Medical Research Journals

MedicalResearch.com Interview with: Benjamin Y. Scheier, MD Division of Hematology/Oncology Department of Internal Medicine University of Michigan, Ann Arbor Medical Research: What is the background for this study? What are the main findings? Dr. Scheier: Existing data suggests that PET/CT has use in the detection of metastases from multiple primary tumor types. However, PET/CT lacks data supporting its use in staging asymptomatic patients with early-stage melanoma, may inconsistently impact treatment decisions, and carries a false-positive finding risk that may detract from its use. To evaluate an evolving practice, this study aims to assess the use of PET/CT in detecting occult metastases in SLN-positive melanoma prior to resection. In this retrospective evaluation of patients with melanoma and clinically silent regional lymph nodes treated at the University of Michigan, only 7% had PET/CT findings that ultimately identified metastatic melanoma and precluded LND. Of the 46 patients who underwent a preoperative PET/CT, 15 (33%) had intense uptake distant from the primary tumor and local lymph node basin. Nine of those 15 patients (60%) had abnormalities biopsied prior to LND. Three of the 9 biopsies yielded metastatic melanoma, a false-positive rate of 67% for PET/CT in identifying distant metastases in asymptomatic patients.

Michael A. Vella, M.D. Veterans Affairs Medical Center Vanderbilt University, NashvilleMedicalResearch.com Interview with: Michael A. Vella, M.D. Veterans Affairs Medical Center Vanderbilt University, Nashville Medical Research: What is the background for this study? What are the main findings? Dr. Vella: We are fortunate to take care of Veterans from all over Middle TN at the Tennnessee Valley Healthcare System Nashville Campus.  A significant number of Veterans travel long distances and invest time and money in order to visit with us.  We noticed that many patients undergoing "low complexity" operations like removal of gallbladders and repair of groin hernia spend a significant amount of time, energy, and, in some cases, money to travel to our facility for post operative visits relative to the amount of time they spend in their evaluations.  We wanted to look at the quality of and Veteran preference for telehealth visits (phone and video) with the idea that, if feasible, we could implement a telehealth program at our facility. In our small pilot study, 23 Veterans underwent sequential phone, video, and in-person visits.  The Veterans were evaluated on four domains at each visit type: general recovery, follow-up needs, wound care needs, and complications.  We then determined the agreement among the three visit types.  There was 100% agreement across the three visit types in the domains of general recovery and follow-up needs.  Percent agreement for wound needs and complications was 96%, reflecting a possible infection on a phone encounter that was not present on clinic or video assessment.  One Veteran in the sample had a wound infection that was detected by both phone and video and confirmed during the in-person visit.  Importantly, there were no instances in which we failed to detect a wound issue or postoperative complication by phone or video.  We also found an association between preference for telehealth visits and distance traveled, although the majority of Veterans in our study preferred telehealth visitation over traditional face-to-face encounters. We found that over the phone and video visits were not only high quality, but were preferred by our Veterans, especially those living far from our facility.  We have implemented a telehealth program for general surgery post operative follow up at our institution and currently evaluate 3-5 patients a week using telehealth modalities with plans to continue to expand.

Aaron L. Schwartz, PhD Department of Health Care Policy Harvard Medical School Boston, Massachusetts MedicalResearch.com Interview with: Aaron L. Schwartz, PhD Department of Health Care Policy Harvard Medical School Boston, Massachusetts   Medical Research: What is the background for this study? What are the main findings? Dr. Schwartz: It is widely believed that much health care spending is devoted to services that provide little or no health benefit to patients. In previous work, we demonstrated that low-value services were commonly delivered to the Medicare population. In this study, we examined whether a new form of paying physicians and hospitals was effective in discouraging the use of low-value services. The payment reform we studied was the Medicare Pioneer Accountable Care Organization (ACO)  Program, a feature of the Affordable Care Act. This program financially rewards health care provider groups who keep spending under a specified budget and achieve high performance on measures of quality of care. This voluntary program employs a similar ACO payment model that some private insurers have adopted.  The hope is that such models can encourage providers to be more efficient by allowing them to share in the savings generated by lower health care spending. In previous work, we demonstrated that the Pioneer ACO Program was associated with lower overall health care spending and steady or improved performance on health care quality measures. However, it was unclear whether providers were focusing on low-value services in their attempts to reduce spending. We examined  2009-2012 Medicare claims data and measured the use of, and spending on, 31 services often provided to patients that are known to provide minimal clinical benefit. We found that patients cared for in the ACO model experienced a greater reduction in the use of low-value services when compared to patients who were not served by ACOs. We attributed a 4.5 percent reduction in low-value service spending to the ACO program. Interestingly, this was a greater reduction than the 1.2 percent reduction in overall spending attributed to the program, which suggests that providers were targeting low-value services in their efforts to reduce spending. In addition, we found that providers with the greatest rate of low-value services prior to the ACO program showed the greatest reduction in these services. We also found similar reductions in service use between services that are more likely to be requested by patients (i.e. early imaging for lower-back pain) and other services.

Professor Jane Pirkis PhD Centre for Mental Health Melbourne School of Population and Global Health University of Melbourne, AustraliaMedicalResearch.com Interview with: Professor Jane Pirkis PhD Centre for Mental Health Melbourne School of Population and Global Health University of Melbourne, Australia Medical Research: What is the background for this study? What are the main findings? Professor Pirkis:  Public sites that gain a reputation as places where people might go to seek to end their lives are a particular problem in suicide prevention.  Any suicide is tragic, but suicides at these sites have an extra level of complexity because they can lead to copycat acts and can have a major impact on people who work at or live near these sites, or visit them for other reasons.  Our meta-analysis, which pooled data from 18 individual studies from around the world,  found that three interventions work really well in reducing suicides at these sites.
  • Restricting access to means (e.g., installing barriers) can reduce suicides at these sites by 90% or more, and
  • encouraging help-seeking (e.g., installing phones that link directly to crisis services) and
  • increasing the likelihood of someone intervening (e.g., installing CCTV cameras, training staff who work at these sites) can each reduce them by around 50%, or more in some cases.  The interventions seem to work well together and complement each other too.  

