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MedicalResearch.com publishes exclusive interviews with researchers from major and specialty medical journals.
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MedicalResearch.com Interviews on contemporary Medical Research with medical researchers from major and specialty medical journals. Editor: Marie Benz, MD info @medicalresearch.com September 25 2013 For Informational Purposes Only: Not for Specific Medical Advice.
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Page 1: MedicalResearch.com - Medical Research Interviews Week in Review

MedicalResearch.comInterviews on contemporary Medical Research with medical researchers from major and specialty medical journals.

Editor: Marie Benz, [email protected]

September 25 2013

For Informational Purposes Only: Not for Specific Medical Advice.

Page 2: MedicalResearch.com - Medical Research Interviews Week in Review

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Smoking Cessation and Electronic CigarettesMedicalResearch.com Interview with:Dr. Chris Bullen MBChB MPH PhD FAFPM FNZCPHMDirector School of Population Health, The University of Auckland

• MedicalResearch.com: What are the main findings of the study?• Dr. Bullen:• E-cigarettes, with or without nicotine, were modestly effective at helping smokers to quit, with similar

levels of abstinence as with nicotine patches, and few adverse events.• At 6 months, verified abstinence was 7·3% with nicotine e-cigarettes, 5·8% with patches, and 4·1% with

placebo e-cigarettes. However, there was insufficient statistical power to conclude superiority of nicotine e-cigarettes to patches or to placebo e-cigarettes.

• No significant differences in rates of adverse events occurrence were found between the groups.• E-cigarettes were very popular throughout the trial, with almost 90% of users stating they would

recommend them to a friend trying to quit smoking.•

MedicalResearch.com: Were any of the findings unexpected?• Dr. Bullen:• Smoking abstinence rates were lower than expected, for e-cigarettes in particular, but also for those in the

patches group.• High levels of continued use of e-cigarettes were found at 6 months, in participants allocated to e-cigarette

and those allocated to patches .

Read the rest of the interview on MedicalResearch.com

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Smoking Cessation and Electronic CigarettesMedicalResearch.com Interview with:Dr. Chris Bullen MBChB MPH PhD FAFPM FNZCPHMDirector School of Population Health, The University of Auckland

• Dr. Bullen:• E cigarettes are about as effective as nicotine patches for quitting, when used with minimal behavioural support.• In the short term (3 to 6 months use) using e-cigarettes appears to be no more harmful than using nicotine patches.• We have very limited data on longer term use of e-cigarettes, but such data as exists suggests the levels of toxins are far

lower than in tobacco smoke (the only alternative to using e-cigarettes for many people) so there is little doubt they are a less harmful option than continuing to smoke.

• They may be considered as an option for some people, who want to quit and stay abstinent, who have tried and failed to do so after trying standard NRTs and other evidence-based cessation medications.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Bullen:• Long term follow up of users who use e-cigarettes for more than 6 months, to monitor adverse effects of long-term use

and concurrent use of tobacco products.• Further cessation and reduction trials of newer models of e-cigarettes that deliver nicotine more reliably and efficiently• Studies of youth uptake of e-cigarettes as a pathway to tobacco use or nicotine dependence.• Citation:• Electronic cigarettes for smoking cessation: a randomised controlled trial• Dr Christopher Bullen MBChB, Colin Howe PhD, Murray Laugesen MBChB, Hayden McRobbie ,MBChB, Varsha Parag MSc,

Jonathan Williman PhD, Natalie Walker PhD,The Lancet, Early Online Publication, 9 September 2013

Read the rest of the interview on MedicalResearch.com

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Breast Cancer: Two Years vs One of Adjuvant RastuzumabMedicalResearch.com Interview with:Prof Aron GoldhirschDepartment of Medicine European Institute of OncologyVia Ripamonti 435, 20141 Milan, Italy

• MedicalResearch.com: What are the main findings of the study?• Prof. Goldhirsch: Two years of adjuvant trastuzumab after standard chemotherapy is not more effective than is 1 year of

treatment with the drug for patients with HER2-positive early breast cancer.• MedicalResearch.com: Were any of the findings unexpected?• Prof. Goldhirsch: Hypothetically, the longer duration exposure to adjuvant trastuzumab was expected to yield a longer DFS,

similarly to other targeted therapies, like endocrine therapy.• MedicalResearch.com: What should clinicians and patients take away from your report?• Prof. Goldhirsch: 1 year of treatment provides a significant disease-free and overall survival benefit compared with

observation (after adjuvant chemotherapy) and remains the standard of care.• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Prof. Goldhirsch: There are several new efficacious drugs for HER2 disease, (TRASTUZUMAB EMTANSINE and

PERTUZUMAB).• An intelligent investigation of their role in the adjuvant setting, for the duration of one year, is a relevant task for clinical

research in the field.• Citation:• 2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controll

ed trial• Goldhirsch A, Gelber RD, Piccart-Gebhart MJ, de Azambuja E, Procter M, Suter TM, Jackisch C, Cameron D, Weber HA, Heinz

mann D, Lago LD, McFadden E, Dowsett M, Untch M, Gianni L, Bell R, Köhne CH, Vindevoghel A, Andersson M, Brunt AM, Otero-Reyes D, Song S, Smith I, Leyland-Jones B, Baselga J; for the Herceptin Adjuvant (HERA) Trial Study Team.

Read the rest of the interview on MedicalResearch.com

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Breast Cancer: Three vs Five Week Post-Operative RadiotherapyMedicalResearch.com Interview with:Prof John R YarnoldDivision of Radiotherapy and ImagingThe Royal Marsden NHS Foundation Trust Sutton, Surrey SM2 5PT, UK

• MedicalResearch.com: What are the main findings of the study?• Prof. Yarnold: A 3-week schedule of curative post-operative radiotherapy for women with breast cancer involving 15

treatments (fractions) delivered Monday to Friday each week, is at least as safe and effective as historical schedules given over 5 or 6 weeks. In fact the 3-week schedule is gentler on the healthy tissues than earlier standard regimens.

MedicalResearch.com: Were any of the findings unexpected?• Prof. Yarnold: The results were not unexpected, but confirm that the relationships between test and control schedules do

not alter between 5 & 10yr. The larger number of events also make the conclusions more robust, statistically speaking.• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Prof. Yarnold: We are testing 2 dose levels of a 1-week schedule against the 3-week schedule in a phase 3 trial in UK (FAST

Forward Trial), and have entered about 2500 of the accrual target of 4000 patients.• Citation:• The UK Standardisation of Breast Radiotherapy (START) Trial A of radiotherapy hypofractionation for treatment of early br

east cancer: a randomised trial.• START Trialists’ Group, Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bliss JM, Brown J, Dewar JA, Dobbs HJ, H

aviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR.

• Lancet Oncol. 2008 Apr;9(4):331-41. doi: 10.1016/S1470-2045(08)70077-9. Epub 2008 Mar 19.

Read the rest of the interview on MedicalResearch.com

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Pregnancy: Midwife vs Standard Maternity Care StudyMedicalResearch.com Interview with:Prof Sally K Tracy DMidMidwifery and Women’s Health Research UnitUniversity of Sydney, Royal Hospital for Women Randwick, NSW, Australia

• MedicalResearch.com: What are the main findings of the study?• Prof. Tracy: We recruited 1748 pregnant women, of all risk types, from two tertiary teaching hospitals in different states in

Australia and allocated them to receive either caseload midwifery care (871) or standard maternity care (877).• The study found more women in caseload midwifery experienced an unassisted vaginal birth without pharmacological

analgesia, and fewer women experienced an elective caesarean. While the trial findings did not show a statistically significant difference in the rate of caesarean sections between either group, the overall rate fell by more than 20 percent from pre-trial levels.

• Newborn infants in both groups achieved similar physical assessment scores (Apgar scores). A slightly lower number of pre-term births and neonatal intensive care admissions among the midwifery caseload group was not statistically significant.

• Important secondary findings of the study include:• 30 percent more spontaneous onset of labour• less induction of labour• less severe blood loss, and• stronger likelihood of breastfeeding at discharge from hospital.• These small differences accounted for an overall difference of AU$566.74 less with caseload midwifery than with standard

care.• Caseload midwifery appeared to alter some of the pathways that recurrently contribute to increased obstetric intervention.

Having this level of continuity of care works on the assumption that women will labour more effectively, need to stay in hospital less time and feel a stronger sense of satisfaction and personal control if they have the opportunity to get to know their midwife at the beginning of pregnancy.

Read the rest of the interview on MedicalResearch.com

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Pregnancy: Midwife vs Standard Maternity Care StudyMedicalResearch.com Interview with:Prof Sally K Tracy DMidMidwifery and Women’s Health Research UnitUniversity of Sydney, Royal Hospital for Women Randwick, NSW, Australia

• MedicalResearch.com: Were any of the findings unexpected?• Prof. Tracy: This was the first randomised trial confirming that caseload midwifery care is

feasible for women of all risk and cost effective at all levels of care.• Given the limited information available about the cost of maternity services in Australia, it’s

significant to find that caseload midwifery produces a saving of $566.74 for each woman who gave birth in the public hospital. It refutes the common misconception that one-to-one caseload midwifery care was expensive.

Read the rest of the interview on MedicalResearch.com

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Pregnancy: Midwife vs Standard Maternity Care StudyMedicalResearch.com Interview with:Prof Sally K Tracy DMidMidwifery and Women’s Health Research UnitUniversity of Sydney, Royal Hospital for Women Randwick, NSW, Australia

• MedicalResearch.com: What should clinicians and patients take away from your report?• Prof. Tracy: The study found that continued care from a named midwife throughout pregnancy, birth, and after the baby is

born (caseload midwifery) is just as safe as standard maternity care (shared between rostered midwives, and medical practitioners in discrete wards or clinics) for all women irrespective of risk, and is significantly cheaper. Caseload midwifery care has been largely overlooked because of the incorrect belief that the service will be too expensive and that the model is not safe for complex pregnancies. Our randomised trial showed that caseload care can achieve similar outcomes to standard care – and it costs the public purse significantly less. The perception that this is a ‘boutique’ service that will cost far too much is incorrect. The midwife is making much better use of her time in responding to the needs of each woman as she is needed – rather than clocking up her 40 hours rostered in a ward or clinic regardless of whether there are women coming though the system at that time. Baby’s have a habit of arriving unexpectedly – and if a woman is booked with a caseload midwife in a small Midwifery group practice – her midwife will be ready to be with her in labour whenever she begins the labour process.

• In addition to this the study should dispel the confusion around the notion that having a caseload midwife means that women will not necessarily get to see a doctor if they need to. Having a caseload midwife means that a woman with a complex pregnancy not only has individualised midwifery care with a midwife whom she has grown to trust, but the collaboration between her midwife and an obstetrician who is also part of the team or formally connected as a consultant to the small group practice, means that the lines of communication between midwives and obstetricians have the potential to be further enhanced.

Read the rest of the interview on MedicalResearch.com

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Pregnancy: Midwife vs Standard Maternity Care StudyMedicalResearch.com Interview with:Prof Sally K Tracy DMidMidwifery and Women’s Health Research UnitUniversity of Sydney, Royal Hospital for Women Randwick, NSW, Australia

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Prof. Tracy: Further study should examine the interface between the ‘core’ rostered midwives employed by the hospital and

the caseload midwife coming in and out of the hospital and community to ascertain how to achieve optimum continuity? We should also look at what is the optimal time for going home and receiving postnatal care – how many visits – of for how many weeks after giving birth? And there could be further work in ascertaining what a sustainable caseload is – 35- 40 women per year? Although we have survey data from 36 weeks during pregnancy and up to 6 months post birth recording the self assessed health status and the experience of the women, it would be very useful to have long term data on the infant and mother wellbeing. Also, given the success of the collaborative effort between obstetricians and midwives in this study it would be useful to research new ways of sharing education and training within this caseload model of care.

• Citation:• Caseload midwifery care versus standard maternity care for women of any risk: M@NGO, a randomised controlled trial

Prof Sally K Tracy DMid,Donna L Hartz PhD,Mark B Tracy FRACP,Jyai Allen BMid,Amanda Forti RM,Bev Hall MIPH,Jan White RM,Anne Lainchbury MMid,Helen Stapleton PhD,Michael Beckmann FRANZCOG,Andrew Bisits FRANZCOG,Prof Caroline Homer PhD,Prof Maralyn Foureur PhD,Alec Welsh FRANZCOG,Prof Sue Kildea PhD

The Lancet – 17 September 2013 DOI: 10.1016/S0140-6736(13)61406-3

Read the rest of the interview on MedicalResearch.com

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Sleep Apnea: CPAP Treatment and Golf PerformanceMedicalResearch.com Interview with:Marc L. Benton, MD, FCCP, FAASMMorristown Medical Center and Atlantic Sleep & Pulmonary Associates,Madison, NJ 07940

• MedicalResearch.com: What are the main findings of the study?• Dr. Benton: When compared to a group of matched controls, 12 male golfers who had moderate-severe

obstructive sleep apnea syndrome (OSAS) demonstrated statistically significant improvement in their ability to play golf (as measured by changes in the Handicap Index, the standardized indicator of golfing performance) after undergoing CPAP treatment for their condition. Treatment adherence among the group placed on CPAP was unusually high.

MedicalResearch.com: Were any of the findings unexpected?• Dr. Benton: The degree of improvement was most substantial in the better (and usually older) golfers. We

originally expected to see the largest improvement among those who were younger with the highest handicaps (and therefore the most room for improvement). In retrospect, however, the better golfers have done a better job of managing the technical and mechanical aspects of golf, and with the cognitive enhancement afforded by successful treatment of their OSAS, they saw measurable improvement early and more significantly than those who were less-skilled. Additionally, we did not expect that the golfers whom we enrolled with OSAS to be essentially fully compliant with their CPAP. Improvement in golf performance appeared to be a strong motivator for our treatment group, many of whom had already failed attempts to use CPAP and in a few cases to even get them to undergo diagnostic sleep studies.

Read the rest of the interview on MedicalResearch.com

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Sleep Apnea: CPAP Treatment and Golf PerformanceMedicalResearch.com Interview with:Marc L. Benton, MD, FCCP, FAASMMorristown Medical Center and Atlantic Sleep & Pulmonary Associates,Madison, NJ 07940

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Benton: Improvement in a number of medical conditions has been well-documented when CPAP has been successfully

offered to selected patients. Similarly, reduced accident rates are noted in commercial drivers with OSAS once treatment has been provided. Improvement in isolated psychometric performance tests also occurs in treated sleep apnea. Golf is a commonly-played sport that incorporates many levels of integrated cognitive and physical functions. If CPAP treatment of OSAS results in measurable improvement in the ability of golfers to perform, it is possible that golf can be seen as a surrogate for other forms of activity where we cannot accurately measure performance improvement – such as our jobs and our day-to-day activities in our social and family environments. Making this connection might help motivate selected patients to seek and/or be compliant with treatment who might otherwise not be interested (especially given the mediocre levels of treatment adherence commonly observed in the treatment of OSAS). Furthermore, the concept that mainstream and beneficial medical therapy (not just for OSAS) can secondarily improve performance in golf and possibly other sports/recreational activities further expands the opportunities for healthcare providers to be successful in our efforts to engage our patients in efforts to improve their health proactively.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Benton: A study similar to this pilot needs to be done with more participants and better-defined control groups to more

clearly define the impact that treating sleep apnea has on golf performance. My expectations, based on a number of factors, is that the impact of treatment is underestimated in this study. It would then be interesting to design future studies to look at the treatment of OSAS and possibly other common medical conditions (asthma probably being the easiest one) and the impact on other sports, activities, and behaviors where performance can be assessed.

• Citation:• Treatment of Obstructive Sleep Apnea Syndrome with Nasal Positive Airway Pressure Improves Golf Performance.

The Journal of Clinical Sleep MedicineMarc L. Benton, MD, FCCP, FAASM; Neil S. Friedman, RN, RPSGTAccepted: 9/9/2013

Read the rest of the interview on MedicalResearch.com

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Parkinson’s Disease: Cognitive Impairment and Plasma CeramidesMedicalResearch.com: Interview with:Michelle M. Mielke, Ph.D.Associate Professor Department of Health Sciences Research Division of EpidemiologyMayo Clinic 200 First Street

SW Rochester, MN 55905

• MedicalResearch.com: What are the main findings of the study?• Dr. Mielke: Among Parkinson’s disease (PD) patients, plasma levels of ceramides and monohexylceramides were higher in patients

with cognitive impairment or dementia compared to patients who were cognitively normal. Levels of these lipids were also higher in the combined group of PD patients compared to non-PD controls but the number of controls were small.

•MedicalResearch.com: Were any of the findings unexpected?

• Dr. Mielke: Previous studies have not examined plasma levels of ceramides and glucosylceramides in PD patients. We hypothesized that plasma levels of ceramides and monohexylceramides would be altered in PD patients and associated with worse cognition, but we did not expect some of the associations to be as strong as they were.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Mielke: There are currently no biomarkers to predict who will develop sporadic PD, or cognitive impairment in patients with PD.

The present findings suggest that plasma ceramide and monohexylceramides could be indicators of who will develop cognitive impairment. This pathway should be examined as a potential therapeutic target for the prevention of, or slowing of, Parkinson’s disease progression.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Mielke: As this is really the first look at these plasma lipids, there is a lot of work to be done. Future studies will use additional

mass spectrometry techniques to separate monohexylceramides into glucosylceramides and galactosylceramides. This is important as the findings are likely driven by glucosylceramides and could be an even stronger predictor when quantified separately. Longitudinal studies of PD patients are also ongoing to determine whether these lipids can predict who will develop dementia and the rate of cognitive decline.

• Citation:• Plasma Ceramide and Glucosylceramide Metabolism Is Altered in Sporadic Parkinson’s Disease and Associated with Cognitive Impa

irment: A Pilot Study• Michelle M. Mielke, Walter Maetzler, Norman J. Haughey, Veera V. R. Bandaru, Rodolfo Savica, Christian Deuschle, Thomas Gasser, An

n-Kathrin Hauser, Susanne Gräber-Sultan, Erwin Schleicher, Daniela Berg, Inga Liepelt-Scarfone• Research Article | published 18 Sep 2013 | PLOS ONE• 10.1371/journal.pone.0073094Read the rest of the interview on MedicalResearch.com

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Lung Cancer: New Plasma Biomarker for Non-Small Cell CancerMedicalResearch.com Interview with:

Jie He, PhD, MDDirector, Laboratory of Thoracic Surgery

President, Cancer Institute & Hospital, Chinese Academy of Medical SciencesChaoyang District, Beijing, 100021

• MedicalResearch.com: What are the main findings of the study?• Dr. Jie He: The main findings of the study is that we have identified IDH1 as an effective plasma biomarker for the diagnosis

of NSCLCs, particularly with high sensitivity and specificity in the diagnosis of lung adenocarcinoma.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Jie He: Yes, we feel a little surprised to see the results can be validated so good. So we are planning to conduct multi-

center screenings to further validate the results.• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Jie He: We have identified IDH1 as a new diagnositc marker for lung cancer, with a good proteintial to be used for

noninvasive early diagnosis of lung cancer.• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Jie He: We are planning to conduct an independent cohort of patients for further validation. And it is necessary to

determine whether plasma IDH1 can be used as a specific biomarker for NSCLCs against other cancers. Moreover, it is also necessary to study the molecular mechanism and clinical implications of IDH1 up regulation.

