Author Interviews, Global Health, HIV, NEJM / 17.07.2019

MedicalResearch.com Interview with: [caption id="attachment_50304" align="alignleft" width="107"]Prof-Richard-Hayes.jpg Prof. Hayes[/caption] Dr. Richard J. Hayes, DSc, FMedSci Professor of Epidemiology and International Health London School of Hygiene and Tropical Medicine MedicalResearch.com: What is the background for this study? Response: HIV incidence rates remain at very high levels in many parts of southern Africa. Universal testing and treatment (i.e., ensuring that everyone in a community tests for HIV and that everyone diagnosed with HIV is started on treatment as soon as possible) has been proposed as a strategy to achieve steep reductions in HIV incidence in generalized epidemics. Prior trials have shown inconsistent results as to whether this strategy could be effective. HPTN 071 (PopART) was carried out in 21 urban communities in Zambia and South Africa, with individual communities randomly assigned into one of three arms: A, B or C. The 14 communities in Arms A and B received annual rounds of home-based HIV testing by community health workers who supported linkage to care, antiretroviral therapy (ART) adherence and other HIV services. The seven communities in Arm C received the local standard of care. We looked to see if the HIV incidence in the communities receiving universal testing and treatment would be lower (over time) compared to the incidence in the standard of care communities.
Author Interviews, Biomarkers, NEJM, Pulmonary Disease / 11.07.2019

