MedicalResearch.com Interview with: [caption id="attachment_33583" align="alignleft" width="125"] Dr. Moreno[/caption] Victor Moreno, PhD. Director of Cancer Prevention and Control Program, Catalan Institute of Oncology-IDIBELL,...
Dr Sabrina Bajwah[/caption]
Dr Sabrina Bajwah
MBChB MRCGP MSc MA PhD
Consultant Palliative Medicine, King’s College NHS Foundation Trust
Honorary Senior Lecturer
King's College London
Cicely Saunders Institute, Department of Palliative Care, Policy and Rehabilitation
London, UK
MedicalResearch.com: What is the background for this study?
Response: Where people die is often important to them and their families, as well as being important for planning health care services. Most people want to die at home, but instead most die in hospital. While the trends have been studied in cancer, other diseases, such as respiratory, are rarely looked at even though they are common and increasing causes of death.
Chronic Obstructive Pulmonary Disease (COPD) and Interstitial Pulmonary Diseases (IPD) are common respiratory conditions. Both conditions result in a high use of hospital services, especially among people in advanced stages. This leads to high healthcare costs.1 In the UK in 2010, it is estimated that IPD costs £16.2 million per year in hospitalisations.2 The NHS spends more than £810 million annually managing COPD, with inpatient stays accounting for around £250 million annually.
Understanding which factors affect place of death is vital for planning services and improving care, especially given our ageing population, rising chronic diseases and the high costs of hospital admissions. Strategies in many countries have sought to improve palliative care and reduce hospital deaths for non-cancer patients, but their effects are not evaluated.
We aimed to determine the trends and factors associated with dying in hospital in COPD and IPD, and the impact of a national end of life care (EoLC) strategy3 to reduce deaths in hospital. This study analysed a national data set of all deaths for COPD and IPD, covering 380,232 people over 14 years.
Dr. Bart Ferket[/caption]
Bart S Ferket, MD, PhD
Assistant Professor, Population Health Science and Policy
Icahn School of Medicine at Mount Sinai
MedicalResearch.com: What is the background for this study?
Response: The annual rate of total knee replacement in the US has doubled since 2000, and especially in those aged 45-65 utilization of this procedure has increased. The increase in practice cannot fully be explained by an increase in the prevalence of osteoarthritis and population growth, and has been partly attributed to expansion to people with less severe symptoms. The total number of procedures performed each year now exceeds 640,000. The evidence for the benefit of total knee replacement has been based on studies without a comparison group of no total knee replacement, and so far only one randomized clinical trial has been published. Although the published literature shows large improvements of pain, physical functioning and overall quality of life following the procedure, patients included in these studies generally had severe preoperative symptoms. A number of studies have suggested, however, that up to a third of recipients of total knee replacement show no benefit, and that those with poor physical functioning before surgery may show larger improvements. Therefore, the current US patient population undergoing total knee replacement might show less significant improvement in symptoms on average as compared with a hypothetical scenario in which eligibility is limited to those with more severe symptoms. 
Dr. Debra Palmer[/caption]
Dr. Debra Palmer (BSc, BND, PhD)
on behalf of my fellow co-authors on this publication
Childhood Allergy and Immunology Research
University of Western Australia
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: We conducted a multicentre trial, Starting Time of Egg Protein (STEP) involving 820 infants, and found a 25% risk reduction in egg allergy with early regular egg intake from 4-6.5 months compared with egg avoidance to 10 months of age, although this did not achieve statistical significance.
So we also investigated in exploratory analyses whether the effect of regular egg introduction in solid foods was modified by any maternal, family or infant characteristics. Our results found that infants from families of higher socioeconomic status and those families who consume few eggs per week could benefit by less egg allergy at 12 months of age from regular egg intake once they start eating solid foods.
Dr. Sahil Khanna[/caption]
Sahil Khanna, M.B.B.S. MS
Division of Gastroenterology and Hepatology
Mayo Clinic, Rochester, Minnesota
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Clostridium difficile infection (CDI) is the most common cause of hospital-acquired diarrhea and has recently shown increasing incidence especially in the community. Novel risk factors for CDI development include the use of gastric acid suppression medication, presence of systemic comorbid conditions, C difficile carriage in water and food sources, amongst others.
