MedicalResearch.com Interview with:
Prof. Dr. med. Kristian Reich
DERMATOLOGIKUM HAMBURG
Hamburg
Medical Research: What is the background for this study? What are the main findings?
Prof. Reich: The Phase 2b X-PLORE study compared a new generation biologic therapy, guselkumab - an inhibitor of IL–23, with the anti–tumor necrosis factor (TNF)–alpha agent adalimumab (Humira®) and placebo in the treatment of moderate-to-severe plaque-type psoriasis. It showed that up to 86 percent of patients treated with guselkumab achieved a Physician’s Global Assessment (PGA) score of cleared psoriasis or minimal psoriasis at week 16, the study’s primary endpoint. Interestingly, levels of efficacy were higher for several guselkumab doses through week 16 when compared to adalimumab. Improvements with guselkumab continued through week 40 with every eight- or twelve-week maintenance treatment. (more…)
MedicalResearch.com Interview with:
Dr. F. Xavier Pi-Sunyer MDDivision of Endocrinology and Obesity Research Center
Columbia University, New York
Medical Research: What is the background for this study? What are the main findings?
Dr. Pi-Sunye: In a large randomized trial, the drug Liraglutide was compared to placebo in overweight and obese non-diabetic volunteers. Over 52 weeks, in combination with diet and increased physical activity, Liraglutide lowered body weight by 8.4 kg as compared to 2.8 kg in placebo. 63% vs 27% lost at least 5% of baseline weight, 33% vs 10% lost more than 10% of baseline weight.
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MedicalResearch.com Interview with:
Dr. Charles Pollack Jr., MA, MD, FACEP
Thomas Jefferson University
Clinical Professor of Emergency Medicine
Philadelphia, PA 19107
MedicalResearch: What is the background for this study? What are the main findings?Dr. Pollack:There are currently no approved specific reversal agents for non–vitamin K antagonist oral anticoagulants. Idarucizumab, an antibody fragment, was developed to specifically reverse the anticoagulant effects of the oral thrombin inhibitor, dabigatran.
RE-VERSE AD is an ongoing, global Phase III patient study initiated in 2014 to investigate idarucizumab in emergency settings in patients taking dabigatran. We undertook this prospective cohort study to determine the safety of 5 g of intravenous idarucizumab and its capacity to reverse the anticoagulant effects of dabigatran in patients who either presented with serious bleeding (group A) or required an urgent invasive procedure (group B) which could not be delayed by eight hours. We intentionally designed the study with very broad inclusion criteria to reflect the types of patients who would require urgent anticoagulant reversal in real-world emergency settings.
The primary end point was the maximum percentage reversal of the anticoagulant effect of dabigatran within 4 hours after the administration of idarucizumab, on the basis of the determination at a central laboratory of the dilute thrombin time or ecarin clotting time. We also diligently collected clinical outcomes as secondary outcomes, being conscious that these may vary considerably due to the heterogeneity of the patients we included in the study.
In our publication in the New England Journal of Medicine, we present the first results from the study, in an interim analysis of the data from the first 90 patients. The data showed that idarucizumab rapidly and completely reversed the anticoagulant effect of dabigatran in 88 to 98% of the patients who had had elevated clotting times at baseline. The reversal effect was evident within minutes. There were no safety concerns related to idarucizumab among the 90 patients involved in this study - including patients who were given idarucizumab on clinical grounds but were later found to have had normal results on clotting tests at baseline. This is consistent with the experience from the more than 200 volunteers who were administered idarucizumab in previous studies.
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MedicalResearch.com Interview with:
Jacob Hollenberg M.D., Ph.D.
Assistant Professor, Cardiologist
Head of Research, Centre for Resuscitation Science
Karolinska Institutet, Stockholm, Sweden
Editor’s note: Dr. Hollenberg and colleagues published two articles in the NEJM this week discussing CPR performed by bystanders in out-of-hospital cardiac arrests.MedicalResearch: What is the background for the first study?Dr. Hollenberg: There are 10,000 cases of cardiac arrest annually in Sweden. Cardiopulmonary Resuscitation (CPR) has been taught to almost a third of Sweden’s population of 9.7 million. In recent years the value of bystander CPR has been debated, largely due to a lack of a randomized trial demonstrating that bystander CPR is lifesaving.
In this study, which included all cases of emergency medical services (EMS) treated and bystander-witnessed out-of-hospital cardiac arrests recorded in the Swedish Cardiac Arrest Registry from January 1, 1990, through December 31, 2011, our primary aim was to assess whether CPR initiated before the arrival of EMS was associated with an increase in the 30-day survival rate.
MedicalResearch: What were the main findings?Dr. Hollenberg: Early CPR prior to arrival of an ambulance more than doubled the chance of survival. (30-day survival rate was 10.5% among patients who underwent CPR before EMS arrival, as compared with 4.0% among those who did not (P<0.001).)
This association held up in all subgroups regardless of sex, age, cause of cardiac arrest, place of arrest, EKG findings or time period (year analyzed).
