MedicalResearch.com Interview with:
Dr. James Yu
Yale School of Medicine
Cancer Outcomes, Public Policy, and Effectiveness Research Center
Yale School of Medicine
Department of Therapeutic Radiology
New Haven, Connecticut
Medical Research: What is the background for this study? What are the main findings?
Response: Hypo fractionated radiation has been shown to be safe and effective, and more convenient for women with early stage breast cancer after lumpectomy. It also has been identified by ASTRO as a practice that physicians can adopt to reduce healthcare expenses for patients and for society. We looked at the National Cancer Database, a database created by the American College of Surgeons for trends in the use of hypo fractionated radiation for breast cancer through 2011. We found that the use of hypofractionated radiation had increased to 22.8% in 2011. I found this remarkable as it predated the ASTRO choosing widely guidelines, and indicated to me that physicians were already thinking of ways of making treatment more convenient and affordable for patients and insurers.
MedicalResearch.com Interview with:
Rachel Blitzblau, M.D., Ph.D.
Butler Harris Assistant Professor
Department of Radiation Oncology
Duke University Medical Center
Durham, NC 27710
MedicalResearch.com Interview with:
Ganesh Sivarajan, MD
Department of Urology
New York University Langone Medical Center
MedicalResearch.com Interview with:
Adeel A. Butt, MD, MS, FACP, FIDSA Vice Chair for Faculty Affairs
Department of Medicine Hamad Medical Corporation, Doha, Qatar
Adjunct Associate Professor of Medicine and Clinical and Translational Science
University of Pittsburgh School of Medicine
Medical Research: What is the background for this study? What are the main findings?
Dr. Butt: Precise rate of progression of liver disease in Hepatitis C (HCV) infection is unknown because the precise time of infection with HCV is seldom known. Knowledge of liver disease progression is critical to determine the optimal time for treatment.
We found that progression of liver disease starts early after acquiring HCV infection. This is more rapid than was previously thought. About 18% of HCV infected persons develop cirrhosis within 10 years of acquiring HCV infection, which is 3-fold higher than demographically similar HCV uninfected persons.
MedicalResearch.com Interview with:
Barbara J Turner MD, MSEd, MA, MACP
James D and Ona I Dye Professor of Medicine
Director, Center for Research to Advance Community Health (ReACH)
University of Texas Health Science Center San Antonio
Medical Research: What is the background for this study? What are the main findings?
Dr. Turner: Daily dose of opioid analgesics has been widely used to assess the risk of overdose death and this risk has been reported to be greatest for a morphine equivalent dose at least 100 to 120 mg per day. However, the total dose of filled opioid prescriptions over a period of time may offer a complementary measure of the risk to that provided by the daily dose. In fact, the total dose is not necessarily a simple linear transformation of the daily dose because not all patients use opioids every day, instead it reflects the total amount of opioids available to a patient.
Among 206,869 national HMO patients aged 18-64 with non-cancer pain filling at least 2 schedule II or III opioid analgesic prescriptions, the rate of overdose was 471 per 100,000 person-years. Over the study period of 3.5 years, risk of drug overdose was two to three times greater for patients with a daily dose >100 mg regardless of the total dose filled or a daily dose of 50-99 mg with a high total dose (>1830 mg) filled a six month interval (versus no opioids). The overdose risk was increased slightly for 50-99 mg per day with a lower total dose and not increased at all for daily doses under 20 mg regardless of the total dose.
MedicalResearch.com Interview with:
Ravi Rajaram MD
Division of Research and Optimal Patient Care, American College of Surgeons Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery and Center for Healthcare Studies in the Institute for Public Health and Medicine
Feinberg School of Medicine, Northwestern University, Chicago, Illinois
Medical Research: What is the background for this study? What are the main findings?
Dr. Rajaram: The Accreditation Council for Graduate Medication Education (ACGME) first implemented restrictions to resident duty hours in 2003. In surgical populations, these reforms have not been associated with a change in patient outcomes.
