Author Interviews, Brigham & Women's - Harvard, JAMA, Surgical Research / 18.01.2015

Soko Setoguchi, MD DrPH Assistant Professor of Medicine Harvard Medical School and Harvard School of Public Health Director of Safety and Outcome Research in Cardiology Associate Physician in the Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women’s HospitalMedicalResearch.com Interview with: Soko Setoguchi, MD DrPH Assistant Professor of Medicine Harvard Medical School and Harvard School of Public Health Director of Safety and Outcome Research in Cardiology Associate Physician in the Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women’s Hospital Medical Research: What is the background for this study? What are the main findings? Dr. Setoguchi: Medicare made a decision to cover Carotid Artery Stenting (CAS) in 2005 after publication of SAPPHIRE, which demonstrated the efficacy of Carotid Artery Stenting (CAS) vs Carotid endarterectomy (CEA) in high risk patients for CEA. Despite the data showing increased carotid artery stenting dissemination following the 2005 National Coverage Determination, peri-procedural and long-term outcomes have not been described among Medicare beneficiaries, who are quite different from trial patients, older and with more comorbidities in general population. Understanding the outcomes in these population is particularly important in the light of more recent study, the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), which established CAS as a safe and efficacious alternative to CEA among non-high-surgical risk patients that also expanded the clinical indication of carotid artery stenting. Another motivation to study ‘real world outcomes in the general population is expected differences in the proficiency of physicians peforming stenting in trial setting vs. real world practice setting. SAPPHIRE and CREST physicians were enrolled only after having demonstrated CAS proficiency with low complication rates whereas hands-on experience and patient outcomes among real-world physicians and hospitals is likely to be more diverse. We found that unadjusted mortality risks over study period of 5 years with a mean of 2 years of follow-up in our population was 32%.  Much higher mortality risks observed among certain subgroups with older age, symptomatic patients and non-elective hospitalizations. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, JAMA, Medicare, Mental Health Research, Pharmacology / 16.01.2015

Dr. Jeanne Madden PhD Instructor, Department of Population Medicine Harvard Medical SchoolMedicalResearch.com Interview with: Dr. Jeanne Madden PhD Instructor, Department of Population Medicine Harvard Medical School   Medical Research: What is the background for this study? What are the main findings? Dr. Madden: When Medicare Prescription Drug Coverage started in 2006, many experts voiced concerns about disabled patients with serious mental illness making the transition from state Medicaid coverage to Medicare.  Our study is one of the first to examine the impact of the transition in mentally ill populations.  People living with schizophrenia and bipolar disorder are at high risk of relapse and hospitalization and are especially vulnerable to disruptions in access to their treatments. We found that the effects of transitioning from Medicaid to Medicare Part D depended on where patients lived.  Transition to Part D in states that put limits on Medicaid drug coverage resulted in fewer patients going without treatment. By contrast, in states with more generous drug coverage, we saw reductions in use, of antipsychotics in particular, after patients shifted to Medicare Part D.  This may have been due to new cost controls used within many private Medicare drug plans.  Given that most states in the US are in this latter category, with the relatively generous Medicaid drug coverage, we also found reductions in antipsychotic use nation-wide. Although a very large group of people made that transition from Medicaid to Medicare in 2006, thousands more still transition every year because when disabled people qualify for Medicare, they must wait 2 years for their benefits kick in.  Also, many other disabled patients are on Medicaid only and don’t qualify for Medicare.  They are of course affected by restrictions on Medicaid coverage, which vary from state to state. (more…)
Author Interviews, CDC, Infections, JAMA, Pediatrics / 16.01.2015

MedicalResearch.com Interview with: Dr. Stefan Goldberg MD Medical Officer in CDC’s Division of Tuberculosis Elimination Clinical Research Branch Medical Research: What is the background for this study? What are the main findings? Dr. Goldberg: A shorter, simpler treatment regimen for children with latent TB infection can help prevent TB disease and reduce future transmission. The results from our study, a multinational, clinical trial, found that a once-weekly regimen of the anti-TB drugs rifapentine and isoniazid taken as directly observed therapy over a period of three months was safe and as effective for children (age 2-17) in preventing TB disease as the standard self-administered nine-month daily regimen of isoniazid alone. The study also showed that children are more likely to complete the shorter course of treatment, which is important given that treatment completion can be difficult. Specifically, we found that 88 percent of the trial participants on the combination regimen completed therapy while 81 percent completed the standard regimen. The CDC’s Tuberculosis Trials Consortium (TBTC), which conducted this study, works to include children in research when their inclusion is scientifically supportable and when children also might benefit from important new tools, such as alternative treatment regimens. This study is an extension of a large, international trial among persons age 12 and older, published by TBTC in 2011, which showed the shorter, simpler regimen to be as safe and effective as standard treatment. (more…)
Author Interviews, Breast Cancer, JAMA / 14.01.2015

