Author Interviews, JNCI, Mental Health Research, Pharmacology, UT Southwestern, Weight Research / 23.08.2017

MedicalResearch.com Interview with: Chen Liu, Ph.D. Assistant Professor Departments of Internal Medicine and Neuroscience Division of Hypothalamic Research The University of Texas Southwestern Medical Center Dallas, Texas 75390-9077  MedicalResearch.com: What is the background for this study? Response: Atypical antipsychotics are second-generation antipsychotics (SGAs) that have been increasingly used to treat a variety of neuropsychiatric conditions such as schizophrenia, depression, and autism. Many patients taking these medications, however, are left in an agonizing dilemma. On one hand, they rely on these drugs’ psychotropic effect for normal functioning in daily life. On the other, many SGAs, including the most widely prescribed olanzapine and clozapine, can cause a metabolic syndrome that is known for excessive weight gain, dyslipidemia, and type-2 diabetes_ENREF_2. Notably, while full-blown type 2 diabetes and morbid obesity typically take years to unfold in the general population, these conditions progress at a much faster pace (within months) following second-generation antipsychotics treatment. Other factors such as ethnicity, age, and sex can also aggravate SGA-induced metabolic syndrome. Together, these peculiar features strongly suggest a distinct etiology underlying SGA-induced metabolic syndrome that has yet been fully elucidated. Currently, there is no medication specifically targeting SGA-induced metabolic syndrome. For many youths and adults taking second-generation antipsychotics, metabolic complications are difficult to manage as lifestyle changes, nutritional consulting, and commonly used anti-diabetic medications only provide limited relief. (more…)
Author Interviews, Education, JAMA, UCLA / 22.08.2017

MedicalResearch.com Interview with: Christian de Virgilio, MD LA BioMed lead researcher and corresponding author for the study He also is the former director of the general surgery residency program Harbor-UCLA Medical Center and the recipient of several teaching awards. MedicalResearch.com: What is the background for this study? What are the main findings? Response: Recent forecasts have predicted the United States will have a deficit of as many as 29,000 surgeons by 2030 because of the expected growth in the nation’s population and the aging of the Baby Boomers. This expected shortfall in surgeons has made the successful training of the next generation of surgeons even more important than it was before. Yet recent studies have shown that as many as one in five general surgery residents leave their training programs before completion to pursue other specialties. Our team of researchers studied 21 training programs for general surgeons and published our findings in the Journal of the American Medical Association Surgery (JAMA Surgery) on August 16, 2017. What we found was the attrition rate among residents training in general surgery was lower than previously determined – just 8.8% instead of 20% – in the 21 programs we surveyed. Our study also found that program directors’ attitudes and support for struggling residents and resident education were significantly different when the authors compared high- and low-attrition programs. General surgeons specialize in the most common surgical procedures, including abdominal, trauma, gastrointestinal, breast, cancer, endocrine and skin and soft tissue surgeries. General surgery residency training follows medical school and generally requires five to seven years. The programs are offered through universities, university affiliated hospitals and independent programs. In this study, the research team surveyed 12 university-based programs, three program affiliated with a university and six independent programs. In those programs, 85 of the 966 general surgery residents failed to complete their training during the five-year period the research team studied, July 1, 2010 to June 30, 2015. Of those who failed to complete their general surgery training, 15 left during the first year of training; 34 during the second year, and 36 during the third year or later. Notably, we found a nearly seven-fold difference between the training program with the lowest attrition rate, 2.2%, and the one with the highest rate, 14.3%, over the five-year period surveyed. In the programs with lower attrition rates, we found about one in five residents received some support or remediation to help ensure they would complete their https://medicalresearch.com/author-interviews/reduction_in_surgical_residents_work_hours/4475/ In the programs with higher attrition rates, the research team reported that only about one in 15 residents received such remediation. (more…)
Author Interviews, Education, Pediatrics, Sleep Disorders, University of Michigan / 22.08.2017

