Author Interviews, Hip Fractures, JAMA, Menopause, Osteoporosis, Vitamin D / 05.08.2015

MedicalResearch.com Interview with: Karen E. Hansen, M.D., M.S. Associate Professor of Medicine University of Wisconsin School of Medicine and Public Health Madison, WI 53705-2281 Medical Research: What is the background for this study? Dr. Hansen: The USPTF says to older community dwelling adults, "don't bother taking vitamin D", the Endocrine Society says "take 2,000-4,000 IU daily" and the Institute of Medicine gave an RDA of 600-800 IU daily. The Endocrine Society argues that optimal vitamin D levels are 30 ng/mL and higher, while the Institute of Medicine concludes that 20 ng/mL and higher indicates optimal vitamin D status. The disagreement between experts prompted my study. Medical Research: What are the main findings? Dr. Hansen: Among postmenopausal women whose vitamin D level was ~21 ng/mL at baseline, there was no benefit of high-dose or low-dose vitamin D, compared to placebo, on spine/hip/total body bone mineral density, muscle fitness by 5 sit to stand test or Timed Up and Go, or falls. We did see a small 1% increase in calcium absorption in the high-dose vitamin arm, but this small increase did not translate into clinically meaningful changes in bone density or muscle tests. (more…)
Author Interviews, JAMA, PTSD / 05.08.2015

Melissa A. Polusny, PhD, LP Staff Psychologist/Clinician Investigator Core Investigator, Center for Chronic Disease Outcomes Research Associate Professor, University of Minnesota Medical School Minneapolis VA Health Care System (B68-2) One Veterans Drive Minneapolis, MN 5541MedicalResearch.com Interview with: Melissa A. Polusny, PhD, LP Staff Psychologist/Clinician Investigator Core Investigator, Center for Chronic Disease Outcomes Research Associate Professor, University of Minnesota Medical School Minneapolis VA Health Care System One Veterans Drive Minneapolis, MN 5541 Medical Research: What is the background for this study? What are the main findings? Dr. Polusny: VA has invested heavily in the dissemination of prolonged exposure therapy and cognitive processing therapy as first-line treatments for PTSD; however, 30% to 50% of Veterans do not show clinically significant improvements and dropout rates are high. Evidence suggests that mindfulness-based stress reduction – an intervention that teaches individuals to attend to the present moment in a non-judgmental, accepting manner – can reduce symptoms of anxiety and depression. This randomized clinical trial compared mindfulness-based stress reduction with present-centered group therapy – sessions focused on current life problems. We randomly assigned 116 Veterans with PTSD to receive nine sessions of mindfulness-based stress reduction therapy (n=58) or nine sessions of present-centered group therapy (n=58). Outcomes were assessed before, during and after treatment, and at two-month follow-up. Exclusion criteria included: substance dependence (except nicotine), psychotic disorder, suicidal or homicidal ideation, and/or cognitive impairment or medical illness that could interfere with treatment. The primary outcome was a change in self-reported PTSD symptom severity over time. Secondary outcomes included interview-rated PTSD severity scores, self-reported depression symptoms, quality of life, and mindfulness skills. Mindfulness-based stress reduction therapy – compared with present-centered group therapy – resulted in a greater decrease in self-reported PTSD symptom severity. Veterans in the mindfulness-based stress reduction group were more likely to show clinically significant improvement in self-reported PTSD symptom severity (49% vs. 28%) at two-month follow-up, but they were no more likely to have loss of PTSD diagnosis (53% vs. 47%). Veterans participating in mindfulness-based stress reduction therapy reported greater improvement in quality of life and depressive symptoms than those in present-centered group therapy; however improvement in depressive symptoms scores did not reach the level of significance. Improvements in quality of life made during treatment were maintained at 2-month follow-up for Veterans in the mindfulness-based stress reduction group, but reports of quality of life returned to baseline levels for those in present-centered group therapy. The dropout rate observed for mindfulness-based stress reduction therapy (22%) in this study was lower than dropout rates reported in previous studies for PE (28.1% to 44%) and CPT (26.8% to 35%). (more…)
Accidents & Violence, Author Interviews, CDC, JAMA, Primary Care / 05.08.2015