Thomas Valley, MD Fellow, Division of Pulmonary and Critical Care University of Michigan Ann Arbor, MIMedicalResearch.com Interview with: Thomas Valley, MD Fellow, Division of Pulmonary and Critical Care University of Michigan Ann Arbor, MI Medical Research: What is the background for this study? What are the main findings? Dr. Valley: There has been dramatic growth in intensive care unit (ICU) use over the past 30 years. As the reasons for this growth are not entirely clear, some have suggested that the ICU is a meaningful source of low-value care. The value of the ICU, however, depends on the net benefit that ICUs provide patients. Prior observational studies assessing the effectiveness of the ICU were limited because patients admitted to the ICU are inherently sicker and more likely to die than patients admitted to the general ward. Given the substantial number of patients with pneumonia who are admitted to an ICU, it is vital to understand whether admission to the ICU is beneficial. In our study of 1.1 million Medicare beneficiaries with pneumonia between 2010 and 2012, we used an instrumental variable, a statistical technique to pseudo-randomize patients based on their proximity to a hospital that uses the ICU frequently for pneumonia, in order to determine whether ICU admission saved lives and at what financial cost. An estimated 13 percent of patients were admitted to the ICU solely because they lived closest to a hospital that used the ICU frequently for pneumonia. Among these patients, ICU admission was associated with a nearly six percent reduction in 30-day mortality compared to general ward admission. In addition, there were no significant differences in hospital costs or Medicare reimbursement between patients admitted to the ICU and to the general ward.

Jeffrey L. Cummings, M.D., Sc.D. Director, Lou Ruvo Center for Brain Health Camille and Larry Ruvo Chair for Brain Health Cleveland Clinic Las Vegas, NV 89106MedicalResearch.com Interview with: Jeffrey L. Cummings, M.D., Sc.D. Director, Lou Ruvo Center for Brain Health Camille and Larry Ruvo Chair for Brain Health Cleveland Clinic  Las Vegas, NV 89106  Medical Research: What is the background for this study? What are the main findings? Dr. Cummings: Agitation is a common problem in Alzheimer’s disease (AD); approximately 70% of patients with AD will experience periods of agitation.  This difficult behavior challenges patients and caregivers, adversely affects quality of life, and may precipitate institutionalization.  There are not drugs approved for treatment of agitation in Alzheimer’s disease. The study reported in JAMA showed that a drug based on a combination of dextromethorphan and quinidine (DM/Q) produced statistically significant and clinically meaningful reduction in agitation in Alzheimer’s disease patients.  The study met its primary outcome (decline in the Neuropsychiatric Inventory agitation scale in drug compared to placebo) and many of its secondary outcomes (e.g, decreases in caregiver stress).  The agent was safe and well tolerated.

MedicalResearch.com Interview with: Dr. Timothy J. FendlerMedicalResearch.com Interview with: Dr. Timothy J. Fendler MD MS Department of Cardiology, Saint Luke’s Mid America Heart Institute Kansas City, Missouri Medical Research: What is the background for this study? What are the main findings? Dr. Fendler: In-hospital cardiac arrest occurs commonly in the United States and is associated with low rates of meaningful survival. This poor prognosis should prompt patient-clinician discussions about goals of care and preferences for future resuscitative efforts. Little is known about how prognosis is aligned with code status decisions among survivors of in-hospital cardiac arrest (in other words, as prognosis worsens, are patients more likely to adopt Do-Not-Resuscitate orders, a sign of less aggressive treatment preferences, should recurrent cardiac arrest occur). We found that, among patients who survive an in-hospital cardiac arrest, there is generally good alignment between prognosis and code status decisions. That is, as prognosis worsens among survivors of in-hospital cardiac arrest, the rate of DNR status adoption increases, on average. However, among patients with very low levels of neurologic functioning and very poor prognosis, nearly two-thirds did not adopt DNR status, despite the fact that only about 4% of these patients with poor prognosis experienced actual favorable neurological survival. These results imply that there could be better alignment between prognosis and goals of care decisions that places the patient's wishes, safety, and quality of life at the forefront of decision-making and decreases the likelihood of undue suffering when the outcome may not be improved by it. Second, survival rates were much lower in patients with DNR orders, compared to those who did not adopt DNR status, after survival from in-hospital cardiac arrest. This was observed regardless of prognosis, implying that patients who adopt DNR status, and thus only request they be treated differently in the setting of recurrent cardiac arrest, may be receiving less aggressive treatment than they prefer, in areas of their care outside of resuscitation from cardiac arrest.

Barbara A. Cohn, PhD Director of the Child Health and Development Studies at the Public Health Institute. Berkeley, CaliforniaMedicalResearch.com Interview with: Barbara A. Cohn, PhD Director of the Child Health and Development Studies at the Public Health Institute. Berkeley, California Medical Research: What is the background for this study? Dr. Cohn: I guessed that pregnancy complications would be an early warning sign of cardiovascular problems because of the extraordinary demands that pregnancy places on a woman’s cardiovascular system. Medical Research: What data were used for this study? Dr. Cohn: The Child Health and Development Studies is a large pregnancy cohort that enrolled more than 20,000 pregnancies in the 1960’s. Women and their families have been followed now for more than 50 years. Information on pregnancy complications was captured from medical records as they occurred, long before cardiovascular disease developed. These data are the basis for the current study. Medical Research: Why hasn’t this study already been done? Dr. Cohn: Long-term, large studies of pregnancy are rare. I first tried to do this study forty years ago when I was in graduate school.   At that time, Dr. Bea van den Berg, the late, second director of the Child Health and Development Studies advised that the study mothers were still too young to observe their cardiovascular disease experience. Now 40 years later, my colleague Piera Cirillo and I have been able to test the idea that combinations of pregnancy complications are linked to cardiovascular disease death for women.

