MedicalResearch.com: Medical Research Exclusive Interviews June 11 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]

June 11 2015

For Informational Purposes Only: Not for Specific Medical Advice.

mailto:[email protected]

Medical Disclaimer | Terms and Conditions

• The contents of the MedicalResearch.com Site, such as text, graphics, images, and other material contained on the MedicalResearch.com Site ("Content") are for informational purposes only. The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on the Hemodialysis.com Site!

• If you think you may have a medical emergency, call your doctor or 911 immediately. MedicalResearch.com does not recommend or endorse any specific tests, physicians, products, procedures, opinions, or other information that may be mentioned on the Site. Reliance on any information provided by MedicalResearch.com or other Eminent Domains Inc (EDI) websites, EDI employees, others appearing on the Site at the invitation of MedicalResearch.com or EDI, or other visitors to the Site is solely at your own risk.

• The Site may contain health- or medical-related materials that are sexually explicit. If you find these materials offensive, you may not want to use our Site. The Site and the Content are provided on an "as is" basis.

Read more interviews on MedicalResearch.com

Improved Hospital Discharge Process May Reduce Medication NonadherenceMedicalResearch.com Interview with:Robin Mathews, MDDuke Clinical Research InstituteDuke University Medical CenterDurham, NC

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

Dr. Mathews: Though treatment for patients with an acute myocardial infarction with evidence based therapies has increased significantly over the years, adherence to these therapies after discharge remain sub optimal. We used a validated instrument, the Morisky scale, to assess patient medication adherence. We found that in a contemporary population of 7,425 patients across 216 hospitals, about 30% of patients were not adherent to prescribed cardiovascular medications as early as 6 weeks after discharge. Patients with low adherence were more likely to report financial hardship as well as have signs of depression. In addition, we found that patients who had follow up arranged prior to discharge and those that received explanations from the provider on the specific medications, were more often adherent to therapies. There was a non significant increase in risk of death or readmission at 2 months (HR [95% CI]: 1.35 [0.98-1.87]) among low adherence patients.

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

http://medicalresearch.com/heart-disease/improved-hospital-discharge-process-may-reduce-medication-nonadherence/14685/












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


• Medical Research: What should clinicians and patients take away from your report?• Dr. Mathews: The reasons for medication non adherence are complex and multifactorial.

Though some factors such as race and age are non modifiable, others such as health literacy, patient perception of side effects, and out of pocket expenses, can be influenced. The transition of a patient from hospital to home is an opportunity to identify patients who may be at increased risk for non adherence. The discharge process should include an assessment of possible barriers to adherence after patients leave the hospital. Once these have been identified, a patient tailored strategy can be used to address these barriers. For instance, while cost may be the main issue for some patients, access to follow up care, or an insufficient understanding of the reasons for medications, may be the primary factor for others. This is an important opportunity for clinicians and providers to potentially improve adherence as well as perhaps impacting down stream outcomes such as readmissions and other adverse cardiovascular events.










http://medicalresearch.com/author-interviews/late-hospital-readmissions-linked-to-chronic-health-and-social-problems/14703/







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

this study?• Dr. Mathews: The discharge process of a patient after an acute myocardial infarction varies

between hospitals across the U.S. Therefore, the identification of specific hospital and provider level practices that positively impact short and long term medication adherence, is critical. Any effective intervention will need to be patient centered and tailored to the specific needs of the patient. Once identified, these should be disseminated as ‘best practices’ in order to provide some standardization to our discharge process.

• Citation:• Early Medication Nonadherence After Acute Myocardial Infarction: Insights into Actionable O

pportunities From the Treatment with ADP receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome Study

• Robin Mathews, Eric D. Peterson, Emily Honeycutt, Chee Tang Chin, Mark B. Effron, Marjorie Zettler, Gregg C. Fonarow, Timothy D. Henry, and Tracy Y. Wang

• Circ Cardiovasc Qual Outcomes 2015; first published on June 2 2015 as doi:10.1161/CIRCOUTCOMES.114.001223










http://medicalresearch.com/heart-disease/chest_pain_in_the_emergeny_room/5109/

http://circoutcomes.ahajournals.org/content/early/2015/06/02/CIRCOUTCOMES.114.001223.abstract














Metformin Linked To Reduced Risk of GlaucomaMedicalResearch.com Interview with:Julia E. Richards, Ph.D.Harold F. Falls Professor of Ophthalmology and Visual Sciences Professor of EpidemiologyDirector, Glaucoma Research Center

The University of Michigan

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

Response: We have a special interest in how the developmental processes of aging increase the risk of late onset diseases. We wondered whether drugs that target known aging pathways might be able to reduce risk of late onset disease. In the aging field, an emerging area of interest has been the category of drugs called caloric restriction mimetic (CRM) drugs, which have been found to extend life span and to reduce risk or delay onset of some late-onset diseases. These caloric restriction mimetic drugs target a set of pathways that have come to be seen as playing roles in longevity. One of these caloric restriction mimetic drugs, metformin, happens to also be one of the most common drugs used in the treatment of type 2 diabetes.

• Glaucoma is a leading cause of blindness worldwide and classical open-angle glaucoma shows onset in late middle age or late age, so we hypothesized that a caloric restriction mimetic drug might be able to reduce the risk of open-angle glaucoma. We used data from a large health services database to compare the rate at which open-angle glaucoma developed in individuals with diabetes mellitus who used metformin versus those who did not use metformin. We predicted that metformin would be associated with reduced risk of open-angle glaucoma.


http://medicalresearch.com/diabetes/metformin-linked-to-reduced-risk-of-glaucoma/14614/










http://medicalresearch.com/cancer-_-oncology/metformin_may_be_protective_against_cancer/8419/








• Medical Research: What are the main findings?

Response: We found that use of metformin was associated with reduced risk of open-angle glaucoma. A 2 gram per day dose of the CRM drug metformin for two years was associated with a 20.8% reduction in risk of developing open-angle glaucoma. When we looked at the highest quartile of drug prescribed (>1,100 grams over a two year period) we found a 25% reduction in risk relative to those taking no metformin. This risk reduction is seen even when we account for glycemic control in the form of glycated hemoglobin, and use of other diabetes drugs was not associated with reduced risk of open-angle glaucoma. A possible explanation for our findings might be that the mechanism of risk reduction is taking place by CRM drug mechanisms that target aging pathways rather than through glycemic control of diabetes.

• In the long run, the approaches to late onset diseases in general will become much more powerful if we can use parallel approaches that simultaneously target both the aging processes going on and the disease-specific pathways going on. In the literature we see caloric restriction mimetic drugs metformin, rapamycin and resveratrol all being explored for their ability to target points in aging pathways in ways that can impact the risk of a variety of late-onset diseases, so it will be important for those interested in the risk factors affecting late onset diseases to pay attention to how caloric restriction mimetic drugs might be altering risk for those late onset diseases.












http://medicalresearch.com/author-interviews/resveratrol-in-food-may-help-maintain-memory-and-mood-function-in-old-age/11478/








• Medical Research: What should clinicians and patients take away from your report?• Response: Our study shows that use of metformin is associated with reduced risk of open-

angle glaucoma and that keeping really good control of blood glucose levels is associated with reduced risk of open-angle glaucoma. But before recommending changes to clinical practice, it would be helpful to perform prospective studies (like a Randomized Clinical trial) to confirm the findings of the present study. This is important because metformin is not without side effects and we would want to be sure that any beneficial effects of using metformin (or higher strengths of metformin) for glaucoma outweigh side effects of this medication. We also need to understand whether metformin protects against glaucoma among persons without diabetes and whether there are subsets of patients who respond better or worse to metformin.

• One of the implications of this study is not a new idea with this study, but one that lots of people may not have heard, which is the idea that this general category of drugs, the caloric restriction mimetic drugs, may have the potential to reduce the risk of other late onset diseases, too. If you go look in the literature you will see that rapamycin, resveratrol, and metformin are all associated with reduced risk of a variety of later onset diseases, and there are lots of other late onset diseases that have not been looked at yet.












http://medicalresearch.com/diabetes/diabetes_metformin_effectiveness_in_african_americans/5854/









this study?• Response: Because this is not a clinical trial, and because this study was limited to a very

specific population of persons with diabetes who do not yet have glaucoma, there are limitations to the conclusions we can draw concerning clinical care. Because this study involved a health services database, it lacked some types of key information we would normally want to track in a glaucoma study such as information on visual fields or cup to disc ratio that might allow us to investigate progression among those who already have glaucoma, so additional studies are needed to understand what effects metformin has on individuals who already have open-angle glaucoma and to understand how metformin impacts specific glaucoma risk factors such as intraocular pressure. This study points towards the need for the next stage of studies to find out whether these findings could apply to persons who do not have diabetes, and to find out whether metformin might be able to affect progression of glaucoma in those who already have the disease.

• Citation:• Lin H, Stein JD, Nan B, et al. Association of Geroprotective Effects of Metformin and Risk of Op

en-Angle Glaucoma in Persons With Diabetes Mellitus. JAMA Ophthalmol. Published online May 28, 2015. doi:10.1001/jamaophthalmol.2015.1440.












http://medicalresearch.com/ophthalmology/decreased-medicare-payment-did-not-mean-increased-volume-for-most-glaucoma-procedures/13647/

http://archopht.jamanetwork.com/article.aspx?articleid=2296909








Large Regional Differences in Cardiovascular Disease BurdenMedicalResearch.com Interview with:Prachi Bhatnagar, MPH, DPhilResearcher University of Oxford

British Heart Foundation Centre on Population Approaches for Non-Communicable Disease PreventionNuffield Department of Population HealthOxford

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

Response: We know that cardiovascular disease presents a large burden to the UK. We aimed to bring together all the main data on cardiovascular disease mortality, morbidity, treatment and economic costs. We found that there are regional inequalities in cardiovascular disease mortality and prevalence in the UK.

• Medical Research: What should clinicians and patients take away from your report?• Response: Although there have been large declines in cardiovascular disease mortality, it still

remains a significant burden to the UK, both in terms of health and economic costs.


http://medicalresearch.com/heart-disease/large-regional-differences-in-cardiovascular-disease-burden/14718/












http://medicalresearch.com/heart-disease/cardiovascular-disease-declining-mortality-increasing-costs-disability/2208/

http://medicalresearch.com/heart-disease/young-and-female-low-socioeconomic-african-americans-at-increased-risk-of-cardiovascular-disease/14522/






Large Regional Differences in Cardiovascular Disease BurdenMedicalResearch.com Interview with:Prachi Bhatnagar, MPH, DPhilResearcher University of Oxford

British Heart Foundation Centre on Population Approaches for Non-Communicable Disease PreventionNuffield Department of Population HealthOxford


this study?• Response: While there is excellent mortality data available, we need more readily available

incidence data for cardiovascular conditions such as myocardial infarction. We also need to understand how to address the regional inequalities described in this paper.

• Citation: • P. Bhatnagar, K. Wickramasinghe, J. Williams, M. Rayner, N. Townsend. The epidemiology of

cardiovascular disease in the UK 2014. Heart, 2015; DOI: 10.1136/heartjnl-2015-307516














http://dx.doi.org/10.1136/heartjnl-2015-307516






Custom Oral Appliance Reduced Sleep Apnea and Restless LegsMedicalResearch.com Interview with:Marie Marklund, DDS senior lecturerDepartment of Odontology, Faculty of MedicineUmeå UniversitySweden

• MedicalResearch: What is the background for this study? What are the main findings?• Response: Snoring and obstructive sleep apnea are common in the population and these

disorders continuously increase because of the ongoing obesity epidemic in many countries. Today, 34% of men and 17% of women in the US suffer from obstructive sleep apnea of all severities. Symptoms include daytime sleepiness, poor sleep quality, headache, insomnia and restless legs. In the longer term, a more severe sleep apnea is associated with serious consequences, such as hypertension, stroke, cancer, traffic accidents and early death.

