Author Interviews, Hospital Readmissions, JAMA, Pediatrics / 11.08.2015

MedicalResearch.com Interview with: Alisa Khan, MD Pediatric hospitalist Boston Children's Hospital and Instructor of Pediatrics Harvard Medical School Medical Research: What is the background for this study? Dr. Khan: Patients can be readmitted to the same hospital they were discharged from or to a different hospital.  In adults, readmissions to different hospitals make up about 20% of all readmissions.  We don’t know a lot about how often different-hospital readmissions happen in children. Insurance companies know hospitals’ true readmission rates (which include when a hospital’s patients are readmitted to the same hospital and when they are readmitted to a different hospital).  However, hospitals don’t know their true readmission rates since they don’t have access to the full information that insurance companies have. If hospitals don’t know their true rates, they may think they are doing better at preventing readmissions than they really (for instance, if all their discharged patients are simply being readmitted to a different hospital).  Hospitals may also draw incorrect conclusions when they compare themselves to one another (like through benchmarking), and may not be able to predict whether they will be subject to penalties by insurers for having excessively high readmission rates. Medical Research: What are the main findings? Dr. Khan: We found that about 1 in 7 pediatric readmissions in New York over a 5-year period were to a different hospital than the hospital the patient was discharged from.   The percentage of different-hospital readmissions varied by hospital and patient characteristics.  Patients who were admitted to non-children’s hospitals, lower-volume hospitals, or urban hospitals had a higher chance of being readmitted to a different hospital, as did patients who were younger, white, privately insured, or who had certain chronic conditions (like mental health, neurologic, and circulatory conditions). We also found a lot of variability in how much individual hospitals would underestimate their true readmission rates if they only used this incomplete same-hospital readmission info.  Some hospitals would underestimate their true readmission rates by only 0.6 relative percentage points while others would underestimate them by 68 points. (more…)
Author Interviews, Fertility, JAMA, Pediatrics / 11.08.2015

Prof. Dr. med. Christian F. Poets Neonatologie, Univ.-Klinikum Tübingen Tübingen GermanyMedicalResearch.com Interview with: Prof. Dr. med. Christian F. Poets Neonatologie, Univ.-Klinikum Tübingen Tübingen Germany Medical Research: What is the background for this study? Prof. Poets: Episodes of intermittent hypoxemia (lack of oxygen) and bradycardia (slow heart rate) are common in very preterm infants and often a subject of considerable concern. However, up to now there has been a lack of knowledge as to how often or how long such episodes may occur without increasing an infant’s risk for impaired development or even death. In this study, we utilized long-term recordings (lasting 8-12 weeks) of oxygen saturation and heart rate obtained as part of the Canadian Oxygen Trial (COT), a large study performed in extremely immature infants and comparing a higher with a lower oxygen saturation target range (85-89 vs. 91-95% oxygen saturation measured by pulse oximetry). For this secondary analysis, we wanted to test the hypotheses that spending a high proportion of time at an oxygen saturation below 80% or a pulse rate <80 beats per minute increases the risk of the following adverse outcomes:
  1. Death after reaching a post-menstrual age of 36 weeks (i.e. 4 weeks before their due date) or disability, determined at 18-22 months corrected age and defined as motor impairment, cognitive or language delay, severe hearing loss, or bilateral blindness;
  2. Motor impairment (determined at 18-22 months corrected age);
  3. Cognitive or language delay (determined at 18-22 months corrected age);
  4. Severe retinopathy of prematurity.
Medical Research: What are the main findings? Prof. Poets: Analyzable recordings and outcome data were available for 1019 infants, of which the least affected 10% spent 0.4%, and the most affected infants 13.5% of the time at an oxygen saturation <80%. We found that the risk to develop all of the adverse outcomes mentioned above increased with the percentage of time spent at an oxygen saturation below 80%, but this was true only for hypoxemic events lasting for at least 1 minute. Episodes with a low heart rate (in the absence of concomitant hypoxemia) were not associated with an increased risk of an adverse outcome. Interestingly, hypoxemic events occurring in infants originally randomized to the higher oxygen group in the original COT study were associated with a stronger increase in the risk of death or disability than such episodes occurring infants randomized to the lower oxygen saturation target range.  (more…)
Author Interviews, JAMA, Neurological Disorders, Ophthalmology, Vanderbilt / 11.08.2015