Dr. Cristiano Ferlini, MD Director of Biomedical Research Rudy and Sally Ruggles Chief of cancer research Western Connecticut Health Network Research InstituteMedicalResearch.com Interview with: Dr. Cristiano Ferlini, MD Director of Biomedical Research Rudy and Sally Ruggles Chief of cancer research Western Connecticut Health Network Research Institute Medical Research: What is the background for this study? Dr. Ferlini: Our aim is to understand why some cancer patients respond well to conventional treatment while others suffer progressive disease.  Nextgen sequencing technologies provide data that shed light on the mechanisms underlying differences in clinical outcome. However, analyses utilizing these data have been focused on human genes. This is to be expected given that the subjects under investigation are indeed humans. We adopted a novel approach in this and a prior study which involved in-depth, comprehensive mapping of microRNA sequences in human cancers to viral genes to assess their presence and significance. Medical Research: What are the main findings? Dr. Ferlini: We discovered a surprising number of viral microRNA sequences in a wide variety of cancer tissues. We also documented an interplay between these viral microRNAs and genes related to anticancer immunity. Both viruses and cancers share a common goal of suppressing the immune system to promote their own survival. Synergistic immunosuppression seems particularly relevant for the Epstein Barr virus, an unfortunate fact given its ubiquity in human populations. After the acute phase of EBV infection, the virus persists indefinitely in a dormant state inside B lymphocytes. When cancers grow, they create a protected microenvironment in which  anticancer immunity is suppressed.  We have obtained evidence suggesting that when EBV infected B cells circulate within these domains, the virus becomes reactivated and produces microRNAs which further amplify immunosuppressive genes.

Gbenga Ogedegbe, MD, MS, MPH FACP Professor of Population Health and Medicine Director, Division of Health and Behavior Director, Center for Healthful Behavior Change Vice Dean, NYU College of Global Public Health NYU Langone School of Medicine Department of Population Health New York, NY 10016MedicalResearch.com Interview with: Gbenga Ogedegbe, MD, MS, MPH FACP Professor of Population Health and Medicine Director, Division of Health and Behavior Director, Center for Healthful Behavior Change Vice Dean,  NYU College of Global Public Health NYU Langone School of Medicine Department of Population Health New York, NY 10016 Medical Research: What is the background for this study? Dr. Ogedebge: Evidence from clinical trials have previously indicated that a common blood pressure medication, angiotensin-converting-enzyme (ACE) inhibitors, (when prescribed as first line treatment) may not provide the same benefits in blacks compared to whites. However blacks are grossly underrepresented in these studies, despite the fact they have disproportionately higher rates of hypertension-related morbidity and mortality than whites. Thus, we chose to study this particular question because it allows us to evaluate this evidence in a large population of hypertensive black patients who receive care in a real-world practice setting. This study evaluates racial differences in cardiovascular outcomes and mortality between hypertensive black and white patients whose treatment was initiated with angiotensin-converting-enzyme (ACE) inhibitors, outside of a clinical trial.  ACE inhibitors are one of several classes of drugs commonly prescribed to individuals with hypertension to prevent deaths, heart attack, kidney failure, heart failure and stroke.

Philip S. Rosenberg, PhD Biostatistics Branch, Senior Investigator Division of Cancer Epidemiology and Genetics National Cancer Institute, 9609 Medical Center Drive Bethesda, MD 20892MedicalResearch.com Interview with: Philip S. Rosenberg, PhD Biostatistics Branch, Senior Investigator Division of Cancer Epidemiology and Genetics National Cancer Institute, 9609 Medical Center Drive Bethesda, MD 20892  Medical Research: What is the background for this study? What are the main findings? Dr. Rosenberg: It has been previously reported that breast cancer burden (number of new cases diagnosed in a year) is expected to rise in the future, mostly due to the aging of the female population in the US. Also, it has been established that the age-adjusted breast cancer incidence rates (cases per 100,000 women per year) are increasing for invasive ER-positive cancers overall and decreasing for ER-negative cancers overall. When taken together, these two trends tend balance each other out, resulting in a somewhat flat breast cancer incidence rate overall.  Though the overall trends for invasive breast cancer have been previously reported, this study uses a more refined forecasting method by including recent birth cohort patterns to forecast breast cancer to 2030 by age group, estrogen receptor-status, and invasive vs. in situ tumors. New in this report are the findings for in situ tumors and the more granular break down by age, ER status, and invasive vs. in situ tumors both for rate and burden (number of cases).

Dr. Tamar Krishnamurti PhD Department of Engineering & Public Policy Carnegie Mellon University Pittsburgh, PA 15213MedicalResearch.com Interview with: Dr. Tamar Krishnamurti PhD Department of Engineering & Public Policy Carnegie Mellon University Pittsburgh, PA 15213  Medical Research: What is the background for this study? What are the main findings? Dr. Krishnamurti: In 2012, the Food and Drug Administration Safety and Innovation Act became law. As part of this law, FDA can assign drugs the “breakthrough” designation. Breakthrough drugs are drugs that are intended to treat a serious or life threatening condition and have shown preliminary evidence of a substantial improvement over existing therapies on at least one one clinically significant endpoint. These clinical endpoints can be surrogate outcomes and don't have to be a direct outcome of the disease. All FDA press releases announcing approval of breakthrough-designated drugs use the term “breakthrough” and about half use the term “promising” when describing the drugs. Our study randomly assigned participants to read 1 of 5 short descriptions of a recently approved drug. These vignettes differed by the term assigned to the drug (e.g. "breakthrough" or "promising") or by whether the basis for the designation was clearly and succinctly explained in the description. We found that using the terms "breakthrough" and "promising" to describe these drugs resulted in people having unwarranted confidence about the effectiveness of breakthrough drugs, which could prevent them from making a fully informed decision about whether to take the drug or not. The influence of these terms on peoples' judgments was mitigated by explaining the regulatory meaning of the drug's approval (which is required in the drug's professional label, but not in public discourse about the drug).