Gastric acid suppression medications such as proton-pump inhibitors (PPIs) and histamine-2 receptor blockers (H2Bs) are commonly prescribed and consumed over the counter for gastroesophageal reflux disease, peptic ulcer disease, or functional dyspepsia, but they are also sometimes prescribed for unnecessary indications, which leads to overuse of these medications. Recurrent CDI after a primary infection is a major problem, with the risk being as high as 50% to 60% after 3 or more Clostridium difficile infections. Data on the association between acid suppression and recurrent CDI are conflicting and therefore we performed a systematic review and meta-analysis to study the association between the use of gastric acid suppression medications and the risk of recurrent CDI.
Dr. Nichols[/caption]
Hazel B. Nichols, PhD, UNC
Assistant professor
Lineberger Comprehensive Cancer Center member
UNC Gillings School of Global Public Health.
MedicalResearch.com: What is the background for this study?
Response: Each year more than 45,000 adolescent and young adult women (AYA, ages 15-39 years) are diagnosed with cancer in the United States. While many of these women may wish to have children in the years following diagnosis, there is currently little information available to address their concerns about the impact of cancer diagnosis and treatment on future pregnancy.
We identified >2,500 women who had a child after their cancer diagnosis using data from the North Carolina Central Cancer registry and statewide birth certificate files. We investigated whether adverse birth outcomes, such as preterm birth and low birth weight, were more common among AYA cancer survivors compared to women without cancer. We also looked at infant Apgar scores, which measure newborn health, and a calculation called small-for-gestational age, which can indicate restricted growth during pregnancy.
Dr. Lappe[/caption]
Joan M. Lappe, Ph.D., R.N., F.A.A.N.
Associate Dean for Research, College of Nursing
Criss/Beirne Professor of Nursing
Professor of Medicine
Creighton University
Omaha NE 68131
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Auerbach[/caption]
Brandon Auerbach, MD, MPH
Acting Instructor
Division of General Internal Medicine
University of Washington
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The question of whether 100% fruit juice causes poor health outcomes in children, such as weight gain, has been a subject of controversy. On one hand, 100% fruit juice contains vitamins and nutrients that many children lack, is often cheaper than whole fruit, and may help kids with limited access to healthy food meet their daily fruit requirements.
On the other hand, leading nutrition experts have expressed concern that fruit juice contains amounts of sugar equal to or greater than those of sugary drinks like regular soda. Guidelines from the American Academy of Pediatrics warn that 100% juice can be a significant source of calories and contribute to obesity if consumed excessively.
Our main finding was that consuming 1 serving/day of 100% fruit juice was not associated with weight gain in children. Children ages 1 to 6 years gained a small amount of weight, but not enough to negatively impact health. Children ages 7 and older gained no weight. We did not study amounts of 100% fruit juice higher than 1 serving/day.
Dr. Christopher O’Connor[/caption]
Christopher M. O’Connor, MD FACC
CEO and Executive Director,
Inova Heart & Vascular Institute
IHVI Administration
Falls Church, Virginia 22042
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Sleep apnea is a very common comorbidity of patients with heart failure (both reduced ejection fraction and preserved ejection fraction). Early evidence from observational and small studies suggested that treating sleep apnea with adaptive servo-ventilation (ASV) therapy may improve patient outcomes. There is minimal clinical evidence about identifying and treating sleep apnea in those who’ve been hospitalized with acute decompensated heart failure. The CAT-HF study was designed to help address this, with the primary endpoint being cardiovascular outcomes measured as a Global Rank Score that included survival free from cardiovascular hospitalization and change in functional capacity as measured by the six-minute walk distance. It was also planned to expand on the SERVE-HF study that was investigating the use of ASV therapy to treat central sleep apnea (CSA) in chronic stable heart failure patients with reduced ejection fraction patients (HFrEF).
Dr. Kamjunke[/caption]
Dr. Norbert Kamjunke
Helmholtz-Centre for Environmental Research UFZ
Department of River Ecology
Magdeburg, Germany
MedicalResearch.com: What is the background for this study?
Response: Aquacultures are of great importance worldwide but pollute pristine headwater streams, lakes, and estuaries.
