Author Interviews, JAMA, Pediatrics, University Texas / 24.08.2015

Jeffrey R. Kaiser, MD, MA Professor of Pediatrics and Obstetrics and Gynecology Section of Neonatology Baylor College of Medicine Texas Children's Hospital Houston, TX 77030MedicalResearch.com Interview with: Jeffrey R. Kaiser, MD, MA Professor of Pediatrics and Obstetrics and Gynecology Section of Neonatology Baylor College of Medicine Texas Children's Hospital Houston, TX 77030 Medical Research: What is the background for this study? What are the main findings? Dr. Kaiser:  The continuous utero-placental-umbilical infusion of glucose ends at birth, and levels decrease during the first 1–2 hours stimulating counterregulatory hormones and promoting successful glucose homeostasis in healthy newborns. This is important because the newborn brain principally uses glucose for energy, and prolonged and severe hypoglycemia has been linked with poor long-term neurodevelopment. Most previous newborn hypoglycemia-outcome studies, however, are problematic because they did not control for maternal educational level and socioeconomic status, factors that are highly associated with childhood neurodevelopment and academic success. Further, little is known about whether newborn transient hypoglycemia (1 low value followed by a second normal value), frequently considered to be a normal physiological phenomena with no serious sequelae, is associated with poor academic achievement. To address this knowledge gap, we compared initial newborn glucose values from the universal glucose-screening database, available only at the University of Arkansas for Medical Sciences (UAMS), to their matched student achievement-test scores in 4th grade (10 years later). After controlling for gestational-age group, race, gender, multifetal gestation, insurance, maternal education, and gravidity, we observed transient hypoglycemia in a heterogeneous cohort of newborns born at a university hospital was associated with lower fourth-grade achievement-test scores—real-world assessments that predict high school graduation, college attendance, and long-term adult economic success. (more…)
Author Interviews, Dermatology, Emory, JAMA, Sexual Health / 23.08.2015

MedicalResearch.com Interview with: Howa Yeung, MD PGY3, Emory Dermatology Emory University Medical Research: What is the background for this study? What are the main findings? Dr. Yeung: Indoor tanning is a well-established and preventable cause for melanomas and non-melanoma skin cancers. Public health efforts in curbing indoor tanning have focused on known high-risk populations, such as young, college-aged, White women. However, other demographic risk factors for indoor tanning remain unknown. As our nation increasingly focuses on addressing and improving the health of lesbian, gay, bisexual, and transgender (LGBT) individuals, more and more evidence demonstrates that various LGBT subpopulations face higher rates of cancer-related behavior risk factors, such as smoking, alcohol use, obesity, etc. We wanted to find out whether risk factors for skin cancer, such as indoor tanning, disproportionately affected LGBT populations. Our study showed higher rates of indoor tanning among gay and bisexual men, with 1.8-fold and 3.6-fold higher odds of tanning bed use within the past year, compared to straight men, after adjusting for sociodemographic factors. Disparities in frequent tanning, defined as using tanning bed 10 or more times within the past year, are even more prominent among gay and bisexual men. In contrast, no significant sexual orientation disparities were noted among women after adjusting for sociodemographic factors. (more…)
Author Interviews, JAMA, Orthopedics, Surgical Research / 22.08.2015