However, in 2011, the ACGME further restricted resident duty hours to include: a maximum of 16 hours of continuous duty for first-year residents (interns), direct supervision of interns at all times, a maximum of 4 hours for transitions in care activities for residents in-house for 24 hours, and that these residents be given 14 hours off prior to returning to work. The association between the 2011 ACGME resident duty hour reform with surgical patient outcomes and resident education has not previously been reported.
The 2011 resident duty hour reform was not associated with a change in death or serious morbidity in the two years after the reform was implemented. Additionally, the 2011 duty hour reform was not associated with a change in any of the secondary outcomes examined, including any morbidity, failure to rescue, surgical site infection, and sepsis.
Furthermore, common measures of surgical resident education, such as in-training examination scores and board certification pass rates, were unchanged after the implementation of the 2011 duty hour reform when compared to scores prior to the reform.
MedicalResearch.com Interview with:
Cheryl K. Walker, MD
Associate Professor
Department of Obstetrics & Gynecology
Faculty, The MIND Institute
School of Medicine, University of California, Davis
Medical Research: What is the background for this study? What are the main findings?
Dr. Walker: Autism spectrum disorder (ASD) is a neurobehavioral condition identified in 1 in 68 U.S. children and is part of a broader group of developmental disabilities that affects 1 in 6 children. Growing evidence suggests that Autism spectrum disorder and developmental delay originate during fetal life. Preeclampsia is a complicated and frequently dangerous pregnancy condition that appears to arise from a shallow placental connection and may increase the risk of abnormal neurodevelopment through several pathways.
Medical Research: What are the main findings?
Dr. Walker: Children with Autism spectrum disorder were more than twice as likely to have been exposed to preeclampsia compared with children with typical development. Risk for ASD was increased further in children born to mothers with more severe presentations of preeclampsia. Mothers of children with developmental delay were more than 5 times more likely to have had severe forms preeclampsia – often with evidence of reduced placental function – compared with mothers of children with typical development.
MedicalResearch.com Interview with:
Dr. Amit Navin Vora MD, MPH
Third Year Cardiovascular Fellow
John Hopkins University
Medical Research: What is the background for this study? What are the main findings?
Response: Current guidelines recommend timely reperfusion in patients presenting with ST-elevation myocardial infarction, with primary PCI being the preferred method if delivered in an expedient fashion. Otherwise, guidelines recommend that eligible patients should be treated with fibrinolysis prior to transfer to a PCI capable hospital. In our study, we used Google Maps to estimate drive times between the initial presenting hospital and the PCI-capable hospital looked at the association between estimated drive time and reperfusion strategy (primary PCI or fibrinolysis) selection.
We found that less than half of eligible patients with an estimated drive time of more than 30 minutes received primary PCI in time, and only half of patients with more than an hour’s drive received lytics before transfer. This suggests that neither primary PCI nor pre-transfer fibrinolytic therapy is being used optimally. Among eligible patients with a drive time of 30-120 minutes, we found no significant mortality difference but higher bleeding risk among patients receiving lytics prior to transfer; this increased bleeding risk was focused in patients that required rescue PCI.
MedicalResearch.com Interview with:
Dr. Julia Lewis, MD, Lead Investigator
Nephrologist and Professor of Medicine
Vanderbilt University Medical Center
Medical Research: What is the background for this study? What are the main findings?
Dr. Lewis: The 48-week Open Label Extension (OLE) study for Auryxia™ (ferric citrate) was conducted to determine long term safety following the Phase 3 52-week active-control period. The study also evaluated changes in serum phosphorus, transferrin saturation (TSAT), serum ferritin, hemoglobin, hematocrit and additional parameters, as well as intravenous (IV) iron and erythropoiesis-stimulating agent (ESA) usage.
In the OLE study, Auryxia demonstrated long-term safety in dialysis-dependent chronic kidney disease (CKD) patients. The results were consistent with those seen in the published pivotal Phase 3 trial.
The study demonstrated that the adverse events (AE’s) profile of Auryxia was similar to that seen in the Phase 3 52-week active-control period. AEs occurred in 142 patients treated with Auryxia. They were primarily non-serious gastrointestinal (GI) - related AE’s, including diarrhea, nausea, vomiting and constipation. Serious adverse events occurred in 75 patients, though none were related to Auryxia. In addition, there were no clinically or statistically significant differences in liver enzymes or aluminum levels observed from baseline to the end of the 48 weeks.
