What Interventions Can Reduce Epidemic Physician Burnout?

MedicalResearch.com Interview with:

Colin P. West, MD, PhD, FACP  Divisions of General Internal Medicine and Biomedical Statistics and Informatics Departments of Internal Medicine and Health Sciences Research Mayo Clinic

Dr. Colin West

Colin P. West, MD, PhD, FACP
Divisions of General Internal Medicine and Biomedical Statistics and Informatics
Departments of Internal Medicine and Health Sciences Research
Mayo Clinic

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

Response: Physician burnout has reached epidemic levels, as documented in national studies of both physicians in training and practicing physicians demonstrating burnout rates in excess of 50%. Consequences include negative effects on patient care, professionalism, physicians’ own care and safety, and the viability of health-care systems. We conducted a systematic review and meta-analysis to better understand the quality and outcomes of the literature on approaches to prevent and reduce burnout.

We identified 2617 articles, of which 15 randomized trials including 716 physicians and 37 cohort studies including 2914 physicians met inclusion criteria. Across interventions, overall burnout rates decreased from 54% to 44%, emotional exhaustion score decreased from 23.82 points to 21.17 points, and depersonalization score decreased from 9.05 to 8.41. High emotional exhaustion rates decreased from 38% to 24% and high depersonalization rates decreased from 38% to 34%.

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Triclosan-Containing Sutures Reduced Surgical Infections in Children

MedicalResearch.com Interview with:
Dr Marjo Renko MD
PEDEGO Research Unit
University of Oulu
Oulu, Finland

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

Response: For over a decade there has been suture materials containing antiseptic agent in the market. Trials in adults have shown some possible benefits from these sutures as in some studies they have reduced occurrence of surgical site infections. Only one small study had so far been published in children and thus we decided to carry out a large trial comparing sutures containing triclosan with ordinary ones.

Our trial included over 1500 children who came to Oulu University Hospital for surgery. Surgical site infections were carefully monitored. Surgical site infections occurred in 2.6 % of the children who received absorbing sutures containing triclosan while that occurred in 5,4 % of the children who received ordinary sutures.

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Addition of Virtual Reality To Treadmill Training Reduced Falls in Older Adults

MedicalResearch.com Interview with:

Anat Mirelman, PhD Director- Laboratory of Early Markers of Neurodegeneration (LEMON) Center for the study of Movement , Cognition and Mobility (CMCM) Department of Neurology Tel Aviv Sourasky Medical Center Sackler School of Medicine, Tel Aviv University Tel Aviv 64239, Israel

Dr. Anat Mirelman

Anat Mirelman, PhD
Director- Laboratory of Early Markers of Neurodegeneration (LEMON)
Center for the study of Movement , Cognition and Mobility (CMCM)
Department of Neurology
Tel Aviv Sourasky Medical Center
Sackler School of Medicine, Tel Aviv University
Tel Aviv 64239, Israel

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

Response: The main aim of this research was to evaluate the efficacy of using a motor cognitive training using virtual reality in reducing fall frequency and fall risk in older adults.

Falls are a leading cause of morbidity and mortality in older adults. The prevalence of falls is huge, with one out of every 3 adults aged 65 years or older will fall at least once per year, with approximately half of these fallers suffering multiple falls in this period . These statistics are even higher in neurodegenerative conditions such as in Parkinson’s disease and in people with cognitive impairments. For example, studies have shown that as much as 80% of people with Parkinson’s disease fall each year. So many older adults are falling.
The consequences of falls are huge.

The most dramatic result is hip fracture. But this is relatively rare. However, even in the absence of a fracture or other injury, falls often lead to fear of falling, social isolation, and depression, which in turn often leads to inactivity, muscle weakness, impaired balance and gait, more falls, more social isolation. In other words, falls often start a vicious cycle, which has many important negative health consequences. Falls are associated with morbidity and mortality and they also have a huge economic impact. In many western countries, 1-2% of healthcare dollars are spent on falls.

For many years, age-associated changes in muscle strength, balance and gait were viewed as the key factors that contribute to the risk of falls. However, more recently, we and others showed that certain aspects of cognition are also critical to safe ambulation. For example people with AD often fall, almost to the same amount as people with PD, highlighting the cognitive component of falls. This makes sense intuitively if we Imagine the cognitive skills we need just to cross a busy intersection. These tasks require executive function, specially, planning, the ability to avoid obstacles, and the ability to perform two or more tasks at the same time.

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Marijuana Use Doubles From 2002-2014

MedicalResearch.com Interview with:

Dr. Wilson Compton MD, Deputy Director National Institute on Drug Abuse

Dr. Wilson Compton

Dr. Wilson Compton MD, Deputy Director
National Institute on Drug Abuse

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

Response: The study found that overall past year marijuana use by adults in the U.S. increased by more than 30% in the past dozen years, and 10 million more people were using marijuana in 2014 than in 2002. Use of marijuana on a daily (or near daily) basis increased even more markedly. In 2002, 3.9 million adults in the U.S. reported using marijuana daily or nearly every day, and the number more than doubled to 8.4 million by 2014. Along with this increase in use, we found that U.S. adults perceptions of the potential harms from using marijuana greatly decreased. Despite scientific evidence of potential harms, adults are much less convinced about dangers associated with using marijuana. These reductions in perceived harm were strongly associated with the increases in use.

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IV Iron Postoperatively May Reduce Infections, Transfusions and Length of Hospital Stay

MedicalResearch.com Interview with:
Alhossain A. Khalafallah, Clinical Professor
Menzies Institute for Medical Research,
University of Tasmania, Australia
Consultant Haematologist
Launceston General Hospital
Australia

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

Response: There are limited data regarding the effect of postoperative anemia on patient’s outcomes. The issue of postoperative anemia was noticeably to affect a large cohort of patients world-wide.

This study was aiming at comparing the new approach with a single ferric carboxymaltose infusion versus standard or routine usual care for management of postoperative anemia.

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Most Childhood Asthma Responds To Evidenced Based Therapy

MedicalResearch.com Interview with:

Francine M. Ducharme, MD, FRCPC Professor, Departments of Paediatrics and Social and Preventive Medicine University of Montreal Associate Director of Clinical Research and Knowledge Transfer, Research Centre, CHU Ste-Justine

Prof. Francine Ducharme

Francine M. Ducharme, MD, FRCPC
Professor, Departments of Paediatrics and Social and Preventive Medicine
University of Montreal
Associate Director of Clinical Research and Knowledge Transfer, Research Centre, CHU Ste-Justine

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

Response: The management of asthma attacks in preschoolers has been the subject of much recent debate. The results of a study published in 2009 had shaken the pediatric world. The study reported that preschool children with viral-triggered flare-ups did not respond to standard treatment and, suggesting that this was due to their young age. Such finding was particularly worrisome as the majority of asthma-related emergency room visits and hospitalizations involve preschool children.

We conducted this large cohort study in which children aged 1 to 17 years with a moderate or severe asthma attack were treated using the established evidence-based therapy adjusted to the severity of exacerbation assessed by the Pediatric Respiratory Assessment Measure (PRAM), administered rapidly. We explored the determinants of the failure of emergency therapy. Age was not a factor. Instead, in addition to attack severity and symptoms between attacks, it was rather the presence of respiratory viral infection or fever triggering the attack that was more often associated with treatment failure, i.e., higher hospitalization rates, more returns to the emergency room, and reduced speed of recovery over the 10 days after discharge. Viral detection occurred more frequently in preschoolers (67%) than in older children (46%) with asthma.
Nevertheless, the results confirm the overall effectiveness of standard treatment, adjusted to the severity of the attack and administered early, in the vast majority of children, regardless of age and viral detection. Indeed, although a failure rate of nearly 40% was expected in this group of children with moderate to severe attack, only 17% of the participants did not respond to standard treatment. This rate was significantly higher (19%) in children with viral infection compared to uninfected children (13%).

