Author Interviews, Technology / 13.05.2016
Pill-Shaped Robot Can Be Swallowed To Assist in Foreign Body Removal or Drug Delivery
MedicalResearch.com Interview with:
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Dr. Shuhei Miyashita[/caption]
Dr. Shuhei Miyashita PhD
Lecturer in Intelligent Robotics
Department of Electronics
University of York, Heslington
York, UK
MedicalResearch.com: What is the background for this device? What are some of the obstacles you and your team face in the development?
Dr. Miyashita: We are developing medical technology that is less invasive and more
autonomous and thus can provide safe and consistent outcomes. The
biggest challenge is how to build a capable medical robot that is
clinically safe. Addressing this challenge requires finding
bio-compatibe materials, safe means of transportation in the body, a
way to reconfigure the robot from pill shape to unfolded shape, and
precise multi-mode control for the location and function of the robot.
Dr. Shuhei Miyashita[/caption]
Dr. Shuhei Miyashita PhD
Lecturer in Intelligent Robotics
Department of Electronics
University of York, Heslington
York, UK
MedicalResearch.com: What is the background for this device? What are some of the obstacles you and your team face in the development?
Dr. Miyashita: We are developing medical technology that is less invasive and more
autonomous and thus can provide safe and consistent outcomes. The
biggest challenge is how to build a capable medical robot that is
clinically safe. Addressing this challenge requires finding
bio-compatibe materials, safe means of transportation in the body, a
way to reconfigure the robot from pill shape to unfolded shape, and
precise multi-mode control for the location and function of the robot.
Dr. Michael Miller[/caption]
Michael Miller, MD, FACC, FAHA
Professor of Cardiovascular Medicine, Epidemiology & Public Health
University of Maryland School of Medicine
Staff Physician, Baltimore VAMC
Director, Center for Preventive Cardiology
University of Maryland Medical Center
Baltimore, Maryland
MedicalResearch.com: What is the background for this study?
Dr. Miller: It has become an article of faith that HDL (the good cholesterol) is an independent risk factor for heart disease. However, previous studies did not examine the importance of HDL after accounting for both LDL (bad cholesterol) and triglycerides (blood fats). This is important because HDL is associated with LDL and triglycerides. We hypothesized that if HDL is truly an independent risk factor, then low HDL levels in isolation would continue to be linked to an increased risk of heart disease while high HDL levels would continue to protect the heart even if LDL and triglycerides levels were elevated.
Dr. Mathias Buttmann[/caption]
PD Dr. Mathias Buttmann
Senior Consultant Neurologist and Head of the Multiple Sclerosis Outpatient Clinic
University of Wuerzburg
Wuerzburg, Germany
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Buttmann: The synthetic anthracenedione mitoxantrone is approved for disease-modifying treatment of patients with aggressive forms of relapsing or secondary progressive multiple sclerosis (MS). It has been known for years that this DNA-intercalating agent increases the risk of acute myeloid leukemia. We performed a retrospective cohort study to investigate whether mitoxantrone also increases the risk for other types of malignancies. We included all 677 mitoxantrone-treated multiple sclerosis patients who were seen at our large German academic MS centre between 1994 and 2007 and collected follow-up information on the occurrence of malignancies, death and causes of death as of 2011. Follow-up was complete in 676 patients. The median age at mitoxantrone initiation was 41 years and the median follow-up duration was 8.7 years. We identified 37 patients with a malignancy after mitoxantrone initiation, among them 4 cases of acute myeloic leukemia and 7 cases of colorectal cancer.
Compared to the general population matched for sex, age and year of occurrence, we calculated an 1.5-fold increased incidence of any type of malignancy, a tenfold increased incidence of acute myeloic leukemia and a threefold increased incidence of colorectal cancer, while the incidence of other types of malignancies was not increased. Higher age at mitoxantrone initiation but neither higher cumulative mitoxantrone dose nor treatment with other immuosuppressive agents was identified as a malignancy risk factor. Fifty-five patients had died, among them 12 from a malignancy. Our study confirmed previous reports on an increased incidence of acute myeloic leukemia after mitoxantrone treatment and newly described an association between mitoxantrone therapy and an increased incidence of colorectal cancer.