• Citation:• Isocitrate Dehydrogenase 1 Is a Novel Plasma Biomarker for the Diagnosis of Non–Small Cell Lung Cancer• Nan Sun, Zhaoli Chen, Fengwei Tan, Baihua Zhang, Ran Yao, Chengcheng Zhou, Jiagen Li, Yibo Gao, Ziyuan Liu, Xiaogang Tan,

Fang Zhou, Max Y.f He, Kang Shao, Ning Li, Bin Qiu, Jian Sun, Yue Yu, Suya Wang, Yuda Zhao, Xuejiao Shi, and Jie He. Dehydrogenase 1 Is a Novel Plasma Biomarker for the Diagnosis of Non–Small Cell Lung Cancer . Clinical Cancer Research, September 2013 DOI: 10.1158/1078-0432.CCR-13-004

Read the rest of the interview on MedicalResearch.com

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Cognitive Impairment and Hospital ReadmissionsMedicalResearch.com Interview with:Mark W. Ketterer, PhD, ABPP Senior Bioscientific StaffHenry Ford Hospital/A2 Detroit, MI 48202Clinical Professor of Psychiatry & Behavioral Neurosciences

Department of Psychiatry Wayne State University

• MedicalResearch.com: What are the main findings of the study:• Dr. Ketterer: A survey of 84 patients admitted to Henry Ford Hospital found 54% to have Moderate-Severe Cognitive

Impairment (CI).

• MedicalResearch.com: Where any of the findings unexpected?• Dr. Ketterer: The prevalence rate of CI in this sample was approximately three times higher than anticipated, and was the

most potent predictor of readmission within 30 days.• Discussion of the causes of readmission rarely mention CI despite the fact that it interferes with pill-taking, dietary

restrictions, early symptom concern/reaction and prescription renewal.• A history of treatment for emotional distress was also a predictor of 30 day readmissions.• MedicalResearch.com: What should patients and providers take away from this report?• Dr. Ketterer: CI has been found to affect not only healthcare utilization, but also Mortality. Greater awareness and

education of cohabiting family, and more reliable med supervision may avoid recurrent medical crises causing readmission and deaths.

• MedicalResearch.com: What further research do you recommend as a result of your report?• Dr. Ketterer: Intervention studies need to test the hypothesis that family behavior can be altered to improve adherence.

Some innovative technologies may also be available to improve med adherence.• Citation:• Behavioral Factors and Hospital Admissions/Readmissions in Patients With CHF

Mark W. Ketterer, Ph.D., Cathy Draus, R.N., James McCord, M.D., Usamah Mossallam, M.D., Michael Hudson, M.D.Psychosomatics, Available online 7 September 2013http://dx.doi.org/10.1016/j.psym.2013.06.019Available online 7 September 2013

Read the rest of the interview on MedicalResearch.com

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Cancer Screening Trials: Weighing the HarmsMedicalResearch.com Interview with:Bruno Heleno, PhD fellowResearch Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Øster

Farimagsgade 5, PO Box 2099, 1014 Copenhagen K, Denmark

• MedicalResearch.com Interview with:Bruno Heleno, PhD fellowResearch Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, PO Box 2099, 1014 Copenhagen K, Denmark

• MedicalResearch.com: What are the main findings of the study?• Answer: In a literature review of cancer screening trials of a wide range of screening interventions, we found that trials seldom report

the information necessary to weigh benefits against harms.•

MedicalResearch.com: Were any of the findings unexpected?• Answer: Overdiagnosis was reported in 7% of 57 cancer screening trials. False-positives were reported for both trial arms in 4% of the

trials, and they were reported for at least the screened arms in 18% of the trials. These are the harms more directly related with screening; yet, according to our criteria, they were reported in a minority of trials.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: We found that the harms of screening were poorly reported in randomized trials, the study design that can provide the best

quality evidence of the effects of screenings. Healthcare decision makers, healthcare practitioners, and, ultimately, patients therefore cannot make informed choices about cancer screening as the information about benefits is more readily available and likely to be of higher quality than the information about harms. This is problematic as many cancer screening programs have important associated harms.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Answer: Researchers, ethical committees with responsibility about trials, and funders need to reflect and agree on which is the minimal

information about harms that should be reported for every upcoming trial of cancer screening. This will bring transparency and will help provide the evidence required for informed decision making.

• Citation:Quantification of harms in cancer screening trials: literature review

• Heleno B ,Thomsen MF ,Rodrigues DS ,Jørgensen KJ ,Brodersen J. Quantification of harms in cancer screening trials: literature review. BMJ 2013;347:f5334

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Colon Cancer: Screening and MortalityMedicalResearch.com Interview with:Aasma Shaukat, M.D., M.P.H.Dept. of MedicineGI Division, MMC 36 University of MinnesotaMinneapolis, MN 55455

• MedicalResearch.com: What are the main findings of the study?• Dr. Shaukat: The study showed that screening for colon cancer using stool cards

consistently reduces risk of death from colon cancer by one-third throughthirty years. The benefit of screening in larger in men compared to women,and for women the benefit seems to start at age 60. However, screening didnot make people live longer.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Shaukat: The continued reduction in risk of death from colon cancer out to 30 years is remarkable, and suggests that taking out benign

polyps may provide long lasting protection against colon cancer.• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Shaukat: Screening for colon cancer reduces risk of death from colon cancer.• Our study emphasizes the importance of screening for colon cancer. The best

screening test is not known at this time. In the meantime, every clinicianand patient should be having a conversation about which test is best forthem, based on risks and benefits.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Shaukat: We are participating in an ongoing study comparing colonoscopy versus stool cards through the Veterans Affairs Medical center

that might tell us which test is best. Results will be available in 10 years.• We also need to study the benefit of screening in women 50-60 more closely.• Citation:• Long-Term Mortality after Screening for Colorectal Cancer• Aasma Shaukat, M.D., M.P.H., Steven J. Mongin, M.S., Mindy S. Geisser, M.S., Frank A. Lederle, M.D., John H. Bond, M.D., Jack S. Mandel, Ph.

D., M.P.H.,and Timothy R. Church, Ph.D.

• N Engl J Med 2013; 369:1106-1114September 19, 2013DOI: 10.1056/NEJMoa1300720

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OCD: Adding Cognitive Therapy to SSIsMedicalResearch.com Interview with:H. Blair Simpson, M.D., Ph.D.Professor of Clinical Psychiatry, College of Physicians and Surgeons at Columbia University

Director of the Anxiety Disorders Clinic and the Center for OCD and Related Disorders at the New York State Psychiatric InstituteNew York, NY 10032

• MedicalResearch.com: What are the main findings of the study?• Dr. Simpson: This is the first RCT to compare two recommended SRI augmentation strategies

for adults with OCD. Adding EX/RP to SRIs was superior to risperidone and to pill placebo in reducing OCD symptoms and improving insight, functioning, and quality of life. Risperidone was not superior to placebo on any outcome.

MedicalResearch.com: Were any of the findings unexpected?• Dr. Simpson: Contrary to our expectations, adding EX/RP (a type of cognitive-behavioral

therapy called Exposure and Response Prevention) to SRIs was superior to adding risperidone on every outcome. These findings are important because antipsychotics are increasingly prescribed to OCD outpatients, and risperidone is recommended as the medication of first choice to augment SRI response. Our results call for increased use of EX/RP for augmenting unsatisfactory SRI effects.

Read the rest of the interview on MedicalResearch.com

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OCD: Adding Cognitive Therapy to SSIsMedicalResearch.com Interview with:H. Blair Simpson, M.D., Ph.D.Professor of Clinical Psychiatry, College of Physicians and Surgeons at Columbia University

Director of the Anxiety Disorders Clinic and the Center for OCD and Related Disorders at the New York State Psychiatric InstituteNew York, NY 10032

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Simpson: OCD patients on SRIs should be offered EX/RP before antipsychotics given EX/RP’s

superior efficacy and less negative side effect profile. Identifying who achieves minimal OCD symptoms from adding EX/RP to SRIs and whether such patients can then successfully discontinue their SRI warrants future research. Whether OCD patients on SRIs who fail to respond to EX/RP (or are unwilling to try it) can benefit from risperidone augmentation remains an unanswered question. Alternative medication augmentation strategies for OCD patients on SRIs are needed.

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

• Dr. Simpson: We are now funded by NIMH to study whether patients who become well after the combination of SRIs and EX/RP can maintain their wellness if the SRI is discontinued. The study is described in more detail at www.ocdtreatmentstudy.com

• We are also developing novel treatment strategies for patients who do not become well from the combination of SRIs and EX/RP. Our current work is described on our website at www.columbia-ocd.org

• Citation:• Simpson H, Foa EB, Liebowitz MR, et al. Cognitive-Behavioral Therapy vs Risperidone for Augmen

ting Serotonin Reuptake Inhibitors in Obsessive-Compulsive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2013;():-. doi:10.1001/jamapsychiatry.2013.1932.

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Addiction: Does Chronic Care Management Improve Outcomes?MedicalResearch.com Interview with:Richard Saitz, MD MPHProfessor of Medicine and EpidemiologyBoston University Schools of Medicine and Public Health

Clinical Addiction Research and Education Unit, Boston Medical Center, Boston, Massachusetts

• MedicalResearch.com: What are the main findings of the study?• Dr. Saitz: Chronic care management in primary care did not improve health outcomes

(abstinence from cocaine, opioids or heavy drinking; or any other clinical outcomes, like addiction consequences, emergency or hospital use, health-related quality of life, addiction severity) for people with alcohol or other drug dependence.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Saitz: Yes. Since addiction is a chronic disease, chronic care management (CCM), that has

been successful for other chronic medical (like asthma, heart failure, diabetes) and chronic mental health conditions (tobacco dependence, depression) should have improved outcomes. The surprising findings have several possible explanations. It may be that addiction treatments are just not effective enough across the spectrum of disease (even though for some specific subgroups they may be very effective, like pharmacotherapy for opioid dependence in people who want treatment). Another possibility is that there could be other ways of implementing disease management.

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Addiction: Does Chronic Care Management Improve Outcomes?MedicalResearch.com Interview with:Richard Saitz, MD MPHProfessor of Medicine and EpidemiologyBoston University Schools of Medicine and Public Health

Clinical Addiction Research and Education Unit, Boston Medical Center, Boston, Massachusetts

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Saitz: The take home message is that although addiction needs to be addressed in primary care

setting and it has to be addressed in a multidisciplinary way and longitudinally, just applying CCM may not result in the improved outcomes one might expect. The concept of CCM is likely sound but needs more work to make sure it will be effective for people with addictions. In general the big take home is that CCM, which has been looked to improve quality and outcomes and reduce cost of care, should not be assumed to be effective without testing it.

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

• Dr. Saitz: Research should test CCM for more specific substance use disorders (just as CCM doesn’t get applied to the vast spectrum of “heart disease,” rather it gets applied, successfully, to patients with symptomatic heart failure of a particular severity level). For example, CCM might be tested for patients with opioid dependence interested in pharmacotherapy treatment. In addition, it would make sense to test different ways of implementing CCM (like more specific care pathways or less specific; or more integration with primary care clinician teams or less; enrolling more or less severe patients) as some features may be more critical to success than others.

• Citation:• Saitz R, Cheng DM, Winter M, et al. Chronic Care Management for Dependence on Alcohol and Other

Drugs: The AHEAD Randomized Trial. JAMA. 2013;310(11):1156-1167. doi:10.1001/jama.2013.277609.

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Spine Pain Patients: Prevalence of Fibromyalgia in Tertiary Pain ClinicMedicalResearch.com Interview with:Chad M. Brummett, M.D.Assistant Professor, University of Michigan Health SystemDepartment of AnesthesiologyDivision of Pain Medicine Ann

Arbor, MI 48109

• MedicalResearch.com: What are the main findings of the study?• Dr. Brummett: The study found that 42% of new patients presenting to a tertiary care pain clinic with a primary spine pain diagnosis

met the American College of Rheumatology (ACR) survey criteria for fibromyalgia, which is a measure of widespread body pain and comorbid symptoms (e.g. trouble thinking, fatigue, mood symptoms, etc.). Patients categorized as fibromyalgia-positive using the survey measure were distinctly different from those not meeting criteria. In a multivariate regression model, independent predictors of being categorized as fibromyalgia-positive were female sex, higher neuropathic pain scores, anxiety, and lower physical function.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Brummett: The high percentage (42%) of people meeting the predefined cut point for fibromyalgia-positive was surprising. These

patients all had primary diagnoses of a spine disorder, not fibromyalgia. Hence, the specific spine disorder may in fact be a broader problem characterized by the widespread body pain and comorbid symptoms commonly associated with fibromyalgia.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Brummett: Whereas this does not “diagnose” the patient with fibromyalgia, it suggests that there is a portion of a spine pain

cohort that has pain that may be more fibromyalgia-like, rather than having pure spine pain. This type of presentation has been termed “centralized pain” by some experts due to the observed changes in central nervous system pain processing that occurs in fibromyalgia. Given that many spine pain interventions/injections target peripheral structures, the presence of fibromyalgia-like phenotype may explain some of the variance and failures seen in procedures like facet/medial branch interventions and epidural steroid injections.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Brummett: Future research is needed to better understand whether the distinct differences in characteristics in the fibromyalgia-

like cohort of spine patients is truly associated with altered neurophysiology or pain processing and whether these differences predict outcomes.

• Citation:• Prevalence of the fibromyalgia phenotype in spine pain patients presenting to a tertiary care pain clinic and the potential treatment i

mplications• Chad M. Brummett, Jenna Goesling, Alex Tsodikov, Taha S. Meraj, Ronald A. Wasserman, Daniel J. Clauw and Afton L. Hassett

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Urinary Catheter Infections: Clinical Assessment vs National Safety Network DefinitionMedicalResearch.com Interview with:Mohamad Fakih, MD, MPHMedical Director, Infection Prevention and ControlSt John Hospital and Medical Center

• MedicalResearch.com: What are the main findings of the study?• Dr. Fakih: Urinary catheters are commonly used in the hospital. Although they

help in the management of the sickest patients, they also present a risk for infection and other harms to the patient. The Centers for Medicaid and Medicare Services (CMS) have made catheter associated urinary tract infections (CAUTI) publicly reportable, and no longer reimburse hospitals for these infections if they occur in hospital setting. The definition of CAUTI is based on the surveillance definition of the National Healthcare Safety Network (NHSN) by the Centers for Disease Control and Prevention (CDC). We looked at clinician practice, including the Infectious Diseases specialist’s impression and compared them to the NHSN definition. We found a significant difference between what clinicians think is a urinary catheter infection and give antibiotics for it compared to the NHSN definition. The NHSN definition predicted clinical infection by the Infectious Diseases specialist in only about a third of the cases. We also found that Infectious Disease specialists considered patients to have true CAUTI in only half of what clinicians treated as CAUTI.

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Urinary Catheter Infections: Clinical Assessment vs National Safety Network DefinitionMedicalResearch.com Interview with:Mohamad Fakih, MD, MPHMedical Director, Infection Prevention and ControlSt John Hospital and Medical Center

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Fakih: The NHSN definition is heavily influenced by the presence of a positive urine

culture of more than a 100,000 colony forming units and the presence of a fever (temperature > 38 degrees celsius). Patients may have asymptomatic bacteriuria and a fever from another source and still be identified as CAUTI using the NHSN definition. A very important result from our study is that the NHSN CAUTI definition does not reflect well the clinical practice of neither the clinicians nor the Infectious Diseases specialists, although it is used for public reporting of CAUTI by hospitals.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Fakih: When approached by infection prevention or other members from quality, the

clinician may not agree with the diagnosis based on the NHSN definition because it does not mirror the clinical diagnosis. Furthermore, patients may be viewing data that do not accurately reflect the clinical disease related to CAUTI. They would need to be cognizant that the CDC NHSN definition is a surveillance definition and not a clinical definition, and that it has its limitations. Finally, clinicians overtreat patients for CAUTI.

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Urinary Catheter Infections: Clinical Assessment vs National Safety Network DefinitionMedicalResearch.com Interview with:Mohamad Fakih, MD, MPHMedical Director, Infection Prevention and ControlSt John Hospital and Medical Center

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

Dr. Fakih: These findings have significant policy implications that potentially will impact both quality improvement efforts and financial reimbursements by CMS. Other hospitals are encouraged to evaluate whether our findings are generalizable to their settings. Related to policy implications, we suggest to consider additional measures to evaluate patient harm related to the urinary catheter, including urinary catheter utilization based on the different intensive care or non-intensive care units involved.

• Check out how to prevent catheter-associated urinary tract infections: www.catheterout.org• Citation:• Clinician practice and the National Healthcare Safety Network definition for the diagnosis o

f catheter-associated urinary tract infection • Fadi Al-Qas Hanna, Oksana Sambirska, Sugantha Iyer, Susanna Szpunar, Mohamad G. Fakih • AJIC: American Journal of Infection Control – 09 September 2013 (10.1016/j.ajic.2013.05.024)

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Unhealthy Aging and Chronic InflammationMedicalResearch.com Interview with:Tasnime Akbaraly PhDInstitut National de la Santé et de la Recherche MédicaleMontpellier, France

• MedicalResearch.com: What are the main findings of the study?• Dr. Akbaraly: The aim of this study was to examine the association between chronic

inflammation and a range of aging phenotypes, assessed approximately 10 years later in a large British population of men and women -The Whitehall II Study-. As inflammation characterises a wide range of pathological processes, we considered several aging phenotypes, including cardiovascular disease (fatal and non-fatal), non-cardiovascular mortality and successful aging which encompasses optimal functioning across different physical, mental, and cognitive domains

• We found that chronic inflammation characterized by high levels of interleukin-6 (>2 pg/mL) twice over the 5-year exposure period nearly halved the odds of successful aging after 10–years of follow-up compared to maintaining low levels of interleukin-6 (<1pg/mL twice over the exposure period). Chronic inflammation was also associated with increased odds of future cardiovascular disease and non-cardiovascular mortality in a dose-response fashion. These associations were found to be independent of socio-economic factors, health behaviours (smoking, physical activity), and conditions such as obesity as well as the use of anti-inflammatory drugs and acute inflammation.

