Medical Research Journals

17 Mar

Posted at 20:57h in Author Interviews, Brigham & Women's - Harvard, Heart Disease, JACC, Outcomes & Safety
MedicalResearch.com Interview with: Stephen W. Waldo, MD Research Fellow in Medicine Massachusetts General Hospital MedicalResearch: What is the background for this study? What are the main findings? Dr. Waldo: Public reporting is intended to improve outcomes for our patients.  Proponents of public reporting applaud the increased transparency that it offers, allowing both patients and physicians to objectively evaluate health care outcomes for a given institution or individual provider.  Previous research has demonstrated, however, that public reporting of procedural outcomes may create disincentives to provide percutaneous coronary intervention for critically ill patients.  The present study sought to evaluate the association between public reporting of outcomes with procedural management and clinical outcomes among patients with acute myocardial infarction.  As the data demonstrate, public reporting of outcomes is associated with a lower rate of percutaneous revascularization and increased overall in-hospital mortality among patients with an acute myocardial infarction, particularly among those that do not receive percutaneous intervention.  This may reflect risk aversion among physicians in states that participate in public reporting, an unintended consequence of this policy.

17 Mar

Posted at 20:07h in Annals Internal Medicine, Author Interviews, Hepatitis - Liver Disease, MD Anderson
Jagpreet Chhatwal Ph.D. Assistant Professor, Department of Health Services Research Division of Cancer Prevention and Population Sciences The University of Texas MD Anderson Center Houston, TXMedicalResearch.com Interview with: Jagpreet Chhatwal Ph.D. Assistant Professor, Department of Health Services Research Division of Cancer Prevention and Population Sciences The University of Texas MD Anderson Center Houston, TX Medical Research: What is the background for this study? What are the main findings? Dr. Chhatwal: More than two million people in the U.S. are infected with Hepatitis C (HCV), a virus found in the liver. In 2012, the Centers for Disease Control and Prevention and the U.S. Preventive Services Task Force both recommended a one-time hepatitis C screening for baby boomers – people born between the years 1946 and 1964. Last year, the Food and Drug Administration approved the medications sofosbuvir and ledipasvir for Hepatitis C treatment. The newly approved oral regimen comes at a staggering price to payers – as much as $1,125 per day. As a result, several payers have questioned if the price is justified. The study results show that using new therapies is cost-effective in the majority of patients. However, the budget required to treat all eligible patients would be $136 billion over the next five years. Compared with the old drugs, new therapies would cost an additional $65 billion, whereas the cost offsets would be only $16 billion.

17 Mar

Posted at 11:15h in Author Interviews, Chocolate, Exercise - Fitness, Heart Disease, JACC, UCLA, UCSD
Pam R. Taub, MD, FACC Assistant Professor of Medicine UC San Diego Health System Division of Cardiology Encinitas, CA 92024MedicalResearch.com Interview with: Pam R. Taub, MD, FACC Assistant  Professor of Medicine UC San Diego Health System Division of Cardiology Encinitas, CA 92024 Medical Research: What is the background for this study? Dr. Taub: Epidemiological studies indicate that the consumption of modest amounts of dark chocolate (DC), which contains the natural cacao flavanol (-)-epicatechin (Epi,) is associated with reductions in the incidence of cardiovascular diseases (CVD). The health benefits of dark chocolate have been attributed to Epi. Clinical studies using cocoa and/or DC in normal volunteers or subjects with CVD have reported improvements in peripheral and coronary vascular endothelial function, blood pressure, lipids, insulin resistance, and inflammatory markers. The mechanism underlying these improvements is thought to be due to increased nitric oxide levels and improved endothelial function. We have also shown that capacity of Epi to favorable impact mitochondria under normal and disease states. We previously conducted pilot study in five patients with heart failure and type II diabetes, and showed that in skeletal muscle (SkM) biopsies there is a severe reduction in mitochondrial volume and cristae, as well as, in structural/functional proteins. After treatment with Epi rich dark chocolate , there was a significant recovery of SkM mitochondrial cristae, structural/functional proteins (e.g. mitofilin), as well as in regulators of mitochondrial biogenesis. However, no studies have examined the capacity of Epi rich dark chocolate to enhance exercise capacity in normal subjects and assess its impact on mitochondrial and oxidative control systems. Medical Research: What are the main findings? Dr. Taub: Seventeen subjects were randomized to placebo (n=8) or DC groups (n=9) and consumed 2 squares of chocolate (20 g, provided by Hershey) for 3 months. We showed in the chocolate group subjects had improved levels of HDL cholesterol and enhanced exercise capacity that is linked to the stimulation of SkM metabolic control endpoints which enhance mitochondrial function.

16 Mar

Posted at 23:23h in Author Interviews, Nature, Neurological Disorders, Stroke

MedicalResearch.com Interview with Filippo Calzolari PhD Institute of Stem Cell Research, ISF-N Helmholtz Zentrum München Neuherberg Germany   MedicalResearch: What is the background for this study? What are the main findings? Dr. Calzolari: Despite their amazing complexity, life-long production of new neurons occurs in only a few well-circumscribed areas in adult mammalian brains, thanks to the...