Dr. Ziming Xuan ScD, SM, MA Assistant Professor, Community Health Sciences School of Public Health Boston University MedicalResearch.com Interview with: Dr. Ziming Xuan ScD, SM, MA Assistant Professor, Community Health Sciences School of Public Health Boston University  Medical Research: What is the background for this study? Dr. Xuan: With respect to background, among the 15000 some teenagers died annually in the US, the 3 leading causes of death were unintentional injuries, homicide, and suicide. Among these fatal youth injuries, 83% homicides were gun-related, and about half of suicides involved a gun (45%). So, The purpose of the study was to investigate the association between state gun law environment and youth gun carrying in the United States, and whether this association is mediated by adult gun ownership. Medical Research: What are the main findings? Dr. Xuan:
  • Among 38 states in our study, 5.7%of high school students living in the 19 states with stricter gun laws carried a gun in past 30 days while 7.3% of students living in states with the weaker gun laws carried a gun.
  • A 10-point increase in the strictness of the state gun law score was associated with a 9% decrease in the odds of youth gun carrying.
  • Across states, restrictive gun laws may reduce youth gun carrying by limiting adult gun ownership.

MedicalResearch.com Interview with: Renato Valenti, MD David Antoniucci, MD Cardiology Department; Careggi Hospital Florence; Italy Medical Research: What is the background for this study? Response: Previous data have shown that high residual platelet reactivity in patients receiving clopidogrel is associated with high risk of ischemic events and cardiac death after PCI at short-  and long-term follow-up. Clopidogrel nonresponders patients of  the  REsponsiveness to CLOpidogrel and StEnt thrombosis (RECLOSE-2) ACS study received an increased dose of clopidogrel or switched to ticlopidine under light transmittance aggregometry (LTA) adenosine diphosphate  (ADP) test guidance. Despite some decrease of ADP test after treatment adjustment, there was no improvement on clinical outcome. Currently no evidence exists that the achievement of an optimal platelet aggregation inhibition in clopidogrel nonresponders  modifies  the risk profile of  these patients. The RECLOSE-3  study invesigated if a new antiplatet therapy with prasugrel in clopidogrel nonresponders can modify the risk profile of these patients and improve the outcome in term of cardiac mortality. From the RECLOSE-3 registry we identified  302 consecutive  patients who were clopidogrel nonresponders.  Nonresponders  switched to prasugrel therapy.  Due to the nonrandomized study design the clinical outcome of clopidogrel nonresponders switched to prasugrel (from RECLOSE-3 study) was compared with the historical cohort of clopidogrel nonresponders of the RECLOSE-2 ACS (248 patients)  study. The primary endpoint of the study was cardiac mortality. The 2-year cardiac mortality rate was  4.0% in the RECLOSE-3 group and 9.7% in the RECLOSE-2 group (p=0.007). The difference in 2-year cardiac mortality remained also considering exclusively patients  with ACS on admission: 3.2% and 9.7%, respectively, p=0.023.At the final model of multivariable analysis, prasugrel treatment was inversely related to the risk of  2-year cardiac death (HR 0.32; p=0.036)  after adjusting for ACS and other well known covariates related to the outcome. Medical Research: What are the main findings? Response: The main finding of the RECLOSE-3 study is that nonresponsiveness to clopidogrel may be a “modifiable risk factor” for cardiac death after PCI. Prasugrel treatment overcomes nonresponsiveness to clopidogrel and results in thrombotic risk similar to the one of clopidogrel responders.

Yi-Wen Chen PhD Candidate, and Darlene Reid, BMR(PT), PhD Professor and Chair Department of Physical Therapy University of Toronto Toronto, OntarioMedicalResearch.com Interview with: Yi-Wen Chen PhD Candidate, and Darlene Reid, BMR(PT), PhD Professor and Chair Department of Physical Therapy University of Toronto Toronto, Ontario Medical Research: What is the background for this study? Response: Tai Chi is a time-honored exercise in China, developed during the Sung Dynasty, which has gained increased popularity in Western society. Most styles of Tai Chi consist of slow rhythmic movements that often emphasize typical attributes of exercise including range of motion, strengthening, balance, and postural alignment. In addition, there are spiritual aspects of Tai Chi that focus on relaxation, breath control, and cultivating internal energy. Several studies have demonstrated its multifaceted benefits in the elderly and in people living with chronic diseases including cancer, cardiovascular diseases, respiratory disorders and arthritis. If you were interested in seeing videos of beginner practices, check out some tai chi online to better clarify the motions previously described. Many individuals that require increased exercise and physical fitness also have one or more comorbidities; 9 out 10 Canadians live with more than one chronic condition and this proportion increases to 98% in adults over the age of 65 years. Increased fitness can increase quality of life and decrease risk of mortality and morbidity in older persons and in many chronic conditions. However, treatment, including exercise is often prescribed within a single specialty. Rarely is information provided to health professionals that integrates therapeutic approaches across several common chronic disorders. Accordingly, we performed a systematic review to determine if Tai Chi is an effective physical activity that improves symptoms, physical function, quality of life and depression in cancer, osteoarthritis (OA), heart failure (HF) and chronic obstructive pulmonary disease (COPD)? We also examined if Tai Chi had similar effects for the same outcome measures across different chronic conditions?