Joanne Klevens, MD, PhD Division of Violence Prevention US Centers for Disease Control and Prevention Atlanta, GeorgiaMedicalResearch.com Interview with: Joanne Klevens, MD, PhD Division of Violence Prevention US Centers for Disease Control and Prevention Atlanta, Georgia Medical Research: What is the background for this study? What are the main findings? Dr. Klevens: The United States Preventive Services Task Force recommends women of reproductive age be screened for partner violence but others, such as the World Health Organization and the Cochrane Collaborative conclude there is insufficient evidence for this recommendation. Our randomized clinical trial allocated 2700 women seeking care in outpatient clinics to 1 of 3 study groups: computerized partner violence screening and provision of local resource list, universal provision of partner violence resource list without screening, or a no-screen/no resource list control group.  No differences were found in women’s quality of life, days lost from work or housework, use of health care and partner violence services, or the recurrence of partner violence after 1 year. In this three-year follow-up, no differences were found in the average number of hospitalizations, emergency room visits or ambulatory care visits. (more…)
Alzheimer's - Dementia, Author Interviews, Diabetes, JAMA, Nutrition / 31.07.2015

Auriel A. Willette, M.S., Ph.D. Food Science and Human Nutrition Neuroscience Interdepartmental Graduate Program Gerontology Interdepartmental Graduate Program Iowa State University, AmesMedicalResearch.com Interview with: Auriel A. Willette, M.S., Ph.D. Food Science and Human Nutrition Neuroscience Interdepartmental Graduate Program Gerontology Interdepartmental Graduate Program Iowa State University, Ames Medical Research: What is the background for this study? What are the main findings? Response: Obesity is a major health concern around the world. Obesity causes insulin resistance, defined in this case as the inability of insulin to bind to its receptor and mediate glucose metabolism. Other researchers and I have recently found that higher insulin resistance is associated with less glucose metabolism in the brains of patients with Alzheimer's disease. This relationship is found primarily in medial temporal lobe, an area necessary for generating new memories of facts and events. This is important because Alzheimer's disease is characterized by progressive decreases in glucose metabolism over time, and partly drives worse memory performance. Insulin resistance in midlife also increases the risk of developing Alzheimer's disease. We wanted to determine if insulin resistance is linked to similar effects in cognitively normal, late middle-aged participants decades before Alzheimer's disease typically occurs. If so, insulin resistance might be an important biological marker to track from middle-age onwards. Thus, we examined the association between insulin resistance, regional glucose metabolism using FDG-PET, and memory function in 150 middle-aged participants, many of whom had a mother or father with Alzheimer's disease. We found that higher insulin resistance was strongly associated with less glucose metabolism throughout many brain regions, predominantly in areas that are affected by Alzheimer's disease. The strongest statistical effects were found in left medial temporal lobe, which again is important for generating new memories. This relationship, in turn, predicted worse memory performance, both immediately after learning a list of words and a 20-minute delay thereafter. The take-home message is that insulin resistance has an Alzheimer's-like association with glucose metabolism in middle-aged, cognitively normal people at risk for Alzheimer's, an association which is related to worse memory. (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Mental Health Research / 30.07.2015

Alexander C. Tsai, MD, PhD Center for Global Health, Massachusetts General Hospital, Boston Harvard Center for Population and Development Studies, Cambridge, MassachusettsMedicalResearch.com Interview with: Alexander C. Tsai, MD, PhD Center for Global Health Massachusetts General Hospital, Boston Harvard Center for Population and Development Studies Cambridge, Massachusetts Medical Research: What is the background for this study? What are the main findings? Dr. Tsai: Suicide is one of the leading causes of death among middle aged women, and the rates have been climbing over the past decade. At the same time, we know that Americans are becoming more and more isolated. As one example, over the past two decades, there has been a tripling in the number of people who say they don't have anyone to confide in about important matters. In our study, we tracked more than 70,000 American women over two decades and found that the most socially isolated women had a threefold increased risk of suicide. (more…)
Author Interviews, Endocrinology, JAMA, Radiology, Surgical Research, UCSF / 28.07.2015

Quan-Yang Duh MD Endocrine surgeon UCSF Medical CenterMedicalResearch.com Interview with: Quan-Yang Duh MD Chief, Section of Endocrine Surgery UCSF Medical Center Medical Research: What is the background for this study? What are the main findings? Dr. Quan-Yang Duh: At UCSF we have a monthly Adrenal Conference (involving surgeons, endocrinologists and radiologists) to discuss patients we are consulted for adrenal tumors. About 30% of these are for incidentally discovered adrenal tumors (versus those found because of specific indications such as clinical suspicion or genetic screening). Of these 15-20% has bilateral adrenal tumors. The evaluation of unilateral incidentaloma has been very well studied and many national guidelines have been published with specific management recommendations. So during our monthly adrenal conference, we have a routine "script" for evaluation and recommendations (rule out metastasis by looking for primary cancer elsewhere, rule out pheochromocytoma and Cushing, resect secreting tumors or large tumors, and if no operation recommended repeat scan in 6 months, etc.). This “script” has worked very well for patients with unilateral incidentaloma. However, we were less certain when we made recommendations about bilateral incidentalomas because there was very little literature or guidelines written about it. We had some gut feelings, but we were not sure that we were recommending the right things. We needed more data. That was the main reason for the study. What we found in our study was that although the possible subclinical diseases were the same – hypercortisolism and pheochromocytoma, the probabilities were different. The patients with bilateral incidentalomas were more likely to have subclinical Cushing’s and less likely to have pheochromocytomas than those with unilateral incidentalomas. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, JAMA / 28.07.2015