MedicalResearch.com Interview with: [caption id="attachment_50147" align="alignleft" width="200"]Dr. Chris Butler,, BA MBChB DCH CCH MD FRCGP (Hon)FFPH FMedSci Professor of Primary Care Nuffield Department of Primary Care Health Sciences, Professorial Fellow at Trinity College Clinical Director Primary Care Clinical Trials Unit University of Oxford Dr. Butler[/caption] Dr. Chris Butler,, BA MBChB DCH CCH MD FRCGP (Hon)FFPH FMedSci Professor of Primary Care Nuffield Department of Primary Care Health Sciences, Professorial Fellow at Trinity College Clinical Director Primary Care Clinical Trials Unit University of Oxford  MedicalResearch.com: What is the background for this study? Response: More than a million people in the UK have COPD, which is a lung condition associated with smoking and other environmental pollutants. People living with the condition often experience exacerbations, or flare-ups, and when this happens, three out of four are prescribed antibiotics. However, two-thirds of these flare-ups are not caused by bacterial infections and antibiotics often do not benefit patients. A simple finger-prick blood test could help prevent unnecessary prescribing of antibiotics for people with the lung condition chronic obstructive pulmonary disease (COPD).  The finger-prick test measures the amount of C- reactive protein (CRP) - a marker of inflammation that rises rapidly in the blood in response to serious infections. People with a COPD flare-up who have a low CRP level in the blood appear to receive little benefit from antibiotic treatment. The General Practitioner (GP) use of a C-Reactive Protein (CRP) Point of Care Test (POCT) to help target antibiotic prescribing to patients with Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) who are most likely to benefit (The PACE Study) determined whether the using a POCT CRP to guide antibiotic treatment decisions for acute exacerbations of COPD reduced antibiotic use without harming patients.
Author Interviews, Brain Injury, Columbia, Critical Care - Intensive Care - ICUs, NEJM, Neurology / 27.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49981" align="alignleft" width="134"]Jan Claassen, MD, PhD, FNCS Associate Professor of Neurology Division of Division of Critical Care and Hospitalist Neurology Columbia University Medical Center Dr. Claassen[/caption] Jan Claassen, MD, PhD, FNCS Associate Professor of Neurology Division of Division of Critical Care and Hospitalist Neurology Columbia University Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Unconsciousness is common and predicting recovery is challenging – often inaccurate. Many patients do not show movements on commands and typically this is interpreted as unconsciousness. Some of these patients may be able to have brain response to these commands raising the possibility of some preservation of consciousness. This has previously been shown months or years after the injury mostly using MRI. We were able to detect this activation at the bedside in the ICU shortly after brain injury. For this we applied machine learning to the EEG to distinguish the brain’s responses to commands. Patients that showed this activation were more likely to follow commands prior to discharge and had better outcomes one year later. 
Anesthesiology, Author Interviews, Geriatrics, NEJM / 23.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49917" align="alignleft" width="128"]Yahya Shehabi  PhD, FANZCA, FCICM, EMBA, GAICD Director of Research, Critical Care and Peri-operative Medicine, Monash Health Professor, School of Clinical Sciences, Faculty of Medicine Nursing and Health Sciences, Monash University Professor Intensive Care Medicine, Clinical School of Medicine, University New South Wales Critical Care and Peri-Operative Medicine Lead – Monash Health Translational Precinct  Dr. Shehabi[/caption] Yahya Shehabi  PhD, FANZCA, FCICM, EMBA, GAICD Director of Research, Critical Care and Peri-operative Medicine, Monash Health Professor, School of Clinical Sciences, Faculty of Medicine Nursing and Health Sciences, Monash University Professor Intensive Care Medicine, Clinical School of Medicine, University New South Wales Critical Care and Peri-Operative Medicine Lead – Monash Health Translational Precinct MedicalResearch.com: What is the background for this study? Response: SPICE III was the final phase of a series of SPICE studies. SPICE I showed 2 important findings, first, deep sedation in the first 48 hours is strongly associated with higher mortality, longer ventilation time and higher risk of delirium. Second; that Dexmedetomidine is mainly used as an adjunct secondary agent 3-4 days after commencing mechanical ventilation and not as a primary sedative agent. In addition, albeit with several limitations, previous RCTs comparing Dexmedetomidine with conventional sedatives showed reduced iatrogenic coma, shortened ventilation time and reduced delirium with Dexmedetomidine treatment. So based on the above we hypothesized that using Dexmedetomidine soon after commencing ventilation as a primary sedative agent, through reducing early iatrogenic coma, ventilation time and delirium, would impact 90 day-mortality.
Author Interviews, Biomarkers, Genetic Research, Infections, NEJM, UCSF / 13.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49751" align="alignleft" width="150"]Dr. Charles Chiu, M.D./Ph.D. Professor, Laboratory Medicine and Medicine / Infectious Diseases Director, UCSF-Abbott Viral Diagnostics and Discovery Center Associate Director, UCSF Clinical Microbiology Laboratory UCSF School of Medicine Dr. Chiu[/caption] Dr. Charles Chiu, M.D./Ph.D. Professor, Laboratory Medicine and Medicine / Infectious Diseases Director, UCSF-Abbott Viral Diagnostics and Discovery Center Associate Director, UCSF Clinical Microbiology Laboratory UCSF School of Medicine MedicalResearch.com: What is the background for this study? Would you describe what is meant by metagenomic sequencing? Response: Metagenomic next-generation sequencing (mNGS) is the use of technology to generate millions of sequence reads to diagnose infection sin patients by characterizing the full range of potential pathogens (bacteria, viruses, fungi, and parasites) in a single sample. Although shown to be a promising diagnostic tool for  infectious diseases in case reports and limited case series (Chiu and Miller Nature Reviews Genetics 20, 341-355 (2019)), to date the “real-life” utility of this approach for patient care has hitherto not been demonstrated.  This study is the first prospective, multi-center study of clinical mNGS testing for the diagnosis of neurological infections in acutely ill hospitalized patients presenting with meningitis and/or encephalitis.
ASCO, Author Interviews, Cancer Research, J&J-Janssen, NEJM, Prostate Cancer / 01.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49474" align="alignleft" width="142"]Dr. Kim Chi. MDProfessor of MedicineMedical Oncologist and Medical Director at BC Cancer – VancouverUniversity of British Columbia,Principal Investigator of the TITAN Study. Dr. Kim Chi[/caption] Dr. Kim Chi. MD Professor of Medicine Medical Oncologist and Medical Director at BC Cancer – Vancouver University of British Columbia, Principal Investigator of the TITAN Study. MedicalResearch.com: What is the background for this study? Response: For more than 70 years, androgen deprivation therapy (ADT) has been the standard of care therapy for patients with metastatic prostate cancer. The Phase 3 TITAN study looked at adding apalutamide (®®®®) to ADT compared with placebo plus ADT in a broad group of patients with metastatic castration-sensitive prostate cancer (mCSPC), regardless of disease volume or prior docetaxel treatment history. Metastatic castration-sensitive prostate cancer is prostate cancer that still responds to androgen deprivation therapy and has spread to other parts of the body. Patients with mCSPC tend to have a poor prognosis, with a median overall survival (OS) of less than five years, underscoring the need for new treatment options. The dual primary endpoints of this study were overall survival and radiographic progression-free survival (rPFS). 
Author Interviews, Boehringer Ingelheim, NEJM, Pharmaceutical Companies, Pulmonary Disease / 30.05.2019

