[caption id="attachment_19759" align="alignleft" width="142"] Dr. Prasad[/caption] MedicalResearch.com Interview with: Vinay Prasad MD, MPH Division of Hematology Oncology in the Knight Cancer Institute Department of...
[caption id="attachment_19759" align="alignleft" width="142"] Dr. Prasad[/caption] MedicalResearch.com Interview with: Vinay Prasad MD, MPH Division of Hematology Oncology in the Knight Cancer Institute Department of...
Dr. Wang[/caption]
MedicalResearch.com Interview with:
Shiyi Wang, MD, PhD
Assistant Professor of Epidemiology (Chronic Diseases)
Yale School of Public Health
Medical Research: What is the background for this study?
Dr. Wang: As magnetic resonance imaging (MRI) of the breast has become part of medical care, there is increasing concern that this highly sensitive test might identify health problems that otherwise would not have had an impact on the patient – so called “overdiagnosis”. However, even if MRI use leads to overdiagnosis, the main “theoretical” benefit of early detection by MRI is to prevent future advanced diseases, the prognosis of which is deleterious. A systematic literature review found that, compared to mammography and/or ultrasound, MRI had a 4.1% incremental contralateral breast cancer (breast cancer in the opposite breast) detection rate. At this point, the impact of MRI on long-term contralateral breast cancer outcomes remains unclear.
Medical Research: What are the main findings?
Dr. Wang: Analyzing the Surveillance, Epidemiology, and End Results-Medicare dataset, we compared two groups of women who had breast cancer (one group receiving an MRI, and the other not) in terms of stage-specific contralateral breast cancer occurrences. We found that after five years, the MRI group had a higher detection rate of cancer in the opposite breast than the non-MRI group (7.2 % vs. 4.0%). Specifically, MRI use approximately doubles the detection rate of early stage contralateral breast cancer, but does not decrease the incidence of advanced stage contralateral breast cancer occurrences after a 5-year follow-up. Our results indicate that nearly half of additional breast cancers detected by the preoperative MRI were overdiagnosed, which means that many of these occult cancers not detected by MRI would not have become clinically evident over the subsequent 5 years. There was no evidence that MRI use was benefiting women because the rate of advanced cancer was similar in the MRI and the non-MRI groups.
[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...
Prof. Molina[/caption]
MedicalResearch.com Interview with:
Dr Jean-Michel Molina
Department of Infectious Diseases
Saint-Louis Hospital and University of Paris Diderot
Paris France
MedicalResearch: What is the background for this study? What are the main findings?
Dr. Molina: Men who have sex with men (MSM) are disproportionately affected by HIV worldwide and represent the today in Europe the largest group in which new HIV infections are diagnosed with no decrease over the last 8 years.
The first study assessing preexposure prophylaxis (PrEP) efficacy among MSM was published in 2010 (the Iprex study) which reported for the first time a 44% reduced incidence of HIV in those randomized to receive daily tenofovir/emtricitabine TDF/FTC (one pill per day) as compared to placebo. Adherence to a daily pill regimen was found to be challenging however since only half of the participants (according to drug detection in blood) were taking their daily regimen. Post-hoc analyses suggested that among those with drugs detectable in plasma, PrEP efficacy could be as high as 92%. However, long term adherence to a daily regimen represents the Achille’s heel of daily PrEP, as shown later in other large PrEP trials among women in Africa (VOICE and Fem-PrEP).
Based on data from animal models we wished to assess whether PrEP with TDF/FTC taken on demand, at the time of sexual activity, could improve adherence, thereby efficacy and also improve safety and cost.
In this randomized double blind placebo controlled trial, on demand PrEP with TDF/FTC reduced the incidence of HIV by 86% in the intent to treat analysis as compared to placebo, and the only 2 participants who became infected in the TDF/FTC arm after more than a year of follow-up, had discontinued the use of PrEP months before infection.
The ANRS Ipergay study reports therefore a very high efficacy of PrEP, similar to that also reported in another PrEP study carried out in the UK among MSM with daily TDF/FTC (PROUD), which results were disclosed at the same time. Both studies have increased awareness about the real potential of PrEP and have had a strong impact on WHO and European guidelines.
