Author Interviews, Gastrointestinal Disease, Sexual Health / 21.06.2016

MedicalResearch.com Interview with: Professor Phil Reed Department of Psychology Swansea University Swansea,U.K MedicalResearch.com: What is the background for this study? How common is the problem of incontinence in women? Dr. Reed: Incontinence is an enormous and under-discussed issue for women’s health – it affects around 25% of adult females, and this can rise to 50-60% after childbirth or in those over 60 years old. This condition is affected by many other factors – such as smoking and obesity – and it can be very common for individuals who are living in poor economic circumstances. Many women with continence problems also show signs of depression and anxiety – perhaps not surprisingly – and these factors can reduce their motivation to engage with physiotherapy treatment for incontinence. This is a great pity, because physiotherapy is a very effective treatment for this problem, and it can be safer (and cheaper) than surgery. So finding ways to support women as they undertake physiotherapy is really important for them and to publically health services. (more…)
Author Interviews / 21.06.2016

MedicalResearch.com Interview with: Morton Leibowitz, M.D., FACC, Senior Physician Clalit Research Institute Clinical Associate Professor of Medicine/Cardiology NYU School of Medicine MedicalResearch.com: What is the background for this study? What is known (and not known) about this subject? Dr. Leibowitz: Statins are upheld as effective treatments in LDL-C lowering and secondary prevention of major cardiovascular events. Results from recent clinical trials of statins in combination with adjunctive medications for secondary prevention have led to renewed emphasis on a concept that "lower is better" for targeting LDL-C in high-risk patients. Recent meta-analyses have suggested and guidelines have incorporated that intensive statin treatment is recommended for secondary prevention of future cardiac events. However, on the question “how low is low enough?” for LDL levels in the management of Ischemic Heart Disease patient - the jury is still out. Past studies do suggest that there is a lower threshold to the beneficial impact of lowering LDL-C, however there still remains uncertainty about what the optimal target is. Some guidelines have suggested a target of LDL below 70 for the group at high-risk for cardiac events, while other guidelines maintain the previously target value of below 100 for these patients. This decision whether indeed "lower is better" has considerable impact on physicians prescription decision-making, and is thus of timely importance. To address this question, one whould need a very large longitudinal dataset of real-world data on actual prescription, dispensing, laboratory and clinical outcomes data, on tens of thousands of patients for over 5 years. Such databases are available at Clalit Health Services, Israel’s largest healthcare payer/provider, that has 100% Electronic Medical Records for well over a decade. The Clalit Research Institute has created such a retrospective cohort to address this policy question. (more…)
Author Interviews, JAMA, Menopause / 21.06.2016

MedicalResearch.com Interview with: Taulant Muka, MD, MPH, PhD Postdoctoral Researcher Department of Epidemiology Erasmus University Rotterdam, The Netherlands MedicalResearch.com: What is the background for this study? Response: Hot flashes, night sweats and vaginal dryness are very common symptoms of menopause, affecting up to 80% of women. Despite the availability of a wide range of pharmacological treatments and the best effort of health care professionals, good control of menopausal symptoms and their adverse effects remains elusive for much of the women. Some women choose hormone replacement therapy to treat menopausal symptoms, but for many others estrogen is not an option as long as some research suggests that it may rise the risk for breast cancer and heart disease. Therefore, 40 to 50% of women in Western countries choose to use complementary therapies, including plant-based therapies. These are many plant based-therapies that have been suggested to improve menopausal symptoms, but there is little guidance about which plant-based therapy is effective. (more…)
Author Interviews, Biomarkers, Heart Disease, JAMA, Personalized Medicine, UCSF / 21.06.2016