15 Mar

Posted at 21:06h in Author Interviews, Cleveland Clinic, Heart Disease, Lancet, Surgical Research
Prof Samir R Kapadia MD Director, Sones Cardiac Catheterization Laboratories Cleveland Clinic Cleveland, OH For patients with severe symptomatic aortic stenosis (AS) who are not candidates for surgical valve replacement, transcatheter aortic valve replacement (TAVR) offers superior benefit to standard therapy, as measured by all-cause mortality, cardiovascular mortality, repeat hospital admission and functional status. PARTNER 1B 5 year data were published simultaneously with PARTNER 1A 5 year data in 2 separate manuscripts in the Lancet (March 15 2105). In this landmark trial, TAVR produced a 22 percent survival benefit and a 28 percent reduced risk of cardiovascular mortality, compared with standard treatment. According to Cleveland Clinic interventional cardiologist Samir Kapadia, MD, lead author of PARTNER 1B, these findings have changed the treatment paradigm for severe Aortic Stenosis patients who can’t undergo surgical Aortic Valve Replacement. “This trial is the first—and will probably be the only—randomized AS trial that includes a standard treatment group, since these results will make it unethical to treat severe AS patients with medical therapy alone without aortic valve replacement. ” he says. Superior survival benefit with TAVR PARTNER 1B is the only rigorous randomized trial of extreme-risk aortic stenosis patients that has prospectively reported the outcomes of TAVR versus standard treatment in patients for whom the estimated probability of death or serious irreversible morbidity after surgical aortic valve replacement was 50 percent or greater. The trial enrolled 358 patients between May 11, 2007 and March 16, 2009; 179 patients were assigned to TAVR with the first-generation Sapien valve and 179 to standard therapy which includes medical therapy and balloon aortic valvuloplasty. TAVR was performed under general anesthesia with common femoral artery access. Guidance was provided by transesophagel echocardiography and fluoroscopy. The mean age of participants was 83. The primary endpoint was all-cause survival. Secondary endpoints included cardiovascular mortality, stroke, vascular complications, major bleeding and functional status.

15 Mar

Posted at 17:15h in Author Interviews, Heart Disease, NEJM, Surgical Research
Barnaby C. Reeves, D.Phil. Professor of Health Services Research, Clinical Trials & Evaluation Unit School of Clinical Sciences, University of Bristol Bristol Royal Infirmary BristolMedicalResearch.com Interview with: Barnaby C. Reeves, D.Phil. Professor of Health Services Research, Clinical Trials & Evaluation Unit School of Clinical Sciences, University of Bristol Bristol Royal Infirmary Bristol Medical Research: What is the background for this study? Response: Variable decisions are made about when to transfuse patients after cardiac surgery. The circumstances of particular patients influence decisions about whether to give a transfusion. Transfusion is a life-saving intervention when a patient is experiencing life-threatening bleeding but most patients have only one or two units of red cells transfused. These transfusions are given at varying levels of anaemia. Some doctors prefer to give a transfusion after cardiac surgery when a patient is only mildly anaemic, believing that the transfusion will promote recovery, while other doctors prefer to wait to transfuse until a patient is substantially anaemic, believing that a transfusion may do more good than harm and is wasteful if it is not needed. Therefore, we carried out a randomized controlled trial comparing restrictive (transfuse when haemoglobin <7.5 g/dL) and liberal transfusion thresholds (transfuse when haemoglobin <9.0 g/dL).* Medical Research: What are the main findings? Response: We obtained written informed consent before surgery but only randomized participants after surgery, in intensive care, if their Hb dropped below 9 g/dL. (Hence, we recruited over 3,500 patients but randomized only 2007.) This design avoids ‘diluting’ any difference between groups by including participants who would not usually be ‘considered’ for transfusion. The primary outcome was the occurrence of one or more serious complications: heart attack, stroke, acute kidney injury, bowel infarction, infection; this included/involved 35.1% of the patients in the restrictive-threshold group and 33.0% of the patients in the liberal-threshold group. This slight difference – more in the restrictive group – was not statistically significant. We then compared the percentages of patients who died; these were 4.2% in the restrictive group and 2.6% in the liberal group. The difference in this secondary outcome was of borderline statistical significance. Frequencies of other secondary outcomes (infections, ischaemic events, days in critical care and hospital, pulmonary complications) were not different in the two groups. We also carried out some pre-specified sensitivity analyses for the primary outcome and all-cause mortality. The two most important ones aimed to avoid dilution of the difference between groups as a result of patients having transfusions or outcome events before randomization. Excluding patients who were transfused before randomization shifted the treatment effect to favour the liberal threshold more strongly, for both the primary outcome and mortality. Excluding patients who experienced an outcome event in the first 24 hours after randomization did not change the treatment effect for either outcome.

15 Mar

Posted at 03:10h in Author Interviews, Dermatology, Infections, JAMA
MedicalResearch.com Interview with: Dr. Ana Ramírez-Boscá, MD Department of Dermatology and Clinical Research UnitDr. Ana Ramírez-Boscá, MD Department of Dermatology and Clinical Research Unit and Vicente Navarro-López, MD Clinical Research Unit and Infectious Diseases Unit Centro Dermatológico Estético, Alicante, SpainVicente Navarro-López, MD Clinical Research Unit and Infectious Diseases Unit Centro Dermatológico Estético, Alicante, Spain   MedicalResearch: What is the background for this study? What are the main findings? Response: Infections have been related with the pathogenesis of guttate psoriasis, however antibiotic treatment does not improve prognosis nor does it affect the evolution of the disease. The association between psoriasis and other infectious diseases has been reported as well, although in these cases there is scarce information on the causative microbial likely involved and the role of these bacteria in the pathogenesis of this skin disease. MedicalResearch: What are the main findings?  Response: Bacterial DNA may be detected in bloodstream of a significant proportion of patients with active plaque psoriasis. Increased levels of pro-inflammatory cytokines in patients with presence of bacterial DNA but not in patients without presence of bacterial genomic fragments suggest a role of bacterial DNA translocation in inducing an inflammatory response. [caption id="attachment_12680" align="alignleft" width="300"]"Guttate psoriasis" by Bobjgalindo - Own work. Licensed under GFDL via Wikimedia Commons - http://commons.wikimedia.org/wiki/File:Guttate_psoriasis.jpg#/media/File:Guttate_psoriasis.jpg Guttate Psoriasis
from Wikipedia[/caption]