MedicalResearch.com Interview with: Galit Dunietz, Ph.D., MPH Epidemiologist, Sleep Disorders Center Department of Neurology University of Michigan Ann Arbor MI MedicalResearch.com: What is the background for this study? What are the main findings? Response: Insufficient sleep has a negative impact on health, cognition and mood and is linked to motor vehicle accidents. However, sleep loss in adolescents has become an epidemic and arises in part from biological processes that delay sleep and wake timing at the onset of puberty. This biology does not fit well with early school start times (before 8:30 a.m.). Despite recommendations from the American Academy of Pediatrics and the American Academy of Sleep Medicine to delay school start times, most schools in the U.S. have current start times before 8:30 a.m. In this nationally representative study of US parents of teens, we examined whether parents supported or opposed later school start times (after 8:30 a.m.). We also examined what may have influenced their opinions. We found that only about half of surveyed parents of teens with early school start times supported later school start times. Opinions appeared to depend in part on what challenges and benefits were expected to result from the change. For example, parents who expected an improvement in their teen’s academic performance or sleep quantity tended to support the change, whereas parents that expected negative impact on afterschool activities or transportation opposed delays in school start times.  We also found that parents had misconception about sleep needs of their adolescents, as the majority perceived 7-7.5 hours of sleep as sufficient, or possibly sufficient even at this young age when 8-10 hours are typically recommended. (more…)
Author Interviews, Opiods, Orthopedics, Pain Research, Stanford / 21.08.2017

MedicalResearch.com Interview with: Tina Hernandez-Boussard, PhD MPH, MS Associate Professor of Medicine, Biomedical Data Science, and Surgery Stanford School of Medicine Stanford, CA 94305-5479 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Opioid addiction is a national crisis.  As surgery is thought to be a gateway to opioid misuse, opioid-sparing approaches for pain management following surgery are a top priority. We conducted a meta-analysis of 39 randomized clinical trials of common non-pharmalogical interventions used for postoperative pain management. We found that acupuncture and electrotherapy following total knee replacement reduced or delayed patients’ opioid use. (more…)
Blood Pressure - Hypertension, Columbia, Technology / 21.08.2017

MedicalResearch.com Interview with: Gregg W. Stone MD Professor of Medicine Columbia University Director of Cardiovascular Research and Education Center for Interventional Vascular Therapy New York Presbyterian Hospital/ Columbia University Medical Center Co-Director of Medical Research and Education The Cardiovascular Research Foundation New York, NY MedicalResearch.com: How does the MobiusHD system work? Response: The MobiusHD System is a thin stent-like device which is implanted during a minimally invasive procedure into the carotid artery. The MobiusHD modifies the activity of baroreceptors located in the carotid artery, increasing arterial vasodilation to reduce blood pressure. (more…)
Accidents & Violence, Author Interviews, Dermatology, JAMA, UCSF, Urology / 17.08.2017

MedicalResearch.com Interview with:
Thomas W. Gaither, BS Department of Urology University of California, San Francisco General Hospital, San Francisco
MedicalResearch.com: What is the background for this study? What are the main findings? Response: We study genitourinary trauma and reconstruction. This study was motivated from a previous study showing that Emergency Room visits due to grooming were increasing over the past nine year. We sought to better characterize who was at most risk for grooming injuries. We found that grooming is extremely common in both men and women and minor injuries occur in about 25% of groomers. Surprisingly, a little over one percent sought medical care due to their injury. Participants at most risk our those who remove all of their pubic hair frequently ( as opposed to those who just trim). We did not find any instruments that were necessarily putting participants at risk for injury. (more…)
Author Interviews, Cancer Research, Cost of Health Care, Duke, JAMA / 11.08.2017