Javaid Iqbal, MD, MSC (Candidate) Institute of Medical Sciences, and Women’s College Research Institute/Women’s College Hospital University of Toronto, Toronto CanadaMedicalResearch.com Interview with: Javaid Iqbal, MD, MSC (Candidate) Institute of Medical Sciences, and Women’s College Research Institute/Women’s College Hospital University of Toronto, Toronto Canada What is the background for this study? What are the main findings? Dr. Iqbal: A woman’s racial/ethnic background predicts her participation in breast cancer control program (i.e., awareness and screening). The ultimate objective of breast cancer control program is to detect cancer at an optimal stage, which is stage I, because women with stage I breast cancer survive longer. Given the racial/ethnic diversity of North America, this poses questions such as “what predicts stage I breast cancer in the multiethnic North American population?”, “what predicts its survival?”, and “does a woman’s ethnic background plays a role in predicting an early stage, and survival?” We studied 373,563 women diagnosed with invasive breast cancer in the United States between 2004 and 2011. We followed these women for 7 years and recorded whether or not they died of breast cancer, or whether they are still alive. We then divided all women into different ethnic groups, in particular white, black, Chinese, Japanese, and Indian/Pakistani (South Asian). For each racial/ethnic group, we estimated proportions of women who were diagnosed with stage I breast cancer, and risk of death at 7 years. Our aim was to determine if the racial/ethnic differences in early stage breast cancer, and its survival were better explained by intrinsic biological differences in tumor characteristics, or by differences in early-detection of breast cancer. We found that a woman’s racial/ethnic background predicted the diagnosis of stage I breast cancer, as well as her risk of dying at 7 years after breast cancer. A black woman was less likely than a white woman to be diagnosed with stage I breast cancer. A black woman was also more likely than a white woman to die of stage I breast cancer 7 years after her diagnosis. The Japanese and Chinese women were more likely than white women to be diagnosed with stage I breast cancer. The risk of death at 7 years was lowest for Indian or Pakistani (South Asian) women. Furthermore, even for small sized (2.0) breast cancers the risk of death at 7 years was higher for black women (9%), compared to white women (5%). Compared to white women, small sized breast cancers in black women were more aggressive at diagnosis, and had spread to lymph nodes and other organs. (more…)
Author Interviews, Hospital Acquired, JAMA / 13.01.2015

Teresa Waters PhD Professor and Chair, Preventive Medicine University of Tennessee Health Science Center Memphis TNMedicalResearch.com Interview with: Teresa Waters PhD Professor and Chair, Preventive Medicine University of Tennessee Health Science Center Memphis TN Medical Research: What is the background for this study? What are the main findings? Dr. Waters: On October 1, 2008, Medicare implemented the Hospital-Acquired Conditions (HACs) Initiative, a policy penalizing hospitals for eight complications of hospital care, also known as never events. Under the HACs Initiative, hospitals could no longer justify a higher level Medicare MS-DRG when caring for a patient who developed 1 of the 8 never events. This Initiative was one in a series of CMS payment reforms intended to increase emphasis on value-based purchasing. We found that Medicare's nonpayment policy was associated with significant improvements in the time trends for central line associated blood stream infections (CLABSIs) and catheter associated urinary tract infections(CAUTIs). For these outcomes, our data from the National Database of Nursing Quality Indicators showed that introduction of the Medicare policy was associated with an 11% reduction in the rate of change in central line associated blood stream infections and a 10% reduction in the rate of change in CAUTIs. We did not find any relationship between introduction of the policy and significant changes in injurious falls or hospital acquired pressure ulcers (two other important never events covered by the policy). We hypothesized that the Hospital-Acquired Conditions Initiative may have a great effect for conditions where there is strong evidence that better hospital processes yield better outcomes or where processes are more conducive to standardization. (more…)
Author Interviews, JAMA, Kidney Disease / 12.01.2015

MedicalResearch.com Interview with: James Flory MD, MSCE Division of Endocrinology and Department of Healthcare Policy and Research Weill Cornell Medical College, NY NY Medical Research: What is the background for this study? What are the main findings? Dr. Flory: Metformin is the first-line drug for type 2 diabetes, with much better evidence for safety and improved clinical outcomes than any alternative. The one major safety concern about metformin is the fear that it can cause lactic acidosis, which led to a Food and Drug Administration black box warning against using metformin in patients with even a modest degree of renal impairment. These fears and warnings were based on serious problems with an older drug in the same class, not on experiences with metformin itself, and over the past 20 years it has become clear that the risk of lactic acidosis with metformin is extremely low, and that this warning against the use of the drug in mild renal failure is overly strict. (Dr. Lipska and colleagues published a superb review of this issue a few years back: Diabetes Care June 2011 vol. 34 no. 6 1431-1437) This is important from a public health perspective because so many patients with diabetes have mild to moderate kidney disease, and we were concerned that the FDA warning was preventing the use of metformin in these patients. Our study was intended to estimate how many patients who would benefit from metformin are not taking it because they have mild kidney disease. We found that rates of metformin use are much lower in patients with mild kidney disease – just the population where the FDA warning discourages use, but modern data show that metformin is safe. In all, at least 1 million patients with type 2 diabetes who would benefit from metformin appear not to be taking it because clinicians are following the FDA warning and being too conservative. (more…)
Author Interviews, Diabetes, Geriatrics, JAMA / 12.01.2015

Kasia Joanna Lipska MD, MHS Assistant Professor of Medicine (Endocrinology) Yale School of Medicine New Haven, CT 06520-8020MedicalResearch.com Interview with: Kasia Joanna Lipska MD, MHS Assistant Professor of Medicine (Endocrinology) Yale School of Medicine New Haven, CT 06520-8020 Medical Research: What is the background for this study? What are the main findings? Dr. Lipska: Diabetes is common and affects about 1 in 4 older adults (65 years or more). For younger adults with diabetes, most guidelines suggest lowering blood sugar levels to a hemoglobin A1c below 7%. However, in older patients, especially those with complex medical problems, the benefits of this strategy are unclear. What’s more, this strategy can cause harm. Aiming for a hemoglobin A1c below seven increases the risk for hypoglycemia. And older adults are especially susceptible to this risk. As a result, many guidelines suggest that treatment should be more cautious for these vulnerable elders and that aiming for “tight” blood sugar control may not be worth the risk. Medical Research: What are the main findings? Dr. Lipska: We looked at diabetes treatment of older adults using nationally representative data from 2001 to 2010. We found that 62% of older adults with diabetes had a hemoglobin A1c below 7%. But what’s really striking is that this proportion was similar for patients who were relatively healthy, for those with intermediate health, and for those with poor health. What’s more, the use of insulin or sulfonylureas (drugs that increase the risk for hypoglycemia) was common and similar across these groups. (more…)
Author Interviews, End of Life Care, JAMA / 12.01.2015

