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MedicalResearch.com - Medical Research Interviews Week in Review

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MedicalResearch.com: Exclusive interviews with medical researchers from major and specialty medical journals and health care meetings.
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MedicalResearch.com Exclusive Interviews with Medical Research and Health Care Researchers Editor: Marie Benz, MD [email protected] February 22 2014 For Informational Purposes Only: Not for Specific Medical Advice.
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Page 1: MedicalResearch.com - Medical Research Interviews Week in Review

MedicalResearch.comExclusive Interviews with Medical Research and

Health Care ResearchersEditor: Marie Benz, MD

[email protected] 22 2014

For Informational Purposes Only: Not for Specific Medical Advice.

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

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Maternal Influenza and Offspring Bipolar DisorderMedicalResearch.com Interview with:Alan S. Brown, M.D., M.P.H.Professor of Clinical Psychiatry and Clinical Epidemiology College of Physicians and Surgeons of Columbia University Director

Unit in Birth Cohort Studies Division of Epidemiology New York State Psychiatric Institute New York, NY

• MedicalResearch.com: What are the main findings of the study?• Dr. Brown: We found that a mother’s exposure to influenza during pregnancy, documented by

antibodies in her serum, increased the risk of bipolar disorder with psychotic symptoms in her offspring. We did not show a relationship between influenza and bipolar disorder not accompanied by psychosis.

MedicalResearch.com: Were any of the findings unexpected?• Dr. Brown: We had expected to find a relationship between influenza and bipolar disorder without

psychotic symptoms based on my previous study; however, influenza was assessed differently between the two studies. And my lab previously showed that prenatal influenza increased the risk of schizophrenia, so the findings of our current study were consistent with an effect of prenatal influenza on psychosis in general, rather than on a particular type of psychotic disorder.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Brown: The study provides support for influenza vaccinations in women planning a pregnancy and

to consider vaccination while pregnant as recommended by several health organizations.• MedicalResearch.com: What recommendations do you have for future research as a result of this

study?• Dr. Brown: We wish to replicate the finding in other samples and examine the pathway by which

maternal influenza and other inflammatory insults alter fetal brain development to lead to psychosis outcomes.

• Citation:• Serological Documentation of Maternal Influenza Exposure and Bipolar Disorder in Adult Offspring

Sarah E. Canetta, Ph.D.; Yuanyuan Bao, M.S.; Mary Dawn T. Co, M.D.; Francis A. Ennis, M.D.; John Cruz, B.S.; Masanori Terajima, M.D., Ph.D.; Ling Shen, Ph.D.; Christoph Kellendonk, Ph.D.; Catherine A. Schaefer, Ph.D.; Alan S. Brown, M.D., M.P.H.

• Am J Psychiatry 2014;:. doi:10.1176/appi.ajp.2013.13070943Read the rest of the interview on MedicalResearch.com

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COPD: Risk from Chinese WaterPipe SmokingMedicalResearch.com Interview with:Chunxue Bai, MD & PhDDirector, Shanghai Respiratory Research InstituteProfessor of Medicine, Chairman, Shanghai Leading academic discipline Chair

, Chinese Alliance against Lung Cancer

• MedicalResearch.com: What are the main findings of the study?• Dr. Bai: Recently, we found a dilemma phenomenon that the incidence of chronic obstructive pulmonary disease (COPD) and lung cancer has remained high in

southwest China despite the 1976 National Stove Improvement Program for indoor air quality.• However, little information is known to the public about a regional endemic related to Chinese waterpipe smoking, which is different from the Arabic waterpipe.

The Chinese waterpipe has been traditionally misconceived as less harmful for three reasons:• (1) no charcoal was used in contrast to the Arabic waterpipe,• (2) tobacco smoke passed through the water as opposed to cigarette smoking and• (3) smoking through a large volume waterpipe could “improve lung function.”• In our study, we provide robust results that the large volume Chinese waterpipe use and exposure are associated with the elevated prevalence of COPD, which

have been identified by epidemiologic, physiologic, radiology, and toxicologic findings for the first time.• MedicalResearch.com: Were any of the findings unexpected?• Dr. Bai: Noted is the five individuals in our study who were tested and confirmed as having lung cancer by computed tomography (CT) and pathology

evaluations:• 3 CWS (lung adenocarcinoma)• 1 CWPS (lung adenocarcinoma) and• 1 CS (lung squamous cell carcinoma). It will cause our attention and strengthen the monitoring of lung cancer.• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Bai: The Chinese waterpipe has been mistaken as less harmful. Our study has provided evidence confirming this misconception. Exposure to active and

passive Chinese waterpipe smoke may be a significant risk factor for developing COPD. The damage from Chinese waterpipe use and exposure are worse than cigarette. Our results highlight smoking cessation in Chinese waterpipe users is as important as in other tobacco products in preventive intervention of COPD.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Bai: In addition to Chinese waterpipe use and exposure are associated with COPD; the PM2.5 from the Chinese waterpipe smoke was twice as high as from

cigarette smoke. Our results also predict the prevalence of COPD will be increased by long-term exposure to high concentrations of PM2.5, which will bring a huge economic and social burden to the globe and calls for more research to be directed toward preventive measures and efforts.

• Citation:• Chinese waterpipe smoking and the risk of chronic obstructive pulmonary disease

She J, Yang P, Wang Y, et al.Published online February 20, 2014.doi:10.1378/chest.13-1499.

• Chest. 2014. doi:10.1378/chest.13-1499•

Read the rest of the interview on MedicalResearch.com

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Atrial Fibrillation: Ablation Found Superior to Conventional Drug TherapyMedicalResearch.com Interview with:Carlos A. Morillo, MD, FRCPC, FACC, FHRS, FESCProfessor Department of Medicine, Cardiology Division

Program Director Cardiac Electrophysiology and Autonomic Physiology Fellowship ,Hamilton, ON, Canada

• MedicalResearch.com Interview with:Carlos A. Morillo, MD, FRCPC, FACC, FHRS, FESCProfessor Department of Medicine, Cardiology DivisionProgram Director Cardiac Electrophysiology and Autonomic Physiology Fellowship,Hamilton, ON, Canada

• MedicalResearch.com: What are the main findings of the study?• Dr. Morillo: The main findings were that Ablation of atrial fibrillation was superior to conventional antiarrythmic

drug therapy in patients with Paroxysmal atrial fibrillation that had not been treated with Antiarrhythmic medications. Ablation extended the time to first recurrence of atrial fibrillation within the 2 year follow-up of the study and significantly reduced the recurrence of repeated episodes of AF.

MedicalResearch.com: Were any of the findings unexpected?• Dr. Morillo: Not really many studies have shown that ablation is better than medications but in patients that

have previously failed Antiarrhythmic drug treatment. We were expecting a greater effect of ablation but still documented a 44% relative risk reduction in recurrence of AF.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Morillo: This study provides further support to offering ablation as first line treatment of Atrial fibrillation in

young patients with paroxysmal atrial fibrillation that have not received Antiarrhythmic drugs previously. The procedure is not free of risks and this procedure should be performed in centres with experience managing patients with atrial fibrillation.

• Citation:• Radiofrequency Ablation vs Antiarrhythmic Drugs as First-Line Treatment of Paroxysmal Atrial Fibrillation (RAAFT-

2)A Randomized Trial• Morillo CA, Verma A, Connolly SJ, et al. Radiofrequency Ablation vs Antiarrhythmic Drugs as First-Line Treatment

of Paroxysmal Atrial Fibrillation (RAAFT-2): A Randomized Trial. JAMA. 2014;311(7):692-700. doi:10.1001/jama.2014.467.Read the rest of the interview on MedicalResearch.com

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Colon Cancer Patients Have Less Diverse Gut BacteriaMedicalResearch.com Interview with: Jiyoung Ahn, PhD

Assistant Professor of Epidemiology Department of Population HealthNYU School of Medicine New York, NY 10016

• MedicalResearch.com: What are the main findings of the study?• Dr. Ahn: Before we did our research, it was suspected that gut bacteria were related to colorectal cancer. We, for the

first time, found colorectal cancer patients have a different gut bacteria composition than healthy subjects.•

MedicalResearch.com: Were any of the findings unexpected?• Dr. Ahn: Not really. Humans host trillions of gut bacteria that help in digestion and other normal functions.

The diverse types of bacteria are important to carry out these activities. A decrease in diversity may indicate a lack of balance in the complex bacterial population. Our research shows that subjects with colon cancer have a less diverse population of gut bacteria. It will take more research to determine if this decreased diversity leads to colon cancer or is a response to having the disease.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Ahn: This research, although in an early stage, is pointing to the possibility that gut microbes are involved in

colon cancer development. If this is correct, the research could open up new ways to protect from this serious disease. Beyond our research program, it remains important now to maintain a healthy diet and follow physician recommendations for screening for the early detection of colon cancer.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Ahn: Our group is working on diet and lifestyle factors determining gut microbe profile. For example, dietary

factors, such as dietary fruit and vegetable and bean intakes, rich sources of dietary fiber, and obesity are suspected factors.

• Citation:• Human Gut Microbiome and Risk for Colorectal Cancer• Jiyoung Ahn, Rashmi Sinha, Zhiheng Pei, Christine Dominianni, Jing Wu, Jianxin Shi, James J. Goedert, Richard B. Hayes,

and Liying Yang• Human Gut Microbiome and Risk of Colorectal Cancer

JNCI J Natl Cancer Inst djt300 doi:10.1093/jnci/djt300 first published online December 6, 2013Read the rest of the interview on MedicalResearch.com

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After Ear Tubes: Eardrops Found Superior to Oral Antibiotics for Ear DischargeMedicalResearch.com Interview with:Dr. T. M. A van Dongen, MD Univ Med Ctr UtrechtJulius Ctr Hlth Sci & Primary Care, Dept EpidemiolUtrecht, Netherlands.

• MedicalResearch.com: What are the main findings of the study?• Answer: We performed a pragmatic trial, in which we randomly assigned 230 children who had acute

tympanostomy-tube otorrhea to receive antibiotic-glucocorticoid eardrops, oral antibiotics or to undergo initial observation. The primary outcome of our study was the presence of ear discharge, 2 weeks after study-group assignment. We also looked at, among others, the duration of the initial otorrhea episode and the total number of days of otorrhea and the number of otorrhea recurrences during 6 months of follow-up. We found that antibiotic–glucocorticoid eardrops were superior to oral antibiotics and initial observation for all outcomes.

• MedicalResearch.com: Were any of the findings unexpected?• Answer: Since acute tympanostomy-tube otorrhea, like acute otitis media, can be self-limiting, initial observation

was thought by some to be a good alternative for antibiotic treatment. We are the first to compare the effectiveness of oral or topical treatment with initial observation. Approximately one in two children managed by initial observation still had otorrhea at 2 weeks and initial observation resulted in more days with otorrhea in the following months than did topical or oral antibiotics. So our results actually suggest that initial observation is not an adequate management strategy in such children.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer:• · Standard patient information usually advises parents to contact a physician when their child’s symptoms of tube

otorrhea persist for more than a week. At that stage, so when parents contact a physician, recommendations from clinical practice guidelines vary widely: some advise physicians to manage with oral antibiotics or more observation, while others suggest prescribing antibiotic eardrops. We recommend updating current patient information and clinical practice guidelines. Our results show it’s best to inform parents to contact a physician when otorrhea occurs, rather than waiting for a week or more to see if otorrhea abates without treatment. In addition, we recommend physicians to treat these children with eardrops shortly after onset of symptoms.

Read the rest of the interview on MedicalResearch.com

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After Ear Tubes: Eardrops Found Superior to Oral Antibiotics for Ear DischargeMedicalResearch.com Interview with:Dr. T. M. A van Dongen, MD Univ Med Ctr UtrechtJulius Ctr Hlth Sci & Primary Care, Dept EpidemiolUtrecht, Netherlands.

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

• Answer: For many years, the use of topical antibiotics in children with acute tympanostomy-tube otorrhea has been questioned for their presumed inability to reach the middle ear. In vivo studies in children with a ‘clean’ ear canal and patent tympanostomy tube as well as in vitro studies reported low rates of spontaneous penetration of eardrops into the middle ear. These studies raised even more doubt about eardrops reaching the middle ear in children with active tube otorrhea. Yet our study of children with middle ear fluid visibly draining through the tympanostomy tube into the ear canal showed that eardrops were highly effective, indicating that its active components do reach the site of infection. As such, one could therefore question whether antibiotic(-glucocorticoid) eardrops may also be effective in children without tubes who develop acute otitis media and present with spontaneous otorrhea. So far, this has not been evaluated in a randomized clinical trial, presumably based upon the same rationale, i.e. that the eardrops would not reach the infected middle ear. Since topical treatment is usually well tolerated, causes no systemic side effects and is less likely to cause antimicrobial resistance as compared to oral antibiotics, a trial of the effectiveness of topical antibiotics versus oral antibiotics in children with acute otitis media presenting with spontaneous otorrhea seems warranted.

• Citation:• A Trial of Treatment for Acute Otorrhea in Children with Tympanostomy Tubes

hijs M.A. van Dongen, M.D., Geert J.M.G. van der Heijden, Ph.D., Roderick P. Venekamp, M.D., Ph.D., Maroeska M. Rovers, Ph.D., and Anne G.M. Schilder, M.D., Ph.D.

• N Engl J Med 2014; 370:723-733February 20, 2014DOI: 10.1056/NEJMoa1301630

Read the rest of the interview on MedicalResearch.com

Page 10: MedicalResearch.com - Medical Research Interviews Week in Review

Glioblastoma: Avastin Did Not Improve Survival or SymptomsMedicalResearch.com Interview with:Minesh P. Mehta, M.B., Ch.B. F.A.S.T.R.O.Professor of Radiation Oncology, University of Maryland School of Medicine

Radiation oncologist, University of Maryland Marlene and Stewart Greenebaum Cancer Center

• MedicalResearch.com: What are the main findings of the study?• Dr. Mehta: RTOG 0825 was a clinical trial evaluating whether the addition of a novel drug that inhibits

tumor vascular growth, bevacizumab, to the standard of care for glioblastoma, an aggressive brain tumor, would prolong survival. Patients were allocated randomly to one of two different treatment regimens – the standard of care, which includes radiotherapy and a drug known as temozolomide, or another regimen of radiation, temozolomide and bevacizumab. The trial design was double-blinded, and therefore, on one arm patients received the bevacizumab, whereas on the other arm they received a placebo. The survival on both arms was equivalent, and therefore it was fairly concluded that bevacizumab failed to prolong survival when given initially as part of treatment for glioblastoma.

• Freedom from progression, referred to as progression-free survival was also measured on this trial, and although bevacizumab appeared to lengthen progression-free survival, this level of benefit did not meet the pre-defined goals, and is therefore regarded as statistically not demonstrating an improvement.

• Additional endpoints included outcomes reported by the patient, including the burden of symptoms, and the impact of these on the quality of life, as well as effects on the brain, known as neurocognitive changes. Bevacizumab did not improve these endpoints either.

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

• Dr. Mehta: This trial was based on an earlier trial in which patients with recurrent glioblastoma were treated with bevacizumab. In that trial, progression of disease was delayed, and tumor shrinkage on brain MRI scans was noted, resulting in FDA approval for use in recurrent glioblastoma. Based on those results, as well as the known biology of this tumor, there was good expectation that a survival benefit would be observed. Failure to observe that was somewhat unexpected and truly disappointing.

Read the rest of the interview on MedicalResearch.com

Page 11: MedicalResearch.com - Medical Research Interviews Week in Review

Glioblastoma: Avastin Did Not Improve Survival or SymptomsMedicalResearch.com Interview with:Minesh P. Mehta, M.B., Ch.B. F.A.S.T.R.O.Professor of Radiation Oncology, University of Maryland School of Medicine

Radiation oncologist, University of Maryland Marlene and Stewart Greenebaum Cancer Center

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Mehta: This agent bevacizumab is known to help several patients with recurrent

glioblastoma, and the results of this trial should not detract from that; patients and physicians need to keep this in mind and recognize that the drug has value in the recurrent setting. Upfront use cannot be supported in terms of improving duration of survival.

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

• Dr. Mehta: improved, but in that trial, the patient-reported outcomes were more favorable for the bevacizumab arm. Therefore, the collective data from both trials regarding these endpoints are expected to be analyzed in greater detail. Further, it is possible that certain subsets of patients might have benefited from the agent, and specific molecular evaluation of individual patients’ tumors is ongoing to tease this out.

• Citation:• A Randomized Trial of Bevacizumab for Newly Diagnosed Glioblastoma• Mark R. Gilbert, M.D., James J. Dignam, Ph.D., Terri S. Armstrong, Ph.D., A.N.P.-B.C., Jeffrey S.

Wefel, Ph.D., Deborah T. Blumenthal, M.D., Michael A. Vogelbaum, M.D., Ph.D., Howard Colman, M.D., Ph.D., Arnab Chakravarti, M.D., Stephanie Pugh, Ph.D., Minhee Won, M.A., Robert Jeraj, Ph.D., Paul D. Brown, M.D., Kurt A. Jaeckle, M.D., David Schiff, M.D., Volker W. Stieber, M.D., David G. Brachman, M.D., Maria Werner-Wasik, M.D., Ivo W. Tremont-Lukats, M.D., Erik P. Sulman, M.D., Kenneth D. Aldape, M.D., Walter J. Curran, Jr., M.D., and Minesh P. Mehta, M.D.

• N Engl J Med 2014; 370:699-708February 20, 2014DOI: 10.1056/NEJMoa1308573

Read the rest of the interview on MedicalResearch.com

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Breast Cancer Brain Metastasis: Genomic and Epigenomic AnalysisMedicalResearch.com Interview with:Bodour Salhia, PhD Assistant Professor Integrated Cancer Genomics DivisionTranslational Genomics Research InstitutePhoenix, Arizona, 85004

• MedicalResearch.com: What are the main findings of the study?• Dr. Salhia: Our study identified novel rare genomic and epigenomic events underlying breast cancer metastasis to brain. We

demonstrated that we could molecularly subtype breast cancer brain metastasis the same way we can subtype primary breast cancer. From this analysis we found that the Luminal B subtype was the most common subtype in our cohort, followed by Her2+/ER- enriched tumors and Basal-like tumors. Each of these subtypes displayed genetic and epigenetic features reminiscent of primary breast cancer. We demonstrated that these tumors have a strong predilection to grow by activating pathways involved in G2/M cell cycle progression, whereas, many genes involved in cell migration were epigenetically silenced. Broad amplification of chromosome 8q was common, which resulted in the upregulation of important genes.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Salhia: Certainly, gain of 8q has been previously described for breast cancer and has been associated with disease

progression and poor patient prognosis. What was surprising to us was the amplification of the cMYC oncogene on 8q without concomitant expression. If we assume that the 8q locus is important in the development of brain metastasis, this data suggests that other genes on 8q (not cMYC) may be driving metastasis to brain.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Salhia: This is an important study that integrated multiple genomic datasets to determine underlying molecular

characteristics of brain metastasis. Survival with brain metastasis remains quite poor. So we want patients to walk away with a sense of hope, as we get closer to finding better ways to treat this disease.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Salhia: Breast cancer brain metastasis is a really significant problem and a huge unmet need. We now want to dig deeper

and uncover more specific genomic links and study new ways to treat these patients so we can dramatically improve outcomes.