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Unhealthy Aging and Chronic InflammationMedicalResearch.com Interview with:Tasnime Akbaraly PhDInstitut National de la Santé et de la Recherche MédicaleMontpellier, France

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Akbaraly: Our study indicates that high interleukin-6 levels at baseline were inversely

associated with most of the components that characterise successful aging; good cardiovascular, respiratory, and musculoskeletal functioning, good mental well-being and the absence of diabetes and disability. Exceptions were components related to good cognitive function and cancer.

• Regarding cognition, a more robust association with inflammation was expected according to available epidemiological literature which provides support for an inflammation-cognitive decline relationship.

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

• Dr. Akbaraly:• Clinicians: The present results shed new light on the importance of assessing long-term

chronic inflammation in geriatric clinical practice to target individuals at risk to develop unhealthy aging.

• Patients: To promote ideal health our study suggests managing long-term chronic inflammation.

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Unhealthy Aging and Chronic InflammationMedicalResearch.com Interview with:Tasnime Akbaraly PhDInstitut National de la Santé et de la Recherche MédicaleMontpellier, France

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

• Dr. Akbaraly:• 1. Our analyses have to be replicated in other population and other countries to extend

the generalisability of the present finding.• 2. We reported that the predictive ability of the aging phenotype is significantly better

when inflammation is assessed with measures repeated at two time points rather than one, we recommend to assess chronic inflammation using multiple assessments of inflammatory markers to be able to distinct the short (acute) and long-term (chronic) impact of the inflammatory process on disease outcomes.

• Citation:• Chronic inflammation as a determinant of future aging phenotypes• Tasnime N. Akbaraly, Mark Hamer, Jane E. Ferrie, Gordon Lowe, G. David Batty, Gareth Hagger

-Johnson, Archana Singh-Manoux, Martin J. Shipley, and Mika Kävimäki• CMAJ cmaj.122072; published ahead of print September 16, 2013, doi:10.1503/cmaj.122072

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Diabetes: Increased Mortality Risk in Regardless of Race or EthnicityMedicalResearch.com Interview with:Dr. Yunsheng Ma MD, PHD, MPHDivision of Preventive and Behavioral Medicine Department of MedicineUniversity of Massachusetts Medical School55 Lake Avenue North, Worcester, MA 01655

• MedicalResearch.com: What are the main findings of the study?• Dr. Ma: Regardless of race/ethnicity, diabetes increases the risk of mortality the same

compared to non-diabetes among different race/ethnicity. However, since there are higher prevalence of diabetes in Black and Hispanic, death rate due to diabetes is much higher in Black and Hispanic, this is because the diabetes prevalence rates are much higher in these population. Therefore, diabetes prevention is key to reduce diabetes related mortality disparities among racial/ethnic groups.

•MedicalResearch.com: Were any of the findings unexpected?

• Dr. Ma: The rate at which women die of diabetes-related diseases such as cardiovascular disease and cancer is the same for all postmenopausal women, regardless of race or ethnicity.

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Diabetes: Increased Mortality Risk in Regardless of Race or EthnicityMedicalResearch.com Interview with:Dr. Yunsheng Ma MD, PHD, MPHDivision of Preventive and Behavioral Medicine Department of MedicineUniversity of Massachusetts Medical School55 Lake Avenue North, Worcester, MA 01655

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Ma: Clinical providers should discuss with women about diabetes prevention strategies including healthy diet and

exercise, especially among Black and Hispanic women. When choosing anti-diabetic medications, an evaluation of woman’s physical state and comorbidities is necessary in addition to the age.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Ma: Previous research indicate diabetes treatment may be different, White may have better access to anti-diabetic

medications, but that may not be helpful for mortality among postmenopausal women. We should evaluate how geriatric syndromes and age mediate the cardiovascular-morbidity and mortality related to all classes of anti-diabetic medications in aging women.

• Citation:• All-Cause, Cardiovascular, and Cancer Mortality Rates in Postmenopausal White, Black, Hispanic, and Asian Women With

and Without Diabetes in the United States• The Women’s Health Initiative, 1993–200

Yunsheng Ma, James R. Hébert, Raji Balasubramanian, Nicole M. Wedick, Barbara V. Howard, Milagros C. Rosal, Simin Liu, Chloe E. Bird, Barbara C. Olendzki, Judith K. Ockene, Jean Wactawski-Wende, Lawrence S. Phillips, Michael J. LaMonte, Kristin L. Schneider, Lorena Garcia, Ira S. Ockene, Philip A. Merriam, Deidre M. Sepavich, Rachel H. Mackey, Karen C. Johnson, and JoAnn E. Manson

• Am. J. Epidemiol. first published online September 17, 2013 doi:10.1093/aje/kwt177

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Obesity: Low Childhood IQ Raises Risk of Midlife Obesity and Late-Life DementiaMedicalResearch.com Interview with:Daniel Belsky, PhDNIA Postdoctoral FellowCenter for the Study of Aging and Human Development Duke University

Box 104410 Durham, NC 27708

• MedicalResearch.com: What are the main findings of the study?• Dr. Belsky: Midlife obesity is linked with increased risk for dementia later in life. Recently, studies have

reported that obese children and teens also have lower IQs. These studies have led scientists to speculate that obesity may harm the brain already in early life. We followed a cohort of 1000 children from birth through midlife (age 38 years) to understand how becoming obese might affect intellectual functioning.

• We measured children’s IQs when they were ages 7-11. We measured the IQs of those same children three decades later (at age 38).

• We found that, as expected, the children who became obesity between age 11 and age 38 years had lower IQs. But they had lower IQs already at age 11, before they became obese. We found no evidence that developing obesity contributed to decline in IQ from childhood to adulthood. This remained true when we accounted for childhood obesity preceding the first IQ measurement and when we focused on cases who developed severe obesity, with metabolic and or inflammatory abnormalities.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Belsky: These findings were not unexpected–previous longitudinal studies have shown that children

with low IQs are at increased risk for obesity--but they do call for new consideration of findings linking obesity with cognitive decline. Low childhood IQ is a risk factor for both midlife obesity and late-life dementia. Therefore, studies linking obesity with dementia may need to consider premorbid IQ lest they overestimate the effects of obesity on cognitive decline.

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Obesity: Low Childhood IQ Raises Risk of Midlife Obesity and Late-Life DementiaMedicalResearch.com Interview with:Daniel Belsky, PhDNIA Postdoctoral FellowCenter for the Study of Aging and Human Development Duke University

Box 104410 Durham, NC 27708

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Belsky: Obesity is unlikely to damage the brain during the first half of the life course.• MedicalResearch.com: What recommendations do you have for future research as a result

of this study?• Dr. Belsky: Future studies should investigate whether associations between midlife obesity

and later life cognitive decline can be explained by premorbid differences in IQ between obese cases and lean controls.

• Citation:• Is Obesity Associated With a Decline in Intelligence Quotient During the First Half of the Life C

ourse?• Daniel W. Belsky, Avshalom Caspi, Sidra Goldman-Mellor, Madeline H. Meier, Sandhya Ramrak

ha, Richie Poulton, and Terrie E. Moffitt• Am. J. Epidemiol. first published online September 12, 2013 doi:10.1093/aje/kwt135

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MRIs of the Knee: How big a role is doctor’s financial stake?MedicalResearch.com Interview with:Matthew P. Lungren, MDDuke University Medical Center

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Lungren: We certainly were curious enough to ask the question, and that is the

motivation for the study in the first place, whether or not there would be a significant difference. But we were surprised that it was such a drastic difference, particularly when you take into account how we designed the study to reduce potential confounding influences. Its important to note that this difference occurred despite otherwise highly similar pathology, demographics and referring physician characteristics between the two groups. Again, these findings suggest that there is a different threshold for ordering MRI examinations which may be due to financial incentive

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Lungren: There’s a great quote by Michael Novack that I think says it all: “Our capacity for

self-deception has no known limits.” Basically this study does raise legitimate questions:• Are these studies being performed unnecessarily?• Are these machines being over utilized because of an unconscious bias? Patients may not

want to second guess their doctor’s decision to order a scan, but it makes sense to ask whether they’re being referred to an imaging center where the doctor has a financial interest. Basically, the goal here is to be more transparent, which should be the default anytime there could be potential for violating the trust of the doctor patient relationship.

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MRIs of the Knee: How big a role is doctor’s financial stake?MedicalResearch.com Interview with:Matthew P. Lungren, MDDuke University Medical Center

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

• Dr. Lungren: We hope that this and other studies like this will capture the attention of the payors, including the government as we move toward cutting costs and eliminating waste from the health care system. Our group supports legislative and payer driven restriction of advanced imaging equipment (CT and MRI) self-referral by clinicians, as well as mandatory formal disclosure of all financial relationships between individual ordering physicians and imaging equipment their patients are referred to, documentation of patient referral source by imaging facilities, and registration of equipment to allow payment data collection.

• Citation:• Lungren MP, et al “Physician self-referral: Frequency of negative findings at MR imaging of the

knee as a marker of appropriate utilization” Radiology 2013; DOI: 10.1148/radiol.13130281.

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Pediatrics: Psychosomatic Problems in Bullied ChildrenMedicalResearch.com Interview with:Gianluca Gini, PhD and Tiziana Pozzoli, PhDDepartment of Developmental and Social PsychologyUniversity of Padua, Padua, Italy

• MedicalResearch.com: What are the main findings of the study?• Answer: Results of this meta-analysis show that bullied children are twice as likely as non-bullied children

to experience psychosomatic symptoms (e.g., headache, stomachache, backache, abdominal pain, dizziness, sleeping problems, poor appetite, bedwetting, skin problems, vomiting), especially in samples that included an higher proportion of boys. Importantly, the same result was found not only with cross-sectional studies but also in a meta-analysis of six studies that employed a longitudinal design.

•MedicalResearch.com: Were any of the findings unexpected?

• Answer: Not really. This meta-analysis confirmed the findings of former studies with a much larger sample of studies and participants from several countries around the world.MedicalResearch.com: What should clinicians and patients take away from your report?

• It is very important that adults be ready to identify children who are at risk of being bullied. The results of this meta-analysis suggest that any recurrent and unexplained somatic symptom can be a warning sign of bullying victimization. Because children do not easily talk about their bullying experiences, adults could approach the issue of bullying through general questions, for example by inquiring about the child’s experience and friends in school. If the child seems to be withdrawn from peers, the adult should ask for the reason and check if teasing, name calling or deliberate exclusion may be involved. Asking if the child feels safe at school can further allow the adult to gain insight into the level of concern that the child is experiencing.

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Pediatrics: Psychosomatic Problems in Bullied ChildrenMedicalResearch.com Interview with:Gianluca Gini, PhD and Tiziana Pozzoli, PhDDepartment of Developmental and Social PsychologyUniversity of Padua, Padua, Italy

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

• Answer: We call for new research efforts aimed at elucidating the mechanisms through which bullying affects children’s health over time. Moreover, there is need for research that investigates how other environmental factors interact with peer victimization experiences to determine health risk. Longitudinal studies that address the mediating role of environmental factors on the peer victimization-health problems link are much needed.

• Citation:• Bullied Children and Psychosomatic Problems: A Meta-analysis• Gianluca Gini and Tiziana Pozzoli

Pediatrics peds.2013-0614; published ahead of print September 16, 2013, doi:10.1542/peds.2013-0614

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Dementia: Lewy Body vs Parkinson’s DiseaseMedicalResearch.com Interview with:Rodolfo Savica, MD, MScDepartment of Neurology, College of Medicine

Division of Epidemiology, Department of Health Sciences Research, College of Medicine, Mayo Clinic, Rochester, Minnesota

• MedicalResearch.com: What are the main findings of this study? • Dr. Savica: This study is the first in North America to explore the incidence of DLB and PDD in a population based sample.

We found that the overall incidence of dementia with Lewy bodies (DLB), considered the second leading cause of neurodegenerative dementia after Alzheimer`s disease, is lower than that of Parkinson`s disease (PD), increases steeply with age, and is markedly higher in men than in women.

• We used the unique population-based medical records linkage system of the Rochester Epidemiology Project, in Olmsted County, MN.

• In particular, the overall incidence of Parkinson Disease Dementia (PDD) was 2.5 cases per 100,000 person-years; whereas the incidence of Dementia with Lewy Bodies (DLB) was 3.5 cases per 100,000 person-years. At, the incidence of Parkinson Disease (14.2 cases per 100,000 person-years) was 4-fold higher than DLB and 2.4 times higher than the incidence of DLB and PDD combined. In addition we found that the incidence of DLB was higher in men than in women; whereas PDD was similar across sexes.

• Furthermore we identified a series of differences in the clinical symptoms between DLB and PDD: DLB cases presented more hallucinations (62.5% vs 20.0%; p˂.001), more cognitive fluctuations (25% vs 8.9%; p.03) and, although not statistically significant, more myoclonus (12.5% vs 4.4%; p=.15).

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Savica: We were somehow surprised that PDD is less common that expected. PDD is also less common than DLB.

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Dementia: Lewy Body vs Parkinson’s DiseaseMedicalResearch.com Interview with:Rodolfo Savica, MD, MScDepartment of Neurology, College of Medicine

Division of Epidemiology, Department of Health Sciences Research, College of Medicine, Mayo Clinic, Rochester, Minnesota

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Savica: The differences in the clinical features may be extremely important to differentiate

between DLB and PDD. This information will be extremely helpful to clarify the correct diagnosis and to guide therapeutic interventions that may be different diseases and sexes.

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

• Dr. Savica: This study is a starting point to highlight and expand the research on DLB and PDD. We have a number of studies already in completion that will provide further help to patients, clinicians and scientist that are involved in DLB and PDD care.

• Citation:• Incidence of Dementia With Lewy Bodies and Parkinson Disease Dementia• Savica R, Grossardt BR, Bower JH, Boeve BF, Ahlskog J, Rocca WA. Incidence of Dementia Wi

th Lewy Bodies and Parkinson Disease Dementia. JAMA Neurol. 2013;():-. doi:10.1001/jamaneurol.2013.3579.

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Social Isolation Linked to MortalityMedicalResearch.com Interview with:Matthew S. Pantell, MD, MSDepartment of PediatricsUniversity of California, San Francisco

• MedicalResearch.com: What are the main findings of the study?• Dr. Pantell: First of all, our study confirms the strong association between social isolation and

mortality in a nationally representative sample from the US. Furthermore, it shows that, within the same national sample, social isolation is a similarly strong predictor of mortality as compared to smoking, obesity, high blood pressure, and high cholesterol. Examining individual components of social isolation, our study shows that, among both women and men, not living with a partner and not participating in religious activities frequently are strong individual predictors of mortality. Finally, our work shows that infrequent social contact is associated with mortality among women, and not participating in social clubs/organizations is associated with mortality among men.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Pantell: It was a little surprising that obesity and cholesterol were not stronger predictors

of mortality. But clinicians are used to monitoring for these risk factors and intervening, which may explain why they did not predict mortality that well.

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Social Isolation Linked to MortalityMedicalResearch.com Interview with:Matthew S. Pantell, MD, MSDepartment of PediatricsUniversity of California, San Francisco

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Pantell: Clinicians and patients should take away that it is important to be aware of and explore patients’ social situation.

Social support is something that is not necessarily discussed in health care visits, but our study suggests that it is something that is just as predictive of death as traditional clinical risk factors. Knowing the amount of social support patients have can potentially help clinicians determine who might benefit from more health care surveillance. If two patients come in with the same medical problems and the only difference is that one is socially isolated and the other is very socially integrated, I would be more worried about the former.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Pantell: The next step would be to determine what to do with this information. Future studies should determine the

possible benefits of screening for social isolation in clinical settings, as well as what interventions should be carried out once someone is identified as being socially isolated. These interventions may come in the form of increasing social support for that person, or, they may also be directed at more medical surveillance of that person. Finally, future studies should aim to understand the mechanisms through which social isolation increases mortality risk.

• Citation:• Social Isolation: A Predictor of Mortality Comparable to Traditional Clinical Risk Factors• Matthew Pantell, David Rehkopf, Douglas Jutte, S. Leonard Syme, John Balmes, and Nancy Adler. (2013). Social Isolation: A P

redictor of Mortality Comparable to Traditional Clinical Risk Factors. American Journal of Public Health. e-View Ahead of Print.

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Adolescents: Bending the Obesity CurveMedicalResearch.com Interview with:Ronald J. Iannotti, PhDPrevention Research Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland

• MedicalResearch.com: What are the main findings of the study?• Dr. Iannotti: Although average BMI percentile increased from 2001 to 2005 it did not increase

from 2005 to 2009. This is consistent with some recent studies that suggest the increase in overweight and obesity may be leveling off. We suggest that we may be ‘bending the curve’. During the same period, physical activity and consumption of fruits and vegetables increased while television watching and consumption of sweets and sweetened beverages decreased. We cannot say whether television watching was replaced with more time spent on computers but we did not find an increase in computer use from 2005 to 2009.

•MedicalResearch.com: Were any of the findings unexpected?

• Dr. Iannotti: YES! . Over the past four or five decades adolescent overweight and obesity have steadily increased along with television watching and consumption of foods high in sugar, while physical activity and the relative consumption of fruits and vegetables has decreased. These results are very encouraging. This would be the first decade in a long time where overweight did not increase substantially and where healthful behaviors increased.

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Adolescents: Bending the Obesity CurveMedicalResearch.com Interview with:Ronald J. Iannotti, PhDPrevention Research Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Iannotti: There is still lots of room for improvement. Most adolescents are not getting 60 minutes of moderate to

vigorous physical activity and day and the consumption of fruits and vegetables is not even close to the recommended 5 servings per day. Because of gender differences, clinicians might focus on increasing physical activity in girls and decreasing their consumption of sweets. For boys, the focus might be on diet and television, decreasing television watching and increasing fruits and vegetables.