14 Mar

Posted at 12:18h in AHA Journals, AHRQ, Author Interviews, Blood Pressure - Hypertension, Electronic Records, NYU/NYMC
Stella Yi, Ph.D., MPH, Assistant Professor Department of Population Health New York University School of MedicineMedicalResearch.com Interview with: Stella Yi, Ph.D., MPH, Assistant Professor Department of Population Health New York University School of Medicine MedicalResearch: What is the background for this study? What are the main findings? Dr. Yi: Self-blood pressure monitoring has been shown to be an effective tool for improving blood pressure control, however most studies have only included white race participants. We were interested in assessing whether distribution of self-blood pressure monitors (intervention) would improve blood pressure and hypertension control over usual care (control) in a 9-month period in a predominantly Hispanic, uninsured population. Systolic blood pressure improved over time in both the intervention (n=409) and the control (n=419) arms by 14.7 mm Hg and 14.1 mm Hg, respectively, as did hypertension control; 39% of study participants overall achieved control at the end of follow-up. However there were no statistical differences between the outcomes in the intervention and usual care groups.

13 Mar

Posted at 20:59h in Author Interviews, JAMA, Opiods, Pharmacology
Theodore J. Cicero, PhD Professor, Vice Chairman for Research Department of Psychiatry, Washington University St Louis, MissouriMedicalResearch.com Interview with: Theodore J. Cicero, PhD Professor, Vice Chairman for Research Department of Psychiatry, Washington University St Louis, Missouri MedicalResearch: What is the background for this study? What are the main findings? Dr. Cicero: Prescription opiate abuse (eg Vicodin, Percocet, OxyContin) has reached epidemic proportions in this country over the past decade. Although most people swallow the drugs whole, a relatively large number either chew the drugs to produce an immediate delivery of large quantities of drugs or they crush them and/or dissolve them in some solvent which makes them useful for intranasal (eg snorting) or intravenous administration. Non-oral routes, particularly injection, represent the most serious public health risk due to a high incidence of infection, including Hepatitis C and HIV, and the much greater severity of abuse. In an effort to reduce these practices, drug companies are introducing so-called abuse deterrent formulations (ADF) which are resistant to crushing or dissolving in an aqueous solution. In one such important effort, the company responsible for distributing one of the most widely abused prescription opiates, OxyContin, introduced an ADF in 2010. Although the abuse deterrent formulations was highly successful in reducing abuse of OxyContin by either chewing, crushing, or dissolving in water, there was none-the-less a clear limit to how effective it was. For example, some people simply switched to the oral route of administration or never did snort or inject the drug, whereas a small number found ways to defeat the abuse deterrent formulations and persisted in harmful patterns of abuse. Unfortunately, there was also an unintended result. ADF-OxyContin caused many individuals to abandon the use of OxyContin - a good thing - in favor of other opiates (a bad thing). Most serious, however, was that 70% of those who switched drugs moved from OxyContin to heroin abuse. Although by no means the only factor, the abuse deterrent formulations has contributed to the wide-spread reports of heroin abuse in suburban and rural Caucasian male and females, a group here-to-fore not the typical heroin users (i.e. poor minorities, living in large urban centers).

13 Mar

Posted at 20:32h in Aging, Author Interviews, Hearing Loss, JAMA
MedicalResearch.com Interview with: Isabelle Mosnier, MD, Praticien Hospitalier ORL Otologie, Implants Auditifs et Chirurgie de la Base du Crâne Centre Référent Implant Cochléaire Adulte d'Ile de France Centre Maladies Rares Surdité Génétique de l'adulte et Neurofibromatose de type 2 Groupe Hospitalier de la PITIE-SALPETRIERE Paris MedicalResearch: What is the background for this study? What are the main findings? Dr. Mosnier: Association between hearing impairment and cognitive decline has been established; however, the impact on cognition through cochlear implantation in profoundly deaf elderly patients is not known. The focus was to determine the impact of hearing rehabilitation including cochlear implant on cognitive functions, in addition to the influence of cognitive factors on cochlear implant outcomes over time.

13 Mar

Posted at 19:39h in Alzheimer's - Dementia, Author Interviews, Karolinski Institute, Lancet
MedicalResearch.com Interview with: Miia Kivipelto MD, PhD, Professor Deputy Head, Senior Geriatrician Aging Research Center and Alzheimer Disease Research Center Karolinska Institutet Clinical Trials Unit, Memory Clinic Karolinska University Hospital Stockholm, Sweden Medical Research: What is the background for this study? What are the main findings? Dr. Kivipelto: Epidemiological studies have linked several modifiable risk factors to cognitive impairment and dementia but evidence from randomized controlled trials (RCT) has been lacking showing the efficacy of the interventions. Because cognitive impairment, dementia and Alzheimer’s disease are complex, multi-factorial disorders, multidomain interventions targeting several risk factors and disease mechanisms simultaneously could be needed for optimum preventive effect. The FINGER study is the first large, long-term RCT indicating that multi-domain intervention can improve and maintain cognitive functioning in at risk elderly people from the general population. We observed a significant intervention effects on the primary outcome (overall cognition), main secondary outcomes (executive functioning and processing speed) as well as on complex memory tasks and risk of cognitive decline. The multidomain lifestyle intervention was feasible and safe.