MedicalResearch.com Interview with: Dr. Fumiko Chino, MD Duke Radiation Oncology Duke School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: The financial burden of cancer treatment is a growing concern. Out-of-pocket expenses are higher for patients with cancer than for those who have other chronic illnesses. Fifty percent of elderly cancer patients spend at least 10% of their income on treatment-related out-of-pocket expenses. Additionally, high financial burden is associated with both increased risk of poor psychological well-being and worse health-related quality of life. A cancer diagnosis has been shown to be an independent risk factor for declaring personal bankruptcy, and cancer patients who declare personal bankruptcy are at greater risk for mortality. These potentially harmful outcomes resulting from financial burden have been recognized as the financial toxicity of cancer therapy, analogous to the more commonly considered physical toxicity. We conducted an IRB approved study of financial distress and cost expectations among patients with cancer presenting for anti-cancer therapy. In this cross-sectional, survey based study of 300 patients, over one third of patients reported higher than expected financial burden. Cancer patients with highest financial distress are underinsured, paying nearly 1/3 of income in cancer-related costs. In adjusted analysis, experiencing higher than expected financial burden was associated with high/overwhelming financial distress (OR 4.78; 95% CI 2.02-11.32; p<0.01) and with decreased willingness to pay for cancer care (OR 0.48, 95% CI 0.25-0.95, p=0.03). Sambla, a Scandinavian lender, has been working with many patients to prevent any financial distress resulting from unexpected medical bills. As a result of customer feedback, it has modified the terms of all loans it issues to allow for jumbo loan sizes and reduced interest rates, combined with longer repayment times to help its borrowers. (more…)
Accidents & Violence, Alzheimer's - Dementia, Author Interviews, Depression, Geriatrics, Karolinski Institute / 11.08.2017

MedicalResearch.com Interview with: Heidi Taipale, PhD Pharm Senior Researcher School of Pharmacy, University of Eastern Finland; and Department of Clinical Neuroscience Karolinska Institutet  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Antidepressant use among older persons has been associated with an increased risk of falling and fall-related events, such as hip fractures, in previous studies. Our previous study identified risk of hip fractures in antidepressant among persons with Alzheimer’s disease. As falling is the main causal factor for head traumas and traumatic brain injuries among older persons, we hypothesized that antidepressant use could also be associated with these injuries. We utilized a nationwide cohort of 70,718 persons newly diagnosed with Alzheimer’s disease, identified from the Finnish registers. The risk of head injuries and traumatic brain injuries was compared between persons initiating antidepressant use and comparison persons of the same age, gender and time since they received diagnoses of Alzheimer’s disease but not using antidepressants. We found a 40-percent increased risk of head injuries and 30-percent increased risk of traumatic brain injuries associated with antidepressant use. Antidepressant use was associated with a higher risk of head injuries especially at the beginning of use – during the first 30 days – but the risk persisted even longer, up to two years. The association was also confirmed in a study design comparing time periods within the same person, thus eliminating selective factors. (more…)
Author Interviews, Flu - Influenza, Kaiser Permanente, Merck, NEJM, Vaccine Studies / 10.08.2017

MedicalResearch.com Interview with: Michael Jackson  PhD, MPH Kaiser Permanente Washington Health Research Institute (KPWHRI) principal investigator for the United States Influenza Vaccine Effectiveness Network  MedicalResearch.com: What is the background for this study?
  • Response: Each year, Kaiser Permanente Washington is one of five sites across the country that participate in the United States Influenza Vaccine Effectiveness Network. The Network reports its early interim results in the MMWRand presents additional interim results to the Advisory Committee on Immunization Practices (ACIP). This New England Journal of Medicine publication is an update of those interim results.
  • The findings in this New England Journal of Medicine are special because prior randomized controlled trials indicated that the nasal spray vaccine (FluMist)—also called live attenuated influenza vaccine (LAIV)—would work well to protect children and teens from the flu, whereas in actual practice we found that the flu shot worked much better, particularly against the predominant strain, A(H1N1)pdm09.
  • The nasal spray vaccine was first seen to be less effective for young children than the flu shot in 2013-2014 for the A(H1N1)pdm09 virus strain. In response, the A(H1N1)pdm09 virus strain used in the nasal spray vaccine was changed for the 2015-2016 influenza season. The 2016/17 season was the first since 2015-2016 to be dominated by the A(H1N1)pdm09 virus, making this our first opportunity to evaluate the updated nasal spray vaccine.
  • The Influenza Vaccine Effectiveness Network evaluated the impact of this change as part of our estimates of influenza vaccine effectiveness in 2015-2016. Preliminary findings from this study were presented to the ACIP in June 2016, which led to the nasal spray vaccine not being recommended in 2016-2017 in the US, although the nasal spray vaccine remains licensed in the US. In 2016-2017, the LAIV A(H1N1)pdm09 vaccine strain was unchanged from 2015-2016.
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Author Interviews, Cost of Health Care, JAMA, Lipids, University of Pittsburgh / 07.08.2017

