Dr. Cohen[/caption]
Gregory H. Cohen, MPhil, MSW
Statistical Analyst
Department of Epidemiology
School of Public Health
Boston University
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: We simulated a stepped care case-finding approach to the treatment of posttraumatic stress in New York City, in the aftermath of Hurricane Sandy.
Stepped care includes an initial triage screening step which identifies whether a presenting individual is in need of Cognitive Behavioral Therapy, or can be adequately treated at a lower level of care.
Our simulation suggests that a stepped care approach to treating symptoms of posttraumatic stress in the aftermath of a hurricane is superior to care as usual in terms of reach and treatment-effectiveness, while being cost-effective.
Dr. Scott Grosse[/caption]
Scott D. Grosse, PhD
National Center on Birth Defects and Developmental Disabilities
CDC
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The U.S. Institute of Medicine (IOM) in 2007 published estimates of the economic costs associated with preterm birth. That report is publicly available: https://www.ncbi.nlm.nih.gov/pubmed/20669423. The total societal cost over a lifetime of a single year’s cohort of infants born preterm was estimated as $26 billion in 2005 US dollars. The study in Pediatrics sought to provide more current estimates of one component of those costs: medical care between birth and 12 months and to answer two additional questions:
Dr. Piedimonte[/caption]
Giovanni Piedimonte, MD
Steven and Nancy Calabrese Endowed Chair for Excellence in Pediatric Care, Research, and Education
Professor & Chair of Pediatrics
Cleveland Clinic Lerner College of Medicine
Case Western Reserve University
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: This study proves that asthmatic children already have a hyperactive calcium channel that’s extremely sensitive to environmental triggers.
If these children contract a virus, such as RSV, the hyperactive channel causes more severe symptoms that may require care in a hospital setting.
When a child developed asthma or bronchitis in the past, doctors thought these conditions could only be triggered by environmental allergens. There was no explanation why two out of three children ages five and under who wheeze and cough – and still test negative for allergies.
We needed to explore the mechanisms of the calcium molecule and the epithelial cells, which seem to trigger these symptoms without an allergic reaction. If the molecule’s behavior is producing the cough, we just need to figure out how to control the molecule to properly deactivate the cough mechanism in the asthmatic child
Prof. Anderson[/caption]
Craig Anderson | MD PhD FRACP
Executive Director
Professor of Neurology and Epidemiology, Faculty of Medicine, UNSW Sydney
Neurologist, Neurology Department, Royal Prince Alfred Hospital
The George Institute for Global Health at Peking University Health Science Center
Haidian District | Beijing, 100088 P.R. China
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: There is much controversy over the benefits of a lower dose of intravenous alteplase, particularly in Asia, after the Japanese regulatory authorities approved a dose of 0.6 mg/kg 10 years ago compared to the US FDA and other regulatory authorities approving 0.9 mg/kg 20 years ago. The investigator inititiated and conducted ENCHANTED trial aimed to determine the effectiveness and safety of these two doses in an international multicentre pragmatic open design.
The main results did not confirm the low-dose to be statistically ‘non-inferior’ partly due to the primary outcome measure chosen and partly due to the statistical approach, but it did confirm that the lower dose was safer with less risk of the major complication of this treatment, that of major bleeding in the brain. However, it would appear that this safety effect was offset by some reduce efficacy in terms of functional recovery.
The aim of this secondary analysis of the trial data was to examine in more detail the differences between low and standard dose alteplase according to the participants’ age, ethnicity (Asian vs non-Asian) and severity of neurological deficit at the time of treatment. We did this because the popular belief is that a lower dose might be preferred in older people, and Asians, because of the potential for more likelihood of bleeding, and preferentially to use the standard dose in those with more severe strokes potentially due to greater ‘clot burden’ from a blocked artery to the brain.
The results showed that the main findings on the outcome of surviving free of disability were the same according to age, ethnicity and stroke severity – that is, there was no preferential dose in any of these groups. Similarly, the safety benefit of low dose alteplase on brain haemorrhage, did not clearly translate into clinical disability outcomes in any of the patient groups studied.
Dr. Bass[/caption]
Anne R. Bass, MD
Associate Professor of Clinical Medicine
Weill Cornell Medical College
Rheumatology Fellowship Program Director
Hospital for Special Surgery
New York, NY 10021
MedicalResearch.com: What is the background for this study?