Benjamin D. Sommers, MD, PhD Assistant Professor of Health Policy & Economics Harvard T. H. Chan School of Public Health / Brigham & Women's Hospital Boston, MA 02115MedicalResearch.com Interview with: Benjamin D. Sommers, MD, PhD Assistant Professor of Health Policy & Economics Harvard T. H. Chan School of Public Health / Brigham & Women's Hospital Boston, MA 02115 Medical Research: What is the background for this study? What are the main findings? Response: The Affordable Care Act (ACA) expanded insurance options for millions of adults, via an expansion of Medicaid and the new health insurance Marketplaces, which had their first open enrollment period beginning in October 2013.  We used a large national survey to assess the changes in health insurance, access to care, and self-reported health since these expansions began.  What we found is that the beginning of the ACA’s open enrollment period in 2013 was associated with significant improvements in the trends of insurance coverage, access to primary care and medications, affordability of care, and self-reported health.  Among low-income adults in Medicaid expansion states, the ACA was associated with improvements in coverage and access to care, compared to non-expansion states. Gains in coverage and access to medicines were largest among racial and ethnic minorities. (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, JAMA, Pediatrics / 28.07.2015

MedicalResearch.com Interview with: Wade Harrison, MPH The Dartmouth Institute for Health Policy & Clinical Practice Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire Medical Research: What is the background for this study? What are the main findings? Dr. Harrison: This study used national birth certificate data to examine time trends in Neonatal Intensive Care Unit (NICU) admission rates for all U.S. newborns and the composition of the cohort of admitted newborns.  Most of the existing studies of neonatal intensive care are limited in examining specific groups of newborns (e.g. those <1500 g, those with a specific complication, within limited geographies, etc.) or only looking at how care is delivered after a baby is admitted, leaving aside the question of whether to admit them in the first place.  This is an important area to study because the newborn period is a critical time for babies and their families to establish good feeding practices and increase bonding among other important needs; also, neonatal intensive care is very expensive and like all medical interventions can carry certain risks.  We found that NICU admission rates increased for all newborns across the birth weight spectrum.  Additionally, although NICUs were initially developed to care for very small and premature newborns, just under half of current NICU admissions are for normal birth weight and full term infants, who are likely to be less ill. (more…)
Author Interviews, FDA, JAMA / 27.07.2015

Dr. Pinar Karaca-Mandic Ph.D Associate Professor, Health Policy & Management School of Public Health Division of Health Policy & Management Minneapolis MN University of MinnesotaMedicalResearch.com Interview with: Dr. Pinar Karaca-Mandic Ph.D Associate Professor, Health Policy & Management School of Public Health Division of Health Policy & Management Minneapolis MN University of Minnesota Medical Research: What is the background for this study? What are the main findings? Dr. Karaca-Mandic: Drug safety has received a lot of attention recently, and FDA's post-marketing drug surveillance program (FAERS) offers and important opportunity to monitor drug safety and update drug warnings. There has been an increasing trend in reports to FAERS of serious adverse drug events and earlier studies suggested that these trends were primarily driven by increased manufacturer reports of serious and unexpected adverse events. While these studies highlighted the overall increase in adverse event rates, manufacturer timeliness in reporting and compliance with the 15 calendar day regulation for expedited reports was unknown, though some recent media coverage has offered anecdotal examples of delay. My co-authors and I were interested in studying not only the reporting of these events, by manufacturers to FDA, but also their timely reporting as required by the Federal regulation. Delays in reporting can have important public health consequences because the FDA uses this information to update drug warnings. We found that about 10% of serious and unexpected adverse events that are subject to the 15-day regulation were not reported by 15 days. We also found that events that involved a patient death were more likely to be delayed. For example, we found that after adjusting for other characteristics of the report and the patient, about 12% of events that involved patient death, and 9% of those that did not involve patient death were delayed beyond 15 days. (more…)
Author Interviews, JAMA, NYU, PTSD / 24.07.2015