13 Mar

Posted at 10:26h in AHA Journals, Author Interviews, Biomarkers, Heart Disease

MedicalResearch.com Interview with: Matthijs A. Velders, MD PhD Uppsala Clinical Research Center Uppsala, Sweden. Medical Research: What is the background for this study? What are the main findings? Dr. Velders: Outcomes in patients with ST-elevation myocardial infarction have been substantially improved by early reperfusion with primary percutaneous coronary intervention, but recurrent events after the acute...

12 Mar

Posted at 19:25h in Author Interviews, Colon Cancer, Genetic Research, JAMA
Matthew B. Yurgelun, MD Instructor in Medicine Harvard Medical SchoolMedicalResearch.com Interview with: Matthew B. Yurgelun, MD Instructor in Medicine Harvard Medical School Medical Research: What is the background for this study? What are the main findings? Dr. Yurgelun: Germline mutations in the TP53 gene are linked to Li-Fraumeni syndrome, which is an inherited syndrome associated with a 73-100% lifetime risk of cancer. Classically, cancers linked to Li-Fraumeni syndrome include early-onset breast cancer, leukemias, soft tissue sarcomas, brain cancer, and adrenocortical cancer, although recent data have shown an increased risk of colorectal cancer as well.  Our study’s primary aim was to determine the frequency of germline TP53 mutations in patients with early-onset colorectal cancer. We studied 457 patients from the multinational Colon Cancer Family Registry who were diagnosed with colorectal cancer at age 40 or younger, and found that 1.3% carried a germline alteration in the TP53 gene.  None of these individuals had personal or family histories of cancer that fulfilled clinical criteria for Li-Fraumeni syndrome.

12 Mar

Posted at 17:57h in Author Interviews, Cost of Health Care, JAMA, Medical Imaging, NYU/NYMC
Danil Makarov, MD Lead Investigator Assistant Professor, Departments of Urology, Population Health and Health Policy Member, Laura and Isaac Perlmutter Cancer Center NYU Langone Medical Center, New York, NYMedicalResearch.com Interview with: Danil Makarov, MD Lead Investigator Assistant Professor, Departments of Urology, Population Health and Health Policy Member, Laura and Isaac Perlmutter Cancer Center NYU Langone Medical Center, New York, NY Medical Research: What is the background for this study? Dr. Makarov: The background for this study is that regional variation in patterns of care and healthcare spending is widely known.  The drivers of this regional variation, though, are poorly understood.  Certain policy groups like the IOM have suggested that policy efforts be focused on individual providers and patients. Programs such as Choosing Wisely, which encourage a dialogue between physicians and patients, are a great example of such efforts.  However, some of our prior research suggests that regional variation is not random and that there might be are regional-level factors which drive variation. To test out our hypothesis, we wanted to see whether inappropriate imaging for two unrelated cancers was associated at a regional level (it should not be). Medical Research: What are the main findings? Dr. Makarov: We found that, at a regional level, inappropriate breast cancer imaging was associated with inappropriate prostate cancer imaging.

12 Mar

Posted at 00:09h in Author Interviews, Genetic Research, McGill, Nature
Prof. Moshe Szyf Ph.D. James McGill Professor of Pharmacology and Therapeutics McGill UniversityMedicalResearch.com Interview with: Prof. Moshe Szyf Ph.D. James McGill Professor of Pharmacology and Therapeutics McGill University Medical Research: What is the background for this study? What are the main findings? Dr. Szyf: Humans exhibit a marked variation in traits both physical and behavioral and different susceptibilities  for developing disease. What causes this inter-individual variation? The prevailing dogma has been that changes in the sequences of genes or heritable genetic differences are responsible for these  differences. We tested here an alternative hypothesis that perhaps some of the reason for this natural variation in traits is not caused by differences in inherited genes but by “epigenetic” changes that alter the way genes work without changing the genes.  The main difference between genetic and epigenetic changes is that epigenetic changes could be introduced by experience and exposure to environment. The experiences that can cause epigenetic changes include physical as well as social environments. Although we had known that epigenetic differences occur in humans and animals we didn’t have evidence that these changes are behind the natural variation in traits that is observed in humans and animals. Ants are an exciting biological paradigm that exhibits quantitative variations in size and therefore provided a unique opportunity to test this hypothesis.

11 Mar

Posted at 23:54h in Author Interviews, JAMA, Pain Research
Matthew J. Bair, MD, MS Research Service, Veterans Affairs Health Services Research and Development, Center for Health Information and Communication Richard L. Roudebush Veterans Affairs Medical Center, Department of Medicine, Indiana University School of Medicine, Health Services Research, Regenstrief Institute, Inc, Indianapolis, IndianaMedicalResearch.com Interview with: Matthew J. Bair, MD, MS Research Service, Veterans Affairs Health Services Research and Development, Center for Health Information and Communication Richard L. Roudebush Veterans Affairs Medical Center, Department of Medicine, Indiana University School of Medicine, Health Services Research, Regenstrief Institute, Inc, Indianapolis, Indiana MedicalResearch.com: What is the background for this study? Dr. Bair: Despite the prevalence and functional, psychological, and economic impact of chronic pain, there have been few intervention studies to treat chronic pain in Veterans. MedicalResearch.com: What are the main findings? Dr. Bair: A stepped-care intervention that combined analgesics, self-management strategies, and brief cognitive behavioral therapy resulted in statistically significant reductions in pain-related disability, pain interference, and pain severity in Veterans with chronic musculoskeletal pain.

