MedicalResearch.com Interview with:
Dr. Wilson Tang MD
Professor of Medicine
Cleveland Clinic Lerner College of Medicine
Case Western Reserve University
Director of the Center for Clinical Genomics
Cleveland ClinicMedical Research: What is the background for this study? What are the main findings?
Dr. Tang: Renal impairment has long been associated with worse outcomes in acute heart failure. Administration of diuretic therapy often obscures accurate assessment of renal function by urine output. Despite extensive literature suggesting the poor outcomes in those with a rise in creatinine following treatment, recent data has suggested that in the presence of effective diuresis, this phenomenon likely represents hemoconcentration and azotemia rather than acute kidney injury. We observed that using a novel and sensitive biomarker that identified acute kidney injury, specific to tubular injury, we can identify those at higher risk of adverse outcomes in patents admitted for acute heart failure. However, after adjusting for standard risk factors, the prognostic value was clearly attenuated.
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MedicalResearch.com Interview with:
Annabelle de St. Maurice MD, MPH
Pediatric Infectious Disease Fellow
Vanderbilt Children's Hospital
Medical Research: What is the background for this study? What are the main findings?
Dr. de St. Maurice: Susceptibility to certain infectious diseases appears to vary by gender. For example, males may be at increased risk of certain infections in childhood, including lower respiratory tract infections such as RSV, however females may have more severe infections, such as influenza, during pregnancy. Some early studies have suggested that males may be at increased risk of pneumococcal infections but this has not been confirmed. Furthermore, whether those potential gender differences remain after introduction of pneumococcal conjugate vaccines is unknown.
Invasive pneumococcal disease, which includes meningitis, bacteremic pneumonia and bacteremia/septicemia, is a significant cause of morbidity and mortality in the United States in children and adults. The 7-valent pneumococcal conjugate vaccine (PCV7) and the 13-valent pneumococcal conjugate vaccine (PCV13) led to declines in invasive pneumococcal disease rates as well as eliminated racial disparities in regards to invasive pneumococcal disease rates. Our study sought to identify potential gender differences in the incidence of invasive pneumococcal disease, and to determine the impact of vaccines on gender differences in the susceptibility to these diseases.
We conducted a large study that used data from a population-based surveillance system of invasive pneumococcal diseases in Tennessee. This is part of a large CDC funded network of surveillance sites for these diseases. For our study, we identified patients with laboratory-confirmed invasive pneumococcal disease, and calculated the incidence of invasive pneumococcal diseases from 1998-2013 by gender. We also stratified the calculations by age groups and race, both well-known factors that affect the occurrence of invasive pneumococcal disease.
Our study found that males had generally higher rates of invasive pneumococcal disease than females across age groups, regardless of race. Although introduction of the pneumococcal conjugate vaccines led to a significant decrease in invasive pneumococcal disease rates, males continued to have higher rates than females in several age groups.
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MedicalResearch.com Interview with:
David E. Gerber, MD
Associate Professor
Division of Hematology-Oncology
Associate Director for Clinical Research
Co-Leader, Experimental Therapeutics Program
Co-Director, Lung Disease Oriented Team
Harold C. Simmons Cancer Center
University of Texas Southwestern Medical Center
Dallas, TX
Medical Research: What is the background for this study? What are the main findings?
Dr. Gerber: In this trial, we compared an immunotherapy and a chemotherapy drug in patients with non-squamous non-small cell lung cancer (NSCLC) whose disease continued to progress after first-line chemotherapy. We found that nivolumab immunotherapy improved overall survival compared to docetaxel chemotherapy and was generally well tolerated. These results are significant because options for patients whose lung cancer progresses after initial treatment are limited.
Nivolumab is an immunotherapy drug that works by inhibiting the cellular pathway known as PD-1 protein on cells that block the body’s immune system from attacking cancerous cells. The idea behind nivolumab and other immunotherapy drugs is to kick-start the body’s natural immune response to a cancer. Cancer develops and grows in part because it has put the brakes on the immune response. These drugs take the foot off the brake, allowing the immune system to accelerate and attack the cancer.