Dr. Hans Hoerauf[/caption]
Prof. Dr. med. Hans Hoerauf
Direktor der Augenklinik
Universitätsmedizin Göttingen
Göttingen
MedicalResearch.com: What is the background for this study?
Dr. Hoerauf: Two treatment options, anti-vascular endothelial growth factors (anti-VEGFs) and corticosteroids, with different mechanisms of action are available for the treatment of macular edema secondary to Central Retinal Vein Occlusion (CRVO). Our study, COMRADE-C, is the first head-to-head study to investigate the clinical efficacy and safety of the European labels of ranibizumab (anti-VEGF) versus dexamethasone intravitreal implant (corticosteroid) in patients with CRVO over six months.
Dr. Katarina Truvé[/caption]
Katarina Truvé PhD
Swedish University of Agricultural Sciences and
Kerstin Lindblad-Toh
Uppsala University
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Truvé: Gliomas are malignant brain tumors that are rarely curable. These tumors occur with similar frequencies in both dogs and humans. Gliomas in dogs are strikingly similar at the biological and imaging level to human tumor counterparts. Some dog breeds such as Boxer and Bulldog are at considerably higher risk of developing glioma. Since these breeds at high risk are recently related, they are most likely carrying shared genetic risk factors. Our goal was therefore to use the dog genome to locate genes that may be involved in the development of glioma in both dogs and humans. We found a strongly associated locus and identified three candidate genes, DENR, P2RX7 and CAMKK2 in the genomic region. We have shown that CAMKK2 is lower expressed in glioma tumors than normal tissue in both dogs and human, and it has been reported that the associated canine mutation in P2RX7 results in a decrease in receptor function.
Dr. Maryam Farvid[/caption]
MedicalResearch.com Interview with:
Maryam Farvid, Ph.D.
Visiting Scientist
Department of Global Health and Population
Harvard T.H. Chan School of Public Health
MedicalResearch: What is the background for this study? What are the main findings?
Dr. Farvid: Breast cancer is one of the most frequently diagnosed cancers and is the second leading cause of cancer deaths among women in the United States. While we know many breast cancer risk factors, few of them are easily modified. Further, evidence suggests that exposure to carcinogens and anti-carcinogens in early life may play an important role. According to this study, what women eat as teens or young adults could affect their breast cancer risk in the future. Teenage girls who eat a lot of fruits may have a lower risk of breast cancer later in life. The risk of breast cancer among women who reported the highest amount of 
Dr-Daniel Benjamin[/caption]
Dr. Daniel J. Benjamin PhD
Associate Professor (Research), USC, 2015-present
Associate Professor (with tenure), Cornell, 2013-2015
Assistant Professor, Cornell University, 2007-2013
Research Associate, NBER, 2013-present
Faculty Research Fellow, NBER, 2009-2013
MedicalResearch.com: What is the background for this study?
Dr. Benjamin: Educational attainment is primarily determined by environmental factors, but decades of twin and family studies have found that genetic factors also play a role, accounting for at least 20% of variation in educational attainment across individuals. This finding implies that there are genetic variants associated statistically with more educational attainment (people who carry these variants will tend on average to complete more formal education) and genetic variants associated statistically with less educational attainment (people who carry these variants will tend on average to complete less formal education). But none of these genetic variants had been identified until our 2013 paper on educational attainment. That paper, which studied a sample of roughly 100,000 individuals, identified 3 genetic variants associated with educational attainment, each of which has a very small effect. In the current paper, we expanded our sample to roughly 300,000 individuals, with the goal of learning much more about the genetic factors correlated with educational attainment.
