MedicalResearch.com: Medical Research Interviews Month in Review

MedicalResearch.com
Exclusive Interviews with Medical Research and
Health Care Researchers
Editor: Marie Benz, MD
info@medicalresearch.com
February 10 2014
For Informational Purposes Only: Not for Specific Medical Advice.

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MedicalResearch.com

NSAIDS and Risk of Miscarriage
MedicalResearch.com Interview with: Dr. Sharon Daniel MD, MPH
Physician, Intern in pediatrics at Soroka Medical Center, Beer-Sheva, Israel PhD Candidate and
Prof. Amalia Levy (MPH, PhD Epidemiologist, Head of the Department of Public Health Principle Investigator.
Ben-Gurion University of the Negev in Beer-Sheva, Israel,

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MedicalResearch.com: What are the main findings of the study?
Answer: We tested the risk for miscarriage following the use of NSAIDs (ibuprofen, diclofenac, naproxen, indomethacin,
etodolac) on the first trimester of pregnancy. We did not find increased risk among women who took those drugs during the
first trimester of pregnancy, although we did find increased risk after the use of indomethacin. We found higher risk after
the use of specific NSAIDs (Celecoxib, Rofecoxib, Etoricoxib) which are usually used to treat inflammatory diseases, only the
exposure group was very small.

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MedicalResearch.com: Were any of the findings unexpected?
Answer: We did not expect to find higher risk following the use of indomethacin. We believe that this specific result is
actually caused by a bias because indomethacin is usually given by gynecologists to treat preterm labor. We think, and our
results also show, that women used indomethacin because of an impending miscarriage and that the drug itself is not a risk
factor.
MedicalResearch.com: What should clinicians and patients take away from your report?
Answer: NSAIDs are increasingly used mostly for fever and pain by both clinicians and patients. Our study shows that their
use during the first trimester does not increase the risk for miscarriage.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Answer: As the use of NSAIDs is increasing during pregnancy we recommend that further studies, with larger exposure
groups, will be performed to assess the risk following the use of COX2 inhibitors (Celecoxib, Etoricoxib). We believe that the
answer to this question is sought by many women who suffer from inflammatory diseases and wish to conceive.
Citation:
Note:
The study was performed in collaboration with Prof. Gideon Koren, Motherisk program, division of clinical pharmacology and
toxicology, hospital for sick children,the university of Toronto (BeMORE- Ben-Gurion Motherisk obstetric registry of exposure
collaboration)
Citation:
Fetal exposure to nonsteroidal anti-inflammatory drugs and spontaneous abortions
CMAJ cmaj.130605; published ahead of print February 3, 2014, doi:10.1503/cmaj.130605 Sharon Daniel, Gideon Koren,
Eitan Lunenfeld, Natalya Bilenko, Ronit Ratzon,and Amalia Levy

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Read the rest of the interview on MedicalResearch.com

Childhood Obstructive Sleep Apnea and Anti-Inflammatory Treatment
MedicalResearch.com Interview with: David Gozal, MD
The Herbert T. Abelson Professor and Chair Department of Pediatrics
Physician-in-Chief, Comer Children’s Hospital
The University of Chicago Chicago, IL 60637

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Dr. Gozal: Our study shows that in children with mild obstructive apnea, treatment with an antiinflammatory combination of 2 medications, namely nasal corticosteroid and oral montelukast is
associated with favorable outcomes in the vast majority of the children. Thus, rather than pursue
treatment with adenotonsillectomy as is currently the case in most places, this study paves the way for
non-surgical alternative therapies in pediatric OSA.
Dr. Gozal: Although we anticipated that a certain proportion of children with mild OSA would not respond
to the treatment, our study informed us that obese children and older children are less likely to benefit
from this non-surgical approach. These findings may therefore require implementation of a different set of
diagnostic and treatment algorithm criteria that includes age and BMI z score as determinants of success
probability for the non-surgical treatment of OSA in children.
Dr. Gozal: That real life experience with a nasal corticosteroid and oral montelukast in the management of
children with mild OSA appears to justify their use in clinical practice, rather than proceed immediately to
surgical adenotonsillectomy. However, we should caution all clinicians that although our study included a
large number of patients, it was retrospective in nature and based on a single center experience, such that
randomized clinical trials will be needed to validate this approach.
Dr. Gozal: The ultimate kernel of evidence-based clinical practice currently relies on multicenter
randomized double blind clinical trials. The cumulative evidence on the use of anti-inflammatory therapy
approaches is currently robust enough to justify the implementation of this type of clinical trial and thus
provide a firm scientific foundation for the use of such treatment in children with OSA.
Anti-Inflammatory Therapy Outcomes for Mild OSA in Children
Kheirandish-Gozal L, et al “Anti-Inflammatory Therapy Outcomes for Mild OSA in Children” Chest 2014.

Elevated Resting Heart Rate and Mortality in Adults
MedicalResearch.com Interview with:
Bríain ó Hartaigh, Ph.D.
Assistant Research Professor of Epidemiology
Dalio Institute of Cardiovascular Imaging
Weill Cornell Medical College

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Answer: Sustained elevations in resting heart rate measured longitudinally over the course of 6 years were
strongly and independently associated with a greater risk of death from all causes in adults aged 65 years
or older.
MedicalResearch.com Were any of the findings unexpected?
Answer: It was particularly interesting to observe that a high resting heart rate was predictive of poorer
survival among the oldest old (aged 80 years and above) in this study cohort, given that the evidence
concerning the change in resting heart rate and its relationship with unhealthy life is sparse among this
age strata.
MedicalResearch.com What should clinicians and patients take away from your report?
Answer: Recently, the European Society of Hypertension/European Society of Cardiology guidelines
proposed the inclusion of elevated resting heart rate when evaluating the cardiovascular risk profile of a
patient. Hence, as an easily measurable and modifiable clinical parameter, resting heart rate should
receive the recognition it deserves and be taken more seriously by clinicians and patients, as it may
constitute a significant threat towards unhealthy life.
MedicalResearch.com What recommendations do you have for future research as a result of this study?
Answer: Public health initiatives that are designed for slowing the resting heart rate (e.g., physical
activity) may serve as a useful adjunct for offsetting the burden of chronic disease, especially in the
burgeoning population of older persons. Though clearly, additional studies are needed to test this notion.
Citation:
Elevations in time-varying resting heart rate predict subsequent all-cause mortality in older adult
Bríain ó Hartaigh, Heather G Allore, Mark Trentalange, Gail McAvay, Stefan Pilz, John A Dodson, and
Thomas M Gill

Falls Main Cause of Adult Traumatic Spinal Cord Injuries
MedicalResearch.com Interview with study leaders:
Shalini Selvarajah MD, MPH
Postdoctoral Research Fellow Center for Surgical Trials and Outcomes Research Department of Surgery
Johns Hopkins University School of Medicine Baltimore, MD 21287.

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Researchers:
· Between 2007 and 2010, the number of serious traumatic spinal cord injuries (TSCI) in the United
States (U.S.) increased, doing so more rapidly among older adults (age ≥65 years) compared to younger
adults (age <65 years). Injuries from falls have overtaken motor vehicle crashes as the main cause of adult
TSCI.
· Older adults are more likely to experience worse outcomes compared to younger adults even after
taking into account severity and mechanism of injury, as well as other co-morbid conditions. Older adults
are 4 times more likely to die in the emergency room, and if admitted to inpatient care, they are 6 times
more likely to die as inpatients compared to younger adults.
· Emergency room charges for treatment of acute TSCI among adults increased 20% from $3,342 per
encounter in 2007 to $4,024 per encounter in 2010 even after accounting for the cost of inflation.
Researchers: Our research is the first to utilize the National Emergency Department Sample (NEDS), the
largest all-payer emergency department database in the U.S., which utilizes emergency room billing data
in a manner that allows representative U.S. population estimates to be determined. Prior to our work, the
last reported national estimate of the burden of TSCI was in 1981. Since then, the National Spinal Cord
Injury Statistical Center has estimated national incidence rates using a combination of regional or facilitybased research conducted in the 1980s and 1990s. These estimates suggest an overall increase in
incidence of TSCI.
Our findings suggest that the average age at injury is 50 years, an increase from 29 years reported in 1981.
Because older adults and younger adults may have different causes of TSCI, we evaluated these groups
separately and determined that the incidence of TSCI was actually increasing only among older adults and
driven mainly by falls. The incidence among younger adults stayed fairly stable throughout the study
period.


Falls Main Cause of Adult Traumatic Spinal Cord Injuries
MedicalResearch.com Interview with study leaders:
Shalini Selvarajah MD, MPH
Postdoctoral Research Fellow Center for Surgical Trials and Outcomes Research Department of Surgery
Johns Hopkins University School of Medicine Baltimore, MD 21287.

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Researchers: In the context of an aging U.S. population, our findings reinforce the need to
prevent injury from falls and trips, which can result in TSCI, especially among older adults.
Preventative efforts will reduce the potential lifelong disability and increasing financial
burden of TSCI.
MedicalResearch.com: What recommendations do you have for future research as a result
of this study?
Researchers: There is a need to consider injury prevention programs tailored for specific age
groups. Future research examining risk factors associated with the occurrence of injury, and
poorer outcomes observed among older adults is necessary. An in-depth assessment of
clinical data at the emergency room as well as during the initial inpatient stay may reveal
useful information that could inform injury prevention and policy.
Citation:
The Burden of Acute Traumatic Spinal Cord Injury among Adults in the United States: An
Update
J Neurotrauma. 2014 Feb 1;31(3):228-38. doi: 10.1089/neu.2013.3098
Epub 2014 Jan 9.
Selvarajah S, Hammond ER, Haider AH, Abularrage CJ, Becker D, Dhiman N, Hyder O, Gupta D,
Black JH 3rd, Schneider EB.


