[caption id="attachment_19645" align="alignleft" width="140"] Dr. Kohler[/caption]
MedicalResearch.com Interview with:
Prof. Malcolm Kohler, MD
Chair Respiratory Medicine
Clinical Director Department of Pulmonology
University Hospital of Zurich
Zurich...
MedicalResearch.com Interview with:
Benjamin Movsas, MD
Chairman of Radiation Oncology
Henry Ford Hospital
Detroit, MichiganMedical Research: What is the background for this study? What are the main findings?
Dr. Movsas: The background is that a recent randomized lung cancer trial (RTOG 0617) showed a lower (rather than a higher) survival among the patients who received a higher dose of radiation (RT). This unexpected finding was puzzling as there were few differences in toxicity between the radiation dose arms noted by health care providers.
The main finding of the quality of life (QOL) analysis was that there was indeed a large difference in QOL as reported by the patients themselves (with lower QOL on the high RT dose arm at 3 months). Moreover, while this study was not randomized for RT technique, about half of the patients received intensity modulated RT (IMRT), a more sophisticated approach than the alternative (3D conformal RT), which can better protect normal tissues. Despite the fact that patients with larger tumors received IMRT, their self reported QOL one year later was significantly better (ie, much less decline in QOL) relative to patients who received 3D conformal RT. Finally, higher QOL at baseline significantly predicated for better survival.
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MedicalResearch.com Interview with:
Mark D. Peterson, Ph.D., M.S.
University of Michigan, Medicine
Department of Physical Medicine and Rehabilitation
Ann Arbor, MIMedical Research: What is the background for this study? What are the main findings?
Dr. Peterson: Cerebral palsy (CP) is a neurodevelopmental condition caused by a disturbance to the developing fetal or infant brain. While the incidence of CP has remained stable in recent years, the mortality rate of children with Cerebral palsy has declined, suggesting that adults with Cerebral palsy represent a growing population whose healthcare needs are poorly understood. More than half of children with Cerebral palsy are independently mobile at 8 years of age; however, a large proportion lose mobility in adulthood. These declines are attributed to pain, fatigue, and muscle weakness, and result in chronic inactivity and accelerated aging. Despite this, there have been virtually no specific surveillance efforts or even epidemiologic studies to examine the prevalence of lifestyle-related chronic diseases in adults with Cerebral palsy. Therefore, the purpose of this study was to examine estimates of chronic conditions in a large, U.S. population-representative sample of adults with CP (n=1,015 fromthe Medical Expenditure Panel Survey (MEPS) (2002-2010). We demonstrated that adults with cerebral palsy had significantly greater estimates of chronic diseases, including diabetes, asthma, hypertension and other heart conditions, stroke, emphysema, joint pain, and arthritis as compared with adults without Cerebral palsy.
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MedicalResearch.com Interview with:
Dr Mairead Black MBChB, MRCOG, MSc
Research Fellow, Wellcome Trust
Clinical Lecturer, Obstetrics and Gynaecology
School of Medicine and Dentistry, Division of Applied Health Sciences
University of Aberdeen
Aberdeen Maternity Hospital, Cornhill Road
Aberdeen AB25 2ZDMedical Research: What is the background for this study? Dr. Black: The current thinking is, if a baby is exposed to labour, then it is also exposed to ‘good bacteria’ that mothers pass on during the birth, and they are also exposed to a degree of natural stress at the time of birth that might make them more resistant to developing future illnesses.
The World Health Organisation formerly recommended that no more than 15 percent of deliveries should be C-sections. However rates in some countries have soared – China and Brazil have rates in excess of 50%, whilst in the UK the figure is 26% with almost half of these being planned in advance.
The main purpose of this study was to explore whether health outcomes in children up to very early adulthood differ according to how they are delivered and whether avoiding labour entirely, i.e. via a planned C-section, could put children at a disadvantage compared to those delivered vaginally or by emergency C-section, where most will have been exposed to labour. The study analysed data from over 300,000 births between 1993 and 2007 across Scotland, using routinely collected data from seven linked databases.