Dr. Movsas[/caption]
MedicalResearch.com Interview with:
Benjamin Movsas, MD
Chairman of Radiation Oncology
Henry Ford Hospital
Detroit, Michigan
Medical 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.
Kevin Bieniek[/caption]
MedicalResearch.com Interview with:
Kevin Bieniek B.Sc.
Biology and Psychology
Neuroscience researcher
Mayo Clinic’s campus in Florida.
Medical Research: What is the background for this study? What are the main findings?
Response: Chronic traumatic encephalopathy (CTE) is a progressive neurodegenerative disorder linked to repetitive traumatic brain injury often sustained through contact sports and military blast exposure. While CTE was first described in boxers in the 1920s, to date many descriptions of CTE have been made in high-profile professional athletes, but the frequency of Chronic traumatic encephalopathy pathology in athletes with more modest contact sports participation is unknown. For this study, researchers at the Mayo Clinic in Jacksonville, FL examined the Mayo Clinic Brain Bank, one of the largest brain banks of neurodegenerative diseases. In searching through medical records of over 1,700 patients, 66 individuals with clinically-documented contact sports participation were identified. Of these 66 former athletes, 21 or 32% had pathologic changes in their brains consistent with CTE. By comparison, none of 198 control individuals that did not have contact sports documentation in their medical records (including 66 women) had CTE pathology. These results have been recently published in the December issue of the journal Acta Neuropathologica <<hyperlink: http://www.springer.com/medicine/pathology/journal/401.
Dr. Schütz[/caption]
MedicalResearch.com Interview with:
Uwe Schütz, M.D.
Radiologist and specialist in orthopedics and trauma surgery
Department of Diagnostic and Interventional Radiology
University Hospital of Ulm
Germany
Medical Research: What is the background for this study? What are the main findings?
Dr. Schütz: In this study, which is a small part of the Trans Europe Foot Race (TEFR) TEFR-project, we investigated the question, what happens to the joints, in detail to the joint cartilage of the lower extremities, when running 4500 km without any day rest for nearly 10 weeks. Is there really a risk for developing an arthrosis when doing this, like some researches and many physicians postulate?
Well, what we find when accompanying 44 ultra-athletes with a modern 1.5Tesla MRI mounted on a custom made 38tonnes truck trailer day by day over 64 days on their way throughout whole Europe is, that the joint cartilage is initially altered by this running burden: It shows signals of cartilage matrix degradation beneath the first 1000 to 1500 km of running. But then the situation changes. When further running occurs, then the cartilage shows the ability to partially regenerate under ongoing running burden. This is a pretty new and astonishing finding, first time measured and observed in human joint in vivo. But knowledge of Scandinavian animal studies show the same behavior in dog cartilage.
Dr. Peterson[/caption]
MedicalResearch.com Interview with:
Mark D. Peterson, Ph.D., M.S.
University of Michigan, Medicine
Department of Physical Medicine and Rehabilitation
Ann Arbor, MI
Medical 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.
Dr. Mairead Black[/caption]
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 2ZD
Medical 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.
Dr. Nahmias[/caption]
MedicalResearch.com Interview with:
Prof. Yaakov Nahmias PhD
Director of the Alexander Grass Center for Bioengineering
Hebrew University of Jerusalem
Medical Research: What is the background for this study?
Prof. Nahmias: The liver has a limitless capacity of the human liver to regenerate from even a massive loss of mass.
However, the intrinsic capacity of liver cells to proliferate is lost when cells are removed from the body.
Medical Research: What are the main findings?
Prof. Nahmias: We found that a weak expression of Human Papilloma Virus (HPV) proteins released hepatocytes from cell-cycle arrest and permitted the cells to multiply in response to Oncostatin M (OSM) an immune cytokine recently found to be involved in liver regeneration.
While previous efforts caused hepatocytes to multiply without control, converting hepatocytes into tumor cells with little metabolic ability, we selected colonies that only multiply in response to OSM.