• • Citation:• Integrated Genomic and Epigenomic Analysis of Breast Cancer Brain Metastasis• Bodour Salhia, Jeff Kiefer, Julianna T. D. Ross, Raghu Metapally, Rae Anne Martinez, Kyle N. Johnson, Danielle M. DiPerna, Kimb

erly M. Paquette, Sungwon Jung, Sara Nasser, Garrick Wallstrom, Waibhav Tembe, Angela Baker, John Carpten, Jim Resau, Timothy Ryken, Zita Sibenaller, Emanuel F. Petricoin, Lance A. Liotta, Ramesh K. Ramanathan, Michael E. Berens, Nhan L. Tran Research Article | published 29 Jan 2014 | PLOS ONERead the rest of the interview on MedicalResearch.com

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Promising Approach to Treat Non-Alcoholic Fatty Liver Disease and Visceral ObesityMedicalResearch.com Interview with: Norbert Stefan, MDHeisenberg Professorship for Clinical and Experimental DiabetologyDepartment of Internal Medicine IV

University Hospital Tübingen Tübingen, Germany

• MedicalResearch.com: What are the main findings of the study?• Dr. Stefan: Currently there is little evidence for an effective and safe pharmacological

treatment of nonalcoholic fatty liver disease (NAFLD). Based on the fact that inhibition of 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD1), the enzyme, that converts inactive cortisone into active cortisol in metabolic tissues such as liver and adipose, was found to be effective to improve lipid metabolism in animals, we hypothesized that inhibition of 11β-HSD1 may also prove to be effective to decrease liver fat content in patients with NAFLD. In our 12 week trial in 82 patients with NAFLD, inhibition of 11β-HSD1 with RO5093151 resulted in a 14 % decrease of liver fat content and in a resolution of NAFLD in 20 % of the patients. This was accompanied by a decrease of liver enzymes. Furthermore, inhibition of 11β-HSD1 brought about a reduction of body weight and total body- and visceral adipose tissue mass, while insulin sensitivity did not change. In agreement with findings from other trials, also in our study 11β-HSD1 inhibition was well tolerated and safe.MedicalResearch.com: Were any of the findings unexpected?

• Dr. Stefan: These findings were not unexpected. High 11β-HSD1 activity in metabolic tissues as the liver and adipose tissue is known to be closely related to features of the Cushing’s disease. Thus, the observed decrease in liver fat content and visceral adipose tissue mass was in agreement with the expected mode of action of a compound that specifically inhibits 11β-HSD1 activity. This supports the hypothesis that targeting 11β-HSD1 is a promising approach to treat NAFLD and visceral obesity.

Read the rest of the interview on MedicalResearch.com

Page 14: MedicalResearch.com - Medical Research Interviews Week in Review

Promising Approach to Treat Non-Alcoholic Fatty Liver Disease and Visceral ObesityMedicalResearch.com Interview with: Norbert Stefan, MDHeisenberg Professorship for Clinical and Experimental DiabetologyDepartment of Internal Medicine IV

University Hospital Tübingen Tübingen, Germany

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Stefan: Our trial was a phase 1b study. Currently there is no approved drug available that

inhibits 11β-HSD1 activity. However, our findings are encouraging in that in more advanced phases such a pharmacological concept may prove to be effective in larger studies.

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

• Dr. Stefan: Further clinical studies are now needed to evaluate whether longer term 11β-HSD1 inhibition might be more effective to reduce liver fat content in NAFLD, and whether it may have beneficial effects in non-alcoholic steatohepatitis. In addition, such trials should further explore whether 11β-HSD1 inhibition may qualify as a pharmacological treatment option for obesity.

• Citation:• Inhibition of 11β-HSD1 with RO5093151 for non-alcoholic fatty liver disease: a multicentre, ra

ndomised, double-blind, placebo-controlled trial

Prof Norbert Stefan MD,Markus Ramsauer PhD,Paul Jordan PhD,Bettina Nowotny MD,Konstantinos Kantartzis MD,Jürgen Machann PhD,Jong-Hee Hwang PhD,Peter Nowotny PhD,Sabine Kahl MD,Jürgen Harreiter MD,Silke Hornemann MD,Prof Arun J Sanyal MD,Prof Paul M Stewart MD,Prof Andreas F Pfeiffer MD,Prof Alexandra Kautzky-Willer MD,Prof Michael Roden MD,Prof Hans-Ulrich Häring MD,Sabine Fürst-Recktenwald MD

The Lancet Diabetes & Endocrinology – 17 February 2014 DOI: 10.1016/S2213-8587(13)70170-0

Read the rest of the interview on MedicalResearch.com

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Many Pregnant Women Have Not Taken Folic Acid to Reduce Neural Tube DefectsMedicalResearch.com Interview with: Prof. Nicholas J. WaldWolfson Institute of Preventive MedicineBarts and the London School of Medicine and Dentistry Queen

Mary University of LondonLondon, United Kingdom

• MedicalResearch.com: What are the main findings of the study?• Prof Wald: The percentage of women who become pregnant without having taken folic acid supplements to

reduce the risk of a neural tube defect declined from a relatively low proportion (35%) to an even lower one (31%) between 1999 and 2012.

• Moreover such use of folic acid in some groups of the population is much lower for example 17% in Afro-Caribbean women and 6% in women aged under 20.

• MedicalResearch.com: Were any of the findings unexpected?• Prof Wald: Only about half of women who had already had a neural tube defect pregnancy took folic acid

supplements prior to their current pregnancy – a group at much higher risk• MedicalResearch.com: What should clinicians and patients take away from your report?• Prof Wald: The main takeaway message is directed to public health authorities and governments rather than

clinicians or patients.• The main message for clinicians and patients is that many women who have already had a neural tube

defect pregnancy are not receiving folic acid supplements before pregnancy and these should be routinely offered and prescribed to all such women.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Prof Wald: The message of this paper is not further research, but further action needed.

Citation:• Prevention of Neural Tube Defects: A Cross-Sectional Study of the Uptake of Folic Acid Supplementation in N

early Half a Million Women• Jonathan P. Bestwick, Wayne J. Huttly, Joan K. Morris, Nicholas J. Wald Research Article | published 19 Feb 2

014 | PLOS ONE 10.1371/journal.pone.0089354Read the rest of the interview on MedicalResearch.com

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Increased Sitting Time Linked to DisabilityMedicalResearch.com Interview with: Dorothy D Dunlop, PhDProfessor, Medicine-Rheumatology

Center for Healthcare Studies – Institute for Public Health and Medicine and Preventive MedicineNorthwestern University Feinberg School of Medicine

• MedicalResearch.com: What are the main findings of the study?• Dr. Dunlop: We know being active, especially doing moderate activity like taking a brisk walk, is good for health. We know a

sedentary lifestyle leads to health problems. What we do not know is whether or not those are two ways of looking at the same question. Does being sedentary like sitting just reflect insufficient activity OR is sedentary time is a separate and distinct risk factor for health problems. Our physical activity research group looked at national US data from the National Health and Nutrition Examination Survey. This is an important study because they monitored physical activity using an accelerometer. We found sedentary behavior such as sitting was its own separate risk factor for disability.MedicalResearch.com: Were any of the findings unexpected?

• Dr. Dunlop: We were impressed at the strength and consistency of the relationship between sedentary time and disability.• MedicalResearch.com: What should clinicians and patients take away from your report?

Dr. Dunlop: “There are two messages here.• First, being physically active is very important. It is well documented that recommended levels of moderate activity reduces the risk

for disability.• Second, being sedentary is a separate and important risk factor. People should focus on both. Be as active as possible. And for

people who spend a large portion of their day sitting, it is beneficial to find opportunities to replace some of that sitting with other activities. The bottom line is to stay active and reduce sitting

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Dunlop: Because our study examined data collected at one point in time, it does not determine sedentary behavior causes

disability. It does draw our attention to the fact sedentary behavior is a problem. Future studies need to look at the relationship of sedentary time and the subsequent development of disability.

• Citation:• Sedentary Time in U.S. Older Adults Associated With Disability in Activities of Daily Living Independent of Physical Activity• JPAH In Press• Authors: Dorothy Dunlop1, Jing Song1, Emily Arnston2, Pamela Semanik3, Jungwha Lee4, Rowland Chang4, and Jennifer M. Hootman5

• Acceptance Date: November 12, 2013• DOI: http://dx.doi.org/10.1123/jpah.2013-0311

Read the rest of the interview on MedicalResearch.com

Page 17: MedicalResearch.com - Medical Research Interviews Week in Review

Blood Clot Risk Elevated for 12 Weeks After ChildbirthMedicalResearch.com Interview with:Dr.Hooman Kamel MDDepartment of Neurology and the Brain and Mind Research InstituteWeill Cornell Medical College in New York City.

• MedicalResearch.com: What are the main findings of the study?• Dr. Kamel: The risk of thrombotic events remains higher than normal for twice as long after

childbirth as previously thought. However, the absolute risk in any given patient is low, especially after the first 6 weeks.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Kamel: Our hypothesis was that the risk of thrombotic events would be higher than normal

beyond 6 weeks, and that is indeed what we found.• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Kamel: Patients and providers should be aware that thrombotic risk remains elevated until 12

weeks after delivery, so that any symptoms of possible thrombosis (e.g., shortness of breath, chest pain, leg swelling or pain, sudden neurological symptoms) are evaluated appropriately.

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

• Dr. Kamel: Our findings suggest that future studies should evaluate the risks and benefits of extended postpartum prophylactic therapy in high-risk women (e.g., those with prior thrombosis).

• Citation:• Risk of Thrombosis Remains Elevated for 12 Weeks After Labor and Delivery• American Stroke Association 2014 Meeting Report: ISC abstract: Abstract: 216

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Advanced Cervical Cancer: Adding Avastin to Chemotherapy Prolonged SurvivalMedicalResearch.com Interview with:Krishnansu S. Tewari, MD, FACOG, FACS| Professor & Director of Research

Principal Investigator – The Gynecologic Oncology Group at UC Irvine, Division of Gynecologic OncologyUniversity of California, Irvine Medical Center Orange, CA 92868

• MedicalResearch.com: What are the main findings of the study?• Dr. Tewari: The main findings of this study were that the addition of bevacizumab to chemotherapy resulted in a

significantly improved survival of 3.7 months in a population of patients that have very limited options. This improvement in overall survival was not accompanied by any significant deterioration in quality of life and serious side effects were limited to 3% to 8% of the study population.MedicalResearch.com: Were any of the findings unexpected?

• Dr. Tewari: The findings were not unexpected. We have known for decades that angiogenesis (ie., the formation of new blood vessels between the cancer and the patient) is an important process in cervical cancer. Angiogenesis allows the cancer to obtain nutrients to supports its growth. We now have a drug that can block angiogenesis and we were very pleased to learn that using this drug resulted in improved survival for these patients.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Tewari: We may have identified a therapeutic mechanism through which we can now improve survival in this

population of patients to allow them to obtain further benefits from newer drugs currently being studied such as other inhibitors of angiogenesis, immunologic therapies, etc. Previously, advanced cervical cancer was a disease in which patients rarely could tolerate multiple lines of chemotherapy (unlike ovarian and breast cancers which can be made into chronic diseases with patients receiving many lines of therapy for many years). Now, with bevacizumab we may be on the cusp of being able to convert this disease into a more chronic one that doesn’t kill patients so quickly.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Tewari: First thing that needs to be done is to get the drug approved by the US FDA so that patients in greatest need can

benefit from this therapy. Then we need to study other types of anti-angiogenesis therapy and immunologic therapy in this population of patients – many such trials are already underway.

• Citation:• Improved Survival with Bevacizumab in Advanced Cervical Cancer• Krishnansu S. Tewari, M.D., Michael W. Sill, Ph.D., Harry J. Long, III, M.D., Richard T. Penson, M.D., Helen Huang, M.S., Lois M

. Ramondetta, M.D., Lisa M. Landrum, M.D., Ana Oaknin, M.D., Thomas J. Reid, M.D., Mario M. Leitao, M.D., Helen E. Michael, M.D., and Bradley J. Monk, M.D.

• N Engl J Med 2014; 370:734-743February 20, 2014DOI: 10.1056/NEJMoa1309748Read the rest of the interview on MedicalResearch.com

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Good Sleep Habits for Children: Early Consistent Bedtime, No Evening TVMedicalResearch.com Interview with: Dr Abi Fisher PhDSenior Researcher, Cancer Research UKHealth Behaviour Research CentreUniversity College London

• MedicalResearch.com: What are the main findings of the study?• Dr. Fisher: Getting sufficient sleep at night is essential to the health and development of young children.

Before the age of 5 years, children who regularly sleep less than 11 hours a night are at an increased risk of poor health, so understanding the factors that determine short sleep is very important. Some key factors were related to shorter sleep in our study, including being from ethnic minority backgrounds, lower socioeconomic groups and watching more than an hour of television in the evening. Whilst these factors have been related to childhood sleep in previous studies, ours was the first to show that the effects of these variables on children’s sleep may be operating through a later bedtime.

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

• Dr. Fisher: These findings are important as they can be used to give parents, caregivers and health professionals constructive advice on how to improve child sleep; an emphasis on an early and consistent bedtime could help promote healthy sleep. Parents should also be encouraged not to allow evening television viewing.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Fisher: Our study was observational, so randomised controlled trials should be carried out with short

sleeping children and their families, to determine whether introducing earlier bedtimes do indeed improve sleep length and quality and improve health outcomes.

• Citation:• Predictors of Shorter Sleep in Early Childhood• Laura McDonald, Jane Wardle, Clare H. Llewellyn, Cornelia H.M. van Jaarsveld, Abigail Fisher• Sleep Medicine – 10 February 2014 (10.1016/j.sleep.2014.01.005)

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Pediatric Oncology: Radiation Free Imaging Test as Alternative to PET/CT ScansMedicalResearch.com: Interview with:Dr Heike Daldrup-LinkAssociate Professor of RadiologyStanford University School of Medicine, Palo Alto

• MedicalResearch.com: What are the main findings of the study?• Answer: We use magnetic resonance imaging, a technology based on magnetic fields rather than radiotracers

or x-rays. The underlying technology is not new – it has been used for tumor staging for many years. This is an advantage as MR scanners are available in nearly every major Children’s Hospital where children with cancer are treated. What is new about our approach is that we combined anatomical and functional images, similar to current approaches that use radiotracers and CT (PET/CT): We first acquired scans that showed the anatomy of the patient very well and we then acquired scans that depict tumors as bright spots with little or no background information. We did that by using an iron supplement as a contrast agent: The iron supplement can be detected by the MRI magnet and improved tumor detection and vessel delineation MR scans. We then fused the anatomical scans with the tumor scans.

• One could compare this to highlighting roads and points of interests (the tumors) simultaneously on a geographic map. Previous MR imaging approaches have either shown the point of interest very well or the anatomical map, but not both. By fusing MR scans that highlight the tumor with MR scans that provide a very detailed anatomical map of the body, we created radiation-free images that shows us very clearly, where tumors are in relation to anatomical landmarks.

• Our radiation free WB-DW MR imaging technique detected 158 of 174 malignant tumors and FDG-PET/CT detected 163 of 174 malignant tumors. The resultant sensitivities, specificities, and diagnostic accuracies were all excellent, with values above 90%, and were not significantly different between the two imaging modalities. Tumour staging results also showed very good agreement between both imaging modalities with a κ of 0.93. At the same time, the associated radiation exposure could be reduced from about 12.5 mSv for the PET scans to zero for the WB-DW scans. Both exams required roughly the same time between tracer injection and end of scan and the estimated exam costs were comparable.

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Pediatric Oncology: Radiation Free Imaging Test as Alternative to PET/CT ScansMedicalResearch.com: Interview with:Dr Heike Daldrup-LinkAssociate Professor of RadiologyStanford University School of Medicine, Palo Alto

• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: Accurate staging of malignant tumors in children and adolescents is critical, as the presence

and location of tumor manifestations throughout the body determines therapy management and prognosis. However, several human population studies have shown that exposure to ionizing radiation above doses of about 50-100 mSv increases the risk for development of secondary cancers later in life. This is especially concerning for young patients because they are more susceptible to the effects of radiation than older patients and they live long enough to encounter secondary cancers later in live.

• We demonstrate that it is possible to provide sensitive tumor staging of children with malignant tumors by using a completely radiation free imaging test as an alternative to PET/CT scans. Maybe, one could compare this to replacing conventional light bulbs with LED lights, which eliminate unwanted heat production. Just as we want light only for our lamps, we want tumor detection only without associated side effects from radiation. Current imaging techniques do not meet our high standards of patient care without side effects. Creating a potential risk of inducing new cancers with our diagnostic imaging tests is not acceptable. Our new radiation-free imaging test provides a solution for this problem. The next step will be to prove our findings in larger patient populations, beyond our single center. We are currently planning a multi-institutional initiative of six major Children’s hospital in the US, who want to compare the value of whole body MRI and PET/CT for staging of Hodgkins lymphoma. And we were recently also contacted by centers in Europe who want to join in. This could potentially evolve into a truly global initiative that could make this imaging test widely available. Our ultimate goal is to provide global access to tumor staging tests with substantially reduced or eliminated radiation exposure.

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Pediatric Oncology: Radiation Free Imaging Test as Alternative to PET/CT ScansMedicalResearch.com: Interview with:Dr Heike Daldrup-LinkAssociate Professor of RadiologyStanford University School of Medicine, Palo Alto

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

• Answer: We evaluated the value of our new imaging test for the initial diagnosis of tumors in pediatric patients. Further studies have to show if this imaging test is also useful for evaluation of a response of the detected tumors to treatment. Such studies are also under way. There are new technological developments that combine radiotracer based imaging studies with our MRI technique. Those imaging tests still have a substantially reduced radiation exposure compared to classical PET/CT scans, but may provide additional information compared to our radiation free scan. Future studies will have to show, which patients will benefit most from a completely radiation-free whole body imaging test, as described in our article, versus new ULD (ultra low dose) PET/MR imaging tests. This is a major focus of our future multi-institutional research efforts.

• Citation:• Published online February 19, 2014 http://dx.doi.org/10.1016/S1470-2045(14)70021-X1• Christopher Klenk, Rakhee Gawande, Lebriz Uslu, Aman Khurana, Deqiang Qiu, Andrew Quon,

Jessica Donig, Jarrett Rosenberg,Sandra Luna-Fineman, Michael Moseley, Heike E Daldrup-Link. Ionising radiation-free whole-body MRI versus ¹⁸F-fluorodeoxyglucose PET/CT scans for children and young adults with cancer: a prospective, non-randomised, single-centre studyLancet (2014) doi.org/10.1016/S1470-2045(

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Mesh Hernia Repairs Associated with Fewer RecurrencesMedicalResearch.com Interview with:Mike K.Liang, MD,Department of Surgery, The University of Texas HealthSciences Center, Lyndon B. Johnson Hospital,Houston, TX 7702

• MedicalResearch.com: What are the main findings of the study?• Dr. Liang: Compared to suture repair, mesh repair of primary ventral hernias (umbilical, epigastric, spigelian, lumbar), the most

common type of ventral hernias, is associated with fewer hernia recurrence but slightly more seromas and surgical site infections.