MedicalResearch.com Interview with: Younsuck Koh Professor of Medicine Professor of Medical Humanities and Social Sciences Chairman, the Organizing Committee of the 12th World Federation of Societies of Intensive and Critical Care Medicine Congress in Seoul Department of Pulmonary and Critical Care Medicine Asan Medical Center, Univ. of Ulsan College of Medicine Seoul, Korea and Jason Phua MBBS, FRCP National University Hospital, Singapore AVF Chairperson. Senior Consultant & Head Division of Respiratory & Critical Care Medicine Medical Research: What is the background for this study? What are the main findings? Response: Provision of humane end-of-life and palliative care for dying patients and their families must remain a focus in today’s intensive care units, which continue to see technological advancements in the forms of life-sustaining measures available. End-of-life care decisions are heavily dependent on the medical, ethical, social, and cultural context. Asia, which accounts for at least half of all patients with critical illness, mechanical ventilation, and intensive care unit deaths internationally, has diverse socioeconomic conditions, cultures, and religions. Therefore, it is likely that substantial difference in the way physicians approach end-of-life care exist between Asia and the West, and among Asian countries and regions themselves. However, prior to our study, little data existed on the end-of-life care practices in this region. We found that even as end-of-life care practices in intensive care units vary significantly across Asian countries and regions, physicians in Asia generally seem less likely to limit life-sustaining treatments than their Western counterparts. Implementation of do-not-resuscitate orders are affected by multiple factors related to country or region, including economic, cultural, religious, and legal differences, as well as personal attitudes. (more…)
Author Interviews, JAMA / 07.01.2015

Sakthivel Sadayappan, PhD, MBA Associate Professor Department of Cell and Molecular Physiology Loyola University Chicago Health Sciences Division Maywood, IL 60153-5500, USA.MedicalResearch.com Interview with: Sakthivel Sadayappan, PhD, MBA Associate Professor Department of Cell and Molecular Physiology Loyola University Chicago Health Sciences Division Maywood, IL  60153-5500, USA. MedicalResearch: What is the background for this study? What are the main findings? Dr. Sadayappan: Hypertrophic cardiomyopathy (HCM) is the most common form of genetic heart defect, affecting 1 in 500 people in the general population. HCM results in excessive thickening of heart muscle without an obvious cause, such as hypertension or exercise stress. Often, HCM results in sudden cardiac arrest as a result of cardiac arrhythmia. Electrocardiogram, echocardiogram and cardiac magnetic resonance imaging are commonly used to diagnose HCM. However, genetic defects in more than 10 genes could also cause HCM, and standard screening for these genes is readily available. Notwithstanding our ability to diagnose the disease, a major challenge arises from its heterogeneity. That is, individuals with the same genetic defect often present with different symptoms, ranging from no symptoms at all to severe heart enlargement. Therefore, treatment options vary from person to person, and, at present, no permanent cure is available for HCM. Beta-blockers, calcium antagonists and anti-arrhythmic drugs are currently being used to manage the disease. However, scientists must discover the reasons that explain why some people experience more severe symptoms than others. In today’s modern world, people are afflicted with stresses including, for example, diabetes, hypertension, hyperlipidemia (high cholesterol), and alcoholism. Therefore, we have hypothesized that additional cardiac stresses can aggravate the onset of Hypertrophic cardiomyopathy. To prove our hypothesis, we used a mouse model having a genetic defect known to affect cardiac muscle contractility. We subjected these mice to severe cardiac stress over a period of 12 weeks. Compared with normal mice, we found that the mutant mice showed significant cardiac abnormalities, including those associated with HCM. Thus, this demonstrated, for the first time, that additional cardiac stress applied in the presence of known genetic defects exacerbates the onset of HCM. (more…)
Author Interviews, Heart Disease, JAMA, University of Pittsburgh / 07.01.2015

Inmaculada Hernandez, PharmD PhD Student, Health Services Research and Policy Deparment of Health Policy and Management Graduate School of Public Health University of Pittsburgh Pittsburgh, PA 15261MedicalResearch.com Interview with: Inmaculada Hernandez, PharmD PhD Student, Health Services Research and Policy Deparment of Health Policy and Management Graduate School of Public Health University of Pittsburgh Pittsburgh, PA 15261 Medical Research: What is the background for this study? What are the main findings? Response: The approval of dabigatran was considered a major contribution to the therapeutic arsenal of anticoagulants since warfarin, whose therapeutic management is complicated, was the only oral anticoagulant approved before 2011. Clinicians therefore considered dabigatran a very promising drug; however, the safety warnings released by the regulatory agencies and the reports of bleeding published in 2011 raised concerns about the safety profile of dabigatran. By the time we initiated our study, the FDA had concluded that dabigatran was associated with similar rates of bleeding than warfarin. However, the results of this observational study were not adjusted by patient characteristics. We therefore compared the risks of bleeding with dabigatran and warfarin adjusting for patient characteristics and using propensity score methods to mitigate selection biases, which observational studies are sensitive to. We found that dabigatran was associated with a higher risk of major bleeding and gastrointestinal bleeding than warfarin. However, the risk of intracranial bleeding was lower with dabigatran. In addition, we found that the increased risk of bleeding with dabigatran was specially higher for African Americans and for patients with chronic kidney disease. (more…)
Author Interviews, JAMA, Mental Health Research, University of Pittsburgh / 06.01.2015

