Author Interviews, JAMA, Surgical Research, Urology / 10.09.2015

MedicalResearch.com Interview with: Blayne Welk MD Assistant Professor in the Division of Urology The University of Western OntarioBlayne Welk MD Assistant Professor in the Division of Urology The University of Western Ontario Medical Research: What is the background for this study? What are the main findings? Dr. Welk: Stress incontinence is a common problem among women. The most frequently used surgical treatment is a mesh-based midurethral sling. This procedure is commonly called a transvaginal sling, and is usually an outpatient procedure that takes about an hour in the operating room. However, there has been significant concern about some of the complications of this procedure, which include chronic pain, and mesh erosions into the urinary tract. This prompted the FDA and Health Canada to issue warnings regarding the use of transvaginal mesh, and numerous lawsuits have been launched against manufactures of transvaginal mesh products. This study by Dr Welk and colleagues identifies the long term rate of surgical treated complications among a group of almost 60,000 women who had mesh based incontinence procedures between 2002-2012. The rate of surgically treated complications at 1 year is 1.2%, however this increased to 3.3% after 10 years of followup. The FDA and Health Canada recommend that surgeons obtain training and experience in their chosen type of midurethral sling, and we demonstrated that patients of high volume surgeons (who frequently performed mesh based incontinence procedures) were 27% less likely to have one of these complications. (more…)
Author Interviews, Diabetes, JAMA / 09.09.2015

Dr. Andy Menke PhD Social & Scientific Systems Inc Silver Spring, MD 20910MedicalResearch.com Interview with: Dr. Andy Menke PhD Social & Scientific Systems Inc Silver Spring, MD 20910 Medical Research: What is the background for this study? What are the main findings? Dr. Menke: Previous studies have shown an increase in diabetes over time. We wanted to use the most recent data available to estimate the prevalence and trends in diabetes in the US population. We found that 14% of US adults had diabetes and the prevalence was higher in blacks, Hispanics, and Asians. About 1 in 3 people with diabetes were unaware that they had the condition and this was even higher in Asians and Hispanics where half were unaware that they had it. Also, among US adults, 1 in 3 people have prediabetes, which means that roughly half of all US adults have either diabetes or prediabetes. Between 1988-1994 and 2011-2012, diabetes prevalence increased by 25% among adults in the US population. The increase over time occurred in every age group, race group, and both genders. (more…)
Author Interviews, Infections, JAMA, OBGYNE / 08.09.2015

Dr. Martin N. Mwangi Researcher Division of Human Nutrition, Nutrition and Health over the lifecourse International Nutrition Unit Wageningen University The Netherlands MedicalResearch.com Interview with: Dr. Martin N. Mwangi Researcher Division of Human Nutrition, Nutrition and Health over the lifecourse International Nutrition Unit Wageningen University The Netherlands   Medical Research: What is the background for this study? Dr. Mwangi : Anemia in pregnancy is a moderate or severe health problem in more than 80 percent of countries worldwide, but particularly in Africa, where it affects 57 percent of pregnant women. Iron deficiency is the most common cause, but iron supplementation during pregnancy has uncertain health benefits. There is some evidence to suggest that iron supplementation may increase the risk of infectious diseases, including malaria. Our main objective was to measure the effect of antenatal iron supplementation on maternal Plasmodium infection risk, maternal iron status, and neonatal outcomes. We randomly assigned 470 pregnant Kenyan women living in a malaria endemic area to daily supplementation with 60 mg of iron (n = 237 women) or placebo (n = 233) until 1 month postpartum. All women received 5.7 mg iron/day through flour fortification during intervention and usual intermittent preventive treatment against malaria. Medical Research: What are the main findings? Dr. Mwangi : Overall, we found no effect of daily iron supplementation during pregnancy on risk of maternal Plasmodium infection. Iron supplementation resulted in an increased birth weight [5.3 ounces], gestational duration, and neonatal length; enhanced maternal and infant iron stores at 1 month after birth; and a decreased risk of low birth weight (by 58 percent) and prematurity. The effect on birth weight was influenced by initial maternal iron status. Correction of maternal iron deficiency led to an increase in birth weight by [8.4 ounces]. (more…)
Author Interviews, C. difficile, JAMA, UC Davis / 08.09.2015