MedicalResearch.com Interview with: Matthew Schrag MD Department of Neurology Yale University New Haven, Connecticut   Medical Research: What is the background for this study? What are the main findings? Dr. Schrag: Central retinal artery occlusion  (CRAO) is a relatively rare disorder that is caused by interruption of blood flow to the retina, usually by a clot or some other embolus.  Despite around 150 years of research, no compelling treatment has been found for this disease.  Treatment with fibrinolytics has been used experimentally for a long time and some of the results have been encouraging.  The point of the current study was to aggregate all of this observational data and compare how patients withCentral retinal artery occlusion do when treated with fibrinolytics versus when they are treated with other approaches or not treated at all. The biggest surprise in the data was the poor performance of conventional treatments at less than half the recovery rate of patients who were simply left alone.  The literature on treating central retinal artery occlusion with ocular massage, hemodilution or anterior chamber paracentesis has never been particularly compelling, but these treatments were thought to be harmless and are often practiced in the acute management of central retinal artery occlusion.  This new analysis strongly suggests that these interventions may be harmful.  While this data is not perfect (it is retrospective, non-randomized, acquired over long periods of time, etc), for me it raises enough doubt that I think ocular massage, anterior chamber paracentesis and hemodilution should be abandoned as treatments for acute CRAO. (more…)
Author Interviews, Emory, JAMA, Kidney Disease / 11.08.2015

Rachel Patzer, PhD, MPH Director of Health Services Research, Emory Transplant Center Assistant Professor Department of Surgery Division of Transplantation Emory University School of MedicineMedicalResearch.com Interview with: Rachel Patzer, PhD, MPH Director of Health Services Research, Emory Transplant Center Assistant Professor Department of Surgery Division of Transplantation Emory University School of Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Patzer: There are two main treatments for patients with end stage kidney disease: dialysis or kidney transplantation.  Kidney transplantation offers the best survival and quality of life compared to dialysis.  However, there is a limited supply of organs in the U.S., so not all patients with end stage organ failure get a kidney transplant. Certain regions of the country have lower access to kidney transplantation than other regions.  The Southeastern United States (GA, NC, and SC) has the lowest rates of kidney transplantation in the nation, and Georgia (GA) is the state that ranks at the very bottom. Our research team and collaborators from the Southeastern Kidney Transplant Coalition sought to examine some of the reasons for why Georgia had the lowest rates of kidney transplantation in the nation.  The transplant centers in our Coalition collaborated to share data on patient referrals from dialysis facilities, where the majority of end stage renal disease patients receive treatment, to transplant centers in Georgia. Referral from a dialysis facility to a transplant center is required for patients to undergo the extensive medical evaluation that is required for a patient to either be placed on the national deceased donor waiting list, or to receive a living donor kidney transplant (e.g. from a friend or family member). There were several major findings: 1)    That overall, referral of patients from a dialysis facility to a kidney transplant center is low (only about 28% of patients with kidney failure are referred to a transplant center within a year of starting dialysis). 2)    There was much variation in referral for transplantation across dialysis facilities in GA, where some facilities referred no patients within a year, and others referred up to 75% of their patient population. (more…)
Author Interviews, JAMA, Outcomes & Safety / 10.08.2015

MedicalResearch.com Interview with: Erika Newton MD, MPH Department of Emergency Medicine Stony Brook University Medical Center Stony Brook, NY and Brenda Sirovich MD, MS Staff Physician Co-Director Outcomes Group VA Medical Center White River Junction, VT Associate Professor of Medicine and of Community and Family Medicine Geisel School of Medicine at Dartmouth, and The Dartmouth Institute for Health Policy and Clinical Practice Division of Trauma Surgery, Department of Surgery Stony Brook University Medical Center Stony Brook, New York Medical Research: What is the background for this study? Response: Clinical performance measures – quality indicators used to evaluate and motivate health care providers' performance – play a central role right now in efforts to improve quality in U.S. health care. But their potential to influence care on a wide scale has some worried about unintended effects. In particular, there’s been growing concern that if performance measures focus disproportionately on underuse of care – that is, measuring whether enough care is being provided – they risk leading to unexpected consequences.   Specifically, if incentives tend to reward clinicians for doing more without attention to whether they do too much – this could inadvertently contribute to the problem of excessive care, or overuse. Medical Research: What are the main findings? Response: We thought it was important to look at what that balance is – between measures of underuse and measures of overuse – in outpatient practice.   We looked at 16 major national collections of performance measures and essentially counted measures targeting underuse (‘Did the clinician do enough?’) versus overuse (‘Did the clinician do too much?’). We found that over 90 percent of 521 outpatient measures targeted underuse, while a mere 7 percent of outpatient measures addressed overuse – in fact nearly half of the collections contained no overuse measures at all. (more…)
Author Interviews, Cancer Research, JAMA, Radiation Therapy, University of Michigan / 08.08.2015

