MedicalResearch.comExclusive Interviews with Medical Research and

Health Care ResearchersEditor: Marie Benz, MD

info@medicalresearch.comFebruary 10 2014

For Informational Purposes Only: Not for Specific Medical Advice.

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NSAIDS and Risk of MiscarriageMedicalResearch.com Interview with: Dr. Sharon Daniel MD, MPHPhysician, Intern in pediatrics at Soroka Medical Center, Beer-Sheva, Israel PhD Candidate andProf. Amalia Levy (MPH, PhD

Epidemiologist, Head of the Department of Public Health Principle Investigator.Ben-Gurion University of the Negev in Beer-Sheva, Israel,

• 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.

• 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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Childhood Obstructive Sleep Apnea and Anti-Inflammatory TreatmentMedicalResearch.com Interview with: David Gozal, MDThe Herbert T. Abelson Professor and Chair Department of PediatricsPhysician-in-Chief, Comer Children’s Hospital

The University of Chicago Chicago, IL 60637

• MedicalResearch.com: What are the main findings of the study?• Dr. Gozal: Our study shows that in children with mild obstructive apnea, treatment with an anti-inflammatory 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.

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

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

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

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Elevated Resting Heart Rate and Mortality in AdultsMedicalResearch.com Interview with:Bríain ó Hartaigh, Ph.D.Assistant Research Professor of EpidemiologyDalio Institute of Cardiovascular ImagingWeill Cornell Medical College

• MedicalResearch.com: What are the main findings of the study?• 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

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Falls Main Cause of Adult Traumatic Spinal Cord InjuriesMedicalResearch.com Interview with study leaders:Shalini Selvarajah MD, MPHPostdoctoral Research Fellow Center for Surgical Trials and Outcomes Research Department of Surgery

Johns Hopkins University School of Medicine Baltimore, MD 21287.

• MedicalResearch.com: What are the main findings of the study?• 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.

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

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Falls Main Cause of Adult Traumatic Spinal Cord InjuriesMedicalResearch.com Interview with study leaders:Shalini Selvarajah MD, MPHPostdoctoral Research Fellow Center for Surgical Trials and Outcomes Research Department of Surgery

Johns Hopkins University School of Medicine Baltimore, MD 21287.

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

date• 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.

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Sports Related Concussions: Gender Related DifferencesMedicalResearch.com Interview with:Dr. Scott L. Zuckerman, MDDepartment of Neurological SurgeryVanderbilt Sports Concussion Center

• MedicalResearch.com: What are the main findings of the study?• 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 Post-Concussion 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.

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

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

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

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Obesity and Colon Polyp RiskMedicalResearch.com Interview with:Jenifer I Fenton Assistant ProfessorDepartment of Food Science and Human NutritionMichigan State University East Lansing, MI 48824

• MedicalResearch.com: What are the main findings of the study?• 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.

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

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

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• 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 StudySarah S. Comstock, Kari Hortos, Bruce Kovan, Sarah McCaskey, Dorothy R. Pathak, Jenifer I. Fenton Published: January 17, 2014PLoS DOI: 10.1371/journal.pone.0085939

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Lung Cancer: Allergic Disease History Might Decrease RiskMedicalResearch.com Interview with: Mariam El-Zein, PhD.Associée de recherche/ Research associateUnité d’épidémiologie et biostatistique / Epidemiology & Biostatistics UnitINRS-Institut Armand-

Frappier Université du Québec

• MedicalResearch.com: What are the main findings of the study?• 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.MedicalResearch.com: Were any of the findings unexpected?

• 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.

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

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

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Diabetes: Association with Depression and Eating DisordersMedicalResearch.com Interview with:Dr Peter de JongeInterdisciplinary Center for Psychopathology and Emotion Regulation

University Medical Center Groningen, University of Groningen, Netherlands

• MedicalResearch.com: What are the main findings of the study?• Dr. de Jonge: The main findings were that depression and impulse control disorders, in particular

binge eating and bulimia were associated with diabetes.

MedicalResearch.com: Were any of the findings unexpected?• 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.• MedicalResearch.com: What should clinicians and patients take away from your report?• 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.

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

• 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, Ca

ldas-de-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.

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Menopause and Poor Sleep QualityMedicalResearch.com Interview with:Chih-Jen Chang, MDDepartment of Family MedicineNational Cheng Kung University Hospital, Tainan, Taiwan

• MedicalResearch.com: What are the main findings of the study?• 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.

MedicalResearch.com: Were any of the findings unexpected?• 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 sleepquality. The results of our study showed that postmenopausal women withoutvasomotor symptoms have poorer sleep quality than premenopausal women.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Chang: Postmenopausal women, even those without vasomotor symptoms, should be alerted to the risk of poor sleep quality.• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Chang: This study used a cross-sectional design and did not allow examination

of a causal relationship between menopause and sleep quality. Conducting aprospective study would be better to address this issue. Moreover, themechanisms underlying how menopause and sleep disturbance interact remainunclear. The changes in sex hormones, the prevalence of breathing-relatedsleep disorders and periodic limb movement disorders, and the level ofpsychological or socioeconomic stress should be assessed in the futureresearch.

• 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]

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Ophthalmology: Using Claims Data to Assess Eye ResearchMedicalResearch.com Interview with: Dr. Flora Lum, MDExecutive Director, The H. Dunbar Hoskins Jr., M.D. Center for Quality Eye Care,American Academy of Ophthalmology

San Francisco, CA 94109-1336

• MedicalResearch.com: What are the main findings of the study? • 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.• MedicalResearch.com: Were any of the findings unexpected? • 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.

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

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Most Drugs Have Ingredients That Come From AnimalsMedicalResearch.com Interview with:Kinesh Patel, Research FellowWolfson Unit for EndoscopySt Mark’s Hospital, Harrow HA1 3UJ, UK

• MedicalResearch.com: What are the main findings of the study?• 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 thedrugs are suitable for vegetarians is difficult to find out conclusively,even after looking at information available on packets, informationleaflets and on the internet.

MedicalResearch.com: Were any of the findings unexpected?• 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 informationavailable to people who wish to know where the ingredients in theirmedication come from. Despite searching a large number of data sources,information on animal origins and manufacturing ingredients was verydifficult to find, even for healthcare professionals.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Patel: Clinicians should discuss patients’ dietary preferences with them before

prescribing medication and find out directly from companies if the productscontain ingredients that would not be compatible with the patient’s views.Patients should not discontinue any medications but should discuss theresults of this study with their physician if they are concerned about thetablets they consume.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• 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 PatelPublished 4 February 2014 BMJ 2014;348:g401

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Pregnancy Exposure to Colds, Dust Mites and Offspring Atopic Dermatitis, HayfeverMedicalResearch.com Interview with:Dr. Sabina Illi, Dipl.-Stat., MPHUniversity Children’s Hospital Lindwurmstr. 480337 Munich Germany

• MedicalResearch.com: What are the main findings of the study?• 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 pre-school 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.

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

• Answer: Yes, all of our findings are new to some extent.• MedicalResearch.com: What should clinicians and patients take away from your report?• 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.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• 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 – Volume 112, Issue 2, February 2014, Pages 132–139.e1

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Epidemic of Cannabis Related Drugged Driving FatalitiesMedicalResearch.com Interview with:Joanne E. Brady SM Senior Staff AssociateDepartment of AnesthesiologyDoctoral Candidate in Epidemiology Columbia University Medical Center

New York, NY 10032 Department of Epidemiology,

• MedicalResearch.com: What are the main findings of the study?• 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.MedicalResearch.com: Were any of the findings unexpected?

• 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.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: Clinicians should remind patients of the potential dangers of medication, marijuana, and

other drug use on driving.• MedicalResearch.com: What recommendations do you have for future research as a result of this

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, 1999-2010

Joanne E. Brady and Guohua LiAm. J. Epidemiol. first published online January 29, 2014 doi:10.1093/aje/kwt327

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Knee Osteoarthritis: Exercise Impact on Pain and DisabilityMedicalResearch.com Interview with:Carsten Juhl, PhD, MPH Research PhysiotherapistForskningsenheden for Muskuloskeletal Funktion og Fysioterapi (FoF)Institut for idræt og biomekanik

Syddansk Universitet

• MedicalResearch.com Interview with:Carsten Juhl, PhD, MPHResearch PhysiotherapistForskningsenheden for Muskuloskeletal Funktion og Fysioterapi (FoF)Institut for idræt og biomekanikSyddansk Universitet

• MedicalResearch.com: What are the main findings of the study?• 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.• MedicalResearch.com: Were any of the findings unexpected?• 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.

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

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• 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..• · Furthermore the dose-response relationship in exercise for knee osteoarthritis should be investigated in individual patient data meta-analyses• · 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.