The phase 3 clinical trial followed more than 500 patients who had non-squamous non-small cell lung cancer (NSCLC): 287 received nivolumab and 268 received the chemotherapy drug docetaxel. The one-year survival rate was 51 percent in the nivolumab arm versus 39 percent in the docetaxel arm. The most common reported side effects with nivolumab were fatigue, nausea, decreased appetite, and weakness, and they were less severe than with docetaxel treatment. In a minority of cases, patients treated with nivolumab also developed autoimmune toxicities affecting various organs.
In addition to studying safety and efficacy, the trial examined the protein biomarker PD-L1, which is believed to play a role in suppressing the immune system. The study results suggested that patients with a higher level of PD-L1 in their cancers may experience the greatest benefit from nivolumab, which targets the related molecule PD1. Using a biomarker helps oncologists predict which patients will do best on which treatment, and plan their treatment accordingly. Other promising predictive biomarkers for cancer immunotherapies include the degree of immune cell infiltration within a tumor and the number of mutations a tumor has.
Specifically, the more mutations a cancer has, the more foreign it appears to the body, thus marking it for immune attack. With lung cancer, we see the greatest number of tumor mutations – and perhaps the greatest benefit from immunotherapy – among individuals with the heaviest smoking history.
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MedicalResearch.com Interview with:
Andrew P. Loehrer, MD
David Torchiana Fellow in Health Policy and Management
Massachusetts General Physicians Organization
Research Fellow
Codman Center for Clinical Effectiveness in Surgery
Department of Surgery
Massachusetts General Hospital
Medical Research: What is the background for this study? What are the main findings?
Dr. Loehrer: The incidence of pancreatic cancer is increasing and is on pace to become the second leading cause of cancer mortality by the year 2020. While surgery remains the only chance for long-term survival, significant and persistent disparities in evaluation for and receipt of surgery remain for underinsured patients across the United States. The Affordable Care Act aims to increase access to care through expansion of health insurance coverage and was modeled on previous reform in the Commonwealth of Massachusetts.
We evaluated the impact of the 2006 Massachusetts health reform on rates of surgery for pancreatic cancer. We found the insurance expansion to be independently associated with a 67% increased rate of resection for pancreatic cancer. While disparities in resection rates by insurance status decreased after the health reform, significant gaps remain between privately-insured patients and government-subsidized/self-pay patients.
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MedicalResearch.com Interview with:
Ambarish Pandey, MD
Cardiology Fellow, PGY5
University of Texas Southwestern Medical Center,
Dallas, Texas 75390
Medical Research: What is the background for this study? What are the main findings?
Dr. Berry: Physical inactivity is considered a major modifiable risk factor for coronary artery disease and the current guidelines recommend atleast 150 min/week (~ 500 MET-min/week) of moderate intensity physical activity to reduce the burden of coronary artery disease. In contrast, the role of physical activity in reducing risk of heart failure is not emphasized in the current guidelines. This is particularly relevant considering the increasing burden of heart failure in the community. Against this background, we performed this study to the dose-response relationship between physical activity levels and risk of heart failure.
We observed a dose dependent inverse association between physical activity levels and heart failure risk. Furthermore, we observed that the current guideline recommended physical activity levels (500 MET-min/week) are associated with only modest reduction in HF risk (< 10%). In contrast, a substantial reduction in heart failure risk was observed at twice and four times the recommended physical activity levels (19% and 35% risk reduction respectively)
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MedicalResearch.com Interview with:
Susan Gray MD
Division of Adolescent Medicine
Boston Children's Hospital
Boston, MA
Medical Research: What is the background for this study? What are the main findings?
Dr. Gray: This is a study of the health care costs of 13,000 privately insured adolescents (13 to 21 years old) cared for in an association of pediatric primary care practices. We found that a tiny fraction (1%) of adolescents accounted almost a quarter of the expenses of the whole cohort. Mental health disorders were the most common diagnosis among these high cost adolescents. The characteristics most strongly associated with high cost were complex chronic medical conditions, behavioral health disorders, and obesity, but many high cost adolescents had no chronic conditions. Pharmacy costs, especially orphan drug costs, were a surprisingly large contributor to high costs for these privately insured adolescents. Primary care costs were very small in high cost patients.
