Author Interviews, Heart Disease, Technology / 03.04.2024

MedicalResearch.com Interview with: Dr. Janarthanan Sathananthan M.D. Chief Medical Officer for Interventional Cardiology Therapies Boston Scientific MedicalResearch.com: What is the background for this study? boston-scientificResponse: Despite significant improvements in the drug-eluting stents that are used to treat patients with coronary artery disease, 10% of the percutaneous coronary interventions (PCIs) in the U.S. today address in-stent restenosis (ISR), which is when a previously stented section of a coronary artery becomes obstructed or narrowed by plaque or scar tissue. These patients require additional intervention to avoid potential complications. In the multicenter, randomized AGENT IDE trial, we evaluated whether the AGENT™ Drug-Coated Balloon (DCB), a balloon catheter coated with anti-restenotic paclitaxel, is superior to an uncoated balloon in patients for treating ISR. The AGENT DCB is currently available in countries outside the U.S. Our goal is to bring this technology to market in the U.S. and finally provide physicians with an alternative to traditional ISR treatments, such as placing additional layers of stents or radiation, which may not provide ideal outcomes in some cases. In October 2023, at the Transcatheter Cardiovascular Therapeutics (TCT) 2023 meeting, we presented the primary endpoint data from our AGENT IDE randomized controlled trial evaluating clinical outcomes in patients with ISR undergoing treatment with the AGENT DCB or conventional balloon angioplasty. The positive results in this primary analysis cohort supported the device’s U.S. Food and Drug Administration (FDA) approval, which we announced on March 1, 2024. Just a few months later, data from the full cohort of 600 patients were published in the Journal of the American Medical Association (JAMA) and shared in a late-breaking presentation at Cardiovascular Research Technologies (CRT) 2024 meeting.  (more…)
Author Interviews, CDC, Infections, JAMA / 01.04.2024

MedicalResearch.com Interview with: Susan S. Huang, MD, MPH Chancellor's Professor, Infectious Diseases School of Medicine Department of Epidemiology and Infection Prevention University of California Irvine School of Medicine, Irvine MedicalResearch.com: What is the background for this study? Would you describe the decolonization techniques?  
  • This study arose from a growing concern about the increasing number and presence of antibiotic-resistant bacteria causing colonization and infection in hospitals and long-term care. CDC has had a longstanding interest in the value of regional control of these contagious pathogens and they funded this study. The study was actually in two parts:
    • –1) Simulate various infection prevention strategies in a model and see which works best, and then
    • - 2) Do it in real life. The SHIELD project was the real-life example of our simulation finding that decolonization would work the best to prevent harm from antibiotic-resistant bacteria.
  • The regional idea is that it takes all of us working together – hospitals, nursing homes, and long-term acute care hospitals – to prevent the spread and sharing of contagious pathogens. What we can accomplish together is far greater than what any of us can do alone.
  • In this study, decolonization was the use of topical chlorhexidine antiseptic soap and povidone-iodine nasal ointments to reduce potentially harmful bacteria on the body during times when patients and residents may be at risk for infection. We swapped out bathing and showering soap with CHG in participating facilities and ensured that staff knew to clean the body well, including wounds, devices, and rashes where germs can hide and cause infection. For CHG, this involved 4% rinse off product in the shower and 2% no-rinse CHG for bed baths.
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Author Interviews, Emory, Infections, JAMA, MRSA / 10.10.2023

MedicalResearch.com Interview with: Dr. John Jernigan, MD MS Clinical Associate Professor of Medicine Division of Infectious Diseases Emory University School of Medicine Branch Chief Epidemiology, Research and Innovations Branch CDC Center for Disease Control MedicalResearch.com: What is the background for this study? Response: Staphylococcus aureus commonly causes infections in ICUs. One approach to preventing these infections is using nasal mupirocin plus chlorhexidine gluconate (CHG) bathing for ICU patients. This practice is known to prevent methicillin-resistant Staphylococcus aureus (MRSA) infections and all-cause. bloodstream infections.  This practice has been broadly adopted in ICUs in the US, but adoption of mupirocin as a universal topical antibiotic has been slowed by concerns for engendering mupirocin resistance. This cluster-randomized trial in adult ICUs was conducted to assess whether universal nasal antiseptic povidone-iodine (iodophor), to which minimal S. aureus resistance is expected, was an acceptable alternative to universal nasal mupirocin for reducing S. aureus and MRSA clinical cultures in the setting of daily CHG bathing. Those who received chlorhexidine (CHG) bathing with mupirocin had an 18% reduction in risk of Staphylococcus aureus clinical cultures and a 15% reduction in risk of methicillin-resistant S. aureus (MRSA) clinical cultures compared to patients who received CHG bathing with intranasal iodophor.  These results show that using mupirocin for nasal decolonization may be preferred over iodophor because it is more effective at preventing S. aureus infections. (more…)
Author Interviews, Breast Cancer, JAMA, OBGYNE, Surgical Research / 04.10.2023

