Author Interviews, End of Life Care, Health Care Systems, JAMA / 08.04.2019

MedicalResearch.com Interview with: Cindy L. Cain, PhD Assistant Professor Department of Sociology University of Alabama at Birmingham Birmingham, AL 35233   MedicalResearch.com: What is the background for this study? What are the main findings? Response: The End of Life Option Act permits terminally ill Californians to request a prescription for medications that would hasten death, providing they meet all requirements of the law and follow the steps outlined by their health care provider. However, the law also allows health care providers and organizations to opt out of participating. Until now, we did not know how common it was for entire health care organizations to opt out. In this study, we found that 61% of the surveyed hospitals prohibited physician participation in the End of Life Option Act. Thirty-nine percent of hospitals did allow participation in the law; these participating hospitals were less likely to be religiously affiliated and more likely to be nonprofit. (more…)
ADHD, Author Interviews, JAMA, OBGYNE, Pediatrics, Pharmacology / 08.04.2019

MedicalResearch.com Interview with: Dr. Angela Lupattelli, PhD School of Pharmacy University of Oslo MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Between 1-4% of pregnant women take at least once a benzodiazepine and/or a z-hypnotic medication during the course of gestation. These medications are generally used intermittently in pregnancy, mainly for treatment of anxiety disorders and sleeping problems, which are not uncommon conditions among pregnant women. However, data regarding the safety of benzodiazepine and/or a z-hypnotic in pregnancy on child longer-term development are sparse. For instance, studies on child motor skills are only available up to toddler age, and little is known in relation to other child developmental domains. So, there is an urgent need to better understand whether prenatal use of benzodiazepine and/or a z-hypnotic medication may pose detrimental longer-term child risks. (more…)
Author Interviews, JAMA, Kidney Disease / 08.04.2019

MedicalResearch.com Interview with: Matthew T James MD, PhD Assistant Professor University of Calgary  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The Acute Kidney Disease and Disorders (AKD) criteria from the KDIGO Acute Kidney Injury guidelines identified many patients who do not meet existing criteria for Chronic Kidney Disease or Acute Kidney Injury (AKI), and the majority of AKD events occured in the community rather than hospital setting. This study characterized the frequency and outcome for patients with AKD (without  AKI) as well as AKD with CKD from among over 1.1 million adults  residing in Alberta Canada who received  kidney function testing and were followed for up to 8 years. (more…)
Author Interviews, Cancer Research, Genetic Research / 08.04.2019

MedicalResearch.com Interview with: Eunhee Yi, Ph.D. Postdoctoral Associate The Jackson Laboratory MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Recurrence after therapy for glioblastoma (GBM) is unavoidable. There are substantial differences among the cells of GBM tumors in the abundance and types of genetic materials. This heterogeneity is a major driver of therapy failure and disease progression. We previously reported that extrachromosomal DNA (ecDNA) elements, which reside outside the linear genome and represent a mechanism to amplify and activate oncogenes, is a potential cause of the increasing genetic diversity in GBM. Our current study is focused on the development of a novel cytogenetic tool to visualize ecDNA to visualize the behavior of these elements in live cells. We have leveraged the unique properties of ecDNA to develop a CRISPR-based “ecDNA tracing toolbox (EDTB)”.  (more…)
AACR, Author Interviews, Breast Cancer, Cancer Research, Surgical Research / 08.04.2019

MedicalResearch.com Interview with: Sharon S. Lum, MD, FACS, Professor Department of Surgery-Division of Surgical Oncology Medical Director of the Breast Health Center Loma Linda University Health Loma Linda University School of Medicine  MedicalResearch.com: What is the background for this study?   Response: Anecdotally, we observed that many patients with advanced HER2+ breast cancer have had tremendous responses to the new targeted therapies and the oncologists were referring them back to surgeons for consideration of local regional therapy. While traditionally surgeons have avoided operating on metastatic breast cancer patients due to the patient’s likelihood of dying from their metastatic disease, these HER2+ patients seemed to be doing so well that surgery might make sense. In our surgical oncology clinic, we seemed to be operating more on these patients. Since these patients seemed to be living longer, they might survive long enough for their primary tumor to become a problem for them. However, we did not have any data to support doing surgery in these cases. Prior studies have demonstrated mixed results regarding the survival benefit from surgery for stage IV breast cancer patients, but these were completed prior to routine use of anti-HER targeted therapies, so we wanted to further examine the role of surgery in HER2+ stage IV breast cancer patients. (more…)
Addiction, Author Interviews, Mental Health Research, Occupational Health, Social Issues / 08.04.2019