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MedicalResearch.com Interview with: Brendan J. Keating, DPhil
Assistant professor of Transplant Surgery
Penn Medicine
Medical Research: What is the background for this study? What are the main findings?Response:Genetic studies in transplantation have been plagued by small samples and very complex phenotypes/outcomes of patients. Transplanted individuals are typically on potent immunosuppression drugs for the rest of their lives, as they have 3.5 million to 10 million variants difference from an unrelated transplanted donor organ. Such populations would certainly benefit from large well-powered genetic studies but only 3 transplant genome-wide genotyping studies comprising a few hundred individuals have been published.
The papers outline the resources in hand for the International Genetics & Translational
Research in Transplantation Network, comprising 22 studies to date (since the publication it has now expanded to 25 studies and > 32,000 subjects with genome-wide genotyping data). We show significant statistical power in iGeneTRAiN to detect main effect association signals across regions such as the MHC region (which harbors the HLA Class I/II regions which are well established to associate with transplantation outcomes). We also show strong genome-wide power to detect transplant outcomes that span all solid organs including graft survival, acute rejection, new onset of diabetes after transplantation (fast becoming the most common comorbidity post-transplantation), and delayed graft function (to date we have looked at this in kidney transplant patients only). We show that iGeneTRAiN is statistically powered to deliver pioneering insights into the genetic architecture of transplant-related outcomes across a range of different solid-organ transplant studies.
The transplant specific GWAS array that we designed (described in depth in the Genome Medicine paper) show that the coverage in key transplant associated regions is much higher than conventional arrays, and we describe the ‘imputation’ pipeline to expand the 780,000 or so variants examined in any given individual to > 15 millions of variants using whole genome sequencing reference datasets.
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MedicalResearch.com Interview with:
Carlos G. Grijalva, MD MPH
Associate Professor
Department of Health Policy
Vanderbilt University Medical Center
Nashville, TN 37212Medical Research: What is the background for this study?
Dr. Grijalva: Influenza is an important cause of disease. Every year influenza causes more than 200,000 hospitalizations in the US. The most effective strategy to prevent influenza infections is vaccination. Several studies have shown that influenza vaccines can prevent fever or respiratory symptoms caused by influenza. However, whether influenza vaccines can prevent more serious complications of influenza such as pneumonia, remains unclear
This was a multicenter collaboration between academic institutions and the centers for disease control and prevention. We used data from the Etiology of Pneumonia in the community or EPIC study, a large prospective study of hospitalizations for pneumonia conducted between 2010 and 2012. The EPIC study enrolled patients from Chicago, IL, Salt Lake City, UT, and Memphis and Nashville, TN. The main goal of the EPIC study was to determine the causes of pneumonia in children and adults hospitalized with pneumonia.
Medical Research:? What are the main findings?
Dr. Grijalva: We conducted a case-control study using data from EPIC. Our study included more than 2700 patients hospitalized for pneumonia, including both children and adults. Approximately 6% of these patients had influenza pneumonia and were identified as cases. Other patients hospitalized for pneumonia that was not caused by influenza were the controls. We compared the history of influenza vaccination between cases and controls. We found that influenza vaccination was associated with a reduced risk of influenza pneumonia that required hospitalization. The estimated vaccine effectiveness was 57%. This means that about 57% of hospitalizations due to influenza-associated pneumonia could be prevented through influenza vaccination.
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MedicalResearch.com Interview with:Corinna Koebnick, PhD
Research scientist with Research & Evaluation
Kaiser Permanente Southern California
MedicalResearch: Please describe your study, what you were looking for, and why.Dr. Koebnick: This study is based on the Kaiser Permanente Southern California Children’s Health Study, which includes all children and adolescents 2–19 years of age in Southern California who are actively enrolled in a large, integrated, managed health care system. We examined the body weight from electronic health records of more than 1.3 million children and adolescents 2-19 years of age from 2008 to 2013.
The objective of this study was to investigate recent trends in pediatric obesity in Southern California between 2008 and 2013. Several recent studies have investigated national trends in childhood obesity in the United States and indicated that childhood obesity rates may have reached a plateau, but are not declining. Ours is one of the few studies that is large enough to be able to detect small changes in the prevalence of obesity in time periods of less than 10 years.