MedicalResearch.com Interview with: [caption id="attachment_49455" align="alignleft" width="200"]Donald Zoz, M.D.,Senior associate directorClinical Development & Medical AffairsBoehringer Ingelheim Pharmaceuticals, Inc. Dr. Zoz[/caption] 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. 
Author Interviews, Immunotherapy, NEJM, Pulmonary Disease / 22.05.2019

MedicalResearch.com Interview with: [caption id="attachment_49320" align="alignleft" width="148"]Gerard J. Criner, MD, FACP, FACCPChair and Professor, Thoracic Medicine and SurgeryLewis Katz School of MedicineTemple University Dr. Criner[/caption] 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.
Author Interviews, Clots - Coagulation, NEJM, Neurology / 09.05.2019

MedicalResearch.com Interview with: [caption id="attachment_49060" align="alignleft" width="165"]Geoffrey A Donnan AOMBBS, MD, FRCP, FRACP, FAAHMSProfessor of NeurologyUniversity of Melbourne, Melbourne Brain Centre,Royal Melbourne and Austin Hospitals Prof. Donnan[/caption] Geoffrey A Donnan AO MBBS, MD, FRCP, FRACP, FAAHMS Professor of Neurology University of Melbourne, Melbourne Brain Centre Royal Melbourne and Austin Hospital MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Currently the thrombolysis time window for acute ischemic stroke is restricted to less than 4.5 hours from stroke onset and patients with wake-up stroke are not eligible. EXTEND is a multi-centre randomised placebo-controlled trial involving patient with acute ischemic stroke who presented between 4.5 to 9 hours of stroke onset or with wake-up-stroke and had penumbral tissue demonstrated on automated perfusion imaging. Patients were randomised to receive either alteplase or placebo. In total there were 225 patients recruited and the patients who received alteplase had higher rate of excellent functional outcome at 3 months (35.4% vs 29.5% adjusted odd ration 1.44 with 95% confidence interval 1.01 – 2.06 p=0.04). Patients who received alteplase achieved higher rate of early neurological improvement at day 3, reperfusion and recanalization at 24 hours. There was numerically more haemorrhage in the alteplase group but this not negate the functional benefit and there was no difference in the rate of mortality between the two groups. 
Author Interviews, Global Health, Infections, NEJM / 08.05.2019

MedicalResearch.com Interview with: [caption id="attachment_49046" align="alignleft" width="133"]Birgit Nikolay PhDMATHEMATICAL MODELLING OF INFECTIOUS DISEASESInstitut Pasteur Dr. Nikolay[/caption] Birgit Nikolay PhD MATHEMATICAL MODELLING OF INFECTIOUS DISEASES Institut Pasteur  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Nipah virus was identified by the World Health Organization as an emerging infectious disease that may cause major epidemics if the pathogen evolves to become more transmissible, leading the organization to prioritize it for research to prevent future health emergencies. In the absence of efficient treatments or vaccines, the only way to control Nipah virus outbreaks is through targeted interventions that limit opportunities of spread. Designing such interventions is challenging in a context where transmission mechanisms remain poorly understood. The study provides important insights to better understand these mechanisms.
Alzheimer's - Dementia, Author Interviews, Merck, NEJM / 10.04.2019

MedicalResearch.com Interview with: Michael F. Egan, MDVice President,  NeuroscienceGlobal Clinical DevelopmentMerck Research LaboratoriesNorth Wales, PAMichael F. Egan, MD Vice President,  Neuroscience Global Clinical Development Merck Research Laboratories North Wales, PA  MedicalResearch.com: What is the background for this study?   Response: Alzheimer’s disease (AD) appears to be due to the gradual accumulation of amyloid over many years (the “amyloid hypothesis”). At some point, it is thought that amyloid triggers abnormalities in tau, which then forms deposits within neurons and leads to progressive neurodegeneration. Amyloid is made up of  a small, sticky peptide, Abeta, which is produced when the enzyme BACE cleaves a large protein called APP.  In our trial, we tested whether a potent BACE inhibitor, verubecestat, could slow disease progression in subjects with early AD (or prodromal AD) by blocking formation of Abeta.  A previous trial in subjects with dementia due to AD failed to find evidence of efficacy. One possible reason for this failure is that subjects had too much amyloid in their brain already.
Author Interviews, Clots - Coagulation, NEJM, Thromboembolism / 02.04.2019