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MedicalResearch.com Interview with:
Prof Nicholas James
STAMPEDE Trial Chief Investigator
Director of the Cancer Research Centre
Warwick Medical School
University of Warwick Coventry and
Professor of Clinical Oncology
Cancer Centre, Queen Elizabeth Hospital
Birmingham
Medical Research: What is the background for this study? What are the main findings?Dr. James: The STAMPEDE trial is a multi-arm, multi-stage trials platform testing a range of different therapies in addition to standard of care (SOC) for men commencing long term androgen deprivation therapy (ADT) for newly diagnosed locally advanced or metastatic prostate cancer. These data from the control arm form part of a pair of publications detailing outcomes in the control arm of STAMPEDE and help to make sense of the forthcoming paper on the randomised comparisons currently in press at the Lancet.
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MedicalResearch.com Interview with:
Soroush Zaghi, MDDepartment of Head and Neck Surgery
David Geffen School of Medicine at UCLA
University of California, Los Angeles
MedicalResearch: What is the central message for clinicians and surgeons from your results?Dr. Zaghi: Multiple studies from different practitioners and institutions agree that Maxillomandibular Advancement (MMA) is a highly effective surgical option for patients with obstructive sleep apnea who cannot tolerate positive pressure therapy and have not found success with other surgical procedures.
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MedicalResearch.com Interview with:
Katharine Yao, MD
Director, Breast Surgical Program
NorthShore University HealthSystem
Illinois
Medical Research: What is the background for this study? What are the main findings?
Dr. Yao: A survey of breast surgeons was conducted to determine their knowledge level with contralateral breast cancer and how contralateral prophylactic mastectomy (CPM) affects survival. Of five knowledge questions, only 60% scored with high knowledge (4 or 5 questions correct) scores. Surgeons mostly scored low on contralateral cancer risks. Most surgeons correctly stated that contralateral prophylactic mastectomy does not provide a survival benefit. Nonetheless, our knowledge questions did not address other important issues about CPM such as operative complications, or contralateral breast cancer risks for other high risk subgroups. Higher knowledge was associated with fellowship training and duration of practice.
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MedicalResearch.com Interview with:
Anup Das
Medical Scientist Training Program
Department of Health Management and Policy
University of Michigan, Ann Arbor
Medical Research: What is the background for this study? What are the main findings?Response: The Centers for Medicare & Medicaid Services (CMS) recently added a new measure of episode spending to the Hospital Value Based Purchasing program. Participation in this program allows hospitals to receive a financial bonus if they perform well on the included measures. This is the first spending measure in the program, and this change now incentivizes hospitals to improve their quality as well as their spending. The measure evaluates spending from three days before a hospitalization through 30 days post-discharge.
In this study, we find that while high-cost hospitals had higher spending levels in each of the three components of an episode of care (pre-admission, index admission, and post-discharge), differences in post-discharge spending were the main determinants of hospital performance on this measure. High-cost hospitals spent on average $4,691 more than low-cost hospitals in post-discharge care. The majority of post-discharge spending comes from skilled nursing facility or readmission costs. Similarly, hospitals that did worse on this new measure of spending over time did so because of increases in their post-discharge spending.
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Ambarish MedicalResearch.com Interview with:
Ambarish Pandey M.D.
Division of Cardiology
University of Texas Southwestern Medical Center
Dallas, TX
Medical Research: What is the background for this study? What are the main findings?
Dr. Pandey: Pulmonary artery (PA) catheters have been used for invasive bedside hemodynamic monitoring for past four decades. The ESCAPE trial, published in October 2005, demonstrated that use of Pulmonary Artery catheter was not associated with a significant improvement in clinical outcomes of patients with heart failure. Accordingly, the current ACC/AHA guidelines discourage the routine use of PA catheter for routine management of acute heart failure in absence of cardiogenic shock or respiratory failure (Class III). Despite the significant evolution of available evidence base and guideline recommendations regarding use of Pulmonary Artery catheters, national patterns of PA catheter utilization in hospitalized heart failure patients remain unknown.
In this study, we observed that use of PA catheter among patients with heart failure decline significantly in the Pre-ESCAPE era (2001 – 2006) followed by a consistent increase in its use in the Post-ESCAPE era (2007-2012). We also observed that the increase in use of Pulmonary Artery catheters is most significant among heart failure patients without underlying cardiogenic shock or respiratory failure.
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MedicalResearch.com Interview with:
Bob Siegerink PhD
Frits R. Rosendaal MD, PhD
Department of Clinical Epidemiology
Leiden University Medical Center
Leiden, the Netherlands
Medical Research: What is the background for this study? What are the main findings?