Danielle Schoffman[/caption]
Danielle E. Schoffman
PhD Candidate
Department of Health Promotion, Education, and Behavior
Arnold School of Public Health
University of South Carolina
Columbia, SC 29208
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: In recent years, there has been large growth in the fast casual (e.g., Panera, Chipotle) restaurant sector, and there is a general perception among consumers that these restaurants are a healthier and fresher alternative to fast food. When we encourage participants in our research studies to reduce their fast food intake, they often ask if these fast casual restaurants also count. We were interested in looking at the calorie data for entrees at both restaurant types to see if they lined up with these assumptions.
We analyzed the calorie content of entrées at 34 fast food and 28 fast casual restaurants, and found that fast food entrées had an average of 760 calories per entrée compared to 561 for fast food entrées . Also, a greater proportion of fast casual restaurant entrées exceeded the median of 640 calories per entrée.
Dr. T. Dianne Langford[/caption]
Dr. T. Dianne Langford PhD
Associate Professor, Neuroscience and Neurovirology
Lewis Katz School of Medicine
Temple University
MedicalResearch.com: What is the background for this study?
Dr. Langford: The ocular-motor system has been shown to reflect neural damage, and one of ocular-motor functions, near point of convergence (NPC), was reported to worsen after a sport-related concussion (Mucha et al. Am J Sport Med). But the effects of subconcussive head impact, a milder form of head injury in the absence of outward symptoms remains unknown. Prior to this study, we found that in a controlled soccer heading experimental paradigm decreased NPC function, and even 24h after the headings, NPC was not normalized back to baseline (Kawata et al. 2016 Int J Sport Med). To extend our findings from the human laboratory study, we launched longitudinal clinical studies in collaboration with the Temple football team, to see if repetitive exposure to subconcussive head impacts negatively affects NPC.
Dr. Brian Boxer Wachler[/caption]
Dr. Brian Boxer Wachler MD
Boxer Wachler Vision Institute
Beverly Hills, California
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: As an eye surgeon, I observed patients tended to have more age spots on the left side of their faces. I was examining a patient with Keratoconus and after I noted her age spots on her left cheeks, I began to look into this phenomenon. It turns out there are many studies that found more skin cancer on the left side of the face compared to the right side of the face. In Australia (where people drive on the left side of the road) it’s the opposite – more skin cancer on the right side of the face. Our study found that cars on average have significantly lower UVA (ultraviolet A) protection in the side windows compared to windshields which have universally high UVA protection. I believe this can be the missing link that can explain higher rates of skin cancer on the side of the face by the driver’s window. There are also more cataracts in left eyes vs right eyes. There was no relationship between high-end cars and low-end cars for side window UV protection – in other words many more pricey cars had just as poor side window UV protection as less expensive cars.
Paul Wilmes[/caption]
Prof. Dr. Paul Wilmes
Associate Professor
Head of the Eco-Systems Biology Research Group
Luxembourg Centre for Systems Biomedicine
University of Luxembourg
Luxembourg
MedicalResearch.com: What is the background for this intestinal model?
Dr. Wilmes: Changes in the human gastrointestinal microbiome are associated with several diseases. To infer causality, experiments in representative models are essential. Widely used animal models exhibit limitations. Therefore, we set out to develop the HuMiX model which allows co-culture of human and microbial cells under conditions representative of the gastrointestinal interface.
Dr. Jaimin Trivedi[/caption]
Jaimin Trivedi, MD, MPH
Instructor
Department of Cardiovascular and Thoracic Surgery
University of Louisville
Louisville, KY 40202
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Trivedi: There is a donor heart shortage in United States and certain donor hearts are likely to be turned down because the donors required cardiopulmonary resuscitation (CPR) prior to procurement. The rationale behind conducting the study was to identify impact of donor CPR and its duration on recipient survival after transplantation.
Our findings show that presence of CPR and duration of CPR does not adversely impact the post heart transplant survival. The study also shows that ejection fraction and peak cardiac troponins between the CPR and non-CPR donors were comparable at time of transplant suggesting recovery of cardiac function.