Similar to the original trial, we witnessed excellent phosphorus control with the drug, along with an increase and then a plateau in serum ferritin and TSAT levels with Auryxia. The plateauing of serum ferritin and TSAT further supports iron absorption is highly regulated by the gastrointestinal track as seen in the 52-week active control period. This suggests that the body absorbs iron as needed for effective erythropoiesis.
Additionally, iron store increases from ferric citrate resulted in, by the end of the extension study, 85% of subjects not using any IV iron.
We presented this data at the 2014 American Society of Nephrology Meeting. The abstract can be found online at www.asn-online.org.
MedicalResearch.com Interview with:
Barbara J. Drew, RN, PhD, FAAN, FAHA
David Mortara Distinguished Professor in Physiological Nursing Research, Clinical Professor of Medicine, Cardiology
University of California, San Francisco (UCSF)
Department of Physiological Nursing San Francisco
MedicalResearch.com Interview with:
Immaculata De Vivo PhD
Associate Professor Harvard Medical School
Director, Dana Farber/Harvard Cancer Center High Throughput Genotyping Core
Facility. Channing Division of Network Medicine
Boston, MA 02115
MedicalResearch: What is the background for this study? What are the main findings?
Dr. De Vivo: Our study found that greater adherence to the Mediterranean diet is associated with longer telomeres. Following a diet closer to the Mediterranean diet, can prevent accelerated telomere shortening. Our unique contribution to the literature is that we provide a potential molecular mechanism, preventing telomere shortening. Telomeres are bits of DNA that protect your chromosomes.
MedicalResearch: Is telomere shortening reversible?
Dr. De Vivo: Telomere shortening is a biological process, the shorten with age.
However, lifestyle choices can help to prevent accelerated shortening.
Fruits, vegetables, olive oil and nuts – key components of the Mediterranean diet have well known antioxidant and anti-inflammatory effects that could balance out the “bad effects” of smoking and obesity.
Silvana Papagerakis M.S., M.D., Ph.D.
Research Assistant Professor, Department of Otolaryngology-Head and Neck Surgery
Director, Oral, Head and Neck Cancer Invasion and Metastasis Laboratory, Ann Arbor MI
MedicalResearch: What is the background for this study? What are the main findings?
Dr. Papagerakis: We had suspicions that these medications somehow had a favorable impact on patient outcomes. This led us to review our large cohort of patients and screen them for common medications, focusing on antacids. In fact, our study did show that people taking antacids are doing better. What this study makes clear is that these medications may be more beneficial to the patients than just controlling side effects of chemotherapy or radiation treatment for head and neck cancer.
MedicalResearch.com Interview with:
Elissa R. Price, MD
Assistant Professor of Clinical Radiology
Director of Clinical Operations, Breast Imaging
Breast Imaging Fellowship Program Director
Department of Radiology and Biomedical Imaging
University of California, San Francisco San Francisco, CA 94115
MedicalResearch: What is the background for this study? What are the main findings?
Dr. Price: Screening mammography recommendations for the 40 - 49 age group is very controversial. 2009 USPTF guidelines emphasized taking patient context into account when making decisions for these young women. Recent publications have suggested risk-based screening strategies. Family history and breast density are important are easily accessible risk factors.
Had we been using this risk-based approach to screening mammography at our institution, we would have missed more than 3Ž4 of the screen detected breast cancers in the 40-49 age group, thereby foregoing most of the survival benefit from screening mammography.
Medicalresearch.com with:
Daniel Safer MD
Department of Psychiatry
Johns Hopkins University School of Medicine
Baltimore, Maryland
Medical Research: What is the nature of this study?
Dr. Safer: A large national sample of annual physician office-based visits by youth (aged 2-19) covering 12 years (1999-2010), focusing on trends in psychiatric DSM-IV diagnoses, with psychiatric diagnostic data analyzed proportionally comparing diagnoses that were subthreshold (not otherwise specified) with those that met full diagnostic criteria.
