Author Interviews, NYU/NYMC, Surgical Research / 12.12.2014
MedicalResearch.com Interview with:
Ganesh Sivarajan, MD
Department of Urology
New York University Langone Medical Center
MedicalResearch.com Interview with:
Karen Dorman Marek, PhD, MBA, RN, FAAN
Bernita 'B' Steffl Professor of Geriatric Nursing
Arizona State University
College of Nursing & Health Innovation
Phoenix, AZ 85004-0696
Medical Research: What is the background for this study? What are the main findings?
Response: For many older adults, self-management of chronic illness is an overwhelming task, especially for those with mild cognitive impairment or complex medication regimens. The purpose of this study was to evaluate cost outcomes of a home-based program that included both nurse care coordination and technology to support self-management of chronic illness, with as an emphasis on medications in frail older adults. A total of 414 older adults, identified as having difficulty self-managing their medications, were recruited at discharge from three Medicare-certified home health care agencies in a large Midwestern urban area. A prospective, randomized, controlled, three-arm, longitudinal design was used. A team consisting of both Advanced Practice Nurses (APNs) and Registered Nurses (RNs) coordinated care to two groups: home-based nurse care coordination (NCC) plus mediplanner group and NCC plus the MD.2 medication-dispensing machine group. Major findings were:
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:
Tina J Hieken, MD
Department of Surgery Associate Professor of Surgery
Mayo Clinic College of Medicine
Rochester, MN 55905
MedicalResearch.com: What is the background for this study?
Dr. Hieken: Many newly diagnosed breast cancer patients undergo breast MRI; Breast MRI includes a component of axillary imaging. However, there is limited data on MRI staging of axilla.
MedicalResearch.com Interview with:
Anders Nissen Bonde MBs
Department of Cardiology
Copenhagen University Hospital Gentofte,
Gentofte, Denmark
Medical Research: What is the background for this study? What are the main findings?
Response: Patients with severe chronic kidney disease have been excluded from
randomized trials of antithrombotic therapy in atrial fibrillation.They
represent a very fragile group as they are both at increased risk of
stroke/thromboembolism and major bleedings, and previous observational
studies have had conflicting conclusions regarding the safety and benefits
of the treatment. A previous study from our department reported both
increased risk of bleeding and reduced risk of stroke with warfarin.
We wanted to assess the net clinical benefit of aspirin and warfarin in
these patients, balancing stroke and major bleeding associated with the
treatment.
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:
Lisa Diamond, MD, MPH, FACP | Assistant Attending
Memorial Sloan-Kettering Cancer Center
Immigrant Health and Cancer Disparities Service
Department of Psychiatry & Behavioral Sciences | Department of Medicine Evelyn Lauder Breast Center New York, NY 10065
Medical Research: What is the background for this study? What are the main findings?
Dr. Diamond: More than 25 million U.S. residents have limited English proficiency, an 80 percent increase from 1990 to 2010. Limited English proficiency (LEP) may impede participation in the English language-dominant health care system. Little is known about the non-English-language skills of physicians in training. In our analysis of the non-English-language skills of applicants to residency programs in the U.S., we found that although applicants are linguistically diverse, most of their languages do not match the languages spoken by the U.S. population with Limited English proficiency.
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:
Brian L. Sprague, PhD
Office of Health Promotion Research,
University of Vermont, Burlington, VT
MedicalResearch: What is the background for this study?
Dr. Sprague: Mammographic breast density refers to the appearance of breast tissue on a mammogram. High breast density means that there is a greater amount of glandular tissue and connective tissue, which appears white on a mammogram. It is more difficult to detect breast cancer on a mammogram when there is greater breast density. It has also been shown that women with dense breasts are at a higher risk of developing breast cancer. Because of these two factors, women with dense breasts have a greater chance of developing breast cancer after a normal screening mammogram than women whose breasts are not dense. Many states have now passed laws that require mammography facilities to inform women with dense breasts so that they are aware of this. Similar legislation is now under consideration at the national level. More than 40% of women undergoing mammography screening have dense breasts.
Researchers are trying to determine whether supplemental breast cancer screening with other tools would improve outcomes for women with dense breasts. One possible approach is to use ultrasound imaging to screen for breast cancer in women with dense breasts after they have had a normal mammogram. We wanted to estimate the benefits, harms, and cost-effectiveness of this approach compared to mammography screening only. No randomized trials or observational studies have assessed long term outcomes after ultrasound screening for women with dense breasts, but we have short term data on how often cancer is diagnosed by ultrasound screening and how often false positive exams occur. We used computer simulation modeling to estimate long term outcomes by combining the currently available data on mammography and ultrasound screening with the best available data on breast cancer risk and survival.