Dr. Erica Spatz[/caption]
Erica Spatz, MD, MHS
Assistant Professor, Section of Cardiovascular Medicine
Center for Outcomes Research and Evaluation
Yale University School of Medicine/Yale-New Haven Hospital
New Haven, CT 06520
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Spatz: Rates of heart attack have declined during the last 15 years. But whether communities of different economic status or in different geographic regions experienced similar declines is unknown, especially as efforts to prevent cardiovascular disease and manage heart attacks may not have been equally successful in communities with different resource capacity.
Our study shows that trends in the incidence of and mortality from heart attack were similar in low, average and high income communities. However, low-income communities had higher hospitalization rates than average and high income communities throughout the 15 year study period. Interestingly mortality rates were similar.
Dr. Anny Xiang[/caption]
Anny H. Xiang, PhD
Kaiser Permanente Southern California Department of Research & Evaluation
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Xiang: Previous studies have identified a link between maternal obesity, diabetes and/or excessive gestational weight gain and long-term obesity risk in children. Our study examined the interplay among all four factors associated with childhood obesity: pre-pregnancy obesity, gestational weight gain, gestational diabetes and breastfeeding. To our knowledge, the interplay among these factors and their independent contributions to childhood obesity with data from a large and multi-ethnic cohort under current standard clinical care had not been previously studied.
The study included 15,710 women who delivered babies at Kaiser Permanente medical facilities in Southern California in 2011. The key findings were:
Dr. Jonathan Shoag[/caption]
Jonathan Shoag MD
Urology Resident at
Cornell Department of Urology and
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Dr. Jim Hu[/caption]
Dr. Jim C. Hu MD
Ronald Lynch Professor of Urologic Oncology
Professor of Urology
Director, Lefrak Center for Robotic Surgery
Attending Urologist, New York-Presbyterian Hospital (Cornell campus)
MedicalResearch.com: What is the background for this study?
Response: Prostate Specific Antigen (PSA) is a blood test that is used to detect prostate cancers and to follow a cancer’s response to treatment. PSA was widely implemented as a screening tool for prostate cancer in the early 1990s, and became a routine test during an annual physical for men over 40. Doctors started using it because values above a “normal” threshold were associated with a greater risk of prostate cancer. Following the adoption of PSA screening in the early 1990s, there has been a large increase in the number of men diagnosed with cancer, and a decrease of approximately 50% in the rate of prostate cancer death.
The PLCO trial was a large randomized trial designed and funded by the National Cancer Institute (NCI) to determine the effect of PSA screening on death from prostate cancer. The trial found that men randomized/assigned to prostate cancer screening had the same number of prostate cancer deaths as men in the control group of the trial, arguing that PSA screening does not decrease prostate cancer mortality.
This was a major piece of evidence used by the United States Preventative Services Task Force (USPSTF) to form its 2012 recommendation against PSA screening. The argument was that in spite of the other evidence showing a benefit to PSA testing, including US epidemiologic trends, and another large randomized trial showing PSA screening was effective (the ERSPC), we now had good evidence showing no benefit to PSA testing in the US. Since 2012 we have seen dramatic declines in prostate cancer screening in the US as a result.
Mr. Brian Tefft[/caption]
Mr. Brian C. Tefft
Senior Research Associate
AAA Foundation for Traffic Safety
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: In December 2012, a new law took effect in Washington state that effectively legalized the possession and use of small amounts of marijuana by adults aged 21 years and older for recreational purposes, and also created a legal limit for driving under the influence of marijuana such that having a concentration of 5.00 nanograms or greater of delta-9-tetrahydrocannabinol (THC, the main psychoactive chemical in marijuana) per milliliter of whole blood while driving in the state of Washington is per se driving under the influence.
