Author Interviews, Dermatology, JAMA, Race/Ethnic Diversity / 16.08.2021

MedicalResearch.com Interview with: Joerg Albrecht, MD, PhD Dermatologist, Internist, Clinical Pharmacologist Division of Dermatology, Department of Medicine Attending Dermatologist, Chair Division of Dermatology Chair system-wide Pharmacy & Therapeutics Committee Cook County Health Chicago, IL  60612 MedicalResearch.com: What is the background for this study? Response: The study was stimulated by data that suggested that an unusually large proportion of inpatient with Hidradenitis suppurativa (HS) were African American. HS is an underdiagnosed disease and the total numbers of inpatients with HS in the year we looked at initially seemed small. So we wanted to test whether this finding held up when the period of observation was extended. Point estimates can be unreliable and we had followed another finding in the data that did not hold up when we looked at other years, so we felt one year was not enough to confirm a trend (more…)
Author Interviews, Duke, JAMA, Nursing, Sexual Health, STD / 12.08.2021

MedicalResearch.com Interview with: Vincent Guilamo-Ramos, PhD MPH, LCSW, RN, ANP-BC, PMHNP-BC, AAHIVS, FAAN Vincent Guilamo-Ramos is dean and professor at the Duke University School of Nursing, vice chancellor for nursing affairs, Duke University, and director of the Center for Latino Adolescent and Family Health (CLAFH) at Duke. Dr. Guilamo-Ramos served as a member of the National Academies of Sciences, Engineering, and Medicine (National Academies) Committee on Prevention and Control of STIs in the U.S. that wrote the recent consensus study report. He also serves as a member of the Presidential Advisory Council on HIV/AIDS (PACHA) and the HHS Panel on Antiretroviral Guidelines for Adults and Adolescents. MedicalResearch.com: What is the background for this study? Response: The National Academies of Sciences, Engineering, and Medicine (National Academies) recently released a consensus study report on prevention and control of sexually transmitted infections (STIs) in the United States. The report entitled “Sexually Transmitted Infections: Adopting a Sexual Health Paradigm” includes a strong emphasis on adolescents and young adults as an important priority population for the response to record-level STI rates that have reached an all-time high for the sixth year in a row in 2019. The report also highlights the well-supported and crucial role of parents in addressing STIs and promoting sexual health among adolescents and young adults. In this new Viewpoint article, my co-authors and I, who contributed to the National Academies report as committee members or consultants, discuss the practical implications for health care professionals of engaging parents in adolescent sexual health services. (more…)
Author Interviews, Blood Pressure - Hypertension, Exercise - Fitness, Heart Disease, JAMA / 05.08.2021

MedicalResearch.com Interview with: Fernando Ribeiro PhD School of Health Sciences Institute of Biomedicine - iBiMED University of Aveiro Aveiro, Portugal MedicalResearch.com: What is the background for this study? What are the main findings? Response: Resistant hypertension is a puzzling problem without a clear solution. The available treatment options to lower blood pressure, namely medication and renal denervation, have had limited success, making nonpharmacological strategies good candidates to optimize the treatment of this condition. Exercise training is consistently recommended as adjuvant therapy for patients with hypertension, yet, it is with a great delay that the efficacy of exercise training is being tested in patients with resistant hypertension. Having that in mind, the EnRicH trial was designed to address whether the benefits of an exercise intervention with proven results in hypertensive individuals are extended to patients with resistant hypertension, a clinical population with low responsiveness to drug therapy. Exercise training was safe and associated with a significant and clinically relevant reduction in 24-hour, daytime ambulatory, and office blood pressure compared with control (usual care). (more…)
Author Interviews, JAMA, Smoking, Tobacco, Tobacco Research, UC Davis / 05.08.2021