MedicalResearch.com Interview with: [caption id="attachment_48324" align="alignleft" width="128"]Yaseen M. Arabi, M.DIntensive Care DepartmentMinistry of National Guard Health AffairsICU 1425, Riyadh, Saudi Arabia Dr. Arabi[/caption] Yaseen M. Arabi, M.D Intensive Care Department Ministry of National Guard Health Affairs Riyadh, Saudi Arabia  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Venous thromboembolism, including deep vein thrombosis and pulmonary embolism, is a complication of critical illness. Studies have demonstrated that despite pharmacologic thromboprophylaxis with unfractionated heparin or low-molecular weight heparin, 5-20% of critically ill patients develop deep vein thrombosis (DVT). The PREVENT trial evaluated whether adjunctive intermittent pneumatic compression reduces incident proximal lower limb DVT as detected on twice-weekly lower limb ultrasonography in critically ill patients receiving pharmacologic thromboprophylaxis with unfractionated heparin or low-molecular-weight heparin. The trial was conducted in 20 sites in Saudi Arabia, Canada, Australia and India and included 2003 patients. The trial found no difference in the primary end point of proximal leg DVT. The addition of intermittent pneumatic compression to pharmacologic thromboprophylaxis did not result in a lower incidence of pulmonary embolism or a composite outcome of venous thromboembolism or death from any cause at 28 days when compared to pharmacologic thromboprophylaxis alone.
Accidents & Violence, Author Interviews, Emergency Care, NEJM, University Texas / 27.03.2019

MedicalResearch.com Interview with: [caption id="attachment_48175" align="alignleft" width="200"]Jeffrey Howard, PhDAssistant ProfessorDepartment of Kinesiology, Health and NutritionUniversity of Texas at San AntonioSan Antonio, TX 78249 Dr. Howard[/caption] Jeffrey Howard, PhD Assistant Professor Department of Kinesiology, Health and Nutrition University of Texas at San Antonio San Antonio, TX 78249 MedicalResearch.com: What is the background for this study? Response:  There is a saying that “the only winner in war is medicine”, which is the first sentence in the article.  The point of that quote is that many medical advances over the last 500 years or more have been learned or propagated as a result of war. With that as the backdrop, the purpose of our study was to provide a more comprehensive assessment of the trauma system than previous work.  We accomplished this by compiling the most complete data to-date on the conflicts, using data from both Afghanistan and Iraq, and analyzing multiple interventions/policy changes simultaneously rather than in isolation.  Previous work had focused primarily on single interventions and within more narrow timeframes.  We wanted to expand the scope to include multiple interventions and encompass the entirety of the conflicts through the end of 2017. 
Author Interviews, Breast Cancer, Chemotherapy, NEJM / 27.03.2019

MedicalResearch.com Interview with: [caption id="attachment_48191" align="alignleft" width="150"]Rita Mehta, MD, HS Clinical Professor,Chao Family Comprehensive Cancer CenterUniversity of California School of Medicine, Irvine  Dr. Mehta[/caption] Rita Mehta, MD, HS Clinical Professor, Chao Family Comprehensive Cancer Center University of California School of Medicine, Irvine  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Most patients with HR-positive breast cancer become resistant to hormonal therapies like aromatase inhibitor-anastrozole over time, and downregulating estrogen receptor was identified as a mechanism for overcoming or delaying resistance to hormonal therapy in advanced HR-positive breast cancer. The prospective, randomized phase III S0226 trial, first reported by us in NEJM 2012, showed that the selective estrogen receptor degrader fulvestrant in combination with anastrozole significantly improved progression-free survival in 707 women with HR-positive metastatic breast cancer in first-line setting. Treatment with the selective estrogen receptor degrader (SERD) fulvestrant achieved a clinically significant and meaningful improvement in overall survival in patients with hormone receptor (HR)-positive advanced breast cancer in first-line therapy, according to the final analysis of overall survival results from the S0226 study reported by us (Mehta et al. NEJM 2019)
  • Results showed that median overall survival improved by 7.8 months with anastrozole plus fulvestrant (median overall survival = 49.8 months) compared to anastrozole (median overall survival = 42.0 months).
  • The improvement was even greater in patients with endocrine naive disease, with an absolute improvement in median overall survival of 11.9 months.
  • No new safety signals were observed with longer follow-up. 
Anesthesiology, Author Interviews, Heart Disease, NEJM, Surgical Research / 27.03.2019