MedicalResearch: How did the patients who survived cardiac arrest do from a disability standpoint?Dr. Hollenberg: We had cerebral performance scores from 474 patients who survived for 30 days after cardiac arrest. (higher scores indicate greater disability).
At the time of discharge from the hospital, 81% of these patients had a score of category of 1. Less than 2% had category scores of 4 or 5.
MedicalResearch: What should patients and providers take away from this report?Dr. Hollenberg:
For patients with an out-of-hospital cardiac arrest, CPR performed by bystanders before the arrival of emergency medical personnel, saves lives. This has been validated by both the size of this study and the consistency of the results over three decades.
CPR education needs to continue and to increase. In Sweden about one-third of the population has been taught CPR. Legislation has recently been passed that mandates CPR be taught to all teenagers in school which should allow an entire generation to become familiar with this lifesaving technique.
The willingness of the public to become involved also needs to increase. We need new ways of educating lay people to recognize cardiac arrest and to motivate them to perform it. The knowledge that bystander CPR saves lives may enhance that motivation.
MedicalResearch.com Interview with:
Alexander N Yatsenko, MD, PhD
Assistant Professor,
Department of OBGYN and Reproductive Science,
Magee-Womens Research Institute,
University of Pittsburgh, PA
Pittsburgh, PA 15213
Medical Research: What is the background for this study? What are the main findings?
Dr. Yatsenko: The known causes of male infertility not due to physical obstruction are usually because of sex-chromosome defects, such as deletions of the Y chromosome or duplication of the entire X chromosome in Klinefelter syndrome. Eight times out of 10, conventional genetic testing doesn’t reveal a chromosomal problem and infertility is considered idiopathic. We wanted to try to find other genetic reasons for the problem.
We found a deletion in part of the DNA coding of the testis-expressed gene 11 (TEX11) on the X-chromosome, which men inherit from their mothers. The alteration caused meiotic arrest, meaning the precursor cells could not properly undergo meiosis. We also found similar TEX11 gene mutations and meiotic arrest in two out of 49 men diagnosed with idiopathic azoospermia in Pittsburgh or at a Poland infertility clinic, and in five out of 240 infertile men assessed at a collaborating Andrology clinic in Muenster, Germany. These genetic findings were confirmed on protein level using patients’ testis biopsies. (more…)
MedicalResearch.com Interview with:
Anees B. Chagpar, MD, MSc, MPH, MA, MBA, FRCS(C), FACS, Associate Professor, Department of Surgery
Director, The Breast Center -- Smilow Cancer Hospital at Yale-New Haven, Assistant Director -- Global Oncology, Yale Comprehensive Cancer Center
Program Director, Yale Interdisciplinary Breast Fellowship
Yale University School of Medicine Breast Centerm
New Haven, CT,
Medical Research: What is the background for this study? What are the main findings?
Response: Every year in the US, nearly 300,000 women are diagnosed with breast cancer -- the majority of these will have early stage breast cancer, and will opt for breast conserving surgery to remove their disease. The goal of this operation is to remove the cancer with a rim of normal tissue all the way around it (i.e., a margin), but sadly, 20-40% of women will have cancer cells at the edge of the tissue that is removed, often mandating a return trip to the operating room to remove more tissue to ensure that no further disease is left behind. No one likes to go back to the operating room -- so we asked the question, "How can we do better?". Surgeons have debated various means of obtaining clear margins. Some have advocated taking routine cavity shave margins -- a little bit more tissue all the way around the cavity after the tumor is removed at the first operation. Others have argued that this may not be necessary; that one could use intraoperative imaging of the specimen and gross evaluation to define where more tissue may need to be removed (if at all) -- i.e., selective margins. We conducted a randomized controlled trial to answer this question. We told surgeons to do their best operation, using intraoperative imaging and gross evaluation, and removing selective margins as they saw fit. After they were happy with the procedure they had performed and were ready to close, we opened a randomization envelope intraoperatively, and surgeons were either instructed to close as they normally would ("NO SHAVE"), or take a bit more tissue all the way around the cavity ("SHAVE").
Patients in both groups were evenly matched in terms of baseline characteristics. The key finding was that patients who were randomized to the "SHAVE" group half as likely to have positive final margins and require a re-operation than patients in the "NO SHAVE" group. On their postoperative visit, we asked patients, before they knew which group they had been randomized to, what they thought of their cosmetic results. While the volume of tissue excised in the "SHAVE" group was higher than in the "NO SHAVE" group, the distribution of patient-perceived cosmetic outcomes were identical in both groups. Complication rate was also no different between the two groups. We will be following patients for five years for long-term cosmetic and recurrence outcomes. (more…)
MedicalResearch.com Interview with:
Mr. Matthew A. Rysavy, B.S and Edward Bell, MD
Department of Pediatrics, University of Iowa
Iowa City, IA
Medical Research: What is the background for this study? What are the main findings?Response: We were interested in understanding reasons for differences in outcomes among extremely preterm infants among hospitals. This has been shown in many studies. We found that differences among hospitals in whether treatment was initiated for infants born at very early gestations (22, 23, 24 weeks' gestation) accounted for a lot of the variation in hospital-level outcomes at these gestational ages.