Chilean salmon production is economically important, contributing ~25% of the worldwide salmon yield
(Chile ranks second of the world’s salmon-producing countries). Salmon
farming has continuously increased in recent decades; the annual
salmonid production in Chile was 820,000 tons in 2012, representing a
value of 4.9 billion USD (32% of the total worldwide value of salmonid
production). Small salmon are reared in land-based aquacultures supplied
with stream water, whereas mid-sized fish are grown in cages in lakes
and adult fish in cages along the coast. The effluents from land-based
aquaculture pollute pristine streams with nutrients, antibiotics and
organic carbon, resulting in oxygen depletion and negative consequences
for the abundance and biodiversity of stream organisms. While
aquacultures have recently started to remove suspended matter from waste
water using sedimentation basins and rotating drum filters, dissolved
components are still discharged untreated. Nutrients and dissolved
organic matter (DOM) originating from the leaching of remaining food
pellets, fish faeces and fish excretions are major components released
by aquacultures. One aquaculture in northern Patagonia was estimated to
release DOM amounting to 21% of the carbon applied as feed and 76% of
the annual fish production.
Dr. Cunha-Vaz[/caption]
José Cunha-Vaz, M.D., Ph.D.
Emeritus Professor of Ophthalmology
University of Coimbra, Portugal
President of AIBILI
Association for Innovation and Biomedical Research on Light and Image
Editor-in-Chief of Ophthalmic Research
Coordinator, Diabetic Retinopathy and Retinal Vascular Diseases,
European Vision Institute Clinical Research Network (EVICR.net)
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: In this study, we evaluated the clinical utility of quantitative measures of microvasculature in optical coherence tomographic angiography (OCTA). Although several studies have demonstrated the potential value of measures of microvasculature in the management of diabetic retinopathy (DR), our study uses the ROC curve to compare the overall value of different approaches. In this age matched population with a range of disease, the mean vessel density measured in the SRL had the highest AUC, indicating that it is best among the methods tested at differentiating normal eyes from eyes with diabetic retinopathy.
Dr. Richard Kryscio[/caption]
Richard J. Kryscio, Ph.D.
Statistics and Chair, Biostatistics and Sanders-Brown Center on Aging
Sanders-Brown Center on Aging
University of Kentucky
MedicalResearch.com: What is the background for this study?
Response: At the time the trial was initiated (2002), there was ample evidence that oxidative stress is an important mechanism in brain aging. Research showed that protein oxidation is linked to the brain’s response to the abnormal proteins seen in Alzheimer disease (amyloid beta plaques in particular) leading to inflammation, DNA repair problems, reduced energy production, and other cellular changes that are identified mechanisms in the Alzheimer brain.
Both vitamin E and selenium are antioxidants. Antioxidants, either through food or supplements, are believed to reduce oxidative stress throughout the body. In the brain, they may reduce the formation of amyloid beta plaques, reduce brain inflammation, and improve other brain processes. Studies in humans support these hypotheses. The Rotterdam study in the Netherlands, as an example, showed that initial blood levels of vitamin E could predict dementia risk. Those people with higher vitamin E levels were 25% less likely to develop dementia. Also, selenium deficiency results in cognitive difficulties and several population-based studies have shown an association between selenium level and cognitive decline (lower selenium levels are linked to thinking changes in the elderly).
Dr. Eric Secemsky[/caption]
Eric A. Secemsky, MD, MSc
Interventional Cardiology Fellow
Massachusetts General Hospital Harvard Medical School
Baim Institute for Clinical Research
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: We know from previous trials that continuing dual antiplatelet therapy longer than 12 months after coronary stenting decreases ischemic events, including spontaneous myocardial infarction and stent thrombosis. However, extending dual antiplatelet therapy is also associated with some increase in bleeding risk. For instance, in the DAPT Study, more than 25,600 patients were enrolled and received both aspirin and a thienopyridine antiplatelet drug (clopidogrel or prasugrel) for one year after stenting. Of these patients, 11,648 participants who had followed the study protocol and had no serious cardiovascular or bleeding events during that first year were then randomized to either continue with dual therapy or to receive aspirin plus a placebo for another 18 months. The overall findings of the DAPT study were that, compared with switching to aspirin only after one year, continuing dual antiplatelet therapy for a total of 30 months led to a 1.6 percent reduction in major adverse cardiovascular and cerebrovascular events – a composite of death, myocardial infarction, stent thrombosis and ischemic stroke – and a 0.9 percent increase in moderate to severe bleeding events.