MedicalResearch.com Interview with: John Pierce, PhD Professor Emeritus Department of Family Medicine and Public Health Moores Cancer Center Director for Population Sciences Co-leader of the Cancer Prevention program UC San Diego MedicalResearch.com: What is the background for this study? What are the main findings? Response: Graphic Warning Labels are to be implemented in the US in July 2022, depending on litigation. This will be about 10 years after they were first proposed.  Meanwhile, 120 other countries have implemented them already. The FDA states that their purpose for the warnings is to provide a constant reminder to smokers about the health consequences of smoking, not to force them to quit. In our study, 3 months of having cigarettes repackaged into graphic warning packs was associated with smokers thinking more about quitting and not getting as much pleasure out of their cigarettes.  However, thinking about quitting is only the first step to conquering a nicotine addiction. (more…)
Author Interviews, Columbia, JAMA, Race/Ethnic Diversity, Telemedicine / 29.07.2021

MedicalResearch.com Interview with: Steffie Woolhandler MD MPH, FACP Professor of Public health and Health Policy CUNY School of Public Health at Hunter College Co-founder and board member Physicians for a National Health Program MedicalResearch.com: What is the background for this study? What are the main findings? Response:   We analzyed a national database of healthcare utilization. We found racial disparities exist in use of specialist MD services by Black- and Native-Americans relative to White-Americans, despite their greater needs.  Hispanic- and Asian-Americans also receive specialist care at low rates.   (more…)
Allergies, Author Interviews, COVID -19 Coronavirus, JAMA, Vaccine Studies, Vanderbilt / 27.07.2021

MedicalResearch.com Interview with: Kimberly G. Blumenthal, MD, MSc Massachusetts General Hospital The Mongan Institute Boston, MA 02114 Matthew S. Krantz, MD Division of Allergy, Pulmonary and Critical Care Medicine Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee   MedicalResearch.com: What is the background for this study? Response: During the initial COVID-19 vaccine campaign with healthcare workers in December 2020, there was an unexpected higher than anticipated rate of immediate allergic reactions after Pfizer and Moderna mRNA vaccines.  This prompted both patient and provider concerns, particularly in those with underlying allergic histories, on the associated risks for immediate allergic reactions with the mRNA vaccines. Because of the significantly improved effectiveness of two doses of an mRNA vaccine compared to one dose, it was important to determine if those who experienced immediate allergic reaction symptoms after their first dose could go on to tolerate a second dose safely.    (more…)
Author Interviews, JAMA, Mental Health Research / 23.07.2021

This story explores suicide and conditions leading to despair. If you are at risk, please stop here and contact the National Suicide Prevention Lifeline for support. 800-273-8255 MedicalResearch.com Interview with: Daniel George, MSc, PhD Associate Professor, Department of Humanities Associate Professor, Department of Public Health Sciences Penn State MedicalResearch.com: What is the background for this study? What are the common diseases of despair?  Response: Last decade, two Princeton economists, Anne Case and Angus Deaton, noted a precipitous rise in self-harming deaths (suicide, alcoholism, accidental poisonings, i.e., overdose) especially among poor whites in midlife with low educational attainment since the 1990s. These deaths were intimately linked with economic changes over the past several decades that have created more despairing conditions for the working class, made people more susceptible to seeking escape, numbness, and relief from physical, mental, and emotional pain. In recent years, the crisis has broadened, and we've seen rising excess mortality in other groups of working-class Americans as overall life expectancy has consistently fallen. Our team at Penn State College of Medicine and Highmark Inc. has previously examined “diseases of despair”, these being patients who are experiencing suicidal ideation or substance use issues and seeking out clinical care before they convert to "deaths of despair". We published a study in BMJ in 2020 showing a marked rise in these clinical diseases of despair across a sample of 12 million insurance carriers in Appalachia and the Rust Belt, again spanning across demographic boundaries. For this study, we honed in on high prevalence census blocks we had identified in our hospital's service area in central Pennsylvania and organized 4 focus groups in both rural and urban areas. We wanted to learn more about what people felt was driving despair in their communities, and what solutions might look like  (more…)
Author Interviews, Cancer Research, COVID -19 Coronavirus, JAMA, Prostate Cancer, Race/Ethnic Diversity / 23.07.2021