MedicalResearch.com Interview with: Hefei Wen, PhD Assistant Professor, Department of Health Management & Policy University of Kentucky College of Public Health MedicalResearch.com: What is the background for this study? Response: Work requirements condition Medicaid eligibility on completing a specified number of hours of employment, work search, job training, or community service. Little is known about how behavioral health and other chronic health conditions intersect with employment status among Medicaid enrollees who may be subject to work requirements. (more…)
Author Interviews, Diabetes, Geriatrics, Stroke / 06.04.2019

MedicalResearch.com Interview with: Philippe Girard, MD, Gérontopôle de Toulouse, CHU Toulouse Toulouse, France MedicalResearch.com: What is the background for this study? Response: The idea for this study came about in 2016 when a systematic review assessing acetaminophen’s adverse event (AEs) profile came out with results suggesting increased mortality and morbidity (Paracetamol: not as safe as we thought? A systematic literature review of observational studies, PMID: 25732175). Pr Yves Rolland had collected data from his IQUARE study (Improving the Quality of Care of Long-Stay Nursing Home Residents in France, PMID: 26782872) including all prescriptions from over 6000 nursing home residents and all their medical history over an 18 month follow-up period. We thought it would be a good idea to assess the safety profile of acetaminophen on this geriatric population.  (more…)
Author Interviews, OBGYNE / 06.04.2019

MedicalResearch.com Interview with: Sarah Baum, MPH investigator at the Texas Policy Evaluation Project Associate at Ibis Reproductive Health MedicalResearch.com: What is the background for this study?   Response: Before 2013, use of medication abortion in Texas mirrored national trends, which have steadily increased since the approval of mifepristone--one of the two medications used for medication abortion--in 2000. However, House Bill 2 (HB 2), which was implemented on November 1, 2013, imposed restrictions on medication abortion and required providers to follow the outdated mifepristone label. HB 2 reduced the gestational age limit to 49 days and generally required four visits. On March 29, 2016, the US Food and Drug Administration (FDA) approved a revised label for Mifeprex® (mifepristone 200 mg) that reflected evidence-based practice, which essentially nullified the medication abortion restrictions in HB 2. The label change brought medication abortion prescribing guidelines in line with evidence-based practice, reducing the number of required in-person visits from four to two and extending the period when patients can take the pill from seven weeks of pregnancy to 10 weeks. (more…)
Author Interviews, ENT, JAMA, Pain Research, Pediatrics, Surgical Research / 05.04.2019

MedicalResearch.com Interview with: Gillian R. Diercks, MD, MPH Instructor in Otolaryngology, Harvard Medical School Department of Otolaryngology Massachusetts Eye and Ear Infirmary Boston, Massachusetts  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Pediatric tonsillectomy is a commonly performed procedure, representing the second most common ambulatory surgery performed on children in the United States, with over half a million children undergoing the surgery annually.  A major concern for surgeons, patients, and their families is the issue of postoperative pain control as pain can last up to 10-14 days after surgery, be quite severe, and result in readmission to the hospital or ED visits for medications and dehydration. In young children and children with sleep apnea we cannot safely administer narcotic pain medications at home.  This leaves limited options for pain control, including acetaminophen and ibuprofen.  However, there are concerns that ibuprofen could potentially increase bleeding risk after surgery because of its effects on platelet function in the blood.  At baseline, the risk of postoperative hemorrhage within the first two weeks after tonsillectomy is around 4.5%, with about 1-1.5% of children requiring a return to the operating room to control severe bleeding.  Our study set out to show that the risk of severe postoperative bleeding when ibuprofen is given for 9 days after tonsillectomy was not increased compared with the bleeding risk when acetaminophen was administered instead. Our study could not conclude that the risk of bleeding is no different when ibuprofen is used, and was suggestive that the bleeding risk may actually be higher. (more…)
Author Interviews, Kidney Disease / 05.04.2019