MedicalResearch.com Interview with:
Sandra Barral Rodriguez, Ph.D
Assistant Professor
G. H. Sergievsky Center & Taub Institute
Columbia University Medical Center
New York, NY 10032
Medical Research: What is the background for this study? What are the main findings?
Dr. Barral: We already know that there is a substantial genetic contribution to the variability observed in different cognitive tasks including memory performance. Previous work reported heritability estimates for episodic memory ranging between 30% and 60%. However, we can’t fully explain why some individuals demonstrate a better memory performance in late life, while others do not.
We have previously defined a cognitive endophenotype based on exceptional episodic memory performance (EEM) and demonstrated that there is a familial aggregation of EEM in families selected on their basis of their exceptional survival, the Long Life Family Study. We performed genome-wide linkage analysis of long-lived families selected on the basis of their exceptional episodic memory and the follow-up SNP association analysis with episodic memory in four independent cohorts of more than 4,000 non-demented elderly cohorts.
Our results provide strong evidence for potential candidate genes related to exceptional episodic memory on 6q24.
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:
Catherine A. Marco, MD, FACEP Professor
Department of Emergency Medicine
Wright State University
Kettering, OH 45429
Medical Research: What is the background for this study? What are the main findings?
Dr. Marco: In 2003, the Accreditation Council for Graduate Medical Education (ACGME) implemented standards on duty hours and supervision. A maximum of 80 hours of duty per week were stipulated. The aim of these standards was to promote resident learning and patient safety. However, evidence has not clearly demonstrated whether the 2003 requirements improved trainee well-being or patient safety. On July 1, 2011, the ACGME implemented additional regulations on duty hours and supervision, including a 16 hour maximum shift length for PGY1 residents. The duty hours standards were implemented to ensure patient safety and provide an excellent teaching environment. Emergency Medicine has additional duty hours requirements for emergency department rotations, including a maximum of 12 continuous scheduled hours, and a maximum 60 scheduled hours per week seeing patients in the emergency department, and no more than 72 duty hours per week.
We found that among a large cohort of 4134 Emergency Medicine residents, the majority of residents stated that they are working the appropriate number of hours to practice independently at graduation. The majority of residents believe that current duty hours regulations improve patient safety. The majority of residents agreed that duty hour regulations are currently appropriate.
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:
Simin Liu, MD, ScD, Professor of Epidemiology
School of Public Health, Professor of Medicine
The Warren Alpert School of Medicine
Director, Molecular Epidemiology and Nutrition
Brown University
MedicalResearch: What is the background for this study? What are the main findings?
Dr. Liu: Cardiovascular Disease (CVD) and type 2 diabetes (T2D) are highly heritable and share many risk factors and show ethnic-specific prevalence. Nevertheless, a comprehensive molecular-level understanding of these observations is lacking. We conducted a comprehensive assessment of whole genome assessment using network-based analysis in >15,000 women and identified eight molecular pathways share in both diseases as well as several “key driver” genes that appear to form the gene networks in which these pathways connect and interact.
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 FranciscoMedicalResearch.comInterview with: Amro Qaddoura BHSc Research Student of Adrian Baranchuk, MD Department of Medicine, Queen's University, Kingston, Ontario, Canada MedicalResearch: What is the...
MedicalResearch.com Interview with:
Marcus Munafò PhD
Professor of Biological Psychology
MRC Integrative Epidemiology Unit
UK Centre for Tobacco and Alcohol Studies
School of Experimental Psychology
University of Bristol United Kingdom
Medical Research: What is the background for this study? What are the main findings?
Dr. Munafo: We were conducting an analysis of data on smoking behaviour and body mass index (BMI), in order to better understand the potential causal effects of smoking on different measures of adiposity. Mendelian randomisation uses genetic variants associated with the exposure of interest (in this case smoking) as proxies for the exposure, in order to reduce the risk of spurious associations arising from confounding or reverse causality. As expected, we found that, among current smokers, a genetic variant associated with heavier smoking was associated with lower BMI, providing good evidence that smoking reduces BMI. However, we also unexpectedly found that the same variant was associated with higher BMI in never smokers. This suggests that this variant might be influencing BMI via pathways other than smoking.
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.