MedicalResearch.com Interview with: Sandrine Colas, MSc, MPH Department of Epidemiology of Health Products French National Agency for Medicines and Health Products Safety (ANSM) Saint-Denis, France Medical Research: What is the background for this study? What are the main findings? Response: Total hip replacement (THR) is to replace a damaged coxofemoral joint with a prosthetic implant. Primary or secondary degenerative osteoarthritis of the hip joint is the main indication for THR (other indications are essentially trauma, which is more common in the elderly and mostly affects women over 80 years of age). The number of THR has increased in all industrialized countries, particularly on account of the ageng population.Total hip replacement is one of the most common and successful surgical procedures in modern practice. Although results are generally good, revision (consisting in changing one or all components of the implant) is sometimes necessary (about 1% per year). Prosthetic revision is a longer and more complex operation than primary implantation and it has a higher incidence of post-surgical complications. Several prosthetic revision risk factors have been highlighted recently in published studies, but results relating to prosthetic and/or patient characteristics and total hip replacement survivorship tend to vary. The existence of an association between the fixation technique and/or bearing surface and prosthetic survivorship has yet to be established. The main aim of our work was therefore to compare total hip replacement short-term survivorship according to cement type and bearing surface, in a large population of subjects who have undergone total hip replacement for reasons other than trauma (25%) and bone tumor (<0.1%), taking prosthetic revision risk factors (age, gender, comorbidities, concomitant medication, implanting center, etc.) into account. Total hip replacement characteristics are related to early implant survivorship. After 33 months of follow-up, antibiotic-impregnated cemented THRs have a better prognosis. MoM total hip replacemenst have a slightly worse prognosis. (more…)
Author Interviews, JAMA, Opiods, Pharmacology / 21.08.2015

Lainie Rutkow, JD, PhD, MPH Associate Professor Department of Health Policy and Management Johns Hopkins Bloomberg School of Public HealMedicalResearch.com Interview with: Lainie Rutkow, JD, PhD, MPH Associate Professor Department of Health Policy and Management Johns Hopkins Bloomberg School of Public Health  Medical Research: What is the background for this study? What are the main findings? Dr. Rutkow: Rates of prescription drug diversion and misuse, as well as overdose deaths, have increased throughout the United States. CDC estimates that each day, 44 people die from a prescription drug overdose. In the mid-2000s, Florida was viewed as the epicenter of this epidemic, with prescription drug overdose deaths increasing more than 80% from 2003 to 2009. In response, Florida enacted several laws to mitigate prescription drug abuse and diversion. Its pill mill law required pain management clinics to register with the state and prohibited physician dispensing of certain drugs. Florida’s Prescription Drug Monitoring Program (PDMP) collects data about dispensing of prescription drugs and can be accessed by physicians and pharmacists. Little is known about how these laws have affected prescribing of opioids. We applied comparative interrupted time series analyses to pharmacy claims data to examine four outcomes related to opioid prescribing in Florida, with Georgia as a comparison state. We found that in the first year of implementation, Florida’s Prescription Drug Monitoring Program and pill mill law were associated with modest reductions in prescription opioid volume, prescriptions written, and the dose per prescription. These declines were statistically significant among the highest volume prescribers and patients at baseline. (more…)
Author Interviews, Diabetes, JAMA, Weight Research / 19.08.2015

Melanie J Davies MB ChB MD FRCP FRCGP Professor of Diabetes Medicine 
NIHR Senior Investigator Leicester Diabetes Unit
Leicester Diabetes Centre Bloom
University of Leicester MedicalResearch.com Interview Invitation Melanie J Davies MB ChB MD FRCP FRCGP Professor of Diabetes Medicine 
NIHR Senior Investigator Leicester Diabetes Unit
Leicester Diabetes Centre Bloom
 University of Leicester   MedicalResearch: What is the background for this study? What are the main findings?
 Dr. Davies: This study was designed to test the efficacy and safety of Liraglutide using a dose of 3mg for weight loss among patients with type 2 diabetes.  It was a large international study in which we compared once daily subcutaneous Liraglutide at a dose of 3mg to Liraglutide 1.8mg which is the current maximum dose licenced in patients with diabetes and placebo.  In all patients we offered a calorie deficit diet and lifestyle advice to increase physical activity.  Our main findings were that the dose of 3mg of Liraglutide resulted in greater weight loss than both other arms of the study indeed 54% of patients at 56 weeks achieved more than 5% weight loss and a further 25% were able to achieve more than 10% weight loss.  The 3mg of Liraglutide compared to the placebo, there were also significant impacts on HbA1c and other cardiovascular risk factors such as systolic blood pressure and lipids as well as improving patient quality of life particularly physical functioning and patient treatment satisfaction.  (more…)
Author Interviews, Cost of Health Care, Infections, JAMA, Pharmacology / 19.08.2015

