MedicalResearch.com - Medical Research Interviews Week in Review

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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Read more interviews on Hemodialysis.com

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

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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.

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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 ecigarette and those allocated to patches .

Read the rest of the interview on MedicalResearch.com

Smoking Cessation and Electronic Cigarettes
Dr. Chris Bullen MBChB MPH PhD FAFPM FNZCPHM
Director School of Population Health, The University of Auckland

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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


Breast Cancer: Two Years vs One of Adjuvant Rastuzumab
Prof Aron Goldhirsch
Department of Medicine European Institute of Oncology
Via Ripamonti 435, 20141 Milan, Italy

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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.
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.
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
controlled trial
Goldhirsch A, Gelber RD, Piccart-Gebhart MJ, de Azambuja E, Procter M, Suter TM, Jackisch C, Cameron D, Weber HA,
Heinzmann 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.


Breast Cancer: Three vs Five Week Post-Operative Radiotherapy
Prof John R Yarnold
Division of Radiotherapy and Imaging
The Royal Marsden NHS Foundation Trust Sutton, Surrey SM2 5PT, UK

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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.
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.
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
breast 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,
Haviland 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.


Pregnancy: Midwife vs Standard Maternity Care Study
Prof Sally K Tracy DMid
Midwifery and Women’s Health Research Unit
University of Sydney, Royal Hospital for Women Randwick, NSW, Australia

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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 preterm 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.



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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.



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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.



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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


Sleep Apnea: CPAP Treatment and Golf Performance
Marc L. Benton, MD, FCCP, FAASM
Morristown Medical Center and Atlantic Sleep & Pulmonary Associates,
Madison, NJ 07940

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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.
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.


Sleep Apnea: CPAP Treatment and Golf Performance
Marc L. Benton, MD, FCCP, FAASM
Morristown Medical Center and Atlantic Sleep & Pulmonary Associates,
Madison, NJ 07940

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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.
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 Medicine
Marc L. Benton, MD, FCCP, FAASM; Neil S. Friedman, RN, RPSGT
Accepted: 9/9/2013


Parkinson’s Disease: Cognitive Impairment and Plasma Ceramides
MedicalResearch.com: Interview with:
Michelle M. Mielke, Ph.D.
Associate Professor Department of Health Sciences Research Division of Epidemiology
Mayo Clinic 200 First Street SW Rochester, MN 55905

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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.
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.
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.
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
Impairment: A Pilot Study
Michelle M. Mielke, Walter Maetzler, Norman J. Haughey, Veera V. R. Bandaru, Rodolfo Savica, Christian Deuschle, Thomas Gasser,
Ann-Kathrin Hauser, Susanne Gräber-Sultan, Erwin Schleicher, Daniela Berg, Inga Liepelt-Scarfone
Research Article | published 18 Sep 2013 | PLOS ONE
10.1371/journal.pone.0073094


Lung Cancer: New Plasma Biomarker for Non-Small Cell Cancer
Jie He, PhD, MD
Director, Laboratory of Thoracic Surgery
President, Cancer Institute & Hospital, Chinese Academy of Medical Sciences
Chaoyang District, Beijing, 100021

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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.

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Dr. Jie He: Yes, we feel a little surprised to see the results can be validated so good. So we are planning to conduct multicenter screenings to further validate the results.
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.
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

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Cognitive Impairment and Hospital Readmissions
Mark W. Ketterer, PhD, ABPP Senior Bioscientific Staff
Henry Ford Hospital/A2 Detroit, MI 48202
Clinical Professor of Psychiatry & Behavioral Neurosciences
Department of Psychiatry Wayne State University

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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).

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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 2013
http://dx.doi.org/10.1016/j.psym.2013.06.019
Available online 7 September 2013

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Cancer Screening Trials: Weighing the Harms
Bruno Heleno, PhD fellow
Research 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

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Bruno Heleno, PhD fellow
Research 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
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.

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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.
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.
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


Colon Cancer: Screening and Mortality
Aasma Shaukat, M.D., M.P.H.
Dept. of Medicine
GI Division, MMC 36 University of Minnesota
Minneapolis, MN 55455

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Dr. Shaukat: The study showed that screening for colon cancer using stool cards
consistently reduces risk of death from colon cancer by one-third through
thirty 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 did
not make people live longer.
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.
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 clinician
and patient should be having a conversation about which test is best for
them, based on risks and benefits.
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; 369:1106-1114
September 19, 2013
DOI: 10.1056/NEJMoa1300720


OCD: Adding Cognitive Therapy to SSIs
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 Institute
New York, NY 10032

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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.
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.