MedicalResearch.com Interview with: Andres F. Correa, MD Assistant Professor Department of Surgical Oncology, and Adrien Bernstein, MD Second Year Urologic Oncology Fellow Fox Chase Cancer Center MedicalResearch.com: What is the background for this study? Response: Unfortunately, it has been well-established that historically Black Americans experience increased cancer specific mortality compared to white patients. In prostate cancer specifically studies have shown that when access to care is equitable this gap resolves. This suggests that biological factors are not driving these differences but rather the result of the complex interplay of social determinants and systemic inequities in our healthcare system. Early in the pandemic, multiple studies demonstrated that minority communities disproportionately shouldered poor COVID-19 outcomes.  On March 13th 2020, the American College of Surgeons recommended against elective procedures; however, the definition of an elective oncologic case was left to the discretion of the provider. As prostate cancer treatment can be safely deferred up to a year follow diagnosis, management of prostate cancer during the initial lockdown period of the COVID-19 Pandemic provided a useful analysis of the differential restrictions placed on non-emergent health care during the Pandemic. (more…)
Author Interviews, Education, JAMA / 20.07.2021

MedicalResearch.com Interview with: Arman Shahriar Medical Student University of Minnesota Medical School Research Consultant HealthPartners Institute MedicalResearch.com: What is the background for this study? What are the main findings? & What should readers take away from your report? Response: Financing medical school is an opaque and important topic because the cost of attendance of medical school has risen much faster than inflation for decades. Over the same time period, the racial wealth gap has widened. We found significant differences in how students of different socioeconomic and racial/ethnic backgrounds are planning to pay for medical school at the time of matriculation. Family or personal financing is far more common for high-income students. Among Black students, family or personal financing was markedly lower than other racial/ethnic groups, which could be a reflection of the wealth gap - which is rooted in structural racism.  This may create educational disparities as the field becomes increasingly racially, ethnically, and socioeconomically diverse; there are many costs outside of tuition and living that may be considered "variable" or "non-essential" but necessary for high-quality education, including expensive board prep materials and transportation during clinical rotations. Furthermore, the stark deficit in family financing may be one reason why Black students currently report the highest debt burden of all racial/ethnic groups.  (more…)
Author Interviews, Education, Gender Differences, JAMA / 17.07.2021

MedicalResearch.com Interview with: Anjali Sergeant McMaster Medicine Class of 2022 MedicalResearch.com: What is the background for this study? What are the main findings? Response: This collaborative study from the University of Toronto and McMaster University found that inpatients in the Greater Toronto Area (GTA) cared for by female physicians had lower mortality rates compared to those cared for by male physicians. Specifically, a 0.47% difference in patient deaths was reported, which is significant in the context of thousands of deaths in Ontario hospitals each year. This supports similar findings from an American study (Tsugawa et. al) published in 2017. Our study also examined gender-based differences in medical practice, including lab and imaging tests ordered, and medications prescribed. Female doctors ordered significantly more imaging tests for their patients but this factor did not explain their lower patient death rates. The mortality difference shrank when accounting for the number of years that doctors were in practice. This suggests that patients of female doctors may have better outcomes partially because more women make up newer medical grads in Canada, who may be more up-to-date on clinical guidelines. (more…)
Author Interviews, JAMA, Kidney Disease, Race/Ethnic Diversity, UCSF / 17.07.2021

MedicalResearch.com Interview with: Chi-yuan Hsu, MD, MSc (he/him/his) Professor and Division Chief Division of Nephrology University of California, San Francisco San Francisco, CA 94143-0532 MedicalResearch.com: What is the background for this study? Response: There has been a great deal of controversy recently about how race should be considered in medicine, including its use in estimating kidney function (e.g. https://jamanetwork.com/journals/jama/fullarticle/2769035).  A recent paper published in JAMA Network Open by Zelnick et al suggested that removing the race coefficient improves the accuracy of estimating kidney function (https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2775076) in the Chronic Renal Insufficiency Cohort, a NIH-funded study (www.cristudy.org). We are core investigators of the Chronic Renal Insufficiency Cohort Study and were not involved in the Zelnick’s study that was based on a public use dataset.  Because we were surprised by the methodological approach they took and the conclusion they came to, we implemented our own analysis of the data. (more…)
Author Interviews, COVID -19 Coronavirus, JAMA / 15.07.2021