• For parents, they should continue to encourage their children to get more exercise and to eat fruits and vegetables. Some types would be to demonstrate the behaviors they want their children to adopt. For example, they could take a walk after dinner with the entire family. When their children do watch television, they could make sure that healthful snacks (for example, cut up fruits and vegetables) are easily available. We tend to be lazy and having good choices easily available makes it more likely that we will make those choices.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Iannotti: We need to continue to monitor these trends and identify whether the changes in health behaviors are causing

this change in the rate of growth in the obesity epidemic.• Citation:• Trends in Physical Activity, Sedentary Behavior, Diet, and BMI Among US Adolescents, 2001–2009• Ronald J. Iannotti and Jing Wang• Pediatrics peds.2013-1488; published ahead of print September 16, 2013, doi:10.1542/peds.2013-1488

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Stroke Risk: Increased Risk with Intraplaque Carotid Artery HemorrhageMedicalResearch.com Interview with:Tobias Saam, MDInstitute of Clinical RadiologyLudwig-Maximilians-Univ Hosp Munich, Germany

• MedicalResearch.com: What are the main findings of the study?• Dr. Saam: The results of our meta-analysis suggest that despite a large degree of detected

heterogeneity of the published studies, the presence of intraplaque hemorrhage by MRI in patients with carotid artery disease is associated with an approximately 5.6-fold higher risk for cerebrovascular events, such as TIA or stroke, as compared to subjects without intraplaque hemorrhage.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Saam: Most of our findings were expected, as several previous studies have shown an

association of carotid intraplaque hemorrhage with ischemic results. We confirmed theses previous studies and were able to provide more precisely risk estimates due to the effect that we were able to include data of 8 separate studies with almost 700 patients and 108 events. However, we were surprised that the annualized event rate in subjects with detectable IPH was really high in subjects with intraplaque hemorrhage compared to subjects without intraplaque hemorrhage (17.7% vs 2.4%).

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Stroke Risk: Increased Risk with Intraplaque Carotid Artery HemorrhageMedicalResearch.com Interview with:Tobias Saam, MDInstitute of Clinical RadiologyLudwig-Maximilians-Univ Hosp Munich, Germany

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Saam: While this result does not necessarily justify the widespread clinical use of carotid MRI in patients it provides a

strong rationale for larger clinical trials to determine whether specific MRI plaque findings in the carotid arteries might be able to risk stratify patients into those who benefit from conservative versus interventional therapy. Furthermore, we showed that symptomatic patients with carotid stenosis and IPH have a particularly high risk of a recurrent event and, as a consequence, might benefit from early interventions.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Saam: We were not able to analyze the event rates of symptomatic patients with IPH and <50% stenosis, given the very

limited data, although there is increasing evidence that such lesions might play a role in the pathogenesis of symptoms in patients with cryptogenic stroke. Several ongoing prospective MRI trials, such as the CAPIAS trial (Carotid Plaque Imaging in Acute Stroke, NCT01284933), are investigating the consequences of such lesions on the occurrence of cerebrovascular events in patients with acute ischemic stroke and without significant carotid artery stenosis.

• Citation:• Meta-Analysis and Systematic Review of the Predictive Value of Carotid Plaque Hemorrhage on Cerebrovascular Events by

Magnetic Resonance Imaging • Tobias Saam; Holger Hetterich; Verena Hoffmann; Chun Yuan; Marcus Treitl; Martin Dichgans; Holger Poppert; Maximilian

Reiser; Fabian Bamberg• Abstract Session Title: Vascular Medicine (Noncoronary): Molecules, Mechanisms and Physiology Abstract 12997:• Circulation. 2012; 126: A12997

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Breast Cancer in Young Women: Decisions that Affect Contralateral Prophylactic MastectomyMedicalResearch.com Interview with:Shoshana M. Rosenberg, ScD, MPHResearcher, Susan F. Smith Center for Women’s Cancers

Dana-Farber Cancer Institute

• MedicalResearch.com: What are the main findings of the study?• Answer: Rates of contralateral prophylactic mastectomy (CPM) have been increasing among all

breast cancer patients, however this trend has been most pronounced among the youngest women with breast cancer. Because of this trend, we sought to better understand why the youngest women – those diagnosed at age 40 or younger – were deciding to have this surgery.

• Many women not considered “high-risk”, e.g., those without a cancer pre-disposing mutation, cited a desire to prevent the breast cancer from spreading as well as a desire to improve survival as reasons for undergoing the procedure, indicating they overestimate the benefit of having this surgery, as CPM does not affect these outcomes. While CPM does reduce the risk of developing breast cancer in the unaffected breast, in women who are not considered “high-risk”, this risk is relatively low, however many women overestimated this risk as well.

• MedicalResearch.com: Were any of the findings unexpected?• Answer: One of the interesting findings was that most women understood that survival does

not depend on what type of surgery is chosen however many women cited improved survival as a reason to have CPM. We think that anxiety and fear of recurrence is likely leading some women to choose CPM (almost all women also cited peace of mind as a reason to have CPM) despite knowing objectively that it does not improve survival. In future work, we hope to more comprehensively investigate this discordance.

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Breast Cancer in Young Women: Decisions that Affect Contralateral Prophylactic MastectomyMedicalResearch.com Interview with:Shoshana M. Rosenberg, ScD, MPHResearcher, Susan F. Smith Center for Women’s Cancers

Dana-Farber Cancer Institute

• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: In addition to more effective risk communication, there is a need to better support women during the decision-

making process by addressing anxiety, fears, and concerns, as our findings suggest that under-attention to these important issues might lead women to choose more surgery than is actually needed.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Answer: Correcting misperceptions and misunderstandings is important however our findings suggest that this needs to be

done in combination with better psychosocial support during the decision-making process. In addition, women should be informed of the potential that certain health and quality of life outcomes might be adversely impacted. In our study, one-third of women said the number of surgeries needed was worse than they had expected and 42% said their sense of sexuality was worse than expected.

• Citation:• Perceptions, Knowledge, and Satisfaction With Contralateral Prophylactic Mastectomy Among Young Women With Breast

Cancer: A Cross-sectional Survey• Shoshana M. Rosenberg, ScD, MPH; Michaela S. Tracy, BA; Meghan E. Meyer, BS; Karen Sepucha, PhD; Shari Gelber, MS, MS

W; Judi Hirshfield-Bartek, MS; Susan Troyan, MD; Monica Morrow, MD; Lidia Schapira, MD; Steven E. Come, MD; Eric P. Winer, MD; and Ann H. Partridge, MD, MPH

• Ann Intern Med. 2013;159(6):373-381. doi:10.7326/0003-4819-159-6-201309170-00003

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Melanoma: PDK1 Kinase Required for Development and MetastasisMedicalResearch.com Interview with:Ze’ev Ronai, Ph.D.Professor and scientific director of Sanford-Burnham Medical Research Institute La Jolla San Diego, Calif.

• MedicalResearch.com: What are the main findings of the study? • Answer: This study provides the first direct evidence of the importance of the PDK1 enzyme

in the development of melanoma and in the metastasis of this aggressive tumor type. We demonstrate, with a genetic mouse melanoma model (harboring the Braf/Pten mutations commonly seen in human melanomas) and/or pharmacological inhibitors against PDK1, that melanoma requires this enzyme for its development, and more so – for its ability to metastasize. Since PDK1 is key kinase that regulates a number of protein kinases, which are currently being assessed in clinical trials (including AKT), our finding points to a new set of targets that could be more amenable for effective combination therapy in melanoma.

• MedicalResearch.com: Were any of the findings unexpected?• Answer: We were surprised by the degree of inhibition seen in melanoma metastasis using

the genetic model, and even more so by how much of the PDK1 activity was AKT-independent, thereby pointing to kinases other than AKT that are regulated by PDK1 as mediators of melanoma development.

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Melanoma: PDK1 Kinase Required for Development and MetastasisMedicalResearch.com Interview with:Ze’ev Ronai, Ph.D.Professor and scientific director of Sanford-Burnham Medical Research Institute La Jolla San Diego, Calif.

• MedicalResearch.com: What should clinicians and patients take awayfrom your report?• Answer: These findings point to a possible new tangible therapeutic target for melanoma

therapy. Since PDK1 inhibitors arecurrently in clinical trials, and others are at advance stages of development, they should be considered for combination therapy with Braf inhibitors, MEK inhibitors or immunotherapies (PD1 inhibitors).

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

• Answer: We are excited about these findings and plan to extend them to better understand which of the >20 kinases regulated by PDK1 is required for the development and metastasis of melanoma, and which of the melanoma patient tumors are more amenable for treatment with PDK1 inhibitors. Validation of our findings in other laboratories, including some of the pharmaceutical companies that have PDK1 inhibitors would be a logical step forward in further assessing PDK1 as melanoma target for therapy.

• Citation:• Genetic inactivation or pharmacological inhibition of Pdk1 delays development and inhibits

metastasis of BrafV600E::Pten–/– melanoma• M Scortegagna, C Ruller, Y Feng, R Lazova, H Kluger, J-L Li, S K De, R Rickert, M Pellecchia, M Bos

enberg and Z A Ronai

Oncogene , (16 September 2013) | doi:10.1038/onc.2013.383Read the rest of the interview on MedicalResearch.com

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Opiod Prescriptions: Marked Increase in 10 Year PeriodMatthew Daubresse, MHSResearch Data AnalystCenter for Drug Safety and EffectivenessJohns Hopkins School of Public HealthBaltimore, MD 21205

• MedicalResearch.com: What are the main findings of the study?• Answer: Over the past decade, prescriptions for non-opioid medications remained stable or declined among ambulatory pain

visits in the United States. In visits for new-onset musculoskeletal pain, non-opioid prescribing decreased from 38% of visits in 2000 to 29% of visits in 2010. During this time, opioid prescriptions nearly doubled. Few patient, provider, and visit characteristics were associated with the likelihood of opioid receipt, suggesting increases in opioid prescribing have occurred generally across different groups of patients.

• MedicalResearch.com: Were any of the findings unexpected?• Answer: We were surprised to discover prescriptions for non-opioid medications remained stable or declined, especially given no

significant change in the proportion of doctor’s office visits with pain or in the proportion of pain visits treated with pain relievers.

• • MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: Clinicians and patients should be fully aware of the trade-offs between different pain-relievers. Efforts to improve the

identification and treatment of pain may have contributed to an over-reliance on prescription opioids and reductions in the use of safer alternatives to opioids like ibuprofen and acetaminophen.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Answer: Future work should examine the large proportion of pain visits that did not result in the receipt of an analgesic. This

type of work would assist in determining whether current levels of pain treatment in the United States are sufficient. With more detailed information related to indication and dosage, future studies could also assist in determining the appropriateness of pain prescriptions.

• Citation:• Ambulatory Diagnosis and Treatment of Nonmalignant Pain in the United States, 2000–2010

M. Daubresse, H.Y. Chang, S. Viswanathan, Y. Yu, N. Shah, R.S. Stafford, S. Kruszewski, G.C. AlexanderValue in Health – May 2013 (Vol. 16, Issue 3, Page A127, DOI: 10.1016/j.jval.2013.03.615)

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Coronary Artery Bypass Grafting: On-Pump vs Off-Pump Trends and MortalityMedicalResearch.com Interview with:Faisal G. Bakaeen, MD FACSDivision of Cardiothoracic Surgery, Michael E. DeBakey

Department of Surgery, Baylor College of Medicine, Houston, TexasThe Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas Department of Cardiovascular Surgery, The Texas Heart Institute at St. Luke’s Episcopal Hospital, Houston, Texas

• MedicalResearch.com: What are the main findings of the study?• Dr. Bakaeen: The relative use of off-pump CABG peaked at 24% in 2003, followed by a slow

decline after that to about 19%. In addition, the conversion rate from off- to on-pump decreased with time and has stayed below 3.5% in recent years. Perioperative mortality rates decreased over time for both on- and off-pump CABG and have stayed below 2% since 2006. The mortality associated with converted cases was high regardless of the surgery year.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Bakaeen: No, we speculated that after an initial hype associated with off-pump surgery,

enthusiasm has dampened and that the utilization rate declined in recent years. Our current study served to confirm and document this trend.

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Coronary Artery Bypass Grafting: On-Pump vs Off-Pump Trends and MortalityMedicalResearch.com Interview with:Faisal G. Bakaeen, MD FACSDivision of Cardiothoracic Surgery, Michael E. DeBakey

Department of Surgery, Baylor College of Medicine, Houston, TexasThe Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas Department of Cardiovascular Surgery, The Texas Heart Institute at St. Luke’s Episcopal Hospital, Houston, Texas

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Bakaeen: Taken into context and in conjunction with reports from recent randomized trials that show no real advantage

to off-pump over on-pump CABG, one can expect an even “tougher sell” for off-pump in the future. In fact, there are concerns relating to a higher risk of incomplete revascularization and the need for subsequent revascularization when CABG is performed off-pump. In a separate study that is based on the same database analyzed here, our group has demonstrated that off-pump CABG may be associated with decreased long-term survival.

• Having said that, the off-pump CABG is useful in select anatomic and physiologic scenarios, such as in patients with porcelain aortas, those with advanced liver or pulmonary disease. In addition, there are surgeons at high volume off-pump centers with necessary infrastructure and resources that have reported matching (or even improving upon) on-pump outcomes.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Bakaeen: I think follow-up studies from the ROOBY, CORONARY, and GOCABE trials will shed interesting light on longer-

term outcomes of the two revascularization strategies. Could off-pump CABG compromise long-term survival?• I don’t think that there will be any new large scale randomized trials comparing on- and off-pump CABG in the future, but I

do think that there is a real need for studies to evaluate how to best teach off-pump techniques to future generations in the face of declining off- (and on-) pump CABG volumes. It is undeniable that the off-pump technique is a useful skill in the armamentarium of cardiac surgeons.

• Citation:• Trends Over Time in the Relative Use and Associated Mortality of On-Pump and Off-Pump Coronary Artery Bypass Graftin

g in the Veterans Affairs System• Bakaeen FG, Kelly RF, Chu D, Jessen ME, Ward HB, Holman WL. Trends Over Time in the Relative Use and Associated Mort

ality of On-Pump and Off-Pump Coronary Artery Bypass Grafting in the Veterans Affairs System. JAMA Surg. 2013;():-. doi:10.1001/jamasurg.2013.3580.

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Dental Caries and Head and Neck CancerMedicalResearch.com Interview with:Mine Tezal, DDS, PhDOral Biology University at BuffaloNYS Center of Excellence in Bioinformatics and Life Sciences

• MedicalResearch.com: What are the main findings of the study? • Dr. Tezal: We observed an inverse association between dental caries and head and neck

cancer (HNSCC), which persisted among never smokers and never drinkers. Besides untreated caries, two other objective measures of long-standing caries history (endodontic treatments and crowns) were also inversely associated with HNSCC with similar effect sizes, supporting the validity of the association. Missing teeth was associated with increased risk of HNSCC in univariate analyses, but after adjustment for potential confounders, its effect was attenuated and was no longer statistically significant.

• MedicalResearch.com: Were any of the findings unexpected? • Dr. Tezal: Yes, an inverse association between dental caries and HNSCC was an unexpected

finding since dental caries has been considered a sign of poor oral health along with periodontal disease. Periodontal disease, a chronic inflammatory disease, was associated with an increased risk of HNSCC, which explains the lack of association with missing teeth since more than half of the teeth are lost due to periodontal disease.

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Dental Caries and Head and Neck CancerMedicalResearch.com Interview with:Mine Tezal, DDS, PhDOral Biology University at BuffaloNYS Center of Excellence in Bioinformatics and Life Sciences

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Tezal: The message, of course, is not to get caries to prevent cancer.• Dental caries is the demineralization of tooth structures by lactic acid from fermentation of carbohydrates by commensal bacteria,

including streptococci, lactobacilli, actinomyces, and bifidobacteria, the same kinds of bacteria used in yogurt production. These commensal bacteria have important roles in local mucosal and systemic immunity, and their reduction has been associated with chronic inflammatory diseases, allergies and cancer. They produce antitumorigenic and antimutagenic compounds, favor an anti-inflammatory response, and inhibit adhesion and growth of pathogenic bacteria.

• It is important to understand that cariogenic bacteria are part of the normal flora, and their presence is not sufficient to cause dental caries in the absence of the other risk factors, such as dental plaque, frequent consumption of sugars, and reduced saliva. In addition, caries is a dental plaque-related disease. Lactic acid bacteria cause demineralization (caries) only when they are in dental plaque at immediate contact with the tooth surface. The presence of these otherwise beneficial bacteria in saliva or on mucosal surfaces may protect the host against chronic inflammatory diseases and HNSCC. We could think of dental caries as a collateral damage, and develop strategies to reduce its risk while preserving the beneficial effects of the lactic acid bacteria. For example, antimicrobial treatment, vaccination or gene therapy against cariogenic bacteria may lead to more harm than benefit in the long run, including a shift in microbial ecology towards pathogenic bacteria, and increased risks of chronic inflammatory diseases and cancer. Instead, strategies preserving microbial ecology beneficial to the host such as mechanical plaque control (brushing and flossing), preservation of saliva, fluoride use, and refraining from frequent intake of sugars, antimicrobials, and smoking may be wiser.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Tezal: This study provides insights for prospective studies to assess potential beneficial effects of lactic acid bacteria and the

associated immune responses on HNSCC.• Citation:• Tezal M, Scannapieco FA, Wactawski-Wende J, et al. Dental Caries and Head and Neck Cancers.

JAMA Otolaryngol Head Neck Surg. 2013;():-. doi:10.1001/jamaoto.2013.4569.

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Hypertension Control: Financial Incentives EffectsMedicalResearch.com Interview with:Laura A. Petersen, MD, MPHMEDVAMC Associate Chief of Staff, ResearchDirector, VA HSR&D Center of Excellence (152) Houston TX 77030Professor of

Medicine Chief, Section of Health Services Research Baylor College of Medicine

• MedicalResearch.com: What are the main findings of the study?• Dr. Petersen: VA physicians randomized to the individual incentive group were more likely than controls to

improve their treatment of hypertension. The adjusted changes over the study period in Veterans meeting the combined BP/appropriate response measure were 8.8 percentage points for the individual-level, 3.7 for the practice-level, 5.5 for the combined, and 0.47 for the control groups. Therefore, a physician in the individual group caring for 1000 patients with hypertension would have about 84 additional patients achieving blood pressure control or appropriate response after 1 year. The effect of the incentive was not sustained after the washout period. Although performance did not decline to pre-intervention levels, the decline was significant. None of the incentives resulted in increased incidence of hypotension compared with controls. While the use of guideline-recommended medications increased significantly over the course of the study in the intervention groups, there was no significant change compared to the control group. The mean individual incentive earnings over the study represented approximately 1.6% of a physician’s salary, assuming a mean salary of $168,000.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Petersen: I thought the change would be sustained after the intervention stopped. It was a long

intervention and I thought people’s practices would change over time. However, it shows that the incentives were working. If their performance had not fallen off after the incentives were stopped, then we might question whether the incentives caused the effect in the first place.