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MedicalResearch.com Interview with:
Professor James Bainbridge, MA, PhD, FRCOphth
Professor of Retinal Studies, UCL Institute of Ophthalmology
NIHR Research Professor, NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of OphthalmologyConsultant Ophthalmologist, Moorfields Eye Hospital NHS Foundation Trust
Medical Research: What is the background for this study? What are the main findings?Prof. Bainbridge : Leber Congenital Amaurosis (LCA) is one of the most common causes of inherited, untreatable blindness in children. There are at least 14 different types of Leber Congenital Amaurosis of which LCA Type 2 (LCA2), caused by defects in the gene RPE65, affects around one in 100,000 people worldwide. Evidence from animal studies support that LCA2 may be amenable to treatment with RPE65 gene replacement therapy.
The main findings of this phase I/II clinical trial confirm our preliminary findings (published in NEJM, 2008) that gene therapy can improve night vision. Improvements peak within the first 12 months after treatment but then decline during the three-year follow-up period which is consistent with the published results and interim findings from other studies of RPE65 gene therapy.
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MedicalResearch.com Interview with:
Catherine L. Chen M.D., M.P.H.
UCSF Dept of Anesthesia
Medical Research: What is the background for this study? What are the main findings?
Dr. Chen: Cataract surgery is a very common and safe surgery that most older adults have in their 70's or 80's. It usually happens as a same-day surgery and most patients only need eye drops to numb the eye with little or no intravenous sedation for a procedure that on average is only 18 minutes long. Given their age, these patients typically have other concurrent medical problems, so even though multiple research studies and professional societies have concluded that routine preoperative testing is not necessary before cataract surgery, we found that this testing still frequently occurs in these patients. More than half of the patients in our study had at least one preoperative test performed in the month before their surgery.
We hypothesized prior to undertaking this study that the older and sicker patients were the ones who were most likely to get preoperative testing. Instead, what we found was that the most important factor that determined whether or not a patient got tested was the ophthalmologist who operated on the patient. This is an important finding because it shows that most patients are not getting extra testing, but the few that do are getting testing because that's the way their ophthalmologist typically prepares his patients for surgery. Most of the time, this testing is not needed and will not affect how well the patient does during and after surgery. (more…)
MedicalResearch.com Interview with:
Pamela S. Douglas, M.D.
Duke University School of Medicine
Duke University Medical Center
Durham, NC 27715
Medical Research: What is the background for this study?
Dr. Douglas: The primary objective of the PROMISE study was to compare the health outcomes of people who went to the doctor with new symptoms such as shortness of breath and/or chest pain that were suggestive of coronary artery disease and that required additional evaluation. This was an important investigation because no large research trial has ever been conducted to help guide the care of such patients. Instead, the selection of tests for such patients—which constitutes at least 4 million patients in the United States each year—has been largely left up to physician and patient preference rather than proven results.
Medical Research: What are the main findings?
Dr. Douglas: 10,003 patients from 193 different medical facilities across the US and Canada agreed to be part of the PROMISE study and were randomized to a functional stress test or an anatomic test Using CT angiography. The study found that the clinical outcomes of participants with suspected coronary artery disease were excellent overall, and were similar in terms of death and major cardiac conditions regardless of whether patients had a functional stress test or a computed tomographic scan. However, the CT scan may be better at ruling out the need for subsequent tests and procedures in patients who are free of heart disease, and involved a lower radiation exposure relative to a stress nuclear study. We also found, in a separately reported study, that the costs of the two diagnostic strategies were similar.
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MedicalResearch.com Interview with:
Dr. H. Jaap Bonjer, PhD, FRCSC
Professor of Surgery
Chair Department of Surgery
VU University Medical Center Amsterdam
Amsterdam
Medical Research: What is...
MedicalResearch.com Interview with:
Henri van Werkhoven
PhD student and
Douwe Postma
PhD student
Julius Center for Health Sciences and Primary Care
University Medical Center Utrecht, Utrecht, The NetherlandsMedical Research: What is the background for this study? What are the main findings?
Response: Community-acquired pneumonia is an important cause of hospitalization and death worldwide. Recommendations for antibiotic treatment in patients hospitalized to a non-ICU ward vary widely between guidelines, because the optimal antibiotic strategy is unknown. Interpretation of the available evidence from clinical studies is complicated by the heterogeneity in designs and findings. In our study, we hypothesized that the most conservative strategy, beta-lactam monotherapy, would be non-inferior to strategies with a broader range of antibiotic coverage. The latter strategies are potentially related to increased antibiotic resistance.
For this purpose, we randomized hospitals to follow three different strategies of preferred antibiotic treatment in consecutive periods of four months. Physicians were allowed to deviate from the preferred antibiotic treatment for medical reasons. We found that a strategy with beta-lactam monotherapy (e.g. amoxicillin) as the preferred treatment was non-inferior to the strategies with beta-lactam/macrolide combination therapy or fluoroquinolone monotherapy for 30 and 90-day all-cause mortality. Also there was no difference in length of hospitalization and rate of complications.