MedicalResearch.com: Were any of the findings unexpected?• Dr. Liang: In current practice, many surgeons continue to repair primary ventral hernias with suture repair only believing that they

can obtain the same outcomes. This study reinforces the concept that even for small hernias, mesh reinforcement is associated with improved long term outcomes at a slightly increased risk of more short term adverse events.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Liang:• Clinicians: meta-analysis is not to answer questions but rather to frame questions properly. Further prospective randomized

controlled trials are needed to properly assess the best role of mesh and suture repair of primary ventral hernias.• Patients: in most situations, mesh repair of primary hernias improve long term outcomes with slight increase in more short term

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

Dr. Liang:• More high quality prospective randomized controlled trials are needed to asses the role of mesh versus suture repair of primary

ventral hernias.• Given the current evidence, use of mesh in most primary hernias will yield better long term outcomes with a slight increase in short

term complications.• Citation:• Comparison of Outcomes of Synthetic Mesh vs Suture Repair of Elective Primary Ventral Herniorrhaphy• A Systematic Review and Meta-analysis• Nguyen MT, Berger RL, Hicks SC, et al. Comparison of Outcomes of Synthetic Mesh vs Suture Repair of Elective Primary Ventral Herni

orrhaphy: A Systematic Review and Meta-analysis. JAMA Surg. 2014;():. doi:10.1001/jamasurg.2013.5014.

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Carcinogens in Food PackagingMedicalResearch.com Interview with:Dr. Jane Muncke PhD Managing DirectorFood Packaging Forum FoundationZurich, Switzerland

• MedicalResearch.com: What are the main conclusions from your work?• Answer: Food packaging is a relevant, but still under-recognized source of chemical

contamination in foods. Everybody is exposed to these chemicals on a daily basis, but we have very little understanding of the actual health effects caused by this chronic exposure source. We propose that epidemiological research tackles chemical exposures from food packaging as a new and highly relevant exposure source. Epidemiologist have played crucial roles in advancing understanding of health issues, for example cardiovascular disease caused by fine particulate air pollution. Through their work they have encouraged toxicologists to ask different questions, thereby supporting the generation of critical knowledge and, essentially, enabling prevention.

•MedicalResearch.com: Which insights were most unexpected to you?

• Answer: We were surprised to find known carcinogens being authorized for the use in food contact materials. As such, the FDA lists asbestos fiber as indirect food additive for the use in rubbers intended for food contact applications. This means that its use is, at least in theory, completely legal in the US. Another chemical of concern is formaldehyde, a known human carcinogen which is used as monomer in melamine formaldehyde tableware. Formaldehyde is also a non-intentionally added substance leaching from plastic soda bottles. Considering how many people consume beverages from such containers on a daily basis we have to assume that exposures to formaldehyde at low levels affect the entire population.

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Carcinogens in Food PackagingMedicalResearch.com Interview with:Dr. Jane Muncke PhD Managing DirectorFood Packaging Forum FoundationZurich, Switzerland

• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: As a consumer, we can make choices to eat as many fresh, unprocessed, organic and, if

possible, unpackaged foods as possible—a recommendation many doctors most likely make already. Furthermore, it is essential to avoid potentially harmful chemical exposures especially during pregnancy, for example arising from increased chemical leaching into hot foods. However, our influence as consumers is unfortunately limited, because we do not know how foods were stored or processed before they reach the stores. And, we do not always have a choice what kind of foods we eat, due to availability, time or budget restrictions. What we need most therefore are chemical regulations that are informed by the most current scientific understanding, with prevention of chronic diseases as main target.

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

• Answer: We hope to inspire epidemiologists to integrate knowledge about chemical exposures from food packaging in their studies. Such exposures are a relatively discrete and measurable route of exposure that would lend itself for amending existing methods, like food frequency questionnaires, dietary intake records or 24h recalls. Ideally, such efforts would be supplemented by biomonitoring for specific target compounds. Consumer behavior at home may be another interesting area of research, i.e. understanding in what container types foods are stored and reheated.

• Citation:• Food packaging and migration of food contact materials: will epidemiologists

rise to the neotoxic challenge?JOURNAL OF EPIDEMIOLOGY AND COMMUNITY HEALTHPublished Feb 19 2014

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Online Physician Rating Sites: Public Awareness and Participation IncreasingMedicalResearch.com Interview with: Dr. David Hanauer, MDAssociate Professor, University of Michigan Medical School1500 East Medical Center Drive

Ann Arbor, MI 48109-5940

• MedicalResearch.com: What are the main findings of the study• Dr. Hanauer: From my perspective, the primary findings were that 65% of the general public is now aware of physician

rating web sites and among those who are aware, about 36% had used them in the prior year. Awareness and usage seems to be rapidly increasing compared to what has been reported in prior studies from just a few years ago. We also found that patients consider word of mouth recommendations (from family/friends) to be almost twice as important as ratings sites are.MedicalResearch.com: Were any of the findings unexpected?

• Dr. Hanauer: I was surprised that the public was truly using these online rating sites to make decisions. In our study, among those who had sought online physician ratings in the prior year, 35% had chosen a doctor based on good ratings and 37% had avoided a doctor based on bad ratings. This is important to because the implications of using these sites are potentially much larger than using similar rating sites for standard consumer goods and services (choosing a movie to watch, for example).

• One thing that wasn’t surprising is how few people actually leave ratings themselves. In our study, 5% of the public had left a rating about a physician. We know from prior work that one of the biggest concerns about such sites is that, because so few people leave ratings, it is hard for people to make judgements about how accurate or representative the ratings are.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Hanauer: Clinicians should be aware that the public is actually using these sites more and more to make decisions so

the information on them could impact whether or not the next potential patient chooses to see them or not. Many clinicians have long been resistant to such ratings, but they seem to be here to stay, and may even be proliferating. It seems as if there are an increasing number of online rating sites for clinicians these days.

• However, from the patient perspective it is important to realize that there isn’t much (if any) regulation of the sites, and it is hard to know how trustworthy many of them are. For example, even for the few (potentially non-represenative) ratings about a physician on a site, can we even know if the rating was real, or what factors it was based on? This may be why patients are still seeking input from family and friends more than rating sites.

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Online Physician Rating Sites: Public Awareness and Participation IncreasingMedicalResearch.com Interview with: Dr. David Hanauer, MDAssociate Professor, University of Michigan Medical School1500 East Medical Center Drive

Ann Arbor, MI 48109-5940

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

• Dr. Hanauer: Given that ratings sites are likely not going away, I think in the future it will be important to understand how to make the sites more reliable so that both clinicians and patients can feel that at least the data are trustworthy. I think it will be important to better understand what patients would like to see in ratings sites, and what clinicians think are reasonable measures to include. Finding the right balance will be tricky.

• Another very important aspect to consider is what actually should go into defining a “good” clinician rating? While some may seem obvious (bedside manners, skills, etc), others may be more controversial (decor of the waiting room, for example). Right now there is no consensus, and as a result different rating sites often measure different things. So a potential healthcare “consumer” may develop a different perspective depending on which site(s) he/she visited.

• Citation:• Hanauer DA, Zheng K, Singer D, Gebremariam A, Davis M. Public Awareness, Perception, and

Use of Online Physician Rating Sites. JAMA. (In Press)

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Pulmonary Fibrosis: High Resolution CT DiagnosisMedicalResearch.com Interview with: Ganesh Raghu, M.D.,FCCP, FACPProfessor of Medicine & Lab Medicine (Adjunct)Division of Pulmonary & Critical Care Medicine University of Washington(UW)

Director,CENTER for Interstitial Lung Disease (ILD),UW Medicine, ILD, Sarcoid and Pulmonary Fibrosis ProgramCo-Director, Scleroderma Clinic, UW Medical center(UWMC) Seattle, WA 98195

• MedicalResearch.com: What are the main findings of the study?• Dr. Raghu: In a subgroup of patients with typical clinical features of Idiopathic pulmonary fibrosis ( IPF) , further evaluation by a

thorough evlauation by regional experts experienced in management of idiopathic pulmonary fibrosis and related diseases may lead to a diagnosis of idiopathic pulmonary fibrosis without the need for surgical lung biopsy if the HRCT features have a Possible-UIP pattern AND if there are no suspicion for environmental factors or collagen vascular diseases to explain the pulmonary fibrosis .

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

• The HRCT pattern of Inconsistent- UIP does not exclude UIP in surgical lung biopsy• MedicalResearch.com: What should clinicians and patients take away from your report?

Dr. Raghu:• General clinicians and confronted patients must familiarise themselves with clinical manifestations of Interstitial lung diseases ,

Idiopathic interstitial pneumonias and Idiopathic pulmonary fibrosis( IPF )• These findings MUST not be extrapolated to the interpretation of HRCT pattern of possible UIP by general /community physicians

and general radiologists• Prompt referral to regional experts, experienced with management of ILD for an accurate diagnosis.• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Raghu: Ascertain sensitivity and specificity of the possible-UIP pattern in consecutive patients evalutated for ILD / idiopathic

interstitial pneumonia• Citation:

• Diagnosis of idiopathic pulmonary fibrosis with high-resolution CT in patients with little or no radiological evidence of honeycombing: secondary analysis of a randomised, controlled trial

• Ganesh Raghu, David Lynch, J David Godwin, Richard Webb, Thomas V Colby, Kevin O Leslie, Juergen Behr, Kevin K Brown, James J Egan,

• Kevin R Flaherty, Fernando J Martinez, Athol U Wells, Lixin Shao, Huafeng Zhou, Patricia S Pedersen, Rohit Sood, A Bruce Montgomery, Thomas G O’Riordan

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TAVR vs Surgical Aortic Valve Replacement for Aortic Stenosis with LV DysfunctionMedicalResearch.com Interview with:Sammy Elmariah, MD, MPHMassachusetts General HospitalBoston, MA

• MedicalResearch.com: What are the main findings of the study?• Dr. Elmariah: Within the randomized PARTNER I trial, we evaluated the effect of left ventricular (LV) dysfunction on clinical outcomes

after transcatheter and surgical aortic valve replacement (TAVR and SAVR, respectively) and the impact of valve replacement technique on recovery of LV function. We found that LV dysfunction, defined as an LV ejection fraction < 50%, had no impact on 30-day and 1-year mortality after either TAVR or SAVR. In those with baseline LV dysfunction, marked improvement in LV ejection fraction was observed within 30-days of valve replacement in approximately half of patients, with an equivalent degree of improvement observed after TAVR and SAVR. Permanent pacemaker at study entry, low mean aortic valve gradient, and high LV ejection fraction were associated with reduced odds of LV functional recovery after valve replacement.

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

• Dr. Elmariah: Yes, we found that patients with LV dysfunction that did not demonstrate improvement in LV function within 30-days of TAVR possessed an increased risk of death at 1-year follow-up. Surprisingly, lack of early LV functional improvement did not influence clinical outcomes after SAVR. The reason for this discrepancy is not readily apparent, although we suspect that injury of the LV during transapical TAVR, paravalvular aortic regurgitation, and conduction abnormalities after TAVR may be involved.

• MedicalResearch.com: What should clinicians and patients take away from this study?• Dr. Elmariah: Our findings highlight the beneficial impact of aortic valve replacement in patients with aortic stenosis and LV

dysfunction and demonstrate that TAVR should be considered a feasible alternative to SAVR regardless of the presence of LV systolic dysfunction.

• MedicalResearch.com: What further research do you recommend as a result of your study?• Dr. Elmariah: Further efforts are needed to identify the reasons responsible for poor clinical outcomes in patients with persistent LV

dysfunction after TAVR. If in fact LV injury during transapical TAVR is found to mediate this observation, alternative approaches may prove to be beneficial in patients with LV dysfunction undergoing TAVR.

• Citation:• Outcomes of Transcatheter and Surgical Aortic Valve Replacement in High-Risk Patients With Aortic Stenosis and Left Ventricular Dys

function: Results From the Placement of Aortic Transcatheter Valves (PARTNER) Trial (Cohort A)• Sammy Elmariah, Igor F. Palacios, Thomas McAndrew, Irene Hueter, Ignacio Inglessis, Joshua N. Baker, Susheel Kodali, Martin B. Leon

, Lars Svensson, Philippe Pibarot, Pamela S. Douglas, William F. Fearon, Ajay J. Kirtane, Hersh S. Maniar, and Jonathan J. Passeri• Circ Cardiovasc Interv. 2013;CIRCINTERVENTIONS.113.000650published online before print November 12 2013, doi:10.1161/CIRCINT

ERVENTIONS.113.000650Read the rest of the interview on MedicalResearch.com

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Pre-Op Vitamin D and Infection Risk Following Gastric Bypass SurgeryMedicalResearch.com Interview with: Sadeq A. Quraishi, MD, MHAMassachusetts General Hospital, Harvard Medical SchoolBoston, Massachusetts

• MedicalResearch.com: What are the main findings of the study?• Dr. Quraishi: Our retrospective study suggests that there is an association between pre-operative 25-hydroxyvitamin D

[25(OH)D] levels and the risk of hospital-acquired infections after gastric bypass surgery. In particular, patients with 25(OH)D levels <30 ng/ml before surgery were almost 4 times more likely to develop a surgical site infection within 30 days of surgery than patients with pre-operative 25(OH)D levels at 30 ng/ml or higher.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Quraishi: While the findings themselves are not surprising, given our emerging understanding of how vitamin D

status affects immune function, the magnitude of this association is rather surprising. We did select a patient cohort at high risk for low 25(OH)D levels and high risk for hospital-acquired infections. As such, further studies are needed to extend our work, to assess the generalizability of our findings to all surgical patients, and to test whether vitamin D supplementation can influence the risk of developing hospital-acquired infections.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Quraishi: We believe that 25(OH)D optimization before surgery is a promising strategy for supporting immune

health through the perioperative setting. Active research in this area by our group and others will help us to better understand whether vitamin D supplementation is indeed helpful, and if so, how much to take and when to take it.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Quraishi: Observational research (such as this study) helps us to generate more questions and provides a rationale

to further pursue an idea – it does not address the issue of causality. To answer the question of whether vitamin D supplementation can reduce the risk of hospital-acquired infections, well-designed, placebo-controlled clinical trials are the next step.

• Citation:• Association Between Preoperative 25-Hydroxyvitamin D Level and Hospital-Acquired Infections Following Roux-en-Y Ga

stric Bypass Surgery.• Quraishi SA, Bittner EA, Blum L, Hutter MM, Camargo CA Jr.

JAMA Surg. 2013 Nov 27. doi: 10.1001/jamasurg.2013.3176. [Epub ahead of print]Read the rest of the interview on MedicalResearch.com

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Alzheimer’s: Celexa Reduced Agitation, Has Modest Cognitive, Cardiac Side EffectsMedicalResearch.com Interview with: Anton P. Porsteinsson M.D.William B. and Sheila Konar Professor of Psychiatry

Director, Alzheimer’s Disease Care, Research and Education Program (AD-CARE)University of Rochester School of Medicine and Dentistry Rochester, N.Y. 14620

• MedicalResearch.com: What are the main findings of the study?• Dr. Porsteinsson: Identifying drugs outside the antipsychotic class with targeted anti-agitation effects that provide greater benefit or lower

risk among patients with Alzheimer’s disease is a research priority. Citalopram, a selective serotonin reuptake inhibitor (SSRI), is frequently used in older individualsand has been suggested as an alternative to antipsychotic drugs for agitation and aggression in dementia. Among 186 patients with probable Alzheimer’s disease and agitation receiving psychosocial intervention, the addition of citalopram compared with placebo robustly and significantly reduced agitation and caregiver distress, but modest cognitive and cardiac adverse effects of citalopram may limit its practical application at the 30 mg/d dose studied in this trial. There are insufficient data on efficacy for agitation at lower doses of citalopram.

MedicalResearch.com: Were any of the findings unexpected?• Dr. Porsteinsson: Three quarters of the way through the study, the Food and Drug Administration (FDA) issued an advisory regarding dose-

dependent risk of QT prolongation with citalopram therapy that subsequently came under scrutiny. We added ECG monitoring and QT interval prolongation was seen in the citalopram group similar to what had been described in the advisory for a younger population and our findings validate the FDA’s action. Furthermore, an unexpected modest cognitive decline was seen in the citalopram group compared to placebo over 9 weeks with no difference in spontaneously reported somnolence or confusion.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Porsteinsson: Neuropsychiatric symptoms occur in a majority of patients with Alzheimer’s disease. Agitation is common, persistent,

difficult to treat, costly, and associated with severe adverse consequences for patients and caregivers. Psychological, environmental and pharmacologic therapies have proven inadequate. Antipsychotics continue to be widely used for agitation, despite serious safety concerns, including increased mortality, and uncertain efficacy. The takeaway message is that there are very limited options for the treatment of this tremendously distressing and difficult to treat behavioral disruption. If non-pharmacological intervention is not beneficial, judicious use of citalopram appears to have a role in managing agitation in patients with Alzheimer’s disease but generally the dose should not surpass 20 mg/d.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Porsteinsson: Given potentially concerning side effects of citalopram at 30 mg/d, further investigation is needed to determine whether

a smaller dose will be as effective.• Citation:• Porsteinsson AP, Drye LT, Pollock BG, et al. Effect of Citalopram on Agitation in Alzheimer Disease: The CitAD Randomized Clinical Trial.

JAMA. 2014;311(7):682-691. doi:10.1001/jama.2014.93.

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Expanded Health Insurance: Hospital Services Use by Young Adults with Behavioral DiagnosesMedicalResearch.com Interview with:Ellen R. MearaAssociate Professor of The Dartmouth Institute

Adjunct Associate Professor in Economics & Nelson A. Rockefeller Center for Public Policy, Dartmouth College

• MedicalResearch.com: What are the main findings of this study?• Answer: When insurance coverage for young adults rose by over 15 percentage points following Massachusetts’ 2006

health reform, use of inpatient care for mental illness and substance use disorders fell and emergency department visits for these conditions grew more slowly for 19 to 25 year olds in Massachusetts relative to other states. Also, their care was much more likely to be paid for by private or public insurance insurers.

•MedicalResearch.com: Where any of the findings surprising?

• Answer: Because treatment for mental illness and substance use disorders has been more responsive to the price patients face, compared with treatment of physical conditions, some policymakers have feared that expanding insurance coverage would lead to rapid growth in spending on treatment of mental illness and substance use disorders, especially in expensive hospital settings. We found that, in Massachusetts, a group with high need for treatment of mental illness and substance abuse, young adults, did not increase use of hospital care compared with other states after 2006.

• MedicalResearch.com: What should patients and providers take take away from your study?• Answer: Takeaway for clinicians and patients – with expanded insurance coverage, when young adults do need hospital

based care, the financial burden to patients and providers is lower.• MedicalResearch.com: What future research do you recommend as a result of your report? • Answer: We need better data on care in outpatient settings, since we cannot distinguish whether lower use of hospital care

in Massachusetts reflects access to effective outpatient care, or some other trend that limited use of hospital care after health reform

• Citation:Use of Hospital-Based Services Among Young AdultsWith Behavioral Health Diagnoses Before and After HealthInsurance Expansions

• Ellen R. Meara, Dartmouth College, Ezra Golberstein, University of Minnesota, Rebecca Zaha, The Dartmouth Institute for Health Policy and Clinical Practice, Shelly F. Greenfield, McLean Hospital, William R. Beardslee, Harvard University and Susan H. Busch, Yale University

• Presented at Association for Public Policy Analysis and ManagementRead the rest of the interview on MedicalResearch.com

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Target: Stroke Program Improved Stroke Treatment Time and OutcomesMedicalResearch.com Interview with:Gregg C Fonarow, UCLA Medical Ctr, Los Angeles, CA;Director, Ahmanson-UCLA Cardiomyopathy CenterProfessor, Department of

Medicine Associate Chief, CardiologyDavid Geffen School of Medicine

• MedicalResearch.com: What are the main findings of the study?• Dr. Fonarow: The study examined data from hospitals that have adopted the American Heart

Association/ American Stroke Association’s national quality initiative, Target: Stroke. The primary aim of Target: Stroke is to increase the number of stroke patients treated with tPA for acute ischemic stroke within 60 minutes or less after hospital arrival. The study demonstrated that patients received stroke therapy significantly faster in hospitals that participated in Target: Stroke. Between 2010 and 2013, the time between hospital arrival and use of tPA (door-to-needle time) dropped by 15 minutes, from 74 to 59 minutes, in hospitals that participated in Target: Stroke. This study found that the percentage of patients treated within the recommended timeframe increased from less than one-third before Target: Stroke to more than half afterwards. The Target: Stroke program goal of 50 percent or more of patients having door-to-needle times within 60 minutes was successfully achieved. Faster treatment was associated with improved patient outcomes and fewer complications, including death.

