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Author Interviews, Cancer Research, JAMA, Stroke / 13.01.2018

MedicalResearch.com Interview with: Babak B. Navi MD, MS Department of Neurology Weill Cornell Medicine New York, New York MedicalResearch.com: What is the background for this study? Response: About 10% of patients with ischemic stroke have comorbid cancer and these patients face an increased risk of stroke recurrence. Many strokes in patients with cancer are attributed to unconventional mechanisms from acquired hypercoagulability. Therefore, many physicians recommend anticoagulation, especially low molecular weight heparins, for the treatment of cancer-associated stroke. However, hypercoagulable stroke mechanisms, such as nonbacterial thrombotic endocarditis, are rarely definitively diagnosed in cancer patients antemortem; while atherosclerosis, which is generally treated with antiplatelet medicines such as aspirin, is common in cancer patients. In addition, many historic indications for anticoagulation in ischemic stroke have been disproven by randomized trials because any reductions in stroke risk were offset by increased risks of bleeding. Given these considerations, we believed that a randomized trial comparing anticoagulation with enoxaparin to antiplatelet therapy with aspirin was necessary to determine the superior strategy, prompting implementation of the TEACH pilot randomized trial. The primary aim of TEACH was to determine whether the random assignment of different antithrombotic strategies to cancer patients with acute ischemic stroke would be sufficiently feasible and safe to proceed with a larger efficacy trial.  (more…)
Author Interviews, JAMA, Neurology / 13.01.2018

MedicalResearch.com Interview with: Fredrik Piehl MD PhD, prof. of Neurology Neuroimmunology Unit. Dept Clinical Neuroscience Neurology Dept. Karolinska University Hospital (Solna) Stockholm MedicalResearch.com: What is the background for this study? What are the main findings? Response: In recent years we have seen a drastic increase in treatment options for relapsing-remitting multiple sclerosis (RRMS). However, it is difficult to deduce long term performance of different drugs based only on data from randomized controlled trials, since such trials are performed in selected patients without major co-morbidities and perhaps also enriched for those with a milder disease course. In addition, most trials only last for two years and lack relevant comparators. This lack of knowledge makes it difficult to predict if a drug will work or not for a given patient, in turn leading to frequent treatment switches but also different treatment practices across countries, regions or even between centers. This is also the case in Sweden, but with the additional aspect that some regions have opted to treat most newly diagnosed RRMS patients with rituximab (Rituxan/Mabthera), a drug not formally approved for RRMS, but with extensive safety data from other indications. (more…)
Alzheimer's - Dementia, Author Interviews, Biomarkers, JAMA, MRI / 12.01.2018

MedicalResearch.com Interview with: Miguel A. Santos-Santos, MD Department of Neurology, Memory and Aging Center University of California San Francisco Autonomous University of Barcelona, Cerdanyola del Valles, Spain MedicalResearch.com: What is the background for this study? Response: Primary progressive aphasia (PPA) is a clinically and pathologically heterogeneous (generally Frontotemporal lobar degeneration [FTLD, generally tau or tdp proteinopathies] or Alzheimer’s disease [AD] pathology) condition in which language impairment is the predominant cause of functional impairment during the initial phases of disease. Classification of PPA cases into clinical-anatomical phenotypes is of great importance because they are linked to different prevalence of underlying pathology and prediction of this pathology during life is of critical importance due to the proximity of molecule-specific therapies. The 2011 international consensus diagnostic criteria established a classification scheme for the three most common variants (the semantic [svPPA], non-fluent/agrammatic [nfvPPA], and logopenic [lvPPA]) of PPA and represent a collective effort to increase comparability between studies and improve the reliability of clinicopathologic correlations compared to the previous semantic dementia and progressive non-fluent aphasia criteria included in the 1998 consensus FTLD clinical diagnostic criteria. Since their publication, a few studies have reported amyloid imaging and pathological results in PPA, however most of these studies are retrospective in nature and the prevalence of FTLD and Alzheimer’s disease pathological findings or biomarkers in each variant has been inconsistent across the literature, therefore prospective validation with biomarker and autopsy data remains scarce and highly necessary. (more…)
Author Interviews, CDC, JAMA, Weight Research / 12.01.2018