Response: The rates of death due to arterial thrombosis have been declining in the past years, which means that there are more patients with a high burden of disease. Arterial thrombosis is a uncommon disease in the young, but the burden of the disease might have a profound impact on their lives. We analyzed data form the RATIO study, in which we followed women with a ischemic stroke and myocardial infarction for up to 20 years. During this time, overall mortality was 2-4 times higher compared to the general population. This increase in risk was mainly driven by deaths from acute vascular events and persisted over the whole course of the follow up.
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MedicalResearch.com Interview with:
Prof. Bor-Luen Chiang
Vice Superintendent, National Taiwan University Hospital
Professor of Graduate Institute of Clinical Medicine and Pediatrics
National Taiwan University
Attending Physician, Department of Medical research
National Taiwan University Hospital and
Yung-Sen Chang, MD MPH
Attending physician, Department of Pediatrics,
Taipei City Hospital Renai Br.
Adjunct Attending Physician, Department of Pediatrics
National Taiwan University Children’s Hospital
Adjunct Instructor, School of Medicine, National Yang-Ming University
Medical Research: What is the background for this study?
Prof. Chang: Sleep disturbance is a common disorder in the children with atopic dermatitis (AD) (reported in 47 to 60%), but no effective way of managing this problem had been established. In our preceding study, we found that lower nocturnal melatonin level was significantly associated with sleep disturbance in the patients with AD. Melatonin is a hormone secreted by the pineal gland which plays an important role in sleep regulation. In addition to sleep-inducing effects, melatonin also has anti-inflammatory and immunomodulatory properties which might be helpful for the management o fatopic dermatitis. Furthermore, melatonin has an excellent safety profile with minimal adverse effects, making it a good choice for children. Therefore, we aimed to evaluate whether melatonin is effective for improving the sleep problems and the dermatitis severity in children with atopic dermatitis.
Medical Research: What are the main findings?
Prof. Chang: From our double-blind, placebo-controlled crossover study, we found that after melatonin treatment, the sleep onset latency shortened by 21.4 minutes compared with placebo (from a mean of 44.9 minutes to 21.6 minutes). The Scoring Atopic Dermatitis Index (higher scores representing more severe dermatitis) also decreased by 9.9 compared with placebo (from a mean of 49.1 to 40.2). No adverse events were reported throughout the study.
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MedicalResearch.com Interview with:Raymond W. Lam, MD, FRCPC
Professor and Associate Head for Research
Department of Psychiatry, University of British Columbia
Director, Mood Disorders Centre, Djavad Mowafaghian Centre for Brain HealthExecutive Chair, Canadian Network for Mood and Anxiety Treatments (CANMAT)
Vancouver, BC, Canada
Medical Research: What is the background for this study?
Dr. Lam: Our multicentre team studied the effects of bright light therapy for nonseasonal depression. Light therapy is a non-pharmacological approach that has been studied as a treatment for seasonal affective disorder (SAD, or "winter depression"), but only a small number of studies has explored the use of light therapy in treating nonseasonal depression.
Clinical depression, known formally as Major Depressive Disorder (MDD) is the most common psychiatric disorder and one of the most common medical conditions worldwide. At any given time, at least 1 person in 20 (5% of the general population) is experiencing MDD, which will become the second-leading cause of disability worldwide by 2020, according to the World Health Organization.(more…)
MedicalResearch.com Interview with:
Jerome A. Leis, MD MSc FRCPC
Staff physician, General Internal Medicine and Infectious Diseases
Physician Lead, Antimicrobial Stewardship Team
Staff member, Centre for Quality Improvement and Patient Safety
Sunnybrook Health Sciences Centre
Assistant Professor, Department of Medicine, University of Toronto
Medical Research: What is the background for this study? What are the main findings?
Dr. Leis: Overuse of urinary catheters leads to significant morbidity among hospitalized patients. In most hospitals, discontinuation of urinary catheters relies on individual providers remembering to re-assess whether patients have an ongoing reason for a urinary catheter. We engaged all of the attending physicians to agree on the appropriate reasons for leaving a urinary catheter in place and developed a medical directive for nurses to remove all urinary catheters lacking these indications. This nurse-led intervention resulted in a significant reduction in urinary catheter use and catheter-associated urinary tract infections, compared with wards that continued to rely on usual practice.
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MedicalResearch.com Interview with:
Jason S. Gold MD FACS
Chief of Surgical Oncology, VA Boston Healthcare System
Assistant Professor of Surgery, Harvard Medical School
Brigham and Women’s Hospital
Medical Research: What is the background for this study?