MedicalResearch.com Interview with: Peter Ganz, MD Chief, Division of Cardiology Director, Center of Excellence in Vascular Research Zuckerberg San Francisco General Hospital Maurice Eliaser Distinguished Professor of Medicine University of California, San Francisco MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Ganz:  The research described in the JAMA paper involved measuring 1,130 different proteins in nearly 2000 individuals with apparently stable coronary heart disease, who were followed up to 11 years. Initially, two hundred different proteins were identified whose blood levels could be related to the risk of heart attacks, strokes, heart failure and death, and ultimately a combination of nine proteins was selected for a risk prediction model, based on their combined accuracy and sensitivity. Application of these findings to samples of patients with stable coronary heart disease demonstrated that some of those who were deemed clinically stable instead had a high risk of adverse cardiovascular outcomes, while other patients with the same clinical diagnosis had a very low risk. Thus, individuals who all carried the same clinical diagnosis of stable coronary heart disease had a risk of an adverse cardiovascular event that varied by as much as 10-fold, as revealed by analysis of the levels of the nine proteins in their blood. Given such large differences in risk and outcomes, patients could reasonably opt to be treated differently, depending on their level of risk. We hope that in the future, management of patients with stable angina will at least in part rely on risk assessment based on levels of blood proteins. (more…)
Author Interviews, Heart Disease, Nature, University Texas, Weight Research / 21.06.2016

MedicalResearch.com Interview with: Mikhail Kolonin, PhD, Associate Professor Director, Center for Metabolic and Degenerative Diseases Harry E. Bovay, Jr. Distinguished University Chair in Metabolic Disease Research The Brown Foundation Institute of Molecular Medicine University of Texas Health Science Center at Houston Houston, TX 77030 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Epidemiology studies have indicated that in obese patients progression of prostate, breast, colorectal, and other cancers is more aggressive. Adipose (fat) tissue, expanding and undergoing inflammation in obesity, directly fuels tumor growth. Adipose tissue is composed by adipocytes and stromal/vascular cells, which secrete tumor-trophic factors. Previous studies by our group have demonstrated that adipose stromal cells, which support blood vessels and serve as adipocyte progenitors, are recruited by tumors and contribute to cancer progression. Mechanisms underlying stromal cell trafficking from fat tissue to tumors have remained obscure. We discovered that in obesity a chemokine CXCL1, expressed by cancer cells, attracts adipose stromal cells to tumors. (more…)
Author Interviews, Dermatology, Infections / 21.06.2016

MedicalResearch.com Interview with: Dr. Jonathan L. Silverberg MD PhD MPH Assistant Professor in Dermatology Medical Social Sciences and Preventive Medicine Northwestern University, Chicago, Illinois MedicalResearch.com: What is the background for this study? What are the main findings? Response: Psoriasis is associated with a number of potential risk factors for developing serious infections, including impaired skin-barrier function, immune dysregulation, use of systemic immunosuppressant and biologic treatments. We hypothesized that adults with psoriasis have higher rates of serious infections. We examined data from the 2002-2012 National Inpatient Sample, which contains a representative 20% sample of all hospitalizations in the United States. We found that psoriasis was associated with multiple serious infections, including methicillin-resistant Staphylococcus aureus, cellulitis, herpes simplex virus infection, infectious arthritis, osteomyelitis, meningitis, encephalitis and tuberculosis. Rates of serious infections increased over all time. Significant predictors of serious infections in patients with psoriasis included non-white race, lower estimated income quartile, and Medicaid, Medicare, or self-pay insurance status. These findings suggest that poor access to adequate dermatologic care may be associated with higher rates of infections. (more…)
Author Interviews, Heart Disease, Stem Cells / 21.06.2016

MedicalResearch.com Interview with: Fu Guosheng MD Professor and Chairman, Department of Cardiology Sir Run Run Shaw Hospital, College of Medicine Zhejiang University Hangzhou, China MedicalResearch.com: What is the background for this study? Response: Acute myocardial infarction (AMI) remains a major cause of long term morbidity and mortality worldwide. Although we can re-vascularize the occluded vessels by cardiac intervention or coronary artery bypass graft (CABG), it is not helpful for the damaged myocardium, which urges us to find a new therapeutic method. An increasing body of evidence from a wide range of experimental animal studies and clinical trials suggests that endothelial progenitor cell (EPC) transplantation can repair “broken” heart by involving direct angiogenesis and secreting protective paracrine factors, which has a bright prospect for clinical application. However, transplantation of autologous EPC has numerous limitations, including the limited supply of expanded EPC, the impaired function and activity of the transplanted cells, and so on. Therefore, it is desirable to develop novel proangiogenic strategies that improve the efficacy of EPC transplantation. (more…)
Author Interviews / 21.06.2016