MedicalResearch.com Interview with: Inmaculada Hernandez, PharmD, PhD Assistant Professor of Pharmacy and Therapeutics University of Pittsburgh School of Pharmacy Pittsburgh, PA 1526 MedicalResearch.com: What is the background for this study? Response: A few months ago, the results of the FOURIER trial were published. This trial was the first one to evaluate the efficacy of PCSK9 inhibitors in the prevention of cardiovascular events, since the approval of these agents was based on trials that evaluated their efficacy in reducing levels of LDL-C. The results of the FOURIER trial did not meet the expectations generated by prior studies that had simulated how much the risk of cardiovascular events should decrease based on the observed reduction in LDL-C levels. A few hours after the publication of the results of the FOURIER trial, Amgen (evolocumab´s manufacturer) announced that it would be willing to engage in contracts where the cost of evolocumab would be refunded for those patients who suffer a heart attack or a stroke while using the drug. (more…)
Author Interviews, BMJ, Brigham & Women's - Harvard, Opiods, Pediatrics / 04.08.2017

MedicalResearch.com Interview with: Krista F. Huybrechts, MS PhD Assistant Professor of Medicine Brigham and Women’s Hospital Harvard Medical School Boston, MA 02120 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Neonatal drug withdrawal is common; in the U.S. about 1 infant is born every 25 minutes with signs of drug withdrawal. Neonatal drug withdrawal is a well-recognized complication of intrauterine exposure to illicit or prescription opioids, but other psychotropic medications can also cause signs of withdrawal. Psychotropic medications are frequently co-prescribed with opioids in pregnancy, and the use of both has increased significantly, raising concerns about an increase in the incidence and severity of neonatal drug withdrawal due to potential drug-drug interactions, but these risks are not well understood. In this study, we found a 30-60% increase in the risk of neonatal drug withdrawal associated with co-exposure to antidepressants, benzodiazepines and gabapentin, compared to opioids alone; no significant increase in risk was observed for atypical antipsychotics and Z-drugs. Exposure to psychotropic polypharmacy along with opioids was associated with a two-fold increased risk of withdrawal. (more…)
Author Interviews, Heart Disease, Menopause, Race/Ethnic Diversity, University of Pittsburgh / 03.08.2017

MedicalResearch.com Interview with: Samar R. El Khoudary, PhD, MPH, BPharm, FAHA Associate Professor, Epidemiology PITT Public Health Epidemiology Data Center University of Pittsburgh Pittsburgh, PA 15260   MedicalResearch.com: What is the background for this study? What are the main findings? Response: Heart fat is associated with greater coronary heart disease risk. Postmenopausal women have greater heart fat volumes than premenopausal women, and the association between specific heart fat depots and calcification in the coronary arteries is more pronounced after menopause. Race, central adiposity, and visceral adiposity are important factors that could impact heart fat volumes. We evaluated whether racial differences in heart fat volumes and in their associations with central (abdominal visceral fat) and general adiposity (as measured by body mass index [BMI]) exist in midlife women. Our study included 524 women from the Study of Women's Health Across the Nation (SWAN) (mean age: 51 years; 62% White and 38% Black) who had data on heart fat volumes, abdominal visceral fat and BMI. After accounting for the potential health effects of lifestyle and socioeconomic factors we found that midlife Black women had less heart fat volumes than white women and not surprisingly, the more fat a women carries overall, the higher her risk for a fatty heart. However, white women with higher BMI had significantly more heart fat, as measured by a CT scan, than black women with the same BMI. For black women, the levels of heart fat were greater if they carried more fat in their midsection, as measured by a cross-sectional CT scan, compared with white women with the same volume of fat in their midsection. The results echo the findings we have reported previously in midlife men and published at the International Journal of Obesity (2015) 39, 488–494. (more…)
Author Interviews, Cleveland Clinic, Orthopedics, Pain Research, Surgical Research / 01.08.2017