MedicalResearch: What are the findings of this study? Dr. Koebnick: Our study provides strong indication that the prevalence of overweight and obesity between 2008 and 2013 has not only plateaued, but also is slowly declining. While the decline in overweight and obesity was less pronounced in girls, adolescents, some minority groups and youth living in low income and low education areas, the decline was remarkably stable across all groups and significant even in minority youth and youth of lower socioeconomic status.
We found the prevalence of overweight and obesity decreased overall by 2.2 percent and 1.6 percent, respectively. This change corresponds to a relative decline of 6.1 percent in overweight youth and 8.4 percent in obese youth. Although a decline was seen across all groups, the decrease was not as strong in adolescents aged 12-19 years, in girls compared to boys, and Hispanic and black children compared to non-Hispanic whites.
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MedicalResearch.com Interview with:
Harry H. Yoon, MD
Mayo Clinic
Rochester, MN 55905
Medical Research: What is the background for this study? What are the main findings?
Dr. Yoon: In the U.S., the survival of patients with colon cancer is known to differ by race, with individuals of black race having worse outcomes than those of white race.
However, it has been difficult to tease apart why the differences in survival exist.
It is generally believed that social or other non-biologic factors (eg, decreased access to care, suboptimal treatment) contribute to the discrepancy. It’s also known that differences in the general medical condition of patients could affect how long a patient lives.
However, it is unknown whether there are race-based differences in the biology of colon tumors themselves. This biology can be reflected in the genetic composition of tumors, as well as by whether and how quickly the cancer returns after the patient has undergone surgery and chemotherapy.
In addition, it is unknown whether race-based differences in biology may be related to the age of the patient at the time of diagnosis. Blacks with colorectal cancer typically have an earlier age of onset than whites do.
A major barrier to addressing these questions are that there are very few large populations of colon cancer patients where everyone had the same disease stage and received uniform treatment, and where patients were monitored for years afterward specifically to see whether the cancer returned. It is much harder to measure whether cancer has returned (ie, cancer recurrence), as compared to simply knowing whether a patient is alive or dead. This difference is important, because knowing about cancer recurrence sheds more light on cancer biology than only knowing about patient survival, since many factors unrelated to cancer biology (eg., heart disease) can affect whether a person is alive or dead.
The most reliable data on cancer recurrence (not just patient survival) generally comes from patients who have enrolled in a clinical trial. In the Alliance N0147 trial, all patients had the same cancer stage (ie, stage III), underwent surgery and received standard of care chemotherapy (ie, “FOLFOX”) after surgery. Patients had uniform, periodic monitoring after chemotherapy to see if the cancer returned.
In other words, examining racial outcomes in this cohort largely eliminates some of the key factors (eg, decreased access to care, suboptimal treatment) that are believed to contribute to racial discrepancies, and provides a unique opportunity to determine if differences in cancer biology between races may exist.
This study was done to see if colon cancers are genetically different based on race, and whether race-based differences exist in cancer recurrence rates.
The study found that tumors from whites, blacks, and Asians were different in terms of the frequency of mutations in two key cancer-related genes, BRAF and KRAS. Tumors from whites were twice as likely to have mutated BRAF (14% in whites compared to 6% in Asians and 6% in blacks). Tumors from blacks had the highest frequency of KRAS mutations (44% in blacks compared to 28% in Asians and 35% in whites). Tumors from Asians were the mostly likely to have normal copies of both genes (67% in Asians compared to 50% in blacks and 51% in whites).
Next, the study found that the colon cancers among blacks had more than double the risk of cancer recurrence, compared to whites. However, this discrepancy was only evident among young patients (ie, aged less than 50 years). Almost 50% of younger black patients experienced colon cancer recurrence within 5 years, compared to ~30% of black patients over age 50, or compared to white or Asian patients regardless of age. The worse outcome among young blacks remained evident even after adjusting for many potential confounding factors, such as tumor grade, the number of malignant nodes, or the presence of BRAF or KRASmutations. Because this question was examined in a clinical trial cohort of uniform stage and treatment, the role of multiple important potential confounders was diminished.
To our knowledge, this is the first report indicating that colon cancers from young black individuals have a higher chance of relapsing after surgery and chemotherapy, compared to those from white individuals.