MedicalResearch.com Interview with: Zhu-Ming Zhang, MD, MPH, FAHA Associate Professor Epidemiological Cardiology Research Center (EPICARE) Wake Forest School of Medicine Medical Center Blvd, Winston Salem, NC 27157 MedicalResearch.com: What is the background for this study? Response: Heart disease still is the leading cause of death globally. About 635,000 new cases of coronary heart disease occur annually in the United States, with an additional 155,000 incidentally discovered asymptomatic silent myocardial infarctions (SMI). Silent myocardial infarctions, defined as the presence of pathological Q waves in the absence of a history of typical cardiac symptoms, is one of the important cardiac abnormalities, and given them medical attention could prevent subsequent adverse outcomes or even their lives. (more…)
Author Interviews, CDC, Fertility, Social Issues / 21.06.2016

MedicalResearch.com Interview with: Ghenet Besera, MPH National Center for Chronic Disease Prevention and Health Promotion CDC MedicalResearch.com: What is the background for this study? Response: The Title X program, established in 1970, offers confidential family planning and related preventive services to both men and women. While most clients are women, Title X also promotes use of services by men through delivery of male-focused services. Men’s family planning needs include services not only related to contraception, but also related to preconception care, infertility, and STD/ HIV services, which affect their reproductive health and overall health. (more…)
Author Interviews, Brigham & Women's - Harvard, CT Scanning, JAMA, Stroke / 21.06.2016

MedicalResearch.com Interview with: Dr. Gregoire Boulouis MD MS Research Fellow at Massachusetts General Hospital / Harvard Med. School Boston, Massachusetts MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Boulouis: Hemorrhagic Stroke or Intracerebral hemorrhage (ICH) still has a poor prognosis. A substantial proportion of patients will experience ongoing intracranial bleeding and their hematomas will grow in size in the first hours following presentation, a phenomenon called 'hemorrhage epxansion'. Patients with hemorrhage expansion have been shown to have significantly worse clinical outcome. If all baseline ICH characteristics (location, initial hemorrhage volume, ..) are non modifiable at the time of diagnosis, hemorrhage expansion, however, represents one of the few potential targets to improve outcome in ICH patients. An accurate selection of patients at high risk of expansion is needed to optimize patients' selection in expansion targetted trials and, eventually, to help stratifying the level of care at the acute phase. In this study, we investigated whether the presence of non-contrast Computed Tomography hypodensities within the baseline hematoma, a very easily and reliably assessed imaging marker, was associated with more hemorrhage expansion. A total of 1029 acute phase ICH patients were included ; approximately a third of them demonstrated CT hypodensities at baseline. In this population, CT hypodensities were independently associated with hemorrhage expansion with an odds ratio of 3.42 (95% CI 2.21-5.31) for expansion in fully adjusted multivariable model. (more…)
Author Interviews, Education, JAMA, Pharmacology, UCSF / 21.06.2016

MedicalResearch.com Interview with: Colette DeJong Medical student at UCSF and Research Fellow at the UCSF Center for Healthcare Value. MedicalResearch.com: What is the background for this study? Response: Data released under the U.S. Sunshine Act reveals that in the last five months of 2013, over half of American physicians received free meals, gifts, or payments from the pharmaceutical industry. Recent studies have shown that doctors who receive large payments from drug companies—such as speaking fees and royalties—are more likely to prescribe expensive brand-name drugs, even when generics are available. Our findings, however, suggest that physicians’ prescribing decisions may be associated with much smaller industry payments than previously thought. We found that doctors who receive a single industry-sponsored meal—with an average value under $20—are up to twice as likely to prescribe the brand-name drug being promoted. (more…)
Author Interviews, BMJ, Pain Research / 21.06.2016