Dr. Brent David MD Academic Chief, Child and Adolescent Psychiatry at Western Psychiatric Institute and Clinic Professor of Psychiatry, Pediatrics & Epidemiology University of Pittsburgh School of Medicine MedicalResearch.com Interview with: Dr. Brent David MD Academic Chief, Child and Adolescent Psychiatry at Western Psychiatric Institute and Clinic Professor of Psychiatry, Pediatrics & Epidemiology University of Pittsburgh School of Medicine Medical Research: What is the background for this study? Dr. David: There are now many studies that show that suicide and suicidal behavior run in families. A family history of suicide increases the risk for suicide attempt and vice versa, so that we believe that the trait that is being passed from parent to child is a tendency to act on suicidal thoughts, resulting in either an attempt or an actual suicide. However, what was not not known was the mechanism by which parents transmitted the risk of suicidal behavior to their children, and what the precursors of suicidal behavior looked like in individuals who were at risk for suicidal behavior, but had not yet engaged in a suicide attempt. Therefore, we conducted a high-risk family study, in which studied the children of parents with mood disorders, about half of whom also had a history of a suicide attempt. Medical Research: What are the main findings? Dr. David: We followed 701 offspring for an average of 5.6 years, and found that those offspring whose parents had made a suicide attempt were almost 5 times more likely to make a suicide attempt themselves, even after accounting for mood disorder in parent and child and past suicidal behavior in the offspring. We found three main pathways by which suicidal behavior was passed from parent to child:
  • Parental mood disorder was transmitted to children, and that was a precursor of a suicide attempt.
  • Parent attempt was related to offspring impulsive aggression, which in turn increased the risk for mood disorder, which then increased the likelihood of a suicide attempt. (We define impulsive aggression as a tendency to response with hostility or aggression to provocation or frustration.
  • Finally, there is a direct path from parent attempt to child attempt, with no precursors or intervening variables.
Implications for clinicians and patients:
  • First, these findings highlight that a parental history of a suicide attempt increases the risk of an attempt in the parent's children. Clinicians who take care of adults who have attempted suicide should make sure that children are assessed as they are at increased risk and that parents know what to look for in the future in order to get their children into needed treatment.
  • Second, the transmission of suicidal behavior from parent to child can be attenuated by preventing the transmission of mood disorder, and of impulsive aggression. There are now evidence based interventions that reduce the likelihood of a child of a depressed parent from developing depression; these treatment involve cognitive behavioral principles and may also involve family interventions. There are now good family-based interventions for impulsive aggression that can attenuate the risk that the child or adolescent will go on to develop a mood disorder, which in turn greatly increases the risk for suicidal behavior.
(more…)
Author Interviews, JAMA, Schizophrenia / 06.01.2015

MedicalResearch.com Interview with: Toshiaki A. Furukawa, MD, PhD Professor and Chair, Department of Health Promotion and Human Behavior Professor, Department of Clinical Epidemiology Kyoto University Graduate School of Medicine / School of Public Health, Yoshida Konoe-cho, Sakyo-ku, Kyoto Japan Medical Research: What is the background for this study? What are the main findings? Dr. Furukawa: The efficacy of antidepressants in the treatment of depressive disorders has recently been called into question as some studies suggested they may have less efficacy for the milder spectrum of the disorder. It is not known if the same would apply to antipsychotics, which constitute the mainstay in the treatment of schizophrenia. We found that, in patients with schizophrenia with acute treatment as well as with predominant negative symptoms, the severer the baseline severity, the greater the magnitude of the benefit from the active treatment in comparison with placebo. (more…)
Author Interviews, JAMA, OBGYNE / 06.01.2015

Dr. Jennifer Kawwass MD Assistant Professor Emory UniversityMedicalResearch.com Interview with: Dr. Jennifer Kawwass MD Assistant Professor Emory University Medical Research: What should clinicians and patients take away from your report? Dr. Kawwass: This study affirms that Assisted Reproductive Technology treatment is relatively safe and that reported complications remain rare.  In the US from 2000-2011, autologous and donor ART procedures were associated with low reported stimulation and surgical complication risks; no concerning trends or patterns were identified. Ovarian hyperstimulation syndrome (OHSS) was the most frequently reported complication among autologous and donor cycles, though less frequent in donor cycles.  Obstetric mortality which may or may not be related to Assisted Reproductive Technology was rare. (more…)
Author Interviews, JAMA, Pediatrics, UCSF / 06.01.2015

Yvonne Wu MD Professor of Clinical Neurology and Pediatrics UCSF School of MedicineMedicalResearch.com Interview with: Yvonne Wu MD Professor of Clinical Neurology and Pediatrics UCSF School of Medicine   Medical Research: What is the background for this study? What are the main findings? Dr. Wu: Newborn infants commonly have elevated bilirubin levels, manifested as jaundice, because the body's mechanisms for breaking down bilirubin have not yet fully matured.  Although high bilirubin levels are almost always well tolerated, extremely high bilirubin levels may lead to brain injury, or kernicterus, which in turn can cause a very severe form of cerebral palsy.  When bilirubin levels are extremely high, or when bilirubin levels remain high despite phototherapy, it is recommended that an exchange transfusion be performed to prevent brain injury and cerebral palsy.  The American Academy of Pediatrics (AAP) has published recommendations on when an exchange transfusion should be performed, based on bilirubin level, age of infant and other clinical factors.  However, no previous study had examined the actual risk of cerebral palsy in infants whose bilirubin levels exceeded the exchange transfusion thresholds. Among 500,000 newborns born at Kaiser Permanente Northern California over a 17-year period, we found 1833 who had at least one bilirubin level above the AAP exchange transfusion level.  There were only 3 cases of cerebral palsy due to kernicterus in this group, even though only 42 (2.3%) of them had received exchange transfusions.  All 3 infants had bilirubin levels at least 5 mg/dL above the AAP exchange transfusion threshold and all 3 infants had 2 or more other risk factors for brain damage, including prematurity, sepsis, hypoxia and the hereditary blood disorder G6PD deficiency.  We did not identify any cases of kernicterus among otherwise well term babies, even at bilirubin levels that exceeded the AAP exchange transfusion threshold. (more…)
Author Interviews, JAMA, Mental Health Research, UCSF / 06.01.2015