MedicalResearch.com Interview with: [caption id="attachment_48112" align="alignleft" width="200"]Dr. Giovanni LandoniIntensive Care and Anesthesia Unit Associate professorUniversità Vita-Salute San Raffaele Dr. Landoni[/caption] Dr. Giovanni Landoni Intensive Care and Anesthesia Unit Associate professor Università Vita-Salute San Raffaele  MedicalResearch.com: What is the background for this study?   Response: Patients undergoing cardiac surgery are still at risk for perioperative complications. Studies to improve clinical outcomes this setting are important. Inhaled anesthetics have pharmacological properties which reduce myocardial infarction size by 50% in laboratory and animal studies and which might decrease postoperative mortality according to aggregated published randomized data.
Author Interviews, Clots - Coagulation, Duke, Heart Disease, NEJM / 21.03.2019

MedicalResearch.com Interview with: [caption id="attachment_20394" align="alignleft" width="200"]Renato D. Lopes MD, MHS, PhD Duke University Medical Center Duke Clinical Research Institute Durham, NC 27705 Dr. Renato Lopes[/caption] Renato D. Lopes MD, MHS, PhD Professor of Medicine Division of Cardiology Duke University Medical Center Duke Clinical Research Institute MedicalResearch.com: What is the background for this study? What are the main findings? Response: In patients with acute coronary syndromes (ACS), approximately 20% to 30% of those with nonvalvular atrial fibrillation (NVAF) have concomitant coronary artery disease (CAD), and 5 to 10% of patients who undergo PCI have NVAF. These patients often receive both antiplatelet therapy and oral anticoagulants; and how best to combine these agents to minimize bleeding risk without compromising protection against thrombosis is an important unanswered question. Analysis of results for bleeding indicated no significant interaction between the two randomization factors permitting independent analysis of results for the two key comparisons. The first showed that apixaban was both non-inferior and significantly superior to VKA for the primary outcome with a 31% reduction in the relative risk for bleeding. Aspirin significantly increased the relative risk for bleeding versus placebo by 89%. Results for the composite of death and hospitalization showed that apixaban resulted in a relative risk reduction of 17%, primarily driven by a reduction in all cause hospitalization. There was no significant difference between results for aspirin versus placebo for this outcome. Analysis of the composite of death and ischemic events indicated no significant differences in results for apixaban versus VKA or aspirin versus placebo.
Author Interviews, Blood Pressure - Hypertension, NEJM, Race/Ethnic Diversity / 20.03.2019