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Early Invasive Cardiac Treatment Provided Longterm Benefit For Patients With Non-STEMI Acute Coronary Syndrome

MedicalResearch.com Interview with:

Prof Lars Wallentin, MD PHD Senior Professor Cardiology, Senior Scientist Cardiology Uppsala Clinical Research Center, Uppsala University

Prof. Lars Wallentin

Prof Lars Wallentin, MD PHD
Senior Professor Cardiology
Uppsala Clinical Research Center,
Uppsala University 

MedicalResearch.com: What is the background for this study?
Response: The FRISC2 study was performed 1996 – 1998 and reported 1999 for the first time a significant reduction in death and myocardial infarction by early invasive compared to non-invasive treatment strategy in patients with non-ST-elevation acute coronary syndrome (NSTE-ACS). The results at 6 months, 1, 2 and 5 years were published in The Lancet and pivotal in changing the treatment guidelines and thereby improving outcomes in patients with NSTE-ACS. These findings were within the next few years verified in the TACTICS-TIMI18 and RITA3 trials. However the later performed ICTUS trial, starting after these results were published and accordingly with a substantial early crossover to the invasive arm, showed neutral results. Recently the reduction in event rates by an early invasive strategy was again validated in patients above 80 years of age, which were less well represented in the initial trials. These benefits of an early invasive strategy have previously been shown sustained for at least five years based on results from the FRISC2, RITA3, and ICTUS trials. The FRISC2 and TACTICS-TIMI18 trials also showed that the benefits with an early invasive strategy seemed confined to patients with signs of myocardial necrosis as indicated by elevated troponin level at entry. In addition the FRISC2 trial found that the benefits were larger in patients with signs of inflammatory activity as indicated by a high level of growth differentiation factor 15 (GDF-15) at entry. These pivotal results have been the basis for the current international treatment guidelines recommending an early invasive treatment strategy in patients with NSTE-ACS and elevated troponin and/or other indicators of a raised risk.
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EPICUP Uses Epigenetic Biomarkers To Identify Cancers of Unknown Primary

MedicalResearch.com Interview with:

Dr. Manel Esteller Director of the Epigenetics and Cancer Biology Program (PEBC) Bellvitge Biomedical Research Institute

Dr. Manel Esteller

Dr. Manel Esteller
Director of the Epigenetics and Cancer Biology Program (PEBC)
Bellvitge Biomedical Research Institute

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

Response: Cancer of Unknown Primary (CUP) occurs when the patient is diagnosed with a metastasis but the primary tumor is not found. It accounts for around 5-10% of tumors around the world and the survival is very poor. Until now, only in 25% of cases the primary site was identified after diagnosis pipeline. We are showing herein that the use of epigenetic profiling, based in the determination of the chemical marks occurring in DNA that are tumor-type specific, reaches a diagnoses of 87% of cases.

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Pre-Hospital Start of IV Thrombolysis Might Result in Improved Functional Outcome in Stroke Patients.

MedicalResearch.com Interview with:
Dr Alexander Kunz MD
Department of Neurology
Charité-University Medicine Berlin
Berlin, Germany

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

Response: Systemic thrombolysis with tissue plasminogen activator (tPA) in acute ischemic stroke has been an approved therapy for over 20 years now. To date, tPA can be administered to eligible patients within a 4.5 hours time window after the onset of symptoms. Results from large thrombolysis trials and meta-analyses have shown, that the beneficial effects of tPA are inversely correlated with the delay from symptoms onset to start of tPA treatment. This relationship is frequently summarized in the slogan “Time is brain!”

Currently, several research groups are evaluating the concept of pre-hospital thrombolysis using a mobile stroke treatment unit (MSTU) in order to achieve significant reductions in onset-to-treatment delays. MSTU are specialized ambulances equipped with a CT scanner and a mini-laboratory.

In Berlin, Germany, we have been operating an MSTU (stroke emergency mobile vehicle, STEMO) since 2011. Previous studies had shown that start of tPA treatment was 25min earlier when patients were cared by STEMO than within conventional care, i.e. admission to hospital by regular ambulance and in-hospital tPA treatment. However, these studies did not prove, that earlier treatment in STEMO is associated with better outcome. Therefore, the aim of the current study was to compare 3-month functional outcome after tPA in patients with acute ischemic stroke who received STEMO care vs conventional care.

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IV Iron Administered Post-Op May Improve Surgical Outcomes

MedicalResearch.com Interview with:
Clinical Professor Alhossain A.Khalafallah
Menzies Institute for Medical Research,
University of Tasmania, Australia
Consultant Haematologist
Senior Staff Specialist
Launceston General Hospital,
Australia

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

Response:
1. Iron deficiency is one of the most common nutritional deficiencies worldwide, affecting up to one third of the population worldwide.
2. Prevalence of anaemia in orthopaedic surgery ranges between 10-20% with the main cause of anaemia identified as nutritional deficiency.
3. New intravenous iron preparations have been developed at a higher purchase price than oral iron. Iron carboxymaltose, as one example, remains underutilised in the treatment of perioperative anaemia.
4. To our knowledge, this study is the first to compare the efficacy, safety and long term effect on iron stores and length of hospital stay in the postoperative anaemia setting.

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Relatively Brief Physical Activity Can Offset Adverse Effects of Prolonged Sitting

MedicalResearch.com Interview with:

Ulf Ekelund, PhD FACSM Professor Department of Sports Medicine Norwegian School of Sport Sciences

Prof. Ulf Ekelund

Ulf Ekelund, PhD FACSM
Professor
Department of Sports Medicine
Norwegian School of Sport Sciences 

MedicalResearch.com: What is the background for this study? What are the main findings?
Response: It is known that long sitting hours may be detrimental to health and previous studies have suggested associations between sitting time and all-cause mortality.However, it is not known whether physical activity can eliminate the increased risk of death associated with long sitting time.

We found that at least one hour of physical activity every day appear to offset the increased risk associated with more than eight hours of sitting. We also found that those who were physically inactive and sat for less than 4 hours every day were at greater risk compared with those who were physically active and sat for more than 8 hours providing further evidence on the benefits of physical activity.

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Pandemic of Global Physical Inactivity Costs Lives and Money

MedicalResearch.com Interview with:

Ding Ding (Melody), Ph.D., MPH NHMRC Early Career Senior Research Fellow/Sydney University Postdoctoral Research Fellow Prevention Research Collaboration Sydney School of Public Health The University of Sydney

Dr. Melody Ding

Ding Ding (Melody), Ph.D., MPH
NHMRC Early Career Senior Research Fellow
Sydney University Postdoctoral Research Fellow
Prevention Research Collaboration
Sydney School of Public Health
The University of Sydney

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

Response: Understanding the true burden of a pandemic is indispensable for informed decision making. After decades of research, we now have established knowledge about how physical inactivity contributes to pre-mature deaths and chronic diseases, but the economic burden of physical inactivity remains unquantified at the global level. Through estimating the economic burden of physical inactivity for the first time, we hope to create a business case for investing in cost-effective actions to promote physical activity at the global levels.

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Genetic Locus of Natural Killer T-cell Lymphoma Risk Identified

MedicalResearch.com Interview with:
Jin-Xin BEI, Ph.D.
Principal Investigator
State Key Laboratory of Oncology in South China
Sun Yat-sen University Cancer Center
Guangzhou China

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

Response: Natural killer T-cell lymphoma (NKTCL) is a rare and aggressive malignancy with remarkable prevalence in Asian and Latin populations, suggesting that the heritable components contribute to the disease risk. Epstein-Barr virus (EBV) infection has been thought to be major factor associated with NKTCL, and EBV DNA load in plasma has been applied in clinical managements, including diagnosis, treatment response and prognosis. However, the genetic component leading to NKTCL predisposition has not been identified.

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Almost A Million Cases of Maternal Syphilis Globally Per year

MedicalResearch.com Interview with:

N. Saman Wijesooriya Public Health Advisor/Technical Advisor Centers for Disease Control and Prevention

N. Saman Wijesooriya

N. Saman Wijesooriya
Public Health Advisor/Technical Advisor
Centers for Disease Control and Prevention

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

Response: The article Global burden of maternal and congenital syphilis in 2008 and 2012: a health systems modeling study by Wijesooriya, et al published in the August 2016 issue of The Lancet Global Health (Open source – http://dx.doi.org/10.1016/S2214-109X(16)30135-8) estimates the incidence and prevalence of maternal and congenital syphilis for both time periods and identifies gaps antenatal care access and syphilis testing and treatment services to assess progress in the global elimination of congenital syphilis, or mother-to-child transmission of syphilis, as a public health problem.

Untreated maternal syphilis is understood to be transmitted from mother-to-child in utero in 50% of cases resulting in tragic adverse pregnancy outcomes, or congenital syphilis infections, including early fetal death, stillbirth, preterm birth, low birthweight, neonatal death, and congenital infections in infants. Since most maternal syphilis infections are asymptomatic, it is recommended that screening for syphilis use a combination of serological tests for pregnant women and treatment of syphilis seropositive women with at least 2.4 million units of benzathine penicillin intramuscularly early in pregnancy to prevent most congenital syphilis infections.

In 2007, the World Health Organization responded to estimates indicating 2 million maternal and 1.5 congenital syphilis infections would occur annually without treatment and launched the global initiative for the Elimination of Congenital Syphilis (ECS). The strategy includes reducing the prevalence of syphilis in pregnant women and mother-to-child transmission of syphilis. The objective is for countries to achieve high performing antenatal care systems providing access to antenatal care to more than 95% of pregnant women, syphilis testing for more than 95% of pregnant women, and treatment for more than 95% of seropositive women to attain a congenital syphilis rate of 50 or fewer cases per 100,000 live births.

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Rubber Band vs Artery Ligation Surgery for Hemorrhoids Compared

MedicalResearch.com Interview with:

Mr Steven Brown MBChB, BMedSci, FRCS, MD Reader in Surgery Honorary Secretary to the ACPGBI Consultant colorectal surgeon University of Sheffield, UK

Mr. Steven Brown

Mr Steven Brown MBChB, BMedSci,
FRCS, MD

Reader in Surgery
Honorary Secretary to the ACPGBI
Consultant colorectal surgeon
University of Sheffield, UK

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

Response: Haemorrhoids are common. One in 4 of us will at some time have symptoms that can be directly attributed to piles. Whilst most symptoms will settle spontaneously or with improvement to our lifestyle, there remains a large group of patients who require intervention to reduce symptomatology. Numerous interventions exist ranging from relatively minor office therapy to procedures that may take several weeks to recover from. Haemorrhoidal artery ligation (HAL) is one of the more recent surgical operations for haemorrhoidal therapy. It has been introduced certainly into the UK associated with a significant element of media hype purporting ‘painless surgery for piles’. Substantial subsequent medical literature has also suggested an efficacy rivaling other more invasive procedures. Too good to be true? Perhaps. Several systematic reviews have highlighted the lack of good quality data as evidence for the advantages of the technique. A well designed randomized controlled trial was required.