MedicalResearch.com Interview with: Michael Ohl, MD, MSPH Associate Professor of Internal Medicine-Infectious Diseases Roy J. and Lucille A. Carver College of Medicine University of Iowa MedicalResearch.com: What is the background for this study? Response: The background is that remdesivir was approved for treatment in 2020 largely based on the results of the Adaptive COVID-19 Treatment Trial 1 (ACTT-1), which found that remdesivir treatment was associated with more rapid recovery from illness among people hospitalized with COVID-19. The intention was that - even if remdesivir did not lead to substantial improvements in survival-  it could help people to recover more quickly and be discharged from hospital sooner, potentially opening scare hospital pends to treat more patients during the pandemic.   (more…)
Author Interviews, Gender Differences, JAMA, University of Pennsylvania / 12.07.2021

MedicalResearch.com Interview with: Nosheen Reza, MD, FACC, FHFSA Assistant Professor of Medicine, Division of Cardiovascular Medicine Penn Center for Inherited Cardiovascular Disease Section of Advanced Heart Failure, Transplantation, and Mechanical Support Hospital of the University of Pennsylvania & the Perelman School of Medicine at the University of Pennsylvania  MedicalResearch.com: What is the background for this study? Response: In academic internal medicine in the United States, gender disparities in salary and promotion have been researched and documented for over 20 years. Despite this, in recent years, the number of women pursuing careers in medicine has increased, and now, more women than men are enrolled in U.S. medical schools. We wanted to take a contemporary look at the composition of the U.S. academic internal medicine physician workforce and evaluate the relationships between the representation of women in each internal medicine specialty with their salaries and academic rank. We hypothesized that even though there may be more women physicians practicing in these specialties compared with prior years, the disparities in academic rank and salary, as compared with men, would still exist. (more…)
Author Interviews, Brigham & Women's - Harvard, Electronic Records, JAMA, Pediatrics, Primary Care / 09.07.2021

MedicalResearch.com Interview with: Lisa Rotenstein, MD, MBA Assistant Medical Director Population Health and Faculty Wellbeing Department of Medicine Brigham and Women's Hospital MedicalResearch.com: What is the background for this study? Response: Our previous work in JAMA Internal Medicine demonstrated significant differences in time spent on the electronic health record (EHR) by specialty, and specifically showed that primary care clinicians spent significantly more total and after-hours time on the EHR than surgical and medical specialty counterparts. Primary care clinicians spent twice as long as surgical colleagues on notes, and received more than twice as many messages from team-mates, five times as many patient messages, and fifteen times as many prescription messages each day. Given these findings, the heavy administrative burden placed on primary care clinicians, and previous data about burnout among primary care clinicians, we wanted to better understand differences in time spent on the EHR among the different types of primary care clinicians. (more…)
Author Interviews, CDC, COVID -19 Coronavirus, Heart Disease, JAMA, UCSD / 01.07.2021

MedicalResearch.com Interview with: Margaret Ryan MD MPH Medical Director of Defense Health Agency Immunization Healthcare Division Pacific Region Office, San Diego CA Clinical Professor at the University of California San Diego MedicalResearch.com: What is the background for this study? What are the main findings? Response: Military clinicians, especially those in the Defense Health Agency Immunization Healthcare Division, first became aware of a few cases of myocarditis following COVID-19 vaccination in early Feb 2021.  These cases included young men who presented with chest pain a few days after 2nd dose of mRNA (Pfizer or Moderna) vaccine.  As more young people became eligible for 2nd doses of vaccine, more cases were identified.  By late April, the military had identified 23 cases of myocarditis, with remarkably similar presentations, after COVID-19 vaccination.  This case series is described in the current issue of JAMA Cardiology. (more…)
Author Interviews, JAMA / 18.06.2021

