AstraZeneca, Author Interviews, Brigham & Women's - Harvard, Diabetes, Heart Disease / 10.09.2019

MedicalResearch.com Interview with: [caption id="attachment_51229" align="alignleft" width="200"]Dr. David Berg MD Senior Fellow in Cardiovascular Medicine and Critical Care Medicine Brigham and Women’s Hospital Postdoctoral Research Fellow with the TIMI Study Group. Dr. David Berg[/caption] Dr. David Berg MD Senior Fellow in Cardiovascular Medicine and Critical Care Medicine Brigham and Women’s Hospital Postdoctoral Research Fellow with the TIMI Study Group. MedicalResearch.com: What is the background for this study? Response: Heart failure is a frequent and important complication of type 2 diabetes mellitus (T2DM), but there are limited tools for identifying which patients with T2DM are at the highest risk of developing heart failure. In this study, we developed and validated the TIMI Risk Score for Heart Failure in Diabetes [TRS-HF(DM)], a novel clinical risk score that identifies patients with T2DM who are at heightened risk for hospitalization due to heart failure. Fortunately, the risk score also identifies patients who have the greatest absolute reduction in the risk of hospitalization for heart failure with a new class of glucose-lowering therapies called sodium-glucose cotransporter-2 (SGLT2) inhibitors. 
Author Interviews, Brigham & Women's - Harvard, Clots - Coagulation, Diabetes, Heart Disease, Lancet / 08.09.2019

MedicalResearch.com Interview with: [caption id="attachment_51192" align="alignleft" width="133"]Deepak L. Bhatt, MD, MPH, FACC, FAHA, FSCAI, FESC Professor of Medicine, Harvard Medical School Executive Director of Interventional Cardiovascular Programs, Brigham and Women’s Hospital Heart & Vascular Center Dr. Deepak L. Bhatt[/caption] Deepak L. Bhatt, MD, MPH, FACC, FAHA, FSCAI, FESC Professor of Medicine, Harvard Medical School Executive Director of Interventional Cardiovascular Programs, Brigham and Women’s Hospital Heart & Vascular Center MedicalResearch.com: What is the background for this study? Response: Dual antiplatelet therapy (DAPT) is known to improve outcomes in patients with acute coronary syndromes (ACS), prior myocardial infarction (MI), or recent coronary stenting. What was unknown is whether patients with diabetes and stable coronary artery disease – a group generally believed to be at high ischemic risk – would benefit from initiation of long-term DAPT with low-dose aspirin plus ticagrelor versus low-dose aspirin (plus placebo). This is what THEMIS was designed to test, with THEMIS-PCI designed prospectively to examine those patients specifically who had a history of previous percutaneous coronary intervention (PCI).
Author Interviews, Brigham & Women's - Harvard, Cancer Research, Chemotherapy / 04.09.2019

MedicalResearch.com Interview with: [caption id="attachment_42572" align="alignleft" width="200"]Bishal Gyawali, MD, PhD Department of Medicine Brigham and Women's Hospital Dr. Bishal Gyawali[/caption] Bishal Gyawali, MD, PhD Department of Medicine Brigham and Women’s Hospital  MedicalResearch.com: What is the background for this study? Response: Cancer drugs are prescribed to the patients based on results from trials. Usually, these are superiority trials meaning the cancer drugs prove that they are better than the treatment we already have. Recently, more and more cancer drugs are approved on the basis of non-inferiority trials. In these trials, the cancer drugs only prove that they are not worse than the treatment we already have ( instead of proving they are better). Such an approach is considered justified if the new drug provides any other benefit such as lower cost, easy to administer or improved quality of life.
Author Interviews, Brigham & Women's - Harvard, JAMA, Medicare / 28.08.2019

MedicalResearch.com Interview with: [caption id="attachment_51047" align="alignleft" width="128"]Jose F. Figueroa, MD, MPH Instructor , Harvard Medical School, Department of Medicine Brigham and Women’s Hospital Dr. Figueroa[/caption] Jose F. Figueroa, MD, MPH Instructor , Harvard Medical School, Department of Medicine Brigham and Women’s Hospital  MedicalResearch.com: What is the background for this study? Response: Hospitalizations related to ambulatory-care sensitive conditions are widely considered a key measure of access to high-quality ambulatory care. It is included as a quality measure in many national value-based care programs. To date, we do not really know whether rates of these avoidable hospitalizations are meaningfully improving for Medicare beneficiaries over time.
AHA Journals, Author Interviews, Brigham & Women's - Harvard, Heart Disease, Nutrition, Vegetarians / 22.08.2019