MedicalResearch.com Interview with: Liping Pan, MD, MPH Epidemiologist, Epidemiology & Surveillance Team Obesity Prevention and Control Branch Division of Nutrition, Physical Activity and Obesity National Center for Chronic Disease Prevention & Health Promotion CDC  MedicalResearch.com: What is the background for this study? Response: Children with severe obesity face significant health and social challenges. Children with obesity and severe obesity are at higher risk for having other chronic health conditions and diseases, such as asthma, sleep apnea, bone and joint problems, and type 2 diabetes. They also have more risk factors for heart disease like high blood pressure, impaired glucose tolerance, and high cholesterol than their normal weight peers. These lifelong health risks associated with severe obesity during early childhood indicate the importance of preventing and identifying severe obesity. Childhood obesity disproportionately affects children living in low-income families. However, no recent trends on severe obesity in this population have been reported. (more…)
Author Interviews, JAMA, Pediatrics, Smoking, Tobacco, Tobacco Research, UCSF / 07.01.2018

MedicalResearch.com Interview with: “hookah” by Ksenia M is licensed under CC BY 2.0Benjamin Chaffee, DDS MPH PhD UCSF School of Dentistry San Francisco, CA 94118 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Non-cigarette tobacco products, which include electronic cigarettes, hookah (tobacco waterpipe), smokeless tobacco, and non-cigarette combustibles, like cigars, are increasingly popular among young people. Considerable debate surrounds whether use of these non-cigarette products encourages youth to begin smoking conventional cigarettes. Several previous studies have shown associations between non-cigarette tobacco use and youth smoking. These studies had largely looked at only one type of tobacco product at a time. This study included more than 10,000 adolescents from all over the United States, surveyed at two time points one year apart. Therefore, this study featured enough participants and detailed information about tobacco behaviors to consider all types of tobacco products in a comprehensive way. We found that each type of non-cigarette tobacco product (i.e., e-cigarettes, hookah, combustibles, or smokeless tobacco) added to smoking risk. Among youth who had never smoked a cigarette at the start of the survey, use of any of the non-cigarette products approximately doubled the odds of cigarette smoking within a year, after adjusting for multiple smoking-related risk factors. Each product independently increased risk. The adolescents most susceptible to future smoking to were those who had tried two or more types of non-cigarette tobacco. (more…)
Author Interviews, Calcium, Geriatrics, JAMA, Vitamin C / 05.01.2018

MedicalResearch.com Interview with: “ZMA och D-vitamin. Intages med dubbelsidig C-brus. #placebomannen” by Robin Danehav is licensed under CC BY 2.0Dr Jia-Guo Zhao Tianjin Hospital Department of Orthopaedic Surgery Tianjin, China MedicalResearch.com: What is the background for this study? Response: The increased social and economic burdens for osteoporotic-related fractures worldwide make its prevention a major public health goal. Calcium and vitamin D supplements have long been considered a basic intervention for the treatment and prevention of osteoporosis. Survey analysis showed that 30–50% of older people take calcium or vitamin D supplements in some developed countries. Many previously published meta-analyses, from the high-ranking medical journals, concluded that calcium and vitamin D supplements reduce the incidence of fracture in older adults. And many guidelines regarding osteoporosis recommend calcium and vitamin D supplements for older people. The final aim for these supplements is to prevent the incidence of osteoporotic-related fracture in osteoporosis management. (more…)
Author Interviews, Cost of Health Care, JAMA / 05.01.2018

MedicalResearch.com Interview with: “Doctors” by Tele Jane is licensed under CC BY 2.0Kathryn R. Tringale, MAS Department of Radiation Medicine and Applied Sciences University of California San Diego, La Jolla MedicalResearch.com: What is the background for this study? What are the main findings? Response: Financial relationships between biomedical industry and physicians are common, and previous work has investigated the potential conflicts of interest that can arise from these interactions. Data show that even small payments in the form of industry sponsored lunches can influence physician prescribing patterns. Given the concern for the potential influence of biomedical industry over practice patterns and potentially patient care, the Open Payments program was implemented under the Affordable Care Act to shed light on these interactions and make reports of these financial transactions publicly available. We recently published a paper in JAMA on industry payments to physicians that found that men received a higher value and greater number of payments than women physicians and were more likely to receive royalty or licensing payments when grouped by type of specialty (surgeons, primary care, specialists, interventionalists). The purpose of the Research Letter discussed here was to further examine differences in the value of payments received by male and female physicians within each individual specialty. The main takeaway from this study is that male physicians, across almost every specialty, are receive more money from biomedical industry compared to female physicians. At first glance, this finding can be interpreted as merely another example of gender disparities in the workplace, which we have seen before with gender gaps in physician salaries and research funding. Indeed, this gender gap may be a product of industry bias leading to unequal opportunity for women to engage in these profitable relationships. Alternatively, these data may be more representative of gender differences in physician decision-making. Previous data has shown that industry engagement can lead to changes in practice patterns, so maybe female physicians acknowledge these conflicts of interest and actively choose not to engage with industry. Unfortunately, we cannot tease out these subtleties from our results, but our paper does reveal a remarkable gender difference among physician engagement with industry. With this being said, whether male or female, everyone needs a bit of help sometimes. The use of loans is a possibility for many people who need a little financial assistance. Regardless of whether men are getting paid a little more than women, they may all need help just as equally. The type of loans that would be worth looking into if this is your current situation is physician loans, which basically allows medical professionals to purchase a home with a low/little down payment while avoiding mortgage insurance. A little bit of help goes a long way, especially when it involves your future. (more…)
Allergan, Author Interviews, JAMA, Ophthalmology / 05.01.2018