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Autism: Autistic Brains Create More Information at RestMedicalResearch.com Interview with:Roberto Fernández Galán, PhDDepartment of Neurosciences, School of MedicineCase Western Reserve UniversityCleveland, OH, USA

• MedicalResearch.com: What are the main findings of the study?• 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.MedicalResearch.com: Were any of the findings unexpected?

• 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.

• MedicalResearch.com: What should clinicians and patients take away from your report?• 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.• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• 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

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Cancer: Pain Measurement in Ambulatory PatientsMedicalResearch.com Interview with:Fengmin Zhao, MS,PhD BiostatisticianDepartment of Biostatistics & Computational Biology Dana-Farber Cancer InstituteBoston, MA 02215

• MedicalResearch.com Interview with:Fengmin Zhao, MS,PhD BiostatisticianDepartment of Biostatistics & Computational Biology Dana-Farber Cancer InstituteBoston, MA 02215

• MedicalResearch.com: What are the main findings of the study?• 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.

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

• 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.

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

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

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Hospital Leadership Important for Quality ImprovementMedicalResearch.com Interview with:Joseph D. Restuccia, DrPH, MPH Professor and Deans Research FellowOperations and Technology Management DepartmentHealth Sector Management

Program Boston University School of Management Boston, MA 02215

• MedicalResearch.com: What are the main findings of the study?• 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.• MedicalResearch.com: Were any of the findings unexpected?• 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.• MedicalResearch.com: What should clinicians and patients take away from your report?• 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.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• 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 CourseMedicalResearch.com Interview with:Golda Ginsburg, Ph.D Professor Director, Research,Division of Child and Adolescent PsychiatryDepartment of Psychiatry and Behavioral Sciences The

Johns Hopkins University School of MedicineBaltimore, Maryland

• MedicalResearch.com: What are the main findings of the study?• 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.

MedicalResearch.com: Were any of the findings unexpected?• Dr Ginsburg: A lower percent of youth maintained their initial treatment gains than expected, suggesting a need for

additional monitoring and relapse prevention.• MedicalResearch.com: What should clinicians and patients take away from your report?• 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.• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• 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

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Atrial Fibrillation: Dabigatran and Risk of Myocardial InfarctionMedicalResearch.com Interview with:Professor Gregory Y.H. Lip MD, FRCPConsultant Cardiologist & Professor of Cardiovascular Medicine, Director – Haemostasis

Thrombosis & Vascular Biology UnitBirmingham, United Kingdom

• MedicalResearch.com: What are the main findings of the study?• [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.

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

• [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 warfarin-naïve cohort newly started on dabigatran.

• MedicalResearch.com: What should clinicians and patients take away from your report?• [GYHL] Some caution may be warranted, when switching prior warfarin-experienced patients with atrial

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

int]Read the rest of the interview on MedicalResearch.com

Tonsillectomy: Substantial Variability in Pediatric Hospital CareMedicalResearch.com Interview with: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• MedicalResearch.com: What are the main findings of the study?• 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.

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

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

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

den, 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

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Football Helmet Types: Large Differences in Concussion RiskMedicalResearch.com Interview with:Steven Rowson, Ph.D.Research Assistant Professor Virginia Tech Wake Forest University

• MedicalResearch.com: What are the main findings of the study?• 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.

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

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Rowson: The study illustrates that differences in the ability to reduce concussion

risk between helmet types exist. Clinicians and patients should becognizant of which helmets are being used, and identify whether there isa need for better head protection.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• 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 thatfuture studies control for the number of times each helmet is impacted. Ifthe study can’t control for the exposure to impact of each helmet type, itwill 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. G

uskiewicz, 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.Read the rest of the interview on MedicalResearch.com

Risk of Suicide, Homicide Increases with Household Firearm AccessMedicalResearch.com Interview with:Andrew Anglemyer, PhD, MPH;Clinical Pharmacy and Global Health SciencesUniversity of California, San Francisco San Francisco, CA

• MedicalResearch.com: What are the main findings of the study?• 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.•

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

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

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

tematic Review and Meta-analysis. Annals of Internal Medicine. 2014 Jan;160(2):101-110.

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Autistic Spectrum Reclassification Should Not Affect Patient Services EligibilityMedicalResearch.com Interview with:Bennett L. Leventhal, MDNathan S. Kline Institue for Psychiatric Research140 Old Orangeburg Road, Building 35 Orangeburg, NY 10962

• MedicalResearch.com: What are the main findings of the study?• Dr. Leventhal: In the American Psychiatric Association’s Diagnostic and Statistical Manual for Mental Disorders, 5 th 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.

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

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

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Weight Loss Healthy Living Program for MenMedicalResearch.com Interview with:Professor Sally WykeDeputy Director, Institute of Health and WellbeingProfessor (Institute of Health and Wellbeing Social Sciences) The

University of Glasgow

• MedicalResearch.com: What are the main findings of the study?• 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.

MedicalResearch.com: Were any of the findings unexpected?• 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.• MedicalResearch.com: What should clinicians and patients take away from your report?• 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.

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

ue 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)62420-4Read the rest of the interview on MedicalResearch.com

Life Expectancy: Urban-Rural Disparities WidenMedicalResearch.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, USAand Mohammad

Siahpush, PhDProfessor, Department of Health Promotion, Social & Behavioral Health University of Nebraska Medical Center

• MedicalResearch.com: What are the main findings of the study?• 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.MedicalResearch.com: Were any of the findings unexpected?

• 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.

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

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• 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 SiahpushAmerican 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 LevelsMedicalResearch.com Interview with:Jason R. Richardson MS, PhD, Associate ProfessorDepartment of Environmental and Occupational MedicineRobert Wood Johnson Medical School

and Resident Member Environmental and Occupational Health Sciences InstitutePiscataway, NJ 08854

• MedicalResearch.com: What are the main findings of the study? • 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.

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

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

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

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Breast Imaging with Combined MRI and Near Infrared SpectroscopyMedicalResearch.com Interview with:Michael MastandunoThayer School of Engineering, Dartmouth CollegeHanover, NH 03755

• MedicalResearch.com: What are the main findings of the study?• 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.

MedicalResearch.com: Were any of the findings unexpected?• 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.• MedicalResearch.com: What should clinicians and patients take away from your report?• 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.

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

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Metastatic Melanoma: High-Dose IL2 and Survival in Autologous Tumor Cell ImmunizationMedicalResearch.com Interview with:Robert O. Dillman, M.D., F.A.C.P. Executive Medical DirectorHoag Institute for Research and Education

Hoag Cancer Institute

• MedicalResearch.com: What are the main findings of the study?• 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 granulocyte-macrophage colony stimulating factor (GM-CSF) compared to injections of irradiated tumor cells with or without GM-CSF (p=0.17)

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

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

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Underserved Patients: Minority Physicians’ RoleMedicalResearch.com Interview with:Dr. Lyndonna Marrast MDFellow in General Internal MedicineCambridge Health Alliance Cambridge, MA 02139

• MedicalResearch.com: What are the main findings of the study?

• 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.

• MedicalResearch.com: Were any of the findings unexpected?• 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.• MedicalResearch.com: What should clinicians and patients take away from your report?

• 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: Diversi

fying the Physician Workforce May Be Key in Addressing Health Disparities. JAMA Intern Med. 2013;():. doi:10.1001/jamainternmed.2013.12756.

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Total Hip Replacements: Failure rate of Cemented vs UncementedMedicalResearch.com Interview with:Keijo T Mäkelä Associate professorDepartment of Orthopaedics and Traumatology Turku University Hospital, RauhankatuTurku, FI-20100, Finland

• MedicalResearch.com: What are the main findings of the study?• Answer:

• The implant survival of cemented total hip replacement was higherthan that of uncemented total hip replacement in patients aged 65years and older in our multinational register study with acomprehensive patient population.• The proportion of uncemented total hip replacement is rapidlyincreasing in Nordic countries. The increased use of uncemented totalhip replacement group is not supported by these data.MedicalResearch.com: Were any of the findings unexpected?

• Answer: Our main finding was quite surprising.• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: Clinicians and patients should be aware or the increased revision risk

when using uncemented implants in patients 65 years and older.• MedicalResearch.com: What recommendations do you have for future research as a result of this

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 cemen

ted and uncemented total hip replacements: register study of combined Nordic database of four nations. BMJ 2014;348:f7592Read the rest of the interview on MedicalResearch.com

Breast Cancer: Urban vs Rural Diagnosis DisparitiesMedicalResearch.com Interview with:Deirdre McLaughlin PhD MAPSAssociate Professor, Principal Research Fellow Centre for Longitudinal and Lifecourse Research andJanni Leung, BHS School

of Population Health University of Queensland

• MedicalResearch.com: What are the main findings of the study?• 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.