MedicalResearch.com Interview with: Michael A. Mont, MD Department of Orthopaedic Surgery Cleveland Clinic Cleveland, OH  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Postoperative pain after total knee arthroplasty (TKA) is a major hurdle for both the patients and the orthopaedists. Many analgesic modalities are currently in use, and can be used alone or in combination in order to augment their effect. Addition of local anesthetic analgesia has been shown to improve pain control and reduce opioid consumption during postoperative period. However, the effects of this analgesia tend to dissipate with time, with the longest duration of action (bupivacaine) of approximately 12 hours. Therefore, long acting local anesthetic (liposomal bupivacaine) has been developed in order to expand the duration of effectiveness of pain relief for up to 96 hours. Many studies evaluated the effectiveness of this anesthetic and demonstrated contradictory results, however, they did not use the same methods and infiltration technique. Therefore, we conducted a prospective, randomized, double-blind, controlled study at 16 hospitals using optimal infiltration techniques. Our study demonstrated significant improvement in pain, decreased opioid consumption, increased time to first opioid rescue, more opioid free patients in liposomal bupivacaine cohort. In addition, there were no unexpected safety concerns. (more…)
Author Interviews, Cost of Health Care, Emory / 31.07.2017

MedicalResearch.com Interview with: Xu Ji PhD Candidate Emory University Department of Health Policy and Management Rollins School of Public Health Emory University Atlanta, GA What is the background for this study? What are the main findings? Response: Gaps in Medicaid coverage (sometimes called “churning”) can disrupt ongoing outpatient care needed to manage chronic conditions, such as depression, and trigger use of emergency care. This study examined how disruptions in Medicaid coverage impacted acute care use—specifically emergency department visits and hospital stays—in nearly 140,000 adults treated for major depression. We found that those with disruptions in Medicaid coverage were more likely to have emergency department visits and longer hospital stays when they went back on Medicaid compared to those with continuous coverage. We also found that disruptions in Medicaid coverage occurred less frequently for Medicaid enrollees with depression in states requiring only yearly recertification (i.e., more streamlined re-enrollment procedures) than those in states that required recertification every six months or more frequently (i.e., more stringent procedures). Eligibility recertification usually requires enrollees to visit the social welfare office to provide income or other documentation to prove eligibility. Failure to complete the recertification process would drop enrollees out of Medicaid. (more…)
Author Interviews, Diabetes, JAMA, Ophthalmology, UC Davis / 30.07.2017

MedicalResearch.com Interview with: Jeffrey R. Willis MD, PhD UC Davis Eye Center University of California, Davis Sacramento California MedicalResearch.com: What is the background for this study? What are the main findings? Response: Diabetic retinopathy is one of the leading causes of blindness in the United States.  Yet there is limited national level data on the impact of worsening DR on quality of life and visual function. Our study aimed to address this knowledge gap by evaluating the functional burden of DR across severity levels, utilizing data from the National Health and Nutrition Examination Survey (NHANES). We found that one-half of US adults with severe non-proliferative diabetic retinopathy (NPDR) or proliferative diabetic retinopathy (PDR) had difficulty with ≥ 1 visual function task, possibly impacting their daily work/activities.  These patients reported a significantly greater vision-related functional burden relative to those with less severe forms of DR. (more…)
Author Interviews, Brain Injury, Cleveland Clinic, Cognitive Issues, MRI, Occupational Health / 29.07.2017

MedicalResearch.com Interview with: Virendra Mishra, Ph.D. Department of Imaging Research Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas MedicalResearch.com: What is the background for this study? What are the main findings? Response: Repetitive head trauma has been shown to be a risk factor for various neurodegenerative disorders, mood swings, depression and chronic traumatic encephalopathy. There has been a significant amount of research into identifying an imaging biomarker of mild traumatic brain injury (mTBI) due to repetitive head trauma. Unfortunately, most of the biomarkers have not been able to find a successful translation to clinics. Additionally, the quest for the mTBI imaging biomarker especially using Magnetic Resonance Imaging (MRI) techniques has been done by looking at either the gray matter (T1-weighted) or the white matter (Diffusion Tensor Imaging) independently; and both have shown changes that are associated with repetitive head trauma. Hence in this study, we wanted to investigate if combining gray matter and white matter information enables us to better predict the fighters who are more vulnerable to cognitive decline due to repetitive head trauma. Our method found seven imaging biomarkers that when combined together in a multivariate sense were able to predict with greater than 73% accuracy those fighters who are vulnerable to cognitive decline both at baseline and follow-up. The imaging biomarkers were indeed a combination of gray and white matter measures of regions reported previously in the literature. A key point in our study was we found the regions predicting cognitive decline without enforcing any assumptions on the regions previously reported. (more…)
Author Interviews, Blood Pressure - Hypertension, Brigham & Women's - Harvard, JAMA / 28.07.2017