• Continuous positive airway pressure is a highly effective treatment for sleep apnea patients. Adherence problems, for instance from nasal stuffiness and claustrophobia reduces its effectiveness. An oral appliance holds the lower jaw forwards during sleep in order to reduce snoring and sleep apneas. This therapy has primarily been suggested for snorers and patients with mild and moderate sleep apnea. No previous placebo-controlled study has, however, evaluated this specific group of patients. Results from more severe sleep apnea patients have shown a good effect on sleep apneas. The effect of oral appliances on daytime symptoms is unclear. Symptomatic improvement is an important outcome for milder sleep apnea patients.


http://medicalresearch.com/author-interviews/custom-oral-appliance-reduced-sleep-apnea-and-restless-legs/14612/











http://medicalresearch.com/stroke/sleep-apnea-increases-stroke-risk-in-atrial-fibrillation-patients/11231/







The primary aims of the present study were to study the effects on daytime sleepiness and quality of life of a custom-made, adjustable oral appliance in patients with daytime sleepiness and snoring or mild to moderate sleep apnea, i.e. the primary target group for this type of therapy. Secondary aims included the effects on sleep apnea, snoring and various other symptoms of sleep disordered breathing such as headaches and restless legs. We found that oral appliance therapy was effective in reducing sleep apneas, snoring and symptoms of restless legs. The apnea-hypopnea index was normal (<5) in 49% of patients using the active appliance and in 11% using placebo, with a numbers needed to treat of three. Daytime sleepiness and quality of life did not differ during active treatment and the placebo intervention. The patients experienced reduced headaches with active treatment, but the results did not differ from placebo. It was concluded, that a custom-made, adjustable oral appliance reduces obstructive sleep apneas, snoring and possibly restless legs. The efficacy on daytime sleepiness and quality of life was weak and did not differ from placebo in this group of patients.



















• MedicalResearch: What should clinicians and patients take away from your report?• Response: An oral appliance is highly effective in reducing obstructive sleep apneas and

snoring. The treatment might also produce other benefits for the patients, such as reduced symptoms of restless legs. It is likely, that subgroups of patients who have specific sleep related symptoms such as headaches will benefit from this treatment, although this was not proven in the present study design.













http://medicalresearch.com/sleep-disorders/obstructive-sleep-apnea/snoring_during_twenties_predictive_of_sleep_apnea_in_forties_/8634/







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

this study?• Response: More research of effects of oral appliances in subgroups of patients with more

identified causes to daytime sleepiness or in patients with specific symptoms, such as headaches, insomnia or restless legs. This approach is facilitated by the ongoing research aiming at phenotyping sleep apnea patients in order to find more specific indications for the various treatment options.

• Citation:• Marklund M, Carlberg B, Forsgren L, Olsson T, Stenlund H, Franklin KA. Oral Appliance Therap

y in Patients With Daytime Sleepiness and Snoring or Mild to Moderate Sleep Apnea: A Randomized Clinical Trial. JAMA Intern Med. Published online June 01, 2015. doi:10.1001/jamainternmed.2015.2051.













http://medicalresearch.com/mental-health-research/depression/cpap_may_improve_depression_in_patients_with_sleep_apnea/9285/

http://archinte.jamanetwork.com/article.aspx?articleid=2296119










Electronic Health Records Allow Agencies To Improve Surveillance and Patient CareMedicalResearch.com Interview with:Dawn Heisey-Grove, MPHCDC

Medical Research:? What are the main findings?

Response: This first published use of Medicare EHR Incentive Program data for national population surveillance reported on an eCQM that is aligned with Million Hearts®, a national initiative launched by the U.S. Department of Health and Human Services to prevent 1 million heart attacks and strokes by 2017. The eCQM tracks the proportion of patients with hypertension who had controlled blood pressure during the reporting period. During the first three years of the EHR Incentive Program (2011-2013), approximately 3 in 10 participating health care professionals reported on this eCQM, making it the 5th most commonly selected measure overall. This represented 63,000 ambulatory care professionals and approximately 17 million patients. On average, 62 percent of patients with hypertension had controlled blood pressure. Read more here.


http://medicalresearch.com/author-interviews/electronic-health-records-allow-agencies-to-improve-surveillance-and-patient-care/14687/








http://millionhearts.hhs.gov/

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6416a3.htm?s_cid=mm6416a3_e







• Medical Research: What should clinicians and patients take away from your report?• Response: Electronic health record systems provide an opportunity to improve patient care

and more easily monitor population health. Using data stored in EHRs, clinicians may be better equipped to generate reports that track the health of high risk patients. In addition, public health could expand its surveillance capabilities, potentially at lower costs and in a more timely fashion, by taking advantage of existing systems such as eCQM reporting. Further alignment of eCQMs across federal and private sector programs will enable clinicians to collect data once and report to selected programs.

















this study?• Response: Future research endeavors should begin to maximize the potential data captured

through eCQM reporting. State and local public health agencies can partner with state, regional, or local health information exchanges; the state primary care associations; the state Medicaid programs; and health systems to explore the use of existing EHR data for surveillance while still ensuring appropriate safeguards to maintain patient privacy. As EHR implementation becomes more widespread, the data collected by these systems will be invaluable for monitoring numerous clinical conditions.

• Citation:• Using Electronic Clinical Quality Measure Reporting for Public Health Surveillance• Weekly• May 1, 2015 / 64(16);439-442










http://medicalresearch.com/stroke/electronic-medical-records-did-not-improve-stroke-outcomes-or-quality-of-care/13993/

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6416a3.htm








HRD Score Can Help Predict Response To Some Chemotherapeutic AgentsMedicalResearch.com Interview with:Dr. Kirsten Timms, PhDProgram DirectorVP Biomarker Discovery at Myriad Genetics Inc

• Medical Research: What is the background for this study? What are the main findings?• Dr. Timms: The Homologous Recombination Deficiency (HRD) score is a tumor biomarker

which quantitates genomic rearrangements associated with defects in DNA damage repair. It has been shown in multiple studies that HRD score can identify tumors sensitive to DNA damaging agents such as platinum salts or PARP inhibitors. Many tumors are spatially heterogeneous: different parts of a tumor show variation at both the genomic level, and in their appearance. This tumor heterogeneity has the potential to negatively impact the accuracy of biomarker tests. This study assessed the consistency of the HRD score in multiple biopsies obtained from the same cancer to understand the impact of tumor heterogeneity on the HRD score. The main finding of this study is that the HRD score is highly conserved between different biopsies of the same tumor.


http://medicalresearch.com/cancer-_-oncology/hrd-score-can-help-predict-response-to-some-chemotherapeutic-agents/14610/










http://medicalresearch.com/cancer-_-oncology/myriad-presents-data-on-expanded-cancer-genetics-and-chemotherapy-susceptibility-testing/14641/







• Medical Research: What should clinicians and patients take away from your report?• Dr. Timms: This study demonstrates that the HRD score is a robust biomarker even in the

presence of tumor heterogeneity. What it means is that any part of a tumor can be used to determine if the tumor is going to respond to treatment with DNA damaging agents. We think that the robustness of the HRD score is because the HRD score measures an intrinsic property of a tumor conserved in every cancer cell.












http://medicalresearch.com/cancer-_-oncology/breast-cancer/assay-may-determine-which-triple-negative-breast-cancers-respond-to-platinum-chemotherapy/13598/








this study?• Dr. Timms: One important question is how cancer treatments affect the HRD score. Will the

HRD score remain the same after a tumor is treated with chemotherapy or radiation? Another important question is how the HRD score compares between the primary tumor and metastatic lesions. This is a very important question because often it is hard to obtain a sample form metastasis while a sample form the primary lesion is available. If the HRD score were conserved in metastatic lesions, there would be no need in obtaining samples from them; a sample from the primary tumor would suffice.












http://medicalresearch.com/cancer-_-oncology/molecule-may-help-ovarian-cancer-patients-overcome-chemotherapy-resistance/14424/






The Infectious Diseases Society of America Comments on the 21st Century Cures Bill Including Antibiotic DevelopmentMedicalResearch.com Interview with:Ms. Amanda JezekDirector of Government RelationsInfectious Diseases Society Of America

• Editor’s Note: The Infectious Diseases Society of America Comments on the

21st Century Cures bill, a bill desigend “to help modernize and personalize health care, encourage greater innovation, support research” including important issues surrounding antimicrobial resistance and antibiotic development.

• Ms. Amanda Jezek has been Director of Government Relations at Infectious Diseases Society of America (ISDA) since July 2011. Ms. Jezek is “is responsible for policy development and advocacy on IDSA priority issues including antimicrobial resistance, antimicrobial and diagnositcs development, preparedness and federal funding’.


http://medicalresearch.com/infections/the-infectious-diseases-society-of-america-comments-on-the-21st-century-cures-bill-including-antibiotic-development/14763/








http://energycommerce.house.gov/cures







• MedicalResearch: What are the main objectives of the 21st Century Cures bill? • Ms. Jezek: This question goes far beyond IDSA’s work on the bill, so I would not be

comfortable being quoted on this. The Energy and Commerce Committee’s website has more information. Very generally, the bill seeks to advance the research and development of new cures for patients with a wide variety of diseases and conditions.

• MedicalResearch: What health care needs and problems does it address? • Ms. Jezek: I can only answer from IDSA’s perspective, keeping in mind that many sections of

this bill go well beyond the field of ID. IDSA is very pleased that the bill prioritizes the research and development of some of the most urgently needed new antibiotics to treat serious or life threatening infections with few or no current treatment options. IDSA is also very pleased that the bill takes important steps to increase funding for NIH, which is urgently needed to ensure adequate investment in biomedical research and support for young people entering or thinking of pursuing research careers.
















• MedicalResearch: Does the proposed legislation address hospital-based infections,

antibiotic resistance, pandemic detection and management, vaccine issues such as mandatory vaccination of school age children, or antibiotics in food sources?

• Ms. Jezek: The bill’s focus is really biomedical research and development and as these issues fall more into the public health sphere, they are not the specific focus of the bill. However, the provisions aimed at antibiotic R&D also include language aimed at making sure the antibiotics are used appropriately and that their use is monitored, both of which are critical for addressing antibiotic resistance.
















• MedicalResearch: Does the legislation enable simplified access to clinical medical research

trials or expedited review of new pharmaceuticals and medications? • Ms. Jezek: I’m only answering from IDSA’s perspective, understanding that we are not

involved in every provision in the bill and other provisions may address these issues. One of the antibiotics provisions, which IDSA has been championing, would allow antibiotics to treat serious or life threatening infections with few or no current treatment options to be studied in smaller, more rapid clinical trials and approved only for the limited population of patients who need them. This approach is needed because some of the most deadly, difficult to treat infections currently occur in small numbers of critically ill patients who are difficult to enroll in clinical trials, making it very difficult and sometimes impossible to populate traditional, large clinical trials.
