Jerome A. Leis, MD MSc FRCPC Division of Infectious Diseases, Sunnybrook Health Sciences Centre Physician Lead, Antimicrobial Stewardship Team Faculty Quality Improvement Advisor, Centre for QuIPS Assistant Professor, Department of Medicine, University of Toronto Sunnybrook Health Sciences Centre Toronto, OntarioMedicalResearch.com Interview with: Jerome A. Leis, MD MSc FRCPC Division of Infectious Diseases Sunnybrook Health Sciences Centre Physician Lead, Antimicrobial Stewardship Team Faculty Quality Improvement Advisor, Centre for QuIPS Assistant Professor, Department of Medicine University of Toronto Sunnybrook Health Sciences Centre Toronto, Ontario Medical Research: What is the background for this study? What are the main findings? Dr. Leis: We know that urinary tract infections are frequently diagnosed among general medicine patients who lack symptoms of this infection.  We wondered whether urinalysis ordering practices in the Emergency Department influence diagnosis and treatment for urinary tract infection among these asymptomatic patients.  We found that over half of patients admitted to the general medicine service underwent a urinalysis in the Emergency Department of which over 80% lacked a clinical indication for this test.  Urinalysis results among these asymptomatic patients did influence diagnosis as patients with incidental positive results were more likely to undergo urine cultures and treatment with antibiotics for urinary tract infection.  The study suggests that unnecessary urinalysis ordering contributes to over-diagnosis and treatment of urinary tract infection among patients admitted to general medicine service. (more…)
Author Interviews, Depression, JAMA, Pediatrics / 18.08.2015

Edward D. Barker, PhD Developmental Psychopathology Group Department of Psychology, King’s College London Institute of Psychiatry LondonMedicalResearch.com Interview with: Edward D. Barker, PhD Developmental Psychopathology Group Department of Psychology, King’s College London Institute of Psychiatry London Medical Research: What is the background for this study? Dr. Barker: The study looks at how the brain may be affected by experiences that happen early in life and adolescence. It has been known for a long time now that people who experience intense adversity are at increased risk of developing depression and other psychiatric problems. Previous research has also shown that both adversity and depression can affect the development of the brain and lead to altered brain structure. In this study, we wanted to examine how early adversity and depression relate to altered brain structure when you examined each within a specific temporal order (i.e., adversity, then depression/anxiety, then brain structure). This study design allowed us to examine not only the effects of adversity and depression, but also if some of the variation in brain structure associated with depression may also be explained by early adversity. Other researchers have previously suggested that some of the variation in brain structure observed in depressed patients may relate to early adversity, but no previous study has examined this prospectively like we did, using the Avon Longitudinal Study of Parents and Children. (more…)
Author Interviews, Breast Cancer, Genetic Research, JAMA, Ovarian Cancer / 13.08.2015

Leif W. Ellisen, M.D., Ph.D Professor of Medicine, Harvard Medical School Program Director, Breast Medical Oncology Co-Leader, Breast Cancer Program MGH Research Scholar MGH Cancer Center Boston, MA 02114MedicalResearch.com Interview with: Leif W. Ellisen, M.D., Ph.D Professor of Medicine, Harvard Medical School Program Director, Breast Medical Oncology Co-Leader, Breast Cancer Program MGH Research Scholar MGH Cancer Center Boston, MA 02114 Medical Research: What is the background for this study? What are the main findings? Dr. Ellisen: The traditional approach to genetic testing for women with suspected hereditary breast and/or ovarian cancer risk is to test for BRCA1 and BRCA2 alone. Recent studies have shown that testing with a multi-gene panel finds relevant risk gene mutations in substantially more women than does testing for BRCA1 and BRCA2 alone. However, one of the concerns about broader multi-gene testing has been that the results really wouldn’t change what you told women about their risk and management – either because the risk associated with the other genes may not be as high as for BRCA1/2, or because the clinical practice guidelines associated with some of the other genes are less specific. Our study sought to determine how often testing such women using a multi-gene panel would find mutations in genes other than BRCA1/2, and more importantly to ask whether finding those mutations would change how you would manage the patient and their family. We found that multi-gene panel testing finds relevant risk gene mutations in substantially more women (approximately 40% more) than does testing for BRCA1 and BRCA2 alone. Furthermore, in a case-by-case analysis we showed that finding mutations in these other genes is likely to change the clinical management that is considered or recommended for the majority of the mutation-positive women and their families.  Notably, our analysis of the predicted management change is based not just on the gene mutation alone, but on how the gene appears to be behaving in that particular family. (more…)
Author Interviews, Fertility, JAMA / 13.08.2015