MedicalResearch.com Interview with: Stephen P. Juraschek, MD, PhD Instructor of Medicine Beth Israel Deaconess Medical Center Harvard Medical School MedicalResearch.com: What is the background for this study? Response: Many adults experience dizziness and light-headedness when they stand up. This is more common in older adults and is related to risk of falling, fractures, fainting, car crashes, and early death. These symptoms are thought to be caused by a drop in blood pressure after standing also called orthostatic hypotension. However, if measured at the wrong time it is possible to miss this important clinical sign. For over 2 decades (since 1996), it has been recommended that orthostatic hypotension be identified by measuring blood pressure within 3 minutes of standing. Furthermore, it was also thought that measurements immediately after standing be avoided because they might be inaccurate (based on fluctuation in blood pressure immediately after standing). As a result, a lot of clinical protocols instructing healthcare staff on measuring orthostatic blood pressure encourage measurement at 3 minutes, but this has not been scientifically evaluated. (more…)
Author Interviews, Education, Heart Disease, JAMA, Lifestyle & Health, Primary Care, UCLA / 28.07.2017

MedicalResearch.com Interview with: Carol M. Mangione, MD, MSPH, FACP Barbara A. Levey, MD, and Gerald S. Levey, MD Endowed chair in medicine David Geffen School of Medicine University of California, Los Angeles Professor of public health at the UCLA Fielding School of Public Health MedicalResearch.com: What is the background for this study? Response: Americans can experience several health benefits from consuming healthy foods and engaging in physical activity. The Task Force recommends that primary care professionals work together with their patients when making the decision to offer or refer adults who are not obese and do not have hypertension, high cholesterol, high blood sugar, or diabetes to behavior counseling to promote healthful diet and physical activity. Our focus was on the impact of a healthful diet and physical activity on cardiovascular risk because this condition is the leading cause of premature morbidity and mortality. The Task Force evaluates what the science tells us surrounding the potential benefits and harms of a particular preventive service. In this case, the Task Force found high quality evidence focusing on the impact a healthful diet and physical activity can have on a patient’s risk of cardiovascular disease. Relying on this evidence, the Task Force was able to conclude that there is a positive but small benefit of behavioral counseling to prevent cardiovascular disease. (more…)
Annals Internal Medicine, Author Interviews, Brigham & Women's - Harvard, Hormone Therapy, Sexual Health, Testosterone / 27.07.2017

MedicalResearch.com Interview with: Carl G Streed Jr. M.D. Pronouns: he, him, his, himself Fellow, Division General Internal Medicine & Primary Care Brigham & Women’s Hospital  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Recent reports estimate that 0.6% of adults in the United States, or approximately 1.4 million persons, identify as transgender. Despite gains in rights and media attention, the reality is that transgender persons experience health disparities, and a dearth of research and evidence-based guidelines remains regarding their specific health needs. The lack of research to characterize cardiovascular disease (CVD) and CVD risk factors in transgender populations receiving cross-sex hormone therapy (CSHT) limits appropriate primary and specialty care. As with hormone therapy in cisgender persons (that is, those whose sex assigned at birth aligns with their gender identity), existing research in transgender populations suggests that CVD risk factors are altered by CSHT. (more…)
Author Interviews, FDA, JAMA, Race/Ethnic Diversity / 25.07.2017

