health Trends(TM) -- to reveal insights on important health issues to inform clinical patient management and health policy. Other Health Trends reports have focused on diabetes, pregnancy and influenza, among others.
Dr. Burns Blaxall[/caption]
Burns C. Blaxall, PhD, FAHA, FACC, FAPS
Director of Translational Science, Heart Institute
Co-Director, Heart Institute Research Core & Biorepository
Professor, UC Department of Pediatrics
MedicalResearch.com: What is the background for this study?
Dr. Blaxall: The development of kidney disease subsequent to chronic heart failure is known clinically as cardiorenal syndrome 2, and is associated with dual organ failure and reduced survival. Furthermore, patients undergoing invasive cardiac procedures that require heart-lung bypass are at significant risk for developing kidney injury. According to the National Kidney Foundation, cardiorenal syndrome 2 presents a considerable economic burden of around $30 billion annually. Previous work has demonstrated the role of G protein-coupled receptor (GPCR) signaling and the activation of G protein βγ (Gβγ) subunits in the development and progression of heart failure, however little is known regarding the role of this signaling pathway in kidney disease.
Dr. James M. Smith[/caption]
Dr. James M. Smith Ph.D
Laboratory Branch, Division of HIV/AIDS Prevention
Centers for Disease Control and Prevention
Atlanta, Georgia
MedicalResearch.com: What is the background for this study?
Dr. Smith: Our laboratory has been developing a macaque model for testing drug release, safety and efficacy of intravaginal rings (IVR) for preexposure prophylaxis (PrEP) against HIV for several years. The initial studies involved both matrix rings, where the drug is dispersed in the silicone matrix of the device, and reservoir rings, which are essentially a polymer tube filled with drug. In collaboration with the Oak Crest Institute of Science and Auritec Pharmaceuticals, Inc., we began testing a new type of intravaginal ring, the pod-IVR. In this innovative design the ring itself is a scaffold that contains compressed polymer-coated drug tablets, or pods, within the ring. Each pod is separate, allowing for a customizable release rate for each drug by varying the number and diameter of the drug release ports for each individual pod. The macaque pod-IVR can accommodate up to six pods whereas the human pod-IVR can accommodate up to 10 pods. The IVR design was developed to allow the delivery of drug combinations and for simple, cost-effective manufacturing.
Dr. Joseph Alvarnas[/caption]
Joseph Alvarnas, MD
Associate clinical professor
Department of hematology and Director of value-based analytics
City of Hope National Medical Center
Duarte, CA
MedicalResearch.com: What is the background for this study?
Dr. Alvarnas: Patients with HIV infection have a significantly increased risk of non-Hodgkin lymphoma and Hodgkin lymphoma. Prior to the availability of effective anti-retroviral therapy, HIV-infected patients with lymphoma had very poor treatment outcomes. Following the availability of effective anti-HIV therapy, patient outcomes for HIV-infected patients now parallel those of non-infected patients. Historically, however, HIV infection has been used as a criterion for not offering patients autologous blood stem cell transplantation outside of centers with unique expertise. The purpose of this trial was to evaluate outcomes, complication rates, and immunological reconstitution of HIV-infected patients following autologous blood stem cell transplantation.
Prof. Philip Home[/caption]
Professor Philip Home D.M., D.Phil
Professor of Diabetes Medicine
Newcastle University
MedicalResearch.com: What is the background for this study? What are the main findings?
Prof. Home: MK1293 is a biosimilar insulin designed with the same amino acid sequence, manufacturing process and formulation as originator insulin glargine (Lantus). This is the clinical proving study in type 1 diabetes, being a 24-week randomized study in 508 participants between MK1293 and Lantus. The primary efficacy endpoint of non-inferiority of HbA1c was met, as was a secondary of equivalence (difference in change from baseline 0.04 (95% CI -0.11, 0.19) %-units), with other measures including hypoglycaemia, insulin antibodies and adverse events also consistent with similarity.
Dr. Kelly Glazer Baron[/caption]
Kelly Glazer Baron, PhD, MPH, C. B.S.M.
Diplomate, Academy of Cognitive Therapy
Northwestern University
Feinberg School of Medicine
Chicago, IL 60611
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: In contrast to several previous studies, being a late sleeper was not associated with higher BMI (good news for late sleepers!!) but it was associated with less healthy behaviors, more fast food, fewer vegetables, lower dairy. It may be possible that these late sleepers who are able to get enough sleep can compensate for their poor diet by controlling overall calories or it could possibly lead to weight gain over time if their habits continue over time.