Sports Related Concussions: Gender Related Differences
Dr. Scott L. Zuckerman, MD
Department of Neurological Surgery
Vanderbilt Sports Concussion Center
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Dr. Zuckerman: Our study evaluated 244 athletes who suffered sports-related concussion (SRC), 122 males and 122 females, and
assessed for gender differences in number, severity, and resolution of post-concussive symptoms using reliable change index (RCI)
methodology applied to days to return to symptom baseline. Both groups were matched on number of prior concussions, age, and days
to first post-concussion assessment, which consisted of the 22 symptom Post Concussion Symptom Checklist from the Immediate PostConcussion Assessment and Cognitive Testing (ImPACT) evaluation tool.
Our results showed little significant variation of individual symptoms between genders; however, females experienced more total
symptoms at baseline and post-concussion. Moreover, concussed female athletes took an average of 2 days longer to return to their
pre-concussion symptom profile compared to concussed male athletes.
Dr. Zuckerman: Yes and no. We were not sure what to expect, as there are well done studies both supporting and refuting gender
differences in symptoms after sports-related concussion. It is also fairly well established that females report more symptoms before and
after sports-related concussion. In that respect, our findings were not surprising. However, it was interesting to find that females took 2
days longer to return to symptom baseline. Do we know why this is? Not exactly, but we must keep in mind that though aspects of
these symptomatic gender differences are statistically significant, inherent gender reporting biases must be taken in context when
interpretingthese types of results.
Dr. Zuckerman: It is important to draw conclusions that do not overstate your results. The wrong conclusion to draw from our study is
that females take longer to recover from sports concussion and suffer more severe effects than males. That conclusion is simply too
grand to claim validly. However, we can say that in our cohort of 244 athletes, it appeared that males and females reported similar
types of symptoms after sports-related concussion, though females reported a higher number of symptoms before and after
concussion, and took approximately 2 days longer to return to their symptom baseline.
Dr. Zuckerman: Further research is needed in delineating clinical outcome difference between males and females and what is gender
reporting bias. Are females simply more vocal/honest about their symptoms? Are males more stoic? Studies, such as ours, cannot tease
this difference out, but this nuance is essential in learning more about the complex process of sports-related concussion.
Citation:
Effect of sex on symptoms and return to baseline in sport-related concussion
Journal of Neurosurgery: Pediatrics
Jan 2014 / Vol. 13 / No. 1 / Pages 72-81
Jan 2014 / Vol. 13 / No. 1 / Pages 72-81Scott L. Zuckerman, M.D., Rachel P. Apple, M.D., Mitchell J. Odom, B.S., Young M. Lee, B.S.P.H.,
Gary S. Solomon, Ph.D., and Allen K. Sills, M.D.


Obesity and Colon Polyp Risk
Jenifer I Fenton Assistant Professor
Department of Food Science and Human Nutrition
Michigan State University East Lansing, MI 48824

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Dr. Fenton: This was a cross-sectional study, and thus, a snapshot in time. Although it cannot infer cause or temporality of
obesity and colon polyp risk in men, it does show that obese men were more likely to have a polyp than their lean
counterpart. In addition, there were serum biomarkers also associated with this risk. This could eventually lead to future
blood tests to identify individuals at greater risk for polyps and inform screening recommendations.
Dr. Fenton: My laboratory has previous research from cell culture and animal studies indicating that leptin, a hormone
associated with obesity, promotes precancerous colon cells. We used the in vitro data as a basis to ask the question in
humans. So, we did hypothesize these associations. However, we were amazed with the strength of the association in such a
small study of being 6.5 times more likely to have a polyp in obese compared to lean individuals.
Dr. Fenton: Obesity is a risk factor for colon cancer and may also be a risk factor for polyp risk. Everyone should be
encouraged to have their recommended screening at the correct age and interval to reduce their risk of colon cancer. These
data suggest that it is particularly important for obese individuals to get a full colonoscopy at the recommended age and
interval based on the result of their colonoscopy.
Dr. Fenton: These data were generated from a small pilot study in caucasian men in Michigan. While other studies support
the observation in other populations, these data cannot be generalized until the results are confirmed in large prospective
cohort studies. It is very important to understand whether polyps might be identified at a younger age or more advanced in
obese individuals. That data could then lead to changes in screening recommendations in the future. Citation:
Adipokines and Obesity Are Associated with Colorectal Polyps in Adult Males: A Cross-Sectional Study
Sarah S. Comstock, Kari Hortos, Bruce Kovan, Sarah McCaskey, Dorothy R. Pathak, Jenifer I. Fenton
Published: January 17, 2014
PLoS DOI: 10.1371/journal.pone.0085939


Lung Cancer: Allergic Disease History Might Decrease Risk
MedicalResearch.com Interview with: Mariam El-Zein, PhD.
Associée de recherche/ Research associate
Unité d’épidémiologie et biostatistique / Epidemiology & Biostatistics Unit
INRS-Institut Armand-Frappier Université du Québec
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Answer: The overall indication is that a prior history of allergic diseases (asthma, eczema or hay fever) might decrease lung cancer risk.
There was a 36% (odds ratio= 0.64, 95% confidence intervals: 0.44-0.93) reduction in lung cancer risk among subjects who reported a
history of asthma. Hay fever was associated with a 67% (odds ratio= 0.33, 95% confidence intervals: 0.19-0.59) reduction in lung cancer
risk. Smoking was accounted for using a comprehensive smoking index that takes into account multiple dimensions of smoking
behaviour (i.e., smoking status, intensity, duration, and time since cessation). A lower risk of lung cancer (reduction by 37%; odds ratio=
0.63, 95% confidence intervals: 0.38-1.07) was found among those having had eczema, but was not statistically significant.
Answer: On the one hand and from a clinical point of view, we were not expecting a strong association between eczema and lung
cancer, as eczema is not connected with the airways. Also, the strongest associations found with hay fever are hard to explain clinically
since allergic rhinitis is not expected to affect the lower respiratory tract. On the other hand, we had hypothesized a consistent risk
pattern across all three allergic diseases if a common biological mechanism were to be involved.
Answer: The findings from our study should be considered within the context of current epidemiological evidence of a relation between
allergic diseases and lung cancer risk, which is still controversial. Our findings do not necessarily inform us on public health strategies or
recommendations to make for lung cancer prevention, but rather calls for further research on possible mechanisms of
immunostimulation, specifically that of the immune surveillance hypothesis which suggests that a hyper-reactive immune system is
more efficient for tumor recognition and elimination.
Answer: Our population-based study considered incident and histologically confirmed lung cancer cases, and we had detailed
information on multiple covariates, including smoking, which are critical aspects in a sound epidemiological study. Yet, our study, as
well as all previous studies, relied on self-reported allergic diseases. It would thus be pertinent to consider immunological markers in
the ascertainment of allergic diseases in cohort studies. As well, the interpretation of our findings, and those of other researchers, relies
on the eventual elucidation of underlying molecular and immunological mechanisms, which should be the focus of future research.
Citation:
History of allergic diseases and lung cancer risk
Mariam El-Zein, PhD1 Marie-Elise Parent, PhD1,2,3 Jack Siemiatycki, PhD2,3 Marie-Claude Rousseau, PhD1,2,3*
1 INRS-Institut Armand-Frappier, Université du Québec, Laval, Québec, Canada
2 Department of Social and Preventive Medicine, University of Montreal, Montréal, Québec, Canada
3 University of Montreal Hospital Research Centre (CRCHUM), Montréal, Québec, Canada
Annals of Allergy, Asthma & Immunology – 17 January 2014 (10.1016/j.anai.2013.12.021)


Diabetes: Association with Depression and Eating Disorders
Dr Peter de Jonge
Interdisciplinary Center for Psychopathology and Emotion Regulation
University Medical Center Groningen, University of Groningen, Netherlands

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Dr. de Jonge: The main findings were that depression and impulse control disorders, in particular binge
eating and bulimia were associated with diabetes.
Dr. de Jonge: Yes, there is quite a literature on the association between depression and diabetes, but far
less on impulse control disorders and diabetes.
Dr. de Jonge: There might be a lifelong pathway in which persons first develop impulse control disorders
and depression which may gradually develop into diabetes. The role of diet may be significant in this
pathway.
Dr. de Jonge: Future research should point out whether these associations are truly prospective, and if by
early treatment of depression and impulse control disorders, diabetes might be prevented.
Citation:
Diabetologia. 2014 Feb 2. [Epub ahead of print]
Associations between DSM-IV mental disorders and diabetes mellitus: a role for impulse control
disorders and depression.
de Jonge P, Alonso J, Stein DJ, Kiejna A, Aguilar-Gaxiola S, Viana MC, Liu Z, O’Neill S, Bruffaerts R, Caldasde-Almeida JM, Lepine JP, Matschinger H, Levinson D, de Girolamo G, Fukao A, Bunting B, Haro JM,
Posada-Villa JA, Al-Hamzawi AO, Medina-Mora ME, Piazza M, Hu C, Sasu C, Lim CC, Kessler RC, Scott KM.