Data from population-based surveys indicate that the proportion of Washington state residents who report using marijuana increased after this law took effect; however, not much was known about the impact of this new law on traffic safety in the state. To investigate the traffic safety impact of the new law, we examined drug test results from drivers involved in motor vehicle crashes that occurred in years 2010 – 2014 in Washington and resulted in the death of at least one person within 30 days of the crash. Specifically, we looked at the proportion of all drivers involved in fatal crashes who had detectable THC in their blood at or shortly after the time of the crash, which generally suggests that the driver had used 
Dr. Ofir Turel[/caption]
Ofir Turel, Ph.D
Professor, Information Systems and Decision Sciences
California State University, Fullerton
Scholar in Residence, Department of Psychology
University of Southern California
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Turel: The study emerged as a response to the growing societal concern regarding potentially problematic information system use” lifestyles”, including videogame addiction, among adolescents. Much research in this domain has focused on negative psychological (e.g., reduced wellbeing, depression) and social/life functioning (e.g., reduction in normal activities, diminished school performance). Less is known regarding potential physiological outcomes of videogame addiction.
Interestingly, the increase in videogame addiction-like symptoms among adolescents happened in conjunction with an increase in sleep curtailment and obesity in this population. These are too growing concerns in North America and perhaps elsewhere. Medical research implies that these three phenomena may be related. Hence, we hypothesized that videogame addiction will be associated with increased sleep curtailment and increased abdominal adiposity; and consequently, indirectly, with cardio-metabolic deficits.
Our findings suggest that videogame addiction predicts reduced 
Dr. Richard Mangano[/caption]
Richard M. Mangano, PhD
Chief Scientific Officer at Relmada Therapeutics
Dr. Mangano has extensive experience leading global R&D programs in both large and small pharmaceutical companies including positions in discovery and clinical research at Hoffmann-La Roche, Lederle Laboratories, Wyeth Research and Adolor Corporation. He served as acting Therapeutic Area Director for Neuroscience at Wyeth before joining Adolor as Vice President of Clinical Research and Development. Dr. Mangano’s expertise includes multiple IND/CTC submissions and NDA/MAA approvals in psychiatry, neurology and gastrointestinal therapeutic areas. Dr. Mangano is also an adjunct professor in the Department of Pharmacology and Physiology at the Drexel University School of Medicine. He lectures in the Drug Discovery and Development Program and in the Psychiatry Department’s Resident Training Program. He has authored 30 peer reviewed publications and over 120 abstracts and presentations. Dr. Mangano holds a B.S degree in Chemistry from Iona College and a PhD degree in Biochemistry from Fordham University. Prior to joining the pharmaceutical industry, he was a research faculty member of the Maryland Psychiatric Research Institute at the University of Maryland School of Medicine.
Dr. Mangano discusses the opioid addiction and the development of abuse-resistant medications.
MedicalResearch.com: What is the background for the development of abuse-resistant medications? How extensive is the problem of opioid addiction?
Dr. Mangano: Recognizing the growing incidence of opioid abuse, misuse, and overdose in the United States, pharmaceutical companies, with the guidance of the FDA, are developing products that can mitigate abuse, while recognizing the importance of maintaining the availability of opioid analgesics for the millions of patients in this country who suffer from pain.
Approximately two million people in the U.S. are addicted to opioids. The market for products that treat opioid dependence has grown significantly due to the rapidly escalating problem of prescription opioid misuse and abuse, a recent resurgence of heroin use, and the growing number of physicians treating opioid dependence.
One of our product candidates, REL-1028 (BuTab), is a proprietary formulation of buprenorphine designed to treat both opioid addiction and moderate to severe chronic pain. Although there is the potential for addiction to buprenorphine, the risk is lower because it is a “partial agonist” of the mu opioid receptor compared with “full agonist” opioids like heroin, morphine, oxycodone, and hydrocodone. As a result, products containing buprenorphine, such as BuTab, should have reduced risk of abuse and physical dependence and would be controlled in Schedule III of the Controlled Substances Act (as opposed to the more restrictive Schedule II). We are also considering a formulation that would include an opioid antagonist that would not interfere with analgesia when taken orally as prescribed but would block the action of buprenorphine if it were to be inhaled or injected.