Dr. Gold: Pancreas cancer is a lethal disease. While advances in the best available care for pancreas cancer are desperately needed, improvements can be made in addressing disparities in care. This study aimed to evaluate associations of social and demographic variables with the utilization of surgical resection as well as with survival after surgical resection for early-stage pancreas cancer.
Medical Research: What are the main findings?
Dr. Gold: The main findings are the following:
1: We found that less than half of patients with early-stage pancreas cancer undergo resection in the United States. Interestingly, the rate of resection has not changed with time during the eight-year study period.
2. We also found significant disparities associated with the utilization of surgical resection for early-stage pancreas cancer in the United States. African American patients, Hispanic patients, single patients, and uninsured patients were significantly less likely to have their tumors removed. There were regional variations in the utilization of surgical resection as well. Patients in the Southeast were significantly less likely to have a pancreas resection for cancer compared to patients in the Northeast.
3. Among the patients who underwent surgical resection for early-stage pancreas cancer, we did not see significant independent associations with survival for most of the social and demographic variables analyzed. Surprisingly, however, patients from the Southeast had worse long-term survival after pancreas cancer resection compared to those in other regions of the United States even after adjusting for other variables.
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MedicalResearch.com Interview with:
Claudia van Borkulo, MSc
University of Groningen, University Medical Center Groningen
Department of Psychiatry,
Research School of Behavioural and Cognitive Neurosciences,
Interdisciplinary Center for Psychopathology and Emotion Regulation,
Groningen, the Netherlands
Medical Research: What is the background for this study? What are the main findings?
Response: We consider psychiatric disorders as complex dynamical systems in which symptoms can interact with each other. This novel network approach to psychopathology – that is new to psychiatry – implies that a more densely connected network of symptoms of a disorder might be indicative of worse prognosis. Having one symptom can easily lead to developing more symptoms in a densely connected network, in which more symptoms reinforce each other. Reversely, a symptom in a less densely connected network will rarely turn on other symptoms. A densely connected network can theoretically be related to an increased vulnerability; because of the high level of mutual reinforcement, a small external stressor can induce a quicker transition from a healthy state to a depressed state for people with a more densely connected network.
In our study, we investigated the association between baseline network structure of depression symptoms and longitudinal course of depression. We compared the baseline network structure of persisters (defined as patients with MDD at baseline and depressive symptomatology at 2-year follow-up) and remitters (patients with MDD at baseline without depressive symptomatology at 2-year follow-up). While both groups have similar symptomatology at baseline, persisters have a more densely connected network compared to remitters. More specific symptom associations seem to be an important determinant of persistence of depression.
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MedicalResearch.com Interview with:
Leonard B. Bacharier, MD
Professor of pediatrics
Clinical Director, Division of Allergy, Immunology and Pulmonary Medicine
St Louis School of Medicine
Washington University
St Louis, MissouriMedical Research: What is the background for this study? What are the main findings?
Dr. Bacharier: Oral corticosteroids such as prednisone have become the standard of care for children whose colds tend to progress and lead to severe wheezing and difficulty breathing.
“But there are some studies that suggest these treatments don’t consistently work for young children. That’s why we want to find ways to prevent upper respiratory infections from progressing to lower respiratory tract illnesses. Once the episode gets going, standard interventions are less effective than would be desired”, reported Dr. Bacharier.
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MedicalResearch.com Interview with: Kevin M. Biglan, M.D., M.P.H
Professor of Neurology and the Associate Chair for Clinical Research
Department of Neurology and the Center for Human Experimental Therapeutics
University of Rochester School of Medicine and Dentistry
Rochester, New YorkMedical Research: What is the background for this study? What are the main findings?
Dr. Biglan: A therapeutic goal of research in Huntington Disease (HD) is the identification of treatments that delay the progression of disease and onset of illness in individuals at risk for developing manifest HD. Designing such efficacy trials is challenging. A major hurdle is the lack of practical primary outcome measures to assess the effect of an intervention on delaying disease onset. Use of the dichotomous endpoint of clinical diagnosis as the primary outcome requires large sample sizes and long duration of follow up in order to show a significant therapeutic effect on delaying disease onset. Continuous measures that can reliably distinguish cytosine-adenine-guanine (CAG) expanded individuals in the pre-manifest period may allow for the identification of potential disease modifying therapies using relatively smaller cohorts followed for shorter periods of time.