The existing literature on  haemorrhoidal artery ligation at the time of the trial suggested the procedure was most effective for less symptomatic haemorrhoids (those that are associated with bleeding and/or minor prolapse; grade II or mild III piles). These type of haemorrhoids also tend to be the most common requiring intervention. The most frequently used alternative procedure for these grade of haemorrhoids in the UK is rubber band ligation (RBL), a simple office therapy not requiring anaesthetic. Hence participants with this grade of haemorrhoids were chosen as the participants with RBL as the comparator. Multiple outcomes were investigated but a patient reported outcome measure of recurrence was chosen as the primary outcome.

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Behavioural Activation Therapy Offers Lower-Cost, Effective Treatment for Depression

MedicalResearch.com Interview with: David A Richards, PhD Professor of Mental Health Services Research and NIHR Senior Investigator University of Exeter Medical School University of Exeter St Luke's Campus Exeter United Kingdom MedicalResearch.com: What is the background for this study? Response: Depression is a common mental health disorder affecting around 350 million people worldwide. Untreated depression is expected to cost the global economy US$5.36 trillion between 2011 and 2030. Many patients request psychological therapy, but the best-evidenced therapy—cognitive behavioural therapy (CBT)—is complex and costly. A simpler therapy—behavioural activation (BA)—might be as effective and cheaper than is CBT. We aimed to establish the clinical efficacy and cost-effectiveness of BA compared with CBT for adults with depression. MedicalResearch.com: What are the main findings? Response: We found that behavioural activation, a simpler psychological treatment than CBT, can be delivered by junior mental health workers with less intensive and costly training, with no lesser effect than CBT. Effective psychological therapy for depression can be delivered without the need for costly and highly trained professionals MedicalResearch.com: What should readers take away from your report? Response: Our findings have substantial implications given the increasing global pressure for cost containment across health systems in high-income countries and the need to develop accessible, scalable interventions in low-income and middle-income countries. Such countries might choose to investigate the training and employment of junior workers over expensive groups of psychological professionals. Our results, therefore, offer hope to many societies, cultures, and communities worldwide, rich and poor, struggling with the effect of depression on the health of their people and economies. MedicalResearch.com: What recommendations do you have for future research as a result of this study? Response: Research into these and other potential strengths of behavioural activation in the context of implementation science is necessary for the hope and promise offered by the COBRA trial to be fulfilled. Now that we have support for BA as a treatment that is clinically effective and cost-effective, we can shift our efforts to focus on what is necessary to produce sustainable large-scale behavioural activation implementation across diverse geographical and cultural settings. MedicalResearch.com: Is there anything else you would like to add? Response: Although many obstacles exist to successful dissemination in addition to training of Mental Health Workers, our findings suggest that health services globally could reduce the need for costly professional training and infrastructure, reduce waiting times, and increase access to psychological therapies. MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community. Citation: Lancet Cost and Outcome of Behavioural Activation versus Cognitive Behavioural Therapy for Depression (COBRA): a randomised, controlled, non-inferiority trial Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions. More Medical Research Interviews on MedicalResearch.com

Prof. David Richards

MedicalResearch.com Interview with:
Professor David A. Richards, PhD
Professor of Mental Health Services Research and NIHR Senior Investigator
University of Exeter Medical School
University of Exeter
St Luke’s Campus
Exeter United Kingdom

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

Response: Depression is a common mental health disorder affecting around 350 million people worldwide. Untreated depression is expected to cost the global economy US$5.36 trillion between 2011 and 2030.

Many patients request psychological therapy, but the best-evidenced therapy—cognitive behavioural therapy (CBT)—is complex and costly. A simpler therapy—behavioural activation (BA)—might be as effective and cheaper than is CBT. We aimed to establish the clinical efficacy and cost-effectiveness of BA compared with CBT for adults with depression.

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Any Amount of Excess Body Weight Associated With Higher Risk of Premature Death

MedicalResearch.com Interview with:

Dr. Shilpa Bhupathiraju, PhD Harvard T.H. Chan School of Public Health

Dr. Shilpa Bhupathiraju

Dr. Shilpa Bhupathiraju, PhD
Harvard T.H. Chan
School of Public Health

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

Response: We wanted to investigate the association between body mass index (BMI) and mortality across major global regions. In doing so, we wanted to take into account important methodological limitations which plagued prior reports of BMI and mortality. One such limitation is reverse causality where a low body weight is the result of an underlying illness rather than the cause. Another major problem is confounding due to smoking where smokers have lower body weights than non-smokers but have much higher mortality rates.

Therefore, to obtain an unbiased association between BMI and mortality, our primary pre-specified analysis was restricted to never smokers and those who had no existing chronic diseases at the start of the study.

In this group, we found that those with a BMI of 22.5-<25 kg/m2 (considered a healthy weight range) had the lowest mortality risk during the time they were followed. The risk of mortality increased significantly with excess body weight. A BMI of 25-<27.5 kg/m2 (in the overweight range) was associated with a 7% higher risk of premature death; BMI of 27.5-<30 kg/m2 (also in the overweight range) was associated with a 20% higher risk; a BMI of 30.0-<35.0 kg/m2 was associated with a 45% higher risk; a BMI of 35.0-<40.0 kg/m2 was associated with a 94% higher risk; and a BMI of 40.0-<60.0 kg/m2 was associated with a nearly 3-fold risk. In general, we found that the association of excess body weight with mortality was greater in younger than older people and in men than women. Most importantly, the associations were broadly consistent in the major global regions we examined, including Europe, North America, Australia and New Zealand, East Asia, and South Asia.

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Fluoxetine – Prozac – May Be Best Choice For Pediatric and Adolescent Depression

MedicalResearch.com Interview with:

Andrea Cipriani, MD PhD Associate Professor Department of Psychiatry University of Oxford Warneford Hospital Oxford UK

Dr. Andrea Cipriani

Andrea Cipriani, MD PhD
Associate Professor
Department of Psychiatry
University of Oxford
Warneford Hospital
Oxford UK

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

Dr. Cipriani: Major depressive disorder is common in young people, with a prevalence of about 3% in school-age children (aged 6–12 years) and 6% in adolescents (aged 13–18 years). Compared with adults, children and adolescents with major depressive disorder are still underdiagnosed and undertreated, possibly because they tend to present with rather undifferentiated depressive symptoms—eg, irritability, aggressive behaviours, and school refusal. Consequences of depressive episodes in these patients include serious impairments in social functioning, and suicidal ideation and attempts. Our analysis represents the most comprehensive synthesis of data for currently available pharmacological treatments for children and adolescents with acute major depressive disorder (5620 participants, recruited in 34 trials).

Among all antidepressants, we found that only fluoxetine was significantly better than placebo. According to our results, fluoxetine should be considered the best evidence-based option among antidepressants when a pharmacological treatment is indicated for children and adolescents with moderate to severe depression. Other antidepressants do not seem to be suitable as routine treatment options.

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Moderate Nuts and Olive Oil Intake Do Not Increase Body Weight in Setting of Mediterranean Diet

MedicalResearch.com Interview with:

Dr Ramon Estruch, MD PhD Senior Consultant in the Internal Medicine Department of the Hospital Clinic Barcelona

Dr. Ramon Estruch

Dr Ramon Estruch, MD PhD
Senior Consultant in the Internal Medicine Department of the Hospital Clinic
Barcelona

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

Dr. Estruch: Although weight stability requires a balance between calories consumed and calories expended, it seems that calories from vegetable fats have different effects that calories from animals on adiposity. Thus, an increase of dietary fat intake (mainly extra virgin olive oil or nuts) achieved naturally in the setting of Mediterranean diet does not promote weight gain or increase in adiposity parameters such as waist circumference.
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Global Economic Downturn Linked To Increase in Cancer Deaths

MedicalResearch.com Interview with:
Dr Mahiben Maruthappu MD
Senior Fellow to the CEO,NHS England
Imperial College
London, UK

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

Dr. Maruthappu: There are over 8 million deaths due to cancer every year.
At the same time, there are around 40 million unemployed people across the OECD, 7
million more than before the recent economic crisis. As a result,
understanding how economic changes affect cancer survival, given the
economic climate, is crucial.

