MedicalResearch.comExclusive Interviews with Medical Research and

Health Care Researchers from Major and Specialty Medical Research Journals and Meetings

Editor: Marie Benz, MD info@medicalresearch.com

June 25 2014

For Informational Purposes Only: Not for Specific Medical Advice.

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Adults with Asperger Syndrome May Experience Increase Risk of Suicidal ThoughtsMedicalResearch.com Interview with:Dr Sarah Cassidy PhDAutism Research Centre,Department of P

• MedicalResearch.com: What are the main findings of the study?• Dr. Cassidy: We found that adults with late diagnosis of Asperger Syndrome (31 years on

average), were at significantly higher risk of contemplating suicide during their lifetime (66%) than those from the general UK population (17%), and a sample of patients with Psychosis (59%).

• We also found that adults diagnosed with Asperger Syndrome with a history of depression, were significantly more likely to experience suicidal thoughts, and suicide plans or attempts, than those with Asperger Syndrome without a history of depression. A higher level of autistic traits was also a significant risk factor for having planned or attempted suicide.

• MedicalResearch.com: Were any of the findings unexpected?• Dr. Cassidy: We found that the odds of experiencing suicidal thoughts in adults with late

diagnosis of Asperger Syndrome is over nine times higher than in the general UK population. This is striking, and confirms anecdotal reports that adults with Asperger Syndrome have a high risk of suicide.

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Adults with Asperger Syndrome May Experience Increase Risk of Suicidal ThoughtsMedicalResearch.com Interview with:Dr Sarah Cassidy PhDAutism Research Centre,Department of P

• MedicalResearch.com: What should clinicians and patients take away from your report?• Dr. Cassidy: Adults with Asperger Syndrome experience many risk factors for depression and suicide,

including lack of support services, poor health outcomes, social exclusion, under-achievement, and unemployment. This risk is preventable with the appropriate support, and demonstrates the need for high quality services for these individuals..

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?• Dr. Cassidy: Our study included individuals with very late diagnosis of Asperger Syndrome in adulthood (31

years old on average). Delay in diagnosis could be an additional risk factor for suicide. The patient questionnaire used in our study included both plans and attempts at suicide in the same question, so it was not possible to disentangle these two related but distinct outcomes, or compare the rate of these to other samples. It will be necessary to explore whether individuals with Asperger Syndrome are significantly more likely to plan or attempt suicide than other clinical groups, or whether these individuals are more likely to attempt suicide without planning. In addition to the social factors known to predispose to depression, the cognitive profile of people with Asperger’s syndrome might further increase the rate and risk of suicidality. For example, cognitive flexibility can be impaired, and might mediate some of the increased suicidality.

• Citation:• Suicidal ideation and suicide plans or attempts in adults with Asperger’s syndrome attending a specialist dia

gnostic clinic: a clinical cohort study

Dr Sarah Cassidy PhD,Paul Bradley MRCPsych,Janine Robinson DClinPsy,Carrie Allison PhD,Meghan McHugh BSc,Prof Simon Baron-Cohen PhDThe Lancet Psychiatry – 25 June 2014 DOI: 10.1016/S2215-0366(14)70248-2Read the rest of the interview on MedicalResearch.comContent Not Intended as Specific Medical Advice

Association of Surgery On Very Low Birth Weight Infants and Subsequent Neurodevelopmental ImpairmentMedicalResearch.com Interview with:Frank H. Morriss, Jr., MD, MPHProfessor of Pediatrics - Neonatology

University of Iowa Carver College of Medicine

• MedicalResearch: What are the main findings of the study?• Dr. Morriss: Our aim was to assess the association between surgery performed during the initial

hospitalization of very low- birth-weight infants and subsequent death or neurodevelopmental impairment at 18-22 months’ corrected age. We conducted a retrospective cohort analysis of patients who were prospectively enrolled in the National Institute of Child Health and Human Development Neonatal Research Network Generic Database from 1998 to 2009. Surgery was classified by the expected anesthesia type as either major surgery that likely would have been performed under general anesthesia; or minor surgery, that is, procedures that could have been performed under non-general anesthesia and in general were shorter in duration. There were 2,186 major surgery patients and 784 minor surgery patients and more than 9,000 patients who did not undergo surgery.

• We found that any surgical procedure increased the adjusted risk of death or neurodevelopmental impairment in low birth weight infants by about 30%. Not all surgical procedures were associated with increased risk, however. Compared with those who did not undergo surgery, patients who were classified as having major surgery had a risk-adjusted odds ratio of death or neurodevelopmental impairment of 1.52 (95% confidence interval 1.24-1.87). However, those who were classified as having minor surgery had no increased adjusted risk. Among survivors who had major surgery compared with those who did not undergo surgery the risk-adjusted odds ratio for neurodevelopmental impairment was 1.56 (95% confidence interval 1.26-1.93), and the risk-adjusted mean Bayley II Mental Developmental Index and mean Psychomotor Developmental Index values were significantly lower.

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Association of Surgery On Very Low Birth Weight Infants and Subsequent Neurodevelopmental ImpairmentMedicalResearch.com Interview with:Frank H. Morriss, Jr., MD, MPHProfessor of Pediatrics - Neonatology

University of Iowa Carver College of Medicine

•MedicalResearch: Were any of the findings unexpected?

• Dr. Morriss: We were happily surprised that those patients whom we classified as minor surgery had no increased adjusted risk of death or neurodevelopmental impairment. In addition, a sensitivity analysis in which we changed the classification of certain abdominal surgical procedures (repair of inguinal hernia, gastroschisis or omphalocele) from minor to major surgery resulted in no increased risk for the major surgery patients, suggesting a relatively low adverse risk for this group of procedures.

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Morriss: Our study supports the concern that surgery usually requiring general anesthesia

during a vulnerable period of infancy has an adverse effect on neurodevelopmental outcome and extends that concern to very low birth weight neonates. Yet, we failed to demonstrate an increased risk of neurodevelopmental impairment after some surgical procedures that may have been performed under anesthesia other than general anesthesia or for shorter surgical duration.

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Association of Surgery On Very Low Birth Weight Infants and Subsequent Neurodevelopmental ImpairmentMedicalResearch.com Interview with:Frank H. Morriss, Jr., MD, MPHProfessor of Pediatrics - Neonatology

University of Iowa Carver College of Medicine

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

• Dr. Morriss: This was a retrospective cohort study in which we were able to adjust for a large number of potentially confounding variables that were in the database, but important factors that are associated with the outcomes, such as analgesia and possibly other drugs, hypoxemia, hypotension and other physiological disturbances, were not available. It will be important in future research to exclude these potentially confounding factors as responsible for adverse outcomes observed. The actual type of anesthesia, the duration of anesthesia and the class of agent used for general anesthesia for each procedure were not available to us, so the classification into major and minor surgery groups may be associated with factors other than anesthesia type, pharmacologic class of agent or duration of exposure that are, in fact, responsible for the observed results. Future studies should consider these factors as contributors to the adverse outcomes.

• We don’t know the postconceptual developmental window of vulnerability for increased risk of adverse outcomes after major surgery in infants; going forward we need to learn this interval so that we can postpone some procedures until after the window closes, if possible. We don’t know if we can effectively administer a neuroprotective agent to neonates who must have major surgery to reduce the risk. There are several ongoing studies, including randomized clinical trials, that may provide these answers.

• Citation:• Morriss FH, Jr, Saha S, Bell EF, et al. Surgery and Neurodevelopmental Outcome of Very Low-Birth-

Weight Infants. JAMA Pediatr. Published online June 16, 2014. doi:10.1001/jamapediatrics.2014.307.

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PCOS Linked To Increased Risk of DiabetesMedicalResearch.com Interview with:Dr Anju JohamPhD student, SPHPMEndocrinologist, Monash Health

• MedicalResearch: What is the background for your study?• Dr. Joham: This research led by Professor Helena Teede and Dr Anju Joham, from the School

of Public Health and Preventive Medicine at Monash University analysed a large-scale epidemiological study, called the Australian Longitudinal Study of Women’s Health (ALSWH).

• Polycystic Ovary Syndrome (PCOS) is a condition affecting nearly 20% of Australian women. Women with PCOS may experience irregular menstrual cycles, reduced fertility, increased risk of diabetes, high cholesterol and psychological features such as depression and reduced quality of life.

• MedicalResearch: What are the main findings of the study?• Dr. Joham: Approximately 6000 women aged between 25-30 years were monitored for nine

years, including nearly 500 women with diagnosed PCOS. Our research found that there is a clear link between PCOS and type 2 diabetes. The incidence and prevalence of type 2 diabetes was three to five times higher in women with PCOS. In analysing the key contributing factors to the increased diabetes risk, we found that having PCOS was in itself a key contributing factor.

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PCOS Linked To Increased Risk of DiabetesMedicalResearch.com Interview with:Dr Anju JohamPhD student, SPHPMEndocrinologist, Monash Health

• MedicalResearch: Were any of the findings unexpected?• Dr. Joham: Obesity is an important contributing factor to increased risk of diabetes. Approximately 60% of women with PCOS are

overweight or obese. We expected that body mass index (a height weight ratioused to indicate if a person is underweight, overweight, obese or an ideal weight for their height) would be related to increased risk of diabetes in women with PCOS. However, in women with PCOS, obesity was not a key trigger of type 2 diabetes. We did find that obesity was a key factor contributing to type 2 diabetes risk in women without PCOS.

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Joham: This research highlights the need for greater awareness and screening, especially in high risk groups including young

women with PCOS. Current diabetes screening guidelines recommend screening over 40 years of age. This may need to be reconsidered in women with PCOS. PCOS is not a well-recognised diabetes risk factor and many young women with the condition do not get regular diabetes screening even pre-pregnancy, despite recommendations from the Australian PCOS evidence based guidelines. We would recommend that women with PCOS should have regular screening for type 2 diabetes, irrespective of their weight. This is especially important in women contemplating future pregnancy.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. Joham: We need more research in PCOS, with further exploration of the relationship between PCOS status, weight and

diabetes. We need to confirm the ideal test for screening for diabetes and then look at the implementation of prevention strategies and effective treatments.

• Citation: Abstract Presented at the 2014 ICE/ENDO Conference• PP04-1 Longitudinal Risk of Type 2 Diabetes in Reproductive-Aged Women with Polycystic Ovary Syndrome• Program: Abstracts – Orals, Poster Preview Presentations, and Posters

Session: PP04-Female Reproductive EndocrinologyClinical/Translational

• Poster Board SAT-0018• Anju Elizabeth Joham, MBBS, FRACP1, Sanjeeva Ranasinha, MEpid, MSc(ApplStat)2, Sophia Zoungas, MBBS, FRACP, PhD2 and Helena

Jane Teede, MBBS, PhD, FRACP3

1Monash University, Clayton VIC, Australia, 2Monash University, Clayton VIC, Australia, 3Monash University, Clayton VIC, Australia

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Epilepsy: Readmissions Increased By Refractory Seizures and Psychiatric ComorbiditiesMedicalResearch.com Interview with:Tracie A. Caller, MD , MPHNeurophysiology FellowDartmouth-Hitchcock Medical Center 1

Medical Center Dr., Lebanon NH 03756, USA

• MedicalResearch: What are the main findings of the study?• Dr. Caller: We identified factors that appeared to increase the risk for a 30 day readmissions in the epilepsy population,

which included refractory seizures but also coexistence of nonepileptic seizures and psychiatric comorbidities.

MedicalResearch: Were any of the findings unexpected?• Dr. Caller: It is somewhat surprising the extent of significant comorbid psychiatric symptomology in epilepsy patients who

experienced 30-day re-encounters. However, this speaks to the significant psychiatric comorbidity in neurological disorders in general, and in epilepsy in particular.

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Caller: Patients with refractory epilepsy and with psychiatric comorbidities are at a high risk for bounce-back ED visits

and readmissions; improved screening techniques and targeted interventions at this population may be helpful.• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. Caller: It is clinically and morally unsound to penalize providers or hospital systems if patients are readmitted due to

factors beyond clinicians’ control, for example in the case of non-epileptic seizures and psychiatric comorbidities which can be difficult to adequately address and treat given the lack of resources, despite an inpatient team’s adherence to best practices guidelines. Thus, policymakers need to be aware of what patient versus systemic factors ought to be specifically targeted for the imposition of financial penalties, and account for the fact that many of the most refractory patients are taken care of at tertiary academic medical centers.

• Citation:• Predictors for readmissions after video-EEG monitoring

Tracie A. Caller, MD, MPH, Jasper J. Chen, MD, MPH, Jessica J. Harrington, Krzysztof A. Bujarski, MD and Barbara C. Jobst, MD

Published online before print June 20, 2014, doi: 10.1212/WNL.0000000000000647 Neurology 10.1212/WNL.0000000000000647

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Whooping Cough Can Still Cause Significant Cough Even In Fully Vaccinated ChildrenMedicalResearch.com: Interview with Kay WangAcademic Clinical LecturerNuffield Department of Primary Care Health SciencesUniversity of Oxford, Oxford, UK

• MedicalResearch: What are the main findings of the study?• Dr. Wang: We have found evidence of recent whooping cough infection in 1 in 5 school age children who see their doctor with

a persistent cough and in 1 in 6 children who have been fully vaccinated against whooping cough. We have also shown that whooping cough can still cause clinically significant cough in fully vaccinated children.

MedicalResearch: Were any of the findings unexpected?• Dr. Wang: Whooping cough has previously been reported as being prevalent among patients with persistent cough in several

countries, including the United States and Canada, so the prevalence of whooping cough which we found in our study was not entirely unexpected. However, our finding that whooping cough can still cause clinically significant cough in fully vaccinated school age children was less expected. This could potentially have implications for the burden of disease in this age group.

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Wang: Clinicians should still consider whooping cough as a possible diagnosis in school age children who present with

persistent cough, even if they have been fully vaccinated. If parents suspect that their child might have whooping cough, they should seek advice from a health care professional, who will be able to assess the child and advise on what steps should be taken next.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. Wang: The findings of our study highlight the need for more research to establish the socioeconomic burden of whooping

cough in school age children and adolescents. This will help inform ongoing discussions about whether the introduction of an adolescent booster vaccination in the UK would be cost-effective.

• Citation:• Whooping cough in school age children presenting with persistent cough in UK primary care after introduction of the preschoo

l pertussis booster vaccination: prospective cohort studyKay Wang academic clinical lecturer 1, Norman K Fry deputy head 2, Helen Campbell senior clinical scientist3, Gayatri Amirthalingam consultant epidemiologist3, Timothy G Harrison head2, David Mant emeritus professor of general practice 1, Anthony Harnden associate professor 1BMJ 2014;348:g3668 doi: 10.1136/bmj.g3668a

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Keloids: Using Drug-Eluting Microneedles To Allow Self TreatmentMedicalResearch.com Interview with Chenjie Xu PhD Assistant Professor of BioengineeringNanyang Technological UniversitySingapore 637457

• MedicalResearch.com Interview with Chenjie Xu PhDAssistant Professor of BioengineeringNanyang Technological UniversitySingapore 637457

• MedicalResearch: What are the main findings of the study?• Answer: Keloid is a long-term dermatological scarring disease characterized by disfiguring lesions resulting from overgrowth of dense fibrous tissue. It is also

unsightly and can even lead to disfigurement and psychological problems of affected patients. This study investigated the use of microneedle technology in the self-management of keloid lesions. Briefly, we have developed a “wearable” microneedle device for transdermal delivery of an anti-metabolite drug (5-FU) to inhibit the proliferation activity of keloid fibroblast. This study has provided evidence for effective inhibition of keloid fibroblasts in vitro and successful translation of this platform can significantly reduce the cost of keloid treatment and improve the patient compliance.

• MedicalResearch: More specifically, the major findings in this study are:• 1. Demonstrated feasibility of generating a cost-effective, self-administered microneedle device for the delivery of anti-fibrosis therapeutic, 5-fluorouracil (5-

FU).• 2. Demonstrated successful delivery of (5-FU).• 3. Demonstrated feasibility of its application to Keloid scars.• 4. Demonstrated 5-FU sustained release kinetics.• 5. Discovered that microneedle delivery can inhibit keloid fibroblast growth.• 6. Demonstrated a rapid, photo-activated fabrication of microneedle devices with encapsulated 5-FU.• MedicalResearch: What should clinicians and patients take away from your report?

Answer:

• 1. A cost-effective, self-administered microneedle device could dramatically alter the traditional modalities of scar treatments. Instead of periodic injections that can cause severe pain and are costly and disruptive to a patient’s schedule, the microneedle intervention is self-administered, effective and extremely low-cost.

• 2. We hope this will be a novel single modality therapeutic for scar treatment, which can greatly benefit the healthcare community and the affected patients, given the lack of good alternatives.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Answer: PEG-DA is a bit fragile. A better biocompatible polymer is desirable.

Citation:• Peng Xue, David Chen Loong Yeo, Yon Jin Chuah, Hong Liang Tey, Yuejun Kang, Chenjie Xu. Drug-eluting microneedles for self-administered treatment of keloids.

TECHNOLOGY, 2014; 02 (02): 144 DOI: 10.1142/S2339547814500137

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Surprising Number of Patients Do Not Take Their Prescribed Statin MedicationMedicalResearch.com Interview with:Dr. Heli Halava: Departments of Public Health and Pharmacology,Turku, Finland

• MedicalResearch: What are the main findings of the study?• Dr. Halava: The associations between lifestyle factors and nonadherence to statin therapy varied by cardiovascular

comorbidity status. Of the participants without cardiovascular comorbidities (n = 6458), 3171 (49.1%) were nonadherent with their statin therapy. Of the participants with cardiovascular comorbidities (n = 2827), 1155 (40.9%) were nonadherent.

• People with cardiovascular comorbidities who had risky drinking behaviours or a cluster of lifestyle risks were at increased risk of nonadherence.

• MedicalResearch: Were any of the findings unexpected?• Dr. Halava: Among individuals without cardiovascular comorbidities, overweight, obesity and former smoking were

predictors of better adherence.• This provides insight into mechanisms of adherence to preventive medication that deserve further study.• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Halava: A recent meta-analysis of 44 epidemiologic studies suggested that almost 1 in 10 cardiovascular events can

be attributed to medication nonadherence (defined as taking less than 80% of the prescribed medication).• Among patients with cardiovascular diseases or diabetes those with high mean alcohol consumption, extreme drinking

occasions or clustering of 3-4 lifestyle risks may be at high risk of nonadherence.• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. Halava: Mechanisms of adherence to preventive medication deserve further study.• Citation:• Lifestyle factors as predictors of nonadherence to statin therapy among patients with and without cardiovascular como

rbiditiesHeli Halava, Maarit Jaana Korhonen, Risto Huupponen, Soko Setoguchi, Jaana Pentti, Mika Kivimäki, and Jussi VahteraCMAJ cmaj.131807; published ahead of print June 23, 2014, doi:10.1503/cmaj.131807

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Lymphedema Knowledge Weak Among Breast Cancer PatientsMedicalResearch.com Interview WithDorothy N. Pierce, DNP, MSN, RN, NP-C, CRN, OCN, CBCN Advanced Practice NurseRutgers Cancer Institute of New

Jersey Rutgers, The State University of New JerseyNew Brunswick, NJ 08901

• MedicalResearch: What are the main findings of the study?• Answer: The main findings from the study were:• Nineteen patients out of 24 (79%) reported lymphedema (LE) symptoms. Majority reporting

symptoms received chemotherapy and were 50 years of age and older.• The most commonly reported symptoms were limb tenderness (n=10), swelling (n=9),

firmness/tightness (n=8), numbness (n=6), heaviness (n=5), impaired movement of the shoulder (n=5), and finger (n=4).

• Overall, the participants had low to moderate lymphedema knowledge. The mean knowledge score was 11.9 with a range from zero to 20.

• Patients beginning radiation therapy for breast cancer often had not received any lymphedema information from health care providers prior to therapy; Lymphedema knowledge is moderate to weak.

•MedicalResearch: Was any of the findings unexpected?

• Answer: It was astonishing that only eight patients out of 24 patients (33%) received any information concerning lymphedema from their healthcare professional. The striking fact that caught my attention was that only one patient received lymphedema information from a nurse.

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Lymphedema Knowledge Weak Among Breast Cancer PatientsMedicalResearch.com Interview WithDorothy N. Pierce, DNP, MSN, RN, NP-C, CRN, OCN, CBCN Advanced Practice NurseRutgers Cancer Institute of New

Jersey Rutgers, The State University of New JerseyNew Brunswick, NJ 08901

• MedicalResearch: What should clinicians and patients take away from your report?• Answer: Any individual diagnosed with breast cancer (BC) will experience a difficult obstacle, and it is imperative to know the

potential complications of treatment, such as lymphedema. Advanced Practice Nurses play a critical role in educating patients about the risk of breast cancer related lymphedema (BCRL) a side effect that may develop after treatment intervention. Patients should be aware of early identification, prevention, and management of complication is imperative. These patients should learn how to reduce their risk early by implementation of written guidelines, educational session on how to reduce their risk of lymphedema, preventing complications should it occur. Collaboration with other specialists for evaluation is essential. It is critical for radiation clinician to maintain open communication with patients and the multidisciplinary healthcare team.

