In Euthyroid Individuals, Higher Free Thyroid Levels Linked To Greater Risk of Atrial Fibrillation

MedicalResearch.com Interview with:
Christine Baumgartner MD
Inselspital
Universitätsspital Bern
Bern, Switzerland
Research Fellow, Division of Hospital Medicine
UCSF

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

Response: Overt and subclinical hyperthyroidism increase the risk of atrial fibrillation, but it is unclear whether subclinical hypothyroidism, which is known to increase cardiovascular events, or thyroid function in the normal range are also associated with incident atrial fibrillation. Given the high prevalence of atrial fibrillation and its associated morbidity and mortality, identifying potentially modifiable risk factors is important. Therefore, we aimed to assess the risk of atrial fibrillation in individuals with subclinical hypothyroidism or variations of thyroid function within the normal range.

Our main findings are that higher free thyroxine levels are associated with an increased risk of atrial fibrillation in euthyroid individuals, but thyroid-stimulating hormone levels within the euthyroid or subclinical hypothyroid range was not related to atrial fibrillation risk.

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Cardiovascular Study Demonstrates Clinical Trial Data Sharing Is Feasible


Hawkins C. Gay, MD, MPH Resident Physician, Internal Medicine Feinberg School of Medicine Northwestern University 

Dr. Gay

MedicalResearch.com Interview with:
Hawkins C. Gay, MD, MPH
Resident Physician, Internal Medicine
Feinberg School of Medicine
Northwestern University

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

Response: The National Academy of Medicine and other leading institutions have highlighted clinical trial data sharing as an important initiative for enhancing trust in the clinical research enterprise. More recently, the International Committee of Medical Journal Editors stipulated that manuscripts published in their journals must clearly state plans for data sharing in the trial’s registration, and the National Institutes of Health now requires a data sharing plan as part of new grant applications. Many clinical trialists rightly debate the costs and time required to curate their data into a format that is usable by third part data analysts. Similarly, there has been debate about the most efficient platforms from which to distribute this data, and different models exist, including governmental (NIH BioLINCC), commercial (ClinicalStudyDataRequest.com), and academic (Yale Open Access Data Project [YODA]) platforms.

Our study sought to explore these questions by conducting a reproduction analysis of the Thermocool Smarttouch Catheter for Treatment of Symptomatic Paroxysmal Atrial Fibrillation (SMART-AF) trial (NCT01385202), which is the only cardiovascular clinical trial available through the YODA platform. Reproduction analyses represent a fundamental approach for and outcome from data sharing but are uncommonly performed even though results change more than one-quarter of the time in reproduction analyses. SMART-AF was a multicenter, single-arm trial evaluating the effectiveness and safety of an irrigated, contact force-sensing catheter for ablation of drug refractory, symptomatic paroxysmal atrial fibrillation in 172 participants recruited from 21 sites between June 2011 and December 2011.

The time from our initial proposal submission to YODA and the final analysis completion was 11 months. Freedom from atrial arrhythmias at 12 months post-procedure was similar compared with the primary study report (74.0%; 95% CI, 66.0-82.0 vs 76.4%; 95% CI, 68.7-84.1). The reproduction analysis success rate was higher than the primary study report (65.8%; 95% CI 56.5-74.2 vs 75.6%; 95% CI, 67.2-82.5). Adverse events were minimal and similar between the two analyses. We could not reproduce all analyses that were conducted in the primary study report; specifically, the analyses relating to contact force range and regression models. The primary reason for non-reproducibility was missing or un-locatable data in the analyzable dataset.

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Significant Amount of Medical Literature Contaminated With Misidentified Cells

MedicalResearch.com Interview with:

Serge Horbach MSc Institute for Science in Society Radboud University Nijmegen

Serge Horbach

Serge Horbach MSc
Institute for Science in Society
Radboud University Nijmegen
 

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

Response: Since the late 60s, researchers have pointed to issues in biomedical research stemming from the misidentification of cells. Starting with controversy around HeLa cells, researchers became aware of cells invading other cell cultures. Currently, 488 cell lines have become mixed up with the wrong cells, still often HeLa cells. This leads to errors in reporting research. For example, some research papers have reported results for “lung cancer cells” that turned out to be liver cancer cells, or even mouse cells.

We wanted to know what happened to past research and set out to estimate the number of scientific publications affected by misidentified cells. By tracing misidentified cells of the ICLAC database in Web of Science, we found 32.755 contaminated publications, or 0,8% of all literature in cell biology. These articles are cited by at least 500.000 other publications.

More worryingly, it turned out that this problem is highly stubborn. Currently, still a few dozen new articles are published every month reporting on other cells than were actually used, leading to a total of 1200 each year. And this number is not decreasing, in spite of a database of misidentified cells, of genetic testing availability, requirements by some prominent journals, or attention for the problem in the literature. We were also able to establish that this is not just a problem for newly emergent countries in the international research community, but also for countries with well-establishments research traditions. In spite of great efforts, the problem of cell misidentification is not at all solved.

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Drugs Receiving Accelerated FDA Approval Often Have Flaws In Their Evidence Base

MedicalResearch.com Interview with:

Huseyin Naci, PhD Assistant Professor of Health Policy LSE Health Department of Social Policy London School of Economics and Political Science London, United Kingdom

Dr. Naci

Huseyin Naci, PhD
Assistant Professor of Health Policy
LSE Health
Department of Social Policy
London School of Economics and Political Science
London, United Kingdom 

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

Response: An increasing proportion of novel therapeutic agents are entering the market on the basis of expedited development and approval programs. The Food and Drug Administration’s (FDA) Accelerated Approval pathway is one such expedited approval program. In our study, we examined the dynamics of research on drugs receiving accelerated approvals. We were particularly interested in the timing and characteristics of research studies including drugs with accelerated approvals.

Our primary findings are the following:

  • First, there is an abundance of research on drugs receiving accelerated approvals. Yet, the majority of this research (about 70%) is of poor quality. Ideally, these drugs are evaluated in so-called randomised controlled trials to establish their efficacy and safety. However, only about a third of all existing studies are randomised controlled trials.
  • Second, a substantial share (about 30%) of the existing research on these drugs is in areas not approved by the FDA. This may be indicative of industry research practices in trying to prioritise identification of new uses for drugs receiving accelerated approvals instead of strengthening their evidence base.
  • Third, when focusing on well-designed studies, only about a half actually evaluate the effectiveness of the accelerated approval drugs. The rest appears to use the accelerated approval drug as background therapy. Interestingly, these two types of studies are conducted concurrently. In other words, while one research group is trying to find out if an accelerated approval drug is effective, other research groups are already using it as part of a background regimen when testing the effectiveness of another, potentially newer drug

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Research Oriented Hospitals Found To Be More Efficient

MedicalResearch.com Interview with:
Antonio García-Romero IE University – IE Business School Madrid, SpainAntonio García-Romero
IE University – IE Business School
Madrid, Spain

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

Response: There is an increasing need for new approaches capable of measuring the “real” effects of research on society. People are interested in knowing what benefits are obtained from scientific research. Our aim in this project was to develop a valid methodology capable of measuring the effects from scientific research on some healthcare outcomes such as the average length of stay in a hospital. Our central hypothesis is that the more research is carried out in hospitals, the more efficient the hospitals are regarding the length of stay (LOS).

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Submission and Publication Bias Against Studies With Negative Results Declining

MedicalResearch.com Interview with:
Gary Evoniuk, PhD

Director of Publication Practices, Medical Communications Quality & Practices
GlaxoSmithKline Research and Development, Research Triangle Park, NC 27709

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

Response: In recent years, industry, and to a lesser extent academia, have been criticised for failing to submit clinical trial data for publication, especially when the data are perceived to be “negative”, (i.e. unfavourable to the drug under study) leading to publication bias. We felt it was important to determine whether this criticism is based on perception or reality and so we conducted what is, to our knowledge the only study to systematically address the issue of submission and publication bias based on study outcome.