MedicalResearch.com Interview with: [caption id="attachment_51018" align="alignleft" width="173"]Megu Baden, MD, PhD Department of Nutrition Harvard T. H. Chan School of Public Health Boston, MA02115 Dr. Baden[/caption] Megu Baden, MD, PhD Department of Nutrition Harvard T. H. Chan School of Public Health Boston, MA02115  MedicalResearch.com: What is the background for this study? Would you give an example of healthful vs non-healthful plantbased diet? Response: Plant-based diets are recommended for health and recently also for their environmental benefits. However, most previous studies defined it as either vegetarian or non-vegetarian, and importantly, without differentiation for the quality of plant foods. As you know, not all plant foods are equally good to our health. Therefore, to capture the quality of plant-based diets, we established overall, healthful and unhealthful plant-based diet indices. A higher score on the overall plant based diet index indicates greater intake of all types of plant foods and less of animal foods. A higher score on the healthful plant based diet index indicates greater intake of only healthy plant foods (whole grains, fruits, vegetables, nuts, legumes, vegetable oils, tea/coffee), and less of less healthy plant foods (fruit juices, refined grains, potatoes, sugar-sweetened beverages, sweets/desserts) and animal foods. A higher score on the unhealthful plant based diet index indicates greater intake of only less healthy plant foods, and less of healthy plant foods and animal foods. In this study, we used these plant-based diet indices and investigated the associations between 12-year changes in plant-based diet quality and subsequent total and cause-specific mortality in two large US cohorts.
Author Interviews, Brigham & Women's - Harvard, Global Health, Infections, Lancet, Pediatrics / 21.08.2019

MedicalResearch.com Interview with: [caption id="attachment_51012" align="alignleft" width="150"]Tori Cowger, MPH Ph.D Student | Population Health Sciences Department of Epidemiology Harvard T.H. Chan School of Public Health Tori Cowger[/caption] Tori Cowger, MPH Ph.D Student | Population Health Sciences Department of Epidemiology Harvard T.H. Chan School of Public Health  MedicalResearch.com: What is the background for this study? Response: Globally, approximately one million cases of tuberculosis disease (TB) and 233,000 TB-related deaths occurred among children aged younger than 15 years during 2018. TB in children and adolescents is clinically and epidemiologically heterogeneous, making diagnosis, care, and prevention challenging. Understanding this heterogeneity can inform TB care and prevention efforts, and efforts to eliminate disparities in TB incidence and mortality in these groups. In this study, we describe the epidemiology of TB among children and adolescents in the United States, and report TB incidence rates for US territories and freely associated states and by parental country of birth, which have not been previously described.
Author Interviews, Breast Cancer, Brigham & Women's - Harvard, Genetic Research / 19.08.2019

MedicalResearch.com Interview with: Tengteng Wang, PhD, MSPH, MBBS Postdoctoral Research Fellow Department of Epidemiology Harvard T.H. Chan School of Public Health Channing Division of Network Medicine Brigham and Women's Hospital MedicalResearch.com: What is the background for this study? Response: Chronic inflammation is a key player in the development of multiple cancer types, including breast cancer. Aspirin is one of the major non-steroidal anti-inflammatory drugs (NSAIDs) which clearly has anti-inflammatory properties. Given this, substantial evidence from laboratory and population studies suggests that taking aspirin may reduce the risk of developing breast cancer. However, the association of aspirin use with death outcomes following breast cancer diagnosis remains inconclusive and inconsistent across studies. Therefore, we choose to focus on mortality outcomes in this paper and we hypothesized that the inconsistent results for aspirin in relation to mortality could be due to differences in the association by patients’ biological profiles, specifically DNA methylation profiles here. 
Author Interviews, Brigham & Women's - Harvard, Opiods / 06.08.2019