Christopher R. Polage, M. D. Associate Professor of Pathology and Infectious Diseases University of California, Davis School of Medicine Medical Director, Microbiology Laboratory and SARC UC Davis Health System MedicalResearch.com Interview with: Christopher R. Polage, M. D. Associate Professor of Pathology and Infectious Diseases University of California, Davis School of Medicine Medical Director, Microbiology Laboratory and SARC UC Davis Health System   Medical Research: What is the background for this study? Dr. Polage: Clostridium difficile is a frequent cause of diarrhea and infection in U.S. hospitals but common diagnostic tests often disagree about which patients are infected or need treatment. We compared clinical symptoms and outcomes in hospitalized patients with different C. difficile test results to determine which type of test (molecular or PCR test versus toxin test) was the better predictor of need for treatment and disease. Medical Research: What are the main findings? Dr. Polage: Twice as many patients were positive by the molecular test versus the conventional toxin test. However, patients with a positive molecular test only had a shorter duration of symptoms than patients with toxins, and outcomes that were similar to patients withoutC. difficile by all test methods. Virtually all traditional complications of C. difficile infection occurred in patients with a positive toxin test; none occurred in patients with a positive molecular test only, despite little or no treatment. (more…)
Author Interviews, Cost of Health Care, JAMA / 08.09.2015

James C. Robinson PhD MPH Leonard D. Schaeffer Professor of Health Economics Director, Berkeley Center for Health Technology Head, Division of Health Policy & Management School of Public Health, University of California– Berkeley University Hall, Berkeley, CA MedicalResearch.com Interview with: James C. Robinson PhD MPH Leonard D. Schaeffer Professor of Health Economics Director, Berkeley Center for Health Technology Head, Division of Health Policy & Management School of Public Health, University of California– Berkeley University Hall, Berkeley, CA   Medical Research: What is the background for this study? What are the main findings? Dr. Robinson: Employers and insurers face wide variation in the prices of similar tests and procedures within the same local communities, resulting from the indifference to price on the part of well-insured patients.  They are raising deductibles to increase price sensitivity, but deductibles mostly target low-cost primary care services whereas their concerns often center on high-cost specialty and facility services.  Some are adopting reference pricing, which sets a maximum insurer contribution for a particular type of test or procedure and then requires consumers selecting more expensive options to pay the difference themselves.  The insurers contribution limit typically is set at the median or other midpoint in the market distribution of prices. We studied the implementation of reference pricing for colonoscopy, using data from the California Public Employees Retirement System (CalPERS) from 2009-13, with a control group from Blue Cross of California.  Our data include detailed claims from almost 300,000 colonoscopy procedures and patients.  We find that patients who must pay the extra fees themselves are much more likely to select cheaper ambulatory facilities for their colonoscopies, compared to consumers who do not face reference pricing.  This leads to lower prices being paid by the employer and significant savings.  Detailed analyses of gastroenterological and cardiovascular complications of the colonoscopy procedures found no adverse effect of reference pricing on quality. (more…)
Author Interviews, Dermatology, JAMA, Melanoma / 03.09.2015

Simone Ribero, M.D., Ph.D. University of Turin Department of Medical Sciences Turin Italy and King’s College London Department of Twin Research and Genetic Epidemiology St Thomas’ campus London, UKMedicalResearch.com Interview with: Simone Ribero,  M.D., Ph.D.  University of Turin Department of Medical Sciences Turin Italy and King’s College London Department of Twin Research and Genetic Epidemiology St Thomas’ campus London, UK Medical Research: What is the background for this study? What are the main findings? Response: The histologic regression is a discussed feature and its prognostic role is debated in literature. Our group has previously described a favorable prognostic role of histological regression in stage I-II melanoma patients. Some clinicians still perform Sentinel Lymph Node biopsy on the basis of regression in thin melanoma considering this feature as able to underestimate Breslow Thickness. In this study we described in a metanalyses with more then 10000 melanoma patients that histological regression is inversely associated with Sentinel Lymph Node positivity. (more…)
Author Interviews, CDC, HIV, JAMA / 02.09.2015