• 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.

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

• MedicalResearch.com: What should clinicians and patients take away from your report?• 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 McLaughlinAnnals 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 ReplacementsMedicalResearch.com Interview with:Professor Nigel ArdenNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal SciencesBotnar Research

Centre Oxford OX3 7LD

• MedicalResearch.com: What are the main findings of the study?• 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.

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

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

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

hritis: 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

-2013-204043Read the rest of the interview on MedicalResearch.com

Vitamin D: Study Finds Little Justification For Prescribing For Most Disease PreventionMedicalResearch.com Interview with:Professor Mark BollandSenior Research Fellow in the Department of MedicineUniversity of Auckland, New Zealand

• MedicalResearch.com: What are the main findings of the study?• 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.

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

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

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• 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 Reidwww.thelancet.com/diabetes-endocrinologyPublished online January 24, 2014 http://dx.doi.org/10.1016/S2213-8587(13)70212-

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Alzheimer’s: Two Phase 3 Trials of Bapineuzumab in Mild-to-Moderate DiseaseMedicalResearch.com Interview with:Stephen Salloway, MD, MSDirector of Neurology and the Memory and Aging Program, Butler Hospital

Professor of Neurology and PsychiatryWarren Alpert Medical School Brown University

• 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 Iwatsu

bo, 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; 370:311-321January 23, 2014DOI: 10.1056/NEJMoa1312889Read the rest of the interview on MedicalResearch.com

FDA Drug Approvals Have Variable Clinical Trial Evidence RecordMedicalResearch.com Interview with:Nicholas S. Downing, ABYale University School of MedicineNew Haven, Connecticut

• MedicalResearch.com: What are the main findings of the study?• Answer: In our systematic review of all new drugs approved by the FDA over an 8 year period, we found that there was

real variability in the quality and quantity of clinical trial evidence used as the basis of the agency’s approval decisions. Some drugs were studied in multiple randomized, double-blinded, controlled clinical trials that provide very helpful information for patients and physicians. However, other drugs were studied in clinical trials that did not produce as much information about their safety and effectiveness.

MedicalResearch.com: Were any of the findings unexpected?• Answer: Several features of this variability were notable.• First, we found that just over one third of drugs were approved on the basis of a single pivotal trial, rather than the

traditional standard of two.Second, almost half of drugs were approved the basis of surrogate outcomes.Finally, only 40% of drug approvals involved a trial comparing the new drug to existing therapy; such information is important because it can help patients and physicians determine the most appropriate indication for its use.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: Patients and physicians should be aware that not all FDA approvals are created equally. Some are approved on

the basis of strong clinical trial evidence, while others on more preliminary evidence.• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Answer: It is important that all drugs, in particular those approved on the basis of preliminary evidence, continue to be

studied in the post-marketing period. Future research should evaluate whether this information is being generated in a consistent manner.

• Citation:Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012

• Downing NS, Aminawung JA, Shah ND, Krumholz HM, Ross JS. Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012. JAMA. 2014;311(4):368-377. doi:10.1001/jama.2013.282034.

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Bereavement During Pregnancy, Early Childhood and Psychosis RiskMedicalResearch.com Interview with: Prof. Kathryn M AbelProfessor of Psychiatry & Honorary Consultant Psychiatrist

University of Manchester and Honorary Senior Lecturer at the Institute of Psychiatry, London.

• MedicalResearch.com: What are the main findings of the study?• Answer: The main study findings were that exposure of a mother to a severe psychological stress of losing a close family member up to

either 6 months before conception or at any time during pregnancy did not increase risk of subsequent psychotic illness in the offspring. Secondly, we found during childhood, if a close family member died then, especially a sibling of the child or one of their parents, these children were at slightly increased risk of developing a psychotic illness later in life. This was most likely to happen following a sudden death especially suicide and in particular following suicide a psychotic mood disorder was more likely than other kinds of psychosis such as schizophrenia (although the risk of schizophrenia was also increased following suicide). This effect was not accounted for by having a family history of a psychotic illness or suicide.MedicalResearch.com: Were any of the findings unexpected?

• Answer: The lack of prenatal effect was unexpected although it was entirely consistent with the largest previous study to date which had found the same lack of effect of prenatal severe bereavement on schizophrenia or bipolar disorder risk. We were particularly interested to find that cause of death was important in predicting risk and that timing of exposure to a death in the close family in childhood was so important and consistently we find that the earlier in childhood this occurred, the greater the risks tended to be in later life.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: More thought is needed in supporting families and young children with experience of close family bereavement and in

mitigating other known risk factors for psychosis such as bullying and social deprivation. It is likely that GPs can have a key role in helping to support bereaved children and families and in working closely with education and social care agencies to consider reducing the opportunity for exposure to other risks that might be avoided.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Answer: More work is needed to understand mechanisms of risk but also of resilience in families in particular perhaps in families with a

history of psychotic disorders. These findings should be replicated in other non-European populations. We cannot assume that animal models are likely to be salient to all human populations and circumstances.

• Citation:• Severe bereavement stress during the prenatal and childhood periods and risk of psychosis in later life: population based cohort study• BMJ 2014;348:f7679 doi: 10.1136/bmj.f7679• K M Abel professor, H P Heuvelman doctoral student, L Jörgensen research associate, C

Magnusson professor, S Wicks postdoctoral research associate, E Susser professor, J Hallkvist postdoctoral research assistant, C Dalman associate professor

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Concussions in Young Female Soccer PlayersMedicalResearch.com Interview with:John W. O’Kane M.D.Associate Professor Family Medicine and Orthopaedics and Sports MedicineMedical Coordinator, U.W. Intercollegiate Athletics

University of Washington Sports Medicine Clinic, Seattle

• MedicalResearch.com: What are the main findings of the study?• Dr. O’Kane: In 11 to 14 year old female elite soccer players the concussion incidence was 13% with a rate of 1.2 per 1000

athletic exposures. Symptoms lasted a median of 4 days and players with light or noise sensitivity, emotional lability, memory loss, nausea, and concentration problems took significantly longer to recover. Heading the ball accounted for 30.5% of concussions and the vast majority of concussions (86%) occurred in games. The majority of players (58.6%) reported playing with symptoms and less than half (44.1%) sought medical attention for their symptoms. Those seeking medical attention were symptomatic longer and were less likely to play with symptoms.

MedicalResearch.com: Were any of the findings unexpected?• Dr. O’Kane: The high number of participants playing despite symptoms and the low number seeking medical attention was

surprising.• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. O’Kane: The players, parents, and coaches on this age group need further education regarding the symptoms of

concussion and the potential serious sequelae of this injury. While every player with symptoms may not have a concussion, the risks of playing with a concussion are sufficiently serious that any symptomatic player should be removed until they are evaluated and cleared by a health professional.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. O’Kane: Youth soccer programs should institute concussion awareness programs. The effectiveness of the programs

should be assessed through further data collection and the programs modified as needed. Further research should evaluate whether or not teaching proper heading technique and/or modifying rules to limit heading for younger players in game situations can reduce risk of concussion. Further studies should also compare short and long term outcomes for those who seek medical care and return to play according to recommended guidelines vs. those who do not seek medical care and/or return to play prematurely.

• Citation:• O’Kane JW, Spieker A, Levy MR, Neradilek M, Polissar NL, Schiff MA. Concussion Among Female Middle-School Soccer Players.

JAMA Pediatr. 2014;():. doi:10.1001/jamapediatrics.2013.4518.

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Transfers of Hospitalized Patients and Insurance StatusMedicalResearch.com Interview with:Janel Hanmer, MD, PhDUniversity of Pittsburgh Medical CenterMontefiore Hospital Pittsburgh, PA 15213

• MedicalResearch.com: What are the main findings of the study?• Dr. Hanmer: We used the National Inpatient Sample – a sample of about 20% of US community hospitals with all discharges from those hospitals

– to examine if insurance status is associated with transfer from one hospital to another. We were looking at patients who were already admitted to the hospital, not the patients who presented to the Emergency Department. We selected the five most common general medicine admissions for adults aged 18 to 64. We found that uninsured patients were less likely to be transferred than privately insured patients in four of the five conditions (about 20-40% less likely). We also found that women were less likely than men to be transferred in five of the conditions (about 35 to 40% less likely).