The Prospective Huntington At-Risk Observational Study (PHAROS)represents the largest observational study to clinically evaluate pre-manifest Huntington Disease wherein both research participants and investigators were unaware of Huntington Disease mutation status. Accordingly, PHAROS was uniquely designed to address, in an unbiased manner, those clinical features most associated with the CAG expansion during the prodromal phase in Huntington Disease. The identification of continuous outcome measures that are associated with HD in the pre-manifest period may facilitate the design and powering of future studies of potential disease modifying therapies prior to traditional motor diagnosis.
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MedicalResearch.com Interview with:
Adam R. Glassman, MS
Jaeb Center for Health Research
Tampa, FL 33647
Medical Research: What is the background for this study? What are the main findings?
Response: Diabetic retinopathy is a complication of diabetes that affects blood vessels in the retina. When diabetic retinopathy worsens to proliferative diabetic retinopathy, blood vessels in the retina can leak fluid or bleed, distorting vision. Diabetic retinopathy is the most common cause of vision loss among people with diabetes and the leading cause of blindness among working-age adults.
Scatter laser treatment, also called panretinal photocoagulation, has been standard therapy for the treatment of proliferative diabetic retinopathy since the 1970s. While effective in preserving central vision, laser therapy can reduce side vision and cause swelling in an area of the retina that is important for central vision. This study aimed to find an alternative therapy that avoided these undesirable side effects.
Eyes in this study were assigned randomly to treatment with intraocular anti-VEGF injections of Lucentis® or scatter laser treatment. The results of this study demonstrate that eye injections of Lucentis® are as effective for vision outcomes at 2 years as laser therapy. On average, vision among eyes treated with Lucentis® improved by about half a line on an eye chart, with virtually no improvement among eyes treated with laser therapy. Compared with laser-treated eyes, eyes treated with Lucentis injection on average had less side vision loss, less frequent development of swelling in the central retina, and fewer complex retina surgeries for retinal bleeding or retinal detachment.
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MedicalResearch.com Interview with:
Samuel Klempner, M.D. Assistant Professor
Division of Hematology/Oncology
UC Irvine Health
Orange, CA 92868Medical Research: What is the background for this study? What are the main findings?
Dr. Klempner: The background for our series is the concept that little is known about the genetic landscape of rare tumors such as acinic cell tumors, and that understanding genetic changes in tumors can identify treatment options. This paradigm can, and should, be extended beyond rare tumor types and many researchers are currently studying various tumor types. Another important background idea is that tumor genomic alterations may be more important than that anatomic site of origin. For example, I would argue that a breast cancer that harbors an EGFR mutation common to lung cancer could be treated similar to a lung cancer based on the genomic changes.
In our study we found another way that the BRAF protein and its downstream signaling may become activated through duplicating part of the protein called the kinase domain. This genetic event causes the pathway to be always "on" which is not normal, and likely drives cancer growth. However, BRAF kinase domain duplication appears sensitive to currently available drugs that target the BRAF pathway, as evidenced by the response in our patient. Thus, finding this change is important and may be able to guide a more personalized therapy choice. Importantly, we found BRAF kinase domain duplication across multiple different tumor types, suggesting this may be a recurrent event in some cancers. A very similar finding, involving duplication of the EGFR kinase domain, was also just reported (Cancer Discovery 2015;5:1155-1163) lending further validation to this mechanism of pathway activation in cancer.
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MedicalResearch.com Interview with:
Shahrzad Mavandadi, PhD
Research Health Science Specialist and Investigator
Veterans Integrated Services Network 4 Mental Illness Research,
Education, and Clinical Center
Corporal Michael J. Crescenz Veterans Affairs Medical Center
Philadelphia, Pennsylvania
Medical Research: What is the background for this study?
Dr. Mavandadi: Mental health (MH) conditions are underidentified and undertreated in later life. This is particularly true among subgroups of older adults who are more vulnerable to developing mental health issues, have poor access to specialty care, and are less responsive to treatment and therapy. Thus, we sought to evaluate longitudinal MH outcomes among low-income, community-dwelling older adults enrolled in an evidence-based, collaborative mental health care management service (i.e., the SUpporting Seniors Receiving Treatment And INtervention (SUSTAIN) program). The SUSTAIN program integrates mental health with primary care (which is where the majority of behavioral health conditions in later life are managed) and provides standardized, measurement-based, software-aided MH assessment and connection to community resources to older adults by telephone.