OCD: Adding Cognitive Therapy to SSIs
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 Institute
New York, NY 10032

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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.columbiaocd.org
Citation:
Simpson H, Foa EB, Liebowitz MR, et al. Cognitive-Behavioral Therapy vs Risperidone for
Augmenting Serotonin Reuptake Inhibitors in Obsessive-Compulsive Disorder: A Randomized
Clinical Trial. JAMA Psychiatry. 2013;():-. doi:10.1001/jamapsychiatry.2013.1932.


Addiction: Does Chronic Care Management Improve Outcomes?
Richard Saitz, MD MPH
Professor of Medicine and Epidemiology
Boston University Schools of Medicine and Public Health
Clinical Addiction Research and Education Unit, Boston Medical Center, Boston, Massachusetts

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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.

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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.


Addiction: Does Chronic Care Management Improve Outcomes?
Richard Saitz, MD MPH
Professor of Medicine and Epidemiology
Boston University Schools of Medicine and Public Health
Clinical Addiction Research and Education Unit, Boston Medical Center, Boston, Massachusetts

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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.
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.

Spine Pain Patients: Prevalence of Fibromyalgia in Tertiary Pain Clinic
Chad M. Brummett, M.D.
Assistant Professor, University of Michigan Health System
Department of Anesthesiology
Division of Pain Medicine Ann Arbor, MI 48109

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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.

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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.
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.
Dr. Brummett: Future research is needed to better understand whether the distinct differences in characteristics in the fibromyalgialike 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
implications
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 Definition
Mohamad Fakih, MD, MPH
Medical Director, Infection Prevention and Control
St John Hospital and Medical Center

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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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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.
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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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
of 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)


Unhealthy Aging and Chronic Inflammation
Tasnime Akbaraly PhD
Institut National de la Santé et de la Recherche Médicale
Montpellier, France

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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.


Montpellier, France

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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 wellbeing 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.

Montpellier, France

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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


Diabetes: Increased Mortality Risk in Regardless of Race or Ethnicity
Dr. Yunsheng Ma MD, PHD, MPH
Division of Preventive and Behavioral Medicine Department of Medicine
University of Massachusetts Medical School
55 Lake Avenue North, Worcester, MA 01655

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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.

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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.


Diabetes: Increased Mortality Risk in Regardless of Race or Ethnicity
Dr. Yunsheng Ma MD, PHD, MPH
Division of Preventive and Behavioral Medicine Department of Medicine
University of Massachusetts Medical School
55 Lake Avenue North, Worcester, MA 01655

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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.
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


Obesity: Low Childhood IQ Raises Risk of Midlife Obesity and Late-Life Dementia
Daniel Belsky, PhD
NIA Postdoctoral Fellow
Center for the Study of Aging and Human Development Duke University
Box 104410 Durham, NC 27708

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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.
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.


Obesity: Low Childhood IQ Raises Risk of Midlife Obesity and Late-Life Dementia
Daniel Belsky, PhD
NIA Postdoctoral Fellow
Center for the Study of Aging and Human Development Duke University
Box 104410 Durham, NC 27708

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Dr. Belsky: Obesity is unlikely to damage the brain during the first half of the life course.
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
Course?
Daniel W. Belsky, Avshalom Caspi, Sidra Goldman-Mellor, Madeline H. Meier, Sandhya
Ramrakha, Richie Poulton, and Terrie E. Moffitt
Am. J. Epidemiol. first published online September 12, 2013 doi:10.1093/aje/kwt135


MRIs of the Knee: How big a role is doctor’s financial stake?
Matthew P. Lungren, MD
Duke University Medical Center

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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
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.


MRIs of the Knee: How big a role is doctor’s financial stake?
Matthew P. Lungren, MD
Duke University Medical Center

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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.


Pediatrics: Psychosomatic Problems in Bullied Children
Gianluca Gini, PhD and Tiziana Pozzoli, PhD
Department of Developmental and Social Psychology
University of Padua, Padua, Italy

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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.

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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.
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.


Pediatrics: Psychosomatic Problems in Bullied Children
Gianluca Gini, PhD and Tiziana Pozzoli, PhD
Department of Developmental and Social Psychology
University of Padua, Padua, Italy

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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


Dementia: Lewy Body vs Parkinson’s Disease
Rodolfo Savica, MD, MSc
Department of Neurology, College of Medicine
Division of Epidemiology, Department of Health Sciences Research, College of Medicine, Mayo Clinic, Rochester, Minnesota

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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.

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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).

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Dr. Savica: We were somehow surprised that PDD is less common that expected. PDD is also less common than DLB.