MedicalResearch.com Interview with: Ali Seifi, MD, FACP, FNCS, FCCM Associate Professor Director of Neuro Critical Care, Fellowship Director, CAST Neurosurgery Critical Care Department of Neurosurgery, Neurology, Anesthesiology and Medicine The University of Texas Health Science Center at San Antonio MedicalResearch.com: What is the background for this study? Stop HiccupsResponse: People get hiccups for several various reasons, most of the time is unknown etiology however the most known cause is when something is triggering the phrenic nerve which is a nerve that goes to the diaphragm and controls our breathing; as example any spicy food, alcoholic beverages, carbonated soda as well as eating fast can trigger this nerve. So far, there has been no tool for treatment of hiccups instantly and this could be since the  exact etiology of hiccups is still unknown and is multifactorial. Our aim was to make a feasible and easy for the public to use, a simple tool that anybody can use at home to get rid of hiccups . We patented and made the FISST, which  is a tool that can stop hiccups instantly by distracting the nerves and muscles which are involved in causing hiccups. Hiccups is a vicious cycle between  Phrenic nerve which contracts Diaphragm and Vagus nerve which contracts the Glottis and Epiglottis. Using FISST, requires intense activity of these two nerves and muscles for a few seconds, and thus it distracts the two nerve and muscles from the vicious cycle of triggers. We think because the FISST use the science behind all other remedies, but in union and under a pre-calculated required pressure and enough  intensity, that can stops hiccups. All other home remedies work only on one of the mentioned 2 nerves or they cannot “Naturally “ generate the required enough intensity to stop the vicious cycle between the 2 nerves.  (more…)
Author Interviews, CDC, COVID -19 Coronavirus, JAMA, Pediatrics / 11.06.2021

MedicalResearch.com Interview with: Angela P. Campbell, MD, MPH Medical Officer Epidemiology and Prevention Branch in the Influenza Division MIS-C Incidence Authorship Group CDC MedicalResearch.com: What is the background for this study?
  • Response: Multisystem inflammatory syndrome in children (MIS-C) is a serious condition associated with COVID-19 where different body parts can become inflamed, including the heart, lungs, kidneys, brain, skin, eyes, and gastrointestinal organs. Children with MIS-C may have a fever and various symptoms, including abdominal (gut) pain, vomiting, diarrhea, neck pain, rash, bloodshot eyes, or feeling extra tired. Not all children with MIS-C have the same symptoms.
  • It is still not known exactly how MIS-C may be linked to prior COVID-19 infection. However, 99% of cases in the CDC national surveillance system tested positive for COVID-19. The remaining 1% were around someone with COVID-19.
  • MIS-C incidence might vary by certain patient characteristics, such as such as race, ethnicity, age, sex and geographic location.
  • In this study we estimated the rate of MIS-C cases overall in the general population as well as the rate of MIS-C cases among those with COVID-19.
(more…)
Accidents & Violence, Author Interviews, JAMA, Surgical Research / 10.06.2021

MedicalResearch.com Interview with: Christopher Conner, MD, PhD Neurosurgery resident McGovern Medical School The University of Texas Health Science Center at Houston MedicalResearch.com: What is the background for this study? Response: There has been a growing understanding in medicine that the incidence of motor vehicle trauma is changing. We have watched as Friday and Saturday night emergencies have declined without a good explanation. Several other studies have investigated this, but the results were not conclusive. We think that is due to a lack of data from the rideshare companies and hospitals directly  (more…)
Author Interviews, JAMA, OBGYNE, USPSTF, Weight Research / 03.06.2021