MedicalResearch.com: Were any of the findings unexpected?• Dr. Hanmer: As clinicians, we expected that uninsured patients would be more likely to be transferred between hospitals because we expected

hospitals to try to transfer unprofitable patients. Our study shows this did not happen. We also had no prior indication that women were less likely to be transfered than men.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Hanmer: The data that we used for this study give a bird’s-eye view of transfers between hospitals. There are several places where this

difference could originate. First, uninsured and female patients may not be requesting transfer as often as insured or male patients. Second, clinicians may not be recommending or initiating transfer as often for uninsured and female patients. Third, receiving hospitals may be putting up barriers to the transfer of uninsured and female patients. We need to tease apart these possible causes before we can give concrete recommendations to patients or clinicians.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Hanmer: We have several areas of research that we think are important:• 1. Evaluating transfer rates of these different groups when we examine both the Emergency Department and the inpatient wards in combination.

Prior research has suggested that the uninsured are more likely to be transferred from the Emergency Department.• 2. Examining the timing and location of interventions. For instance, are uninsured patients more or less likely to receive an intervention before

transfer when compared to an insured patient?• 3. Examining the net effect of transfers on outcomes like mortality, complications, and length of stay. While we presume that transfers are

generally a good thing (they provide access to subspecialty care and advanced treatments) they also expose patients to the risks of physically transferring between hospitals, a break in the continuity of care, and possibly to unnecessary tests and procedures.

• Citation:Insurance Status and the Transfer of Hospitalized Patients: An Observational Study

• Janel Hanmer, Xin Lu, Gary E. Rosenthal, Peter Cram; Insurance Status and the Transfer of Hospitalized PatientsAn Observational Study. Annals of Internal Medicine. 2014 Jan;160(2):81-90.

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Breast Cancer: Cognitive Therapy Plus Hypnosis For Radiation FatigueMedicalResearch.com Interview with: Guy H. Montgomery, Ph.D.Director, Integrative Behavioral Medicine ProgramCancer Prevention and Control Department

of Oncological Sciences Icahn School of Medicine at Mount SinaiNew York, NY 10029-6574

• MedicalResearch.com: What are the main findings of the study?• Dr. Montgomery: A brief psychological intervention comprised of cognitive behavioral techniques

and hypnosis (CBTH) reduced fatigue during, and for up to six months after, radiotherapy in breast cancer patients.

MedicalResearch.com: Were any of the findings unexpected?• Dr. Montgomery: Yes. We were surprised to see that the effects of the CBTH intervention persisted

for 6 months.• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Montgomery: That CBTH, a brief psychological intervention, can reduce fatigue and improve

breast cancer radiotherapy patients’ quality of life.• MedicalResearch.com: What recommendations do you have for future research as a result of this

study?• Dr. Montgomery: It would be interesting to see if these effects persist beyond 6 months, and apply

to other radiotherapy patient populations.• • Citation:• Randomized Controlled Trial of a Cognitive-Behavioral Therapy Plus Hypnosis Intervention to Control

Fatigue in Patients Undergoing Radiotherapy for Breast Cancer• Guy H. Montgomery, Daniel David, Maria Kangas, Sheryl Green, Madalina Sucala, Dana H. Bovbjerg,

Michael N. Hallquist, and Julie B. Schnur• JCO JCO.2013.49.3437; published online on January 13, 2014;Read the rest of the interview on MedicalResearch.com

Genetic Factors Explain Substantial Part of Physical Aggression DifferencesMedicalResearch.com Interview with:Eric Lacourse, Ph.D. Professeur agrégéDépartement de sociologie Université de MontréalGroupe de Recherche sur l’Inadaptation

Psychosociale chez l’enfant Centre de Recherche de l’Hôpîtal Ste-Justine

• MedicalResearch.com: What are the main findings of the study? • Dr. Lacourse: The gene-environment analyses revealed that early genetic factors were pervasive in accounting for developmental

trends, explaining most of the stability and change in physical aggression, ” Lacourse said. “However, it should be emphasized that these genetic associations do not imply that the early trajectories of physical aggression are set and unchangeable. Genetic factors can always interact with other factors from the environment in the causal chain explaining any behaviour.”

MedicalResearch.com: Were any of the findings unexpected?• Dr. Lacourse: “The results of the gene-environment analyses provided some support for the genetic set-point hypotheses, but mostly

for the genetic maturation hypotheses,” Lacourse said. “Genetic factors always explained a substantial part of individual differences in physical aggression. More generally, the limited role of shared environmental factors in physical aggression clashes with the results of studies of singletons in which many family or parent level factors were found to predict developmental trajectories of physical aggression during preschool.” Our results suggest that the effect of those factors may not be as direct as was previously thought.

• MedicalResearch.com: What should clinicians and patients take away from your report? • Dr. Lacourse: Long-term studies of physical aggression clearly show that most children, adolescents and adults eventually learn to use

alternatives to physical aggression. “Because early childhood propensities may evoke negative responses from parents and peers, and consequently create contexts where the use of physical aggression is maintained and reinforced, early physical aggression needs to be dealt with care,” Lacourse said. “These cycles of aggression between children and siblings or parents, as well as between children and their peers, could support the development of chronic physical aggression

• MedicalResearch.com: What recommendations do you have for future research as a result of this study? • Dr. Lacourse: Future research should focus on similar but different phenotypes such as ADHD and ODD. They should also investigate

gene-environment interactions with early adversity and other stressful life events occurring to one or both twins. Studies should also investigate how gene-environment interplay at different developmental period (childhood, adolescence and emerging adulthood).

• Citation:• Eric Lacourse, PhD, Michel Boivin, PhD, Mara Brendgen, PhD, Amélie Petitclerc, PhD, Alain Girard, MSc, Frank Vitaro, PhD, Stéphane

Paquin, PhD candidate, Isabelle Ouellet-Morin, PhD, Ginette Dionne, PhD and Richard E. Tremblay, PhD published “A longitudinal twin study of physical aggression during early childhood: Evidence for a developmentally dynamic genome” in Psychological Medicine on January 21, 2014.

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Reducing Risk of Diabetes with Berries in DietMedicalResearch.com Interview with:Prof Aedin CassidyUniversity of East Anglia,Norwich Research Park, Norwich

• MedicalResearch.com: What are the main findings of the study?• Answer: We know fruits and vegetables seem to be particularly important for prevention of heart disease and diabetes

but what constituent may responsible for these benefits is unclear. These foods contain powerful bioactive compounds called flavonoids and in lab and animal experiments we know that flavonoids can reduce inflammation, improve BP, keep our arteries healthy and flexible, improve blood flow and reduce cholesterol levels. Our previous work had shown that a higher level of one class of flavonoids, the anthocyanins, responsible for the brilliant red/blue colours in fruits and other plant foods/products, could reduce the risk of developing type 2 diabetes and of having a heart attack. This study builds on this and now we have evidence in humans that following intake of one portion of berries per day we can see these heart health benefits, and benefits on how we control our insulin and glucose levels.

• MedicalResearch.com: Were any of the findings unexpected?• Answer: Of all the flavonoids that we studies it was the anthocyanins that seemed to offer the greatest benefit.• MedicalResearch.com: What should clinicians and patients take away from your report?

Answer: To reduce their risk of type 2 diabetes and heart disease, consumers should add more anthocyanin rich foods to their habitual diet- small changes in intake would have a great impact on prevention efforts

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Answer: We have now commenced a large clinical trial feeidng different doses of berries, rich in anthocyanins to

participants who are at mild/moderate risk of developing type 2 diabetes and this 6 month trial will hopefully further advance our understanding of the importance of anthocyanins in reducing risk of type 2 diabetes.

• Citation:• Intakes of Anthocyanins and Flavones Are Associated with Biomarkers of Insulin Resistance and Inflammation in Wom

en• Jennings A, Welch AA, Spector T, Macgregor A, Cassidy A.• J Nutr. 2013 Dec 11. [Epub ahead of print]

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Most Advanced Age Adults are Women, Many Living in CommunityMedicalResearch.com Interview withPaula A. Rochon MD, MPH, FRCPCVice President, Research, Women’s College HospitalSenior Scientist, Women’s College Research

Institute Professor, Department of MedicineUniversity of Toronto, Ontario Canada

• MedicalResearch.com: What are the main findings of the study?• Dr. Rochon: Our main findings are that there are now more than 1800 centenarians in Ontario. Among those

over 100 years of age, 60 per cent are 101 years of age or older. In addition, most centenarians are women (85 per cent), and this percentage increases to 90 per cent among those who are 105 years of age and older.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Rochon: We found that more than 40 per cent of centenarians in Ontario are living in the community, and

that some of these individuals receive no publicly funded home care support. However, we were unable to capture the use of informal or privately funded care. We also learned from our study that while almost all centenarians in Ontario receive care from a primary care physician, only about 5 per cent of them are assessed by geriatricians.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Rochon: Many older adults of advanced age are living in the community. Most older adults are women. Our

findings suggest that strategies are required to find ways to provide support to older adults in the community.• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Rochon: Future research should continue to investigate the profile and health service use of centenarians, so

that the delivery of health services to this important older population can be improved.• Citation:• Demographic Characteristics and Healthcare Use of Centenarians: A Population-Based Cohort Study