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Smoking During Pregnancy Raises Risk of Schizophrenia in Offspring

MedicalResearch.com Interview with:

Alan S. Brown, M.D., M.P.H. Professor of Psychiatry and Epidemiology Columbia University Medical Center Director, Program in Birth Cohort Studies, Division of Epidemiology New York State Psychiatric Institute

Dr. Alan Brown

Alan S. Brown, M.D., M.P.H.
Professor of Psychiatry and Epidemiology
Columbia University Medical Center
Director, Program in Birth Cohort Studies, Division of Epidemiology
New York State Psychiatric Institute

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

Dr. Brown: Smoking during pregnancy is a risk factor for several pregnancy-related outcomes including low birthweight and preterm birth. Evidence for a link with schizophrenia is scant. We analyzed a maternal biomarker of smoking called cotinine, a nicotine metabolite, in mothers of nearly 1,000 schizophrenia cases and 1,000 controls in a national birth cohort in Finland. We found that heavy smoking in pregnancy was related to a 38% increase in schizophrenia risk in offspring and that as cotinine levels increased even in the more moderate smokers risk of schizophrenia also increased.

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Controversy Over Salt Content Continues

Salt-SodiumMedicalResearch.com Interview with:
Prof Andrew Mente PhD
Clinical Epidemiology and Biostatistics, McMaster University
Hamilton, Canada

MedicalResearch.com Editor’s Note:  Dr. Mente discusses his Lancet publication regarding salt intake below.  Dr. Mente’s findings are disputed by the American Heart Association (AHA).  A statement from the AHA follows Dr. Mente’s comments.

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

Prof. Mente: Several prospective cohort studies have recently reported that both too little and too much sodium intake is associated with cardiovascular disease or mortality. Whether these associations vary between those individuals with and without high blood pressure (hypertension) is unknown.

We found that low sodium intake (below 3 g/day), compared to average intake (3 to 6 g/day), is associated with more cardiovascular events and mortality, both in those with high blood pressure and in those without high blood pressure. So following the guidelines would put you at increased risk, compared to consuming an sodium at the population average level, regardless of whether you have high blood pressure or normal blood pressure.

High sodium intake (above 6 g/day) compared to average intake, was associated with harm, but only in people with high blood pressure (no association in people without high blood pressure).

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Compression Stockings May Not Reduce Post Thrombotic syndrome in DVT Patients

MedicalResearch.com Interview with:

Riyaz Bashir MD, FACC, RVT Professor of Medicine Director, Vascular and Endovascular Medicine Department of Medicine Division of Cardiovascular Diseases Temple University Hospital Philadelphia, PA 19140

Dr. Riyaz Bashir

Riyaz Bashir MD, FACC, RVT
Professor of Medicine
Director, Vascular and Endovascular Medicine
Department of Medicine
Division of Cardiovascular Diseases
Temple University Hospital
Philadelphia, PA 19140

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

Dr. Bashir: The use of compression stockings in the prevention of post thrombotic syndrome following an episode of deep vein thrombosis is common in clinical practice. However, the evidence to suggest its efficacy has been put into question by the recent publication of the SOX trial. Since this was the largest randomized controlled trial to date addressing this issue, it has led to clinicians questioning whether compression stockings should be used at all in these patients.

The main finding of this meta-analysis was that in patients with deep venous thrombosis, use of elastic compression stockings does not significantly reduce the development of post thrombotic syndrome. However the current body of evidence is limited and we believe at present it is too early to give up on the use of this therapy, which may benefit many subgroups of patients.

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Worsening Depression in Older Adults May Be Early Indicator of Dementia

MedicalResearch.com Interview with:

Saira Saeed Mirza, MD, PhD Department of Epidemiology Erasmus MC, Rotterdam

Dr. Saira Saeed Mirza

Saira Saeed Mirza, MD, PhD
Department of Epidemiology
Erasmus MC, Rotterdam

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

Dr. Mirza: Depressive symptoms appearing in late-life have been extensively studied for their relationship with dementia. They not only very frequently occur in demented patients, but also predict dementia. In this context, depressive symptoms have largely been assessed at a single time point only. However, depression is a disorder which remits and relapses, and symptoms do not remain same over the years. Given this pattern of disease progression, it is more important to study the course of depression over time in relation to long-term health outcomes such as dementia, rather than assessing it at a single time-point, which will neglect the course of depression. This is important as people follow different courses of depression, and different courses of depression might carry different risks of dementia.

When we studied the course of depressive symptoms over 11 years in community dwelling older adults in Rotterdam, and the subsequent risks of dementia, we observed that only those who had increasing or worsening depressive symptoms were at a higher risk of dementia. In this group of people, about one in five persons developed dementia. Interestingly, people suffering from high depressive symptoms at a single time point were not at a higher dementia risk than those without depressive symptoms.

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Eosinophil Count Identifies COPD Patients Who May Benefit From Inhaled Steroids

MedicalResearch.com Interview with:

Danny MvBryan, MD Vice president, Clinical Development & Medical Affairs, Respiratory Boehringer Ingelheim Pharmaceuticals, Inc.

Dr. Danny MvBryan

Danny McBryan, MD
Vice president, Clinical Development & Medical Affairs, Respiratory
Boehringer Ingelheim Pharmaceuticals, Inc.

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

Dr. MvBryan: The new post-hoc analysis from the WISDOM study shows a routine blood test could help identify the small minority of patients with severe or very severe COPD who may benefit from the addition of inhaled corticosteroids (ICS). This post-hoc analysis was recently published online in The Lancet Respiratory Medicine.

For 80 percent of patients in the WISDOM study, the use of ICS on top of SPIRIVA HANDIHALER (a long-acting muscarinic antagonist – LAMA) and salmeterol (a long-acting beta-agonist – LABA) had no additional benefit in reducing the risk of exacerbations, compared to SPIRIVA HANDIHALER and the LABA without ICS.

The post-hoc analysis shows that these patients can be easily identified by measuring the level of white blood cells, called eosinophils. Patients with levels lower than 4 percent (300 cells/µL) were associated with a lack of response to ICS.

The WISDOM study evaluated stepwise withdrawal of inhaled corticosteroids (ICS) in severe to very severe COPD patients with a history of exacerbation. WISDOM was a 12-month, double-blind, parallel-group, active-controlled study in which all patients received triple therapy (tiotropium 18 μg once daily, salmeterol 50 μg twice daily and fluticasone 500 μg twice daily) for a six-week run-in period. Patients were randomized 1:1 to continue triple therapy or stepwise withdrawal of ICS over 12 weeks (dose reduction every six weeks).

The WISDOM data show that in patients with severe to very severe COPD, the risk of moderate/severe exacerbations during one year of follow-up was non-inferior between those patients who continued on inhaled corticosteroids and those where ICS therapy was withdrawn in a stepwise manner.

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Transfusions in Resource Poor Settings Can Become Safer With UV-Based Pathogen Inactivation

MedicalResearch.com Interview with:

Prof Jean-Pierre Allain Principal Investigator, Department of Haematology University of Cambridge, Cambridge Blood Centre Cambridge UK

Prof. Jean Pierre Allain

Prof Jean-Pierre Allain
Principal Investigator, Department of Haematology
University of Cambridge, Cambridge Blood Centre
Cambridge UK

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

Prof. Allain: In sub-Saharan Africa (SSA), 70% of the transfusions are in the form of  whole blood units (generally 1 or 2). Lack of resources limit the safety
measures to donor questionnaire, viral/bacterial testing (HIV, HCV, HBV
and Syphilis). Other measures used in rich countries i.e. nucleic acid
testing, filtration, bacterial culture etc. are not done because of cost.
Pathogen reduction would be an effective way to overcome these issues as
it is able to inactivate viruses, bacteria, parasites and nucleated
cells in one go, provided it is applied to whole blood and affordable.

The study consisted in assessing the efficacy of such a method (Mirasol
using riboflavin and UV illumination) taking inactivation of plasmodium
as major endpoint of a randomised controlled clinical trial called AIMS
(African Investigation of Mirasol System).

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Advanced colorectal cancer still has a poor prognosis and more active drugs are urgently needed

MedicalResearch.com Interview with:
Silvia Marsoni, M.D.
Director Clinical Research Office
FPO – Istituto di Candiolo IRCCS
Institute for Cancer Research @ Candiolo
10060 Candiolo (TO) – Italy

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

Dr. Marsoni: In the Lancet Oncology of April 20 2016, clinical investigators of 4 major Italian academic institutions presented the results of the HERACLES trial, the first phase 2 trial in patients with refractory colorectal cancer and HER2 amplification. HERACLES is based on robust preclinical data, previously generated by the same authors in patient-derived xenografts (PDX) of metastatic colorectal cancers harboring amplification of the HER2 oncogene. The HER2 positive PDXs responded to the anti HER2 combination of trastuzumab and lapatinib, but not to either drug alone.

After validation of the commercial assays to test for HER2 positivity in colorectal cancer specimens, the authors tested the experimentally selected combination of trastuzumab plus lapatinib in HER2-amplified metastatic colorectal cancer patients. They screened 914 patients who were refractory to chemotherapy and had KRAS codon 12/13 wild-type colorectal carcinoma, identifying 46 patients as having HER2-positive disease, enrolling 27 eligible patients into the study. Eight (30%) patients achieved objective responses — the highest proportion ever reported in treatment-refractory patients. One (4%) patient achieved a complete response; 20 (74%) achieved eithera complete response, partial response, or stable disease; median response duration was 9·5 months, median progression-free survival was 5·2 months (95% CI 4–8); and median overall survival was 11·5 months (95% CI 8–17). In this heavily pretreated population – all patients had received and failed standard chemotherapies and anti EGFR antibodies, and mostly also anti-agiogenic therapy – , these outcome data are extraordinary, and they show the relevance of HER2 as a target in the treatment of colorectal cancer. These results represent a breakthrough, even though they apply to a limited subgroup of patients of a very common and lethal malignancy.