Charles R. Marmar, MD The Lucius Littauer Professor and Chair, Department of Psychiatry, NYU Langone Medical Center and Director of the Steven and Alexandra Cohen Veterans Center at NYU LangonMedicalResearch.com Interview with: Charles R. Marmar, MD The Lucius Littauer Professor and Chair, Department of Psychiatry, NYU Langone Medical Center and Director of the Steven and Alexandra Cohen Veterans Center at NYU Langone MedicalResearch: What is the background for this study? What are the main findings? Dr. Marmar: Approximately 2.7 million men and women served in Vietnam, and, for those who returned, many have suffered for decades from a variety of psychological problems resulting from their experiences and other injuries such as traumatic brain injury (TBI). The 25-year National Vietnam Veterans Longitudinal Study (NVVLS) was a way we could determine at various points in time how veterans were faring emotionally four decades after their service. While the vast majority are resilient, there are still over 270,000 Vietnam veterans who still have some form of post-traumatic stress disorder (PTSD) and one-third of these veterans have depression. We followed up with veterans who participated in the National Vietnam Veterans Readjustment Study (NVVRS) from 1984 to 1988 who were evaluated for PTSD. The NVVRS group represented a probability sample of those who served in Vietnam. Of the 1,839 participants still alive, 1,409 participated in at least one phase of the NVVLS, which involved a health questionnaire, health interview and clinical interview. The results showed that between 4.5 percent and 11.2 percent of male Vietnam veterans and 6.1 and 8.7 percent of the female veterans are currently experiencing some level of PTSD. About 16 percent of veterans in the study reported an increase of more than 20 points on a PTSD symptom scale compared to 7.6 percent who reported a decrease of greater than 20 points. (more…)
Author Interviews, Brain Injury, JAMA, Outcomes & Safety, UCLA / 23.07.2015

Aaron J. Dawes, MD Fellow, VA/RWJF Clinical Scholars Program Division of Health Services Research, University of California Los Angeles Los Angeles, CA 90024MedicalResearch.com Interview with: Aaron J. Dawes, MD Fellow, VA/RWJF Clinical Scholars Program Division of Health Services Research, University of California Los Angeles Los Angeles, CA 90024 Medical Research: What is the background for this study? What are the main findings? Dr. Dawes: In the fall of 2013, we formed the Los Angeles County Trauma Consortium, building upon a prior administrative relationship between LA County’s 14 trauma centers. We added health research researchers from UCLA and USC, and shifted the focus of the group from logistical issues to quality improvement. As a first project, our hospitals wanted to know if there was any variation in how traumatic brain injury patients are cared for across the county. Traumatic brain injury accounts for over 1/3 of all injury-related deaths in the U.S. and is the number one reason for ambulance transport to a trauma center in LA County. When we looked at the data, we found widespread variation in both how these patients were cared for at different hospitals and what happened to them as a result of that care. After adjusting for important differences in patient mix, we found that mortality rates varied by hospital from roughly 25% to 55%. As we tried to explain this variation, we looked into how often hospitals complied with two evidence-based guidelines from the Brain Trauma Foundation, hoping that we could eventually develop an intervention to boost compliance with these recommended care practices. While compliance rates varied even more widely than mortality—from 10 to 65% for intracranial pressure monitoring and 7 to 76% for craniotomy—they did not appear to be associated with risk-adjusted mortality rates. Put simply, we found no connection between how often hospitals complied with the guidelines and how likely their patients were to survive. (more…)
Author Interviews, Duke, Education, Heart Disease, JAMA / 22.07.2015

Carolina Malta Hansen, M.D Duke Clinical Research InstituteMedicalResearch.com Interview with: Carolina Malta Hansen, M.D Duke Clinical Research Institute Medical Research: What is the background for this study? What are the main findings? Dr. Hansen: Approximately 300,000 persons in the United States suffer an out-of-hospital cardiac arrest every year and under 10% survive. Cardiopulmonary resuscitation (CPR) and defibrillation within the first few minutes of cardiac arrest can increase the chance of survival from under 10% to over 50%. In 2010, the HeartRescue program in North Carolina initiated statewide multifaceted interventions to improve care and outcomes for cardiac arrest patients in North Carolina. The project included public training programs in defibrillators and compression-only CPR at schools, hospitals and major events such as the N.C. State Fair, plus additional instruction for EMS and other emergency workers on optimal care for patients in cardiac arrest. We found that following these four years of initiatives to improve care and outcomes for cardiac arrest patients, the proportion of patients who received bystander CPR and first responder defibrillation increased by more than 25% to approximately 50%, the combination of bystander CPR and first responder defibrillation increased from 14% to 23%. Survival with favorable neurologic outcome increased from 7% to 10% and this increase was only observed among patients who received bystander CPR. Finally, we found that compared to patients who received CPR and defibrillation by emergency medical services (EMS), patients who received bystander and/or first responder CPR, defibrillation, or both, were more likely to survive. The combination of bystander CPR and bystander defibrillation was associated with the best survival rates but remained low during the study period with no increase over time. (more…)
Author Interviews, Brigham & Women's - Harvard, Heart Disease, JAMA, Statins / 14.07.2015

