Author Interviews, Beth Israel Deaconess, Cognitive Issues, Diabetes, Neurology / 11.07.2015

Vera Novak, MD PhD Associate Professor of Neurology Dept. of Neurology, Stroke Division Director Syncope and Falls in the Elderly Laboratory Beth Israel Deaconess Medical Center Boston, MAMedicalResearch.com Interview with: Vera Novak, MD PhD Associate Professor of Neurology Dept. of Neurology, Stroke Division Director Syncope and Falls in the Elderly Laboratory Beth Israel Deaconess Medical Center Boston, MA MedicalResearch: What is the background for this study? Dr. Novak: Diabetes mellitus (DM) is a major contributor to morbidity and mortality. Type 2 diabetes mellitus affects more than 44 million people in the U.S., and its numbers are growing rapidly, affecting up to 27% of older adults. Diabetes mellitus accelerates brain aging by about 5 years1, manifests as a widespread generalized atrophy2, and promotes earlier onset of vascular dementia and Alzheimer’s disease (AD).3,4 Diabetes mellitus -related atrophy manifests as worse cognitive function, memory, and gait, especially during a dual task, 5,6 and even a tight glycemic control did not improve cognitive function in participants of the large clinical trials 7. MedicalResearch: What are the main findings? Dr. Novak: Sixty-five participants (aged 66± 9.2 years) 35 with T2DM and 30 non-diabetic controls participated in this study. After 2 years of follow-up, participants with T2 Diabetes mellitus had diminished vascular reactivity in the brain (an ability to increase blood flow in responses to a task or metabolic demands) and performed worse on multiple cognitive tasks (in particular verbal learning and memory). In T2DM group, lower cerebral vasoreactivity correlated with worse performance on daily living activities. Specifically, the lower vasodilatation (ability to increase blood flow) was associated with worse mental functions. In addition, those with higher markers of inflammation had greater decline in vascular function in the brain. (more…)
Author Interviews, Heart Disease, Psychological Science, Sexual Health, University Texas / 11.07.2015

Amelia Stanton, Graduate Student Department of Psychology The University of Texas at Austin Austin, TXMedicalResearch.com Interview with: Amelia Stanton, Graduate Student Department of Psychology The University of Texas at Austin Austin, TX Medical Research: What is the background for this study? What are the main findings? Response: Heart rate variability (HRV) has emerged as a valuable non-invasive test to assess autonomic nervous system (ANS) activity. Several studies have linked low resting Heart rate variability to mental health conditions including depression, anxiety, and alcohol dependence, indicating these disorders may be related to an imbalance in autonomic activity. As Heart rate variability is an index of the balance of sympathetic nervous system (SNS) and parasympathetic nervous system activity (PNS), it has proven a useful tool for examining the relative role of SNS activity in female sexual arousal. Moderate SNS dominance (relative to PNS activity) has been shown to predict women’s genital arousal in the laboratory, while high levels of SNS activation have been shown to inhibit genital arousal. Based on this background evidence and on a growing clinical literature indicating that low HRV (generally indicative of high SNS) is associated with negative health outcomes, we predicted a positive linear relationship between Heart rate variability and sexual arousal function. That is, we predicted that women with autonomic balance indicating moderate or low resting SNS activity (relative to PNS activity) would be less likely than women with autonomic balance indicating high resting SNS to report clinically relevant sexual arousal dysfunction. We also predicted that this relationship would hold for overall sexual function. To test this hypothesis, sexual arousal function, overall sexual function, and resting HRV were assessed in 72 women, aged 18-39. The main finding of the study is that women with below average Heart rate variability were significantly more likely to report sexual arousal dysfunction (p < .001) and overall sexual dysfunction (p < .001) than both women with average HRV and women with above average HRV. Based on these results, we concluded that low HRV may be a risk factor for female sexual arousal dysfunction and overall sexual dysfunction. (more…)
Author Interviews, Colon Cancer, Duke, Weight Research / 10.07.2015

S. Yousuf Zafar, MD, MHS Associate Professor of Medicine Duke Cancer Institute Duke Clinical Research InstituteMedicalResearch.com Interview with: S. Yousuf Zafar, MD, MHS Associate Professor of Medicine Duke Cancer Institute Duke Clinical Research Institute Medical Research: What is the background for this study? What are the main findings? Dr. Zafar: Multiple studies have suggested that obesity and colorectal cancer are related. For instance, obesity has been linked with an increased incidence of colon cancer. Obesity has also been associated with a greater risk of colon cancer recurrence. To date, no study has looked at the role of obesity in outcomes for patients with metastatic colorectal cancer. In our study of over 6000 patients receiving treatment for metastatic olcolorectal cancer, we found that patients with the lowest body mass index (BMI) were at greatest risk for worse survival. This does not mean that obesity is good. More likely, it means that those who are very underweight are least able to tolerate the best treatment, or being very underweight is a biologic marker of poor prognosis. (more…)
Author Interviews, Blood Pressure - Hypertension, NYU, Pediatrics, Toxin Research / 10.07.2015