11 Mar

Posted at 22:38h in Author Interviews, JAMA, Orthopedics, Surgical Research
Prof. Amar Rangan Clinical Professor, Trauma & Orthopaedic Surgery School of Medicine & Health, Durham University & Consultant Orthopaedic Surgeon The James Cook University Hospital MiddlesbroughMedicalResearch.com Interview with: Prof. Amar Rangan Clinical Professor, Trauma & Orthopaedic Surgery School of Medicine & Health, Durham University & Consultant Orthopaedic Surgeon The James Cook University Hospital Middlesbrough Medical Research: What is the background for this study? What are the main findings? Prof. Rangan: The majority of fractures of the proximal humerus (broken shoulders) occur in people older than 65 years. Although surgical treatment is being increasingly used for the more serious (displaced) fractures, it has been unclear whether surgical intervention (fracture fixation or humeral head replacement) produces consistently better outcomes than non-surgical treatment (arm-sling); both followed by physiotherapy. Our multicentre randomized controlled trial (ProFHER), funded by the UK National Institute for Health Research’s Health Technology Assessment Programme, recruited 250 patients aged 16 years or older (mean age, 66 years) who presented at the orthopedic departments of 32 acute UK National Health Service hospitals between September 2008 and April 2011 after sustaining the most common types of acute displaced fracture of the proximal humerus. Data for 231 patients (92.4% of 250) included in the primary analysis showed that there was no significant difference between the two treatment groups over two years or at 6, 12 and 24 months follow-up in self-reported pain and function scores. Nor were there significant differences on measures of health-related quality of life, complications related to surgery or shoulder fracture, later surgery or treatment for these complications, and death.

11 Mar

Posted at 21:11h in Author Interviews, Diabetes, Heart Disease, JAMA, Lipids, Statins
Joost Besseling PhD-student Academic Medical Center Dept. of Vascular Medicine AmsterdamMedicalResearch.com Interview with: Joost Besseling PhD-student Academic Medical Center Dept. of Vascular Medicine Amsterdam Medical Research: What is the background for this study? What are the main findings? Response: Statins are associated with an increased risk for type 2 diabetes mellitus (DM). The exact mechanism for this adverse event is largely unknown, although the upregulation of the low-density lipoprotein receptor (LDLR) has been suggested to play a role. In familial hypercholesterolemia (FH) the uptake of LDL-cholesterol via the LDLR is decreased due to a genetic defect. We found that the prevalence of type 2 DM is 50% lower in relative terms in patients with familial hypercholesterolemia. Moreover, there was a dose-response relationship: the more severe the genetic defect that causes familial hypercholesterolemia, the lower the prevalence of type 2 DM.

11 Mar

Posted at 12:01h in Author Interviews, Cost of Health Care, Critical Care - Intensive Care - ICUs, Mayo Clinic, Outcomes & Safety, Pediatrics, Pediatrics
Marc Ellsworth, M.D Neonatology fellow at the Mayo Clinic Children’s CenterMedicalResearch.com Interview with: Marc Ellsworth, M.D Neonatology fellow at the Mayo Clinic Children’s Center MedicalResearch: What is the background for this study? Dr. Ellsworth: Inhaled Nitric Oxide (iNO) is a drug that has FDA approval for use in neonates >34 weeks gestational age. It is used for severe respiratory failure secondary to pulmonary hypertension. However, it has been previously shown that neonatologists have been using this medication off-label and especially in the most premature neonates. Over the last 10 years there have been multiple large studies trying to determine a clinical use (ie long term benefit) for iNO in preterm neonates (patients where there is no FDA approval for iNO use currently). Despite evidence of short term benefit (improved clinical stability) use of this drug has not been shown to improve long-term outcomes (death and chronic lung disease) in premature neonates. As a result of these findings the National Institute of Child Health and Human Development (NICHD) released a consensus guideline in 2011 indicated that available evidence did not support the routine use of iNO in preterm neonates and discouraged this use of this expensive therapy in preterm neonates. Similarly, in 2014 the American Academy of Pediatrics issued a similar statement with similar recommendations. In 2014 a group of NICUs (collectively called the Neonatal Research Network) associated with the NICHD published a report showing that the use of Inhaled Nitric Oxide in preterm infants (ie off-label) decreased following the report in 2011. However, I did not feel that these NICUs were representative of the United States alone as the Neonatal Research Network consists of only a handful of NICUs (~15) and is directly associated with the NICHD. As a result I wanted to get a better idea of Inhaled Nitric Oxide use in a population based study to see if the trends were similar (ie use of iNO has been decreasing) on a much larger, more representative scale. (Editorial comment: My anecdotal experience was that rates of iNO use off-label have not decreased in preterm neonates since the 2011 report).