MedicalResearch.com Interview with: [caption id="attachment_48022" align="alignleft" width="133"]Dike B. Ojji, M.D., Ph.D, FWACP, FACPDepartment of MedicineFaculty of Clinical SciencesUniversity of Abuja Dr. Ojji[/caption] Dike B. Ojji, M.D., Ph.D, FWACP, FACP Department of Medicine Faculty of Clinical Sciences University of Abuja MedicalResearch.com: What is the background for this study? Response: We decided to do this research because there were no large RCTs before now that have compared the efficacy of contemporary combination therapies among any black populations in spite of the high burden of hypertension and its complications (such as heart failure, cerebrovascular accident and chronic kidney) in this population, and also the fact that majority require 2 or more medications to control their blood pressure.
Author Interviews, Genetic Research, Heart Disease, Lipids, NEJM, Statins / 13.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47926" align="alignleft" width="133"]Brian A Ference, MD, MPhil, MSc, FACC, FESCProfessor and Director of Research in Translational TherapeuticsExecutive Director, Centre for Naturally Randomized TrialsStrangeways Research LaboratoryUniversity of CambridgeCambridge, UK Dr. Ference[/caption] Brian A Ference, MD, MPhil, MSc, FACC, FESC Professor and Director of Research in Translational Therapeutics Executive Director, Centre for Naturally Randomized Trials Strangeways Research Laboratory University of Cambridge Cambridge, UK MedicalResearch.com: What is the background for this study? Response: Bempedoic acid is a novel therapy currently in development that lowers LDL-C by inhibiting ATP-citrate lyase, an enzyme in the same cholesterol biosynthesis pathway as HMG-CoA reductase (the target of stains).  However, whether lowering LDL-C by inhibiting ATP-citrate lyase will reduce the risk of cardiovascular events to the same extent as lowering LDL-C by inhibiting HMG-CoA reductase with a statin is unknown. We conducted a “naturally randomized trial” using Mendelian randomization in more than 650,000 participants who experienced more than 100,000 cardiovascular events to evaluate the potential clinical benefit of lowering LDL-C by inhibiting ATP-citrate lyase as compared to lowering LDL-C by inhibiting HMG-CoA reductase.
Author Interviews, Brigham & Women's - Harvard, NEJM, Opiods / 13.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47869" align="alignleft" width="125"]Wenjia Zhu, PhD. Marshall J. Seidman FellowDepartment of Health Care PolicyHarvard Medical School Dr. Zhu[/caption] Wenjia Zhu, PhD. Marshall J. Seidman Fellow Department of Health Care Policy Harvard Medical School  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The current opioid epidemic continues to cause deaths and tremendous suffering in the United States, driven in large part by overuse of prescription opioids. Of special concern are new opioid prescriptions, i.e. opioids given to patients who have not used opioids before, which research tells us are an important gateway to long-term opioid use, misuse, overdoes and death. Recently, in their efforts to curb over prescribing of opioids, the CDC issued guidelines (December 2015 in draft form; March 2016 in final version) to encourage opioid prescribers to limit the use, duration and dose of opioids, particularly opioids to first-time users. Despite these, little is known about the prescribing of opioids to first-time users on a national scale, particularly among commercially insured patients. In this study, we examined national monthly trends in the rate at which opioid therapy was started among commercially insured patients. Using administrative claims from Blue Cross Blue Shield Association commercial insurers from 2012 to 2017, we analyzed more than 86 million commercially insured patients across the United States.
Author Interviews, Infections, NEJM / 13.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47923" align="alignleft" width="200"]Susan Swindells MBBSProfessor and Medical Director, HIV ClinicDepartment of Internal MedicineUniversity of Nebraska Medical CenterOmaha, NE  Dr. Swindells[/caption] Susan Swindells MBBS Professor and Medical Director, HIV Clinic Department of Internal Medicine University of Nebraska Medical Center Omaha, NE MedicalResearch.com: What is the background for this study? What are the main findings?  Response: More than one quarter of the world’s population is infected with tuberculosis (TB), and there is effective treatment for this but only a small fraction of those eligible actually receive it.   TB is the leading cause of death for people with HIV infection, globally.  One of the major problems with currently available treatments for TB infection is that they take too long, and people just stop taking them after a while.  We identified an ultra-short course of treatment (only one month) and tested it against the conventional 6-month course of treatment. Our main findings were that the new short course was just as effective as the standard 6 month course, more patients taking the short course completed their treatment, and had less adverse effects. 
Author Interviews, Heart Disease, Imperial College, Lipids, NEJM, Statins / 13.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47863" align="alignleft" width="187"]Prof. Kosh Ray, MB ChB, MD, MPhil Faculty of Medicine, School of Public HealthChair in Public Health (Clinical)Imperial College London Dr. Ray[/caption] Prof. Kosh Ray, MB ChB, MD, MPhil Faculty of Medicine, School of Public Health Chair in Public Health (Clinical) Imperial College London MedicalResearch.com: What is the background for this study? What are the main findings? Response: Bempedoic acid is the first in class of a new therapy for lowering LDL cholesterol. This is the largest and longest study to date with this therapy and involved about 2200 pts with patients with either established cardiovascular disease or familial hypercholestrolaemia and in whom LDL was > 70mg/dl or 1.8 mmol/L despite maximally tolerated statins. %0% were on high intensity statins and the majority of the rest on moderate intensity. The aim was to show long term safety 1 year and efficacy at 24 weeks and at 1 year. 
Author Interviews, Cancer Research, NEJM / 13.03.2019