MedicalResearch.com Interview with: Sanket Dhruva, MD, MHS, FACC Cardiology, VA Connecticut Healthcare System Robert Wood Johnson Foundation Clinical Scholar Yale University MedicalResearch.com: What is the background for this study? What are the main findings? Response: In 2012, Congress passed the Food & Drug Administration (FDA) Safety and Innovation Act, with the goal of increasing enrollment and availability of data in important patient groups such as the elderly, women, and racial and ethnic minorities. In 2014, as mandated by the legislation, the FDA released an Action Plan to address these issues. This Action Plan included the goal of increasing the transparency by posting demographic information of pivotal (or key) clinical trials used to support approval decisions. We examined how often these data were available in 2015 for all studies used to support approval of all original high-risk medical devices approved in the calendar year following the FDA Action Plan. Examples of these medical devices include stents, bone grafts, heart valves, and spinal cord stimulators. We wanted to understand if age, sex, and race and ethnicity data were available and if the results of clinical studies supporting these medical devices were analyzed to assess if there were differences in safety and effectiveness by these important demographic factors. Our main findings are that FDA Summaries publicly reported age for 65% of study populations, sex for 66%, and race and/or ethnicity for 51%. Analyses to assess if demographic factors may have impacted device safety and effectiveness were only conducted by age for 9%, by sex for 17%, and by race for 4% of clinical studies. (more…)
Annals Internal Medicine, AstraZeneca, Author Interviews, Brigham & Women's - Harvard, Heart Disease, Merck, Pharmacology / 25.07.2017

MedicalResearch.com Interview with: Alexander Turchin, MD,MS Director of Quality in Diabetes Associate Professor, Harvard Medical School Brigham and Women's Hospital Boston, MA MedicalResearch.com: What is the background for this study? Response: Cardiovascular disease is the # 1 cause of death in the U.S. and worldwide. Statins are some of the most effective medications available for prevention of cardiovascular events. However, many patients stop statins, frequently because of adverse reactions. In our study we aimed to assess the risk-benefit balance of trying a statin again after experiencing an adverse reaction. (more…)
Alzheimer's - Dementia, Author Interviews, Columbia, Nutrition / 24.07.2017

MedicalResearch.com Interview with: Yian Gu, PhD Assistant Professor of Neuropsychology (in Neurology and Taub Institute for Research on Alzheimer's Disease and the Aging Brain) Columbia University Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: We have previously shown that elderly individuals who consume healthier diet (certain foods, nutrients, and dietary patterns) have larger brain volume, better cognition, and lower risk of developing Alzheimer’s disease. The current study aimed to examine the biological mechanisms for the relationship between diet and brain/cognitive health.  (more…)
Accidents & Violence, Author Interviews, CDC, Emory, Gender Differences, Race/Ethnic Diversity / 21.07.2017

MedicalResearch.com Interview with: EmikoPetrosky MD M.P.H Science Officer, National Violent Death Reporting System at Centers for Disease Control and Prevention Centers for Disease Control and Prevention Emory University Rollins School of Public Health MedicalResearch.com: What is the background for this study? Response: Homicide is one of the leading causes of death for women aged 44 years and younger. In 2015, 3,519 girls and women died by homicide in the United States.  It is the 5th leading cause of death for women under 45 years age (defining women as 18-44 years of age). The National Violent Death Reporting System (NVDRS) links together data from death certificates, coroner/medical examiner reports, and law enforcement reports, resulting in more information about the circumstances of death than what is available elsewhere. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, JAMA, Mental Health Research / 20.07.2017

MedicalResearch.com Interview with: Bastian Ravesteijn PhD Department of Health Care Policy Harvard Medical School  MedicalResearch.com: What is the background for this study? What are the main findings? Response: We find that higher out-of-pocket costs for mental health care could have the unintended consequence of increasing the use of acute and involuntary mental health care among those suffering from the most debilitating disorders. (more…)
Author Interviews, Brigham & Women's - Harvard, Heart Disease, JAMA, Pediatrics / 19.07.2017

MedicalResearch.com Interview with: Holly Gooding, MD, MSc Assistant Professor of Medicine and Pediatrics Harvard Medical School Division of Adolescent/Young Adult Medicine Boston Children's Hospital Division of General Internal Medicine Brigham and Women's Hospital Boston, MA MedicalResearch.com: What is the background for this study? What are the main findings? Response: Dr Stephanie Chiuve and colleagues at the Harvard TH Chan School of Public Health developed the Healthy Heart Score to predict the risk of heart disease in older adults based on lifestyle factors measured in middle age. We have known for some time that the precursor to heart disease – known as atherosclerosis – actually starts in childhood and adolescence. We calculated the Healthy Heart Score for young adults ages 18-30 years old and found it works in this age group as well. (more…)
Aging, Author Interviews, Brigham & Women's - Harvard, JAMA, Weight Research / 19.07.2017