MedicalResearch.com Interview with: Gabriele Martelli, MD Breast Unit, Surgery Fondazione IRCCS Istituto Nazionale dei Tumori Milan, Italy MedicalResearch.com: What is the background for this study? Response: Approximately 8% of breast cancer cases are associated with pathogenic germline variants of the BRCA1 or BRCA2 genes. Women with a pathogenic BRCA1 variant have lifetime risks of breast or ovarian cancer of 45% to 80% and 30% to 60%, respectively. Women with a pathogenic BRCA2 variant have lifetime risks of breast or ovarian cancer of 35% to 60% and 10% to 25%, respectively. BRCA1 breast cancer is often more aggressive than sporadic disease, while BRCA2 breast cancer is often of similar aggressivity to sporadic disease. However, few studies have investigated outcomes of breast-conserving surgery, prophylactic mastectomy, or prophylactic salpingo-oophorectomy in patients with BRCA1/2 breast cancer. We conducted a cohort study to assess outcomes of breast-conserving surgery vs mastectomy, prophylactic mastectomy vs no prophylactic mastectomy, and prophylactic salpingo-oophorectomy vs no prophylactic salpingo-oophorectomy in patients with BRCA1/2 breast cancer. (more…)
Author Interviews, Health Care Systems, JAMA, Sleep Disorders, Yale / 18.01.2023

MedicalResearch.com Interview with: César Caraballo-Cordovez, MD Postdoctoral Associate Yale/YNHH Center for Outcomes Research and Evaluation (CORE) New Haven, CT 06511 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Our group has been interested in how patients’ experience during hospitalization impacts their recovery and their health for a while. In 2013, Dr. Harlan Krumholz (senior author of the current study) identified that patients who were recently hospitalized experienced a period of generalized risk for myriad adverse health events, a condition that he named ‘post-hospital syndrome’. One of the possible explanations for this observation is that the stress from being hospitalized negatively impacts patients’ health during their stay in the hospital and after being discharged. The stress in a hospital may come from different sources–including sleep deprivation. Sleep is fundamental for recovery, and there are many challenges for patients to have adequate sleep while being hospitalized. Among the many sources of sleep interruption are early morning blood draws. Blood draws are often performed in the early morning in order to have recent lab tests results available during morning medical rounds. However, this common practice may disrupt patients’ recovery by interrupting their sleep. We were interested in determining to what extent blood draws contribute to early morning sleep disruptions and whether there has been recent progress in reducing them. We used data from Yale New Haven Hospital from 2016 to 2019 and found that nearly 4 in 10 of total daily blood draws were collected between 4:00am and 7:00am–a proportion that was persistently high over the 3 years we studied. Importantly, we found that this occurred across patients with different sociodemographic characteristics, including older individuals who are at highest risk of adverse health events from sleep deprivation. (more…)
Author Interviews, JAMA, Mental Health Research, USPSTF, Weight Research / 23.03.2022

MedicalResearch.com Interview with: Lori Pbert, Ph.D Professor, Department of Population and Quantitative Health Sciences Associate chief of the Division of Preventive and Behavioral Medicine Founder and Director of the Center for Tobacco Treatment Research and Training University of Massachusetts Medical School Dr. Pbert joined the U.S. Preventive Services Task Force in January 2019 MedicalResearch.com:  What is the background for this study?  Response: This is the first time that the Task Force has looked at the evidence around screening for eating disorders. It was important to address this topic because of the serious harm that these conditions can cause to people’s physical and mental health, and the tremendous toll eating disorders have on individuals and families. MedicalResearch.com:  What are the main findings? Response: After reviewing the limited available research, we determined there is not enough evidence to recommend for or against screening teens and adults for eating disorders in adolescents and adults who do not have signs or symptoms of an eating disorder or concerns about their eating. It’s important to note that this recommendation is not for people who are showing signs or symptoms of eating disorders, like rapid weight loss or gain, slow heart rate, delayed puberty, or a disruption of menstruation, or for those expressing concern about their eating. (more…)
Author Interviews, COVID -19 Coronavirus, Critical Care - Intensive Care - ICUs, JAMA / 13.12.2021