Vitaly A Kushnir MD The Center for Human Reproduction New York, NY 10021MedicalResearch.com Interview with: Vitaly A Kushnir MD The Center for Human Reproduction New York, NY 10021 Medical Research: What is the background for this study? What are the main findings? Dr. Kushnir: In January 2013, the American Society for Reproductive Medicine declared the technique of oocyte cryopreservation no longer experimental, although they body did call for further study. Vitaly A. Kushnir, M.D., of the Center for Human Reproduction, and colleagues used 2013 data from 380 U.S fertility centers to compare live birth and cycle cancellation rates using either fresh or cryopreserved donor oocytes. The study found roughly 20 percent of donor cycles used cryopreserved oocytes and 80 percent fresh oocytes. Of those embryos transferred, 56 percent that started as fresh oocytes resulted in live births compared to just 47 percent of those that started as cryopreserved oocytes. (more…)
Author Interviews, Biomarkers, Dermatology, JAMA, Pulmonary Disease, University of Pennsylvania / 12.08.2015

Misha A. Rosenbach, MD Assistant Professor of Dermatology at the Hospital of the University of Pennsylvania Assistant Professor of Dermatology in MedicineMedicalResearch.com Interview with: Misha A. Rosenbach, MD Assistant Professor of Dermatology at the Hospital of the University of Pennsylvania Assistant Professor of Dermatology in Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Rosenbach: Sarcoidosis is an inflammatory disease of unknown etiology where genetically susceptible patients develop multi-organ granulomatous inflammation in response to an as-yet unidentified stimulus.  Patients with sarcoidosis typically have granulomatous inflammation in their lungs, but the second most commonly affected organ is the skin; the eyes, lymph nodes, liver, heart, brain, and other organs can be affected as well.  Patients with sarcoidosis can experience a few disease trajectories; some spontaneously recover, while others have persistent, active inflammation, whereas another group can experience inflammation which leads to scarring and fibrosis.  It can be challenging to distinguish these cohorts of patients based on their lungs alone. The skin is much easier to evaluate, as it is right there on the surface, and can be examined by physicians without resorting to invasive tests or radiography.  At Penn, we developed a novel cutaneous sarcoidosis assessment tool, called the Cutaneous Sarcoidosis Activity and Morphology Instrument (CSAMI), which is designed to accurately measure how inflamed skin sarcoid lesions are in a given patient, as well as describing which type of cutaneous lesion patients’ have.  The CSAMI has in previously studies been shown to be reliable when used by dermatologists, with excellent inter-rater and intra-rater reproducibility. In this study, we had a group of Pulmonologists, Rheumatologists, and Dermatologists (representing the groups of physicians who most commonly care for patients with sarcoidosis, especially if there is skin involvement) evaluate a group of patients with cutaneous sarcoidosis, using the CSAMI and another sarcoidosis activity instrument, the SASI, which has also previously been used to measure skin sarcoidosis activity in a number of settings.  We were able to demonstrate that these cutaneous scoring tools are reliable and reproducible and able to accurately measure cutaneous sarcoidosis disease activity in a variety of patients with a range of skin disease severity.  We also compared the physician scores to patients’ own evaluations of their disease, and showed that the CSAMI (physician impression of disease) correlated well with patients’ own perception of their disease activity and severity. (more…)
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…)