Menopause and Poor Sleep Quality
Chih-Jen Chang, MD
Department of Family Medicine
National Cheng Kung University Hospital, Tainan, Taiwan

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Dr. Chang: Postmenopausal women without vasomotor symptoms (hot flushes and night sweats) have poorer sleep quality
than premenopausal women. In addition, menopause and snoring are associated with an increased risk of poor sleep quality
independently of cardiometabolic factors and lifestyle.
Dr. Chang: Previous studies of the association between menopause and sleep quality emphasized the severity of vasomotor
symptoms because women ask health providers for help in managing vasomotor symptoms that interfere with their daily
lives. Many women might therefore ignore potentially harmful symptoms other than vasomotor symptoms, such as sleep
disturbance, which is associated with increased risk of diabetes, obesity, and metabolic syndrome. However, the lack of
studies in women without vasomotor symptoms made it difficult to clarify the relationship between menopause and sleep
quality. The results of our study showed that postmenopausal women without
vasomotor symptoms have poorer sleep quality than premenopausal women.
Dr. Chang: Postmenopausal women, even those without vasomotor symptoms, should be alerted to the risk of poor sleep
quality.
Dr. Chang: This study used a cross-sectional design and did not allow examination
of a causal relationship between menopause and sleep quality. Conducting a
prospective study would be better to address this issue. Moreover, the
mechanisms underlying how menopause and sleep disturbance interact remain
unclear. The changes in sex hormones, the prevalence of breathing-related
sleep disorders and periodic limb movement disorders, and the level of
psychological or socioeconomic stress should be assessed in the future
research.
Citation:
Menopause is associated with self-reported poor sleep quality in women without vasomotor symptoms
Hung HC, Lu FH, Ou HY, Wu JS, Yang YC, Chang CJ.
Menopause. 2014 Jan 6. [Epub ahead of print]


Ophthalmology: Using Claims Data to Assess Eye Research
MedicalResearch.com Interview with: Dr. Flora Lum, MD
Executive Director, The H. Dunbar Hoskins Jr., M.D. Center for Quality Eye Care,
American Academy of Ophthalmology
San Francisco, CA 94109-1336

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Dr. Lum: This study anticipates the increased use of claims data for research.
The study recommends a checklist for authors to use in reporting claims data analyses, and
discusses the advantages and limitations of using claims data.
Dr. Lum: There is variability in the methods and descriptions of claims data analyses, and as these
increase in number and importance, its encouraged that researchers use rigorous methods.
Dr. Lum: Clinicians are advised to look for sound methodology in interpreting these claims data
analyses. Clinicians are also advised to use newer billing codes to identify disease severity levels
and to distinguish accurately among different disease conditions.
MedicalResearch.com: What recommendations do you have for future research as a result of this
study?
Dr. Lum: Researchers should use sound, rigorous methods as identified in the study, and report
with sufficient details so that readers are armed with the appropriate information to evaluate these
studies.
Citation:
Use of Health Care Claims Data to Study Patients with Ophthalmologic Conditions
Joshua D. Stein, Flora Lum, Paul P. Lee, William L. Rich, Anne L. Coleman
Ophthalmology – 15 January 2014 (10.1016/j.ophtha.2013.11.038)


Most Drugs Have Ingredients That Come From Animals
Kinesh Patel, Research Fellow
Wolfson Unit for Endoscopy
St Mark’s Hospital, Harrow HA1 3UJ, UK

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Dr. Patel: Most drugs prescribed in primary care have ingredients that come from
animals, but the animals they come from is not always clear and whether the
drugs are suitable for vegetarians is difficult to find out conclusively,
even after looking at information available on packets, information
leaflets and on the internet.

Dr. Patel: Yes. We did not expect such a large number of drugs to contain animal
products and were also surprised at the poor quality of information
available to people who wish to know where the ingredients in their
medication come from. Despite searching a large number of data sources,
information on animal origins and manufacturing ingredients was very
difficult to find, even for healthcare professionals.
Dr. Patel: Clinicians should discuss patients’ dietary preferences with them before
prescribing medication and find out directly from companies if the products
contain ingredients that would not be compatible with the patient’s views.
Patients should not discontinue any medications but should discuss the
results of this study with their physician if they are concerned about the
tablets they consume.
Dr. Patel: Future research could look at drugs used in hospital practice to see if the
same issues apply as well as over-the-counter medications.
Citation:
Suitability of common drugs for patients who avoid animal products
Kate C Tatham and Kinesh P Patel
Published 4 February 2014 BMJ 2014;348:g401


Pregnancy Exposure to Colds, Dust Mites and Offspring Atopic Dermatitis, Hayfever
Dr. Sabina Illi, Dipl.-Stat., MPH
University Children’s Hospital Lindwurmstr. 4
80337 Munich Germany
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Answer: We observed that the offspring of atopic pregnant women that showed symptoms of atopy during pregnancy, i.e. atopic dermatitis or hay
fever, had a higher risk of having the respective atopic disorder themselves. However, we do not know whether this is due to timing, i.e. pregnancy,
or whether it merely mirrors the severity of maternal disease.
Furthermore, in our study pregnant mothers with repeated colds during pregnancy were at increased risk of having a child that wheezed at preschool age, this was statistically independent of the intake of medication.
We also took dust samples from the child’s home at the early age of 3 months. Interestingly, a contrasting effect of the level of endotoxin from the
child’s mattress, a component of the cell-wall of gram-negative bacteria, and of mite allergen exposure was observed in that the lowest risk for mite
sensitization at pre-school age was observed in those children with both low mite allergen exposure and high endotoxin exposure.

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Answer: Yes, all of our findings are new to some extent.
Answer: As long as the immunological mechanisms leading to our findings are not well understood it is hard to give any recommendations to
clinicians or patients. In our case, we are not speaking about patients but about pregnant women. Pregnancy comprises a very complex interaction of
various immunological factors that are to some part genetically predetermined and to some part influenced by external factors such as environment
and infections. Thus, I would strongly refrain from giving any direct advice such as “don’t catch a cold when pregnant”. In a previous study, we
observed that repeated episodes of runny nose in the first year of life of the newborn child were protective for wheeze in later in life. So far, these
seemingly contrasting observations cannot be explained, as we know too little about the involved immunological processes. I believe our results are
fairly preliminary and need confirmation in further studies before any recommendations can be given.
Answer: Our study on perinatal factors in the evolution of atopic and asthmatic disorders is an explorative, observational study. It comprises only
526 mothers and has a follow-up period of only 5 years. We have no lab data on immunological factors. Furthermore, we have a quite homogeneous
study group with all mothers coming from the fairly affluent region of Greater Munich. I recommend a much larger long-term study that aims at
assessing as many environmental, infectious and lifestyle factors in pregnancy as possible. In parallel, immunological factors need be assessed
prospectively in order to shed light into the extremely complex immunological processes going on in pregnancy.
Citation:
Perinatal influences on the development of asthma and atopy in childhood
Sabina Illi, PhDJuliane Weber, MD∗,
Anne Zutavern, MD∗, Jon Genuneit, MD†, Rudolf Schierl, PhD‡,
Christine Strunz-Lehner, MPH∗, Erika von Mutius, MD∗
Annals of Allergy, Asthma & Immunology
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Volume 112, Issue 2, February 2014, Pages 132–139.e1


Epidemic of Cannabis Related Drugged Driving Fatalities
Joanne E. Brady SM Senior Staff Associate
Department of Anesthesiology
Doctoral Candidate in Epidemiology Columbia University Medical Center
New York, NY 10032 Department of Epidemiology,

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Answer: The prevalence of non-alcohol drugs detected in fatally injured drivers in the U.S.
increased from 17% in 1999 to 28% in 2010. The increases are largely driven by the tripling in the
prevalence of cannabis.
Answer: We expected to find an increase in non-alcohol drugs. But the magnitude of the increase in
cannabis is shocking. If this trend continues, the prevalence of motor vehicle crashes with fatally
injured drivers testing positive for non-alcohol drugs will overtake crashes with fatally injured
drivers testing positive for alcohol in five years.
Answer: Clinicians should remind patients of the potential dangers of medication, marijuana, and
other drug use on driving.
study?
Answer: Future research should continue monitoring the epidemic of drugged driving and develop
intervention programs to reduce injuries and fatalities resulting from impaired driving.
Citation:
Trends in Alcohol and Other Drugs Detected in Fatally Injured Drivers in the United States, 19992010
Joanne E. Brady and Guohua Li
Am. J. Epidemiol. first published online January 29, 2014 doi:10.1093/aje/kwt327

