MedicalResearch.com: Medical Research Exclusive Interviews July 29 2015

MedicalResearch.comExclusive Interviews with Medical Research and

Health Care Researchers from Major and Specialty Medical Research Journals and Meetings

Editor: Marie Benz, MD [email protected]

July 29 2015

For Informational Purposes Only: Not for Specific Medical Advice.

mailto:[email protected]

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Over Quarter-Million Vietnam Vets Have Some Form of PTSDMedicalResearch.com Interview with:Charles R. Marmar, MDThe Lucius Littauer Professor and Chair, Department of Psychiatry, NYU Langone Medical Center and

Director of the Steven and Alexandra Cohen Veterans Center at NYU Langone

• MedicalResearch: What is the background for this study? What are the main findings?• Dr. Marmar: Approximately 2.7 million men and women served in Vietnam, and, for those

who returned, many have suffered for decades from a variety of psychological problems resulting from their experiences and other injuries such as traumatic brain injury (TBI).

• The 25-year National Vietnam Veterans Longitudinal Study (NVVLS) was a way we could determine at various points in time how veterans were faring emotionally four decades after their service. While the vast majority are resilient, there are still over 270,000 Vietnam veterans who still have some form of post-traumatic stress disorder (PTSD) and one-third of these veterans have depression.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

http://medicalresearch.com/author-interviews/over-quarter-million-vietnam-vets-have-some-form-of-ptsd/16062/


















http://medicalresearch.com/menopause/should-the-ovaries-be-removed-at-time-of-hysterectomy-for-benign-disease/1236/



• We followed up with veterans who participated in the National Vietnam Veterans Readjustment Study (NVVRS) from 1984 to 1988 who were evaluated for PTSD. The NVVRS group represented a probability sample of those who served in Vietnam. Of the 1,839 participants still alive, 1,409 participated in at least one phase of the NVVLS, which involved a health questionnaire, health interview and clinical interview.

• The results showed that between 4.5 percent and 11.2 percent of male Vietnam veterans and 6.1 and 8.7 percent of the female veterans are currently experiencing some level of PTSD.

• About 16 percent of veterans in the study reported an increase of more than 20 points on a PTSD symptom scale compared to 7.6 percent who reported a decrease of greater than 20 points.























• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Marmar: The primary take-home message is that the majority of men and women who

served in Vietnam are resilient across 40 years. However, equally important, the minority of individuals who are symptomatic 15 years ago or more are likely to have increases rather than decreases in the severity of the symptoms. That is why it is never too late to seek help and benefit from psychotherapy, medications, and, where indicated, marital and family therapy.

• PTSD can be debilitating, especially when there are other issues involved such as depression, substance abuse and now the social and health challenges that may accompany aging.

• Veterans should know that they are not alone and that there is no stigma attached to seeking help. As a society, we should strive to make mental health services more affordable and available to veterans and their families.























• MedicalResearch: What recommendations do you have for future research as a result of this study?

• Dr. Marmar: Tracking the effects of war-time trauma in Vietnam War veterans is enormously helpful for future studies.

• In fact, there is a novel five-year multicenter study well underway led by researchers at our Cohen Veterans Center that is looking into objective biological markers of post-traumatic stress and traumatic brain injury (TBI) in returning soldiers of the wars in Iraq and Afghanistan. The goal is to transform the way mental health disorders are diagnosed by identifying specific physiological markers that can tell clinicians definitively that a person is suffering from PTS, TBI, depression or a combination. Presently, there is no single valid diagnostic test that can independently confirm either diagnosis and we hope to change that. It is a multicenter effort. Emory University School of Medicine, Stanford University School of Medicine, Fort Detrick, and the Department of Defense are also involved in this research.

• Citation:• Marmar CR, Schlenger W, Henn-Haase C, et al. Course of Posttraumatic Stress Disorder 40 Yea

rs After the Vietnam War: Findings From the National Vietnam Veterans Longitudinal Study. JAMA Psychiatry. Published online July 22, 2015. doi:10.1001/jamapsychiatry.2015.0803.
















http://archpsyc.jamanetwork.com/article.aspx?articleid=2398184









Soybean Oil May Not Be As Healthy As Previously ThoughtMedicalResearch.com Interview with;Poonamjot Deol, Ph.D. Asst. Project Scientist,University of California, Riverside,Department of Cell Biology & NeuroscienceRiverside, CA

• MedicalResearch: What is the background for this study? What are the main findings?• Dr. Deol: The consumption of soybean oil in the United States has increased more than

1000% in the last four decades (Blasbalg et al, 2011) due to a number of factors, including results from studies in the 1960s that found a positive correlation between saturated fatty acids and the risk of cardiovascular disease. In the United States soybean oil now accounts for 60 percent of edible oil consumed; this increase in the consumption of soybean oil parallels the increase in obesity rates in the country. Furthermore, there has also been an increase in the global consumption of soybean oil with approximately 40 million tons of soybean oil being produced worldwide in 2007, which is about one half of all the edible vegetable oil and one-third of all fats and seed oils produced. During the same time period, fructose consumption in the U.S. has also increased significantly from about 37 grams per day in 1977 to about 49 grams per day in 2004. While there has been an extensive scrutiny of the role that fructose and saturated fats may play in the development of metabolic syndrome, there is a relative lack of studies investigating the role that soybean oil may play in causing obesity.


http://medicalresearch.com/author-interviews/soybean-oil-may-not-be-as-healthy-as-previously-thought/16085/














http://medicalresearch.com/weight-research/genetically-modified-soybean-oil-plenish-only-slightly-healthier/12425/

http://medicalresearch.com/author-interviews/prevalence-of-us-adults-with-metabolic-syndrome-stabilizing-but-still-high/14196/







• We conducted this study to understand the role of saturated versus unsaturated fat, as well as fructose in the development of obesity and its associated co-morbidities diabetes, insulin resistance (IR) and nonalcoholic fatty liver disease (NAFLD). We found that mice fed a diet moderately high in fat from soybean oil (unsaturated fat) showed statistically significant increases in weight gain, adiposity, diabetes, IR and very severe NAFLD compared to mice on a diet consisting primarily of coconut oil (saturated fat). The high fructose diet did not cause as much obesity or diabetes as the high soybean oil diet but it did cause a very fatty liver and rectal prolapse (a symptom of inflammatory bowel disease).

• The main finding from this study is that in mice a diet high in soybean oil is more detrimental to metabolic health than a diet high in fructose or coconut oil.
















http://medicalresearch.com/weight-research/genetically-modified-soybean-oil-plenish-only-slightly-healthier/12425/







• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Deol: Our results suggest that unsaturated fats particularly those from soybean oil may

not be as healthy as was previously thought. Even though others have shown beneficial cardiovascular effects of soybean oil, clinicians should consider the potential harmful metabolic effects of soybean oil, that our study has found, when suggesting dietary recommendations to patients.

• It should be noted, however, that this study was conducted in mice and we don’t have any human data as of yet. That being said, the amount of fat and fructose used in the study is similar to what an average American consumes.























• Dr. Deol: These findings should be validated in humans and the obesogenic components of soybean oil should be identified.

• Citation:• Soybean Oil Is More Obesogenic and Diabetogenic than Coconut Oil and Fructose in Mouse: P

otential Role for the Liver.• Poonamjot Deol, Jane R. Evans, Joseph Dhahbi, Karthikeyani Chellappa, Diana S. Han, Stephen

Spindler, Frances M. Sladek • PLOS ONE Published: July 22, 2015DOI: 10.1371/journal.pone.0132672
















http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0132672











Effects of Intermittent Fasting Promising But Poorly StudiedMedicalResearch.com Interview with:Benjamin D. Horne, PhD, MPH, FAHA, FACCDirector, Cardiovascular and Genetic Epidemiology, Intermountain Heart Institute

Adjunct Assistant Professor, Genetic Epidemiology Division, Department of Medicine,University of Utah

Medical Research: What is the background for this study? What are the main findings?

Dr. Horne: A rapidly expanding set of results from animal studies exists regarding the effects of intermittent fasting among animals. Many pilot studies of intermittent fasting have been performed now, too, but the body of literature regarding the human response to fasting is incomplete. This study sought to determine how preliminary and incomplete the evidence is in humans regarding the health benefits and the harmful side-effects of intermittent fasting. The purpose was to determine how reliable the evidence is that people should be engaging in fasting to improve their health. In particular, one major concern is that diet gurus and even some scientists are marketing intermittent fasting to the public through diet books and other methods that produce additional income for them, but it is unclear whether their claims can be supported.


http://medicalresearch.com/weight-research/effects-of-intermittent-fasting-promising-but-poorly-studied/16077/










http://medicalresearch.com/weight-research/intermittent_fasting_effects_on_hunger_and_weight_gain/5227/








The main findings of the study are that only three controlled clinical trials of intermittent fasting in humans have been published that were designed rigorously and included a control group in addition to the fasting intervention arm of the study. One of the three had a pre-specified primary outcome (weight loss) and another used the Bonferroni correction to account for inflated false positive results due to multiple hypothesis tests (the third study unfortunately did neither, which is the common approach in human studies of intermittent fasting). These three controlled trials only used surrogate or intermediate endpoints, though, such as weight, cholesterol, or other risk factors for disease. The three trials also have substantial limitations, including small sample sizes (~30 people total), a fasting regimen that was studied for less than three months, and no evaluation of clinical safety outcomes. Only one of the three trials was registered on ClinicalTrials.gov, a site instituted as part of the FDA Modernization Act and a pre-requisite for trials that are published in scientifically sound medical journals and are to be reviewed by the FDA.



















Two observational studies of the association of intermittent fasting with clinical events (i.e., coronary artery disease diagnosis and diabetes diagnosis) also have been published. These two studies included 200 patients and 445 patients. They were performed in patients drawn from a general population in which a large proportion of people engage in fasting intermittently over a period of decades. These observational studies provide the only evidence that fasting is associated with a lower risk of disease outcomes. Such studies are limited, though, by adjustment for only known or measured confounders, making it possible that some important factors may be unobserved in the studies that would account for the fasting benefit that was observed. No randomized controlled clinical trial of fasting for clinical events or disease outcomes has been performed, though, thus these five studies are the whole body of reliable evidence that intermittent fasting is beneficial to humans.












http://medicalresearch.com/diabetes/periodic_fasting_may_lower_risk_of_diabetes_and_heart_disease/5966/








• Medical Research: What should clinicians and patients take away from your report?• Dr. Horne: Clinicians and the public should understand from the results of this study that

intermittent fasting is a promising but poorly studied behavior. Fasting may provide some health benefit, but it does not have the rigorous and extensive data at this time that are needed to be able to recommend fasting as a health intervention. Substantial additional data are needed from many additional well-designed, rigorously controlled, clinically-relevant trials of intermittent fasting prior to utilizing it to improve health in a way that avoids unexpected and unwanted harmful side-effects.



