MedicalResearch.com Interview with: Liise-anne Pirofski, M.D. Mitrani Professor of Biomedical Research Chief, Division of Infectious Diseases Albert Einstein College of Medicine and Montefiore Medical Center Liise-anne Pirofski, MD on behalf of lead authors Mila Ortigoza MD, PhD, Assistant professor at NYU Langone Health and Hyunah Yoon MD, Assistant Professor, Albert Einstein Medical Center and the CONTAIN COVID-19 trial authors and team MedicalResearch.com: What is the background for this study? Response: The study was designed to determine the efficacy of COVID-19 convalescent plasma (CCP) in hospitalized patients with COVID-19. It was designed and launched in New York City in April 2020 during the height of the first COVID-19 pandemic wave and later extended to sites in Miami, Houston, and other regions affected by subsequent waves of the pandemic. At that time, there were no validated therapeutic options for COVID-19, and there was clinical equipoise for CCP use in hospitalized patients. COVID-19 convalescent plasma was considered worthy of investigation because of the historical success of convalescent plasma in prior pandemics and epidemics dating to the beginning of the 20th century, and importantly, biological plausibility because convalescent plasma contains antibodies to agents from which people have recovered, and case series and observational studies showing signals of CCP efficacy in patients with COVID-19. The trial was designed to focus on patients with moderate to severe COVID-19 who required supplemental oxygen, but not mechanical intubation. At the time the trial was designed, hospitals in New York City were overwhelmed with severely and critically ill patients with COVID-19, an entirely new disease about which more and more was learned over the 11 months the trial was conducted.  (more…)
Aging, Author Interviews, Cost of Health Care, JAMA, University of Michigan / 10.02.2020

MedicalResearch.com Interview with: Renuka Tipirneni, MD, MSc, FACP Assistant Professor Holder of the Grace H. Elta MD Department of Internal Medicine Early Career Endowment Award 2019-2024 University of Michigan Department of Internal Medicine Divisions of General Medicine and Hospital Medicine and Institute for Healthcare Policy & Innovation Ann Arbor, MI 48109 MedicalResearch.com: What is the background for this study? Response: While U.S. adults age 50-64 previously had more limited options for health insurance before Medicare at age 65, the Affordable Care Act expanded the number of options, including Marketplace plans (e.g., through HealthCare.gov) and Medicaid. This expanded set of options may complicate decisions about health insurance near retirement. In addition, several policy challenges to the Affordable Care Act may add uncertainty to the decision-making process. (more…)
Alzheimer's - Dementia, Author Interviews, JAMA, Mental Health Research, Sleep Disorders / 23.08.2019

MedicalResearch.com Interview with: Chenlu Gao, MA Graduate Student Department of Psychology and Neuroscience Baylor University Michael Scullin, PhD Assistant Professor Department of Psychology and Neuroscience Baylor University  MedicalResearch.com: What is the background for this study? Response: According to the World Alzheimer Report, dementia affects 50 million adults worldwide, and this number is expected to approach 131 million by 2050. Dementia patients often require assistance with daily activities from caregivers. The Alzheimer’s Association reported that, in the United States, 16 million caregivers spend on average 21.9 hours per week providing care for patients with dementia. Being a caregiver is stressful, which not only challenges emotional, cognitive, and physical health, but is also associated with shorter and poorer sleep at night. If a caregiver cannot obtain restorative sleep at night, their quality of life and their abilities to perform the caregiving role can be compromised. For example, sleep loss may jeopardize caregivers’ memory, causing them to forget medications or medical appointments for the patients. Sleep loss can also impair immune functions, causing the caregivers to suffer from illnesses. In the long-term, sleep loss is associated with cortical thinning and accumulation of beta-amyloid and tau, which increase the risks of dementia. Undoubtedly, there is a need to systematically study whether caregivers sleep less or worse during the night and whether we can improve their sleep quality through low-cost behavioral interventions. To answer these questions, we systematically reviewed and meta-analyzed 35 studies with data from 3,268 caregivers of dementia patients.     (more…)
Author Interviews, JAMA / 04.07.2019

MedicalResearch.com Interview with: Lucy Schulson, MD MPH Section of General Internal Medicine Boston University School of Medicine Boston, Massachusetts MedicalResearch.com: What is the background for this study? What are the main findings? Response: Research in the early 2000s in California demonstrated that racial and ethnic minorities, immigrants, and those with limited English proficiency (LEP) experienced high rates of discrimination in healthcare. Since those studies were published, California has made concerted efforts at the state and local level to address health equity; these efforts may have impacted perceptions of discrimination in health care. However, it is not known how perceptions of discrimination in healthcare have changed over the last ten years overall and for specific groups. This study sought to compare perceptions of discrimination in health care in 2003-2005 compared to 2015-2017 overall, for racial and ethnic minorities, among immigrants, and among those with Limited English Proficiency (LEP).  (more…)