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MedicalResearch.com Interview with:
Sripal Bangalore, MD, MHA, FACC, FAHA, FSCAI
Director of Research, Cardiac Catheterization Laboratory,
Director, Cardiovascular Outcomes Group,
Associate Professor of Medicine,
New York University School of Medicine,
New York, NY 10016
Medical Research: What is the background for this study? What are the main findings?
Dr. Bangalore: Prior studies have shown a mortality benefit of bypass surgery over stenting. But these studies compared bypass surgery with older generation stents which are no longer used. We used data from the New York state registry of patients who underwent stenting or bypass surgery for 2 or more blockages of coronary arteries. With data from over 18,000 patients we found that there was no difference between stenting and bypass surgery for long term mortality. In addition we found that both procedures have trade offs. Bypass surgery has upfront risk of death and stroke whereas PCI has long term risk of needing a repeat procedure. In addition, in patients who underwent incomplete revascularization, there was increase in myocardial infarction with PCI.
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MedicalResearch.com Interview with: Loren G. Miller, M.D., M.P.H.
Los Angeles Biomedical Research Institute
(LA BioMed) Infectious Disease Specialist
Medical Research: What is the background for this study?Dr. Miller: Skin and skin structure infections are extremely common reasons for persons
to seek medical care in the U.S., accounting for approximately 14.2 million
outpatient visits in 2005, the latest year for which statistics are
available, and 850,000 hospital admissions. Until this study was completed,
the most effective approach to outpatient antibiotic treatment of
uncomplicated skin infections in the era of community-acquired
methicillin-resistant Staphylococcus aureus (MRSA) was unclear. Prior to
this research, there were no data on which antibiotics were best for
treatment of these common skin infections.
Medical Research: What are the main findings?Dr. Miller: Two antibiotics frequently prescribed to treat serious skin infections -
clindamycin and trimethoprim sulfamethoxazole (TMP-SMX) - had similar rates
of success in curing uncomplicated infections in outpatients. They also had
similar rates of side effects.
To conduct the study, we recruited outpatients from emergency departments,
clinics and other healthcare facilities associated with Los Angeles County's
Harbor-UCLA Medical Center, University of Chicago Medical Center, San
Francisco General Hospital and Vanderbilt University Medical Center from May
2009 to August 2011. We studied 524 adults and children with uncomplicated
skin infections who had cellulitis, abscesses of 5 centimeters or more or
both. In the multicenter, double blind, randomized clinical trial, 264
received clindamycin and 260 received TMP-SMX. We followed the outpatients
for a month after their treatment.
We found similar outcomes for both groups - 80.3% of the outpatients who
received clindamycin and 77.7% of the outpatients in the group that received
TMP-SMX were cured within seven to 10 days after the end of their treatment.
These are not considered significant differences, so our evaluation is that
these two commonly prescribed antibiotics for serious skin infections are
similarly effective in treating uncomplicated skin infections in children
and adults who have few or no major co-existing conditions.
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MedicalResearch.com Interview with:
Barnaby C. Reeves, D.Phil.
Professor of Health Services Research, Clinical Trials & Evaluation Unit
School of Clinical Sciences, University of Bristol
Bristol Royal Infirmary Bristol
Medical Research: What is the background for this study?
Response: Variable decisions are made about when to transfuse patients after cardiac surgery. The circumstances of particular patients influence decisions about whether to give a transfusion.
Transfusion is a life-saving intervention when a patient is experiencing life-threatening bleeding but most patients have only one or two units of red cells transfused. These transfusions are given at varying levels of anaemia. Some doctors prefer to give a transfusion after cardiac surgery when a patient is only mildly anaemic, believing that the transfusion will promote recovery, while other doctors prefer to wait to transfuse until a patient is substantially anaemic, believing that a transfusion may do more good than harm and is wasteful if it is not needed. Therefore, we carried out a randomized controlled trial comparing restrictive (transfuse when haemoglobin <7.5 g/dL) and liberal transfusion thresholds (transfuse when haemoglobin <9.0 g/dL).*
Medical Research: What are the main findings?
Response: We obtained written informed consent before surgery but only randomized participants after surgery, in intensive care, if their Hb dropped below 9 g/dL. (Hence, we recruited over 3,500 patients but randomized only 2007.) This design avoids ‘diluting’ any difference between groups by including participants who would not usually be ‘considered’ for transfusion.
The primary outcome was the occurrence of one or more serious complications: heart attack, stroke, acute kidney injury, bowel infarction, infection; this included/involved 35.1% of the patients in the restrictive-threshold group and 33.0% of the patients in the liberal-threshold group. This slight difference – more in the restrictive group – was not statistically significant.
We then compared the percentages of patients who died; these were 4.2% in the restrictive group and 2.6% in the liberal group. The difference in this secondary outcome was of borderline statistical significance. Frequencies of other secondary outcomes (infections, ischaemic events, days in critical care and hospital, pulmonary complications) were not different in the two groups.