MedicalResearch.com Interview with: Steven Woloshin, MD MS Professor of The Dartmouth Institute Professor of Medicine Professor of Community and Family Medicine The Center for Medicine in the Media Dartmouth Institute for Health Policy and Clinical Practice Lebanon, New Hampshire MedicalResearch.com: What is the background for this study? What are the main findings? Response: There has been a lot of debate about the legal maneuvers (ie, transferring patents to the Mohawk Indians) Allergan has employed to delay marketing of generic alternatives to Restasis (cyclosporine ophthalmic emulsion 0.05%).   But there is a more fundamental question that has received little attention:  Does Restasis work?  It is not approved in the European Union, Australia or New Zealand where registration applications were "withdrawn prior to approval due to insufficient evidence of efficacy" in 2001.   Although Canada approved Restasis, its national health technology assessment unit, unconvinced of meaningful benefit, recommended Canada not pay for it - according to our research, no Canadian provincial or federal drug plan currently does.   Nevertheless, Americans have spent $8.8 billion in total sales between 2009 and 2015 on Restasis, including over $2.9 billion in public monies through Medicare Part D. (more…)
Author Interviews, JAMA, Multiple Sclerosis, Radiology / 04.01.2018

MedicalResearch.com Interview with: Netta Levin MD PhD fMRI lab Neurology Department Hadassah Hebrew University Medical Center Jerusalem  MedicalResearch.com: What is the background for this study? Response: Multiple sclerosis (MS) is an autoimmune demyelinating disease of the central nervous system, manifesting with episodes of local inflammatory processes, called relapses. The most useful surrogate laboratory test for MS is magnetic resonance imaging (MRI), in which dissemination of demyelinating lesions in space and time are the hallmark of the disease. However, there is a discrepancy between the lesion load - the number, size, and location of the lesions - and the clinical state of the patients, reflected in their disability. This discrepancy is known as the “clinico-radiological paradox” and suggests that something other than the well-known mechanisms of demyelination, remyelination, and axonal loss may tip the scale of recovery from an acute episode. Global effects of the local damage and compensatory mechanisms were suggested as an explanation to this paradox. In this study, we compared the visual system of patients with clinically isolated syndrome optic neuritis (ON) to patients with clinically isolated episodes in other functional systems, exploring changes, both anatomical and functional, caused to the system following the demyelinating episode. Optic neuritis was deemed a good in vivo model for studying the pathophysiology of tissue damage and repair in MS due to its characteristic clinical manifestation and to the visual pathways’ amenability to investigation using various techniques. To assess anatomical wiring ,i.e the white matter fibers themselves , we used diffusion tensor imaging (DTI). To assess functional networking as reflected by signal synchronization between distinct brain regions, we used resting state fMRI. (more…)
Author Interviews, Heart Disease, JAMA, Surgical Research / 04.01.2018

MedicalResearch.com Interview with: Edward L. Hannan, PhD, MS, MS, FACC Distinguished Professor and Associate Dean Emeritus University at Albany School of Public Health Rensselaer, NY 12144     MedicalResearch.com: What is the background for this study? What are the main findings? Response: We have done a lot of work on complete revascularization (CR) vs. incomplete revascularization (IR) already, and as a follow-up it seemed as if there may be different types of IR that are associated with even worse outcomes relative to CR and other IR. Incomplete revascularization is associated with worse outcomes if it involves multiple vessels, vessels with severe stenosis, or significant proximal left anterior descending artery vessel (PLAD) stenosis. (more…)
Author Interviews, JAMA, OBGYNE, Pediatrics / 03.01.2018