Medicalresearch.com with:
Frank B. Hu, MD, PhD
Professor of Nutrition and Epidemiology
Harvard School of Public Health
Professor of Medicine Harvard Medical School
Boston, MA 02115
Medical Research: What is the background for this study?
Dr. Hu: Type 2 diabetes (T2D) affects approximately 26 million people in the United States and 366 million people worldwide, and thus primary prevention of T2D has become a public health imperative. The relation between consumption of different types of dairy and risk of type 2 diabetes remains uncertain.
MedicalResearch.com Interview with:
Dr. John K. DiBaise MD
Gastroenterology and Hepatology
Mayo Clinic, Scottsdale Arizona
Medical Research: What is the background for this study? What are the main findings?
Dr. DiBaise: Despite nearly 25 years of safe and effective use of proton pump inhibitors (PPI), in recent years there have been an increasing number of reports suggesting potentially harmful effects and harmful associations with their use. One such association with PPI use has been Clostridium difficile infection (CDI) which can cause severe and recurrent episodes of diarrhea. Previous reports evaluating the microbes present within the gastrointestinal tract (ie, gut microbiome) of individuals with CDI have shown a reduction in overall microbial community diversity. We studied the gut microbiome in healthy individuals both before and after using a proton pump inhibitors for one month and found a similar reduction in microbial diversity while taking the PPI that did not entirely revert back to the ‘normal’ baseline after being off the medication for a month. While this does not demonstrate a causal association between proton pump inhibitors use and CDI, it demonstrates that PPI use creates a situation in the gut microbial environment that may increase the individual’s susceptibility to CDI.
MedicalResearch.com Interview with:
Dr. Jennifer Marin MD MSc
Director of Emergency Ultrasound
Division of Pediatric Emergency Medicine
Assistant Professor of Pediatrics and Emergency Medicine
University of Pittsburgh School of Medicine
Medical Research: What is the background for this study? What are the main findings?
Dr. Marin: Overuse of diagnostic imaging in the emergency department has become a focus of concern from policy makers, patients, and physicians. There are evidence-based clinical decision rules and policy recommendations published in order to optimize the use of such imaging. However, physicians don't necessarily use these tools in their decision-making. Head computed tomography (CT) imaging for patients with minor head trauma is a common CT performed in the emergency setting. Our study sought to evaluate how often physicians adhered to the American College of Emergency Physicians (ACEP) Clinical Policy on Neuroimaging. The policy outlines which patients warrant a CT in the setting of minor head trauma based on certain factors, such as age, mechanism of injury, and signs and symptoms of head trauma. What we found is that when the policy recommends that a head CT be performed, it is obtained more than 90% of the time. However, when a head CT is not recommended, it is actually obtained in nearly half of those patients. We hope this will draw attention to decision rules and clinical policies, such as that from ACEP, and remind physicians that using these tools can assist in appropriate imaging practices.
MedicalResearch.com Interview with:
Stephen D. Ginsberg, Ph.D., Associate Professor
Departments of Psychiatry and Physiology & Neuroscience
New York University Langone Medical Center
Center for Dementia Research
Nathan Kline Institute Orangeburg, NY 10962
Medical Research: What is the background for this study? What are the main findings?
Dr. Ginsberg: We tested the hypothesis that long-term calorie restriction positively alters gene expression within the hippocampus, a critical learning and memory area vulnerable in aging and Alzheimer’s disease. To test this hypothesis, we conducted experiments on female mice that were given food pellets 30% lower in calories than what was fed to the control group. The mice ate fewer calories derived from carbohydrates. Analyses were performed on mice in middle and old age to assess any differences in gene expression over time. Our data analysis revealed that the mice that were fed a lower calorie diet had fewer changes in approximately 900 genes that are linked to aging and memory.
MedicalResearch.com Interview with:
Michele D. Levine Ph.D.
Associate Professor of Psychiatry and Psychology
Western Psychiatric Institute and Clinic
Department of Statistics, University of Pittsburgh, Pittsburgh PA
Medical Research: What is the background for this study? What are the main findings?
