Author Interviews, Boehringer Ingelheim, NEJM, Pharmaceutical Companies, Pulmonary Disease / 30.05.2019

MedicalResearch.com Interview with: Donald Zoz, M.D., Senior associate director Clinical Development & Medical Affairs Boehringer Ingelheim Pharmaceuticals, Inc. MedicalResearch.com: What is the background for this study? How does nintedanib differ from other treatments for SSc-ILD? What are the main findings?  Response: SENSCIS is a Phase III double-blind, randomized placebo-controlled trial that included 576 patients in 32 countries. It is the largest trial to have been conducted in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD). The primary endpoint was the annual rate of decline in forced vital capacity (FVC) over 52 weeks. At the end of the 52-week trial, patients receiving nintedanib had an adjusted annual rate of decline in FVC (mL/year) of -52.4 with nintedanib versus -93.3 with placebo (absolute difference 41.0mL/year [95% CI 2.9, 79.0]; p=0.04). This corresponds to a relative difference of 44% reduction in lung function decline. There are currently no approved treatments for SSc-ILD., BI conducted the SENSCIS study to evaluate in SSc-ILD patients the impact of nintedanib. Nintedanib, a selective tyrosine kinase inhibitor, is an antifibrotic agent. Results of the study, which were published in The New England Journal of Medicine and presented at the American Thoracic Society (ATS) International Conference, showed that nintedanib slowed the loss of pulmonary function by 44% in patients with SSc-ILD relative to placebo, as measured by FVC over 52 weeks.  (more…)
Author Interviews, Dermatology / 30.05.2019

MedicalResearch.com Interview with: Lara B. McKenzie, PhD, MA Principal Investigator in the Center for Injury Research and Policy Research Institute at Nationwide Children's Hospital Associate Professor in the Department of Pediatrics College of Medicine and the Division of Epidemiology College of Public Health at The Ohio State University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Social media and other online tools have changed the way people seek and share health information. Recent consumer interest in natural, organic, and ethically-made personal care products has led to an increase of shared recipes for homemade products including sunscreen. The study found that nearly all (95%) pins, or bookmarks, for homemade sunscreen positively portrayed the effectiveness of homemade sunscreens and most (68%) recommended recipes for homemade sunscreens that offered insufficient UV radiation protection. Sun Protection Factor (SPF) claims were made in a third of pins with a range of SPF 2 to SPF 50. This is concerning because the ingredients recommended in homemade sunscreen pins offer minimal scientifically proven broad-spectrum protection from UV radiation yet are widely shared and promoted as safe alternatives to commercial sunscreens on Pinterest. Homemade sunscreen products are risky because they are not regulated or tested for efficacy like commercial sunscreens. When you make it yourself, you don’t know if it’s safe or effective. With rising skin cancer rates, the use of effective broadband sunscreen is critical to protect the skin from UV radiation and reduce incidence of skin cancer.  (more…)
Author Interviews, Clots - Coagulation, Duke, Genetic Research, Heart Disease, JAMA / 30.05.2019

MedicalResearch.com Interview with: Thomas J. Povsic, MD, PhD Interventional Cardiologist Duke Clinical Research Institute Duke University School of Medicine Durham, North Carolina  MedicalResearch.com: What is the background for this study?  Response: The background for this study is that it is unknown how mandatory reporting of CYP2C19 metabolizer status affects how doctors treat patients or to what degree provision of this information would affect choice of a P2Y12 inhibitor within a clinical trial. As part of the GEMINI-ACS trial, all patients underwent CYP2C19 metabolizer testing.  This trial enrolled patients with a recent acute coronary syndrome and randomized them to aspirin or a low dose of rivaroxaban.  All patients were also to be treated with ticagrelor or clopidogrel, which was at the discretion of the investigator.  Investigators were given information regarding the CYP2C19 metabolizer status about a week after randomization.  Importantly prior to randomization, all investigators were asked how they expected to use this information, and then we followed what they actually did. (more…)
Anesthesiology, Author Interviews, Duke, OBGYNE, Opiods, Pain Research, Surgical Research / 29.05.2019