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Financial Ties of Principal Investigators Associated With Positive Outcomes

MedicalResearch.com Interview with:
Salomeh Keyhani MD
Associate professor of general internal medicine
San Francisco VA Medical Center and University of California
San Francisco, CA 94121, USA

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

Response: Randomized controlled trials are the foundation of the evidence base. We examined the prevalence of financial ties in randomized controlled trials and also examined the relationship of financial ties of principal investigators (PI) with trial outcome. We defined a financial tie as the direct compensation (e.g., consulting fees) of a PI by the drug manufacturer of interest. Although there have been past studies that have examined this relationship, many did not separate financial ties from funding source for the trial and many were focused on one specialty, journal, or type of drug.

This study identified a random sample of RCTs published in 2013 that were focused on assessing drug efficacy. Both the disclosure section of the paper and several online databases (Medline, Google, Propublica’s Dollars for Doctors, and the US Patent Office) were searched for evidence of financial ties. Principal investigators financial ties with industry were independently associated with positive study outcomes.

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Teashirt Gene Links Kidney Disease and Autism Spectrum Disorders

MedicalResearch.com Interview with:

Prof Adrian S. Woolf Chair, Professor of Paediatric Science  University of Manchester, UK

Prof. Adrian Woolf

Prof Adrian S. Woolf
Chair, Professor of Paediatric Science
University of Manchester, UK

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

Response: Several years ago, Laurent Fasano discovered that the Drosophila teashirt gene was needed to pattern the body of embryonic flies.

He then found that this transcription factor had three similar genes in mammals.

Working with Adrian Woolf in the UK, they found that Teashirt-3 (Tshz3) was needed in mice to make muscle form in the ureter When the gene was mutated, mice were born with ureters that were ‘blown-up’ and they failed to milk urine from the kidney with the bladder.

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Authors’ Prestige May Influence Some Medical Research Reviewers

MedicalResearch.com Interview with:

Kanu Okike MD MPH Department of Orthopaedic Surgery, Kaiser Moanalua Medical Center Honolulu, Hawaii

Dr. Kanu Okike

Kanu Okike MD MPH
Department of Orthopaedic Surgery, Kaiser Moanalua Medical Center
Honolulu, Hawaii

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

Response: Many journals in the social sciences practice double-blind review, in which reviewers and authors are both blinded to each others’ identities. In medicine, on the other hand, most journals practice single-blind review, in which authors’ identities are known to reviewers. Concerns have been raised that this could lead to biased reviews, however, especially in the case of well-known authors.

In our study, we composed a fabricated test manuscript and randomized reviewers for an orthopaedic journal to receive single-blind (prestigious authors listed) or double-blind (no authors listed) versions. In our study, the reviewers who were under the impression that the manuscript was written by prestigious authors (single-blind review) awarded higher marks and also recommended acceptance more often, in spite of the fact that the manuscripts were otherwise identical.

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Reporting of Adverse Events in Published and Unpublished Studies of Health Care Interventions May Differ

MedicalResearch.com Interview with:

Dr Su Golder PhD Research Fellow Department of Health Sciences University of York

Dr. Su Golder

Dr Su Golder PhD
Research Fellow
Department of Health Sciences
University of York

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

Response: Serious concerns have emerged regarding publication bias or selective omission of outcomes data, whereby negative results are less likely to be published than positive results. There remains considerable uncertainty about the extent of unpublished data on adverse events beyond that reported in the published literature. We aimed to estimate the potential impact of additional data sources and the extent of unpublished information when conducting syntheses of adverse events.

We found that less published papers contain adverse events information. The median percentage of published documents with adverse events information was 46% compared to 95% in the corresponding unpublished documents. There was a similar pattern with unmatched studies, for which 43% of published studies contained adverse events information compared to 83% of unpublished studies.

We also found even when adverse events are reported in the published and unpublished versions of the same study that the numbers of adverse events do not always match The percentage of adverse events that would have been missed had each analysis relied only on the published versions varied between 43% and 100%, with a median of 64%.
Lastly we found that inclusion of unpublished data increased the precision of the pooled estimates (narrower 95% confidence intervals) in three-quarters of pooled analyses, but did not markedly change the direction or statistical significance of the risk in most cases.

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Early Menopause Linked To Increased Risk of Heart Disease and Carotid Atherosclerosis

MedicalResearch.com Interview with:
Taulant Muka, MD, MPH, PhD
Postdoctoral Researcher
Erasmus University, Rotterdam

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

Response: Menopause marks a major life transition for women, resulting in the loss of ovarian follicle development. Although menopause is a universal phenomenon among women, the timing of the final menstrual period differ greatly between women, and is considered a marker of aging. By quantifying data of nearly 310,329 non-overlapping women, we found that women who experienced an early menopause (i.e. younger than 45 years) have an excess risk of CHD, CVD-mortality and all-cause mortality. Furthermore, being 45-49 years at menopause compared to ≥50 years was associated with increased risk of carotid atherosclerosis.

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Risk of breast cancer associated with a diagnosis of atypical ductal hyperplasia may be lower than previously reported

MedicalResearch.com Interview with:
Tehillah S. Menes, MD

Department of Surgery
Tel Aviv-Sourasky Medical Center
Tel Aviv, Israel

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

Response: Atypical ductal hyperplasia (ADH) is a known risk factor for breast cancer. The diagnosis is made by a biopsy showing a uniform proliferation of cells lining the ducts of the breast. These cells have monomorphic round nuclei and characteristically fill only part of the involved duct. Women diagnosed with ADH are recommended to undergo increased surveillance and offered chemoprevention (i.e. Tamoxifen) for risk reduction.
Most studies reporting on the risk of subsequent breast cancer in women with ADH were done prior to the wide use of screening mammography and percutaneous needle biopsy. Our study examined 10-year risk of invasive breast cancer in women diagnosed with ADH (by needle biopsy or excisional biopsy), using data collected by the Breast Cancer Surveillance Consortium (BCSC).

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Localized Prostate Cancer: Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy

MedicalResearch.com Interview with:

Professor Jenny Donovan  PhD   OBE FMedSci NIHR-SI AcSS FFPHM Director, NIHR CLAHRC West (National Institute for Health Research Collaboration for  Leadership in Applied Health Research and Care West) at University Hospitals Bristol NHS Trust Bristol, UK

Prof. Jenny Donovan

Professor Jenny Donovan  PhD
OBE FMedSci NIHR-SI AcSS FFPHM
Director, NIHR CLAHRC West
(National Institute for Health Research Collaboration for
Leadership in Applied Health Research and Care West)
at University Hospitals Bristol NHS Trust
Bristol, UK

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

Response: PSA testing identifies many men with prostate cancer, but they do not all benefit from treatment. Surgery, radiation therapy and various programs of active monitoring/surveillance can be given as treatments for fit men with clinically localized prostate cancer. Previous studies have not compared the most commonly used treatments in terms of mortality, disease progression and patient-reported outcomes. In the ProtecT study, we used a comprehensive set of validated measures, completed by the men at baseline (before diagnosis), at six and 12 months and then annually for six years.

The main finding is that each treatment has a particular pattern of side-effects and recovery which needs to be balanced against the findings from the paper reporting the clinical outcomes (Hamdy et al).

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Some Personality Traits Revealed In How You Walk

MedicalResearch.com Interview with:

Mr Liam Satchell Research Associate Department of Psychology University of Portsmouth, UK

Mr. Liam Satchell

Mr Liam Satchell
Research Associate
Department of Psychology
University of Portsmouth, UK

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

Response: Most people in general are really interested in trying to understand “body language”, how a person behaves may give clues to their psychology. However, psychology has rarely engaged in an empirical investigation of what information about personality may be available in largely automatic movements, such as walking. We brought together techniques from psychology research and sports and exercise science to investigate what features of personality may be available in gait.