• MedicalResearch: What recommendations do you have for future research because of this study?• Answer: Unfortunately, little research was found in the literature about the outcomes of breast cancer related lymphedema,

particularly in the radiation oncology setting. To my knowledge, this is the first study to examine patients’ breast cancer related lymphedema knowledge and self-reported symptoms among patients receiving radiation therapy. With all that has been identified about lymphedema knowledge and symptoms some questions still linger. More research evaluating whether specific symptoms attributes to breast cancer related lymphedema are truly less common among breast cancer patients pre radiation rather than during radiation will help clarify whether these symptoms are related to radiation. Because this research has not supported increase symptoms in patients at risk for breast cancer related lymphedema, studies investigating symptoms during radiation is needed.

• This study has been extended to recruit more patients and follow the patients for a longer period. In addition, future research should consider for replication of this study at multiple radiation oncology sites in various geographic locations across the United States. In addition, this information can be utilized to establish a provider assessment protocol (including patient assessment and patient education).

• Citation: • American Association of Nurse Practitioners Abstract June 17-21, 2014• Pierce D, et al: Lymphedema Knowledge and Symptoms in Breast Cancer Patients Receiving Radiation Therapy

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Overall Hospitalizations for Stroke Decrease, but Racial Disparities RemainMedicalResearch.com Interview with: Wuwei (Wayne) Feng MD MS FANAAssistant Professor, Department of NeuroscienceDepartment of Health Science & Research Medical

University of South Carolina Stroke CenterThe Center of Rehabilitation Research in Neurological Conditions

• MedicalResearch: What are the main findings of the study?• Dr. Feng: Stroke hospitalization rate is decreasing in the elderly, but increasing in the

young/middle aged population, but this increase is mainly driven by the increase in blacks (not in whites) which incurred persistent racial disparity in stroke. It has tremendous economic impact as outlined in the paper. Of hospital charges totaling $2.8 billion over 10-year period, $453.2 million (16.4%) are associated with racial disparity (79.6% from patients <65 years).

• By way of background: • 84,179 stroke hospitalizations occurred in South Carolina from 2001 to 2010. Blacks accounted

for 29,846 (35.5%) and whites accounted for 54,333 (64.5%) of the strokes. Among blacks, 50.4% were <65 years of age compared to 29.6% among whites. The overall stroke hospitalization rate decreased over the 10-year period. There was a significant reduction in stroke hospitalization rate in the older (≥65 years old) populations, for both blacks and whites.

• Whereas, in the younger populations (<65 years old), the overall rate of stroke hospitalizations actually increased significantly; however this increase was only associated with black patients. For example, the hospitalization rate per 100,000 for young blacks was 121 in 2001, 139 in 2005 and 142 in 2010 (a 17.3% increase from 2001).

• This racial disparity was more severe in the younger group with the highest disparity seen in the 45-54 year age groups for both ischemic strokes (having a clot) and intra-cerebral hemorrhagic strokes.

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Overall Hospitalizations for Stroke Decrease, but Racial Disparities RemainMedicalResearch.com Interview with: Wuwei (Wayne) Feng MD MS FANAAssistant Professor, Department of NeuroscienceDepartment of Health Science & Research Medical

University of South Carolina Stroke CenterThe Center of Rehabilitation Research in Neurological Conditions

• MedicalResearch: Were any of the findings unexpected?• Dr. Feng: Yes. The results are completed unexpected. We did not expect to see the persistent

racial disparity in the middle-aged population.• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Feng: Clinicians should be more vigilant of young patients presenting with stroke-like

symptoms, especially in those young people with several vascular risk factors. Generally stroke-like symptoms were attributed to others disease conditions by patients. Clinicians should aggressively treat and modify vascular risk factors, such as diabetes, dyslipidemia, diabetes, weight control and smoking cessation.

• For patients, they should stay healthy, eat and exercise well, start a healthy life style when they are still young. Do annual check with physician, identify and treat underlying diseases, such as high blood pressure, diabetes and hyperlipidemia, at an early stage, to prevent stroke down the road.

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Overall Hospitalizations for Stroke Decrease, but Racial Disparities RemainMedicalResearch.com Interview with: Wuwei (Wayne) Feng MD MS FANAAssistant Professor, Department of NeuroscienceDepartment of Health Science & Research Medical

University of South Carolina Stroke CenterThe Center of Rehabilitation Research in Neurological Conditions

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

• Dr. Feng: • 1) We need to monitor the trends of this increase in stroke hospitalization in the middle age

population;• 2) We need to do a better job to quantify the long term cost of younger-age strokes we were

only able to quantify the cost with acute care);• 3) The impact of early obesity/diabetes, hypertension and hyperlipidemia on stroke incidence

in middle age populations;• 4) Expansion of medical access in young to middle aged populations and its impact on the risk

of stroke.• Citation:• Persistent Racial Disparity in Stroke Hospitalization and Economic Impact in Young Adults in t

he Buckle of Stroke Belt• Andrea D. Boan, Wuwei (Wayne) Feng, Bruce Ovbiagele, David L. Bachman, Charles Ellis, Robe

rt J. Adams, Steven A. Kautz, and Daniel T. Lackland• Stroke. 2014;STROKEAHA.114.004853published online before print June 19 2014, doi:10.116

1/STROKEAHA.114.004853

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Heart Failure: Some Women May Benefit More Than Men from CRT-D TherapyMedicalResearch.com Interview with:David Strauss, M.D., Ph.D., Senior Author Medical OfficerCenter for Devices and Radiological Health

U.S. Food and Drug Administration, Silver Spring, Md

• MedicalResearch: What are the main findings of the study?• Dr. Strauss: The underrepresentation of women in clinical trials for cardiac resynchronization

therapy (CRT) devices, as with other devices, has made it difficult to assess differences in the safety and effectiveness of these devices for women vs. men. The FDA is exploring the potential of pooling and analyzing data from multiple trials to bridge the knowledge gap for certain subpopulations (such as women) often underrepresented in medical device clinical trials. By conducting one such meta-analysis, the FDA found that women benefit from cardiac resynchronization therapy (CRT) significantly more than men do.

•MedicalResearch: Were any of the findings unexpected?

• Dr. Strauss: Prior studies have suggested that patients with a left bundle branch block (electrical conduction disorder of the heart) benefit most from cardiac resynchronization therapy, and patients with a longer QRS duration (time for electrical activation of the heart, represented by the large wave seen on an ECG recording) of 150 milliseconds or more benefit most from CRT. However, the prior studies were not able to thoroughly investigate this effect separately in women and men. This was difficult to do because women only represented approximately 20 percent of the patients in each clinical trial. By pooling data from multiple trials we were able to increase the number of patients to answer specific questions about cardiac resynchronization therapy in women.

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Heart Failure: Some Women May Benefit More Than Men from CRT-D TherapyMedicalResearch.com Interview with:David Strauss, M.D., Ph.D., Senior Author Medical OfficerCenter for Devices and Radiological Health

U.S. Food and Drug Administration, Silver Spring, Md

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Strauss: In this combined analysis of 3 large CRT trials in patients with mild heart failure, we found

that women benefit from cardiac resynchronization therapy significantly more than men do. Patients of both sexes with a left bundle branch block (LBBB) benefited. However, women did so at a shorter QRS duration than men (130 milliseconds in women vs. 150 milliseconds in men). In the patients with LBBB and shorter QRS duration, women had a 76 percent reduction in heart failure or death, while there was no significant benefit in men. In patients with a LBBB and a longer QRS duration, both women and men benefited from CRT. These findings are important to communicate because women are less likely than men to receive CRT.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. Strauss: This research highlights that sex-specific analysis is important in research studies. Combining

patient-level data from multiple clinical trials to investigate outcomes and performance in subpopulations, especially in underrepresented groups, is encouraged and should be done more often.

• Later this summer, the FDA intends to finalize a guidance document that provides a clear framework for how to analyze and communicate data on women in medical device trials.

• The FDA also intends to release an Action Plan that contains recommendations for improving the completeness and quality of analyses of data on women, as well as other populations, in summaries of product safety and effectiveness data and in labeling.

• Citation:• Cardiac Resynchronization Therapy in Women: US Food and Drug Administration Meta-analysis of Patient

-Level Data

Robbert Zusterzeel MD, Kimberly A. Selzman MD, MPH, William E. Sanders MD, MBA, Daniel A. Caños PhD, MPH, Kathryn M. O’Callaghan BSE, Jamie L. Carpenter MSPH, Ileana L. Piña MD, MPH, David G. Strauss MD, PhD

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Resistance Exercise May Improve Cancer SurvivalMedicalResearch.com Interview with: Xuemei Sui, MD, MPH, PhDAssistant Professor, Department of Exercise ScienceDivision of Health Aspects of Physical Activity Arnold School of Public Health

University of South Carolina Columbia, SC 29208

• MedicalResearch: What are the main findings of the study?• Dr. Sui: In the present study, cancer survivors who reported performing resistance exercise

(RE) at least 1 day of the week had a 33% lower risk of all-cause mortality compared with individuals who did not report participation in resistance exercise. Further, there was an inverse relationship between resistance exercise and all-cause mortality in those who were physically active, but not in those who were physically inactive. Although leisure-time physical activity was not associated with a lower risk of all-cause mortality, the present results support the benefits of resistance exercise and physical activity was during cancer survival.

• MedicalResearch: Were any of the findings unexpected?• Dr. Sui: Our results are consistent with previous literature demonstrating positive effects of

exercise in cancer patients. Physical activity (PA) is a modifiable risk factor known to decrease the occurrence of disease and all-cause mortality in healthy populations. Additionally, regular PA can lead to the maintenance of and/or improvements in body composition, physical function, and overall quality of life in cancer survivors.

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Resistance Exercise May Improve Cancer SurvivalMedicalResearch.com Interview with: Xuemei Sui, MD, MPH, PhDAssistant Professor, Department of Exercise ScienceDivision of Health Aspects of Physical Activity Arnold School of Public Health

University of South Carolina Columbia, SC 29208

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Sui: This is the first prospective study to examine the associations between resistance

exercise and all-cause mortality in cancer survivors. Although preliminary, clinicians should be aware of the long-term benefits of regular physical activity participation, especially resistance exercise in cancer survivors.

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

• Dr. Sui: Future prospective randomized controlled trials should be designed to address potential mechanisms between resistance exercise and health outcomes, including all-cause and disease-specific mortality, during cancer survival.

• Citation:• The Effect of Resistance Exercise on All-Cause Mortality in Cancer Survivors• Hardee, Justin P. et al.• Mayo Clinic Proceedings• Published Online: June 21, 2014• DOI: http://dx.doi.org/10.1016/j.mayocp.2014.03.018

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Heart Attack Admissions In China Quadrupled Over 10 YearsMedicalResearch.com Interview with:Professor Lixin Jiang MD, PhD, F.A.C.C. National Clinical Research Center of Cardiovascular Diseases

State Key Laboratory of Cardiovascular DiseaseFuwai Hospital, National Center for Cardiovascular Diseases Beijing , China

• MedicalResearch: What are the main findings of the study?• Professor Jiang: In this first representative nationwide assessment of quality of care in China,

we studied 13,815 hospital admissions for STEMI in 162 hospitals across China over the past decade. We found that the incidence of hospital admission for STEMI quadrupled from 3.7 per 100,000 in 2001 to 15.8 per 100,000 in 2011.

• There were substantial changes in testing and treatment patterns. Over the study period, the rate of testing for troponin increased from 21.4% in 2001 to 66.5% in 2011. Additionally, based at the ideal patients’ analysis, the use of several highly effective treatments for STEMI, including aspirin, clopidogrel and statins, improved over the study period. However, other therapies known to reduce mortality in STEMI patients – such as β-blockers and ACE inhibitors – were underused with only 57.7% of patients receiving beta-blockers and 66.1% ACE inhibitors respectively in 2011.

• While the proportion of patients receiving reperfusion therapy remained constant, there was a notable shift away from fibrinolysis, which was the primary means of reperfusion in 2001, towards primary PCI. However, in 2011, only 27.6% of patients admitted to Chinese hospitals for STEMI received primary PCI, the gold standard of treatment, while 27.4% received fibrinolytic therapy in the ideal patients.

• Despite increasing overall intensity of treatment, procedure use, and testing, no significant change in the rate of in-hospital death from STEMI was seen over the study period.

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Heart Attack Admissions In China Quadrupled Over 10 YearsMedicalResearch.com Interview with:Professor Lixin Jiang MD, PhD, F.A.C.C. National Clinical Research Center of Cardiovascular Diseases

State Key Laboratory of Cardiovascular DiseaseFuwai Hospital, National Center for Cardiovascular Diseases Beijing , China

• MedicalResearch: Were any of the findings unexpected?• Professor Jiang: There were several unexpected findings of the study. The quadrupling of the

incidence of hospitalizations for STEMI was particularly notable.• Also, despite a sharp rise in the use of primary PCI, only 55% of patients received any reperfusion

therapy – a proportion that remained constant over our decade-long study period. Improvements in other aspects of the management of STEMI were not uniform. While the growing use of biomarkers and several important medications was encouraging, there was little change in the use of reperfusion, beta-blockers and ACE inhibitors. Even though there were some notable improvements in the quality of care, we did not find a significant change in in-hospital mortality.

• MedicalResearch: What should clinicians and patients take away from your report?• Professor Jiang: Clinicians should recognize the power of direct measurement in illuminating

clinical care and outcomes – and the importance of such studies in identifying targets for improvement. Improving access and addressing cost are important, but clinical quality is also a facet of health care that must be measured and made transparent. Providing health care is not enough. All nations must seek to provide access to the highest quality health care. Studies such as these are essential to focus everyone in the health care system on what is being accomplished and what goals need to be set for the future. Clinicians everywhere need to seek knowledge of health system performance for patients – and patients should encourage efforts to raise quality. The paper is about China, which has 20% of the world’s population, but the results and approach have implications for every country.

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Heart Attack Admissions In China Quadrupled Over 10 YearsMedicalResearch.com Interview with:Professor Lixin Jiang MD, PhD, F.A.C.C. National Clinical Research Center of Cardiovascular Diseases

State Key Laboratory of Cardiovascular DiseaseFuwai Hospital, National Center for Cardiovascular Diseases Beijing , China

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Professor Jiang: To address the identified opportunities to further improve

acute myocardial infarction care in China, the government has already committed funds to support the National Center for Cardiovascular Disease to initiate the China-PEACE Improvement Study. This initiative will pioneer innovative strategies to elevate the quality of cardiovascular care throughout China and augments an ongoing commitment to cardiovascular care by the Chinese government. (Yang Z, Jiang L. Building clinical research capacity in China: the National Clinical Research Centres. Lancet November 28, 2013). To support these efforts there is a need for studies to understand better the obstacles to high quality care, the disparities in quality, patient and institutional characteristics associated with quality of care, and the lessons from the best performers. We need continuing good science to inform efforts to improve.

• Moreover, the ongoing China-PEACE Prospective studies will help us understand outcomes from the patient perspective over time, including information about symptoms, function, stress and other domains.

• Citation:• ST-segment elevation myocardial infarction in China from 2001 to 2011 (the China PEACE-Retrospectiv

e Acute Myocardial Infarction Study): a retrospective analysis of hospital data• Jing Li PhD, Xi Li PhD, Qing Wang MS , Shuang Hu PhD , Yongfei Wang MS , Prof Frederick A Masoudi

MD , Prof John A Spertus MD , Prof Harlan M Krumholz MD , Prof Lixin Jiang MD or the China PEACE Collaborative Group

• The Lancet, Early Online Publication, 24 June 2014• doi:10.1016/S0140-6736(14)60921-1

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Early Primary Care Follow Up May Reduce Readmissions For High Risk Surgery PatientsMedicalResearch.com Interview with:Benjamin S. Brooke, M.D., Ph.D. Assistant Professor of SurgeryDivision of Vascular Surgery University of Utah School of Medicine

• MedicalResearch: What are the main findings of the study?• Dr. Brooke: This study was designed to evaluate whether high-risk surgical patients who visit a

primary care provider (PCP) during the early period following hospital discharge are less likely to be readmitted within 30-days. We examined this question by performing a retrospective cohort analysis of Medicare beneficiaries (2003-2010) who underwent a high risk surgery (open thoracic aortic aneurysm repair) as well as a control group of patients who underwent a lower risk surgical procedure (open ventral hernia repair), and then determining whether there was evidence of early PCP follow-up.

• In risk-adjusted analyses, we found that early primary care provider-follow-up was associated with a significant lower likelihood of 30-day readmission for high-risk patients undergoing open thoracic aortic aneurysm repair, particularly if a post-operative complication had occurred. In comparison, early primary care provider follow-up did not have a significant effect on lowering readmissions in uncomplicated patients and those undergoing lower-risk operations such as ventral hernia repair.

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

• Dr. Brooke: These findings suggest that improving coordination of care between the surgical team and patients outpatient PCPs may provide an opportunity to reduce 30-day readmissions for high-risk surgical patients. Patients who suffer post-operative complications or have other risk factors for readmission following complex surgery should be scheduled for early PCP follow-up at the time of hospital discharge.

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Early Primary Care Follow Up May Reduce Readmissions For High Risk Surgery PatientsMedicalResearch.com Interview with:Benjamin S. Brooke, M.D., Ph.D. Assistant Professor of SurgeryDivision of Vascular Surgery University of Utah School of Medicine

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

• Dr. Brooke: The findings of this study suggest that future research needs to focus more closely on the post-discharge care of surgical patients as a strategy for improving outcomes.

• Citation: • Abstract 193: Primary Care Utilization Reduces Risk of Readmission among High-Risk Vascular

Surgery Patients: Coordinating of Post-Discharge Care Matters

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Lifetime Intellectual Enrichment Might Delay Cognitive ImpairmentMedicalResearch.com Interview with:Prashanthi Vemur, Ph.D.Mayo Clinic Rochester, Minnesota

• MedicalResearch: What are the main findings of the study?• Dr. Vemuri: Lifetime intellectual enrichment might delay the onset of cognitive impairment and be used as a successful

preventive intervention to reduce the impending dementia epidemic. We studied two non-overlapping components of lifetime intellectual enrichment: education/occupation-score and mid/late-life cognitive activity measure based on self-report questionnaires. Both were helpful in delaying the onset of cognitive impairment but the contribution of higher education/occupation was larger.

• MedicalResearch: Were any of the findings unexpected?• Dr. Vemuri: We found that an individual with low education/occupation benefited more by engaging in high mid/late-

life cognitive activity than an individual with high education/occupation.• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Vemuri: A significant protection against cognitive impairment can be gained from engagement in high mid/late-life

cognitive activity irrespective of the subject’s life-long non-leisure activity through education and occupation. Mid/late-life cognitive activity was helpful in delaying the onset of cognitive impairment by at least 3 years irrespective of the number years of education. High mid/late-life engagement in cognitively stimulating activities (75th percentile) corresponded to engaging in several cognitively stimulating activities at least 3 times a week during mid/late-life. Examples of these activities include reading books and magazines, playing games and music, artistic activities, crafts, group activities, social activities, and computer activities.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. Vemuri: Future reduction in the epidemic of dementia will come from public investments to increase access to

education, better jobs and increasing the elderly engagement in cognitively stimulating activities.• Citation:• Vemuri P, Lesnick TG, Przybelski SA, et al. Association of Lifetime Intellectual Enrichment With Cognitive Decline in the

Older Population. JAMA Neurol. Published online June 23, 2014. doi:10.1001/jamaneurol.2014.963.

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Booming Need for Long-Term Dementia Care Requires Multifactorial SolutionsMedicalResearch.com Interview with:Regina Shih PhDSenior Behavioral Scientist at the RAND Corporation.

• MedicalResearch: What are the main findings of the study?• Dr. Shih: RAND identified 25 high-impact policy options to improve the delivery, workforce,

and financing of long term care, with a specific eye toward those with dementia and their caregivers. Undertaking these 25 policy options would achieve five goals: increasing public awareness of dementia and its signs and symptoms; improving access to long-term care; promoting high-quality, person-centered care; providing better support for family caregivers; and reducing the burden of dementia costs on individuals and their families.

• Of these 25 policy options, we identified four unique options that have never been identified in any national plan on dementia or long-term care. This is likely because we focused on the intersection between dementia and long-term care, rather than just one or the other. And, rather than only focusing on actions that federal agencies can take, we identified policy options by interviewing 30 different stakeholders in the public and private sectors at the local, state, and national levels. These unique, high-impact policy options have to do with

• Linking private health insurance with private long-term care insurance;• Including home and community-based services in state Medicaid plans;• Establishing cross-setting teams focused on returning the person with dementia to the

community;• Expanding financial compensation to family caregivers.