MedicalResearch.com Interview with: Teresa M. Attina, MD, PhD, MPH and Leonardo Trasande, MD, MPP Department of Pediatrics NYU Langone Medical Center Medical Research: What is the background for this study? Response: Phthalates are environmental chemicals widely used in consumer and personal care products, and often found in plastic to increase flexibility. Di-2-ethylhexylphthalate (DEHP) is of particular interest because industrial processes to produce food frequently use plastic products containing DEHP. Because recognition of potential health risks related to DEHP exposure has increased, DEHP is being replaced by di-isononyl phthalate (DINP) and di-isodecyl phthalate (DIDP), two phthalates with similar chemical properties. Specifically, DINP is used in plastic products for food packaging, and DIDP is used in furnishings, cookware, medications, and several other consumer products. These alternatives have not been substantially studied for toxicity in laboratory studies because these studies are not required for regulatory approval: unlike the EU, in the US the current regulatory framework assumes that chemicals are safe until proven toxic. Medical Research: What are the main findings? Response: We examined DINP and DIDP levels in urine samples from children and adolescents (6 to 19 years old) who participated in the National Health and Nutrition Examination Survey between 2009 and 2012, to assess if these levels were associated with blood pressure measurements. Diet, physical activity, gender, race/ethnicity, income, and other factors that can contribute to increased blood pressure were also included in the analysis. A significant association was found between high blood pressure and DINP/DIDP levels in study participants. This is not a cause-and-effect relationship but it suggests that phthalates may contribute to increased blood pressure. (more…)
Author Interviews, Cost of Health Care, OBGYNE, Yale / 10.07.2015

Xiao Xu, Ph.D. Assistant Professor Department of Obstetrics, Gynecology & Reproductive Sciences Yale School of MedicineMedicalResearch.com Interview with: Xiao Xu, Ph.D. Assistant Professor Department of Obstetrics, Gynecology & Reproductive Sciences Yale School of Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Xiao Xu: While research has shown hospital variation in costs of care for other conditions, we know little about whether and how hospitals differ in costs of childbirth related care. With nearly 4 million births each year, childbirth is the most common reason for hospital admission in the U.S. Understanding the pattern and causes of variation in resource utilization during childbirth among hospitals can help inform strategies to reduce costs. Our study used data from 463 hospitals across the country and analyzed hospital costs of maternity care for low-risk births. We found that hospital varied widely in average facility costs per maternity stay. (more…)
Author Interviews, Mayo Clinic, Opiods, Tobacco Research / 10.07.2015

W. Michael Hooten, M.D Professor of Anesthesiology Mayo ClinicMedicalResearch.com Interview with: W. Michael Hooten, M.D Professor of Anesthesiology Mayo Clinic Medical Research: What is the background for this study? Dr. Hooten: The purpose of the study was to investigate a gap in knowledge related to the progression of short-term opioid use to longer-term use. Medical Research: What are the main findings? Dr. Hooten: The main findings are that a history of substance abuse or tobacco use is associated with the progression from short-term to a longer-term pattern of opioid prescribing. (more…)
Author Interviews, Cancer Research, End of Life Care, JAMA, Johns Hopkins / 10.07.2015

Amol Narang MD Radiation Oncology Resident Johns Hopkins MedicineMedicalResearch.com Interview with: Amol Narang MD Radiation Oncology Resident Johns Hopkins Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Narang: The care provided to cancer patients at end-of-life can be intense, including frequent ER visit, hospitalizations, and ICU stays in the last month of life, administration of chemotherapy in last two weeks of life, and late referrals to hospice. Providing high-intensity treatments at end-of-life has been associated with reduced patient quality-of-life and increased caregiver bereavement. Advance care planning represents an opportunity for patients to indicate their preferences for end-of-life care to try to ensure that the care that they receive at end-of-life is consistent with their values, and has been endorsed by oncologic professional societies, such as ASCO and the NCCN. As such, we wanted to assess if oncologists’ long-standing recognition of the merits of advance care planning has translated into increased participation in advance care planning by cancer patients, and to determine which forms of advance care planning are associated with intensity of care given at end-of-life. From 2000-12, we found that the only type of advance care planning that increased was the assignment of a power of attorney (52% in 2000 to 74% in 2012). However, having a power of attorney was not associated with receiving less aggressive end-of-life care. On the other hand, having a living wills and engaging in a discussion with a provider or loved one about preferences for end-of-life care were both associated with reduced treatment intensity. However, the frequency with which cancer patients created a living or discussed their preferences for end-of-life care did not increase over the study period; importantly, 40% of patients dying of cancer never communicated their preferences for care at end-of-life with anyone. (more…)
Author Interviews, Education, Johns Hopkins, Outcomes & Safety, Surgical Research / 08.07.2015