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

• Dr. Fonarow: It was surprising that the quality improvement intervention was so successful in all types of patients including young and older, men and women, white, black, and Hispanic patients as well as those with greater and lesser stroke severity.

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Target: Stroke Program Improved Stroke Treatment Time and OutcomesMedicalResearch.com Interview with:Gregg C Fonarow, UCLA Medical Ctr, Los Angeles, CA;Director, Ahmanson-UCLA Cardiomyopathy CenterProfessor, Department of

Medicine Associate Chief, CardiologyDavid Geffen School of Medicine

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Fonarow:• Target: Stroke was successful. The timeliness of tPA administration improved substantially after initiation of

the multidimensional AHA/ASA Target: Stroke quality initiative. The proportion of patients with door-to-needle times ≤60 minutes increased from 29.6% to 53.3%. There was also a more than 4-fold increase in the annual rate of improvement in patients with door-to-needle time ≤60 minutes. This improvement was accompanied by lower in-hospital mortality, symptomatic intracranial hemorrhage, and overall tPA complications with more patients able to be discharged to home.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Fonarow: These findings further reinforce the importance and clinical benefits of faster administration of

intravenous tPA. By showing that the timeliness of tPA administration can be improved at the national level, these findings also support further expansion of the Target: Stroke initiative. Future studies should evaluate hospital and systems factors associated with the greatest improvement in performance.

• Citation:• International Stroke Conference 2014: Abstract LB 12

Title: Improving Door-to-Needle Times in Acute Ischemic Stroke: Principal Results from the Target: Stroke Initiative

• Authors: Gregg C Fonarow, UCLA Medical Ctr, Los Angeles, CA; Xin Zhao, Duke Clinical Res Inst, Durham, NC; Eric E. Smith, Univ of Calgary, Calgary, AB, Canada; Jeffrey L. Saver, UCLA Neurology, Los Angeles, CA; Mathew J. Reeves, Michigan State Univ, East Lansing, MI; Deepak L. Bhatt, Brigham and Women’s Hosp, Boston, MA; Ying Xian, Adrian Hernandez, Eric D. Peterson, Duke Clinical Res Inst, Durham, NC; Lee H. Swhwamm, Massachusetts General Hosp, Boston, MA

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Blood Pressure Damage to Blood Vessels Detectable In Retinal Blood Vessel ThickeningMedicalResearch.com Interview with:Maria Lorenza MuiesanDepartment of Clinical and Experimental SciencesUniversity of Brescia, Internal MedicineBrescia, Italy.

• MedicalResearch.com: What are the main findings of the study?• Dr. Muisean: An increase in the ratio of retinal arteries wall thickness to lumen diameter may serve as an in-vivo parameter of

microvascular damage. We conducted a study that examined the relationship between changes in retinal arterioles wall thickness/ lumen diameter and several measures of blood pressure, including clinic brachial blood pressure, 24 hours brachial blood pressure and central aortic blood pressure. We found that the an increase of wall-to-lumen ratio of retinal arterioles was most closely related to 24 hours blood pressure.

We also confirmed previous finding of our group, showing that changes in retinal arterioles were significantly associated with an increase in aortic stiffness, an index of macrovascular damage, further supporting the concept that microvasculature and macrovasculature are strongly interrelated.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Muisean: Some previous results, obtained with measurements of clinic blood pressure and of central aortic pressure by pulse

wave analysis, found a closer relationship with aortic central blood pressure.• Our findings indicate that 24 hours pressure load may be a stronger determinant of microvasculature changes than a single

measurement of aortic central pressure.• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Muisean: The evaluation of the arterioles in the fundus oculi by Scanner Doppler Laser Flowmetry is a noninvasive and easily

repeatable procedure and shows that retinal arterioles changes are related to 24 hours blood pressure load as well as to non-invasive measures of aortic stiffness.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Muisean: New technologies, presently under clinical evaluation, may help in the future to noninvasively assess microvascular

structural alterations and to better stratify CV risk of hypertensive patients with consequent optimization of treatment. The wider use of a noninvasive approach for the stratification of risk in the majority of hypertensive patients may be proposed, since microvascular structure may represent an intermediate endpoint in the evaluation of the effects of antihypertensive treatment.

• Citation:• Relationship of Wall-to-Lumen Ratio of Retinal Arterioles With Clinic and 24-Hour Blood Pressure , Massimo Salvetti, Claudia Agabiti

Rosei, Anna Paini, Carlo Aggiusti, Anna Cancarini, Sarah Duse, Francesco Semeraro, Damiano Rizzoni, Enrico Agabiti Rosei, and Maria Lorenza Muiesan

• Hypertension. 2014;HYPERTENSIONAHA.113.03004published online before print February 10 2014, doi:10.1161/HYPERTENSIONAHA.113.03004

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Alcohol Toxic to Placenta During PregnancyMedicalResearch.com: Interview with: Sylvia LuiTommy’s Maternal and Fetal Health Research CentreThe University of Manchester

• MedicalResearch.com: What are the main findings of the study?• Answer: The research shows women who drink alcohol at moderate or heavy levels in the early stages of their pregnancy might damage the growth and function of

their placenta – the organ responsible for supplying everything that a developing infant needs until birth

MedicalResearch.com: Were any of the findings unexpected?• Answer: Yes, as we did not expect the strong effect on placental function. The results add weight to existing research in this area - that alcohol has negatively effects

pregnancy or fetal development, but previous studies have used the upper limits of alcohol concentration, and at levels that would not be found in the human body. Our results show that the damage caused by alcohol may start with an abnormally developing placenta, and that it can happen very early on in pregnancy – perhaps before a woman knows she is pregnant – in the very early weeks and at drinking levels as found in an average population.

• The aim of this project was to investigate and provide clarity on the effects of alcohol at low, moderate and ‘binge’ levels, on the developing placenta and hence pregnancy and the baby.

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

Answer: It can often be a few weeks before a woman discovers she’s pregnant, and this research shows that moderate drinking during those vital first weeks can have a big impact on the development of the baby. Low levels had no effect and perhaps awareness of alcohol units should be a key factor in educating women about their pregnancy. However research shows that it is difficult for people to judge how much they are drinking according to the recommended daily units, and are often incorrect. It is also recognised that alcohol is one of the most well-known, and most avoidable, toxin in pregnancy.

• Many pregnancies are unplanned, but for those actively planning a family this research raises questions about whether women should consider their alcohol intake even before they fall pregnant.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Answer: Our main focus in this study was the effect on placental growth and placental taurine transport, as they are major contributors towards fetal development.

Future studies on other placental functions that are known to be indicators of a healthy pregnancy, such as hormone production, would further show how alcohol and acetaldehyde impacts pregnancy. Changes in hormone levels are known to change maternal metabolism, hence a successful pregnancy and fetal well-being.

• Future research would also include alcohol and acetaldehyde’s effects on placental barrier function. The placenta is a barrier in preventing unwanted substances crossing from mother to baby. Though alcohol and acetaldehyde freely crosses the placenta to the baby, how they affect the placenta’s ability to acts as a barrier against other toxins is unknown.

• On a broader scale, future investigations would include possible preventative therapies such as diet supplements. Studies in animals have shown that folic acid is protective against effects of alcohol. Extra taurine intake, after alcohol, has been shown to decrease brain lesions in animal models. Further work is required to investigate whether supplementation, through the mother, has any side effects, or can improve pregnancy outcomes where there may have been alcohol exposure. There are many questions to be still answered, but the placenta is a valuable means to investigate pregnancy-related problems due to its crucial role in a healthy pregnancy.

• Citation:• Detrimental effects of ethanol and its metabolite, acetaldehyde, on first trimester human placental cell turnover and function.” S. Lui, R.L. Jones, N.J. Robinson, S.L. Gr

eenwood, J.D. Aplin, C.L. Tower was published on 4 February in PLoS One

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TAVR for Aortic Stenosis: Improvement in Quality of LifeMedicalResearch.com Interview with:Caroline A. Kim, MD, MS;Beth Israel Deaconess Medical CenterBoston, MA 02215.

• MedicalResearch.com: What are the main findings of the study?• Dr. Kim: We conducted a systematic review of 62 studies that examined functional status and

quality of life in patients who underwent transcatheter aortic valve replacement (AVR) for their symptomatic severe aortic valve stenosis. In 11,205 patients who underwent TAVR, a clinically meaningful improvement was seen in physical functional measures and disease-specific quality of life measures, whereas improvement in psychological measures or more general health measures were modest and inconsistent. Given the dismal prognosis of severe aortic stenosis treated conservatively, it was clear that transcatheter AVR improved functional status and quality of life. However, there was insufficient evidence that compares these patient-centered outcomes between transcatheter AVR and surgical AVR.MedicalResearch.com: Were any of the findings unexpected?

• Dr. Kim: The majority of studies had major methodological limitations that did not allow accurate estimation of overall benefits of transcatheter AVR. Although many patients with severe aortic stenosis may place a higher value on improving the quality of life than prolonging survival, we were surprised to learn that most research only focused on procedural success or mortality; very few studies compared transcatheter AVR and surgical AVR. In most studies, measures of functional status and quality of life other than the New York Heart Association functional class were seldom studied. Furthermore, it was evident that some patients did not benefit from transcatheter AVR.

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TAVR for Aortic Stenosis: Improvement in Quality of LifeMedicalResearch.com Interview with:Caroline A. Kim, MD, MS;Beth Israel Deaconess Medical CenterBoston, MA 02215.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Kim: Here are the take-home points from our work:• 1) Transcatheter AVR improves survival, physical function, and some measures of quality of life

compared with conservative treatment.• 2) However, these observed benefits of transcatheter AVR were not observed from all patients treated

with transcatheter AVR. Some did not receive any meaningful benefits.• 3) The functional and quality-of-life benefits of transcatheter AVR compared with surgical AVR remain to

be examined. Previous research showed similar survival rates.• 4) Until more evidence accrues, clinicians and patients should weight potential risks and benefits of the

two procedures, individuals’ risk factors for complications (medical comorbidities and frailty) and life expectancy, to select patients who are most likely to benefit. This point is not directly supported from our work, but it is a general statement based on current evidence.

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

• Dr. Kim: We call for more prospective studies that compare functional status and quality of life between transcatheter AVR and surgical AVR to better inform clinicians and patients in making treatment decisions for symptomatic severe aortic stenosis. More research is needed to develop an algorithm that identifies those who are more likely to benefit from transcatheter AVR than surgical AVR.

• Citation:• Caroline A. Kim, Suraj P. Rasania, Jonathan Afilalo, Jeffrey J. Popma, Lewis A. Lipsitz, Dae Hyun Kim; Func

tional Status and Quality of Life After Transcatheter Aortic Valve ReplacementA Systematic Review. Annals of Internal Medicine. 2014 Feb;160(4):243-254.

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Stroke: Intracranial Atherosclerosis as a Major Risk FactorMedicalResearch.com Interview with:M. Arfan Ikram, MD, PhDDepartments of Radiology, Epidemiology, and Neurology Erasmus Medical Center,Rotterdam, the Netherlands

• MedicalResearch.com: What are the main findings of the study?• Dr. Ikram: The main finding of the study, carried out within the Rotterdam Study and led by drs. Daniel

Bos and Arfan Ikram (both from the Erasmus Medical Center Rotterdam, the Netherlands), was that intracranial atherosclerosis is a major risk factor for stroke in the Western (white) population. Traditionally, intracranial atherosclerosis has not been considered of major importance to stroke risk in Western populations. In contrast, most research on intracranial atherosclerosis originates from Asian and African populations, where is was actually recognized as the most important risk factor of stroke. Our study demonstrates that also in the Western population intracranial atherosclerosis is a major risk factor for stroke and should get more focus in clinical practice. Moreover, our findings indicate that its contribution to the proportion of all strokes is greater than that of atherosclerosis in other vessel beds that are further away from the brain.

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

• Dr. Ikram: Our hypothesis was that atherosclerosis that is located in the vasculature directly supplying the brain would have more influence on the development of stroke compared to locations further away from the brain (such as heart or aorta). This was in conjunction with the second hypothesis that intracranial atherosclerosis would be a major risk factor of stroke in Western populations too. In that sense, our finding that intracranial atherosclerosis was indeed a strong risk factor for stroke, was not entirely unexpected. However, the magnitude of the association was larger than we anticipated. Especially, the finding that the association between intracranial atherosclerosis and stroke firmly remained after adjustment for the presence of atherosclerosis in the carotid bifurcation, aortic arch and the coronary arteries, emphasizes the importance of intracranial atherosclerosis.

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Stroke: Intracranial Atherosclerosis as a Major Risk FactorMedicalResearch.com Interview with:M. Arfan Ikram, MD, PhDDepartments of Radiology, Epidemiology, and Neurology Erasmus Medical Center,Rotterdam, the Netherlands

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

Dr. Ikram: Over the past decades, there has not been much attention for intracranial atherosclerosis as cause of stroke in the Western (white) population. With the current study we demonstrated that from different important sites where atherosclerosis frequently occurs (carotid bifurcation, aorta, coronary arteries), the presence and amount of intracranial atherosclerosis seems to be the most important with regard to strokes. In other words, intracranial atherosclerosis is an underestimated risk factor for stroke and deserves significantly more attention in current practice.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Ikram: The next step in research should include the investigation of the predictive value of intracranial

carotid artery calcification for stroke. To a certain extent there is some analogy with the coronary arteries and coronary events, especially myocardial infarction. Compared to the extensive research that has been performed in this field, it is evident that much research is still to be done to assess the value of intracranial atherosclerosis as a potential predictor of stroke. The coronary calcium score for example, has proven added value in the prediction of acute cardiac disease beyond the Framingham risk score profile.Additionally, more research is needed on prevention and treatment of intracranial atherosclerosis. In recent years, there have been some clinical trials specifically targeting intracranial atherosclerosis in stroke patients, but have not been entirely conclusive. Further research should also focus on preventing intracranial atherosclerosis in healthy populations.

• Citation:• Intracranial Carotid Artery Atherosclerosis and the Risk of Stroke in Whites: The Rotterdam Study• Daniel Bos MD, PhD, Marileen L. P. Portegies MD, Aad van der Lugt MD, PhD, Michiel J. Bos MD, PhD, Peter J.

Koudstaal MD, PhD, Albert Hofman MD, PhD, Gabriel P. Krestin MD, PhD, Oscar H. Franco MD, PhD, Meike W. Vernooij MD, PhD, M. Arfan Ikram MD, PhD

• JAMA Neurol. 2014;71(4):-. doi:10.1001/jamaneurol.2013.6223Read the rest of the interview on MedicalResearch.com

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Obesity: Linked to Genetics of Appetite and SatietyMedicalResearch.com Interview with:Dr Clare Llewellyn PhD Cpsychol Lecturer in Behavioural Obesity ResearchHealth Behaviour Research CentreDepartment of Epidemiology and Public

Health University College London, London

• MedicalResearch.com: What are the main findings of the study?• Dr. Llewellyn:This study indicated that appetite – and, in particular, satiety sensitivity (how quickly you feel

full during eating, or how long you remain full after eating) – could be one of the mechanisms through which ‘obesity genes’ influence body weight.

• We know that body weight has a strong genetic basis, but the mechanisms through which ‘obesity genes’ influence weight are largely unknown.

• We showed that children with a higher genetic predisposition to obesity (estimated from a score comprising 28 known obesity-related genes) not only had more body fat (a larger BMI and waist circumference), but importantly they were also less sensitive to satiety.MedicalResearch.com: What should clinicians and patients take away from your report?

• Dr. Llewellyn: Children who demonstrate low satiety sensitivity are at greater risk of obesity. This appetitive characteristic is something for parents and clinicians to be aware of.

• Satiety sensitivity could be targeted for pharmacological and behavioural interventions, to prevent or treat obesity. For example, children who demonstrate low satiety sensitivity could be taught techniques to improve their fullness signals when eating, such as slowing their eating speed. Another approach might be to provide better advice to parents and children about appropriate portion sizes, and limiting ‘seconds’. Pharmaceutical companies could develop drugs that increase satiety responsiveness to food.

• Citation:• Satiety Mechanisms in Genetic Risk of Obesity• Clare H. Llewellyn PhD, Maciej Trzaskowski PhD, MSc, Cornelia H. M. van Jaarsveld PhD, Robert Plomin PhD,

Jane Wardle PhD• JAMA Pediatr. 2014;168(4):-. doi:10.1001/jamapediatrics.2013.4944

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COPD: Treatment with twice daily N-acetylcysteine 600 mgMedicalResearch.com Interview with: Jinping Zheng MD FACCPon behalf of Prof. Nanshan ZhongProf. Nanshan Zhong –Jinping Zheng, MD, FCCP Guangzhou Institute of Respiratory Disease

First Affiliated Hospital of Guangzhou Medical University151 Yanjiang Rd. Guangzhou 510120, China

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

Answer: PANTHEON is the largest, evidence-based study of long-term treatment with N-acetylcysteine (NAC) in COPD patients conducted to date. The main finding of this study is that 1-year of treatment with high dose NAC (600mg twice daily) was effective at reducing exacerbations in patients with COPD, especially in the earlier stage [GOLD II (moderate) of disease. NAC was well tolerated.

• MedicalResearch.com: Were any of the findings unexpected?• Answer: We expected but failed to demonstrate the improvement of the SGRQ total scores in COPD patients treated with

NAC, The low SGRQ was probably attributable to the low severity of COPD spirometric impairment.• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: Oral administration of NAC, an anti-oxidant and mucolytic medicine, is recommended as a valuable treatment

for prevention of progression in patients with COPD. The treatment strategy of NAC includes higher dose, longer term and earlier (moderate severity) administraton.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Answer: Future studies are needed to explore efficacy in patients with mild COPD (GOLD I); We also recommend that the

thio-compound mucolytics (NAC or Carbocisteine) should be put in the list of routine management of COPD in COPD guidelines such as GOLD (Global Initiative for Chronic Obstructive Lund Disease), owing to their similar efficacy comparing with ICS/LABA, the characters of cheaper, safe and easier to handle (oral administration).

• Citation:• Twice daily N-acetylcysteine 600 mg for exacerbations of chronic obstructive pulmonary disease (PANTHEON): a randomi

sed, double-blind placebo-controlled trial

Prof Jin-Ping Zheng MD,Prof Fu-Qiang Wen MD,Prof Chun-Xue Bai MD,Prof Huan-Ying Wan MD,Prof Jian Kang MD,Prof Ping Chen MD,Prof Wan-Zhen Yao MD,Prof Li-Jun Ma MD,Xia Li MS,Luca Raiteri MD,Marco Sardina MD,Yi Gao MD,Bai-Song Wang PhD,Prof Nan-Shan Zhong MD,on behalf of the PANTHEON study group

The Lancet Respiratory Medicine – 30 January 2014 DOI: 10.1016/S2213-2600(13)70286-8

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Gene Modifies Response to Topiramate in Heavy DrinkersMedicalResearch.com Interview with: Henry R. Kranzler, MDProfessor, Department of PsychiatryDirector of the Center for Studies of Addiction.