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Booming Need for Long-Term Dementia Care Requires Multifactorial SolutionsMedicalResearch.com Interview with:Regina Shih PhDSenior Behavioral Scientist at the RAND Corporation.

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Shih: Clinicians have an important role to play in improving dementia long-term care. It

has been estimated that the United States has only about half the number of certified geriatricians needed to care for the growing aging baby boomer population.

• We have recommended policy options to provide specialized geriatric training, creating incentives to stay in the direct care workforce, and expanding nurse delegation laws. In addition, we suggest that encouraging health care providers to use cognitive assessment tools will help front-line clinical staff (e.g., during Medicare visits) identify early signs of cognitive impairment and connect patients to the resources they need to plan for their care.

• Our report actively involved patients and patient groups in the policy dialogue. These are the groups that are primarily affected by policy solutions. They spoke consistently about the need to minimize transitions — dementia patients experience more transitions than people with other chronic conditions, and these are most disruptive to patients with dementia. Because dementia patients rely so heavily on family caregivers, our policy recommendation is to identify them jointly in care settings, which will go a long way to improve dementia patients’ quality of care and coordination of care across settings.

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Booming Need for Long-Term Dementia Care Requires Multifactorial SolutionsMedicalResearch.com Interview with:Regina Shih PhDSenior Behavioral Scientist at the RAND Corporation.

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

• Dr. Shih:• We identified several important research directions.• First, the nation needs to improve the delivery of long-term care through applied research on

interventions that work best for individuals with dementia.• Second, the effects of nurse delegation on patient and family caregiver outcomes need to be

examined.• Third, our nation’s financing system is in dire need of a broad solution. The costs and details

of how best to implement a national financing system is a large research topic.• In the meantime, more research is also needed to find out why people do not know about, or

decide to purchase private long-term care insurance to protect against the high costs of long-term care for dementia.

• Citation:• Improving Dementia Long-Term Care: A Policy Blueprint

by Regina A. Shih, Thomas W. Concannon, Jodi L. Liu, Esther Friedmanhttp://www.rand.org/pubs/research_reports/RR597.html

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New Blood Test May Be Better Able To Detect Increased Risk of MiscarriageMedicalResearch.com Interview with:Dr. Ali AbbaraImperial College London, United Kingdom

• Dr. Abbara: What are the main findings of the study?• MedicalResearch: We found that a novel blood test for kisspeptin was able to identify asymptomatic

pregnant women who were at increased risk of subsequent miscarriage. Blood kisspeptin performed better than the more commonly measured pregnancy hormone BHCG in identifying women at increased risk of miscarriage. MedicalResearch: Were any of the findings unexpected?

• Dr. Abbara: The study results were consistent with previous basic science research suggesting that kisspeptin may be an important regulator of normal placental formation.

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Abbara: Blood kisspeptin levels may be a useful screening test to identify women at increased risk of

miscarriage.• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. Abbara: This study opens up a novel avenue of research which will assess whether identifying women at

increased risk of miscarriage at an early enough stage in the miscarriage process would allow us to target investigations and treatments which may alter the course of pregnancy in these women.

• Citation:• Abstract presented at the 2014 ICE/Endo• OR04-2 Plasma Kisspeptin Measurement during Early Pregnancy Is a Highly Predictive Marker of Subsequent

Miscarriage• Program: Abstracts – Orals, Poster Preview Presentations, and Posters

Session: OR04-Female Reproductive EndocrinologyClinical/Translational

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Is There An Association Between Economic Crisis, Unemployment and Suicide?MedicalResearch.com Interview with:Grégoire Rey Directeur du CépiDcCépiDc-Inserm Hopitâl Bicêtre France

• MedicalResearch: What are the main findings of the study?• Dr. Rey: We found that, between 2000 and 2010, unemployment and suicide rates were

globally associatedin eight Western European countries (Austria, Finland, France, Germany, the Netherlands, Spain, Sweden, and the UK). However, this ecological association was weak (0.3% increase in suicide rate for a 10% increase in unemployment rate). Across countries, it was inconsistently confounded by the effect of other concomitant features of the economic crisis.

• MedicalResearch: Were any of the findings unexpected?

• Dr. Rey: Although France has one of the highest OECD employment protection indexes among the analyzed countries, it has the strongest central estimation of the unemployment–suicide association, with a 1.9% increase in suicide rate for a 10% increase in unemployment rate. This is an unexpected result on the basis of the conclusions of Stuckler and collaborators’ study (The public health effect of economic crises and alternative policy responses in Europe: an empirical analysis. Lancet 2009), which found that expenses on labor market policies could mitigate the increase in suicides during economic crises.

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Is There An Association Between Economic Crisis, Unemployment and Suicide?MedicalResearch.com Interview with:Grégoire Rey Directeur du CépiDcCépiDc-Inserm Hopitâl Bicêtre France

• MedicalResearch: What should policy makers and the general population take away from your report?

• Dr. Rey: The associations highlighted between the economic crisis, unemployment, and suicide mortality are weak, and vary according to the country. They are deeply sensitive to the socio-economic and cultural context of each country. Thus, these associations should not be considered as causal.

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

• Dr. Rey: Our study highlights that the unemployment-suicide association is inconsistently confounded by the effect of other concomitant features of the economic crisis. This inconsistency provides arguments against its causal interpretation. Identifying the actual origins of suicide increase during the financial crisis appears essential in order to implement efficient public health policies. Further research should explore individual data including professional status, with a sufficiently wide cohort as suicides remain relatively rare events.

• Citation:• Impact of unemployment variations on suicide mortality in Western European countries (200

0-2010)Moussa Laanani,Walid Ghosn,Eric Jougla, Grégoire Rey• J Epidemiol Community Health jech-2013-203624Published Online First: 18 June 2014 doi:10.1

136/jech-2013-203624

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Domestic Abuse May Affect African American and Caribbean Black Women DifferentlyMedicalResearch.com Interview with: Krim K. Lacey, PhDResearch Fellow, Research Center for Group DynamicsProgram for Research on Black Americans (PRBA)

Institute for Social Research University of Michigan Ann Arbor, MI

• MedicalResearch: What are the main findings of the study?• Dr. Lacey: The main findings from this nationally representative study were that U.S. Black women

abused by a domestic partner, on a whole were vulnerable to various negative physical and mental health problems.

• While the findings of the study support the few previous studies conducted on women within this population, this study was the first population-based, predominantly black sample that used structured clinical assessments. Importantly, the study substantiates other arguments that the Black population is not culturally monolithic, that African American and Caribbean Black women are affected differently by severe intimate partner violence.

• Another key finding was the association identified between eating disorders and intimate partner violence, which in general, has been largely underexplored.

• Finally, the study provided national information on the health outcomes of Caribbean Black women; one of the fastest growing subgroups within the Black population.

• MedicalResearch: Were any of the findings unexpected?Dr. Lacey: As I mentioned, we found differences in physical and mental health outcomes between abused African American and Caribbean Black women. Substantively, intimate partner violence was associated with poor physical health, dysthymia, alcohol dependence and drug abuse for African American women. Among Caribbean women, intimate partner violence was associated with binge eating. These were two possible coping and response outcomes that we did not anticipate finding and that can have significant impact on women’s health in varying ways.

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Domestic Abuse May Affect African American and Caribbean Black Women DifferentlyMedicalResearch.com Interview with: Krim K. Lacey, PhDResearch Fellow, Research Center for Group DynamicsProgram for Research on Black Americans (PRBA)

Institute for Social Research University of Michigan Ann Arbor, MI

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Lacey: It is important for clinicians to recognize the noted differences in outcomes/responses

among these different cultural groups. Although the study suggests the consequences of violence may be greater for African American victims than Caribbean Blacks. For instance, substance use was associated with intimate partner violence and may be an immediate method used by African American women in dealing with their experience. Caribbean women may use more culturally acceptable ways of dealing with violence, which may be in the form of binge eating. Therefore, clinicians should not only recognize these potential differences in coping mechanisms among women, but develop more culturally appropriate interventions in addressing them.

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

• Dr. Lacey: In addition to greater awareness for the differences that exist among populations within racial groups, it is also important to give more recognition to social, cultural environment, and contextual factors that influence abuse while exacerbating the health conditions. These factors may be a source of barriers for intervention and treatment of women who experience violence by an intimate partner.

• Citation:• Severe Physical Violence and Black Women’s Health and Well-Being

Krim K. Lacey, PhD, Karen Powell Sears, PhD, Niki Matusko, BS, and James S. Jackson, PhDAmerican Journal of Public Health. e-View Ahead of Print.doi: 10.2105/AJPH.2014.301886

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Falls May Be Increased By High Doses of Blood Pressure Medications in ElderlyMedicalResearch.com Interview with: Dr. Michele CallisayaFaculty of Medicine, Nursing & Health SciencesMonash University, Clayton

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

• Dr. Callisaya: Falls are common in older people and can lead to hip fracture and loss of mobility. Blood pressure reducing medications are commonly taken by older people to protect against heart attacks and stroke, but may have some unwanted side effects such as light-headedness and loss of balance. We found that older people who were on large doses of such medications were at increased risk of falling.

• MedicalResearch: Were any of the findings unexpected?• Dr. Callisaya: Interestingly, our findings suggest that the dose of antihypertensive medication is at least as

important, if not more important, than the type of antihypertensive in explaining this increased risk of falling.

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Callisaya: When prescribing blood pressure medications, or increasing their dose in older people, care

needs to be taken to balance the individual’s risk of falling against their perceived benefit in protecting against stroke or heart attack. Each person should be individually and carefully assessed for risk and benefit.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. Callisaya: It will be important to conduct clinical trials to see if we can optimize the dose of

blood pressure medications in older people such that their risk of falls is reduced while maintaining cardiovascular protection.Citation:

• Greater Daily Defined Dose of Antihypertensive Medication Increases the Risk of Falls in Older People—A Population-Based Study

• Callisaya ML1, Sharman JE, Close J, Lord SR, Srikanth VKAm Geriatr Soc. 2014 Jun 16. doi: 10.1111/jgs.12925. [Epub ahead of print]

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Why Are Patients With Lung Cancer Admitted to ICUs?MedicalResearch.com Interview with: Colin R. Cooke, MD, MSc, MS;Assistant Professor of Medicine,Division of Pulmonary & Critical Care MedicineFaculty, Center for Healthcare Outcomes &

Policy University of Michigan

• MedicalResearch: What are the main findings of the study?• Dr. Cooke: There were three primary findings from our study.• First, we determined that between 1992 and 2005 there was almost a 40% increase in the number of admissions

to an intensive care unit (ICU) among patients with lung cancer who were hospitalized for reasons other than surgical removal of their cancer.

• Second, most of this increase was because doctors were admitting these patients to intermediate intensive care units. These are units that provide greater monitoring and nurse staffing than typically available in general hospital wards, but usually also have less ability to provide life support measures than full service ICUs.

• Third, over the same period the reasons for ICU admission have changed. Although the most common reason for admission continues to be for problems related to the patients’ lung cancer, problems such as breathing difficulties requiring a ventilator and severe infections are increasingly common.

• These findings suggest that although overall use of the ICU for patients with lung cancer is increasing over time, providers may be shifting some of the intensive care for lung cancer patients toward less aggressive settings such as the intermediate care unit.

• MedicalResearch: Were any of the findings unexpected?• Dr. Cooke: One somewhat unexpected finding was the temporal changes in the type of ICU in which patients

received the majority of their care. As discussed above, much of the increase in admission to the ICU was due to admissions to intermediate ICUs. Although we’re unable to determine the most appropriate ICU setting for each lung cancer patient, we know that the 6 month mortality for this group is quite high, prompting some providers to question the appropriateness of admission of such patients to full service ICUs. Our findings suggests that instead of admitting lung cancer patients to full-service ICUs, providers may appreciate the poor prognosis of hospitalized patients with lung cancer and consciously admit them to less aggressive settings.

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Why Are Patients With Lung Cancer Admitted to ICUs?MedicalResearch.com Interview with: Colin R. Cooke, MD, MSc, MS;Assistant Professor of Medicine,Division of Pulmonary & Critical Care MedicineFaculty, Center for Healthcare Outcomes &

Policy University of Michigan

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Cooke: In light of the high 6 month mortality of lung cancer patients, clinicians and patients

should consider goals of care prior to ICU admission. Patients who want and need life support measures may be better served in a full service ICU. Patients who opt to forgo aggressive life sustaining measures may still benefit from intermediate ICU care if they have a need for intensive nursing care or non-invasive therapies. Finally, other patients may be best served on a regular hospital floor or hospice unit with involvement of palliative care services.

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

• Dr. Cooke: There are several potential avenues of research that our study motivates.• First, we need a better understanding of why patients with lung cancer are admitted to both

intermediate ICUs as well as full-service ICUs, and whether or not the trends we’re observing reflect provider’s understanding of patient treatment preferences.

• Second, relatively little is know about how intermediate ICUs are used in the United States generally, which patients end up in such units, and how hospitals are using them as alternative locations for care delivery to an ICU.

• Citation:• Aggressiveness of intensive care use among patients with lung cancer in the SEER-Medicare registry• Colin R. Cooke, MD, MSc, MS; Laura C. Feemster, MD, MSc; Renda Soylemez Wiener, MD, MPH; Ma

ya E. O’Neil, PhD; Christopher G. Slatore, MD, MSc• Chest. 2014. doi:10.1378/chest.14-0477

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Stroke Patients Have Chronic Disease At High Risk For ReadmissionsMedicalResearch.com Interview with: Cheryl Bushnell, MD, MHS Associate Professor of NeurologyDirector, Wake Forest Baptist Stroke CenterWake Forest Baptist School of

Medicine Winston Salem, NC 27157

• MedicalResearch: What are the main findings of the study?• Dr. Bushnell: We found that readmitted patients were significantly more likely to have more

severe strokes, and to have been hospitalized two or more times during the year prior to the initial stroke admission, independent of other clinical factors, such as congestive heart failure, heart disease, or stroke complications (pneumonia, acute renal failure).

• MedicalResearch Were any of the findings unexpected?• Dr. Bushnell: Not really. For patients who are hospitalized frequently and then have stroke, it

is not surprising that they might be readmitted within 30 days of stroke discharge. However, what we also found is that regardless of a lack of hospitalizations prior to the stroke, the stroke appears to be a harbinger of readmissions even after 30 days.

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Stroke Patients Have Chronic Disease At High Risk For ReadmissionsMedicalResearch.com Interview with: Cheryl Bushnell, MD, MHS Associate Professor of NeurologyDirector, Wake Forest Baptist Stroke CenterWake Forest Baptist School of

Medicine Winston Salem, NC 27157

• MedicalResearch What should clinicians and patients take away from your report?• Dr. Bushnell: This illustrates that stroke is a chronic disease—in other words, stroke patients

are at high risk for more hospitalizations because of having a stroke. As a result, these patients may not be receiving appropriate post-acute services, including primary care, stroke specialty care, rehabilitation, and community services to keep them home and out of the hospital.

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

• Dr. Bushnell: If our model is validated in a larger study, it could then be used in electronic health records to provide a potentially reproducible, efficient and effective means of selecting patients most at risk for subsequent hospital readmission (prior to discharge). A logical next step is to develop innovative tools and programs for stroke patients, focused on post-acute services, to keep patients from being readmitted.

• Citation:• Predictors of 30-Day Hospital Readmission Following Ischemic and Hemorrhagic Stroke• Strowd RE1, Wise SM1, Umesi UN1, Bishop L1, Craig J2, Lefkowitz D1, Reynolds PS1, Tegeler C1

, Arnan M1, Duncan PW1, Bushnell CD3.Am J Med Qual. 2014 Jun 11. pii: 1062860614535838. [Epub ahead of print]

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Rheumatoid Arthritis: Oral JAK Inhibitor Tofacitinib May Be Superior to MethotrexateMedicalResearch.com Interview withBethanie Wilkinson, Ph.D.Pfizer Groton, CT 06340

• MedicalResearch: What are the main findings of the study?• Dr. Wilkinson: ORAL Start showed that XELJANZ (tofacitinib citrate) 5 and 10 mg twice daily (BID), taken by

itself without methotrexate (MX), inhibited the progression of structural damage and reduced the signs and symptoms of rheumatoid arthritis (RA), and was statistically significantly superior to methotrexate on these measures at Month 6 (primary endpoint) and at all measured time points up to 24 months in patients with rheumatoid arthritis who had not previously received methotrexate or therapeutic doses of methotrexate. XELJANZ is not indicated in patients who had not previously received methotrexate.

• Both doses of XELJANZ met the study’s co-primary efficacy endpoints of mean change from baseline in van der Heijde modified Total Sharp Score (mtss) [0.18 and 0.04 (both P<0.001) for tofacitinib 5 and 10 mg BID, respectively, versus 0.84 for MTX], and ACR70 response rates [25.5% and 37.7% for tofacitinib 5 and 10 mg BID (both P<0.001) versus 12.0% for MTX], at Month 6.

• These results were sustained at all measured time points up to 24 months.•

MedicalResearch: Were any of the findings unexpected?• Dr. Wilkinson: This was the first time that tofacitinib was compared directly head to head with

methotrexate and the results indicated that tofacitinib was superior to methotrexate for the efficacy measures of inhibition of radiographic progression and signs and symptoms for Rheumatoid Arthritis (RA) in patients with rheumatoid arthritis who had not previously received methotrexate or therapeutic doses of methotrexate; while these results were not necessarily unexpected they were important in that they provide confirmation that there is another effective oral therapy for moderate to severe rheumatoid arthritis patients that have had an inadequate response to MTX. There were no unexpected or new safety signals seen in this study.

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Rheumatoid Arthritis: Oral JAK Inhibitor Tofacitinib May Be Superior to MethotrexateMedicalResearch.com Interview withBethanie Wilkinson, Ph.D.Pfizer Groton, CT 06340

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Wilkinson: This Phase 3 study in patients with moderately to severely active rheumatoid

arthritis (RA) who had not previously received methotrexate (MTX) or therapeutic doses of MTX met its primary endpoints. This study showed that XELJANZ taken by itself was statistically significantly superior to MTX in measures of clinical, radiographic and functional efficacy Rheumatoid Arthritis outcomes, and these results were measured at 6 months as the primary endpoint and sustained over two years. This is important since some people don’t adequately respond, eventually stop responding, or have intolerance to MTX.

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

• Dr. Wilkinson: Future studies of the comparison on methotrexate in other populations as well as continuing pharmacovigilance will provide additional information on the risk:benefit profile of this therapy.

• Citation:• Tofacitinib versus Methotrexate in Rheumatoid Arthritis• Eun Bong Lee, M.D., Roy Fleischmann, M.D., Stephen Hall, M.D., Bethanie Wilkinson, Ph.D., Jo

hn D. Bradley, M.D., David Gruben, Ph.D., Tamas Koncz, M.D., Sriram Krishnaswami, Ph.D., Gene V. Wallenstein, Ph.D., Chuanbo Zang, Ph.D., Samuel H. Zwillich, M.D., and Ronald F. van Vollenhoven, M.D. for the ORAL Start Investigators

• N Engl J Med 2014; 370:2377-2386June 19, 2014DOI: 10.1056/NEJMoa1310476Read the rest of the interview on MedicalResearch.comContent Not Intended as Specific Medical Advice

Pancreatic Cancer: Vaccine-Based Therapy May Make Tumors More Susceptible To TreatmentMedicalResearch.com Interview with: Lei Zheng, M.D., Ph.D.Assistant Professor of Oncology and Surgery Gastrointestinal Cancer Program Division of Immunology

The Sidney Kimmel Comprehensive Cancer Center and Department of Oncology Johns Hopkins University School of MedicineBaltimore, MD 2123

• MedicalResearch: What are the main findings of the study?• Dr. Zheng: This study shows for the first time that treatment with a vaccine-based immunotherapy directly re-programs the

pancreatic cancer microenvironment, allowing the formation of lymphoid aggregates, which are organized, lymph node-like, functional immune structures and which convert an immunologically quiescent tumor into an immunologically active tumor.