Judy Huang, M.D. Professor of Neurosurgery Program Director, Neurosurgery Residency Program Fellowship Director, Cerebrovascular Neurosurgery Johns Hopkins HospitalMedicalResearch.com Interview with: Judy Huang, M.D. Professor of Neurosurgery Program Director, Neurosurgery Residency Program Fellowship Director, Cerebrovascular Neurosurgery Johns Hopkins Hospital Medical Research: What is the background for this study? What are the main findings? Dr. Huang: Residents are medical school graduates who are in training programs working alongside and under supervision of more senior physicians, known as attendings. Patients are sometimes wary of having residents assist in their operations, but an analysis of 16,098 brain and spine surgeries performed across the United States finds that resident participation does not raise patient risks for postoperative complications or death. (more…)
AHA Journals, Author Interviews, Connective Tissue Disease, Heart Disease, NYU / 08.07.2015

Mohamed Boutjdir, PhD, FAHADirector of the Cardiovascular Research Program VA New York Harbor Healthcare System Professor, Depts of Medicine, Cell Biology and Pharmacology, State University of New York Downstate Medical Center and NYU School of Medicine, New York, NYMedicalResearch.com Interview with: Mohamed Boutjdir, PhD, FAHA Director of the Cardiovascular Research Program VA New York Harbor Healthcare System Professor, Depts of Medicine, Cell Biology and Pharmacology, State University of New York Downstate Medical Center and NYU School of Medicine, New York, NY Medical Research: What is the background for this study? What are the main findings? Dr. Boutjdir: Patients with autoimmune diseases including Sjogren’s syndrome, systemic lupus erythematosus and other connective tissue diseases who are seropositive for anti-SSA/Ro antibodies may present with corrected QTc prolongation on the surface ECG. This QTc prolongation can be arrhythmogenic and lead to Torsades de Pointes fatal arrhythmia. In our study, we established for the first time an animal model for this autoimmune associated QTc prolongation that is reminiscent of the clinical long QT2 syndrome. We also demonstrated the functional and molecular mechanisms by which the presence of the anti-SSA/Ro antibodies causes QTc prolongation by a direct cross-reactivity and then block of the hERG channel (Human ether-a-go-go-related gene). This hERG channel is responsible for cardiac repolarization and its inhibition causes QTc prolongation. We were able to pinpoint to the target epitope at the extracellular pore forming loop between segment 5 and segment 6 of the hERG channel. (more…)
Author Interviews, Brigham & Women's - Harvard, Heart Disease, JACC, Lifestyle & Health / 08.07.2015

Liana C. Del Gobbo, PhDPostdoctoral Research Fellow Friedman School of Nutrition Science & Policy Tufts University Boston MAMedicalResearch.com Interview with: Liana C. Del Gobbo, PhD Postdoctoral Research Fellow Friedman School of Nutrition Science & Policy Tufts University Boston MA Medical Research: What is the background for this study? What are the main findings? Dr. Del Gobbo: Heart failure most commonly develops in adults over 65 years old- the most rapidly growing portion of the US population. The condition greatly reduces the quality of life of older adults. Heart failure is the leading cause of hospitalizations in the US among those on Medicare, and is associated with large  health care costs. Prevention is key for reducing the burden of this disease. A detailed analysis of factors that might help prevent heart failure, such as a person's pattern of eating (as well as individual foods), in addition to other lifestyle factors (eg. smoking, physical activity, etc), had not been previously examined all together, in the same study. To get a fuller picture of how to prevent this condition, this study examined the relative importance of dietary habits and other lifestyle factors for development of heart failure. Our paper shows that older adults can cut their risk in half by adhering to a few healthy lifestyle factors, including moderate physical activity, modest alcohol consumption (eg. more than one drink/week, but not more than 1-2 drinks/day), not smoking, and maintaining a healthy weight. (more…)
Author Interviews, Columbia / 03.07.2015

Prof. Patrick L Kinney Ph.D. Professor of Environmental Health Sciences and Director, Columbia Climate and Health Program Mailman School of Public Health Columbia University, New York, NYMedicalResearch.com Interview with: Prof. Patrick L Kinney Ph.D. Professor of Environmental Health Sciences and Director, Columbia Climate and Health Program Mailman School of Public Health Columbia University, New York, NY Medical Research: What is the background for this study? Dr. Kinney: Many previous assessments have concluded that climate change will lead to large reductions in winter mortality. Medical Research: What are the main findings? Dr. Kinney: We carried out analyses that contradict this conclusion.  We argue that climate change won’t have much impact one way or the other on winter mortality. (more…)
Author Interviews, Columbia, Diabetes, NEJM, Weight Research / 03.07.2015

Dr. F. Xavier Pi-Sunyer MD Division of Endocrinology and Obesity Research Center Columbia University, New YorkMedicalResearch.com Interview with: Dr. F. Xavier Pi-Sunyer MD Division of Endocrinology and Obesity Research Center Columbia University, New York Medical Research: What is the background for this study? What are the main findings? Dr. Pi-Sunye: In a large randomized trial, the drug Liraglutide was compared to placebo in overweight and obese non-diabetic volunteers. Over 52 weeks, in combination with diet and increased physical activity, Liraglutide lowered body weight by 8.4 kg as compared to 2.8 kg in placebo. 63% vs 27% lost at least 5% of baseline weight, 33% vs 10% lost more than 10% of baseline weight. (more…)
Author Interviews, Cancer Research, JNCI, NIH, OBGYNE / 02.07.2015