[caption id="attachment_47928" align="alignleft" width="200"] One example of actinic keratoses on hands DermNZ[/caption] MedicalResearch.com Interview with: Maud Jansen, MD | Resident Dermatology | PhD candidate Dermatologie, Maastricht MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Actinic keratosis is the most frequent premalignant skin disease in the white population and is caused by exposure to ultraviolet radiation. With a prevalence of 37.5% among whites 50 years of age or older, actinic keratosis is one of the most frequent reasons for patients to visit a dermatologist. If left untreated, actinic keratosis may develop into squamous cell carcinoma. Current guidelines provide no clear recommendations about which treatment approach is preferred. Currently, the choice of treatment often depends on the preferences of patients and their treating physicians. Evidence from randomized trials with direct comparison between treatments and with long-term follow-up is scarce. Frequently prescribed and studied field-directed treatment approaches are 5-fluorouracil cream, imiquimod cream, photodynamic therapy (PDT), and ingenol mebutate gel. We investigated the effectiveness of these four frequently used field-directed treatments (for multiple lesions in a continuous area). Over 600 patients in four different hospitals (Maastricht UMC+, Zuyderland (Heerlen), VieCuri (Venlo and Venray) en Catharina (Eindhoven)participated in the study. Patients were randomly assigned to one of the four treatments. The main result of our study was that we found that after 12 months of follow-up, 5% fluorouracil cream was the most effective treatment in the treatment of patients with multiple actinic keratosis lesions. Moreover, patient satisfaction and increase in health-related quality of life were highest in the 5-fluorouracil group.
ASCO, Author Interviews, Cancer Research, NEJM, Prostate Cancer / 25.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47619" align="alignleft" width="180"]Prof. Karim Fizazi, MD, PhD Head of the Department of Cancer Medicine Institute Gustave Roussy Prof. Fizazi[/caption] Prof. Karim Fizazi, MD, PhD Head of the Department of Cancer Medicine Institute Gustave Roussy MedicalResearch.com: What is the background for this study? How does darolutamide differ from other medications for prostate cancer? Response: Despite recent treatment advances, there is still significant unmet need for new therapeutic options for men with non-metastatic castration-resistant prostate cancer (nmCRPC). In laymen’s terms, nmCRPC is cancer that has not spread beyond the prostate region; PSA levels are elevated, despite treatment with hormone therapy, and men with nmCRPC generally feel well and do not have symptoms. The unmet medical need is for treatments that achieve disease control and delay the spread of the cancer without impacting their daily lives or increasing the burden of disease with treatment side effects. While the current treatments in this space are effective in delaying onset of metastases, the side effects can be unpleasant and disruptive to men’s lives; particularly cognitive issues, seizures, impact on balance which may lead to falls and bone fractures, rash and hypertension. Furthermore, new treatment options that have limited interactions with medications typically used in this patient population are also important. 
Author Interviews, Breast Cancer, Brigham & Women's - Harvard, Chemotherapy, NEJM / 24.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47551" align="alignleft" width="135"]Aditya Bardia, MBBS, MPH Director, Precision Medicine, Center for Breast Cancer, Attending Physician, Massachusetts General Hospital Cancer Center Harvard Medical School, Boston, MA 02114 Dr. Bardia[/caption] Aditya Bardia, MBBS, MPH Director, Precision Medicine, Center for Breast Cancer, Attending Physician Massachusetts General Hospital Cancer Center Harvard Medical School Boston, MA 02114 MedicalResearch.com: What is the background for this study? Response: Metastatic triple negative breast cancer is associated with aggressive tumor biology, and tends to affect younger patients and African Amerians. The response rate with standard chemotherapy regimens in patients with pre-treated metastatic TNBC ranges from 10-15%, and median progression-free survival ranges from 3-4 months. The median survival of metastatic TNBC is around 12 months and has not changed in the past 20 years. Thus, treatment of metastatic triple negative breast cancer represents an unmet clinical need.  
Author Interviews, Dermatology, MRI, NEJM / 06.02.2019

MedicalResearch.com Interview with:

[caption id="attachment_47332" align="alignleft" width="200"]Dr. Martina Callaghan PhD Head of Physics & Senior Lecturer Wellcome Centre for Human Neuroimaging Institute of Neurology University College London London   Dr. Callaghan[/caption]

Dr. Martina Callaghan PhD Head of Physics & Senior Lecturer Wellcome Centre for Human Neuroimaging Institute of Neurology University College London London

MedicalResearch.com:  What is the background for this study?  What are the main findings?

Response: As mirrors the situation in the general population, we found that an increasing number of volunteers who were seeking to enter cognitive neuroscience studies at our Centre had tattoos. However, the magnetic fields used in magnetic resonance imaging (MRI) pose a potential safety risk for people with tattoos. A number of case reports have described such incidents.  However, as these describe isolated cases retrospectively, there was not enough information to objectively assess the risk of tattoo-related adverse reactions for persons having an MRI scan.  Therefore, in 2011, we decided to embark upon this first prospective study to quantitatively assess this risk.