MedicalResearch.com Interview with: Rudolf Lucas, PhD Professor Pharmacology and Toxicology Vascular Biology Center, Division of Pulmonary Medicine Michael P. Madaio, MD Sydenstricker Professor and Chairman Department of Medicine Medical College of Georgia Augusta University Augusta, Georgia 30912, USA.   MedicalResearch.com: What is the background for this study? Response: The pro-inflammatory cytokine tumor necrosis factor (TNF) is a crucial mediator of glomerulonephritis, but the cytokine is also important in defense to bacterial infections. As such, chronically inhibiting TNF, using soluble TNF receptor constructs or neutralizing anti-TNF antibodies can promote infection. In this study, we wanted to develop a novel therapeutic strategy to specifically inhibiting deleterious TNF signaling, while preserving the beneficial anti-bacterial actions of the cytokine. (more…)
Author Interviews, BMJ, Cancer Research, HPV, OBGYNE, Sexual Health, Vaccine Studies / 05.04.2019

MedicalResearch.com Interview with: Dr. Tim Palmer Honorary Senior Lecturer Department of Pathology University of Edinburgh Edinburgh, UK  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: High risk HPV infection is the obligate cause of between 70 and 90% of cervical cancers, depending upon the country. The development of vaccines against the commonest hr-HPV types has the potential to reduce the burden of cervical cancer, especially in low and middle income countries that cannot afford screening programmes. Cervical cancer affects predominantly women in their 30s and is a major public health issue even in countries with well-established screening programmes. Scotland has had a successful immunisation programme since 2008, and women immunised at age 12 to13 have been screened since 2015. We can therefore demonstrate the effect of hr-HPV immunisation on the pre-invasive stages of cervical cancer. (more…)
AACR, Author Interviews, Cancer Research, HPV, University of Michigan, Vaccine Studies / 05.04.2019

MedicalResearch.com Interview with: Diane Harper, M.D., M.P.H., M.S. Professor of Family Medicine and Obstetrics and Gynecology Senior Associate Director, Michigan Institute for Clinical and Health Research Physician Director for Community Outreach, Engagement and Health Disparities, Rogel Cancer Center Michigan Medicine  MedicalResearch.com: What is the background for this study? Response: There is no current cure for women with HPV infection that has progressed to CIN 2/3 disease. The only treatment is for the diseased cervix, and does not eliminate the risk of another CIN 2/3 from the HPV infection 15-20 years later. This vaccine is made from a live virus that has 3 genes inserted:  human cytokine IL-2, and modified forms of HPV 16 E6 and E7 proteins. When the vaccine is injected subcutaneously, the proteins for HPV 16/E6 and E7 and the cytokine LI-2 proteins are made. These proteins trigger the immune response.  This is very different form imiquimod which is topical and not specific for HPV. (more…)
Alcohol, Author Interviews, Genetic Research, Nature, University of Pennsylvania / 05.04.2019

MedicalResearch.com Interview with: Henry R. Kranzler, MD Professor of Psychiatry Perelman School of Medicine University of Pennsylvania MedicalResearch.com: What is the background for this study? What are the main findings? Response: Alcohol consumption and alcohol use disorder (AUD) are moderately heritable traits.  To date, genome-wide association studies (GWAS) have not examined these traits in the same sample, which limits an assessment of the extent to which genetic variation is unique to one or the other or shared. This GWAS examined a large sample (nearly 275,000 individuals) from the U.S. Veterans Affairs Million Veteran Program (MVP) for whom data on both alcohol consumption and alcohol use disorder diagnoses were available from an electronic health record.  We identified 18 genetic variants that were significantly associated with either alcohol consumption, AUD, or both. Five of the variants were associated with both traits, eight with consumption only, and five with alcohol use disorder only.  (more…)
Author Interviews, Heart Disease, Nutrition, Red Meat / 04.04.2019