We also carried out some pre-specified sensitivity analyses for the primary outcome and all-cause mortality. The two most important ones aimed to avoid dilution of the difference between groups as a result of patients having transfusions or outcome events before randomization. Excluding patients who were transfused before randomization shifted the treatment effect to favour the liberal threshold more strongly, for both the primary outcome and mortality. Excluding patients who experienced an outcome event in the first 24 hours after randomization did not change the treatment effect for either outcome. (more…)
MedicalResearch.com Interview with:
Carla M. Pugh, M.D., Ph.D. FACS
Associate Professor, Vice Chair, Education and Patient Safety
Clinical Director, UW Health Clinical Simulation Program
Section of Trauma, Acute Care Surgery, Burn and Surgical Critical Care Division of General Surgery University of Wisconsin, School of Medicine and Public Health, Madison, WI
Medical Research: What is the background for this study? What are the main findings?
Dr. Pugh: The clinical breast examination is routinely performed on millions of women each year. It is used for screening breast cancer and is also routinely performed on women presenting with symptomatic breast conditions.
In this study we assessed the performance of the clinical breast examination among a large sample of practicing physicians. There were two main goals to the study. The first goal was to identify current recommendations for performing the clinical breast examination and investigating how this relates to examination sensitivity or finding a mass. The second and more general goal was to develop a method for objective assessment of clinical skills.
Novel clinical breast examination simulators were used in this study; in addition to their ability to present different pathologies and multiple clinical scenarios, they were all integrated with advanced force sensors. These sensors include approximately 2000 discrete sensing elements, measuring force level and distribution thought the breast examination. These sensors provide information at a level of detail that is not possible with observation alone.
Four models were used in this study; two models presenting superficial soft masses and two models representing hard chest wall masses. The study was performed from 2013 to 2014 with 553 physicians performing the clinical breast examination on our models. The participants were recruited at three annual clinical meetings: 136 at the American Society of Breast Surgeons, 236 at the American Academy of Family Physicians, and 181 at the American College of Obstetricians and Gynecologists.
The study found a significant relationship between the force used during palpation and the accuracy of the assessment of the deep-tissue lesions. More specifically, the study found that some physicians don’t apply enough force during the examination putting them at high risk of missing deep-tissue lesions. Since force can’t be measured by human observation this underscores the added value of integrating sensors into clinical simulators. (more…)
MedicalResearch.com Interview with:
Michael D Hill, MD MSc FRCPC
Calgary Stroke Program
Professor, Dept Clinical Neurosciences
Hotchkiss Brain Institute
University of Calgary, Cumming School of Medicine
Foothills Hospital, Calgary, Canada
Medical Research: What is the background for this study? What are the main findings?Dr. Hill: Major ischemic stroke with blocked proximal arteries results in 60-80% death and disability. Recent studies of endovascular treatment were neutral. Evolution of technology has resulted in advances in the devices. Key features of past trials of endovascular therapy were, underdeveloped imaging paradigms for patient selection, slow treatment times and poor reperfusion rates.
Medical Research: What should clinicians and patients take away from your report?Dr. Hill: Simply, endovascular therapy for major ischemic stroke over and above best medical care (ie. IV tPA) is effective . It reduces disability and saves lives. The NNT is very low 4, making it one of the largest proven effect sizes in all of medicine. BUT, it applies only under selected conditions.
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MedicalResearch.com Interview with:
Halle C.F. Moore, M.D.
Cleveland Clinic Foundation
Taussig Cancer Institute
Cleveland, OH 44195
Medical Research: What is the background for this study? What are the main findings?Dr. Moore: Ovarian failure is a common long-term side effect of chemotherapy. Previous studies investigating whether suppressing ovarian function during chemotherapy treatment will preserve ovarian function following chemotherapy have had mixed results. Our study found that suppressing the ovaries with the GnRH analog goserelin during chemotherapy treatment for early stage ER-negative breast cancer resulted in a reduced risk of ovarian failure two years after initiation of treatment.
Also, more women who received the goserelin with chemotherapy became pregnant than women who received chemotherapy without goserelin.
In addition, there was an apparent improvement in survival among the goserelin group, confirming the safety of this approach in this patient population.
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MedicalResearch.com Interview with:
Kari Johansson, PhD
Department of Medicine Solna, Karolinska Institutet
Clinical Epidemiology
Karolinska University Hospital
Stockholm, Sweden
MedicalResearch: What is the background for this study? What are the main findings?
Dr. Johannson: The number of women who are obese in early pregnancy has increased dramatically over the last decades. Consequently, there has been a dramatic rise in the number of women becoming pregnant after bariatric surgery. In Sweden the number of births of women with a history of bariatric surgery has increased from 150 (≈0.15%) to more than 500 (0.5%) per year between 2006 and 2011. The positive effects of bariatric surgery on health outcomes, such as diabetes and cardiovascular disease, are reasonably well-studied, but less is known about the effects on pregnancy and perinatal outcomes. We therefore conducted a population-based study, using data from nationwide Swedish registers.