Dr. Ankur Pandya Ph.D. Assistant Professor of Health Decision Science Department of Health Policy and Management Harvard T.H. Chan School of Public Health Boston, MA MedicalResearch.com Interview with: Dr. Ankur Pandya Ph.D. Assistant Professor of Health Decision Science Department of Health Policy and Management Harvard T.H. Chan School of Public Health Boston, MA Medical Research: What is the background for this study? What are the main findings? Dr. Pandya: The American College of Cardiology and the American Heart Association (ACC-AHA) cholesterol treatment guidelines were controversial when first released in November 2013, with some concerns that healthy adults would be over-treated with statins. We found that the current 10-year ASCVD risk threshold (≥7.5%) used in the ACC-AHA cholesterol treatment guidelines has an acceptable cost-effectiveness profile (incremental cost-effectiveness ratio of $37,000/QALY), but more lenient ASCVD thresholds would be optimal using cost-effectiveness thresholds of $100,000/QALY (≥4.0%) or $150,000/QALY (≥3.0%). (more…)
Author Interviews, JAMA, OBGYNE / 13.07.2015

Diana W. Bianchi, M.D. Executive Director, Mother Infant Research Institute Vice Chair for Research and Academic Affairs, Department of Pediatrics Tufts Medical CenterMedicalResearch.com Interview with: Diana W. Bianchi, M.D. Executive Director, Mother Infant Research Institute Vice Chair for Research and Academic Affairs Department of Pediatrics Tufts Medical Center Medical Research: What is the background for this study? What are the main findings? Response: Noninvasive Prenatal Testing (NIPT) is the fastest growing genetic test. It has been available since late 2011. Over 2 million tests have been performed worldwide. Cancer in pregnancy is rare, and only occurs in 1 in 1,000 pregnant women. About 0.2 per cent of noninvasive prenatal tests that use sequencing of maternal plasma DNA have a so-called “false positive” result. In most cases this is not an error, but there is a biological explanation for the discrepancy between the abnormal noninvasive prenatal test result and a normal fetal chromosome result obtained from a diagnostic procedure, such as amniocentesis or chorionic villus sampling (CVS). We are very interested in the underlying biological explanations for the false positive cases, and it turns out that a clinically silent tumor in the mother is one of them. The mother’s tumor is shedding DNA into her blood that is detected by the prenatal test. In a large clinical dataset of over 125,000 pregnant women who had a DNA sequencing screen for fetal chromosome abnormalities there were 10 women who were subsequently found to have cancer. We retrospectively analyzed the DNA sequencing results in 8 of these women and found that they had abnormalities in multiple areas of the genome, suggesting that it was DNA from the tumor that was shed into the maternal blood and being detected by the prenatal screen. The noninvasive prenatal sequencing test result that was most suggestive of a cancer risk was the presence of more than one aneuploidy. This finding was present in 7 of the 10 women who had cancer. In three of the eight women we studied it was the abnormal prenatal test result that triggered a subsequent work-up that led to the diagnosis of cancer. (more…)
Author Interviews, Cancer Research, End of Life Care, JAMA / 10.07.2015