The recent revision of dietary guidelines regarding consumption of fats and cholesterol that have been in place for more than 35 years highlights these concerns. The guidelines to avoid fats and cholesterol in the diet may have contributed substantially to the obesity epidemic we are fighting today wherein a rush to make a recommendation to the public many years ago about fats and cholesterol ultimately caused more harm than benefit to the health of members of the public. In place of using exciting animal research and a few poorly-designed human studies to change dietary practices, methodical and reasoned approaches to evaluating intermittent fasting are needed that are based on established scientific and clinical methodologies for developing reliable data from which high-quality guidelines and policies can be derived.












http://medicalresearch.com/heart-disease/saturated_fatty_acid_and_coronary_artery_disease/4184/








Further, in reference to the intermittent fasting fad diets that are being marketed today, it is unlikely that fasting twice per week or more is healthy for the average individual. While weight loss is a given if a substantial decrease in caloric intake occurs (consider the logical extreme of fasting 7 days per week: yes, you will lose weight, but at what cost?), such excessive amounts of fasting are not sustainable over the long-term. Once someone stops following such intense fasting regimens, the weight will be gained again without some compensatory change in behavior such as changing the type of food that is consumed or increasing the amount of physical activity. Further, the weight that is gained back is likely to be unhealthy tissue, not lean muscle. Further, the stress that fasting excessively places on the body may also damage tissues and organs, making them more susceptible to disease or directly causing harm to their function. Care should be taken by anyone considering the use of intermittent fasting as a health intervention and consultation with a wise clinician is recommended prior to beginning an intense fasting regimen such as fasting twice per week or more.



















• Medical Research: What recommendations do you have for future research as a result of this study?

• Dr. Horne: Additional, well-controlled randomized clinical trials of intermittent fasting are needed. These studies should evaluate not weight loss but changes in blood pressure, cholesterol, blood sugar, cognitive function, and other outcomes. Separate studies should be performed for each of those outcomes, with one outcome per study pre-specified as the primary outcome on which the success of the study rests. Registering those studies on ClinicalTrials.gov prior to the start of the study, as required by reputable medical journals, will help ensure the validity and reliability of the study results. In those studies, secondary hypothesis tests that suggest that fasting influences other outcomes should either be tested prospectively in additional studies or should at least have their statistical significance corrected for multiple comparisons. These new studies should be non-pilot studies that enroll hundreds or thousands of individuals and they should also evaluate safety of fasting, not just its effectiveness. Little is known about the intermediate-term and long-term harms that fasting may cause.












http://medicalresearch.com/weight-research/intermittent_fasting_effects_on_hunger_and_weight_gain/5227/








• Furthermore, clinical events should be studied as the outcomes in intermittent fasting studies so that direct evaluation of the diseases that we intend to prevent can be performed. Clinical relevance is substantially limited without the study of clinical event outcomes.

• Once definitive data are established in humans that intermittent fasting does more than cause weight loss, including possibly reducing the risk of diabetes and coronary disease, additional research will be needed. Little is known about the optimal frequency or duration for each fasting episode or how long through one’s life it should be practiced. Recommendations for practicing fasting and for integrating it into clinical guidelines and policy should be held back until definitive efficacy and safety data are available.

• Citation:• Benjamin D Horne, Joseph B Muhlestein, and Jeffrey L Anderson• Health effects of intermittent fasting: hormesis or harm? A systematic review

Am J Clin Nutr ajcn109553; First published online July 1, 2015. doi:10.3945/ajcn.115.109553












http://ajcn.nutrition.org/content/early/2015/07/01/ajcn.115.109553.abstract








Chemotherapy At End Of Life May Bring More Harm Than GoodMedicalResearch.com Interview with: Holly G. Prigerson, Ph.D.Irving Sherwood Wright Professor in GeriatricsProfessor of Sociology in MedicineDirector, Center for Research on End of Life Care

Weill Cornell Medical College

• Medical Research: What is the background for this study? What are the main findings?

Dr. Prigerson: End-stage cancer patients are often offered “palliative chemotherapy” so we wanted to know if it, indeed, palliated their symptoms. ASCO guidelines recommend chemotherapy only be given to those with good performance status(e.g. ecog scores < 3).

• We found over half of these cancer patients (who died a median of 3.8 months from our baseline assessment), were receiving chemotherapy at our baseline assessment and that it did not improve quality of life in the last week of life for patients with poor baseline performance status and it significantly harmed quality of life in the patient’s final week for those with good performance status.


http://medicalresearch.com/cancer-_-oncology/chemotherapy/chemotherapy-at-end-of-life-may-bring-more-harm-than-good/16070/












http://medicalresearch.com/cancer-_-oncology/most-young-cancer-patients-receive-intensive-measures-at-end-of-life/15605/






Chemotherapy At End Of Life May Bring More Harm Than GoodMedicalResearch.com Interview with: Holly G. Prigerson, Ph.D.Irving Sherwood Wright Professor in GeriatricsProfessor of Sociology in MedicineDirector, Center for Research on End of Life Care

Weill Cornell Medical College

• Medical Research: What should clinicians and patients take away from your report?• Dr. Prigerson: For terminally ill cancer patients, regardless of performance status, more harm

than benefit to quality of life appears to result from use of chemotherapy. There is a need for open, honest discussion of the pros and cons of chemo for this group of patients.


• Dr. Prigerson: We need to examine the factors influencing receipt of palliative chemotherapy and the mechanisms through which it results in worse quality of death. We also need to examine cost effectiveness of such care.

• Citation:• Prigerson HG, Bao Y, Shah MA, et al. Chemotherapy Use, Performance Status, and Quality of L

ife at the End of Life. JAMA Oncol. Published online July 23, 2015. doi:10.1001/jamaoncol.2015.2378.














http://medicalresearch.com/cancer-_-oncology/hospice_care_for_advanced_cancer_decreased_aggressive_care_and_costs_in_last_year_of_life/8909/

http://medicalresearch.com/author-interviews/community-based-palliative-care-teams-reduce-unnecessary-acute-care-end-life/5826/

http://oncology.jamanetwork.com/article.aspx?articleid=2398177









DVT: Clot Removal Outcomes Better In Hospitals With Higher Volume of ProceduresMedicalResearch.com Interview with:Riyaz Bashir MD, FACC, RVT Professor of MedicineDirector, Vascular and Endovascular Medicine Department of Medicine

Division of Cardiovascular DiseasesTemple University Hospital

Medical Research: What is the background for this study?

Dr. Bashir: Catheter-based thrombus removal also known as Catheter Directed Thrombolysis (CDT) is a minimally invasive therapeutic intervention that has evolved over the past two decades to reduce the incidence of post thrombotic syndrome (PTS), a very frequent and disabling complication of proximal deep vein thrombosis (DVT). Catheter-based thrombus removal has been shown to reduce this lifestyle limiting complication of DVT and as a result we have observed a significant increase in the utilization rates of CDT across United States. Recent nationwide observational data suggests that higher adverse events such as intracranial hemorrhage rates and need for blood transfusions are seen with CDT use. Nonetheless specific reasons for these findings have not been explored prior to this study.


http://medicalresearch.com/author-interviews/dvt-clot-removal-outcomes-better-in-hospitals-with-higher-volume-of-procedures/16103/














http://medicalresearch.com/author-interviews/dvts_clot_busing_procedure_gaining_in_safety_and_utilization/6489/








• Medical Research: What are the main findings?• Dr. Bashir: This study showed a significant inverse relationship between the institutional

Catheter-based thrombus removal volumes and safety outcomes like death and intracranial hemorrhage. The institutions with higher volume of CDT cases annually (greater than or equal to 6 cases) were associated with lower in-hospital mortality rates and lower intracranial hemorrhage rates as compared to institutions, which performed less than 6 cases annually. This study also showed that at high volume institutions there was no difference in terms of death or intracranial bleeding rates between CDT plus anticoagulation versus anticoagulation alone.
















http://medicalresearch.com/author-interviews/oral-anticoagulation-medications-have-led-to-more-patients-treated-for-atrial-fibrillation/15994/








• Medical Research: What should clinicians and patients take away from your report?• Dr. Bashir: These findings highlight the importance of standardization of Catheter-based

thrombus removal practice and bring into focus the factors that may decrease adverse bleeding complications. Our observation that the major safety outcomes (death and intracranial hemorrhage) were not significantly different between patients undergoing CDT as compared to patients undergoing anticoagulation therapy alone at high volume centers suggests that these complications can be minimized. Patients with leg DVT – especially young patients – should feel comfortable considering clot removal, particularly at a high volume center, as a viable option to prevent post thrombotic syndrome.
















http://medicalresearch.com/heart-disease/unpredictable_anticoagulation_with_warfarin/9788/









• Dr. Bashir: As utilization of Catheter-based thrombus removal continues to increase we propose that institutions follow a standardized CDT protocols that include careful patient selection as well as patient monitoring. In addition, establishment of centers of excellence in treating venous thromboembolic disease may provide the necessary framework within which bleeding risk to the patient can be minimized. We also need to monitor these outcomes at institutional and regional levels on an ongoing basis for quality improvement purposes.

• Citation:• Impact of Institutional Volume on Outcomes of Catheter Directed Thrombolysis in the Treatm

ent of Acute Proximal Deep Vein Thrombosis: A 6-Year United States Experience (2005-2010)• Harish Jarrett, Chad J. Zack, Vikas Aggarwal, Vladimir Lakhter, Mohammad A. Alkhouli, Huaqin

g Zhao, Anthony Comerota, Alfred A. Bove, and Riyaz Bashir• Circulation. 2015;CIRCULATIONAHA.115.015555published online before print July 21 2015, doi

:10.1161/CIRCULATIONAHA.115.015555
















http://circ.ahajournals.org/citmgr?gca=circulationaha;CIRCULATIONAHA.115.015555v1











Socioeconomic Factors Affect High Health Care UtilizationMedicalResearch.com Interview with: Laura Rosella, PhD MHScAssistant Professor, Dalla Lana School of Public Health, University of TorontoScientist, Public Health Ontario

Adjunct Scientist, Institute for Clinical Evaluative SciencesToronto, Ontario


Response: High-cost users of health care generally refer to the top five per cent of health care users. They are a small portion of the population who consume a disproportionately high share of health care resources. We undertook a study to explore the social and economic determinants that were associated with future, high cost users. That is, the characteristics of these individuals before they proceed on a trajectory of high health care utilization. By understanding these associations we can better understand the role that socio-economic factors play in future health care utilizations and costs.


http://medicalresearch.com/author-interviews/socioeconomic-factors-affect-high-health-care-utilization/16079/




















• Medical Research: What should clinicians and patients take away from your report?• Response: In our study we demonstrated that individual, household and neighbourhood

socio-economic , such as income, education and food security, increase the likelihood of becoming a high-cost users in the future. This demonstrates that the issue of high-cost users is rooted not only in declining health status and suboptimal health care, but also in the growing inequities in Canadian society. Ultimately, looking at the broader factors that lead people to become high-cost users is crucial to improving population health, health system sustainability and equitable quality of care.















http://medicalresearch.com/tobacco-research/tobacco-taxes-reduce-health-expenses-and-increase-worker-productivity/15986/









• Response: In order to improve health outcomes and potentially mitigate high health care costs, factors must be addressed from within and outside the health care system. Inequities in socio-economic status and health are at the core of public health; using collaborative, intersectoral approaches and policies will allow us to address high-cost users of health care by aligning public health and health care goals.