MedicalResearch.com Interview with: “Breastfeeding welcome here” by Newtown grafitti is licensed under CC BY 2.0Clare Relton, PhD School of Health and Related Research University of Sheffield, Sheffield, England MedicalResearch.com: What are the key findings of your report? Response: Our five year research project explored whether offering financial incentives (shopping vouchers) for breastfeeding increased breastfeeding. We studied what happened to breastfeeding rates at 6 to 8 weeks post-partum in areas in England with low (<40%) breastfeeding prevalence. Our cluster randomized clinical trial (which included 10 010 mother-infant dyads) showed that areas with the financial incentive had significantly higher rates of breastfeeding at 6 to 8 weeks (37.9% vs 31.7%) compared to usual care. The financial incentive scheme was widely acceptable to healthcare providers (midwives, health visitors, doctors) and mothers. The financial incentives made it easier for everyone to discuss breastfeeding and mothers reported feeling valued (supported and rewarded) for breastfeeding. (more…)
Author Interviews, Diabetes, JAMA, Race/Ethnic Diversity, Weight Research / 02.01.2018

MedicalResearch.com Interview with: Michael P. Bancks, PhD Northwestern University Chicago, Illinois  MedicalResearch.com: What is the background for this study? What are the main findings? Response: We know that the disparity in diabetes between black and white youth and young adults is growing, but the reasons why are unclear. We also know that traditional risk factors for diabetes, such as obesity and low socioeconomic status, are more common among blacks as compared with whites. Our study describes how the unequal rates of these traditional diabetes risk factors explain or account for the higher rates of diabetes among blacks. (more…)
Author Interviews, Diabetes, JAMA, Nutrition, Pediatrics / 02.01.2018

MedicalResearch.com Interview with: “Baby Bottle” by brokinhrt2 is licensed under CC BY 2.0Mikael Knip, MD, PhD Professor of Pediatrics TRIGR PI  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Experimental studies have indicated that the avoidance of early exposure to cow's milk proteins reduces the cumulative incidence of autoimmune diabetes in animal models of human type 1 diabetes, e.g. BB rats and NOD mice. Epidemiological studies in humans have suggested that there may be a link between type 1 diabetes and short breastfeeding or early introduction of infant formulas. All regular infant formulas contain intact cow's milk proteins. The main finding was that weaning to an extensively hydrolyzed formula did not reduce the cumulative incidence of Type 1 diabetes in at-risk children by the mean age of 11 years. The extensively hydrolyzed formula did not contain any intact cow's milk proteins but only small peptides (maximal size 2000 daltons). (more…)
Author Interviews, Bipolar Disorder, Depression, JAMA / 01.01.2018

MedicalResearch.com Interview with: Andre Russowsky Brunoni, MD, PhD Coordinator, Service of Interdisciplinary Neuromodulation, Laboratory of Neurosciences  Department and Institute of Psychiatry Coordinator, Interdisciplinary Center for Applied Neuromodulation, University Hospital University of São Paulo São Paulo, Brasil  MedicalResearch.com: What is the background for this study? What are the main findings? Response: In this study, our aim was to evaluate the safety and efficacy of transcranial direct current stimulation (tDCS) as an add-on treatment for patients with bipolar depression. There are a only few treatment alternatives for bipolar depression, which often have important side effects. Thus, we wanted to evaluate the efficacy of this non-pharmacological treatment. We found that active vs. sham tDCS effected greater response and remission for patients with bipolar depression. The frequency of adverse effects was similar, including treatment-emergent affective switches. However, higher rates of skin redness were observed in the active group. (more…)
Author Interviews, Brigham & Women's - Harvard, Diabetes, End of Life Care, JAMA / 01.01.2018

MedicalResearch.com Interview with: Dr. Laura A. Petrillo MD Instructor in Medicine Harvard Medical School, and Palliative Care Physician Massachusetts General Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Response: Hospice is end-of-life care focused on maximizing quality of life. Hospice often involves reducing or stopping treatments that are unlikely to have short-term benefit in order to avoid uncomfortable side effects. About a quarter of Americans die in nursing homes, and some of them receive hospice care in their final days. We looked at whether adults with type 2 diabetes experience low blood sugar while on hospice in veterans’ nursing homes, since low blood sugar signals inappropriately aggressive diabetes treatment in patients close to death and contributes to unnecessary discomfort. We found that one in nine people experienced low blood sugar at least once while receiving hospice care. Among people who were on insulin, the number was one in three. (more…)
Author Interviews, Autism, JAMA, Nutrition, OBGYNE / 27.12.2017