• MedicalResearch: How will patients benefit from bill?• Ms. Jezek: The bill will help enable the development of new safe and effective antibiotics to

treat infections that could otherwise be lethal. Such antibiotics could literally mean the difference between life or death for patients with these infections.

• MedicalResearch: What should health care providers be aware of if the legislation passes?• Ms. Jezek: I think all of the components that IDSA is pursuing—specifically regarding

antibiotic development and NIH funding—would be of great interest to providers given their potential impact on new treatment options for patients.
















• MedicalResearch: Is funding for implementation of the bill included in the legislation?• Ms. Jezek: As I understand it, the Committee is still working on some of this, so I can only

provide a partial answer. For the NIH funding-the bill would authorize new money for NIH for the next 3 years, but the Appropriations Committee in Congress would still need to actually appropriate that money. However, the NIH Innovation Fund in the bill would provide mandatory funding for NIH for the next 5 years, and this would not have to be approved by the Appropriations Committee. Some parts of the bill (such as the limited population antibiotic development provision discussed above) are not expected to require additional funding, as it is merely addressing a regulatory barrier. Lastly, some funding items are still being worked out.

• Citation:• (See a two-page Fact Sheet of H.R. 6 HERE. )










http://energycommerce.house.gov/sites/republicans.energycommerce.house.gov/files/114/Cures2015FACTSHEET.pdf






Blood Based Biomarker May Guide Therapy For Advanced Prostate CancerMedicalResearch.com Interview with:Emmanuel S. Antonarakis, M.B.B.CHDepartment of Urology and OncologyJohns Hopkins University School of MedicineBaltimore, Maryland


Dr. Antonarakis: In a previous publication, we reported that detection of the androgen receptor splice variant 7 (AR-V7; an abnormal version of the androgen receptor) in circulating tumor cells from patients with advanced prostate cancer was associated with resistance to hormonal therapies such as abiraterone and enzalutamide. Here, we aimed to explore the role of AR-V7 in the context of chemotherapy treatment. We showed that detection of AR-V7 was not associated with resistance to the chemotherapy drugs docetaxel or cabazitaxel, and that AR-V7-positive patients could still derive benefit from these chemotherapies.


http://medicalresearch.com/cancer-_-oncology/prostate-cancer/blood-based-biomarker-may-guide-therapy-for-advanced-prostate-cancer/14787/










http://medicalresearch.com/cancer-_-oncology/prostate-cancer/new-optical-tool-may-identify-patients-at-high-risk-of-recurrent-prostate-cancer/14389/







• Medical Research: What should clinicians and patients take away from your report?• Dr. Antonarakis: In patients who have AR-V7-positive circulating tumor cells, chemotherapy

(with docetaxel or cabazitaxel) might be more effective than hormonal therapy (with abiraterone or enzalutamide). However, in patients who have AR-V7-negative circulating tumor cells, hormonal therapies and chemotherapies may work equally well while the former has less toxic side effects. Therefore, blood-based testing for AR-V7 might prove useful in helping to guide patients in terms of selecting the optimal treatment for their advanced prostate cancer.












http://medicalresearch.com/cancer-_-oncology/prostate-cancer/prostate-cancer-psa-changes-patients-treated-treated-second-line-chemotherapy/2177/








this study?• Dr. Antonarakis: Our findings certainly require confirmation in larger prospective studies, and

such studies are already ongoing. For example, in one study we will prospectively assess the clinical utility of three blood-based AR-V7 tests in 120 patients with advanced prostate cancer who are about to begin treatment with abiraterone or enzalutamide. In another randomized phase-2 study, men will be randomized to receive either abiraterone/enzalutamide or cabazitaxel, and will be prospectively tested for AR-V7 before trial entry and also at the time of progression. Such studies will be able to determine the broader clinical significance of the AR-V7 biomarker test in a multi-center fashion.

• Citation:• Antonarakis ES, Lu C, Luber B, et al. Androgen Receptor Splice Variant 7 and Efficacy of Taxane

Chemotherapy in Patients With Metastatic Castration-Resistant Prostate Cancer. JAMA Oncol. Published online June 04, 2015. doi:10.1001/jamaoncol.2015.1341.












http://oncology.jamanetwork.com/article.aspx?articleid=2300763








Women On Both Diabetes and Depression Medications Have Increased Risk of Myocardial InfarctionMedicalResearch.com Interview withDr. Karin Rådholm MD Ph.D.

Division of Community Medicine, Primary Care, Department of Medicine and Health Sciences, Faculty of Health Sciences, Linköping University

Department of Local Care West, County Council of Östergötland,Linköping, Sweden • MedicalResearch: What is the background for this study? • Dr. Rådholm: Psychosocial risk factors and depressive disorders often co-occur with general medical

comorbidities, such as myocardial infarction. Depression is more common in patients with diabetes than in patients without diabetes. About 10-30% of patients with diabetes have a comorbid depressive disorder, which is double the estimated prevalence of depression in individuals without diabetes. There is an association between comorbid depressive symptoms and diabetes complications. This is believed to be mainly due to poor adherence to treatment recommendations and diabetes self-management activities, but could also possibly be due to biological and behavioural causes that could predispose for both metabolic and affective disorders. The general risk of myocardial infarction is strongly dependent on age and sex, where men have an earlier disease onset compared to women. In the general population women are at much lower risk for ischemic heart disease mortality than men are. However, women with diabetes are at especially high risk for coronary heart disease, relatively more so than men with type 2 diabetes, meaning that the impact of diabetes on the risk of coronary death is significantly greater for women than men. The age- and gender-specific risk for myocardial infarction due to diabetes with coexistent depression has not previously been described. Data on all dispensed drug prescriptions in Sweden are available in the Swedish Prescribed Drug Register and all myocardial infarctions are registered in the Myocardial Infarction Statistics. These registers are population-based and have a total national coverage and high validity, which has been previously shown. Prescribed and dispensed antidiabetics and antidepressants were used as markers of disease.

• Our objective was to prospectively explore the gender- and age-specific risk of first myocardial infarction in people treated with antidiabetic and/or antidepressant drugs compared to participants with no pharmaceutical treatment for diabetes or depression in a nationwide register study.


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















http://medicalresearch.com/heart-disease/majority-of-myocardial-infarction-patients-did-not-achieve-risk-factor-control/13904/








Department of Local Care West, County Council of Östergötland,Linköping, Sweden • MedicalResearch: What are the main findings?• Dr. Rådholm: The main findings from this population-based, nation-wide register study of 3

965 839 participants, are that the combination of pharmacologically treated diabetes mellitus and use of antidepressants substantially increased the risk of a first myocardial infarction compared to categories of none or either of the conditions alone.

• The hazard ratio for having a first myocardial infarction for women 45-64 years with antidiabetics and antidepressants combined was increased over 7 times vs. women not having either diabetes or depression. The corresponding hazard ratio in men was 3.1.
























Department of Local Care West, County Council of Östergötland,Linköping, Sweden • MedicalResearch: What should clinicians and patients take away from your report?• Dr. Rådholm: All patients, especially women with comorbid diabetes and depression should

be given careful attention for risk factor control.• MedicalResearch: What recommendations do you have for future research as a result of

this study?• Dr. Rådholm: Future research should include randomised controlled trials addressing

depression treatment and disease mechanisms in diabetes patients.• Citation:• Use of antidiabetic and antidepressant drugs is associated with increased risk of myocardial

infarction: a nationwide register study• Diabetic MedicineK. Rådholm A.-B. Wiréhn J. Chalmers3 and C. J. Östgren• DOI: 10.1111/dme.12822

















http://onlinelibrary.wiley.com/doi/10.1111/dme.12822/abstract










JAMA Study Compares Diagnostic Tests For DementiaMedicalResearch.com Interview with: Kelvin TSOI BSc, PhDResearch Associate Professor, Stanley Ho Big Data Decision Analytics Research Centre

Associate Professor (by Courtesy), School of Public Health and Primary CareFaculty of MedicineThe Chinese University of Hong Kong

• MedicalResearch: What is the background for this study? What are the main findings?• Dr. Tsoi: Dementia is a global public health problem afflicting millions of old age population.

The Mini-Mental State Examination (MMSE) is the most widely applied test for dementia screening. In fact, there are over 40 tests available for dementia screening and many of them are available for free, but the diagnostic performances of these tests were not yet systematically evaluated. To identify the best alternative in the long list of screening tests, we conducted a systematic review to quantitatively analyze the diagnostic accuracy of these screening tests.

• Among 149 eligible studies included over 49,000 participants, we found that the MMSE is a frequently used test for dementia screening. The sensitivity and specificity of MMSE for detection of dementia were combined to be 81.3% and 89.1% respectively. Compared with the other screening tests, the Mini-Cog and the Addenbrooke’s Cognitive Examination Revised (ACE-R) showed the best diagnostic performance which was comparable to that of the MMSE. For mild cognitive impairment (MCI), the Montreal Cognitive Assessment (MoCA) showed comparable performance to the MMSE with 88.9% sensitivity & 74.8% specificity.


http://medicalresearch.com/mental-health-research/alzheimers-dementia/jama-study-compares-dementia-diagnostic-tests/14774/



















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

Dr. Tsoi: The Mini-Cog and the ACE-R showed better performance than that of the other screening tests for dementia screening. The MoCA showed better performance than the others for MCI screening. Although the MMSE is the only proprietary instrument for dementia screening, the other screening tests were shown to be comparably effective but are easier to perform and freely available.





















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

this study?• Dr. Tsoi: This study evaluated the existing literature with large sample size, but the screening

tests were compared across different populations with various inclusion criteria. The future studies can further verify the test results on the same group of screening subjects.

• Citation:• Tsoi KF, Chan JC, Hirai HW, Wong SS, Kwok TY. Cognitive Tests to Detect Dementia: A Systemati

c Review and Meta-analysis. JAMA Intern Med. Published online June 08, 2015. doi:10.1001/jamainternmed.2015.2152.























Antibiotic Impregnated Catheters Can Reduce Central Line-Associated Bloodstream InfectionMedicalResearch.com Interview with:Stephanie Bonne, MD, FACSAssistant ProfessorTrauma, Acute, and Critical Care Surgery

Washington University in St. Louis


Response: We had previously implemented education programs in our ICU in an attempt to decrease our Central Line-Associated Bloodstream Infection (CLABSI) rate. We were, however, unable to come to zero. We were looking for innovative ways to lower our CLABSI rate, and the use of Clorhexidine/Silver Sulfadiazine catheters was unable to move our CLABSI rate. We decided to try Minocycline/Rifampin catheters, and monitor our Central Line-Associated Bloodstream Infection rate.

• Medical Research: What should clinicians and patients take away from your report?• Response: The use of Minocycline/Rifampin impregnated catheters can lower Central Line-

Associated Bloodstream Infection rate, particularly in ICUs who have been unable to reach a Central Line-Associated Bloodstream Infection rate of zero with other measures.


http://medicalresearch.com/infections/antibiotic-impregnated-catheters-can-reduce-central-line-associated-bloodstream-infection/14782/













Antibiotic Impregnated Catheters Can Reduce Central Line-Associated Bloodstream InfectionMedicalResearch.com Interview with:Stephanie Bonne, MD, FACSAssistant ProfessorTrauma, Acute, and Critical Care Surgery

Washington University in St. Louis


this study?• Response: Future research could include larger scale studies of this product, as well as

studying the effects of other types of antibiotic impregnated catheters, like peripherally inserted central catheters.