• Citation:• Am J Prev Med. 2015 Aug;49(2):161-71. doi: 10.1016/j.amepre.2015.02.018. Epub 2015 May

8.• Looking Beyond Income and Education: Socioeconomic Status Gradients Among Future High-

Cost Users of Health Care.• Fitzpatrick T1, Rosella LC2, Calzavara A3, Petch J4, Pinto AD5, Manson H6, Goel V7, Wodchis WP8.•















http://medicalresearch.com/author-interviews/smoking-addiction-and-mental-health-issues-linked-to-frequent-emergency-department-visit/14474/

http://www.ncbi.nlm.nih.gov/pubmed/25960393


























More Women Reach 100 Than Men, But Men Who Do Are HealthierMedicalResearch.com Interview with:Nisha C. Hazra MScDepartment of Primary Care and Public Health Sciences,King’s College London, London, UK


Response: Our study was motivated by limited evidence about the health status of very old people, the fastest growing group of the UK population with significant implications for future NHS health-care costs. Our findings indicated an increasing number of people reaching the age of 100 years, with the increase being higher among women comparing to men (a ratio of 4 to 1). Another interesting finding was that men reaching 100 years tended to be healthier than their female counterparts. In particular, women were more likely to present multiple chronic diseases compared to men and tended to be more frail, experiencing more falls, fractures, incontinence and hearing/visual impairments.


http://medicalresearch.com/author-interviews/agingmore-women-reach-100-than-men-but-men-who-do-are-healthier/16081/
















• Medical Research: What should clinicians and patients take away from your report?• Response: Our study showed that centenarians present with a complex mix of

chronic conditions and functional disabilities that require possibly different treatment approaches than with younger patients. Therefore utilization of health care services and associated health care costs may increase substantially. More research around the health of the oldest old is needed to better understand these implications and to better manage old age quality of life and care. There was evidence that not all centenarians are disabled or unhealthy and we should invest more into research that aims to identify modifiable factors that can be targeted to promote healthy lifespan in very old people. Other centenarians lived with chronic conditions and disability, and it is important that the healthcare system focuses on the quality of life of these people rather than clinical outcomes.












http://medicalresearch.com/author-interviews/life_expectancy_limited_by_multiple_chronic_health_conditions/6610/








• Response: There is a need to identify preventative measures against old age illness and impairment, and to accurately project future health care costs associated with the aging of the UK population. We also must identify why some individuals reach the age of 100 without major health problems and why others do not. Lastly, we will need to understand why more women are living to extreme old ages and also to understand why, once reaching the age of 100, men tend to be healthier.

• Citation:• Differences in Health at Age 100 According to Sex: Population-Based Cohort Study of Centena

rians Using Electronic Health Records• Nisha C. Hazra MSc1,*,Alex Dregan PhD1,2,Stephen Jackson MD3 and Martin C. Gulliford MA1,2

• J Am Geriatr Soc 63:1331–1338, 2015.












http://onlinelibrary.wiley.com/doi/10.1111/jgs.13484/abstract


























Dietary Patterns May Play A Role In Risk Of Hodgkin LymphomaMedicalResearch.com Interview with:Mara Meyer Epstein, ScDAssistant ProfessorMeyers Primary Care InstituteUniversity of Massachusetts Medical School

• MedicalResearch: What is the background for this study? What are the main findings?• Dr. Epstein: Hodgkin lymphoma is a relatively rare cancer, with about 9,000 new cases

diagnosed in the US each year. Hodgkin lymphoma is most commonly diagnosed in earlier (aged 15-34 years) or later adulthood (aged ≥50 years). The causes of the disease are not well understood, and most identified risk factors are not modifiable (for example, age, sex, family history, and infection with Epstein-Barr virus [EBV]). Previous studies have suggested that chronic inflammation may play a role in the development of Hodgkin lymphoma. Therefore, it is possible that a factor that can influence inflammation, such as diet, may be associated with risk of Hodgkin lymphoma. Discovering modifiable risk factors for Hodgkin lymphoma could offer a means for preventing this disease. The few existing studies of diet and Hodgkin lymphoma risk have focused on individual nutrients or foods; this is the first study to examine dietary pattern and risk of Hodgkin lymphoma. By examining dietary patterns instead of individual foods, we sought to assess Hodgkin lymphoma risk from the food combinations that may more closely reflect typical dietary habits.


http://medicalresearch.com/author-interviews/dietary-patterns-may-play-a-role-in-risk-of-hodgkin-lymphoma/16073/














The current study includes 435 cases of Hodgkin lymphoma and 563 controls with no history of cancer from Massachusetts and Connecticut who were enrolled in the study between 1997 and 2000. Cases and controls provided information about their average intake of 61 food and beverage items over the year prior to the study. By evaluating foods commonly consumed by the study participants, we identified four major dietary patterns; high vegetable intake, high meat intake, high intake of fruit and low-fat dairy, and high intake of desserts and sweets. We looked for associations between each dietary pattern and risk of Hodgkin lymphoma overall, and also separately by age group (<50 years or ≥50 years old), tumor EBV status (positive or negative), and by tumor cell pattern (nodular sclerosis or mixed cellularity). The dietary pattern characterized by high intake of desserts and sweets was associated with a statistically significant increased risk of Hodgkin lymphoma among younger adults, and in particular, a 2-fold increased risk among younger adults with EBV-negative tumors. The dietary pattern featuring high meat intake was associated with a 3-fold increased risk of Hodgkin lymphoma among older adults, and again, we saw a stronger association among older adults with EBV-negative tumors, although the number of such cases in this group was small. We did not observe a clear association between the high vegetable dietary pattern, or the dietary pattern high in fruit and low-fat dairy intake, with Hodgkin lymphoma risk, and we also did not find any clear associations with EBV-positive tumors, which were relatively infrequent in the study population. The findings described above were obtained from statistical calculations that also took into account known Hodgkin lymphoma risk factors, other lifestyle factors, total caloric intake, and body mass index.










http://medicalresearch.com/infections/diverse-herpes-viruses-share-ability-to-suppress-immune-response/11070/







• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Epstein: Since this is the first study to examine dietary patterns and risk of Hodgkin

lymphoma, additional research is needed to replicate these results in other study populations. However, our study suggests that in addition to other known benefits, following a healthy dietary pattern, and in particular one with limited consumption of meat and sweets, may also help to reduce risk of Hodgkin lymphoma.










http://medicalresearch.com/cancer-_-oncology/2-genetic-variations-predict-second-cancers-after-radiation-for-children-with-hodgkin-lymphoma/33/








• Dr. Epstein: Additional research is warranted to identify modifiable risk factors for Hodgkin lymphoma, to characterize the underlying biological mechanisms by which the disease develops, and to develop primary and secondary prevention strategies that can diminish both shorter- and longer-term consequences of a Hodgkin lymphoma diagnosis. Additional studies of dietary patterns would be informative in more ethnically diverse and larger populations, and would support a more detailed look at variability in the dietary associations with Hodgkin lymphoma risk among disease subtypes. Also, our results should be replicated in prospective studies, which are designed to assess dietary intake before cancer development and follow study participants over time to better examine the influence of long-term diet and its timing on risk of Hodgkin lymphoma. We also encourage future research in Hodgkin lymphoma to examine associations separately in younger and older adults.

• Citation:• Mara M. Epstein, Ellen T. Chang, Yawei Zhang, Teresa T. Fung, Julie L. Batista, Richard F. Ambin

der, Tongzhang Zheng, Nancy E. Mueller, and Brenda M. Birmann• Dietary Pattern and Risk of Hodgkin Lymphoma in a Population-Based Case-Control Study• Am. J. Epidemiol. first published online July 15, 2015 doi:10.1093/aje/kwv072










http://medicalresearch.com/author-interviews/vegetarian-dietary-patterns-and-mortality/854/

http://aje.oxfordjournals.org/content/early/2015/07/15/aje.kwv072.abstract










TNF Gene May Link Rheumatoid Arthritis and Heart DiseaseMedicalResearch.com Interview with:Philippe Bouillet, PhDWalter and Eliza Hall InstituteParkville, Vic Australia


Dr. Bouillet: This study was initiated when we discovered mice that developed rheumatoid arthritis as a result of what was obviously a spontaneous dominant genetic mutation. Using several approaches, we identified the mutation as the insertion of a mobile genetic element called retrotransposon into the regulatory sequences of the gene encoding tumor necrosis factor (TNF). The mutation caused excessive amounts of TNF to be produced, a known cause of rheumatoid arthritis. The surprise came when some mice with the mutation died prematurely and suddenly with from heart disease. We showed that excess TNF also led to inflammation of the aortic and mitral valves, causing aortic regurgitation. Depending on the genetic background of the mice, the disease could also culminate in aortic aneurysm and death.We also investigated the regulatory region of the TNF gene and identified novel regulators and a new genetic element that normally make sure that levels of serum TNF are kept within reasonable limits, high enough to ensure its numerous physiological functions, low enough to prevent its harmful effects such as those described here.


http://medicalresearch.com/genetic-research/tnf-gene-may-link-rheumatoid-arthritis-and-heart-disease/16083/









http://medicalresearch.com/author-interviews/blood-test-may-distinguish-osteoarthritis-from-rheumatoid-arthritis/12933/







• Medical Research: What should clinicians and patients take away from your report?• Dr. Bouillet: This is the first report that valvular disease may be caused by excessive TNF

levels and it should be of interest to cardiologists. Anti-TNF biologics have been very successful in the treatment of rheumatoid arthritis and ankylosing spondylitis, and they may prove to be useful for heart valve disease as well.











http://medicalresearch.com/infections/biologics_increase_incidence_not_mortality_from_opportunistic_infections/4535/








• Dr. Bouillet: While anti-TNF therapies are successful in controlling some inflammatory diseases, their cost, the need of repetitive injections and the development of resistance in some patients show that other treatment options are required. We are investigating further the role of the new regulators, as we believe that they may lead to alternative ways of controlling levels of TNF in patients.

• Citation:• Derek Lacey, Peter Hickey, Benedicta D. Arhatari, Lorraine A. O’reilly, Leona Rohrbeck, Helen

Kiriazis, Xiao-Jun Du, and Philippe Bouillet. Spontaneous retrotransposon insertion into TNF 3 UTR causes heart valve disease and chronic polyarthritis′ . PNAS, July 2015 DOI: 10.1073/pnas.1508399112











http://medicalresearch.com/author-interviews/rheumatoid-arthritis-remission-sustainable-tapering-biologics/8791/

http://dx.doi.org/10.1073/pnas.1508399112






High Dose CT Imaging Has Potential To Damage DNAMedicalResearch.com Interview with:Patricia Kim Phuong Nguyen MD andJoseph C. Wu, MD, PhDStanford Cardiovascular InstituteStanford University School of Medicine, Stanford, California

• Medical Research: What is the background for this study? What are the main findings?• Response: The application of CT imaging has greatly increased in the last two decades, raising

concern over the effects of low dose radiation exposure from medical imaging.• In this study, we recruited 67 patients who underwent CT imaging for various cardiovascular

indications including:• 1) Pre atrial fibrillation ablation

2) Pre Trans-catheter valve replacement3) Aortic dissection, and4) coronary artery disease.