MedicalResearch.com Interview with: Chien-Wen Tseng, M.D., M.P.H., M.S.E.E. The Hawaii Medical Service Association Endowed Chair Health Services and Quality Research Professor, and Associate Research Director Department of Family Medicine and Community Health University of Hawaii John A. Burns School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: Gaining weight during pregnancy is natural but gaining too little or too much weight can be harmful for pregnant people and their babies. For the first time, the Task Force reviewed the evidence and found that counseling pregnant people on healthy weight gain during pregnancy can lower their risk for diabetes during pregnancy, emergency cesarean deliveries, and babies born with a birth weight that is too high. Pregnant people may not know what amount of weight gain is healthy during pregnancy, or how weight gain can affect their pregnancy and baby. We recommend that clinicians offer all pregnant people counseling on healthy weight gain throughout their pregnancy for healthier, safer pregnancies. (more…)
Author Interviews, Autism, Cannabis, JAMA, Pediatrics / 28.05.2021

MedicalResearch.com Interview with: Daimei Sasayama, M.D., Ph.D. Department of Psychiatry Shinshu University MedicalResearch.com: What is the background for this study? Response: The diagnosis of autism spectrum disorder (ASD) is increasing worldwide. A 2016 US survey reported a prevalence of 1.85% in 8-year-olds, and a birth cohort study in Denmark reported that the future cumulative incidence of ASD could exceed 2.8%. Our recent regional cohort study in Japan reported an even higher cumulative incidence of 3.1%. So we examined whether the cumulative incidence in our regional cohort represents the nationwide incidence in Japan.  (more…)
Author Interviews, Cancer Research, Colon Cancer, JAMA, USPSTF / 26.05.2021

MedicalResearch.com Interview with: Martha Kubik, Ph.D., R.N. Professor and Director School of Nursing College of Health and Human Services George Mason University MedicalResearch.com: What is the background for this study? Response: Colorectal cancer is the third leading cause of cancer deaths in the United States, yet about a quarter of people ages 50 to 75 have never been screened for this devastating disease. Fortunately, we know that screening for colorectal cancer is effective and saves lives. New science about colorectal cancer in people younger than 50 years old has enabled us to expand our previous guidelines to recommend that all adults ages 45 to 75 be screened for colorectal cancer to reduce their risk of dying from this disease.  (more…)
Anesthesiology, Author Interviews, Cognitive Issues, Heart Disease, JAMA, Surgical Research, UCSF / 22.05.2021

MedicalResearch.com Interview with: Elizabeth L. Whitlock, MD, MSc John W. Severinghaus Assistant Professor In Residence Anesthesia & Perioperative Care UCSF Medical Center MedicalResearch.com: What is the background for this study? Response: We have known for a while that, rarely, some older adults suffer substantial, durable cognitive decline after surgery, particularly after coronary artery bypass grafting (CABG) surgery; a larger proportion experience a decline in cognitive test performance which doesn't necessarily affect function, but which has caused concern among researchers.  This cognitive decline was attributed, in part, to the cardiac bypass pump. ​Many of the studies had methodological limitations which made it difficult to be sure that the cognitive change was due to surgery and not due more generally to heart problems or atherosclerotic disease, which may also imply cerebrovascular atherosclerosis. Using a large database of older adults who undergo regular cognitive testing, we identified individuals who underwent CABG and compared them to those who underwent percutaneous coronary intervention (PCI), a minimally invasive, non-surgical method of opening blocked coronary arteries.  This allowed us to model the rate of memory decline before surgery - which hadn't been done in previous studies - and compare it to the rate of memory decline after surgery in older adults who had serious heart disease (some of whom were treated with CABG, and some treated with PCI). (more…)
Author Interviews, Breast Cancer, JAMA, Race/Ethnic Diversity / 17.05.2021