MedicalResearch.com Interview with: Ashraf Habib, MDChief of the Division of Women’s Anesthesia and Professor of AnesthesiologyDuke University Ashraf Habib, MD Chief of the Division of Women’s Anesthesia Professor of Anesthesiology Duke University  MedicalResearch.com: What is the background for this study? What are the main findings? Response: This was a multicenter study conducted in 13 clinical sites in the United States enrolling patients undergoing elective Cesarean-section and receiving spinal anesthesia. 186 patients were enrolled and randomized to receive EXPAREL, a long-acting, non-opioid option to manage postsurgical pain, administered via transversus abdominis plane (TAP) field block, mixed with plain bupivacaine or TAP block with plain bupivacaine alone. A TAP block numbs the nerves that supply the abdominal wall. We presented the data at the 51st Annual Meeting of the Society of Obstetric Anesthesia and Perinatology (SOAP) in Phoenix, AZ. We aimed to collect clinical evidence that a multimodal postsurgical pain regimen using a TAP block with EXPAREL (bupivacaine liposome injectable suspension) together with regularly scheduled acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) could reduce opioid consumption more so than a standard multimodal pain control approach that combines TAP block with standard bupivacaine, regularly scheduled acetaminophen, and NSAIDs. (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, FDA, JAMA, Pharmacology / 29.05.2019

MedicalResearch.com Interview with: Bishal Gyawali  MD PhD
  • Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
  • Department of Oncology, Department of Public Health Sciences, and Division of Cancer Care and Epidemiology, Queen’s University, Kingston, Ontario, Canada
MedicalResearch.com: What is the background for this study? What are the main findings? Response: Accelerated approval pathway from the FDA allows cancer drugs to come to market sooner by showing improvement in surrogate measures such as change in tumor size. Surrogate measures do not reflect clinical benefit in terms of living longer or feeling better. So, when a drug receives accelerated approval, the drug is required to undergo a confirmatory trial to confirm that true clinical benefit from the drug actually exists. Last year, a paper from the FDA argued that accelerated approval pathway is working effectively because 55% of such drugs confirmed clinical benefit. However, we saw that most of those drugs were actually improving only a surrogate measure even in confirmatory trials. So the confirmatory trials were not confirming clinical benefit but actually confirming benefit in a surrogate endpoint. We investigate that issue in our study using updated results from the confirmatory trials that were ongoing at the time of FDA review. Our main finding is that only one-fifth of cancer drugs that received accelerated approval actually improved overall survival later in confirmatory trials. For, 20% of other drugs, the confirmatory trials tested the same surrogate endpoint as did the preapproval trial. For another 21%, the confirmatory trial showed benefit in a surrogate endpoint different from the one used in preapproval trial. Furthermore, when drugs fail to confirm clinical benefits in confirmatory trials, they still continue to remain on market.  (more…)
Author Interviews, Exercise - Fitness, JAMA, Mental Health Research, Pediatrics, UCLA / 29.05.2019

MedicalResearch.com Interview with: Molly C. Easterlin, MD Fellow, UCLA National Clinician Scholars Program Clinical Instructor, Pediatrics, Cedars-Sinai Medical Center  MedicalResearch.com: What is the background for this study? Response: Adverse childhood experiences or ACEs (including physical or emotional neglect or abuse, sexual abuse, domestic abuse, exposure to household substance misuse or mental illness, parental separation or divorce, and parental incarceration) are common with about half of children experiencing 1 and one-quarter of children experiencing 2 or more. Children exposed to adverse childhood experiences have worse mental health throughout life, including higher rates of depression and anxiety. However, little is known about what factors improve long-term mental health in those exposed to ACEs. Additionally, as far as we are aware, no studies have looked at team sports participation as a potential factor that may be associated with improved mental health among those with adverse childhood experiences. (more…)
Author Interviews, Social Issues / 29.05.2019