Author Interviews, Cancer Research, Esophageal, NEJM, Surgical Research / 11.01.2019

MedicalResearch.com Interview with: [caption id="attachment_46825" align="alignleft" width="130"]Guillaume Piessen, MD, PhD University Hospital Centre Lille, France Prof. Piessen[/caption] Guillaume Piessen, MD, PhD University Hospital Centre Lille, Franc MedicalResearch.com: What is the background for this study? Response: Patients requiring surgery for esophageal cancer fare better after undergoing a hybrid minimally invasive esophagectomy (HMIE) with a combined laparoscopy+thoracotomy procedure compared to an open esophagectomy (OE), according to results of the MIRO trial published in the last issue of the New England Journal Of Medicine (link article). This French prospective multi-center randomized controlled study was funded by the French National Cancer Institute (Grant n° 1907). The study was conducted by Pr Mariette who sadely passed away in 2017 and Pr Piessen (Department of Digestive and Oncological Surgery, CHU Lille), under the hauspice of FRENCH (Fédération de Recherche EN Chirurgie) and FREGAT (French Eso-Gastric Tumors) working group (https://www.fregat-database.org/fr/). Postoperative morbidity, especially pulmonary complications, affects more than half of patients after open esophagectomy for esophageal cancer. Hybrid minimally invasive esophagectomy (HMIE) combines a laparoscopic abdominal phase with an open thoracotomy, which may have specific advantages including lower rate of pulmonary complications, without laparoscopic tumor dissection limiting potential tumor spillage and easier reproducibility of the technique [12]. Postoperative morbidity, especially pulmonary complications, affects more than half of patients after open esophagectomy for esophageal cancer. Hybrid minimally invasive esophagectomy (HMIE) combines a laparoscopic abdominal phase with an open thoracotomy, which may have specific advantages including lower rate of pulmonary complications, without laparoscopic tumor dissection limiting potential tumor spillage and easier reproducibility of the technique [12].
Author Interviews, NEJM, Pediatrics, Smoking, Tobacco, Tobacco Research, University of Michigan / 30.12.2018

MedicalResearch.com Interview with: [caption id="attachment_46749" align="alignleft" width="159"]Richard Miech Ph.D Professor Principal Investigator, Monitoring the Future Institute for Social Research University of Michigan Dr. Miech[/caption] Richard Miech Ph.D Professor Principal Investigator, Monitoring the Future Institute for Social Research University of Michigan MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Every year Monitoring the Future conducts a survey to examine trends in adolescent substance use.  We draw a random sample of schools from a list of all schools in the United States and conduct our survey in ~400 schools.  Our survey is representative of U.S. 8th, 10th, and 12th grade students.  In other words, our results are what you would find if you surveyed every single 8th, 10th, and 12th graders in the United States, within the bounds of a small sampling error of a few percentage points. An increase in vaping is the big news for 2018.  In 10th and 12th grade the increase in nicotine vaping was the largest we've ever seen for any substance in the past 43 years.  As a result of this increase in nicotine vaping, overall use of nicotine increased as well, which suggests that vaping is drawing youth into nicotine use.  We also saw a significant increase in marijuana vaping.
Author Interviews, Cancer Research, NEJM, Pancreatic / 21.12.2018

MedicalResearch.com Interview with: [caption id="attachment_46620" align="alignleft" width="168"]Pr Thierry Conroy | Director Prof. Conroy[/caption] Prof. Thierry Conroy MD, Director Department of Medical Oncology Institut de Cancérologie de Lorraine Vandoeuvre-lès-Nancy CEDEX MedicalResearch.com: What is the background for this study? Response:  Surgery of pancreatic cancer offers the only chance of cure. Despite the low response rate (5% - 9%) of gemcitabine in metastatic disease, a 6-month regimen of adjuvant therapy with gemcitabine increases 5-year survival from 10% to 20% and is recognized as standard of care. However, recurrence rate remain high despite adjuvant treatment with 69-75% of patients relapsing within 2 years. -       The combination of bolus and continuous infusion Fluorouracil, Folinic Acid, Irinotecan and Oxaliplatin (Folfirinox) was shown to increase response rate (31.6% versus 9.4%) in metastatic disease as compared to Gemcitabine and increase survival (11.1 versus 6.8 months). -       Deletion of bolus Fluorouracil in the Folfirinox regimen (mFOLFIRINOX) decreased toxicity and do not reduce efficacy in advanced disease. -       We performed a randomized trial in patients with good performance status, ECOG 0-1 CA 19.9 ≤ 180 U/L and no cardiac contraindication to fluorouracil.