11 Mar

Posted at 11:50h in Author Interviews, Critical Care - Intensive Care - ICUs, Hospital Readmissions, Infections, JAMA, University of Michigan
Hallie Prescott, MD, MSc Clinical Lecturer, Internal Medicine Division of Pulmonary & Critical Care Medicine University of Michigan Health System Ann Arbor, MI 48109-2800MedicalResearch.com Interview with: Hallie Prescott, MD, MSc Clinical Lecturer, Internal Medicine Division of Pulmonary & Critical Care Medicine University of Michigan Health System Ann Arbor, MI 48109-2800   Medical Research: What is the background for this study? What are the main findings? Dr. Prescott: The post-hospital period has been widely recognized as a vulnerable time for patients. In particular, patients who survive sepsis are frequently readmitted to the hospital in the following three months. In this study, we examined data from 2,600 survivors of sepsis, a severe infection that leads to organ failure. About 42% of the sepsis patients were readmitted in the next 90 days, similar to the rate seen for patients hospitalized for other acute conditions. However, the reasons for hospital readmission after sepsis are different. A greater number of patients are re-hospitalized for “ambulatory-care sensitive conditions”, which are conditions that could potentially be prevented or treated early in the outpatient setting to avoid a hospital stay.

11 Mar

Posted at 01:23h in Allergies, Author Interviews, FASEB, Imperial College
Professor Jane A. Mitchell Head of Vascular Biology Section Head of Cardiothoracic Pharmacology National Heart and Lung Institute, Institute of Cardiovascular Medicine & Science, Imperial College, LondonMedicalResearch.com Interview with: Professor Jane A. Mitchell Head of Vascular Biology Section Head of Cardiothoracic Pharmacology National Heart and Lung Institute, Institute of Cardiovascular Medicine & Science, Imperial College, London Medical Research: What is the background for this study? What are the main findings? Response: In 2006 a drug called TGN1412 was given to 6 healthy male volunteers as a final test for safety. The drug had passed all of the preclinical tests and showed no problem when it was given to laboratory animals. However when it was given to people it caused a catastrophic side effect known as a ‘cytokine storm response’. All 6 volunteers became sick very quickly and needed immediate hospital treatment, they nearly died and remain at risk of immune problems still. We found a way to mimic the effects of TGN1412 in the laboratory using stem cell technology to engineer two different types of cells from the same donor to be grown and mixed together in a dish. Our test is better than the current tests used because it mimics better the human body and uses cells from one individual donor.

11 Mar

Posted at 01:06h in Annals Internal Medicine, Author Interviews, Heart Disease, Outcomes & Safety
MedicalResearch.com Interview with: Harindra C. Wijeysundera MD PhD FRCPC Interventional Cardiology, Schulich Heart Centre, Sunnybrook Health Sciences Centre Scientist, Sunnybrook Research Institute (SRI) Assistant Professor, Dept. of Medicine & Institute of Health Policy, Management and Evaluation University of Toronto Adjunct Scientist, Institute for Clinical Evaluative Sciences (ICES) Toronto, ON, Canada Medical Research: What is the background for this study? What are the main findings? Dr. Wijeysundera: Given the rapid increase in health care costs, there has been growing emphasis on the more rational use of resources.  One such effort is the development of appropriate use  criteria.  Such criteria have been developed in many areas of medicine, including in cardiology for diagnostic angiography.  The underlying rationale for a test to be appropriate is that its anticipated benefit outweighs its anticipated harms.  However, there is a paucity of empirical evidence validating this conceptual framework. Our goal was to validate the 2012 appropriate use criteria for diagnostic coronary angiography, by examining the relationship between the appropriateness of a coronary angiography in patients with suspected stable ischemic heart disease and the proportion of patients who were found to have obstructive coronary artery disease.  We used data obtained from the Cardiac Care Network registry of Ontario, Canada.  This is a population based registry of all cardiac procedures in the province of Ontario.  We examined 48,336 patients and found that 58.2% of angiographic studies were classified as appropriate, 10.8% were classified as inappropriate, and 31.0% were classified as uncertain. Overall, 45.5% of patients had obstructive CAD. In patients with appropriate indications for angiography, 52.9% had obstructive CAD, with 40.0% undergoing revascularization. In those with inappropriate indications, 30.9% had obstructive CAD and 18.9% underwent revascularization; in those with uncertain indications, 36.7% had obstructive CAD and 25.9% had revascularization. Although more patients with appropriate indications had obstructive CAD and underwent revascularization (P < 0.001), a substantial proportion of those with inappropriate or uncertain indications had important coronary disease.  Our conclusion was that despite the association between appropriateness category and obstructive CAD, this study raises concerns about the ability of the appropriate use  criteria to guide clinical decision making.

11 Mar

Posted at 00:51h in Author Interviews, Electronic Records, JAMA
MedicalResearch.com Interview with: Jonathan Pell, MD Assistant Professor Hospital Medicine University of Colorado DenverJonathan Pell, MD Assistant Professor Hospital Medicine University of Colorado Denver Medical Research: What is the background for this study? Dr. Pell: Back in 2001, the Institute of Medicine's charter document Crossing the Quality Chasm proposed that the health care system needs to do a better job of patient centered care. In order to provide true patient centered care, we must provide patients and their families with the knowledge and tools they need to make autonomous and informed decisions about their healthcare. A patient cannot make informed decisions about their healthcare without having easy access to their own health information. Almost 15 years later, we are still discussing whether or not patients should have immediate electronic access to information in their electronic health record. Studies have shown that giving outpatients direct electronic access to their test results and even doctors notes does not cause patients worry or confusion, and there is no undue burden on care providers explaining this newly accessible information to their patients - if they can deliver thinking of you flowers from Flowercard, there's no reason they can't deliver a simple print-out of relevant information. Despite this, many institutions still have a moratorium on release of patients' test results, and the duration of this moratorium is variable from institution to institution. The technology to deliver this type of information real-time to patients is readily available. We decided to explore the effect of giving hospitalized patients real-time access to their test results and hospital medication list/schedule.