MedicalResearch.com Interview with: Peter Belmi PhD Assistant Professor of Leadership and Organizational Behavior Darden School of Business University of Virginia MedicalResearch.com: What is the background for this study?  Response: We wanted to understand how socioeconomic inequalities perpetuate from one generation to the next. Some scholars have suggested that social inequalities persist because of systemic prejudice that make it difficult for those at the bottom to improve their standing. Other scholars have suggested that structural inequalities may be hard to dismantle because those who wield the most influence are motivated to preserve their advantages. And other scholars have suggested that inequality may perpetuate when mainstream institutions do not acknowledge the values and norms of individuals from underrepresented groups. (more…)
Author Interviews, CDC, Flu - Influenza, Vaccine Studies / 29.05.2019

MedicalResearch.com Interview with: Megan C. Lindley, MPH Deputy Associate Director for Science Immunization Services Division CDC MedicalResearch.com: What is the background for this study? Response: Despite longstanding recommendations from the Advisory Committee on Immunization Practices, healthcare personnel influenza vaccination coverage remains below the Healthy People 2020 target of 90%. Healthcare employers use a variety of strategies to promote influenza vaccination among healthcare personnel, including facility-level mandates for vaccination. Several U.S. states have also enacted laws related to healthcare personnel influenza vaccination, but the effect of these laws on vaccination uptake is unclear. Our study used influenza vaccination coverage data reported by over 4,000 U.S. hospitals to examine three kinds of laws: (1) Assessment laws, which require hospitals to assess healthcare personnel influenza vaccination status; (2) Offer laws, which require hospitals to offer the influenza vaccine to healthcare personnel; and (3) Ensure laws, which require hospitals to require healthcare personnel to demonstrate proof of influenza vaccination. (more…)
Author Interviews, Epilepsy, FDA / 29.05.2019

MedicalResearch.com Interview with: Dr. Steven S. Chung, MD Executive Director and Program Chair Neuroscience Institute and Director of the Epilepsy Program Banner – University Medical Center MedicalResearch.com: What is the background for this study? How is Nayzilam different from other treatments for epilepsy? Who/How is it administered?  Response: NAYZILAM is the first medication and only FDA-approved nasal option for treating seizure clusters. NAYZILAM allows for administration by a non-healthcare professional to patients when a seizure cluster occurs, which could provide significant value to patients who currently have limited treatment options for SC. The effectiveness of NAYZILAM was established in a randomized, double-blind, placebo-controlled trial (Study 1; NCT 01390220). Study 1 was conducted in two phases: an open-label Test Dose Phase followed by a randomized, double-blind, placebo-controlled, Comparative Phase. In the Test Dose Phase, tolerability was assessed in 292 patients. Patients were excluded from participation in the Comparative Phase if they failed to meet pre-defined blood pressure, heart rate, sedation, electrocardiogram, and peripheral oxygen saturation criteria. In the Comparative Phase, 201 patients treated a single seizure cluster episode in an outpatient setting. Numerical differences in favor of NAYZILAM were observed on each of the components of the treatment success responder definition; termination of seizure(s) within 10 minutes after initial dose of study drug (80.6 versus 70.1%) and the absence of seizure recurrence between 10 minutes and 6 hours after the initial dose of study drug (58.2 versus 37.3%). Study 1 also evaluated the occurrence and time to next seizure after the initial blinded dose of study drug. A smaller proportion of NAYZILAM-treated patients experienced the next seizure within 24 hours after the initial blinded dose of study drug (37.3% versus 46.3%). NAYZILAM-treated patients experienced a statistically longer time-to-next-seizure than the placebo group.   (more…)
Author Interviews, Baylor University Medical Center Dallas, Gastrointestinal Disease / 28.05.2019