Dr. Georges Naasan MD Neurologist, Clinical Instructor UCSF Memory and Aging CenterMedicalResearch.com Interview with: Dr. Georges Naasan MD Neurologist, Clinical Instructor UCSF Memory and Aging Center Medical Research: What is the background for this study? What are the main findings? Dr. Naasan: Degenerative diseases of the brain can lead to dysfunction in judgment, emotional processing, social decorum and self-awareness. In turn, such dysfunctions may result in criminal behavior that appears for the first time in middle-aged adults or even later in life. We studied 2397 patients from the Memory and Aging Center at UCSF and found 204 (8.5%) that had a criminal behavior as part of their illness. The large majority of these patients were patients with a specific type of neurodegenerative disease called behavioral variant of frontotemporal dementia, followed by a group of people with a disease called semantic variant of primary progressive aphasia. People with Alzheimer's disease, a disease that does not usually interrupt the functions mentioned above, were the least likely to exhibit criminal behavior. The common manifestation of criminal behaviors in people with the behavioral variant frontotemporal dementia included theft, sexual advances trespassing and public urination in contrast to people with Alzheimer's disease who, when such behaviors were present, primarily committed traffic violations often secondary to cognitive impairment. (more…)
Author Interviews, JAMA, Surgical Research, Weight Research / 06.01.2015

David Arterburn, MD, MPH, FACP Associate Investigator Group Health Research Institute Seattle, WA 9810MedicalResearch.com Interview with: David Arterburn, MD, MPH, FACP Associate Investigator Group Health Research Institute Seattle, WA 98101   and David L. Maciejewski PhD Center for Health Services Research in Primary Care Durham VA Medical Center, Durham, North CarolinaDavid L. Maciejewski PhD Center for Health Services Research in Primary Care Durham VA Medical Center, Durham, North Carolina MedicalResearch.com: Why was this study needed? Response: There were several reasons to conduct this study.  First, although complications and death during and soon after bariatric surgery have progressively declined over the past several decades, there is simply very little long-term evidence on the survival benefits of bariatric surgery in Americans having surgical procedures that are being used today in routine practice. Second, we felt that it was important to look at the impact of bariatric surgery among veterans because they represent an older male cohort often with multiple medical comorbidities, which is different from the typical bariatric patient in the United States, who is often younger and female. MedicalResearch.com: How was your study conducted? Response: We conducted a retrospective observational study using high-quality data from national Department of Veterans Affairs electronic databases and the VA Surgical Quality Improvement Program. We identified veterans who underwent bariatric surgery in VA medical centers from 2000 to 2011. Three quarters of them were men. We matched them to control patients using an algorithm that included age, sex, VA geographic region, body mass index (BMI), diabetes, and Diagnostic Cost Group. We then compared survival across bariatric patients and matched controls using Kaplan-Meier estimators and stratified, adjusted Cox proportional hazards analyses.  MedicalResearch.com: What were the main findings of your study? Response: This study had three important results: 1)      Our analysis showed no significant association between bariatric surgery and death from all causes in the first year of follow-up. In other words, having bariatric surgery was not significantly related to a veteran’s chance of dying in the first year compared to not having surgery. 2)      We had an average follow-up of 6.9 years in the surgical group and 6.6 years in the matched control group. After one to five years, adjusted analyses showed significantly lower mortality in the patients who had surgery: 55% lower, with a hazard ratio of 0.45. The finding was similar at 5 or more years, with a hazard ratio of 0.47. This means that bariatric surgery was associated with lower long-term mortality – that is, better long-term survival among veterans, which is consistent with limited non-VA research that has addressed this same question. 3)      Finally, we also found that the relationship between surgery and survival were similar comparing men and women, patients with and without diagnosed diabetes, and patients who had bariatric surgery before versus after year 2006. (more…)
Author Interviews, HPV, JAMA, Vaccine Studies / 05.01.2015

Anders Hviid, M.Sc., Dr.Med.Sci. Senior Investigator, Statens Serum InstitutMedicalResearch.com Interview with: Anders Hviid, M.Sc., Dr.Med.Sci. Senior Investigator, Statens Serum Institut Medical Research: What is the background for this study? Response: After the widespread introduction of HPV vaccination of adolescent girls, a number of safety concerns have emerged. In this case, demyelinating diseases, including multiple sclerosis, occurring after HPV vaccination has been reported in social media, news media and medical journals. Medical Research: What are the main findings? Response: In a study of almost 4 million Danish and Swedish women, we found no support for an increased risk of multiple sclerosis or other demyelinating diseases following HPV vaccination. (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Nutrition / 05.01.2015

Qi Sun, MD ScD Assistant Professor of Medicine Channing Division of Network Medicine Brigham and Women's Hospital and Harvard Medical School Assistant Professor Department of Nutrition, Harvard School of Public Health 665 Huntington Avenue, Boston, MA 02115MedicalResearch.com Interview with: Qi Sun, MD ScD Assistant Professor of Medicine Channing Division of Network Medicine Brigham and Women’s Hospital and Harvard Medical School, Assistant Professor, Department of Nutrition Harvard School of Public Health Boston, MA 02115 Medical Research: What is the background for this study? What are the main findings? Dr. Sun: While we know whole grains are beneficial for reducing the risk of some major chronic diseases, such as heart disease and diabetes, evidence regarding whether whole grains are also able to lower mortality is sparse. We therefore want to answer this important research question in the current analysis. Using data collected from two prospective cohort studies consisted of more than 100 thousand US men and women, we found that whole grain intake was significantly associated with lower total mortality and lower cardiovascular mortality, but not cancer mortality. For every serving (28 grams) of whole grain intake per day, the total mortality is reduced by 5% and cardiovascular mortality by 9%. (more…)
Author Interviews, Brigham & Women's - Harvard, Diabetes, JAMA / 02.01.2015

Seth A. Berkowitz, MD, MPH Division of General Internal Medicine Massachusetts General Hospital, BostonMedicalResearch.com Interview with: Seth A. Berkowitz, MD, MPH Division of General Internal Medicine Massachusetts General Hospital, Boston Medical Research: What is the background for this study? What are the main findings? Dr. Berkowitz: Prior studies had looked the association between single unmet basic material needs and diabetes control, but hadn't necessarily looked at multiple things people may not be able to afford, which more closely mirrors real-life. Also, prior studies had been done in a 'pre-Affordable Care Act' setting, while, by being in Massachusetts, our study was conducted in a setting of near-universal healthcare coverage that is similar to what the rest of the US is moving towards. We found that difficulties meeting basic material needs, such as difficulties affording food, known as food insecurity, and having financial barriers to taking medications, called cost-related medication underuse, are associated with worse diabetes control and increased use of costly health services in diabetes patients, despite near-universal health insurance coverage (more…)
Accidents & Violence, Author Interviews, JAMA, Mental Health Research, Pediatrics / 01.01.2015