MedicalResearch.com Interview with: Dr Alan Fayaz MA MBBS MRCP FRCA FFPMRCA Consultant in Anaesthesia and Pain Medicine University College London Hospital NHS Foundation Trust MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Fayaz: Despite fairly well established negative consequences of chronic pain (social, psychological, biological) very little is known about the burden of chronic pain in the United Kingdom. For example healthcare costs relating to chronic pain in the USA outstrip those of Cancer and Cardiovascular disease, and yet the profile of chronic pain (as disease in its own right) is not nearly as well established as either of those conditions. Surprisingly, prior to our study, there was little consensus regarding the prevalence of chronic pain in the UK. The purpose of our review was to synthesise existing data on the prevalence of various chronic pain phenotypes, in the United Kingdom, in order to produce accurate and contemporary national estimates. (more…)
Annals Internal Medicine, Author Interviews, Primary Care, UCLA / 21.06.2016

MedicalResearch.com Interview with: John N. Mafi, MD, MPH Assistant Professor of Medicine Division of General Internal Medicine and Health Services Research UCLA David Geffen School of Medicine Los Angeles, CA 90024 Affiliated Adjunct in Health Policy RAND Corporation Santa Monica, CA 90401 MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Mafi: The U.S. healthcare system faces a looming shortage of primary care physicians, with some estimates as high as 20,000 physicians by the year 2020. In addition, fewer and fewer trainees enter primary care careers because of the harder work and lower salaries. Combine this with the passage of the Affordable Care Act and the millions of newly insured patients looking for a primary care provider, and you have created a perfect storm where timely access to primary care becomes essentially unachievable. Many advocate for expanding the role of nurse practitioners and physician assistants to mitigate the physician shortage. But this is controversial as most doctors believe nurse practitioners provide inferior care to doctors and many feel that expanding their role would worsen the value and efficiency of the U.S. healthcare system. While studies suggest they provide similar quality of care to physicians, few have actually evaluated whether they provide greater amounts of inefficient or low value care. Low value care is important because it can harm patients (antibiotics for colds don’t help patients and have harmful side effects) and they can raise healthcare costs. In this context, we used a large national database on ambulatory visits to compare the quality and efficiency of care among nurse practitioners, physician assistants, and physicians in the U.S. primary care setting. In our 15 year analysis of nearly 29,000 patients who saw either a nurse practitioner, physician assistant, or a physician, we found similar rates of inappropriate antibiotic use for colds, unnecessary imaging (such as x-rays, CT scans, and MRI scans) for back pain and headache, and potentially necessary referrals to specialists for these same three conditions. (more…)
Author Interviews, Diabetes, Exercise - Fitness, University of Pittsburgh / 21.06.2016

MedicalResearch.com Interview with: Dr-Andrea-M-KriskaDr. Andrea M. Kriska PhD MS Professor, Department of Epidemiology Graduate School of Public Health Pittsburgh, PA 15261 MedicalResearch.com: What is the background for this study? Dr. Kriska:  The Diabetes Prevention Program (DPP) was a well administered national research study primarily supported by the National Institutes of Health (NIDDK) that demonstrated that lifestyle intervention with weight loss and physical activity goals can prevent type 2 diabetes in diverse, high risk US adults. The importance of physical activity in preventing diabetes development in the DPP until now was thought to be due to its role in achieving weight loss and weight maintenance but activity was not considered a strong key factor alone. The lifestyle group had a significantly greater increase in physical activity and decrease in weight than the other two groups. They also had a 58% decrease in diabetes incidence compared to the control group. The successful decrease in T2D held across all age, sex, baseline BMI and ethnicity/race subgroups. Despite the fact that the lifestyle intervention was then offered to all participants, in the follow-up years, the lifestyle participants still maintained a lower cumulative diabetes incidence that could not be explained by differences in weight loss. (more…)
Author Interviews, Brigham & Women's - Harvard, Microbiome, Nature / 21.06.2016