MedicalResearch.com Interview with: Dr. Rhonda Souza, MD Baylor University Medical Center Center for Esophageal Research Dallas, TX 75246  MedicalResearch.com: What is the background for this study?   Response: Eosinophilic esophagitis (EoE) is a modern disorder of the esophagus caused by an allergy to certain foods. EoE causes esophageal symptoms like difficulty swallowing and heartburn and is diagnosed when biopsies of the esophagus taken during endoscopy show numerous eosinophils, which are a type of inflammatory blood cell.  There are few established treatments for EoE. One such treatment is a diet that eliminates the offending food allergens, and another is to use steroids to reduce the number of eosinophils in the esophagus. However, the most common treatment for adults with eosinophilic esophagitis is to use proton pump inhibitors (PPIs), which block the proton pumps in stomach cells that make acid.  In earlier studies, we found that PPIs also can block proton pumps in esophageal cells.  Those proton pumps are activated by chemicals that the body produces in response to allergens including interleukin (IL)-13 or IL-4.  Il-13 and IL-4, which cause the esophagus to produce eotaxin-3, a molecule that attracts eosinophils. What remained unknown, however, was the mechanism whereby these interleukins activate proton pumps in the EoE esophagus. In our present study, we explored whether IL-4 works by increasing calcium levels in esophageal cells from EoE patients. (more…)
Author Interviews, Dermatology / 28.05.2019

MedicalResearch.com Interview with: Venkateswarlu (Venkat) NelabhotlaPresident & Board MemberVyome Therapeutics Inc., Venkateswarlu (Venkat) Nelabhotla President & Board Member Vyome Therapeutics Inc.,  MedicalResearch.com: What is the background for this study? Response: There are only a handful of antibiotics that are approved for use against the bacterial strain P.acnes that causes acne vulgaris. Because of the lack of new antibiotic treatment options, similar antibiotics are overused resulting in 1 out of 3 patients developing resistance against treatment, ultimately causing a decline in response rates. There is a clear unmet medical need for these patients; currently, patients do not have access to topical antibiotic treatments capable of an effective response without generating resistance. This study was designed to test the efficacy of VB-1953 in such moderate to severe acne patients, who were carrying resistant acne-causing bacteria and had failed to respond to currently approved antibiotics. VB-1953, a bactericidal topical gel formulated antibiotic, differs from these older generation antibiotics in its novel mechanism of action, through which it can kill both sensitive as well as resistant bacteria, while also reducing inflammation . The earlier generation of antibiotics, including treatments like clindamycin, are bacteriostatic in action, i.e. they merely prevent the growth of acne-causing bacteria. VB-1953 is the first bactericidal antibiotic for the treatment of acne that kills acne-causing bacteria. VB-1953 also retards the development of resistance, and reduces inflammation associated with acne via an independent immunomodulatory effect.  (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Lipids / 28.05.2019

MedicalResearch.com Interview with: Samia Mora, MD, MHS Associate Physician, Brigham and Women's Hospital Associate Professor of Medicine, Harvard Medical School Brigham and Women's Hospital Department of Medicine Preventive Medicine Boston, MA 02115  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Lipid testing plays a major role in cardiovascular disease (CVD) risk screening, prediction, and treatment. In the past decade, several pivotal studies (including the Women’s Health Study, the Copenhagen City Heart Study, and the Copenhagen General Population Study) compared populations of individuals who had fasting lipid testing with populations of individuals who had nonfasting lipid testing, and found that non-fasting lipids were at least as good as fasting lipids in cardiovascular risk screening and predicting CVD risk. To date, however, no study has examined the cardiovascular predictive value of lipids measured on the same individuals who had both fasting and nonfasting lipid testing. This is important because individual-level variability in fasting versus nonfasting lipids may not be captured when looking at population-level risk associations, and evidence from randomized studies is lacking. Furthermore, it is unclear whether substituting nonfasting lipids would misclassify cardiovascular risk for individuals who may be eligible for statin therapy. (more…)
Author Interviews, Outcomes & Safety, Primary Care / 28.05.2019