Activation with OSM triggered cell growth with a doubling time of 40 hours. Removal of OSM caused growth to stop, allowing the cells to regain a high level of metabolic activity within 4 days.
We produced hepatocytes from ethnically diverse individuals. Importantly, the growing hepatocytes showed a similar toxicology response to normal human hepatocytes across 23 different drugs.
Dr. Dagher[/caption]
Medical research.com Interview with:
Rada K. Dagher, Ph.D.
Assistant Professor
University of Maryland School of Public Health
Department of Health Services Administration
College Park, MD 20742
MedicalResearch: What is the background for this study?
Dr. Dagher: In the United States, 51% of all pregnancies are unintended, and these happen disproportionately among racial and ethnic minorities. For example, in 2008, rates of unintended pregnancies were 69% among African American women, 56% among Hispanic women, and 40% among White women. Our study utilized 2006-2010 data from a nationally representative dataset, the National Survey of Family Growth, to investigate the reasons behind these racial/ethnic disparities.
MedicalResearch: What are the main findings of this study?
Dr. Dagher: The main findings of this study are as follows. Age and marital status differences explained both racial and ethnic disparities, where being single and younger than 20 years old at the time of conception contributed to the differences in unintended pregnancy between African American and White women, and between Hispanic and White women. However, there were also unique factors explaining the differences in unintended pregnancy between African Americans and Whites (respondent’s mother’s age at first birth, income, and insurance status) and the differences between Hispanics and Whites (U.S. born status and educational level). These findings provide support for culturally-tailored public health interventions that target at-risk groups of women such as younger, unmarried, lower income, lower educated, non-U.S. born women and those with public insurance, in order to reduce racial/ethnic disparities in unintended pregnancy.
MedicalResearch: What should clinicians and patients take away from your report?
Dr. Dagher: Our findings suggest that interventions to reduce racial and ethnic differences in unintended pregnancy should take into account multiple factors at multiple levels of influence. For example, at the policy level, the Affordable Care Act has mandated that health plans cover women’s preventative health care, including contraceptives, without cost sharing. Thus, primary care providers could educate their patients about these new policy provisions and encourage them to take advantage of them, especially patients at higher risk of unintended pregnancy such as women who are younger than 20, unmarried, non-U.S. born, have lower income, and those with public insurance.
Prof. Nicolas James[/caption]
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.
Dr. Ratanawongsa[/caption]
MedicalResearch.com Interview with:
Neda Ratanawongsa, MD, MPH
CMIO for CareLinkSF
Associate Professor, Division of General Internal Medicine
UCSF Center for Vulnerable Populations
Physician, Richard H. Fine People's Clinic (RHPC)
San Francisco, CA 94110
Medical Research: What is the background for this study?
Dr. Ratanawongsa: Many people are concerned about the growing intrusion of computers into the patient-provider relationship. Touted as systems that will make care safer and more cost-effective, electronic health records (EHRs) have proliferated rapidly across the country, fueled by HITECH funding. However, some health care professionals feel like computers keep them from connecting with their patients. Also prior research has shown that computer use can change communication in the exam room and shift agenda from patients' concerns toward medical talk.
Safety net patients already face communication barriers in routine care, particularly language and literacy barriers. Although EHRs could help improve care and communication with these vulnerable patients by helping clinicians fill in the gaps (e.g., what happened in the ED, what medication were you given by that specialist), EHRs could also worsen communication by drawing clinicians' focus away from patients during visits.
Dr. Soroush Zaghi[/caption]
MedicalResearch.com Interview with:
Soroush Zaghi, MD
Department 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.
Dr. Rigucci[/caption]
MedicalResearch.com Interview with:
Dr Silvia Rigucci MD
Department of Neurosciences, Mental Health and Sensory Organs
Sapienza University of Rome
Rome, Italy
Medical Research: What is the background for this study? What are the main findings?
Dr Rigucci: Nowadays, ‘skunk-like’ products contain more Δ9-tetrahydrocannabinol (THC) than they did around a decade ago and they have been shown to induce psychotic symptoms. Therefore, exploring the impact of cannabis potency on brain structure is becoming particularly important.