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Hypertension Control: Financial Incentives EffectsMedicalResearch.com Interview with:Laura A. Petersen, MD, MPHMEDVAMC Associate Chief of Staff, ResearchDirector, VA HSR&D Center of Excellence (152) Houston TX 77030Professor of

Medicine Chief, Section of Health Services Research Baylor College of Medicine

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Petersen: These results do show that financial incentives can be an important tool in

positively impacting patient care. As similar types of pay for performance initiatives are instituted by the Affordable Care Act, more research into the way that providers and patients respond will be important to guide health care policy

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

• Dr. Petersen: Future research should explore who system-level changes to promote sustained changes in physician behavior can be incentivized

• Citation:• Petersen LA, Simpson K, Pietz K, et al. Effects of Individual Physician-Level and Practice-Level F

inancial Incentives on Hypertension Care: A Randomized Trial. JAMA. 2013;310(10):1042-1050. doi:10.1001/jama.2013.276303.

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Atrial fibrillation: Surgical and Transcatheter AblationMedicalResearch.com Interview with:Elisa Ebrille, MDDepartment of Cardiology, School of MedicineFiorenzo Gaita, M.D.Director Division of Cardiology Department of Medical

Sciences University of Turin, Turin, Italy

• MedicalResearch.com What are the main findings of the study?• Answer: We evaluated 33 patients with long-standing atrial fibrillation and valvular heart

disease who underwent valve surgery and concomitant cryoablation (pulmonary veins isolation, mitral isthmus and roof line lesions) from 2000 to 2002. The surgically created ablation lesion was validated with electroanatomic mapping. Percutaneous radiofrequency ablation was performed in cases with lesion incompleteness and these patients were followed for over 10 years.

• A hybrid approach, combining surgical ablation procedure consisting of pulmonary veins isolation and creation of left atrial linear lesions (mitral isthmus and roof lines), along with endocardial ablation, when necessary, led to a significant clinical improvement in patients with long-standing atrial fibrillation and valvular heart disease during a long-term follow-up (> 10 years).

• With the hybrid approach, pulmonary veins isolation and transmural left atrial linear lesions were obtained in a high percentage of patients (79%). When achieved and electrophysiologically demonstrated, the complete ablation scheme was effective in more than 80% of patients in maintaining sinus rhythm throughout follow-up.

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Atrial fibrillation: Surgical and Transcatheter AblationMedicalResearch.com Interview with:Elisa Ebrille, MDDepartment of Cardiology, School of MedicineFiorenzo Gaita, M.D.Director Division of Cardiology Department of Medical

Sciences University of Turin, Turin, Italy

• MedicalResearch.com Were any of the findings unexpected?• Answer: As already demonstrated by our previous study (Gaita F et al. Circulation 2005;111:136-142), we

expected patients with valvular heart disease and long-standing atrial fibrillation had dilated and remodeled atria. In this subset of patients, ablation results reported in the literature have been dismal. Moreover, we expected that surgical ablation alone did not necessarily mean that the completeness and transmurality of the lesions created was achieved. First, because transmurality is technically difficult to achieve in the left mitral isthmus since it is a thick area. Secondly, because nitrous oxide cryoenergy was utilized for surgical ablation (creating a lesion depth of no more than 4-5 mm). Thirdly, because both surgical and transcatheter ablation used an endocardial approach, making it more difficult to obtain the transmurality. We also expected that the transcatheter evaluation of the transmurality of the surgically created lesions and the detection of conduction gaps together with the capability of adding an endocardial touch-up ablation to eliminate the conduction gaps, would allow a correct and meaningful evaluation of atrial fibrillation recurrences during the follow-up.

• It was surprising to see that, at the end of a very long-term follow-up period (more than 10 years), when the electrophysiologic evaluation demonstrated completeness of the lesions created (with surgical cryoablation alone or with transcatheter radiofrequency energy touch-up), the success rate in maintaining sinus rhythm was 81%. Moreover, comparing the clinical results of patients in which a complete linear lesion scheme was obtained to patients in which the conduction gaps still persisted after the hybrid approach, a statistically significant difference in the freedom from permanent atrial fibrillation survival curves was noted. A complete linear lesion scheme, either surgically created or completed by radiofrequency energy, correlated positively with the procedural success at 10-year follow-up.

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Atrial fibrillation: Surgical and Transcatheter AblationMedicalResearch.com Interview with:Elisa Ebrille, MDDepartment of Cardiology, School of MedicineFiorenzo Gaita, M.D.Director Division of Cardiology Department of Medical

Sciences University of Turin, Turin, Italy

• MedicalResearch.com What should clinicians and patients take away from your report?• Answer: Atrial fibrillation is the most common sustained cardiac arrhythmia in the general

population and ablation has become a major therapeutic technique over the past few years. For many years, at least three major schools of thought tried to explain the underlying mechanisms of atrial fibrillation, recognizing the importance of atrial dilation and remodeling in valvular patients. Surgical atrial fibrillation ablation evolved from the original Cox-Maze strategy toward a minimally invasive procedure with good results. Percutaneous transcatheter ablation, trying to mimic the surgical ablation scheme, has also proven to be effective in maintaining sinus rhythm. However, up to now most of the published studies on atrial fibrillation ablation have had limited follow-up.

• New hybrid approaches, combining surgical and percutaneous ablation, are now emerging to enhance the success rates of these two procedures. In fact, surgical ablation does not necessarily ensure the completeness and transmurality of the lesions created. The evaluation of the transmurality of the surgically created lesions with an electrophysiologic study and the detection of conduction gaps with the capability of adding an endocardial touch-up ablation when necessary, allowed improving the long-term efficacy of the atrial fibrillation ablation procedure.

• Considering the need for very long-term follow-up data, as stressed also by the recently published guidelines, our paper attempted to provide the adequate data. To our knowledge, this represents the longest follow-up reported in the literature of atrial fibrillation ablation.

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Atrial fibrillation: Surgical and Transcatheter AblationMedicalResearch.com Interview with:Elisa Ebrille, MDDepartment of Cardiology, School of MedicineFiorenzo Gaita, M.D.Director Division of Cardiology Department of Medical

Sciences University of Turin, Turin, Italy

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

• Answer: The conclusion of our study was that, in patients with long-standing atrial fibrillation and valvular heart disease, the hybrid approach with surgical cryoablation consisting of pulmonary veins isolation and left atrial linear lesions combined with transcatheter radiofrequency ablation was highly effective in maintaining sinus rhythm or significantly reducing the atrial fibrillation burden in a very long-term follow-up. An electrophysiological evaluation, to validate the transmurality of the surgically created lesions and to complete the lesion scheme applying radiofrequency energy, improved the long-term efficacy of the ablation procedure.

• Further validation of our findings in multi-centered studies, investigation in a larger patient population, as well as prospective randomized studies would be needed to ensure the best approach for ablation strategy.

• Citation:• Very Long-Term Results of Surgical and Transcatheter Ablation of Long-Standing Persistent A

trial Fibrillation.• Gaita F, Ebrille E, Scaglione M, Caponi D, Garberoglio L, Vivalda L, Barbone A, Gallotti R.• Department of Cardiology, School of Medicine, University of Turin, Turin, Italy.

Ann Thorac Surg. 2013 Jul 31. pii: S0003-4975(13)01141-7. doi: 10.1016/j.athoracsur.2013.05.054. [Epub ahead of print]Read the rest of the interview on MedicalResearch.com

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Hypertension: Lower Chloride Levels Associated with Increased MortalityMedicalResearch.com Interview with:Dr Sandosh PadmanabhanInstitute of Cardiovascular and Medical SciencesUniversity of Glascow, Scotland

• Dr. Padmanabhan: In the study “Serum Chloride Is an Independent Predictor of Mortality in Hypertensive Patients” we analysed data on 12,968 patients with hypertension followed up at the Glasgow Blood Pressure Clinic. We found that patients in the lowest quintile of serum Cl− (<100 mmol/L), compared with all other patients, had a 23% higher mortality (all-cause, cardiovascular, and non-cardiovascular). Each 1-mmol/L increase in serum Cl− was associated with a 1.1% to 1.5% lower all-cause mortality, cardiovascular mortality and non-cardiovascular mortality. This was independent of serum concentrations of sodium, bicarbonate or potassium. We did not find any association with longitudinal blood pressure control.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Padmanabhan: The finding that serum chloride <100mol/L was associated with higher

mortality was unexpected. The commonly held view, that sodium is the major determinant of BP and adverse outcomes, has resulted in the assumption that any independent effect of chloride is irrelevant. This is because serum chloride was considered an inert bystander in electrochemical equilibrium across cell membranes. Despite serum chloride being a routine measurement of all clinical biochemistry panel, there has only been only one previous paper in 1995 which also showed a low serum chloride was associated with higher mortality.

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Hypertension: Lower Chloride Levels Associated with Increased MortalityMedicalResearch.com Interview with:Dr Sandosh PadmanabhanInstitute of Cardiovascular and Medical SciencesUniversity of Glascow, Scotland

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Padmanabhan: It is too early to say what mechanisms are operative in the inverse

association of serum chloride with long-term mortality. Our study should raise awareness among clinicians to consider serum chloride levels as a risk predictor.

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

• Dr. Padmanabhan: A lot of research is required to dissect the underpinning mechanism that relates low serum chloride to increased mortality. There is emerging evidence that immune mechanisms have a role in selective Cl− accumulation in the skin which is associated with salt-sensitive hypertension. Other areas of research include chloride transmembrane fluxes, the role of chloride in processes ranging from maintenance of cell volume, apoptosis, insulin secretion, neuronal excitability and vascular inflammation.

• Citation:• Serum Chloride Is an Independent Predictor of Mortality in Hypertensive Patients Mccallum, L

. et al. (2013)

.Hypertension . ISSN 0194-911X(doi:10.1161/HYPERTENSIONAHA.113.01793) (In Press)

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Gastrointestinal Endoscopes: Frequency of Improper CleaningMedicalResearch.com Interview with:Cori L. Ofstead, MSPHPresident and CEO OFSTEAD & ASSOCIATES400 Selby Avenue, Suite V |Blair Arcade WestSaint Paul, MN 55102-4520

• MedicalResearch.com: What are the main findings of the study?• Dr. Ofstead: Our researchers found evidence that endoscope reprocessing lapses, which involved a failure to properly clean and disinfect

endoscopes after patient use, were very common. These lapses occurred in hospitals, clinics, and ambulatory surgery centers, and involved various steps of the process. In many cases, the reprocessing problems persisted for months or years before being discovered. Over the past several years, thousands of patients have been exposed to contaminated endoscopes, which had significant implications for both patients and their medical providers. For example, we found quite a few cases where exposed patients had to be notified that proper procedures were not followed. In some cases, testing confirmed transmission of pathogens with an increase in morbidity and mortality.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Ofstead: Although reprocessing lapses were very common and several of the incidents involved the exposure of numerous patients

to contaminated endoscopes, only one report appeared in a peer-reviewed journal. Our discovery that these lapses went unnoticed for so long was unexpected, too.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Ofstead: Clinicians should make sure their institutions have developed policies and procedures to ensure the endoscopes they use

are properly cleaned and disinfected after each use. Facilities should conduct routine monitoring to evaluate the effectiveness of their processes with regard to contaminant removal. Patients who are notified of exposure to a contaminated endoscope should speak with their physicians about the testing needed to determine whether they have acquired a blood-borne virus or any other pathogens that can colonize the gut and cause problems later.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Ofstead: Epidemiologic investigations are needed to evaluate the impact of reprocessing practices on patient outcomes. Research is

also needed to determine whether current reprocessing guidelines and policies are adequate to ensure patient safety.• Citation:• Reported gastrointestinal endoscope reprocessing lapses: The tip of the iceberg

Alexandra M. Dirlam Langlay, Cori L. Ofstead, Natalie J. Mueller, Pritish K. Tosh, Todd H. Baron, Harry P. Wetzler AJIC: American Journal of Infection Control – 09 September 2013 (10.1016/j.ajic.2013.04.022)

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Child Care Settings: Prevalence of Fetal Alcohol SyndromesMedicalResearch.com Interview with:Svetlana Popova, M.D., M.P.H., Ph.D.Senior Scientist, Social and Epidemiological Research, Centre for Addiction and Mental HealthAssistant

Professor, Factor-Inwentash Faculty of Social Work, University of TorontoGraduate Faculty Associate Member, Institute of Medical Science, University of Toronto

• MedicalResearch.com: What are the main findings of the study?• Dr. Popova: We conducted a systematic literature review and meta-analysis of internationally

published and unpublished studies that reported the prevalence of FAS and/or FASD in all types of child care systems (e.g., orphanage, foster care, boarding school, adoption centre, or child welfare system).

• The primary objective was to estimate a pooled (combined) prevalence for FAS and FASD in various child care systems using data from existing studies that used an Active Case Ascertainment method (when researchers/clinicians actively seek and diagnose FASD cases). The available data was analyzed by using a standard statistical technique (called meta-analysis).

• This study revealed that the vast majority of existing studies report that the prevalence of Fetal Alcohol Spectrum Disorder (FASD) in the various child-care settings in the different countries is extremely high.

• Our analysis of these studies demonstrated that the pooled prevalence of FAS in child care settings (6%) was found to be approximately 9-30 times higher than the prevalence of FAS in the general population of North America, which is reported to range from 2 to 7 cases per 1,000 individuals in the USA and 1 per 1,000 in Canada. Thus, children in care represent a high-risk population for FASD.

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Child Care Settings: Prevalence of Fetal Alcohol SyndromesMedicalResearch.com Interview with:Svetlana Popova, M.D., M.P.H., Ph.D.Senior Scientist, Social and Epidemiological Research, Centre for Addiction and Mental HealthAssistant

Professor, Factor-Inwentash Faculty of Social Work, University of TorontoGraduate Faculty Associate Member, Institute of Medical Science, University of Toronto

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Popova: There were a couple of extreme findings. For example, the prevalence of FAS in orphanages for children with special

needs in Russia ranged from about 43% to 68%. However, there were no cases reported for FASD among children from China, which were adopted by USA parents. However, larger studies are needed before any conclusions can be drawn based on the above findings.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Popova: This study has important international implications. It showed that children housed in the various child-care settings

throughout the world can be considered a high-risk population for FASD. We hope that the results of this study will attract attention to the needs of children in care affected by prenatal alcohol exposure. We hope that routine screening for FASD in this high-risk population will be established in order to facilitate early diagnosis. Screening for FASD among children in care is imperative – this can be done by a child’s pediatrician/family physician during their routine health examination. Early diagnosis can lead to early participation in developmental interventions, which can in turn, improve the quality of life for children with an FASD and their families. Early interventions may also increase the potential for the prevention of secondary disabilities (e.g., school failure and drop-out, addictions, mental health problems, sexually deviant behavior, dependent living, involvement with the law, and incarceration). These secondary disabilities occur because behaviors can become more extreme when left untreated.

• Research has shown that early diagnosis and providing an appropriate environment improves outcomes and decreases the risk for additional impairments by up to four fold.

• It was also reported that adopting a child with FASD at a young age could prove to be beneficial since it gives the adoptive parents a greater opportunity to provide the structure, nurture, and the right set of circumstances to promote the growth and development of the child. Providing a positive environment may help the child to overcome difficulties that may arise later on in life. Research shows that children with FASD have the best outcomes when living in a stable, loving and nurturing home and have a highly structured and consistent living environment. Therefore, these children prenatally exposed to alcohol need loving homes even more than others.

• We also hope that this study will raise awareness of the severe consequences of prenatal alcohol exposure and, hopefully, prevent further alcohol-exposed pregnancies across the globe. Clinicians should be screening pregnant women and women of child-bearing age for alcohol-use disorders so that early interventions can be put in place.

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Child Care Settings: Prevalence of Fetal Alcohol SyndromesMedicalResearch.com Interview with:Svetlana Popova, M.D., M.P.H., Ph.D.Senior Scientist, Social and Epidemiological Research, Centre for Addiction and Mental HealthAssistant

Professor, Factor-Inwentash Faculty of Social Work, University of TorontoGraduate Faculty Associate Member, Institute of Medical Science, University of Toronto

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

• Dr. Popova: More research studies are needed in the field of prenatal alcohol exposure and FASD across the globe. For example, we still do not know the prevalence of FASD in the vast majority of the countries. The first step in understanding the severity and impact of FASD is to determine how many people have these conditions.

• We need to know how many people with FASD exist not only in general populations, but also among “special” populations such as heavy drinking women, aboriginal populations, children in care, prison populations, where the risk of prenatal alcohol exposure might be substantially higher.

• Once this information is available, policies and programs can be planned to benefit those living with FASD and to prevent more children from being born with these conditions.

• Citation:• Prevalence of Fetal Alcohol Spectrum Disorders in Child Care Settings:A Meta-analysis

Shannon Lange, Kevin Shield, Jürgen Rehm, and Svetlana PopovaPediatrics peds.2013-0066; published ahead of print September 9, 2013, doi:10.1542/peds.2013-0066

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Ischemic Stroke: Predicting Asymptomatic CAD from Intracranical Arterial CalcificationsMedicalResearch.com Interview with:Dr. Eung Y. KimDepartment of Radiology Gachon University Medical CenterIncheon, South Korea.

• MedicalResearch.com: What are the main findings of the study?• Answer: The extent of calcification involving intracranial artery significantly correlates with that of coronary artery in

patients with ischemic stroke. The Agatston score measured in the intracranial arteries may be an independent predictor of asymptomatic coronary artery disease in patients with ischemic stroke.

• MedicalResearch.com: Were any of the findings unexpected?• Answer: There was no significant correlation of the calcium score or volume between the middle cerebral artery and

coronary artery. It may be because the number of patients with calcifications in their middle cerebral arteries was only 6 (1.9%).

• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: One of the major causes of morbidity and mortality in patients with ischemic stroke is coronary artery disease

(CAD), which does not show any symptoms or signs in many cases when they present. Therefore, identifying patients at high risk of asymptomatic CAD by using unenhanced head CT would be helpful in the care of patients with stroke by providing guidelines for CAD screening.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Answer: Our study was conducted in a retrospective manner. Thus, a prospective study with larger population may help

provide a score of intracranial artery calcification with higher sensitivity and specificity for prediction of asymptomatic CAD. Additionally, it would be interesting to see if Caucasian patients show the same result because it has been reported that they have relatively lower prevalence of intracranial atherosclerosis.

• Citation:• Ischemic Stroke: Measurement of Intracranial Artery Calcifications Can Improve Prediction of Asymptomatic Coronary Art

ery Disease• Radiology. 2013 Sep;268(3):842-9. doi: 10.1148/radiol.13122417. Epub 2013 May 14.• Ahn SS, Nam HS, Heo JH, Kim YD, Lee SK, Han KH, Choi BW, Kim EY.