While there is a strong evidence base for the efficacy of collaborative care models for me conditions, little is known about the amount or level of patient and provider support that is needed to achieve optimal behavioral health outcomes. Thus, we specifically examined outcomes among older adults randomized to one of two program arms of varying intensity: MH symptom monitoring alone or mental health symptom monitoring plus MH care management. MH care management involved care managers who provided education, counseling, and decision support to patients and their primary care providers, a licensed mental health clinician who supervised the care managers, and the use of an algorithm to help guide pharmacological and non-pharmacological treatment plans. The sample consisted of 1018 older adults prescribed an antidepressant or anxiolytic by their non-behavioral health providers who presented with clinically significant symptoms at intake.
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MedicalResearch.com Interview with:
Dr. Mai-Britt Guldin PhD
Department of Public Health
Aarhus UniversityMedical Research: What is the background for this study?
Dr. Guldin: The background for this study is that death of a parent in childhood is experienced by 3-4% of children in Western societies, and we know such a loss is one of the most stressful and potentially harmful events in childhood. Therefore, we aimed to investigate how parental death may influence the long-term risk of suicide and how this risk differes by cause of parental death, age at loss, sex of child, socioeconomic factors and parental history of psychiatric illness.The sample size in this study is unparalleled by other studies on risk of suicide.
Medical Research: What are the main findings?
Dr. Guldin: The main findings were that in a population of 7.302,033 (in three Scandinavian countries), we identified 189,094 persons who lost a parent before the age of 18. Of these bereaved persons, 265 died from suicide. Compared to a control group of persons matched by age and sex, but who did not lose a parent before the age of 18, suicide was twice as common in the bereaved cohort (IRR = 2.02; 95% CI, 1.67-2.44). The risk remained high for at least 25 years of follow-up. The risk was particularly high for children who lost a parent due to suicide, but was also high for children who lost a parent due to other causes. The risk tended to be particularly high for boys who lost a mother and children losing a parent before the age of six.
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MedicalResearch.com Interview with:
Frederick W. Vonberg, MA, MBBS
Research Fellow in Neurocritical Care
Boston Children's Hospital and Harvard Medical School
Medical Research: What is the background for this study? What are the main findings?
Response: An association between schizophrenia and epilepsy has long been suspected, ever since people noticed similarities in some aspects of the presentation of the two conditions, and in their epidemiology. For example, people with epilepsy are thought to be more at risk of developing schizophrenia. Furthermore, a psychosis resembling schizophrenia can characterize some forms of epilepsy. Whether this link reflected an overlap in the genetics of the two conditions has remained a mystery, however. In this study, we used a recently developed computational technique to show that there is a significant positive correlation between the genetic variants that are associated with epilepsy and with those that are associated with schizophrenia.
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MedicalResearch.com Interview with:
Ying Xian, PhD
Assistant Professor of Medicine.
Member in the Duke Clinical Research Institute
Medical Research: What is the background for this study? What are the main findings?Dr. Xian: Intravenous tissue plasminogen activator (tPA) is the only FDA approved medical therapy to reduce disability and improve outcomes for patients with acute ischemic stroke. But treatment with tPA also carries the risk of symptomatic intracranial hemorrhage (sICH), which is often fatal. Nearly half of ischemic stroke patients are taking antiplatelet drugs such as aspirin and/or clopidogrel prior to stroke. We found these patients had higher risk for sICH when treated with tPA. But the risk is relatively small. For every 147 patients on aspirin treated with tPA, only 1 more symptomatic intracranial hemorrhage as compared with those treated with tPA without prior antiplatelet therapy. The risk is slightly higher among those on dual antiplatelet therapy of aspirin and clopidogrel (number needed to harm 60). Despite the higher bleeding risk, patients treated with tPA on prior antiplatelet therapy appeared to have better functional outcomes in terms of ambulatory status and modified Rankin scale than those not on prior antiplatelet therapy. Therefore, overall the benefits of thrombolytic therapy may outweigh the risks.
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MedicalResearch.com Interview with: Dr. Ulla Uusitalo PhD
University of South Florida, Tampa
Medical Research: What is the background for this study? What are the main findings?
Dr. Uusitalo: The TEDDY Study is an international prospective cohort study with the primary goal to identify environmental causes of Type 1 Diabetes (T1D). It is carried out in six clinical research centers, in four countries: University of Colorado Health Science Center (US), Georgia Regents University (US), Pacific Northwest Diabetes Research Institute (US), Turku University Hospital (Finland), Institute of Diabetes Research (Germany), and Lund University (Sweden), since 2004.