• MedicalResearch: Were any of the findings unexpected?• Dr. Zheng: The above described lymphoid aggregates were not observed or reported in pancreatic tumors from patients who

were not treated by the vaccine.• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Zheng: Many malignancies including pancreatic cancer may not be “non-immunogenic” tumors as we have thought. This

misconcept may have drastically slowed the development and application of immune-based therapies for these cancers. Vaccine based immunotherapy may reprogram these cancers, by converting them from a “non-immunogenic” tumor, into an “immunogenic” tumor.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. Zheng: Our study demonstrates that the formation of these immune regulatory structures within pancreatic tumors is the

first step toward establishing optimal anticancer immune responses within pancreatic tumors since these lymphoid aggregates can express both activating (“good”) and inhibitory (“bad”) immune signatures. These data support combination immunotherapies that include both vaccines that induce T cells and facilitate T cell trafficking into the tumors given together with the treatments that boost the “good” immune regulatory signals or block the “bad” immune regulatory signals. Thus, our study has suggested a new model for developing more effective immunotherapy for traditionally “non-immunogenic” tumors like pancreatic cancer. One of future researches is to investigate the combinational immunotherapies that include both cancer vaccines and the treatments that boost the “good” immune regulatory signals or block the “bad” immune regulatory signals such as PD-1.

• Citation:• Immunotherapy Converts Nonimmunogenic Pancreatic Tumors into Immunogenic Foci of Immune Regulation

Eric R. Lutz, Annie A. Wu, Elaine Bigelow, Rajni Sharma, Guanglan Mo, Kevin Soares, Sara Solt, Alvin Dorman, Anthony Wamwea, Allison Yager, Daniel Laheru, Christopher L. Wolfgang, Jiang Wang, Ralph H. Hruban, Robert A. Anders, Elizabeth M. Jaffee, and Lei Zheng

• Cancer Immunol Res Published OnlineFirst June 18, 2014; doi:10.1158/2326-6066.CIR-14-0027Read the rest of the interview on MedicalResearch.comContent Not Intended as Specific Medical Advice

Electronic Health Records Can Present Ongoing Patient Safety ConcernsMedicalResearch.com Interview with: Dr. Hardeep Singh MD, MPHChief the Health Policy, Quality & Informatics Program

Veterans Affairs Center for Innovations in Quality, Effectiveness and SafetyMichael E. DeBakey VA Medical Center in Houston, Texas Associate professor at Baylor College of Medicine

• MedicalResearch: What are the main findings of the study? • Dr. Singh: EHRs use can prompt new patient safety concerns, and many of these problems are complex and difficult to detect. We sought

to better understand the nature of these patient safety concerns and reviewed 100 closed investigations involving 344 technology-related incidents arising between 2009 and 2013 at the Department of Veterans Affairs (VA).

• We evaluated safety concerns related to technology itself as well as human and operational factors such as user behaviors, clinical workflow demands, and organizational policies and procedures involving technology. Three quarters of the investigations involved unsafe technology while the remainder involved unsafe use of technology. Most (70%) investigations identified a mix of 2 or more technical and/or non-technical underlying factors.

• The most common types of safety concerns were related to the display of information in the EHR; software upgrades or modifications; and transmission of data between different components of the EHR system.

•MedicalResearch: Were any of the findings unexpected?

• Dr. Singh: EHR-related safety concerns involving both unsafe technology and unsafe use of technology persist long after ‘go-live’ and despite the sophisticated EHR infrastructure represented in our data source.

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Singh: Despite sophisticated technology, electronic health records (EHRs) can present patient safety concerns long after they “go live”.

This is not just a technology-related problem–we recommend taking a ‘sociotechnical’ approach to understand and fix these issues. The VA adopted EHRs in 1999 and is a leader in patient safety and the use of health information technology. It runs a non-punitive voluntary reporting system for health information technology safety reporting and analysis. Currently, few healthcare institutions have reporting and analysis capabilities similar to the VA. As more institutions adopt EHRs within and outside the U.S., we suggest that our findings may be useful in guiding broader proactive efforts to ensure close monitoring of patient safety in EHR-enabled health care settings.

• MedicalResearch: What recommendations do you have for future research as a result of this study? • Dr. Singh: Research on how to develop and operationalize sophisticated monitoring systems to unearth the complex mix of human and

technological causes behind these problems is needed.• Citation:

An analysis of electronic health record-related patient safety concernsDerek W Meeks,Michael W Smith,Lesley Taylor,Dean F Sittig,Jean M Scott,Hardeep Singh

• J Am Med Inform Assoc amiajnl-2013-002578Published Online First: 20 June 2014 doi:10.1136/amiajnl-2013-002578

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Patients With Advanced Cancer May Not Have Same End-of-Life Perspective As Their PhysiciansMedicalResearch.com Interview with Daniel Rocke, MDDuke Medicine Department Otolaryngology

• MedicalResearch: What are the main findings of the study?• Dr. Rocke: I think the main point is that, to quote the paper, “end-of-life decision making by patients with cancer

and their caregivers is significantly affected by their preference for quality of life or quantity of life, but OHNS physicians’ decision making is not.” This is important because physicians counseling patients making end-of-life decisions are coming at these decisions from a different perspective that may not line up with their patients. If physicians recognize this, I think that these end-of-life discussions can be more productive

•MedicalResearch: Were any of the findings unexpected?

• Dr. Rocke: We assumed that both groups would be affected by baseline attitudes. It was interesting that the physicians were not, and we have suggested that the experience of having cancer may lead people to think about questions of quality of life vs quantity of life in ways that those who have never had cancer may not have.

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Rocke: I think it’s something for physicians to keep in mind when having discussions with patients – physicians

don’t have the same baseline attitudes as their patients and if physicians assume that their perspective is the same as their patients, this may lead to less effective discussion.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. Rocke: We suggested why there were these differences, but we don’t know. We also don’t know how these

differences affect end-of-life discussions in the real world. We took a snapshot of lots of physicians, but these discussions are intensely personal. These differences may not matter in these one-on-one situations.

• Citation:• Rocke DJ, Beumer HW, Taylor DH, Jr, Thomas S, Puscas L, Lee WT. Physician and Patient and Caregiver Health Attitu

des and Their Effect on Medicare Resource Allocation for Patients With Advanced Cancer. JAMA Otolaryngol Head Neck Surg. 2014;140(6):497-503. doi:10.1001/jamaoto.2014.494.

• Read the rest of the interview on MedicalResearch.comContent Not Intended as Specific Medical Advice

Heavy Episodic Alcohol Use Raises Risk of Heart AttackMedicalResearch.com: Interview with:Dr. Darryl P. Leong MBBS(Hons) MPH PhD FRACP FESCHamilton General Hospital237 Barton Street East Canada

• MedicalResearch: What are the main findings of the study?• Dr. Leong: The main findings of this study are that while low-moderate levels of alcohol use are

associated with a reduced risk of myocardial infarction, this protective association was not seen in peoples of all ethnicities.

• Secondly, heavy alcohol use (≥6 drinks) within a 24 hour period was associated with a significant increase in the immediate risk of myocardial infarction.

MedicalResearch: What should clinicians and patients take away from your report?• Dr. Leong: Key messages are that alcohol use should not necessarily be considered as protective

against myocardial infarction in all ethnicities, and that heavy episodic alcohol use should be discouraged, as it is linked with an increased risk of myocardial infarction.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. Leong: Further research is needed to examine the relationship between the quantity and type of

alcohol consumed, the social circumstances surrounding alcohol use, and the occurrence of cardiovascular disease. We also need a better understanding of the role of genetic variation in mediating any protective or harmful effects of alcohol consumption.Citation:

• Patterns of Alcohol Consumption and Myocardial Infarction Risk: Observations from 52 Countries in the INTERHEART Case-Control Study

• Darryl P. Leong, Andrew Smyth, Koon K. Teo, Martin McKee, Sumathy Rangarajan, Prem Pais, Lisheng Liu, Sonia S. Anand, and Salim Yusuf, on behalf of the INTERHEART investigators

• Circulation. 2014;CIRCULATIONAHA.113.007627published online before print June 13 2014, doi:10.1161/CIRCULATIONAHA.113.007627Read the rest of the interview on MedicalResearch.comContent Not Intended as Specific Medical Advice

Breast Cancer: Black Patients Had Fewer Sentinel Lymph Node BiopsiesMedicalResearch.com Interview with: Dalliah Black, MD F.A.C.S.Department of Surgical Oncology The University of TexasMD Anderson Cancer Center, Houston

• MedicalResearch: What are the main findings of the study?• Dr. Black: This is a retrospective study from 2002 – 2007 using the SEER/Medicare

database of over 31,000 women with node negative breast cancer evaluating the utilization of sentinel node biopsy (SNB) as it transitioned from an optional method for axillary staging to the standard of care instead of complete axillary lymph node dissection (ALND). We found that SNB use increased each year in both white and black breast cancer patients throughout the study period. However, SNB was less often performed in black patients (62.4%)compared to white patients (73.7%) and this disparity persisted through 2007 with a 12% difference. Appropriate black patients more often had an ALND instead of the minimally invasive sentinel node biopsy which resulted in worse patient outcomes with higher lymphedema rates in black patients. However, when black patients received the minimally invasive SNB, their rates of lymphedema were low and comparable to white patients who received SNB.

MedicalResearch: Were any of the findings unexpected?• Dr. Black: Yes, the findings were unexpected. We did not expect to see a persistent racial

difference in sentinel node biopsy use to as recent as 2007. We also did not expect to find that a disparity in the surgical treatment of breast cancer could negatively affect patient outcomes. This study highlights that even what surgeons do for the treatment of breast cancer can adversely impact a patient’s outcome.

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Breast Cancer: Black Patients Had Fewer Sentinel Lymph Node BiopsiesMedicalResearch.com Interview with: Dalliah Black, MD F.A.C.S.Department of Surgical Oncology The University of TexasMD Anderson Cancer Center, Houston

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Black: This study demonstrates the need for continued widely disseminated education to inform the medical community

of practice changes and guidelines of care so that all patients benefit from improvements in breast cancer treatment. Patients should also seek out guidelines for cancer care so that they can advocate for themselves and become familiar with what is acceptable or standard practice in order to minimize worse outcomes. Luckily, there is a lot of good patient directed education information from reputable national groups that are accessible for most patients.

• Also, we do not know why this disparity exists given that this is a retrospective database study. There are likely many factors that affect what type of care a patient receives including patient preference, the treating physicians, hospital type and location, and other socioeconomic factors.

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

Dr. Black: This study yields additional questions such as examining treatment decision making between the patient and healthcare team, understanding what factors determine why certain patients receive certain types of care, how national guideline practice changes are disseminated throughout our country to reach all physicians, and implementing programs to ensure that breast cancer patients receive the standard of care.

• We also found a higher rate of lymphedema in black patients receiving ALND compared to white patients. Future research examining factors that may predispose black women to lymphedema will be helpful in creating ways to minimize this complication.

• Examining surgical disparities in other disadvantaged and at risk patients of other ethnicities and low sociodemographics is also needed.

• Citation:• Racial Disparities in Sentinel Lymph Node Biopsy in Women with Breast Cancer• Black DM, Jiang J, Kuerer HM, Buchholz TA, Smith BD. Racial Disparities in Adoption of Axillary Sentinel Lymph Node Biopsy a

nd Lymphedema Risk in Women With Breast Cancer. JAMA Surg. Published online June 18, 2014. doi:10.1001/jamasurg.2014.23.

•

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Text Messaging May Help Diabetics Improve Glycemic ControlMedicalResearch.com Interview with:Athena Philis-Tsimikas, M.D.Corporate Vice PresidentScripps Whittier Diabetes Institute, a subsidiary of Scripps Health

• MedicalResearch: What are the main findings of the study?• Dr. Philis-Tsimikas: Findings from the Dulce Digital study suggest that a text message-based self-

management intervention improves glycemic control in high risk Latinos with type 2 diabetes.• Researchers recruited 126 Latinos with type 2 diabetes and HbA1c greater than 7.5% from

federally-qualified health centers (FQHCs) that serve disadvantaged populations to investigate the impact of a diabetes self-management intervention delivered via mobile text messaging. Cell phones were provided to patients who did not have them, along with text messaging instructions.

• Patients were randomized after completing clinical and self-reported measurements at baseline and these assessments were then repeated at 3 and 6 months. Both Dulce Digital and control groups received usual care. The Dulce Digital group received three types of text messages — educational and motivational; medication reminders; and blood glucose monitoring prompts — two to three messages each day initially, with frequency tapering over 6 months. Project Dulce staff then monitored blood glucose responses, assessed reasons for hyperglycemia or hypoglycemia and encouraged follow up with providers as needed.

• Still ongoing, the current analyses included 106 completed participants (mean age= 49.25±9.49 years, 74% female), 52 of which were Dulce Digital participants. Findings showed significantly greater decreases in HbA1c with text messages compared with usual care only (9.4% to 8.4%, vs. 9.5% to 9.3%, P<.05) at 6 month follow-up. No significant group differences, however, have been observed for lipids, weight or blood pressure.

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Text Messaging May Help Diabetics Improve Glycemic ControlMedicalResearch.com Interview with:Athena Philis-Tsimikas, M.D.Corporate Vice PresidentScripps Whittier Diabetes Institute, a subsidiary of Scripps Health

• MedicalResearch: Were any of the findings unexpected?• Dr. Philis-Tsimikas: At the six-month mark, it was found that the Dulce Digital participants had a

significantly larger decrease in HbA1c test levels than the control group. From these results, we can infer that the patient is getting the text messages, reading the text message, and checking their blood glucose. These are sent back and a RN is acting on the results. We can see that these patients are actually engaged.

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Philis-Tsimikas: The use of mobile phones in health care is very promising, especially when it

comes to low-income populations with chronic diseases.• By using text messages we were able to circumvent many of the barriers these patients face,

such as lack of transportation or childcare, while still being able to expand the reach of diabetes care and education.

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

• Dr. Philis-Tsimikas: Potential next steps include incorporating text messaging into conventional self-management education programs. Patients may be seen in one-on-one visits or groups visits and then have the text messages added as supplements once they get home. Messages would continue as ongoing reminders of care over the next six months.

• Citation:• Initial results of the Dulce Digital study were presented at the 74th Scientific Sessions of the Ame

rican Diabetes Association in San Francisco on June 13.Read the rest of the interview on MedicalResearch.comContent Not Intended as Specific Medical Advice

MedicalResearch.com: Interview withMette Andersen NexøPsychologist, Ph.D. student at The National Research Center for the Working EnvironmentCopenhagen Area, Denmark

• MedicalResearch: What is the background for this study?• Answer: The present study is a systematic assessment of the influence of a spectrum of thyroid

diseases on ability to work. By presenting new information on the possible socioeconomic consequences of thyroid diseases, the results can help bring awareness to important needs for rehabilitation of thyroid patients.

MedicalResearch: What are the main findings of the study?• Answer: Graves’ disease patients with eye complications were seven times more likely than

healthy peers to have an extended sick leave from work within a year of diagnosis. In subsequent years, the risk diminished but remained twice as high compared to healthy peers. Patients with Graves’ orbitopathy also had difficulties returning to work after sick leave or unemployment and was more than four times as likely to retire on a disability pension compared to healthy controls.

• People with hyperthyroidism without eye complications also faced a heightened risk of taking an extended sick leave. They were twice as likely as peers to miss weeks of work due to illness within a year of diagnosis.

• While the risk of taking sick leave was not significantly affected, people with autoimmune hypothyroidism faced longer recovery than healthy peers if they had to take sick leave in the first year after diagnosis. In subsequent years, there were no significant indication that the hypothyroidism affected workplace absenteeism.

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MedicalResearch.com: Interview withMette Andersen NexøPsychologist, Ph.D. student at The National Research Center for the Working EnvironmentCopenhagen Area, Denmark

• MedicalResearch: Were any of the findings unexpected?• Answer: The results indicate that some of the thyroid conditions may have considerable work

disability and therefore demonstrate needs for rehabilitation. At the same time the results also indicate that the work disability diminish with time – presumably because of the effects of treatment.

• MedicalResearch: What should clinicians and patients take away from your report?• Answer Hyperthyroidism (Graves’ disease and toxic nodular goiter) and hypothyroidism may

impact the ability to work, increase the risk and length of sick leave and make it difficult to return to work. These risks are most pronounced in the first year after being diagnosed with these diseases and attenuates in subsequent years. Patients with Graves’ disease who also have eye complications (Graves’ orbitopathy) are at highest risk of permanent work disability.

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

• Answer The next step is to identify how the socioeconomic consequences of thyroid diseases can be prevented. An important contribution of future research would be to identify treatment and work related factors that help people maintain their ability to work and remain employed.

• Citation:Increased Risk of Long Term Sickness Absence, Lower Rate of Return to Work, and Higher Risk of Unemployment and Disability Pensioning for Thyroid Patients: A Danish Register-based Cohort StudyRead the rest of the interview on MedicalResearch.comContent Not Intended as Specific Medical Advice

Animal Model Demonstrates Pediatric Use of Sunscreen Prevents MelanomaMedicalResearch.com Interview with:John L. VandeBerg PhDSouthwest National Primate Research Center Texas Biomedical Research InstituteSan Antonio, TX 78245-0549

• MedicalResearch: What are the main findings of this study?

Dr. VandeBerg: Despite the increasing use of sunscreen in recent decades, the incidence of melanoma continues to rise by 3% annually, leading to concerns that sunscreen may not be effective in preventing melanoma despite its efficacy in preventing sunburn. Our results established in the laboratory opossum, which is the only natural mammalian model of UVB-induced melanoma, that SPF 15 sunscreen applied to infants prior to low dose UVB radiation leads later in life to a 10-fold reduction in pre-melanotic lesions, which are known to progress to malignant melanoma.

•MedicalResearch: Were any of the findings unexpected?

• Dr. VandeBerg: This result was not unexpected in that it confirmed the hope that sunscreens do protect against melanoma, but the result was not a foregone conclusion.

• MedicalResearch: What should patients and providers take away from this report?• Dr. VandeBerg: This report confirms the importance of consistent use of sunscreen prior to exposure to sunlight. Because the animals used in

the study were infants and because adult laboratory opossums are not susceptible to UVB-induced melanoma, the results suggest that application of sunscreen to infants and young children may be crucial to the prevention of melanoma later in life. The importance of consistency in the use of sunscreen with infants is emphasized by the fact that the infant opossums were exposed to only nine doses of UVB which were so low that they did not cause reddening of the skin (erythema). Therefore, even limited exposure to sunlight early in life may well increase the risk of melanoma in adulthood.

• MedicalResearch: What further research do you recommend as a result of your work?• Dr. VandeBerg: Future research should be conducted to determine• 1) if sunscreens other than the one used in this study, particularly the newly marketed oral sunscreens, are effective in reducing risk of

melanoma,• 2) if increasing the SPF value of a sunscreen beyond SPF 15 further reduces risk of melanoma or has no added value,• 3) if oral anti-oxidants alone or in combination with sunscreen reduce the risk of melanoma.• Citation:• Modeling sunscreen mediated melanoma prevention in the laboratory opossum (Monodelphis domestica)

Hareesh B. Nair, Allen Ford, Edward J. Dick Jr, Ralph H. Hill Jr and John L. VandeBergPigment Cell & Melanoma ResearchJune 2014

• DOI: 10.1111/pcmr.12283

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Periodic Fasting May Lower Risk of Diabetes and Heart diseaseMedicalResearch.com Interview with:Benjamin D. Horne, PhD, MPH, FAHA, FACCDirector, Cardiovascular and Genetic Epidemiology, Intermountain Heart Institute

Adjunct Assistant Professor, Genetic Epidemiology Division, Department of Medicine, University of Utah

• MedicalResearch: What is the background for this study? • Dr. Horne: The Fasting II trial was a single-arm interventional trial of 24-hour water-only fasting among pre-diabetics with

metabolic syndrome. The participants were adults with fasting blood glucose >100 mg/dL and at least two other components of the metabolic syndrome, including high triglycerides, low HDL cholesterol (the “good” cholesterol), high blood pressure, or high waist circumference. The participants were asked to fast once per week for 6 weeks, with multiple goals in this pilot study. This is the first interventional trial of fasting in people with pre-diabetes or diabetes.

• MedicalResearch: What are the main outcomes of the study?• Dr. Horne: Compared to baseline, with other outcomes including changes in weight, LDL cholesterol, human growth hormone,

and red blood cell count. These outcomes were chosen based on prior research that we and others have performed. Another purpose of the trial was to evaluate whether individuals with pre-diabetes would be willing to comply with a fasting regimen, which was uncertain but necessary to understand for future, larger studies.

• The study found that glucose was unchanged over the six weeks of the trial among 12 individuals who enrolled, but weight decreased a statistically significant although modest amount (1.6 kg) over the six weeks. Compliance with the study’s fasting intervention was 100% during the 6 weeks of the study and no adverse events were reported including fainting episodes, migraine headaches, or hypoglycemia. Importantly, we validated our 2011 finding that, during each 24 hour fasting period, the concentration of LDL cholesterol (the “bad” cholesterol) in the blood increases, while over the long-term (in this case, 6 weeks) the baseline LDL level dropped significantly (about 13%).

• These findings indicate that fasting may directly reduce cardiac and metabolic risk factors and, thus, have a long-term impact on coronary disease and diabetes if fasting is engaged in repeatedly over a period of years. These results support several prior studies in which we showed that routine periodic fasting across the lifespan is, in fact, linked to a lower risk of diabetes and a lower risk of coronary artery disease.