Department of Radiology, Research Institute of Radiological Science, Department of Neurology, and Biostatistics Collaboration Unit, Medical Research Center, Yonsei University College of Medicine, Seoul, Korea; Department of Radiology, University Hospital, 234 Goodman St, Cincinnati, OH 45219Read the rest of the interview on MedicalResearch.com

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URI: Safety and Effectiveness of an Oral CPC SprayMedicalResearch.com Interview with:Pranab K. Mukherjee, Ph.D.Assistant Professor Center for Medical MycologyDepartment of Dermatology University Hospitals Case Medical Center

Case Western Reserve University Cleveland, OH 44106-5028

• MedicalResearch.com: What are the main findings of the study?• Answer: We performed a randomized double-blinded placebo-controlled pilot clinical trial to assess the safety, tolerability and

effectiveness of a cetylpyridinium chloride (CPC)-based oral spray in the prevention of acute upper respiratory tract infections (URIs).• The tested CPC spray (ARMS-I, developed by Arms Pharmaceutical LLC, Cleveland, OH) was safe and exhibited high tolerability and

acceptability among study participants• The product exhibited a trend to protect against URIs (55% relative reduction compared to the placebo), based on confirmed URIs, post-

medication exit interviews, and daily electronic diaries completed by study participants• There was statistically significant reduction in frequency of cough and sore throat in the active group• The number of days (duration) of cough was significantly reduced in the active group compared to placebo arm• URI-associated viruses (influenza, rhinovirus and coronavirus) were detected in three individuals, all in the placebo arm. No virus was

detected in the active arm/• No drug-related adverse events or oral lesions were observed• Previous vaccination status of the study participants did not affect the study outcome.• MedicalResearch.com: Were any of the findings unexpected?• Answer: Use of ARMS-I showed increasing protection against URIs with continued use of the product (did not reach statistical significance),

suggesting a potential “residual effect”.• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: ARMS-I spray may have utility in the prevention of URIs and associated symptoms.• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Answer: Perform a Phase-III randomized double-blinded placebo-controlled clinical trial to confirm the efficacy of ARMS-I in reducing the

frequency, severity and duration of URIs.• Citation:• Interscience Conference on Anti-Microbial Agents and Chemotherapy

Source reference: Ghannoum M, et al “A barrier-forming oral formulation exhibits sustained post-antimicrobial effect” ICAAC 2013; Abstract B-031.

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PAD: Trends in Hospital Outcomes and MorbidityMedicalResearch.com Interview with: Nasser Malyar, MDDivision of Vascular MedicineDepartment of Cardiovascular Medicine University Hospital MuensterAlbert-Schweitzer-Campus 1,

A1 48149 Muenster, Germany

• MedicalResearch.com: What are the main findings of the study?• Dr. Malyar: The main findings of the study were that• 1) PAD as a main or co-diagnosis is common among in-hospital treated patients• 2) The prevalence of PAD among hospitalized patients is disproportionately increasing, particularly in the

subset with critical limb ischemia• 3) Despite all efforts and increasingly use of endovascular and surgical revascularization procedures PAD

patients still have a poor in-hospital outcome in terms of limb amputation and in-hospital mortality• 4) Last but not least the reimbursement costs for in-hospital treatment of patients with PAD are markedly

increasing.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Malyar: Previous population-based estimations predicted an increase of PAD due to ageing of

population and increase of atherosclerotic risk factors in general and especially of those having critical limb ischemia. However, the magnitude of the increase we found was unexpectedly high. It was also striking that the rate of limb amputation and mortality among PAD patients during the index hospitalization remains alarmingly high with only a slight trend towards decreasing rate in both outcome measures.

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PAD: Trends in Hospital Outcomes and MorbidityMedicalResearch.com Interview with: Nasser Malyar, MDDivision of Vascular MedicineDepartment of Cardiovascular Medicine University Hospital MuensterAlbert-Schweitzer-Campus 1,

A1 48149 Muenster, Germany

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Malyar: The data presented should help to increase the awareness for PAD in general, and the

prognostic implication of this disease among patients, physicians and all other health care providers. Early recognition and application of adequate therapeutic measures might not only impact the direct limb related functional status and quality of life but also the general prognosis of these underdiagnosed and undertreated patients.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Malyar: From other reports and the current guidelines there is a clear recommendation for diagnostic

angiography and revascularization in all patients wit critical limb ischemia. Nevertheless, although this was not in the focus of our study, the rates of angiography and revascularization were surprisingly low in this contemporary cross-sectional analysis. Thus, these data demonstrate the need for a more focused and dedicated clinical research and cooperation of diverse disciplines involved in the medical management of vascular patients to develop strategies for reducing the still high number of limb amputations and the excessive high mortality rates among PAD patients.

• Citation:• Recent trends in morbidity and in-hospital outcomes of in-patients with peripheral arterial disease: a

nationwide population-based analysis Eur Heart J first published • Nasser Malyar, Torsten Fürstenberg, Jürgen Wellmann, Matthias Meyborg, Florian Lüders, Katrin Gebauer,

Holger Bunzemeier, Norbert Roeder, and Holger Reineckeonline July 17, 2013 doi:10.1093/eurheartj/eht288

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Obesity: Gene Ecscr is New Target for Treatment of Metabolic SyndromeMedicalResearch.com Interview with:Koji Ikeda, MD, PhDAssistant Professor Department of CardiologyGraduate School of Medical Science,

Kyoto Prefectural University of Medicine Kyoto, Japan

• MedicalResearch.com: What are the main findings of the study? • Dr. Ikeda: The main findings of this study is the identification of a novel mechanism that regulates glucose homeostasis and energy

metabolism, provided by Ecscr. Consequently, Ecscr modifies the insulin sensitivity and the progression of obesity, indicating that Ecscr is a new target for the treatment of metabolic syndrome.

• MedicalResearch.com: Were any of the findings unexpected? • Dr. Ikeda: Honestly, these findings were really unexpected to us. We are working on the research of angiogenesis in the Department of CV

med. Therefore, we were not so much interested in the research of metabolism. Luckily, we happened to find that Ecscr, a gene that we ourselves previously identified and since then we have been working on, is highly expressed in adipose tissues. This finding urged us to investigate a possible role of Ecscr on fat metabolism, and we found the unexpected role of Ecscr in the glucose homeostasis and energy metabolism.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Ikeda: Our paper also revealed an importance of fat angiogenesis in the maintenance of fat functions. Enhancing fat angiogenesis protect

fat from hypoxia, and thus, prevent the inflammation of the white fat and help to keep burning fat in the brown fat.• Ecscr is a unique pharmacotherapeutic target to modify the fat angiogenesis, and therefore, to treat and/or prevent the obesity and metabolic

syndrome.• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Ikeda: Considering a result of this study, Ecscr inhibitor may be a new drug to prevent and/or treat obesity and metabolic syndrome.• We have already begun the research to isolate small compounds that inhibit the Ecscr functions. Hopefully, we could find several seed or lead

compounds of Ecscr inhibitor, and develop a new drug to fight against obesity and metabolic syndrome.• Citation:• Ecscr regulates insulin sensitivity and predisposition to obesity by modulating endothelial cell functions• Yoshiki Akakabe, Masahiro Koide, Youhei Kitamura, Kiyonari Matsuo, Tomomi Ueyama, Satoaki Matoba, Hiroyuki Yamada, Keishi Miyata, Yuichi

Oike Koji Ikeda• Nature Communications 4

Article number: 2389 doi:10.1038/ncomms3389

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Breast Cancer: Survival Outcomes Predicted by Chemotherapy Response on MRIMedicalResearch.com Interview with:Nariya Cho, MDDepartments of Radiology

Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Republic of Korea.

• MedicalResearch.com: What are the main findings of the study?• Dr. Cho: Smaller reduction in tumor volume and a smaller reduction in washout component

on dynamic contrast agent–enhanced MR imaging assessed by computer-aided evaluation after neoadjuvant chemotherapy were independent parameters of worse recurrence-free survival and overall survival in breast cancer patients who received neoadjuvant chemotherapy.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Cho: Another interesting result of our study was that achievement of pathologic complete

response (pCR) was associated with favorable recurrence-free survival in a univariate analysis but did not remain a significant variable associated with recurrence-free survival in a multivariate analysis. This result might be caused by the paradoxical feature of the triple-negative breast cancer, which means that patients with the triple-negative phenotype showed higher rates of pCR. It has also been suggested that molecular subtype should be considered for MR imaging monitoring of the response to neoadjuvant chemotherapy.

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Breast Cancer: Survival Outcomes Predicted by Chemotherapy Response on MRIMedicalResearch.com Interview with:Nariya Cho, MDDepartments of Radiology

Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Republic of Korea.

• Dr. Cho: Actually, there are multiple MR imaging protocols, coil equipment, and computer-aided evaluation programs in clinical use. Variability of kinetic parameters or different threshold values that depended on MR systems could have led to different results. In addition, the variability in cycles of neoadjuvant chemotherapy, the status of adjuvant treatment could have affected the survival outcomes.

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

of this study?• Dr. Cho: This study was retrospective with a relatively short-term follow-up period. A larger

study with an external validation cohort may be necessary in the future.• Citation:• Survival Outcomes of Breast Cancer Patients Who Receive Neoadjuvant Chemotherapy: Assoc

iation with Dynamic Contrast-enhanced MR Imaging with Computer-aided Evaluation

Ann Yi, Nariya Cho, Seock-Ah Im, Jung Min Chang, Seung Ja Kim, Hyeung-Gon Moon, Wonshik Han, In-Ae Park, Dong-Young Noh, and Woo Kyung Moon

• Radiology September 2013 268:3 662

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Subarachnoid Hemorrhage: Outcomes and Ethnic VariationR. Loch Macdonald, M.D., Ph.D., F.R.C.S.(C), F.A.A.N.S., F.A.C.S.Keenan Endowed Chair in SurgeryHead, Division of Neurosurgery St. Michael’s HospitalProfessor of Surgery, University of Toronto

Toronto, Ontario, Canada M5B 1W8

• MedicalResearch.com: What are the main findings of the study?• Answer: We found that Asian/Pacific Islander patients with a rupture brain aneurysm were more likely to die and Hispanic

patients less likely to die after brain aneurysm rupture.• African-American patients were more likely than Caucasians to require institutional care following discharge from the

hospital, although their risk of death while in the hospital was similar.• • MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: The ethnicity of a patient matters for many reasons - what drugs work best, how to treat the patient and such.• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Answer: We believe that fundamental understanding of the genetic influences on outcome for subarachnoid hemorrhage

could lead to understanding of the causes of poor outcome in this condition, as well as ways to potentially improve outcome.

• Citation:• Racial/ethnic differences in inpatient mortality and use of institutional postacute care following subarachnoid

hemorrhage: Clinical article• Blessing N. R. Jaja, M.B.B.S., M.Sc., Gustavo Saposnik, M.D., M.Sc., F.R.C.P.C., Rosane Nisenbaum, Ph.D., Benjamin W. Y. Lo,

M.D., M.Sc., F.R.C.S.C., Tom A. Schweizer, Ph.D., Kevin E. Thorpe, M.Math., Ph.D., and R. Loch Macdonald, M.D., Ph.D., F.R.C.S.

• Journal of NeurosurgeryPosted online on 10 Sep 2013.

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Value of a Hospitalists-Led, Post-Discharge ClinicMedicalResearch.com Interview with:Lauren Doctoroff, MDHospitalist, Hospital Medicine Program Beth Israel Deaconess Medical Center

Medical Director, HCA Post Discharge Clinic and PACT Transitional Care ProgramInstructor, Harvard Medical School Boston, MA 02215

• MedicalResearch.com What are the main findings of the study?• Dr. Doctoroff: A dedicated post discharge clinic, staffed by hospitalists, led to a shorter interval to a clinic visit for patients

after discharge. Patients with resident primary care doctors and those who are African American were most likely to use the clinic. The care provided in the clinic, in terms of testing, was consistent with the remainder of the practice.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Doctoroff: The fact that the clinic led to a substantially shorter time for all patients post hospitalization in the clinic, not

just those seen in the clinic was a surprise. This likely reflects the significant difference in interval for patients seen in the discharge clinic relative to those seen in the practice as a whole.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Doctoroff: For patients, leaving the hospital can be stressful, and a visit within a few days to a doctor can be reassuring.

Our results suggest that clinics can find novel ways to make sure patients get seen quickly if they look broadly for answers. By extension, patients should speak with their physicians about this and other models if access following discharge is difficult or delayed.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Doctoroff: The clinical effect of expedited post discharge access, in terms of the effect on decreasing the risks associated

with transition, such as medication errors and hospital readmissions, is the natural corollary to this study.• Citation:• The Characteristics and Impact of a Hospitalist-staffed Post-discharge Clinic • Lauren Doctoroff, Ank Nijhawan, Diane McNally, Anita Vanka,

Roger Yu, Kenneth J. Mukamal • The American Journal of Medicine – 30 August 2013 (10.1016/j.amjmed.2013.03.025)

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AFib: Progression after Failed Ablation Drug Therapy vs Re-AblationMedicalResearch.com Interview with:Dr. Evgeny Pokushalov, MD, PhDState Research Institute of Circulation Pathology, Rechkunovskaya 15, 630055 Novosibirsk 55, Russia

• MedicalResearch.com: What are the main findings of the study?• Dr. Pokushalov: The main finding of this study is that after the failure of the first catheter ablation procedure for PAF, a redo

ablation was more effective at eradicating recurrent AF than treatment with AAD.• In this randomized controlled clinical trial, we observed that:• 1. The AF progression rate was considerably higher in patients randomized to AAD (79%) use compared with patients

treated with a second ablation procedure (25%).• 2. The AF burden significantly increased on AAD during followup compared with patients of reablation group (18.8±11.4%

versus 5.6±9.5%, respectively).• 3. There was a much greater rate of progression to persistent AF if AAD was used rather than redo ablation (23% versus 4%,

respectively).• These findings support the need for consideration of a timely intervention in patients with PAF who have responded

inadequately to an initial PVI.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Pokushalov: The findings, that redo AF ablation was substantially more effective than AAD in reducing the progression

and prevalence of AF after the failure of an initial ablation were unexpected. We weren’t absolutely sure that it will be so. It is well known, that catheter ablation is more effective than AAD, but we did not know the impact of catheter ablation on the progression of AF.

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AFib: Progression after Failed Ablation Drug Therapy vs Re-AblationMedicalResearch.com Interview with:Dr. Evgeny Pokushalov, MD, PhDState Research Institute of Circulation Pathology, Rechkunovskaya 15, 630055 Novosibirsk 55, Russia

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Pokushalov: options after a first ablation failure, demonstrating the superiority of reablation versus AAD as accurately

determined by comprehensive monitoring over extended follow-up.In fact, we found that freedom from AF at the end of the 36-month follow-up period was severalfold higher in patients treated with a reablation (58%) compared with patients treated with AAD (12%). In addition, AF progression was suppressed by reablation, but progressed in patients treated with AAD.

• Primarily, this study is start-up for future international multicenter studies. If our results will be proved by other studies, it can change guidelines and ablation can be first line therapy in the future. If a patient come to cardiologist after catheter ablation and some paroxysms of atrial fibrillation still happen, nevertheless ablation procedure gives us opportunity to stop progression of AF.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Pokushalov: It is a pilot study. And results of this study are important finding for all cardiology society and for patients.

We have only one recommendation. Researchers should conduct more international multicenter studies focusing on progression, that can reveal subgroups of patients needed to be analized accurately in future.

• Citation:• Progression of Atrial Fibrillation After a Failed Initial Ablation Procedure in Patients With Paroxysmal Atrial Fibrillation: A

Randomized Comparison of Drug Therapy Versus Reablation • Pokushalov E, Romanov A, De Melis M, Artyomenko S, Baranova V, Losik D, Bairamova S, Karaskov A, Mittal S, Steinberg JS.• State Research Institute of Circulation Pathology, Novosibirsk, Russia.• Circ Arrhythm Electrophysiol. 2013 Aug 1;6(4):754-60. doi: 10.1161/CIRCEP.113.000495. Epub 2013 Jun 7.

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Prostate Cancer: Validation of Upgrading Risk ToolMedicalResearch.com Interview with:David F Jarrard, MDVice Chair for Clinical Affairs Professor of UrologyJohn Livesey Chair in Urologic Oncology

• MedicalResearch.com: What are the main findings of the study?• Dr. Jarrard: We have developed and externally validated an accurate nomogram for predicting Gleason score 6 upgrading for use

in low-risk prostate cancer patients. This nomogram incorporates only variables available at the time of diagnosis and is unique in its assessment of clinical as well as pathological factors. Furthermore, we externally validated this study in patients with Gleason 6 prostate cancer of which 90% met the D’Amico criteria for low-risk cancer at 2 other centers (total 2000 patients). This nomogram will aid in the decision-making process of patients diagnosed with low-risk prostate cancer.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Jarrard: The incorporation of obesity in predicting upgrading was an unexpected finding that was validated at the

participating centers.• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Jarrard: The use of this nomogram by patients with lower risk prostate cancer provides further information that can be used

in the decision to treat prostate cancer or monitor it.• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Jarrard: The nomogram provides a basis for risk stratification. The use of additional molecular markers may further improve

the stratification of risk for prostate cancer patients.• The nomogram is available for the public at

https://www.urology.wisc.edu/research/researchers-labs/jarrard/prostate_cancer_predictor• Citation:• Development and multi-institutional validation of an upgrading risk tool for Gleason 6 prostate cancer.• Truong M, Slezak JA, Lin CP, Iremashvili V, Sado M, Razmaria AA, Leverson G, Soloway MS, Eggener SE, Abel EJ, Downs TM, Jarrard

DF.• Department of Urology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.• Cancer. 2013 Sep 4. doi: 10.1002/cncr.28303.

[Epub ahead of print]Read the rest of the interview on MedicalResearch.com

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HIV and Increased Risk of Need for DialysisMedicalResearch.com Interview with:Magnus G. Rasch MDFaculty of Health Sciences, University of Copenhagen1455 København K, Denmark Department of Infectious Diseases

Copenhagen University Hospital, Rigshospitalet, Denmark

• MedicalResearch.com: What are the main findings of the study?• Dr. Rasch: In the study “Increased risk of dialysis and end-stage renal disease among HIV patients in

Denmark compared with the background population” we found that the risk of acute renal replacement therapy (aRRT) and the risk of chronic renal replacement therapy (cRRT) was increased substantially in HIV patients compared with the background population.

• The risk of aRRT was highest the first year after HIV diagnosis.• Factors associated with increased risk of aRRT were intravenous drug use, hypertension and an AIDS-

defining illness. Risk factors for cRRT were hypertension and baseline estimated glomerular filtration rate.

• MedicalResearch.com: What should patients and clinicians take away from this report?• Dr. Rasch: We found no association between tenofovir, atazanavir or the combination

atazanavir/tenofovir and risk of aRRT or cRRT. This was quite surprising since many previous studies have described renal adverse events when using HAART regimens containing on of the two drugs or a combination of them.