Dr. John Weiser MD MPH Medical epidemiologist Division of HIV/AIDS Prevention CDC MedicalResearch.com Interview with: Dr. John Weiser MD MPH Medical epidemiologist Division of HIV/AIDS Prevention CDC  Medical Research: What is the background for this study? What are the main findings? Dr. Weiser: Ryan White was an Indiana teenager diagnosed with AIDS in the late 1980s. As a result of fear and stigma, he was barred from school and went on to become a national advocate for HIV education and acceptance. This year marks the 25th anniversary of his death and passage of the Ryan White CARE Act creating The Ryan White HIV/AIDS Program (RWHAP) which provides funding for healthcare facilities to deliver needed medical care and support services for hundreds of thousands of poor, uninsured, and underinsured Americans. While increased access to Medicaid and private insurance under the Affordable Care Act will provide coverage for medical care, it might not provide coverage for support services so it is likely that the RWHAP will continue to play a key role in providing these crucial services. Overall, 34.4 percent of facilities received Ryan White HIV/AIDS Program funding and 72.8 percent of patients received care at RWHAP-funded facilities. Many of the patients at Ryan White HIV/AIDS Program -funded facilities had multiple social determinants of poor health, with patients at RWHAP-funded facilities more likely to be ages 18 to 29; female; black or Hispanic; have less than a high school education; income at or below the poverty level; and lack health care coverage. Despite the greater likelihood of poverty, unstable housing and lack of health care coverage, nearly 75 percent of patients receiving care at RWHAP-funded facilities achieved viral suppression. The percentage of ART (antiretroviral therapy) prescribing was similar for patients at RWHAP-funded compared with non-funded facilities. Patients at RWHAP-funded facilities were less likely to be virally suppressed. However, individuals at or below the poverty level and those ages 30 to 39 who received care at a RWHAP-funded facility compared with those who received care at a non-RWHAP-funded facility were more likely to achieve viral suppression. (more…)
Accidents & Violence, Author Interviews, JAMA, UCSF / 02.09.2015

Benjamin N. Breyer MD, MAS, FACS Associate Professor in Residence Department of Urology University of California, San Francisco Chief of Urology, San Francisco General Hospital Director, UCSF Male Genitourinary Reconstruction and Trauma Surgery Fellowship MedicalResearch.com Interview with: Benjamin N. Breyer MD, MAS, FACS Associate Professor in Residence Department of Urology University of California, San Francisco Chief of Urology, San Francisco General Hospital Director, UCSF Male Genitourinary Reconstruction and Trauma Surgery Fellowship   Medical Research: What is the background for this study? What are the main findings? Dr. Breyer: Our group has studied genitourinary-specific injuries associated with bicycles using a national surveillance injury database called NEISS (National Electronic Injury Surveillance System), that monitors injuries associated with specific products.  In the current study, we examined trends in all bicycle-related injuries from  1997 to 2013.  We found an increase in bicycle-related injuries over the study period, even after adjusting for growth in the US population.  Even more concerning, we found the percentage of bicycle-related injuries resulting in admission increased 120%, suggesting the injuries sustained while cycling are becoming more severe.  These trends appear to be driven by a substantial rise in both injuries and admissions in individuals over 45 years of age, which likely reflects a change in the demographic of cyclists in the US - multiple studies have shown an increase in the cycling participation of adults over the age of 45. Bicycles are no longer children's toys - they are increasingly being used by adults as a means of transportation and physical activity. The rise in cycling in adults over the age 45 appears to be driving both the increase in injuries and admissions, suggesting that older individuals are at increased risk for sustaining severe injury while cycling. (more…)
Author Interviews, Diabetes, JAMA, Kidney Disease / 01.09.2015

George L. Bakris MD Professor of Medicine Director, Comprehensive Hypertension Center University of Chicago MedicineMedicalResearch.com Interview with: George L. Bakris MD Professor of Medicine Director, Comprehensive Hypertension Center University of Chicago Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Bakris: Aldosterone receptor antagonists such as spironolactone are known to reduce mortality from heart failure and reduce albuminuria, a well-known marker of diabetic kidney disease progression. Finerenone is a novel nonsteroidal aldosterone receptor antagonist and is associated with less hyperkalemia (high blood potassium levels) compared to traditional aldosterone receptor blockers like spironolactone. The current study was a dose finding study to ascertain the optimal dose of finerenone for reducing urine albumin (a key risk marker in people with diabetic kidney disease) that is also associated with the smallest rise in serum potassium. The main findings are that in a dose dependent manner finerenone reduced albuminuria and at the highest dose a modest rise in serum potassium. Finerenone was also very well tolerated.  (more…)
Author Interviews, Heart Disease, JAMA, Thromboembolism / 01.09.2015