MedicalResearch.com Interview with: Amir Bashan, PhD, and Yang-Yu Liu, PhD Channing Division of Network Medicine Brigham and Women’s Hospital and Harvard Medical School Boston, Massachusetts MedicalResearch.com: What is the background for this study? What are the main findings? Response:  We coexist with a vast number of microbes—our microbiota—that live in and on our bodies, and play important roles in human physiology and diseases. Our microbiota is inherently dynamic and changes throughout our lives. The changeability of our microbiota offers opportunities for microbiome-based therapies, e.g. fecal microbiota transplantation (FMT) and probiotic administration, to restore or maintain our healthy microbiota. Yet, our microbiota is also highly personalized and possess unique microbial “fingerprints” in both species assemblages and abundance profiles. This raises fundamental concerns regarding the efficacy and long-term safety of generic microbiome-based therapies. In particular, it is not known whether the underlying ecological dynamics of these communities, which can be parameterized by growth rates, and intra- and inter-species interactions in population dynamics models, are largely host-independent (i.e. universal) or host-specific. If the inter-individual variability reflects host-specific dynamics due to differences in host lifestyle, physiology or genetics, then generic microbiome manipulations may have unintended consequences, rendering them ineffective or even detrimental. In this case, we have to design truly personalized interventions, which need to consider not only the unique microbial state of an individual but also the unique dynamics of the underlying microbial ecosystem. In addition, host-specific microbial dynamics, if they exist, raise a major safety concern for FMT, because although the healthy microbiota are stable in the donor’s gut, they may be shifted to an undesired state in the recipient’s gut. Alternatively, microbial ecosystems of different subjects may exhibit universal dynamics, with the inter-individual variability mainly originating from differences in the sets of colonizing species. We can design general interventions to control the microbial state (in terms of species assemblage and abundance profile) of different individuals. (more…)
Author Interviews, Melanoma, Technology / 21.06.2016

MedicalResearch.com Interview with: Orit Markowitz, MD Director of Pigmented Lesions and Skin Cancer The Mount Sinai Hospital and Assistant Professor of Dermatology Icahn School of Medicine at Mount Sinai Director of Pigmented lesions clinic Brooklyn VA, Adjunct Professor, Dermatology SUNY Downstate Medical Center, Brooklyn, NY Chief of Dermatology Queens General Hospital, Jamaica, NY MedicalResearch.com Editors’ Note: As part of an ongoing series of occasional article on cancer prevention, Dr. Markowitz from The Mount Sinai Hospital discusses skin cancer and the use Optical Coherence Tomography in skin cancer diagnosis and treatment. MedicalResearch.com: How common is the problem of non-melanoma skin cancer? Are they difficult to detect and treat? Dr. Markowitz: Skin cancer is the most commonly diagnosed cancer in the United States. Non melanoma skin cancers, including basal cell carcinomas and squamous cell carcinomas, are the most common malignancies of the skin, constituting around 80 percent of all skin cancers. The annual cost of treating skin cancers in the U.S. is estimated at $8.1 billion, with $3.3 billion for melanoma. (more…)
Annals Internal Medicine, Author Interviews, Cost of Health Care, Hepatitis - Liver Disease / 20.06.2016

MedicalResearch.com Interview with: J. Morgan Freiman, MD Infectious disease research fellow Boston Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Freiman:  There are 130-150 million persons infected with chronic HCV with 75% of all cases occurring in low- and middle- income countries (LMICs). Diagnosis is a 2-step process that starts with screening for exposure with an assay that detects antibodies to HCV (anti-HCV), followed by nucleic acid testing (NAT) for persons with reactive anti-HCV to measure HCV ribonucleic acid (RNA) and confirm active viremia. In LMICs diagnostic capacity is low, and fewer than 1% of patients are aware of their infection. Additionally, a significant proportion of patients who test positive for anti-HCV are lost to follow-up before nucleic acid testing. The 2-step diagnostic process is thus a major bottleneck to the HCV cascade of care. Testing for hepatitis C virus core antigen (HCVcAg) is a potential replacement for NAT. Our systematic review evaluated the accuracy of diagnosis of active HCV infection among adults and children for 5 commercially available HCVcAg tests compared with NAT. We found that HCVcAg assays with signal amplification have high sensitivity, high specificity, and have the potential to replace NAT in settings with high HCV prevalence. (more…)
Accidents & Violence, Author Interviews, Ophthalmology, Technology / 20.06.2016