Dr. Reshma Jagsi MD, DPhil Associate Professor and Deputy Chair for Faculty and Financial Operations in the Department of Radiation Oncology at the University of Michigan Health System Research Investigator at the Center for Bioethics and Social Sciences in Medicine University of MichiganMedicalResearch.com Interview with: Reshma Jagsi, MD, DPhil Associate Professor and Deputy Chair Department of Radiation Oncology University of Michigan Medical Research: What is the background for this study? What are the main findings? Response: In recent years, there has been accumulating evidence from clinical trials that have supported the long-term safety and effectiveness of shorter courses of radiation therapy—“hypofractionated radiation therapy”—for patients with breast cancer.  However, little has been known about the experiences of patients during treatment, especially when this new approach is administered outside the setting of closely controlled clinical trials.  Our study examined the side effects and patient-reported experiences during radiation treatment of over 2000 breast cancer patients in the state of Michigan.  It found that women who received hypofractionated treatment were less likely to report side effects (including skin reaction and fatigue) than patients treated with more traditional courses of radiation treatment, delivered daily over 5-6 weeks or longer. (more…)
Author Interviews, Hospital Readmissions, JAMA, Johns Hopkins / 08.08.2015

Timothy M. Pawlik, MD, MPH, MTS, PhD, FACS, FRACS (Hon.)Professor of Surgery and Oncology John L. Cameron M.D. Professor of Alimentary Tract Diseases Chief, Division of Surgical Oncology Program Director, Surgical Oncology Fellowship Director, Johns Hopkins Medicine Liver Tumor Center Multi-Disciplinary Clinic Johns Hopkins Hospital Baltimore, MD 21287MedicalResearch.com Interview with: Timothy M. Pawlik, MD, MPH, MTS, PhD, FACS, FRACS (Hon.) Professor of Surgery and Oncology John L. Cameron M.D. Professor of Alimentary Tract Diseases Chief, Division of Surgical Oncology Program Director, Surgical Oncology Fellowship Director, Johns Hopkins Medicine Liver Tumor Center Multi-Disciplinary Clinic Johns Hopkins Hospital Baltimore, MD 21287 MedicalResearch: What is the background for this study? What are the main findings? Dr. Pawlik: In 2012, the Centers for Medicare and Medicaid Services (CMS) introduced the Hospital Readmission Reduction Program (HRRP) whereby hospitals with higher than expected 30-day readmission incur financial penalties. Initially proposed to target readmissions following acute myocardial infarction, pneumonia and congestive heart failure, the program has since expanded to encompass knee and hip replacement surgery with the inclusion of additional surgical procedures anticipated in the near future. Although initial results from the Hospital Readmission Reduction Program have been promising, several concerns have been raised regarding potential limitations in methodological approach; specifically in the ability to adequately risk-adjust and account for variations in patient, provider and disease. As a consequence, many fear that the Hospital Readmission Reduction Program may disproportionately penalize safety-net hospitals as well as hospitals caring for “sicker” and more vulnerable populations. In the current study we sought to investigate factors associated with the variability in 30-day readmission among a cohort of 22,559 patients discharged following a major surgical procedure at the Johns Hopkins Hospital between 2009 and 2013. Overall, 30-day readmission was noted to be 13.2% varying from 2.1% to 24.8% by surgical specialty / procedure and from 2.1% to 32.9% by surgeon. Non-modifiable patient specific factors such as preoperative comorbidity, insurance status and race / ethnicity, were found to be most predictive of 30-day readmission as well as postoperative factors such as complications and length of stay both of which may also be influenced by preoperative comorbidity. Overall, we noted that 2.8% of the variation in 30-day readmission was attributed to provider-specific factors, 14.5% of the variability was due differences in surgical specialty / procedure while over 84% of the variability in 30-day readmission remained unaccounted for due to non-modifiable patient-specific factors. (more…)
Author Interviews, Dermatology, JAMA, NIH, Pain Research / 07.08.2015

Edward W. Cowen, MD, MHSc Dermatology Branch, Center for Cancer Research National Cancer Institute Bethesda, MarylandMedicalResearch.com Interview with: Edward W. Cowen, MD, MHSc Dermatology Branch, Center for Cancer Research National Cancer Institute Bethesda, Maryland Medical Research: What is the background for this study? Dr. Cowen: Cutaneous leiomyomas are benign smooth muscle proliferations that are associated with pain that is typically not well-controlled by topical remedies or systemic pain medication. Hereditary leiomyomatosis and renal cell cancer is a rare syndrome in which patients may have dozens or even hundreds of these painful tumors. We sought to determine if botulinum toxin injected directly into leiomyomas may ameliorate discomfort and improve quality of life in patients who experience significant pain from cutaneous leiomyomas. Medical Research: What are the main findings? Dr. Cowen: In a double-blinded placebo-controlled study, we found that injection of botulinum toxin was associated with improved skin-related quality of life (p = 0.007) and decreased skin-specific pain (p = 0.048) on the Dermatology Life Quality Index. A trend for decreased pain (p = 0.06) by visual analog score was reported in the botulinum toxin treated group compared to the placebo group. (more…)
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…)