We found that frequent use of high potency cannabis significantly affects the structure of white matter fibers in the brain, independently of the presence of a psychotic disorder.
Prof. Gordon Smith[/caption]
MedicalResearch.com Interview with:
Gordon C S Smith, MD PhD DSc FMedSci
Professor & Head of Department,
Obstetrics and Gynaecology,
Cambridge University
Cambridge UK
Medical Research: What were the key findings of the study?
Dr. Smith: We demonstrated that using ultrasound to scan all women in the last 3 months of pregnancy increased the detection of small babies. Our routine approach to antenatal care identified 1 in 5 small babies. Our research approach on the same patients, where all women were scanned in the last third of pregnancy, resulted in 3 in 5 small babies being detected.
We also found that, when we identified small babies, there was a scan measurement which helped us to distinguish which of those small babies were at increased risk of complications.
Medical Research: What's the problem with small babies?
Dr. Smith: We have known for many years that small babies are at increased risk of subsequent complications, both in the short term and long term. For example, they are more likely than normal sized babies to have difficulties during labour due to shortage of oxygen.
We assume that this is because their growth has been restricted. This leads to them being less well prepared to face the stress of labour. We think that the poor growth usually occurs because of a problem in the way the placenta functions. The placenta, also known as the afterbirth, is the organ which allows the transfer of nutrients and oxygen to the baby. If the placenta isn’t functioning properly it is likely to impair the growth of the baby in the womb.
If we suspect during a pregnancy that the baby is small, it influences a number of aspects of the care of the mother. For example, we might deliver the baby earlier, we might recommend delivery in a high risk unit. It might also influence decisions about whether a mother has a caesarean delivery, or how the baby is monitored during labour.
Dr. Daniels[/caption]
MedicalResearch.com Interview with:
Lori Daniels, MD, MAS, FACC
Professor of Medicine
Director, Coronary Care Unit
UCSD Division of Cardiology
Sulpizio Cardiovascular Center
La Jolla, CA
Medical Research: What is the background for this study?
Dr. Daniels: A large number of individuals who are at risk for developing cardiovascular disease (CVD) may not be identified as “at risk” by traditional screening methods. Blood-based biomarkers provide a possible way, in conjunction with traditional risk factor screening, to assess risk in individuals. Two such biomarkers which are gaining widespread attention are NT-proBNP and cardiac troponin T (TnT). NT-proBNP is secreted by cardiac muscle cells in response to stretch, while TnT is consider a marker of cardiac cellular damage. Previous studies have shown that each of these markers is associated with long-term risk of cardiovascular outcomes in the general population. Race and ethnicity have been shown to affect the levels of these markers, and whether these markers are equally predictive of future cardiovascular risk in various ethnic groups has not been well studied.
The Multi-Ethnic Study of Atherosclerosis (MESA) is an NIH-funded, multicenter, prospective, population-based study of white, black, Hispanic, and Chinese individuals without clinical CVD at baseline. Participants had blood drawn at a baseline study visit in 2000-2002, and again several years later, in 2004-2005. They have been followed for the development of CVD since then.
The purpose of this study was to learn whether NT-proBNP (single and serial measures) and TnT are predictive of incident cardiovascular disease in a diverse cohort of 5592 participants from the MESA. We also wanted to learn whether the addition of these biomarkers to established CVD risk prediction scores, including the 2013 American College of Cardiology (ACC)/American Heart Association (AHA) Pooled Cohort Risk Equation and the Framingham Risk Score, could improve performance of the risk score.
Dr. Yao[/caption]
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.
Dr. Thompson[/caption]
MedicalResearch.com Interview with:
Professor Benjamin Thompson PhD
School of Optometry and Vision Science
Faculty of Science, University of Waterloo
Waterloo, Ontario
Canada
Medical Research: What is the background for this study?