MedicalResearch.com Interview with: Janice D. Walker, RN, MBA Beth Israel Deaconess Medical Center MedicalResearch.com: What is the background for this study? Response: In 2010-2011, we launched a pilot intervention in which a limited number of primary care doctors shared the notes they wrote about an office visit with their patients via secure online portals they accessed through their health systems; this practice became known as open notes (our program is called “OpenNotes”). We then surveyed patients and their primary care providers to get feedback on their experiences and published the results in the Annals of Internal Medicine in 2012. After the study, the three large health systems that participated—Beth Israel Deaconess Medical Center in Boston, University of Washington Medicine in Seattle, and Geisinger in rural Pennsylvania—made open notes available across ambulatory specialties. In this paper, “OpenNotes After 7 Years: Patient Experiences with Ongoing Access to their Clinicians’ Outpatient Visit Notes," we wanted to examine the ongoing experiences and perceptions of patients who read ambulatory notes written by a broad range of doctors, nurses and other clinicians. We did this by surveying patients who had been seen in a hospital or community based practice, were registered on their patient portal, and had at least one note available to read in a recent 12-month period. The main measures include patient-reported behaviors and their perceptions concerning the benefits and risks of reading their visit notes. (more…)
Author Interviews, JAMA, Mental Health Research, Surgical Research, UCSF / 27.05.2019

MedicalResearch.com Interview with: Carter Lebares, MD Assistant Professor of Surgery Director, Center for Mindfulness in Surgery Department of Surgery, UCSF  MedicalResearch.com: What is the background for this study?  Response: This study was inspired by extensive evidence of the effectiveness of mindfulness-based interventions (MBIs) for mitigating stress and enhancing performance in other high-stress populations like police and the military.  We know that overwhelming stress is related to burnout and to cognitive errors - two critical issues within surgery, today. This prompted us to tailor and streamline an MBI specifically for surgeons, and to test it in our trainees. (more…)
Author Interviews, Frailty, Hospital Readmissions, JAMA, Stanford, Surgical Research / 27.05.2019

MedicalResearch.com Interview with: hospital-frailty-surgeryKara Anne Rothenberg.MD Postdoctoral Research Fellow, Vascular Surgery Shipra Arya, MD SM FACS Associate Professor of Surgery Stanford University School of Medicine MedicalResearch.com: What is the background for this study? Response: There is a growing body of literature showing that frailty, a syndrome where patients have increased vulnerability to a stressor (such as surgery), is associated with increased postoperative complications, failure to rescue, and hospital readmissions. The Risk Analysis Index (RAI), is an easy to use frailty measurement tool that better predicts postoperative mortality than age or comorbidities alone. As the rates of outpatient surgeries rise nationwide, we noted that most of the surgical frailty studies focus only on inpatient surgeries. Elective, outpatient surgery is generally considered low risk for complications and unplanned readmissions, however we hypothesized that for frail patients, it might not be. (more…)
Author Interviews, Heart Disease, JAMA, NIH, Stroke / 27.05.2019

MedicalResearch.com Interview with: Lenore J. Launer, PhD. Chief Neuroepidemiology Section Intramural Research Program National Institute on Aging MedicalResearch.com: What is the background for this study? What are the main findings? Response: The prevalence of cerebral infarction on MRI can be as high as 30% in community-based studies. These lesions detected on brain MRI, are often clinically silent, but are associated with impairments in cognitive and physical function and can increase the risk for clinical events. For a large number, the origin of these brain lesions is unknown. There is also a lack of population-based data on unrecognized myocardial infarction, which is associated with an increased for clinical coronary disease and mortality. Unrecognized MI was detected in 17% of participants using state-of-the-art cardia MRI, a more sensitive measure of the lesions, than the standard ECG. We investigated the contribution to these lesions of recognized and unrecognized myocardial infarction [MI] identified on cardiac MRI. We found both recognized and unrecognized myocardial infarction increased the risk for cerebral infarction, and that in particular unrecognized MI was associated with cerebral infarction of embolic origins of an unknown source. Given their prevalence, unrecognized MI may be an underestimated contributor to the risk for cerebral infarction in older persons.  (more…)
Addiction, Author Interviews, OBGYNE, Pediatrics, Tobacco Research, UCSD / 25.05.2019