MedicalResearch.com: What should clinicians and patients take away from your report?

Dr. Marsoni: This is the first trial to assess the combination of trastuzumab and lapatinib in patients with HER2-positive colorectal carcinoma. Our findings show that the dual HER2-targeted therapy of trastuzumab and lapatinib is active, in the absence of any chemotherapy backbone, in heavily pretreated patients with metastatic disease. Additionally, our results indicate that the extent of HER2 gene copy number elevation and HER2 expression might be associated with response to treatment.

Dr. Marsoni: What recommendations do you have for future research as a result of this study?

Dr. Marsoni: The results of this study could change the day-to-day clinical care management of patients with advanced HER2-positive colorectal cancer. Our findings could lead to the use of trastuzumab and lapatinib in earlier lines of treatment, with a possibility of chemotherapy-free regimens, for patients with HER2-positive tumors. A phase 3 trial is warranted to provide more definitive data.

MedicalResearch.com: Is there anything else the authors would like to state?

Silvia Marsoni, the trial clinical coordinator at the Candiolo Cancer Institute in Turin, states that “Our results show that HER2 amplification is a clinically relevant genetic alteration in metastatic colorectal cancer. This alteration can be screened for with established diagnostic tools, can be acted on at the therapeutic level, and occurs in 3–5% of patients with KRAS codon 12/13 wild-type metastatic colorectal cancer, similar to that of other genetic alterations for which licensed drugs are effective (eg, in lung cancer).”

Livio Trusolino, who conducted the preclinical studies at the Candiolo Cancer Institute, states that “Our results have been achieved through a precision oncology programme that started with preclinical findings in pertinent in-vivo models, was strengthened by a rigorous methodological effort for molecular diagnosis, and finally resulted in the identification of a new therapeutic option for patients with HER2-positive colorectal cancer tumours”.

Finally, Salvatore Siena from the Niguarda Cancer Center in Milan, the principal investigator of the clinical programme, states “We are proud to provide positive results of a targeted therapy for metastatic colorectal cancer, several years after the first publication in 2004 of the efficacy of EGFR-targeted monoclonal antibody. HER2-targeted therapy is a new tool in the therapeutic armamentarium for HER2-positive metastatic colorectal cancer”.

HERACLES is an independent research trial funded by the major Italian cancer charity AIRC (Associazione Italiana per la Ricerca sul Cancro – Programma Speciale AIRC 5per1000) and by the Fondazione Oncologia Niguarda. We also acknowledge contributions from F Hoffman-La Roche.

Citation:

Dual-targeted therapy with trastuzumab and lapatinib in treatment-refractory, KRAS codon 12/13 wild-type, HER2-positive metastatic colorectal cancer (HERACLES): a proof-of-concept, multicentre, open-label, phase 2 trial

Sartore-Bianchi, Andrea et al. Published Online: 20 April 2016

The Lancet Oncology , Volume 0 , Issue 0 ,
DOI: http://dx.doi.org/10.1016/S1470-2045(16)00150-9

 

Simple Blood Test To Identify COPD Patients Who Will Benefit from Inhaled Steroids

MedicalResearch.com Interview with:
Dr Henrik Watz MD
Pulmonary Research Institute at Lung Clinic Grosshansdorf
Airway Research Center North, German Center for Lung Research
Grosshansdorf, Germany

Medical Research: What is the background for this study? What are the main findings?

Dr Watz : While bronchodilators are the mainstay therapy for all patients with COPD some patients benefit from the addition of inhaled corticosteroids in case of frequent exacerbations. So far only little data exist that help clinicians to better characterize those patients that may benefit from the continuation of inhaled corticosteroids on top of dual bronchodilation with a LABA and a LAMA.

Post-hoc analyses of the WISDOM dataset suggest that those patients, who have blood eosinophil counts of 4 % or greater or 300 eosinophils per µL or more have less exacerbations, when inhaled corticosteroids are continued compared to patients, in whom inhaled corticosteroids are withdrawn. Patients with less than 4 % eosinophils or less than 300 eosinophils in peripheral blood, who represent 80 % of the study population in WISDOM, did not benefit from a continuation of inhaled corticosteroids.

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Ponatinib Currently Not Indicated As First Line CML Chronic Phase Therapy

MedicalResearch.com Interview with:

Prof Jeffrey H Lipton, PhD, MD, FRCPC  Princess Margaret Cancer Centre Toronto, ON Canada

Prof. Jeffrey Lipton

Prof Jeffrey H Lipton, PhD, MD, FRCPC
Princess Margaret Cancer Centre
Toronto, ON Canada

MedicalResearch.com: What is the background and purpose for this study?

Dr. Lipton: Ponatinib is a third generation tyrosine kinase inhibitor that has been shown to be extremely effective in treating patients with chronic myeloid leukemia resistant to other drugs.  Because of this, it was decided to look at it in newly diagnosed patients in a randomized study against imatinib.  The study was terminated prematurely because of evidence of vascular toxicity that became evident in the phase 1 and 2 studies of ponatinib in previously treated patients with resistant disease.   Continue reading

Does Delaying PCI in STEMI Heart Attack Improve Outcomes?

MedicalResearch.com Interview with:

Dr Henning Kelbæk MD Department of Cardiology Roskilde Hospital,Denmark

Dr. Henning Kelbæk

Dr Henning Kelbæk MD
Department of Cardiology
Roskilde Hospital,Denmark

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

Dr. Kelbæk : In some patients with large acute myocardial infarcts, stent implantation has been connected with an increased risk of downstream embolization of thrombus material and disturbances in flow impairing the prognosis of the patients. In accordance, previous smaller studies have shown a benefit in angiographic and other parameters in patients having their stent implanted several hours after the artery was opened, allowing the infarct-related lesion to ’cool down’ and residual thrombus to dissolve under antithrombotic treatment, whereas larger randomised trials focusing on clinical data have been missing.

Our trial demonstrates, a bit surprisingly, that delaying or deferring stent implantation does not improve the clinical outcome of these patients.  Continue reading

Sustained Release Dexamfetamine Reduced Cocaine Use in Crack Addicts

MedicalResearch.com Interview with:

Mascha Nuijten MSc Researcher/ PhD candidate Brijder Research (PARC) The Hague The Netherlands

Mascha Nuijten

Mascha Nuijten MSc
Researcher/ PhD candidate
Brijder Research (PARC)
The Hague
The Netherlands

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

Response: Crack-cocaine dependence is a complex disorder, for which no proven effective pharmacotherapy is yet available. Prior to our study, sustained-release dexamfetamine was found to be a promising treatment for cocaine dependence in several studies, but no studies so far had shown a convincing benefit in terms of substantial cocaine use reductions. Therefore, we investigated the efficacy of sustained-release (SR) dexamphetamine in a robust dose of 60 mg/day in chronic crack-cocaine dependent patients.

We found that the number of days of cocaine use decreased with almost 40% in the dexamfetamine group, compared with 9% in the matched placebo group. In addition, the number of cocaine self-administrations on days that patients used crack-cocaine decreased with 43% in the dexamfetamine group and with 7% in the placebo group. Thus, SR dexamfetamine both contributed to cocaine abstinence and to cocaine use reductions.

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Infertility Risk after Chemotherapy For Pediatric Cancers Varies Between Men and Women

MedicalResearch.com Interview with:

Eric J. Chow, MD, MPH Hematology-Oncology Attending physician, Seattle Childrens Hospital Assistant professor of Pediatrics, University of Washington School of Medicine Member of the Clinical Research and Public Health Sciences Divisions Fred Hutchinson Cancer Research Center

Dr. Eric Chow

Eric J. Chow, MD, MPH
Hematology-Oncology
Attending physician, Seattle Childrens Hospital
Assistant professor of Pediatrics, University of Washington School of Medicine
Member of the Clinical Research and Public Health Sciences Divisions
Fred Hutchinson Cancer Research Center 

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

Dr. Chow: Adverse effects on reproductive health including fertility is a known side effect of cancer therapy, particularly among survivors of childhood cancer. However, much of this risk has been linked to radiation exposure and less is known about the effects of chemotherapy treatment alone, particularly newer drugs now being used more widely. We used data from over 10,000 survivors of childhood cancer (plus nearly 4000 siblings) who are part of the Childhood Cancer Survivor Study (CCSS) which tracks people who were diagnosed with the most common types of childhood cancer before the age of 21 and treated at 27 institutions across the US and Canada between 1970 and 1999, and who had survived at least 5 years after diagnosis. The CCSS is a resource study open to all investigators and funded by the US National Cancer Institute (ccss.stjude.org). We specifically examined the effect of various doses of 14 commonly used chemotherapy drugs on pregnancy and livebirth and excluded survivors who received any radiotherapy to the pelvis or the brain.

MedicalResearch.com:  What are the main findings?