• Citation:• Effectiveness of Minocycline/Rifampin vs Chlorhexidine/Silver Sulfadiazine-Impregnated Cent

ral Venous Catheters in Preventing Central Line-Associated Bloodstream Infection in a High-Volume Academic Intensive Care Unit: A Before-and-After Trial

• Stephanie Bonne, MD, FACS John E. Mazuski, MD, PhD, FACS,

Carie Sona, RN Marilyn Schallom, RN Walter Boyle, MD Timothy G. Buchman, PhD, MD, FACS Grant V. Bochicchio, MD, MPH, FACS, Craig M. Coopersmith, MD, FACS Douglas J.E. Schuerer, MD, FACS

• Journal of the American College of Surgeons• Available online 27 May 2015










http://medicalresearch.com/general-medicine/central_venous_catheters_raise_infection_risk_in_cancer_patients/6601/

http://www.sciencedirect.com/science/article/pii/S1072751515003750















Use of Mesh Surgery For Prolapse Continues To RiseMedicalResearch.com Interview with:Bilal Chughtai, MD & Art Sedrakyan, MD, PhDDepartment of UrologyWeill Cornell Medical College


Response: Since 2008, the U.S. Food and Drug Administration has released number of public health notifications cautioning the use of mesh in pelvic organ prolapse (POP) surgery. Despite these notifications and subsequent public scrutiny, studies have reported a large increase of mesh use in female patients with pelvic organ prolapse during the last decade. In light of the reported rise in mesh utilization, we sought to determine the use of mesh in prolapse surgery and compare short-term outcomes of prolapse surgery with or without mesh.

• After identifying 7,338 and 20,653 patients who underwent prolapse repair procedures with and without mesh in a 4-year period, we found that mesh use increased 44.7%. Most patients were under 65 (62.3%), and there were more patients older than 65 years in the mesh group (44.3% versus 35.4%). Overall, complications were not common. However, patients who received mesh were more likely to experience urinary retention within 90-days and had a higher chance of having re-intervention at 1 year. Mesh use was also associated with higher risk of urinary retention in older patients (≥ 65 year olds) and re-intervention within 1 year in younger patients (<65 year olds).


http://medicalresearch.com/author-interviews/use-of-mesh-surgery-for-prolapse-continues-to-rise/14813/

















• Medical Research: What should clinicians and patients take away from your report?• Response: Younger patients (<65) should be aware that they are at higher risk for mesh

exposure and re-intervention. Elderly patients (≥65) should be aware that they are at higher risk for developing urinary retention after POP surgical repair with mesh. Clinicians should counsel patients about these risks.




















this study?• Response: The use of mesh continues to rise, and therefore, more research needs to be

conducted to ensure its safety. The FDA has ordered manufacturers to conduct post market surveillance studies; however, it will take years before this data will be available. Future research evaluating the use and safety of mesh for pelvic organ prolapse surgical repair would greatly benefit from a comprehensive registry.

• Citation:• Chughtai Bilal, Mao Jialin, Buck Jessica, Kaplan Steven, Sedrakyan Art. Use and risks of surgica

l mesh for pelvic organ prolapse surgery in women in New York state: population based cohort study BMJ 2015; 350 :h2685













http://www.bmj.com/content/350/bmj.h2685








CDC Study Finds No Pattern Suggesting Vaccines Contributed To Or Caused DeathsMedicalResearch.com Interview with:Dr. Pedro Moro, MD, MPHImmunization Safety Office Division of Healthcare Quality Promotion

Centers for Disease Control and PreventionAtlanta, GA 3033


Response: The Vaccine Adverse Event Reporting System (VAERS) is a US national vaccine safety surveillance system, co-administered by the Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA). VAERS accepts reports of adverse events (possible side effects) following vaccination. Anyone can submit a report to VAERS.

• The study team searched VAERS for US reports of death after any vaccination from 7/1/1997 to 12/31/2013.• During that time period, VAERS received 2,149 death reports, with most (68.4%) occurring in children. Among

children, the most common causes of death were:• o sudden infant death syndrome (44%)• o asphyxia, or lack of oxygen to the brain (6%)• o septicemia, or blood poisoning from a bacterial infection (5%)• o pneumonia (5%)• Among adults, the most common causes of death were:• o diseases of the circulatory system (47%)• o diseases of the respiratory system (15%)• o infections and parasitic diseases (12%)• o tumors (4%)• The main causes of death seen in VAERS reports were consistent with the most common causes of death in the

US population. When studied separately, none of these causes of death have found to be related to vaccines. This finding is reassuring, and consistent with previous research on vaccine safety.


http://medicalresearch.com/author-interviews/cdc-study-finds-no-pattern-suggesting-vaccines-contributed-to-or-caused-deaths/14805/

















• Medical Research: What should clinicians and patients take away from your report?• Response: First and foremost, vaccines are safe, effective, and save lives. There are strong

systems in place to make sure that vaccines are safe, including VAERS.• The primary goal of VAERS is to detect possible safety problems that may be related to

vaccination. If, after an initial evaluation, CDC and FDA scientists determine that a potential safety issue requires further investigation, former studies can be conducted using other, more robust data sources. However, VAERS data do have limitations. One of the limitations is that a report to VAERS does not necessarily mean that the vaccine caused the adverse event.

• In this study, researchers reviewed reports of death after vaccination and found no patterns which would indicate that vaccines caused or contributed to the deaths.

















Cognitive Therapy May Be Safe and Effective For Chronic InsomniaMedicalResearch.com Interview with:Dr David CunningtonSleep Physician & DirectorMelbourne Sleep Disorders CentreEast Melbourne Australia

• Medical Research: What should clinicians and patients take away from your report?• Response: Cognitive behaviour therapy is an effective treatment for chronic insomnia, that is

safe and produces long-term results. As such, it should be considered as a first line treatment for chronic insomnia, and is a valid alternative to using hypnotic medications.

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

• Response: This systematic review and meta-analysis has shown that cognitive behaviour therapy is effective. However, barriers to this treatment being more widely available are lack of skilled practitioners, cost and access to healthcare. Future research should look at how cognitive behaviour therapy can be made more accessible using new technologies.

• Citation:• Drug-free sleep solution: Cognitive behavior therapy effective for chronic insomnia• James M. Trauer, MBBS; Mary Y. Qian, MBBS; Joseph S. Doyle, PhD; Shantha M. W. Rajaratna

m, PhD; and David Cunnington, MBBS• Ann Intern Med. Published online 9 June 2015 doi:10.7326/M14-2841


http://medicalresearch.com/author-interviews/cognitive-therapy-may-be-safe-and-effective-for-chronic-insomnia/14729/










http://medicalresearch.com/sleep-disorders/womens-sexual-desire-may-be-sleep-dependent/12952/

http://annals.org/article.aspx?articleid=2301405










Cognitive Therapy May Be Safe and Effective For Chronic InsomniaMedicalResearch.com Interview with:Dr David CunningtonSleep Physician & DirectorMelbourne Sleep Disorders CentreEast Melbourne Australia


Response: Insomnia is a very common problem with 15-20% of adults having chronic insomnia, that is, trouble getting to sleep or staying asleep most days for 3 months or more. The most commonly used treatment is sleeping pills or hypnotics, however, they don’t address the underlying disorder, and come with potential side effects. Also, sleeping tablets just mask the symptoms, and as soon as tablets are stopped, symptoms recur. People with chronic insomnia think and behave differently around sleep, which perpetuates their symptoms. The key to improving symptoms in the long run is addressing thoughts and behaviours around sleep, which is what cognitive behaviour therapy does.

• Our study showed that cognitive behaviour therapy reduced the time taken to get to sleep by 20 minutes and reduced the amount of time spent awake after falling asleep by nearly 30 minutes. These effects were maintained out to 12 months after treatment. These reductions in time taken to get to sleep and time spent awake are similar to those reported in clinical trials of hypnotics.












http://medicalresearch.com/author-interviews/insomnia-major-contributor-fatal-falls-motor-vehicle-accidents/8701/









this study?• Response: CDC will continue to monitor and assess death reports to VAERS to ensure public

confidence in the immunization program.• Citation:• Pedro L. Moro, Jorge Arana, Maria Cano, Paige Lewis, and Tom T. Shimabukuro• Deaths reported to the Vaccine Adverse Event Reporting System (VAERS), United States, 1997

-2013 Clin Infect Dis. first published online May 28, 2015 doi:10.1093/cid/civ423












http://cid.oxfordjournals.org/content/early/2015/05/27/cid.civ423.abstract









Pediatric Hospitalizations For Children Dropped Almost 90% After Rotavirus Vaccine ImplementedMedicalResearch.com Interview with:Eyal Leshem, MDDivision of Viral Diseases,US Centers for Disease Control and Prevention,Atlanta, Georgia


Response: Routine vaccination of US children to protect against rotavirus began in 2006. The purpose of this study was to examine the effect of implementation of rotavirus vaccine on gastroenteritis and rotavirus hospitalizations of children younger than 5 years old.

• The main finding from this study is that hospitalizations for diarrhea in U.S. children younger than 5 years old decreased dramatically during 2008 to 2012 following implementation of routine rotavirus vaccination in 2006. Additionally, seasonal peaks of hospitalizations for rotavirus illness were considerably reduced after the vaccine was implemented compared to years prior to rotavirus vaccination.

• By 2012, rates of rotavirus hospitalization declined by approximately 90% across all settings and age groups. Factors such as increasing vaccine coverage as well as herd immunity resulting in less transmission of rotavirus may be responsible for this large decrease.


http://medicalresearch.com/pediatrics/pediatric-hospitalizations-for-children-dropped-almost-90-after-rotavirus-vaccine-implemented/14809/

















• Medical Research: What should clinicians and patients take away from your report?• Response: Rotavirus vaccination is the most effective method to prevent serious rotavirus

illness in young children. The findings of this study confirm the importance of continued efforts to increase rotavirus vaccination rates to match those of other established childhood vaccines.













http://medicalresearch.com/infections/rotavirus-vaccine-risk-intussusception/3382/








this study?• Response: Continued monitoring of vaccine impact will provide information regarding long-

term effects of rotavirus vaccine to the public as well as clinicians, public health professionals, and other stakeholders. Further study of methods to increase rotavirus vaccine coverage through enhancing access to healthcare and communicating the benefits of vaccine is recommended.

• Citation: JAMA• Leshem E, Tate JE, Steiner CA, Curns AT, Lopman BA, Parashar UD. Acute Gastroenteritis

Hospitalizations Among US Children Following Implementation of the Rotavirus Vaccine. JAMA. 2015;313(22):2282-2284. doi:10.1001/jama.2015.5571.













http://medicalresearch.com/infections/household-members-protected-against-some-rotavirus-infections-when-infants-vaccinated/11302/






Blood Pressure Medication ARBs Should Be Resumed As Soon As Possible After SurgeryMedicalResearch.com Interview with:Susan Ming Lee, MD, FRCPC, MAS (Clinical Research)Clinical Instructor, Dept. of Anesthesia and Perioperative Care

University of California, San Francisco

Medical Research: What are the main findings?

Dr. Lee: Angiotensin receptor blockers (often referred to as ARBs) are common medications used to treat high blood pressure, heart disease, and kidney disease. Doctors sometimes stop these medications briefly around the time of surgery, since they are known to cause low blood pressure under general anesthesia. Doctors may hesitate to restart ARBs after surgery because they are worried about low blood pressure or kidney function. Prior to our research, there was little information to guide the optimal timing of restarting ARBs after surgery.


http://medicalresearch.com/author-interviews/blood-pressure-medication-arbs-should-be-resumed-as-soon-as-possible-after-surgery/14777/







http://medicalresearch.com/author-interviews/antihypertensive_medications_gender_differences/9872/








Medical Research: What are the main findings?