University of Pennsylvania Perelman School of Medicine, Philadelphia

• MedicalResearch.com: What are the main findings of the study? • Dr. Kranzler: The study had two main findings:• First, topiramate, at a maximal dosage of 200 mg/day, which is lower than the 300 mg/day used in prior treatment trials, substantially

reduced the frequency of heavy drinking and increased the frequency of abstinent days more than placebo. The lower dosage was well tolerated.

• Second, a variant in a gene that encodes a receptor subunit that binds topiramate moderated the response to topiramate. That is, C-allele homozygotes in the single nucleotide polymorphism rs2832407 in GRIK1, the gene encoding the GluK1 subunit of the kainate receptor, were the subgroup that accounted for the effects of topiramate on heavy drinking. This has important implications for the personalized treatment of alcohol use disorder, in that 40% of people of European ancestry have this genotype and, if confirmed, these findings would make it possible to screen people genetically to select an effective treatment.

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

• Dr. Kranzler: Although the moderating effect of rs2832407 was hypothesized beforehand, the magnitude of the effect was surprisingly large.

• MedicalResearch.com: What should clinicians and patients take away from your report? • Dr. Kranzler: Topiramate can be used to reduce heavy drinking in people whose goal is sensible drinking, rather than only those with a

goal of abstinence. This is consistent with prior studies. Although it requires replication before it can be widely recommended, the finding of genetic moderation could make it possible to select patients for whom topiramate would be the medication of choice to treat alcohol use disorder.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study? • Dr. Kranzler: The findings of moderation require replication. We are planning a study in which patients are selected in advance based

on genotype and then treated with topiramate to validate our initial findings. I am also working with investigators in Australia on a plan to replicate the findings there.

• Citation:• Topiramate Treatment for Heavy Drinkers: Moderation by a GRIK1 Polymorphism• Henry R. Kranzler, M.D.; Jonathan Covault, M.D., Ph.D.; Richard Feinn, Ph.D.; Stephen Armeli, Ph.D.; Howard Tennen, Ph.D.; Albert J

. Arias, M.D.; Joel Gelernter, M.D.; Timothy Pond, M.P.H.; Cheryl Oncken, M.D., M.P.H.; Kyle M. Kampman, M.D. Am J Psychiatry 2014;:. doi:10.1176/appi.ajp.2013.13081014

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Type 2 Diabetes: Weight Gain Pattern Before DiagnosisMedicalResearch.com Interview with:Dorte VistisenSenior researcher, MSc PhD 469 – EpidemiologyDK-2820 Gentofte Denmark

• MedicalResearch.com: What are the main findings of the study?• Dr. Vistisen: Our study highlights the complexity of type 2 diabetes. We show that in most people the

development of type 2 diabetes is preceded by many years of overweight and not by massive weight gain.MedicalResearch.com: Were any of the findings unexpected?

• Dr. Vistisen: We expected to find different patterns in obesity development, but we were surprised that the majority of those developing diabetes had such a stable weight pattern in the overweight range in the years preceding diabetes.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Vistisen: We hope this study will help clinicians to recognise that other factors than obesity is important in

prevention of type 2 diabetes. For instance physical inactivity, smoking, unhealthy diet, genes and maybe environmental pollutants, possibly in interaction with slight overweight.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Vistisen: First of all, our results need to be confirmed in other studies including populations with a different

ethnic mix and younger populations. Secondly, researchers should move away from the “one-size fits all” approach when studying risk factors for diabetes, because there are many different pathways leading to this disease. A better understanding of this heterogeneity in diabetes development, especially of the interplay between different risk factors, is needed.

• Citation:• Patterns of Obesity Development before the Diagnosis of Type 2 Diabetes: The Whitehall II Cohort Study• Dorte Vistisen, Daniel R. Witte, Adam G. Tabák, Christian Herder, Eric J. Brunner, Mika Kivimäki, Kristine Færch Pu

blished:

February 11, 2014• DOI: 10.1371/journal.pmed.1001602

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Non Partner Sexual Violence Affects Many Women WorldwideMedicalResearch.com Interview with:Professor Naeemah AbrahamsSenior Specialist Scientist: Gender & Health Research Unit, South African Medical Research Council

Extraordinary Professor: Faculty of Community Health Sciences -School of Public Health: University of the Western CapeAssociate Professor: Faculty of Health Sciences – School of Health and Rehabilitation Sciences: University of Cape Town

• MedicalResearch.com: What are the main findings of the study?• Prof. Abrahams: We found a global estimate of non-partner sexual violence of 7.2% for women 15 years and older – but this estimate

varied across the globe. The regions with the highest prevalence was Sub Sahara Africa Central and Southern with a prevalence was 21% in the central region and 17.4 % in the Southern region. This is nearly 3 times the global estimate . The region with the lowest prevalence was Asia South at 3.3%. The low level could be due to a number of reasons. Firstly data from this region was very limited – from 2 countries only and we have found that if sexual violence questions are added to other larger studies the level of disclosure is not very high. It is also more likely that people from Asia region do not disclose the violence in research studies because of stigma and shame.

MedicalResearch.com: Were any of the findings unexpected?• Prof. Abrahams: We think that the estimate of 7.2% is an underestimate. This is mainly due to the huge data gaps that we found and we

were surprised at how wide spread it was. We had expected to find more data at country level.• MedicalResearch.com: What should clinicians and patients take away from your report?• Prof. Abrahams: Non partner sexual violence is a health problem that affects many women and it is very likely that women attending

services particularly mental health services have a history of sexual violence. It is important to refer women for support and services if a clinician come across it. Also the WHO has developed a set of clinical guidelines for health care workers and health policy makers http://www.who.int/reproductivehealth/publications/violence/9789241548595/en/index.html and clinician must see how they are best able to assist their patients by using these guidelines.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Prof. Abrahams: It is important for countries collect their own population data to be able to determine the levels of all forms of gender

based violence and to use this to understand the patterns and to develop interventions that are relevant to their settings. There are many examples of good research prevalence studies and instruments that have been developed on gender based violence which can be adapted to country settings.

• Citation:• Worldwide prevalence of non-partner sexual violence: a systematic review• Naeemah Abrahams, Karen Devries, Charlottoe Watts, Christina Pallitto, Max Petzold, Simukai Shamu, Claudia GarcÍ a-Moreno

www.thelancet.com• Published online February 12, 2014 http://dx.doi.org/10.1016/S0140-6736(13)62243-6

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Genetic Variants Alter Monoclonal Antibody EffectsMedicalResearch.com Interview with:Jun-ichi Nishimura, M.D., Ph.D.Assistant Professor Department of Hematology and OncologyOsaka University Graduate School of MedicineC9, 2-2 Yamadaoka

, Suita, Osaka 565-0871, Japan

• MedicalResearch.com Interview with:Jun-ichi Nishimura, M.D., Ph.D.Assistant Professor Department of Hematology and OncologyOsaka University Graduate School of MedicineC9, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan

• MedicalResearch.com: What are the main findings of the study?• Dr. Nishimura: Our major findings are a C5 mutation (c.2654G→A) in Japanese patients with PNH prevents binding and

blockade by eculizumab, a humanized monoclonal antibody that targets complement protein C5 and inhibits terminal complement–mediated hemolysis associated with PNH, while retaining the functional capacity of the mutant C5 to cause hemolysis.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Nishimura: Yes, one patient with a poor response to eculizumab was referred to us from Argentina. Although the known

C5 polymorphism (c.2654G→A) was not identified in this patient, a new mutation (c.2653C→T) was detected in the base next to the known polymorphism, suggesting the importance of this site in C5 recognition by eculizumab.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Nishimura: Today’s take home messages are that the polymorphism in the target protein might be important to consider in

patients with a poor response to the antibody-based treatments for various diseases.• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Nishimura: We will need to verify the distribution of these variants, especially among Asian, South American, Middle

Eastern, and African countries.• Citation:• Genetic Variants in C5 and Poor Response to Eculizumab• Jun-ichi Nishimura, M.D., Ph.D., Masaki Yamamoto, M.D., Shin Hayashi, M.D., Ph.D., Kazuma Ohyashiki, M.D., Ph.D., Kiyoshi An

do, M.D., Ph.D., Andres L. Brodsky, M.D., Ph.D., Hideyoshi Noji, M.D., Kunio Kitamura, M.D., Ph.D., Tetsuya Eto, M.D., Toru Takahashi, M.D., Masayoshi Masuko, M.D., Ph.D., Takuro Matsumoto, M.D., Yuji Wano, M.D., Tsutomu Shichishima, M.D., Ph.D., Hirohiko Shibayama, M.D., Ph.D., Masakazu Hase, Ph.D., Lan Li, M.D., Krista Johnson, M.Sc., Alberto Lazarowski, Ph.D., Paul Tamburini, Ph.D., Johji Inazawa, M.D., Ph.D., Taroh Kinoshita, Ph.D., and Yuzuru Kanakura, M.D., Ph.D.

• N Engl J Med 2014; 370:632-639February 13, 2014DOI: 10.1056/NEJMoa1311084

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Mental Health Improved with Smoking CessationMedicalResearch.com Interview with: Gemma Taylor MSc MBPsS Doctoral Researcher andPaul Aveyard and PhD MRCP MRCGP FFPG Professor of Behavioral Medicine Fellow of Wolson College

Primary Care Clinical Sciences The University of Birmingham Birmingham United Kingdom

• MedicalResearch.com: What are the main findings of the study?• Answer: Smoking cessation is associated with improvements in mental health compared with continuing to smoke. The

effect sizes seem as large for those with psychiatric disorders as those without and are equal or larger to effect estimates of antidepressant treatment for mood and anxiety disorders.

MedicalResearch.com: Were any of the findings unexpected?• Answer: We hypothesized that the misattribution hypothesis would be correct – that chronic exposure to tobacco leads to

poor mental health because when people have not smoked for a while they begin to feel anxious, irritable, and depressed. Thus after breaking the nicotine-withdrawal cycle through cessation, we would find that stopping smoking would be associated with an improvement in mental health. We did not expect the effect to be so large and so consistent across studies though.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: Sustained smoking cessation is associated with improvements in mental health, for general population and

psychiatric populations. Clinicians should know that needing to smoke to deal with stress is not a reason to smoke. It’s likely that such a patient will improve their stress by stopping smoking.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Answer: We think the evidence points strongly to this effect being causal- that stopping smoking improves mental health-

but we can’t know for sure. A large trial in which patients with mental health problems were randomised to get special help to stop or usual care would help us know for sure that it’s stopping smoking that leads to the health improvement.

• Citation:• Change in mental health after smoking cessation: systematic review and meta-analysis• Taylor G ,McNeill A ,Girling A ,Farley A ,Lindson-Hawley N ,Aveyard P. Change in mental health after smoking cessation: syst

ematic review and meta-analysis. BMJ 2014;348:g1151

• BMJ

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Poor Sleep Predicts Pain in Older AdultsMedicalResearch.com Interview: Dr. John McBethArthritis Research UK Primary Care CentreKeele University in Staffordshire

• MedicalResearch.com: What are the main findings of the study?• Dr. McBeth: In this study, reporting musculoskeletal pain was common with just under half of

participants reporting some pain and one quarter reporting widespread pain. Of those who were free of WP at baseline, 19% reported new onset widespread pain at three year follow up.

• In addition to osteoarthritis, sleep, cognitive impairment, anxiety and physical health independently predicted the onset of widespread pain and are important treatment targets. In this study non-restorative sleep was the strongest predictor of new onset widespread pain. Sleep is a modifiable target that could improve outcome in this patient group.

MedicalResearch.com: Were any of the findings unexpected?• Dr. McBeth: We did expect osteoarthritis to improve the prediction of onset of widespread

pain but this was not found. This highlights the need to look at combined treatment targets to osteoarthritis for managing widespread pain.

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Poor Sleep Predicts Pain in Older AdultsMedicalResearch.com Interview: Dr. John McBethArthritis Research UK Primary Care CentreKeele University in Staffordshire

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. McBeth: Currently the management and treatment of musculoskeletal pain in older adults is

suboptimal. Clinical approaches that target multiple sites of osteoarthritis may be useful. However the clinical approach to managing widespread pain in older adults may need to move beyond focusing on treatment of osteoarthritis and consider combined interventions. This study suggests that in addition to osteoarthritis, sleep, cognitive impairment, anxiety and physical health are important treatment targets. In this study non-restorative sleep was the strongest predictor of new onset widespread pain. Sleep is a modifiable target that could improve outcome in this patient group.

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

• Dr. McBeth: The clinical effectiveness of pharmacological and non-pharmacological approaches to sleep should be tested in randomized controlled trials. Future studies should seek to identify other factors that increase the risk of developing new onset widespread pain in older people and that may offer targets for pain reduction. Such mechanisms are likely to be multi-factorial including common factors known to be associated with reporting widespread pain, age-specific social factors that influence pain reporting, and changes in pain processing mechanisms. The role of these psychosocial factors and new onset WP in older people may be a useful line of future inquiry.

• Citation: • Predictors of New Onset Widespread Pain in Older Adults- Results from the Prospective Population-b

ased NorStOP Study.” John McBeth, Rosie J Lacey and Ross Wilkie. Arthritis & Rheumatology; Published Online: February 13, 2014 (DOI: 10.1002/art.38284).

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Tamoxifen Found in Some Dietary SupplementsMedicalResearch.com Interview with: Simon D. Brandt, PhDReader in Bioactive Drug ChemistrySchool of Pharmacy & Biomolecular Sciences Liverpool John Moores University

Associate Editor “Drug Testing and Analysis” (Wiley)

• Author’s background comment:• This type of work represents one of our areas of activity related to multi-disciplinary

approaches to harm reduction which combines public health work with research on various properties of bioactive substances.

• MedicalResearch.com: What are the main findings of the study?• Answer: As part of our work related to so-called lifestyle and image-enhancing drugs and

legal highs/bath salts, we became interested in a particular “food/dietary supplement” called “Esto Suppress” because it was discussed on some Internet forums dedicated to the topic of bodybuilding. Some forum members were speculating that tamoxifen might be present in this particular product. The reason for this speculation came from the chemical name that was written on the label which pointed in that direction. This particular product was also widely available from a number of online retailers and while some indications existed that the same chemical name was mentioned, others were seen to list a modified version of that name which did not always make much chemical sense. We test purchased four “Esto Suppress” samples in a local fitness store and confirmed that three of them contained the breast cancer drug tamoxifen.

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Tamoxifen Found in Some Dietary SupplementsMedicalResearch.com Interview with: Simon D. Brandt, PhDReader in Bioactive Drug ChemistrySchool of Pharmacy & Biomolecular Sciences Liverpool John Moores University

Associate Editor “Drug Testing and Analysis” (Wiley)

• MedicalResearch.com: Were any of the findings unexpected?• Answer: Yes, but perhaps in a slightly twisted way. The presence of prescription medicines and/or non-medicinal

chemical analogues has been increasingly observed throughout the world within the last 10 years and reflects how trade and manufacturing has developed in a globalised world. “Herbal” or “natural supplements” are popular targets for being spiked with synthetic and biologically active drugs but the problem is that these are not mentioned on the list of ingredients which causes tremendous concern about adverse drug reactions and these have been frequently reported by regulatory agencies in the United States and Europe. In this particular case, however, one could think of it as a “hidden in plain sight” situation since one of the chemical names that can be used for tamoxifen was actually present on the label. In other words, we did not expect that the label was actually telling the truth. Given the anti-estrogen properties of tamoxifen, one could see why the product was actually called “Esto Suppress”.

• For obvious reasons, tamoxifen is by its very nature a medicinal product which means that it would fall under medicines regulation so it should not be available as a “food”, “herbal” or “dietary supplement” in the first place.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: Across the globe growing numbers of people are turning to potent drugs in the hope of getting a better

body, empowering themselves, and increasing their well-being. There has also been an explosive growth in products sold as ‘all natural’ food or herbal supplements aimed at the ‘enhancement’ market. Tamoxifen and, of course, all medicines are prescribed for a particular purpose within a tightly regulated system to ensure quality of care and protection. The potential exposure to prescription-only medicines without any knowledge of their presence in a “supplement” is therefore concerning, especially since this exposure tends to occur without professional supervision. From a more general perspective, it might be useful for healthcare providers obtain an increasing awareness with the idea to obtain information from their patients regarding use of any kind of “supplement”.

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Tamoxifen Found in Some Dietary SupplementsMedicalResearch.com Interview with: Simon D. Brandt, PhDReader in Bioactive Drug ChemistrySchool of Pharmacy & Biomolecular Sciences Liverpool John Moores University

Associate Editor “Drug Testing and Analysis” (Wiley)

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

• Answer: I suspect that different problems may require different questions. For example: a) it sometimes seems that there is an increasing tendency to turn to a range of substances and products in the attempt to improve image and performance and there is a need to understand who is using these products, what the patterns of use are and what the causes are; b) what are the potential harms to users in order to develop prevention programmes and harm reduction measures? c) life and trade within a globalised word places significant challenges to regulatory systems and law and this makes it difficult to address questions about supply and demand as well; d) dissemination of findings related to substances being present in those products may help to facilitate information-exchange and monitoring to support regulators and policy makers. In addition, it might also help to engage health care professionals who deal with front line exposure to patients who might be able to share their own experiences with these type of products too.

• Citation:• Is the breast cancer drug tamoxifen being sold as a

bodybuilding dietary supplement?• Michael Evans-Brown, Scientific Analyst• Andreas Kimergård, Jim McVeigh, Martin Chandler, Simon D. Brandt• European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), Lisbon, Portugal

MJ 2012; 344 doi: http://dx.doi.org/10.1136/bmj.e468 (Published 2 February 2012) • Cite this as: BMJ 2012;344:e468

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Bike Sharing Benefits and Risks Differ by Age, GenderMedical Research.com Interview with: James WoodcockSenior Research AssociateUK CRC Centre for Diet and Activity ResearchMRC Epidemiology Unit, University of Cambridge

• MedicalResearch.com: What are the main findings of the study?• Dr. Woodcock: The cycle hire scheme in London has benefited health through increasing physical activity. This reduces risk from a range of diseases

including heart disease, type 2 diabetes, and depression. These benefits were at a population level bigger than the harms the cyclists faced from injury risk or air pollution exposure. Looking at the harms air pollution did not make much difference. The injury risk for users of the hire bikes appears to not be higher and may be lower than that for general cycling in the same area. However, the injury risks for general cycling in the cycle hire zone were quite high and benefits for cyclists would be greater if these risks were reduced. When we broke results for general cycling in the area down by age & gender we found two interesting findings. Firstly, that the risks faced by women were higher than for men and so benefits were less clear. Secondly, when we looked at results by age group the trade-off improved very considerably as people got older and for younger people (under 30) there may actually be harms.MedicalResearch.com: Were any of the findings unexpected?

• Dr. Woodcock: Previously only one study, of which we are aware, has looked at the risk for cyclists by age and this was for the low risk environment of the Netherlands and only looked at mortality. Our finding that the benefits from being active are much larger for middle aged and older people than for younger people are not surprising if one considers that most of the diseases affected by physical activity are not in the main affecting young people (apart from depression). However, previous work has not explored this issue. Injury risks also increase with age so understanding how both benefits and harms increase but the benefits much faster than the harms is an interesting finding. Perhaps most surprising is that the injury risks could probably be reduced so that even in the under 30s there is a positive health trade-off. Of course if being active when you are young builds habits that keep you active as you get older then the benefits will be much larger. We also did not model lags between activity and health outcomes, which again could improve the story for younger people.