Dr. Chow: We found that among male cancer survivors, the chance of pregnancy by age 45 was only around 50%, compared to 80% for siblings. However, among female cancer survivors, the chance of pregnancy by age 45 was approximately 70%, compared to over 80% for siblings. In male survivors, the likelihood of fathering a child generally decreased as cumulative exposure to alkylating drugs increased. High cumulative doses of several alkylating drugs (cyclophosphamide, ifosfamide, procarbazine) and cisplatin were linked with a significantly reduced likelihood of fathering a child.

In female survivors, only busulfan and high doses of lomustine were directly linked with lower likelihood of pregnancy. Overall, female survivors were still less likely to conceive compared to siblings but the effect was much smaller compared to men. However, in women, the difference was more pronounced for those who delayed pregnancy until they were aged 30 or older.

MedicalResearch.com: What should clinicians and patients take away from your report?

Dr. Chow: This is one of the largest studies of pregnancy and livebirth in cancer survivors of any age who were not exposed to radiation to the pelvis or brain (both of which can affect fertility). Importantly, our study features a broad range of commonly used chemotherapy drugs, given at varying doses, which allowed us to establish more precise dose thresholds associated with reduced likelihood of having (female) or fathering (male) a pregnancy for survivors of childhood cancer. Our findings showed an association between risk and exposure to cisplatin among male survivors, a finding not consistently reported in survivors of childhood cancer previously. Female survivors can be reassured by the result that chemotherapy-specific effects in women who did not receive any radiotherapy to the pelvis or brain were generally few in relation to these reproductive outcomes, except with exposure to the highest cumulative doses.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Dr. Chow: The association of risk with cisplatin exposure among male survivors should be investigated further, given the increase in use of that drug in many contemporary pediatric treatment protocols. 

MedicalResearch.com: Is there anything else you would like to add?

Dr. Chow: Counseling of patients and families about fertility preservation before initiation of cancer therapy is important. In particular, sperm banking should be encouraged for all newly diagnosed pubertal men, since this is a proven method of fertility preservation.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:

Pregnancy after chemotherapy in male and female survivors of childhood cancer treated between 1970 and 1999: a report from the Childhood Cancer Survivor Study cohort

Chow, Eric J et al.

The Lancet Oncology , Volume 0 , Issue 0 ,
DOI: http://dx.doi.org/10.1016/S1470-2045(16)00086-3

Published 22 March 2016

 

 

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

More Medical Research Interviews on MedicalResearch.com

 

Dr. Eric Chow (2016). Infertility Risk after Chemotherapy For Pediatric Cancers Varies Between Men and Women MedicalResearch.com

Arimidex and Tamoxifen Both Useful for Early Breast Cancer But with Different Safety Profiles

MedicalResearch.com Interview with:

Professor Jack Cuzick, PhD, FMedSci, FRCP(hon) Director, Wolfson Institute of Preventive Medicine and Head, Centre for Cancer Prevention Queen Mary University of London.

Prof. Jack Cuzick

Professor Jack Cuzick, PhD, FMedSci, FRCP(hon)
Director, Wolfson Institute of Preventive Medicine and
Head, Centre for Cancer Prevention
Queen Mary University of London.

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

Dr. Cuzick: Ductal carcinoma in situ (DCIS) is a very early form of breast cancer, where cancer cells are present in milk ducts, but have not spread to the surrounding breast tissue. It is estimated that approximately a fifth of all screen-detected breast cancers are DCIS, with around 4,800 people diagnosed with DCIS in the UK each year.

Our IBIS-II DCIS trial looked at 2,980 postmenopausal women with DCIS in 14 countries, who were either given anastrozole or tamoxifen for five years after surgery.

The two groups had a similar number of cases of the disease recurring, whether they took tamoxifen or anastrozole. Those who took anastrozole had an 11 per cent lower rate of recurrence of DCIS or invasive cancer than those who took tamoxifen, but this difference was not significant. The similar NSABP B-35  trial found a 29% reduction with anastrozole and the combined analysis of the two trials indicated a significant 21% reduction.

The key difference between the two groups were in the side effects of the medication. Women who took anastrozole experienced fewer womb and ovarian cancers and non melanoma skin cancers, and fewer deep vein thromboses and gynecological issues, compared with those who took tamoxifen. However more fractures and musculoskeletal side effects were seen among those receiving anastrozole.

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Vaginal Progesterone Did Not Prevent Preterm Death or Delivery

MedicalResearch.com Interview with:

Charles J. Lockwood, MD Member of of the March of Dimes Board of Trustees Dean at Morsani College of Medicine Senior Vice President, USF Health and Professor of Obstetrics & Gynecology, and Public Health The University of South Florida

Dr. Charles Lockwood

Charles J. Lockwood, MD
Member of of the March of Dimes Board of Trustees
Dean at Morsani College of Medicine
Senior Vice President, USF Health and Professor of Obstetrics & Gynecology, and Public Health The University of South Florida 

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

Dr. Lockwood: There remain questions about the utility of vaginal progesterone therapy in asymptomatic women with singleton gestations at risk for preterm birth. The OPPTIMUM study investigators conducted a double-blind, randomized, placebo-controlled trial of vaginal progesterone delivered via a pessary releasing 200 mg per day (n=618) vs. placebo (n=610) from around 22 to 34 weeks gestation among women at high risk for prematurity on the basis of a characteristic history and/or the presence of cervicovaginal fetal fibronectin or a cervical length less than 25 mm in length on transvaginal ultrasound.  The primary endpoints were fetal death or preterm birth before 34 weeks (obstetrical outcome), or a composite of neonatal mortality or morbidities (neonatal outcome).  The authors found that progesterone had no significant impact on either primary endpoint, with an adjusted OR of 0·86, 95% CI: 0·61-1·22 for obstetrical outcomes and an OR of 0·62, 95% CI:0·38-1·03 for neonatal outcomes.

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Bacterial Alterations Precede Necrotising Enterocolitis In Low Birthweight Infants

MedicalResearch.com Interview with:
Phillip I. Tarr, MD
Melvin E. Carnahan MD Professor of Pediatrics
Director, Pediatric Division of Gastroenterolgy and Nutrition
Washington University in St Louis School of Medicine
St Louis, MO 63110, USA

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

Dr. Tarr: There is a longstanding belief that gut bacteria are relevant to the developing necrotising enterocolitis (NEC). We have established dysbiosis in the gut before NEC occurs, suggesting this ecological perturbation might be causal.

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Outcome of Psychosis Better If Patients Stop Cannabis

MedicalResearch.com Interview with:
Dr Sagnik Bhattacharyya
Reader in Translational Neuroscience and Psychiatry
Institute of Psychiatry, Psychology & Neuroscience, KCL
Consultant Psychiatrist, Early Intervention Pathway
Director, Maudsley Early Intervention in Dual Diagnosis clinic
Psychosis Clinical Academic Group, South London & Maudsley NHS Foundation Trust
King’s Health Partners 

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

Dr. Bhattacharyya: Cannabis is the most commonly used illicit drug in the world and its use has been linked to the onset of psychotic disorders such as schizophrenia. Whilst a lot of research has investigated the association between cannabis use and the development of psychosis, there is less clarity regarding the consequences of continued cannabis use in those with an established psychotic disorder. We therefore pooled together all available evidence from studies that specifically looked at the effects of cannabis use on outcome following the onset of psychosis. Based on data from more than 16000 patients with a first episode or more established psychosis, our results show that continued cannabis use is consistently associated with poor outcome in the form of more relapses (as indexed by psychiatric hospitalisation), longer hospitalisations and increased positive symptoms. However, outcomes were not as bad if cannabis use was discontinued following the onset of psychosis.

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Fosaprepitant reduces chemoradiotherapy-induced emesis in patients treated for cervical cancer

MedicalResearch.com Interview with:
Dr Christina H Ruhlmann PhD

Department of Oncology
Odense University Hospital, Denmark 

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

Response: The background for the GAND-emesis study is the result of a phase II study in patients with gynecological cancer receiving fractionated radiotherapy and concomitant weekly cisplatin 40 mg/m2. In that study, patients received weekly antiemetic prophylaxis with palonosetron and prednisolone, and we found that 57% of patients were continuously free from emesis (sustained no emesis) during 5 weeks of treatment. We hypothesized that the addition of a NK1 receptor antagonist could increase the number of patients with sustained no emesis, and we therefore planned the GAND-emesis study: a multinational, randomised, placebo-controlled, double-blind study that has recently been published.

MedicalResearch.com: What are the main findings?

Response: In the GAND-emesis study we compared efficacy of weekly antiemetic prophylaxis with fosaprepitant, palonosetron, and dexamethasone to placebo, palonosetron, and dexamethasone during 5 weeks of radiotherapy and concomitant weekly cisplatin 40 mg/m2 for cervical cancer. The primary endpoint was sustained no emesis during 5 weeks of treatment (competing risk analysis). We found that the proportion of patients with sustained no emesis was 48.7% for the placebo group compared with 65.7% for the fosaprepitant group, and the treatments were well tolerated. To our knowledge, this is the first study to investigate the efficacy of a NK1 receptor antagonist during 5 weeks of chemoradiotherapy.