The prognosis following early ischemic and bleeding events has previously been well described. However, data for events occurring beyond 1 year after PCI are limited. As such, we sought to assess the cumulative incidence of death following ischemic and bleeding events occurring among patients in the DAPT Study beyond 1 year after coronary stenting.
Dr. Blayne Welk[/caption]
Blayne Welk, MD, FRCSC
Assistant Professor of Surgery
Western University
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Concerns have been raised by regulatory agencies and patients about possible serious psychiatric side effects associated with the use of 5 alpha reductase inhibitors. These medications can be used for both enlarged prostates and alopecia.
We used administrative data to assess for potential psychiatric side effects associated with finasteride and dutasteride usage in older men with benign prostatic enlargement.
In our study we found that there was no increased risk of suicide associated with the use of these medications. However, there was a small increase in both self-harm and new onset depression associated with the use of 5 alpha reductase inhibitors.
Dr. Sara Saberi[/caption]
Sara Saberi, MD
Assistant Professor
Inherited Cardiomyopathy Program
Frankel Cardiovascular Center
University of Michigan Hospital and Health Systems
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Patients with hypertrophic cardiomyopathy are often told not to exercise or to significantly curb their exercise due to concern over the potential risk of increased ventricular arrhythmias and sudden cardiac death. There is no data regarding risks/benefits of exercise in HCM though. There is, however, data that shows that patients with HCM are less active and more obese than the general population AND a majority feel that exercise restrictions negatively impact their emotional well-being.
So, we devised a randomized clinical trial of a 16-week moderate-intensity aerobic exercise program versus usual activity with the primary outcome being change in peak VO2 (oxygen consumption). This exercise intervention resulted in a 1.27 mL/kg/min improvement in peak VO2 over the usual activity group, a statistically significant finding. There were no major adverse events (no death, aborted sudden cardiac death, appropriate ICD therapies, or sustained ventricular tachycardia). There was also a 10% improvement in quality of life as measured by the Physical Functioning scale of the SF-36v2.
Dr. Matthias Götberg[/caption]
Dr. Matthias Götberg MD PhD
Department of Cardiology, Clinical Sciences
Lund University, Skåne University Hospital
Lund, Sweden
MedicalResearch.com: What is the background for this study?
Response: Cardiologists encounter patients with narrowing of the coronary arteries on a daily basis. They typically use visual estimation of the severity of narrowing when performing coronary angiography, but it is difficult to accurately assess, based on a visual estimation alone, whether a stent is needed to widen the artery and allow the blood to more freely.
FFR (Fractional Flow Reserve) is more precise tool and results in better outcomes than using angiography alone to assess narrowing of the coronary arteries. With FFR, the doctor threads a thin wire through the coronary artery and measures the loss of blood pressure across the narrowed area. To acquire an accurate measurement, the patient must be given adenosine, which is a drug that dilates the blood vessels during the procedure. This drug causes discomfort; patients describe having difficulty breathing or feeling as if someone is sitting on their chest. The drug also adds to the cost of the procedure and can have other rare but serious side effects.
iFR (Instantaneous Wave-Free Ratio) is also based on coronary blood pressure measurements using a thin wire, but unlike FFR, it uses a mathematical algorithm to measure the pressure in the coronary artery only when the heart is relaxed and the coronary blood flow is high. As a result, a vasodilator drug is not needed.
iFR has been validated in smaller trials and have been found to be equally good as FFR to detect ischemia, but larger randomized outcome trials are lacking.
iFR-Swedeheart is a Scandinavian Registry-based Randomized Clinical Trial (RRCT) in which 2000 patients were randomized between iFR and FFR as strategies for performing assessment of narrowed coronary vessels. The primary composite endpoint at 12 months was all-cause death, non-fatal myocardial infarction, and unplanned revascularization.
RRCT is a new trial design originating from Scandinavia using existing web-based national quality registries for online data entry, randomization and tracking of events. This allows for a very high inclusion rate and low costs to run clinical trials while ensuring robust data quality.