• Dr. Woodcock: What should clinicians and patients take away from your report?• MedicalResearch.com: That achieving the full potential benefits from cycling requires getting people who are middle-aged to older cycling and that

there are big differences in injury risk between settings and so it should be possible to reduce the risks cyclists face. Benefits would also be larger if less active people got cycling. Based on data on existing cyclists we assumed that the additional cyclists were already more active than the average person.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Woodcock: Our uncertainty analysis shows which uncertainties make the biggest difference to final results and issues like the shape of the dose

response curve for physical activity make a big difference. As more data come out it will be possible to confirm if the hire bike users are at lower risk and if so why this might be. Perhaps the priority though should be research that understands how we can make cycling a normal choice across the life course and so achieve the potential benefits.

• Citation:• Health effects of the London bicycle sharing system: health impact modelling study• Woodcock J ,Tainio M ,Cheshire J ,O’Brien O ,Goodman A. Health effects of the London bicycle sharing system: health impact modelling study. BMJ

2014;348:g425

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Increased Risk of Flu-Like Illnesses After Well-Child VisitsMedicalResearch.com Interview with:Philip M. Polgreen, MD, MPH.Associate Professor of Internal Medicine - Infectious DiseasesUniversity of Iowa Carver College of Medicine

• MedicalResearch.com: What are the main findings of the study?• Dr. Polgreen: In this paper, to determine if well-child visits are associated with increased risk for

subsequent influenza-like-illness visits, we used a large database that tracks healthcare expenditures of families over time. Controlling for other factors such as the presence of other children, insurance and demographics, we found that well-child visits were a risk factor for subsequent influenza-like-illness within the next two weeks for a patient or for a family member. The estimated probability of a subsequent influenza-like illness visit was increased by 3.2 percentage points for those with well-child visit. We estimated that this additional risk translates to over 700,000 cases of influenza-like-illness per year in the United States. Total costs (lost wages, medical costs, etc.) for these infections could amount to $500 million annually.

MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Polgreen: Well child visits are critical for monitoring and promoting child health. However, our

results demonstrate that more attention should be devoted to reducing the risk of spreading respiratory infections in waiting rooms and clinics, especially during respiratory virus season. Infection control guidelines currently exist that are designed to reduce the risk of outpatient disease transmission, such as separate waiting rooms for ill and healthy children and the prompt isolation of patients who are visibly ill. and the use of masks along with environmental cleaning and proper hand hygiene. However, to increase patient safety in outpatient settings, more attention should be paid to these guidelines by healthcare professionals, patients and their families.

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Increased Risk of Flu-Like Illnesses After Well-Child VisitsMedicalResearch.com Interview with:Philip M. Polgreen, MD, MPH.Associate Professor of Internal Medicine - Infectious DiseasesUniversity of Iowa Carver College of Medicine

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

• Dr. Polgreen: A great deal of energy and expense has been devoted to understanding and controlling infections in the inpatient setting, but the infection control community needs to focus more energy on controlling infections in outpatient settings as well.

• First, more research should focus on monitoring adherence to infection control guidelines in outpatient clinics. Although there are precautions that can be taken to reduce infection transmission in clinics, we do not know to what extent these precautions are routinely used, especially in busy clinics. If hand-hygiene compliance is poor, and potentially infectious patients are not wearing masks, preventable infections will continue to occur.

• Second, more work needs to be done to discover how to make the existing guidelines as easy to follow as possible.

• Third, future work needs to focus on interventions in clinical settings to further estimate and quantify risks and to develop new interventions and approaches to decrease these risks.

• Citation:

Are Well-child Visits a Risk Factor for Subsequent Influenza-Like-Illness Visits• Reference: Jacob E. Simmering, Linnea A. Polgreen, Joseph E. Cavanaugh, Philip M. Polgreen.

Are Well-child Visits a Risk Factor for Subsequent Influenza-Like-Illness Visits? Infection Control and Hospital Epidemiology 35:3 (March 2014).

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Oral Health and Diabetes: Effects of Health CoachingMedicalResearch.com Interview with:Ayse Basak Cinar, Assistant ProfessorThe Department of OdontologyThe Faculty of Medical and Health Resources2200 Copenhagen N Denmark

• MedicalResearch.com: What are some of the unique or enlightening findings of this study that haven’t been published before?

• Answer: To our knowledge, this is the first randomized controlled intervention study comparing the impact of individualized Health Coaching (HC) to formal Health Education (HE); applying HC as a holistic intervention for management of more than one specific type of chronic disease, namely oral health and diabetes management.

• The present study has two phases [the Turkish Phase, Turkey (2010-2012) and the Danish Phase, Denmark (2012- ...)]. The unique/enlightening figures from the Turkish phase as follows:

• The HC group compared to the HE group had significantly higher improvement at;• HbA1c* (reduction: 0, 8% vs. 0%), and Periodontal Attachment Loss (PAL) (56% vs. 26%), (p≤0.01)• Tooth Brushing Self-Efficacy (TBSE) (increase: 61% vs.25%) and stress (reduction: 16% vs. 1%), (p≤0.01).

Among the high risk group patients (HbA1c≥8%), the reduction at HbA1c (-1.5%) and PAL (- 63%) was highly significant in the HC group compared to those at the HE group (-0-5% vs. -18%), (p≤0.03).

• The impact of HC on HbA1c was significant (p=0.002) but the impact of HE on HbA1c was not significant (p=0.68).• Improvement of Community Periodontal Need Index (CPI) from baseline to post intervention i. the HC group was

73% and it was 20.8% for HE group, (p=0.001).• This improvement at CPI had a higher significant impact on reduced HbA1c in the HC group compared to the HE

group (p=0.02).• Improved TBSE was correlated with favourable HbA1c levels (HbA1c<6.5%, p<0.05) and quality of life (p<0.01) in the

HC group.• Among the patients brushing their teeth at least once a day, the HC group patients compared to those in the HE

group were more likely to be physically active (89% vs. 60%) and to have higher self-efficacy (≥ mean: 71% vs.43%), (p<0.01).

• Feeling stressed was significantly reduced only in the HC group.

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Oral Health and Diabetes: Effects of Health CoachingMedicalResearch.com Interview with:Ayse Basak Cinar, Assistant ProfessorThe Department of OdontologyThe Faculty of Medical and Health Resources2200 Copenhagen N Denmark

• MedicalResearch.com: Were you surprised by any of the findings?• Answer: Some results that we are surprised are as follows:• The degree of reduction at HbA1c levels and improvement at periodontal health• The impact of HC on HbA1c among high risk patients• The association between toothbrushing frequency and physical activity• Toothbrushing self-efficacy scale used in the present research is originally designed by AB Cinar et al.**and its validity and reliability were tested by earlier studies. It is

exciting to find out how this scale works, in terms of its significant interrelation with toothbrushing frequency and HbA1c. That may show that the scale may be used to assess the toothbrushing frequency and also one of the health promotion tools to improve HbA1c levels.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Answers: Clinicians from different disciplines such as dentistry and medicine, in particular, could try to integrate HC in their practice. In HC, patients are the expert and

reliable resource of information regarding personal strategies for oral-related and diabetes-related behavior/lifestyle changes. This differs somewhat from traditional oral health/diabetes education where the dentist/physician by definition is the expert who provides information. In coaching, education is provided in line with the patient’s goals, and information must be meaningful in the context of the patient’s needs and expectations. Coaches elicit ideas and resource from patients, encouraging them to explore and to understand about their health problems in the framework of their daily life routines and social environment.

• While dentists, physicians, and diabetes educators undergo extensive education and training to learn “what is best” for patients, the education/training mostly misses “how” to achieve that best. “How” is implied in the patient’s motivation and patient’s needs to find out his/her motivators with support and encouragement of health care providers who take off their “medical profession” shoes and put on “HC” shoes. It is vital that patients learn to connect their health goals and lifestyle to a vision of health in a greater picture, which is a critical step in developing the best strategies for lasting behavior change 499 thereby to maintain better oral health and diabetes management.

• Toothbrushing Self-efficacy may be a practical start point for empowerment and toothbrushing can be used as an effective and practical behavior to observe personal success in diabetes management; so dentists may use these as a practical point to improve diabetes management skills of their patients or patients can start adjust healthy behaviors/lifestyles by adopting regular toothbrushing. For example, the success of a coaching group patient at adoption of healthy behaviors in the Turkish phase of the research from baseline to post-intervention can be given an example: A 60 year old obese lady who has could never adopt regular physical exercise in her daily life practice, was used to brush her teeth 3-5 times a week. She preferred to be coached first for regular toothbrushing behavior so she was coached for this particular type of behavior for few sessions and then she set up a goal with the coach for adoption of regular physical activity. After 6 months, she told that she was starting her daily physical exercises while she was brushing her teeth in the morning and then by that `start` she was going out for regular walks. Another coaching patient has found that it is better for him to brush his teeth after he ate dinner as he was falling asleep on the sofa after dinner. By the time when he experienced that he could come over his laziness to brush his teeth during the night, he started eating healthier. Another patient started to be socially active by believing in herself that she could do something positive and healthy for her life such as regular toothbrushing. Clinical parameters of these patients (periodontal health and HbA1c) showed significant improvement in line with these personal success stories.

• Regular toothbrushing cannot be always the entry point, of course, for adopting other healthy behaviors but it can act most of the time as an initial motivator for activating positive beliefs in one`s self and can be a very effective initial behavior to adopt other positive healthy lifestyles. Every positive change starts when a person believes himself/herself that he/she `can` succeed a specific type of behavior. Patients with diabetes type two need to be motivated; not to be told; for action/performance to unlock their potential to adopt healthy lifestyles and to overcome challenges; that is the point where physicians need to integrate HC as a communication tool in their practice.

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Oral Health and Diabetes: Effects of Health CoachingMedicalResearch.com Interview with:Ayse Basak Cinar, Assistant ProfessorThe Department of OdontologyThe Faculty of Medical and Health Resources2200 Copenhagen N Denmark

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

• Answer: The findings of the present study highlights that there is a need for further research to assess the impact of similar interventions on diabetes and oral health management, so that a common HC -based health promotion strategy can be set up for patients with diabetes type 2 to improve their quality of life. Additionally toothbrushing self-efficacy may be a practical start point for empowerment of patients with diabetes type 2; and further studies may bring new insights and more effective outcomes for health promotion for diabetes patients.

• Citation:• “Smile healthy to your diabetes”: health coaching-based intervention for oral health and di

abetes management.• Cinar AB, Oktay I, Schou L.

Clin Oral Investig. 2013 Dec 21. [Epub ahead of print]

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Coronary Artery Disease: Vitamin D Did Not Affect Disease ProgressionMedicalResearch.com Interview with: Eirik Magnus Meek DegerudDepartment of Clincal Medicine University of Bergen

• MedicalResearch.com: What are the main findings of the study?• Answer: That among patients with established coronary artery disease there was no observable relationship between the

amount of vitamin D circulating in their blood and the extent of disease progression during the following year.•

MedicalResearch.com: Were any of the findings unexpected?• Answer: Based on the results of cross-sectional studies and the mechanistic framework provided by animal and in-vitro studies,

we thought that a role in atherosclerosis could explain why vitamin D status was associated with cardiovascular events in many large observational cohorts. Knowing that few longitudinal studies had investigated the relationship between vitamin D status and the extent of coronary artery disease, we believed that any effect of vitamin D would become evident in our observational data and were excited about this. Right now, taking recent publications in to account, vitamin D status does not seem to be relevant to disease progression. However, some studies report an association with disease development.MedicalResearch.com: What should clinicians and patients take away from your report?

• Answer: Provided that the patient with coronary artery disease is sufficient (25-hydroxyvitamin D concentration above 50 nmol/L) in vitamin D and receive adequate treatment, we do not observe any beneficial contribution from vitamin D status in terms of slowing down disease progression.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Answer: Groups that have data available on repeated measurements of coronary artery disease and vitamin D status should

analyse this relationship and publish their findings. The literature is scarce and these results are important. There are some large ongoing randomised placebo controlled trials assessing the effect of vitamin D on cardiovascular events. The VITAL trial in USA, with expected results in 2016, also planned sub studies assessing the effect of vitamin D supplements on soft end-points using non-invasive imaging techniques. Provided that they do find an effect of vitamin D on the risk of myocardial infarction, the results regarding soft end points would be very exciting indeed.

• Citation:• Vitamin D status was not associated with ‘one-year’ progression of coronary artery disease, assessed by coronary angiography in

statin-treated patients• Eur J Prev Cardiol. 2014 Jan 30. [Epub ahead of print]• Degerud E, Løland KH, Nygård O, Midttun O, Ueland PM, Seifert R, Strand E, Bleie O, Dierkes J.

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COPD: Editorial Regarding Earlier Diagnosis by Primary CareMedicalResearch.com: Interview with: Professor Chris van WeelEmeritus Professor of Family Medicine/General PracticeRadboud University Nijmegen, The Netherlands

Professor of Primary Health Care Research, Australian National University, Canberra

• Background from Professor Chris van Weel• Thank you for the opportunity to respond to your questions. My paper was a commentary to the

study of Jones and colleagues, Opportunities to diagnose chronic obstructive pulmonary disease in routine care in the UK: a retrospective study of a clinical cohort looking at the implications of the study findings.

• MedicalResearch.com: What are the main findings of the study?• Answer: Jones and colleagues reported that in the UK, there are many missed opportunities to

diagnose COPD. My comments are that this is not a unique UK problem, but a universal one: under-diagnosis or late diagnosis of COPD is a universal problem in most if not all countries in the world.

• To understand it, it is important to analyse more in-depth the diagnostic challenge in primary care, for general practitioners(GP)/family physicians (FP). The paper of Jones highlights this diagnostic problem – symptoms of COPD are initially insidious and may fluctuate over time. And from my earlier research it is also clear that patients ‘adept’ their daily activities (less physical activities) and therefore may underplay or even become unaware of, their symptoms.

• At the same time, this is a problem for the physician, when encountering these symptoms. As I highlighted in my commentary, GPs/FPs have to pay attention to other possible diseases that might cause these symptoms: pneumonia, heart failure, lung cancer. The ‘low key symptoms’ and the need of applying a broad diagnostic scope together cause what Jones and his colleagues called the ‘missed opportunities’ to diagnose COPD.

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COPD: Editorial Regarding Earlier Diagnosis by Primary CareMedicalResearch.com: Interview with: Professor Chris van WeelEmeritus Professor of Family Medicine/General PracticeRadboud University Nijmegen, The Netherlands

Professor of Primary Health Care Research, Australian National University, Canberra

• MedicalResearch.com: Were any of the findings unexpected?• Answer: The findings of Jones and colleagues are neither new nor unexpected. My commentary has focused on how health care should respond to these findings and here, I

think it is time to reconsider our approach. The repeated findings of late diagnosis of COPD and missed opportunities to diagnose it more timely, have resulted in guidelines and recommendations to strengthen the knowledge from respiratory medicine, and make GPs/FPs more aware, more knowledgeable in this field.

• My recommendation is to change this, and build the approach on an important finding of Jones et al, in that patients have been in contact with their GP/FP (for respiratory reasons and/or other reasons for encounter) before COPD was diagnosed (continuity of care’). In my commentary I recommend as a solution for a more timely diagnosis, better use of the continuity of care: the diagnostic opportunities did present themselves, and through a better follow-up the GP/FP could build a more detailed picture of the nature of respiratory symptoms, their severity and impact: by revisiting patients’ respiratory symptoms and daily functioning on the next occasion the patient visits the FP/practice – irrespective of what reason for visit the patient may have, therefore independent of the patient presenting again respiratory signs symptoms.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: My view therefore, the ‘take-home’ message of the Jones research and my commentary is, that we need more/better primary care for timely diagnosis, and I see COPD

here just as a case study: it is also true for other important (chronic) diseases, that all most of the time start with insidious, ‘vague’ signs and symptoms.• Primary health care, with strong well educated and equipped GP’s/FP’s and their teams in the community should be the leading structure of the health care system.• An additional point not to overlook is prevention. The study of Jones focused on diagnosing COPD and so was my commentary. But we should not forget that there are as many

opportunities to prevent COPD and prevention may be a better option for people’s health than treatment. Again, primary care can promote disease prevention better than specialty oriented health care.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Answer: In the UK and the Netherlands, where patients are listed with a GP/FP and access all their health care through that GP/FP practice. This structures continuity of care

and makes it possible to trace these ‘missed opportunities’ in the primary care patients’ records. Other countries do not (yet) have this structure. There is a urgent need of research in the development in many countries around the world – including the US – on the implementation in the structure of health care of more and better continuity, of more and better primary health care.

• Citations:• Comment by Professor Chris van Weel:

www.thelancet.com/respiratoryPublished online February 13, 2014 http://dx.doi.org/10.1016/S2213-2600(14)70029-3 1Towards earlier diagnosis of COPD

• ———————————————————• Citation

• Opportunities to diagnose chronic obstructive pulmonary disease in routine care in the UK: a retrospective study of a clinical cohortRupert C M Jones MD,Prof David Price MD,Dermot Ryan MD,Erika J Sims PhD,Julie von Ziegenweidt,Laurence Mascarenhas MSc,Anne Burden MSc,David M G Halpin DPhil,Robert Winter MD,Prof Sue Hill PhD,Matt Kearney MRCGP,Kevin Holton,Anne Moger MSc,Daryl Freeman MRCGP,Alison Chisholm MSc,Prof Eric D Bateman PhD,on behalf of The Respiratory Effectiveness GroupThe Lancet Respiratory Medicine – 13 February 2014DOI: 10.1016/S2213-2600(14)70008-6

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HPV Virus Not Killed by Common SanitizersMedicalResearch.com Interview with: Craig Meyers, Ph.D.Distinguished ProfessorDepartment of Microbiology and Immunology H107The Penn State College of Medicine Hershey, PA 17033

• MedicalResearch.com: What are the main findings of the study?• Dr. Meyers: The human papillomavirus type 16 (HPV16) is the most common HPV type associated with human cancer. It has always been

assumed that HPV16 was susceptible to commonly used disinfectants. However, this has never been tested. We developed the only reproducible method to grow authentic HPV in the laboratory. Our studies show that highly resistant virus; more so than other non-enveloped viruses previously tested. Simply stated that any materials in a healthcare facility that rely on disinfectants (those presently used by healthcare facilities) do absolutely nothing to HPV. This suggests the possibility of risk of infection from inanimate objects, particularly those use in healthcare and dental clinics that depend on disinfectant treatment. Additionally it has been reported that at any one time 20% of individuals with anogenital HPV infections have the virus on their fingertips and the common hand sanitizers do nothing to inactivate the virus.

MedicalResearch.com: Were any of the findings unexpected?• Dr. Meyers: We were actually surprised at how highly resistant HPV was against the spectrum of disinfectants we tested. Glutaraldehydes

(GTA) and ortho-pthalaldehyde (OPA) are commonly used to sterilize OB/GYN equipment and some dental equipment. The common recommendation is to soak the equipment for ≈40 minutes, we exposed the virus to GTA and OPA for up 48 hours and saw no decrease in infectivity.