Volume 62, Issue 1, January 2014, Pages: 86–93, J Am Geriatr Soc 62:86–93, 2014.Paula A. Rochon, Andrea Gruneir, Wei Wu, Sudeep S. Gill, Susan E. Bronskill, Dallas P. Seitz, Chaim M. Bell, Hadas D. Fischer, Anne L. Stephenson, Xuesong Wang, Andrea S. Gershon and Geoffrey M. Anderson

Article first published online : 2 JAN 2014, DOI: 10.1111/jgs.12613Read the rest of the interview on MedicalResearch.com

Life Enjoyment Predicts Less Physical Decline with AgeMedicalResearch.com Interview with: Professor Andrew Steptoe, MA, DPhil, DSc, FMedSciDirector, Institute of Epidemiology and Health Care University

College LondonBritish Heart Foundation Professor of Psychology Department of Epidemiology and Public HealthLondon WC1E 6BT

• MedicalResearch.com: What are the main findings of the study?• Dr. Steptoe: We are trying to understand whether positive well-being has beneficial effects as far as health and physical function is concerned. The main

findings are that the risk of developing impairments in activities of daily living (things life being able to bath or shower without help) over the next few years among older people is lower in people who enjoy life more. In addition, enjoyment of life predicted less decrease in walking speed over our 8 year study period in this sample of older men and women. Of course, these associations could be due to many things: the people with greater enjoyment of life could be more affluent, have less physical illness or disability to start with, or have healthier lifestyles at the outset, and these factors could predict the changes in physical function over time. But what we found is that baseline health, economic circumstances, and lifestyle explain only part of the association between enjoyment of life and deterioration in function. So the research suggests that enjoyment of life contributes to healthier and more active old age.

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

• Dr. Steptoe: We have previously found that enjoyment of life is a predictor of longer life; so older people who report greater enjoyment are less likely to die over the next 5 to 8 years than those with lower enjoyment of life. What this study showed was that older people who enjoy life are also at lower risk for developing problems of disability and declining physical function as well.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Steptoe: As life expectancy improves in the population, we need to attend to the quality of life at older ages. Limitations in how well people can perform

ordinary activities are very important for quality of life. So we need to understand better the factors that contribute to good physical function and capacity at older ages. Of course, this is an observational study, which means that we cannot be certain about cause. Although it seems plausible to us that low positive well-being causes faster acceleration of age-related declines in physical function, we cannot be certain that other factors were not responsible. We tried to measure as many other factors as we could – baseline health, impairments in mobility, socioeconomic position, lifestyle factors such as regular physical activity, and so on – but there were other factors that we did not measure that might have been relevant.

• This research suggests that among other things, we should think about the positive aspects of life and experience of older people. Not only are these important issues in themselves, they might have benefits in terms of physical function. These could in turn help us contain the spiraling costs of social and health care among older sectors of society.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Steptoe: We need to understand better the biological pathways that link positive well-being and physical function. We need to find out whether we can

improve enjoyment of life for older people, and if so, whether this will have an impact on their physical function. And we need to know how these factors operate across different parts of the world, particularly in lower and middle income countries where longevity is increasing at a high rate.

• Citation:• Enjoyment of life and declining physical function at older ages: a longitudinal cohort study• Andrew Steptoe, Cesar de Oliveira, Panayotes Demakakos, and Paola Zaninotto• CMAJ cmaj.131155; published ahead of print January 20, 2014, doi:10.1503/cmaj.131155

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Cannabis Withdrawal: Nabiximols as an Agonist Replacement TherapyMedicalResearch.com Interview with:David J. Allsop, PhDNational Cannabis Prevention and Information Centre, National Drug and Alcohol Research Centre, Faculty of Medicine

Now with the School of Psychology, University of Sydney, Sydney, Australia

• MedicalResearch.com: What are the main findings of the study?• Dr. Allsop: We found that administering a botanical preparation of the cannabinoids Tetrahydrocannabidiol (THC – the main psychoactive ingredient in cannabis) and Cannabidiol (a lesser known component

of the cannabis plant thatcounteracts the psychotogenic effects of THC with anxiolytic properties) todependent cannabis smokers during initial abstinence from cannabissubstantially dampened their withdrawal experience. In essence this is akinto Nicotine Replacement Therapy (NRT) but for cannabis users. It might seemobvious – sure you give cannabis users a cannabis preparation and they findit easier to quit – but this is important because it has never been donebefore – and we currently have no consensus evidence based medicines tooffer cannabis users who ask for help.

Beyond dampening their cannabis withdrawal symptoms (irritability, sleepdifficulties, cravings for cannabis etc), we also observed a strong impactof this new drug on retaining cannabis patients in treatment. Basicallywhat we found is that 50% of the people on placebo had gone home before theend of the inpatient detox, whereas 85% of the people receiving theexperimental drug (sativex) were still in treatment at the end. This is areally important finding as cannabis users, like most other drugs ofdependence, are notoriously difficult to retain in treatment. Having a toolsuch as sativex, to keep people coming back to treatment facilities,enables a greater opportunity to expose people to the other health servicesinvolved in treatment, such as cognitive behavioural therapy delivered bypsychologists. All up, greater retention in treatment should lead to bettertreatment outcomes – everyone’s a winner.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Allsop: We administered the highest dose of sativex that has ever been administered

to humans – delivering some 85mg of THC and about the same amount of CBD in a day, and yet the patients couldn’t tell whether they were on sativex orplacebo! This means that they were not getting intoxicated by the highdoses of cannabinoids that we were delivering (in fact we asked them on ascale of 0-10 how intoxicated they were after each dose and most werearound 2, and it was not different for the two treatment groups). This isimportant information because any criticism of this type of “replacement”therapy is usually based on the fact that giving psychoactive substances topatients who are addicted to them could lead to abuse and diversion of themedication. However in this study we demonstrate that it is highly unlikelythat sativex, with this combination of cannabinoids, would be desirable onthe street or as a substance of abuse in and of itself. To support this, wealso found that people on the cannabinoid drug didn’t suffer any type ofrebound withdrawal from the drug itself when we stopped administering itand observed them closely for another three days. If people are not gettingstoned from the drug, cannot tell if they are on it or on the placebo, anddon’t suffer any withdrawals – well then there is no reason that it shouldn’tbe accepted by physicians treating people with cannabis dependence.

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Cannabis Withdrawal: Nabiximols as an Agonist Replacement TherapyMedicalResearch.com Interview with:David J. Allsop, PhDNational Cannabis Prevention and Information Centre, National Drug and Alcohol Research Centre, Faculty of Medicine

Now with the School of Psychology, University of Sydney, Sydney, Australia

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Allsop: The take home message is that cannabis withdrawal is a real issue for

dependent cannabis users and can seriously jeopardize a quit attempt.Cannabis users however rarely see the link between their crabby mood,irritability and snappiness, even anger, depression, anxiety, cravings andsleep difficulties during initial abstinence from cannabis and should beeducated about what to expect when they try to give up. If patients knowthat their sleep problems and irritability will pass after 1 to 2 weeksthey might be more inclined to tough it out rather than relapse to cannabisuse. Unfortunately Sativex is a very tightly controlled medicine in mostjurisdictions around the world. Its available to doctors in a small handfulof countries for people with spasticity from multiple sclerosis – but theguidelines and regulations around its use make it difficult to use for eventhat indication. So its unlikely that people will be able to get it forcannabis dependence in the near future. However we hope that this studymarks the beginning of the process of making people aware of the issue, andthat it highlights to clinicians and policy makers that cannabis dependenceis a major issue that can be better managed with this drug if only it wereavailable.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Allsop: This study was pretty unanimous in its findings – Sativex definitely

dampens the experience of cannabis withdrawal and retains people intreatment for longer. However we did it in an inpatient setting in order tosafely test its appropriateness for this indication. Most cannabis userswouldn’t want to go into a hospital detox facility for this relatively mildbut persistent (and significant) indication. It would be akin to sending acigarette smoker into an inpatient detox unit for their cigarettes. It justdoesn’t happen. So what we need now is to test Sativex out on the street soto speak. We need to find out whether cannabis treatment seekers in theirhome environment are benefited from this drug. Do they actually reduce orstop smoking cannabis when they have access to it? After that study is done- if it works – well there is no argument left for not approving thismedication for treating cannabis dependence.

• Citation:• Nabiximols as an Agonist Replacement Therapy During Cannabis Withdrawal

A Randomized Clinical Trial• Allsop DJ, Copeland J, Lintzeris N, et al. Nabiximols as an Agonist Replacement Therapy During Cannabis Withdrawal: A Randomized Clinical Trial. JAMA Psychiatry.