MedicalResearch.com Interview with: Ying Liu, MD, PhD Assistant Professor Washington University School of Medicine Department of Surgery, Division of Public Health Sciences St. Louis, MO MedicalResearch.com: What is the background for this study? Response: Non-Hispanic African American women experience a disproportional burden of poor breast cancer outcomes than non-Hispanic White women, which is associated with a higher incidence of triple-negative breast cancer (TNBC), more advanced stages at diagnosis, and lower treatment adherence. However, the differences in clinical treatment and outcomes between African American women with TNBC and their White counterparts have not been well defined. (more…)
Author Interviews, Dermatology, JAMA, OBGYNE, Pediatrics / 09.05.2021

MedicalResearch.com Interview with: Niklas Worm Andersson, MD Department of Epidemiology Research Statens Serum Institut, Copenhagen Denmark  MedicalResearch.com: What is the background for this study? Response: "Findings from some previous fetal safety studies on topical corticosteroid use in pregnancy have raised concerns for an increased risk of newborns being small for gestational age or having low birth weight, in particular among pregnancies where larger amounts of potent to very potent agents have been used." (more…)
Author Interviews, Blood Pressure - Hypertension, JAMA, USPSTF / 07.05.2021

MedicalResearch.com Interview with: John B. Wong, M.D. Chief Scientific Officer Vice chair for Clinical Affairs Chief of the Division of Clinical Decision Making and Primary care Clinician Department of Medicine at Tufts Medical Center   MedicalResearch.com: What is the background for this study? Response: Hypertension affects nearly half of all adults in the United States and is a major risk factor for many serious health conditions. Fortunately, by screening all adults for hypertension, clinicians can improve their patient’s health. The Task Force continues to recommend screening all adults for hypertension so that they can get the care they need to help prevent health conditions such as heart attack, stroke, and kidney failure. (more…)
Author Interviews, CDC, Clots - Coagulation, COVID -19 Coronavirus, JAMA / 05.05.2021

MedicalResearch.com Interview with: Isaac See, MD Centers for Disease Control and Prevention COVID-19 Response Team Atlanta, Georgia MedicalResearch.com: What is the background for this study? Response: On February 27, 2021 the U.S. Food and Drug Administration (FDA) granted emergency use authorization for the Janssen/Johnson & Johnson (J&J) COVID-19 Vaccine in people 18 years of age or older in the United States.  The Janssen/J&J COVID-19 Vaccine uses a replication-deficient (i.e., cannot cause infections) human adenovirus vector.  In mid-March, the European Medicines Agency announced that they had conducted a preliminary investigation of cases of blood clots and low counts of blood cells called platelets in patients who had recently received the Oxford/AstraZeneca COVID-19 Vaccine, which uses a replication-deficient chimpanzee adenovirus vector.  This syndrome of blood clots and low platelet counts has been called thrombosis with thrombocytopenia syndrome, or TTS.  The European investigation showed that over 70% of their cases specifically involved blood clots in particular veins inside the brain, a condition caused cerebral venous sinus thrombosis (CVST), in addition to low platelet counts (thrombocytopenia is the medical term for low platelet counts). CVST is already a rare condition, and CVST with thrombocytopenia is even rarer.  By April 12, 2021, approximately 7 million doses of the Janssen/J&J COVID-19 Vaccine had been given in the United States, and six cases of CVST and thrombocytopenia after receipt of the Janssen/J&J COVID-19 Vaccine had been reported to the U.S. Vaccine Adverse Event Reporting System (VAERS), which is the U.S. national vaccine safety monitoring system.  The next day (April 13, 2021) CDC and FDA recommended a pause in use of the vaccine recommended to allow for further investigation of these events.  On April 23, 2021 data about the first 12 cases reported after authorization of the Janssen/J&J COVID-19 Vaccine were presented at an emergency meeting of the Advisory Committee on Immunization Practices (ACIP) to decide what to recommend regarding the Janssen COVID-19 vaccine.  The ACIP concluded that the benefits of resuming Janssen COVID-19 vaccination among persons aged 18 years or older outweighed the risks and reaffirmed its interim recommendation under the FDA’s Emergency Use Authorization.  The FDA’s Emergency Use Authorization includes a new warning for rare clotting events among women aged 18 to 49 years. Our report provides clinical details about these first reported 12 U.S. cases of CVST and thrombocytopenia following receipt of the Janssen COVID-19 Vaccine. (more…)
Author Interviews, Gender Differences, JAMA, Surgical Research / 28.04.2021