MedicalResearch.com Interview with: Davide Dulcis, PhD Associate Professor Department of Psychiatry, UCSD School of Medicine University of California, San Diego La Jolla, CA 92093-0603 MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Previous studies in humans have shown that pre-natal and early life exposure to nicotine can lead to altered children behavior and propensity for drug abuse, but the precise mechanisms involved are still unclear. In this pre-clinical study we showed how nicotine “primes” neurons of the mouse brain’s reward center for a fate they normally would not have taken, making them more susceptible to the effects of nicotine when the animals are again exposed to nicotine later in life, said Dr. Benedetto Romoli, first author of the research article.   (more…)
Author Interviews, Cognitive Issues, Gender Differences / 24.05.2019

MedicalResearch.com Interview with: Tom Chang PhD, BS, MIT Associate Professor of Finance and Business Economics Marshall School of Business MedicalResearch.com: What is the background for this study? What are the main findings? Response: There have been many studies showing that women prefer higher indoor temperatures than men, however nobody looked at the effect of temperature on performance. We show that the battle for the thermostat is not just about the comfort. It is much more – in our experiment, women’s cognitive functioning is the best at high temperatures, whereas men’s at low temperatures. Significantly, the positive effect of increased temperatures on women’s performance is much stronger than the negative effect on men. The most surprising was that the effect of temperature on women is so strong. For instance, at low temperatures, men outperform women in a simple math task. However, when we increase the temperature, women become better and better (1.76% increase of solved tasks with each 1 Celsius increase), and at high temperatures women and men perform on the same level – the gender difference disappears.  (more…)
Author Interviews, Hearing Loss, JAMA, NIH, NYU / 24.05.2019

MedicalResearch.com Interview with: Jan Blustein, MD PhD Professor of Health Policy and Medicine Wagner Graduate School and School of Medicine New York University, New York MedicalResearch.com: What is the background for this study?   Response: The National Institutes of Health (NIH), the nation’s largest public funder of health research, provides annual reports about levels of funding for many diseases and conditions.  These reports, issued as part of the NIH’s Research, Condition and Disease Categorization (RCDC) process, allow members of the public to track funding across key conditions and across time. Hearing loss is not included among the reported conditions. This runs counter to two of the NIH’s stated goals, according to researcher Jan Blustein (M.D., Ph.D.), professor of health policy and medicine at New York University’s Robert F. Wagner Graduate School of Public Service, in a Research Letter in the May 15th issue of the Journal of the American Medical Association Otolaryngology and Head & Neck Surgery. “First, the NIH is committed to transparency about how it divides funds across diseases and conditions,” said Dr. Blustein.  “Second, it has said that it will prioritize its funding to those conditions that cause the greatest disease burden.”  Hearing loss causes great disease burden, ranking 10th in the U.S. among all conditions as a contributor to Disability Adjusted Life Years (a widely-used measure of disease burden), according to the World Health Organization. (more…)
Author Interviews, Dental Research, Opiods, Pain Research / 23.05.2019

MedicalResearch.com Interview with: Dr. Katie Suda, PharmD, M.S. Associate Professor College of Pharmacy University of Illinois at Chicago Dr. Susan Rowan, DDS Clinical Associate Professor, Executive Associate Dean of Clinical Affairs College of Dentistry University of Illinois at Chicago,  MedicalResearch.com: What is the background for this study?  Dr. Katie Suda: Dentists treat a lot of pain – we have all probably had the experience of a terrible tooth ache. All dentists treat pain worldwide so we would not expect a large difference in which pain medication is prescribed. However, our results show that US dentists prescribe opioids more frequently than is likely needed. This is especially true because studies have shown that non-opioid pain medications are similar or more effective for the treatment of oral pain.  (more…)
Allergan, Author Interviews, Bipolar Disorder, Mental Health Research / 23.05.2019