MedicalResearch.com Interview with: Ashley S. Felix, PhD Bethesda, MD MedicalResearch: What is the background for this study? What are the main findings? Dr. Felix: Endometrial cancer prognosis is strongly affected by disease stage, or the extent of spread from the primary site. Endometrial cancers can spread via the lymph nodes, blood vessels, through the uterine wall, or through the fallopian tube into the peritoneal cavity. The last of these mechanisms is poorly understood, but appears to be a more common mode of spread for aggressive histologic subtypes of endometrial cancer. We hypothesized that women who previously underwent tubal ligation (TL) and later developed endometrial cancer would have lower stage disease, possibly by blocking passage of tumor cells along the fallopian tubes. Further, we hypothesized that TL would be associated with better prognosis, due to its relationship with lower stage. We found that women in our study who previously had tubal ligation were more likely to have lower stage endometrial cancer compared with women who did not report a previous tubal ligation. Specifically, tubal ligation was inversely associated with stage III and stage IV cancer across all subtypes of the disease, including aggressive histologic subtypes. Further, in statistical models of tubal ligation, tumor stage, and mortality, we observed no independent association with improved survival, suggesting that tubal ligation impacts mortality mainly through its effects on stage. (more…)
Author Interviews, Heart Disease, JAMA, University of Pittsburgh, Weight Research / 02.07.2015

Anita P. Courcoulas M.D., M.P.H., F.A.C.S Professor of Surgery Director, Minimally Invasive Bariatric & General Surgery University of Pittsburgh Medical CenterMedicalResearch.com Interview with: Anita P. Courcoulas M.D., M.P.H., F.A.C.S Professor of Surgery Director, Minimally Invasive Bariatric & General Surgery University of Pittsburgh Medical Center Medical Research: What is the background for this study? Dr. Courcoulas: This study is a randomized clinical trial that was originally funded through the American Recovery and Reinvestment Act of 2009 (ARRA) as a high priority comparative effectiveness topic; the goal of which was to better understand the role of surgical versus non-surgical treatments for Type 2 diabetes mellitus (T2DM) in people with lower Body Mass Index (BMI) between 30 and 40 kg/m2. This report highlights longer-term outcomes at 3 years following random assignment to either an intensive lifestyle weight loss intervention for 1 year followed by a low-level lifestyle intervention for 2 years or surgical treatments (Roux-en-Y gastric bypass [RYGB] or laparoscopic adjustable gastric banding [LAGB]) followed by low-level lifestyle intervention in years 2 and 3. (more…)
Author Interviews, Health Care Systems, Yale / 01.07.2015

MedicaIngrid Nembhard, PhD, MS Associate Professor, Yale School of Public Health & Yale School of Management Associate Director, Health Care Management Program YalelResearch.com Interview with: Ingrid M. Nembhard PhD MS Yale University New Haven, CT Medical Research: What is the background for this study? What are the main findings? Dr. Nembhard: Many health care organizations (hospital, medical groups,  etc.) have sought to address well-documented quality problems by implementing evidence-based innovations, that is, practices, policies, or technologies that have been proven to work in other organizations. The benefits of these innovations are often not realized because adopting organizations experience implementation failure—lack of skillful and consistent use of innovations by intended users (e.g., clinicians). Past research estimates that implementation failure occurs at rates greater than 50% in health care. The past work also shows organizational factors expected to be facilitators of implementation are not always helpful. In this work, we examined a possible explanation for the mixed results: different innovation types have distinct enabling factors. Based on observation and statistical analyses, we differentiated role-changing innovations, altering what workers do, from time-changing innovations, altering when tasks are performed or for how long. We then examined our hypothesis that the degree to which access to groups that can alter organizational learning—staff, management, and external network— facilitates implementation depends on innovation type. Our longitudinal study of 517 hospitals’ implementation of evidence-based practices for treating heart attack confirmed our thesis for factors granting access to each group: improvement team’s representativeness (of affected staff), senior management engagement, and network membership. Although team representativeness and network membership were positively associated with implementing role-changing practices, senior management engagement was not. In contrast, senior management engagement was positively associated with implementing time-changing practices, whereas team representativeness was not, and network membership was not unless there was limited management engagement. (more…)
Author Interviews, Breast Cancer, Radiation Therapy, UCLA / 01.07.2015