Aditya Bardia MBBS, MPH Attending Physician, Massachusetts General Hospital Cancer Center, Assistant Professor, Harvard Medical School Boston, MA 02114MedicalResearch.com Interview with: Aditya Bardia MBBS, MPH Attending Physician, Massachusetts General Hospital Cancer Center, Assistant Professor, Harvard Medical School Boston, MA 02114   Medical Research: What is the background for this study? What are the main findings? Response:  Multiple studies have consistently shown that African American women with cancer, including breast cancer, have worse outcomes than Caucasian counterparts. While socioeconomic issues, including access to care plays an important role, the contribution of tumor biology has been less clear. In this study, utilizing exome sequencing data, we linked the racial distribution of primary breast cancer with tumor genotypic traits, including somatic mutations, gene-expression profiles and intra-tumor heterogeneity. We observed that in addition to having a higher prevalence of triple negative breast cancer than Caucasian women (something that has been documented in the literature), African American women had a significantly higher prevalence of TP53 mutations, TNBC basal-like 1 and mesenchymal stem-like tumors, and intratumor genetic heterogeneity, and all of which suggest more aggressive tumor biology, suggesting that differences in tumor genomic profile contribute, at least partly, to the known racial disparity in survival between African Americans and Caucasians breast cancer patients.

Dr Ayman Chit PhD Sanofi Pasteur Swiftwater, PA 18370MedicalResearch.com Interview with: Dr Ayman Chit PhD Sanofi Pasteur Swiftwater, PA 18370 Medical Research: What is the background for this study? What are the main findings? Dr. Chit: Our analysis used data from a large-scale, multi-center efficacy trial, in which a higher-dose split-virus inactivated influenza vaccine (IIV-HD, Fluzone® High-Dose vaccine, Sanofi Pasteur) was compared to a standard-dose split-virus inactivated influenza vaccine (IIV-SD, Fluzone vaccine, Sanofi Pasteur) in persons 65 years of age and older.  These data were supplemented with US healthcare cost data. In the efficacy trial, a total of 31,989 adults 65 years of age and older were randomly assigned in a 1:1 ratio to receive either IIV-HD or IIV-SD and followed for six to eight months post-vaccination for the occurrence of influenza, serious adverse events, and medical encounters. Healthcare utilization (HCU) data were captured for all participants through a surveillance program that covered each influenza season, including the following events occurring within 30 days after any respiratory illness: use of prescription and non-prescription medications (limited to antipyretics/analgesics/non-steroidal anti-inflammatory drugs, antivirals and antibiotics), emergency room visits, non-routine or urgent care visits, and hospitalizations. In addition, all hospitalizations were captured for participants for the entire duration of the study. The primary results from the efficacy trial were published in The New England Journal of Medicine, which reported that IIV-HD was 24.2% (95% confidence interval [CI], 9.7% to 36.5%) more effective in preventing laboratory-confirmed influenza-like illness compared to IIV-SD.1 In the current supplemental analysis of the trial, we used US healthcare cost data to evaluate economic impacts of using IIV-HD compared to IIV-SD within the efficacy trial participants. In this analysis, total healthcare payer costs (the combined costs of study vaccine, prescription drugs, emergency room visits, non-routine and urgent-care visits, and hospital admissions) were about $116 less per person.
  1. DiazGranados et al, NEJM, 2014;14;371(7):635-45 

Wenqi Gan, MD, PhD Assistant Professor Department of Preventive Medicine and Environmental Health University of Kentucky College of Public Health Lexington, KY 40536MedicalResearch.com Interview with: Wenqi Gan, MD, PhD Assistant Professor Department of Preventive Medicine and Environmental Health University of Kentucky College of Public Health Lexington, KY 40536 Medical Research: What is the background for this study? Dr. Wenqi Gan: In epidemiologic studies on health effects of noise exposure, community noise is typically assessed using noise prediction models, occupational noise is assessed using self-reports or historical records. These methods are able to estimate community noise exposure in residential areas and occupational noise exposure in the workplace; however, these methods are not able to accurately reflect actual personal noise exposure in the home and workplace. The lack of personal noise exposure information is a major limitation of previous studies, which could cause underestimations of the true health effects of noise exposure. Bilateral high-frequency hearing loss, an objective indicator for long-term exposure to loud noise, may be used to investigate health effects of noise exposure. Medical Research: What are the main findings? Dr. Wenqi Gan: This study includes 5223 people aged 20-69 years who participated in the US National Health and Nutrition Examination Survey 1999-2004. Compared with people with normal high-frequency hearing, people with bilateral high-frequency hearing loss were approximately two times more likely to have coronary heart disease. This association was particularly striking for people who were chronically exposed to loud noise in the workplace or leisure time. For example, for currently employed workers with occupational noise exposure history, the possibility of having coronary heart disease increased more than four times. This study confirms that chronic exposure to loud noise is associated with increased risk of coronary heart disease.

MedicalResearch.com Interview with: Sindy Magnan, MD, MSc, FRCPC Division of Radiation Oncology, Department of Medicine CHU de Québe Université Laval Québec City, Québec, Canada Medical Research: What is the background for this study? What are the main findings? Dr. Magnan : Androgen deprivation is the standard therapy for patients with advanced or recurrent prostate cancer. Intermittent administration of this treatment could offer several advantages over the standard continuous administration by delaying the development of castration-resistant disease and by reducing the drugs’ adverse effects. However, this mode of administration remains controversial. We thus conducted a systematic review with meta-analysis of randomized controlled trials to compare the effectiveness and tolerability of intermittent versus continuous androgen deprivation. Intermittent therapy was non-inferior to continuous therapy with respect to overall survival. No major difference in global quality of life was observed between the two interventions, but some quality-of-life criteria, mainly in relation with physical and sexual functioning, seemed improved with intermittent therapy.