MedicalResearch.com Interview with: Saeed Mastour Alshahrani, MPH, PhD School of Public Health, Loma Linda University, California, USA College of Applied Medical Sciences, King Khalid University Abha, Saudi Arabia  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: -The consumption of red and processed meat has been associated with risks of importance to public health including cardiovascular diseases and cancer. Several studies have found that red and processed meat intake was associated with an increased risk of mortality. However, levels of meat intake in those studies were relatively high. It remains of interest whether even relatively low intake levels of red and processed meat might be associated with greater mortality, compared to zero intake.  (more…)
Author Interviews, Gout, NIH, OBGYNE / 04.04.2019

MedicalResearch.com Interview with: Jack A. Yanovski, MD, PhD Senior Investigator Section on Growth and Obesity, DIR, NICHD National Institutes of Health Hatfield Clinical Research Center Bethesda, MD 20892‐1103 MedicalResearch.com: What is the background for this study? Response: Studies of both mouse models and people suggest that obesity induced inflammation may promote insulin resistance and progression to diabetes. Others have proposed that suppressing this chronic, low level inflammation may slow the onset of diabetes. Nod-like Receptor Family Pyrin Domain Containing 3 (NLRP3) has recently been shown to play a strong role in promoting the inflammatory state in obesity. Colchicine, traditionally used to suppress or prevent inflammation in gout and other disorders is believed to inhibit formation of the NLRP3 inflammasome. Our group hypothesized that colchicine would improve obesity associated inflammation in adults with metabolic syndrome who had not yet developed type 2 diabetes. (more…)
Author Interviews, Nutrition, Social Issues, Sugar / 03.04.2019

MedicalResearch.com Interview with: Professor Sofia B. Villas‐Boas Ph.D and Scott Kaplan, Ph.D. Candidate Department of Agricultural & Resource Economics, University of California, Berkeley, CA 94720‐3310  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The background leading up to this study is the fact that  in 2014, the city of Berkeley passed the nation’s first sugar-sweetened beverage tax, also called soda tax, through a 75% YES public vote. Using beverage sales data from U. C Berkeley campus retailers, we find that sales of soda fell relative to non-SSB beverages by 10-20% after the election outcome and before the tax was ever passed on to consumers. We know this to be the case because the campus only passed through the higher prices to consumers in middle of 2016. This effect is also found when we look at beverage sales in retail outlets near U C Berkeley. There, quantity dropped after the Yes election outcome relative to quantity changes in counterfactual stores (in retailers near other U C campuses where the tax was not passed and with comparable patterns of sales to those in the city of Berkeley at baseline). (more…)
Author Interviews, Diabetes, Genetic Research, JAMA, Mental Health Research, Schizophrenia / 03.04.2019

MedicalResearch.com Interview with: Prof Sabine Bahn MD PhD MRCPsych FRSB Cambridge Centre for Neuropsychiatric Research Jakub Tomasik, PhD Department of Chemical Engineering and Biotechnology University of Cambridge   MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Schizophrenia patients are at increased risk of impaired glucose metabolism, yet the comorbidity between the two conditions cannot be fully explained by known risk factors such as obesity, smoking, stress or antipsychotic medication. Previous family and genome-wide studies have suggested that the co-occurrence between schizophrenia and impaired glucose metabolism might be due to shared genetic factors, as exemplified by increased risk of diabetes in first-degree relatives of schizophrenia patients, but the biological mechanisms underlying this association remain unknown. We examined the association between insulin resistance, schizophrenia polygenic risk and response to treatment in 58 drug-naive schizophrenia patients and 58 matched healthy individuals while controlling for a range of demographic (age, gender, body mass index), lifestyle (smoking, alcohol and cannabis use) and clinical (psychopathology scores, treatment drug) factors. We found that insulin resistance, a key feature contributing to the development of type 2 diabetes, significantly correlated with schizophrenia polygenic risk score in patients, with higher genetic risk of schizophrenia associated with increased insulin resistance. Furthermore, we found that patients with higher insulin resistance were more likely to switch medication during the first year of treatment, which implies lower clinical response.  (more…)
Allergies, Author Interviews, Dermatology, Heart Disease, JAMA / 03.04.2019