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JAMA Study Updates Goals of Cost-Effective Health Care

MedicalResearch.com Interview with:

Gillian D. Sanders-Schmidler Ph.D. Professor of Medicine Duke Evidence Synthesis Group, Director Duke Evidence-based Practice Center, Director Duke Clinical Research Institute Duke University

Dr. Gillian D. Sanders-Schmidler

Gillian D. Sanders-Schmidler Ph.D.
Professor of Medicine
Duke Evidence Synthesis Group, Director
Duke Evidence-based Practice Center, Director
Duke Clinical Research Institute
Duke University

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

Response: In 1996, the original panel on cost effectiveness in health and medicine published recommendations for the use of cost effectiveness analysis. During the 20 years since the original panel’s report, the field of cost-effectiveness analysis has advanced in important ways and the need to deliver health care efficiently has only grown. In 2012 the Second Panel on Cost Effectiveness in health and Medicine was formed with a goal of reviewing and updating the recommendations.

This paper summarizes those recommendations. This process provided an opportunity for the Panel to reflect on the evolution of cost-effectiveness analysis and to provide guidance for the next generation of practitioners and consumers.

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One Size Fits All Strategy No Longer Works For Treatment of Ovarian Cancer

MedicalResearch.com Interview with:

Larissa A. Meyer, MD MPH F.A.C.O.G. Assistant Professor Dept of Gynecologic Oncology and Reproductive Medicine Houston, TX 77030-1362

Dr. Larissa Meyer

Larissa A. Meyer, MD MPH F.A.C.O.G.
Assistant Professor
Dept of Gynecologic Oncology and Reproductive Medicine
Houston, TX 77030-1362

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

Response: Despite the completion of two randomized controlled trials, controversy regarding the optimal approach for the treatment of advanced ovarian cancer remains. Our observational study highlights the importance of thoughtful selection of individuals for primary cytoreductive surgery for advanced ovarian cancer. Our results suggest that primary cytoreductive surgery may improve survival for patients with stage IIIC ovarian cancer who are likely to achieve an optimal cytoreduction, while neoadjuvant chemotherapy may be the preferred option for many women with stage IV ovarian cancer.

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Study Outlines Risk Factors for Infectious Endocarditis After TAVR

MedicalResearch.com Interview with:

Josep Rodés-Cabau, MD Director, Catheterization and Interventional Laboratories Quebec Heart and Lung Institute Professor, Faculty of Medicine, Laval University Quebec City, Quebec, Canada

Dr. Rodés-Cabau

Josep Rodés-Cabau, MD
Director, Catheterization and Interventional Laboratories
Quebec Heart and Lung Institute
Professor, Faculty of Medicine, Laval University
Quebec City, Quebec, Canada

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

Response: Infectious endocarditis (IE) is one of the most serious complications after surgical prosthetic valve replacement. There are however scarce data regarding the incidence, predictive factors, treatment, and outcomes of IE post-TAVR. To date, the present study represents the largest series of IE post-TAVR, and the main findings can be summarized as follows: (1) the incidence of infective endocarditis (IE) post-TAVR is similar to that reported for IE after surgical prosthetic valve replacement; (2) among patients undergoing TAVR, younger age, male sex, a history of diabetes mellitus, and moderate-to-severe residual aortic regurgitation were associated with a higher risk of IE, (3) Enterococci species was the most frequently isolated pathogen, (4) IE post-TAVR was associated with a very high rate of in-hospital complications and mortality during index hospitalization and at follow-up.

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Adolescent Girls Not Adequately Screened For Pregnancy Before Chemo or CT Scans

MedicalResearch.com Interview with:

Pooja Rao, MD, MSCE Assistant Professor Division of Pediatric Hematology/Oncology Milton S. Hershey Medical Center Penn State College of Medicine

Dr. Pooja Rao

Pooja Rao, MD, MSCE
Assistant Professor
Division of Pediatric Hematology/Oncology
Milton S. Hershey Medical Center
Penn State College of Medicine

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

Response: Although many chemotherapy drugs can cause birth defects, no standardized guidelines exist for pregnancy screening in adolescent female patients with cancer. Additionally, little is known about how often they are screened prior to receiving treatment.

Our study found that adolescent girls are not adequately screened for pregnancy prior to receiving chemotherapy or CT scans that could potentially harm a developing fetus. Adolescents with acute lymphoblastic leukemia, the most common childhood cancer, had the lowest pregnancy screening rates of the patients studied.

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Three Criteria To Identify Out-of-Hospital Cardiac Arrest Patients With No Chance of Survival

MedicalResearch.com Interview with:

Prof. Xavier Jouven Service de Cardiologie Hôpital Européen Georges Pompidou Paris

Prof. Xavier Jouven

Prof. Xavier Jouven
Service de Cardiologie
Hôpital Européen Georges Pompidou
Paris

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

Response: There are many cardiac arrests (around 300 000 per year in United States). The possibility to collect organs from a certain proportion of those cardiac arrests represents an important opportunity to fill the gap of the organ shortage.

It is absolutely mandatory to identify patients with no chance of survival. This study showed 3 criteria which allow this early identification. Several thousands of patients die every year waiting for organ transplantation.

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90% of Americans Live Within Short Driving Distance To Eye Care

MedicalResearch.com Interview with:

Dr. Cecelia Lee

Dr. Cecelia Lee

Cecilia S. Lee, MD
Department of Ophthalmology
University of Washington School of Medicine
Seattle, WA

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

Response: Access to eye care is a critical issue currently in the United States. With the expected increase in the aging US population, many eye diseases are age-related and there is an expected associated increase in demand for eye care. Prior studies have estimated access to care in many different ways including looking at providers per zipcode, utilization of billing codes, and distance to provider. We sought to estimate the access to eye care providers using a much more accurate way to estimate the driving distance to provider. Specifically, we recreated a driving route system similar to Google Maps or Apple Maps for navigation to plot direct driving routes.

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The GLORIA-AF Registry: Two Year Follow Up of Dabigatran for Non-Valvular A Fib Reported

MedicalResearch.com Interview with:

Menno Huisman, MD, PhD Associate professor Department of Medicine Leiden University Medical Center The Netherlands

Dr. Menno Huisman

Menno Huisman, MD, PhD
Associate professor
Department of Medicine
Leiden University Medical Center
The Netherlands

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

Response: GLORIA™-AF is one of the largest ongoing global registry programs examining the use of oral antithrombotic agents in real-world clinical practice. The program is designed to characterize the population of newly diagnosed patients with non-valvular atrial fibrillation (NVAF) at risk for stroke, and to study patterns, predictors and outcomes of different regimens for stroke prevention.

At the ESC Congress 2016, we presented the first Phase II results of GLORIA-AF from approximately 3,000 NVAF patients, which showed that treatment with PRADAXA was associated with low incidences of stroke, major bleeding and life threatening bleeding. Less than 1% of PRADAXA-treated patients experienced a stroke over two years (0.63%). Major bleeding occurred in 1.12% of PRADAXA-treated patients and 0.54% experienced a life-threatening bleed.

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Penn Reports Successful Pilot Study of Liquid Biopsy To Monitor Advanced Lung Cancer

MedicalResearch.com Interview with:

Erica L. Carpenter, MBA, PhD Research Assistant Professor, Department of Medicine Director, Circulating Tumor Material Laboratory Division of Hematology/Oncology Abramson Cancer Center Perelman School of Medicine at the University of Pennsylvania

Dr. Erica Carpenter

Erica L. Carpenter, MBA, PhD
Research Assistant Professor, Department of Medicine
Director, Circulating Tumor Material Laboratory
Division of Hematology/Oncology
Abramson Cancer Center
Perelman School of Medicine at the University of Pennsylvania

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

Response: The advent of precision medicine practices for cancer patients, including the use of drugs that target specific tumor mutations, has necessitated improved diagnostics with real-time molecular monitoring of patients’ tumor burden. While biopsy material, obtained surgically or through fine needle aspirate, can provide tissue for next generation sequencing (NGS) and mutation detection, this requires an invasive often painful procedure for the patient. In many cases, especially in more advanced disease when multiple metastases are present, such tissue cannot be obtained or can only be obtained from a single tumor site, thus limiting the sensitivity of tissue-based biopsy.