MedicalResearch.com Interview with: Joseph A Simonetti, MD MPH Research Fellow Harborview Injury Prevention & Research Center University of Washington Seattle, WA, USA Medical Research: What is the background for this study? What are the main findings? Dr. Simonetti: Studies have consistently shown that children living in households where firearms are stored safely have a lower risk of suffering firearm injuries, including lethal firearm injuries, compared to those living in households where firearms are stored unlocked and/or loaded. Safe firearm storage is widely recommended by public health experts, professional medical societies, and gun rights organizations, especially for households where children might be suffering from mental heath and substance abuse issues that put them at increased risk for suicide or unintentional injury. Our goal was to find out if those recommendations were being effectively implemented in the community. To do this, we used survey data that assessed mental health conditions and firearm access among a nationally representative sample of US adolescents. Medical Research: What are the main findings? Dr. Simonetti: First, we confirmed previous findings that a large proportion of US adolescents have access to a firearm in the home. Of those who reported living in a home with a firearm, 40% said they could immediately access and shoot the firearm. Second, the prevalence of most mental health diagnoses was similar between adolescents who did and did not report firearm access. However, a greater proportion of adolescents with firearm access had drug and alcohol disorders compared to adolescents who reported living in a home with a firearm but did not have access to the firearm. The main finding was that children with mental health risk factors for suicide were just as likely to report in-home firearm access as those without identified risk factors. This finding held true even when comparing firearm access between children with no identified risk factors and those who reported a recent suicide attempt, who arguably have the highest suicide risk in this sample. (more…)
Author Interviews, JAMA, Multiple Sclerosis / 31.12.2014

Dr. Richard Nash MD Colorado Blood Cancer InstituteMedicalResearch.com Interview with: Dr. Richard Nash MD Colorado Blood Cancer Institute   Medical Research: What is the background for this study? What are the main findings? Dr. Nash: Multiple sclerosis is an autoimmune disease of the central nervous system which causes significant disability and in some cases results in patients being wheel-chair bound or bed-ridden. It is a significant medical problem amongst young adults. We undertook this study because current Multiple sclerosis therapies were not adequate for effective long-term control of the disease in the majority of the patients. High-dose immunosuppressive therapy followed by autologous hematopoietic cell transplantation is an effective treatment for many hematological malignancies. It causes a profound immunosuppression. Based on this effect on the immunological system, we initiated a clinical trial of this treatment modified for autoimmune disorders. The study was supported by the Immune Tolerance Network and NIAID, NIH. In a phase 2 clinical trial of 25 patients all of whom were followed for at least 3 years, we demonstrated that 80% of patients had no evidence of disease activity. No other Multiple sclerosis treatments were given after the study treatment. Adverse events were similar to what we have observed for this treatment in patients with hematological malignancies. No significant acute neurological adverse events were observed. (more…)
Author Interviews, JAMA, Surgical Research, Weight Research / 31.12.2014

Jeffrey A. Gusenoff, MD Associate Professor of Plastic Surgery Co-Director, Life After Weight Loss Program Co-Director, BodyChangers Director, Post-Bariatric Body Contouring Fellowship UPMC Department of Plastic SurgeryMedicalResearch.com Interview with: Jeffrey A. Gusenoff, MD Associate Professor of Plastic Surgery Co-Director, Life After Weight Loss Program Co-Director, BodyChangers Director, Post-Bariatric Body Contouring Fellowship UPMC Department of Plastic Surgery Medical Research: What is the background for this study? What are the main findings? Dr. Gusenoff: With the rise in massive weight loss patients from bariatric surgery or diet and exercise, more patients are choosing to have a thighplasty to remove excess skin of the inner thigh. Many techniques exist for treating this, but there aren't many studies that look into the safety of these procedures in massive weight loss patients. What we found is that  many patients have scars that go all the way down the thigh with a fairly high complication rate of almost 70%. (more…)
Author Interviews, JAMA, Smoking / 31.12.2014

Dr Hayden McRobbie MB ChB PhD Reader in Public Health Interventions Wolfson Institute of Preventive Medicine Barts and The London School of Medicine and Dentistry Queen Mary University of LondonMedicalResearch.com Interview with: Dr Hayden McRobbie MB ChB PhD Reader in Public Health Interventions Wolfson Institute of Preventive Medicine Barts and The London School of Medicine and Dentistry Queen Mary University of London Medical Research: What is the background for this study? What are the main findings? Dr. McRobbi: Varenicline is an effective smoking cessation aid that acts primarily to alleviate the symptoms of tobacco withdrawal discomfort, thereby making quitting easier. It also reduces the rewarding effects of cigarettes smoked which may enhance the drugs smoking cessation effect by reducing the enjoyment of smoking prior to quitting and preventing a lapse, after quitting, progressing to relapse. In some people the standard dose of varenicline (2mg/day) results in a decrease in the enjoyment of smoking prior to quitting and that these people appear to have higher quit rates that those that don’t experience this reaction to smoking. The randomised placebo controlled trial was designed to investigate whether increasing the varenicline dose (up to 5mg/day) in smokers who show no reaction to the standard dose improves treatment outcomes compared to remain on the standard dose. Medical Research: What are the main findings? Dr. McRobbi: Whilst the increased dose, compared with the standard dose, reduced the enjoyment of smoking prior to quitting it had no additional effect on alleviating tobacco withdrawal symptoms or smoking cessation rates at 12 weeks post quit date (26% vs. 23%). (more…)
Author Interviews, JAMA, OBGYNE / 28.12.2014