Dr. Mitchell Kamrava MD Department of Radiation Oncology University of California Los Angeles Los Angeles, CAMedicalResearch.com Interview with: Dr. Mitchell Kamrava MD Department of Radiation Oncology University of California Los Angeles Los Angeles, CA Medical Research: What is the background for this study? What are the main findings? Dr. Kamrava: Breast conservation (lumpectomy followed by radiation) is known, based on multiple randomized trials with over 20 years of follow-up, to provided equivalent outcomes as mastectomy.  The radiation component of breast conservation has standardly been delivered to the whole breast.  Studies show that the majority of breast recurrences occur near the lumpectomy cavity causing some to ask whether it is necessary to treat the whole breast in order to reduce the risk of a recurrence. Partial breast radiation delivers treatment just to the lumpectomy cavity with a small margin of 1-2 cm.  It’s delivered in a shorter time of 1 week compared with about 6 weeks for standard whole breast radiation and 3-4 weeks for hypofractionated whole breast radiation. The original method developed to deliver partial breast radiation is interstitial tube and button brachytherapy.  This uses multiple small little tubes that are placed through the lumpectomy cavity to encompass the area at risk.  One end of these tubes can be connected to a high dose rate brachytherapy machine that allows a motorized cable with a very small radiation source welded to the end of it to be temporarily pushed in and out of each of the tubes so that the patient can be treated from “inside out”.  This helps concentrate the radiation to the area of the lumpectomy cavity while limiting exposure to normal tissues.  This treatment is most commonly delivered as an out-patient two times per day for a total of 10 treatments. The main finding from our paper is that in reviewing the outcomes on over 1,000 women treated with this technique with an average follow-up of 6.9 years that the 10 year actuarial local recurrence rate was 7.6% and in women with more than 5 years of follow-up physician reported cosmetic outcomes were excellent/good in 84% of cases. (more…)
Author Interviews, Columbia, JACC, PTSD, Women's Heart Health / 30.06.2015

Jennifer A. Sumner, Ph.D.MedicalResearch.com Interview with: Jennifer A. Sumner, Ph.D. Columbia University Mailman School of Public Health New York, NY 10032 Medical Research: What is the background for this study? What are the main findings? Dr. Sumner: Cardiovascular disease, which includes conditions like heart attack and stroke, is the leading cause of death worldwide. Stress has long been thought to increase risk of cardiovascular disease, and posttraumatic stress disorder (PTSD) is the quintessential stress-related mental disorder. Some individuals who are exposed to traumatic events, such as unwanted sexual contact, the sudden unexpected death of a loved one, and physical assault, develop PTSD, which is characterized by symptoms of re-experiencing the trauma (e.g., nightmares), avoidance of trauma reminders (e.g., avoiding thinking about the trauma), changes in how one thinks and feels (e.g., feeling emotionally numb), and increased physiological arousal and reactivity (e.g., being easily startled). PTSD is twice as common in women as in men; approximately 1 in 10 women will develop PTSD in their lifetime. Research has begun to suggest that rates of cardiovascular disease are higher in people with PTSD. However, almost all research has been done in men. My colleagues and I wanted to see whether PTSD was associated with the development of cardiovascular disease in a large sample of women from the general public. We looked at associations between PTSD symptoms and new onsets of heart attack and stroke among nearly 50,000 women in the Nurses’ Health Study II over 20 years, beginning in 1989. Women with the highest number of PTSD symptoms (those reporting 4+ symptoms on a 7-item screening questionnaire) had 60% higher rates of developing cardiovascular disease (both heart attack and stroke) compared to women who were not exposed to traumatic events. Unhealthy behaviors, including lack of exercise and obesity, and medical risk factors, including hypertension and hormone replacement use, accounted for almost 50% of the association between elevated PTSD symptoms and cardiovascular disease. We also found that trauma exposure alone (reporting no PTSD symptoms on the screening questionnaire) was associated with elevated cardiovascular disease risk compared to no trauma exposure. Our study is the first to look at trauma exposure and PTSD symptoms and new cases of cardiovascular disease in a general population sample of women. These results add to a growing body of evidence suggesting that trauma and PTSD have profound effects on physical health as well as mental health. (more…)
Author Interviews, Cleveland Clinic, JAMA, Prostate Cancer / 30.06.2015