Response: Blood thinners are used after orthopedic surgery to prevent blood clots from forming in the legs and traveling to the lungs. They are also used in patients with certain heart diseases to prevent strokes. Blood thinners, like warfarin, are effective but can be associated with serious bleeding complications, especially if the wrong dose is given. Genetic testing can help doctors predict the right warfarin dose to use in an individual patient.
In this trial, ≈1600 elderly patients undergoing hip or knee replacement were randomly assigned to receive warfarin dosing based on genetics plus clinical factors (like height, weight and gender), or based on clinical factors alone. The specific genes tested wereVKORC1, CYP2C9, and CYP4F2 which influence warfarin metabolism and the body’s ability to produce clotting factors.
Dr. Basson[/caption]
Marc D. Basson, MD, PhD, MBA
Professor of Surgery, Pathology, and Biomedical Science
Senior Associate Dean for Medicine and Research
University of North Dakota School of Medicine & Health Sciences
Grand Forks, ND 58202
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: I and other surgeons have previously had the experience of caring for patients with appendicitis who had recently undergone colonoscopy, and wondered if there might be a connection. However, colonoscopy and appendicitis are both common events, and so it would be difficult to tell whether they are linked or just coincidences from scattered occurrences.
After obtaining appropriate regulatory approvals, we identified almost 400,000 veterans from the US Department of Veterans Affairs database who had undergone screening colonoscopy and compared their rates of appendectomy and acute appendicitis in the week following colonoscopy to rates of appendectomy and appendicitis over each of the following 51 weeks. We asked the question in several different ways and verified our results by examining surgical and pathology reports. Depending on how the question was asked and appendicitis or appendectomy defined, rates of appendectomy and appendicitis were clearly 4-9 times higher in the first week after diagnostic colonoscopy. This wasn’t true when we asked whether appendectomy was more common after several other procedures that also required sedation and contact with the medical system.
Dr. Stewart[/caption]
Andrew F. Stewart MD
Irene and Dr. Arthur M. Fishberg Professor of Medicine
Director, Diabetes, Obesity and Metabolism Institute
Institute at the Icahn School of Medicine at Mount Sinai
New York, NY 10029
MedicalResearch.com: What is the background for this study?
Response: Diabetes results ultimately from an inadequate number of insulin-producing “beta” cell in the pancreas. Ideally, these would regenerate when they are lost or damaged, but unfortunately inducing them to regenerate or proliferate has proven impossible until recently.
In 2015 and others we identified the first class of drugs – the harmine analogues - that are able to induce human beta cells to proliferate. In this study, we wanted to identify additional pathways that can lead to human beta cell proliferation at higher rates than we had been able to induce with harmine. For this we turned to a rare type of benign (i.e., not malignant, not cancer) tumor of the beta cells in the pancreas called “insulinomas”. These tiny tumors overproduce insulin and cause hypoglycemia (low blood glucose) which in turn causes seizures, loss of consciousness and confusion. Once they are discovered, then can easily be removed via laparoscopic surgery, and the person is cured. Since they are so rare, and since they are benign and easily cured, insulinomas have not been included in large genome sequencing studies of patients wit cancer. However, we reasoned that they must hold the genomic recipe or wiring diagram for inducing human beta cells to replicate, so we perfumed next-generation DNA and RNA sequencing on a large series (38) of insulinomas.
MedicalResearch.com Interview with:
Tony Wing Lai Mak , MBChB, MBA, FRCPath, FRCPA, FHKCPath, FHKAM(Path
Hospital Authority Toxicology Reference Laboratory
Princess Margaret Hospital, Hong Kong
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Proprietary Chinese medicines (pCMs) and health products are generally believed to be natural and safe. However, the safety of pCMs and health products has been compromised by the illicit practice of adulteration with undeclared drugs. Such adulteration can have serious and even fatal consequences. Previous reports of pCM and health product adulteration were mainly routine surveillance data or case reports/series with a small number of affected patients.
The present study in Hong Kong, to our knowledge, is the largest case series that reports an overview of the use of various adulterated Proprietary Chinese medicine and health products and the resulting adverse effects. From 2005 to 2015, we have identified 404 cases involving the use of 487 adulterated pCMs or health products with a total of 1234 adulterants detected. The adulterants consisted of approved drugs, banned drugs, drug analogues and animal thyroid tissue.