MedicalResearch.com Interview with: Sylvie S.L. Leung Yinko, MSc, RD Division of Clinical Epidemiology Research Institute of McGill University Health Centre (RI MUHC) Montreal (QC) and Louise Pilote, MD, MPH, PhD Professor of Medicine McGill University and Director of the Division of General Internal Medicine McGill University Health Centre Medical Research: What is the background for this study? What are the main findings? Response: Patients with premature acute coronary syndrome (ACS) are a vulnerable population of young or middle-aged adults at risk for future cardiovascular events. However, while health behaviors such as diet, physical activity, smoking, alcohol consumption and recreational drug use are important lifestyle factors that can influence cardiovascular risk, there is limited information about health behaviors in this population group. Additionally, there is indication in the literature regarding sex and age differences in health behaviors, but whether such differences exist in patients with premature acute coronary syndrome remained to be explored. Using data from GENESIS-PRAXY (GENdEr and Sex determInantS of Cardiovascular Disease from bench to beyond in PRemature Acute Coronary Syndrome), a large-scale prospective cohort study across Canada, US and Switzerland, we explored the health behavior profile of patients with premature ACS. As well, we examined whether there is a change in health behaviors 1 year post-ACS and assessed sex differences. Our results showed that the health behavior profile of men and women with premature Acute Coronary Syndrome are worse than that of the general population. We found a high prevalence of poor health behaviors in a young population with only modest changes after Acute Coronary Syndrome. Health behaviors remained suboptimal and worse than the general population, especially with regards to diet, smoking and recreational drug use. Sex differences existed in the prevalence of these behaviors at baseline and 1 year post-ACS but not in the magnitude of change after the ACS event.

MedicalResearch.com Interview with: Dr Daniel Boden Emergency Medicine Consultant Derby Hospitals NHS Foundation Trust Medical Research: What is the background for this study? What are the main findings? Dr. Boden: The overall objective was to evaluate whether there is an association between an intervention to reduce medical bed occupancy and both performance on the 4-hour target and hospital mortality. We undertook a before-and-after study in Derby teaching Hospitals NHS Foundation Trust (a large UK District General Hospital) over a 32 month period. A range of interventions were undertaken to reduce medical bed occupancy within the Trust. Performance on the four-hour target and hospital mortality (HSMR, SHMI and Crude Mortality) were compared before, and after, intervention. Daily data on medical bed occupancy and percentage of patients meeting the four-hour target was collected from hospital records. Segmented regression analysis of interrupted time-series method was used to estimate the changes in levels and trends in average medical bed occupancy, monthly performance on the target and monthly mortality measures (HSMR, SHMI and crude mortality) that followed the intervention. Medical Research: What are the main findings? Dr. Boden:
  • Mean medical bed occupancy decreased significantly from 93.7% to 90.2% (p=0.02).
  • The trend change in 95% target performance, when comparing pre- and post-intervention, revealed a significant improvement (p=0.019). The intervention was associated with a mean reduction in all markers of mortality (range 4.5% - 4.8%). SHMI (p=0.02) and Crude Mortality (p=0.018) showed significant trend changes after intervention.
  • Our conclusion is that lowering medical bed occupancy is associated with reduced patient mortality and improved ability of the acute Trust to achieve the 95% four hour target. Whole system transformation is required to create lower average medical bed occupancy.

Peter Caravan, PhD Co-Director, Institute for Innovation in Imaging (I3) Martinos Center for Biomedical Imaging Massachusetts General Hospital Associate Professor of Radiology Harvard Medical SchoolMedicalResearch.com Interview with: Peter Caravan, PhD Co-Director, Institute for Innovation in Imaging (I3) Martinos Center for Biomedical Imaging Massachusetts General Hospital Associate Professor of Radiology Harvard Medical School Medical Research: What is the background for this study? What are the main findings? Dr. Caravan: The motivation for this work was to develop a technique that would allow the detection of thrombus (clot) anywhere in the body after injection of a molecular probe called 64Cu-FBP8.  Current techniques for thrombus detection are limited to specific vascular territories.  In instances where the location of the thrombus is unknown or if there is suspicion of multiple thrombi, then multiple imaging tests must be performed.  We sought to develop a test that could be used to find clots anywhere:  brain, thorax, abdomen, legs and in arteries, veins, or the cardiac chambers.  In addition to whole body thrombus detection, we sought a technique that could address some of the limitations with current thrombus imaging techniques.  For example computed tomography (CT), which is used to detect pulmonary emboli, requires a contrast agent that cannot be used in patients with poor kidney function.  Transesophageal echocardiography used to identify thrombus in the chambers of the heart requires that the patient be sedated. Our approach is to use a small peptide that recognizes the protein fibrin, which is a key component of blood clots.  We tagged the peptide with an isotope of copper, Cu-64, that allows the peptide to be detected by positron emission tomography (PET). 64Cu-FBP8 binds specifically to fibrin but not to other proteins in the blood and this means that the uptake in the clot is high while background signal is very low.  We combined PET imaging which finds the clot with CT imaging or magnetic resonance imaging (MRI).  By overlaying the PET image with the CT or MRI image, we could precisely localize the clot within the We were interested to see if the age of the clot impacted our ability to detect it.  We imaged animals with a total of 42 arterial or venous clots and then the images were analyzed by two reviewers who had no prior knowledge of the location of the clot.  Overall the accuracy was 98% for detection. Another key finding was that the uptake of 64Cu-FBP8 strongly correlated with the amount of fibrin in the clot and that younger, fresher clots had more fibrin than older clots.  This could be very useful in distinguishing newer clots which may be the source of cardiovascular events from older, clots that may pose less risk. We also showed using combined PET-MRI that we could detect multiple blood clots in the animal in a single whole body scan.  The procedure involves a single intravenous administration of 64Cu-FBP8 and clots in the deep veins of the legs or in the carotid arteries were readily detected.