MedicalResearch.com Interview with: Amber Reck Atwater, M.D. Dermatology Residency Program Director Associate Professor of Dermatology Director, Contact Dermatitis Clinic Duke Dermatology  MedicalResearch.com: What is the background for this study? What are the main findings? Response: We completed an evaluation of our Duke Dermatology patients who underwent patch testing for possible allergy to their cardiac devices - pacemakers and defibrillators. From March 1, 2012 to September 15, 2017 we saw 11 patients with suspected allergy to their devices.  Concern for allergy, skin eruption, skin symptoms, and concern for infection were common. 73% of patients had erythema at their implant scars; pruritus and pain were also noted.  Six of our patients had relevant reactions, and the most common allergies were metals, silicone and rubber accelerators.  (more…)
Author Interviews, Cost of Health Care, General Medicine, Hospital Readmissions, JAMA, Race/Ethnic Diversity / 02.04.2019

MedicalResearch.com Interview with: Teryl K. Nuckols, MD Vice Chair, Clinical Research Director, Division of General Internal Medicine Cedars-Sinai Medical Center  MedicalResearch.com: What is the background for this study?   Response: Healthcare policymakers have long worried that value-based payment programs unfairly penalize hospitals treating many African-American patients, which could worsen health outcomes for this group. For example, policy experts have suspected that the Medicare Hospital Readmission Reduction Program unevenly punishes institutions caring for more vulnerable populations, including racial minorities. They've also feared that hospitals might be incentivized to not give patients the care they need to avoid readmissions. The study Investigators wanted to determine whether death rates following discharges increased among African-American and white patients 65 years and older after the Medicare Hospital Readmission Reduction Program started. (more…)
Allergies, Author Interviews, Immunotherapy, Lancet / 02.04.2019

MedicalResearch.com Interview with: Arnon Elizur MD Director, The Institute of Allergy, Immunology & Pediatric Pulmonology Yitzhak Shamir Medical Center Zerifin, Israel MedicalResearch.com: What is the background for this study?   Response: Tree nuts are among the most common food allergies and are a major cause of fatal and near fatal reactions. Patients with tree nut allergy are often allergic to several nuts, further increasing the risk of accidental exposures, dietary limitations, and the emotional burden and anxiety in affected patients. In the past 10 years, oral immunotherapy (OIT) has shown promise as a treatment modality for milk, egg and peanut allergies. However, limited data exists on oral immunotherapy for tree nuts and the treatment is complicated by the high prevalence of co-allergy to several nuts. (more…)
AHA Journals, Author Interviews, Heart Disease, Karolinski Institute / 02.04.2019

MedicalResearch.com Interview with: Gabriel Riva, Graduate Student Department of Medicine, Solna (MedS), Karolinka Institute MedicalResearch.com: What is the background for this study? What are the main findings? Response: During the last decade there has been a gradual adoption of compression-only CPR, as an option to conventional CPR with chest compressions and rescue breaths, in international CPR guidelines. The simplified technique is recommended for bystanders who are untrained and in "telephone assisted CPR". One of the reasons was the assumption that more people would actually do CPR with the simplified technique.  We could in this nationwide study running over 3 guideline periods demonstrate a 6-fold higher proportion of patients receiving compression-only CPR and a concomitant almost doubled rate of CPR before emergency medical services arrival over time. This very large increase in simplified CPR was surprising to us, especially considering there has never been any public campaigns promoting compression-only CPR in Sweden and training still include compressions and ventilations.  New first aid certified students will go through these updates to ensure the best possible assistance for emergencies. (more…)
Author Interviews, Clots - Coagulation, NEJM, Thromboembolism / 02.04.2019