Knee Osteoarthritis: Exercise Impact on Pain and Disability
Carsten Juhl, PhD, MPH Research Physiotherapist
Forskningsenheden for Muskuloskeletal Funktion og Fysioterapi (FoF)
Institut for idræt og biomekanik Syddansk Universitet
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Carsten Juhl, PhD, MPH
Research Physiotherapist
Forskningsenheden for Muskuloskeletal Funktion og Fysioterapi (FoF)
Institut for idræt og biomekanik
Syddansk Universitet
Dr. Juhi: The main findings of this study including 48 RCTs with more than 4000 patients were that
[1] exercise therapy programs focusing on a single type of exercise were more efficacious in reducing pain and patient-reported disability than those
mixing several types of exercise with different goals within the same session;
[2] the number of supervised sessions enhances the benefits of the aerobic exercise;
[3] exercise focusing on the knee extensor muscle strength only, may increase the benefits of resistance training and
[4] exercise seems to be effective therapy for knee osteoarthritis, regardless of age, sex, BMI, radiographic status or baseline pain.
Dr. Juhi: It was actually surprising that interventions with different type of exercise within the same exercise session were less effective than sessions
with only a single exercise type and I think that this should be investigated further in direct comparisons. Furthermore we expect that increasing
intensity of strength training had an impact on reduction of pain and disability, but this was not confirmed in the study and the one study comparing
strength with high and low intensity.
Dr. Juhi: In order to achieve the best effect of exercise therapy for patients with knee osteoarthritis exercise interventions should focus on a single
type of exercise. In patients with poor aerobic capacity and muscle strength, aerobic exercise and strength training should be performed on different
days in order to achieve the best effect. These exercise programs should be supervised and carried out at least three times a week.
Dr. Juhi: The above recommendation should be confirmed in trials with a direct comparison on single versus multiple exercise type; exercise two
versus three times or more a week..
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Furthermore the dose-response relationship in exercise for knee osteoarthritis should be investigated in individual patient data meta-analyses
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In order to investigate the impact of different exercise program characteristics it is important that future exercise interventions are described in
details concerning intensity, length of exercise program, number of supervised sessions, duration of individual supervised sessions, and number of
sessions per week.
Citation:
Impact of exercise type and dose on pain and disability in knee osteoarthritis: A systematic review and meta-regression analysis of randomized
controlled trials
Arthritis Rheum. 2013 Dec 18. doi: 10.1002/art.38290. [Epub ahead of print]
Juhl C, Christensen R, Roos EM, Zhang W, Lund H.


Autism: Autistic Brains Create More Information at RestMedicalResearch.com Interview with:
Roberto Fernández Galán, PhD
Department of Neurosciences, School of Medicine
Case Western Reserve University
Cleveland, OH, USA

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Dr. Galán: The main finding is that autistic brains create more information at rest than non-autistic brains. This is consistent
with the classical view on autism as withdrawal into self. It is also consistent with a recent theory on autism, the “Intense
World Theory”, which claims that autism results from hyper-functioning neural circuitry, leading to a state of excessive
arousal. From both perspectives, the classical and the IWT, communication and social deficits associated with autism result
from having a more intense inner life and a higher level of introspection.
Dr. Galán: Our results were indeed unexpected although in hindsight, they fit very well with the theories on autism referred
to above. There was another revelation, on a philosophical level, that pertains to the classical dichotomy between mind and
body: while the body is a material entity and its physiological processes can be measured and quantified in various ways,
measuring mental processes, such as introspection is not trivial. Surprisingly enough, a mathematical framework that
engineers routinely use in the design of electronic devices, known as information theory, when applied to the analysis of
brain activity at rest could take neatly apart autistic brains from non-autistic brains, suggesting that it can measure
introspection, or perhaps some other cognitive feature that is distinct in autism.
Dr. Galán: There are two take-home messages.
The first one is that the analysis of brain activity, even when recorded on a large scale, such as with
magnetoencephalography (MEG), has a strong potential for developing novel biomarkers for autism and possibly other
cognitive types as well.
The second one is that although we cannot tell what the subjects are thinking, we can tell that autistic brains create more
information at rest, which suggests that they process information differently even in the absence of significant stimuli.
Dr. Galán: This study demonstrates the benefits of applying interdisciplinary approaches from engineering, mathematics and
neuroscience to understand how the brain works, and how typical and atypical brains differ from each other.
Citation:
Information Gain in the Brain’s Resting State: A New Perspective on Autism
Published online 2013 December 24.
doi: 10.3389/fninf.2013.00037
José L. Pérez Velázquez and Roberto F. Galán


Cancer: Pain Measurement in Ambulatory Patients
Fengmin Zhao, MS,PhD Biostatistician
Department of Biostatistics & Computational Biology Dana-Farber Cancer Institute
Boston, MA 02215
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Fengmin Zhao, MS,PhD Biostatistician
Department of Biostatistics & Computational Biology Dana-Farber Cancer Institute
Boston, MA 02215
Dr. Zhao: We analyzed 2,761 patients in this study. We found that at initial assessment, 53.0% of patients had no pain, 23.5% had mild pain, 10.3%
had moderate pain, and 13.2% had severe pain. Overall, one third of patients with initial pain had pain reduction within 1 month of follow-up, and
one fifth had an increase. Inadequate pain management was significantly associated with pain deterioration in these patients, as were lower baseline
pain level, younger age, and poor health status. Of the patients without pain at initial assessment, 28.4% reported pain at the follow-up assessment
(8.9% of them were moderate to severe pain), and more than half of them received inadequate pain management.

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Dr. Zhao: An unexpected finding of our study was that improvement in pain levels varied with baseline pain levels. Patients with lower baseline pain
level were more likely to have pain deterioration.
It is now clear that baseline pain severity is an indicator of pain management complexity and an important element to consider when designing pain
intervention clinical trials to improve the assay sensitivity of these trials.
Dr. Zhao: The main message of the study is that pain remains a significant concern in ambulatory oncology. Pain is not only prevalent but also
persistent and dynamic in cancer patients. Inadequate pain management is the main problem for effective pain control, partly due to the adverse
effects of analgesics.
For clinicians, it is not enough to simply ask about pain at each visit. There needs to be improvement in the way clinicians select and titrate
analgesics, utilize expert consultants, and understand patient’s concerns about adverse effects of analgesics, There needs to be close monitoring
patients for the analgesic’s pain control effect and its adverse effects that is also feasible in the modern clinical oncology setting. Such monitoring
requires knowledge and skills at the individual level and also the system level. Clearly, effective and culturally competent communication and patient
education are needed.
Dr. Zhao: More studies are needed to better understand the reasons for inadequate pain management in ambulatory oncology and to explore new
ways to deliver effective care and to monitor and continuously improve that aspect of the patient experience. In addition, studies about biological
mechanisms of cancer-related pain are important to better understand pain and to guide targeted interventions.
Citation:
Determinants of Pain Severity Changes in Ambulatory Patients With Cancer: An Analysis From Eastern Cooperative Oncology Group Trial E2Z02
Fengmin Zhao, Victor T. Chang, Charles Cleeland, James F. Cleary, Edith P. Mitchell, Lynne I. Wagner, and Michael J. Fisch
JCO.2013.50.6071; published online on December 23, 2013;


Hospital Leadership Important for Quality Improvement
Joseph D. Restuccia, DrPH, MPH Professor and Deans Research Fellow
Operations and Technology Management Department
Health Sector Management Program Boston University School of Management Boston, MA 02215

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Dr. Restuccia: The study resulted in three major findings regarding quality improvement activities in VA.
The first is that of the three general categories, to date VA hospitals have devoted the most substantial effort to quality
improvement activities (QIAs) related to prevention.
The second is that a strong alignment of goals between senior medical center leadership and inpatient medicine service
leadership is the greatest predictor of an institution’s use of QIAs.
The third is that the medical centers that employ hospitalists, physicians who specialize in the practice of hospital medicine,
show the strongest QIA adoption across all three categories.
Dr. Restuccia: It was somewhat surprising that use of nurse practitioners or physician assistants did not have any impact of
the extent of QIAs implemented.
Dr. Restuccia: Our findings demonstrate that the importance of hospital leadership to quality improvement. If leaders are
committed to improve quality it is much more likely to happen, especially if they use hospitalists on the medicine service.
Dr. Restuccia: As our study design was cross-sectional, future research is needed using a longitudinal study design to better
determine causality and to investigate the relationship between contextual factors and QIAs on quality performance. In
addition, similar study should be conducted outside of VA to determine the extent our findings are generalizable outside of
VA.
Citation:
The Association of Hospital Characteristics and Quality Improvement Activities in Inpatient Medical Services
Restuccia JD, Mohr D, Meterko M, Stolzmann K, Kaboli P.
J Gen Intern Med. 2014 Jan 15. [Epub ahead of print]


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Pediatric Anxiety Disorders: Treatment Follow Up Course
Golda Ginsburg, Ph.D Professor Director, Research,
Division of Child and Adolescent Psychiatry
Department of Psychiatry and Behavioral Sciences The Johns Hopkins University School of Medicine
Baltimore, Maryland

Dr Ginsburg: This study examined the long-term outcomes of youth treated for an anxiety disorders.
Findings revealed that almost half of anxious youth treated for an anxiety disorder were in remission
(i.e., did not meet diagnostic criteria for any of the three study entry anxiety disorders) at an average of six
years since starting treatment. Youth showing clinically meaningful improvement after 12 weeks of
treatment, were more likely to be in remission, had lower anxiety severity, and had better functioning
compared to youth who showed minimal or no initial clinical improvement.
Treatment type did not affect long-term outcomes.
Dr Ginsburg: A lower percent of youth maintained their initial treatment gains than expected, suggesting a
need for additional monitoring and relapse prevention.
Dr Ginsburg:
Initial positive response to an evidenced-based treatment increases the probability for remission.
Continued monitoring and regular “check- ups” are warranted even for youth who show an initial
treatment response.
Dr Ginsburg:
Identify additional variables that predict who will relapse
Identify relapse prevention strategies to prevention relapse
Citation:
Ginsburg GS, Becker EM, Keeton CP, et al. Naturalistic Follow-up of Youths Treated for Pediatric Anxiety
Disorders. JAMA Psychiatry. 2014;():. doi:10.1001/jamapsychiatry.2013.4186