The six most common categories of adulterants detected were nonsteroidal ant-inflammatory drugs (18%), anorectics (15%), corticosteroids (14%), diuretics and laxatives (11%), oral antidiabetic agents (10%), and erectile dysfunction drugs (6%). Sibutramine, an anorectic that has been withdrawn from the market owing to its association with increased cardiovascular events and strokes, was the most common adulterant identified. A significant proportion of patients (65.1%) had adverse effects that were attributable to these illicit products, including 14 severe and two fatal cases. These illicit Proprietary Chinese medicine and health products pose severe health hazards to the public.
Dr. Bayer[/caption]
Monika Bayer PhD.
Institute of Sports Medicine Copenhagen
Bispebjerg Hospital
Denmark
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Acute muscle strain injuries display a major clinical problem with a high incidence rate for both professional and amateur athletes and are associated with substantial risk for recurrence. Common clinical practice advices to follow the RICE (Rest – Ice – Compression – Elevation) principle after strain injuries but it has not been investigated whether patients really benefit from a period of rest or whether an early of loading following the injury would improve recovery.
In this study, amateur athletes were divided into two groups: one group started rehabilitation two days after the trauma, the other group waited for one week and began rehabilitation after nine days. All athletes had a clear structural defect of the muscle-connective tissue unit following explosive movements. We found that protraction of rehabilitation onset caused a three-week delay in pain-free recovery. In all athletes included, only one suffered from a re-injury.
Dr. Jolliffe[/caption]
David Jolliffe, PhD
Centre for Primary Care and Public Health
Blizard Institute
Barts and the London School of Medicine and Dentistry
London
MedicalResearch.com: What is the background for this study?
Response: Asthma affects more than 300 million people worldwide and is estimated to cause almost 400,000 deaths annually. Asthma deaths arise primarily during episodes of acute worsening of symptoms, known as attacks or ‘exacerbations’, which are commonly triggered by viral upper respiratory infections. Vitamin D is thought to protect against such attacks by boosting immune responses to respiratory viruses and dampening down harmful airway inflammation.
Several clinical trials have tested whether vitamin D supplementation might protect against asthma attacks, but individually their results are inconclusive. In the current study, we pooled raw data from 955 asthma patients who took part in 7 separate trials, which allowed us to answer two questions:
1, Does vitamin D protects against asthma attacks overall, when data from all trials are pooled?
2, Do people who have lower vitamin D levels to start with particularly benefit from supplementation?
Mr. Shahbazian[/caption]
Mr. Jonathan Shahbazian, MPH
Johns Hopkins Bloomberg School of Public Health
Baltimore
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Our study was designed to investigate risk factors for drug resistance in MRSA found in dust on surfaces in the home. We undertook this investigation because we were concerned first that people living in the home could pick up MRSA from these surfaces, and second, that if they picked up drug-resistant MRSA, it would be more difficult to treat them.
Our main finding was that use of antibiotics by either people or pets in the home, as well as use of biocidal cleaning products, was associated with multidrug resistance (MDR) in home MRSA. This study is the first to report that use clindamycin in either humans or domestic animals was not associated with risk of MDR in the home environment.
We also found that mupirocin treatment was associated with a slight increase in mupirocin resistance in the household environment, which could complicate decolonization efforts that rely on use of nasal mupirocin ointment. We found that 100% of our MRSA isolates from rural homes were MDR, suggesting living in a rural household may be a risk factor. We also found the presence of domestic pets was associated with MDR MRSA in the home environment while the presence of unwanted pests, such as mice or cockroaches, was associated with non-MDR MRSA strains at the three-month visit.
Coffee
Dr. Capp[/caption]
Roberta Capp MD
Assistant Professor
Director for Care Transitions in the Department of Emergency Medicine
University of Colorado School of Medicine
Medical Director of Colorado Access Medicaid
Aurora Colorado
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Medicaid clients are at highest risk for utilizing the hospital system due to barriers in accessing outpatient services and social determinants.
We have found that providing care management services improves primary care utilization, which leads to better chronic disease management and reductions in emergency department use and hospital admissions.
Dr. Nagrath[/caption]
Dr. Sunitha Nagrath, PhD
Associate Professor, Chemical Engineering
University of Michigan
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Lung cancer is leading cause of cancer-related mortality, and detecting it in earlier stages is crucial to improving outcomes for patients. The motivation for this study lies in understanding the phenotypic and genetic make-up of lung cancer during its early stages, using a blood sample (blood biopsy). We have done this by employing a microfluidic device to capture cancer cells circulating in the blood that is obtained from the peripheral veins and the pulmonary vein (a vein next to the tumor itself) from patients with early stage lung cancers. The idea behind using blood from the pulmonary vein was to obtain a richer yield of these circulating tumor cells, which are rare in the blood.