2014;():. doi:10.1001/jamapsychiatry.2013.3947.

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Macular Degeneration: Incidence, Susceptibility and Dietary AntioxidantsMedicalResearch.com Interview with:Jie Jin Wang MMed (Clin Epi) MAppStat PhDProfessor Australian NHMRC Senior Research Fellow (Level B) Centre for Vision Research

Westmead Millennium Institute University of Sydney C24Westmead Hospital, NSW 2145 Australia

• MedicalResearch.com: What are the main findings of the study?• Answer: We documented a consistent association between high dietary intake of lutein/zeaxanthin (LZ) and a reduced long-term risk

of early age-related macular degeneration (AMD) in persons who carry ≥2 risk alleles of either or both the complement factor H (CFH-rs1061170) and/or the age-related maculopathy susceptibility gene 2 (ARMS2-rs10490924) in two older population-based cohorts.

• MedicalResearch.com: Were any of the findings unexpected?• Answer: These findings are not unexpected. Studies including previous reports from the Blue Mountains Eye Study and the Rotterdam

Study cohorts suggested a protective association of antioxidants including L/Z with AMD. A previous systematic review and meta-analysis (1, 2), published in BMJ 2007, showed no protective role of dietary antioxidant vitamins (including L/Z) on primary prevention of AMD, however, studies included in this review did not look at subgroups stratified by genetic risk levels.

• 1) Chong EW, Wong TY, Kreis AJ, Simpson JA, Guymer RH. Dietary antioxidants and primary prevention of age related macular degeneration: systematic review and meta-analysis. BMJ 2007;335(7623):755

• 2) Evans J. Primary prevention of age related macular degeneration. BMJ 2007;335(7623):729• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: Our finding suggest a reduced risk of age-related macular degeneration associated with higher dietary intakes of lutein/

zeaxanthin in persons carrying 2 or more risk alleles from the CFH (rs1061170) and ARMS2 (rs10490924) variants. The take home message would be that persons carrying high genetic susceptibility to AMD may be able to lower their genetic risk by changing their dietary behaviors.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Answer: The finding showing a protection against AMD from high dietary lutein/ zeaxanthin intake in persons with high genetic risk

raises the possibility of personalized preventive interventions. To translate this research finding into prevention practice, one can target subgroups of the population who have high genetic susceptibility to this condition.

• Citation:• Genetic Susceptibility, Dietary Antioxidants, and Long-term Incidence of Age-related Macular Degeneration in Two Populations.• Wang JJ, Buitendijk GH, Rochtchina E, Lee KE, Klein BE, van Duijn CM, Flood VM, Meuer SM, Attia J, Myers C, Holliday EG, Tan AG, Smit

h WT, Iyengar SK, de Jong PT, Hofman A, Vingerling JR, Mitchell P, Klein R, Klaver CC.• Ophthalmology. 2013 Nov 28. pii: S0161-6420(13)00942-1. doi: 10.1016/j.ophtha.2013.10.017. [Epub ahead of print]

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Sepsis: Hospital Case Volume and OutcomesMedicalResearch.com Interview with:Allan J. Walkey, M.D., M.ScBoston University School of MedicinePulmonary CenterBoston, Massachusetts

• MedicalResearch.com: What are the main findings of the study?• Dr. Walkey: Thank you for the interest in our study. Current evidence-based treatments for severe sepsis (ie, infection+systemic

inflammatory response+ end organ dysfunction) include specific processes of care rather specific therapeutics. These processes include early administration of antibiotics, early fluid resuscitation, and lung protective ventilation strategies. We hypothesized that hospitals with more ‘practice’ at treating patients with severe sepsis may have more effective care processes leading to improved patient outcomes. We examined more than 15,000 severe sepsis admissions from 124 US academic medical centers. Our findings supported our hypothesis. After adjustment for patient severity of illness and hospital characteristics, mortality in the highest quartile severe sepsis case volume hospitals was 22% and mortality in lowest severe sepsis case volume hospitals was 29%. The 7% absolute mortality difference would result in an estimated number needed to treat in high severe sepsis volume hospitals to prevent one death in low case volume hospitals of 14 (though we advise caution in interpretation of a number needed to treat in an observational study). Costs and length of stay were not different across levels of severe sepsis case volume. Results were robust to multiple subgroup and sensitivity analyses.

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

• Dr. Walkey: We were surprised that the case volume-outcome association was weaker among surgical patients than among medical patients.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Walkey: Hospital-level processes of care likely make a difference when it comes to improving mortality for patients with

severe sepsis.• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Walkey: We need to determine which specific processes are most highly associated with improved outcomes in severe

sepsis.• Citation:• Hospital Case Volume and Outcomes among Patients Hospitalized with Severe Sepsis• Dr. Allan J Walkey and Dr. Renda Soylemez Wiener

American Journal of Respiratory and Critical Care Medicine 0 0:ja

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High Volume Hospitals and Discharge to Home after Colon SurgeryMedicalResearch.com Interview with: Daniel A. Anaya, MD, FACSAssociate Professor of Surgery – Surgical Oncology Michael E. DeBakey Department of Surgery Baylor College of MedicineChief, General Surgery & Surgical Oncology SectionDirector, Liver Tumor Program andDr. Courtney J.

Balentine, MDFirst author and surgical resident at Baylor College of Medicine

• MedicalResearch.com: What are the main findings of the study?• Dr. Anaya: That a good proportion of patients having colorectal operations will need additional assistance to recover during the

postoperative period, resulting in being discharged to other facilities (nursing facilities, skilled care, etc) after surgery, and that hospitals where a higher-volume of colorectal operations are performed are more likely to discharge patients back to home after surgery.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Balentine: We did expect that higher volume hospitals would be more likely to get patients home after surgery but the magnitude

of the difference was still a surprise.• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Balentine:• For clinicians: when referring your patients for surgery, not only is it important to look at how well your surgeons perform by traditional

quality measures (morbidity and mortality, but also whether your patients are really making it home and recovering the ability to function independently after surgery.

• For patients: it’s important to realize that surgery is a difficult process that often takes quite a while to recover from. Even hospitals that do a lot of surgery and have very good outcomes still often need to send their patients to a short or long term care facility to help with recovery.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Anaya: We plan to explore what features of high volume hospitals allow better rates of discharge to home. Once we identify

important differences in practice between high and low volume centers we can help all hospitals do a better job of helping patients to get home after surgery. We are also exploring patient features associated to higher chance of needing care during the recovery period. We have found that older patients are at increased risk and are working on better understanding what conditions, in addition to age alone, can help predict and anticipate those needs. Our overall goal is to be able to understand the different factors affecting the recovery period and the ability for a given patient to regain functional independence after surgery.

• Citation:• Association of High-Volume Hospitals With Greater Likelihood of Discharge to Home Following Colorectal Surgery• Balentine CJ, Naik AD, Robinson CN, et al. Association of High-Volume Hospitals With Greater Likelihood of Discharge to Home Following

Colorectal Surgery. JAMA Surg. 2014;():. doi:10.1001/jamasurg.2013.3838.

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Metastatic Breast Cancer: Surgical Removal of Primary Tumor and Axillary NodesMedicalResearch.com Interview with:Dr. R.A. Badwe, MSDirector, Tata Memorial CentreE. Borges Marg, Parel Mumbai 400 012

• MedicalResearch.com: What are the main findings of the study?• Answer: The trial was a randomized control study involving 350 women with per primum metastatic breast cancer. These women were divided into two

groups from February 2005 to May 2013. One group underwent surgery and radiotherapy (LRT) (n=173) while another group of 177 women were spared these (no LRT). Both groups had undergone six successful rounds of chemotherapy before their recruitment into the trial. Women who underwent surgery had the primary breast tumour and lymph nodes removed, followed by locoregional radiation therapy.

• The primary endpoint of the study was overall survival (OS). At a median follow-up of 17 months, no difference was observed in OS between the groups; the OS rates were 19.2% and 20.5%, respectively, (HR = 1.04; 95%CI, 0.80-1.34; P = 0.79). The lack of a survival benefit is due to a trade-off between local control and distant disease progression. The results indicated that women who underwent surgery and had improved locoregional control and significantly worse distant progression-free survival compared with women who did not undergo surgery (HR = 1.41; 95% CI, 1.08-1.85; P = .01). Progression of distant disease was 42% more likely (P = .01) in the LRT arm whereas the risk of local progression was 84% lower with LRT.