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MedicalResearch.com Interview with:
Dr. Germaine Louis Buck PhD
Senior Investigator and Director of the Division of Epidemiology, Statistics and Prevention Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health Medical Research: What is the background for this study? What are the main findings?
Dr. Germaine Buck: We wanted to develop intrauterine standards for ultrasound measured fetal growth, given that none currently exist for contemporary U.S. pregnant women. Moreover, we wanted to determine if a single standard would be possible for monitoring all pregnant women, or if the standard needed to be tailored to pregnant women’s race/ethnicity. This added step attempted to address the equivocal data about whether or not race/ethnicity is an important determinant of optimal fetal growth.
Analyzing data from 1,737 low risk pregnant women with uncomplicated pregnancies who had 5 ultrasounds done at targeted times during pregnancy, we found significant differences in estimated fetal weight across the 4 maternal race/ethnic groups. These differences were apparent beginning about 16 weeks gestation and continuing throughout pregnancy. The differences in these curves were apparent when assessing infant’s birthweight, as well. Overall, estimated fetal weights while women were pregnant were highest for White mothers followed by Hispanic, Asian, and Black mothers. A 245 gram difference in estimated fetal weight was observed at 39 weeks gestation between pregnant White and Black women. This pattern was then observed for measured birth weight, with highest birthweights for White then Hispanic, Asian, and Black infants.
Other differences emerged by maternal race/ethnicity for individual fetal measurements: longest bone (femur & humerus) lengths were observed for Black fetuses emerging at 10 weeks gestation, larger abdominal circumference for White fetuses emerging at 16 weeks gestation, larger head circumference for White fetuses emerging at 21 weeks gestation, and larger biparietal diameter for White fetuses emerging at 27 weeks gestation in comparison to other groups.
The race/ethnic differences in fetal size were highly significant and across gestation. If a single White standard was used for estimating fetal weight for non-White fetuses in pregnant women, between 5% and 15% of their fetuses would have been misclassified as being in the <5th percentile of estimated fetal weight.
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MedicalResearch.com Interview with:
Timothy Anderson, M.D.
Chief medical resident
Department of Internal Medicine
University of Pittsburgh
Medical Research: What is the background for this study? What are the main findings?
Dr. Anderson: My coauthors and I analyzed the public disclosures of all publicly traded U.S. health care companies listed on the NASDAQ exchange and New York Stock Exchange in January 2014 that specialized in pharmaceuticals, biotechnology, medical equipment and providing health care services. Of the 442 companies with publicly accessible disclosures on boards of directors, 180 – or 41 percent – had one or more academically affiliated directors in 2013. These individuals included chief executive officers, vice presidents, presidents, provosts, chancellors, medical school deans, professors and trustees from 85 non-profit academic research and health care institutions. These individuals received compensation and stock shares from companies which far exceeds payment for other relationships such as consulting. In some cases compensation approaches or exceeds average professor and physician salaries.
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MedicalResearch.com Interview with:
Adela Hruby PhD
Adjunct Instructor, Friedman School of Nutrition Science and Policy
Research Fellow, Harvard School of Public Health
Fellow, Oak...
MedicalResearch.com Interview with:
Wisit Cheungpasitporn, MD
Nephrology Fellow
Departments of Nephrology and Hypertension
Program director: Suzanne Norby, MD
Co-authors: Charat Thongprayoon, MD, Oisin A O'Corragain, MD, Peter J Edmonds, BS, Wonngarm Kittanamongkolchai, MD, Stephen B Erickson, MD
Project mentor: Stephen B. Erickson, MD Departments of Nephrology and Hypertension
Mayo Clinic, Rochester, MN
Medical Research: What is the background for this study?Dr. Cheungpasitporn: High-fructose corn syrup consumption in the form of sugar-sweetened soda has dramatically increased worldwide and associated with risk factors for chronic kidney disease (CKD) including diabetes mellitus (DM) and metabolic syndrome. Recently, artificial sweeteners have become commonly used in soda marketed as ‘diet’ alternatives. Recent studies have demonstrated that diet soda consumption may also be associated with weight gain, metabolic syndrome and cardiovascular disease. The risks of CKD in individuals with sugar-sweetened or diet soda consumption, however, were conflicting. We therefore conducted a meta-analysis to assess the associations between CKD and the consumption of sugar sweetened and diet soda. The findings of our study were recently published in Nephrology (Carlton). 2014; 19(12):791-7.