• The findings are similar to findings that a few studies of obese individuals have shown for intermittent fasting and alternate-day fasting, but this study’s results occurred from a less intense fasting regimen than those obesity studies, suggesting that the more rigorous or intense regimens may not be needed if fasting is used as a perpetual lifestyle change rather than a short-term diet. This is of importance because no studies to date have evaluated the potential harms of intense fasting regimens, including malnutrition, development of eating disorders, and incidence of cardiac hypertrophy.

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Periodic Fasting May Lower Risk of Diabetes and Heart diseaseMedicalResearch.com Interview with:Benjamin D. Horne, PhD, MPH, FAHA, FACCDirector, Cardiovascular and Genetic Epidemiology, Intermountain Heart Institute

Adjunct Assistant Professor, Genetic Epidemiology Division, Department of Medicine, University of Utah

• MedicalResearch: What should clinicians and patients take away fro this report?• Dr. Horne: Clinicians and patients should realize that insufficient research has been performed to

recommend fasting as a medical intervention. Fasting is not a quick fix for health problems. While it may be possible to fast safely using one of the fasting regimens historically practiced in various societies, the optimal fasting approach that appropriately balances the likely benefits and potential harms of the practice is unknown. Further, the amount of fasting needed to obtain the correct benefit for any specific individual is also unclear, but it is expected that intense fasting regimens are necessary only for those at high risk of chronic disease, while less intense regimens may be acceptable for apparently healthy individuals. Anyone wishing to begin a fasting regimen at this time should consult with their personal physician and engage the physician in an active monitoring program to ensure appropriate health is maintained.

• MedicalResearch: What future research do you recommend as a result of this study?• Dr. Horne: Future research opportunities on the health effects of fasting are plentiful. The present

study will serve as a basis for a much larger study of hundreds of pre-diabetics and should lead to additional interventional studies in other population segments. Further research is required to not only fully characterize the causal effects of fasting but to discover what fasting duration, frequency, and extended term of practice are needed to realize the benefits of fasting for each individual based on personal requirements.

• Citation:• Abstract presented at the 2014 American Diabetes Meeting• Fasting reduces cholesterol levels in prediabetic people over extended period of time

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Hospital Weekend Rehabilitation Services Improve Outcomes and May Save MoneyMedicalResearch.com Interview with: Natasha K BruscoManager of Physiotherapy Services, Cabrini Health

PhD Candidate, Physiotherapy Department, Faculty of Health Science,La Trobe University, Bundoora, Victoria, Australia

• MedicalResearch: What are the main findings of the study?• Answer: This economic evaluation reports that providing additional Saturday rehabilitation, compared to Monday to Friday

rehabilitation alone, is likely to be cost saving per quality adjusted life year gained and for a minimal clinically important difference in functional independence. This builds on previous literature that reports that additional Saturday rehabilitation can improve functional independence and health related quality of life at discharge and may reduce patient length of stay.

• MedicalResearch: Were any of the findings unexpected?• Answer: In this study the likely reduction in patient length of stay and cost were expected based on the pilot study. What was

not expected was the likely reduction in overnight stays to the health service in the 30 day period post discharge. This result suggested that the improved functional status achieved at discharge, by the group who received the additional Saturday rehabilitation, had a flow on effect of continued reduction in health service utilisation post discharge from rehabilitation.

• MedicalResearch: What should clinicians and patients take away from your report?• Answer: The provision of weekend rehabilitation services has the potential for better patient outcomes as well as

cost savings for the health service. The short term cost of providing the additional Saturday rehabilitation service is outweighed by the likely reduction in length of stay and cost per admission, as well as improved clinical outcomes.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Answer: This study did not include the socioeconomic impact on the community once patients are discharged from

rehabilitation including return to work. The longer term economic outcomes post discharge, also warrant future research, which is planned. A final consideration may be investigation of a 7 day rehabilitation service versus the 6 day service examined in the current study.

• Citation:• Are weekend inpatient rehabilitation services value for money? An economic evaluation alongside a randomized controlled tri

al with a 30 day follow up

Brusco NK1, Watts JJ, Shields N, Taylor NF.BMC Med. 2014 May 29;12(1):89. doi: 10.1186/1741-7015-12-89.

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Depression Linked To Higher Risk of Heart DiseaseMedicalResearch.com: Interview with Dr. Amit J.Shah MDAssistant Research ProfessorAssistant Professor, Department of EpidemiologyEmory, Rollins School of Public Health

• MedicalResearch: What are the main findings of the study?• Dr. Shah: We discovered that in a group of patients who were undergoing heart evaluation with coronary angiography, symptoms of depression

predicted increased risk of coronary artery disease and death in women aged 55 years or less. This relationship was stronger in these women than older women, as well as in men aged 55 years or less. Over 1 in 4 women aged 55 years or less had moderate to severe depression, which was higher than any other group; these women had over twice the risk of having heart disease or dying over the next 3 years compared to those with none or mild depression.

• MedicalResearch: Were any of the findings unexpected?• Dr. Shah: We were impressed with how consistent the findings were; that these young, depressed women both had more coronary artery

disease and risk of death, while older women and younger men did not have these associations with depression. We also found that depressed men aged 65 or older had increased risk of death compared to those without depression, which was somewhat surprising. Finally, we were surprised that the increased risk of coronary artery disease in these young, depressed women did not explain their increased risk of death.

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Shah: Clinicians should view depression as a risk factor for heart disease in young women alongside with smoking and diabetes.

Psychiatrists may, in light of this, recommend lifestyle changes that may also have emotional benefits such as exercise. Other clinicians may consider discussing depression when surveying patients for heart disease risk factors. The American Heart Association recently released a statement suggesting that depression be recognized as a risk factors similar to other traditional risk factors.

• MedicalResearch: What recommendations do you have for a future study as a result of this study?• Dr. Shah: As the next step, it is important to do studies that evaluate the social and biological reasons behind these findings, as this could help

figure out the best way to prevent future deaths. In our lab, we are evaluating the biological effects of sudden stress in young women who have suffered from heart attacks, and comparing them to similarly aged men with recent heart attacks. Other clinical trials should also be done with various depression treatments, including antidepressants, which are commonly used but need more research to evaluate safety and efficacy in such high risk patients.

• Citation:• Sex and Age Differences in the Association of Depression With Obstructive Coronary Artery Disease and Adverse Cardiovascular Events• Amit J. Shah,Nima Ghasemzadeh,Elisa Zaragoza Macias,Riyaz Patel,Danny J. Eapen,Ian J. Neeland,Pratik M. Pimple,A. Maziar Zafari, Arshed A. Q‐

uyyumi, and Viola Vaccarino• J Am Heart Assoc. 2014;3:e000741, originally published June 18, 2014, doi:10.1161/JAHA.113.000741 •

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Do Antidepressants During Pregnancy Promote Cardiac Birth Defects?MedicalResearch.com Interview InvitationDr. Krista Huybrechts MD PhD Brigham & Women’s Hospital Department of MedicineDivision of Pharmacoepidemiology &

PharmacoeconomicsBoston, MA 02120

• MedicalResearch: What are the main findings of the study?• Dr. Huybrechts: In this cohort study including 949,504 pregnant women enrolled in Medicaid, we examined

whether the use of selective serotonin reuptake inhibitors (SSRIs) and other antidepressants during the first trimester of pregnancy is associated with increased risks for congenital cardiac defects. In order to control for potential confounding by depression and associated factors, we restricted the cohort to women with a depression diagnosis and used propensity score adjustment to control for depression severity and other potential confounders. We found no substantial increased risk of cardiac malformations attributable to SSRIs. Relative risks for any cardiac defect were 1.25 (95%CI, 1.13-1.38) unadjusted, 1.12 (1.00-1.26) depression-restricted, and 1.06 (0.93-1.22) depression-restricted and fully-adjusted. We found no significant associations between the use of paroxetine and right ventricular outflow tract obstruction (1.07, 0.59-1.93), or the use of sertraline and ventricular septal defects (1.04, 0.76-1.41); two potential associations that had been of particular concern based on previous research findings.

• MedicalResearch: Were any of the findings unexpected?• Dr. Huybrechts: In 2005, based on early results of two epidemiologic studies, the FDA warned healthcare

professionals that early prenatal exposure to paroxetine may increase the risk of congenital cardiac malformations. Since then, several studies have evaluated the teratogenicity of SSRIs and other antidepressants. Existing studies have reported different associations, often in the context of multiple comparisons. It has remained unclear, however, whether these associations are causal, or due to systematic error or chance. We designed the study to test one specific hypothesis with enough statistical power, while minimizing biases. We did not know a priori whether we were going to confirm or refute the hypothesis. Our results do not support earlier findings of an association between antidepressants and cardiac anomalies, in particular for paroxetine and sertraline.

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Do Antidepressants During Pregnancy Promote Cardiac Birth Defects?MedicalResearch.com Interview InvitationDr. Krista Huybrechts MD PhD Brigham & Women’s Hospital Department of MedicineDivision of Pharmacoepidemiology &

PharmacoeconomicsBoston, MA 02120

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Huybrechts: Decisions by clinicians and women about whether to continue or discontinue

treatment with antidepressants during pregnancy must balance potential risks of treatment with the risks of not treating women with severe depression. Our results suggest that first trimester use of antidepressants does not substantively increase the risk of specific cardiac defects. The accumulated evidence implies low absolute risks and argue against the existence of important cardiac teratogenic effects for the most commonly used antidepressant medications.

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

• Dr. Huybrechts: This study addresses only one piece of the complex puzzle about the safety of antidepressants during pregnancy. More research is necessary to evaluate the risks and benefits of using these medications during pregnancy for both women and their newborns, including outcomes such as pre-term birth and neonatal withdrawal, and the safety issues that can result from withholding a needed treatment in pregnant women with severe depression that requires medication.

• Citation:• Antidepressant Use in Pregnancy and the Risk of Cardiac Defects• Krista F. Huybrechts, Ph.D., Kristin Palmsten, Sc.D., Jerry Avorn, M.D., Lee S. Cohen, M.D., Lewis B

. Holmes, M.D., Jessica M. Franklin, Ph.D., Helen Mogun, M.S., Raisa Levin, M.S., Mary Kowal, B.A., Soko Setoguchi, M.D., Dr.P.H., and Sonia Hernández-Díaz, M.D., Dr.P.H.

• N Engl J Med 2014; 370:2397-2407June 19, 2014DOI: 10.1056/NEJMoa1312828Read the rest of the interview on MedicalResearch.comContent Not Intended as Specific Medical Advice

Multifactorial Causes For Increase In Overdoses From Opiod PainkillersMedicalResearch.com Interview with:Nicholas B. King, PhD, Biomedical Ethics UnitMcGill University Montreal QC Canada

• MedicalResearch: What are the main findings of the study?• Dr. King: Unintentional overdoses from prescription opioid painkillers have been rising sharply in

the US and Canada during the past two decades, killing thousands of people every year. A lot has been written about the subject in both popular media and scholarly literature, but we still don’t have a very good idea of why this has happened. So we tried to objectively and systematically assess evidence for what has contributed to increasing mortality. We found the following:

• (1) The evidence base for why mortality has increased is very thin, and more research is urgently required.

• (2) We found evidence for at least 17 different causes of increased mortality. We found the most evidence for the following factors: dramatically increased prescription and sales of opioids; increased use of strong, long-acting opioids like oxycodone and methadone; combined use of opioids and other (licit and illicit) drugs and alcohol; and social and demographic characteristics. We found little evidence that internet sales of pharmaceuticals and errors by doctors and patients–factors commonly cited in the media–have played a significant role.

•MedicalResearch: Were any of the findings unexpected?

• Dr. King: On the whole, we were surprised by how few studies have actually investigated the causes of increased mortality in a rigorous manner. We were also surprised to find little solid evidence for several factors that have received substantial coverage in media and in commentaries/editorials, namely: errors by physicians and patients; internet sales of opioids; and so-called “pill mills.”

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Multifactorial Causes For Increase In Overdoses From Opiod PainkillersMedicalResearch.com Interview with:Nicholas B. King, PhD, Biomedical Ethics UnitMcGill University Montreal QC Canada

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. King: Clinicians, patients, and policymakers should take away the following messages:• (1) Increased mortality is driven by many different factors, including the prescribing behavior of physicians, particularly the

prescription of opioid analgesics for chronic non-cancer pain, and the prescription of stronger, long-acting opioids; patients’ and other users’ behaviors, including use of opioids in conjunction with alcohol, sedatives, and anti-depressants; and systemic factors such as the liberalizing of opioid prescribing guidelines.

• (2) There is likely no one-size-fits-all strategy for reducing mortality in the US and Canada, which will require novel, multisectoral public health approaches that address multiple determinants and are targeted at specific populations.

• (3) This should also sound a cautionary note for global efforts to increase access to opioids. Currently, the US and Canada rank #1 and #2 in per capita opioid consumption, and in many poor countries prescription opioids are unavailable. Since lack of access to opioids is considered to be a violation of a basic human right to freedom from unnecessary pain, many are pushing for increased opioid access in low in come countries. Our findings show some of the possible ways that this could lead to increased deaths, and thus might be useful in preventing other countries from following the same path as the US and Canada.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. King: One of our principal findings is that there is a serious lack of solid, well-designed research that is intended to identify the

causes of increased opioid-related mortality, and almost none explaining the sociodemographic differences in opioid-related mortality.

• Recommendation #1 is for well-designed research explicitly designed to identify causes of mortality increases on national, state/province, and local levels.

• Recommendation #2 is for research designed to identify causes of variations in opioid-related mortality according to race/ethnicity, age, gender, socioeconomic status, and urban/rural residence.

• Finally, recommendation #3 is for research that tries to investigate how to prevent similar increases in opioid-related mortality as access to opioids is increased in other countries.

• Citation:• Determinants of Increased Opioid-Related Mortality in the United States and Canada, 1990–2013: A Systematic Review• Nicholas B. King, Veronique Fraser, Constantina Boikos, Robin Richardson, Sam HarperAmerican Journal of Public Health:

Posted online on 12 Jun 2014

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Study Links Loss Of APC Gene with Autistic Behaviors and Cognitive ImpairmentsMedicalResearch.com Interview withMichele Jacob, Ph.D. Professor of NeuroscienceSackler School of Graduate Biomedical SciencesTufts University

• MedicalResearch: What are the main findings of the study?• Dr. Jacob: Autistic-like behaviors and cognitive impairments associate with loss of the Adenomatous Polyposis Coli (APC) gene. We

deleted APC chiefly from excitatory neurons in the mouse developing forebrain; the mice exhibited changes in synapse maturation and density, reduced social interest, increased repetitive behaviors, and learning deficits. In addition, we found molecular changes that define a novel role for APC in linking to and regulating the levels of particular proteins that function in synaptic adhesion complexes and signaling pathways that are required for normal learning and memory consolidation.

•MedicalResearch: Were any of the findings unexpected?

• Dr. Jacob: Yes. One of the signaling molecules altered by APC loss is presenilin1. Presenilin gene mutations are the leading cause of familial Alzheimer‘s disease. The role of presenilin in neurodevelopmental brain disorders is not well defined.

• In addition, we found excessive levels of Wnt responsive gene expression caused by APC loss. This change is also predicted for spontaneous mutations in another gene, CHD8, recently identified as a high confidence risk factor for sporadic autism. Thus, our findings are likely relevant to autism and intellectual disabilities caused by other human gene mutations, not only APC.

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

Dr. Jacob: We are gaining new insights into molecular changes in the developing brain of mouse models that display cognitive and autistic-like disabilities. Identifying key pathways that are deregulated is critical for defining new targets and developing new and effective therapeutic strategies.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. Jacob: To utilize diverse genetic mutant and inflammation mouse models that display autistic-like behaviors to elucidate the

critical molecular perturbations and relevant brain regions. Defining convergent changes is essential to design specific therapeutic approaches to ameliorate the disabilities.

• Citation:• Adenomatous polyposis coli protein deletion leads to cognitive and autism-like disabilities

J L Mohn, J Alexander, A Pirone, C D Palka, S-Y Lee, L Mebane, P G Haydon and M H JacobMolecular Psychiatry , (17 June 2014) | doi:10.1038/mp.2014.61

•

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Study Finds No Increase In Suicide Events With ADHD Drug TreatmentsMedicalResearch.com Interview with:Dr. Henrik Larsson PhD Associate ProfessorDepartment of Medical Epidemiology and Biostatistics Karolinska Institute Stockholm, Sweden

• MedicalResearch: What are the main findings of the study?• Dr. Larrson: We found no evidence for an overall increased rate of suicide related events

associated with the use of stimulant or non-stimulant drug treatment for ADHD. If anything, the results pointed to a potential protective effect of drugs for ADHD on suicidal behaviour, particularly for stimulant drugs.

MedicalResearch: Were any of the findings unexpected?• Dr. Larrson: ADHD medications influence the core symptoms of ADHD such as impulsivity

which in turn is a well-established risk factor for suicidal behavior, thus, pointing at a potential protective effect of ADHD medications.

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Larrson: Our study found no evidence for a harmful effect of ADHD drug treatment on

suicidal behaviour irrespective of whether the drug was stimulant or non-stimulant.• MedicalResearch: What recommendations do you have for future research as a result of

this study?• Dr. Larrson: The observed protective effect of stimulant drugs on suicidal behaviour among

ADHD patients who received only stimulant drugs needs further investigation.• Citation:

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What is the Sweet Spot For Hypertension Control?MedicalResearch.com Interview withCarlos J. Rodriguez, MD, MPHDepartment of Medicine and Public Health Sciences, Wake Forest University School of Medicine Winston-Salem, North Carolina

• MedicalResearch: What are the main findings of the study?• Dr. Rodriguez: As a clinician there is a notion suggesting that lower blood pressure is better but our

current research to date is controversial and not conclusive. We wanted to study a large group of people with hypertension and see whether over 20 years of follow up, if a lower systolic blood pressure would be associated with lower cardiovascular events (heart attack, stroke, heart failure, angina). We hypothesized that there would be a linear association between blood pressure and events, that lower blood pressure would be associated with lower events and that as the blood pressure went up there would be more events. We found this was not the case but that hypertensives with a blood pressure between 120-138mmhg have the greatest benefit and those with a blood pressure less than 120mmhg did not have additional benefit.

• MedicalResearch: What should clinicians and patients take away from your report? • Dr. Rodriguez: Our study does emphasize that the greatest clinical benefit comes from getting patients

below 140mmhg. This was not a treatment study so I do not think it changes treatment but it does bring into question the notion of whether lower blood pressure is better.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. Rodriguez: The SPRINT treatment trial is underway to help answer this question and provide a clinical

recommendation. We should all participate and support the completion of the SPRINT clinical trial.• Citation:• Rodriguez CJ, Swett K, Agarwal SK, et al. Systolic Blood Pressure Levels Among Adults With Hypertension a

nd Incident Cardiovascular Events: The Atherosclerosis Risk in Communities Study. JAMA Intern Med. Published online June 16, 2014. doi:10.1001/jamainternmed.2014.2482.

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Texting Bans and Reduction in Roadway DeathsMedicalResearch.com Interview with: Alva O. Ferdinand, DrPH, JDTexas A&M Health Science CenterSchool of Public Health College Station, TX 77843

• MedicalResearch: What are the main findings of the study?• Answer: Over the last decade, several states have enacted legislating making it illegal to text while driving. However, little

is known about the impact that state texting-while-driving bans have had on roadway crash-related fatalities. Some states have banned all drivers from texting while driving while others have banned only young drivers from this activity. Furthermore, some states’ texting bans entail secondary enforcement, meaning an enforcement officer must have another reason to stop a vehicle before citing a driver for texting while driving, and other states’ texting bans entail primary enforcement, meaning an enforcement officer does not have to have another reason for stopping a vehicle.

• We conducted a longitudinal panel analysis examining within-state changes in roadway fatalities after the enactment of state texting-while-driving bans using roadway fatality data as captured in the Fatality Analysis Reporting System between 2000 and 2010. To further examined the impact of these bans on various age groups, as younger individuals are thought to engage in texting while driving more often than older individuals. States that had enacted texting-while-driving bans during the study period were considered “treatment” states and states that had not passed texting-while-driving bans were considered “control” states.

• We found that states with primary laws banning young drivers only saw an average of an 11% reduction in roadway following the enactment of such bans during the study period. States with primary laws banning all drivers were also associated with significant reductions for those aged 15 to 21 and those who were 65 years old or older. States with secondarily enforced bans, whether banning all drivers or young drivers only, did not see any significant reductions in roadway fatalities.