• It is not surprising that HIV-patients have increased risk of acute and chronic renal complications and thus clinicians should still be careful to monitor renal function in these patients. It seems however that both tenofovir and atazanavir don’t increase the risk of dialysis compared to other drugs. To our knowledge this is the only study to evaluate specific drugs and their impact on the risk of dialysis in HIV-patients on a larger scale.

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HIV and Increased Risk of Need for DialysisMedicalResearch.com Interview with:Magnus G. Rasch MDFaculty of Health Sciences, University of Copenhagen1455 København K, Denmark Department of Infectious Diseases

Copenhagen University Hospital, Rigshospitalet, Denmark

• MedicalResearch.com: What further research do you suggest as a result of this report?• Dr. Rasch: We suggest that more research should be done on this area since it has great

implication on the handling of patients in everyday clinical practice.• Citation:• Increased risk of dialysis and end-stage renal disease among HIV patients in Denmark comp

ared with the background population• Nephrol Dial Transplant.• Rasch MG, Helleberg M, Feldt-Rasmussen B, Kronborg G, Larsen CS, Pedersen C, Pedersen G,

Gerstoft J, Obel N.• Faculty of Health Sciences, University of Copenhagen, 1455 København K, Denmark.• 2013 Aug 24. [Epub ahead of print]

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COPD: Comparing Tiotropium Delivery DevicesMedicalResearch.com Interview with:Dr. Robert A. Wise MDProfessor of Medicine Johns Hopkins University School of Medicine5501 Hopkins Bayview CircleBaltimore, MD 21224

• MedicalResearch.com: What are the main findings of the study?• Dr. Wise: The TIOSPIR trial was a landmark study, one of the largest ever conducted for chronic obstructive

pulmonary disease (COPD). It was designed to test the comparative safety and effectiveness of two delivery devices of tiotropium, a long-acting bronchodilator. One formulation is the Respimat multi-dose soft mist inhaler and the other formulation is the single dose HandiHaler dry powder inhaler.

• After following more than 17000 patients for an average of 2.3 years, TIOSPIR showed that there was no difference in either the safety in terms of mortality or adverse cardiovascular events between the two devices. Moreover, both devices showed similar effectiveness in terms of time to first COPD exacerbation.

• A lung function substudy in 1370 patients showed that the 5 microgram dose of Respimat was equivalent to the HandiHaler as a bronchodilator, but the 2.5 microgram dose was not quite as effective.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Wise: Although the tiotropium HandiHaler had been associated with lower mortality rates in a large,

long-term studies, preliminary analysis of smaller short-term studies with the newer Respimat device had raised concerns whether the Respimat device was associated with higher mortality. This large trial comparing the two devices in terms of mortality allayed these concerns and found that the Respimat did not have increased risk compared to the traditional HandiHaler. These findings support the findings that the 5 microgram Respimat has similar bronchodilating efficacy and systemic absorption as the 18 microgram HandiHaler.

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COPD: Comparing Tiotropium Delivery DevicesMedicalResearch.com Interview with:Dr. Robert A. Wise MDProfessor of Medicine Johns Hopkins University School of Medicine5501 Hopkins Bayview CircleBaltimore, MD 21224

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

• Dr. Wise: These findings should give clinicians and patients reassurance that they have the option of taking tiotropium safely by either HandiHaler or Respimat in countries where both devices are available. The tiotropium Respimat is currently available in 70 countries, but is not approved for use in the United States at the present time.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Wise: This study demonstrates that very large trials with adequate duration of follow-up are necessary

to determine with adequate precision whether newer drugs are safe and effective compared to standard formulations.

• Citation:• Tiotropium Respimat Inhaler and the Risk of Death in COPD• Robert A. Wise, M.D., Antonio Anzueto, M.D., Daniel Cotton, M.S., Ronald Dahl, M.D., Theresa Devins,

Dr.Ph., Bernd Disse, M.D., Daniel Dusser, M.D., Elizabeth Joseph, M.P.H., Sabine Kattenbeck, Ph.D., Michael Koenen-Bergmann, M.D., Gordon Pledger, Ph.D., and Peter Calverley, D.Sc. for the TIOSPIR Investigators

• NEJM September 8, 2013DOI: 10.1056/NEJMoa1303342

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Childhood Obesity Prevention: Improving Household RoutinesMedicalResearch.com Interview with:Dr. Elsie TaverasMassachusetts General Hospital for ChildrenDivision of General Pediatrics, Department of Pediatrics100 Cambridge St, 15th

Floor Boston, MA 02114

• MedicalResearch.com: What are the main findings of the study?• Dr. Taveras: The main findings of the study were that, overall, the body mass index of children in the intervention group

dropped an average of 0.18, while it rose 0.21 in the control group. Children in the intervention group were sleeping about 45 minutes longer than children in the control group. Time spent watching television on weekends dropped about an hour per day in the intervention group, leading to a significant difference from the control group, which increased weekend TV viewing. Both groups had a small reduction in weekday TV viewing, with a greater decrease in the intervention group, as well.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Taveras: Rapid weight gain in children aged 2-5 can lead to higher rates of obesity later in life. It is important to improve

household routines in order to slow weight gain in young children so that we can keep them off an obesity trajectory that would be hard to alter by the time they enter middle school.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Taveras: Future studies should be designed to specifically examine the effectiveness of text messages in supporting

healthful weight-related behavior change among families with young children. Strategies to motivate parents to remove a TV from which they sleep with their child should also be examined. How barriers to limiting TV viewing may differ on weekends and weekdays, and how the association between obesity risk and family meal frequency and quality may differ by race/ethnicity and/or income also warrant further investigation. Future studies with a longer follow-up are also needed to determine the maintenance of the behavior changes that were observed in this study.

• Citation:• Haines J, McDonald J, O’Brien A, et al. Healthy Habits, Happy Homes: Randomized Trial to Improve Household Routines for

Obesity Prevention Among Preschool-Aged Children. JAMA Pediatr. 2013;():-. doi:10.1001/jamapediatrics.2013.2356.

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Diabetes: (Hp) 1-1 genotype Less Favorable Cardiac, Cognitive ProfilesMedicalResearch.com Interview with:Ramit Ravona-Springer M.D., PsychiatristDirector of Memory Clinic,Sheba Medical Center, Tel Hashomer, Israel

• MedicalResearch.com: What are the main findings of the study?• Answer: In a cohort of elderly, cognitively normal type 2 diabetes (T2D) subjects, those with Haptoglobin (Hp) 1-1 genotype

present lower cognitive performance compared to Hp 2 carriers (Hp 1-2 and Hp 2-2). The contribution of cardiovascular risk factors to cognition was significantly higher in subjects with Hp1-1 genotype compared to Hp 2 carriers.

• MedicalResearch.com: Were any of the findings unexpected?• Answer: Previous studies have shown that Hp 2-2 genotype is associated with a less favorable cardiovascular profile. Since the

latter is associated with cognitive function, Hp 2 allele could be expected to be associated with lower cognitive performance. However, the role of Hp in vascular pathology may differ according to the vascular bed (brain versus periphery): the frequency of Hp 1-1 genotype was significantly higher and frequency of Hp 2 allele was significantly lower in a cohort of subjects with first symptomatic lacunar stroke due to small vessel disease compared to their frequency in healthy controls.

• MedicalResearch.com: What should clinicians and patients take away from your report? • Answer: Hp genotype may be considered in the future as a factor that is associated with cognitive outcomes of T2D.

Nevertheless, the results cannot yet be implemented since they are based on cross sectional data. We cannot rule out that these results reflect an artifact of the selection of subjects. Hp 2 carriers, who tend to have more cardiovascular disease, might have had higher mortality, morbidity, or cognitive impairment that precluded their participation in the study. The longitudinal follow up of this sample is essential to shed light on this potential limitation and the interpretation of the current results.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Answer: Future studies should study the association of Hp genotype with rate of cognitive decline, risk for Mild Cognitive

Impairment and dementia and the modifying effect of T2D characteristics on this association.• Citation:• Haptoglobin 1-1 Genotype Is Associated With Poorer Cognitive Functioning in Type 2 Diabetic Elderly • Ramit Ravona-Springer, Anthony Heymann, James Schmeidler, Elizabeth Guerrero-Berroa, Mary Sano, Rachel Preiss, Keren Koif

man, Hadas Hoffman, Andrew Levy, Jeremy M. Silverman, and Michal Schnaider-Beeri• Diabetes Care published ahead of print August 29, 2013, doi:10.2337/dc12-2250

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Effects of Positive Mood and Exercise on Mortality and HospitalizationsMedicalResearch.com Interview with:Madelein Hoogwegt, MSc PromovendaCenter of Research on Psychology in Somatic diseases (CoRPS)

Department of Medical and Clinical PsychologyKamer P711 Tilburg University 5000 LE Tilburg

• MedicalResearch.com: What are the main findings of the study?• Answer: The main finding was that we found a significant relation between positive affect and mortality, and that exercise

explained this relationship. With respect to the second outcome, hospitalization, we found a significant relation between positive affect and hospitalization, a significant relation between positive affect and hospitalization, but exercise did not mediate this relationship.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: The most important implication of this study is now we know that exercise plays an important role in the

association between positive affect and prognosis, we should focus not only on increasing positive affect in cardiac rehabilitation, but we should also make sure that patients perform exercise on a regular basis, as exercise is both associated to increased levels of positive affect, and to improved prognosis. The beneficial effects of positive affect induction and increasing daily exercise could be increased when both aspects are implemented in rehabilitation settings. Practitioners should emphasize that incorporating a healthy exercise pattern is of utmost importance, not only to recover from the cardiac event and to stay in good condition, but also to improve emotional state. In addition, screening for emotional distress is important, as we know that patients with emotional distress are at high risk of not performing regular exercise due to their mood state. Screening for emotional distress, and importantly, subsequent inclusion of the distressed patients in rehabilitation or psychological interventions, is crucial when it comes to decreasing the devastating effects of emotional distress on both quality of life and prognosis.

• Patients should try to incorporate exercise in their daily pattern. Although this is more easily said than done, there are lots of ways to facilitate this. For example, patients can participate in a cardiac rehabilitation program, in which exercise is an important component and is guided by experienced physicians and physiotherapists, or ask family members to join physical activities. In case of anxiety for performing physical activities, which is a normal reaction pattern after a cardiac event, counseling by a psychologist could also help to gain and maintain a healthy exercise pattern, as the psychologist can help the patient reduce anxiety and regain confidence in one’s body.

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Effects of Positive Mood and Exercise on Mortality and HospitalizationsMedicalResearch.com Interview with:Madelein Hoogwegt, MSc PromovendaCenter of Research on Psychology in Somatic diseases (CoRPS)

Department of Medical and Clinical PsychologyKamer P711 Tilburg University 5000 LE Tilburg

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Answer: It is important that more research is performed on the effect of exercise intensity and type of

exercise. This is something that we have not been able to incorporate in our analyses. Furthermore, the research should be expanded to other races and societies, although we do not expect results to be different. Most importantly, intervention trials should be started in order to investigate how we can best combine psychological and physical counseling, in order to reduce emotional distress and improve life style in patients with cardiac disease.

• Citation:• Exercise mediates the association between positive affect and 5-year mortality in patients with ischemic he

art disease• Madelein T. Hoogwegt, Henneke Versteeg, Tina B. Hansen, Lau C. Thygesen, Susanne S. Pedersen, and Ann-

Dorthe Zwisler• Circ Cardiovasc Qual Outcomes. 2013;CIRCOUTCOMES.113.000158published online before print September

10 2013, doi:10.1161/CIRCOUTCOMES.113.000158

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Methamphetamine: Research Aims to Disrupt Drug-Associated MemoriesMedicalResearch.com Interview with:Courtney A. Miller, PhDAssistant ProfessorDepartment of Metabolism & Aging Department of Neuroscience

The Scripps Research Institute Jupiter, FL 33458

• MedicalResearch.com: What are the main findings of the study?• Dr. Miller: The relapse rate for drug abusers, smokers and alcoholics is high because abstinence is so difficult. A major factor

is the craving that drug associations can trigger. These range from seeing the neighborhood where someone used to buy, in the case of illicit drugs, to social drinking for a smoker. We’ve found a way to disrupt these drug-associated memories without affecting other, more benign memories.

MedicalResearch.com: Were any of the findings unexpected?• Dr. Miller: The main finding was unexpected. Everything we know about how the brain stores memories suggests that all

memories rely on the same mechanisms. But we found that the structural state of brain cells storing memories associated with methamphetamine is unique, so we exploited that to selectively erase them.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Miller: We’re still a long way from a therapeutic, but there’s the potential for a surprisingly simple treatment.• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Miller: While we’re excited about the results of this study, it’s raised more questions than answers. For example, we

don’t yet know why the structural state of neurons is different when methamphetamine is involved. We’re also looking into the potential of this manipulation to disrupt memories for other drugs (e.g. nicotine) and for traumatic events, which would be promising for the treatment of PTSD.

• Citation:• Selective, Retrieval-Independent Disruption of Methamphetamine-Associated Memory by Actin Depolymerization

Erica J. Young, Massimiliano Aceti, Erica M. Griggs, Rita A. Fuchs, Zachary Zigmond, Gavin Rumbaugh, Courtney A. MillerBiological Psychiatry – 09 September 2013 (10.1016/j.biopsych.2013.07.036)

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Barrett’s Esophagus, Erosive Esophagitis, GI Symptoms and H. Pyloriz MedicalResearch.com Interview with:Joel H. Rubenstein, MD, MSc, FACG, FASGEResearch Scientist, Veterans Affairs Center for Clinical Management Research

Assistant Professor, Division of Gastroenterology, University of Michigan Medical SchoolVA Medical Center Ann Arbor, MI 48105

• MedicalResearch.com: What are the main findings of the study?• Dr. Rubenstein: In a set of case-control studies within the same population, we found that H.

pylori was inversely associated with erosive esophagitis, and with Barrett’s esophagus, but we did not find such a relation with symptoms of gastroesophageal reflux disease (GERD).

• MedicalResearch.com Were any of the findings unexpected?• Dr. Rubenstein: Infection with H. pylori has been inversely associated with esophageal

adenocarcinoma, and its precursor, Barrett’s esophagus, in many studies. The prevailing hypothesis accounting for that relationship has been that H. pylori infecting the body of the stomach leads to diminished gastric acid production, and hence decreased GERD. However, there is no direct evidence that such a mechanism explains the inverse association of H. pylori with Barrett’s esophagus or the cancer. In addition, in most individuals infected with H. pylori in Western populations, the infection is limited to the antrum of the stomach, which could actually lead to increased gastric acid production. Our results confirmed the expected inverse association of H. pylori with Barrett’s esophagus, and with erosive esophagitis, but suggest that mechanisms other than diminished GERD may be responsible.

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Barrett’s Esophagus, Erosive Esophagitis, GI Symptoms and H. Pyloriz MedicalResearch.com Interview with:Joel H. Rubenstein, MD, MSc, FACG, FASGEResearch Scientist, Veterans Affairs Center for Clinical Management Research

Assistant Professor, Division of Gastroenterology, University of Michigan Medical SchoolVA Medical Center Ann Arbor, MI 48105

• MedicalResearch.com What should clinicians and patients take away from your report?• Dr. Rubenstein: Our study was an epidemiologic one, and not focused on treatment. However, for clinicians, this study

should serve as a reminder that H. pylori is not associated with GERD symptoms. In geographic regions where gastric cancer is not endemic, testing and treating for H. pylori in individuals without gastric ulcers or dyspepsia is unlikely to help them, and could potentially harm them since H. pylori might protect against esophageal cancer.

• MedicalResearch.com What recommendations do you have for future research as a result of this study?• Dr. Rubenstein: Other potential mechanisms for the inverse association of H. pylori with Barrett’s esophagus and

esophageal adenocarcinoma need to be explored. For instance, we previously found that extracted DNA from H. pylori directly down-regulated inflammatory responses in a mouse model of colitis; perhaps H. pylori DNA refluxed into the esophagus has a similar anti-inflammatory effect. Perhaps H. pylori itself is not responsible; instead there might other associated differences in esophageal or gastric microbiota that are responsible. Similarly, there might be host genetic differences (such as in genes regulating inflammatory responses) that simultaneously predispose to infection with H. pylori and protect against Barrett’s esophagus.

• Citation:• Association between Helicobacter pylori and Barrett’s Esophagus, Erosive Esophagitis, and Gastroesophageal Reflux Symp

toms.• Rubenstein JH, Inadomi JM, Scheiman J, Schoenfeld P, Appelman H, Zhang M, Metko V, Kao JY.• Center for Clinical Management Research, Ann Arbor Veterans Affairs Medical Center, Ann Arbor, MI; Division of Gastroenter

ology, Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI.• Clin Gastroenterol Hepatol. 2013 Aug 26. pii: S1542-3565(13)01231-7. doi: 10.1016/j.cgh.2013.08.029. [Epub ahead of print

]

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Diabetes: Cardiovascular Events and Geriatric Scale ScoresMedicalResearch.com Interview with:Jean-Pierre Le Floch, MDDiabetology-EndocrinologyVillecresnes Medical Hospital94440 Villecresnes

• MedicalResearch.com: What are the main findings of this study?• Answer: The main finding of the study is the association between classical macrovascular complications of diabetes and

impaired scores of five geriatric scale scores exploring cognition, activities of daily life, instrumental activities, mood and nutrition.

• MedicalResearch.com: Where any of the findings unexpected:• Answer: These findings were not totally unexpected, but had not commonly been studied in elderly diabetic patients. Using

multivariate analyses (logistic model), with factors commonly associated with cardiovascular complications, such as age, BMI, lipids and HbA1c levels, some of these associations remains significant, notably with cognitive impairment and reduced activities of daily living.

• MedicalResearch.com: What should patients and clinicians take from this report?• Answer: The main impact for clinical practice deals with the potential benefits of a thorough screening and management of

geriatric function in elderly (70 years old and above) type 2 diabetic patients.• MedicalResearch.com: What further research do you recommend as a result of this report?• Answer: Of course, our results should be confirmed by other studies. In addition, this analysis concerns the transversal

results at baseline of the GERODIAB study. Therefore, it should be confirmed by follow-up results. These would be done in GERODIAB, which is a French five-years follow-up study.

• Citation:• Cardiovascular events and Geriatric Scale Scores in Elderly (70 years-old and above) Type 2 Diabetic Patients at Inclusion i

n the Gerodiab Cohort. • Bauduceau B, Doucet J, Le Floch JP, Verny C; the SFD / SFGG Intergroup.