Dr. Levine: Many women quit smoking as a result of pregnancy. However, psychiatric disorders, which are prevalent among smokers can contribute to weight gain. Thus, we sought to examine the relationship between maternal psychiatric disorders and gestational weight gain in a sample of pregnant former smokers. Results from the present study demonstrate that the rates of psychiatric disorders were high among pregnant former smokers and that more than half of women gained more weight than recommended by the IOM. Although a history of having had any psychiatric disorder was not associated with gestational weight gain, a history of alcohol use disorder specifically was positively related to gestational weight gain.
MedicalResearch.com Interview with:
Dr. Grace Hsiao-Wei Lo
Baylor College of Medicine
Assistant Professor, Section of Immunology, Allergy and Rheumatology, Department of Medicine, Baylor College of Medicine
Faculty, Immunology, Allergy, and Rheumatology Section,
Michael E. DeBakey VA Medical Center
Medical Research:What is the background for this study? What are the main findings?
Dr. Hsiao-Wei Lo: Controversy exists regarding whether running is harmful versus beneficial to the knee. There is concern that chronic repetitive loading of the knee could physically damage structures within the knee. Alternatively, runners have a lower body mass index, which we know is protective of knee osteoarthritis. Limitations of prior studies evaluating the relationship between running and osteoarthritis include that they have been small studies and they have focused on those participating in a high level or an elite level of running which may not be very generalizable. Addressing the question of whether running is associated with osteoarthritis is of particular relevance given that recent CDC guidelines recommend that all adults participate in regular physical activity, as there is definitive evidence that increased physical activity is associated with reduced cardiovascular events and mortality.
To address this question, we used data from a multicenter observational study, the Osteoarthritis Initiative (OAI). Of 2,683 participants, 56 percent were female, the mean age was 64.5 and the mean BMI was 28.6. Twenty-nine percent of the participants reported that they ran at some time in their lives.
Patients had knee X-rays, were given symptom assessments, and were asked to complete the Lifetime Physical Activity Questionnaire (LPAQ), identifying the top three most frequently performed physical activities (≥ 10 times in life) they performed at different age ranges throughout their life. Age ranges included 12-18, 19-34, 35-49, and 50 years or older.
Knee X-rays were taken and then scored for evidence of radiographic OA using the Kellgren-Lawrence (KL) grade scale. Participants with KL grades of two or higher were considered as having radiographic OA (ROA). The researchers also measured if participants had frequent knee pain. Researchers considered a participant to have symptomatic OA (SOA) if they had at least one knee with both ROA and frequent knee pain. Anyone with a total knee replacement was classified as having frequent knee pain, ROA and SOA.
After collecting all the data, the researchers reported that runners, regardless of the age when they ran, had a lower prevalence of knee pain, ROA and SOA than non-runners. For people who had run at any time in their lives, 22.8 percent had SOA compared to 29.8 percent of non-runners. People with the lowest BMI scores were the most likely to report being habitual runners. Regular running, even at a non-elite level, not only does not increase the risk of developing knee osteoarthritis but may protect against it, the researchers concluded.
MedicalResearch.com Interview with:
Weian Zhao PhD
Assistant Professor at the Sue and Bill Gross Stem Cell Research Center, Chao Family Comprehensive Cancer Center, Department of Biomedical Engineering, Edwards Lifesciences Center for Advanced Cardiovascular Technology and Department of Pharmaceutical Sciences at University of California, Irvine.
Medical Research: What is the background for this study?
Dr. Zhao: Bloodstream infections are a major cause of illness and death. In particular, infections associated with antimicrobial-resistant pathogens are a growing health problem in the U.S. and worldwide. According to the Centers for Disease Control & Prevention, more than 2 million people a year globally get antibiotic-resistant blood infections, with about 23,000 deaths. The extremely high mortality rate for blood infections is due, in part, to the inability to rapidly diagnose and treat patients in the early stages. The present gold standard to detect a blood infections, is a blood culture and it takes 2-5 days for the detection and the identification of the bacteria. Recent molecular diagnosis methods, including polymerase chain reaction, can reduce the assay time to hours but are often not sensitive enough to detect bacteria that occur at low concentrations in blood, as is common in patients with blood infections. Therefore, less expensive and less technically demanding methods are urgently needed for the rapid and sensitive identification of blood infections.