Keith P. West, Jr., Dr.P.H., R.D. Professor and Director Program and Center in Human Nutrition Department of International Health Bloomberg School of Public Health Johns Hopkins University Baltimore, Maryland 21205MedicalResearch.com Interview with: Keith P. West, Jr., Dr.P.H., R.D. Professor and Director Program and Center in Human Nutrition Department of International Health Bloomberg School of Public Health Johns Hopkins University Baltimore, Maryland 21205 Medical Research: What is the background for this study? What are the main findings? Dr. West: Deficiencies in vitamins and minerals (micronutrients) that must be provided by the diet, are a major public health concern in undernourished societies.  In rural South Asia, where some 35 million babies are born each year, maternal micronutrient deficiencies are common and may increase risk of adverse pregnancy outcomes such as preterm birth, low birth weight or stillbirth and infant mortality.  Further, a newborn of low birth weight faces higher risks of poor postnatal growth, infection and mortality.  Where prenatal care exists, iron-folic acid supplements are often prescribed as standard care to prevent iron deficiency anemia.  But it is likely that many micronutrient deficiencies emerge from an inadequate diet, raising the possibility that a supplement that provides each day a recommended dietary allowance of most essential vitamins and minerals  could measurably improve the health of the mother, fetus and infant.  Because prenatal multinutrient supplements are rarely taken in low income countries, it is important to assess their potential to  improve health before recommending this practice.  We did this be conducting a large prenatal supplementation trial in rural Bangladesh, randomizing  44,567 pregnant women in their 1st trimester to receive a supplement with 15 vitamins and minerals or only iron and folic acid, followed their pregnancies and survival of their 28,516 infants to 6 months of age. Medical Research: What are the main findings? Dr. West:  The multiple micronutrient supplement had the effect of extending the length of gestation compared to the iron-folic acid supplement, by about 2 days on average.  This was enough to lower risk of preterm birth, below 37 weeks,  by 15%.  The extra time in the womb also allowed the fetus to grow a little larger, increasing birth weight (by 54 grams or about 2 ounces) as well as length and other measures of size, leading to a 12% reduction in low birth weight.  In addition, there was an 11% reduction in risk of stillbirth.  These are all indications of a healthier pregnancy.  Although we observed a 14% lower mortality from all causes in girls, there was not a similar effect in boys, leading to no overall effect.  We are continuing to investigate possible reasons for this difference. (more…)
Author Interviews, Hearing Loss, HIV, JAMA, UCSD / 27.12.2014

dr-peter-torre Dr. Peter Torre III PhD Associate Professor, Audiology Director, Recreational Noise Exposure and Hearing Lab San Diego State UniversityMedicalResearch.com Interview with: Dr. Peter Torre III PhD Associate Professor, Audiology Director, Recreational Noise Exposure and Hearing Lab San Diego State University Medical Research: What is the background for this study? What are the main findings? Dr. Torre: The primary purpose of our study was to evaluate hearing sensitivity in HIV+ and HIV- adults. And subsequently, in HIV+ adults only, to examine whether HIV disease variables or treatment was associated with hearing sensitivity. The main findings were that HIV+ adult had poorer hearing for both the lower and higher frequencies compared with HIV- adults, although we did not find any significant associations between HIV variables and treatment variables with hearing loss. (more…)
Author Interviews, JAMA, Pediatrics / 26.12.2014

Seetha Shankaran MD Director, Neonatal-Perinatal Medicne Children's Hospital of Michigan and Hutzel Women's Hospital Detroit, MIMedicalResearch.com Interview with: Seetha Shankaran MD Director, Neonatal-Perinatal Medicne Children's Hospital of Michigan and Hutzel Women's Hospital Detroit, MI Medical Research: What is the background for this study? What are the main findings? Dr. Shankaran: The background for this study is that term newborn infants born following lack of blood flow and oxygen to the brain are at high risk for death or disability, including motor and developmental handicaps. Hypothermia (lowering the core body temperature to 33-34°C for 72 hours has been shown to decrease the rate of death or disability to 44 to 55%. Hypothermia is currently the only proven therapy to reduce these devastating outcomes. The hypothermia therapy provided to term newborns was based on laboratory experiments that demonstrated that in animal models subjected to hypoxia and ischemia, cooling reduced brain injury. In the NICHD Neonatal Research Network (a group of academic centers across the US), in 2005 we reported the first trial of whole-body cooling to 33.5°C for 72 hours and noted a reduction in death or disability in infancy.  When the infants in the study where followed to childhood, we noted that this reduction in death or disability continued to childhood. Recent laboratory experiments have demonstrated that brain injury continues for days or weeks after the hypoxic-ischemic injury. Other laboratory experiments noted that cooling for a greater depth than 33-34°C (as long as the temperature does not decrease much lower) can reduce brain injury further. Based on this information, in the NICHD Neonatal Research Network we designed a study, among term infants with moderate or severe encephalopathy to compare longer cooling and deeper cooling to see if death or disability can be reduced. Term infants with moderate or severe encephalopathy were randomly assigned at <6 hours of age to 4 groups of therapy; 33.5°C for 72 hours, 32.0°C for 72 hours, 33.5°C for 120 hours and 32.0°C for 120 hours. The  goal was to compare death or disability rates between the 2 durations of cooling (72 hours vs. 120 hours) and 2 depths of cooling (33.5 C vs. 32.0°C) and was designed to recruit 726 infants. A independent data safety and monitoring committee was appointed by the director of NICHD to monitor safety events after the first 50 infants were enrolled and then following the enrollment of every 25 infants. The safety events monitored included mortality in the neonatal intensive care unit (NICU), cardiac arrhythmia, persistent acidosis and major vessel bleeding or thrombosis. The study was started in October 2010. Medical Research: What is the background for this study? What are the main findings? Dr. Shankaran: In November 2013 the study was closed by the data safety and monitoring committee after 8 reviews of study data, following recruitment of 364 neonates because of emerging safety concerns as well as futility analyses. The NICU death rates were 7% (7 of 95) for the 33.5°C for 72 hour group, 14% (13 of 90) for the 32.0°C for 72hr group, 16% (15 of 96) in the 33.5°C for 120 hour group and 17% for the 32.0°C for 120 hour group. The adjusted risk ratio (95% CI) for death for the 120 hour vs. the 72 hour was not significantly different 1.37 (0.92-2.04) nor was it significantly different for the 32.0°C group compared to the 33.5°C group 1.24 (0.69-2.25).  The safety outcomes were similar between the 120 vs. 72 hour groups and the 32.0°C vs. the 33.5°C groups, except that major bleeding occurred among 1% in the 120 group vs. 3% in the 72 hours group, RR 0.25 (0.07-0.91). Futility analyses noted that the probability of detecting benefit of longer cooling, deeper cooling or both for death in the NICU was <2%. The follow -up of infants enrolled into the study for 18 months is on-going. (more…)
Author Interviews, Blood Pressure - Hypertension, Case Western, Dermatology, JAMA, Weight Research / 26.12.2014