Dr. Lee: Our study of over 30,000 veterans shows that nearly one third of veterans admitted to hospital for non-cardiac surgery are not restarted on their usual ARBs within two days of their operation. This delay in resuming ARBs is associated with increased death rates in the first month after surgery. In fact, even accounting for factors that might contribute to why doctors would withhold ARB (such as low blood pressure, kidney dysfunction, or other comorbidities), 30-day postoperative mortality was increased approximately 50% in those without resumption of ARBs, and this effect was even greater in younger patients under age 60. Our findings of reduced rates of infections, pneumonia, heart failure, and kidney failure in those that resumed ARBs soon after surgery suggest that early resumption may also reduce complications after surgery.









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








• Medical Research: What should patients and clinicians take away from this report?• Dr. Lee: Our study highlights to clinicians and patients the importance of promptly resuming

medications after surgery that patients were previously on at home. Specifically, restarting ARBs as soon as possible after surgery may lead to lower mortality and reduced postoperative complications.

















this study?• Dr. Lee: Future research should further investigate the optimal time for restarting ARBs after

surgery. As part of our study, we repeated our analysis using different time-points for restarting ARBs (e.g. 1, 7, and 14-days) and found that withholding ARBs was detrimental at all these other time points. In the future, we may even find that continuing ARBs right through the day of surgery is better than stopping for one day. The next step would be to conduct a prospective study, where we deliberately compare a group in which we stop and then resume ARBs and a group in which we don’t stop them at all.

• Citation:• Susan M. Lee, Steven Takemoto, Arthur W. Wallace. Association between Withholding

Angiotensin Receptor Blockers in the Early Postoperative Period and 30-day Mortality. Anesthesiology, 2015; 1 DOI: 10.1097/ALN.0000000000000739









http://dx.doi.org/10.1097/ALN.0000000000000739






Social Support From Friends and Family Linked To Lower MortalityMedicalResearch.com Interview with:Katie Becofsky Ph.D.Weight Control and Diabetes Research CenterThe Miriam HospitalProvidence, RI

• Medical Research: What is the background for this study? What are the main findings?• Dr. Becofsky: Previous research has provided clear evidence of a relationship between social

relations (e.g., frequency of social participation, perceived social support) and mortality risk. We investigated two specific aspects of social relations- source of social support and size of weekly social network- in more detail. The purpose of our study was to examine the associations between different sources of social support (relative, friend, and partner support), as well as size (and source) of weekly social network, on mortality risk in a large cohort of patients from the Aerobics Center Longitudinal Study. We found that perceived support from one’s spouse/partner and relatives, as well as weekly social interaction with a network of 6-7 friends, was associated with lower long-term mortality risk. When the sources were reversed, the effects did not stand- perceived social support from friends did not affect mortality risk, nor did the quantity of weekly familial contacts.


http://medicalresearch.com/weight-research/social-support-from-friends-and-family-linked-to-lower-mortality/14869/










http://medicalresearch.com/general-medicine/lifestyle_interventions_reduced_risk_of_diabetes_cardiac_mortality/4646/






Social Support From Friends and Family Linked To Lower MortalityMedicalResearch.com Interview with:Katie Becofsky Ph.D.Weight Control and Diabetes Research CenterThe Miriam HospitalProvidence, RI

• Medical Research: What should clinicians and patients take away from your report?• Dr. Becofsky: Just as an active lifestyle and healthy diet lower mortality risk, so too does

receiving support from loved ones and staying socially engaged.• Medical Research: What recommendations do you have for future research as a result of

this study?• Dr. Becofsky: Just as we design interventions to promote healthy eating and smoking

cessation, it may be worthwhile to design health interventions that teach interpersonal communication skills. For individuals who are unmarried, widowed, or not close with relatives, pet ownership may be an alternative to human social support, and should be explored in intervention trials. Larger scale strategies may include efforts to de-stigmatize and promote family and marriage counseling, as well as efforts to encourage physicians to discuss the importance of social relations with patients.

• Citation:• Influence of the Source of Social Support and Size of Social Network on All-Cause Mortality• Becofsky, Katie M. et al.

Mayo Clinic Proceedings Published Online: June 05, 2015DOI: http://dx.doi.org/10.1016/j.mayocp.2015.04.007












http://dx.doi.org/10.1016/j.mayocp.2015.04.007






Early Autism Intervention Produces Long Term BenefitsMedicalResearch.com Interview with:Annette Estes, Ph.D.Research Associate Professor of Speech and Hearing Sciences Adjunct Research Associate Professor of Psychology

Director, University of Washington Autism Center Susan & Richard Fade Endowed ChairCenter on Human Development and DisabilityUniversity of Washington


Dr. Estes: Although a number of studies have shown the positive effects of early intervention on children’s abilities during the preschool period, there have been few studies to date that have followed children longitudinally to find out if these gains are sustained. We found that two years after completing the intervention, children maintained their gains in cognitive and adaptive behavior skills and also showed a reduction in autism symptoms. The results suggest that early intervention results in long term benefits for children across a wide range of skills. Children who received the ESDM intervention as toddlers later showed fewer autism symptoms at school age.


http://medicalresearch.com/mental-health-research/autism/early-autism-intervention-produces-long-term-benefits/14871/














http://medicalresearch.com/mental-health-research/autism/pediatric-office-visits-may-miss-autism-diagnosis/10610/








• Medical Research: What should clinicians and patients take away from your report?• Dr. Estes: Early intensive behavioral intervention has been found to be efficacious in

improving developmental outcomes for young children with autism spectrum disorder. Children were able to maintain the developmental gains that they made in early, intensive, in-home intervention over a 2-year follow-up period. These children did not exhibit developmental regression or lose skills, even after substantial reductions in services. Intellectual, language, and adaptive functioning gains made as a result of early intervention may generalize to new domains of functioning, such as reduced Autism Spectrum Disorder symptom severity, 2 years later.
















http://medicalresearch.com/mental-health-research/autism/autism_gene_that_removes_defective_proteins_may_be_altered/7564/









this study?• Dr. Estes: Research is needed to extend these results to a more diverse range of families and

communities to assess the effectiveness of early autism intervention.• Citation:• Annette Estes, Jeffrey Munson, Sally J. Rogers, Jessica Greenson, Jamie Winter, Geraldine

Dawson. Long-Term Outcomes of Early Intervention in 6-Year-Old Children With Autism Spectrum Disorder. Journal of the American Academy of Child & Adolescent Psychiatry, 2015; DOI: 10.1016/j.jaac.2015.04.005
















http://dx.doi.org/10.1016/j.jaac.2015.04.005






Most Patients With Atrial Fibrillation Are Symptomatic and Have Impaired Quality of LifeMedicalResearch.com Interview with:James V. Freeman MD, MPH, MSYale University School of MedicineNew Haven, CT


Dr. Freeman: Atrial fibrillation (AF) substantially increases the risk of major adverse clinical outcomes such as stroke and death, but it can also cause frequent symptoms, affect patient’s functional status, and impair their quality of life. While prior studies have reported the range of AF-related symptoms in patient populations, these studies were generally from highly selected patients and referral based practices, and may not reflect results in community practice or results with contemporary AF management. Using the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF), a large, contemporary, prospective, community-based outpatient cohort, we evaluated the type and frequency of symptoms in patients with Atrial fibrillation. In addition, we measured the degree to which physician assessed symptom severity (using the European Heart Rhythm Association [EHRA] classification system) was correlated with patient reported quality of life (assessed by the Atrial Fibrillation Effect on QualiTy-of-life [AFEQT] questionnaire). Finally, we association between symptoms or quality of life with clinical outcomes, including death, hospitalization, stroke and major bleeding.


http://medicalresearch.com/heart-disease/most-patients-with-atrial-fibrillation-symptomatic-and-have-impaired-quality-of-life/14880/







http://medicalresearch.com/stroke/despite-high-risk-of-stroke-some-atrial-fibrillation-patients-not-adequately-anticoagulated/12852/







In our community-based study, the majority of AF patients (61.8%) were symptomatic (EHRA >2) and 16.5% had severe or disabling symptoms (EHRA 3-4). EHRA symptom class was well correlated with the AFEQT quality of life score (Spearman correlation coefficient -0.39). Over 1.8 years of follow-up, Atrial fibrillation symptoms were associated with a higher risk of hospitalization (adjusted HR for EHRA ≥2 vs EHRA 1 1.23, 95% CI 1.15-1.31) and a borderline higher risk of major bleeding. Lower quality of life was associated with a higher risk of hospitalization (adjusted HR for lowest quartile of AFEQT vs highest 1.49, 95% CI 1.2-1.84), but not other major adverse events including death.















• Medical Research: What should clinicians and patients take away from your report?• Dr. Freeman: In our community-based study, most patients with Atrial fibrillation were

symptomatic and had impaired quality of life. Patient-reported quality of life correlated closely with physician-assessed symptom severity. AF symptoms and lower quality of life were associated with higher risk of hospitalization but not mortality during follow-up. This finding is noteworthy because the patients with the highest burden of symptoms and the lowest quality of life were substantially younger and healthier than less symptomatic patients and those with higher self-reported quality of life. These patients did not have an increased risk of death, stroke, myocardial infarction or major bleeding, suggesting that their hospitalizations were likely related to their symptoms and lower quality of life and not major adverse event









http://medicalresearch.com/general-medicine/women-with-atrial-fibrillation-at-greater-risk-of-stroke-than-men/11921/








this study?• Dr. Freeman: We need further validation of the EHRA and AFEQT scoring systems as objective

means of evaluating AF related symptom burden and quality of life, respectively. In addition, we need more studies evaluating interventions targeted at improvement in symptoms and quality of life in the patients with the highest symptom burden and lowest quality of life due to AF to see if we can decrease their risk for hospitalization and resource utilization. Possible interventions worthy of study include aggressive AF outpatient follow-up or Atrial fibrillation rhythm control therapies.

• Citation:• Association Between Atrial Fibrillation Symptoms, Quality of Life, and Patient Outcomes: Resu

lts From the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF).

• James V. Freeman, DaJuanicia N. Simon, Alan S. Go, John Spertus, Gregg C. Fonarow, Bernard J. Gersh, Elaine M. Hylek, Peter R. Kowey, Kenneth W. Mahaffey, Laine E. Thomas, Paul Chang, Eric D. Peterson, and Jonathan P. Piccini

• Circ Cardiovasc Qual Outcomes. 2015;CIRCOUTCOMES.114.001303published online before print June 9 2015, doi:10.1161/CIRCOUTCOMES.114.001303









http://medicalresearch.com/heart-disease/sleep_apnea_predicts_atrial_fibrillation_after_cabg/9534/














Lack of Random Allocation of Participants May Make Observational Research MisleadingMedicalResearch.com Interview with:Andrew Grey, MDDepartment of MedicineUniversity of AucklandAuckland, New Zealand

• Medical Research: What is the background for this study? What are the main findings?• Dr. Grey: Observational research is commonly conducted and often published in prominent

medical journals, leading to reporting of the results by news media. Because of methodological limitations, in particular the absence of random allocation of participants to the interventions being studied, observational studies cannot be used to draw conclusions about causality. We wondered whether these important study limitations were apparent in news reporting of observational studies.