MedicalResearch.com Interview with: Dr. Marte Bjørk, MD PhD Department of Clinical Medicine University of Bergen, Department of Neurology Haukeland University Hospital Bergen, Norway MedicalResearch.com: What is the background for this study? Response: In utero antiepileptic drug exposure are associated with neurodevelopmental problems in the child. We looked into if maternal folate during pregnancy could reduce the risk of autistic traits in children of women in need of antiepileptic drugs in pregnancy. The rationale for the hypothesis that folate could be beneficial, was that many antiepileptic drugs interact with folate metabolism. Folic acid supplement use is also associated with slightly reduced risk of autism in children of women from the general population. (more…)
Author Interviews, Chemotherapy, JAMA, Ovarian Cancer / 26.12.2017

MedicalResearch.com Interview with: Debra Richardson, MD, FACOG, FACS Associate Professor, Section of Gynecologic Oncology, Oklahoma TSET Phase I Program Stephensen Cancer Center The University of Oklahoma MedicalResearch.com: What is the background for this study? What are the main findings? Response: Ovarian cancer is the leading cause of gynecologic cancer deaths. Pazopanib is an oral multitarget tyrosine kinase inhibitor of VEGF receptors 1, 2, and 3; platelet-derived growth factor (PDGF) receptors α and β and c-KIT. Weekly paclitaxel is an active agent for recurrent ovarian cancer. This was a national, randomized, double-blind, placebo controlled phase 2b trial of weekly paclitaxel with or without pazopanib for the treatment of recurrent ovarian cancer. The primary objective was to estimate the progression-free survival (PFS) hazard ratio (HR) of the combination of weekly paclitaxel (80mg/m2 D1, 8, 15 every 28 days) and pazopanib (800mg PO daily) compared with weekly paclitaxel and placebo in women with persistent or recurrent ovarian cancer. 106 women were enrolled. There was no difference in median PFS, overall survival (OS), or proportion responding. Severe hypertension was more common on the pazopanib plus paclitaxel arm. More patients discontinued treatment on the paclitaxel arm for disease progression, and more on the pazopanib plus paclitaxel arm for adverse events. Patients with VEGFA CC genotype may be more resistant to weekly paclitaxel than those with the AC or AA genotype. (more…)
Author Interviews, JAMA, OBGYNE / 26.12.2017

MedicalResearch.com Interview with: Gabriele Saccone, MD Department of Neuroscience Reproductive Sciences and Dentistry School of Medicine University of Naples Federico II Naples, Italy MedicalResearch.com: What is the background for this study? Response: Preterm birth is a major cause of perinatal morbidity and mortality. About 15 million infants were born too soon every year, causing 1.1 million deaths. The cervical pessary is a silicone device that has been studied to prevent preterm birth. However, the efficacy of this device in preventing preterm birth is still subject of debate. (more…)
Author Interviews, Cancer Research, Esophageal, Gastrointestinal Disease, JAMA / 21.12.2017

MedicalResearch.com Interview with: Dr. Edward D. McCoul, MD, MPH Ochsner Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Population-level data suggests a link between gastroesophageal reflux disease and cancer of the throat and sinuses in adults over 65 years of age.  T he strength of association between reflux and cancer is strongest for anatomic sites closest to the esophagus, where acid and other stomach contents may have the greatest exposure. (more…)
Accidents & Violence, Author Interviews, Emergency Care, ENT, JAMA / 21.12.2017

“Qtip” by Rafael Castillo is licensed under CC BY 2.0MedicalResearch.com Interview with: Eric T. Carniol, MD, MBA Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology–Head and Neck Surgery, University of Toronto Toronto, Ontario, Canada MedicalResearch.com: What is the background for this study? What are the main findings? Response: Tympanic membrane perforations (aka "popped" or "burst" ear drum) is a common complaint of patients presenting to the emergency room, primary care offices, and otolaryngologist (ENT doctors) offices. These may be caused by trauma, infections, or other causes. As well, many patients will use qtips (cotton-tipped applicators) to clean ears and remove ear wax and are unaware of the potential harms of doing so. This study was designed to examine the cause of ear drum perforations as diagnosed in emergency departments in the United States. Foreign body instrumentation of the ear (qtips, hair combs, hair pins, needles, etc) were the cause of 61.2% of perforations. Cotton tip applicators are the single leading cause of traumatic tympanic membrane perforation in all age groups except young adults (13-18) and 19-36 year olds, in which it is the second largest cause (behind water trauma). Children less than 18 years old constitute nearly 2/3 of all ear drum perforations in the emergency department. (more…)
Author Interviews, JAMA, Psychological Science / 18.12.2017