• A wide range of doses were sampled. We detected damage to DNA and a small percentage of death of T lymphocytes isolated from patients who were exposed to greater than 7.5 mSv of radiation.

• No damage was detected in patients exposed to very low doses (less than or equal 7.5 mSv).This study did not look at the relationship between radiation and cancer.


http://medicalresearch.com/radiology/high-dose-ct-imaging-has-potential-to-damage-dna/16129/














High Dose CT Imaging Has Potential To Damage DNAMedicalResearch.com Interview with:Patricia Kim Phuong Nguyen MD andJoseph C. Wu, MD, PhDStanford Cardiovascular InstituteStanford University School of Medicine, Stanford, California

• Medical Research: What should clinicians and patients take away from your report?• Response: Clinicians and patients should be aware that radiation producing tests at doses

greater than 7.5 mSV can lead to cell damage. The lowest possible doseshould be used in all patients for any CT imaging.


• Response: We can test the effect of cumulative radiation because our study only showed the effects of a single dose of radiation. We can also develop further dose reducing strategies given that we are unable to use current strategies for patients who have irregular rhythms or who are obese.

• Citation:• Assessment of the Radiation Effects of Cardiac CT Angiography Using Protein and Genetic Bio

markers• Patricia K. Nguyen, MD , †, ‡, , ∗ ,Won Hee Lee, PhD , ‡∗ ,Yong Fuga Li, PhD§,Wan Xing Hong, BS , ‡∗

,Shijun Hu, PhD , ‡∗ ,Charles Chan, PhD‖,Grace Liang, BS∗,Ivy Nguyen, BS∗,Sang-Ging Ong, PhD, ‡∗ ,Jared Churko, PhD , ‡∗ ,Jia Wang, PhD¶,Russ B. Altman, PhD§,Dominik Fleischmann, MD , #∗

,Joseph C. Wu, MD, PhD , ‡∗ #JACC: Cardiovascular Imaging Available online 22 July 2015











http://medicalresearch.com/radiology/coronary-ct-angiography-can-detect-soft-coronary-plaque-in-asymptomatic-patients/14658/

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Some Adverse Events Not Reported in Regulated Time Frame To FDAMedicalResearch.com Interview with: Dr. Pinar Karaca-Mandic Ph.DAssociate Professor, Health Policy & ManagementSchool of Public Health

Division of Health Policy & Management Minneapolis MNUniversity of Minnesota

Dr. Karaca-Mandic: Drug safety has received a lot of attention recently, and FDA’s post-marketing drug surveillance program (FAERS) offers and important opportunity to monitor drug safety and update drug warnings. There has been an increasing trend in reports to FAERS of serious adverse drug events and earlier studies suggested that these trends were primarily driven by increased manufacturer reports of serious and unexpected adverse events. While these studies highlighted the overall increase in adverse event rates, manufacturer timeliness in reporting and compliance with the 15 calendar day regulation for expedited reports was unknown, though some recent media coverage has offered anecdotal examples of delay. My co-authors and I were interested in studying not only the reporting of these events, by manufacturers to FDA, but also their timely reporting as required by the Federal regulation. Delays in reporting can have important public health consequences because the FDA uses this information to update drug warnings.


http://medicalresearch.com/medication-research/some-adverse-events-not-reported-in-regulated-time-frame-to-fda/16088/




















We found that about 10% of serious and unexpected adverse events that are subject to the 15-day regulation were not reported by 15 days. We also found that events that involved a patient death were more likely to be delayed. For example, we found that after adjusting for other characteristics of the report and the patient, about 12% of events that involved patient death, and 9% of those that did not involve patient death were delayed beyond 15 days.






















• Medical Research: What should clinicians and patients take away from your report?• Dr. Karaca-Mandic: FDA uses FAERS reports to effectively monitor drug safety and update

drug warnings. Therefore, timely reporting of adverse events is crucial from a patient safety perspective. While further enforcement is important for reducing delayed reporting from a policy perspective, a simple alternative would be for the patients, clinicians and other patient advocates to directly report the adverse events to FDA instead of through the manufacturer. Currently, very few reports (about 2% in 2013 example) are directly reported to the FDA.















http://medicalresearch.com/medication-research/evidence-of-value-of-orphan-drugs-inconsistent/15498/









• Dr. Karaca-Mandic: The federal regulation requires the manufacturers to report the serious and adverse events as soon as possible, but no later than 15 days after receiving the information, and then continue investigating and provide periodic follow up reports. It may be that delayed reporting occurs because manufacturers want to investigate and verify the adverse events, especially those that involve death before they report to FDA. Our study is silent with respect to the optimality of the federal regulation, but it is important to conduct further research to investigate reasons of delayed reporting and of reporting quality in general.

• Citation:• Ma P, Marinovic I, Karaca-Mandic P. Drug Manufacturers’ Delayed Disclosure of Serious and U

nexpected Adverse Events to the US Food and Drug Administration. JAMA Intern Med. Published online July 27, 2015. doi:10.1001/jamainternmed.2015.3565.

• Dr. Pinar Karaca-Mandic Ph.D (2015). Some Adverse Events Not Reported in Regulated Time Frame To FDA















http://medicalresearch.com/medication-research/fda-drug-approvals-variable-clinical-trial-evidence-record/3485/

http://archinte.jamanetwork.com/article.aspx?articleid=2398401









Neonatal Intensive Care Admissions Increased For All Birth Weight NewbornsMedicalResearch.com Interview with:Wade Harrison, MPHThe Dartmouth Institute for Health Policy & Clinical Practice

Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire


Dr. Harrison: This study used national birth certificate data to examine time trends in Neonatal Intensive Care Unit (NICU) admission rates for all U.S. newborns and the composition of the cohort of admitted newborns. Most of the existing studies of neonatal intensive care are limited in examining specific groups of newborns (e.g. those <1500 g, those with a specific complication, within limited geographies, etc.) or only looking at how care is delivered after a baby is admitted, leaving aside the question of whether to admit them in the first place. This is an important area to study because the newborn period is a critical time for babies and their families to establish good feeding practices and increase bonding among other important needs; also, neonatal intensive care is very expensive and like all medical interventions can carry certain risks. We found that NICU admission rates increased for all newborns across the birth weight spectrum. Additionally, although NICUs were initially developed to care for very small and premature newborns, just under half of current NICU admissions are for normal birth weight and full term infants, who are likely to be less ill.


http://medicalresearch.com/pediatrics/neonatal-intensive-care-admissions-increased-for-all-birth-weight-newborns/16066/







http://medicalresearch.com/pediatrics/quality_program_improved_outcomes_in_neonatal_icus/7038/








• Medical Research: What should clinicians and patients take away from your report?• Dr. Harrison: This study was descriptive and so it is unable to answer the question of why

these increased admissions are occurring (beyond showing that it is not due to increases in the number of premature births, twins, etc.) but we believe it raises questions about how we are using this intensive and costly resource. This includes questions about the potential for overuse. It is our hope that it stimulates further reflection and discussion among pediatricians and neonatologists about how to best match the level of care to our patients’ needs, and that health services researchers examine what factors from patient need and maternal health to healthcare system and physician practice patterns might explain these trends as well as the potential outcomes.

• For patients, I think it is always good that parents ask questions, understand, and are informed of the care their children receive, and that it is our responsibility as physicians to always educate and explain what we are doing and the reasons for our treatment decisions.

















• Dr. Harrison: As noted above, I hope there is further research into the causes of these trends – whether they are based on patient need, patient preferences, or physician and health system factors – and into the costs and outcomes of care whether beneficial or not. Some of this will need to be done using other data sources as well such as registries or claims data sets.

• Citation:• Harrison W, Goodman D. Epidemiologic Trends in Neonatal Intensive Care, 2007-2012.

JAMA Pediatr. Published online July 27, 2015. doi:10.1001/jamapediatrics.2015.1305. •









http://archpedi.jamanetwork.com/article.aspx?articleid=2381545








Immunosuppressed Melanoma Patients Have More Aggressive DiseaseMedicalResearch.com Interview with:Christina Y. Lee BA Department of DermatologyPedram Gerami, MDRobert H. Lurie Cancer CenterFeinberg School of Medicine

• Medical Research: What is the background for this study? What are the main findings?• Response: Melanoma is responsible for the majority of skin cancer-related mortality. While

AJCC staging of melanoma provides highly valuable information that helps predict the behavior of cutaneous melanoma, there are likely a number of other variables not included that may help predict which melanomas may result in metastasis. Some of these data points are not be easily assessed or available in large databases. In this study, we sought to assess a broad range of specific clinical factors directly obtained from clinic notes that may help predict melanoma behavior. The study consisted of a large cohort of patients with clinical follow up from our melanoma center at Northwestern University. Some examples of evaluated characteristics include a documented history of tanning bed use, blistering sunburns, or outdoor activity. In our study, patients who were older or immunosuppressed at the time of diagnosis were associated with aggressive tumor behavior in multivariate statistical analysis, when controlled for traditional AJCC factors such as tumor depth, ulceration, and mitotic figures.


http://medicalresearch.com/author-interviews/immunosuppressed-melanoma-patients-have-more-aggressive-disease/16152/




















• Medical Research: What should clinicians and patients take away from your report?• Response: Our study suggests that older and immunosuppressed patients who are diagnosed

with melanoma are at particularly high risk for aggressive disease independent of other traditional prognostic parameters in the AJCC. Immunosuppression in our study included organ transplant recipients, HIV positivity, and iatrogenic immunosuppression. This subset of patients may greatly benefit from close clinical surveillance to detect early signs of metastasis.
















http://medicalresearch.com/cancer-_-oncology/organ_transplantation_what_is_the_risk_of_cancer_transmission/5116/








• Response: There has been extensive research performed on the incidence of melanoma in relation to immunosuppressed patients. Solid-organ transplant recipients and HIV positive patients are well-studied groups of immunocompromised patients, with an increase of melanoma incidence reported extensively. However, though increased incidence is heavily documented, debate still remains regarding the clinical course of melanoma in these populations, as fewer studies have addressed disease progression in immunosuppressed individuals. We believe larger studies are necessary to look at how specific forms of immunosupression impact the disease course of melanoma and to further validate our findings that immunosupression is an independent prognostic parameter.