Dr. Natalia Trayanova[/caption]
Natalia Trayanova PhD, FHRS, FAHA
Murray B. Sachs Endowed Chair
Professor of Biomedical Engineering
Joint Appointment, Medicine
Johns Hopkins University
Institute for Computational Medicine
Johns Hopkins University
Baltimore, MD
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Trayanova: The methodology for modeling cardiac electrical function has matured sufficiently that we can now create computational models of the electrical functioning of the entire heart. My research is focused on translating this methodology into the clinic. The goal is to create, if you will, "a virtual heart for every patient", that will enable the physician to play our scenarios that manifest the heart dysfunction in the given patient, and to enable physicians to make personalized decisions about patient treatment. The present paper is the first application of this overall vision.
The motivation for this particular paper was that determining which patients are at risk for sudden cardiac death represents a major unmet clinical need. Patients at risk receive life-saving implantable defibrillators (ICDs), but because of the low sensitivity and specificity of current approach (based on low ejection fraction), risk assessment is inaccurate. Thus, many patients receive ICDs without needing them, while others die of sudden cardiac death because they are not targeted for 
Dr. Vikas Gulani[/caption]
Dr. Vikas Gulani MD, PhD
Director, MRI, University Hospitals Case Medical Center
Associate Professor, Radiology
CWRU School of Medicine
Cleveland, OH
MedicalResearch.com: What is the background for this study?
Dr. Gulani: For men that have a suspicion for prostate cancer either via the prostate specific antigen (PSA) test or a digital rectal exam, the current standard of care is to perform a transrectal ultrasound (TRUS) guided biopsy to detect cancer. The problem with TRUS biopsy is that most tumors are not visible on ultrasound and hence many significant cancers are missed. At the same time this strategy detects a high number of low risk, indolent cancers, and leads to overtreatment of disease that would be better left untreated.
Diagnostic MRI and MRI-guided biopsy (cognitive, ultrasound-MR fusion, or in-gantry) have been shown to be effective in detecting clinically significant prostate cancer. However, despite these advantages there is reluctance to incorporate MRI into standard practice because it is perceived to be expensive. Our goal was to determine if this presumption is true, and evaluate the cost-effectiveness of the MRI-guided techniques most commonly used.
MedicalResearch.com: What are the main findings?
Dr. Gulani: We found that every MRI strategy we evaluated was cost-effective compared to standard biopsy. Cognitive MRI guided biopsy – where the operator performs an ultrasound biopsy based on knowledge of lesion location from the MRI – was the most cost-effective strategy compared to standard biopsy. In-gantry MRI yielded the highest net health benefits as measured in quality adjusted life years.
Dr. Han Liang[/caption]
Dr. Han Liang PhD
Associate Professor and Deputy Department Chair, Department of Bioinformatics and Computational Biology
The University of Texas MD Anderson Cancer Center
Faculty Member, Baylor College of Medicine
Houston, TX
MedicalResearch: What is the background for this study? What are the main findings?
Dr. Liang: An individual’s sex has been long recognized as a key factor affecting the risk of cancer development and management. However, previous studies on the sex effect have been limited to individual genes, single molecular data types, and single cancer lineages.
We performed a comprehensive analysis of molecular differences between male and female patients in a diversity of cancer types and revealed two sex-effect groups.
One group contains a small number of sex-affected genes, whereas the other shows much more extensive sex-biased molecular signatures. More than half of clinically actionable genes (e.g., therapeutic targets or biomarkers) show sex-biased signatures.
Dr. Dominik Mischkowski[/caption]
Dominik Mischkowski, co-author of the study
Former Ph.D. student at Ohio State
Now at the National Institutes of Health
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Mischkowski: We tested in two double blind experiments whether the popular physical painkiller acetaminophen reduces empathy for the pain of other people. In the first experiment (N=80), participants completed measures of empathy (i.e., perceived pain and personal distress) while reading hypothetical about the physical and social mishaps of other people. We found that acetaminophen reduced empathy for pain in these scenarios. In Study 2 (N=114), we replicated and extending these findings, showing that acetaminophen also decreased empathy (i.e., perceived pain, personal distress, and empathic concern) for another study participant experiencing ostracism or painful noise blasts. Furthermore, noise unpleasantness accounted for the effect of acetaminophen on empathy for noise pain.