Atrial Fibrillation: Dabigatran and Risk of Myocardial Infarction
Professor Gregory Y.H. Lip MD, FRCP
Consultant Cardiologist & Professor of Cardiovascular Medicine, Director – Haemostasis Thrombosis & Vascular Biology Unit
Birmingham, United Kingdom

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[GYHL] In this large-scale nationwide cohort study, we found that switching to dabigatran increased the
risk of MI compared to continued warfarin usage in the early period after switching. Caution may be
warranted especially when switching prior VKA-experienced patients with atrial fibrillation to dabigatran.
This risk was not evident in the warfarin-naïve cohort newly started on dabigatran.
[GYHL] Dabigatran may provide less protection against myocardial infarction( MI) than warfarin in patients
with atrial fibrillation.
In a nationwide cohort study, we found that switching to dabigatran increased the risk of MI compared to
continued warfarin usage in the early period after switching. This risk was not evident in the warfarinnaïve cohort newly started on dabigatran.
[GYHL] Some caution may be warranted, when switching prior warfarin-experienced patients with atrial
fibrillation to dabigatran.
[GYHL] More data from real world post marketing data needed, as well as randomised trials
Citation:
Myocardial ischemic events in ‘real world’ patients with atrial fibrillation treated with dabigatran or
warfarin: A nationwide cohort study.
Larsen TB, Rasmussen LH, Gorst-Rasmussen A, Skjøth F, Rosenzweig M, Lane DA, Lip GY.
Am J Med. 2013 Dec 18. pii: S0002-9343(13)01073-5. doi: 10.1016/j.amjmed.2013.12.005. [Epub ahead of
print]


Tonsillectomy: Substantial Variability in Pediatric Hospital Care
Dr. Sanjay Mahant, MD, FRCPC
Division of Pediatric Medicine, Pediatric Outcomes Research Team (PORT), Department of Pediatrics, Institute of Health Policy, Evaluation and
Management, University of Toronto, Child Health Evaluative Sciences, Research Institute, Hospital for Sick Children, Toronto, Canada

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Dr. Mahant: In a large cohort of children undergoing same-day tonsillectomy at 36 children’s hospitals in the U.S., we
observed substantial variability in several areas. These include: processes of care, the use of steroids and antibiotics – for
which there are national guidelines that outline the recommended use of these medications – and outcomes of usage, as
well as revisits to hospital after surgery for complications within 30 days following surgery.
Dr. Mahant: We were surprised at the degree of variation between hospitals in the use of medications (steroids and
antibiotics) on the day of surgery, as well as the number of revisits to hospitals after the surgery for complications within the
first 30 days. We expected to see some variation, but did not expect to see such a large range.
Dr. Mahant: For clinicians, our study highlights that complications after tonsillectomy that require a return visit to hospital
are not uncommon. It also provides data on quality measurement and hospital revisit rates, which will be helpful for
hospitals’ tonsillectomy quality improvement efforts.
Patients should take away that while tonsillectomy is a very common surgery in children, complications do occur and can be
serious. Families should understand the goal of surgery and the potential complications for their child when making a
decision about whether the child should undergo surgery.
Dr. Mahant: We need to understand factors that are important for reducing hospital revisits for complications following
tonsillectomy. Studying high-performing hospitals may be important to elucidating these factors. Furthermore, quality
improvement work is needed to implement current evidence of best practices into hospitals.
Citation:
Variation in Quality of Tonsillectomy Perioperative Care and Revisit Rates in Children’s Hospitals
Sanjay Mahant, Ron Keren, Russell Localio, Xianqun Luan, Lihai Song, Samir S. Shah, Joel S. Tieder, Karen M. Wilson, Lisa
Elden, and Rajendu Srivastava, for the Pediatric Research in Inpatient Settings (PRIS) Network
Pediatrics peds.2013-1884; published ahead of print January 20, 2014, doi:10.1542/peds.2013-1884


Football Helmet Types: Large Differences in Concussion Risk
Steven Rowson, Ph.D.
Research Assistant Professor Virginia Tech Wake Forest University
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Dr. Rowson: We found that there were large differences in concussion risk between football helmet types. This is the first study to
address this question while controlling for the number of times each helmet type was impacted.
This allowed us to compare apples to apples. For example, we’re not comparing starters who frequently get hit in one helmet type to
second string players who don’t get hit as much.
Dr. Rowson: We expected to find differences in performance between the two helmet
types, but finding over a 50% reduction in concussion risk was a little
surprising.
Dr. Rowson: The study illustrates that differences in the ability to reduce concussion
risk between helmet types exist. Clinicians and patients should be
cognizant of which helmets are being used, and identify whether there is
a need for better head protection.
Dr. Rowson: We only investigated two helmet types in this first study. Future work
should consider all helmet types, but with that said, it is critical that
future studies control for the number of times each helmet is impacted. If
the study can’t control for the exposure to impact of each helmet type, it
will be difficult to draw meaningful conclusions.
Citation
Can helmet design reduce the risk of concussion in football?
Steven Rowson, Ph.D., Stefan M. Duma, Ph.D., Richard M. Greenwald, Ph.D., Jonathan G. Beckwith, M.S., Jeffrey J. Chu, M.S., Kevin M.
Guskiewicz, Ph.D., Jason P. Mihalik, Ph.D., Joseph J. Crisco, Ph.D., Bethany J. Wilcox, B.S., Thomas W. McAllister, M.D., Arthur C.
Maerlender, Ph.D., Steven P. Broglio, Ph.D., Brock Schnebel, M.D., Scott Anderson, B.S., and P. Gunnar Brolinson, D.O.
Address correspondence to: Steven Rowson, Ph.D., 440 Kelly Hall, 325 Stanger St., Blacksburg, VA 24061. email: srowson@vt.edu.
Journal of Neurosurgery
published online January 31, 2014; DOI: 10.3171/2014.1.JNS13916.


Risk of Suicide, Homicide Increases with Household Firearm Access
Andrew Anglemyer, PhD, MPH;
Clinical Pharmacy and Global Health Sciences
University of California, San Francisco San Francisco, CA
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Dr. Anglemyer: Over all, you are more than 3 times more likely to commit suicide if you have access to a firearm than if you do not. And, among
men only, they are nearly 4 times more likely to commit suicide if they have access to a firearm than if they do not.
Additionally, over all, you are 2 times more likely to be a victim of homicide if you have access to a firearm than if you do not.
We also found that females have a higher likelihood of being a victim of homicide, than males when considering firearm access. And we know from
empirical data that the majority of female victims knew their assailant—which, to us, suggests that they were victims of domestic violence.

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Dr. Anglemyer: What we as researchers do in a systematic review and meta-analysis is look at all the available data and synthesize that data–we
pool the evidence. So, what we found is not really new evidence; what IS new is that we have looked at ALL the available evidence to help
understand the true risks. So, if there were any ambiguity about the safety of firearms, at least in terms of suicide or being a victim of homicide, we
hope we have provided evidence to clear this up.
Another important point is that most reviews summarize the body of evidence and find that there’s at least a little inconsistency between
studies. That’s not really what we see here. Of 15 studies, 14 found significantly higher odds of suicide or homicide and 1 found a non-significantly
higher odds of suicide.
Dr. Anglemyer: To be clear, this isn’t a study about how “bad” guns are. This is a study about understanding the risks with owning a gun—and not
just the risk of accidental injury, but, at least in the present case, the risk of intentional harm. And impulsivity seems to be a major player
here. What’s important to understand is that most of these studies controlled for a history of mental illnesses, which means that the risk of suicide
was independent of any diagnosed history of mental illness in most cases.
Assuming impulsivity is the driving force here, what we’re seeing is some people are sometimes making very bad, impulsive decisions, the
ramifications of those decisions are obviously very deadly.
In terms of patients and clinicians, our evidence can only help people make informed decisions about whether a firearm is right for them. If there are
members in a particular household who are depressed or if there is a volatile relationship, easy access to a firearm could be potentially dangerous.
Dr. Anglemyer: We feel that a gap in firearms research is in two areas in particular: studies of homicide perpetration (our study focused on homicide
victimization) and studies determining the protective effect of firearms (e.g., how likely one is to use a firearm for protection versus use it for harms).
There are a number of studies out there we did not include. They are different types of studies that collect data on a population level. So, for
example, the rates of homicide or the rates of firearm access in a given population, and the researcher will make inferences based off of those
rates. Though our review did not cover these types of studies, we feel that they have an important role in firearms research to examine the potential
trends over time or potential impact of policies in different regions.
Citation:
Andrew Anglemyer, Tara Horvath, George Rutherford; The Accessibility of Firearms and Risk for Suicide and Homicide Victimization Among
Household MembersA Systematic Review and Meta-analysis. Annals of Internal Medicine. 2014 Jan;160(2):101-110.