• Citation:• Immunosuppression is an independent prognostic factor associated with aggressive tumor be

havior in cutaneous melanoma.• Donahue T1, Lee CY1, Sanghvi A1, Obregon R1, Sidiropoulos M1, Cooper C1, Merkel EA1

, Yélamos O1, Ferris L2, Gerami P3.• J Am Acad Dermatol. 2015 Jul 21. pii: S0190-9622(15)01858-7. doi: 10.1016/j.jaad.2015.06.05

2. [Epub ahead of print]
















http://medicalresearch.com/author-interviews/larger-study-finds-no-link-between-melanoma-and-viagra/15178/































Living Close To Fast Food Restaurants Not Linked To ObesityMedicalResearch.com Interview with:Junfeng Jiao, PhDAssistant Professor, The University of Texas at Austin School of ArchitectureDirector, Urban Information LabAustin, Texas

• Medical Research: What is the background for this study? • Dr. Jiao: The increase in obesity rates has been explained by dietary changes including the

consumption of high-energy, low-nutrient foods. Over the past thirty years, trends reveal increases of eating away from home. Public Health professionals have hypothesized that the heightened exposure to the ubiquitous fast food establishments may be an avenue through which health and diets are impacted.


http://medicalresearch.com/weight-research/living-close-to-fast-food-restaurants-not-linked-to-obesity/16159/















• Medical Research: What are the main findings?• Dr. Jiao: This study examined whether the reported health impacts of eating at a fast food or

quick service establishment on a frequent basis were associated with having such a restaurant near home. Results indicated that eating at a fast food or quick service restaurant two times or more per week was related with perceived poor health status, overweight, and obese. Simply living close to such establishments was not related to negative health outcomes such as being overweight or obese, having cardiovascular disease (CVD) or diabetes.

















• Medical Research: What should clinicians and patients take away from your report?• Dr. Jiao: The findings of this study provide insight into factors affecting higher body mass

index and perceived poor health status. The distance from home to the closest fast food or quick service establishment was not associated with being overweight or obese. However, populations with lower levels of mobility may be more influenced by the environment near their home. Disadvantaged groups also appeared to be more likely to live in neighborhoods with concentrations of unhealthy food sources. In accord with numerous other studies, demographic and socioeconomic characteristics were strong predictors of the health outcomes investigated in this study. These results and findings may be useful in organizing community health strategies targeting obesity and associated health risks.











http://medicalresearch.com/pediatrics/commercialism-school-food-beverages/3369/








• Dr. Jiao: Future research should investigate the complete spatial extent of food consumption habits including the home- and work-based environments, amongst others. As this study was based on a sample of King County’s adult population, additional investigation into populations living in areas that have different distributions of health outcomes may yield different results. The Urban Information Lab at the University of Texas at Austin will continue to explore the health impact of eating at fast food and quick service restaurants considering variations in people’s physical activity status.

• Citation:• Health Implications of Adults’ Eating at and Living near Fast Food or Quick Service Restaurant

s• J Jiao1, A V Moudon2, S Y Kim3, P M Hurvitz2 and A DrewnowskiNutrition & Diabetes

(2015) 5, e171; doi:10.1038/nutd.2015.18Published online 20 July 2015











http://medicalresearch.com/author-interviews/fast_food_marketing_targets_middle_income_black_and_rural_kids/8867/

http://www.nature.com/nutd/journal/v5/n7/full/nutd201518a.html



















Minorities Have Largest Gains In Health Care Access with ACAMedicalResearch.com Interview with:Benjamin D. Sommers, MD, PhDAssistant Professor of Health Policy & Economics

Harvard T. H. Chan School of Public Health / Brigham & Women’s HospitalBoston, MA 02115


Response: The Affordable Care Act (ACA) expanded insurance options for millions of adults, via an expansion of Medicaid and the new health insurance Marketplaces, which had their first open enrollment period beginning in October 2013. We used a large national survey to assess the changes in health insurance, access to care, and self-reported health since these expansions began. What we found is that the beginning of the ACA’s open enrollment period in 2013 was associated with significant improvements in the trends of insurance coverage, access to primary care and medications, affordability of care, and self-reported health. Among low-income adults in Medicaid expansion states, the ACA was associated with improvements in coverage and access to care, compared to non-expansion states. Gains in coverage and access to medicines were largest among racial and ethnic minorities.


http://medicalresearch.com/author-interviews/minorities-have-largest-gains-in-health-care-access-with-aca/16068/

















• Medical Research: What should clinicians and patients take away from your report?• Response: National trends in coverage, access to care, and self-reported health are improving

under the ACA. This is new evidence suggesting that the ACA coverage expansions are working as intended. There is still more work to be done, as barriers to access remain for some Americans. But as the ACA continues to enroll more people in coverage, we expect to see these positive trends continue.












http://medicalresearch.com/author-interviews/womens-out-of-pocket-expenses-for-contraceptives-drop-after-aca/15735/









• Response: It’s still fairly early on in the law’s implementation – we’ve only completed the first two open enrollment periods, and many states are still debating whether to take up the option to expand Medicaid under the ACA. Following trends in coverage, access, and self-reported health over time and looking at other types of data – including medical claims and health outcomes – will be very important ways to increase our understanding of the law’s effect on the U.S. health care system.

• Citation:• Sommers BD, Gunja MZ, Finegold K, Musco T. Changes in Self-reported Insurance Coverage, A

ccess to Care, and Health Under the Affordable Care Act. JAMA. 2015;314(4):366-374. doi:10.1001/jama.2015.8421.

•












http://medicalresearch.com/author-interviews/aca-medicaid-expansion-will-require-more-primary-care-providers-especially-in-low-income-areas/15003/

http://jama.jamanetwork.com/article.aspx?articleid=2411283









Bilateral Adrenal Incidentalomas May Have Different Etiology Than UnilateralMedicalResearch.com Interview with:Quan-Yang Duh MDEndocrine surgeonUCSF Medical Center

• Medical Research: What is the background for this study? What are the main findings?

Dr. Quan-Yang Duh: At UCSF we have a monthly Adrenal Conference (involving surgeons, endocrinologists and radiologists) to discuss patients we are consulted for adrenal tumors. About 30% of these are for incidentally discovered adrenal tumors (versus those found because of specific indications such as clinical suspicion or genetic screening). Of these 15-20% has bilateral adrenal tumors.

• The evaluation of unilateral incidentaloma has been very well studied and many national guidelines have been published with specific management recommendations. So during our monthly adrenal conference, we have a routine “script” for evaluation and recommendations (rule out metastasis by looking for primary cancer elsewhere, rule out pheochromocytoma and Cushing, resect secreting tumors or large tumors, and if no operation recommended repeat scan in 6 months, etc.). This “script” has worked very well for patients with unilateral incidentaloma.


http://medicalresearch.com/radiology/bilateral-adrenal-incidentalomas-may-have-different-etiology-than-unilateral/16098/
















• However, we were less certain when we made recommendations about bilateral incidentalomas because there was very little literature or guidelines written about it. We had some gut feelings, but we were not sure that we were recommending the right things. We needed more data. That was the main reason for the study.

• What we found in our study was that although the possible subclinical diseases were the same – hypercortisolism and pheochromocytoma, the probabilities were different. The patients with bilateral incidentalomas were more likely to have subclinical Cushing’s and less likely to have pheochromocytomas than those with unilateral incidentalomas.


















• Medical Research: What should clinicians and patients take away from your report?• Dr. Quan-Yang Duh: The work up for bilateral adrenal incidentalomas is similar to that for

unilateral incidentalomas. However, patients with bilateral incidentalomas are more likely to have subclinical Cushing’s and less likely to have pheochromocytoma. This difference should be kept in mind when clinicians evaluating these patients.



















• Dr. Quan-Yang Duh: Because our study used data that were from patients who were referred to us to be discussed at our Adrenal Conference, there is likely to be a selection bias (probably higher proportion with clinically significant diseases). It would be interesting to prospectively study ALL patients with adrenal from a radiology department and see whether our results are confirmed.

• Citation:• Pasternak JD, Seib CD, Seiser N, et al. Differences Between Bilateral Adrenal Incidentalomas a

nd Unilateral Lesions. JAMA Surg. Published online July 22, 2015. doi:10.1001/jamasurg.2015.1683.












http://archsurg.jamanetwork.com/article.aspx?articleid=2398416









Community-Acquired Pneumonia Requiring Hospitalization Remains Significant Burden Especially For ElderlyMedicalResearch.com Interview with:Seema Jain, MDMedical Epidemiologist

Epidemiology and Prevention Branch, Influenza DivisionCenters for Disease Control and Prevention Atlanta, GA 30329

• Medical Research: What is the background for this study? What are the main findings?• Dr. Jain: Community-acquired pneumonia is a leading infectious cause of hospitalization and

death among U.S. adults. The last population-based study of community-acquired pneumonia was conducted in the 1990s before the pneumococcal conjugate vaccine and improved diagnostics (molecular detection and urine antigen tests) were available. Thus, this was an opportune time to examine this question again. The CDC Etiology of Pneumonia in the Community (EPIC) study attempts to fill in gaps in knowledge about pneumonia in adults, including older adults, by providing estimates of the incidence of community-acquired pneumonia hospitalizations in U.S. adults, as well as its viral and bacterial causes.

• The main findings were that the burden of community-acquired pneumonia requiring hospitalization in adults was substantial, with the greatest burden found in adults 80 years of age and older. Human rhinovirus (HRV), influenza and Streptococcus pneumoniae were the most commonly detected pathogens. However, no pathogen was detected in the majority of adults hospitalized with community-acquired pneumonia.


http://medicalresearch.com/author-interviews/community-acquired-pneumonia-requiring-hospitalization-remains-significant-burden-especially-for-elderly/16117/











http://medicalresearch.com/infections/pneumococcal-vaccines-prove-highly-effetive-in-preventing-severe-illness/11309/








• Medical Research: What should clinicians and patients take away from your report?• Dr. Jain: • Increasing coverage of recommended influenza and pneumococcal vaccines and developing

effective vaccines and treatments for human metapneumovirus (HMPV), respiratory syncytial virus (RSV) and parainfluenza viruses (PIV) could reduce the pneumonia burden among adults.

• It’s crucial for adults, especially older adults and adults with certain medical conditions, to receive recommended influenza and pneumococcal vaccines to prevent pneumonia.

• A yearly flu vaccine is recommended for everyone age 6 months and older.• Pneumococcal vaccines are recommended for all adults age 65 and older and for adults

younger than 65 years who have certain medical conditions or who smoke cigarettes.• In the majority (62%) of patients, no pathogen was detected, highlighting the need for

development of new, more sensitive rapid diagnostic tests and methods to accurately identify pneumonia pathogens and target appropriate treatment.













http://medicalresearch.com/infections/respiratory-syncytial-virus-rsv-infections-linked-to-respiratory-failure-in-adults/14720/









• Dr. Jain: We need future research to help the development of better diagnostic tests for determining microbiological causes of pneumonia, including tests that can distinguish between bacteria, viruses, and other pathogens. In addition, for the respiratory pathogens we do know contribute to pneumonia but for which we do not have any prevention methods, such as HMPV and RSV, we need to develop prevention methods that could reduce the burden of disease, this includes vaccines. We also need to determine factors associated with use of vaccines that we have at hand- both for influenza and pneumococcus- to increase uptake in the adult population.