MedicalResearch.com Interview with: Yan Zheng Research Fellow, Department of Nutrition Harvard T.H. Chan School of Public HealthYan Zheng Research Fellow, Department of Nutrition Harvard T.H. Chan School of Public Health MedicalResearch.com: What is the background for this study? What are the main findings? Response: Most people gain weight cumulatively during young and middle adulthood. Because the amount of weight gain per year may be relatively small, it may go unnoticed by individuals and their doctors—but the cumulative weight gain during adulthood may eventually lead to obesity over time. Compared to studies of attained body weight or BMI, the investigation of weight change may better capture the effect of excess body fat because it factors in individual differences in frame size and lean mass. (more…)
Author Interviews, Baylor College of Medicine Houston, Biomarkers, Brain Cancer - Brain Tumors, Cancer Research, PNAS / 19.07.2017

MedicalResearch.com Interview with: Chonghui Cheng, M.D., Ph.D. Associate Professor Department of Molecular & Human Genetics Lester & Sue Smith Breast Center Baylor College of Medicine Houston, TX77030 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Understanding the mechanisms that give cancer cells the ability to survive and grow opens the possibility of developing improved treatments to control or cure disease. In the case of glioblastoma multiforme, the deadliest type of brain cancer, abnormal EGFR signaling is frequently observed. Treatment with the EGFR inhibitor erlotinib attempts to kill cancer cells. However, the clinical benefit of treatment with this and other EGFR inhibitors has been limited by the development of drug resistance. Scientists at Baylor College of Medicine discovered that the molecule CD44s seems to give cancer cells a survival advantage. Eliminating this advantage by reducing the amount of CD44s resulted in cancer cells being more sensitive to the deadly effects of the drug erlotinib. (more…)
Addiction, Alcohol, Author Interviews, NIH / 17.07.2017

MedicalResearch.com Interview with: Lorenzo Leggio, M.D., Ph.D. Chief of the Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, a NIAAA intramural laboratory MedicalResearch.com: What is the background for this study? MedicalResearch.com: What is the background for this study? What are the main findings? Response: Aldosterone is an important hormone involved in the control of blood pressure and electrolytes via its mineralcorticoid receptor (MR). In addition to its roles in the periphery in our body, aldosterone also acts on the brain where the MR is particularly present in regions like the amygdala. The amygdala plays an important role in stress, anxiety and excessive alcohol drinking. Back in 2008, we conducted a small pilot study where we found that alcohol-dependent patients with higher blood aldosterone concentrations have higher alcohol craving. (more…)
Author Interviews, Dental Research, Microbiome, University of Pennsylvania / 14.07.2017

MedicalResearch.com Interview with: Dana T. Graves DDS Department of Periodontics School of Dental Medicine University of Pennsylvania Philadelphia, PA MedicalResearch.com: What is the background for this study? What are the main findings? Response: It was previously thought that diabetes did not have a significant effect on oral bacteria. We found that diabetes caused a change in the composition of the oral bacteria. This change caused resulted in a bacterial composition that was more pathogenic and stimulated more inflammation in the gums and greater loss of bone around the teeth. (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, Dermatology, HIV, JAMA, Kaiser Permanente, Merck / 13.07.2017

MedicalResearch.com Interview with: Maryam M. Asgari, MD, MPH Department of Dermatology Massachusetts General Hospital, Department of Population Medicine Harvard Medical School, Boston, Massachusetts Division of Research, Kaiser Permanente Northern California, Oakland MedicalResearch.com: What is the background for this study? What are the main findings? Response: Nonmelanoma skin cancer – defined as basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) – is a common malignant condition, affecting more than 2 million Americans every year. BCCs are more common than SCCs among individuals with healthy immune systems, while SCCs are more predominate than BCCs among people who are immunocompromised. We examined how laboratory markers used to evaluate HIV disease progression may be associated with subsequent nonmelanoma skin cancer risk in white patients previously diagnosed with at least one such cancer from 1996 to 2008.  We measured CD4 count, viral load and subsequent nonmelanoma skin cancer. The study included 455 participants with HIV and 1,952 without HIV. All were members of the Kaiser Permanente Northern California health care plan. (more…)