The main findings are that women who had a history of bariatric surgery were much less likely to develop gestational diabetes (2% compared to 7%; P<0.001) and give birth to large-for-gestational age babies (9% vs 22%; P<0.001). On the other hand, the operated women were twice as likely to give birth to babies who were small for gestational age (16% vs 8%), and have pregnancies of shorter duration (273 vs 277.5; P<0.001). (more…)
MedicalResearch.com Interview with:
Seema Jain, MD
Medical Epidemiologist
Epidemiology and Prevention Branch, Influenza Division
Centers for Disease Control and Prevention
Atlanta, GA 30329
MedicalResearch: What is the background for this study? What are the main findings?Dr. Jain: Pneumonia is the leading cause of hospitalization among children in the United States with medical costs estimated at almost $1 billion in 2009. The Centers for Disease Control and Prevention’s Etiology of Pneumonia in the Community (EPIC) study was a multi-center, active population-based surveillance study that aimed to estimate the incidence and etiology of community-acquired pneumonia requiring hospitalization in U.S. children. Children in the study were enrolled from January 2010 to June 2012 in three U.S. children’s hospitals in Memphis, Nashville, and Salt Lake City. Study staff tested children using a range of laboratory tests for viral and bacterial respiratory pathogen detection.
During the study period, the EPIC study team enrolled 2,638 children, of which 2,358 (89 percent) had radiographically-confirmed pneumonia. The median age of children in the study was 2 years old. Intensive care was required for 497 (21 percent) of the children, and three children died. Among 2,222 children with radiographic pneumonia and specimens available for both bacterial and viral testing, a pathogen was detected in 1802 (81%). One or more viruses were detected in 1,472 (66%) of these children. Bacteria were detected in 175 (8%), and bacterial and viral co-detection occurred in 155 (7%). The study estimated that annual pneumonia incidence was 15.7/10,000 children during the study period. The highest incidence was among children younger than 2 years old (62.2/10,000). Respiratory syncytial virus (RSV) was the most common pathogen detected (28%), and it was associated with the highest incidence among children younger than 2 years old with pneumonia. Human rhinovirus was detected in 22 percent of cases, but it was also identified in 17 percent of asymptomatic controls who were enrolled, by convenience sample, at the same site during the same time period; thus, making it challenging to interpret the meaning of human rhinovirus detection in children hospitalized with pneumonia. Other detected pathogens were human metapneumovirus (13%), adenovirus (11%), Mycoplasma pneumoniae (8%), parainfluenza viruses (7%), influenza (7%), coronaviruses (5%), Streptococcus pneumoniae (4%), Staphylococcus aureus (1%), and Streptococcus pyogenes (<1%). The low prevalence of bacterial detections likely reflects both the effectiveness of bacterial conjugate vaccines and suboptimal sensitivity of bacterial diagnostic tests. (more…)
MedicalResearch.com Interview with:
Adam Glassman, M.S.
Director, DRCRnet Coordinating Center
Jaeb Center for Health Research
Tampa, FL 33647
Medical Research: What is the background for...
MedicalResearch.com Interview with: Sandra M Swain, MD, FACP, FASCO
Medical Director, Washington Cancer Institute
MedStar Washington Hospital Center
Washington DC 20010
MedicalResearch: What take-home message would you like the general public to understand about this new analysis from the Cleopatra study?Potential Key Message Options:
Updated results from the CLEOPATRA study showed that people treated with the combination of pertuzumab, trastuzumb and chemotherapy lived 15.7 months longer than those who received trastuzumab and chemotherapy alone (median survival of 56.5 months versus 40.8 months).
The survival improvement of nearly 16 months observed in CLEOPATRA is unprecedented among studies of metastatic breast cancer. This is the kind of survival improvement that those of us who treat breast cancer strive for, and this data will be incredibly meaningful to patients and their families.
Furthermore, the median survival of nearly five years observed in CLEOPATRA patients treated with the pertuzumab regimen is the longest ever observed in a clinical study of people with HER2-positive metastatic breast cancer, once one of the most aggressive forms of breast cancer.
Patients who responded with shrinkage of their tumor had a response that was 8 months longer with the pertuzumab regimen compared to the trastuzumab and chemotherapy regimen.
MedicalResearch.com Interview with:Dr Bruce Campbell MBBS(Hons), BMedSc, PhD, FRACP
Consultant Neurologist, Head of Hyperacute Stroke
Department of Neurology Royal Melbourne Hospital
NHMRC Early Career Research Fellow
Melbourne Brain Centre @ RMH Department of Medicine
University of Melbourne Australia
MedicalResearch: What is the background for this study? What are the main findings?Dr. Campbell: EXTEND-IA was a randomised trial comparing standard thrombolysis with tPA plus endovascular stent-thrombectomy versus tPA alone in ischemic stroke patients selected for the presence of major vessel occlusion and salvageable brain tissue using CT perfusion imaging. It was designed in 2011 at a time when there was uncertainty about the effectiveness of endovascular therapy which deepened in 2013 with the publication of 3 neutral trials. The recent publication of the Dutch MR-CLEAN study showing improved outcomes with stent-thrombectomy was a major advance and prompted a data safety and monitoring committee review of the EXTEND-IA data leading to early termination of the trial for efficacy.