• Citation:• Community-Acquired Pneumonia Requiring Hospitalization among U.S. Adults• Seema Jain, M.D., Wesley H. Self, M.D., M.P.H., Richard G. Wunderink, M.D., Sherene Fakhran

, M.D., M.P.H., Robert Balk, M.D., Anna M. Bramley, M.P.H., Carrie Reed, Ph.D., Carlos G. Grijalva, M.D., M.P.H., Evan J. Anderson, M.D., D. Mark Courtney, M.D., James D. Chappell, M.D., Ph.D., Chao Qi, Ph.D., Eric M. Hart, M.D., Frank Carroll, M.D., Christopher Trabue, M.D., Helen K. Donnelly, R.N., B.S.N., Derek J. Williams, M.D., M.P.H., Yuwei Zhu, M.D., Sandra R. Arnold, M.D., Krow Ampofo, M.D., Grant W. Waterer, M.B., B.S., Ph.D., Min Levine, Ph.D., Stephen Lindstrom, Ph.D., Jonas M. Winchell, Ph.D., Jacqueline M. Katz, Ph.D., Dean Erdman, Dr.P.H., Eileen Schneider, M.D., M.P.H., Lauri A. Hicks, D.O., Jonathan A. McCullers, M.D., Andrew T. Pavia, M.D., Kathryn M. Edwards, M.D., and Lyn Finelli, Dr.P.H. for the CDC EPIC Study Team

• July 14, 2015DOI: 10.1056/NEJMoa1500245Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.












http://medicalresearch.com/pediatrics/respiratory-viral-infections-leading-to-pneumonia/12044/

http://www.nejm.org/doi/full/10.1056/NEJMoa1500245
















Overnight Sleep Loss Can Have Long Term Metabolic ConsequencesMedicalResearch.com Interview with:Jonathan Cedernaes M.D., Ph.D.Department of NeuroscienceUppsala University Sweden


Dr. Cedernaes: Previous studies have demonstrated that experimental sleep loss and simulated shift work (i.e. misalignment of circadian rhythms) reduces energy expenditure and insulin sensitivity, providing links to why sleep loss may increase the risk of e.g. type-2 diabetes and obesity. Such phenotypes have also been observed in animals in which clock genes are ablated. Clock genes regulate the circadian rhythms of all cells and variants in these have also been associated with increased risk of obesity, insulin resistance and type-2 diabetes in humans. Almost no study has however investigated whether overnight wakefulness – mimicking a situation which recurrently occurs in shift work – can affect the expression of such clock genes in metabolically important tissues, i.e. adipose tissue and skeletal muscle, in humans. Such gene expression changes may both acutely and more long-term be regulated by changes in methylation, i.e. an epigenetic change, which have been found in blood of e.g. shift workers and in e.g. adipose tissue of type-2 diabetic subjects. However, whether sleep loss can lead to epigenetic changes has been unknown, and therefore also whether this could affect genes important for metabolism, such as the core clock genes which are essential for orchestrating and synchronizing downstream metabolic processes according to our circadian rhythms.


http://medicalresearch.com/sleep-disorders/overnight-sleep-loss-can-have-long-term-metabolic-consequences/16121/









http://medicalresearch.com/genetic-research/epigenetics-not-just-genes-control-many-complex-traits/12610/







• With this background in mind, I and associate professor Christian Benedict set out to conduct a study to investigate how one night of sleep loss altered gene transcription and methylation of core clock genes in adipose tissue and skeletal muscle, and whether this would be reflected at the systemic level by an impaired glucose tolerance test in healthy young individuals.

• For the study, we had 15 participants undergo two almost 2-day long sessions in our lab, with the first night of each session serving as a baseline or habituation night, with a normal sleep period. On the second night, in random order, participants slept a full night (8.5 hours) in one session, and were kept awake the entire night while being bed-restricted in the other of two sessions. After each of these conditions, we took biopsies in the fasting condition from the subcutaneous adipose tissue and the skeletal muscle.

















In collaboration with researchers from the Karolinska Institute, Gothenburg University and the German Institute of Human Nutrition, we were able to observe transcriptional repression of clock genes in the muscle, but not in the adipose tissue following sleep loss compared with normal sleep. Instead, we found methylation of regulatory elements of clock genes to be increased in the adipose tissue but not the skeletal muscle following sleep loss compared with normal sleep. Finally, we observed that participants had an impaired glucose tolerance test when they had been kept awake as compared with their response after sleep.

















• Medical Research: What should clinicians and patients take away from your report?• Dr. Cedernaes: Our study provides evidence for a potential new link as to why sleep loss may

impair metabolism in humans. Our findings support the notion that sleep loss can have a negative impact on tissues that are key for maintaining glucose homeostasis, by altering how the circadian clocks in these tissues function.

• Chronic “social jet-lag”, where one maintains different sleep-wake times on weekends compared with workdays, has been linked to an increased risk of obesity and type-2 diabetes. Given our results, even such more subtle sleep-wake differences may involve changes to expression and regulation of core clock genes in peripheral tissues, as deviations/perturbations of these from normal levels may promote insulin resistance in humans.

















As even one night of sleep loss can alter peripheral tissues’ clock gene expression and gene regulation, and since animal models show that clock gene disruptions are detrimental to metabolic integrity, it may not be surprising that repeated exposure to overnight wakefulness as in shift work can have serious metabolic consequences over time. If certain important epigenetic changes following sleep loss (for example around clock genes) are not reset as quickly as they arise (say after a full night of recovery sleep), this could provide an explanation for why shift work and prolonged periods of sleep loss could have more long-lasting consequences, which it may take some time to fully recover from. Importantly, our findings of elevated post-glucose tolerance test glucose levels after one night of sleep loss show that even the most recent sleep history of patients should be critically assessed when evaluating patients’ metabolic health status.











http://medicalresearch.com/addiction/alcohol/clock-genes-linked-to-alcohol-use-and-abuse/10804/








• Dr. Cedernaes: Even though we used a within-subject design, in which subjects serve as their own controls, our findings need to be replicated in larger samples, and also studied in women, older subjects and individuals already suffering from metabolic conditions (such as type-2 diabetes and obesity). It will also be important to examine how long-lasting epigenetic changes due to sleep loss may be.

• Citation:• J Clin Endocrinol Metab. 2015 Jul 13:JC20152284. [Epub ahead of print]• Acute sleep loss induces tissue-specific epigenetic and transcriptional alterations to circadian

clock genes in men.• Cedernaes J1, Osler ME2, Voisin S1, Broman JE1, Vogel H3,4, Dickson SL4, Zierath JR2, Schiöth HB1

, Benedict C1.






































Sexual Function Improved With Lidocaine Cream in Breast Cancer SurvivorsMedicalResearch.com Interview with:Martha F. Goetsch, MD, MPHOregon Health & Science UniversityPortland, OR 97239

• MedicalResearch: What is the background for this study?• Dr. Goetsch: Women who are survivors of breast cancer now number about 3 million in the

US. Therapy for breast cancer is anchored in creating a state of postmenopause in which estrogen is eliminated from the system. One of the most difficult symptoms of lack of estrogen is dyspareunia, the term for pain with intercourse. The old term “vulvovaginal atrophy” has been changed to “genitourinary syndrome of menopause” by agreement of two specialty societies. Because of my focus in the gynecologic specialty of vulvar pain, I have felt that this menopausal symptom is more than a condition of atrophy. Additionally, my clinical experience has led me to believe that the exquisite tenderness is located in the vulvar vestibule rather than in the vagina. The vestibule is the inner vulva or entryway before the vagina. This study was devised to answer these hypotheses.

• I predicted that the population most likely to represent the worst examples of postmenopausal dyspareunia was the population of women who cannot use estrogen due to being survivors of breast cancer. I treated the problem as a pain problem rather than solely a problem of dryness.


http://medicalresearch.com/cancer-_-oncology/breast-cancer/sexual-function-improved-with-lidocaine-cream-in-breast-cancer-survivors/16127/











http://medicalresearch.com/cancer-_-oncology/breast-cancer/endocrine-therapies-for-young-breast-cancer-patients-can-cause-abrupt-menopause-symptoms/15514/







• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Goetsch: First, our results point out that the levels of pain in women with

postmenopausal dyspareunia can be severe. Additionally, dramatic success in preventing pain was achieved without treating the severe atrophy, and the exquisite mucosal tenderness was localized in the vulvar vestibule. Pain could successfully be prevented by a liquid applied by the patient herself when she needed it. The adage “Use it or lose it” was proven wrong since women improved in all aspects of sexual function. These findings may be relevant to large numbers of women without a history of breast cancer who have postmenopausal dyspareunia despite use of vaginal estrogens because the location of treatment may need to be the vestibule rather than the vagina.













http://medicalresearch.com/cancer-_-oncology/breast-cancer/breast-cancer-tamoxifen-affect-cognitive-function-postmenopausal-women/6479/








• Dr. Goetsch: Larger studies need to confirm these results. Survivorship clinics need to explore whether women can be successfully taught this technique by those who may not be vulvar experts. Further studies need to include postmenopausal women who have not had breast cancer to ascertain how generalizable these findings may be. Research could answer whether topical estrogens should be applied to the vulvar vestibule for greatest success in ameliorating the problem of postmenopausal dyspareunia. And finally, research is needed to characterize this vestibular pain condition.

• Citation:• A Practical Solution for Dyspareunia in Breast Cancer Survivors: A Randomized Controlled Tria

lMartha F. Goetsch, Jeong Y. Lim, and Aaron B. CaugheyJCO JCO.2014.60.7366; published online on July 27, 2015;













http://jco.ascopubs.org/content/early/2015/07/24/JCO.2014.60.7366.abstract









ACE Inhibitors Not A Good First Choice For Hypertension in BlacksMedicalResearch.com Interview with:Sripal Bangalore, MD, MHA, FACC, FAHA, FSCAIDirector of Research, Cardiac Catheterization Laboratory,New York University Langone

School of Medicine,Principal Investigator ISCHEMIA-CKD trial

• Medical Research: What is the background for this study? What are the main findings?• Dr. Bangalore: Angiotensin converting enzyme inhibitors (ACEi) are a common class of

antihypertensive agents used for the management of hypertension. In many national and international hypertension guidelines, they are recommended as a first line agent. However, their efficacy and safety in hypertensive Blacks is not known.

• In an analysis of hypertensive blacks we found that ACEi were consistently inferior to that of calcium channel blockers or thiazide diuretics with a higher risk of cardiovascular events.


http://medicalresearch.com/author-interviews/ace-inhibitors-not-a-good-first-choice-for-hypertension-in-blacks/16196/












http://medicalresearch.com/author-interviews/kidney_disease/3935/








• Medical Research: What should clinicians and patients take away from your report?• Dr. Bangalore: Although ACEi are recommended as first line agents by national and

international guidelines, they likely are not a great choice for hypertensive blacks. In fact few of the guidelines recognize this and recommend calcium channel blockers or diuretics for hypertensive blacks–consistent with the results seen in our study.














http://medicalresearch.com/cancer-_-oncology/breast-cancer/no_link_between_calcium_channel_blockers_and_breast_cancer/7322/









• Dr. Bangalore: We need studies to figure out why ACEi do not work well in hypertensive blacks.