MedicalResearch.com Interview with: Jennifer Mack, MD, MPH Pediatric oncologist Dana-Farber/Boston Children’s Cancer and Blood Disorders Center Medical Research: What is the background for this study? What are the main findings? Dr. Mack: This study evaluated the intensity of end-of-life care received by adolescents and young adults (AYAs) with cancer. Little was previously known about the kind of end-of-life care these young patients receive. We evaluated the care of 663 Kaiser Permanente Southern California patients who died between the ages of 15 and 39 between the years 2001 and 2010. We found that more than two-thirds of adolescents and young adults received at least one form of intensive end-of-life care before death. This includes chemotherapy in the last two weeks of life (11%), more than one emergency room visit in the last month of life (22%), intensive care unit care in the last month of life (22%), and hospitalization in the last month of life (62%). Medical Research: What should clinicians and patients take away from your report? Dr. Mack: A majority of dying young people with cancer receive intensive measures at the end of life. Older patients who know they are dying usually do not want to receive intensive measures, which are associated with a poorer quality of life near death. High rates of intensive measures raise the concern that young people may experience unnecessary suffering at the end of life. However, it is also important to recognize that adolescents and young adult patients may have different priorities than older patients, and may be more willing to accept intensive measures in order to live as long as possible. Clinicians, patients, and family members should talk about what is most important to patients at the end of life so that their values can be upheld, whether patients prioritize doing everything possible to live as long as possible or focus on quality of life. Medical Research: What recommendations do you have for future research as a result of this study? Dr. Mack: Future research should further examine end-of-life decision-making for adolescents and young adults, including the reasons for receipt of intensive measures. Citation: JAMA Oncology irene.sege@childrens.harvard.edu MedicalResearch.com Interview with: Jennifer Mack, MD, MPH Pediatric oncologist Dana-Farber/Boston Children’s Cancer and Blood Disorders Center Medical Research: What is the background for this study? What are the main findings? Dr. Mack: This study evaluated the intensity of end-of-life care received by adolescents and young adults (AYAs) with cancer. Little was previously known about the kind of end-of-life care these young patients receive. We evaluated the care of 663 Kaiser Permanente Southern California patients who died between the ages of 15 and 39 between the years 2001 and 2010. We found that more than two-thirds of adolescents and young adults received at least one form of intensive end-of-life care before death. This includes chemotherapy in the last two weeks of life (11%), more than one emergency room visit in the last month of life (22%), intensive care unit care in the last month of life (22%), and hospitalization in the last month of life (62%). (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, Clots - Coagulation, JAMA, Surgical Research / 10.07.2015

Robert J. Lewandowski, MD FSIRAssociate Professor of Radiology Director of Interventional Oncology Department of Radiology Northwestern University Feinberg School of MedicineMedicalResearch.com Interview with: Robert J. Lewandowski, MD FSIR Associate Professor of Radiology Director of Interventional Oncology Department of Radiology Northwestern University Feinberg School of Medicine Medical Research: What is the background for this study? What are the main findings? Response: Retrievable inferior vena cava filters (rIVCF) were designed to provide temporary prevention from pulmonary embolism and then be removed when no longer needed. With permanent United States Food and Drug Administration (FDA) indication, these devices now account for the majority of IVC filters placed. Most rIVCFs placed are never removed because of poor clinical follow up, failed retrieval procedures, or patients not being offered the opportunity for filter removal secondary to prolonged dwell time; the latter has previously been correlated with retrieval failure. Retrievable IVCFs appear to be subject to greater device related complications (e.g., filter penetration of the IVC, filter migration, filter fracture) relative to permanent devices; furthermore, the rates of these complications appear to increase with filter dwell time. This prompted the FDA to issue a 2010 safety alert urging removal of rIVCFs once they are deemed no longer necessary. In the present study, we sought to determine whether rIVCF dwell time affects technical success of the retrieval procedure. Over a six-year period, 648 retrieval procedures were performed at our institution, with filter dwell times ranging from 0-108 months. We found that filter dwell time did not negatively impact IVC filter retrieval success nor did it increase our adverse events from the retrieval procedure. With advanced, adjunctive IVC filter retrieval techniques, rIVCFs can be safely and reliably removed despite long dwell times. (more…)
Author Interviews, Heart Disease, JAMA / 09.07.2015

MedicalResearch.com Interview with: Dr Emanuele Di Angelantonio FESC FAHA University Lecturer | University of Cambridge Director | MPhil in Public Health, University of Cambridge Deputy Director | NIHR Biomedical Research Unit in Donor Health and Genomics Honorary Consultant | NHS Blood and Transplant Department of Public Health and Primary Care Strangeways Research Laboratory Cambridge, UK Medical Research: What is the background for this study? What are the main findings? Response: Previous research as mainly focused on individual with one cardiometabolic condition alone and, despite it could be expected that having more than one condition poses a greater risk, this is the first study that is able to precisely quantify how much is worst. Furthermore, given that the conditions we study (diabetes, heart attack, and stroke) share several risk factors, it could be expected that the combination of these will not be  multiplicative. We were somewhat surprised to find that participants who had 1 condition had about twice the rate of death; 2 conditions, about 4 times the rate of death; and all 3 conditions, about 8 times the rate of death. We  estimated that at the age of 60 years, men with any two of the cardiometabolic conditions studied would on average have 12 years of reduced life expectancy, and men with all three conditions would have 14 years of reduced life expectancy. For women at the age of 60 years, the corresponding estimates were 13 years and 16 years. The figures were even more dramatic for patients at a younger age. At the age of 40 years, men with all three cardiometabolic conditions would on average have 23 years of reduced life expectancy; for women at the same age, the corresponding estimate was 20 years. (more…)
Author Interviews, Cancer Research, Genetic Research, JAMA / 08.07.2015