• MedicalResearch: Were any of the findings unexpected?• Answer: We were a little surprised to see that primarily enforced texting bans were not associated with significant

reductions in fatalities among those aged 21 to 64. However, our analyses indicated that states that had passed overarching hand-held bans (i.e. bans prohibiting the use of cell phones without hands-free technology altogether) on all drivers saw significant reductions in fatalities among this particular age group. Thus, although texting-while-driving bans were most effective for reducing traffic-related fatalities among young individuals, handheld bans appear to be most effective for adults.

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Texting Bans and Reduction in Roadway DeathsMedicalResearch.com Interview with: Alva O. Ferdinand, DrPH, JDTexas A&M Health Science CenterSchool of Public Health College Station, TX 77843

• MedicalResearch: What should clinicians and patients take away from your report?• Answer: Our results indicate states that have enacted texting-while-driving bans with

secondary enforcement should consider revising their legislation to entail primary enforcement. Moreover, states that have not enacted any texting-while-driving are missing out on opportunities to prevent avoidable roadway deaths. Our analyses indicated reductions in total roadway fatality counts of at least 2.3% in states with these bans. This equates to an average of 19 deaths prevented per year in states with these bans.

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

• Answer: Our study only looked at one roadway outcome following a roadway crash — death. There are many other outcomes that can come about as a result of texting while driving. These include emergency department visits, hospitalization, minor injuries just requiring first aid at the scene of the crash, property damage and sustained injury. Future research should look at the impact of texting-while-driving bans on these more common roadway outcomes.

• Citation:• Alva O. Ferdinand, Nir Menachemi, Bisakha Sen, Justin L. Blackburn, Michael Morrisey, and Le

onard Nelson. (2014). Impact of Texting Laws on Motor Vehicular Fatalities in the United States. American Journal of Public Health. e-View Ahead of Print.

• doi: 10.2105/AJPH.2014.301894

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Inflammatory Bowel Disease: Risk of Cancer with TNF-α Antagonists?MedicalResearch.com Interview with:Nynne Nyboe Andersen, MD, PhD studentDepartment of Epidemiology Research Statens Serum Institut2300 Copenhagen, Denmark

• MedicalResearch: What are the main findings of the study?• Dr. Andersen: Previous studies evaluating the risk of cancer associated with the use of TNF-α antagonists are mainly based on data from randomized

clinical trials with a short follow up time. Consequently, we used the national Danish registries to conduct a nationwide population-based cohort study assessing the risk of cancer in patients with inflammatory bowel disease (IBD) exposed to these drugs from their introduction in 1999 until 2012. We included more than 56.000 patients with IBD and among those 4500 were exposed to TNF-α antagonists, contributing with almost 20.000 person-years of follow-up.

• Our main results revealed that the risk of overall cancer was significantly increased in the analysis adjusted for propensity score and potential confounders except for azathioprine, however, when we additionally adjusted for azathioprine use the relative risk decreased markedly leaving no significant increased risk of cancer. Given the upper limit of the confidence intervals, this study could rule out a more than 36% relative increase in the risk of overall cancer over a median follow-up of 3.7 years among TNF-α antagonist-exposed patients with 25% of these followed for 6 years or longer. We also did some stratified analyses according to cumulative number of TNF-α inhibitor doses, and time since first TNF-α inhibitor dose, but these results did not reveal any significantly increased risk of cancer nor did the analyses on site-specific cancers.

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Andersen: The study confirms and expands on previous literature and provides reassuring results on the long-term safety of TNF-α antagonists.

Although a small increase in the risk of overall cancer may be observed in patients exposed to TNF-α antagonists, this increase in risk might be attributable to concomitant use of azathioprine. Thus, our study provides the clinicians with an updated safety profile regarding malignancy risk associated with TNF-α antagonists based on the entire Danish IBD population and these results can most likely be extended to other Western countries. For the patients our study provides reassuring results and may therefore facilitate the decision between clinicians and patients whether or not to begin or continue treatment.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. Andersen: Keeping in mind the often protracted progression of cancer there is a need of continuous population-based studies with even longer

follow up time. Further, our study was not powered to rule out a more than 2-fold increased risk of different site-specific cancers including skin cancer, hematopoietic and lymphoid tissue cancer and there is a need of even larger scale population-based study to assess this. Further, there is a lack of data regarding the cancer risk of the different TNF-α antagonists separately.

• Citation:• Association Between Tumor Necrosis Factor-α Antagonists and Risk of Cancer in Patients With Inflammatory Bowel Disease• Nynne Nyboe Andersen MD, Björn Pasternak MD, PhD, Saima Basit MSc, Mikael Andersson MSc, Henrik Svanström MSc, Sarah Caspersen MD, Pia

Munkholm MD, DMSc, Anders Hviid MSc, DMSc, Tine Jess MD, DMSc• JAMA. 2014;311(23):2406-2413. doi:10.1001/jama.2014.5613

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Warfarin Dosing: Do Genotype-Based Algorithms Improve Outcomes?MedicalResearch.com Interview with:David L. Brown, MD, FACC Professor of MedicineCardiovascular Division Washington University School of Medicine

St. Louis, MO 63110

• MedicalResearch: What are the main findings of the study?• Dr. Brown: This meta-analysis of randomized controlled trials showed that using a genotype-

based warfarin dosing algorithm did not improve the process or outcomes of anticoagulation compared to using a clinical dosing algorithm.

• MedicalResearch: Were any of the findings unexpected?• Dr. Brown: The findings may be surprising to many clinicians and investigators since the

genotypes used to adjust warfarin dosing in the included studies are responsible for approximately one-third of the variation in dose requirement among patients taking warfarin.

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Brown: They should take away that although personalized medicine is an attractive concept,

its implementation requires proof of patient benefit just like another new test, drug or procedure.• MedicalResearch: What recommendations do you have for future research as a result of this

study? • Dr. Brown: As new genetic polymorphisms are discovered and new algorithms are developed,

they will need to be tested in appropriately sized trials to demonstrate clinical benefit.• Citation:• Stergiopoulos K, Brown DL. Genotype-Guided vs Clinical Dosing of Warfarin and Its Analogues: Me

ta-analysis of Randomized Clinical Trials. JAMA Intern Med. Published online June 16, 2014. doi:10.1001/jamainternmed.2014.2368.

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Communication Skills Training For Oncologists Helps Both Patients and ProvidersMedicalResearch.com Interview with:Yosuke Uchitomi, MD, PhD Professor and Chairman, Department of Neuropsychiatry,

Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences,Okayama, Japan

• MedicalResearch: What are the main findings of the study?• Dr. Uchitomi: This study demonstrated the effect of communication skills training (CST) consisted of didactic lecture, role-plays,

and peer discussion for oncologists with extensive experience in comprehensive cancer center hospitals in improving the psychological distress of cancer patients as well as oncologist performances and confidence in communicating with patients, using a randomized design. Reasons for this positive result might include that the communication skills training program had been developed based on patient preferences regarding the communication of bad news and oncologists’ needs.

MedicalResearch: Were any of the findings unexpected?• Dr. Uchitomi: All communication skills dealt with in the communication skills training program enhanced the oncologists’

repertoire for dealing with difficult situations clinically. Interestingly, these increased performance skills did not prolong the consultation time. This result suggests the possibility that a patient’s psychological distress can be reduced without increasing demands on the labor of oncologists in busy clinical practice.

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Uchitomi: Communication skills (setting up the supporting environment of the interview, make consideration for how to

deliver the bad news, provision reassurance and addressing the patient’s emotion with empathetic responses) that comply with patient preferences can be taught to oncologists with extensive experience and their utilization decreases patient distress.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. Uchitomi: We need to evaluate the long-term effects, that oncologists who participated in a CST workshop maintained their

communication skills at a high level a few months or years.• Furthermore, our study might provide a direction for future research in the application of CST for more health professionals in

oncological practice, in order to help oncologists deal with unrecognized distress among patients diagnosed with cancer.• Citation:• Effect of Communication Skills Training Program for Oncologists Based on Patient Preferences for Communication When Receivi

ng Bad News: A Randomized Controlled Trial• Maiko Fujimori, Yuki Shirai, Mariko Asai, Kaoru Kubota, Noriyuki Katsumata, and Yosuke Uchitomi• JCO JCO.2013.51.2756; published online on June 9, 2014;

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Acid Reflux More Frequent During Naps than Nighttime SleepMedicalResearch.com Interview with:Ronnie Fass, M.D., FACG, Professor of Medicine Case Western Reserve UniversityDirector, Division of Gastroenterology and Hepatology

, Head, Esophageal and Swallowing Center, Metro Health Medical CenterCleveland, OH

• MedicalResearch: What are the main findings of the study?• Dr. Fass: This is the first study to compare the extent of acid reflux between nighttime sleep

and daytime naps in patients with Gastroesophageal reflux disease. The results of our study show that naps are associated with significantly greater esophageal acid exposure compared to sleep. Acid reflux events were more frequent and their total duration was longer during naps when compared with acid reflux events during nighttime sleep. Additionally, the fraction of time that the subjects were experiencing acid reflux with pH < 4 was significantly higher during naps than nighttime sleep and subjects experienced more symptoms due to acid reflux during their nap than their sleep.

• MedicalResearch: Were any of the findings unexpected?• Dr. Fass: The degree of esophageal acid exposure during nap time was much greater than

originally anticipated when compared with the degree of esophageal acid exposure during nighttime sleep.

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Acid Reflux More Frequent During Naps than Nighttime SleepMedicalResearch.com Interview with:Ronnie Fass, M.D., FACG, Professor of Medicine Case Western Reserve UniversityDirector, Division of Gastroenterology and Hepatology

, Head, Esophageal and Swallowing Center, Metro Health Medical CenterCleveland, OH

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Fass: The study suggests that napping is a more vulnerable period of acid reflux events and GERD-related

symptoms than sleep time, probably because it is primarily comprised of stages N1 and N2 sleep. Nighttime sleep on the other hand, is also comprised of periods of deep sleep that appear to be suppressive of acid reflux events. Thus, in as much as acid reflux is worse during napping, the often occurring habit of napping after meals may result in more severe clinical sequelae of GERD than if sleep confined to the usual nocturnal bedtime. Furthermore, the common practice in many cultures of taking a nap immediately after a heavy meal during lunchtime, may in fact increase patients’ risk of developing GERD-related complications. Further studies are needed to establish this hypothesis.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. Fass: Studies have demonstrated that Gastroesophageal reflux during recumbancy is more commonly

associated with a much more severe and complicated GERD. Our study suggests that napping may drive even further the severity of GERD and the likelihood that patients will develop GERD-related complications. Future studies need to look into the impact of napping on the severity of GERD, both at the symptoms and mucosal level. In addition, assessment of the different domains of GERD-related symptoms (frequency, severity and duration), should be pursued in a prospective fashion in those that nap versus those who do not nap on a daily basis.

• Citation:• Naps are More Commonly Associated with Gastroesophageal Reflux, Compared With Nocturnal Sleep

Laya Nasrollah, MD, Carla Maradey-Romero, Lokesh K. Jha, MD1Rakshith Gadam, MD, Stuart F. Quan, MD,

Ronnie Fass, MD• Clinical Gastroenterology and Hepatology

Available online 4 June 2014

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Patients With Mental Illness More Likely To Be Victims of HomicideMedicalResearch.com Interview with:Professor Louis ApplebyProfessor of Psychiatry C.B.EThe University of Manchester in the UK

• MedicalResearch: What are the main findings of the study?• Professor Appleby: “Patients with mental illness are two and a half times more likely to be victims of homicide than people in the general

population according to our research published in The Lancet Psychiatry today.• “In this study, the National Confidential Inquiry into Suicide and Homicide by People with Mental Illness (NCI), based at The University of

Manchester, examined data on the victims and perpetrators of all homicides in England and Wales between January, 2003 and December, 2005.

• We found that during the 3-year study period, 1496 people were victims of homicide, and 6% (90) of them had been under the care of mental health services in the year before their death. A third (29) of these patient victims were killed by other patients with mental illness.

• In 23 homicides in which the victim was a mental health patient killed by another mental health patient, the victim and the perpetrator were known to each other either as partners (9, 35%), family members (4, 15%), or acquaintances (10, 38%). In 21 of these 23 cases, both the victims and perpetrators were undergoing treatment at the same National Health Service Trust.

• Alcohol and drug misuse (victims 66%, perpetrators 93%) and a history of violence (victims 24%, perpetrators 24%) were common among both patient victims and perpetrators. The study also found that in the 3 years to 2005, 213 mental health patients were convicted of homicide—accounting for 12% of all homicide convictions.”

MedicalResearch: Were any of the findings unexpected?• Professor Appleby: “Historically, society has been more concerned about the risk of patients committing violence than the vulnerability of

patients to violent acts. However, our findings show that specialist mental health providers in England and Wales can expect one of their patients to be the victim of homicide roughly every 2 years.”

• MedicalResearch: What should clinicians and patients take away from your report?• Professor Appleby: “Assessing patients for risk of suicide and violence is common practice, but screening for risk of becoming victims of

violence is not. Understanding that a patient’s risk can depend on the environment they are in—for example their use of alcohol or drugs, or their contact with patients with a history of violence—and properly assessing these risk factors should become a key part of clinical care plans.”

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Professor Appleby: “The National Confidential Inquiry into Suicide and Homicide by People with Mental Illness will continue to look at trends

and figures for suicide and homicide and hope our findings can be used to inform and improve current medical practice.”• Citation:• Cathryn Rodway, Sandra Flynn, David While, Mohammed S Rahman, Navneet Kapur, Louis Appleby, Jenny Shaw. Patients with mental illness as

victims of homicide: a national consecutive case series. Lancet Psychiatry, June 2014 DOI: 10.1016/S2215-0366(14)70221-4

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Nervous System Peptides May Contribute To Ovarian FailureMedicalResearch.com Interview with:Sergio R. Ojeda, D.V.M.Division Head and Senior Scientist Division of Neuroscience

Division of Neuroscience, OR National Primate Research Center/Oregon Health and Science University , Beaverton OR 97006

• MedicalResearch: What are the main findings of the study?• Dr. Ojeda: The study shows that a receptor for two growth factors (brain-derived neurotrophic factor [BDNF]

and neurotrophin 4/5 [NT4/5]) that are known to be important for development of the nervous system is also essential for maintaining oocyte integrity and survival in the mammalian ovary. Intriguingly, the full-length form of this receptor (known as NTRK2-FL) is not expressed in oocytes until the time of the first ovulation. At this time, the pre-ovulatory gonadotropin discharge stimulates granulosa cells of ovarian follicles to produce not only more BDNF, but also more of a peptide known as kisspeptin, to induce the formation of NTRK2-FL in oocytes. To date, kisspeptin was known to be only critical for the hypothalamic control of reproduction. To induce NTRK2-FL, BDNF binds to truncated NTRK2 receptors (NTRK2-T1), which are abundant in oocytes throughout prepubertal development. Kisspeptin, on the other hand, does so by activating its receptor KISS1R, also expressed in oocytes. Once present after the first ovulation, NTRK2-FL is able to activate a survival pathway in oocytes following gonadotropin stimulation, presumably at every cycle. In the absence of NTRK2-FL, oocytes die, follicular structure disintegrates and a condition of premature ovarian failure ensues.

MedicalResearch: Were any of the findings unexpected?• Dr. Ojeda: Two findings were unexpected;• 1) That the presence of NTRK2-FL in oocytes is required for gonadotropins to support oocyte survival after

puberty, but not before the first ovulation, and• 2) That preovulatory levels of gonadotropins require the dual release of BDNF and kisspeptin from granulosa

cells of antral follicles to induce the expression of NTRK2-FL in oocytes. These findings indicate that oocyte survival after puberty is maintained by recurrent preovulatory increases in pituitary gonadotrophin secretion, but that, surprisingly, this effect is mediated by the concerted action of a neurotrophic factor (BDNF) and a neuroendocrine peptide (kisspeptin).

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Nervous System Peptides May Contribute To Ovarian FailureMedicalResearch.com Interview with:Sergio R. Ojeda, D.V.M.Division Head and Senior Scientist Division of Neuroscience

Division of Neuroscience, OR National Primate Research Center/Oregon Health and Science University , Beaverton OR 97006

• MedicalResearch: What should clinicians and patients take away from your report? • Dr. Ojeda: That loss of ovarian function during adulthood may be caused not only by

endocrine factors but also by loss of function of two peptides previously known to be only important for nervous system development and for the hypothalamic control of reproduction.

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

• Dr. Ojeda: It will be important to carry out studies to determine if common genetic variation affecting the genes encoding BDNF and its receptor NTRK2-FL, in addition to KISS1 (the gene encoding kisspeptin) and KISS1R (the gene encoding the kisspeptin receptor) are affected in patients with premature ovarian failure. If this proven to be the case, it will be important to find ways to treat the disorder by administering BDNF and kisspeptin agonists.

• Citation:• Loss of Ntrk2/Kiss1r signaling in oocytes causes premature ovarian failure• Dorfman MD1, Garcia-Rudaz C, Alderman Z, Kerr B, Lomniczi A, Dissen GA, Castellano JM,

Garcia-Galiano D, Gaytan F, Xu B, Tena-Sempere M, Ojeda SR.Endocrinology. 2014 May 30:en20141111. [Epub ahead of print]

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Genetic Structures Underlying Depression and Anxiety During DevelopmentMedicalResearch.com Interview with:Monika Waszczuk 1+3 PhD StudentMRC SGDP Research Centre Institute of Psychiatry, King’s College LondonDeCrespigny Park London UK

• MedicalResearch: What are the main findings of the study?• Answer: Little is known about the genetic influences on the relationship between depression and anxiety disorders across development. We used

two population-based prospective longitudinal twin and sibling studies to investigate phenotypic associations between the symptoms of these disorders, and tested genetic structures underlying these symptoms across three developmental stages: childhood, adolescence and early adulthood.

• We found that depression and anxiety disorder symptoms are largely distinct in childhood and are influenced by largely independent genetic factors. Depression and anxiety symptoms become more associated and shared most of their genetic etiology from adolescence. An overarching internalizing genetic factor influencing depression and all anxiety subscales emerged in early adulthood. These results provide preliminary evidence for different phenotypic and genetic structures of internalizing disorder symptoms in childhood, adolescence and young adulthood, with depression and anxiety becoming more associated from adolescence.

• MedicalResearch: Were any of the findings unexpected?• Answer: This study was the first to look at the genetic structures underpinning depression and anxiety separately at three different developmental

stages. Unexpectedly, we found that childhood, adolescence and adulthood are characterized by different phenotypic and genetic relationships between these symptoms. Previous literature suggested that childhood and adolescence depression may differ, but this is the first study that investigated these developmental changes with relation to a range of anxiety disorder symptoms comprehensively across development.

• MedicalResearch: What should clinicians and patients take away from your report?• Answer: Our results support transdiagnostic treatment approaches for anxiety and depression disorders, which are designed to target common

elements of several disorders in one protocol. While disorder-specific treatment may be more appropriate for pediatric patients, treatment focused on a range of symptoms common to internalizing disorders may be more appropriate for older patients. Finally, our findings affirm the need to continue examining the classification of mood and anxiety disorders in diagnostic systems.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Answer: An overarching genetic internalizing factor provides preliminary support for broadening phenotypic definitions in molecular genetic

studies in adult participants. However, future research should acknowledge that depression and anxiety can differ with age, and thus focus on more narrow age ranges across development. Future studies should also examine the longitudinal relationship between depression and a range of anxiety disorder symptoms, to investigate the degree of genetic continuity characterizing these symptoms.

• • Citation:• Waszczuk MA, Zavos HS, Gregory AM, Eley TC. The Phenotypic and Genetic Structure of Depression and Anxiety Disorder Symptoms in Childhood,

Adolescence, and Young Adulthood. JAMA Psychiatry. Published online June 11, 2014. doi:10.1001/jamapsychiatry.2014.655.

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Prevention of Breast Cancer in High-Risk Postmenopausal WomenMedicalResearch.com Interview with: Jack Cuzick PhDCentre for Cancer PreventionWolfson Institute of Preventive MedicineQueen Mary University of London, London UK

• Dr. Cuzick offers the manuscript below to put the results of the Anastrozole for prevention of breast cancer in high-risk postmenopausal women (IBIS-II): an international, double-blind, randomised placebo-controlled trial in focus for MedicalResearch.com.