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Diabetes, Genetic Research, Heart Disease, Nature / 02.04.2019

MedicalResearch.com Interview with: Eirini Marouli William Harvey Research Institute Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London MedicalResearch.com: What is the background for this study?   Response: Epidemiological studies suggest that shorter stature is associated with increased risk of coronary artery disease (CAD) or type 2 diabetes (T2D). It is not clear though whether these associations are causal or there are other factors mediating these effects. When randomized trials are inappropriate or impossible, we can use Mendelian Randomisation as a good alternative to study the causal relationship between a trait and a disease. Here, we examined over 800 places in the human genome known to be associated with adult height and evaluated how genetically predicted height can affect the risk of CAD or T2D. Furthermore, we evaluated the role of several risk factors including, cholesterol, triglycerides, blood pressure, body mass index, fat percentage, socio-economic parameters including education and income as well as lung function. Lung function was assessed by spirometry measures including FEV1: forced expiratory volume in 1 second, FVC: forced vital capacity. (more…)
Author Interviews, Heart Disease, JAMA, Lipids / 02.04.2019

MedicalResearch.com Interview with: Victor Wenze Zhong, Ph.D. Postdoctoral fellow Department of Preventive Medicine Feinberg School of Medicine Northwestern University Chicago, IL 60611  MedicalResearch.com: What is the background for this study? Response: Dietary cholesterol is a common nutrient in human diet. Eggs, specially egg yolks, are the single richest source of dietary cholesterol among all commonly consumed foods. The associations between dietary cholesterol consumption and cardiovascular disease and mortality remain controversial despite decades of research. Eating less than 300 mg of dietary cholesterol per day was the guideline recommendation before 2015. However, the most recent 2015-2020 Dietary Guidelines for Americans no longer include a daily consumption limit for dietary cholesterol and recommend weekly egg consumption as part of the healthy US-style eating pattern. Whether these recommendations are appropriate have been intensely debated. (more…)
Author Interviews, JAMA, Social Issues / 01.04.2019

MedicalResearch.com Interview with: Rajan Sonik, PhD JD MPH Research Scientist Tucker-Seeley Research Lab Leonard Davis School of Gerontology Postdoctoral Research Fellow Leonard D. Schaeffer Center for Health Policy and Economics Leonard Davis School of Gerontology University of Southern California Los Angeles, CA 90089-3333 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Not everyone who is eligible for public benefits like Supplemental Security Income (SSI) tries to receive them. One distinguishing factor is that those who apply for benefits disproportionately experience shocks (e.g., divorce, job loss, health problems) and sharp increases in material hardships (e.g., food insecurity, housing insecurity) shortly before applying. Typically, these increases in hardships are then partially—but not fully—alleviated by receipt of the public benefits. Given strong associations between these hardships and poor health outcomes, we wanted to examine whether health status might fluctuate before and after the receipt of public benefits as well. We examined SSI in particular given its focus on individuals with disabilities, keeping in mind the particular health vulnerabilities experienced by this population. In line with patterns previously observed for material hardships, we found in a nationally representative sample that the health status of eventual SSI recipients worsened significantly in the period prior to program entry. After enrollment began, the decline in health status stopped but was not fully reversed. In the paper, we discuss why these findings were more likely to be driven by changes in material hardship levels rather than changes in disability status. (more…)
Author Interviews, Cancer Research, FDA, JAMA / 01.04.2019