MedicalResearch.com Interview with: Anthony Almazan MD Candidate Harvard Medical School MedicalResearch.com: What is the background for this study? Response: Gender-affirming surgeries are procedures offered to alleviate psychological distress and affirm the gender identities of transgender and gender diverse (TGD) people. Requests for these surgeries have been increasing in the United States over the past decade. However, the mental health benefits of these procedures have remained controversial due to the limited evidence base on this subject. (more…)
Author Interviews, Dermatology, JAMA, Technology / 28.04.2021

MedicalResearch.com Interview with: Yun Liu, PhD Google Health Palo Alto, California MedicalResearch.com: What is the background for this study? Would you describe the system?  Does it use dermatoscopic images? Response: Dermatologic conditions are extremely common and a leading cause of morbidity worldwide. Due to limited access to dermatologists, patients often first seek help from non-specialists. However, non-specialists have been reported to have lower diagnostic accuracies compared to dermatologists, which may impact the quality of care. In this study, we built upon prior work published in Nature Medicine, where we developed a computer algorithm (a deep learning system, DLS) to interpret de-identified clinical images of skin conditions and associated medical history (such as whether the patient reported a history of psoriasis). These clinical images are taken using consumer-grade hardware such as point-and-shoot cameras and tablets, which we felt was a more accessible and widely-available device compared to dermatoscopes. Given such images of the skin condition as input, the DLS outputs a differential diagnosis, which is a rank-ordered list of potential matching skin conditions. In this paper, we worked with user experience researchers to create an artificial intelligence (AI) tool based on this DLS. The tool was designed to provide clinicians with additional information per skin condition prediction, such as textual descriptions, similar-appearing conditions, and the typical clinical workup for the condition. We then conducted a randomized study where 40 clinicians (20 primary care physicians, 20 nurse practitioners) reviewed over 1,000 cases -- with half the cases with the AI-based assistive tool, and half the cases without. For each case, the reference diagnosis was based on a panel of 3 dermatologists.  (more…)
Author Interviews, Cancer Research, Gender Differences, HPV, JAMA, Vaccine Studies / 27.04.2021

MedicalResearch.com Interview with: Michelle M. Chen, MD/MHS Clinical Lecturer Department of Otolaryngology-Head and Neck Surgery University of Michigan MedicalResearch.com: What is the background for this study? Response: HPV is the most common sexually transmitted infection in the United States and associated with several malignancies including oropharyngeal, cervical, vaginal, vulvar, penile, and anal cancers. In 2020, the FDA expanded the indications for HPV vaccination to include the prevention of oropharyngeal cancer, which is the most common HPV-associated malignancy and about 80% of oropharyngeal cancer patients are male. HPV vaccination rates are closely tracked for adolescents but less is known about vaccination rates for young adults. The goal of our study was to understand HPV vaccinations for young adult men and women, ages 18-21.  (more…)
Author Interviews, COVID -19 Coronavirus, JAMA, OBGYNE, Pediatrics / 23.04.2021

MedicalResearch.com Interview with: Aris Papageorghiou MBChB, MRCOG Professor of Fetal Medicine and the Clinical Research Director Oxford Maternal and Perinatal Health Institute University of Oxford MedicalResearch.com: What is the background for this study? Response: Our study was really guided by a key question: does Covid-19 in pregnancy increase the risk of adverse maternal and neonatal outcomes as compared with pregnant women who do not have the infection? The question is highly relevant because of the known deleterious effects of other coronavirus infections in pregnancy, e.g. SARS (severe acute respiratory syndrome) and MERS-CoV (Middle East respiratory syndrome coronavirus). In order to answer this question we undertook this multinational cohort study. (more…)