• Healthcare facilities often base their use of GTA and OPA to inactivate HPV on published articles. However, if you read these these articles they state that they do not know what will kill HPV but suggest certain disinfectants based on their ability to kill other viruses. What is surprising that people who are in decision making positions often do not know what these references actually say.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Meyers: Equipment that cannot be sterilized by autoclaving is not necessarily sterile. There is a potential for nonsexual transmission

of HPV infections.• MedicalResearch.com:What recommendations do you have for future research as a result of this study?• Dr. Meyers: Policy changes are needed. We can no longer think that just because a disinfectant works on another virus that it will have

similar efficacy on HPV. The test is fairly simple and disinfectants can now be tested.• Citation:• Susceptibility of high-risk human papillomavirus type 16 to clinical disinfectants

J. Antimicrob. Chemother. first published online February 4, 2014 doi:10.1093/jac/dku006Jordan Meyers, Eric Ryndock, Michael J. Conway, Craig Meyers, and Richard Robison

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Annual Mammograms Did Not Save Lives in 25 Year StudyMedicalResearch.com Interview with: Anthony Miller, MDDirector, Canadian National Breast Screening StudyProfessor Emeritus, Dalla Lana School of Public HealthUniversity of Toronto

• MedicalResearch.com: What are the main findings of the study?• Prof. Miller: The study involved 89,835 women aged 40 to 59. All underwent an annual physical breast

examination, while half were randomly assigned to undergo annual mammograms for five years, beginning in 1980.

• During the five-year screening period, 666 invasive breast cancers were diagnosed in the mammography arm and 524 in the controls. Over the 25 year follow-up 180 women in the mammography arm and 171 women in the control arm died of breast cancer. The overall hazard ratio for death from breast cancer diagnosed during the screening period associated with mammography was 1.05 (95% CI: 0.85 – 1.30). The findings for women aged 40-49 and aged 50-59 were almost identical.

• After 15 years of follow-up an excess of 106 cancers was observed in the mammography arm, attributable to over-diagnosis, i.e. 22% of screen-detected invasive breast cancers, half of those detected by mammography alone. This represents one over-diagnosed breast cancer for every 424 women screened by mammography.

• By 2005, 3,250 of the 44,925 women in the mammography arm of the study were diagnosed with breast cancer, and 500 had died of it. The control group of 44,910 women had 3,133 breast cancer diagnoses and 505 breast cancer deaths.

• We conclude that annual mammography in women aged 40-59 does not reduce mortality from breast cancer beyond that of physical examination or usual care when adjuvant therapy for breast cancer is freely available.

• MedicalResearch.com: Were any of the findings unexpected?• Prof. Miller: Yes, in that when we began the study we expected to find a benefit from mammography screening.

However, during the course of the study other research suggested that because of advances in the treatment of breast cancer the benefits from mammography were likely to be small, and that the harms from mammography screening, false positive detections and over-diagnosis, could overwhelm any benefits from mammography screening

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Annual Mammograms Did Not Save Lives in 25 Year StudyMedicalResearch.com Interview with: Anthony Miller, MDDirector, Canadian National Breast Screening StudyProfessor Emeritus, Dalla Lana School of Public HealthUniversity of Toronto

• MedicalResearch.com: What should clinicians and patients take away from your report?• Prof. Miller: Women should reconsider the value of mammography, and concentrate more

on being aware of their breasts and ensuring that if any potential problem, e.g. a lump or change in shape of a breast occurs, they are examined by a skilled physician. Mammography then has an important role in diagnosis. Clinicians should ensure they allocate sufficient time to breast examinations, and understand and seek the signs of early breast cancer.

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

• Prof. Miller:• Careful re-evaluation of all breast cancer screening trials, taking fully into consideration the

advances in breast cancer treatment that have occurred.• Research into biomarkers (especially tissue markers) that can help inform the probable

prognosis of detected breast cancers.• Citation:• Twenty five year follow-up for breast cancer incidence and mortality of the Canadian National

Breast Screening Study: randomised screening trial

BMJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g366 (Published 11 February 2014) • Cite this as: BMJ 2014;348:g366

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Teledermatololgy As Triage Tool For Dermatology Hospital ConsultationMedicalResearch.com Interview with:Dr. Misha A. RosenbachAssistant Professor of Dermatology Hospital of the University of Pennsylvania Section Editor,

JAMA Dermatology Patient Page

• MedicalResearch.com: What are the main findings of the study? Dr. Rosenbach: There is strong agreement between teledermatologists and in-person dermatologists when evaluating inpatients at a tertiary care academic hospital. The primary aim of this study was to assess telederm as a triage tool. Many dermatologists are not full-time hospitalists, but work in private practice or clinics which may be remote from affiliated hospitals. The goal was to evaluate whether teledermatology could help those providers assess the acuity of inpatient consults. There was strong concordance. If an in-person dermatologist felt a patient needed to be seen that day, the teledermatologists independently suggested the same course of action in 90 percent of cases. Similarly, if the in-person dermatologist felt an inpatient needed a biopsy, the teledermatologists agreed in 95 percent of cases. Moreover, when it came to specific diagnostic agreement, the inperson dermatologist evaluating the hospitalized inpatients and the teledermatologists evaluating images completely agreed on a diagnosis 82 percent of the time, and partially agreed in 88 percent of cases. This suggests that teledermatology can be used by remote providers to evaluate hospitalized inpatients in terms of the acuity of their skin issues. This could allow remote providers to offer some patients with benign-appearing conditions outpatient appointments shortly after discharge, and could help consulting dermatologists batch appointments for one day that’s convenient for them to see all the non-acute inpatient consults which should be seen during a hospital stay, but don’t necessarily require same-day consultations. Perhaps most importantly, dermatologists could recognize truly acute skin issues and realize the need to go in to see the patient in person for those urgent and emergent diagnoses.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Rosenbach: I think the very high rates of agreement, particularly the high rates of diagnostic agreement

(secondary aim), were higher than maybe would have been predicted.

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Teledermatololgy As Triage Tool For Dermatology Hospital ConsultationMedicalResearch.com Interview with:Dr. Misha A. RosenbachAssistant Professor of Dermatology Hospital of the University of Pennsylvania Section Editor,

JAMA Dermatology Patient Page

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Rosenbach: Dermatology is a critical branch of medicine. The skin is an organ, and, like

any other, it can be sick. Sometimes the skin can be critically ill, and require rapid dermatology consultation, evaluation, and targeted treatment. Sometimes skin findings are a sign of an internal, multi-system process. Dermatology has a critical place within the hospital, in the inpatient setting. Teledermatology may help expand access for patients to reach and be seen by a dermatologist, even when one is not available in person. Teledermatology seems to be an accurate tool for triaging inpatient consults, and given the high rates of diagnostic concordance in this pilot study, may offer a way to remotely diagnose and in some cases manage patients with skin disease when an in-person dermatologist is not available.

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

• Dr. Rosenbach: This was a 50 patient pilot study, at a large academic medical center, evaluating sick, complex patients. To generalize the results, it should be repeated in a variety of settings (including community hospitals, and emergency rooms), and with larger numbers of patients. Citation: Barbieri JS, Nelson CA, James WD, et al. The Reliability of Teledermatology to Triage Inpatient Dermatology Consultations. JAMA Dermatol. 2014;():. doi:10.1001/jamadermatol.2013.9517.

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Restless Legs Syndrome: Lyrica Found Superior to MirapexMedicalResearch.com Interview with:Dr. Richard P. AllenDepartment of Neurology Johns Hopkins UniversityBaltimore, MD 21224,

• MedicalResearch.com: What are the main findings of the study?• Dr. Allen: This study should serve to change medical practice by reducing use of pramipexole and

ropinirole to avoid the insidious worsening of restless legs syndrome that occurs for many on these drugs.• Pramipexole (Mirapex) a medication that mimics dopamine in the brain in usual therapeutic doses for

treatment of restless legs syndrome (RLS) works at first but over time one year makes the disease worse for up to 9% of the patients on 0.5 mg a day.

• Pregabalin (Lyrica) an anti-convulsant and pain drug that works on a calcium channel in the brain in therapeutic dose for RLS (300 mg a day) does not make the disease worse (There is some natural progression of the disease shown to occur fro 1 – 2% or patients over a year.. seen in this study).

• Pregabalin is in the short run as effective as pramipexole (over 12 weeks) and in the long run over 52 weeks more effective.

• These results confirm what had been expected that the dopamine drug pramipexole makes worse Restless Legs Syndrome while a drug not directly acting on the dopamine system does NOT make restless legs syndrome worse.

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

• Dr. Allen:• 1. The amount of restless legs syndrome worsening with pramipexole at 0.5 mg over was more than

expected for only one year of treatment- indicating a possible bigger than anticipated problem.• 2. The non-dopamine drug pregabalin was as effective and in the long run slightly more effective than the

dopamine drug pramipexole.

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Restless Legs Syndrome: Lyrica Found Superior to MirapexMedicalResearch.com Interview with:Dr. Richard P. AllenDepartment of Neurology Johns Hopkins UniversityBaltimore, MD 21224,

• MedicalResearch.com: What should clinicians and patients take away from your report?• Pramipexole: • 1. The commonly used drug pramipexole (Mirapex) and the similar drug ropinirole (Requip)

are deceptive in that they work great for restless legs syndrome a while but then with continued use for many make the RLS disease worse than before treatment.

• 2. Pramipexole and ropinirole make a bad disease worse.• 3. Alternative treatments should be considered where appropriate.• 4. The alternative non-dopamine drug pregabalin (Lyrica) and its similar drug gabapentin

enacarbil (Horizant) do not make the disease worse and are as effective.• 5. Also the very long acting dopamine drug rotigotine (Nupro patch) appears not to make the

disease worse at least over 1 – 5 years of treatment and is also effective.

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Restless Legs Syndrome: Lyrica Found Superior to MirapexMedicalResearch.com Interview with:Dr. Richard P. AllenDepartment of Neurology Johns Hopkins UniversityBaltimore, MD 21224,

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

• Dr. Allen:• 1. Evaluation of mechanisms producing the worsening of restless legs syndrome on the short

and intermediate acting dopamine drugs that does not appear to occur as much if at all on very long acting dopamine drugs.

• This is suggested in clinical data but not proven, it needs to be established in long-term trials along with study of effects that produce the worsening of RLS. This wold help design better drugs.

• 2. Evaluation of how pregabalin makes RLS better.• 3. The interaction of these drugs and the worsening of restless legs syndrome with iron status

of RLS (Low iron status increases the risk of drug induced worsening of RLS in clinical studies).

• Citation:• Comparison of Pregabalin with Pramipexole for Restless Legs Syndrome• Richard P. Allen, Ph.D., Crystal Chen, M.D., Diego Garcia-Borreguero, M.D., Ph.D., Olli Polo, M.

D., Sarah DuBrava, M.S., Jeffrey Miceli, Ph.D., Lloyd Knapp, Pharm.D., and John W. Winkelman, M.D., Ph.D.

• N Engl J Med 2014; 370:621-631February 13, 2014DOI: 10.1056/NEJMoa1303646

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EHR: Electronic Health Records and Cost Challenges to ImplementationMedicalResearch.com Interview with;Dr Sarah Slight, School of MedicinePharmacy and Health, Wolfson Research InstituteUniversity of Durham, United Kingdom.

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

• Dr. Slight: Our study identified four main cost categories associated with the implementation of EHR systems, namely: infrastructure (e.g., hardware and software), personnel (e.g., project management and training teams), estates / facilities (e.g., furniture and fittings), and other (e.g., consumables and training materials). Many factors were felt to impact on these costs, with different hospitals choosing varying amounts and types of infrastructure, diverse training approaches for staff, and different software applications to integrate with the new system.

MedicalResearch.com: Were any of the findings unexpected?• Dr. Slight: In this study, we sought to categorise implementation costs that have a direct implication on processes and workflow. Productivity

losses were found to be very difficult to track. For example, completion of a paper order form was routinely held to be faster than the new EHR system equivalent; however comparative completion times will vary by: individual; EHR software system; clinical functionality involved; level of training; and by level of staff performing the task. No hospital in this study monitored the task completion time of its staff; however complementary time motion studies, for example, may be useful.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Slight: With cost considered one of the most significant barriers to EHR adoption, it is important for hospitals and governments to be

clear from the outset as to the categories of costs involved and the factors that may impact on these costs. We believe that the cost categories identified in this study can assist hospitals in the development of their business plans.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Slight: This study focused on the EHR systems being implemented as part of the National Care Records Service, which were all vendor-

based systems. Clearly, the costs of implementing such systems may differ from those of a home-grown system, thus limiting generalizability. The unprecedented, nationally imposed system has now be superseded by locally chosen and implemented solutions, which in turn creates huge challenges around the secure exchange of confidential clinical information among disparate systems and health care settings. This is a potential area for future research.

• Citation:A qualitative study identifying the cost categories associated with electronic health recordimplementation in the UKSlight SP, et al. J Am Med Inform Assoc

• 2014; 0:16. doi:10.1136/amiajnl-20

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Tobacco Appeal Would Be Reduced By Standarized PackagingMedicalResearch.com Interview with:Dr Jenny L HatchardUniversity of Bath and UK Centre for Tobacco and Alcohol Studies

• MedicalResearch.com: What are the main findings of the study?• Dr. Hatchard: Our study found that global tobacco companies’ claims that standardised packaging ‘won’t work’

should be viewed sceptically.• The aim of standardised packaging, with no logos, brand imagery, symbols, or promotional text, is to restrict the

already limited opportunities that tobacco companies have to market their products, and deter people from starting smoking. It was introduced in Australia in 2012 and the UK Government is currently considering following suit.

• We analysed the evidence cited by four global tobacco companies in their lengthy responses (1521 pages in total) to a recent UK Government consultation on standardised packaging for cigarettes.Of 77 pieces of evidence cited to argue that standardised packaging ‘won’t work’, only 17 addressed the impact of standard packs on smoking. None of the 17 were published in a peer-reviewed journal and 14 of the 17 (82 per cent) were either commissioned by or linked to the tobacco industry. This link was not clearly stated in some companies’ consultation submissions.

• Prior to the government’s consultation, an independent systematic review concluded there was ‘strong evidence’ that standardised packaging would reduce the appeal of tobacco products and increase the impact of health warnings.

• In our study we compared the quality of this tobacco industry evidence with that of the evidence included in the systematic review. We found that the both quality of the systematic review evidence supporting standardised packaging is significantly greater than the quality of the industry evidence opposing it.

• We concluded that, with few exceptions, evidence cited by global tobacco companies to promote their claim that standardised packaging ‘won’t work’ lacks either policy relevance or key indicators of quality.

• The contrast between the quality and relevance of tobacco industry evidence versus the evidence in the systematic review was clear. This underlines the need for health policymakers to be alert to the provenance of evidence cited by corporate actors who oppose regulation which aims to benefit public health.

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Tobacco Appeal Would Be Reduced By Standarized PackagingMedicalResearch.com Interview with:Dr Jenny L HatchardUniversity of Bath and UK Centre for Tobacco and Alcohol Studies

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Hatchard: The volume of evidence cited by tobacco companies was not unexpected as existing

research has demonstrated the importance the industry places on packaging as a means of marketing their products.

• Similarly, unfortunately, the absence of independent, peer-reviewed and relevant evidence to support industry claims that standardised packaging ‘won’t work’ reflects the large body of literature which has documented the global tobacco industry’s practice of manufacturing evidence in the past.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Hatchard: Evidence plays a central role in policymaking, not just in the UK, but globally. At the same

time, transnational corporations have the capacity to swamp public consultations by citing large volumes of evidence and can delay the policy process. It is vitally important for policymakers to critically appraise evidence cited by corporate interests opposed to public health legislation – analysis of subject matter, independence and peer-review status offers a straightforward method for achieving this.

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

• Dr. Hatchard: In the future we hope to complement this study by examining the role of evidence in the health policy process from policymakers’ perspectives. This would enable the development of a transparent understanding of how policymakers view evidence cited by corporate interests opposed to regulation of their products, how they judge its credibility and how they use it to inform health policy.

• Citation:• Hatchard et al. A critical evaluation of the volume, relevance and quality of evidence submitted by the to

bacco industry to oppose standardised packaging of tobacco products Online First doi:10.1136/bmjopen-2013-00375Read the rest of the interview on MedicalResearch.com

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Acupuncture Needles May Have Quality Control IssuesMedicalResearch.com Interview with:Professor Yi Min Xie, FTSE, FIEAust Director, Centre for Innovative Structures and MaterialsDeputy Head of School, Research & Innovation School

of Civil, Environmental and Chemical EngineeringRoyal Melbourne Institute of Technology (RMIT University) Melbourne 3001, Victoria Australia

• MedicalResearch.com: What are the main findings of the study?• Professor Yi Min Xie: This study examined acupuncture needles of two of the most popular brands in the world.

Significant surface irregularities and defects at needle tips were found, especially of needles from one of the two brands. The main conclusion of the study was that acupuncture needle manufacturers, including the well established ones, should review and improve their quality control procedures for the fabrication of acupuncture needles.

• MedicalResearch.com: Were any of the findings unexpected?• Professor Yi Min Xie: The first disposal acupuncture needles were introduced in the late 1970s. After more than three

decades of developments in both regulatory standards and manufacturing techniques, it would be reasonable for both acupuncturists and patients to expect high quality in such a widely used clinical device. The findings from this study were of concern, as acupuncture needles from even one of the most highly regarded manufacturers exhibited significant surface irregularities and defects.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Professor Yi Min Xie: Some of the commonly seen adverse effects of acupuncture, such as bleeding, haematoma/bruising

or strong pain, might be caused by poor quality needles with malformed tips.• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Professor Yi Min Xie: In this study, no clear correlation was found between the surface roughness/imperfection of

individual needles and the corresponding force/torque amplitudes. Further research is needed to determine the relationship between the needle surface conditions and the force/torque magnitudes of acupuncture manipulation.

• Citation:• Examination of surface conditions and other physical properties of commonly used stainless steel acupuncture needles

Yi Min Xie Shanqing Xu Claire Shuiqing Zhang, Charlie Changli XueXie YM, et al Acupunct Med2014; 0:1-9. doi:10.1136/acupmed-2013-010472

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COPD Diagnosis Often DelayedMedicalResearch.com Interview with:Erika J. Sims, PhD Senior Researcher Research in Real Life Ltd Cambridge, CB24 3BARupert C M Jones MD Plymouth University Peninsula School of Medicine and Dentistry, Plymouth, UK

Prof David Price MD Centre of Academic Primary Care, University of Aberdeen, Aberdeen, UK

• MedicalResearch.com: What are the main findings of the study?• Authors: The main findings are that the majority of patients with COPD identified in our study, had

visited their doctor with respiratory symptoms prior to the diagnosis being made, but that the underlying cause of their symptoms – COPD – wasn’t diagnosed. Indeed, in the 5 years before being diagnosed with COPD, 85% of patients had visited their doctors with respiratory problems without the diagnosis being made. Furthermore, some patients repeatedly attended and received treatment and multiple chest X-rays before they had the diagnosis made. We also identified a large increase in the proportion of patients with comorbidity over the duration of the study, and that patients with comorbidity appear to be being diagnosed with COPD at any earlier stage. As this study includes data on 38,000 people with a diagnosis of COPD identified from two large general practice databases in the UK – Optimum Patient Care Research Database and Clinical Practice Research Datalink, we believe our findings are generalisable to UK and international primary and secondary care.

• MedicalResearch.com: Were any of the findings unexpected?• Authors: Although our findings were not unexpected, we were surprised at the scale of the

problems in COPD, and that some people were having repeated course of antibiotics or steroids as well as chest X-ray, often over many years, before spirometry was performed. We showed that patients with a comorbidity appear to be diagnosed with COPD at an earlier stage suggesting that opportunities to evaluate patients for COPD while attending their GP for other reasons are being taken.