• Citation:• Am J Med. 2015 Jun 11. pii: S0002-9343(15)00445-3. doi: 10.1016/j.amjmed.2015.04.034. [Ep

ub ahead of print]• Outcomes with Angiotensin-Converting Enzyme Inhibitors vs Other Antihypertensive Agents i

n Hypertensive Blacks.• Bangalore S1, Ogedegbe G2, Gyamfi J3, Guo Y3, Roy J4, Goldfeld K3, Torgersen C3, Capponi L5

, Phillips C6, Shah NR7.












































Protein Link Between Brain/Heart Function and FertilityMedicalResearch.com Interview with:Carmen J. Williams, M.D., Ph.D. Principal InvestigatorNational Institute of Environmental Health

• Medical Research: What is the background for this study? • Dr. Williams: G-protein coupled receptors are used by almost all cells to receive signals from

the outside of the cell and transduce these signals into actions within the cell. There are hundreds of these receptors, but many of them link to a protein named Gq to transmit their signals to other cellular proteins. Gq is found in most cells, including eggs, and activating Gq protein is one way to artificially activate the egg to begin developing into an embryo, even though it is not the way sperm normally do this. In fact, if the egg is activated before the sperm arrives it prevents the sperm from binding and fusing with the egg, so fertilization cannot take place. As a result, we thought that a mechanism might be in place within eggs to prevent them from being activated prematurely by signals that could activate Gq by triggering G-protein coupled receptors. RGS2 was a good candidate for this function because it binds to Gq in a way that prevents Gq from transmitting signals to other cellular proteins.


http://medicalresearch.com/medical-research-centers/nih/protein-link-between-brainheart-function-and-fertility/16199/













• Medical Research: What are the main findings?• Dr. Williams: We found that RGS2 is highly expressed in immature mouse oocytes at the RNA

level. This RNA is not translated into protein, however, until immediately before ovulation when the immature oocytes mature into fertilizable eggs. To determine the function of RGS2 we used RNA interference to deplete the RGS2 protein from mature eggs. These RGS2-depleted eggs could be fertilized by sperm, which induced normal calcium signals in the eggs.. However, when we removed the outer coat of the egg with an acidic solution prior to fertilizing the eggs, we found that the eggs began releasing calcium and developing into early embryos in the absence of sperm. It turned out that the acid exposure, which can activate Gq signaling, was inducing the calcium responses in eggs that lack RGS2. We also found that the neurotransmitter acetylcholine, which activates Gq signaling, caused calcium release and premature development in RGS2-depleted eggs. From these studies we concluded that RGS2 prevents premature calcium release in eggs by inhibiting G-protein coupled receptor signaling via Gq.









http://medicalresearch.com/stem-cells/scientists-complete-first-steps-toward-making-sperm-and-eggs-from-skin-stem-cells/12077/







• • To determine if RGS2 functions in vivo, we obtained mice in which RGS2 had been genetically

knocked out. These mice produce significantly smaller litters than their wild type counterparts. Importantly, eggs retrieved from Rgs2 knockout mice underwent premature calcium release, which changes the extracellular coat surrounding the egg to be more difficult for sperm to penetrate. Our results demonstrate that in eggs, RGS2 acts to suppress calcium release prior to fertilization and in this way keeps the egg fertilizable by sperm for a longer period of time after ovulation.















• Medical Research: What should clinicians and patients take away from your report?• Dr. Williams: The most important take-home message is that proteins like RGS2 that are

involved in regulating how the brain and heart function can also be important in regulating fertility. As a result, therapies that are developed for treating diverse medical problems such as anxiety and hypertension can also affect reproductive health. This should be kept in mind when considering the risks and benefits of specific medical treatments, particularly in reproductive age women.
















• Dr. Williams: We would like to determine if there are additional Gq-linked receptors expressed in the egg that might be stimulated to cause premature calcium release. Doing so would help identify drugs or other compounds that might interfere with egg fertilizability. It would also be very useful to determine how oocytes suppress translation of very highly expressed RNAs until maturation, when the proteins are needed for specific functions in the mature egg. Finally, because premature egg activation is associated with infertility and development of ovarian teratomas, it might also be useful to determine if any of the known polymorphisms in the RGS2 gene in humans are associated with these medical conditions.

• Citation:• Development. 2015 Jul 9. pii: dev.121707. [Epub ahead of print]• Regulator of G-protein signaling 2 (RGS2) suppresses premature calcium release in mouse egg

s.• Bernhardt ML1, Lowther KM2, Padilla-Banks E1, McDonough CE1, Lee KN3, Evsikov AV4

, Uliasz TF2, Chidiac P3, Williams CJ5, Mehlmann LM









http://medicalresearch.com/author-interviews/decreasing-financial-burden-of-ivf-may-encourage-single-embryo-transfers-reduce-multiple-births/14000/




























Elevated Neurotensin Level May Predict Breast Cancer in WomenMedicalResearch.com Interview with:Karla M. Gonye, MBAPresident, sphingotec LLCCambridge, Massachusetts

• MedicalResearch: What is the background for this study?• Response:• In experimental studies, Neurotensin and neurotensin expression was highly

associated to breast cancer tissue – Dupouy et al (2009) investigated the expression of NTS and NTSR1 in normal human

breast tissue and in invasive ductal carcinomas (IDCs) and found that NTS is expressed in ductal and invasive components of IDCs. The high expression of NTSR1 is associated with the SBR grade 3 (p<0.05), larger tumor size (p<0.01), and the number of metastatic lymph nodes (p<0.05).

– It was concluded from this paper that NTS/NTSR1 is a contributor to breast cancer progression.

– Souaze et al (2006)also studied IDCs and found 34% of all tumors were positive for neurotensin and 91% positive for the NT1 receptor, suggesting the contribution of neurotensin’s involvement in the signaling cascade within breast cancer progression. In this study, it was found that disruption of neurotensin receptor signaling by silencing RNA or using a specific NT1 antagonist in nude mice xenografted with an aggressive cell line SR48692, caused the reversion of transforming functions that lead to tumor growth.

– These findings support the contribution of neurotensin to breast cancer progression.




Wu, Z. et al (2013) reviewed the contribution of the neurotensinergic system to cancer progression, as well as the regulation and mechanisms of the system in order to highlight its potential as a therapeutic target, and its prospect for its use as a treatment in certain cancers. This summarizes nicely the oncogenic effects of neurotensin after stimulation signaling proliferation, survival, migration, invasion and neoangeogeneis. Several other papers published demonstrate the effects of neurotensin in cancers including breast cancer. New studies such as Roselli et al (2015) further demonstrate the role of neurotensin in aggressive breast cancer. At sphingotec, it was hypothesized that disease progression begins earlier than symptoms are present and that elevated expression of neurotensin in the blood would be an indicator of future breast cancer; measurement of this hormone peptide was possible with the company’s expertise, and that test could be developed to precisely measure neurotensin. This method is published in Ernst et al (2006) in Peptides. To test the hypothesis, the first clinical study was conducted in a cohort of normal healthy population that was indentified from the Malmo Diet and Cancer study, a prospective epidemiological study of 28,449 men and women. Of this group, a subset of 4632 randomly selected subjects were identified and neurotensin was measured in all subjects. Subjects were adjusted for known breast cancer risk factors such as age, age of menarche, heredity of cancer (all), hormone status, etc. (see Table 3, Melander et al JAMA 2012) so that the factors did not influence outcomes. On a 10-15 follow up period, of these subjects, 123 breast cancer events were found to be associated with higher levels of neurotensin, with the highest quartile associated with the highest levels of neurotensin and the lowest quartile associated with the lowest levels of neurotensin. The association of elevated neurotensin was found to be statistically significant for prediction of breast cancer.




• MedicalResearch: What are the main findings?• Response:• Elevated neurotensin levels were associated with breast cancer.• Each SD increase of proneurotensin was associated with an HR of 1.44 (95% CI, 1.21-1.71) for

the risk of future breast cancer, and the top vs. bottom quartiles of proneurotensin were associated with an HR of 2.44 (95% CI, 1.44-4.15) for risk of breast cancer (Table 3).

• Elevated neurotensin was also associated with diabetes and cardiovascular disease, mediated through the NTSR3/SORT1 gene in individuals with a genetic variant; however the strongest overall association was with breast cancer

• The association was seen in women not men.




• The findings in the Malmo Diet and Cancer study were later validated in a separate and independent cohort known as the Malmo Prevention Project (MPP). This was another epidemiological cohort of 18,449 men and women in which a case control study was conducted to compare 130 subjects with breast cancer to a group of 1439 subjects without breast cancer. The subjects with breast cancer had significantly higher neurotensin levels. Results conclude that: Proneurotensin [odds ratio (OR) per standard deviation (SD) increment of LN-transformed proneurotensin] was significantly related to incident breast cancer [OR, 2.09; 95% confidence interval (CI), 1.79–2.44; P < 0.001; adjusted for age, body mass index (BMI), smoking, and hormone replacement therapy].

• The main difference between MDC and MPP was that the age group in MPP was about 10 years older than MDC and the follow up time was shorter.







• MedicalResearch: What should clinicians and patients take away from your report?Response:

• Neurotensin is an independent risk predictor of future breast cancer in women without a family history of the disease.

• When put in the context of other known risk factors that clinicians utilize today to counsel patients, such as age, smoking, age of menarche, menopausal status, a proneurotensin level is a much stronger and independent predictor of future breast cancer particularly in the group of women do not have a family history of breast cancer

• Understanding factors related to disease progression can allow a woman and her clinician to understand her risk and allow for interventions. Such interventions may be to control modifiable risk factors

• Given the annual incidence of breast cancer, clinicians should be eager and excited to learn what more they can do identify women at highest risk women for breast cancer and discuss treatment/interventions with their patients.





• Response:• Combination of pro-NT and pro-ENK – do they combined improve risk prediction? In process• How do these two biomarkers perform in women with family history (BRCA 1/2 mutation)

taken into account – does it add to risk prediction? In process• How do these two biomarkers perform in women on Hormone Replacement Therapy – can

patients be reclassified into different risk categories? In process• How do these two biomarkers perform in different ethnic groups – US, African American,

Hispanic, Asian American In process• What are interventional strategies that can be used to reduce pro-neurotensin levels and

increase pro-enkephalin levels as a way to reduce breast cancer risk? In process• How can these biomarkers be incorporated to improve other risk models such as GAIL, Tyrer-

Cuzick, BRCApro, others? Planning• Can pro-NT/pro-ENK be used to identify women at highest risk to guide HRT, more intensive

screening – Ultrasound, MRI, Tomosynthesis?• Can pro-ENT/pro-ENK be used to guide Tamoxifen use?




• Citation:• Cancer Epidemiol Biomarkers Prev. 2014 Aug;23(8):1672-6. doi: 10.1158/1055-9965.EPI-13-1

200. Epub 2014 Jun 12.• Validation of plasma proneurotensin as a novel biomarker for the prediction of incident breas

t cancer.• Melander O1, Belting M2, Manjer J3, Maisel AS4, Hedblad B5, Engström G6, Nilsson P5,Struck J7

, Hartmann O7, Bergmann A8, Orho-Melander M6.