Aung Ko Win, MBBS MPH PhD Research Fellow NHMRC Early Career Clinical Research Fellow Centre for Epidemiology and Biostatistics Melbourne School of Population and Global Health The University of Melbourne VIC 3010 AustraliaMedicalResearch.com Interview with: Aung Ko Win, MBBS MPH PhD Research Fellow NHMRC Early Career Clinical Research Fellow Centre for Epidemiology and Biostatistics Melbourne School of Population and Global Health The University of Melbourne VIC 3010 Australia Medical Research: What is the background for this study? What are the main findings? Response: About 2-5% of uterine cancer are associated with an underlying genetic condition mainly Lynch syndrome. Lynch syndrome is caused by a mutation in one of the mismatch repair genes. At least 1 in 1000 people in the population have a mutation that causes Lynch syndrome and these people have a very high risk of cancers mainly bowel and uterine cancers. One in three women with a mutation in one of the mismatch repair genes are likely to develop a uterine cancer in their lifetime. The only way to reduce the risk of uterine cancer for these women is to remove the uterus. There is no current recommendation for screening method to detect uterine cancer early. Almost nothing is known about if and how lifestyle factors and hormonal factors can modify their risk of uterine cancer. By studying 1128 women with a mutation that causes Lynch syndrome who were recruited from Australia, New Zealand, Canada and the USA, we found that later age at first menstrual cycle, having one or more live births, and using hormonal contraceptive use for one year or longer were associated with a lower risk of uterine cancer. (more…)
Author Interviews, Insomnia, JAMA, Mental Health Research / 07.07.2015

Jason Ong, Ph.D., CBSM Associate Professor, Department of Behavioral Sciences Director, Behavioral Sleep Medicine Training Program Rush University Medical CenterMedicalResearch.com Interview with: Jason Ong, Ph.D., CBSM Associate Professor, Department of Behavioral Sciences Director, Behavioral Sleep Medicine Training Program Rush University Medical Center Medical Research: What is the background for this study? What are the main findings? Response: Insomnia is a very common sleep problem that was previously thought to be related to another medical or psychiatric condition.  Evidence now supports the notion that insomnia can emerge as a disorder distinct from the comorbid condition.  In this study, we evaluated the effectiveness of cognitive behavioral therapy for insomnia (CBT-I), the most widely used nonpharmacologic treatment for insomnia, in the context of medical and psychiatric comorbidities. We conducted a systematic review and meta-analysis of 37 studies and found that 36% of patients who received cognitive behavioral therapy for insomnia were in remission at post-treatment compared to 17% who received a control or comparison condition.  CBT-I had medium to large effects for improving sleep quality and reducing the amount of time awake in bed.  Positive findings were also found on the comorbid condition, with greater improvements in psychiatric conditions compared to medical conditions. (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, CDC, Dermatology, JAMA / 02.07.2015

Dr Gery GuyMedicalResearch.com Interview with: Gery P. Guy Jr., PhD, MPH Health Economist Division of Cancer Prevention and Control Centers for Disease Control and Prevention Medical Research: What is the background for this study? What are the main findings? Dr. Guy: Indoor tanning exposes users to intense ultraviolet radiation, which damages the skin and can cause skin cancer, including melanoma (the deadliest type of skin cancer), basal cell carcinoma, and squamous cell carcinoma. Previous research has demonstrated that indoor tanning is common among adults in the United States. This study examined the changes in prevalence and frequency of indoor tanning among adults in the United States. Our study found significant reductions in indoor tanning among all adults, women, and men. From 2010 to 2013, 1.6 million fewer women and 400,000 fewer men indoor tanned. While these reductions are encouraging, nearly 10 million adults continue to indoor tan at least once a year. These individuals are trading a tan for an increased risk of skin cancer. While the tan is temporary, the risk for skin cancer is permanent. (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…)
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, Autism, JAMA, OBGYNE / 25.06.2015