Through this study, we found that the pulmonary vein does yield a much higher quantity of circulating tumor cells, and also often harbors these cells in large clusters. We further went on to study the significance of these clusters, and found that these clusters indicated aggressive traits such as resistance to treatment, and could also potentially suggest poorer patient outcomes at long term.
Dr. Nam[/caption]
Robert Nam, MD, FRCSC
Ajmera Family Chair in Urologic Oncology
Professor of Surgery
University of Toronto
Head, Genitourinary Cancer Site
Odette Cancer Centre
Sunnybrook Health Sciences Centre
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The well known potentially lethal complications of anti-thrombotic medications of cerebral and gastrointestinal bleeding complications are well known. However, more common bleeding related complications are not well described . In particular, gross hematuria is a well known complication of these medications but its frequency and severity is unknown. We sought to characterize this association among a large population-based cohort consisting of over 2.5 million patients from the Province of Ontario, Canada, using hematuria-related complications was endpoints. These were defined as undergoing invasive urologic procedures, hospital admissions or emergency visits for gross hematuria.
Dr. Berglund[/caption]
Staffan Berglund MD PhD
Umeå University
Sweden
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Iron deficiency has been associated with impaired neurodevelopment and iron supplementation is recommended to those at risk. While it is well known that very low birth weight infants are at risk of iron deficiency, less has been known regarding the large subgroup of children born with only marginally low birth weight (2000-2500g). In the present study, we previously showed that this relatively common group of otherwise healthy children is at risk of iron deficiency during infancy (Berglund Pediatrics 2010;126).
In the study published this week, we now also found that supplementation during the first six months of life had long term positive effects on their behavioral profile, with significant reduction of externalizing behavioral problems.
Dr. Beam[/caption]
Andrew L. Beam, PhD
Instructor in Biomedical Informatics
Department of Biomedical Informatics
Harvard Medical School
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: This study is one piece of a larger story regarding the use of 17-alpha-hydroxyprogesterone caproate (17P) to treat recurrent preterm birth. This drug was originally only available in a compounded form, but since receiving an orphan drug designation in 2011, a branded and manufactured form was marketed under the name "Makena". This branded form was then sold for a much higher price than the compounded version, but a study that provided concrete data on pricing and outcomes had not been done.
Tami H Skoff
Centers for Disease Control and Prevention
Atlanta, Georgia
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Infants are at greatest risk for severe pertussis (whooping cough) morbidity and mortality, especially during the first months of life before infant immunizations begin. CDC and the Advisory Committee on Immunization Practices (ACIP) currently recommend that women receive a dose of Tdap during the third trimester of each pregnancy. This recommendation has been in place since 2012. By getting Tdap, pregnant women pass critical short-term protection to their unborn babies. This helps protect babies until they are old enough to start getting their own whooping cough vaccines at 2 months of age.
The purpose of our study was to evaluate the effectiveness of maternal Tdap during pregnancy at preventing whooping cough in infants <2 months of age.
In our evaluation, Tdap administration during the third trimester of pregnancy prevented more than 3 in 4 (78%) infant cases. Additionally, Tdap vaccination during pregnancy was even more effective (90%) at preventing whooping cough serious enough that the baby had to get treatment in a hospital.
Dr. Osarogiagbon[/caption]
Raymond U. Osarogiagbon, MBBS, FACP
Translational Lung Cancer Research
Multidisciplinary Thoracic Oncology Program
Baptist Centers for Cancer Care
Memphis, TN
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Most long-term survivors of lung cancer are among the patients who were fortunate enough to be identified early enough to undergo curative-intent surgery. In the US, 60,000 individuals undergo curative-intent surgery for lung cancer every year. This number is likely to increase over the next few years as lung cancer screening becomes more widely adopted. Unfortunately, fewer than 50% of patients who undergo curative-intent surgery actually survive up to 5 years.
We show that the quality of surgery, especially the quality of pathologic nodal staging is a powerful driver of survival differences between groups of patients. In general, pathologic nodal staging (important as it is stratifying patients into risk groups so those at high risk can be offered additional treatments to increase the chances of cure while those at truly low risk can be left alone without exposure to cost and side-effects of additional treatments) is very poorly done. We show how the percentage of patients whose pathologic staging met sequentially more stringently-define thoroughness of staging metrics falls off sharply, while the survival sequentially increases.