Endocrinology, Begin Hospital, 69 avenue de Paris, 94160 Saint Mandé.Diabetes Care. 2013 Aug 29. [Epub ahead of print]

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Severe Stroke and IV-tPA TreatmentMedicalResearch.com Interview with:R. Gilberto González, MD, PhDMassachusetts General HospitalDepartment of Radiology, PO Box 9657Boston, MA

• MedicalResearch.com: What are the main findings of the study?• Dr. González: Administration of IV tPA to patients with a severe stroke syndrome caused by occlusion of the distal internal

carotid artery and/or the proximal middle cerebral arteries results in good outcomes in 35% compared to 17% of similar patients who did not receive tPA.

MedicalResearch.com: Were any of the findings unexpected?• Dr. González: The high rate of good outcomes was unexpected.• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. González: IV tPA can double the rate of good outcomes in patients with major artery occlusions.• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. González: Clinical research on producing better outcomes in the class of stroke patients using other methods such as

endovascular recanalization should use this outcome rate in estimating sample sizes if comparison with IV tPA is being considered.

• Citation:• Good Outcome Rate of 35% in IV-tPA–Treated Patients With Computed Tomography Angiography Confirmed Severe Anteri

or Circulation Occlusive Stroke • R. Gilberto González, Karen L. Furie, Gregory V. Goldmacher, Wade S. Smith, Shervin Kamalian, Seyedmehdi Payabvash,

Gordon J. Harris, Elkan F. Halpern, Walter J. Koroshetz, Erica C.S. Camargo, William P. Dillon, and Michael H. Lev• Stroke. 2013;STROKEAHA.113.001938published online before print September 3 2013, doi:10.1161/STROKEAHA.113.001938

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Pediatric Cardiology Chest Pain Guideline ValidationDavid R. Fulton, M.D.Associate Cardiologist-in-Chief for AdministrationTommy Kaplan Chair in Cardiovascular StudiesChief, Cardiology Outpatient ServicesDepartment of Cardiology Children’s Hospital

Boston Boston, MA 02115

• MedicalResearch.com: What are the main findings of this study?• Dr. Fulton: The main findings of this study demonstrated that using a quality improvement methodology

(SCAMPs), a diverse population of children and adolescents with chest pain could be managed with relative uniformity and cost effectiveness in a multi-center collaborative. Only 2 patients of the 1016 children who formed the basis for this review were shown to have a cardiac etiology. The clinicians were able to screen and reach a diagnostic conclusion in a large segment of this population using history, physical examination and ECG.

• MedicalResearch.com: Where any of the findings unexpected?• Dr. Fulton: The SCAMP recommended minimal testing other than the use of echocardiography when

prompted by abnormalities in the above triad, but clinicians were encouraged to diverge from the guideline as long as reasons for their decisions were stated. Though not necessarily expected, the frequency of testing was minimally different between the regional groups and the large academic medical center. Simultaneously, the frequency of exercise testing and Holter monitor recordings were vastly reduced. Since the approach was adapted widely among groups of providers with virtually similar conclusions, the algorithm was clearly scalable along the continuum from small private practice cardiologists to a that of a large academic center.

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Pediatric Cardiology Chest Pain Guideline ValidationDavid R. Fulton, M.D.Associate Cardiologist-in-Chief for AdministrationTommy Kaplan Chair in Cardiovascular StudiesChief, Cardiology Outpatient ServicesDepartment of Cardiology Children’s Hospital

Boston Boston, MA 02115

• MedicalResearch.com: What should patients and clinicians take away from this report?• Dr. Fulton: This report should suggest to primary care providers as well as pediatric cardiologists that most children with

chest pain do not have a cardiac etiology and can be managed with a thoughtful approach to basic clinical assessment reducing the need for unnecessary resource utilization. Patients should feel reassured that life-threatening cardiac disease in children who present with chest pain is rare and management with a minimal amount of testing represents rational clinical care.

• MedicalResearch.com: What further research do you suggest as a result of your study?• Dr. Fulton: SCAMPs proved to be a very useful tool for chest pain management and holds promise for extension to many

areas of clinical medicine including both inpatient and outpatient health care delivery. We are in the process of expanding and testing this model in a variety of symptoms, clinical conditions, disease states and process workflows.

• Citation:• Regional Implementation of a Pediatric Cardiology Chest Pain Guideline Using SCAMPs Methodology • Gerald H. Angoff, David A. Kane, Niels Giddins, Yvonne M. Paris, Adrian M. Moran, Victoria Tantengco, Kathleen M. Rotondo,

Lucy Arnold, Olga H. Toro-Salazar, Naomi S. Gauthier, Estella Kanevsky, Ashley Renaud, Robert L. Geggel, David W. Brown, and David R. Fulton

• Pediatrics peds.2013-0086; published ahead of print September 9, 2013, doi:10.1542/peds.2013-0086

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At-Risk Patients for Psychosis and Impaired Functional OutcomesMedicalResearch.com Interview with:Ricardo E. Carrión, PhDDivision of Psychiatry ResearchThe Zucker Hillside Hospital, North Shore–Long Island Jewish Health System, Glen Oaks, New

YorkCenter for Psychiatric Neuroscience, The Feinstein Institute for Medical Research, North Shore–Long Island Jewish Health System, Manhasset, New York

• MedicalResearch.com: What are the main findings of your study:• Answer: Reduced neurocognition, poor functioning, and other behavioral symptoms at

baseline were associated with an increased risk of long-term social difficulties and school/work problems in adolescents and young adults at high clinical risk for psychosis.

• MedicalResearch.com: Where any of the findings unexpected?• Answer: At the conclusion of our study, we found that a large portion of the CHR subjects in

our sample had poor social and role functioning, regardless of the development of a full-blown psychosis. In fact, one third (32.6%) of the sample continued to have relationship and school/work difficulties. This is a quite high rate and represents a public health problem in its own right. These results emphasize the need for a flexible perspective on outcome in at-risk individuals. Functional disability is not solely dependent on the progression of full-blown psychosis, because many individuals who did not convert continued to present with poor functioning.

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At-Risk Patients for Psychosis and Impaired Functional OutcomesMedicalResearch.com Interview with:Ricardo E. Carrión, PhDDivision of Psychiatry ResearchThe Zucker Hillside Hospital, North Shore–Long Island Jewish Health System, Glen Oaks, New

YorkCenter for Psychiatric Neuroscience, The Feinstein Institute for Medical Research, North Shore–Long Island Jewish Health System, Manhasset, New York

• MedicalResearch.com: What should patients and clinicians take away from this report?• Answer: We now recognize that adolescents who display early warning signs of later psychiatric illness, especially psychosis,

have a variety of functional disabilities that can profoundly influence educational attainment, work objectives, and social interactions, even if full psychosis doesn’t develop. Most intervention studies so far have focused on prevention of progression to psychosis. By identifying individuals vulnerable to later functional disability during adolescence, we expect to develop interventions before illness progression, at a time when treatment will be most effective. Our emphasis is to avoid medication when possible and focus on psychosocial treatments that we expect to be effective at young ages.

• • MedicalResearch.com: What recommendations do you have for future research as a result of your study?• Answer: In light of evidence that a large proportion of individuals at clinical high risk do not develop full-blown psychosis,

finding markers that may identify patients at high risk for functional impairments may provide a pathway to prevent the disability associated with the illness. These teenagers and young adults are both at risk for psychosis and functional disability. Prevention is needed for emerging psychosis, as well as for helping these individuals cope with persistent relationship and occupational problems.

• Also, from a clinical perspective, our emphasis is to development treatments recommended by our research findings. In the future, we will be stressing improving social skill development and work adaptation. At present, though, we are conducting a trial evaluating the effects of Omega 3 Fatty Acid or fish oil on symptoms and functional deficits. The fish oil trial is still open and accepting volunteers who meet our at-risk criteria.

• Citation:• Carrión RE, McLaughlin D, Goldberg TE, et al. Prediction of Functional Outcome in Individuals at Clinical High Risk for

Psychosis. JAMA Psychiatry. 2013;():-. doi:10.1001/jamapsychiatry.2013.1909.

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Colon Cancer Detection Using Gene Mutation Study of Stool SamplesDr. Bettina Scholtka Universität PotsdamInstitut für ErnährungswissenschaftAbt. ErnährungstoxikologieArthur-Scheunert-Allee 114-11614558 Nuthetal, Germany.

• MedicalResearch.com: What are the main findings of the study?• Answer: The extremely high sensitivity of the WTB-HRM technique allows to find

very low amounts of different types of colon cancer initiating genemutations even in stool samples of patients. The method is able tofind the expected mutations as well as unknown mutations. So, byapplying WTB-HRM to a panel of especially selected marker genes, it ispossible to detect cancer precursors in feces before they progressinto a malignant stage.

• MedicalResearch.com: Were any of the findings unexpected?• Answer: We expected a quite good sensitivity of this technique because of

earlier experiments. But the ultra-high sensitivity of our assay wasquite surprising as well as the fact that we could detect mutationsbeing situated outside the DNA sequences that hybridized with our LNAblocker molecules.

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Colon Cancer Detection Using Gene Mutation Study of Stool SamplesDr. Bettina Scholtka Universität PotsdamInstitut für ErnährungswissenschaftAbt. ErnährungstoxikologieArthur-Scheunert-Allee 114-11614558 Nuthetal, Germany.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: It is worth to invest the time for performing a two-step method like

WTB-HRM consisting of mutation enrichment and mutation detection, inorder to achieve the sensitivity needed for non-invasive low-leveldetection of cancer initiating mutations. By using WTB-HRM cancerprecursors can be detected in a stool sample of patients. By removingthose cancer precursors the disease could be prevented in many cases.Patients should be aware that many types of cancer can only be curedif they are detected early. Participating in screening programs ishighly recommended.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Answer: The WTB-HRM method should be applied on a gene marker panel

specifically selected for the detection of colon cancer precursors. Amulticenter study should be performed in order to validate thesensitivity and specificity of the technique in comparison with thestandard screening method colonoscopy in a representative number ofpatients.

• Citation:• Ultrasensitive Detection of Unknown Colon Cancer-Initiating Mutations Using the Example of the

Adenomatous Polyposis Coli Gene Christian Gerecke, Conny Mascher,Uwe Gottschalk Burkhard Kleuserand Bettina ScholtkaCancer Prev Res September 2013 6:9 898-907; doi:10.1158/1940-6207.CAPR-13-0145

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Weight Loss: Influence of Genetics on Success of High-Fat vs Low Fat DietsMedicalResearch.com Interview with:Lu Qi, MD, PhD, FAHAAssistant Professor of MedicineHarvard Medical SchoolAssistant Professor of Nutrition HarvardSchool

of Public Health

• MedicalResearch.com: What are the main findings of the study?• Answer: It has been known that weight loss diets may improve metabolic status, in parallel with reduction of body weight.

We found that the beneficial of various weight loss diets, such as high-fat and low-fat diets, may be different for people carrying different genotype.

• MedicalResearch.com: Were any of the findings unexpected?• Answer: For long time, it is thought that a diet may affect people uniformly. However, our findings show evidence that this

may be not true.• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: When people consider to reduce body weight or improve their metabolic status, they would choose the

appropriate method, for example various weight-loss diets, according to their genetic feature. It is time to think about change from one-size-fits-all diet intervention toward personalized manner, by referring to ‘individuality’ of human genome.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Answer: I would suggest to perform more comprehensive evaluation, for instance using genome-wide approach, in multiple

intervention trials.Citation:

• IRS1 Genotype Modulates Metabolic Syndrome Reversion in Response to 2-Year Weight-Loss Diet Intervention: The POUNDS LOST trial

• Qibin Qi, Min Xu, Hongyu Wu, Liming Liang, Catherine M. Champagne, George A. Bray, Frank M. Sacks, and Lu Qi• Diabetes Care published ahead of print September 5, 2013, doi:10.2337/dc13-0018

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DNR: Clinical PerspectivesMedicalResearch.com Interview with:Dr. Amy Sanderson MDDepartment of AnesthesiologyPerioperative & Pain MedicineBoston Children’s Hospital Boston, Massachusetts

• MedicalResearch.com: What are the main findings of the study? • Dr. Sanderson: There is substantial variability in the interpretation of a DNR order. 66.9% of clinicians believed that a DNR order

indicates limitation of resuscitative measures only on cardiopulmonary arrest, whereas 33.1% considered a DNR order to be the threshold for the limitation of treatments not specifically related to resuscitation. 68.7% of clinicians reported that the care of a patient changes once a DNR order is written. Of those reporting changes in care, 11.2% reported that this happens only if a cardiopulmonary arrest occurs, while 36.7% believed that there is an increased attention to comfort. Finally, 52.1% reported that care changes beyond both resuscitative measures and focusing on comfort, including limitation or withdrawal of diagnostic and therapeutic interventions. Most clinicians reported that resuscitation status discussions happen later in the illness course than is ideal.

MedicalResearch.com: Were any of the findings unexpected?• Dr. Sanderson: We found it encouraging that the vast majority of clinicians did not feel that they were giving up on their patients

once a Do-Not-Resuscitate order is in effect since we believe that clinicians can offer optimal care to patients regardless of their resuscitation status.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Sanderson: Clinicians use the DNR order not only as a guide for therapeutic decisions during a cardiopulmonary arrest but also as

a surrogate for broader treatment directives. Most clinicians believe that DNR discussions should take place earlier than they actually do.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study? • Dr. Sanderson: Interventions aimed at improving clinician knowledge and skills in advance care discussions as well as the

development of orders that address overall goals of care may improve care for children with serious illness.• Citation:• Clinician Perspectives Regarding the Do-Not-Resuscitate Order.• Sanderson A, Zurakowski D, Wolfe J.

Department of Anesthesiology, Perioperative & Pain Medicine, Boston Children’s Hospital, Boston, Massachusetts.JAMA Pediatr. 2013 Aug 26. doi: 10.1001/jamapediatrics.2013.2204. [Epub ahead of print]

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Diabetes: Stroke and Measure of Kidney Function, GFRMedicalResearch.com Interview with:Yongjun Wang, MDDepartment of Neurology, Beijing Tiantan HospitalCapital Medical University, Beijing, China

• MedicalResearch.com: What are the main findings of the study?• Answer: Our study demonstrated that reduced eGFR was independently associated with all-

cause mortality and other post-stroke outcomes in type 2 diabetic patients; stroke subtype analysis in our cohort showed that this association was only evident in ischemic stroke and TIA. We also observed a U-shaped relationship between variation of eGFR and post-stroke outcomes, that is, increased odds ratios were seen among those with low and high levels of eGFR. The cutoff points of eGFR associated with poor outcomes of stroke were eGFR<45 ml/min/1.73m2 and≥ 120 ml/min/1.73m2, respectively.

• MedicalResearch.com: Were any of the findings unexpected?• Answer: Previous studies found that the association between eGFR and adverse outcomes

appeared to be J-shaped, that is, reduce eGFR was associated with poor outcomes in many settings, while in our study we demonstrated that higher eGFR (≥ 120 ml/min/1.73m2) was also associated with increased risks of all-cause mortality and stroke recurrence.

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Diabetes: Stroke and Measure of Kidney Function, GFRMedicalResearch.com Interview with:Yongjun Wang, MDDepartment of Neurology, Beijing Tiantan HospitalCapital Medical University, Beijing, China

• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: The clinical implications of our findings are important as it provides evidence that

prevention and management of CKD is very important measure for type 2 diabetic patients with ischemic stroke or TIA, especially among those whose eGFR<45 ml/min/1.73m2 or ≥120 ml/min/1.73m2.

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

• Answer: There may be important racial and environmental differences that limit generalizability of our results and await results of future studies in association of higher eGFR with stroke outcomes in other ethnic groups.

• Citation:• Association of glomerular filtration rate with outcomes of acute stroke in type 2 diabetic

patients: results from the China National Stroke Registry.• Luo Y, Wang X, Wang Y, Wang C, Wang H, Wang D, Liu L, Jia Q, Liu G, Zhao X, Wang Y; on behalf

of the CNSR investigators.• Department of Nephrology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.

Diabetes Care. 2013 Sep 5. [Epub ahead of print]

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Page 102: MedicalResearch.com - Medical Research Interviews Week in Review

Myocardial Infarction Survival and Diet QualityMedicalResearch.com Interview with:Shanshan Li, MD, MSc, ScDDepartment of Epidemiology, Harvard School of Public Health, Boston, MassachusettsOn behalf of Drs. Chuive, Flint, Pai

, Forman, Hu, Willett, Mukamal and Rimm.

• MedicalResearch.com: What are the main findings of the study?• Answer: In our prospective study of diet quality among MI survivors, we found that a higher diet quality

post-MI, measured by Alternative Healthy Eating Index 2010, was associated with 24% lower death rate and 26% lower death rate from cardiovascular disease. Greater improvement of diet quality from pre- to post-MI was associated with 30% lower death rate and 40% lower cardiovascular disease death rate. In addition to reducing the bad fats intake, for example, saturated and transfat intake, MI patients also tended to reduce the good healthy polyunsaturated fats.

• MedicalResearch.com: Were any of the findings unexpected?• Answer: Given the fact the MI patients in our study were health care professionals and they are likely to

receive the best and up-to-date medical care, we were surprised to see how substantial the death rate could be further reduced by eating a healthy diet.

• In our study, we also found the associations between post-MI diet quality and improvements in diet quality from pre- to post-MI with mortality were stronger for women than for men, which is different from our previous studies of diet and primary prevention of CHD. This might be due to greater death rate among women, differences in MI clinical etiology and presentation. Future studies are needed to investigate this gender difference to confirm the results.

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Myocardial Infarction Survival and Diet QualityMedicalResearch.com Interview with:Shanshan Li, MD, MSc, ScDDepartment of Epidemiology, Harvard School of Public Health, Boston, MassachusettsOn behalf of Drs. Chuive, Flint, Pai

, Forman, Hu, Willett, Mukamal and Rimm.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: For clinicians: Educate your patients about eating a healthy diet and making better

dietary choices. Dietary recommendations for MI secondary prevention need to pay more emphasis on polyunsaturated fat intake, and reduce sugar-sweetened beverages and fruit juice consumption.

• For patients: Start eating a healthy diet now and it is never too late to make dietary changes.• MedicalResearch.com: What recommendations do you have for future research as a result of

this study?• Answer: In future, a large dietary secondary prevention trial is needed.• Citation:• Better Diet Quality and Decreased Mortality Among Myocardial Infarction Survivors• Li S, Chiuve SE, Flint A, et al. Better Diet Quality and Decreased Mortality Among

Myocardial Infarction Survivors. JAMA Intern Med. 2013;():-. doi:10.1001/jamainternmed.2013.9768.

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