Hui Zhu, MD, ScD Section Chief, Urology Section Louis Stokes Cleveland Veterans Affairs Medical Center and Staff, Glickman Urological and Kidney Institute, Cleveland Clinic Foundation Cleveland, Ohio MedicalResearch.com Interview with: Hui Zhu, MD, ScD Section Chief, Urology Section Louis Stokes Cleveland Veterans Affairs Medical Center and Staff, Glickman Urological and Kidney Institute, Cleveland Clinic Foundation Cleveland, Ohio MedicalResearch: Tell me a little bit about the impetus for this study. What gap in knowledge were you trying to fill?  Dr. Zhu: Prostate cancer is a very challenging disease to understand and manage. For the minority of men, prostate cancer is a lethal disease, and in fact, it is the second leading cause of cancer death in American men, behind only lung cancer. However, for the majority of men, prostate cancer poses little risk of death. In fact, about 1 man in 7 will be diagnosed with prostate cancer during his lifetime, but only 1 man in 38 will die from prostate cancer. In an effort to avoid suffering and death from prostate cancer for those men with the lethal form, the early detection of prostate cancer (before the disease has reached a stage when it is no longer curable) through widespread prostate cancer screening was instituted in the late 1980s and early 1990s. As a result, prostate cancer diagnosis increased substantially, and most prostate cancers were detected at an early, treatable stage. Screening successfully reduced the risk of death from prostate cancer by 20%. Unfortunately, our best available screening tests, i.e. prostate-specific antigen (PSA) testing and the digital rectal exam, do not differentiate well between lethal and nonlethal prostate cancer. Consequently, screening is associated with a high risk of overdiagnosis of nonlethal prostate cancer. As a result, about 800 men must be screened and about 30 men must be diagnosed and treated to avoid one death from the prostate cancer, according to recent results from the largest prostate cancer screening trial. Since the natural history of newly diagnosed screen-detected prostate cancer is difficult to predict (i.e. lethal or nonlethal), most prostate cancers have been treated aggressively, leading to overtreatment of many nonlethal cancers. Aside from receiving unnecessary treatment, these men are exposed to the potential side effects and complications of treatment, including erectile dysfunction and urinary incontinence. In response to the harms associated with screening and treatment, the US Preventative Services Task Force issued a statement in 2011 (formalized in 2012) recommending against prostate cancer screening in all men. Unfortunately, while minimizing the risks of overdiagnosis and overtreatment for men with nonlethal prostate cancer, this solution eliminates any of the potential benefits of screening for those men with the lethal form of the disease. As urologists, our solution is different. Rather than throw the baby out with the bathwater, we prefer to preserve PSA screening and its benefits by addressing and hopefully minimizing its associated risks. To achieve this, our goal is to better distinguish between those men who have lethal vs. nonlethal prostate cancer, limiting treatment only to those men who have the lethal form of the disease at an early stage when it is still curable. The dilemma is that our currently available diagnostic tests are unable to accurately differentiate lethal from nonlethal prostate cancer with 100% certainty at the time of initial diagnosis. The solution, or at least part of the solution, is active surveillance. In men who appear to have nonlethal (“low risk”) cancer at the time of diagnosis, it now appears to be safe to observe these cancers, at least initially. This is the concept behind active surveillance. Active surveillance entails carefully monitoring men with low-risk prostate cancer using serial testing and reserving the option of treatment for those men with prostate cancers that exhibit lethal characteristics. In this way, active surveillance preserves the benefits of screening while minimizing the harms of overdiagnosis and overtreatment. Active surveillance was first introduced in the early 2000s, but its efficacy and safety have only been elucidated recently over the last 5 years. Given that active surveillance may be one solution to the screening dilemma, we wanted to evaluate contemporary active surveillance utilization, which is the impetus for our study. Based on the most recent data available to us, we chose the years 2010-2011, which coincide to the time immediately before and during the release of the US Preventative Services Task Force statement against PSA screening. (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, JNCI / 30.06.2015

Timothy P. Padera, PhD Edwin L. Steele Laboratories Department of Radiation Oncology MGH Cancer Center, Massachusetts General Hospital and Harvard Medical School Boston, Massachusetts 02114MedicalResearch.com Interview with: Timothy P. Padera, PhD Edwin L. Steele Laboratories Department of Radiation Oncology MGH Cancer Center, Massachusetts General Hospital and Harvard Medical School Boston, Massachusetts 02114 MedicalResearch: What is the background for this study? What are the main findings? Dr. Padera: Systemic therapy benefits cancer patients with lymph node metastases; however all phase III clinical trials to date of antiangiogenic therapy have failed in the adjuvant setting. We have previously reported the lack of efficacy of antiangiogenic therapies in pre-clinical models of spontaneous lymphatic metastasis, however there were no mechanistic data to explain these observations. Here, we developed a novel chronic lymph node window model to facilitate new discoveries in the mechanisms of growth and spread of lymph node metastases. Our new data provide pre-clinical evidence along with supporting clinical evidence that angiogenesis does not occur in the growth of metastatic lesions in the lymph node. These results reveal a mechanism of treatment resistance to antiangiogenic therapy in adjuvant setting, particularly those involving lymph node metastases. (more…)
Author Interviews, Flu - Influenza, Vaccine Studies, Wistar / 29.06.2015

Scott E. Hensley, Ph.D. Assistant Professor Wistar Institute Philadelphia, PA 1910MedicalResearch.com Interview with: Scott E. Hensley, Ph.D. Assistant Professor Wistar Institute Philadelphia, PA 1910   Medical Research: What is the background for this study? What are the main findings? Response: Previous studies documented that the the 2014-2015 H3N2 flu vaccine strain was antigenically distinct compared to most recent H3N2 flu strains.  Recent H3N2 strains possess several mutation and it was previously unknown which of these mutations contributed to the 2014-2015 vaccine mismatch.  We used a reverse-genetic engineering approach to identify specific viral mutations that contributed to the 2014-2015 vaccine mismatch. (more…)
Author Interviews, Biomarkers, Cancer Research, Johns Hopkins / 26.06.2015