MedicalResearch.com Interview with: [caption id="attachment_50561" align="alignleft" width="141"]Lauren A. Hoffman, Ph.D. Research Fellow Recovery Research Institute Center for Addiction Medicine Massachusetts General Hospital Harvard Medical School Dr. Hoffman[/caption] Lauren A. Hoffman, Ph.D. Research Fellow Recovery Research Institute Center for Addiction Medicine Massachusetts General Hospital Harvard Medical School MedicalResearch.com: What is the background for this study?   Response: In 2017, an estimated 11.4 million Americans reported past-year opioid misuse1 and opioid-related overdose accounted for more than 47,000 deaths2. Prior research has helped further our understanding of the prevalence and consequences of opioid misuse, but we know substantially less about recovery from opioid use problems. Recovery-focused research conducted to-date has largely focused on alcohol use disorder, the most common type of substance use disorder. Characterizing recovery from opioid use problems and the pathways that individuals take to resolve such problems can ultimately help identify effective ways to address opioid misuse. Using data from the first national probability-based sample of US adults who have resolved a significant substance use problem (National Recovery Survey3), we provide the first national prevalence estimate of opioid recovery, and characterize treatment/recovery service use and psychological well-being in individuals who resolved a primary problem with opioids, relative to individuals who resolved a primary alcohol problem. We focused our cross-sectional investigation of service use and well-being on 2 time-horizons associated with continued vulnerability: <1 year since problem resolution (early-recovery) and 1 – 5 years since problem resolution (mid-recovery).
Author Interviews, Brigham & Women's - Harvard, Heart Disease, Race/Ethnic Diversity / 05.08.2019

MedicalResearch.com Interview with: [caption id="attachment_50551" align="alignleft" width="200"]Muhammad Ali Chaudhary, MD Research Scientist | Center for Surgery and Public Health Department of Surgery | Brigham and Women’s Hospital Harvard Medical School | Harvard T. H. Chan School of Public Health Dr. Chaudhary[/caption] Muhammad Ali Chaudhary, MD Research Scientist Center for Surgery and Public Health Department of Surgery Brigham and Women’s Hospital Harvard Medical School Harvard T. H. Chan School of Public Health MedicalResearch.com: What is the background for this study? Response: Many studies have documented disparities in cardiovascular care for minorities, specifically African Americans compared to white patients. Coronary artery bypass grafting (CABG) is a common procedure in the United States, and the outcomes and post-surgical care for African Americans tend to be worse. We examined whether patients insured through TRICARE — a universal insurance and equal-access integrated healthcare system that covers more than 9 million active-duty members, veterans and their families — experienced these disparities. We found no racial disparities in quality-of-care outcomes, providing insights about the potential impacts of universal insurance and an equal-access health care system. The study included 8,183 TRICARE patients, aged 18-64, who had undergone CABG. The study took its data from TRICARE health care claims from the Military Health System Data Repository for the years of 2006 to 2014.
Accidents & Violence, Author Interviews, Brigham & Women's - Harvard, JAMA, Ophthalmology / 01.08.2019

MedicalResearch.com Interview with: [caption id="attachment_50514" align="alignleft" width="163"] Dr. Hwang[/caption] Daejoon Alex Hwang, PhD Instructor in Ophthalmology Investigator, Schepens Eye Research Institute of Mass. Eye and Ear Harvard Medical School MedicalResearch.com: What is the background for this study?   Response: Yellow night driving glasses are sold with promises to reduce headlight glare from oncoming traffic and help aging individuals see better at night. Despite a 1997 ruling by the Federal Trade Commission against one company’s claims, the products still remain popular online. We tested three commercially available yellow lens night driving glasses and compare their effectiveness with clear lens glasses on our novel headlight glare simulator in the driving simulator.
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, ENT, Surgical Research / 25.07.2019

MedicalResearch.com Interview with: [caption id="attachment_50402" align="alignleft" width="133"]Vinay K. Rathi, MD Otolaryngology Resident | Massachusetts Eye and Ear Project Manager | Partners Ambulatory Care MBA Candidate | Harvard Business School Dr. Rathi[/caption] Vinay K. Rathi, MD Otolaryngology Resident | Massachusetts Eye and Ear Project Manager | Partners Ambulatory Care MBA Candidate | Harvard Business School  MedicalResearch.com: What is the background for this study?  Response: This study is a secondary subgroup analysis that follows on the heels of a recently published study in The New England Journal of Medicine (NEJM) examining physician reimbursement for surgical procedures in the Medicare Physician Fee Schedule (PFS), which both public and private insurers use to determine payment rates for clinician services. Although it is widely understood that physician time (i.e., the amount of physician time required to perform a procedure) is perhaps the most important factor used to determine payment rates, the Centers for Medicare and Medicaid Services (CMS) has historically relied upon limited and potentially biased survey data to estimate physician time. Leveraging time data from American College of Surgeons National Quality Improvement Program, the authors of the recent NEJM study demonstrated that CMS does not appear to systematically misestimate intraoperative times, but there are substantial discrepancies that may result in over- or undercompensation for certain procedures and specialties.
Annals Thoracic Surgery, Author Interviews, Beth Israel Deaconess, Brigham & Women's - Harvard, Geriatrics, Heart Disease, Primary Care / 23.07.2019