• Our analysis demonstrated low levels of reporting of limitations of observational research in the Abstract section of published papers and accompanying journal press releases, and in news stories generated in response to publication of the research. The reporting of the limitation that causal inferences could not be drawn was very low.

• Failing to identify and report limitations of observational research might promote the initiation and/or continuation of medical practices based on low level evidence.


http://medicalresearch.com/author-interviews/lack-of-random-allocation-of-participants-may-make-observational-studies-misleading/14887/













Lack of Random Allocation of Participants May Make Observational Research MisleadingMedicalResearch.com Interview with:Andrew Grey, MDDepartment of MedicineUniversity of AucklandAuckland, New Zealand

• Medical Research: What should clinicians and patients take away from your report?• Dr. Grey: Research aimed at improving the quality of reporting of medical research might

improve the translation of evidence into medical practice.• Citation:• Wang MM, Bolland MJ, Grey A. Reporting of Limitations of Observational Research. JAMA Int

ern Med. Published online June 08, 2015. doi:10.1001/jamainternmed.2015.2147.

















Treatment With TNF-α inhibitors Raises Short Term Risk Of Infection in Inflammatory Bowel DiseaseMedicalResearch.com Interview with:Nynne Nyboe Andersen, MD, PhD studentDepartment of Epidemiology ResearchStatens Serum Institut

Copenhagen, Denmark


Dr. Andersen: The use of TNF-α inhibitors, including infliximab, adalimumab and certolizumab pegol to treat people with inflammatory bowel disease is increasing worldwide and has upgraded the medical treatment modalities. However, concerns about their safety, including an increased risk of serious infections have persisted because they suppress the immune system. Previous meta-analyses based on randomized controlled trials did not suggest an increased risk of serious infections in people with inflammatory bowel disease treated with TNF-α inhibitors compared to placebo. However, the trials included in the meta-analyses were designed to investigate efficacy, and not to analyze risk of rare adverse events such as serious infections and often represent selected populations. Therefore, observational studies are essential to evaluate safety in a real world setting; however, results from these studies have been conflicting. Thus, as the risk of infections associated with TNF-α inhibitor treatment in people with inflammatory bowel disease is unclear we aimed at investigating this potential risk in a population-based setting based on the entire Danish inflammatory bowel disease population.


http://medicalresearch.com/author-interviews/treatment-with-tnf-%CE%B1-inhibitors-raises-short-term-risk-of-infection-in-inflammatory-bowel-disease/14889/













http://medicalresearch.com/cancer-_-oncology/inflammatory_bowel_disease_risk_of_cancer_with_tnf_antagonists/5875/







Copenhagen, Denmark

In a propensity score matched cohort we found a significant 63% increased risk of serious infections within 90 days after treatment initiation. When we prolonged follow-up to 356 days the risk was attenuated and no longer significant. For site-specific serious infections, we found increased point estimates for sepsis, urological/gynecological infections, and skin and soft tissue infections; but these results should be interpreted cautiously because of limited power.





















Copenhagen, Denmark


this study?• Dr. Andersen: Our study’s ability to conclude on specific infections and on different TNF-α

inhibitors separately was limited because of power issues and should be assessed in future even larger scale population-based studies.

• Citation:• Nyboe Andersen Nynne, Pasternak Björn, Friis-Møller Nina, Andersson Mikael, Jess Tine. Asso

ciation between tumour necrosis factor-α inhibitors and risk of serious infections in people with inflammatory bowel disease: nationwide Danish cohort studyBMJ 2015; 350 :h2809

























Copenhagen, Denmark

• Medical Research: What should clinicians and patients take away from your report?• Dr. Andersen: Our study provides the clinicians with an updated safety profile regarding

infections risk associated with TNF-α inhibitors based on the entire Danish population with inflammatory bowel disease and these results can most likely be extended to other Western countries. It is important to stress that the benefit of TNF-α inhibitor treatment in people with inflammatory bowel disease is unquestionable nevertheless our findings call for increased clinical awareness of potential infectious complications among people using these drugs, especially early in the course of treatment.















http://medicalresearch.com/author-interviews/herpes-zoster-risk-may-be-elevated-in-psoriasis-patients-on-combination-therapy/13474/






stander CPR Saves Lives – Mobile App May Help Save MoreMedicalResearch.com Interview with:Jacob Hollenberg M.D., Ph.D.Assistant Professor, CardiologistHead of Research, Centre for Resuscitation ScienceKarolinska Institutet, Stockholm, Sweden

• Editor’s note: Dr. Hollenberg and colleagues published two articles in the NEJM this week

discussing CPR performed by bystanders in out-of-hospital cardiac arrests.• MedicalResearch: What is the background for the first study?• Dr. Hollenberg: There are 10,000 cases of cardiac arrest annually in Sweden.

Cardiopulmonary Resuscitation (CPR) has been taught to almost a third of Sweden’s population of 9.7 million. In recent years the value of bystander CPR has been debated, largely due to a lack of a randomized trial demonstrating that bystander CPR is lifesaving.

• In this study, which included all cases of emergency medical services (EMS) treated and bystander-witnessed out-of-hospital cardiac arrests recorded in the Swedish Cardiac Arrest Registry from January 1, 1990, through December 31, 2011, our primary aim was to assess whether CPR initiated before the arrival of EMS was associated with an increase in the 30-day survival rate.


http://medicalresearch.com/heart-disease/bystander-cpr-saves-lives-mobile-app-may-help-save-more/14821/



















• MedicalResearch: What were the main findings?• Dr. Hollenberg: Early CPR prior to arrival of an ambulance more than doubled the chance of

survival. (30-day survival rate was 10.5% among patients who underwent CPR before EMS arrival, as compared with 4.0% among those who did not (P<0.001).)

• This association held up in all subgroups regardless of sex, age, cause of cardiac arrest, place of arrest, EKG findings or time period (year analyzed).





















• MedicalResearch: How did the patients who survived cardiac arrest do from a disability

standpoint?• Dr. Hollenberg: We had cerebral performance scores from 474 patients who survived for 30

days after cardiac arrest. (higher scores indicate greater disability).• At the time of discharge from the hospital, 81% of these patients had a score of category of 1.

Less than 2% had category scores of 4 or 5.





















• MedicalResearch: What should patients and providers take away from this report?• Dr. Hollenberg: • For patients with an out-of-hospital cardiac arrest, CPR performed by bystanders before the

arrival of emergency medical personnel, saves lives. This has been validated by both the size of this study and the consistency of the results over three decades.

• CPR education needs to continue and to increase. In Sweden about one-third of the population has been taught CPR. Legislation has recently been passed that mandates CPR be taught to all teenagers in school which should allow an entire generation to become familiar with this lifesaving technique.

• The willingness of the public to become involved also needs to increase. We need new ways of educating lay people to recognize cardiac arrest and to motivate them to perform it. The knowledge that bystander CPR saves lives may enhance that motivation.





















• MedicalResearch: Greater public involvement in CPR overlaps with your second NEJM study

that discusses a mobile phone application. What is the background for this study?• Dr. Hollenberg: Knowing that bystander CPR saves lives, we were looking for new ways to

reach patients in the first critical minutes after a cardiac arrest. Training as much of the public as possible is important but still leaves the availability of a trained bystander to serendipity.

• We evaluated a totally new system using mobile positioning technology that recruited CPR-trained volunteers we called “short-message-service lifesavers”. Lay volunteers were recruited and trained in CPR.

• During the study, EMS dispatchers who suspected that a patient had a cardiac arrest activated the mobile-phone positioning system (as well as ambulance, fire and police vehicles). All such volunteers within a radius of 500 meters from the patient received a computer-generated telephone call and a text message with information on the patient’s location. Patients were randomly assigned in a 1:1 ratio to one of two study groups: in one group, lay volunteers received a text notification; in the control group, no notification was sent.





















• The primary outcome was the rate of bystander-initiated CPR before the arrival of an

ambulance or first responders: 61.6% of the patients in the intervention group (188 of 305 patients) received bystander-initiated CPR, as compared with 47.8% of the patients in the control group (172 of 360 patients).

• In addition, we know that out-of-hospital cardiac arrests that occur in the home are associated with worse outcomes. In this study, lay trained volunteers were able to start CPR in the patient’s home.

• We are not suggesting lay volunteers supplant an EMS system but rather as a valuable add-on in the first critical 2-4 minutes after a cardiac arrest.





















• MedicalResearch: What further developments and research are you planning as a result of

this work?• Dr. Hollenberg: In the next few days we intend to launch a new service, based on GPS

technology, to allow volunteers to fetch the nearest available public AED (automated external defibrillator). This mobile app, available for iPhone and Android, will match the location of all available AEDS with available volunteers. We think this is a very valuable way to get the critical defibrillator to point of need.

• Citation:• Early Cardiopulmonary Resuscitation in Out-of-Hospital Cardiac Arrest• Ingela Hasselqvist-Ax, R.N., Gabriel Riva, M.D., Johan Herlitz, M.D., Ph.D., Mårten Rosenqvist,

M.D., Ph.D., Jacob Hollenberg, M.D., Ph.D., Per Nordberg, M.D., Ph.D., Mattias Ringh, M.D., Ph.D., Martin Jonsson, B.Sc., Christer Axelsson, R.N., Ph.D., Jonny Lindqvist, M.Sc., Thomas Karlsson, B.Sc., and Leif Svensson, M.D., Ph.D.

• N Engl J Med 2015; 372:2307-2315June 11, 2015• Mobile-Phone Dispatch of Laypersons for CPR in Out-of-Hospital Cardiac Arrest• Mattias Ringh, M.D., Mårten Rosenqvist, M.D., Ph.D., Jacob Hollenberg, M.D., Ph.D., Martin J

onsson, B.Sc., David Fredman, R.N., Per Nordberg, M.D., Hans Järnbert-Pettersson, Ph.D., Ingela Hasselqvist-Ax, R.N., Gabriel Riva, M.D., and Leif Svensson, M.D., Ph.D.

• N Engl J Med 2015; 372:2316-2325June 11, 2015Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.














http://www.nejm.org/doi/full/10.1056/NEJMoa1405796


















Noninvasive Prenatal Testing May Detect Maternal CancerMedicalResearch.com Interview with:Prof. Joris VermeeschHoofd Moleculaire CytogeneticaCoordinator Genomics CoreUniversity of Leuven, University Hospitals Leuven, Belgium


Dr. Vermeesch: We developed a novel analysis methodology for Noninvasive prenatal testing (NIPT), which not only interrogates the common trisomies, but looks at variations across all chromosomes. We obtain a kind of genome wide copy number variation plot. By applying this analysis method for Noninvasive prenatal testing, we have strict quality parameters. If faulty, we ask for a second sample. In one pregnant woman, the second sample showed exactly the same aberrations as in the first sample. We excluded this variation to be caused by a maternal constitutional chromosomal rearrangement and also excluded this aberration to be from fetal origin. This prompted us to assume a maternal cancer was the cause. Three such cases were observed, all three women were referred to the oncology unit and all three were proven to show a cancer.


http://medicalresearch.com/cancer-_-oncology/noninvasive-prenatal-testing-may-detect-maternal-cancer/14916/















http://medicalresearch.com/genetic-research/prenatal-blood-tests-for-down-syndrome-good-but-not-perfect/13347/







• Medical Research: What should clinicians and patients take away from your report?• Dr. Vermeesch: Our data suggest that by slight changes in the analysis protocols, a false

positive trisomy 21 as a result of the presence of a maternal cancer, can be recognized as such. If such a profile is identified, those women should/could be referred to the oncology unit. In Leuven, women with such a profile are first referred to the geneticist and subsequently to the oncology unit where Prof. Amant is in charge of a unit “cancer during pregnancy”. We consider this finding as an unexpected added benefit of Noninvasive prenatal testing because early cancer detection prompts treatment, even during pregnancy, and improves outcome.
























this study?• Dr. Vermeesch: First, we need to establish the sensitivity and specificity on a larger cohort of

patients. In our study, we witnessed 3 cases in 4000 pregnancies. Because this is the cancer incidence of women in this age group, we consider the test sensitive. Also, with the parameters we defined, we referred only three women to the oncology unit. Hence the test looks also specific. Nevertheless, we need to determine whether this is also the case in a larger group of patients.