One possible environmental factor related to Type 1 Diabetes etiology is diet. Dietary supplements including probiotics as well as various types of infant formulas including probiotic fortified infant formula are studied. The microbial composition of gut has been shown to be associated with the development of Type 1 Diabetes. Colonization of the infant gut starts already in utero and early microbial exposures have been found to be important in defining the trajectory of colonization. Probiotics have been demonstrated to induce favorable immunomodulation and it has been suggested that probiotic treatment could prevent T1D. Therefore we wanted to study the early exposures of probiotic and risk of islet autoimmunity, a condition often preceding Type 1 Diabetes.
This study produced very interesting results. The main finding was that we found 60% decrease in the risk of islet autoimmunity among children with HLA genotype of DR3/4 (high risk), who were exposed to probiotics during the first 27 days of life.
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MedicalResearch.com Interview with:
Dr. Christina Mangurian MD
Associate Professor of Clinical Psychiatry
UCSF School of Medicine and the
UCSF Department of Psychiatry's first Director of Diversity
Medical Research: What is the background for this study? What are the main findings?
Dr. Mangurian: People with severe mental illness (SMI, e.g., schizophrenia and bipolar disorder) die 25 years earlier than the general population, often from cardiovascular disease. The ADA and APA guidelines recommend annual diabetes screening of this population when taking certain antipsychotic medications. Despite these guidelines, nearly 70% of this population remain unscreened. This has huge public health implications and likely costs our public health system a tremendous amount in undiagnosed disease.
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MedicalResearch.com Interview with:
Farzin Fakhry, MD PhD Candidate
Depts. of Epidemiology & Radiology
Erasmus MC Rotterdam, the Netherlands and
Myriam Hunink MD, PhD Professor
Professor of Radiology and Clinical Epidemiology
Erasmus University Medical Center Rotterdam
Adjunct Professor of Health Decision Science
Harvard T.H. Chan School of Public Health, Boston
Medical Research: What is the background for this study? What are the main findings?Response: Intermittent claudication is the classical symptomatic form of peripheral arterial disease (PAD) and affects approximately 20-40 million people worldwide. These patients experience significant functional disability resulting in a sedentary lifestyle and reduced quality of life. In the Endovascular Revascularization And Supervised Exercise (ERASE) study we compared a combination therapy of endovascular revascularization plus supervised exercise versus the recommended care of supervised exercise only as first-line treatment for patients with intermittent claudication.
Results from the ERASE study showed that after one year follow up patients in both groups showed significant improvements in their treadmill walking distance and disease specific quality of life. Yet, patients receiving the combination therapy had more rapid and significantly greater improvement in their walking performance and disease specific quality of life compared to the patients following a supervised exercise program only.
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MedicalResearch.com Interview with:
Dr. David Bluemke MD, PhD, MsB
Director of Radiology and Imaging Sciences
NIH Clinical Center
Bethesda, MDMedical Research: What is the background for this study? What are the main findings?Dr. Bluemke: Heart disease is the most common reason for death and disability of adults in the United States and worldwide. This study evaluated 1,840 adults in six communities throughout the United States, ages 45-84. In normal adults, the heart is a muscle, but various injuries to the heart (the most severe being a myocardial infarction/ heart attack) occur over an individual’s lifetime. These injuries result in heart muscle being replaced by a scar composed of fibrous tissue. The main finding is that even in healthy, middle and older adults, about 1 in 12 adults in the U.S. have developed scars in the heart. Most of these (80%) are not detected by their doctor, or by other tests such as ECG.
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MedicalResearch.com Interview with:
William N. William Jr., MD
Associate Professor
Chief, Head and Neck Section
Department of Thoracic / Head and Neck Medical Oncology
The University of Texas M. D. Anderson Cancer Center
Houston, TX
Medical Research: What is the background for this study? What are the main findings?
Dr. William: Oral pre-malignant lesions are often characterized as white and/or red patches in the mouth and are considered risk factors for oral cancer. This is why it might be best for people to go get oral cancer screening done if they suspect that there might be a problem. However, not all oral pre-malignant lesions will turn into cancer, but when this happens, surgery is usually recommended, many times leading to serious speech and swallowing dysfunction. Chemoprevention is the use of compounds to prevent cancers from happening before they occur. One of the greatest challenges in developing chemopreventive agents is to identify the population at highest cancer risk.