Here we report on a prospective cohort of 102 consecutively enrolled patients with advanced non-small lung cancer (NSCLC) for whom a non-invasive liquid biopsy was used for real-time detection of therapeutically targetable mutations. Tissue samples were only obtainable for 50 of the 102 patients, and these tissue biopsies were analyzed using a 47-gene Next Generation Sequencing (NGS) panel at Penn’s Center for Personalized Diagnostics. Concordance of results for the 50 patients who received both tests was close to 100% when the samples were obtained concurrently.

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Triclosan in Household Dust Linked To Antibiotic Resistance

MedicalResearch.com Interview with:

Erica Marie Hartmann PhD Assistant Professor Dept. of Civil & Environmental Engineering Northwestern University Evanston, IL 60208

Dr. Erica Hartmann

Erica Marie Hartmann PhD
Assistant Professor
Dept. of Civil & Environmental Engineering
Northwestern University
Evanston, IL 60208

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

Response: The antimicrobial chemical triclosan has been found in almost every dust sample that has ever been tested worldwide, and we already know that triclosan can cause an increase in antibiotic resistance genes in wastewater. This study is the first to show a link between antibiotic resistance genes and antimicrobial chemicals in indoor dust, which people tend to come into contact with more than wastewater.

This finding is important because the World Health Organization has identified a huge information gap in community-acquired antibiotic-resistant infections; the use of antimicrobial chemicals in homes and other non-medical buildings could be contributing to the development of antibiotic resistance outside of hospital settings. This study was published in the wake of the FDA decision last week to ban the use of triclosan and several other antimicrobial chemicals in soaps. While the FDA decision is a good first step, it’s not the end the problem. Antimicrobial chemicals like triclosan are in a lot of different products. Right now, we don’t know how much of the triclosan we see in dust comes from soap vs. other products (building materials, paints, plastics, etc.).

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Lung Cancer: Adjusting Afatinib Dose Reduced Side Effects With No Impact on Efficacy

MedicalResearch.com Interview with:

Chih-Hsin Yang MD PhD Department of Oncology National Taiwan University Hospital

Dr. Chih-Hsin Yang

Chih-Hsin Yang MD PhD
Department of Oncology
National Taiwan University Hospital

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

Response: LUX-Lung 3 and LUX-Lung 6 are multicenter, randomized, open-label, Phase III trials of afatinib versus chemotherapy (pemetrexed / cisplatin and gemcitabine / cisplatin, respectively) as first-line treatment for patients with EGFR mutation-positive, advanced and metastatic non-small-cell lung cancer (NSCLC). Both trials met their primary endpoint of PFS with afatinib significantly delaying tumor growth when compared to standard chemotherapy.

A post-hoc analysis of the studies was conducted to look at the incidence and severity of common adverse events (AEs) before and after afatinib dose reduction and the PFS was compared between patients who dose reduced within the first 6 months of treatment and those who did not.

The results showed dose reductions were associated with decreases in the incidence and severity of treatment-related AEs, while median progression-free survival (PFS) was similar in patients who dose-reduced within the first six months of treatment versus those who did not (LUX-Lung 3, 11.3 vs 11 months; LUX-Lung 6, 12.3 vs 11 months).

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Body Mass Index Linked to LV Mass in Career Male Firefighters

MedicalResearch.com Interview with:

Maria Korre, ScD Post-Doctoral Research Fellow Environmental & Occupational Medicine & Epidemiology Program Department of Environmental Health Harvard T.H. Chan School of Public Health

Maria Korre

Maria Korre, ScD
Post-Doctoral Research Fellow
Environmental & Occupational Medicine & Epidemiology Program
Department of Environmental Health
Harvard T.H. Chan School of Public Health

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

Response: Cardiovascular disease (CVD) is the leading cause of on-duty death among firefighters (45% of on-duty fatalities) and a major cause of morbidity. It is crucial to note though, that the risk of on-duty CVD events is not evenly distributed among all firefighters, but is highly concentrated among the most susceptible individuals. Given that firefighting is an inherently dangerous occupation and many of its hazards cannot be engineered out of the job, we have concentrated our efforts on understanding what can make an individual firefighter susceptible.

As in the general population, these cardiovascular events are largely due to coronary heart disease (CHD), however, there is an increasing recognition of the role of left ventricular (LV) hypertrophy/cardiomegaly in the risk of sudden cardiac death (SCD) independent of the presence of CHD. Evidence suggests an improved prognostic value, when LV hypertrophy is based on the accurate assessment of LV mass.

LV mass is a strong predictor of CVD events and despite it’s critical prognostic significance, it’s measurement and role in clinical practice has yet to be established.

In this paper we aimed to identify the most important predictors of LV mass after indexing for height among career male firefighters as assessed by both echocardiography and cardiac magnetic resonance.

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In Utero Exposure to Ethinyl Estradiol Linked to Tamoxifen Resistance and Breast Cancer Recurrence

MedicalResearch.com Interview with:

Leena Hilakivi-Clarke, PhD Professor of Oncology Georgetown University Washington, DC 20057

Dr. Leena Hilakivi-Clarke

Leena Hilakivi-Clarke, PhD
Professor of Oncology
Georgetown University
Washington, DC 20057

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

Response: About 70% of women who develop breast cancer express estrogen receptors in their cancer. These patients are treated with endocrine therapies that target estrogen receptors. Endocrine therapies are effective in half of the patients, but the other half are resistant to the treatment and recur. Prior to the start of endocrine therapy, there is no way to predict who will respond to it and who will have recurrence of breast cancer. Therefore, it is not known which patients might benefit from an additional therapy to prevent recurrence, and what that additional therapy would entail. We wondered if resistance to endocrine therapy (we used tamoxifen) is pre-programmed by maternal exposure to the estrogenic endocrine disrupting chemical ethinyl estradiol (EE2). Previously, we and others have found that EE2 and other estrogenic compounds, when given during pregnancy, increase breast cancer risk in the female offspring in animal studies and among humans. The current study was done using a preclinical animal model that was used 50 years ago to discover that tamoxifen is an effective endocrine therapy for estrogen receptor positive breast cancer patients.

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Key Risk Factors of Non-Healing Bone Fractures Identified

MedicalResearch.com Interview with:

R. Grant Steen, PhD Medical Affairs, Bioventus LLC Durham, North Carolina

Dr. R. Grant Steen

R. Grant Steen, PhD
Medical Affairs,
Bioventus LLC
Durham, North Carolina

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

Response: When we started this research, it was really only guesswork as to how big a problem fracture nonunion really is. What we’ve done is to work with an enormous database of patient health claims, with two goals.

First, we wanted to characterize how common fracture nonunion is among patients across a wide age range.
Second, we wanted to identify risk factors that make a patient more likely to have problems healing.

We’ve now succeeded in both aims. We know that roughly 5% of fracture patients will go to nonunion, and we know a whole host of risk factors that predispose them to do so.
Most of the risk factors that we’ve identified—with a few exceptions—would not be a surprise to physicians who treat fracture patients. However, what we’ve done is to put all of these risk factors in a broader context, so that we know which risk factors are most important and which are less so.