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COPD Diagnosis Often DelayedMedicalResearch.com Interview with:Erika J. Sims, PhD Senior Researcher Research in Real Life Ltd Cambridge, CB24 3BARupert C M Jones MD Plymouth University Peninsula School of Medicine and Dentistry, Plymouth, UK

Prof David Price MD Centre of Academic Primary Care, University of Aberdeen, Aberdeen, UK

• MedicalResearch.com: What should clinicians and patients take away from your report?• Authors: We wish to highlight the need to consider COPD as a possibility and arrange spirometry in

patients presenting with respiratory symptoms and infections especially if they have risk factors such as smoking. It is important to consider comorbid conditions when COPD is diagnosed and when other long term conditions such as diabetes and ischaemic heart disease are diagnosed to consider comorbid COPD. As Prof van Weel states the problem is not unique to COPD and it is not always easy for GPs to make all diagnoses at an early stage.

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

• Authors: Research needs to be undertaken to evaluate how the findings of this study could be best implemented into routine primary care. It would also be interesting to examine the evolution of chronic diseases over time in a large patient cohort to identify patterns and risk factors for multiple co-morbidities including early life factors.

• Citation:• Opportunities to diagnose chronic obstructive pulmonary disease in routine care in the UK: a retros

pective study of a clinical cohort

Rupert C M Jones MD,Prof David Price MD,Dermot Ryan MD,Erika J Sims PhD,Julie von Ziegenweidt,Laurence Mascarenhas MSc,Anne Burden MSc,David M G Halpin DPhil,Robert Winter MD,Prof Sue Hill PhD,Matt Kearney MRCGP,Kevin Holton,Anne Moger MSc,Daryl Freeman MRCGP,Alison Chisholm MSc,Prof Eric D Bateman PhD,on behalf of The Respiratory Effectiveness Group

The Lancet Respiratory Medicine – 13 February 2014 DOI: 10.1016/S2213-2600(14)70008-6

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Hospital Infection Control Adherence VariableMedicalResearch.com Interview with:Patricia W. Stone, PhD, FAANColumbia University School of NursingNew York, NY 10032.

• MedicalResearch.com: What are the main findings of the study?• Dr. Stone: Our study found variation in the presence of infection control policies directed at central-line

bloodstream infections, ventilator-associated pneumonia and catheter-associated urinary tract infections. Even when present, the policies were adhered to only about half of the time.

MedicalResearch.com: Were any of the findings unexpected?• Dr. Stone: Given that these evidence-based guidelines are aimed at preventing healthcare-associated

infections which result in approximately 100,000 thousand deaths annually, the extent of non-compliance is disappointing.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Stone: We would like clinicians to take this report as a call for action- we should be doing every

single thing we can, every day, for every patient, to avoid preventable infections.• MedicalResearch.com: What recommendations do you have for future research as a result of this

study?• Dr. Stone: Implementation and compliance with policies aimed at urinary tract infections were seen

least frequently. Dissemination and implementation studies are needed to improve the evidence base for prevention of these infections and increase compliance.

• Citation:• State of infection prevention in US hospitals enrolled in the National Health and Safety Network• Patricia W. Stone, Monika Pogorzelska-Maziarz, Carolyn T.A. Herzig, Lindsey M. Weiner, E. Yoko Furuya, A

ndrew Dick, Elaine Larson• AJIC: American Journal of Infection Control – February 2014 (Vol. 42, Issue 2, Pages 94-99, DOI: 10.1016/

j.ajic.2013.10.003)Read the rest of the interview on MedicalResearch.com

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Genital Warts: Efficacy of Two Doses of HPV Vaccine MedicalResearch.com Interview with:Lisen Arnheim DahlströmAssociate Professor (Docent)Institutionen för medicinsk epidemiologi och biostatistikDepartment of Medical Epidemiology and

Biostatistics Karolinska Institutet Sweden

• MedicalResearch.com: What are the main findings of the study?• Answer: The main finding, when studying HPV vaccine effectiveness against condyloma by dose level is that 3

doses offered the maximum protection, although 2 doses also offered a substantial protection.

MedicalResearch.com: Were any of the findings unexpected?• Answer: This study is an important complement to the clinical trials as they only have data on immunogenicity by

dose level and not disease outcomes. Further, our population-based study may also be more generalisable to the more diverse populations actually getting vaccinated.

• Still, the most important outcomes precancerous lesions and cervical cancer needs to be studied as well.• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: Clinicians and patients should stick to the recommended dose-schedule until other recommendations

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

Answer: There are still questions to be answered.• Will 3 doses still offer protection when measured with longer follow-up time?• Will the results be different or the same when we will study girls who received the vaccine within the school

vaccination program i.e they are younger (10-12 years (better immunity?)) than those in our study, higher vaccination coverage and herd immunity may be achieved?

• Further, what will the result be when we study outcomes such as precancerous lesions of the cervix?• Citation:• Herweijer E, Leval A, Ploner A, et al. Association of Varying Number of Doses of Quadrivalent Human Papillomavir

us Vaccine With Incidence of Condyloma. JAMA. 2014;311(6):597-603. doi:10.1001/jama.2014.95.

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Breast Cancer: Guidelines on Margins for Breast-Conserving SurgeryMedicalResearch.com Interview Invitation with:Monica Morrow MDAnne Burnett Windfohr Chair of Clinical Oncology

Chief Breast Service memorial Sloan Kettering Cancer Center

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

• Dr. Morrow: The study is the report of a Consensus panel examining the question of whether more widely clear lumpectomy margins than no ink on tumor decrease local recurrence. A metaanalysis of published literature was used as the primary evidence base for the conclusion.

• MedicalResearch.com: Where any of the findings surprising?• Dr. Morrow: There has been a pervasive feeling that bigger margins are better margins. In the current era, when the

majority of patients receive some form of systemic therapy, which not only prolongs survival, but reduces local recurrence, evidence does not show this to be true. While this may surprise some, it is worth noting that the NSABP has always used the definition of no ink on tumor as a negative margin in their clinical trials with excellent local control outcomes.

• MedicalResearch.com: What should providers and patients take away from this report?• Dr. Morrow: The consensus does not indicate that re-excision should never be done to obtain more widely clear

margins. What it does say is that rules such as all margins must be >2mm which are in place in many institutions are not supported by evidence and lead to unnecessary surgery.

• MedicalResearch.com: What further research do you recommend as a result of this work?• Dr. Morrow: This guideline is specific to patients with invasive cancer treated with whole breast irradiation. It would be

useful to have similar data for patients with ductal carcinoma in situ and those receiving pre-operative chemotherapy.• Citation:• Society of Surgical Oncology-American Society for Radiation Oncology consensus guideline on margins for breast-conse

rving surgery with whole-breast irradiation in stages I and II invasive breast cancer

Moran MS, Schnitt SJ, Giuliano AE, Harris JR, Khan SA, Horton J, Klimberg S, Chavez-Macgregor M, Freedman G, Houssami N, Johnson PL, Morrow M.

• J Clin Oncol. 2014 Feb 10. [Epub ahead of print]Read the rest of the interview on MedicalResearch.com

Page 79: MedicalResearch.com - Medical Research Interviews Week in Review

Optimal Sleep Quality and Morning or Evening Exercise?MedicalResearch.com Interview with:Matthew Buman PhDSchool of Nutrition and Health Promotion, Arizona State University

Arizona State University, School of Nutrition and Health PromotionPhoenix, AZ

• MedicalResearch.com: What are the main findings of the study?• Dr. Buman: We found that that exercise at night (within 4 hours of bedtime) was not associated with

poor sleep compared with individuals that did not exercise before bed. However, we also found that morning exercise appears to be associated with optimal sleep quality.

MedicalResearch.com: Were any of the findings unexpected?• Dr. Buman: Popular opinion and national sleep recommendations suggest exercise should be avoided prior

to sleep. This study is consistent with other literature that has found no relationship between nighttime exercise and poor sleep.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Buman: Our results indicate that given the many health benefits of exercise, individuals should be

encouraged to exercise prior to bed if that fits best with their schedule.• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Buman: While our study did examined self-identified ‘poor sleepers’ and found no relationship

between nighttime exercise and sleep quality, future studies should more closely examine whether insomniacs may be more prone to exacerbated sleep complaints following nighttime exercise. This study also needs to followed up with prospective studies and objective measures of physical activity and sleep.

• Citation:• Does Nighttime Exercise Really Disturb Sleep? Results from the 2013 National Sleep Foundation Sleep in

America Poll • Matthew Buman, Barbara Phillips, Shawn D. Youngstedt, Christopher E. Kline, Max Hirshkowitz• Sleep Medicine – 10 February 2014 (10.1016/j.sleep.2014.01.008)

Read the rest of the interview on MedicalResearch.com

Page 80: MedicalResearch.com - Medical Research Interviews Week in Review

Breast Cancer Risk Increased by SmokingMedicalResearch.com Interview with:Masaaki Kawai MD, PhDDivision of Public Health Sciences, Fred Hutchinson Cancer Research CenterSeattle, Washington

• MedicalResearch.com Interview with:Masaaki Kawai MD, PhDDivision of Public Health Sciences, Fred Hutchinson Cancer Research CenterSeattle, Washington

• MedicalResearch.com: What are the main findings of the study?• Answer: Ever-smokers had a 1.3-fold increased risk of breast cancer. They also had a 1.4-fold

increased risk of ER-positive breast cancer. Current/recent smokers with a 10 pack-year history of smoking had a 1.6-fold increased risk of ER-positive breast cancer.MedicalResearch.com: Were any of the findings unexpected?

• Answer: We couldn’t find the association between smoking and risk of triple-negative breast cancer.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: Smoking is associated with cancer risk, and may also be associated with ER+ breast

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

of this study?• Answer: To suggest that women never start smoking, or quit smoking as soon as possible.• Citation:• Kawai, M., Malone, K. E., Tang, M.-T. C. and Li, C. I. (2014), Active smoking and the risk of estr

ogen receptor-positive and triple-negative breast cancer among women ages 20 to 44 years. Cancer. doi: 10.1002/cncr.28402Read the rest of the interview on MedicalResearch.com

Page 81: MedicalResearch.com - Medical Research Interviews Week in Review

Type 1 Diabetes: Efficacy of Carbohydrate CountingMedicalResearch.com Interview with: Kirstie BellDiabetes Dietitian, CDE & PhD CandidateHuman Nutrition UnitThe University of Sydney

• MedicalResearch.com: What are the main findings of the study?• Answer: Overall, the evidence to support carbohydrate counting is limited, with current data

showing a non-significant improvement in HbA1c. Pooled results from 7 quality randomised control trials studies showed carbohydrate counting had no significant effect on glycemic control (-0.35%, p = 0.096). There was a significant improvement in HbA1c of 0.64% points in studies in adults that were conducted in a parallel design.

• This is the first meta-analysis of carbohydrate counting in type 1 diabetes. Up until now, it has not been known what improvement in glycemic control can be expected. Current international guidelines for diabetes management have been based merely on gradings of the available evidence. However, assessing the overall effectiveness of carbohydrate counting is critical in clinical practice to guide medical and dietary management decisions.MedicalResearch.com: Were any of the findings unexpected?

• Answer: It was surprising how few quality, randomised controlled trials were published. Carbohydrate counting is considered the gold-standard method of adjusting mealtime insulin doses yet this meta-analysis shows the scarcity of high-level evidence to support this recommendation.

Read the rest of the interview on MedicalResearch.com

Page 82: MedicalResearch.com - Medical Research Interviews Week in Review

Type 1 Diabetes: Efficacy of Carbohydrate CountingMedicalResearch.com Interview with: Kirstie BellDiabetes Dietitian, CDE & PhD CandidateHuman Nutrition UnitThe University of Sydney

• MedicalResearch.com: What should clinicians and patients take away from your report?• Answer: Overall, there is limited evidence to recommend carbohydrate counting over other dietary interventions for

improving glycemic control in type 1 diabetes.• This does not mean we should abandon carbohydrate counting in practice. This is a well-established intervention and is still

the best method known for matching insulin to meals.• The non-significant result does however highlight that there are some limitations to the efficacy of carbohydrate counting

in practice and that clinicians and patients may not be able to expect ideal glycemic control even with perfect carbohydrate counting.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Answer: This study emphasises the need additional evidence to support carbohydrate counting in practice. This would

provide the opportunity to further improve clinical practice by investigating better ways of doing things. For example, there are different methods of counting carbohydrates including counting in grams, exchanges and portions. Additional studies using these different methods, will allow analysis of whether any method is superior to the others and thus further improve clinical practice.

• There is also a lack of evidence for carbohydrate counting in children and adolescents. We could only identify 1 randomised, controlled study in this area yet carbohydrate counting is widely used in this population.

• This meta-analysis also opens the doors to looking at alternative methods for determining mealtime insulin doses. Recent studies from around the world have been examining the effect fat and protein has on insulin requirements and whether mealtime insulin dosing needs to be expanded to encompass more than just carbohydrate counting. This meta-analysis provides a benchmark for comparing carbohydrate counting with these new dietary interventions.

• Citation:• Efficacy of carbohydrate counting in type 1 diabetes: a systematic review and meta-analysis

Kirstine J Bell BNutrDiet,Alan W Barclay PhD,Peter Petocz PhD,Stephen Colagiuri FRACP,Prof Jennie C Brand-Miller PhDThe Lancet Diabetes & Endocrinology – 1 February 2014 ( Vol. 2, Issue 2, Pages 133-140 ) DOI: 10.1016/S2213-8587(13)70144-X

Read the rest of the interview on MedicalResearch.com

Page 83: MedicalResearch.com - Medical Research Interviews Week in Review

Most Women Remain Sexually Active into theirs 50s, 60s and Beyond.MedicalResearch.com Interview with:Holly Thomas, MDGeneral Internal Medicine Fellow, Women’s Health and Clinical ResearchUniversity of Pittsburgh Pittsburgh, PA 15213

• MedicalResearch.com: What are the main findings of the study?• Dr. Thomas: We found that, despite popular perception, the majority of women (85%) who are sexually active at

midlife will remain sexually active four years later. We also found that the majority of women score low on a measure of sexual function. However, low sexual function scores did not mean women stopped having sex. In fact, the score on the sexual function measure did not predict whether women maintained sexual activity. Finally, we found that importance of sex was a strong predictor of whether women remained sexually active. Women who felt sex was moderately to extremely important in their lives were 3 times more likely to maintain sexual activity.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Thomas: We thought that low sexual function scores would mean women would stop having sex. Surprisingly, the

majority of women remained sexually active regardless of their sexual function scores.• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Thomas: Clinicians and patients should recognize that most women continue to be sexually active into their 50s,

60s, and beyond, and sex continues to be important to them.• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Thomas: Prior research on female sexual function has mostly focused on physical symptoms, such as lubrication

and pelvic pain. We believe that research on women’s sexuality should take a more holistic view and incorporate other aspects of sexual function, such as importance of sex, intimacy with one’s partner, and overall sexual satisfaction.

• Citation:• Importance of Sex Associated with Maintaining Sexual Activity for Midlife Women

Thomas HN, Chang CH, Dillon S, Hess R. Sexual activity in midlife women: Importance of sex matters. JAMA Internal Medicine. Forthcoming (accepted for publication) 2014.

Read the rest of the interview on MedicalResearch.com

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Severe Flu Associated with Younger Age, Lack of VaccinationMedicalResearch.com Interview with: Dr Cameron Wolfe MBBS(Hons), MPHAssistant Professor of MedicineClinical / Transplant Infectious DiseasesDuke University Medical Center

• MedicalResearch.com: What are the main findings of the study?• Dr. Wolfe: The major findings of the study were that at least in our center, there was a significant burden of critical illness

due to H1N1 influenza infection. The average age of the patients admitted to the hospital was just 28yrs, consistent with the younger patient age in 2009 when H1N1 emerged. Most critically, we also observed a significantly lower rate of influenza vaccine uptake in patients admitted to the Intensive Care Units at our center.

MedicalResearch.com: Were any of the findings unexpected?• Dr. Wolfe: We did not anticipate such a stark difference in the vaccination rate between patients admitted to the ICU

versus the regular wards. Although this only represents a single center experience, and so drawing broader conclusions is challenging, this research does hint that influenza vaccination may have a protective effect against the most severe disease.

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Wolfe: Firstly, clinicians need to be cautious about the false negative rates associated with upper respiratory influenza

tests, especially ‘rapid-flu’ tests. In our study a number of patients with critical illness had negative rapid-flu tests, before their diagnosis was confirmed with lower respiratory tract samples. Secondly, this report should serve as another reason to continue offering influenza vaccine to our patients, as there appears to be a protective effective against severe influenza disease.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study? • Dr. Wolfe: We will need to verify our data against national data that should be available later in the influenza season. It

will also be important for larger teaching hospitals to compare the rates of vaccination in their critically ill patients and see if we can verify the lower vaccination rates.

• Citation:• High ICU admission rate for 2013-2014 Influenza is associated with a low rate of vaccination• Dr. Jelena Catania, Dr. Loretta G Que, Dr. Joseph A Govert, Dr. John W Hollingsworth, and Dr. Cameron R Wolfe• American Journal of Respiratory and Critical Care Medicine 0 0:ja

Read the rest of the interview on MedicalResearch.com

Page 85: MedicalResearch.com - Medical Research Interviews Week in Review

Suspected Appendicitis in Children: Point of Care Ultrasound EvaluationMedicalResearch.com Interview with:Jim Tsung, MD, MPH Department of Emergency MedicineMount Sinai School of Medicine Guggenheim PavilionNew York, NY 10029

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

Dr. Tsung:• 1. Point-of-care ultrasound performed by clinicians was as accurate as ultrasound performed in the radiology department for evaluating

appendicitis in children.• 2. This led to significant reductions in emergency department stays when point-of-care ultrasound was able to contribute to the decision to send

the patient to the operating room or to discharge home without further imaging studies. On average, a 2 hour (46%) reduction in ED LOS for patients only requiring radiology ultrasound and a 6 hour (68%) reduction in ED LOS for patients that needed CT scan.

• 3. Point-of-care ultrasound can also reduce the rate of CT scans obtained when used as a front-line test, 44% to 27%.

MedicalResearch.com: Were any of the findings unexpected?• Dr. Tsung:• 1. In 4 instances, patients received a disposition (go to operating room or discharge home) when point-of-care ultrasound results were conclusive

and radiology ultrasound results were inconclusive. Ordinarily patients with inconclusive radiology ultrasound results go onto receive CT scan in our hospital.

• MedicalResearch.com: What should clinicians and patients take away from your report? • When Point-of-care ultrasound are conclusive:• 1. Patient’s ED length of stay maybe reduced, especially important in overcrowded emergency departments and

2. Cancer-causing radiation from CT scans can be avoided, very important in children as they are much more sensitive to radiation than adults are.• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Tsung:• 1. Future research on training and education methods to teach front-line clinicians including medical students, and residents how to use point-of-

care ultrasound to diagnose appendicitis.• 2. Future research on methods to improve the sensitivity of ultrasound to rule-out appendicitis; this will help decrease the CT scan rate even

further.• Citation:

The Effect of Point-of-care Ultrasonography on Emergency Department Length of Stay and Computed Tomography Utilization in Children With Suspected Appendicitis

• Academic Emergency Medicine 2014; 21: 163–170 © 2014 by the Society for Academic Emergency Medicine• Presented at the Pediatric Academic Societies Annual Meeting, Washington, DC, May 2013; and the Society for Academic Emergency Medicine An

nual Meeting, Atlanta, GA, May 2013Read the rest of the interview on MedicalResearch.com


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