• MedicalResearch.com: Were any of the findings unexpected?• Answer: Preclinical evidence by fisher et al suggests that removal of a primary tumor may facilitate growth of metastatic disease. Fisher et al found that

metastasis increased in mice after tumor removal due to a serum growth factor capable of stimulating distant cells (Cancer Res. 1989;49(8):1996-2001).• Retrospective institutional series and population-based series in clinical cohorts, in contrast, suggest favorable impact of surgery and/or local

radiotherapy in these patients. A systematic review of these studies showed a 35% reduction in deaths in patients who have had surgical intervention. The retrospective analyses however are fraught with selection biases.

• The present study results support the preclinical evidence and refute the results of the systematic review of the retrospective studies, which showed a 35% reduction in deaths in patients who have had surgical intervention.

• MedicalResearch.com: What should clinicians and patients take away from your report• Answer: The take home message is that the indication for surgery of the primary tumor in women with metastatic breast cancer should be would be

limited to palliation, for fungating or bleeding primary breast tumors.• MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Answer: We recommend that surgery in metastatic breast cancer be reserved for only the palliative setting.• But simultaneously we feel that we need to evaluate why the distant tumor grows faster after removal of the primary. The possible inhibitory effect that

the primary tumor exerts needs to be evaluated.• Additionally pooled analyses from the various ongoing studies may yield sufficient power to detect smaller difference sand give a complete answer.• Citation: Abstract Presented at:• San Antonio Breast Cancer Symposium

Badwe R, et al “Surgical removal of primary tumor and axillary lymph nodes in women with metastatic breast cancer at first presentation: A randomized controlled trial” SABCS 2013; Abstract S2-02.

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Sedentary Behavior Associated with Higher Risk of DeathMedicalResearch.com Interview with:Rebecca Seguin, PhD, CSCSCornell University, Division of Nutritional SciencesIthaca NY 14853

• MedicalResearch.com: What are the main findings of the study?• Answer: The main findings of the study are that regardless of demographic factors and physical activity levels, women who

spent the most time engaged in sedentary behaviors had higher risk of death and women who spent the least amount of time engaged in sedentary behaviors.

MedicalResearch.com: Were any of the findings unexpected?• Answer: We didn’t necessarily expect to see an elevated risk for cancer death among these women but in fact we did. That

was very interesting.• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: What clinicians and patients should most take away from the study is that it is really important that regardless of how

much you exercise in a formal way, it is also very important to reduce time spent just sitting and being sedentary. For example, even if you have a sedentary job you can still get up throughout the day and move. Make an effort to get up and move for five minutes every hour. Or, use the bathroom on another floor and take the stairs to get there. During conference calls, stand up and march in place or do squats or lunges or lift weights; anything to be more active during the day if you have a sedentary job.

• If someone is retired they also should make an effort to not sit for prolonged periods of time. There are lots of ways to do this. For example , if watching television or reading, get up during commercial breaks or at regular intervals.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Answer: We need research with diverse populations that use objective measures of physical activity and sedentary time to

best understand risks and benefits across age groups and gender, and that account for things such as physical function, occupation, and other factors related to health status.

• Citation:• Sedentary Behavior and Mortality in Older Women The Women ‘s Health Initiative

Rebecca Seguin, David M. Buchner, Jingmin Liu, Matthew Allison, Todd Manini, Ching-Yun Wang, JoAnn E. Manson, Catherine R. Messina, Mahesh J. Patel, Larry Moreland, Marcia L. Stefanick, Andrea Z. LaCroix

American Journal of Preventive Medicine – February 2014 (Vol. 46, Issue 2, Pages 122-135, DOI: 10.1016/j.amepre.2013.10.021)Read the rest of the interview on MedicalResearch.com

Workplace Strategies to Reduce Sitting TimeMedicalResearch.com Interview with: Maike Neuhaus, MPsychAustralian Postgraduate Award PhD CandidateCancer Prevention Research Centre School of Population HealthThe University of

Queensland Herston, QLD 4006 Australia

• MedicalResearch.com: What are the main findings of the study? • Answer: Substantial epidemiological evidence shows that high volumes of sedentary behaviour – simply put too much sitting- are linked to detrimental

health outcomes such as overweight and obesity, type 2 diabetes, some cancers, and all-cause mortality. Desk-based office workers typically spend around 75% of their work hours sitting at their desks or in meetings. Furthermore, they are unlikely to compensate for these high volumes of sitting time at work with less sedentary activities outside of work. Office workers are thus a high-risk group and an important target for intervention.

• The Stand Up UQ study examined best-practice approaches to reduce excessive sitting in office workers. Three separate groups of administrative office workers from The University of Queensland in Brisbane, Australia, participated in this study: One group received height-adjustable workstations only; another group received the same height-adjustable workstations plus additional individual (e.g. face-to-face coaching) and organisational strategies (e.g. management consultation, staff information session) to reduce workplace sitting; the third group served as control group and maintained their usual work-practice. Results showed that relative to the control group, the group receiving height-adjustable workstations and additional strategies had a three-fold greater reduction in sitting time than the group receiving height-adjustable workstations only. These findings have important practical and financial implications for workplaces targeting sitting time reductions.

• MedicalResearch.com: Were any of the findings unexpected?• Answer: The workplace health promotion literature certainly speaks to the need for comprehensive approaches to improving health behaviour in the work

force. Furthermore, we know from intervention studies aiming to increase moderate-to-vigorous intensity physical activity that individuals benefit from more intense support than just the provision of exercise equipment. However, to date, knowledge about the determinants of sedentary behaviour is limited, with mechanisms influencing this behaviour potentially being very different from those identified in physical activity research studies. It was therefore interesting to find such distinct results.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: Due to advances in technology, we now sit more than ever before, particularly so in desk-based office workplaces. Considering the detrimental

health impacts of too much sitting, it is important to consider strategies to reduce sitting. Our study results suggest that workplaces should implement multiple strategies including activity-permissive work stations along with organisational and individual behaviour change elements in order to achieve substantial reductions in sitting time.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Answer: Future studies should investigate if any particular strategies may be more effective than others. Considering the financial ramifications for

workplaces when implementing such interventions, it is of particular interest to examine if there is a difference in the effectiveness of individual vs. organisational behaviour change strategies applied in the Stand Up UQ study. Larger scale randomised controlled trials are currently underway to assess the sustainability of sitting time reductions over time, as well as potential impacts on health biomarkers.

• Citation:Workplace Sitting and Height-Adjustable Workstations

• Maike Neuhaus, Genevieve N. Healy, David W. Dunstan, Neville Owen, Elizabeth G. EakinAmerican Journal of Preventive Medicine – January 2014 (Vol. 46, Issue 1, Pages 30-40, DOI: 10.1016/j.amepre.2013.09.009)

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Low Daily Alcohol Consumption Associated with Longer SurvivalMedicalResearch.com Interview with: Andrea Bellavia MScInstitute of Environmental Medicine, Karolinska InstitutetStockholm, Sweden

• Dr. Montgomery: What are the main findings of the study?• Answer: We evaluated for 15 years a cohort of Swedish men and women and observed, after taking into

account various socio-demographic, dietary, and lifestyle factors, that a low daily consumption of alcoholic beverages is tied with longer survival.Dr. Montgomery: Were any of the findings unexpected?

• Answer: The positive long-term effects of a regular moderate consumption of alcoholic beverages had already been suggested and are probably due to a reduction in the risk of CVD. We confirmed this result in a large cohort and added a time-dimension to the association.

• Dr. Montgomery: What should clinicians and patients take away from your report?• Answer: The wrong take-home message would be that we have to drink alcoholics to live longer. We know that

the consumption of alcoholic beverages provides various negative effects, especially short-term. However, our finding that on the long term people benefit from regular alcohol consumption suggest that to improve the overall health of the population the effort should not be on ´if to drink´ but on ‘how to drink’ (for example regular and limited consumption, during launches).

• Dr. Montgomery: What recommendations do you have for future research as a result of this study?• Answer: It would be interesting to evaluate if the observed association is similar across alcoholic beverages or

if wine, beer, and liquors have different behaviors. Also, an essential piece of information would be to understand the trade-off between positive long-term effects and negative short term effects of alcohol consumption.

• Citation:• Alcohol consumption and mortality: a dose-response analysis in terms of time

Andrea Bellavia, Matteo Bottai, Alicja Wolk, Nicola OrsiniAnnals of Epidemiology – 06 January 2014 (10.1016/j.annepidem.2013.12.012)

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Adverse Drug Events and PreventabilityMedicalResearch.com Interview with: Katja M Hakkarainen, M.Sc.Pharm.Doctoral researcher Nordic School of Public Health NHVGuest teacher, Doctoral studentSection for Social Medicine

Department of Public Health and Community Medicine, Institute of Medicine Sahlgrenska Academy, University of GothenburgGothenburg, Sweden

• MedicalResearch.com: What are the main findings of the study?• Answer: In total 12% of the adult general public was found to experience harm from medicines, i.e. adverse drug events (ADEs), when we

scrutinised the medical and dispensing records of 4970 adults in Sweden during three months, including 29 inpatient care departments in three hospitals, 110 specialised outpatient clinics, and 51 primary care units. Most ADEs were adverse drug reactions (also called side effects) and sub-therapeutic effects. Commonly used drugs caused most ADEs, with a high frequency of adverse drug reactions from antidepressants and cardiovascular drugs as well as sub-therapeutic effects of analgesics and cardiovascular drugs. Of all ADEs, 39% were potentially preventable, because the drug therapy or use was judged suboptimal.MedicalResearch.com: Were any of the findings unexpected?