For example, it has been known for a long time that smoking is a risk factor for nonunion. What we’ve shown is that, in the scheme of things, it’s not all that important. Let me be more precise here, because this is an important point. If all you know about a patient is that they smoke, we’ve shown that smoking is associated with a 62% increase in risk of nonunion. That’s a lot. But, as you learn more about that patient and can factor that new knowledge into a risk prediction, it turns out that smoking, all by itself, increases the risk of nonunion by only about 20%. However, smoking is a surrogate marker for a range of other risk factors that also increase risk, including male gender, cardiovascular disease, obesity, vitamin D deficiency, alcoholism, and so on. Once you factor these separate risk factors into your new nonunion prediction, you have a much more nuanced—and probably much more accurate—prediction of nonunion risk.
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Low-Intensity Interventions Addressing Social Needs In Pediatric Settings Can Improve Child Health

MedicalResearch.com Interview with:
Laura M. Gottlieb, MD, MPH
Department of Family and Community Medicine,
2Center for Health and Community
University of California, San Francisco

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

Response: Numerous studies have demonstrated that childhood exposures to social adversities, like family financial insecurity, food insecurity, and housing instability, lead to poorer health outcomes across the life course. These social adversities disproportionately affect low-income and racial minority populations. In response to this evidence there have been calls to address social needs in pediatric clinical care settings. For example, recently the American Academy of Pediatrics’ Task Force on Childhood Poverty endorsed the promotion of evidenced-based strategies to reduce the negative health effects of poverty on low-income children, including by increasing the availability of clinic-based interventions addressing social risks.

In response to these calls to action, a growing number of pediatric health care organizations are screening for and address families’ social needs. There is a critical need for more evidence on the effectiveness of these types of interventions. Many of the studies conducted so far have focused primarily on assessing program process outcomes or impacts on families’ social needs, but have not evaluated actual health outcomes resulting from program participation.

To our knowledge, this study was the first randomized clinical trial evaluating the impacts of a pediatric social needs navigation program on child health.

The reported number of social needs identified at baseline ranged from 0 to 11 out of 14 possible items, with a mean [SD] of 2.7[2.2] needs identified by participating families. Family participation in the navigation program intervention significantly decreased families’ reports of social needs by a mean (SE) of .39(0.13) vs. an increase of a mean (SE) of .22(0.13) in the active control arm. Participation in the navigation program also significantly improved parent-reported overall child health, with a mean (SE) change of -.036(0.05), compared to the active control arm with a mean (SE) change of -0.12(0.05). At 4 months post enrollment, the number of social needs reported by those that participated in the navigation program decreased by a mean (SE) of .39(0.13).

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Stem Cells Drive Vascular Calcification in Arteriosclerosis

MedicalResearch.com Interview with:
Rafael Kramann, MD, FASN
RWTH Aachen University
Division of Nephrology and Clinical Immunology
Pauwelsstr 30
52074 Aachen, Germany

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

Response: Vascular calcification contributes centrally to the increased cardiovascular morbidity and mortality in patients with diabetes or chronic kidney disease.

Vascular calcification is of major clinical importance as it predicts cardiovascular events, affects plaque stability contributing to stroke and myocardial infarction and also contributes to chronic heart failure by stiffening of the arterial wall. However, the cellular origin of vascular calcification is incompletely understood. While it is known that resident vascular smooth muscle cells and circulating macrophages are involved the contribution of adventitial cells is controversial and partly unknown.

Our data indicates that adventitial progenitor cells marked by expression of Gli1 are key drivers of vascular calcification in athero- and arteriosclerosis. Genetic ablation of this cell population completely abolished vascular calcification in a mouse model of high lipid load and chronic kidney disease. Identification of this progenitor population might be the first step towards a cell-specific targeted therapy of vascular calcification.

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Roundworm Infection Transmitted By Raccoons Has Serious Neurologic Complications

MedicalResearch.com Interview with:

Anita D. Sircar, MD Epidemic Intelligence Service Division of Parasitic Diseases and Malaria Center for Global Health CDC

Dr. Anita Sircar

Anita D. Sircar, MD
Epidemic Intelligence Service
Division of Parasitic Diseases and Malaria
Center for Global Health
CDC

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

Response: Baylisascaris procyonis is a roundworm commonly found in raccoons. It can be found anywhere in the United States where raccoons live. People, especially children, can be infected by this roundworm when they accidentally ingest contaminated raccoon feces. Infection with Baylisascaris procyonis can have severe outcomes in people such as blindness and even death if not treated promptly.

Despite expansion of the geographic distribution of Baylisascaris procyonis in the last 14 years and probable increasing human exposure, baylisascariasis is likely an underreported disease: only 22 documented cases were reported in the United States during 1973–2010.

During May 2013–December 2015, seven additional cases of baylisascariasis were identified among patients in the United States through testing at CDC, including six cases of central nervous system disease and one of ocular disease. Laboratory and clinical information for each patient was gathered and reviewed in a case series to contribute to knowledge about Baylisascaris procyonis infection. All seven patients survived, although approximately half had residual neurologic sequelae.

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Atrial Fibrillation Associated With Wide Range of Cardiovascular Events

MedicalResearch.com Interview with:
Ayodele Odutayo, DPhil student
Centre for Statistics in Medicine
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences
University of Oxford, Oxford, UK

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

Response: Atrial fibrillation is associated with an increased risk of all cause mortality and stroke, as well as higher medical costs and a reduced quality of life. The association between atrial fibrillation and cardiovascular outcomes other than stroke is less clear.

We found that atrial fibrillation is associated with a wide range of cardiovascular events, including cardiovascular mortality, major cardiovascular events, heart failure, ischaemic heart disease, chronic kidney disease, and sudden cardiac death, as well as stroke and all cause mortality. The relative and absolute risk increase associated with many of these events is greater than that of stroke. Interventions are needed to reduce the risk of non-stroke cardiovascular outcomes in adults with atrial fibrillation.

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Earned Income Tax Credits Linked To Improved Health Parameters

MedicalResearch.com Interview with:

Peter Muennig, MD, MPH Associate Professor Mailman School of Public Health Columbia University New York, NY 10032

Dr. Peter Muennig

Peter Muennig, MD, MPH
Associate Professor
Mailman School of Public Health
Columbia University
New York, NY 10032

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

Response: We looked that the supplemental Earned Income Tax Credit
( EITC ) programs offered by states to determine whether they have health impacts or not.

We found that, on average, folks who live in states that offer supplemental EITC showed improvements in health after EITC was implemented.

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Pemphigus Incidence Much Higher Among Jews Than Arabs in Northern Israel

MedicalResearch.com Interview with:

Khalaf Kridin, MD Department of Dermatology Rambam Health Care Campus Haifa Israel

Dr. Khalaf Kridin

Khalaf Kridin, MD
Department of Dermatology
Rambam Health Care Campus
Haifa Israel

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

Response: Pemphigus shows an uneven geographic and ethnic distribution. A high incidence of pemphigus was observed in some ethnic groups, namely Ashkenazi Jews and those of Mediterranean origin. This observation has been shown to be strongly related to several HLA-class II genes; HLA-DRB1*04 and HLA-A*10 which have been more frequently found among Ashkenazi Jewish pemphigus patients. We sought to estimate trends in the incidence of pemphigus in northern Israel in the years 2000-2015, in relation to the major ethnic groups who inhabit the same geographic area and exposed to the same environmental elements.

The overall estimated incidence of pemphigus in northern Israel was 7.2 per million inhabitants per year (95% CI, 6.2-8.3). The incidence in the Jewish population was 3-fold higher than that in Arabs; 9.6 vs. 3.2 cases per million per year, respectively, p<0.0001), and higher among women than men; 9 vs. 5.3 cases per million per year, respectively, p<0.0001). Patients of Arab ancestry tend to present with the disease at earlier age, in line with observations from Arab and Mediterranean countries.

A declining trend in the incidence of pemphigus throughout the last 16 years in northern Israel was observed.