Dementia: Lewy Body vs Parkinson’s Disease
Rodolfo Savica, MD, MSc
Department of Neurology, College of Medicine
Division of Epidemiology, Department of Health Sciences Research, College of Medicine, Mayo Clinic, Rochester, Minnesota

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


Social Isolation Linked to Mortality
Matthew S. Pantell, MD, MS
Department of Pediatrics
University of California, San Francisco

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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.

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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.


Social Isolation Linked to Mortality
Matthew S. Pantell, MD, MS
Department of Pediatrics
University of California, San Francisco

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


Adolescents: Bending the Obesity Curve
Ronald J. Iannotti, PhD
Prevention Research Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland

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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.

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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.


Adolescents: Bending the Obesity Curve
Ronald J. Iannotti, PhD
Prevention Research Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland

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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.
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


Stroke Risk: Increased Risk with Intraplaque Carotid Artery Hemorrhage
Tobias Saam, MD
Institute of Clinical Radiology
Ludwig-Maximilians-Univ Hosp Munich, Germany

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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.

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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%).


Stroke Risk: Increased Risk with Intraplaque Carotid Artery Hemorrhage
Tobias Saam, MD
Institute of Clinical Radiology
Ludwig-Maximilians-Univ Hosp Munich, Germany

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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.
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


Breast Cancer in Young Women: Decisions that Affect Contralateral Prophylactic Mastectomy
Shoshana M. Rosenberg, ScD, MPH
Researcher, Susan F. Smith Center for Women’s Cancers
Dana-Farber Cancer Institute

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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.


Breast Cancer in Young Women: Decisions that Affect Contralateral Prophylactic Mastectomy
Shoshana M. Rosenberg, ScD, MPH
Researcher, Susan F. Smith Center for Women’s Cancers
Dana-Farber Cancer Institute

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Answer: In addition to more effective risk communication, there is a need to better support women during the decisionmaking 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.
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, onethird 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,
MSW; 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


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

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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.

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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 AKTindependent, thereby pointing to kinases other than AKT that are regulated by PDK1 as
mediators of melanoma development.


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

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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).
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
Bosenberg and Z A Ronai
Oncogene , (16 September 2013) | doi:10.1038/onc.2013.383


Opiod Prescriptions: Marked Increase in 10 Year Period
Matthew Daubresse, MHS
Research Data Analyst
Center for Drug Safety and Effectiveness
Johns Hopkins School of Public Health
Baltimore, MD 21205

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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.
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.
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.
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. Alexander
Value in Health – May 2013 (Vol. 16, Issue 3, Page A127, DOI: 10.1016/j.jval.2013.03.615)


Coronary Artery Bypass Grafting: On-Pump vs Off-Pump Trends and Mortality
Faisal G. Bakaeen, MD FACS
Division 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

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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.

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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.


Coronary Artery Bypass Grafting: On-Pump vs Off-Pump Trends and Mortality
Faisal G. Bakaeen, MD FACS
Division 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

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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.
Dr. Bakaeen: I think follow-up studies from the ROOBY, CORONARY, and GOCABE trials will shed interesting light on longerterm 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
Grafting 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
Mortality of On-Pump and Off-Pump Coronary Artery Bypass Grafting in the Veterans Affairs System. JAMA Surg. 2013;():. doi:10.1001/jamasurg.2013.3580.


Dental Caries and Head and Neck Cancer
Mine Tezal, DDS, PhD
Oral Biology University at Buffalo
NYS Center of Excellence in Bioinformatics and Life Sciences

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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.
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.


Dental Caries and Head and Neck Cancer
Mine Tezal, DDS, PhD
Oral Biology University at Buffalo
NYS Center of Excellence in Bioinformatics and Life Sciences

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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.

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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.
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 Effects
Laura A. Petersen, MD, MPH
MEDVAMC Associate Chief of Staff, Research
Director, VA HSR&D Center of Excellence (152) Houston TX 77030
Professor of Medicine Chief, Section of Health Services Research Baylor College of Medicine

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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 individuallevel, 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 preintervention 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.

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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.


Hypertension Control: Financial Incentives Effects
Laura A. Petersen, MD, MPH
MEDVAMC Associate Chief of Staff, Research
Director, VA HSR&D Center of Excellence (152) Houston TX 77030
Professor of Medicine Chief, Section of Health Services Research Baylor College of Medicine

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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
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
Financial Incentives on Hypertension Care: A Randomized Trial. JAMA. 2013;310(10):10421050. doi:10.1001/jama.2013.276303.


Atrial fibrillation: Surgical and Transcatheter Ablation
Elisa Ebrille, MD
Department of Cardiology, School of Medicine
Fiorenzo Gaita, M.D.
Director Division of Cardiology Department of Medical Sciences University of Turin, Turin, Italy

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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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