Autistic Spectrum Reclassification Should Not Affect Patient Services Eligibility
Bennett L. Leventhal, MD
Nathan S. Kline Institue for Psychiatric Research
140 Old Orangeburg Road, Building 35 Orangeburg, NY 10962
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Dr. Leventhal: In the American Psychiatric Association’s Diagnostic and Statistical Manual for Mental Disorders, 5th Edition (DSM5) released in May 2013, changes
include major alterations in criteria for developmental disorders, in particular, the DSMIV diagnostic criteria for Pervasive Developmental Disorder (PDD), including
elimination of subtypes found in DSMIV such as Asperger Disorder and PDD NOS. Additionally, DSM 5 adds a new diagnostic category, Social Communication Disorder
(SCD): individuals with SCD have difficulties similar to ASD but these problems are solely restricted to the realm of social communication and do not include the
restrictive and repetitive behaviors found in ASD.
Apparent differences between DSMIV PDD and DSM5 ASD criteria have led to debates, in both the scientific and lay communities, over whether these changes in
diagnostic criteria will: materially affect ASD prevalence; alter the way individuals will be diagnosed with ASD; and, possibly, the eligibility of individuals for clinical
and other services. Such debates are creating controversy amongst professionals, as well as confusion and anxiety for service providers, policy makers, and, most
importantly, for patients and their families.
In order to answer these pressing questions, we computed DSM5 ASD and SCD prevalence and compare them to DSMIV PDD prevalence estimates, utilizing our
published, total-population Korean prevalence data. We also describe individuals previously diagnosed with DSMIV PDD when diagnoses change with DSM-5 criteria.
The target population was all 7-12-year-old children in a South Korean community (n= 55,266), those in regular and special education schools and a disability registry.
We utilized the Autism Spectrum Screening Questionnaire for systematic, multi-informant (both parents and teachers) screening. Parents of screen-positive children
were offered comprehensive assessments using standardized diagnostic procedures, including the Autism Diagnostic Interview-Revised (ADI-R) and Autism Diagnostic
Observation Schedule (ADOS). Board certified child and adolescent psychiatrists made consensus best estimate clinical diagnoses using DSMIV PDD and DSM5 ASD
and SCD criteria.
DSM5 ASD estimated prevalence is 2.20% (CI: 1.77-3.64). Combined DSM-5 ASD and SCD prevalence (0.49%) is virtually the same as DSM-IV PDD prevalence (2.64%).
Most children with Autistic Disorder (99%), Asperger Disorder (92%), and PDD NOS (63%) met DSM-5 ASD criteria, whereas 1%, 8% and 32%, respectively, met SCD
criteria. All remaining children (2%) had other psychopathology, principally Attention Deficit Hyperactivity Disorder (ADHD) and anxiety disorder. These data provide
essentially no support for the concerns that individuals affected with DSMIV PDD will “lose a diagnosis” with the advent of DSM5.
Dr. Leventhal: When ASD and SCD are combined, then virtually everyone with a DSMIV PDD remains on the “new spectrum.” Since, until proven otherwise, the
treatments for ASD and SCD remain the same or similar, it is important for children moving to SCD (and their families), to continue receiving the interventions they
received with the DSMIV PDD diagnosis. And, for those falling out of the DSM5 ASD/SCD group, they appear to have other significant and impairing disorders that are
also important and certainly deserve the care and attention appropriate for those conditions; clinicians should promptly point these children in the right directions,
even though ASD is not that direction. Whether the label is PDD, ASD or SCD, extant diagnostic criteria are helpful in identifying a relatively large, clinically
meaningful group of individuals and families who deserve comprehensive evaluations and evidence-based treatments, as early as possible.
Dr. Leventhal: There is a need to follow up the DSMIV- DSM 5 divergent children to understand the natural course and outcomes of their conditions and how they are
related or unrelated to ASD.
Citation:
A Comparison of DSM-IV PDD and DSM-5 ASD Prevalence in an Epidemiologic Sample
Young Shin Kim, Eric Fombonne, Yun-Joo Koh, Soo-Jeong Kim, Keun-Ah Cheon, Bennett Leventhal
Journal of the American Academy of Child & Adolescent Psychiatry – 23 January 2014 (10.1016/j.jaac.2013.12.021)


Weight Loss Healthy Living Program for Men
Professor Sally Wyke
Deputy Director, Institute of Health and Wellbeing
Professor (Institute of Health and Wellbeing Social Sciences) The University of Glasgow

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Prof. Wyke: The FFIT programme was very effective. The men who did the programme lost nine times as much weight as
the men who did not. On average, they lost over 5.5kg (11lbs)and kept it off for the full 12 months.
In addition, we found highly significant differences in favour of the intervention objectively-measured waist, percentage
body-fat, systolic and diastolic blood pressure, and self-reported physical activity, diet and indicators of well-being and
physical aspects of quality of life.
Prof. Wyke: Although none of these findings were unexpected we were really delighted with the extent to which the
programme worked to improve outcomes across the board.
Prof. Wyke: Too often we have slipped into thinking that men are not really interested in their health or their bodies. FFIT is
a really good example to show that men can be just as motivated as women to make positive changes to their health if
programmes can be designed to appeal to them.
Prof. Wyke: We are already undertaking further research to consider whether elements of the programme are adaptable for
delivery in European Football Clubs, in secure institutions and in rugby union football clubs in the UK. We think it’s really
important to evaluate how weight loss can be maintained in the long term and that other, innovative programmes be
rigorously developed and evaluated to the same standard.
Citation:
A gender-sensitised weight loss and healthy living programme for overweight and obese men delivered by Scottish Premier
League football clubs (FFIT): a pragmatic randomised controlled trial
Prof Kate Hunt PhD,Prof Sally Wyke PhD,Cindy M Gray PhD,Prof Annie S Anderson PhD,Adrian Brady MD,Christopher Bunn
PhD,Prof Peter T Donnan PhD,Prof Elisabeth Fenwick PhD,Eleanor Grieve MPH,Jim Leishman BSc,Euan Miller MA,Prof
Nanette Mutrie PhD,Petra Rauchhaus BSc,Alan White PhD,Prof Shaun Treweek PhD
The Lancet – 21 January 2014
DOI: 10.1016/S0140-6736(13)62420-4


Life Expectancy: Urban-Rural Disparities Widen
MedicalResearch.com Interview with: Gopal K. Singh, Ph.D., M.S., M.Sc.
Senior Epidemiologist/Health Care Administrator Office of Epidemiology and Research Rockville, MD 20857, USA
and Mohammad Siahpush, PhD
Professor, Department of Health Promotion, Social & Behavioral Health University of Nebraska Medical Center
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Answer: There are significant disparities in life expectancy between rural and urban areas of the United States – and these disparities have widened over the past 4
decades. In 1969, life expectancy was 0.4 years longer in urban than in rural areas (70.9 vs. 70.5 years). In 2009, the life expectancy difference between urban and
rural areas increased to 2.0 years (78.8 vs. 76.8 years). Much of the disparity appears to have increased since 1990. Life expectancy has increased more rapidly in
urban than in rural areas, which has contributed to the widening gap in life expectancy.
Life expectancy is lower in more rural areas. In 2005-2009, life expectancy was 79.1 years in large metro areas, 77.8 in small metro areas, 76.9 years in small-urban
towns, and 76.7 years in rural areas. So, the difference in life expectancy between the most-urban and most-rural was 2.4 years.
Mortality from cardiovascular diseases, unintentional injuries (mostly motor-vehicle accidents), lung cancer, and COPD is much higher in rural than in urban areas,
and these causes collectively account for 70% of the overall rural-urban gap in life expectancy and 54% of the life expectancy gap between the urban rich and rural
poor.
For each racial/ethnic group, people in rural areas have lower life expectancy than those in urban areas. The largest difference was for American Indians/Alaska
Natives. Americans Indians/Alaska Natives have a life expectancy of 85.8 years in urban areas, 11 years more than their counterparts in rural areas. Socioeconomic
disparities only partly account for rural-urban disparities in life expectancy. More affluent residents in urban and rural areas have higher life expectancy than their
lower-income counterparts. Life expectancy for the rural poor was 74.4 years, compared with 80.6 years for rural rich and 80.7 years for the urban rich.
Answer: Yes. There are dramatic inequalities in life expectancy when you consider race/ethnicity, gender, poverty, and rural-urban populations simultaneously. Life
expectancy currently ranges from 67.7 years among poor black/African-American men in non-metropolitan areas to 89.6 among Asian/Pacific Islander women in
metropolitan areas – a difference of about 22 years. Moreover, what is surprising is that the rural poor and rural blacks/African-Americans currently experience life
expectancy and survival chances that urban rich and urban whites enjoyed four decades earlier.
Answer: Chronic diseases associated with lifestyle factors such as heart disease, respiratory diseases, lung and colorectal cancers, diabetes, and kidney diseases are
becoming increasingly important determinants of excess mortality in rural areas and among the rural poor. So, clinicians and patients both need to pay particular
attention to adverse health impacts of preventable chronic conditions; behavioral risks such as smoking, physical inactivity, obesity, and poor diet; and lower seatbelt
use, inadequate motor-vehicle safety, and faster driving on rural roads. Of course, clinicians and healthcare providers also need to be aware of the role of broader
and more upstream social determinants of health (such as education, income, employment, affordable housing, access to food/good nutrition, and opportunities for
physical activity); deficits in many of these social resources can put the residents in both rural and urban areas at higher risk of adverse health outcomes, injuries, and
lower life expectancy.
Answer: Future research should continue to monitor rural-urban disparities in life expectancy and mortality from major causes of death to see if health disparities are
narrowing or widening. Such monitoring is important in that it allows both researchers and policy makers to evaluate if specific social, public-health, and/or medical
interventions (such as smoking reduction, anti-obesity measures, and improved healthcare access) are working towards population health improvement in rural
areas or reversing the widening health gap between rural and urban areas.
Citation:
Widening Rural-Urban Disparities in Life Expectancy, U.S., 1969- 2009
Gopal K. Singh, Mohammad Siahpush
American Journal of Preventive Medicine – February 2014 (Vol. 46, Issue 2, Pages e19-e29, DOI: 10.1016/j.amepre.2013.10.017)