MedicalResearch.com Interview with: Jeff C. Rabin, O.D., M.S., Ph.D., F.A.A.O., Dipl. Vision Science Professor and Assistant Dean for Graduate Studies, Research and Assessment Chief, Visual Neurophysiology Service University of the Incarnate Word Rosenberg School of Optometry San Antonio, TX MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Rabin: The use of hand-held cellphones during driving has been widely banned but the impact of hands-free communication on visual performance remained unclear. Therefore, we used a standard automobile Bluetooth device suspended above our visual display and determined that hands-free communication significantly delayed response time to detect low contrast black-white and color targets. Moreover, hands-free communication decreased sensitivity of “color-blind” subjects to detect targets corresponding to their color deficiency and all subjects showed a tendency for decreased sensitivity for detection of small, low contrast black-white targets. (more…)
Addiction, Author Interviews, Cocaine, Science / 20.06.2016

MedicalResearch.com Interview with: Dr Karen Ersche PhD University of Cambridge Department of Psychiatry Brain Mapping Unit Herchel Smith Building Cambridge UK MedicalResearch.com: What is the background for this study? Dr. Ersche: Cocaine addiction is a major public health problem that is associated with significant harm - not just for the individual, but also for their families and for society as a whole. Without medically proven pharmacological treatments, therapeutic interventions mainly rely on psychosocial approaches, but behaviour in people with cocaine addiction remains extremely difficult to change. The impetus for this study was to find out why people with cocaine addiction are so resistant to change. One possibility would be that they have a strong tendency to develop habits, which means that they show patterns of behaviour that are not under direct voluntary control. (more…)
Author Interviews, Health Care Systems / 20.06.2016

MedicalResearch.com Interview with: Renuka Tipirneni, MD, MSc Clinical Lecturer in Internal Medicine University of Michigan Department of Internal Medicine, Division of General Medicine North Campus Research Complex, Bldg 16, Rm 472C Ann Arbor, MI MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Tipirneni: One year after Medicaid expansion in Michigan, 600,000 individuals had enrolled in the program and there was concern that new enrollees would crowd doctor’s offices and new patients would not be able to get an appointment. We found that the opposite occurred – primary care appointment availability for new Medicaid patients increased. This study builds on a previous study looking at what happened in the first four months after Medicaid expansion. In the earlier study, we found that appointment availability for new Medicaid patients had increased in the first few months after expansion. Even though the number of enrollees in the Medicaid expansion program doubled since then, the new study found that appointment availability remained increased for new Medicaid patients one year after expansion. (more…)
Author Interviews, Primary Care, Vitamin K / 20.06.2016

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Mental Health Research, Pediatrics, Psychological Science, Radiology / 19.06.2016

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. (more…)
Annals Internal Medicine, Author Interviews, Pharmacology / 17.06.2016

MedicalResearch.com Interview with: 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 [email protected] 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). (more…)
Author Interviews, OBGYNE, Race/Ethnic Diversity / 17.06.2016

MedicalResearch.com Interview with: 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. (more…)
AHA Journals, Author Interviews, Heart Disease, Technology, Yale / 17.06.2016

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Heart Disease, Outcomes & Safety / 17.06.2016

MedicalResearch.com Interview with: 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. (more…)
AHA Journals, Author Interviews, Columbia, Compliance, Heart Disease / 17.06.2016

MedicalResearch.com Interview with: 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. (more…)
AHA Journals, Author Interviews, CT Scanning, Diabetes, Heart Disease / 17.06.2016

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Depression, JAMA, OBGYNE, Pediatrics / 17.06.2016

MedicalResearch.com Interview with: 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. (more…)