Line Melgaard MSc. Industrial Medicine, PhD student AALBORG Univerity Hospital Thrombosis Research Center Aalborg Aalborg Hospital Science and Innovation Center Aalborg DenmarkMedicalResearch.com Interview with: Line Melgaard MSc. Industrial Medicine, PhD student AALBORG Univerity Hospital Thrombosis Research Center Aalborg Aalborg Hospital Science and Innovation Center Aalborg Denmark Medical Research: What is the background for this study? What are the main findings? Response: In recent years, use of the CHA2DS2-VASc score in predicting ischemic stroke, thromboembolism, and death has extended beyond the original disease state (atrial fibrillation) for which it was proposed. In addition, it is recognized that the cluster of multiple stroke risk factors included within the CHA2DS2-VASc score increases the risk of ischemic stroke, thromboembolism, and death, whether or not atrial fibrillation is present. Thus, there is a need to study the extent to which concomitant atrial fibrillation modifies the pattern of the association between CHA2DS2-VASc score and the risk of ischemic stroke, thromboembolism, and death in patients with heart failure.
  • Our principal findings were that patients with heart failure had a high risk of ischemic stroke, thromboembolism, and death, whether or not atrial fibrillation was present.
  • Second, the CHA2DS2-VASc score was able to modestly predict these endpoints, and had a moderately high negative predictive value at 1-year follow-up.
  • Third, at high CHA2DS2-VASc scores (≥4), patients with heart failure without atrial fibrillation had high absolute risk of ischemic stroke, thromboembolism, and death, and the absolute risk increased in a comparable manner in patients with heart failure with and without atrial fibrillation, exhibiting a clear dose-response relationship. Indeed, the absolute risk of thromboembolic complications was higher among patients without atrial fibrillation compared to patients with concomitant atrial fibrillation at high CHA2DS2-VASc score (≥4).
(more…)
Author Interviews, JAMA, Multiple Sclerosis, OBGYNE / 01.09.2015

PD Dr. Kerstin Hellwig Neurologische Abteilung Universitätsklinikum St. Josef Hospital BochumMedicalResearch.com Interview with: PD Dr. Kerstin Hellwig Neurologische Abteilung Universitätsklinikum St. Josef Hospital Bochum Medical Research: What is the background for this study? What are the main findings? Dr. Hellwig: The relapse risk is elevated in women with Multiple Sclerosis after delivery. We found that women with Multiple Sclerosis who breastfed exclusively had a significant lower relapse risk, than women who did not breastfed at all or breastfed some but not exclusively. After the introduction of supplemental feedings, the relase risk was similar between both groups. (more…)
Author Interviews, Breast Cancer, Duke, Genetic Research, JAMA / 27.08.2015

Michaela Ann Dinan Ph.D. Assistant Professor in Medicine Member of Duke Cancer Institute Duke University School of MedicinMedicalResearch.com Interview with: Michaela Ann Dinan Ph.D. Assistant Professor in Medicine Member of Duke Cancer Institute Duke University School of Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Dinan: For many years we have known that overall, women with early stage, hormone receptor positive breast cancer show an overall survival benefit from the receipt of adjuvant chemotherapy.  However, depending on the age of the patient, we have also known that between 3 to 10% of patients appear to be truly experiencing this survival benefit and that we are treating a lot of women unnecessarily.  The use of the Oncotype DX assay has provided additional information for patients to assess who at low risk of disease progression and can forgo chemotherapy. In this study we looked to see whether the adoption of this assay was associated with reduce rates of chemotherapy in women over the age of 65.  We found that somewhat surprisingly, there was no overall association with receipt of the assay and use of chemotherapy.  However, in women who had high risk disease, receipt of the assay was associated with reduced rates of chemotherapy use.  In patients with low risk disease, receipt of the assay was associated with increased chemotherapy use. (more…)
Author Interviews, Heart Disease, JAMA / 27.08.2015