• Second, it seems warranted to start pre-symptomatic cancer detection studies in the broader population.

• Citation:• Amant F, Verheecke M, Wlodarska I, et al. Presymptomatic Identification of Cancers in Pregna

nt Women During Noninvasive Prenatal Testing. JAMA Oncol. Published online June 05, 2015. doi:10.1001/jamaoncol.2015.1883.

[email protected]




















mailto:[email protected]






AKAP4 Is a Promising Blood Biomarker For Early Detection of Lung CancerMedicalResearch.com Interview with:Qihong Huang, M.D., Ph.D.Associate professor in the Tumor Microenvironment and Metastasis ProgramThe Wistar Institute


Dr. Huang: Lung cancer is the leading cause of cancer deaths in both men and women in the United States and results in more deaths globally than breast, prostate and colon cancers combined. While the five year survival rate for early stage non-small cell lung cancer (NSCLC) is above 50%, it is less than 5% in patients with metastatic disease. Clearly, early detection can save lives, but accurate screening tests for high-risk individuals are still lacking. Although low dose computed tomography (LDCT) has been successfully used for screening in high-risk populations, multiple negative factors are associated with recurrent LDCT screening, including false-positives and false-negatives, unnecessary invasive procedures, radiation exposure, global availability of the technology and cost. Although several non-invasive tests for lung cancer using body fluids such as blood, urine or sputum are under investigation, none are currently available.

• When low dose computed tomography is used for screening, patients who are 50 years old or older are frequently diagnosed with pulmonary nodules. However, only a small fraction of the nodules detected are subsequently diagnosed as lung cancer. In cases where it is difficult to differentiate malignant from benign nodules, it is recommended that patients with these indeterminate nodules be followed with serial LDCT, which increases radiation exposure and financial cost. A simple, inexpensive blood test that differentiates malignant from benign nodules would fill an important clinical need.


http://medicalresearch.com/cancer-_-oncology/lung-cancer/akap4-is-a-promising-blood-biomarker-for-early-detection-of-lung-cancer/14902/










http://medicalresearch.com/cancer-_-oncology/lung-cancer-screening-with-low-dose-ct/1295/

http://medicalresearch.com/cancer-_-oncology/minimal-dose-ct-superior-to-chest-x-ray-for-detection-of-recurrent-lung-cancer/698/







In this study, we validated AKAP4 as a highly accurate biomarker in a cohort of 264 blood samples from patients with known non-small cell lung cance and 135 controls samples from two different sites including a subset of controls with high risk lung nodules. When all 264 lung cancers were compared with all 135 controls, the area under the ROC curve (AUC) was 0.9714. When 136 stage I NSCLC lung cancers were compared with all controls, the AUC is 0.9795, and when all lung cancer patients were compared to 27 controls with histologically confirmed benign lung nodules – a comparison of significant clinical importance – the AUC was 0.9825. AKAP4 expression increases significantly with tumor stage but independently of age, gender, smoking history or cancer subtype. Follow-up studies in a small number of resected NSCLC patients revealed a decrease of AKAP4 expression post-surgical resection that remained low in patients in remission and increased with tumor recurrence. AKAP4 is a highly accurate biomarker for the detection of early stage lung cancer, lung cancer recurrence, and distinguishing malignant from benign lung nodules.


















• Medical Research: What should clinicians and patients take away from your report?• Dr. Huang: AKAP4 is a promising blood biomarker for the early detection of lung cancer,

recurrence, and distinguishing malignant from benign lung nodules. A total of 399 samples (264 lung cancer samples and 135 control samples) in this study is a fairly large sample size for a pilot study. However, further validation in larger sample size is needed. If the sensitivity and specificity of AKAP4 can be validated in larger cohort of patients, it would represent the best biomarker to date for cost-effective early detection of lung cancer patients. It is possible that a combination of a blood test and low-dose CT is powerful for the detection of early stage lung cancer and distinguishing malignant from benign lung nodules, thus significantly improving the survival of lung cancer patients while dramatically lowering the cost of the screening.



















this study?• Dr. Huang: We will validate the findings in larger sample size. Samples will be collected from

multiple hospitals. If the results from this study are validated, we will conduct clinical trials to determine the assay can be used for the detection of early stage lung cancer, lung cancer recurrence, and distinguish malignant from benign lung nodules.

• Citation:• Qihong Huang et al. AKAP4 is a circulating biomarker for non-small cell lung cancer.

Oncotarget, May 2015

















Lump Sum Payments To Long-term Care Hospitals May Have Created Incentive To Discharge PatientsMedicalResearch.com Interview with:Yan S. Kim, MD PhDDelivery Science Fellow Division of ResearchKaiser Permanente Northern California

Oakland, CA 94612

• Medical Research: What is the background for this study? What are the main findings?• Dr. Kim: Long-term care hospitals first emerged in the 1980s as an alternative to lengthy

acute-care hospital stays for patients with complex medical problems who need prolonged hospital-level care. In 2002, Medicare changed its payment method for these facilities from cost-based to a lump sum per admission based on the diagnosis. Under this system, which is still in place, Medicare pays these hospitals a higher rate for patients who stay a minimum number of days based on the patient’s condition. Shorter stays are paid much less and longer stays do not necessary generate higher reimbursements.

• Using Medicare data, we analyzed a national sample of patients who required prolonged mechanical ventilation – the most common, and among the most costly, conditions for patients in long-term care hospitals – to examine whether this payment policy has created incentives to base discharge decisions on payments. We found that in the years after the policy’s implementation there was a substantial spike in the percentage of discharges on and immediately after the minimum-stay threshold was met, while very few patients were discharged before the threshold. By contrast, prior to 2002, discharges were evenly distributed around the day that later became the short-stay threshold. These findings confirm that the current payment policy has created unintended incentives for long-term care hospitals to base the timing of patient discharges on payments and highlight how responsive these hospitals are to payment incentives.


http://medicalresearch.com/author-interviews/lump-sum-payment-to-long-term-care-hospitals-may-have-created-incentive-to-discharge-patients/14929/














Oakland, CA 94612

• Medical Research: What should clinicians and patients take away from your report?• Dr. Kim: This is a study on the impact of the current Medicare payment policy on the timing

of patient discharges from long-term care hospitals. Our findings have significant and timely implications for policy-makers as they consider alternative ways to structure payments to these hospitals to ensure that the incentives are aligned with the medical needs of patients.
















Oakland, CA 94612


this study?• Dr. Kim: Our study calls for an urgent need to reexamine long-term care hospitals’ role in the

care continuum for complex patients and to align incentives so that the care provided is in the best interest of the patients. In order to successfully overhaul the payment system to ensure that it correctly incentives the provision of high quality care, future studies need to focus on better understanding the types of care provided within long-term care hospitals, the quality of such care, and whether they are delivering on outcomes that matter to patients.

• Citation:• Medicare Payment Policy Creates Incentives For Long-Term Care Hospitals To Time Discharges

For Maximum Reimbursement

Yan S. Kim, Eric C. Kleerup, Patricia A. Ganz, Ninez A. Ponce, Karl A. Lorenz, and Jack Needleman

• Health Aff June 2015 34:6907-915; doi:10.1377/hlthaff.2014.0778










http://content.healthaffairs.org/content/34/6/907.abstract?=right










New Borrelia Tick-Borne Disease Confirmed in Series of 51 PatientsMedicalResearch.com Interview with:Dr. Philip Molloy, MDImugen Medical Director


Response: There is a newly described tick-borne infection in the US, first case published in NEJM Man 2013 (from Imugen researchers). We then developed and validated both PCR and serologic blood tests. Physicians started ordering these tests, and many additional cases were uncovered, 51 of which are described in this paper.

• Medical Research: What should clinicians and patients take away from your report?• Response: Be aware of yet another pathogen transmitted to humans from ticks, and don’t

assume it’s Lyme. Tests are available to help sort it out. Imugen has been offering these tests commercially since 2013.

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

• Response: We plan to continue to characterize cases and study the epidemiology of this infection.

• Citation:• Borrelia miyamotoi Disease in the Northeastern United States: A Case Series • Philip J. Molloy, MD; Sam R. Telford III, ScD; Hanumara Ram Chowdri, MD; Timothy J. Lepore,

MD; Joseph L. Gugliotta, MD; Karen E. Weeks, BS; Mary Ellen Hewins, BS; Heidi K. Goethert, ScD; and Victor P. Berardi

• Ann Intern Med. Published online 9 June 2015 doi:10.7326/M15-0333Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

http://medicalresearch.com/infections/new-borrelia-tick-borne-disease-confirmed-in-series-of-51-patients/14925/



















Functional Status Is Important Predictor of Hospital ReadmissionMedicalResearch.com Interview with:Jeffrey C. Schneider, M.D. Medical Director, Trauma, Burn & Orthopedic ProgramAssistant Professor, Dept. of Physical Medicine and

Rehabilitation Harvard Medical SchoolSpaulding Rehabilitation HospitalBoston, MA 02129


Response: Hospitalizations account for the largest share of healthcare costs in the U.S., comprising nearly one-third of all healthcare expenditures. In 2011, readmissions within 30 days of hospital discharge represented more than $41 billion in hospital costs. Financial penalties for excess 30-day hospital readmissions were instituted by the Centers for Medicare and Medicaid Services in 20124; more than 2,200 hospitals were fined a total of $280 million in reduced Medicare payments in fiscal year 2013.

• Most readmission risk prediction models have targeted specific medical diagnoses and have utilized comorbidities and demographic data as the central risk factors for hospital readmission. Yet, large U.S. administrative datasets have demonstrated poor discriminative ability (c-statistics: 0.55-0.65) in predicting readmissions. However, few studies have considered functional status as potential readmission risk factors.