Medical Research: What are the main findings?
Dr. Cheungpasitporn: Five studies (2 prospective cohort studies, 2 cross-sectional studies and a case-control study) were included in our analysis of the association between consumption of sugar-sweetened soda (≥1-2 drinks of sugary soda/day) and CKD. We found an overall 1.58-fold increase CKD risk in individuals who regularly consumed sugar-sweetened soda with the pooled risk ratio (RR) of 1.58 (95% CI 1.00–2.49). Four studies (2 prospective cohort studies, a cross-sectional studies and a case-control study) were included to assess the association between CKD and diet soda consumption (≥1-2 drinks of diet soda/day). Despite a trend of chronic kidney disease risk in individuals with diet soda consumption with the pooled RR of 1.33 (95% CI 0.82–2.15), this association was not statistically significant.
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MedicalResearch.com Interview with: Anthony V. D'Amico, MD, PhD
Chief, Division of Genitourinary Radiation Oncology
Professor of Radiation Oncology, Harvard Medical School
Medical Research: What is the background for this study? What are the main findings?
Dr. D'Amico: Controversy exists as to whether androgen deprivation therapy (ADT) used to treat prostate cancer can cause fatal cardiac events.
We found that in men with moderate to severe comorbidity based most often on a history of a heart attack that the use of 6 months of androgen deprivation therapy to treat non metastatic but clinically significant prostate cancer was associated with both an increased risk of a fatal heart attack and shortened survival.
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MedicalResearch.com Interview with:
Susanna C. Larsson PhD, Associate Professor
Associate professor, Nutritional Epidemiology
Institute of Environmental Medicine
Karolinska Institutet
Stockholm, Sweden
Medical Research: What are the main findings?
Dr. Larsson: A high dietary cholesterol intake has been postulated to increase the risk of cardiovascular disease. Egg is a rich source of dietary cholesterol and has been positively associated with risk of heart failure in previous prospective studies. High consumption of eggs has also been associated with a higher risk of myocardial infarction in diabetic patients.
Medical Research: What is the background for this study?
Dr. Larsson: We investigated the association between egg consumption and risk of cardiovascular diseases in two population-based prospective cohort studies of approximately 38,000 Swedish men and 33,000 Swedish women. Findings from our study indicate that egg consumption does not increase the risk of myocardial infarction, ischemic stroke, or hemorrhagic stroke. High egg consumption (one or more times per day) was associated with an elevated risk of heart failure in men but not in women. Egg consumption was not associated with an increased risk of heart failure, myocardial infarction, or stroke in individuals with diabetes.
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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.
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MedicalResearch.com Interview with:
Phuc Le, Ph.D., M.P.H.
Center for Value-Based Care Research, Medicine Institute
Cleveland, OHMedical Research: What is the background for this study? What are the main findings?
Dr. Phuc Le: The live attenuated herpes zoster vaccine is approved by the FDA for persons aged 50 years and above. However, the Advisory Committee on Immunization Practices recommends it for only persons aged 60 years and older. Therefore, we aimed to analyze the vaccine’s cost-effectiveness among persons aged 50-59 years to see if ACIP’s recommendation is reasonable. We found that the vaccine is not cost-effective among people at aged 50 years, having an incremental costs of $323,000 per QALY gained, which is 3 times more than a commonly accepted threshold ($100,000/QALY).
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MedicalResearch.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.
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MedicalResearch.com Interview with:
Aaron L. Schwartz, PhDDepartment 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.
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MedicalResearch.com Interview with:
Dr. Ilse S. Pienaar
Honorary Lecturer in Neuroscience at Imperial College London
(& Snr. Lecturer in Cellular Pathology, Northumbria University)
Centre for Neuroinflammation & Neurodegeneration
Division of Brain Sciences Faculty of Medicine
Imperial College London
Hammersmith Hospital Campus
London United Kingdom
Medical Research: What is the background for this study? What are the main findings?Dr. Pienaar: A highly heterogeneous brainstem structure, the pedunculopontine nucleus (PPN) has been deemed a promising target for the delivery of deep-brain stimulation (DBS), to alleviate aspects of Parkinson's disease (PD), especially gait and postural instability. However, optimal therapeutic targeting of the PPN has been hampered due to DBS being unable to discriminate between cell types being targeted. We optomised a novel technique, Designer Receptors Exclusively Activated by Designer Drugs (DREADD) in a rat model of PD, by which to target only the PPN cholinergic neurons. A series of behavioral tests revealed that selective stimulation of the PPN cholinergics completely reverses gait problems and postural instability in the PD rats.