Jay R. Desai, PhD, MPH HealthPartners Institute for Education and Research Minneapolis, MN 55425MedicalResearch.com Interview with: Jay R. Desai, PhD, MPH HealthPartners Institute for Education and Research Minneapolis, MN 55425 Medical Research: What is the background for this study? What are the main findings? Dr. Desai: SUPREME-DM is a consortium of 11 integrated health systems throughout the United States that serve a culturally and economically diverse population of 16 million members. This study monitors changes in cardiovascular outcomes from 2005 through 2011 among the 1.2 million members identified with diabetes and a matched sample of 1.2 million members without diabetes. We found very encouraging and sustained declines in the rates of myocardial infarction/acute coronary syndrome (MI), stroke, heart failure (HF), and all-cause mortality among adults with and without diabetes.   Declines were greatest among the 15% adults who were already at high risk for cardiovascular events (such as people with diabetes or a prior history of heart disease). There was less improvement in cardiovascular event rates and mortality among the other 85% of members with low to moderate cardiovascular risk. (more…)
Author Interviews, JAMA, Social Issues / 26.08.2015

Adi V. Gundlapalli, MD, PhD Associate Professor of Internal Medicine University of Utah School of Medicine and University of Utah Hospitals and ClinicsInformatics, Decision Enhancement, and Analytic Sciences Center VA Salt Lake City Health Care System, Salt Lake City, Utah MedicalResearch.com Interview with: Adi V. Gundlapalli, MD, PhD Associate Professor of Internal Medicine University of Utah School of Medicine and University of Utah Hospitals and ClinicsInformatics, Decision Enhancement, and Analytic Sciences Center VA Salt Lake City Health Care System, Salt Lake City, Utah   Medical Research: What is the background for this study? What are the main findings? Dr. Gundlapalli: We wanted to explore the hypothesis that those separated for misconduct-related reasons would have more difficulty reintegrating into their communities post-deployment, with homelessness as an extreme example of such difficulties. Misconduct-related separations from the military are associated with subsequent adverse civilian outcomes that are of substantial public health concern. This study analyzed the association between misconduct-related separations and homelessness among recently returned active-duty military service members. Using US Department of Veterans Affairs (VA) data, investigators identified 448,290 Veterans who were separated from the military (end date of last deployment) between October 1, 2001 and December 31, 2011; had been deployed to Iraq and/or Afghanistan; and had subsequently used VA healthcare. Homelessness was determined by an assignment of “lack of housing” during a VA healthcare visit, by participation in a VA homelessness program, or both. Veterans’ housing status was followed through April 30, 2012. We assessed risk for homelessness as a function of separation category (e.g., normal, misconduct, early release), controlling for patient demographics and military service covariates, including service-related disability, branch, rank, and combat exposure. In our opinion, the most significant finding was that 26% of Veterans who were separated for misconduct related reasons were homeless at their first VA encounter; and this number climbed to 28% within one year after their first VA encounter. Additionally, the likelihood of being homeless at the first VA encounter was nearly 5 times greater for those separated for misconduct-related reasons as compared to normal separations; this climbed to nearly 7 times greater at one year after the first VA encounter. Collectively, these results represent the strongest risk factor for homelessness among US Veterans observed to date, and helps to explain the higher risk of homelessness observed among Veterans, despite access to VA benefits and services. (more…)
Alzheimer's - Dementia, Author Interviews, JAMA / 26.08.2015