The key findings from EXTEND-IA were that the addition of stent-thrombectomy to tPA led to a dramatic increase in restoration of blood flow to the brain from 34% to 89%. This translated to markedly improved outcomes at 3 months with 71% of stent-thrombectomy patients compared with 40% of tPA-only patients regaining independence. The 3 trials released today were remarkably consistent in their outcomes and this provides a solid evidence base to recommend stent-thrombectomy as the new standard of care for patients with large vessel ischemic stroke.
Patients who were treated with stent-thrombectomy in EXTEND-IA had more than double the rate of reperfusion (restoration of blood flow to the brain) compared to the standard tPA patients and this translated to a 31% absolute increase in the proportion of patients living independently at 3 months.
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MedicalResearch.com Interview with:
Elmi Muller, M.B., Ch.B., M.Med.
University of Cape Town–Surgery
Groote Schuur Hospital Observatory Cape Town
Cape Town, South AfricaMedical Research: What is the background for this study?
Dr. Muller: South Africa currently offers dialysis and transplantation as a treatment option for patients with End Stage Renal Disease (ESRD). However, dialysis is not freely available to everyone, but severely limited and only available to a selected group of patients. This means that patients get assessed when they present with ESRD and they only get accepted onto a dialysis programme if they fulfill certain criteria. These criteria are criteria to assess the patient’s medical fitness in general as well as social criteria to assess whether the patient will be compliant with follow-up. In most state hospitals, patients will only be accepted onto a dialysis program if they are also fit to receive a transplant in the long run. The idea is that dialysis programs should naturally feed into transplant programs. Therefore a patient who is not a suitable transplant candidate will normally be turned down for dialysis.
In 2008, when the HIV positive-to-positive program started, patients with ESRD and HIV would be turned down for dialysis. The reason was that they were seen as unfit for transplantation and therefore not suitable dialysis patients. This meant that anybody with HIV and ESRD was doomed to die. This situation remained unchallenged for a number of years, especially as the rollout of antiretroviral therapy was quite slow in the state sector.
Because of very high HIV rates in the country, more and more HIV positive brain-dead donors presented to the Groote Schuur Hospital Transplant team. These donors were mostly braindead people who were worked up for organ donation (after consent was obtained from the family) and who then turned out to be HIV positive. In 2008 it made sense to try and marry this supply of donors with the group of HIV positive patients without any treatment options in the country.
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MedicalResearch.com Interview with:
David G. Kent, Ph.D
From the Cambridge Institute for Medical Research and Wellcome Trust–Medical Research Council Stem Cell Institute University of Cambridge
Medical Research: What is the background for this study? What are the main findings?
Dr. Kent: Cancers are the result of the sequential acquisition of errors in the genetic code. Most studies have focused on the sum of these mutations (e.g., A+B+C = cancer) but no study in patients has asked the question of whether or not the order of genetic mutations impacts the disease (e.g., does A to AB equal B to BA). We studied patients with chronic blood disorders (known as myeloproliferative neoplasms, or MPNs) that are precursors to cancer to access the earliest stages of tumour development and studied whether or not the order of mutation acquisition impacted disease. We studied patients with mutations in two genes (JAK2 and TET2) and showed that the order of acquisition of these mutations impacted timing of clinical presentation, disease subtype, frequency of thrombotic events, and differed in their response to targeted therapy in the lab. (more…)
MedicalResearch.com Interview with:
Dr. Martin S. Schlumberger MD
Department of Nuclear Medicine and Endocrine Oncology
Centre de Référence Tumeurs Réfractaires de la Thyroïde
Institut Gustave Roussy and University Paris-Sud
Villejuif, France
Medical Research: What is the background for this study? What are the main findings?
Dr. Schlumberger: Patients with advanced refractory thyroid cancer is rare (4-5 patients/million population) but portends a poor prognosis with a median overall survival of 3-5 years from the diagnosis of metastases.
Before the availability of kinase inhibitors there was no effective treatment, and for this reason placebo was used as control in SELECT trial. This trial showed an improvement of PFS lenvatinib vs placebo (hazard ratio: 0.21; 99% CI: 0.14–0.31, P<0.001; median PFS: 18.3 vs 3.6 months, respectively) and objective response rate of 65% with some complete responses. Time to response was short (2 months).
Similar benefits were observed in naive patients and in patients who had been treated with another tyrosine kinase inhibitor, demonstrating the absence of cross resistance.
Toxicity was significant and could be controlled with dose reduction and symptomatic treatment.
Medical Research: What should clinicians and patients take away from your report?(more…)
MedicalResearch.com Interview with:
Douglas B. Jacobs B.S., MD/MPH Candidate
Harvard T.H. Chan School of Public Health
Medical Research: What is the background for this study?
Response: In May 2014, a formal complaint submitted to the Department of Health and Human Services contended that four Florida insurers were structuring their formularies in a way that discouraged enrollment from HIV positive beneficiaries. These insurers placed all HIV drugs, including generics, on the highest cost-sharing tiers.