• Answer: The 12% ADE prevalence for the general public, corresponding to 25% of all persons with outpatient and inpatient healthcare encounters, was high compared to previous estimates of approximately 5% of inpatients suffering from ADEs. Thus, most ADEs occur in outpatient settings. We were also surprised to find sub-therapeutic effects equally common to adverse drug reactions, as adverse drug reactions have gained much more attention in previous literature on ADEs.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: For preventing ADEs more efficiently, large-scale efforts to improve the quality and safety of healthcare at organisational level are

needed. This requires the commitment of clinicians and care units, collaboration with patients, researchers and safety experts, and strong political will and leadership. Because ADEs occur across care settings and are caused by widely used drugs, the burden of ADEs is unlikely to decrease considerably through exclusively focusing on specific events, patient groups, or care units.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Answer: Firstly, actions to prevent ADEs must be further studied (previous question). Secondly, definitions and classifications for ADEs shall be

improved. Because existing definitions and classifications were partially inconsistent, we developed our own categorisation, dividing ADEs into adverse drug reactions, sub-therapeutic effects, intoxications, dependence and misuse, and morbidities due to untreated indications. This was found informative because associated drugs, affected organs, preventability, and seriousness differed for these sub-categories of ADEs. Therefore, we recommend future research on preventing, detecting, and mitigating ADEs to categorise these events. In the future, a consensus on a standard definition and classification of ADEs should be reached.

• Citation:• Prevalence, nature and potential preventability of adverse drug events – A population-based medical record study of 4970 adults

British Journal of Clinical Pharmacology• K M Hakkarainen, H Gyllensten, A K Jönsson, K Andersson Sundell, M Petzold and S Hägg• Accepted manuscript online: 25 DEC 2013 01:38AM EST | DOI: 10.1111/bcp.12314

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Safety Net Hospitals: Death Rates After Major ComplicationsMedicalResearch.com Interview with Elliot Wakeam MDCenter for Surgery and Public HealthBrigham and Women’s Hospital Boston MA 02115

• MedicalResearch.com: What are the main findings of the study?• Dr. Wakeam: Our study examined failure to rescue (FTR), or death after postoperative complications, in safety net hospitals. Prior

work has shown that hospital clinical resources can improve rescue rates, however, despite having higher levels of technology and other clinical resources that should lead to better rates of patient rescue, safety net hospitals still had greater rates of death after major complications.

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

• Dr. Wakeam: The conventional wisdom regarding safety net hospitals would suggest that difficult financial circumstances lead to poor access to high technology and clinical resources. This concept has been used to partially explain poor outcomes in these facilities that have been shown in prior research. However, we in fact found that safety net hospitals had the same or greater access to many resources. Despite greater access to advanced resources and technology, their mortality and FTR rates were still greater.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Wakeam: Our report suggests that safety net hospitals need to focus on organizational factors, as well as ways to better utilize

the resources which they do possess, to improve patient rescue. There is no doubt that safety net hospitals serve a vital role in our society, and serve a challenging patient population, but new strategies are needed to address emerging disparities in care. Furthermore, any existing financial and clinical disparities in safety net hospitals will be exacerbated in states that do not expand Medicaid, because uncompensated care payments to these hospitals are set to be eliminated under the Affordable Care Act.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Wakeam: Future research on FTR needs to ‘drill down’ on the organizational and hospital cultural factors that may impact FTR.

Safety net hospitals need to focus on these elements as they attempt to improve FTR. Policy makers will need to grapple with the impact of decreasing funds for uncompensated care, and the adverse impact that this will have on struggling safety net hospitals.

• Citation:Failure to Rescue in Safety-Net HospitalsAvailability of Hospital Resources and Differences in Performance

• Wakeam E, Hevelone ND, Maine R, et al. Failure to Rescue in Safety-Net Hospitals: Availability of Hospital Resources and Differences in Performance. JAMA Surg. 2014;():. doi:10.1001/jamasurg.2013.3566

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OTC Pediatric Liquid Medications: Recommendations for Dosing DirectionsMedicalResearch.com Interview with:Dr. Daniel S. Budnitz MD MPH CAPT, USPHSDivision of Healthcare Quality Promotion

Director of the Centers for Disease Control and Prevention’s Medication Safety ProgramAtlanta, Georgia

• MedicalResearch.com: What are the main findings of the study?• Dr. Budnitz: To reduce dosing errors when administering orally ingested over-the-counter (OTC) liquid medications,

especially among children, the US Food and Drug Administration (FDA) released and the Consumer Healthcare Products Association (CHPA) released recommendations for how to display dosing directions and markings on dosing devices.

• This study assessed recommendation adherence for national brand name orally ingested OTC liquid pediatric analgesics/antipyretics and cough, cold, and allergy products available after the FDA guidance was finalized in 2011. To identify and prioritize specific areas for improvement, recommendations were categorized as ‘top tier’ (potential to address ≥3-fold errors) or ‘low tier’ (intended to improve clarity and consistency).

• Of 68 products, 91% of dosing directions and 62% of dosing devices adhered to all top tier recommendations; 57% of products adhered to every top tier recommendation, and 93% adhered to all or all but one. A dosing device was included with all products (e.g., oral syringe, dosing cup). No dosing directions used atypical volumetric units (e.g., drams), and no devices used volumetric units that did not appear in dosing directions. Six products used trailing zeros or failed to use leading zeros with decimal doses; eight did not use small font for fractions. Appropriate use of zeros and decimals is important to avoid 10-fold overdoses; using small font for fractions (½ vs. 1/2) helps avoid potential 4-fold errors if 1/2 interpreted as 1 or 2. Product adherence to low tier recommendations ranged from 26% to 91%.

MedicalResearch.com: Were any of the findings unexpected?• Dr. Budnitz: It was notable that the most common unit used in dosing directions and on dosing devices was

milliliter (mL), with 74% of assessed products using mL alone or in combination with teaspoons. Dosing and measuring liquid medicines in metric units (mL) rather than “spoons” (teaspoons and tablespoons) discourages use of household spoons (which are not calibrated dosing devices) and aligns with standards used in inpatient settings.

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OTC Pediatric Liquid Medications: Recommendations for Dosing DirectionsMedicalResearch.com Interview with:Dr. Daniel S. Budnitz MD MPH CAPT, USPHSDivision of Healthcare Quality Promotion

Director of the Centers for Disease Control and Prevention’s Medication Safety ProgramAtlanta, Georgia

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Budnitz:• Messages for Clinicians:• To prevent errors related to confusion around units, clinicians are encouraged to use mL when recommending liquid medication

dosing for OTC medicines as well as for prescription medicines.• To help ensure accurate dosing, clinicians should encourage patients and caregivers to use the included dosing devices, not

household spoons to measure doses.• Messages for Patients/Caregivers:• Patients and caregivers should always read the dosing directions and the measuring scales on dosing devices carefully. Pay particular

attention to the units to avoid giving 5 teaspoons when the directions recommend 5 mL. Pay particular attention to decimals to avoid giving 25 mL if directions recommend 2.5 mL.

• Patients and caregivers should not use kitchen spoons for dosing medicines, but should use the dosing devices included with the medicines. If a measuring device is misplaced, ask your pharmacist as they can recommend an appropriate device (often for free or at low cost).

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Budnitz: Findings from this study suggest that the voluntary FDA guidance and CHPA guideline encouraged adherence to

recommendations for dosing directions and devices for many brand name liquid OTC products. Further improvement efforts should prioritize potential multi-fold dosing errors.

• Generic OTC products as well as prescription products dispensed from retail pharmacies were not assessed, but future studies might assess these in the future.

• Finally, it may be appropriate to review and revise recommendations judged to be low tier and less likely to result in clinically significant dosing errors and to clarify recommendations that required interpretation by study investigators.

• Citation:Adherence to Label and Device Recommendations for Over-the-Counter Pediatric Liquid Medications

• Daniel S. Budnitz, Maribeth C. Lovegrove, and Kathleen O. Rose• Pediatrics peds.2013-2362; published ahead of print January 6, 2014, doi:10.1542/peds.2013-2362

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