Nishant Agrawal M.D. Associate Professor of Otolaryngology Johns Hopkins University School of MedicineMedicalResearch.com Interview with: Nishant Agrawal M.D. Associate Professor of Otolaryngology Johns Hopkins University School of Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Agrawal: The idea of the study really arose from the specificity of genetic changes that characterize and are the hallmark of cancer cells.  Only cancer cells contain these mutations so their detection in bodily fluids was a reasonable expectation.  The current study builds on previous work from our group that tumor DNA can be detected in the bodily fluids of patients with many different types of solid malignancies.  The main findings of the study are that tumor DNA in saliva and plasma provides a non-invasive biomarker for head and neck cancer.  The take home message is that tumor DNA has potential to be used as a biomarker for screening, early detection, monitoring during treatment, and surveillance after cancer treatment is completed. (more…)
Author Interviews, BMJ, Brigham & Women's - Harvard, Menopause, Orthopedics / 26.06.2015

MedicalResearch.com Interview with: Dr Matthew Miller Department of Health Science Northeastern University Department of Health Policy and Management, Harvard T.H. Chan School of Public Health Harvard University Boston, Massachusetts and Yi-Han Sheu Department of Epidemiology Harvard T.H. Chan School of Public Health Harvard University Boston, Massachusetts Medical Research: What is the background for this study? Response: Selective serotonin reuptake inhibitors (SSRIs) were recently approved by the FDA to treat vasomotor symptoms associated with menopause. No prior study has directly examined whether fracture risk is increased among perimenopausal women who initiate SSRIs or among a population of women without mental disorders more generally.. Medical Research: What are the main findings? Response: We found that SSRIs treatment for non-psychiatric conditions at doses customarily used to treat depression is, all else equal, associated with higher rates of fractures -- an effect that first became evident several months after beginning treatment and, importantly, persisted over the five year study period. (more…)
AHA Journals, Author Interviews, NYU / 25.06.2015

Dr. Bernadette Boden-Albala MPH, DrPH Associate Dean of Program Development NYU’s College of Global Public HealthMedicalResearch.com Interview with: Dr. Bernadette Boden-Albala MPH, DrPH Associate Dean of Program Development NYU’s College of Global Public Health Medical Research: What is the background for this study? What are the main findings? Response: Stroke is a leading cause of morbidity and mortality globally and in the US.  The US Food and Drug Administration has approved tissue plasminogen activator (tPA) as treatment for acute ischemic strokes within 3 hours of the onset of stroke symptoms.  However, less than 25% of eligible stroke patients arrive to an emergency department (ED) in time to receive treatment with tPA.  Our study, the Stroke Warning Information and Faster Treatment (SWIFT), compares the effect of an interactive intervention (II) with enhanced educational (EE) materials on recurrent stroke arrival times. The II group included in-hospital interactive group sessions consisting of a community placed preparedness PowerPoint presentation; a stroke survivor preparedness narrative video; and the use of role-playing techniques to describe stroke symptoms. Both groups received standardized educational materials focused on being prepared to recognize and react to stroke symptoms plus a medical alert bracelet so medical professionals would recognize them as SWIFT participants. We found that at follow-up, 42 percent of these patients arrived to the emergency room within 3 hours compared to only 28 percent at baseline, a 49 percent increase in the proportion of all patients arriving within three hours of symptom onset. Among Hispanics, there was a 63 percent increase.  While there was no difference in the proportion arriving within 3 hours between intervention groups, the intensive intervention appeared to be more beneficial in those with early recurrent events within the first 30 days. (more…)
AHRQ, Antibiotic Resistance, Author Interviews, Baylor College of Medicine Houston, JAMA, Urinary Tract Infections / 25.06.2015

Barbara W. Trautner, MD, PhD Houston Veterans Affairs Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center Section of Infectious Diseases, Department of Medicine Baylor College of Medicine, Houston, TexasMedicalResearch.com Interview with: Barbara W. Trautner, MD, PhD Houston Veterans Affairs Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center Section of Infectious Diseases Department of Medicine Baylor College of Medicine, Houston, Texas Medical Research: What is the background for this study? What are the main findings? Dr. Trautner: Reducing antimicrobial overuse, or antimicrobial stewardship, is a national imperative. If we fail to optimize and limit use of these precious resources, we may lose effective antimicrobial therapy in the future. CDC estimates that more than $1 billion is spent on unnecessary antibiotics annually, and that drug-resistant pathogens cause 2 million illnesses and 23,000 deaths in the U.S. each year. The use of antibiotics to treat asymptomatic bacteriuria (ASB) is a significant contributor to antibiotic overuse in hospitalized and nursing home patients, especially among patients with urinary catheters. In catheterized patients, ASB is very often misdiagnosed and treated as catheter-associated urinary tract infection (CAUTI). Therefore, we designed the “Kicking CAUTI: The No Knee-Jerk Antibiotics Campaign intervention” to reduce overtreatment of ASB and to reduce the confusion about distinguishing CAUTI from asymptomatic bacteriuria. This study evaluated the effectiveness of the Kicking CAUTI intervention in two VAMCs between July 2010 and June 2013. The primary outcomes were urine cultures ordered per 1,000 bed-days (inappropriate screening for ASB) and cases of ASB receiving antibiotics (overtreatment). The study included 289,754 total bed days, with 170,345 at the intervention site and 119,409 at the comparison site. Through this campaign, researchers were able to dramatically decrease the number of urine cultures ordered. At the intervention site, the total number of urine cultures ordered decreased by 71 percent over the course of the intervention. Antibiotic treatment of asymptomatic bacteriuria decreased by more than 75 percent during the study. No significant changes occurred at the comparison site over the same time period. Failure to treat catheter-associated urinary tract infection when indicated did not increase at either site. (more…)
Author Interviews, Neurological Disorders, NYU, Opiods, Pain Research, Pharmacology / 25.06.2015