MedicalResearch.com Interview with: [caption id="attachment_50354" align="alignleft" width="140"]Christina C. Wee, MD, MPH Associate Professor of Medicine Harvard Medical School Director , Obesity Research Program Division of General Medicine Beth Israel Deaconess Medical Center (BIDMC) Associate Program Director, Internal Medicine Program, BIDMC Deputy Editor of the Annals of Internal Medicine Dr. Wee[/caption] Christina C. Wee, MD, MPH Associate Professor of Medicine Harvard Medical School Director , Obesity Research Program Division of General Medicine Beth Israel Deaconess Medical Center (BIDMC) Associate Program Director, Internal Medicine Program, BIDMC Deputy Editor of the Annals of Internal Medicine MedicalResearch.com: What is the background for this study? Response: New research is showing that for many people without diagnosed heart disease, the risk of bleeding may outweigh the benefits of taking a daily aspirin particularly in adults over 70 years of age.  The American Heart Association and the American College of Cardiology recently updated their guidelines and now explicitly recommend against aspirin use among those over the age of 70 who do not have existing heart disease or stroke. Our study found that in 2017,  a quarter of adults aged 40 years or older without cardiovascular disease – approximately 29 million people – reported taking daily aspirin for prevention of heart disease. Of these, some 6.6. million people did so without a physician's recommendation.
Author Interviews, Brigham & Women's - Harvard, JAMA, Nutrition, Weight Research / 22.07.2019

MedicalResearch.com Interview with: [caption id="attachment_50363" align="alignleft" width="128"]Frank Qian, MPH Department of Nutrition Harvard T. H. Chan School of Public Health Boston, Massachusetts Frank Qian[/caption] Frank Qian, MPH Department of Nutrition Harvard T. H. Chan School of Public Health Boston, Massachusetts MedicalResearch.com: What is the background for this study? Response: Plant-based diets have really grown in popularity in the last several years, particularly among the younger generation in the United States, many of whom are adopting a plant-based or vegetarian/vegan diet. However, the quality of such a diet can vary drastically. While many prior studies have demonstrated beneficial associations for risk of type 2 diabetes with healthful plant-based foods such as fruits, vegetables, nuts/seeds, whole grains, and legumes, the opposite is true for less healthful plant-based foods such as potatoes and refined grains such as white rice. In addition, some animal-based foods, such as dairy and fish, have shown protective associations against the development of type 2 diabetes, so strict vegetarian diets which exclude these foods may miss out on the potential benefits. Given these divergent findings, we sought to pool all the available data from prior cohort studies to analyze whether the overall association of a diet which emphasizes plant-based foods (both healthful and unhealthful) are related to risk of type 2 diabetes.
Author Interviews, Brigham & Women's - Harvard, Heart Disease, JACC, Lung Cancer, Radiation Therapy / 10.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49629" align="alignleft" width="200"]Raymond H Mak, MD Assistant Professor of Radiation Oncology Harvard Medical School Dr. Mak[/caption]   Raymond H Mak, MD Assistant Professor of Radiation Oncology Harvard Medical School Radiation Oncology Brigham and Women's Hospital     [caption id="attachment_49693" align="alignleft" width="200"]Dr-Katelyn M. Atkins Dr. Atkins[/caption]   Katelyn M. Atkins MD PhD Harvard Radiation Oncology Program Dana-Farber Cancer Institute Brigham and Women’s Hospital Boston, Massachusetts     MedicalResearch.com: What is the background for this study? What are the main findings? 
  • Lung cancer remains the leading cause of cancer-related death worldwide and nearly half of patients will require radiation therapy as part of their care.
  • Cardiac toxicity following radiotherapy has been well-studied in breast cancer and lymphomas, however the impact of cardiac toxicity following lung cancer radiotherapy has historically been under-appreciated due to the high risk of lung cancer death.
  • Recent studies highlighting cardiac toxicity following lung cancer radiotherapy have been limited by small numbers of patients and, to our best knowledge, have not included validated cardiac event endpoints defined by the American Heart Association (AHA)/American College of Cardiology (ACC).
Author Interviews, Brigham & Women's - Harvard, Prostate Cancer, Weight Research / 10.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49690" align="alignleft" width="200"]Barbra Dickerman, PhD Research Fellow Department of Epidemiology Harvard T.H. Chan School of Public Health Boston, MA Dr. Dickerman[/caption] Barbra Dickerman, PhD Research Fellow Department of Epidemiology Harvard T.H. Chan School of Public Health Boston, MA MedicalResearch.com: What is the background for this study? Response: Obesity is associated with a higher risk of advanced prostate cancer and poorer prognosis after diagnosis. However, emerging evidence suggests that the specific distribution of body fat may be an important prognostic factor for prostate cancer outcomes. In this original investigation, we analyzed body fat distribution on computed tomography imaging and the risk of being diagnosed with, and dying from, prostate cancer. This study was conducted among 1,832 Icelandic men with over a decade of follow-up in the Age, Gene/Environment Susceptibility-Reykjavik Study.
Author Interviews, Brigham & Women's - Harvard, Exercise - Fitness, JAMA / 02.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49426" align="alignleft" width="133"]I-Min Lee, MD, ScDProfessor of Medicine, Harvard Medical SchoolProfessor of EpidemiologyHarvard T.H. Chan School of Public Health Prof. I-Min Lee[/caption] I-Min Lee, MD, ScD Professor of Medicine, Harvard Medical School Professor of Epidemiology Harvard T.H. Chan School of Public Health  MedicalResearch.com: What is the background for this study? Response: While we have many studies showing that physical activity is beneficial for health, there are few data on steps and health, particularly long-term health outcomes.  An expert committee – the 2018 Physical Activity Guidelines Advisory Committee, which reviewed the scientific evidence to support the recently released Physical Activity Guidelines for Americans, 2nd edition – noted this (i.e., the relation between steps and health outcomes) to be a critical gap in knowledge, since many individuals are using wearables and monitoring their step counts. We often hear the number 10,000 steps cited as a daily goal, but the basis for this number is unclear. It likely originated as a marketing tool: in 1965, the Yamasa Clock and Instrument Company, Japan sold a pedometer called “Manpo-kei” – “ten thousand steps meter” in Japanese. For many older people, 10,000 steps/day can be a very daunting goal; thus, we wanted to investigate whether this was necessary for lower mortality rates in older women.  Additionally, steps taken can be fast or slow, and there are no published studies on step intensity and long-term health outcomes.  Note that walking pace and step intensity are not the same concept: walking pace gauges intensity when walking purposefully (e.g., for exercise or transportation), while step intensity assesses an overall best natural effort in our daily life.
Author Interviews, Brigham & Women's - Harvard, Cancer Research, FDA, JAMA, Pharmacology / 29.05.2019