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Alzheimer Disease and Elevated Pesticide DDT Levels
Jason R. Richardson MS, PhD, Associate Professor
Department of Environmental and Occupational Medicine
Robert Wood Johnson Medical School and Resident Member Environmental and Occupational Health Sciences Institute
Piscataway, NJ 08854

Dr. Richardson: We had 3 main findings in our study.
First, Alzheimer Disease patients had almost 4 times the levels of serum DDE when compared to controls.
Second, those carrying APOE4, which is a strong risk factor for AD, had much worse cognitive function when they also had
high DDE levels. I should not that “high” DDE levels are relative. The levels we observed are consistent with the highest
levels in the general population of the US.
Third, we found that exposure to cells to DDT and DDE levels similar to those found in the serum of people living near
contaminated sites increased levels of a protein that contributes to amyloid plaques in Alzheimer Disease.
Dr. Richardson: The higher levels observed in Alzheimer Disease had previously been reported by our group in a small
number of patients in a previous study (Richardson et al., 2009). This study was designed to replicate those findings in a
larger cohort and from two independent sites (UTSW and Emory).
Dr. Richardson: For research clinicians, I hope they take away that environmental factors are important along with genetic
factors. For clinicians and current patients, it is unfortunate that our study does not provide immediate help or relief. We do
hope that our work will spur additional research on environmental factors in Alzheimer Disease and, if our studies are
expanded and replicated, our data might provide a means for identifying people that may be at risk of developing Alzheimer
Disease in the future.
Dr. Richardson: First, we hope to replicate our findings in a much larger number of patients and in additional cohorts. We
hope that others will replicate these findings as well. Second, there is a need for more mechanistic research to understand
how DDT/DDE contributes to Alzheimer Disease. Finally, we also need to understand who might be more at risk for the
untoward effects of DDT/DDE. For example, what genetic variants might make someone more sensitive or not excrete the
chemicals as well.
Citation:
DDT in Blood Associated with Increased Alzheimer Risk
Jason R. Richardson PhD, Ananya Roy ScD, Stuart L. Shalat ScD, Richard T. von Stein PhD, Muhammad M. Hossain PhD, Brian
Buckley PhD, Marla Gearing PhD, Allan I. Levey MD, PhD, Dwight C. German PhD
JAMA Neurol. 2014;71(3):-. doi:10.1001/jamaneurol.2013.6030

Breast Imaging with Combined MRI and Near Infrared Spectroscopy
Michael Mastanduno
Thayer School of Engineering, Dartmouth College
Hanover, NH 03755

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Answer: The study was able to illustrate the design and clinical testing of an MRI breast coil for combined MRI and Near
Infrared Spectroscopy. The coil was tested on 8 healthy volunteers spanning all bra cup sizes and mammographic density
categories. In the past, MRI/NIRS imaging was only possible in C and D cup sized breasts. The system also will give
researchers the ability to target lesions in hard-to-reach areas close to the chest wall. With the successful completion of this
study, simultaneous MRI/NIRS is possible in all breast sizes, tissue compositions, and lesion locations.

Answer: We were not expecting to be able to provide as complete coverage to auxiliary regions of the breast as we are.
Since this is a common lesion location, that is very encouraging.
Answer: Clinicians should take way that while MRI/NIRS imaging is still an emerging technique, it is potentially a very useful
one. MRI/NIRS characterizes breast lesions’ total hemoglobin, oxygen saturation, water and lipid content, and scattering
prior to biopsy. These functional quantities could serve as biomarkers to help distinguish malignant lesions from benign
ones. This technique is now capable of accommodating all breast sizes and lesion locations.
Answer: The future of this technology will be determined by a large patient study in breast cancer patients. The system is
ready and a clinical trial would help to really determine the effectiveness of the technique as a predictor of malignant breast
cancer.
Citation:
Adaptable Near-Infrared Spectroscopy Fiber Array for Improved Coupling to Different Breast Sizes During Clinical MRI
Michael A. Mastanduno, Fadi El-Ghussein, Shudong Jiang, Roberta DiFlorio-Alexander, Xu Junqing, Yin Hong, Brian W. Pogue,
Keith D. Paulsen
Academic Radiology – February 2014 (Vol. 21, Issue 2, Pages 141-150, DOI: 10.1016/j.acra.2013.09.025)


Metastatic Melanoma: High-Dose IL2 and Survival in Autologous Tumor Cell Immunization
Robert O. Dillman, M.D., F.A.C.P. Executive Medical Director
Hoag Institute for Research and Education
Hoag Cancer Institute
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Dr. Dillman: The main finding of this study is that among 149 metastatic melanoma patients treated with high-dose interleukin-2 (IL2), survival was
much better in the subset of 32 patients who also were treated with patient-specific vaccines (that is active specific immunotherapy or ASI) that
contained antigens from tumor cell lines derived from there own metastases that had been surgically resected. The 5-year survival rate from the
date of starting IL2 was 39% in those receiving vaccine compared to 13% in those who did not (p<0.001). A number of studies have reported that a
5-year survival rate of 15% is typical for patients treated with IL2. The data also suggested that 5-year survival was better in the 25 patients who
received the vaccine after, rather than before IL2 (46% vs 14%), p<0.001). Among the 32 ASI-treated patients, there was a trend for survival benefit
for the 16 patients treated with autologous dendritic cells pulsed with antigens from the autologous melanoma cells and injected with granulocytemacrophage colony stimulating factor (GM-CSF) compared to injections of irradiated tumor cells with or without GM-CSF (p=0.17)
Dr. Dillman: We were testing the null hypothesis that having received such a vaccine had no effect on survival for patients treated with IL2. The
results of the study suggest otherwise. Through the years there have been a number of papers suggesting that various immunotherapy treatments
may have been interactive whether given concurrently or sequentially. The limitation of this study is that it is retrospective, and the data is not as
powerful as that from a randomized trial. There is one randomized trial in metastatic melanoma that compared IL2 to IL2 with a peptide vaccine,
which showed a strong trend toward a survival benefit for the addition of the vaccine. There is randomized trial data suggesting that the combination
of dendritic cells and irradiated tumor cells injected with GM-CSF is associated with better survival than injections of tumor cells and GM-CSF.
Dr. Dillman: Active specific immunotherapy utilizing the antigens from autologous tumor stem cells may be an important adjunctive treatment to
other immunotherapy approaches. Additional clinical trials designed to confirm the benefit and safety of this approach in metastatic melanoma are
scheduled for the near future. It is important to note that these patient specific products can only be derived from metastatic melanoma; so this is
not an option for melanoma prevention, or the treatment of localized melanoma.
For many years IL2 has been a standard treatment, but it is toxic, and in high doses, it has to given in a hospital setting; so it has not been widely
embraced by practicing oncologists. There are a lot of exciting therapeutic advances taking place for the treatment of metastatic melanoma,
including tyrosine kinase inhibitors that block aberrant intracellular signal transduction, and monoclonal antibodies that inhibit T-lymphocyte
checkpoints by blocking a specific receptor or ligand. We can anticipate future randomized trials in which this active specific immunotherapy
approach will be tested as an adjunct to these other therapies, especially monoclonal antibodies to T-lymphocyte checkpoint targets such as CTLA-4
and PD1 or its ligand.
Citation:
High-Dose IL2 in Metastatic Melanoma: Better Survival in Patients Immunized with Antigens from Autologous Tumor Cell Lines.
Dillman RO, Depriest C, McClure SE.
Cancer Biother Radiopharm. 2013 Dec 31.
[Epub ahead of print]


Underserved Patients: Minority Physicians’ Role
Dr. Lyndonna Marrast MD
Fellow in General Internal Medicine
Cambridge Health Alliance Cambridge, MA 02139

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Dr. Marrast: We found that disadvantaged patients (categorized as racial and ethnic minorities, non-English home language
speakers, being low income, having Medicaid, or reporting fair or poor health) were more likely than other patients to be
cared for by a minority physician.
A majority, 54%, of black, Hispanic and Asian patients received care from a minority doctor and the vast majority, 70%, of
those who report not speaking English at home got care from a minority physician.
Among all racial groups there was a high likelihood of receiving care from a physician of the same race.
A higher proportion of patients of black doctors were obese and needed an emergency room visit in the last 12 months but
this was not the case for patients of Asian and Hispanic physicians.
Dr. Marrast: The findings are generalizable to those with a usual source of care. Fewer US residents currently have a person
that they go to for their usual source of care than 2 decades ago. Additional research is needed to understand why this may
be.

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Dr. Marrast: With the increasing diversity of the US population, diversity should be an explicit mission of medical
establishments. Medical schools serve as a “valve” in the supply of physicians. We need to ensure that public institutions are
held socially accountable in producing physicians that will serve all strata of the US population. The needs of all communities
should dictate the doctors that are produced.
MedicalResearch.com: What recommendations do you have for future research?
Dr. Marrast: Future research focused on understanding what the barriers are to medical schools increasing the ranks of
minority physicians. Additional work is needed to demonstrate the benefits of diversity in health care settings. Lastly, there
is a need to monitor the impact of the Affordable Care Act on underserved populations.
Citation:
Marrast LM, Zallman L, Woolhandler S, Bor DH, McCormick D. Minority Physicians’ Role in the Care of Underserved Patients:
Diversifying the Physician Workforce May Be Key in Addressing Health Disparities. JAMA Intern Med. 2013;():.
doi:10.1001/jamainternmed.2013.12756.