Dr. Mia T. Minen, MD, MPH Director, Headache Services at NYU Langone Medical Center Assistant professor, Department of Neurology MedicalResearch.com Interview with: Dr. Mia T. Minen, MD, MPH Director, Headache Services NYU Langone Medical Center Assistant professor, Department of Neurology   Medical Research: What is the background for this study? What are the main findings? Dr. Minen: We conducted a survey on opioid and barbiturate use among patients visiting a headache center to find out which medications they were receiving for treatment. There’s limited evidence that long-term use of these medications can help treat headaches or migraines, and even short-term use in small quantities can cause medication overuse headache. It is important to determine which providers start these medications so that educational interventions can be tailored to these physician specialties to try to prevent situations such as incorrect prescribing practices and medication overuse. In this sample of patients from a specialty headache center, approximately 20 percent of patients -- or 1 in 5 -- were using opioids or barbiturates, and about half had been prescribed these medications at some point in the past for their headaches. These findings show that opioids and barbiturates are commonly prescribed to patients with headaches. While two-thirds of patients found opioids or barbiturates helpful, many did not like them, were limited by side effects or did not find them to be helpful. Emergency department physicians were reported to be the most frequent first prescribers of opioids and general neurologists were the most frequent prescribers of barbiturate-containing medications. Primary care physicians were also identified as frequent first prescribers of these medications. (more…)
Author Interviews, Cannabis, JAMA, Johns Hopkins / 25.06.2015

Ryan Vandrey, Ph.D. Associate Professor Behavioral Pharmacology Research Unit Johns Hopkins University School of Medicine Baltimore, MD 21224MedicalResearch.com Interview with: Ryan Vandrey, Ph.D. Associate Professor Behavioral Pharmacology Research Unit Johns Hopkins University School of Medicine Baltimore, MD 21224 Medical Research: What is the background for this study? What are the main findings? Dr. Vandrey: The background for the study was that I have had several conversations with individuals that led me to believe that there was insufficient regulation of products of all types being sold in medical cannabis dispensaries.  In order to evaluate that, we needed to do a study.  We decided to test edible products because that is a growing market, and, because it involves some level of manufacturing, there is greater chance for dose variability and inaccuracy.  The main finding was that the majority of products were purchased from retail stores selling cannabis products for medical use were significantly mislabeled with regards to the dose of THC and other cannabinoids. (more…)
Author Interviews, Heart Disease, JACC, University of Michigan / 24.06.2015

MedicalResearch.com Interview with: Jessica Parsh MD Hitinder Gurm MBBS Department of Internal Medicineb University of Michigan Health System Medical Research: What is the background for this study? What are the main findings? Response: Chronic kidney disease (CKD) is associated with adverse events after percutaneous coronary interventions (PCI). Estimated glomerular filtration rate (eGFR) is used for CKD stage classification and there are several widely used eGFR equations, including the Cockcroft-Gault, CKD-EPI, and MDRD. Others have shown that the CKD-EPI equation is more accurate, more precise and less bias. The current Kidney Disease Improving Global Outcomes (KDIGO) guidelines recommend the use of CKD-EPI. Even so, there remains wide variability among equation choice between different institutions as well as between different health care providers (physicians, pharmacists, etc). In addition, in a recent survey, up to 12% of providers were "unsure" of which equation they used. Furthermore, the FDA has no clear guidelines regarding equation selection for pharmacokinetic studies of novel medications and the equation used for development of a particular drug is not always clearly labeled on package inserts. Using data from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium for almost 130,000 patients who underwent PCI, we investigated whether use of different eGFR equations would lead to discrepant eGFR output, how this would lead to CKD stage reclassification and whether CKD stage reclassification by a certain equation led to improved risk prognostication for adverse events. We also studied how calculation of eGFR by various equations would affect drug dosing recommendations for common renally-dosed antiplatelet and antithrombotic medications. We found that there was wide discrepancy among the eGFR output of the various equations and this led to significant CKD stage reclassification (with agreement on stage classification as low as 56% for CKD-EPI and Cockcroft-Gault). Further, our data from receiver operating characteristic analysis and net reclassification index analysis support CKD-EPI as superior for risk prognostication for renal adverse outcomes of acute kidney injury and new requirement for dialysis. In regards to drug dosing, agreement between all three equations on dosing adjustment was as low as 34% (bivalirudin with eGFR cutoff < 30 ml/min/1.732). (more…)