• The Prevention of Breast Cancer• The first human evidence that drug treatment might reduce the incidence of breast cancer was reported in

19851, where it was found that use of tamoxifen in a trial of women with breast cancer to reduce recurrence of existing tumours also had a major impact on new tumours in the opposite breast, reducing them from 10 to 3. That observation has subsequently been confirmed in several other adjuvant trials and an overview of all such trials indicates that after an average of about 8 years of follow up, 5 years of tamoxifen reduced new contralateral tumours by 39%, with similar effects in years 0-5 and 5-10 in women with oestrogen receptor positive or unknown primary tumours2. These observations and positive results from animal studies3, led to the evaluation of 5 years of tamoxifen in women without breast cancer, but at high risk in 4 large trials. A recent overview4 indicates a 33% reduction in all breast cancer after a 10 years follow up, with a larger reduction in years 0-5 (48%), when treatment was given, and a continuing (22%) effect in years 5-10. Reductions were seen for oestrogen receptor positive invasive cancer (44%) and DCIS (28%), but no effect was seen for both oestrogen receptor negative invasive cancer, where in fact a non-significant 13% (P=0.4) increase was observed. Somewhat larger effects were seen for these other selective estrogen receptor modulators (SERMs) – raloxifene, lasofoxifene and arzoxifene – in trials of osteoporotic women, where the primary endpoint was fracture reduction4. A subsequent head-to-head trial of raloxifene vs tamoxifen, showed tamoxifen to be about 20% more effective, but raloxifene had fewer side effects5. Lasofoxifene not only showed benefits for breast cancer reduction but also reduced fracture rates and heart disease6, and this multi-dimensional set of benefits makes it an attractive candidate for prevention.

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Prevention of Breast Cancer in High-Risk Postmenopausal WomenMedicalResearch.com Interview with: Jack Cuzick PhDCentre for Cancer PreventionWolfson Institute of Preventive MedicineQueen Mary University of London, London UK

• More recently the aromatase inhibitors have been shown to be more effective than tamoxifen in the treatment of postmenopausal women with ER positive breast cancer, and again the first evidence that it might be more effective for prevention came from its effect on contralateral tumours in the ATAC trial7. That observation has now been widely replicated8, and the combined evidence suggested that about 45% of the cancers not prevented by tamoxifen are prevented by an aromatase inhibitors. Thus, given that tamoxifen produces a 40% reduction in the trials of tamoxifen vs nothing, a 65% – 70% reduction would be projected for the aromatase inhibitors (AIs).

• Two large studies have now been conducted to evaluate the roles of aromatase inhibitors in prevention in high risk women without breast cancer. The MAP.3 study9 evaluated exemestane in 4560 women and reported after a 35 month median follow up; the IBIS-2 study looked at anastrozole in 3846 women and report after 60 months median follow up. Both studies found a 53% in all breast cancer (including DCIS) and larger reductions were seen for invasive ER positive disease.

• The side effect profiles of tamoxifen and the aromatase inhibitors are somewhat different. The major side effects of tamoxifen are endometrial cancer and thromboembolism, although both are rare. For aromatase inhibitors increased fracture rates due to, lower oestrogen levels, was seen with the ATAC trial10, but IBIS-2 showed that this could be managed by performing a bone density scan (DXA) initially, giving a bisphosphonate to osteoporotic women and repeat testing with bisphosphonate use as needed for those who are osteopenic. As a result fracture rates were only slightly and non-significantly raised (from 7.6% to 8.5%). A similar lack of fracture increase was seen in the MAP.3 trial9. Musculoskeletal aches and pains and vasomotor symptoms (hot flushes) were the commonest side effects, but the rates in the placebo arm were 90% (58% vs 64%) and 85% (49% vs 57%), resp. of those in the active treatment arm, indicating that many of these side effects are being wrongly attributed to the treatment in uncontrolled situations.

• Tamoxifen and raloxifene are approved by the FDA for prevention in the USA, and recently NICE approval was granted in the UK. Given the better efficacy and tolerability of aromatase inhibitors it seems likely that NICE will also approve them soon as well. However, a major challenge remains in achieving greater usage in high risk women, where benefits clearly outweigh risks. One attractive option is to integrate a preventive consultation into the breast screening programme. This seems an ideal time to assess breast cancer risk and a single centre study in Manchester11 found that the offer of discussing risk and preventive actions at this time were positively received by 95% of the women approached. Such an activity requires the availability of a trained research nurse or doctor to provide this information, but would only be needed for the first screening appointment.

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Prevention of Breast Cancer in High-Risk Postmenopausal WomenMedicalResearch.com Interview with: Jack Cuzick PhDCentre for Cancer PreventionWolfson Institute of Preventive MedicineQueen Mary University of London, London UK

• A comprehensive risk assessment requires 3 elements:• Aquestionnaire based identification of known risk factors, such as those used in the Tyrer-Cuzick

model12;• Measurement of breast density from the mammogram;• and where acceptable, measurement of the genetic risk profile. This would be based on the large

number of SNPs identified (76 validated SNPs currently reported), which individually have a small impact on risk but when combined into a risk score are likely to provide useful additional, but not definitive, risk assessment information13. Initial indications are that these 3 components are largely independent and each provides a similar amount of information for the population in general.

• With an accurate method to assess risk now available, the stage is set to discuss a range of preventive actions which at one end would include bilateral mastectomy for the very few women at extremely high risk (typically > 70% lifetime risk), to preventive therapy with aromatase inhibitors, tamoxifen or raloxifene for high risk women (25-70% risk), and lifestyle changes, including more physical activity and weight control for those at average or slightly increased lifetime risk (10-25%), as well as for high risk individuals. Weight control has proved a difficult goal for the general population, and simple programmes to increase physical activity are likely to be the most attractive in terms of acceptability. While increased physical activity has been shown to be associated with reduced breast cancer rates in several observational studies14,15 , the level of exercise required may be difficult to achieve in the general population, and other confounding factors may also impact these findings. Randomised trials are needed to fully evaluate the achievable benefits of exercise in breast cancer prevention16,17.

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Pulmonary Embolism: Thrombolytic Therapy Benefits Must Be Balanced With Risk of Cerebral BleedMedicalResearch Interview with: Jay Giri, MD MPHAssistant Professor, Perelman School of MedicineDirector, Peripheral Intervention

Interventional Cardiology & Vascular Medicine Cardiovascular Division University of Pennsylvania

• MedicalResearch: What are the main findings of the study?• Dr. Giri: Use of thrombolytics was associated with lower all-cause mortality and increased rates of intracranial hemorrhage. These results

were also seen in intermediate-risk pulmonary embolism. Finally, it appeared that patients under age 65 might be at less bleeding risk from thrombolytics.

• MedicalResearch: Were any of the findings unexpected?• Dr. Giri: Most importantly, we discovered that thrombolytic therapy was associated with mortality benefit in intermediate-risk

pulmonary embolism. This is a hotly debated topic and no prior study has had the statistical power to demonstrate this finding. Of course, this potential benefit must be balanced against potential bleeding risks in the individual patient which we also attempted to clarify.

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Giri: For intermediate risk pulmonary embolism, clinicians should consider a tailored approach to therapy for an individual patient,

taking into account potential bleeding risks as well as potential benefits in symptom resolution and mortality.• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. Giri: Future research should be dedicated to development of risk stratification models for bleeding and intracranial hemorrhage in all

patients, but especially the elderly, with thrombolytic therapy. Additionally, research should focus on standardization of dosages of thrombolytics and method of administration (peripheral intravenous versus catheter-directed therapy into the pulmonary arteries) to accrue maximal clinical benefits with minimization of bleeding risk.

• There is a current effort to expand the use catheter-directed thrombolytic therapy into intermediate-risk pulmonary embolism. While intuitively appealing, we must hold this therapy to the same threshold of evidence that peripheral IV-based thrombolysis has been measured by, especially given dramatically increased costs with modern systems. Thus far, significant evidence from randomized trials has not been accumulated for this approach.

• Finally, future trials should mandate longer-term follow-up of pulmonary embolism patients treated with thrombolytics to determine whether late benefits/harms emerge from their use.

• Citation:• Thrombolysis for Pulmonary Embolism and Risk of All-Cause Mortality, Major Bleeding, and Intracranial Hemorrhage: A Meta-analysis• Saurav Chatterjee MD, Anasua Chakraborty MD, Ido Weinberg MD, Mitul Kadakia MD, Robert L. Wilensky MD, Partha Sardar MD, Dharam J.

Kumbhani MD, SM, MRCP, Debabrata Mukherjee MD, MS, Michael R. Jaff DO, Jay Giri MD, MPH• JAMA. 2014;311(23):2414-2421. doi:10.1001/jama.2014.5990•

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Use of Platelet Inhibitor Cilostazol To Treat Vasospastic AnginaMedicalResearch.com Interview with:Professor June-Hong Kim, Division of Cardiology

Department of Internal Medicine and Research Institute for Convergence of Biomedical Science and Technology,Pusan National University Yangsan Hospital Yangsan, South Korea;

• MedicalResearch: What are the main findings of the study?• Dr. Kim: In vasospastic angina, the cilostazol group significantly reduced relative ireduction of of weekly incidence of chest pain

compared with placebo group (−66.5±88.6% vs −17.6±140.1%, respectively, p=0.009).. Other clinical parameters such as a change in the frequency of chest pain (−3.7±0.5 vs −1.9±0.6, respectively, p=0.029), a change in the chest pain severity scale (−2.8±0.4 vs −1.1±0.4, respectively, p=0.003), and the proportion of chest pain-free patients (76.0% vs 33.3%, respectively, p=0.003) also significantly favored cilostazol.

• MedicalResearch: Were any of the findings unexpected?Dr. Kim: Cilostazol has been mainly used as an antiplatelet agent in the area of cardiovascular drugs. Although the vasodilatory effect of cilostazol has also been studied in many of preclinical studies, there are few studies for providing its vasodilatorty efficacy for vasospastic angina through the clinical trials. Our study group had previously reported the potential benefit of cilostazol for reducing symptome of vasospastic angina in a pilot study (PEVA study, Cardiovasc Ther 2013;31:179–85). To my best knowledge, it was the first report to suggest the therapeutic effect of cilostazol in vasospastic angina. The STELLA trial is the subsequent study to confirm our pilot study result with more scientific evidence through the randomised, multicenter, double blind, placebo-controlled trial. The study result of STELLA is consistent with our pilot report,showing that there was a 78.9% relative reduction in the score of angina intensity and a 73.5% reduction in the angina frequency after adding cilostazol to conventional medications (all p values <0.001). Any of findings was not unexpected in both of our studies (PEVA and STELLA).

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

Dr. Kim: Cilostazol is effective in treating vasospastic angina refractory to conventional amlodipine therapy, and does not cause any serious adverse events. Cilostazol may be considered as an add-on therapy for patients with refractory vasospastic angina.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. Kim: Studies of larger sample size with longer follow-up periods should be needed. Also, rather objective parameter such as

acetylcholine or ergonovine provocation test before and after cilostazol than subjective parameter (chest pain symptom only) should be tested in further studies to provide more scientific evidence.

• Citation:• Original article: A randomised, multicentre, double blind, placebo controlled trial to evaluate the efficacy and safety of cilostazol in

patients with vasospastic anginaEun-Seok Shin,Jae-Hwan Lee,Sang-Yong Yoo,Yongwhi Park,Young Joon Hong,Moo Hyun Kim,Jong-Young Lee,Chang-Wook Nam,Seung-Jea Tahk,Jeong-Su Kim,Young-Hoon Jeong,Cheol Whan Lee,Hwa Kyoung Shin,June-Hong Kim

• Heart heartjnl-2014-305986Published Online First: 16 June 2014 doi:10.1136/heartjnl-2014-305986Read the rest of the interview on MedicalResearch.comContent Not Intended as Specific Medical Advice

POTS – Postural Tachycardia Syndrome: May Be UnderRecognized and UnderTreatedMedicalResearch.com Interview with Prof. Julia I. Newton:Dean of Clinical Medicine & Professor of Ageing and MedicineClinical Academic Office The Medical School

Newcastle University

• MedicalResearch: What are the main findings of the study?• Prof. Newton: In this study we have explored for the first time the characteristics of patients with Postural tachycardia in the UK• Postural Tachycardia Syndrome patients are predominantly female, young, well educated and have significant and debilitating symptoms that

impact significantly upon their quality of life.• Despite this, there is no consistent treatment, high levels of disability and associated comorbidity.• Although individuals presented with symptoms at the same age, those attending a specialist clinic received a diagnosis quicker.• Symptom burden for those with Postural tachycardia is high and comparable to that seen in Chronic Fatigue Syndrome.• Chronic Fatigue Syndrome is recognized by the WHO as a neurological disorder and by the Disability Discrimination Act 2005 as a disability. At

the current time those with Postural Tachycardia Syndrome suffer to the same extent as those with Chronic Fatigue Syndrome but do not receive the same protection from the law.

• It is important that more work is done to understand the underlying autonomic abnormality in those with Postural Tachycardia Syndrome in order to allow us to develop targeted treatments that are effective and go beyond the currently available simply symptomatic management.

• MedicalResearch: Were any of the findings unexpected?• Prof. Newton: High levels of comorbidity particularly Chronic Fatigue Syndrome and Ehlers Danlos Syndrome is important as it might point

towards an underlying overlapping mechanism.• Interestingly 24% of Postural Tachycardia Syndrome patients from Postural tachycardia UK and the 33% of the clinic cohort were taking no

medication for their postural tachycardia.• MedicalResearch: What should clinicians and patients take away from your report?• Prof. Newton: It is becoming increasingly clear that historically many patients with Postural Tachycardia Syndrome were given a diagnosis

of Chronic Fatigue Syndrome / Myalgic Encephalomyelitis. This is important when the public health implications of CFS/ME (Chronic Fatigue Syndrome /Myalgic Encephalomyelitis) and fatigue in its more general sense, is considered.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Prof. Newton: It is important that we begin to understand the pathophysiology of Postural Tachycardia Syndrome which will help us develop

targeted treatments that will be evidence based. This will lead to treatmetns that will improve the quality of life of this increasingly recognised group of patients

• Citation:• McDonald C, Koshi S, Busner L, Kavi L, Newton J. Postural tachycardia syndrome is associated with significant symptoms and functional impairm

ent predominantly affecting young women: a UK perspective. BMJ Open. 2014

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Current Criteria May Mislabel Many Hospital ReadmissionsMedicalResearch.com Interview with:Greg D. Sacks, MD, MPHDepartment of Surgery, David Geffen School of Medicine at UCLA

• MedicalResearch: What are the main findings of this study?•

Dr. Sacks: This study evaluated the all-cause readmissions measure developed by the Centers for Medicare and Medicaid Services to penalize hospitals for unplanned readmissions. By evaluating readmissions of surgical patients at a single academic medical center, we found that the readmissions measure was able to identify only a third of the planned readmissions and mislabeled the remaining two thirds of planned readmissions as unplanned. This discrepancy was a result of the measure’s reliance on administrative claims data, which disagreed in 31% of cases with clinical data abstracted from the patient’s chart. Also, almost a third (27%) of the readmissions in this study were for reasons unrelated to the original hospitalization.

MedicalResearch: What should patients and clinicians take away from this report?• Dr. Sacks: Hospital readmissions after surgery are complex, are caused by a wide range of clinical and social

factors, and do not always represent poor care quality. Policy measures that penalize hospitals should ensure that the data used are reliable and do not penalize hospitals for factors that are beyond their control. Readmissions unrelated to the index hospital stay should be considered as a separate entity and should not be included in measures that aim to grade hospital performance.

• MedicalResearch: What future research do you recommend as a result of this work?• Dr. Sacks: Researchers should develop reliable ways to identify and measure unplanned, preventable, and

related readmissions. These readmissions are most likely to represent lapses in care for which hospitals can be held accountable and would offer useful feedback to guide hospitals in their quality improvement efforts.

• Citation:• Sacks GD, Dawes AJ, Russell MM, et al. Evaluation of Hospital Readmissions in Surgical Patients: Do Administrativ

e Data Tell the Real Story?. JAMA Surg. Published online June 11, 2014. doi:10.1001/jamasurg.2014.18.

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Canola Oil May Improve Glycemic Control, Reduce Cardiovascular Risk FactorsMedicalResearch.com Interview with: David J.A. JenkinsProfessor and Canada Research Chair in Nutrition and Metabolism,

Dept. of Medicine and Nutritional Sciences, Faculty of Medicine,University of Toronto, Toronto, ON, Canada

• MedicalResearch: What are the main findings of the study?• Prof. Jenkins: The main findings were that inclusion of just over an once (31g) of canola oil in low glycemic

index diets of type 2 diabetes study participants, to further reduce the glycemic load (GL), reduced HbAIC more than a high cereal fiber diet, as predicted. However the Canola oil low GL diet also reduced serum TG and LDL-C and thus Framingham risk score for cardiovascular disease. The effect was seen most clearly in those at highest CHD risk and those with features of the metabolic syndrome.

• MedicalResearch: Were any of the findings unexpected?• Prof. Jenkins: The unexpected findings were the magnitude of the effect on HbAIC in those with features of the

metabolic syndrome and the lack of advantage over and above that achieved by a high cereal (wheat) fiber diet in those without metabolic syndrome features. Thus the treatment difference in HbAIC for participants with a systolic BP greater than 130 was over 0.4%, considered by FDA to be a therapeutic effect (i.e. above 0.3 -0.4%). On the other hand those on the test with lower BP values at baseline showed no significant advantage over the control.

• Perhaps in retrospect these data should not be unexpected since others have also noted that those with a greater likelihood of insulin resistance showed the greatest benefits of low glycemic index/glycemic load diets. Thus Ebbling and Ludwig (1) demonstrated that a treatment difference in weight loss in overweight study participants was only seen in those who had raised 30 min postprandial insulin levels as a marker of insulin resistance (1). Earlier, Liu et al. noted in the Nurses’ Health Study that only women with a BMI greater that 23Kg/m2 showed an increase in CHD risk with a higher glycemic load diet (2), another association with insulin resistance.

• We conclude that those with the greater degree of insulin resistance are likely to benefit most from interventions such as reducing the dietary GI/GL that reduce post prandial glycemia.

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Canola Oil May Improve Glycemic Control, Reduce Cardiovascular Risk FactorsMedicalResearch.com Interview with: David J.A. JenkinsProfessor and Canada Research Chair in Nutrition and Metabolism,

Dept. of Medicine and Nutritional Sciences, Faculty of Medicine,University of Toronto, Toronto, ON, Canada

• MedicalResearch: What should clinicians and patients take away from your report?• Prof. Jenkins: Clinicians and patients may want to continue the focus on plant foods in the diet and

consider including Canola oil in their diets not only for cooking purposes but more importantly as the cold oil in salad dressings, on boiled vegetables to increase palatability and on snack foods such as bruschetta in much the same situation as olive oil is used in Mediterranean cuisine. The uses of both olive (PREDIMED)(3) and Canola (Lyon Heart Study) (4) have been shown to reduce CVD in clinical trials. Canola oil may be used with advantage as part of a low glycemic load diet with focus on legumes (chick peas, beans and lentils) and other low GI foods such as parboiled rice, burglar, heavy pumpernickel bread and with the use of nuts to further lower the glycemic load.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Prof. Jenkins: The future research called for by this and other similar studies is the pressing need for

long term hand endpoint (MACE etc.) studies to indicate the possible advantages of these dietary interventions, and identification of the individuals most likely to benefit. An unified call for studies in this area is especially warranted when funding agencies are staying away from funding diet and lifestyle trials due to their very significant cost, a cost which nevertheless is in proportion to the public good to be derived from the subsequent evidence based diet and lifestyle advice.

• In terms of the studies themselves every effort should be made to recruit vulnerable populations to derive the greatest benefit from low GI/GL diets. It is likely that studies on individuals without significant broad evidence of insulin resistance may be flawed by type 2 error, with potentially useful interventions discarded due to negative results that may have shown significant benefits if applied to individuals at higher risk

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Canola Oil May Improve Glycemic Control, Reduce Cardiovascular Risk FactorsMedicalResearch.com Interview with: David J.A. JenkinsProfessor and Canada Research Chair in Nutrition and Metabolism,

Dept. of Medicine and Nutritional Sciences, Faculty of Medicine,University of Toronto, Toronto, ON, Canada

• Ebbeling CB, Leidig MM, Feldman HA, Lovesky MM, Ludwig DS. Effects of a low-glycemic load vs low-fat diet in obese young adults: a randomized trial. JAMA. 2007 May 16;297(19):2092-102.

• Liu S, Willett WC, Stampfer MJ, Hu FB, Franz M, Sampson L, Hennekens CH, Manson JE. A prospective study of dietary glycemic load, carbohydrate intake, and risk of coronary heart disease in US women. Am J Clin Nutr. 2000 Jun;71(6):1455-61.

• Estruch R, Ros E, Salas-Salvadó J, Covas MI, Corella D, Arós F, Gómez-Gracia E, Ruiz-Gutiérrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pintó X, Basora J, Muñoz MA, Sorlí JV, Martínez JA, Martínez-González MA; PREDIMED Study Investigators. Primary prevention of cardiovascular disease with a Mediterranean diet. N Engl J Med. 2013 Apr 4;368(14):1279-90. doi: 10.1056/NEJMoa1200303. Epub 2013 Feb 25.