MedicalResearch.com Interview with: Emerson Chen, MD Chief Fellow, Hematology-Oncology, PGY-6 Oregon Health & Science University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Many cancer drugs are approved annually giving the appearance of innovation; however, some drugs may have been approved because of a lower bar. Use of lesser endpoints like response rate (how tumor shrinks) and progression-free survival (how tumor has delayed growth) have been proposed to speed trials when compared against traditional endpoints like overall survival (how long patients might live). Using published trials that led to cancer drug approval from 2006 to 2017, we estimated how long it would take to get each of these three endpoints across all cancer drugs and indications to see how much time we could save by using these weaker but faster endpoints. We see that many trials using overall survival used less time than anticipated, and many trials using response rate or progression-free survival actually took quite a bit of time.  In part that is due to researchers needing to document the duration of the response. But, whatever the reason, the time to get each of the three endpoints is actually more similar than different, and we estimate that our current use of  these faster endpoints are saving us only 11 months compared to using only overall survival. (more…)
Author Interviews, Health Care Systems, Outcomes & Safety, University of Pennsylvania / 01.04.2019

MedicalResearch.com Interview with: Kira L. Ryskina  MD MS Assistant Professor Of Medicine Division of General Internal Medicine Perelman School of Medicine, University of Pennsylvania  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Post-acute care in skilled nursing facilities (SNF or sometimes called subacute rehab) is a very common discharge destination after a hospital stay. Patients discharged to these facilities represent more clinically complex and high-need patients than patients discharged home. We wanted to understand how soon after discharge from the hospital to a skilled nursing facility are patients seen by a physician. We found that first visits by a physician or advanced practitioner (a nurse practitioner or physician assistant) for initial medical assessment occurred within four days of SNF admission in 71.5 percent of the stays. However, there was considerable variation in days to first visit at the regional, facility, and patient levels. One in five initial physician visits occurred more than 4 days after admission to skilled nursing facilities.  In 10.4 percent of stays there was no physician or advanced practitioner visit. Much of the variability in visit timing had to do with SNF characteristics and geography compared to patient clinical or demographic characteristics. Patients who did not receive a physician visit had nearly double the rates of readmissions or deaths compared to patients who were seen.  (more…)
Author Interviews, Cancer Research, Infections, STD, Vaccine Studies / 01.04.2019

MedicalResearch.com Interview with: Lisa T. Wigfall, PhD, MCHES(R) Assistant Professor, Health and Kinesiology Texas A&M MedicalResearch.com: What is the background for this study? Response: Human papilloma virus (or HPV) is a very common sexually transmitted infection that can cause some types of cancer. These include anal, cervical, oral, penile, vaginal, and vulvar cancers. Some people such as people who are HIV-positive and men who have sex with men have a greater risk for developing HPV-associated cancers. The risk of developing anal cancer is significantly higher for men who have sex with men who are also HIV-positive. Our study included adults who were at risk for becoming HIV-positive, which included having unprotected anal sex. (more…)
Author Interviews, Biomarkers, Lancet, OBGYNE, Pediatrics / 01.04.2019

MedicalResearch.com Interview with: Catalin S. Buhimschi MD, MMS, MBA Professor of Obstetrics and Gynecology Division of Maternal Fetal Medicine Director of Obstetrics Department of Obstetrics and Gynecology Chicago, IL, 60612 MedicalResearch.com: What is the background for this study? What are the main findings? Response: In 2008, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal–Fetal Medicine Units Network published the results of a randomized controlled trial of magnesium sulfate for the prevention of cerebral palsy (CP). The results of this trial suggested that fetal exposure to magnesium sulfate before anticipated early preterm delivery did not reduce the combined risk of moderate to severe cerebral palsy or death, although the rate of cerebral palsy was reduced among survivors. As such, the search for a biomarker or a therapeutic solution to prevent CP had to continue. We are grateful to the NICHD for giving us access to the umbilical cord blood samples retrieved at the time of birth for the infants enrolled, who were also followed for 2 years postnatally. We discovered that fetus’s ability to switch-on haptoglobin (Hp) expression in response to inflammation was associated with reduction of intra-ventricular hemorrhage (IVH) and/or death, and cerebral palsy and/or death. Fetuses unable to mount such a response in-utero had an increased risk of adverse outcomes. (more…)