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TAVR: Women Have More Short Term Complications But Better One-Year Survival

MedicalResearch.com Interview with:

Michael A. Gaglia Jr., MD, MSc, FACC, FSCAI Scientific Lead, Population Research Medstar Cardiovascular Research Network Interventional Cardiology Medstar Heart and Vascular Institute Washington, DC 20010

Dr. Michael Gaglia

Michael A. Gaglia Jr., MD, MSc, FACC, FSCAI
Scientific Lead, Population Research
Medstar Cardiovascular Research Network
Interventional Cardiology
Medstar Heart and Vascular Institute
Washington, DC 20010

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

Response: Cardiovascular outcomes vary according to gender in a variety of disease states. For example, short-term mortality is higher among women presenting with an acute coronary syndrome in comparison to men. There is a similar trend for higher short-term mortality of women undergoing coronary artery bypass grafting, although this is in part due to a relatively higher burden of comorbidities. Female gender is also a well-established risk factor for bleeding complications after percutaneous coronary intervention.

In regards to women undergoing surgical aortic valve replacement for severe aortic stenosis (AS), however, the data is equivocal; some studies suggest higher mortality for women, whereas others suggest improved survival for women.

The emergence of transcatheter aortic valve replacement (TAVR) as the preferred therapeutic option for patients with severe AS at high or extreme risk for surgery offered another opportunity to examine gender disparities in outcomes. The evidence base for the impact of gender upon TAVR, however, is still evolving. A recent meta-analysis suggested improved long-term survival among women after TAVR. And in general, previous studies also suggest more vascular and bleeding complications in women when compared to men. The goal of this study was relatively simple: to compare outcomes between women and men undergoing TAVR at a single center.

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Liquid Biopsies Hold Promise of Diagnosing Response to Chemotherapy

MedicalResearch.com Interview with:

Karen L. Reckamp, M.D. Associate Professor City of Hope Comprehensive Cancer Center Duarte, CA 91010

Dr. Karen Reckamp

Karen L. Reckamp, M.D.
Associate Professor
City of Hope Comprehensive Cancer Center
Duarte, CA 91010

MedicalResearch.com: What is the background for this study? What are the main findings?
Response:
• Approximately 60% of patients with non-small cell lung cancer (NSCLC) receiving EGFR tyrosine kinase inhibitors (TKIs) will develop TKI resistance through the acquisition of the EGFR T790M mutation.
• A major challenge for assessing EGFR mutation status in advanced NSCLC is the availability of suitable biopsy tissue for molecular testing, specifically for determination of the emergence of T790M following progression on initial EGFR TKI therapy.
• The objective of this study was to demonstrate that a highly sensitive and quantitative next-generation sequencing analysis of EGFR mutations is feasible from urine and plasma, providing comparable clinical information while potentially mitigating the issues associated with tissue biopsies.
• This blinded, retrospective study was conducted on matched tissue, urine and plasma specimens collected from 63 patients with Stage IIIB-IV NSCLC enrolled in the TIGER-X trial of rociletinib, an investigational 3rd generation tyrosine kinase inhibitor (TKI), targeting T790M.

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Vitamin A May Inhibit Pancreatic Cancer by Preventing Desmoplasia That Surrounds Tumor

MedicalResearch.com Interview with:

Armando E. del Río Hernández, PhD European Research Council Fellow Head, Cellular and Molecular Biomechanics Laboratory http://biomechanicalregulation-lab.org/ Senior Lecturer, Department of Bioengineering Imperial College London

Dr. del Río Hernández

Armando E. del Río Hernández, PhD
European Research Council Fellow
Head, Cellular and Molecular Biomechanics Laboratory
http://biomechanicalregulation-lab.org/
Senior Lecturer, Department of Bioengineering
Imperial College London

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

Response: Pancreatic cancer is an extremely aggressive disease with an unacceptably low survival rate that has not changed during the last 40 years despite significant efforts aimed at developing therapies against cancer cells.

Pancreatic cancer is characterised by an extensive desmoplasia, which forms the majority of the tissue around the tumour. This desmoplastic tissue is known to help the tumour to grow and metastasize, and hinders drug delivery.

We have focused our efforts on understanding how pancreatic stellate cells (PSCs), which are the key effectors that orchestrate the desmoplastic reaction in pancreatic cancer, can promote tumour progression. PSCs in healthy pancreas have abundant vitamin A storage in their cytoplasm and exist in a quiescent state that guarantees a balanced tissue homeostasis. In pancreatic cancer, loss of this balance activates PSCs, which lose the vitamin A content and remodel the surrounding tissue to make it favourable for cancer cell invasion.
We found that treating PSCs which ATRA (All trans-retinoic acid), the active metabolite of vitamin A mechanically reprograms PSCs to promote quiescence in vitro. Quiescent PSCs are unable to remodel the microenvironment to allow pancreatic cancer cell invasion.

To get more information about our findings please find the article in the open access journal Nature Communications:http://www.nature.com/articles/ncomms12630

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Early Palliative Care Improved Patients’ Symptoms and Coping Skills

MedicalResearch.com Interview with:

Joseph A. Greer, Ph.D. Program Director, Center for Psychiatric Oncology & Behavioral Sciences Associate Director, Cancer Outcomes Research Program, Massachusetts General Hospital Cancer Center Yawkey Center, Boston, MA 02114

Dr. Joseph Greer

Joseph A. Greer, Ph.D.
Program Director, Center for Psychiatric Oncology & Behavioral Sciences
Associate Director, Cancer Outcomes Research Program,
Massachusetts General Hospital Cancer Center
Yawkey Center, Boston, MA 02114

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

Response: Many patients with advanced cancer have a high symptom burden, increased depression symptoms, misperceptions about their prognosis, and difficulties in making decisions about care at the end of life.

To address these challenges and improve care for this vulnerable population, our research team initially conducted a small, single-group pilot study of early palliative care integrated with standard oncology care for patients with advanced lung cancer.

This study showed that the model of integrated care was feasible and acceptable to patients and their families. Specifically, the majority of patients in the study were able to meet with a palliative care clinician at least monthly from the time of diagnosis of metastatic lung cancer, in order to receive help with managing symptoms as well as support for coping with the disease and making decisions about treatment. We then conducted a follow-up randomized controlled trial of early, integrated palliative care in a sample of approximately 150 patients with metastatic non-small cell lung cancer. This study was published in the New England Journal of Medicine in 2010 and showed that those patients who received early palliative care reported significantly improved quality of life, mood, prognostic awareness, and end-of-life care compared to those who received standard oncology care alone.

To confirm the findings of our prior research and to determine whether the benefits of early integrated palliative care would apply to a larger sample of patients with diverse malignancies, we recently completed another randomized trial of this same model of care in a sample of 350 patients with incurable lung and gastrointestinal cancers. In this trial, we observed that patients who received the early palliative care intervention reported higher quality of life and improved mood by 24 weeks but not at the primary end-point of 12 weeks. Our team was surprised to find that the trajectory of quality of life and depression symptoms over time was different for individuals with incurable lung versus gastrointestinal cancers in this study. As expected, the palliative care intervention positively buffered the decline in quality of life by 12 weeks for patients with incurable lung cancer, as we had seen in our prior trial. However, the group of patients with gastrointestinal cancers reported an improvement in their quality of life by the 12-week time point regardless of whether they received the palliative care intervention.

We are still exploring possible reasons for this difference, such as whether changes in cancer therapy may have reduced symptoms and improved quality of life in the group of patients with gastrointestinal cancer.

In addition, we were pleased to learn that the early integrated palliative care intervention led to improvements in how patients cope with their illness. For example, compared to patients in the usual oncology care group, those who received early, integrated palliative care were more likely to learn ways to accept their diagnosis and to take positive actions to make their lives better. So, in addition to treating patients’ symptoms, the palliative care clinicians in this study were bolstering people’s adaptive coping skills.