Dr. Eric Reiman MD Executive Director, Banner Alzheimer’s Institute (BAI) Chief Executive Officer, Banner Research, Clinical Director of the Neurogenomics Division at the Translational Genomics Research Institute (TGen) Professor of Psychiatry, University of Arizona Director, Arizona Alzheimer’s ConsortiumMedicalResearch.com Interview with: Dr. Eric Reiman MD Executive Director, Banner Alzheimer’s Institute (BAI) Chief Executive Officer, Banner Research Clinical Director of the Neurogenomics Division at the Translational Genomics Research Institute (TGen) Professor of Psychiatry, University of Arizona Director, Arizona Alzheimer’s Consortium Phoenix Arizona   Medical Research: What is the background for this study? What are the main findings? Dr. Reiman: Beta-amyloid plaque deposition is a cardinal feature of Alzheimer’s disease. Recent positron emission tomography (PET) have suggested that about one-fourth of patients with the clinical diagnosis of mild-to-moderate Alzheimer’s dementia—and more than a third of those who had no copies of the APOE4 gene, the major genetic risk factor for Alzheimer’s—do not have appreciable amyloid plaque deposition. We wondered whether this finding reflected an absence of appreciable brain amyloid, particularly in APOE4 non-carriers, or instead an underestimation of amyloid plaques using PET. In those patients with minimal plaque deposition, we also wondered what percentages had neuropathological evidence of another dementia-causing disease, neurofibrillary tangle pathology (the other cardinal feature of Alzheimer’s, or no known pathological contribution. We surveyed data from the 100 APOE4 non-carriers and 100 APOE4 carriers who had the clinical diagnosis of mild-to-moderate Alzheimer’s dementia during their last visit at any of the nation’s Alzheimer’s Disease Centers and had an autopsy performed within the next 2 years. As we reported in JAMA Neurology, 37 percent of APOE4 non-carriers and 13 percent of APOE4 carriers with a clinical diagnosis of mild-to-moderate Alzheimer’s had minimal evidence of neuritic or diffuse amyloid plaques—and those for whom we had brain samples had no evidence of increased soluble amyloid. A proportion of individuals had a different neuropathological diagnosis. While nearly half of those patients with minimal amyloid or any other pathology had extensive tangle formation, a similar percentage was found in cognitively unimpaired persons in the same age range. Our findings suggest the PET findings are correct – that a quarter of all patients (and more than a third of APOE4 non-carriers) with the clinical diagnosis of Alzheimer’s dementia do not have appreciable amyloid pathology, and that about 10 to 15 percent of patients do not have a clear explanation for their dementia. (more…)
Author Interviews, Blood Pressure - Hypertension, Cognitive Issues, Geriatrics, JAMA / 25.08.2015

MedicalResearch.com Interview with: Justine Moonen and Jessica Foster-Dingley On behalf of the principal investigators: Roos van der Mast, Ton de Craen, Wouter de Ruijter and Jeroen van der Grond Department of Psychiatry, Leiden University Medical Center Leiden, the Netherlands Medical Research: What is the background for this study? What are the main findings? Response: Mid-life high blood pressure is a well-known risk factor for cerebrovascular pathology and, consequently, cognitive decline in old age. However, the effect of late-life blood pressure on cognition is less clear. It has been suggested that at old age not a higher, but a lower blood pressure increases the risk of cognitive decline as well as neuropsychiatric symptoms. Older persons are at risk for impaired regulation of their cerebral blood flow, and stringently lowering their blood pressure may compromise cerebral blood flow, and thereby cognitive function. Therefore, we hypothesized that increasing blood pressure by discontinuation of antihypertensive treatment would improve cognitive and psychological functioning. We performed a community-based randomized controlled trial in a total of 385 participants aged ≥75 years with mild cognitive deficits and without serious cardiovascular disease, and who were all receiving antihypertensive treatment. Persons were randomized to continuation or discontinuation of antihypertensive treatment. Contradictory to our expectation, we found that discontinuation of antihypertensive treatment in older persons did not improve cognitive functioning at 16-week follow-up. (more…)
Author Interviews, Geriatrics, JAMA, Statins / 24.08.2015

Michael Johansen MD MS Assistant Professor - Clinical Dept of Family Medicine The Ohio State UniversityMedicalResearch.com Interview with: Michael Johansen MD MS Assistant Professor - Clinical Dept of Family Medicine The Ohio State University Medical Research: What is the background for this study? What are the main findings? Dr. Johansen: -Over the last 15 years there has been increasing emphasis placed on the use of statins to decrease people's risk of heart attacks and strokes. Individuals with known heart disease are recommended to be on statins. However, there is no convincing evidence that elderly individuals (>79 years of age) without heart disease benefit from statins. Therefore, we investigated how use patterns of statins has changed over the last ~14 years. We identified a dramatic increase in statin use in the very elderly during the time of the study. As of 2012, around 1/3 of very elderly individuals without heart disease took a statin during that year. (more…)
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…)