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Dengue During Pregnancy Linked to Adverse Fetal Outcomes

MedicalResearch.com Interview with:
Mrs Enny S Paixão

London School of Hygiene & Tropical Medicine
London UK 

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

Response: Dengue is a vector borne disease endemic in more than 100 countries (mainly in South America and southeast Asia) and is spreading to new areas, with outbreaks of increasing magnitude and severity. It is estimated that each year, 390 million people are infected with dengue and 96 million develop clinical symptoms. Despite of the importance of this disease, the effects of disease during pregnancy on fetal outcomes remain unclear. Using the published scientific literature, we investigated the risk of stillbirth, miscarriage, preterm birth, and low birth weight for women who had dengue infection during pregnancy.

This study showed some evidence that dengue infection alone, in the absence of clinical symptoms, does not affect the outcome of pregnancy, but also that clinical dengue during pregnancy seems to increase the frequency of stillbirth, prematurity, and low birthweight.

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Botulinum Toxin A Injections Helpful For Some Patients With Peripheral Neuropathic Pain

MedicalResearch.com Interview with:
Nadine Attal, MD PhD
Professeur associée de l’UVSQ
INSERM U 987 et CETD
CHU Ambroise Paré
92100 Boulogne-Billancourt

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

Dr. Attal: The background for this study is based on the findings of experimental studies in animals and healthy subjects indicating that botulinum toxin type A  (BTX-A) may have analgesic activity independent of its effect on muscle tone.

BTX-A has been reported to have analgesic effects against peripheral neuropathic pain in prior trials, but the quality of the evidence was generally low, as it was derived mostly from small pilot studies and no study has evaluated the relevance of repeated administrations for the treatment of NP. Furthermore, the clinical profiles of the patients responding to BTX-A have not been fully characterized.

MedicalResearch.com: What should clinicians and patients take away from your report?

Dr. Attal: They should take away that two repeated subcutaneous administrations of botulinum toxin type A are effective in peripheral  neuropathic pain but mostly in patients with allodynia and/or limited thermal deficits. BTX-A also appears to be particularly effective on paroxysmal pain (ie electric shock like pain).

Finally, the efficacy of a second administration of BTX-A is enhanced over the first injection.

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Cesarean Section May Increase Risk of Childhood Leukemia

MedicalResearch.com Interview with:

Erin Marcotte, Ph.D. Assistant Professor Division of Epidemiology and Clinical Research Department of Pediatrics University of Minnesota

Dr. Erin Marcotte

Erin Marcotte, Ph.D.
Assistant Professor
Division of Epidemiology and Clinical Research
Department of Pediatrics
University of Minnesota

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

Dr. Marcotte: Recently there have been several studies that indicate a higher risk of immune-related disorders, such as type-I diabetes, asthma, and allergies, among children born by cesarean delivery. Our analysis used pooled data from 13 independent studies of childhood leukemia that were conducted in 9 different countries. We used data on over 33,000 children to investigate the relationship between birth by cesarean delivery and risk of childhood leukemia. We did not find an association between cesarean delivery overall and childhood leukemia. However, when we looked at emergency cesarean deliveries and pre-labor (planned) cesarean deliveries separately, we found a 23% increase in risk of acute lymphoblastic leukemia among children born by pre-labor cesarean delivery.

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Patients May Benefit From New Combination Therapy For HER2-Negative Metastatic Breast Cancer

MedicalResearch.com Interview with:

Massimo Cristofanilli, MD, FACP Professor of Medicine Associate Director of Translational Research and Precision Medicine Department of Medicine-Hematology and Oncology Robert H Lurie Comprehensive Cancer Center Feinberg School of Medicine Chicago, IL 60611

Dr. Massimo Cristofanilli

Massimo Cristofanilli, MD, FACP
Professor of Medicine
Associate Director of Translational Research and Precision Medicine
Department of Medicine-Hematology and Oncology
Robert H Lurie Comprehensive Cancer Center
Feinberg School of Medicine
Chicago, IL 60611 

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

Dr. Cristofanilli: The majority of breast cancer are estrogen-receptor positive and therefore candidate for treatment with endocrine therapy in the adjuvant and advanced settings. The most significant issue in the management of estrogen-receptor positive metastatic breast cancer is the development of drug resistance. Very few effective options are available for patients that demonstrate progression of disease while on standard endocrine therapy, particularly in premenopausal women and/or women that have even progressed on chemotherapy. The study demonstrated that the combination of fulvestrant with palbociclib, a novel inhibitor of CDK4/6 kinases, significantly improve response to treatment and delays disease progression with minimal toxicity.  Continue reading

Study Identifies Predictors of Treatment-Resistant Schizophrenia

Theresa Wimberley PhD student National Centre for Register-based Research School of Business and Social Sciences Aarhus University

Theresa Wimberley

MedicalResearch.com Interview with:
Theresa Wimberley
PhD student
National Centre for Register-based Research
School of Business and Social Sciences
Aarhus University

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

Response: Approximately 30% of patients with schizophrenia suffer from treatment-resistant schizophrenia, i.e. they do not respond to first-line antipsychotic treatment. Identification of high-risk patients as early as possible is crucial in order to optimize treatment and improve prognosis. In a large population-based cohort of patients diagnosed with schizophrenia we found the following candidate predictors of treatment resistance:

  • younger age at diagnosis,
  • living in less urban areas,
  • paranoid schizophrenia subtype,
  • a history of psychiatric hospital admission,
  • personality disorder,
  • suicide attempt, and
  • psychotropic drug use.

    Additionally, as opposed to other studies using treatment-based proxies for treatment-resistant schizophrenia, this study not only considered clozapine users as treatment resistant. We extended the proxy definition to include patients eligible for clozapine, as clozapine is considered to be under-prescribed. We found similar results regardless of definition used.

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Immune Modulator Ozanimod Shows Promise in Multiple Sclerosis

MedicalResearch.com Interview with:

Dr Jeffrey A Cohen MD Neurological Institute Cleveland Clinic, Cleveland OH 44195, USA

Dr. Jeffrey Cohen

Dr Jeffrey A Cohen MD
Mellen Center, Neurological Institute
Cleveland Clinic, Cleveland
OH 44195, USA

Medical Research: What is the background for this study? What are the main findings?

Dr. Cohen: Fingolimod, a non-selective sphingosine 1-phosphate receptor (S1PR) modulator, was the first oral medication approved to treat relapsing multiple sclerosis.  Though generally well tolerated, fingolimod’s first dose cardiac effects and other potential adverse effects complicate its use.  Ozanimod is a selective S1PR modulator with several other potentially advantageous pharmacologic properties.

The results of phase 2 RADIANCE trial were recently published.  In this trial, participants were randomized to placebo (n=88), ozanimod 0.5 mg (n=87), or ozanimod 1 mg (n=83) PO once daily for 24 weeks.  The mean cumulative number of gadolinium-enhancing lesions on monthly MRI scans at weeks 12-24, the primary endpoint, was reduced from 11.1 +/- 29.9 with placebo to 1.5 +/- 3.7 with ozanimod 0.5 mg and 1.5 +/- 3.4 with ozanimod 1 mg (both p<0.0001).  Other MRI endpoints supported the primary endpoint.  Ozanimod was well tolerated with good safety.  Importantly, the dose up-titration protocol effectively mitigated first dose cardiac effects.

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Two Generic Lamotrigine Medications Demonstrate Bioequivalence in Epilepsy

MedicalResearch.com Interview with:

Dr. Michael Privitera MD Professor of the Department of Neurology and director of the Epilepsy Center University of Cincinnati Neuroscience Institute

Dr. Michael Privitera

Dr. Michael Privitera MD
Professor of the Department of Neurology and director of the Epilepsy Center
University of Cincinnati Neuroscience Institute 

Medical Research: What is the background for this study? What are the main findings?

Dr. Privitera: Generic substitution of medications has saved the American health care system billions of dollars per year. However, based on a series of uncontrolled studies, patients and clinicians share concerns that generic substitution of antiepileptic drugs may lead to loss of efficacy or emergence of adverse effects. To answer this question we undertook a prospective, randomized study that tested bioequivalence of two generic products of the antiepileptic drug lamotrigine. Lamotrigine was identified in several publications as a possible source of problems after generic switches. FDA studies test a single generic versus the brand name product in a single dose study in normal volunteers. We designed a study that would be most likely to show a difference between generics if one existed. We compared the two generic lamotrigine products showing the most difference in prior testing in patients with epilepsy taking the drug daily using rigorous pharmacokinetic methods. Each patient took each of the two generics for 2 four week periods. Our study showed the two generics were essentially indistinguishable and easily met bioequivalence standards. No patient had loss of seizure control or unexpected adverse effects.

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Small Cash Transfers Encourage Mothers To Participate In AIDS Prevention Program

MedicalResearch.com Interview with:

Dr Marcel Yotebieng, PhD Department of Epidemiology Ohio State University, 304 Cunz Hall Columbus, OH

Dr. Marcel Yotenbieng

Dr Marcel Yotebieng, PhD
Department of Epidemiology
Ohio State University, 304 Cunz Hall
Columbus, OH

Medical Research: What is the background for this study? What are the main findings?