MedicalResearch.com Interview with: Dr. Stephen Stahl MD PhD Professor of Psychiatry University of California San Diego  MedicalResearch.com: What is the background for this study? How does cariprazine differ from other medications for bipolar depression?  MedicalResearch.com: It is important to note that cariprazine, a dopamine D3-preferring D3/D2 receptor and serotonin 5-HT1A receptor partial agonist, is approved for the treatment of schizophrenia (1.5-6 mg/d) and bipolar mania (3-6 mg/d) in adults. It is not yet approved for depressive episodes related to bipolar I disorder (bipolar depression). In these data that focus on the investigational use for the treatment of bipolar depression, cariprazine has demonstrated efficacy vs placebo (PBO) in 3 phase 2/3 studies of patients with bipolar depression (NCT01396447, NCT02670538, NCT02670551). These analyses investigated the efficacy of cariprazine in patients with bipolar depression and concurrent manic symptoms (mixed features).  (more…)
Author Interviews, Brain Injury, Cognitive Issues, Technology / 22.05.2019

MedicalResearch.com Interview with: Dr. Henry W. Mahncke PhD Research neuroscientist CEO of Posit Science Corporation  MedicalResearch.com: What makes this study newsworthy?  Response: Mild Traumatic Brain Injury (mTBI) is a complex condition to treat. Patients can report many symptoms (e.g., cognitive deficits, depression, anxiety, stress, fatigue, pain, sleep difficulties, disorientation, emotional issues). Prior to this study, conducted at five military and veterans’ medical centers, there has been no highly-scalable intervention to treat the cognitive deficits associated with mTBI. This study showed that a plasticity-based, computerized, brain-training app can drive statistically and clinically significant gains in overall cognitive performance. Given the number of service members and vets with persistent cognitive deficits from TBIs, that’s a big deal. (more…)
Author Interviews, JAMA, Lipids, Pediatrics / 22.05.2019

MedicalResearch.com Interview with: Amanda Marma Perak, MD, MS Assistant Professor of Pediatrics (Cardiology) and Preventive Medicine MedicalResearch.com: What is the background for this study? Response: Blood cholesterol is a critical initiator of atherosclerotic plaques in the arteries that can lead to heart attack in adulthood. It is well established that these changes in the blood vessels occur already in childhood. Thus, it is important to know the status of cholesterol levels in youth to inform public health efforts aimed at preventing cardiovascular disease in the population. In the US there have been changes in childhood obesity prevalence (which may worsen cholesterol levels), the food supply (such as reduction of trans fats which may improve cholesterol levels), and other factors in recent years. We therefore designed a study to examine trends in cholesterol levels among youth in recent years. (more…)
Author Interviews, Cost of Health Care, JAMA / 22.05.2019

MedicalResearch.com Interview with: Dan Ly, MD, MPP Ph.D. Program in Health Policy Harvard MedicalResearch.com: What is the background for this study? Response: There is some mixed evidence regarding whether state level tort reform reduces defensive medicine, or the practicing of medicine in such a way to reduce medical liability. This includes “positive” defensive medicine, or performing certain tests and procedures to reduce such liability. Other research finds that the perception of malpractice risk drives such defensive medicine, including the use of diagnostic imaging, such as CT scans and MRIs. I was interested in exploring what influenced the perception of this risk, hypothesizing that, for a physician, a report of an injury against one’s colleague might increase the perception of this risk and lead to an increase the use of diagnostic imaging. (more…)
Annals Internal Medicine, Author Interviews, Technology / 22.05.2019

MedicalResearch.com Interview with: Coleman Drake, PhD Assistant Professor, Health Policy and Management Pitt Public Health University of Pittsburgh Graduate School of Public Health  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Telemedicine is frequently proposed as a solution to improve access to care in rural areas where driving to the nearest physician can take up to several hours. However, there needs to be sufficient broadband infrastructure for patients to actually use telemedicine. We found that broadband infrastructure is often insufficient to support telemedicine in the most rural areas, particularly in areas where there is inadequate access to primary care physicians and psychiatrists.  (more…)
Author Interviews, Colon Cancer / 22.05.2019