Dr. Jonathan L. Silverberg MD PhD MPH Assistant Professor in Dermatology, Medical Social Sciences and Preventive Medicine Northwestern University, Chicago, IllinoisMedicalResearch.com Interview with: Dr. Jonathan L. Silverberg MD PhD MPH Assistant Professor in Dermatology, Medical Social Sciences and Preventive Medicine Northwestern University, Chicago, Illinois Medical Research: What is the background for this study? Dr. Silverberg: Previous studies found associations between obesity and atopic dermatitis (AD). However, little was known about the association between AD and metabolic risk factors, such as central obesity and high blood pressure. (more…)
Author Interviews, HIV, JAMA / 26.12.2014

Jared Baeten, MD PhD Professor, Departments of Global Health and Medicine Adjunct Professor, Department of Epidemiology University of Washington Seattle, WA 98104MedicalResearch.com Interview with: Jared Baeten, MD PhD Professor, Departments of Global Health and Medicine Adjunct Professor, Department of Epidemiology University of Washington Seattle, WA 98104 Medical Research: What is the background for this study? What are the main findings? Dr. Baeten: The medication tenofovir disoproxil fumarate is used widely for the treatment of HIV-1 infection and, more recently, as pre-exposure prophylaxis (PrEP) to protect against HIV-1 infection for at-risk HIV-1 uninfected persons.  Its use has been associated with declines in the estimated glomerular filtration rate (eGFR) when used as part of antiretroviral treatment by HIV-1 infected persons, but limited data are available for risk when used as PrEP for HIV-1 prevention. Using data from the largest randomized, placebo-controlled trial of PrEP, among heterosexual women and men in Africa, eGFR changes were assessed during prospective follow-up in those receiving pre-exposure prophylaxis and compared to those receiving placebo.  PrEP use resulted in a small (-1.59 mL/min/1.73m2, 95% CI -2.44, -0.74) but statistically significant decline in eGFR that was non-progressive over a median of 18 months and a maximum of 36 months of follow-up.  PrEP use was not accompanied by a substantial increase in the risk of clinically relevant (≥25%) eGFR decline. (more…)
Author Interviews, JAMA, Obstructive Sleep Apnea, Pediatrics, University Texas, UT Southwestern / 26.12.2014

Ron B. Mitchell, MD Professor of Otolaryngology and Pediatrics William Beckner Distinguished Chair in Otolaryngology Chief of Pediatric Otolaryngology UT Southwestern and Children's Medical Center Dallas ENT Clinic Dallas, TX 75207MedicalResearch.com Interview with: Ron B. Mitchell, MD Professor of Otolaryngology and Pediatrics William Beckner Distinguished Chair in Otolaryngology Chief of Pediatric Otolaryngology UT Southwestern and Children's Medical Center Dallas ENT Clinic Dallas, TX 75207 Medical Research: What is the background for this study? What are the main findings? Dr. Mitchell: The “gold standard” for the diagnosis of and quantification of obstructive sleep apnea (OSA) is polysomnography (PSG or a ‘sleep study’). However, the majorities of T&A procedures are done without PSG and are based on a clinical diagnosis. This is because PSG is expensive, requires overnight observation and is often unavailable. It is important to diagnose and quantify OSA as it allows for surgical planning and predicts the need and type of treatment after surgery. We used data from the Childhood Adenotonsillectomy (CHAT) study; a large multicenter trial (RCT), to look at the ability of clinical parameters to predict the severity of obstructive sleep apnea in children scheduled for a T&A. The main findings of the study are that certain clinical parameters such as obesity and African American race as well as high scores on certain validated questionnaires (such as the pediatric sleep questionnaire- PSQ) are associated, but cannot predict OSA severity. PSG remains the only way to measure objectively the severity of OSA. (more…)
Author Interviews, Cost of Health Care, JAMA, Pediatrics / 24.12.2014

Dr. Ricardo Mosquera MD Assistant professor of Pediatrics at The University of Texas Health Science Center at Houston Medical School Clinic Director, UT Physicians, of the UTHealth Medical School.MedicalResearch.com Interview with: Dr. Ricardo Mosquera MD Assistant professor of Pediatrics at The University of Texas Health Science Center at Houston Medical School Clinic Director, UT Physicians, of the UTHealth Medical School. Medical Research: What is the background for this study? What are the main findings? Dr. Mosquera: There is not strong scientific evidence to support the use of medical homes.  Medical homes have not been demonstrated to decrease adverse outcomes or costs in children. Such benefits are most likely for high-risk children with chronic illness.  We conducted a rigorous and well designed, randomized controlled trial to determine if an enhanced medical home providing comprehensive care decreases serious illness  (death, prolonged hospitalization>7 days, or intensive care unit admissions) and/or cost among high-risk chronically ill children. An enhanced medical home decreased both adverse outcomes (decreased serious illness, hospitalizations, PICU admissions, and serious illness by ~50%) and cost (~$10.000 less per child/year). (more…)