MedicalResearch.com Interview with: Thomas Foltynie MD PhD Senior Lecturer and Honorary Consultant Neurologist Unit of Functional Neurosurgery Institute of Neurology and National Hospital for Neurology and Neurosurgery University College London MedicalResearch.com: What is the background for this study? What are the main findings? Response: Stimulation of the Nucleus Basalis of Meynert can enhance cholinergic innervation of the cortex in animal models and has been previously reported to have beneficial cognitive effects in a single patient with Parkinson’s Disease dementia. In this double blind crossover trial, six patients with Parkinson’s Disease underwent low frequency stimulation to the NBM bilaterally.  While there were no consistent objective improvements in cognitive performance, there was a marked reduction in visual hallucinations in two of the participants. . (more…)
Author Interviews, Cancer Research, JAMA, Johns Hopkins / 16.12.2017

MedicalResearch.com Interview with: Gonzalo Torga, MD Urology Department Johns Hopkins Hospital Baltimore, MD 21287 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Liquid biopsy is a new and noninvasive alternative to tumor tissue sequencing, and it is intended to specifically detect and sequence tumor DNA circulating in patients’ blood. The results are used to help guide oncologists to tailor the best treatment for patients at each point of their disease. Our research was initially aimed at finding the best commercial lab to test samples from metastatic prostate cancer patients. We wanted to make the best choice for our patients, so we started submitting the samples to both places at the same time to compare results. However, we found significant disparities in the results from identical patient samples submitted to two different commercial liquid biopsy providers, and we believed it would be important to share them with the oncology community. The two liquid biopsy panels compared were the Guardant360, from Guardant Health, Inc., which sequenced at least part of the coding sequences of 73 genes; and the PlasmaSELECT panel from Personal Genome Diagnostics, which sequenced coding segments of 64 genes.  Both laboratories were licensed by Clinical Laboratory Improvement Amendments (CLIA) and accredited by the College of American Pathologists (CAP), and report having high sensitivity (in this case, the ability to correctly identify mutations when they occur) and high specificity (the ability to correctly report as negative when those mutations are not present). The two companies differ in which genes, and regions within each gene, are covered. Just 25 of the 40 patients in the study had at least one genetic mutation reported within the overlapping genetic sequences covered by both companies. Even when the companies were analyzing DNA from the same blood drawn, their results rarely matched each other. When comparing results within the overlapping genetic sequences, the results from both companies completely matched for all the mutations reported in only 7.5 percent (3 of 40 patients) of cases. In 15 percent of the patients (6 of 40), both companies’ results matched for at least one of the reported mutations. In 40 percent (16 of 40) of the patients, no mutations reported that were potentially covered by both panels were detected by both companies. (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, Genetic Research, JAMA / 15.12.2017

MedicalResearch.com Interview with: Annette S. Kim, MD, PhD Associate Professor, Harvard Medical School Brigham & Women's Hospital Boston MA 02115  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The recent debate on laboratory developed tests (LDTs) and FDA-approved companion diagnostics (FDA-CDs) has centered upon both the regulatory and performance aspects of LDTs and we, at the College of American Pathologists (CAP), had the data through our proficiency testing (PT) programs to address the latter point, performance that we wanted to share with the community.  We analyzed almost 7000 PT responses on three molecular oncology tests, those for BRAF, EGFR, and KRAS mutations, and found that both LDTs and FDA-CDs demonstrated excellent performance, with both test types exceeding 97% accuracy overall. The second key finding of the study was that more than 60% of all laboratories in our study that were using an FDA-CD kit report using it with modifications from the FDA-approved protocol.  These modifications in fact render these test LDTs.  These modifications appear to be driven by the exigencies of real day-to-day clinical practice that requires adapting the assays to meet the needs of a variety of clinical situations that may not be accommodated by the FDA-approved protocol.  These modifications include, for example, the testing of other tumor types that may carry targetable variants, different types of input specimen preparations available in pathology such as cytology smears or other fresh specimens rather than paraffin blocks, and availability of different methods of DNA quantification that those mandated by the FDA approval based upon pre-existing technologies in the laboratories.  In the clinical laboratory, we are always acutely aware that there is a patient awaiting this result. Therefore, we validate our assays to ensure that we can provide reliable and accurate results from our laboratory under as many varied clinical situations as possible. These data support that practice. (more…)
Accidents & Violence, Author Interviews, JAMA, Karolinski Institute, Mental Health Research, Pediatrics / 14.12.2017