This formal complaint served as the impetus for this research. We wanted to discover if this was a phenomenon that was isolated to Florida, or if it was national in scope, and what the implications would be for HIV positive beneficiaries. As such, we analyzed what we called “adverse tiering”—in which all drugs for certain conditions are placed in the highest cost sharing tiers—in 12 states in the federal marketplace. We compared cost-sharing for a commonly prescribed class of HIV medication, called Nucleoside Reverse Transcriptase Inhibitors, or NRTIs.
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MedicalResearch.com Interview with:
Andrew Moran, MD, MPH
Herbert Irving Assistant Professor of Medicine
Columbia University Division of General Medicine
Presbyterian Hospital New York, NY 10032
Medical Research: What is the background for this study? What are the main findings?
Response: In 2014, a panel appointed by the Eighth Joint National Committee on the Detection, Evaluation and Treatment of High Blood Pressure (JNC 8) recommended new guidelines for high blood pressure (hypertension ) treatment in U.S. adults. The guidelines made sweeping changes to the prior guidelines and stirred up controversy among hypertension and public health experts. Essentially, the panel recommended more conservative treatment targets that narrowed the population eligible for treatment with blood pressure-lowering medications. Nonetheless, about 28 million U.S. adults have uncontrolled hypertension even under the new more conservative guidelines. We asked the question: are the new guidelines cost-effective? That is, does treating this common condition with the available medicines add more health and reduce medical costs? It is surprising that this question has rarely been answered before.
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MedicalResearch.com Interview with:
Richard C. Dart, M.D., Ph.D
Denver Health & Hospital Authority
Professor, University of Colorado School of Medicine
Medical Research: What is the background for this study? What are the main findings?
Dr. Dart: For the past two decades, prescription opioid medication abuse has increased significantly in the US. An estimated 25 million people initiated nonmedical use of pain relievers between 2002 and 2011. In 2010 the number of death attributed to prescription opioid medications reached 16,651. The RADARS® System (Researched Abuse, Diversion and Addiction Related Surveillance) has been monitoring prescription drug abuse and diversion for over 13 years. We use a “mosaic” approach, measuring abuse and diversion from multiple perspectives, to describe this hidden phenomenon as comprehensively as possible.
For the current publication we used 5 separate RADARS® System programs to collect data and the study period was from January 2002 through December 2013. We noticed a substantial increase of prescription drug abuse from 2002 through 2010, followed by a flattening or decrease in 2010 and, lastly, a decline in 2011 through 2013. We also noticed a similar pattern in opioid-related deaths. Nonmedical use did not change significantly among college students.
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MedicalResearch.com Interview with:
Daniel Polsky PhD
Executive Director, Leonard Davis Institute of Health Economics
Professor of Medicine and Health Care Management
Perelman School of Medicine and the Wharton School
University of Pennsylvania
Medical Research: What is the background for this study? What are the main findings?
Dr. Polsky: The Medicaid Fee bump, a provision of the Affordable Care Act (ACA), raised Medicaid payments to Medicare levels in 2013 and 2014 for selected services and providers expired on January 1, 2015 before policymakers had much empirical evidence about its effects. The federally funded increase in reimbursements was aimed at expanding access to primary care for the growing number of Medicaid enrollees. The reimbursement increase expired at the end of 2014 in most states. We found that this policy worked to increase the number of providers offering primary care appointments to Medicaid patients. The Medicaid pay bump was associated with a 7.7 percentage points increase in new patient appointment availability without longer wait times. This increase in availability was largest in the states where primary care physicians received the largest increase in their Medicaid reimbursements.
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![Prof. Dr. Kristian Reich, Dermatologikum Hamburg, Hamburg 07.04.2009 | Prof. Dr. Kristian Reich, Dermatologikum Hamburg, Hamburg, Germany, 07.04.2009 | [© (c) Martin Zitzlaff, Emilienstr.78, 20259 Hamburg, Germany, Tel. +491711940261, http://www.zitzlaff.com, martin@zitzlaff.com, Postbank Hamburg BLZ 20010020 Kto.-Nr. 10204204, MwSt. 7%, Veroeffentlichung nur gegen Honorar (MFM) und Belegexemplar, mit Namensnennung]](https://medicalresearch.com/wp-content/uploads/Professor-Reich.jpg)
MedicalResearch.com Interview with:
Prof. Dr. med. Kristian Reich
DERMATOLOGIKUM HAMBURG
Hamburg
Medical Research: What is the background for this study? What are the main findings?
Prof. Reich: The Phase 2b X-PLORE study compared a new generation biologic therapy, guselkumab - an inhibitor of IL–23, with the anti–tumor necrosis factor (TNF)–alpha agent adalimumab (Humira®) and placebo in the treatment of moderate-to-severe plaque-type psoriasis. It showed that up to 86 percent of patients treated with guselkumab achieved a Physician’s Global Assessment (PGA) score of cleared psoriasis or minimal psoriasis at week 16, the study’s primary endpoint. Interestingly, levels of efficacy were higher for several guselkumab doses through week 16 when compared to adalimumab. Improvements with guselkumab continued through week 40 with every eight- or twelve-week maintenance treatment. (more…)