Dr. Anjel Vahratian PhD MPH
Maternal and Child Health Epidemiologist
Branch Chief at the National Center For Health Statistics
Centers for Disease Control and Prevention
MedicalResearch.com: Why did you conduct this study?
Response: Our research focuses on the health of women as they age and transition from the childbearing period. During this time, women may be at increased risk for chronic health conditions such as diabetes and cardiovascular disease.
As insufficient sleep is a modifiable behavior that is associated with these chronic health conditions, we wanted to examine how sleep duration and quality varies by menopausal status.
Dr. Lapointe-Shaw[/caption]
Dr. Lauren Lapointe-Shaw, MD
Physician at University Health Network
Department of Medicine
University of Toronto
MedicalResearch.com: What is the background for this study?
Response: Readmissions after hospital discharge are common and costly. We would like to reduce these as much as possible. Early physician follow-up post hospital discharge is one possible strategy to reduce readmissions. To this end, incentives to outpatient physicians for early follow-up have been introduced in the U.S. and Canada. We studied the effect of such an incentive, introduced to Ontario, Canada, in 2006.
Prof. Vancheri[/caption]
Professor Carlo Vancheri
Professor of Respiratory Medicine,
University of Catania, Italy and Director of the Regional Referral Centre for Rare Lung Diseases and the Laboratory of Experimental Respiratory Medicine.
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The aim of Boehringer Ingelheim’s INJOURNEY trial was to investigate the safety profile of Ofev (nintedanib) in combination with pirfenidone in treating patients with idiopathic pulmonary fibrosis (IPF). Nintedanib and pirfenidone, the only two FDA-approved drugs for the treatment of IPF, are able to slow down the progression of the disease, reducing the forced vital capacity (FVC) decline of about 50%, but this is not a cure. The target for the future is to have even more effective treatments. In the meanwhile, it is necessary to optimize the use of the available drugs. The medical treatment of other pulmonary diseases such as COPD, asthma or pulmonary hypertension is already based on different combinations of drugs.
This 12-week, open-label, randomized study was designed to evaluate the safety, tolerability and pharmacokinetics of nintedanib with add-on pirfenidone, compared with nintedanib alone in patients with IPF. Change in FVC, the established efficacy endpoint in IPF trials, was evaluated as an exploratory endpoint.
The primary endpoint of the INJOURNEY trial was the percentage of patients with on-treatment gastrointestinal adverse events from baseline to week 12 of randomized treatment, and the results showed that the combination of nintedanib and add-on pirfenidone resulted in a manageable safety and tolerability profile, similar to the profile of each drug individually in the majority of patients. Results also indicated there may be a slower decline in FVC in patients treated with pirfenidone along with nintedanib compared with nintedanib alone, suggesting a potential benefit of the combination. However, further research will be necessary to fully evaluate the efficacy of the combination.
Dr. Keane[/caption]
Florence K Keane MD
Resident, Radiation Oncology
Harvard Radiation Oncology Program
Boston, Massachusetts
MedicalResearch.com: What is the background for this study?
Response: Checkpoint inhibitors (CPIs) have recently transformed the management of patients with metastatic lung cancer, demonstrating significant improvements in overall and progression-free survival in both the first-line setting in patients with increased expression of PD-L1 (≥50%) and in patients with previously treated NSCLC who have progressed on chemotherapy. CPIs are also moving into the treatment of patients with localized lung cancer, with the recently published PACIFIC trial demonstrating a significant improvement in progression-free survival in patients with inoperable stage III NSCLC treated with adjuvant durvalumab after definitive chemoradiotherapy.
However, CPIs are associated with unique toxicities as compared to cytotoxic chemotherapy, including pulmonary, endocrine, neurologic, gastrointestinal, and dermatologic adverse events, which may be fatal in some cases. The risk of autoimmune pneumonitis with checkpoint inhibitors is estimated to be on the order of 5%. Many patients with lung cancer will require radiotherapy for palliation of symptoms. Thoracic radiotherapy (TRT) is also a risk factor for pneumonitis, with a dose- and volume-dependent impact on risk. However, it is unknown whether treatment with CPIs and TRT is associated with increased risk of toxicity.