MedicalResearch.com Interview with: Emma Björkenstam PhD Department of Public Health Sciences Karolinska Institutet MedicalResearch.com: What is the background for this study? What are the main findings? Response: My research team and I have previously shown that childhood adversity is associated with an elevated suicide risk in young adults, and this increased risk may be explained by maladaptive trajectories during adolescence. We also know that adolescent violent offending is linked with suicide, but up until now, less was known about the role of violent offending in the association between childhood adversity and later suicide. Our main finding in the current study, based on almost half a million Swedes, is that individuals with a history of childhood adversity who also engage in violent offending in late adolescence, have a substantial increased risk of suicide. (more…)
ADHD, Author Interviews, Brigham & Women's - Harvard, Heart Disease, JAMA, OBGYNE / 14.12.2017

MedicalResearch.com Interview with: Krista F. Huybrechts, MS PhD Assistant Professor of Medicine Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women's Hospital Harvard Medical School Boston, MA 02120   MedicalResearch.com: What is the background for this study? What are the main findings? Response: In recent years, use of stimulant medications in adults, including women of reproductive age, has increased substantially. However, data regarding the safety of stimulant medications in early pregnancy are sparse and conflicting.  For example, two recent cohort studies failed to detect an association between use of methylphenidate in early pregnancy and overall or cardiac malformations, while another found an 81% increased risk of cardiac malformations, although the estimate was imprecise. Given the rapidly increasing use of stimulant medications during pregnancy and among women of reproductive age who may become pregnant inadvertently, there is an urgent need to better understand their safety. (more…)
Author Interviews, Diabetes, JAMA, Ophthalmology, Technology / 13.12.2017

MedicalResearch.com Interview with: Dr. Tien Yin Wong MD PhD Singapore Eye Research Institute, Singapore National Eye Center, Duke-NUS Medical School, National University of Singapore Singapore MedicalResearch.com: What is the background for this study? What are the main findings? Response: Currently, annual screening for diabetic retinopathy (DR) is a universally accepted practice and recommended by American Diabetes Association and the International Council of Ophthalmology (ICO) to prevent vision loss. However, implementation of diabetic retinopathy screening programs across the world require human assessors (ophthalmologists, optometrists or professional technicians trained to read retinal photographs). Such screening programs are thus challenged by issues related to a need for significant human resources and long-term financial sustainability. To address these challenges, we developed an AI-based software using a deep learning, a new machine learning technology. This deep learning system (DLS) utilizes representation-learning methods to process large data and extract meaningful patterns. In our study, we developed and validated this using about 500,000 retinal images in a “real world screening program” and 10 external datasets from global populations. The results suggest excellent accuracy of the deep learning system with sensitivity of 90.5% and specificity of 91.6%, for detecting referable levels of DR and 100% sensitivity and 91.1% specificity for vision-threatening levels of DR (which require urgent referral and should not be missed). In addition, the performance of the deep learning system was also high for detecting referable glaucoma suspects and referable age-related macular degeneration (which also require referral if detected). The deep learning system was tested in 10 external datasets comprising different ethnic groups: Caucasian whites, African-Americans, Hispanics, Chinese, Indians and Malaysians (more…)
Author Interviews, Endocrinology, JAMA, Menopause, OBGYNE / 13.12.2017