Total Hip Replacements: Failure rate of Cemented vs Uncemented
Keijo T Mäkelä Associate professor
Department of Orthopaedics and Traumatology Turku University Hospital, Rauhankatu
Turku, FI-20100, Finland

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Answer:
• The implant survival of cemented total hip replacement was higher
than that of uncemented total hip replacement in patients aged 65
years and older in our multinational register study with a
comprehensive patient population.
• The proportion of uncemented total hip replacement is rapidly
increasing in Nordic countries. The increased use of uncemented total
hip replacement group is not supported by these data.
Answer: Our main finding was quite surprising.
Answer: Clinicians and patients should be aware or the increased revision risk
when using uncemented implants in patients 65 years and older.
study?
Answer: International collaboration databases can produce clinically highly
relevant information.
Citation:
Mäkelä KT ,Matilainen M ,Pulkkinen P ,Fenstad AM ,Havelin L ,Engesaeter L ,et al. Failure rate of
cemented and uncemented total hip replacements: register study of combined Nordic database of
four nations. BMJ 2014;348:f7592


Breast Cancer: Urban vs Rural Diagnosis Disparities
Deirdre McLaughlin PhD MAPS
Associate Professor, Principal Research Fellow Centre for Longitudinal and Lifecourse Research and
Janni Leung, BHS School of Population Health University of Queensland
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Answer: Breast cancer patients living in rural areas were diagnosed later than breast cancer patients living in urban areas. Evidence
from Australia, Egypt, Italy, Canada, Poland, South Africa, Denmark, and parts of the United States indicated that patients residing in
rural areas were more likely to be diagnosed with more advanced breast cancer. Our meta-analysis showed that rural breast cancer
patients had 1.19 higher odds (95% confidence interval= 1.12-1.27) of diagnosis of a late stage breast cancer compared to urban breast
cancer patients.

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MedicalResearch.com: What are the possible explanations?
Answer: Mammography is likely to detect early stage tumors and the differences in diagnostic stage between women living in rural and
urban areas have been attributed to the lower take-up of screening services among rural women. Our results indicate that rural women
are diagnosed with later stage breast cancer and this may be reflective of difficulty accessing cancer screening services in rural areas.
However, it may also indicate decreased awareness of the importance of regular breast screening or the significance of attending to
early symptoms. This may be related to rural disadvantage in accessing preventive cancer care.
Answer: The examination of health disparities between urban and rural populations is important because breast cancer is the most
prevalent cancer in women. Although a significant proportion of the world’s population resides outside urban areas, most research
focuses on urban samples. As a result, the number of studies available for review was limited. Studies from the United States
represented 13 of the 24 studies reviewed and the remaining studies were drawn from Australia (2), New Zealand (2), Denmark (1),
Canada (1), South Africa (1), Egypt (1), Italy (1), Norway (1) and Poland (1) and this limits the generalizability of our conclusions.
Furthermore, in the small number of studies that included both urban and rural samples, there were some variations in the definition of
rurality and urbanity across different studies. Findings of rural and urban differences in breast cancer stage may differ across different
states or areas within each country. The rural population is under-represented in the existing literature and has been under-researched.
Simply generalizing findings from urban populations to rural populations is not appropriate. Researchers could usefully agree on a
standard definition of ‘rurality’ to allow more coherent comparisons across studies.
Answer: Since breast cancer is the most prevalent cancer in women and it is one of the few cancers for which population screening
technologies are available, early detection of breast cancer should be emphasized in order to ensure a higher survival rate. Preventive
cancer care, particularly screening programs in rural areas, may help reduce the health discrepancy. Rural healthcare providers should
be encouraged to opportunistically discuss breast cancer screening when seeing eligible female patients.
Citation:
Disparities in breast cancer stage at diagnosis in urban and rural adult women: a systematic review and meta-analysis
Sallyanne Nguyen-Pham, Janni Leung, Deirdre McLaughlin
Annals of Epidemiology – 30 December 2013 (10.1016/j.annepidem.2013.12.002)

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Hormone Replacement Therapy Found Protective of Hip, Knee Joint Replacements
Professor Nigel Arden
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences
Botnar Research Centre Oxford OX3 7LD

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Professor Arden: We found that in a cohort of women who had used hormone replacement therapy (HRT) and underwent
knee or hip replacement their risk of implant revision was reduced by about 40% compared to non-users of HRT.
Professor Arden: No. HRT has milder but similar effects to bisphosphonates on bone, and we expected to find a protective
effect on implant revision risk related possibly to a reduction of bone destruction (osteolysis) around the impland and
consequent loosening.
Professor Arden: There is observational evidence that drugs used usually to prevent osteoporosis and fractures might have a
beneficial effect on implant survival in patients undergoing knee or hip replacement. Randomised, placebo-controlled trials,
are needed to confirm the efficacy of these medications.
Professor Arden: Randomised, placebo-controlled trials, on the effects of bone therapies on patient-reported outcomes and
revision risk amongst patients undergoing knee/hip replacement are urgently needed. These might be cost-effective
interventions that might improve patients’ care. We are currently working on an application for funding along these lines.
Citation:
Hormone replacement therapy and mid-term implant survival following knee or hip arthroplasty for osteoarthritis: a
population-based cohort study
D Prieto-Alhambra, M K Javaid, A Judge, J Maskell, C Cooper, N K Arden, on behalf of the COASt Study Group
Ann Rheum Dis annrheumdis-2013-204043Published Online First: 22 January 2014 doi:10.1136/annrheumdis-2013-204043


Vitamin D: Study Finds Little Justification For Prescribing For Most Disease Prevention
Professor Mark Bolland
Senior Research Fellow in the Department of Medicine
University of Auckland, New Zealand

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Prof. Bolland: We pooled data from randomised controlled trials of vitamin D supplements in traditional meta-analyses and
trial sequential analyses to assess the effect on important health outcomes. We found that vitamin D supplements (with or
without calcium) had no effect on myocardial infarction, stroke, total cancer, or total fracture, and further similar trials are
unlikely to alter these conclusions. For hip fracture, the results were more complicated. There was uncertainty as to whether
vitamin D by itself increased the risk of hip fracture or had no effect, whereas the combination of vitamin D with calcium had
no effect on hip fracture in people living in the community, but reduced hip fracture risk in two trials of elderly women living
in residential care.
Prof. Bolland: There are widely diverging views on the effectiveness of vitamin D supplements. The findings will probably
come as no surprise to people who have held sceptical views about the effectiveness of vitamin D supplementation. On the
other hand, people who have endorsed calls for widespread vitamin D supplementation will probably view these results as
surprising.
Prof. Bolland: There is little justification currently for prescribing vitamin D to prevent heart attack, stroke, cancer, or
fractures in otherwise healthy people living in the community. For people at risk of osteomalacia because of very low
vitamin D levels (frail elderly people living in residential care, people who actively avoid the sun, and people with deeply
pigmented skin), it is worth considering taking vitamin D supplements on an individual basis. For other people, vitamin D
supplements are unnecessary.
Prof. Bolland: Doing more trials that are similar to existing one are difficult to justify, so future trials will have to have a
strong evidence base as to why their results are likely to differ from existing trials. Research should focus on better defining
what vitamin D level is adequate for health.
Citation:
The effect of vitamin D supplementation on skeletal, vascular, or cancer outcomes: a trial sequential meta-analysis
Mark J Bolland, Andrew Grey, Greg D Gamble, Ian R Reid
www.thelancet.com/diabetes-endocrinologyPublished online January 24, 2014 http://dx.doi.org/10.1016/S22138587(13)70212-


Alzheimer’s: Two Phase 3 Trials of Bapineuzumab in Mild-to-Moderate Disease
Stephen Salloway, MD, MS
Director of Neurology and the Memory and Aging Program, Butler Hospital
Professor of Neurology and Psychiatry
Warren Alpert Medical School Brown University

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MedicalResearch.com: What are the main findings of this study?
Dr. Salloway: With the aging of the population, the G-8 and the US Congress have made finding
new treatments for Alzheimer’s disease by 2025 a top priority.
These were the first large anti-amyloid monoclonal antibody trials. While the clinical outcomes
were disappointing, we learned important new information that is already guiding new trials. These
include:
Treating Alzheimer’s disease earlier, when amyloid plays its most critical role and brain injury is not
well established.
Using amyloid biomarkers to focus treatment only on those with amyloid pathology.
Combining treatments as we do in cancer, HIV, and heart disease to maximize benefit, and
Finding medications that can safely reduce amyloid burden to a greater extent:
Citation:
Two Phase 3 Trials of Bapineuzumab in Mild-to-Moderate Alzheimer’s Disease
Rachelle S. Doody, M.D., Ph.D., Ronald G. Thomas, Ph.D., Martin Farlow, M.D., Takeshi
Iwatsubo, M.D., Ph.D., Bruno Vellas, M.D., Steven Joffe, M.D., M.P.H., Karl
Kieburtz, M.D., M.P.H., Rema Raman, Ph.D., Xiaoying Sun, M.S., Paul S. Aisen, M.D., Eric
Siemers, M.D., Hong Liu-Seifert, Ph.D., and Richard Mohs, Ph.D. for the Alzheimer’s Disease
Cooperative Study Steering Committee and the Solanezumab Study Group
N Engl J Med 2014; 370:311-321
January 23, 2014
DOI: 10.1056/NEJMoa1312889

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