Response: With the current World Health Organization recommended treatment for the prevention of mother-to-child HIV transmission (PMTCT), the risk of transmission of HIV from an infected mother to her baby can be cut from 35-45% to less than 5% in breastfeeding population and <1% in non-breastfeeding population. But in sub-Saharan Africa where over 90% of HIV-infected pregnant women worldwide live, transportation costs and opportunity costs to attend regular clinic visits (to collect drugs) have been identified as important barriers to PMTCT. The provision of economic incentives has the potential to help women overcome these economic barriers. In addition, by creating immediate rewards that “nudge” individuals towards positive health behaviors, financial incentives can also address psychological barriers to health-seeking behavior of HIV-infected pregnant and breastfeeding women. This is the first study to use small cash incentives to encourage women to attend clinic visit and received available PMTCT care. We found that, among newly diagnosed HIV-infected women, small, incremental cash incentives resulted in increased retention along the  prevention of mother-to-child HIV transmission cascade and uptake of available services.

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Proton Radiation Therapy: Treats Pediatric Brain Tumor With Fewer Long Term Side Effects

MedicalResearch.com Interview with:

Dr. Torunn Yock, MD Director, Pediatric Radiation Oncology Associate Professor, Harvard Medical School Radiation Oncology Quality Assurance Massachusetts General Hospital, Proton Center Boston, MA

Dr. Torunn Yock

Dr. Torunn Yock, MD
Director, Pediatric Radiation Oncology
Associate Professor, Harvard Medical School
Radiation Oncology Quality Assurance
Massachusetts General Hospital, Proton Center
Boston, MA

Medical Research: What is the background for this study?

Dr. Yock: Proton radiotherapy is a highly targeted form of radiation therapy that can spare normal tissues better than standard x-ray/photon based radiotherapy. Because, all side effects from radiotherapy come from radiation dose to normal healthy tissues, it is widely believed that proton radiotherapy has great potential to mitigate the side effects of treatment, both acute and long term side effects. There have been many planning studies that show that proton radiation can achieve a more highly conformal dose distribution and appear to spare 50% or more normal tissue from unnecessary irradiation.  However, there have been only a handful of retrospective studies that report disease control and side effects of treatment. While the technology looked promising, the definitive clinical data has been lacking to date. Because of this lack of clinical outcome data, the role and benefit of proton radiotherapy has been a subject of great debate in the oncology community.  Critics assert that proton radiotherapy is expensive and unproven and therefore a leading culprit in escalating costs of oncologic health care. Proponents assert that when used in the appropriate patient setting, the margin of benefit in terms of improved health outcomes, outweighs the increased cost of treatment.

We embarked on this study to answer help answer the call for prospectively collected clinical outcome data to better define the most appropriate role for proton radiotherapy. Importantly, this study addresses both disease control and side effects of treatment in a pediatric medulloblastoma cohort of children.

Medical Research: What are the main findings?

Dr. Yock: This study shows that disease control in the pediatric medulloblastoma population is very much the same as that which is achieved by photon based radiotherapy treatments. However, more importantly, late side effects commonly attributed to radiotherapy such as neurocognitive decline over time and hearing loss appear to be improved compared with published photon treated cohorts of pediatric medulloblastoma patients.  Additionally, adverse late side effects on the cardiopulmonary, GI, and reproductive systems were essentially eliminated.

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One In Three Middle Age Patients Will Develop Diabetes

MedicalResearch.com Interview with:

Dr Abbas Dehghan PhD Assistant Professor, Department of Epidemiology Erasmus University Medical Centre Rotterdam, Netherlands

Dr. Abbas Dehghan

Dr Abbas Dehghan PhD
Assistant Professor, Department of Epidemiology
Erasmus University Medical Centre
Rotterdam, Netherlands

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

Dr. Dehghan: Diabetes is an important health treat given its serious complications including cardiovascular disease, blindness, kidney failure, and lower-extremity amputations. Descriptive studies have so far either reported the prevalence of diabetes which is a snapshot of the percentage of people who have diabetes or the risk that people will develop diabetes in next 5 or 10 years. These estimates are not optimal since they overlook the risk of developing diabetes later in life. We calculated the lifetime risk of type 2 diabetes which is the risk that every person carries to develop type 2 diabetes up to end of his life. Moreover, we provided estimates for prediabetes, a high risk status that people experience before developing diabetes, and need for insulin therapy that might indicates severity of the disease.

MedicalResearch.com: What are the main findings? 

Dr. Dehghan: Our data suggest that the lifetime risk of developing prediabetes for a normoglycemic individual aged 45 years is one in two, and one in three nondiabetic individuals aged 45 years will develop diabetes. Three-quarters of individuals with prediabetes at age 45 years will eventually progress to diabetes, and half of the patients with diabetes at the same age will start insulin treatment. Stratification by BMI showed that normoglycemic people with healthy weight at age 45 years had a significantly lower prediabetes lifetime risk compared with overweight and obese individuals. Stratification by waist circumference showed similar effects on lifetime risks for diabetes in individuals with prediabetes. Similarly, in individuals with diabetes, the lifetime risk for insulin use among patients with diabetes was higher with increasing BMI and waist circumference.
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Azithromycin Shortens Asthma Symptoms in Children

Professor of Pediatrics Hans Bisgaard, MD, DMSc Copenhagen Prospective Studies on Asthma in Childhood Herlev and Gentofte Hospital, University of Copenhagen, Denmark.

Prof. Bisgaard

More on Asthma on MedicalResearch.com
MedicalResearch.com Interview with:
Hans Bisgaard, MD, DMSc
Professor of Pediatrics
The Faculty of Health Sciences
University of Copenhagen
Head of the Copenhagen Prospective Studies on Asthma in Childhood
University  of Copenhagen and Naestved Hospital

Medical Research: What is the background for this study?

Dr. Bisgaard: Childhood asthma is often preceded by recurrent asthma-like symptoms in relation to airway infections in the first years of life. Bacteria and viruses are equally associated with the risk of episodes of asthma-like symptoms in these children, suggesting antibiotics as a potential treatment for such episodes.

Medical Research: What are the main findings?

Dr. Bisgaard: Our study demonstrates a clinically significant shortening of symptom duration by 63% after intervention. The effect size increased with early initiation of treatment, showing a reduction in episode duration of 83% if treatment was initiated before day 6 of the episode. Azithromycin was effective in shortening the episodes even though no pathogenic bacteria was detected. This study is, to our knowledge, the first randomized trial of azithromycin treatment of acute episodes of asthma-like symptoms in young children with a history of recurrent episodes.

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More Invasive Approach May Improve Cardiac Outcomes in Geriatric Patients

Click Here for More on Heart Disease on MedicalResearch.com

MedicalResearch.com Interview with:
Bjørn Bendz MD PhD
and Nicolai K. TegnMD
Department of Cardiology, Oslo University Hospital,
Rikshospitalet Oslo, Norway 

Medical Research: What is the background for this study? What are the main findings?

Response: According to life expectancy statistics, a person who reaches age 80 can expect to live an average of 8 years (in men) and 9 years (in women).

People over 80 yrs are underrepresented in clinical trials, they are less likely to receive treatment according to guidelines. Our study, which directly targets the over-80 population, is the first to demonstrate that a more invasive strategy results in better outcomes in these patients. We believe our study provides a sufficient basis to recommend an invasive approach.”

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Fetal Alcohol Syndrome Linked to 400 Comorbid Conditions

Svetlana Popova, M.D., Ph.Ds., M.P.H. Senior Scientist Social and Epidemiological Research, Centre for Addiction and Mental Health Associate Professor, Epidemiology Division, Dalla Lana School of Public Health, University of Toronto Associate Professor, Factor-Inwentash Faculty of Social Work, University of Toronto Graduate Faculty Associate Member, Institute of Medical Science, University of Toron

Dr. Svetlana Popova

MedicalResearch.com Interview with:
Svetlana Popova, M.D., Ph.Ds., M.P.H.
Senior Scientist
Social and Epidemiological Research, Centre for Addiction and Mental Health
Associate Professor, Epidemiology Division, Dalla Lana School of Public Health, University of Toronto
Associate Professor, Factor-Inwentash Faculty of Social Work, University of Toronto
Graduate Faculty Associate Member, Institute of Medical Science, University of Toronto

MedicalResearch: What is the background for this study?

Dr. Popova: It has been known for many years that prenatal alcohol exposure is associated with a number of adverse health consequences for both the mother and developing fetus. Women who consume alcohol during pregnancy place their child(ren) at risk of developing Fetal Alcohol Spectrum Disorders (FASD), and can experience a number of other adverse pregnancy outcomes including stillbirth, spontaneous abortion, premature birth, intrauterine growth retardation, and low birth weight. It was also previously known that people with FASD have many comorbidities (the simultaneous presence of two or more chronic diseases or conditions in a patient) due to the permanent damage of prenatal alcohol exposure on the fetus. However, until now it was unknown how many and what type of diseases, and at what frequencies they occur. Therefore, we reviewed the medical and epidemiological literature to identify the disease conditions that have been found to occur in people with FASD. Then based on the identified studies we estimated the pooled (combined) prevalence of the comorbid conditions found to occur among individuals with Fetal Alcohol Syndrome (FAS; the most severe and visibly identifiable form of FASD). We restricted our analysis to FAS because it is the only expression of FASD in the World Health Organization’s International Classification of Diseases, version 10 (ICD-10).

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