MedicalResearch.com Interview with: Dr. Suzanne Fenske, MD Assistant Professor of Obstetrics, Gynecology and Reproductive Science Icahn School of Medicine at Mount Sinai  MedicalResearch.com: What is the background for this study? What are the main findings? Response: USPSTF recommendations are based off several studies, but is mainly based off of the Women's Health Initiative. The Women's Health Initiative was a 15 year prevention study with a focus on death, disability and impaired quality of life in postmenopausal women. This study was originally performed in 1991. The USPSTF reevaluated the data along with several other studies to assess the role of hormone replacement therapy in prevention of chronic diseases such as heart disease, stroke, blood clot, gallbladder disease, dementia.  The USPSTF has found that hormone replacement therapy has some benefit in reducing the risk of fractures, and, potentially, diabetes.  The USPSTF has found that hormone replacement therapy can increase the risk of coronary artery disease, stroke, blood clot, gall bladder disease, urinary incontinence and dementia. With these risks, the USPSTF states that hormone replacement therapy should not be used as a preventative medicine, but, rather, used for treatment of symptomatic menopause and not prevention of osteoporosis or heart disease. (more…)
Author Interviews, Breast Cancer, Cancer Research, JAMA, Technology / 13.12.2017

MedicalResearch.com Interview with: Babak Ehteshami Bejnordi Department of Radiology and Nuclear Medicine Radboud University medical center, NijmegenBabak Ehteshami Bejnordi Department of Radiology and Nuclear Medicine Radboud University medical center, Nijmegen MedicalResearch.com: What is the background for this study? Response: Artificial intelligence (AI) will play a crucial role in health care. Advances in a family of AI popularly known as deep learning have ignited a new wave of algorithms and tools that read medical images for diagnosis. Analysis of digital pathology images is an important application of deep learning but requires evaluation for diagnostic performance. Accurate breast cancer staging is an essential task performed by the pathologists worldwide to inform clinical management. Assessing the extent of cancer spread by histopathological analysis of sentinel lymph nodes (SLN) is an important part of breast cancer staging. Traditionally, pathologists endure time and labor-intensive processes to assess tissues by reviewing thousands to millions of cells under a microscope. Using computer algorithms to analyze digital pathology images could potentially improve the accuracy and efficiency of pathologists. In our study, we evaluated the performance of deep learning algorithms at detecting metastases in lymph nodes of patients with breast cancer and compared it to pathologist’s diagnoses in a diagnostic setting. (more…)
Author Interviews, Endocrinology, Fertility, JAMA, OBGYNE, Thyroid Disease / 13.12.2017

MedicalResearch.com Interview with: Professor Tianpei Hong, MD, PhD Of behalf of Prof. Jie Qiao and all the coauthors, Director, Department of Endocrinology & Metabolism Director, Department of Laboratory Medicine Peking University Third Hospital Beijing, China MedicalResearch.com: What is the background for this study?
  • Ÿ           Women who test positive for thyroid autoantibodies have been reported to be at 2- to 3-fold higher risk of spontaneous miscarriage than those who test negative. However, the effect of levothyroxine on miscarriage among women with positive thyroid autoantibodies and normal thyroid function has been documented in limited studies with conflicting results.
  • Ÿ           Given the substantial difficulty achieving successful pregnancy among infertile women, identifying optimal treatment for infertile women who test positive for thyroid autoantibodies is particularly important. There are a few randomized clinical trials showing a beneficial effect of levothyroxine treatment on pregnancy outcomes among women undergoing in vitro fertilization and embryo transfer (IVF-ET). However, the sample size of those trials was rather small which may weaken the quality of the evidence.
  • Ÿ           Therefore, the Pregnancy Outcomes Study in euthyroid women with Thyroid Autoimmunity after Levothyroxine (POSTAL) study was conducted in Peking University Third Hospital to evaluate whether levothyroxine treatment initiated before IVF-ET could decrease the miscarriage rate and improve the live birth rate in infertile women who tested positive for antithyroperoxidase antibody but had normal thyroid function.
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Author Interviews, Cost of Health Care, JAMA / 12.12.2017

MedicalResearch.com Interview with: Renuka Tipirneni, MD, MSc Clinical Lecturer in Internal Medicine University of Michigan Department of Internal Medicine, Division of General Medicine, and Institute for Healthcare Policy & Innovation Ann Arbor, MI MedicalResearch.com: What is the background for this study? What are the main findings? Response: Several states have submitted proposals to require Medicaid expansion enrollees to work, actively seek work or volunteer, or risk losing Medicaid coverage. The current federal administration has signaled a willingness to approve the waivers states need to enact such requirements. In our survey of over 4000 Medicaid expansion enrollees in Michigan, we found that nearly half of enrollees have jobs, another 11 percent can’t work, likely due to serious physical or mental health conditions, and another 27% are out of work but also are much more likely to be in poor health. (more…)