The Erlotinib Prevention of Oral Cancer (EPOC) trial involved 379 patients at five sites across the country. All had premalignant lesions in their mouths. Following study enrollment, participants were evaluated for LOH, a chromosomal abnormality characterized by the loss of chromosomal regions, which include tumor suppressor genes. Patients who tested positive for LOH were considered to be at high risk for oral cancer and were randomized to receive either erlotinib (an EGFR inhibitor drug) or a placebo for one year. The study’s primary endpoint was to determine if fewer patients treated with erlotinib would develop oral cancer, compared to those that received placebo. The EPOC study demonstrated that LOH predicted a higher oral cancer risk. LOH-negative patients had a three-year cancer-free survival rate of 87 percent compared to 74 percent for the LOH-positive group. However, patients who took erlotinib showed no statistical difference in terms of cancer-free survival rates after three years: 74 percent for participants given erlotinib compared to 70 percent for those taking placebo. Patients with both LOH and EGFR copy number gains had the highest incidence of cancer, but still did not benefit from erlotinib.
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MedicalResearch.com Interview with:
Dr. Brad A. Bryan Ph.D Assistant ProfessorBiomedical Sciences
Texas A&M University Health Science Center, Houston, TX
Department of Biomedical Sciences
Texas Tech University Health Sciences Center
Medical Research: What is the background for this study? What are the main findings?
Dr. Bryan: In 2008 it was serendipitously discovered that the beta blocker propranolol was effective in treating a common benign pediatric vascular tumor called infantile hemangioma. Over the past few years, my lab has been working on elucidating the molecular mechanisms underlying this pediatric tumor and part of this research involved uncovering how propranolol selectively inhibited these tumors. At the same time these studies were taking place, other members of my lab were working on pre-clinical drug development for a malignant vascular tumor called angiosarcoma. Patients with angiosarcoma are faced with very few effective treatment options and abysmal survival rates, so we decided to see if the efficacy of beta blockade observed in infantile hemangiomas transferred to angiosarcomas. Using preclinical in vitro and in vivo assays, we demonstrated that propranolol was very effective at inducing cell death, blocking migration, and inhibiting tumor growth in our angiosarcoma models. This work was subsequently published in Plos One (Stiles et al., 2013). I then collaborated with Dr. William Chow from San Francisco to test propranolol off-label (propranolol is FDA approved to treat high blood pressure, heart dysrhythmias, thyrotoxicosis, and essential tremors) in a patient suffering from a rapidly expanding angiosarcoma covering a large portion of his face. In the window between diagnosis of the tumor and the start of chemotherapy, we placed the patient on oral propranolol. The redness of the tumor very rapidly lessened and remarkably by only one week of treatment the tumor margins appeared to significantly shrink. We examined biospies of the tumor before and after only one week of propranolol and found that the proliferation of the tumor cells was markedly decreased following beta blockade. After a combination of propranolol, chemotherapy, and radiation that lasted several months, the patient had no detectable metabolically active tumor or distant metastases. We published these findings in JAMA Dermatology (Chow et al., 2015).
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MedicalResearch.com Interview with:
Saleh A Almenawer, MD
Neurosurgeon, Hamilton Health Sciences
McMaster University
Hamilton, ON CanadaMedical Research: What is the background for this study?
Dr. Almenawer: The current standard therapy for acute ischemic stroke is intravenous tissue plasminogen activator (tPA), which improves survival and functional outcomes when administered as early as possible after stroke. However, the use of intravenous tPA is limited by the narrow therapeutic time window (< 4.5 hours) and by important contraindications, including coagulopathy, recent surgery, or stroke or head injury within the past 3 months. This leaves as few as 10% of patients presenting with ischemic stroke eligible for treatment with tPA. Moreover, intravenous tPA is associated with long recanalization times and poor revascularization rates in proximal large vessel occlusion, and the prognosis of these patients remains poor. The limitations of intravenous tPA have spurred interest in endovascular thrombectomy for acute ischemic stroke, analogous to thrombolysis versus percutaneous coronary intervention for myocardial infarction. Several randomized clinical trials (RCTs) have compared clinical outcomes of mechanical thrombectomy to standard medical treatment with intravenous tPA. The current study was a meta-analysis of RCTs that aimed to answer the question of whether endovascular thrombectomy is associated with better clinical outcomes than intravenous tPA, and accordingly, whether endovascular thrombectomy should replace intravenous tPA as the new standard of care for ischemic stroke.
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