J. Michael McWilliams MD, PhD Associate Professor andMedicalResearch.com Interview with: J. Michael McWilliams MD, PhD Associate Professor and Dr. Michael Barnett MD Researcher and General Medicine Fellow Dept. of Health Care Policy Harvard Medical School Boston MADr. Michael Barnett MD Researcher and General Medicine Fellow Dept. of Health Care Policy Harvard Medical School Boston MA Medical Research: What is the background for this study? Response: The financial impact of Medicare’s Hospital Readmissions Reduction Program on hospitals is growing.  In this year’s round of penalties, nearly 2,600 hospitals were collectively fined $420 million for excess readmissions. There has been concern that the risk-adjustment methods used by Medicare to calculate a hospital’s expected readmission rate is inadequate, meaning that hospitals disproportionately serving sicker and more disadvantaged patients are being penalized because of the populations they serve rather than their quality of care.  Specifically, Medicare accounts only for some diagnoses, age and sex but no other clinical or social characteristics of patients admitted to the hospital. No study to date has examined the impact adjusting for a comprehensive set of clinical and social factors on differences in readmission rates between hospitals. We did this by using detailed survey data from the Health and Retirement Study linked to information on admissions and readmissions in survey participants’ Medicare claims data.  We then compared differences in readmission rates between patients admitted to hospitals in the highest vs. lowest quintile of publicly reported readmission rates, before vs. after adjusting for a rich set of patient characteristics.  These included self-reported health, functional status, cognition, depressive symptoms, household income and assets, race and ethnicity, educational attainment, and social supports. Medical Research: What are the main findings? Response: Our two most important findings were: 1) Patients admitted to hospitals with higher readmission rates are sicker and more socially disadvantaged in a variety of ways than patients admitted to hospitals with lower readmission rates. 2) After adjusting for all measurable patient factors that are not accounted for in standard Medicare adjustments, the difference in readmission rates between hospitals with high vs. low readmission rates fell by nearly 50%.

Martin Neovius PhD Department of Medicine, SolnaMedicalResearch.com Interview with: Martin Neovius PhD Department of Medicine, Solna Medical Research: What is the background for this study? What are the main findings? Dr. Neovius: Long-term real world data on economic effects of bariatric surgery versus nonsurgical treatment are scarce. We have previously looked at long-term drug costs, inpatient and outpatient care in the overall bariatric surgery population (Neovius, Narbro et al, JAMA 2012). However, overall findings may mask important subgroup variations. Based on data from the Swedish Obese Subjects (SOS) study, we documented large drug cost savings over 15 years after bariatric surgery versus non-surgically treated controls in patients who had diabetes and prediabetes before intervention. No savings were seen in patients who were euglycemic at baseline. In terms of overall healthcare costs, we saw cost-neutrality versus non-surgically treated patients for the diabetes group, while costs were higher for both patients with normal blood glucose and those with prediabetes (due to the initial high cost of surgery and inpatient care). For the subgroup of patients with diabetes, we also found that patients with recent diabetes onset had more favorable economic outcomes than patients with established diabetes. 

Dr Mark Webber PhD, MSc, BSc Senior Research Fellow School of Immunity and Infection University of Birmingham and the National Institute for Health Research (NIHR) Surgical Reconstruction and Microbiology Research Centre (SRMRC)MedicalResearch.com Interview with: Dr Mark Webber PhD, MSc, BSc Senior Research Fellow School of Immunity and Infection University of Birmingham and the National Institute for Health Research (NIHR) Surgical Reconstruction and Microbiology Research Centre (SRMRC) Medical Research: What is the background for this study? What are the main findings? Dr. Webber: Infection is a major problem for patients who suffer burn injuries and these are vary hard to treat with traditional antibiotics which struggle to effectively reach the wound and kill the bugs. One alternative which has been used in the Queen Elizabeth Hospital in Birmingham for some time is the use of acetic acid, basically vinegar. Acetic acid has long been known to be a useful antimicrobial but clinicians in Birmingham have found it to be effective in treating wounds infected, particularly with Pseudomonas. There is though very little science about what concentration of acetic acid would work best and how it kills bugs. We have shown the acetic acid works well against lots of different bugs and at much lower concentrations than are used in practice. Importantly we showed that the acetic acid works well against bugs stuck to a surface - in what's known as a 'Biofilm'. Biofilms are typically highly drug resistant.

Daniela Carnevale, PhD, Researcher Laboratory of Giuseppe Lembo, MD, PhD Dept. of Molecular Medicine "Sapienza" University of Rome & Dept. of Angiocardioneurology and Translational Medicine IRCCS Neuromed - Technology Park Località CamerelleMedicalResearch.com Interview with: Daniela Carnevale, PhD, Researcher Laboratory of Giuseppe Lembo, MD, PhD Dept. of Molecular Medicine "Sapienza" University of Rome & Dept. of Angiocardioneurology and Translational Medicine IRCCS Neuromed - Technology Park Località Camerelle Medical Research: What is the background for this study? Dr. Carnevale: Nowadays, one of the most demanding challenge in medicine is preserving cognitive functions during aging. It is well known that cardiovascular risk factors have a profound impact on the possibility of developing dementia with aging. However, we have no means to investigate this aspect in patients with cardiovascular diseases. Indeed, although we have clear clinical paradigms to explore target organ damage of vascular diseases like hypertension, we are less prepared to afford the brain damage that may result from chronic vascular diseases and impact on cognitive functions. Thus, we aimed at finding a diagnostic paradigm to assess brain damage that could predict for future development of dementia. Since it is becoming increasingly clear that hypertension may determine cognitive decline, even before manifest neurodegeneration, we elaborated a paradigm of analysis that are essentially focused on brain imaging and cognitive assessment. In particular, we used diffusion tensor imaging (DTI) on magnetic resonance that allows to reconstruct white matter connections that correlate with selective cognitive functions, and specifics tests for the evaluation of subtle alterations of cognitive functions.