Dr. Thompson: Our investigation was part of the longitudinal Infant Development and Environment and Lifestyle (IDEAL) study that was designed to investigate the effect of prenatal methamphetamine exposure on neurodevelopment. Although the negative impact of prenatal drug exposure on a wide range of neurodevelopmental outcomes such cognitive and motor function is established, the effect on vision is not well understood. To address this issue, vision testing was conducted when children in the New Zealand arm of the IDEAL study turned four and half years of age.
Although the primary focus of the IDEAL study was the impact of methamphetamine on neurodevelopment, the majority of children enrolled in the study were exposed to a range of different drugs prenatally including marijuana, nicotine and alcohol. Many children were exposed to multiple drugs. This allowed us to investigate the impact of individual drugs and their combination on the children’s visual development.
Alongside standard clinical vision tests such as visual acuity (the ‘sharpness’ of vision) and stereopsis (3D vision), we also tested the children’s ability to process complex moving patterns. This test, known as global motion perception, targets a specific network of higher-level visual areas in the brain that are thought to be particularly vulnerable to neurodevelopmental risk factors.
Prof. Maillard[/caption]
MedicalResearch.com Interview with:
Prof. Jean-Yves Maillard
Professor of Pharmaceutical Microbiology
College of Biomedical and Life Sciences
Cardiff School of Pharmacy and Pharmaceutical Sciences
Cardiff University
Cardiff United Kingdom
Medical Research: What is the background for this study? What are the main findings?
Prof. Maillard: Environmental surfaces in healthcare and other settings become contaminated with a variety of infectious agents which may survive long enough to infect susceptible hosts, either directly or through secondary vehicles such as hands. Therefore, routine decontamination of environmental surfaces, in particular those that are frequently touched, is crucial to reduce the risk of infections. Such decontamination is often performed by wiping the target surface with disinfectant-soaked or pre-wetted wipes. However, the label claims of wipes marketed for this purpose are often based upon testing that does not reflect their field use, where contact times are frequently no more than a few seconds with wide variations in the pressure applied during wiping. In addition, wipes impregnated with a disinfectant or detergent can potentially transfer microbial contaminants to a wider area, when the same wipe is used on multiple surfaces.
A device called the ‘Wiperator’ was invented to address these issues. It can be used to test wipes with predetermined pressures, wiping times and number of wiping strokes, using a standardized rotary action. It can not only assess the decontaminating efficiency of the test wipe, but also its ability to transfer the acquired contamination to clean surfaces. The test procedure developed using the device is now a standard (E2967) of ASTM International, a highly-respected standards-setting organization.
The Wiperator was used in a multi-laboratory collaborative to test commercially-available wipes for their ability to decontaminate metal disks that had been experimentally-contaminated with vegetative bacteria representing healthcare-associated pathogens. The used wipes were subsequently tested for their potential to transfer viable bacteria to clean surfaces. The contact time for wiping and transfer was 10 seconds. Only one of the wipes tested reduced the contamination to an undetectable level while not transferring any viable bacteria to a clean surface. All others left behind detectable levels of contamination on the wiped disks and transferred the contamination to clean surfaces.
Dr. Berg[/caption]
MedicalResearch.com Interview with:
Karina Birgitta Berg MD
Department of Ophthalmology
Oslo University Hospital
Oslo, Norway
Medical Research: What is the background for this study? What are the main findings?
Dr. Berg: Neovascular age-related macular degeneration (nAMD) has been the leading cause of vision loss in the elderly population of Western countries. Inhibition of vascular endothelial growth factor (VEGF) with medications such as bevacizumab and ranibizumab injected into the eye, has dramatically reduced the incidence of social blindness from this disease. Bevacizumab was marketed for intravenous cancer treatment, while ranibizumab was later developed and approved for intraocular treatment of nAMD. Due to similar clinical effects and a strikingly low cost compared to ranibizumab, bevacizumab has remained widely used as an off-label treatment for the treatment of nAMD. In order to preserve vision results over time, most patients need injections repeatedly. Treatment on a monthly basis has shown good vision improvement, while monitoring monthly and treating only when signs of recurrences appear, is less successful. The aim of a treat-and-extend protocol is to gradually increase the treatment intervals, while avoiding potentially harmful recurrences. This treatment modality has become commonly used, entailing fewer patient visits and less burden upon health care systems.