MedicalResearch.com Interview with: [caption id="attachment_49366" align="alignleft" width="200"]Bishal Gyawali  MD PhD Med Onc. Asst. Professor  Dr. Gyawali[/caption] 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. 
Author Interviews, Brigham & Women's - Harvard, JAMA, Lipids / 28.05.2019

MedicalResearch.com Interview with: [caption id="attachment_49391" align="alignleft" width="133"]Samia Mora, MD, MHSAssociate Physician, Brigham and Women's HospitalAssociate Professor of Medicine, Harvard Medical SchoolBrigham and Women's HospitalDepartment of MedicinePreventive MedicineBoston, MA 02115  Dr. Mora[/caption] 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.
Author Interviews, Brigham & Women's - Harvard, Opiods, Orthopedics, Pain Research, Surgical Research / 16.05.2019

MedicalResearch.com Interview with: [caption id="attachment_49201" align="alignleft" width="135"]Marilyn M. Heng, MD, MPH, FRCSCOrthopaedic Trauma SurgeonAssistant Professor of Orthopaedic SurgeryHarvard Medical School Dr. Heng[/caption] Marilyn M. Heng, MD, MPH, FRCSC Orthopaedic Trauma Surgeon Assistant Professor of Orthopaedic Surgery Harvard Medical School  MedicalResearch.com: What is the background for this study?   Response: The ultimate background for this study does come from the larger context of the opioid epidemic that is seen worldwide but particularly in North America. Orthopaedic surgeons should take responsibility as being among the top prescribers of opioids. The more specific background that led to this specific study was the observation that several colleagues would insist that a drug like hydromorphone was so dangerous that they would not prescribe it but seemed okay prescribing large amounts of oxycodone.  It seemed like an urban myth that the type of opioid was what made it dangerous, so that led us to do the study to see if there was evidence for that.