• Karla M. Gonye, MBA (2015). Elevated Neurotensin Level May Predict Breast Cancer in Women MedicalResearch.com






























Patients With Health Insurance Receive Up To Triple Amount Of Preventive CareMedicalResearch.com Interview with:Jared Fox, PhDCDC Office of the Associate Director for Policy

• Dr. Fox: Increasing the number of people who get preventive care is important to keep people healthier, avoid complications from illnesses, reduce long-term health care costs, and prevent premature deaths. By one estimate, over 100,000 lives could be saved each year if more people got their recommended preventive care.

• By providing access to affordable insurance coverage and eliminating out-of-pocket costs for recommended preventive care in most health plans, the Affordable Care Act has reduced cost as a barrier to preventive care. This report could serve as a baseline for tracking the effects of some of the ACA’s preventive care provisions that might occur after 2012.

• The services in this study are recommended by the US Preventive Services Task Force and the Advisory Committee for Immunization Practices. The nine preventive services that were part of this study were: screenings for blood pressure, breast cancer, cervical cancer, cholesterol, colon cancer, and diabetes; healthy diet counseling; and vaccination for hepatitis A and B. The data is from the 2011 and 2012 National Health Interview Survey.

• In 2011 and 2012, people with health insurance received needed preventive care at up to three times the rate of those without insurance. People with higher household incomes also got more recommended preventive care than those with lower incomes.


http://medicalresearch.com/author-interviews/patients-with-health-insurance-receive-up-to-triple-amount-of-preventive-care/16218/







http://medicalresearch.com/author-interviews/health_insurance_regular_healthcare_visits_linked_to_hypertension_control/8388/







• Medical Research: What should clinicians and patients take away from your report?• Dr. Fox: Insurance coverage is a very important part of securing access to care. But it’s also

important for people to know what preventive care is recommended for them so that they can make an appointment to get that care. Similarly, it’s important for physicians to make sure their patients are up-to-date on their recommended preventive services. People can visit www.cdc.gov/prevention to learn more about the care that is recommended for them and their loved ones, along with important questions to ask their healthcare provider. The site includes an interactive tool that highlights the services recommended for a particular individual based on their age, sex, and risk factors. Clinicians can also use the tool to find the appropriate clinical guidance, contraindications, and billing codes for the services recommended for their patients.








http://www.cdc.gov/prevention








• Dr. Fox: This report could serve as a baseline for tracking the effects of some of the ACA’s preventive care provisions that might occur after 2012. In prior insurance expansion efforts, increases in preventive care were observed. For example, after the 2008 expansion of Medicaid in Oregon, people who were given access to Medicaid through a lottery were significantly more likely to have received certain preventive services as compared to those who were not selected for Medicaid coverage. It took several years after the coverage expansion in Oregon for researchers to be able to measure changes and publish their findings. Monitoring the effects of the ACA will be an ongoing process.

• Citation:• Receipt of Selected Clinical Preventive Services by Adults — United States, 2011–2012• MMWR Weekly• July 17, 2015 / 64(27);738-742• Jared B. Fox, PhD1; Frederic E. Shaw, MD, JD








http://medicalresearch.com/pediatrics/millions_us_children_do_not_receive_key_health_care_preventive_services/7823/

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6427a2.htm










Topical and Injected Placebos More Effective Than PillsMedicalResearch.com Interview with:Raveendhara R Bannuru MD, PhD, FAGEDirector, Center for Treatment Comparison and Integrative Analysis (CTCIA)Asst

Professor of Medicine, Tufts University School of MedicineSpecial & Scientific Staff, Center for Arthritis and Rheumatic DiseasesTufts Medical Center Boston, MA

• Medical Research: What is the background for this study? • Dr. Bannuru: Placebos are used to determine the efficacy of a wide variety of treatments for

medical conditions such as osteoarthritis. A sound understanding of potential differences among placebos is essential for determining the relative efficacy of such treatments.

• Medical Research: What are the main findings?• Dr. Bannuru: Our results indicate that different types of placebos do in fact differ in efficacy.

Placebo injections and topical placebos were both found to be more effective than orally administered placebos for reducing knee osteoarthritis pain.


http://medicalresearch.com/pain-research/topical-and-injected-placebos-more-effective-than-pills/16223/


















Topical and Injected Placebos More Effective Than PillsMedicalResearch.com Interview with:Raveendhara R Bannuru MD, PhD, FAGEDirector, Center for Treatment Comparison and Integrative Analysis (CTCIA)Asst

Professor of Medicine, Tufts University School of MedicineSpecial & Scientific Staff, Center for Arthritis and Rheumatic DiseasesTufts Medical Center Boston, MA

• Medical Research: What should clinicians and patients take away from your report?• Dr. Bannuru: Clinicians and patients should consider the method of administration when

choosing treatments for knee osteoarthritis pain, as intra-articular injections and topical creams are associated with placebo benefits in addition to their active treatment effects.


• Dr. Bannuru: Selection of appropriate placebo controls is an important consideration in the design of future clinical trials. Moreover, future research should rule out potential confounding study factors such as trial design or patient population differences as explanations for differences among placebo types. Such endeavors could thereby confirm the potential clinical benefits associated with treatment administration methods.

• Citation:• Bannuru RR, McAlindon TE, Sullivan MC, Wong JB, Kent DM, Schmid CH. Effectiveness and Im

plications of Alternative Placebo Treatments: A Systematic Review and Network Meta-Analysis of Osteoarthritis Trials. Ann Intern Med. [Epub ahead of print 28 July 2015] doi:10.7326/M15-0623















http://medicalresearch.com/pain-research/acetaminophen-may-not-be-effective-for-osteoarthritis-low-back-pain/13252/

http://medicalresearch.com/mental-health-research/placebo_responses_to_anti_psychotic_medications_increasing/8117/

http://annals.org/article.aspx?articleid=2398908









Single Use Sharps Recycling Many Reduce C. diff InfectionsMedicalResearch.com Interview with:Dr. Monika Pogorzelska-Maziarz PhD MPHThomas Jefferson University, Jefferson School of NursingPhiladelphia, PA 19107

• Medical Research: What is the background for this study? What are the main findings?•

Dr. Pogorzelska-Maziarz: Sharps disposal containers are ubiquitous in healthcare facilities and there is a growing trend toward hospitals using reusable sharps containers. Several research studies have raised concerns about the potential for sharps containers to become a source of pathogen transmission within the healthcare setting but this issue that has not been systematically studied. This is an important issue given that contamination of the hospital environment has been shown to be an important component of pathogen transmission.

• To examine whether the use of reusable versus single use sharps containers was associated with rates of Clostridium difficile, we conducted a cross-sectional study of acute care hospitals. Survey data on the different types of sharps containers used were collected from over 600 hospitals and this data was linked to the Medicare Provider Analysis and Review (MedPAR) dataset, which contains facility characteristics and C. diff infections data. We found that hospitals using single-use containers had significantly lower rates of C. diff versus hospitals using reusable containers after controlling for hospital characteristics such as geographic region, teaching status, ownership type, hospital size and urbanicity. This is an important finding giving the ubiquitous nature of sharps containers in the health care setting, the growing trend toward hospitals using reusable sharps containers and the high burden of C. diff in the hospital setting.


http://medicalresearch.com/infections/single-use-sharps-recycling-many-reduce-c-diff-infections/16227/







http://medicalresearch.com/infections/c-difficile/clostridrium_difficile_infections_in_us_hospitals_doubled_over_decade/7959/







• Medical Research: What should clinicians and patients take away from your report?• Dr. Pogorzelska-Maziarz: If C. diff is not properly eradicated from the patient’s environment,

it can pose a risk for transmission. This study is the first study to show a link between the use of single use sharps containers and lower C. diff rates and additional studies should be conducted to confirm this link due to the potential infection control implications raised.











http://medicalresearch.com/infections/c-difficile/c-diff-most-common-health-care-infection/12069/








• Dr. Pogorzelska-Maziarz: Since this is the first study to show this link, additional studies are needed to replicate this finding. Additionally, studies should be conducted in other settings such as long-term care facilities where the burden of C. diff is high and explore the relationship between the use of sharps containers and other types of pathogens for which environmental contamination is a known factor in transmission.

• Citation:• Relationship between sharps disposal containers and Clostridium difficile

infections in acute care hospitalsAmerican Journal of Infection Control

• Monika Pogorzelska-Maziarz, PhD, MPH• Jefferson College of Nursing, Thomas Jefferson University, Philadelphia, PA• Published Online: July 28, 2015











http://medicalresearch.com/infections/decline-c-difficile-may-due-decreased-antibiotic-exposure/2030/

http://www.ajicjournal.org/article/S0196-6553(15)00667-7/abstract












Socially Isolated Women Have Greater Risk of SuicideMedicalResearch.com Interview with:Alexander C. Tsai, MD, PhD Center for Global HealthMassachusetts General Hospital, BostonHarvard Center for Population and Development Studies Cambridge

, Massachusetts

• Medical Research: What is the background for this study? What are the main findings?• Dr. Tsai: Suicide is one of the leading causes of death among middle aged women, and the

rates have been climbing over the past decade. At the same time, we know that Americans are becoming more and more isolated. As one example, over the past two decades, there has been a tripling in the number of people who say they don’t have anyone to confide in about important matters. In our study, we tracked more than 70,000 American women over two decades and found that the most socially isolated women had a threefold increased risk of suicide.


http://medicalresearch.com/mental-health-research/socially-isolated-women-have-greater-risk-of-suicide/16156/


















, Massachusetts

• Medical Research: What should clinicians and patients take away from your report?• Dr. Tsai: There are many factors that may play a role in whether people take their own lives.

Mental illnesses like depression may be an important factor, but most of the women in our study actually did not have symptoms of depression. One takeaway for readers is that participating in a broad range of social relationships can be good for your health, regardless of whether you are struggling with symptoms of depression or other mental illnesses. There are many different kinds of relationships, ranging from family members and relatives, to friends you meet in neighborhood associations or religious groups. One takeaway for clinicians is to be aware that social isolation can be bad for your health. Understanding their patients’ social worlds can be incredibly useful in helping clinicians keep their patients healthy.














http://medicalresearch.com/diabetes/women-on-both-diabetes-and-depression-medications-have-increased-risk-of-myocardial-infarction/14792/







, Massachusetts


• Dr. Tsai: It is becoming increasingly clear that social relationships matter for health. We know much less about what kinds of interventions can be done for socially isolated people, whether it would involve helping them to strengthen existing social networks or even creating new ones.

• Citation:• Tsai AC, Lucas M, Kawachi I. Association Between Social Integration and Suicide Among Wom

en in the United States. JAMA Psychiatry. Published online July 29, 2015. doi:10.1001/jamapsychiatry.2015.1002.























Health & Medicine

MedicalResearch.com: Medical Research Exclusive Interviews July 29 2015