Dr Siddharth Singh[/caption]
Siddharth Singh, MD, MS
Postdoctoral Fellow, NLM/NIH Clinical Informatics Fellowship
Division of Biomedical Informatics
Clinical Assistant Professor of Medicine, Division of Gastroenterology, Department of Internal Medicine,
University of California
San Diego, La Jolla
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Singh: Over the last 4 years, four new medications have been approved for long-term use for weight loss by the FDA. We sought to evaluate the comparative effectiveness and tolerability of these medications through a systematic review and network meta-analysis. Based on 28 trials in over 29,000 overweight or obese patients, we observed that magnitude of weight loss achieved with these agents is variable, ranging from 2.6kg with orlistat to 8.8kg with phentermine-topiramate. Over 44-75% of patients are estimated to lose at least 5% body weight, and 20-54% may lose more than 10% of body weight; phentermine-topiramate was the most efficacious, whereas lorcaserin was the best tolerated.
Prof. Frances Balkwill[/caption]
Professor Frances Balkwill OBE, FMedSci
Lead, Centre for Cancer and Inflammation
Barts Cancer Institute
Queen Mary University of London
London
MedicalResearch.com: What is the background for this study?
Prof. Balkwill: We wanted to find out if chemotherapy altered patients immune system especially the immune cells that co-exist with cancer cells in tumors.
We studied women with ovarian cancer who often receive chemotherapy after diagnosis but before surgery. This meant, at least in some of them, we could study a biopsy taken before treatment began and also a biopsy taken during the operation.
Dr. Angela Sauaia[/caption]
Angela Sauaia MD PhD
Professor of Public Health, Medicine, and Surgery
University of Colorado Denver
MedicalResearch.com: What is the background for this study? What are the main findings?
Authors: Americans mourn firearm related fatalities every day. Mass shootings are just the tip of the iceberg of the daily tragedy witnessed by trauma surgeons in emergency rooms. Industries strive to reduce the perils associated with motor vehicles, pedestrian and bicycles accidents, just to cite a few, through technology and education. Firearms move in the exact opposite direction. They are becoming progressively more dangerous and we have done little in terms of education to prevent accidents. The same trend is true for monitoring statistics. It is not difficult to obtain statistics on which type of car was associated with more accidents or fatalities. Conversely, trying to obtain data on which type of firearms are more likely to result in accidents or death is extremely difficult. We used the best data we could find and found that, contrary to every other injury mechanism, firearm injuries are becoming more lethal. In simple words, if you get into a car accident today, you are more likely to survive it due to improvements in trauma care and safety of vehicles than 10 years ago. On the other hand, if you get shot today, you are more likely to die than if you were shot 10 years ago, despite our excellent trauma care.
Ambika Satija[/caption]
Ambika Satija
Departments of Nutrition & Epidemiology
Harvard T. H. Chan School of Public Health
Boston, MA
MedicalResearch.com: What is the background for this study?
Response: In this study, we followed more than 200,000 male and female health professionals across the U.S. for more than 20 years who had regularly filled out questionnaires on their diet, lifestyle, medical history, and new disease diagnoses as part of three large long-term studies.
Dr. Anna Alkozei[/caption]
Anna Alkozei, Ph.D.
Postdoctoral Research Fellow
SCAN Lab, Psychiatry Department
University of Arizona
Tucson, AZ 85724-5002
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Alkozei: We know that exposure to blue wavelength light, which is similar to the kind of light that we get on a bright sunny day, can improve attention and alertness during the day as well as at night. We wanted to extend previous findings by investigating whether blue light exposure can affect cognitive functioning after the blue light exposure period had already ended. We found that thirty minutes of exposure to blue wavelength light during the day, in comparison to an amber light exposure led to subsequently faster reaction times on a cognitive task forty minutes after the light exposure had already ended. Participants who were exposed to blue light also showed more efficient responding, which means they answered more items correctly per second, than individuals who were exposed to amber placebo light. Finally, we also found that individuals who were exposed to blue light showed greater activation within the prefrontal cortex when performing the task, an area necessary for optimal cognitive performance, than individuals who were exposed to amber light.
Anna Therese Lehnich[/caption]
Anna-Therese Lehnich
Zentrum für Klinische Epidemiologie (ZKE)
c/o Institut für Medizinische Informatik
Biometrie undEpidemiologie (IMIBE)
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Sleep disturbances and their consequences are often underestimated but they are of high importance with respect to public health. We were interested in the question whether drugs labeled as sleep disturbing in the summary of product characteristics actually lead to more sleep disorders like difficulties falling asleep, difficulties maintaining sleep, and early morning arousal. To answer this question, we analyzed data of 4,221 persons from Germany.