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Storage Time Can Effect Plasma Biomarker Results

MedicalResearch.com Interview with:
Stefan Enroth, Associate Professor, PhD
Dept. of Immunology, Genetics & Pathology
Uppsala University

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

Response: One basic requirement of life science research is the quality of samples. Proper handling and rigorous biobanking of clinical samples is very important when for instance collecting samples for rare diseases, for monitoring individual variation in longitudinal studies and when conducting prospective studies of biomarkers and risk of developing for instance cardiovascular disease. In epidemiological studies using case and control cohorts, great care is taken to ensure that the cases and controls are matched in terms of for instance age, anthropometrics and lifestyle exposures such as smoking or alcohol consumption. Technical factors and sampling handling history are not as commonly used. There has been a lack of studies that systematically investigated the effects of for instance storage-time on a larger set of plasma proteins. With emerging high-throughput technologies enabling measurements of a high number of proteins simultaneously on a population level, biomarker research will enter a new era and the more knowledge we have on what factors that influence circulating biomarker levels – such as plasma proteins, the higher the chances are of finding new clinically important biomarkers for disease.

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Long-Term Bone Loss Linked to Antidepressants May Be Ameliorated By Beta Blockers

MedicalResearch.com Interview with:

Patricia Ducy, PhD Associate Professor Department of Pathology & Cell Biology Columbia University New York, NY 10032

Dr. Patricia Ducy

Patricia Ducy, PhD
Associate Professor
Department of Pathology & Cell Biology
Columbia University
New York, NY 10032

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

Response: In the past few years, several large clinical studies have reported an association between the use of selective serotonin reuptake inhibitors (SSRIs) and an increased risk of bone fractures. Yet, a few studies conducted on small cohorts using these drugs for a short time showed a decrease in bone resorption parameters and thus minor bone gain.

To understand this paradox and to define how the deleterious effect of SSRIs could be prevented we conducted a series of studies in mice treated with fluoxetine, the active molecule of the widely prescribed SSRI Prozac.

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Severe Periodontitis Associated with Insulin Resistance

MedicalResearch.com Interview with:

In-Seok Song, DDS, PhD Clinical Assistant Professor Oral and Maxillofacial Surgeon Department of Dentistry, Korea University Anam Hospital, Seoul, Republic of Korea

In-Seok-Song

In-Seok Song, DDS, PhD
Clinical Assistant Professor
Oral and Maxillofacial Surgeon
Department of Dentistry, Korea University Anam Hospital,
Seoul, Republic of Korea

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

Response: Periodontitis is a well-known cause of various systemic diseases including cardiovascular disease, type 2 diabetes. As for type 2 diabetes, insulin resistance is responsible for the low-grade systemic inflammation, which can deteriorate body function throughout pancreatic β-cell dysfunction and impaired fasting glucose. There are emerging evidences that insulin resistance is a cause of periodontal disease progression among Korean adults as well as other citizens including American, French, Finnish, and the British.

In this study, we hypothesized that insulin resistance aggravates the severity of periodontitis. We investigated the associations between type 2 diabetes, insulin resistance, and severe periodontitis. The associations between severe periodontitis and insulin resistance in non-obese adults with normal body mass index (BMI) or waist circumference (WC) were also evaluated.

We found that non-abdominal obese adults with insulin resistance were more likely to have severe periodontitis compared to metabolically healthy adults with normal waist circumference. Insulin resistance without abdominal obesity can be considered an independent risk factor of severe periodontitis.

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Breast Cancer: Long-term Prognostic Factors in the Boost vs No Boost Trial

MedicalResearch.com Interview with:

Conny Vrieling, M.D., Ph.D. Radiation Oncologist Clinique des Grangettes Geneva

Dr. Conny Vrieling

Conny Vrieling, M.D., Ph.D.
Radiation Oncologist
Clinique des Grangettes
Geneva

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

Response: In the early ’90s, the EORTC (European Organisation for Research and Treatment of Cancer) ran the “boost no-boost” trial, randomizing 5569 early-stage breast cancer patients, treated with breast-conserving surgery and whole-breast irradiation, between no boost and a 16-Gy boost. A third of the patients were included in a central pathology review. The 10-year follow-up results of this subpopulation showed that young age and high-grade invasive carcinoma were the most important risk factors for ipsilateral breast tumor recurrence (IBTR).

In this study, we re-analyzed with long-term follow-up the pathological prognostic factors related to IBTR, with a special focus on the evolution of these effects over time.

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Despite Valuable Biomarkers Clinical Evaluation Still Important in Diagnosing Heart Attack

MedicalResearch.com Interview with:

Dr. Juan Sanchis Full professor of Medicine Cardiology Department, University Clinic Hospital. Medicine Department, University of Valencia Valencia. Spain

Dr. Juan Sanchis

Dr. Juan Sanchis
Full professor of Medicine
Cardiology Department, University Clinic
Hospital. Medicine Department, University of Valencia
Valencia. Spain

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

Response: Decision making in acute chest pain in the emergency departments
remains challenging despite the introduction of new troponin assays
(high-sensitivity assays) capable of detecting any amount of
myocardial damage.

The upper limit of normality of high-sensitivity
troponin is established at the 99th percentile of a normal reference
population. This is the limit for the diagnosis of acute myocardial
infraction. Detectable troponin levels below the 99th percentile,
though non diagnostic of acute myocardial infarction, might be
considered as of uncertain significance since some patients might
still suffer from unstable angina. Undetectable troponin (far below
the 99th percentile), however, could rule out unstable angina meaning
that such patients could safely be discharged from the emergency
department according to some studies. Therefore, if this were fully
demonstrated, clinical evaluation could play a secondary role.

We investigated clinical data in comparison to undetectable
high-sensitivity troponin in patients with normal high-senstivity
troponin levels (below the 99th percentile).

The main findings indicate that clinical data can guide decision making and perform at
least equally well as undetectable high-sensitivity troponin for
ruling out unstable angina, in patients presenting at the emergency
department with chest pain and normal troponin.

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Breastfeeding May Protect Against Genetic Tendency Toward Pediatric Asthma

MedicalResearch.com Interview with:
Olga Gorlanova
Wissenschaftliche Assistenzärztin
Paediatric Pneumology Research Group
Universitäts-Kinderspital beider Base

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

Response: Previous research has investigated how childhood asthma and early wheeze can develop as the result of a complex interaction between environmental exposures, such as tobacco exposure, older siblings and an individual’s genetic profile. Genes associated with childhood asthma risk are located on chromosome 17, called 17q21. Our study asked the question: could the effect of 17q21 on respiratory symptoms in infants be modified by breastfeeding? Continue reading

US Task Force Recommends TB Screening For Those Who Have Lived in High Risk Settings

MedicalResearch.com Interview with:

Dr. Francisco Garcí Task Force member and director Chief medical officer Pima County Department of Health Tucson, AZ

Dr. Francisco Garcia

Dr. Francisco García M.D. M.P.H.
Task Force member and
Director and Chief medical officer at
Pima County Department of Health
Tucson, AZ

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

Response: Tuberculosis infection is one of the most common infectious diseases in the world.

Although less common in the United States, many people still become infected every year and are at risk of getting sick and spreading the infection to others. We know there are effective screening tests that can detect latent tuberculosis infection before people become sick with active tuberculosis disease. Additionally, there are effective treatments to prevent people from progressing from latent tuberculosis infection to active tuberculosis disease.

Thus, for people with increased risk of contracting tuberculosis, the Task Force recommends screening for latent tuberculosis infection.

People who are considered at increased risk include those who were born in or have lived in countries where tuberculosis is highly prevalent, or who have lived in congregate settings where exposure to tuberculosis is more likely, such as homeless shelters or correctional facilities.

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MRI Generally Safe For Fetus in First Trimester, But Gadolinium Should Be Avoided Unless Strongly Indicated

MedicalResearch.com Interview with:
Dr. Joel G. Ray MD, MS, FRCPC

Professor, Department of Medicine, University of Toronto
Professor Department of Obstetrics and Gynecology
St. Michael’s Hospital

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

Response: We have little information about the fetal safety to of MRI in the first trimester of pregnancy, or that of MRI with gadolinium contrast performed at any point in pregnancy.