MedicalResearch.com Interview with: Ali S. Khashan, Ph.D. Irish Centre for Fetal and Neonatal Translational Research (INFANT) Cork, Ireland Medical Research: What is the background for this study? What are the main findings? Dr. Khashan: The Caesarean section rate is increasing worldwide reaching 30% in some western countries and 50% in China and Brazil. As a result, it is becoming increasingly important to understand the long-term effects this procedure may have on both mother and child. Previously, our group conducted a systematic review and meta-analysis of published literature and found birth by Caesarean to be associated with approximately 20% increased risk of autism spectrum disorder (ASD), compared to birth by vaginal delivery. This means if the risk of ASD in children born by vaginal delivery were 1%, and the association was causal, the risk of autism spectrum disorder in children born by Caesarean section is 1.2% i.e. two additional ASD cases per 1000 births. However, studies were limited, and we were unable to determine what was driving this association. In our new study, now published in JAMA Psychiatry, we investigated this issue further with the largest study on this subject to date, including all children born in Sweden between 1982 and 2010. Our study included data on over 2.9 million people and accounted for variety of factors known to be associated with both Caesarean section and autism spectrum disorder. After controlling for known confounders, such as maternal age and psychiatric history as well as various other perinatal and socio-demographic factors, we confirmed our previous findings that birth by Caesarean was associated with approximately 20% increased risk of autism spectrum disorder, compared to birth by vaginal delivery. However, with this analysis it remained unclear whether the increased risk was due to the Caesarean section itself, or some genetic or environmental factor that we were unable to measure. To determine if it was birth by Caesarean section or another unknown factor which led to an increased risk of ASD, we compared children with autism spectrum disorder to their non-diagnosed brothers and sisters. In other words, we analysed pairs of siblings in which one was diagnosed with ASD and one was not, to determine if birth by Caesarean was associated with increased risk of ASD within families. In this way, we attempted to indirectly account for genetic and family environment factors that are shared by siblings but we were unable to measure in the general population. In this analysis, which included data on over 13,000 sibling pairs, there was no longer any association between birth by Caesarean section and ASD. Overall, these results indicate that though birth by Caesarean section may be associated with an increased risk of ASD, it is likely due to family factors such as genetics or environment, rather than the Caesarean section itself. These findings are more informative than many previous studies as we had the largest sample size on this topic to date and estimated the association between Caesarean section and the risk of autism spectrum disorder while comparing siblings born by different methods of delivery. This allowed us to control for many factors that other studies did not. (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, JAMA, Surgical Research, Technology / 25.06.2015

Vanita Ahuja, MD, MPH Department of General Surgery York Hospital, York, PennsylvaniaMedicalResearch.com Interview with: Vanita Ahuja, MD, MPH  Department of General Surgery York Hospital, York, Pennsylvania MedicalResearch: What is the background for this study? What are the main findings? Dr. Ahuja: Robotic-assisted surgery has been slowly accepted within the medical community. Felger et al. (1999), Falk et al. (2000), and Loumet et al. (2000) state that specific to cardiac surgery, the advantages of the robot in coronary artery bypass grafting (CABG) and valvular operations were demonstrated with increased visualization, ease of harvest, and quality of vascular anastomoses as early as 1999. However, Giulianotti, et al. (2003), Morgan et al. (2005), and Barbash et al. (2010) suggest that although safety and efficacy are supported, it is not conclusive yet that robot-assisted surgery is cost-effective, given the high cost of the robot itself, longer operating times, and the short life of the robotic instruments. The purpose of our paper was to compare outcomes of complications, length of stay (LOS), actual cost, and mortality between non-robotic and robotic-assisted cardiac surgery. In general surgery and subspecialties, the use of the robot has increased significantly over the past few years. It has been noted that robotic surgery improves on laparoscopic surgery by providing increased intra-cavity articulation, increased degrees of freedom, and downscaling of motion amplitude that may reduce the strain on the surgeon. The biggest growth in robotic surgery has been seen in the fields of gynecology and urology. Recently, Wright et al. reported an increase in robotic assisted hysterectomy from 0.5 percent of the procedures in 2007 compared to 9.5 percent in 2010 for benign disease. In their study, robotic assisted surgery had similar outcomes to laparoscopic surgery but higher total cost of $2,189 more per case. In urologic surgery, Leddy et al. reported in 2010 that radical prostatectomy remains the biggest utilization of robotic assisted surgery in urology with 1% in 2001 to 40% of all cases in 2006 performed in the United States. Utilizing a nationwide database from 2008-2011, subjects were propensity matched by 14 patient characteristics to reduce selection bias in a retrospective study. The patients were then divided into three groups by operation types: valves, vessels and other type. Univariate analysis revealed that robotic-assisted surgery, compared to non-robotic surgery, had higher cost ($39,030 vs. $36,340), but lower LOS (5 vs. 6 days) and mortality (1% vs. 1.9%, all p<0.001). For those who had one or more complications, robotic-assisted cardiac surgery had fewer complications (27.2%) to non-robotic cardiac surgery (30.3%, p < .001). (more…)