Jayant S Vaidya MBBS MS DNB FRCS PhD
Professor of Surgery and Oncology,
Scientific Director, Clinical Trials Group,
Division of Surgery and Interventional Science,
University College London
Whittington Health - Clinical Lead for Breast Cancer
Royal Free Hospital
University College London Hospital
MedicalResearch.com: What is the background for this study? What are the main findings?
Prof. Vaidya: TARGIT-A randomised clinical trial (
Dr. Jed Kaminetsky[/caption]
Dr. Jed Kaminetsky MD
Clinical Assistant Professor
Department of Urology
NYU Langone Medical Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Kaminetsky: Nocturia is a voiding disorder not well treated by available drugs for overactive bladder and benign prostatic hypertrophy. Desmopressin stimulates the kidneys to concentrate the urine which results in a greatly reduced volume of urine formation for a period of time. Serenity Pharmaceuticals has spent many years developing a low dose nasal spray version of desmopressin called Noctiva specifically for nocturia. The study reported now is a large, placebo controlled phase 3 trial to confirm the statistical efficacy and clinical benefit of this treatment for nocturia.
Dr. Yeh[/caption]
Dr. James Song-Jeng Yeh, MD
Brigham and Women's Hospital
Boston MA
MedicalResearch.com: What is the purpose for this study?
Dr. Yeh: A number of factors influence physicians’ prescribing behavior, including physician’s knowledge and understanding of the drugs. Pharmaceutical detailing and financial incentives may affect such behavior. My interest in evidence-based medicine and how medical knowledge is translated into practice lead me to think about how physicians’ financial relationships with the pharmaceutical industry may affect prescribing patterns.
In our study, we linked the Massachusetts physicians open payment database with the Medicare drug prescription claims database to determine if financial relationships with the industry are associated with increased brand-name statin drug prescribing. The open payment database reports payments that physicians receive from pharmaceutical and medical device industries. The open payment database when linked to the drug prescription claims database allowed us to answer this question.
We looked at year 2011, when two of the most commonly prescribed brand-name statin drugs (Lipitor and Crestor) were not yet available in generic formulation.
The outcome measured was what percentage of all statin prescription claims (both generic and brand-name) were brand-names.
Dr. Taylor-Phillips[/caption]
Dr Sian Taylor-Phillips PhD
Assistant Professor of Screening and Test Evaluation
Division of Health Sciences
Warwick Medical School
University of Warwick
Coventry
MedicalResearch.com: What is the background for this study?
Dr Taylor-Phillips : Psychologists have been investigating a phenomenon of a drop in performance with time on a task called ‘the vigilance decrement’ since World War 2. In those days radar operators searched for enemy aircraft and submarines (appearing as little dots of light on a radar screen). People thought that the ability to spot the dots might go down after too much time spent on the task. Many psychology experiments have found a vigilance decrement, but most of this research has not been in a real world setting.
In this research we wanted to know whether there was a drop in performance with time on a task for breast screening readers looking at breast x-rays for signs of cancer. (Breast x-rays or mammograms show lots of overlapping tissue and cancers can be quite difficult to spot). This was a real-world randomised controlled study in UK clinical practice.
In the UK NHS Breast Screening Programme two readers examine each woman’s breast x-rays separately for signs of cancer. They look at batches of around 35 women’s x-rays. At the moment both readers look at the x-rays in the same order as each another, so if they both experience a drop in performance, it will happen at the same time. We tested a really simple idea of reversing the batch order for one of the readers, so that if they have a low ebb of performance it happens when they are looking at different women’s breast x-rays.