10 Mar

Posted at 21:59h in Author Interviews, Breast Cancer, NEJM
Carla M. Pugh, M.D., Ph.D. FACS Associate Professor, Vice Chair, Education and Patient Safety Clinical Director, UW Health Clinical Simulation Program Section of Trauma, Acute Care Surgery, Burn and Surgical Critical Care Division of General Surgery University of Wisconsin, School of Medicine and Public Health, Madison, WI MedicalResearch.com Interview with: Carla M. Pugh, M.D., Ph.D. FACS Associate Professor, Vice Chair, Education and Patient Safety Clinical Director, UW Health Clinical Simulation Program Section of Trauma, Acute Care Surgery, Burn and Surgical Critical Care Division of General Surgery University of Wisconsin, School of Medicine and Public Health, Madison, WI Medical Research: What is the background for this study? What are the main findings? Dr. Pugh: The clinical breast examination is routinely performed on millions of women each year. It is used for screening breast cancer and is also routinely performed on women presenting with symptomatic breast conditions. In this study we assessed the performance of the clinical breast examination among a large sample of practicing physicians. There were two main goals to the study. The first goal was to identify current recommendations for performing the clinical breast examination and investigating how this relates to examination sensitivity or finding a mass. The second and more general goal was to develop a method for objective assessment of clinical skills. Novel clinical breast examination simulators were used in this study; in addition to their ability to present different pathologies and multiple clinical scenarios, they were all integrated with advanced force sensors. These sensors include approximately 2000 discrete sensing elements, measuring force level and distribution thought the breast examination. These sensors provide information at a level of detail that is not possible with observation alone. Four models were used in this study; two models presenting superficial soft masses and two models representing hard chest wall masses. The study was performed from 2013 to 2014 with 553 physicians performing the clinical breast examination on our models. The participants were recruited at three annual clinical meetings: 136 at the American Society of Breast Surgeons, 236 at the American Academy of Family Physicians, and 181 at the American College of Obstetricians and Gynecologists. The study found a significant relationship between the force used during palpation and the accuracy of the assessment of the deep-tissue lesions. More specifically, the study found that some physicians don’t apply enough force during the examination putting them at high risk of missing deep-tissue lesions. Since force can’t be measured by human observation this underscores the added value of integrating sensors into clinical simulators.

09 Mar

Posted at 22:02h in Author Interviews, Colon Cancer, JAMA, Vegetarians
Michael J. Orlich, MD, PhD Program Director, Preventive Medicine Residency Loma Linda University Co-Investigator, Adventist Health StudiesMedicalResearch.com Interview with: Michael J. Orlich, MD, PhD Program Director, Preventive Medicine Residency Loma Linda University Co-Investigator, Adventist Health Studies Medical Research: What is the background for this study? What are the main findings? Dr. Orlich: Colorectal cancer is the second leading cause of death from cancer in the United States.  Screening efforts such as colonoscopies have helped save many lives by detecting pre-cancerous polyps and removing them.  However, it is even better to prevent cancers from forming in the first place.  We call this primary prevention.  Diet is a potentially important approach to reduce the risk of developing colorectal cancer.  In this analysis, we compared those eating different categories of vegetarian dietary patterns to those eating a non-vegetarian diet.  About half of our study population was classified as non-vegetarian, which we defined as eating meat at least weekly.  The other half of our population we called vegetarian and further divided them into four different vegetarian groups:  semi-vegetarians ate meat but less than once per week; pesco-vegetarians ate fish but avoided other meats; lacto-ovo-vegetarians avoided meat but ate eggs and/or dairy products; and vegans avoided all meats, eggs, and dairy.  All vegetarians together had on average a 22% relative reduction in the risk of developing colorectal cancer, compared to non-vegetarians, after carefully adjusting for many other factors.  Pesco-vegetarians in particular had a much lower risk compared to non-vegetarians.

09 Mar

Posted at 13:42h in Author Interviews, Cancer Research, JAMA
Prof. Sigurdur Y Kristinsson Professor of Hematology University of IcelandMedicalResearch.com Interview with: Prof. Sigurdur Y Kristinsson Professor of Hematology University of Iceland MedicalResearch: What is the background for this study? What are the main findings? Prof. Kristinsson: Multiple myeloma is always preceded by a precursor condition called monoclonal gammopathy of undetermined significance (MGUS). MGUS is characterized by a detectable monoclonal protein in persons without evidence for end-organ damage or other related plasma cell or lymphoproliferative disorders. MGUS is very common and is detected in approximately 5 percent of persons 70 years or older. However, only a small proportion of MGUS progresses to a malignant disorder, in fact the annual risk of progression to multiple myeloma or other related disorders is on average 1 percent, with varying risks according to risk groups. Current guidelines suggest, depending on the individual patient’s clinical risk score, life-long monitoring of MGUS individuals to detect progression to multiple myeloma or related disorders. At this time, the impact of annual monitoring on the outcome of patients who eventually develop multiple myeloma is unclear. Using high-quality population-based data from Sweden, we estimated the impact of prior knowledge of MGUS diagnosis and comorbidities on multiple myeloma survival, by performing a large population-based study using data on more than 14,000 multiple myeloma patients diagnosed in Sweden 1976-2005, with follow-up through 2007. The hypothesis that detection and follow-up of MGUS may influence survival in multiple myeloma is unlikely to ever be tested in a prospective clinical study due to the large sample size required with long follow-up time, and consequent extreme costs. We found that multiple myeloma patients with prior knowledge of MGUS had significantly 15% better survival, despite having significantly more comorbidities. Interestingly, low-risk MGUS (with very low M-protein) had highest risk of death. The observation that low M-protein concentration at MGUS diagnosis was associated with poorer multiple myeloma survival may reflect less frequent clinical follow-up. Our observations stress the importance of clinical follow-up in MGUS, regardless of risk stratification.