The multicenter prospective randomized Lucentis Compared to Avastin Study (LUCAS) was aimed at comparing the efficacy and safety of bevacizumab versus ranibizumab when following a treat-and-extend protocol. The patients received monthly injection treatment until inactive disease was achieved. The treatment interval was then increased by two weeks at a time up to a maximum of 12 weeks. In the event of a recurrence, the treatment interval was reduced by two weeks at a time. The study demonstrated equivalent results in vision improvement with bevacizumab and ranibizumab after two years of treatment. Treatment according to a treat-and-extend protocol was safe with good visual results when extending up to 10 weeks, while recurrences at 12-week intervals had a negative impact on the final results on vision.
Prof. Coomarasamy[/caption]
MedicalResearch.com Interview with:
Arri Coomarasamy, MBChB, MD, FRCOG
Professor of Gynaecology and Reproductive Medicine
University of Birmingham
Medical Research: What is the background for this study? What are the main findings?
Professor Coomarasamy: Progesterone is a natural hormone that is essential to maintain a healthy pregnancy, and more than 60 years ago clinicians and researchers began to ask if progesterone supplementation in the first trimester of pregnancy could help to reduce the risk of miscarriage for women with a history of recurrent miscarriage. The evidence achieved in some small controlled clinical trials conducted before the PROMISE (progesterone in recurrent miscarriage) trial suggested a benefit from progesterone therapy, but without sufficient certainty to usefully guide clinical practice.
Five years after it began, the PROMISE trial has provided a definitive result. It is clear, it is important, and it is not the result that many anticipated. Our study of more than 800 women with a history of unexplained recurrent miscarriage has shown that those who received progesterone treatment in early pregnancy were no less likely to miscarry than those who received a placebo (or dummy treatment). This was true whatever their age, ethnicity, and medical history.
Dr. Storebø[/caption]
MedicalResearch.com Interview with:
Dr. Ole Jakob Storebø
Region Zealand, Child and Adolescent Psychiatric Department, Roskilde
Region Zealand Psychiatry
Psychiatric Research Unit, Slagelse
University of Southern Denmark
Department of Psychology
Faculty of Health Science,
Odense Denmark
Medical Research: What is the background for this study? What are the main findings?
Dr. Storebø: Despite widespread use of methylphenidate for the treatment of children and adolescents with attention deficit hyperactivity disorder (ADHD), a comprehensive systematic review of its benefits and harms has not yet been conducted. Over the past 15 years, several reviews investigating the efficacy of methylphenidate for ADHD (with or without meta-analyses) have been published. Each of these reviews, however, has several shortcomings and these are described in detail in the review. The most important concerns are that none of these reviews are based on a pre-published protocol, and most assessed neither the risk of bias (systematic errors) of included trials nor adverse events. Moreover, none of these reviews considered the risk of random errors. Therefore, their interpretation of findings is unlikely to have taken into account the poor reporting of adverse events, the impact of combining data from small trial samples, or the impact of risk of bias on their analyses; information about adverse events is also missing from several RCTs. Because of this it is our opinion that these previous reviews might have overestimated the true treatment effect.
We found that Methylphenidate may improve ADHD symptoms, general behaviour and quality of life in children and adolescents aged 18 years and younger with ADHD. We rated the evidence to be of very low quality and, as a result, we cannot be certain about the magnitude of the effects from the meta-analyses. The evidence is limited by serious risk of bias in the included trials, under-reporting of relevant outcome data, and a high level of statistical variation between the results. We found no evidence for serious adverse events, but a lot of non-serious adverse events. Most of these are well known but the number of adverse events might even be higher than the number we found due to underreporting of adverse events. We know very little about the long term effects or harms as most of the trials in our review did not measure outcomes beyond 6 months. The risk of rare, serious adverse events seem low over the short duration of follow-up of the trials that reported on harms, but in general there was inadequate reporting of adverse events in many trials.
Dr. Ambarish Pandey[/caption]
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.