MedicalResearch.com Interview with: Dr. Reinier G. S. Meester, PhD Postdoctoral scholar in the Department of Medicine Division of Gastroenterology and Hepatology Stanford MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Incidence of colorectal cancer has increased for decades in adults under age 50 years in the United States. However, there is still uncertainty regarding the underlying causes of this increase. We studied the patterns in the stage at diagnosis from cancer registry data to assess whether the increases may be due more common use of colonoscopy in the ages 40-49 years, which account for nearly 3 out of 4 young-onset cases. If the increase in incidence were the result of earlier detection from increased colonoscopy use, earlier stage at diagnosis would be expected, whereas if the increased incidence were the result of true rises in risk, relatively later stage at diagnosis would be expected. Our results suggest that the incidence of late-stage (metastatic) colorectal cancer increased at almost twice the relative rate since 1995 (2.9% per year) compared to earlier stages (1.3-1.4% per year). Over 1 in 4 young-onset cases are now diagnosed at a late stage vs. approximately 1 in 5 cases in the 1990s. (more…)
Author Interviews, Immunotherapy, NEJM, Pulmonary Disease / 22.05.2019

MedicalResearch.com Interview with: Gerard J. Criner, MD, FACP, FACCP Chair and Professor, Thoracic Medicine and Surgery Lewis Katz School of Medicine Temple University  MedicalResearch.com: What is the background for this study? Response: An earlier, Phase II trial of benralizumab found a non-statistically significant reduction in COPD exacerbation rate for patients with eosinophilic inflammation in the airways. In this Phase III trial, the researchers sought to discover whether benralizumab's ability to deplete the airways of blood eosinophils in patients with eosinophilic inflammation would lead to a reduction in COPD exacerbations. The Phase III, randomized, double-blind, placebo-controlled, parallel-group clinical trials GALATHEA and TERRANOVA evaluated the efficacy and safety of benralizumab for the prevention of exacerbations in patients with moderate to very severe COPD, eosinophilic inflammation, and increased risk of exacerbations. Benralizumab is a type of drug called an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody. It is approved by the FDA for the treatment of severe eosinophilic asthma. (more…)
Author Interviews, CDC, OBGYNE, Pediatrics, Sexual Health, STD / 21.05.2019

MedicalResearch.com Interview with: Lee Warner, PhD Chief of the Women’s Health and Fertility Branch Division of Reproductive Health CDC MedicalResearch.com: What is the background for this study? Response: Previous research has found lower prevalence of condom use combined with the most effective reversible contraceptive methods among teens, but this is the first study to our knowledge to confirm the finding among sexually active teen mothers in the postpartum period. Our new paper finds that only 3 in 10 postpartum teen mothers report using condoms combined with a more effective contraceptive method (either long-acting reversible contraception or LARC or a non-LARC hormonal method). Dual use was 50 percent lower among LARC users compared with users of non-LARC hormonal methods. (more…)
Accidents & Violence, Author Interviews, Pediatrics / 20.05.2019

MedicalResearch.com Interview with: Jeffrey Colvin, MD, JD Department of Pediatrics Children's Mercy Hospital Kansas City, MO 64111  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Prior studies have found that infants spend an average of 5-6 hours a day in sitting devices. Sitting devices include car seats, swings, infant seats, and strollers. Given how much time infants are spending in sitting devices, we wanted to know if sleep-related infant deaths (such as Sudden Infant Death Syndrome or "SIDS") was occurring in those devices. We examined over 10,000 infant sleep-related deaths from 45 states. We found that 3% (or 348) of the deaths occurred in sitting devices. Two-thirds of the deaths in sitting devices were in car seats. What was most surprising was that less than 10% of the deaths in car seats occurred in cars. Instead, the great majority occurred in the child's home or the home of a relative, friend, or babysitter. In 1/3 of the deaths in car seats, the supervising adult was asleep.  (more…)