08 Mar

Posted at 12:48h in Author Interviews, Gastrointestinal Disease, Nature, Nutrition
Benoit Chassaing, Ph.D. Post-Doctoral Fellow Dr. Gewirtz's lab. Institute for Biomedical Sciences Center for Inflammation, Immunity, & Infection Georgia State University Atlanta GA 30303MedicalResearch.com Interview with: Benoit Chassaing, Ph.D. Post-Doctoral Fellow Dr.  Gewirtz's lab. Institute for Biomedical Sciences Center for Inflammation, Immunity, & Infection Georgia State University Atlanta GA 30303 Medical Research: What is the background for this study? What are the main findings? Dr. Chassaing: A key feature of inflammatory bowel diseases and metabolic syndrome is alteration of the gut microbiota in a manner that promotes inflammation. Importantly, incidence of IBD and metabolic syndrome has been markedly increasing since about the mid-20th century, and this dramatic increase has occurred amidst constant human genetics, suggesting a pivotal role for an environmental factor. We considered that any modern additions to the food supply might play an important role, and addition of emulsifiers to food seems to fit the time frame of increased incidence in these diseases. We found that emulsifiers, which are added to most processed foods to aid texture and extend shelf life, can alter the gut microbiota composition and localization to induce intestinal inflammation that promotes development of inflammatory bowel disease and metabolic syndrome.

07 Mar

Posted at 17:18h in Author Interviews, NEJM
Michael D Hill, MD MSc FRCPC Calgary Stroke Program Professor, Dept Clinical Neurosciences Hotchkiss Brain Institute University of Calgary, Cumming School of Medicine Foothills Hospital, Calgary, CanadaMedicalResearch.com Interview with: Michael D Hill, MD MSc FRCPC Calgary Stroke Program Professor, Dept Clinical Neurosciences Hotchkiss Brain Institute University of Calgary, Cumming School of Medicine Foothills Hospital, Calgary, Canada Medical Research: What is the background for this study? What are the main findings? Dr. Hill: Major ischemic stroke with blocked proximal arteries results in 60-80% death and disability.  Recent studies of endovascular treatment were neutral.  Evolution of technology has resulted in advances in the devices.  Key features of past trials of endovascular therapy were, underdeveloped imaging paradigms for patient selection, slow treatment times and poor reperfusion rates. Medical Research: What should clinicians and patients take away from your report? Dr. Hill: Simply, endovascular therapy for major ischemic stroke over and above best medical care (ie. IV tPA) is effective . It reduces disability and saves lives.  The NNT is very low 4, making it one of the largest proven effect sizes in all of medicine.  BUT, it applies only under selected conditions.

07 Mar

Posted at 12:55h in Author Interviews, Herpes Viruses, Pediatrics, Pediatrics, Vaccine Studies
MedicalResearch.com Interview with: Su-Ying Wen, MD Chief of Department of Dermatology, Taipei City Hospital, Renai Branch, Taipei City, Taiwan Department of Dermatology, Taipei City Hospital, Renai Branch, Taipei City, Taiwan Medical Research: What is the background for this study? What are the main findings? Dr. Su-Ying Wen: Though herpes zoster is seen as a disease of the elderly, it can affect individuals in any age group including children. There are limited population-based data regarding pediatric herpes zoster. We reported a higher incidence rate of pediatric herpes zoster than in previous studies. The higher incidence observed in this population-based study might be because it was measured in a cohort of children who were all infected with varicella rather than as other reports including individuals free of varicella infection in the denominator. Children younger than 2 years at the diagnosis of varicella had a significantly higher risk and shorter duration of developing herpes zoster.

07 Mar

Posted at 01:59h in AHA Journals, Author Interviews, CDC, Salt-Sodium
Dr. Sandra L. Jackson, Ph.D., M.P.H Epidemic intelligence service fellow Centers for Disease Control and Prevention, Chamblee, GAMedicalResearch.com Interview with: Dr. Sandra L. Jackson, Ph.D., M.P.H Epidemic intelligence service fellow Centers for Disease Control and Prevention, Chamblee, GA Medical Research: What is the background for this study? What are the main findings? Dr. Jackson: With more than 90 percent of U.S. adults exceeding recommended sodium intake levels, healthcare providers can play a key role in counseling patients on the importance of limiting salt in the diet. To assess the impact of medical advice on an individual’s efforts to reduce sodium intake, CDC researchers examined self-reported telephone survey information from nearly 174,000 U.S. adults. Overall, more than half of the respondents reported watching or reducing their sodium intake in 2013 – but less than one quarter (23 percent) said they received advice from a doctor or healthcare professional about sodium reduction. Of those that received the medical advice, 82 percent reported taking action to limit their sodium intake. In comparison, only 44 percent of respondents who reported not receiving medical advice said they took steps to reduce sodium. The substantial proportion of patients who are not receiving medical advice (77%), according to these findings, reveals a missed opportunity to reduce sodium intake, particularly among groups that have a higher risk of developing cardiovascular disease. This includes African Americans, and those with high blood pressure, diabetes or chronic kidney disease.