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MedicalResearch.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.
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MedicalResearch.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 89106Medical 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.
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MedicalResearch.com Interview with:
Avik Chatterjee, MD, MPH
Physician, Boston Health Care for the Homeless Program
Instructor, Harvard Medical School
Associate Epidemiologist, Division of Global Health Equity, Brigham and Women's Hospital
Boston, MA
Medical Research: What is the background for this study? What are the main findings?
Dr. Chatterjee: Substance use, sexual activity and violent behaviors are common during adolescence. Understanding risk factors for these behaviors will improve our ability to prevent them and their sequelae. The Chaos, Hubbub and Order Scale (CHAOS) is a measure of household physical and social disorder, and higher CHAOS score, as reported by parents, has been shown to be correlated with less self-regulatory behavior in children. Thus, CHAOS could be a risk factor for the above behaviors in adolescents. We used data from the RISE study, in which 929 adolescents completed face-to-face and computer-assisted (for sensitive questions) interviews about their health behaviors to analyze the relationship between CHAOS score and risky health behaviors. We found that students with highest CHAOS score, compared to those with zero CHAOS score, had elevated odds for tobacco use (3x), alcohol use (2.5x), any substance use at school (6x) and fighting in the past 12 months (2x).
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MedicalResearch.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.
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MedicalResearch.com Interview with:
Linda J Ewing PhD RN
Department of Psychiatry and
Lora E Burke PhD, MPH, RN, FAAN
Department of Health and Community Systems
University of Pittsburgh School of Nursing
Pittsburgh, PennsylvaniaMedical Research: What is the background for this study? What are the main findings?
Response: This study was the product both of work done in Dr. Burke’s lab as well as cumulative findings of other investigators demonstrating that improved self-efficacy is related to positive changes in health behaviors (e.g., physical activity, increased Intake of healthier foods, such as fruits and vegetables). Given that, we designed a behavioral weight loss study that included an intentional focus on enhancing participant self-efficacy for healthy behaviors related to weight loss maintenance. No previous study had self-efficacy enhancement as a focus of intervention with the long-term goal of increasing weight loss maintenance. Thus our study focused on mastery performance of weight loss related behaviors. Findings supported our hypothesis; participants in both arms of the study (standard behavioral weight loss (SBT) and SBT with self-efficacy enhancement (SBT+SE) achieved clinically significant weight loss. Participants in the SBT+SE group had greater weight loss maintenance while those in the SBT group had clinically significant weight regain.
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MedicalResearch.com Interview with:
Dr. Tamar Krishnamurti PhD
Department of Engineering & Public Policy
Carnegie Mellon University
Pittsburgh, PA 15213Medical 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).
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MedicalResearch.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.
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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.
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MedicalResearch.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.
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MedicalResearch.com Interview with:
Dr. Wilson Tang MD
Professor of Medicine
Cleveland Clinic Lerner College of Medicine
Case Western Reserve University
Director of the Center for Clinical Genomics
Cleveland Clinic
Medical Research: What is the background for this study? What are the main findings?
Dr. Tang: Renal impairment has long been associated with worse outcomes in acute heart failure. Administration of diuretic therapy often obscures accurate assessment of renal function by urine output. Despite extensive literature suggesting the poor outcomes in those with a rise in creatinine following treatment, recent data has suggested that in the presence of effective diuresis, this phenomenon likely represents hemoconcentration and azotemia rather than acute kidney injury. We observed that using a novel and sensitive biomarker that identified acute kidney injury, specific to tubular injury, we can identify those at higher risk of adverse outcomes in patents admitted for acute heart failure. However, after adjusting for standard risk factors, the prognostic value was clearly attenuated.
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