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Clinical Trial of 3 Nasal Sprays For HHT Nosebleeds Showed None Better Than Placebo

MedicalResearch.com Interview with:

Dr. Kevin J. Whitehead MD Adjunct Associate Professor, Pediatrics Associate Professor, Internal Medicine University of Utah

Dr. Kevin Whitehead

Dr. Kevin J. Whitehead MD
Adjunct Associate Professor, Pediatrics
Associate Professor, Internal Medicine
University of Utah

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

Response: Hereditary hemorrhagic telangiectasia (or Osler-Weber-Rendu Syndrome) is a genetic vascular malformation syndrome that results in arteriovenous malformations. This syndrome is found in 1:5000 individuals, and is inherited in autosomal dominant fashion. It is often under diagnosed by the medical community (some estimate that 90% of patients do not know that they are affected).

In the skin and mucous membranes small AVMs – termed telangiectasias – form, and they have the potential to rupture and bleed. This happens most commonly in the nose, and 95% of patients with HHT have recurrent nose bleeding (epistaxis). While other dangerous internal organ AVMs also form, epistaxis is the most important determinant of quality of life for these patients. This epistaxis can lead to anemia, heart failure and rarely death. Patients often seek therapy for epistaxis, but cautery or laser treatment of the telangiectasias tends to provide only temporary benefit. Definitive therapy to eliminate epistaxis requires surgical closure of the nasal passages, and is too drastic for most patients.

We sought to test medical therapy for HHT-related epistaxis with our best candidate drugs in nose spray form. The drugs with the most anecdotal support include bevacizumab (an anti-angiogenic drug), estriol (an estrogen), and tranexamic acid (an inhibitor of fibrinolysis). Our patients received a nose spray with one of these drugs or a saline placebo and used two sprays in each nostril daily for 12 weeks and recorded their nose bleed frequency and duration in a daily diary.

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Cord Blood Transplant in Leukemia With Minimal Residual Disease

MedicalResearch.com Interview with:

Dr. Filippo Milano, MD, PhD Assistant Member, Clinical Research Division Associate Director Cord Blood Transplantation Cord Blood Program Assistant Professor, University of Washington Fred Hutchinson Cancer Research Center

Dr. Filippo Milano

Dr. Filippo Milano, MD, PhD
Assistant Member, Clinical Research Division
Associate Director Cord Blood Transplantation
Cord Blood Program
Assistant Professor, University of Washington
Fred Hutchinson Cancer Research Center

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

Response: When first introduced, cord blood (CB) graft was used only as a last resort when no suitable conventional donor could be identified, largely due to the limiting cell doses available in a cord blood graft. A CB graft, however, is attractive due to the increased level of HLA disparity that can be tolerated, without increased risk of graft versus host disease, allowing nearly all patients to find such a donor.

The main intent of the study was to evaluate whether or not, at our Institution, cord blood SHOULD STILL BE considered only AS an alternative DONOR or IF instead outcomes were comparable to those obtained with more “conventional” types of transplants from matched and mismatched unrelated donors.

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Building Better Eyedrops For Drug Delivery

MedicalResearch.com Interview with:

Heather Sheardown PhD PEng FCAE Scientific Director 20/20 NSERC Ophthalmic Materials Network Professor, Department of Chemical Engineering Canada Research Chair in Ophthalmic Biomaterials McMaster University

Dr. Heather Sheardown

Heather Sheardown PhD PEng FCAE
Scientific Director 20/20 NSERC Ophthalmic Materials Network
Professor, Department of Chemical Engineering
Canada Research Chair in Ophthalmic Biomaterials
McMaster University

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

Response: Putting drops in the eye is well accepted from the standpoint of practitioners but is problematic for many patients. Therefore, particularly in cases where multiple drops are required in a day such as is the case with certain infections for example or a lifetime of drops is required such as is the case with diseases like glaucoma, patient compliance is a real issue. In addition, as much as 95% of any drop instilled in the eye is lost within the first 5 minutes, meaning that drug concentrations within the drop need to be higher to ensure that the required dose gets into the patient’s eye.

Therefore there is a real need for a better alternative to traditional eyedrops is needed. We have developed a new method of formulating drugs for delivery as drops that adhere to the mucous layer of the tear film, allowing for smaller amounts of drug to be delivered over a prolonged period of time. This means that fewer drops with lower drug concentrations can be delivered. This is a micelle based system that allows for the formulation of more hydrophobic drugs. A mucoadhesive component associated with the micelle binds to the mucin layer of the tears, meaning that the residence time on the eye is similar to that of this layer – between 4 and 7 days. Drug is slowly released from the micelle, allowing for prolonged treatment.

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Inflammatory Molecule Links Metabolic Environment and Innate Immunity

MedicalResearch.com Interview with:

David Underhill, PhD Professor of Biomedical Sciences Research scientist, F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute Cedars-Sinai

Dr. David Underhill

David Underhill, PhD
Professor of Biomedical Sciences
Research scientist, F. Widjaja Foundation Inflammatory Bowel and Immunobiology Research Institute
Cedars-Sinai
Los Angeles, CA

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

Response: “Innate immunity” is the body’s natural resistance to microbial infection and stands in contrast to “adaptive immunity,” which is the body’s learned response to infection (e.g. antibodies and vaccines). In the standard model of innate immunity that has emerged over the last several decades, scientists have come to understand that the human genome encodes many “receptors” that have evolved as sensors for specific common microbial molecules, such as bacterial or viral DNA or components of bacterial or fungal cell walls. The job of these receptors is to survey the environment (skin, blood, etc.) for potentially dangerous microbes and initiate inflammatory responses if they are found. These activities are essential for defense against infection, and people and animals with defects in these sensors or the responses they trigger can be susceptible to infection.

My laboratory has been interested for more than a decade in identifying these innate sensors and the microbial targets that they recognize. In this study, we were looking for the sensor that allows white blood cells (e.g. macrophages and dendritic cells) to detect Gram-positive bacterial cell walls and trigger a specific inflammatory response: secretion of the potent inflammatory mediator interleukin-1β (IL-1β).
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Over the Counter Lice Remedies Unlikely to Be Effective

MedicalResearch.com Interview with:

William Ryan B.V.Sc. Ryan Mitchell Associates LLC Westfield, NJ and Ellen Koch, MD Division of Pediatric Dermatology Johns Hopkins Medicine, Baltimore, Maryland

Head Louse

William Ryan B.V.Sc.
Ryan Mitchell Associates LLC
Westfield, NJ and
Bernard Cohen, MD
Professor Dermatology and
Ellen Koch, MD
Division of Pediatric Dermatology
Johns Hopkins Medicine, Baltimore, Maryland

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

Response: As a group we were concerned about the misinformation that continues to be promulgated on the internet and through other sites. Importantly, the group consisted of experts with specific experience in the management of head louse infestations, from pediatric dermatology, pediatrics, school nursing and head louse research fields. Even information sources that we would have expected to be credible are outdated, unreliable or both, often continuing myths about head louse infestations and how they can be controlled.  We wanted to provide a balanced and informed perspective that would help physicians and parents recognize that head louse infestations do not present a serious problem, and can be well managed with an informed approach to treatment.

The main findings are that over the counder products (permethrin/pyrethrins) are unlikely to be effective, and that that there are safe and effective products that are available by prescription.

Interestingly, head lice do affect Indian and African children in their home countries, but virtually nonexistent in African Americans in North America. There has been speculation about hair grooming regimen or structure of African American hair but the cause is unknown.  In a study we performed assessing resistance to over the counter pediculicide components over a decade ago in Baltimore, we were not able to find a single African American child with head lice. We were not able to recruit any patients from the Baltimore City Schools.

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