Wael A. Jaber, MD FACC, FAHA Professor of Medicine Cleveland Clinic Lerner College of Medicine Fuad Jubran Endowed Chair in Cardiovascular Medicine Heart and Vascular Institute Cleveland Clinic Cleveland, OH MedicalResearch.com Interview with: Wael A. Jaber, MD FACC, FAHA Professor of Medicine Cleveland Clinic Lerner College of Medicine Fuad Jubran Endowed Chair in Cardiovascular Medicine Heart and Vascular Institute Cleveland Clinic  Cleveland, OH Medical Research: What is the background for this study? What are the main findings? Prof. Jaber: Risk stratification of patients presenting with atrial fibrillation often includes a non-invasive evaluation for coronary artery disease. However, the yield of such testing in patients without angina or anginal-equivalent symptoms is uncertain. That is, how often do we find silent myocardial ischemia? In our cohort of 1700 consecutive patients with atrial fibrillation, less than 5% had ischemia on nuclear stress testing, even though comorbidities were prevalent. Moreover, in patients with ischemia that had invasive coronary angiography, less than half had obstructive coronary artery disease.

Chiara Dall'Ora MSc Nursing and Midwifery Sciences University of SouthamptonMedicalResearch.com Interview with: Chiara Dall'Ora MSc Nursing and Midwifery Sciences University of Southampton  Medical Research: What is the background for this study? What are the main findings? Response: There is a trend for healthcare employers to adopt longer shifts, typically 2 shifts per day each lasting 12 hours. This allows nurses to work fewer shifts each week. Changes are driven by perceived efficiencies for the employer, and anecdotal reports of improved work life balance for employees because they work fewer days per week. However, it is unclear whether these longer shits adversely affect nurses' wellbeing, in terms of burnout, job dissatisfaction, dissatisfaction with work schedule flexibility and intention to leave the job. We found that when nurses work 12 h shifts or longer they are more likely to experience high burnout, dissatisfaction with work schedule flexibility and intention to leave their job, compared to nurses working 8 h or less. All shifts longer than 8 hours are associated with nurses' job dissatisfaction.

Jingyuan Fu, Ph.D. Associate professor of genetics University Medical Center Groningen NetherlandsMedicalResearch.com Interview with: Jingyuan Fu, Ph.D. Associate professor of genetics University Medical Center Groningen Netherlands  Medical Research: What is the background for this study? What are the main findings? Dr. Jingyuan Fu: Abnormal blood lipid levels are important risk factors for cardiovascular diseases. Because of that, a common advice is to have a healthy lifestyle or take lipid-lowering drugs like statin to control the blood lipid level. However, the problem is only partially solved. Cardiovascular disease remains the No 1 cause of death globally, representing 31% of all global deaths.  The primary purpose of the study is to look for a new solution in humans’ gut. Over millions of years, microbes and humans have formed a truly symbiotic relationship. Human body contains 10 trillion bacteria, 10x more than human cells. They help digest food and train our immune systems. As less than 30% of bacteria in human gut can be cultured, we know very little how they are and what they do in our gut. With the state-of-art deep sequencing technology, we are now able to see who are there. The research questions would be how much effect these bacteria could affect the blood lipids levels and which bacteria play important role. No such an analysis was done in large-scale human population. Our study was the first to provide solid evidence for the associations between gut bacteria and blood lipids. Although we cannot conclude cause-effect relationship yet, it serves an important step in narrowing possible therapeutic targets.

Joshua W. Miller, PhD Professor and Chair Dept. of Nutritional Sciences Rutgers The State University of New Jersey New Brunswick, NJ 08901 MedicalResearch.com Interview with: Joshua W. Miller, PhD Professor and Chair Dept. of Nutritional Sciences Rutgers The State University of New Jersey New Brunswick, NJ 08901  Medical Research: What is the background for this study? What are the main findings? Response: In recent years, there has been a growing scientific literature on the associations between low vitamin D status in older adults and risk of Alzheimer's disease/dementia, cognitive impairment and decline, and brain atrophy.  The vast majority of these studies have been conducted in predominantly white populations.  The relatively unique aspect of our study was that over half of the cohort consisted of African Americans and Hispanics.  What we found in our cohort (mean age ~75y, n=382 at baseline) was that participants with vitamin D deficiency (serum 25-hydroxyvitamin D <12 ng/ml) or vitamin D insufficiency (serum 25-hydroxyvitamin D between 12 ng/ml and <20 ng/ml) on average experienced faster rates of cognitive decline in episodic memory and executive function than participants with adequate vitamin D status.  Importantly, the association between vitamin D status and the rate of decline in cognitive function was independent of race/ethnicity.  However, the prevalence of low vitamin D status in the study participants was significantly higher in the African American and Hispanic participants compared with the White participants.  This is most likely due to the fact that darker skin pigmentation reduces the ability of sunlight to induce vitamin D synthesis in the skin.  It may also reflect differences in dietary intake of vitamin D and supplement use between the different race/ethnicity groups, though we did not assess this in our study.  Thus, though the rate of cognitive decline in African Americans and Hispanics does not seem to be more or less affected by low vitamin D status than in Whites, because African Americans and Hispanics have a higher prevalence of low vitamin D status, as subpopulations they may be more prone to rapid cognitive decline in old age.  Further studies addressing this possibility are needed.