• There is increasing evidence that functional status is a good predictor of other health outcomes. To date, acute care hospital administrative databases do not routinely include functional status measures. Therefore, inpatient rehabilitation setting is an ideal population in which to examine the impact of functional status on readmission risk, because


http://medicalresearch.com/general-medicine/functional-status-is-important-predictor-of-hospital-readmission/14921/













http://medicalresearch.com/author-interviews/late-hospital-readmissions-linked-to-chronic-health-and-social-problems/14703/








• (1) inpatient rehabilitation patients often have complex care transitions after acute care

discharge, and represent a significant proportion of total readmissions; (• 2) inpatient rehabilitation facilities routinely document functional status using a valid

instrument—the FIM®; and• (3) a majority of U.S. IRFs participate in one of the only national datasets that contain

standardized functional data—the Uniform Data System for Medical Rehabilitation.• Limitations of prior work include small and single-center study designs, narrowly defined

patient populations, and defining readmissions beyond the 30-day period. Overall, there is a lack of literature on the utility of function as a readmission predictor in a large population of medical patients. Moreover, function is a modifiable risk factor with potential to impact readmission outcomes if function-based interventions are instituted early. Therefore, the objective of this study was to compare functional status with medical comorbidities as predictors of acute care readmissions in the medically complex rehabilitation population. We hypothesized that acute care readmission prediction models based on functional status would outperform models based on comorbidities,and that the addition of comorbidity variables to function-based models would not significantly enhance predictive performance.















http://medicalresearch.com/heart-disease/depression-illicit-drug-use-linked-to-readmissions-after-lvad-placement/13859/








• To test our hypothesis we performed a retrospective database study of 120,957 patients

from 1041 facilities in the Uniform Data System for Medical Rehabilitation admitted to inpatient rehabilitation facilities under the medically complex impairment group code between 2002 and 2011. In our analysis, a Basic Model based on gender and functional status was developed using logistic regression to predict the odds of 3-, 7-, and 30-day readmission from inpatient rehabilitation facilities to acute care hospitals.

• Functional status was measured by the FIM® motor score. The Basic Model was compared to six other predictive models—three Basic Plus Models that added a comorbidity measure to the Basic Model and three Gender-Comorbidity Models that included only gender and a comorbidity measure. The three comorbidity measures used were the Elixhauser index, Deyo-Charlson index, and Medicare comorbidity tier system. The c-statistic was the primary measure of model performance. Basic Model c-statistics predicting 3-, 7-, and 30-day readmissions were 0.69, 0.64, and 0.65, respectively.

• The best-performing Basic Plus Model (Basic+Elixhauser) c-statistics were only 0.02 better than the Basic Model (0.70, 0.65, 0.66) and the best-performing Gender-Comorbidity Model (Gender+Elixhauser) c-statistics were more than 0.07 worse than the Basic Model (0.57, 0.57, 0.57).






















• Medical Research: What should clinicians and patients take away from your report?• Response: Functional status is a frequently overlooked risk factor for readmissions and is a

more valuable predictor of readmission risk than medical comorbidities in the medically complex inpatient rehabilitation population. Our results add to the growing body of evidence that functional status is an important predictor of readmissions. There is opportunity to improve current national readmission risk models to more accurately predict readmissions and more fairly reimburse hospitals based on performance.















http://medicalresearch.com/author-interviews/most-patients-go-back-to-same-hospital-for-30-day-readmissions/13794/









this study?• Response: Early mobilization is an area that has been studied recently and shown to improve

clinical outcomes and reduce healthcare costs. Acute care hospitals do not routinely collect functional status information. Future efforts are needed to explore early clinical assessment and treatment of functional impairments to reduce hospital readmissions. Additionally, studies are needed in other populations to further assess the robustness of this study’s findings.

• Citation:• J Gen Intern Med. 2015 May 9. [Epub ahead of print]• Functional Status Outperforms Comorbidities in Predicting Acute Care Readmissions in Medic

ally Complex Patients.• Shih SL1

, Gerrard P, Goldstein R, Mix J, Ryan CM, Niewczyk P, Kazis L, Hefner J, Ackerly DC, Zafonte R, Schneider JC.















http://www.ncbi.nlm.nih.gov/pubmed/25956826












Oncotype DX Breast Cancer Assay Quickly Adopted Under Medicare GuidelinesMedicalResearch.com Interview with:Michaela Dinan, Ph.D.Duke Clinical Research Institute and Duke Cancer Institute Department of MedicineDuke University School of

Medicine Durham, North Carolina


Response: I think it will be critical to further explore the implications of Oncotype DX breast cancer assay (ODX testing) in women with breast cancer. The ODX test helps predict which cancers will be more aggressive as well as guide recommendations as to which patients would most likely benefit from chemotherapy. I think we should look to see what impact this test is really having on the use of chemotherapy and its associated costs and outcomes for real-world breast cancer patients.


http://medicalresearch.com/cancer-_-oncology/breast-cancer/oncotype-dx-breast-cancer-assay-quickly-adopted-under-medicare-guidelines/14909/





















• Medical Research: What should clinicians and patients take away from your report?• Response: Another interesting finding of this study was the lack of variation in ODX use by

race, geography, or, socioeconomic status. Often for emerging medical technologies, we tend to see differences in initial use for these patient populations. Our analysis did not examine why we didn’t see this differential utilization with the emergence of Oncotype DX breast cancer assay, but clinicians and patients should be aware that the test is available to them without obvious barriers to its use in cases where it is medically indicated.
























this study?• Response: We wanted to examine how ODX was being used in real-world practice at the

population level. ODX has been examined in clinical trials and limited academic settings but we know that these patients are often younger, have fewer medical comorbidities, and do not necessarily accurately reflect the majority patients with cancer. In our study, we observed that ODX was being used predominately in accordance with guidelines which recommend the test for women with estrogen-receptor positive, node negative disease. We also looked just at women under the age of 70 who met guideline criteria for testing, because this population would include those women who were more likely to be chemotherapy candidates, and we saw a rapid uptake of the test between 2005 and 2009, with use of the test increasing from 8% to 39%.

• Citation:• Dinan MA, Mi X, Reed SD, Hirsch BR, Lyman GH, Curtis LH. Initial Trends in the Use of the 21-G

ene Recurrence Score Assay for Patients With Breast Cancer in the Medicare Population, 2005-2009. JAMA Oncol. 2015;1(2):158-166. doi:10.1001/jamaoncol.2015.43.
























Pre-Frontal Brain Cortex Size Linked To Moral ReasoningMedicalResearch.com Interview with:Dr. rer. nat. Kristin Prehn, Dipl.-Psych.Charité Universitätsmedizin BerlinDepartment of Neurology & NeuroCure Clinical Research CenteBerlin Germany

• MedicalResearch: What is the background for this study? What are the main findings?• Dr. Prehn: The study is based on the theory by renowned American psychologist Lawrence

Kohlberg stating that people progress through different levels of moral reasoning. At lower levels, individuals judge moral issues based on self-interest or laws and rules. Individuals at the post-conventional level also take into account deeper principles and shared ideals. The Kohlbergian theory influenced moral psychology and education for decades. No study to date, however, had investigated in which way moral development is reflected in human brain structure and function.

• In our study, we compared gray matter brain volume in healthy young subjects who either reached the post-conventional level or did not reach that level so far. We found that subjects at the post-conventional level showed larger volume in a specific brain region of the prefrontal cortex which is essential for moral reasoning as well as the integration of emotion and cognition during human behavior.


http://medicalresearch.com/neurological-disorders/pre-frontal-brain-cortex-size-linked-to-moral-reasoning/14914/

























• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Prehn: For the first time, Kohlberg’s influential theory on moral development is supported

by neuroscientific evidence. The study offers exciting insights into the brain and shows that subjects at different levels of moral reasoning differ in brain structure. In the future, this technique might also be used to evaluate at a neuroscientific level the efficacy of educational approaches fostering moral development.



























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

• Dr. Prehn: The current results are exciting, however, many questions still remain open. For instance, it is presently unclear how different levels of moral reasoning map on to cognitive abilities that are central to moral reasoning, such as perspective taking, empathy, awareness of moral issues and the needs of other people. Moreover, it is not know whether the observed brain structural changes are the cause or the effect of higher moral development. Finally, we also aim to investigate the effects of educational programs (such as formal ethics training) on changes in brain structure and function in a longitudinal approach.

• Citation:• Neural Correlates of Post-Conventional Moral Reasoning: A Voxel-Based Morphometry Study• Kristin Prehn , Marc Korczykowski, Hengyi Rao , Zhuo Fang, John A. Detre, Diana C. Robertson • PLOS One Published: June 3, 2015 DOI: 10.1371/journal.pone.0122914





















http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0122914








More Screen Time Linked To Lower Bone Mass In BoysMedicalResearch.com Interview with:Anne Winther MscDepartment of Health and Care Sciences, UiT The Arctic University of Norway

Division of Rehabilitation Services, University Hospital of North Norway, Tromsø, Norway


Response: Norway has one of the highest reported incidences of osteoporotic fractures in the world. Research on fracture risk has primarily focused on bone mass in the elderly. However, there is a growing awareness of the importance of bone mass during growth as a compensation for the inevitable bone loss and prevention of fractures in the elderly . A recent study on Norwegian adolescents´ lifestyle and bone health concluded that peak bone mass seem to be modifiable by lifestyle factors as higher physical activity levels were strongly associated with bone mass. The other way around; low levels of physical activity may have considerable negative effects on bone health, and increasing sedentary behavior in place of sports and play during growth is worrying. In this study we explored the associations between self-reported hours spent in front of television/computers during weekends along with self reported hours spent on leisure time physical activities and bone mass density (BMD) levels at the hip. This population based study, Fit Futures 1 consisting of 388 girls and 359 boys 15-17 years old was conducted in 2010/2011, and repeated two years later including 66% of the original cohort (Fit Futures 2; 312 girls and 231 boys).


http://medicalresearch.com/pediatrics/more-screen-time-linked-to-lower-bone-mass-in-boys/14906/





















• Boys spent more time in front of computers and television than girls; approximately 5 and 4 hours, compared with 4 and 3 hours daily in weekends and weekdays, respectively.

• Physical activity levels were adversely related to leisure time computer use at weekends. However, 20 % of the girls and 25 % of the boys balanced 2-4 hours in front of the screen daily with more than 4 hours of sports and hard training per week.

• Screen time at weekends was negatively associated with bone mass density levels in boys and positively in girls, after adjustments of several confounders known to affect bone, including age, puberty, physical activity levels and weekday screen time.

• Moreover; these contrasting patterns persisted two years later.
















http://medicalresearch.com/author-interviews/bone-mineral-density-repeat-testing-improve-fracture-risk-prediction/2023/








• Medical Research: What should clinicians and patients take away from your report?• Response: Screen based sedentary behavior has a negative influence on bone in adolescent

boys, whereas participation in recreational sports or performing sports at a competitive level seems to exert significant beneficial effect on bone health. The best way to promote good bone health in this age group as well as further into adulthood is to encourage participation in sports and play, as physical activity during adolescence promote physical activity practice in later life.
















http://medicalresearch.com/author-interviews/higher_social_class_linked_to_lower_risk_of_bone_fractures/4736/









this study?• Response: These results should be followed up more than 2 years in longitudinal studies ,

including changes in both exposure and outcome variables. lt would also be preferable with objective measurements of sedentary behavior and physical activity.

• The gender difference is striking, and the explanation unclear. Study of body composition in terms of fat mass and lean mass, and their relationships to bone mass may shed light of these differences

• Citation:• Leisure time computer use and adolescent bone health—findings from the Tromsø Study,

Fit Futures: a cross-sectional study • Anne Winther, Luai Awad Ahmed, Anne-Sofie Furberg, Guri Grimnes, Rolf Jorde, Ole Andreas

Nilsen, Elaine Dennison, Nina Emaus• BMJ Open 2015;5:6 e006665 doi:10.1136/bmjopen-2014-006665
















http://bmjopen.bmj.com/content/5/6/e006665.abstract?sid=a210b0b5-7dfc-49a0-9cf3-b69ac04dffef











MedicalResearch.com: Medical Research Exclusive Interviews June 11 2015

Health & Medicine

Transcript of MedicalResearch.com: Medical Research Exclusive Interviews June 11 2015