• de Lorgeril M, Renaud S, Mamelle N, Salen P, Martin JL, Monjaud I, Guidollet J, Touboul P, Delaye J. Mediterranean alpha-linolenic acid-rich diet in secondary prevention of coronary heart disease. Lancet. 1994 Jun 11;343(8911):1454-9.

• • Citation:• Effect of Lowering the Glycemic Load With Canola Oil on Glycemic Control and Cardiovascula

r Risk Factors: A Randomized Controlled Trial • David J.A. Jenkins, Cyril W.C. Kendall, Vladimir Vuksan, Dorothea Faulkner, Livia S.A. Augustin,

Sandra Mitchell, Christopher Ireland, Korbua Srichaikul, Arash Mirrahimi, Laura Chiavaroli, Sonia Blanco Mejia, Stephanie Nishi, Sandhya Sahye-Pudaruth, Darshna Patel, Bashyam, Edward Vidgen, Russell J. de Souza, John L. Sievenpiper, Judy Coveney, Robert G. Josse, and Lawrence A. Leiter

• Diabetes Care published ahead of print June 14, 2014, doi:10.2337/dc13-2990 1935-5548

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Pediatric Trends in Energy Intake, ObesityMedicalResearch.com Interview with: Michelle A. Mendez, PhD Assistant ProfessorDepartment of Nutrition University of North Carolina at Chapel HillGillings School of Public Health Chapel Hill, NC

• MedicalResearch: What are the main findings of the study?• Dr. Mendez: Using national surveillance data to examine trends in energy intake among children, we found that there was

an initial decline in intakes from 2003-4 through 2007-08, which mirrored evidence that child obesity in the US may have begun to decline in that period. Subsequently, however, in 2009-10, energy intake increased in older children aged 12-19y, and reached a plateau in children aged <11y. This shift is consistent with reports that, particularly in older children, the downward trend in obesity levels may have been reversed in recent years.

• MedicalResearch: Were any of the findings unexpected?• Dr. Mendez: Instead of looking at trends only in mean or median intakes, we looked at changes over time across the

entire distribution of energy intake. We hoped that even if there was an increase in median intakes, we would not see evidence of a upturn in energy intake among the children at the upper range in the distribution. However, the recent increase in energy intake was similar to or even larger at the 90the percentile than the increase in median intake.

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Mendez: These findings highlight the need for continued vigilance, and for more research to identify effective

strategies–including dietary approaches–to improve nutrition throughout childhood and adolescence.• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. Mendez: We need to identify the contributors to this increase in energy intake among children, as well as the food

patterns that help to avoid over-consumption. This is a challenge with our increasingly complex food supply. We are working to improve our ability to more precisely quantify intakes in order to improve our ability to identify how to improve food choices to combat obesity.

• Citation:• Shifts in the Recent Distribution of Energy Intake among U.S. Children Aged 2–18 Years

Michelle A. Mendez, Daniela Sotres-Alvarez, Donna R. Miles, Meghan M. Slining, and Barry M. Popkin• Reflect Potential Abatement of Earlier Declining Trends J. Nutr. jn.114.190447; first published online June 11, 2014.

doi:10.3945/jn.114.190447

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Uveal Melanoma: MEK Inhibition with Selumetinib Provided Clinical BenefitMedicalResearch.com Interview with:Dr. Richard D. Carvajal MDDirector, Developmental Therapeutics; Elizabeth and Felix Rohatyn Chair for Junior Faculty

Memorial Sloan Kettering Cancer Center

• MedicalResearch: What are the main findings of the study?• Dr. Carvajal: This is the first study to show that a systemic therapy provides significant clinical benefit in a

randomized fashion to patients with advanced uveal melanoma, a population of patients who have very limited treatment options. This clinical benefit has never previously been demonstrated with other agents, both conventional or investigational.

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Carvajal: This is an important step forward for patients with advanced uveal melanoma who have a poor

prognosis and very limited treatment options. Selumetinib provides the first systemic therapy with proven efficacy in patients with advanced uveal melanoma and provides a platform for the development of new combinatorial therapeutic approaches

• MedicalResearch: What recommendations do you have for future research as a result of this study?Dr. Carvajal: Accrual to SUMIT, an international phase III trial of Selumetinib in combination with DTIC versus chemotherapy alone (NCT01974752), has recently begun. SUMIT is the first study with registration intent to be conducted for patients with advanced uveal melanoma. We hope that this study will confirm the efficacy of MEK inhibition observed in our current trial. In addition, based upon preclinical data demonstrating that the efficacy of MEK inhibition can be enhanced with the addition of either AKT inhibition or PKC inhibition, a study of trametinib alone or in combination with GSK2141795 (NCT01979523) and a study of MEK162 and AEB071 (NCT01801358) are also ongoing. Each of these three trials have been designed to try to build upon the efficacy observed with single agent MEK inhibition utilizing distinct combinatorial strategies.

• Citation:• Abstract Presented at the ASCO 2014 Meeting• “Trial Demonstrates Benefit of Oral MEK Inhibitor for Aggressive Uveal Melanoma• Phase II study is the first trial to demonstrate a role for systemic therapy”

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Waist Circumference May Not Be Associated With Cardiometabolic FactorsMedicalResearch.com Interview with:Gerard Ngueta Population Health and Optimal Health Practices Research Unit,CHU de Québec Research Centre, QuébecQuébec, Canada

• MedicalResearch: What are the main findings of the study?• Answer: The main findings of our study are as follows :• 1- Contrary to body mass index (BMI), the waist circumference alone (which indicate central obesity or fat distribution) is not

associated with cardiometabolic factors under study (i.e., insulin, triglycerides, systolic blood pressure and high-density lipoproteins levels). Thus, the apparent association –as found in previous studies- appears to be mediated through overall obesity (i.e., BMI). In the other words, the association observed in the previous studies between waist circumference and the cardiometabolic risk factors cited above could be mainly due to the strong correlation between waist circumference and BMI.

• 2- It is possible to estimate the independent contribution of overall fat and central fat on cardiometabolic risk factors by applying the residual model as previously suggested by Willet and Stampfer.

• MedicalResearch: Were any of the findings unexpected?• Answer: Findings as reported were expected given that waist circumference largely includes BMI (i.e., BMI predicts waist

circumference) and not the opposite.• MedicalResearch: What should clinicians and patients take away from your report?• Answer: The overall obesity is more important in the Cree and Inuit population, as compared with central obesity. Waist

circumference management without targeting overall obesity would be less efficient to decrease the risk of cardiometabolic events, regardless of sex and age. Study participants were aboriginal, with high prevalence of obesity. Thus, our conclusion may be limited to similar populations.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Answer: Further studies should be focused on other ethnicities and group of individuals (e.g., elderly, athletes,…) to confirm

the relevance of residual waist approach.• Citation:• Does waist circumference uncorrelated with BMI add valuable information?• Gerard Ngueta, Elhadji A Laouan-Sidi, Michel Lucas• J Epidemiol Community Health jech-2014-204005Published Online First: 10 June 2014 doi:10.1136/jech-2014-204005

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Waist Circumference May Not Be Associated With Cardiometabolic FactorsMedicalResearch.com Interview with: Gerard NguetaPopulation Health and Optimal Health Practices Research Unit,CHU de Québec Research Centre, Québec Québec, Canada

• MedicalResearch: What are the main findings of the study?• Answer: The main findings of our study are as follows :• 1- Contrary to body mass index (BMI), the waist circumference alone (which indicate central obesity or fat distribution) is not

associated with cardiometabolic factors under study (i.e., insulin, triglycerides, systolic blood pressure and high-density lipoproteins levels). Thus, the apparent association –as found in previous studies- appears to be mediated through overall obesity (i.e., BMI). In the other words, the association observed in the previous studies between waist circumference and the cardiometabolic risk factors cited above could be mainly due to the strong correlation between waist circumference and BMI.

• 2- It is possible to estimate the independent contribution of overall fat and central fat on cardiometabolic risk factors by applying the residual model as previously suggested by Willet and Stampfer.

• MedicalResearch: Were any of the findings unexpected?• Answer: Findings as reported were expected given that waist circumference largely includes BMI (i.e., BMI predicts waist

circumference) and not the opposite.• MedicalResearch: What should clinicians and patients take away from your report?• Answer: The overall obesity is more important in the Cree and Inuit population, as compared with central obesity. Waist

circumference management without targeting overall obesity would be less efficient to decrease the risk of cardiometabolic events, regardless of sex and age. Study participants were aboriginal, with high prevalence of obesity. Thus, our conclusion may be limited to similar populations.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Answer: Further studies should be focused on other ethnicities and group of individuals (e.g., elderly, athletes,…) to confirm

the relevance of residual waist approach.• Citation:• Does waist circumference uncorrelated with BMI add valuable information?• Gerard Ngueta, Elhadji A Laouan-Sidi, Michel Lucas• J Epidemiol Community Health jech-2014-204005Published Online First: 10 June 2014 doi:10.1136/jech-2014-204005

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Diabetes: Metformin Effectiveness in African Americans May Be Greater Than In WhitesMedicalResearch.com Interview with L. Keoki Williams, MD, MPHCenter for Health Policy and Health Services ResearchDepartment of Internal Medicine Henry

Ford Health SystemDetroit, Michigan 48104

• MedicalResearch: What are the main findings of the study?• Dr. Williams: Metformin is recommended as first line treatment for type 2 diabetes, and

these recommendations are based on the results of clinical trials performed almost exclusively in white individuals. This is the first study to specifically assess whether metformin is effective at reducing blood glucose levels in African American individuals. In our large study of over 19,000 individuals, we showed that metformin was consistently more effective at reducing glycated hemoglobin (HbA1c) levels (a measure of long-term blood glucose control) in African Americans when compared with white individuals.

•MedicalResearch: Were any of the findings unexpected?

• Dr. Williams: We were surprised by the consistency of our findings. Regardless of how well controlled (or uncontrolled) diabetes was at baseline, African American patients appeared to respond consistently better to metformin than did white patients. In addition, the magnitude of the difference was also surprising (on the order of 0.5%), which is quite large when one considers that the average baseline HbA1c level was 7.5% in our study population and that being “controlled” on treatment is defined as a HbA1c level less than 7.0%. Therefore, the difference in treatment response was well within the range of influencing whether patients achieved diabetes “control.

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Diabetes: Metformin Effectiveness in African Americans May Be Greater Than In WhitesMedicalResearch.com Interview with L. Keoki Williams, MD, MPHCenter for Health Policy and Health Services ResearchDepartment of Internal Medicine Henry

Ford Health SystemDetroit, Michigan 48104

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Williams: Although our study was based on observational data, the consistency of our findings support

the current guidelines regarding metformin’s use. Namely, as metformin appears to be effective (if not more effective) in African American individuals, it should also be considered the first line treatment for type 2 diabetes in this group, as well. However, further studies are needed to assess whether the greater reduction in HbA1c levels in African Americans also translates to greater improvement in hard clinical outcomes, such as microvascular (e.g., retinopathy and nephropathy) and macrovascular (e.g., myocardial infarction and peripheral vascular disease) events.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. Williams: This work highlights the importance of assessing medication response in all race-ethnic groups,

as groups may have different rates of treatment-related benefits and harms. Therefore, important next steps would be to assess metformin response in other population groups, as well as to replicate our findings in other African American individuals with type 2 diabetes. Additional areas for future research include identifying the genetic factors that influence metformin response. If these genetic determinants are present in multiple race-ethnic groups, they may occur at different frequencies, thereby manifesting as treatment response differences.

• Citation:• Differing Effects of Metformin on Glycemic Control by Race-ethnicity• L. Keoki Williams, Badri Padhukasahasram, Brian K. Ahmedani, Edward L. Peterson, Karen E. Wells, Esteban G

onzález Burchard, and David E. Lanfear• DOI: http://dx.doi.org/10.1210/jc.2014-1539

Accepted: May 08, 2014• Published Online: June 12, 2014

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Type 2 Diabetes: Combination JANUVIA and Metformin May Delay Need for InsulinMedicalResearch.com Interview with: Peter Stein, M.D.Vice president, Clinical Research for Diabetes and DndocrinologyMerck Research Laboratories.

• MedicalResearch: What are the main findings of the study?• Dr. Stein: This late-breaking observational study assessed the differences in time to initiation

of insulin use and the proportion of the population initiating insulin among patients with type 2 diabetes taking the combination of JANUVIA® (sitagliptin) and metformin, and patients taking the combination of a sulfonylurea and metformin. In this study, patients treated with a combination of JANUVIA and metformin initiated insulin therapy at a slower rate during the period of observation than patients treated with a combination of sulfonylurea and metformin.

• In this study, the percentages of patients initiating insulin by years one through six were 3.6, 8.4, 12.9, 17.7, 22.4, 26.6 for patients taking JANUVIA; and 4.1, 9.4, 14.6, 21.0, 27.1, 34.1 for patients taking a sulfonylurea. An analysis of the data overall (Kaplan-Meier method) showed that patients taking JANUVIA progressed more slowly to insulin use than patients taking a sulfonylurea (p=0.0034). The Cox proportional hazard regression analysis indicated that by year six, patients in the JANUVIA group were 24 percent less likely to initiate insulin during the period of observation compared to patients taking a sulfonylurea (HR = 0.76; p = 0.0011).

• Similar results were observed in the sub-group of patients with a baseline A1C of less than 9 percent (HR = 0.77; p = 0.0128]; however there was no statistically significant difference in time to insulin initiation in the sub-group with a baseline A1C of greater than or equal to 9 percent (HR = 0.75; p = 0.1818).

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Type 2 Diabetes: Combination JANUVIA and Metformin May Delay Need for InsulinMedicalResearch.com Interview with: Peter Stein, M.D.Vice president, Clinical Research for Diabetes and DndocrinologyMerck Research Laboratories.

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Stein: Type 2 diabetes is a progressive disease, so that over time many patients need to

add insulin to their treatment regimens to maintain blood sugar control. This study provides insight about different oral treatment regimens and their possible effect on initiation of insulin under real-world conditions. Real-world research is an important complement to clinical trials as we seek to improve patient health outcomes.

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Type 2 Diabetes: Combination JANUVIA and Metformin May Delay Need for InsulinMedicalResearch.com Interview with: Peter Stein, M.D.Vice president, Clinical Research for Diabetes and DndocrinologyMerck Research Laboratories.

• Dr. Stein: These findings provide meaningful insights for physicians in the practice setting.• Results of this observational study need to be confirmed through a randomized clinical trial, the gold standard

of clinical research.• There were a number of limitations for this study:• Day-of-supply for prescription and stopping dates of medications were unavailable for a considerable number

of patients.• Treatment sequences were primarily estimated based on the prescription dates.• While the database captured prescription and medication information, it could not be ascertained that

patients adequately followed the prescribing physicians’ instructions in filling their prescriptions or taking the medications. It is possible that patients never or only partially filled the prescription.

• Due to the absence of prescription refill data, the prescription data alone could not fully account for treatment adherence and therapy type (i.e., dual therapy versus triple therapy).

• The Cox proportional hazard regression analysis does not account for changes in concomitant therapies and/or comorbidities that may have occurred after initiation of sitagliptin or sulfonylurea.

• Although propensity score matching creates balanced treatment groups based on observed baseline characteristics, the possibility of potential imbalances between matched groups with regard to unobserved characteristics cannot be excluded.

• Due to the methods employed in this analysis, the time period in which an outcome can be observed must be pre-specified and patients without complete data needed to be excluded.

• Citation:• Data presented at the 74th Scientific Sessions of the American Diabetes Association• Assessing time to insulin use among type 2 diabetes patients treated with sitagliptin or sulfonylurea plus metfo

rmin dual therapyRead the rest of the interview on MedicalResearch.comContent Not Intended as Specific Medical Advice

Obesity and Mortality: Association Varies By Age, GenderMedicalResearch.com: Interview with Tapan Mehta, Ph.D. Assistant ProfessorSchool of Health ProfessionsUniversity of Alabama at Birmingham

• MedicalResearch: What are the main findings of the study?• Dr. Mehta: Grade 1 obesity’s (body mass index [BMI] 30 to < 35) association with reduced

longevity has lessened over calendar time for older white men (age >60) but not for younger middle aged (age ≤60) men. For white women, there is evidence of a decline in the association of obesity, both for Grade 1 obesity and grade 2-3 obesity (BMI ≥35), with reduced longevity across all adult ages.

• To the extent that these associations can be taken as indicators of causation, this implies that the harmfulness of obesity-mortality association has declined over calendar time in white women across all ages. However, the decline in the harmfulness of obesity-mortality association is limited to older grade 1 obese white men.

MedicalResearch: Were any of the findings unexpected?• Dr. Mehta: Overall, the results seem to suggest that while obesity-mortality association may

have become less deleterious over calendar time for white women across ages, this trend does not hold for younger and middle-aged white men. This was somewhat surprising finding especially since:

• One of the possible and plausible explanations for the reduction in the harmfulness of obesity-mortality association is improvements in medicine and screening procedures over calendar time

• Existing gender gaps in medical care and treatment between men and women.

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Obesity and Mortality: Association Varies By Age, GenderMedicalResearch.com: Interview with Tapan Mehta, Ph.D. Assistant ProfessorSchool of Health ProfessionsUniversity of Alabama at Birmingham

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Mehta: This is a population-level study that informs policy makers, funders and medical community about

the trend in the obesity-mortality association over calendar time. This study informs clinicians and patients that:

• a) The reduction in deleteriousness of obesity-mortality association varies by gender and the grade of obesity.• Although there has been a decline in the harmfulness of obesity-mortality association in some groups, obesity

especially grade 2-3 obesity continues to remain associated with reduced longevity in younger and middle-aged white men and women.

• MedicalResearch: What recommendations do you have for future research as a result of this study?• Dr. Mehta: Our findings suggest but not prove that advances in medicine, screening procedures and

interventions may have reduced the excess mortality associated with overweight and grade 1 obesity. There are other explanations possible as well for the decline. Recommendations for future studies:

• Research needs to be done to directly evaluate some of these explanations/hypotheses. For example identifying and evaluating which treatments have reduced the association of obesity-mortality at the population level would help us identify and focus on strategies that seem to be working.

• Our rigorous methodological framework can be applied to evaluate similar questions such as whether the excess mortality associated with other cardiometabolic conditions has changed over calendar time.

• As more longitudinal data on minorities becomes available we will be able to evaluate these scientific questions using our rigorous study design and methods.

• The role and trends in gender gaps and disparities in medical care is also an interesting aspect that can be studied to further build upon this work.Citation:

• Mehta, T., Fontaine, K. R., Keith, S. W., Bangalore, S. S., de los Campos, G., Bartolucci, A., Pajewski, N. M. and Allison, D. B. (2014), Obesity and mortality: are the risks declining? Evidence from multiple prospective studies in the United States. Obesity Reviews. doi: 10.1111/obr.12191Read the rest of the interview on MedicalResearch.comContent Not Intended as Specific Medical Advice

Tennis Elbow: Study Finds Saline Injections As Good As PRP – Platelet Rich PlasmaMedicalResearch.com: Interview with:Dr. Patrick Le GouxRheumatologist Hôpitaux universitaires Paris Ouest FranceFrench Tennis Federation medical staff

• MedicalResearch: What are the main findings of the study?• Dr. Le Goux: The therapeutic effect of platelet-rich plasma (PRP) of two ultrasound guided

PRP injections at 4 weeks interval compared to two saline injections (as placebo or treatment of reference) is similar on a visual analogic scale for epicondylitis of recent evolution (3 months duration maximum) in a prospective randomized double blind study with 12 months follow up. We have no intrinsic or inherent benefit of the PRP injections.

• MedicalResearch: Were any of the findings unexpected?• Dr. Le Goux: Despite no confirmation of the own clinical effect of the platelet-rich plasma we

could conclude that the similar favorable outcome of the injections in both groups of the study may be connected to the technique Ultrasound guided intra-tendinous injections which can stimulate the tendon repair process. The therapeutic effect may be linked to the mechanical or irritant effect of the injected substance and / or the effect of the needling by intratendinous injection. This action may be called “prolotherapy”

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Tennis Elbow: Study Finds Saline Injections As Good As PRP – Platelet Rich PlasmaMedicalResearch.com: Interview with:Dr. Patrick Le GouxRheumatologist Hôpitaux universitaires Paris Ouest FranceFrench Tennis Federation medical staff

• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Le Goux: There is a gap between outcomes and findings of works in vitro (experimental

studies ) which seem to attest the efficiency of growth factors containing PRP, and the data of clinical randomized trials which conclude to a very conflicting evidence. In clinical practice there is a lack of homogeneity of different preparations of PRP and the platelet concentrate may not work for many reasons (balance of factors pro and anti-angiogenic with neutralization for therapeutic effect, unknown variables concerning the activation these growth factors, platelet count different according to the patients .

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

• Dr. Le Goux: First, we have to improve the preparation of PRP, to find techniques to isolate and activate the pro-angiogenic factors to work better in the healing process of the tendon.

• Secondly, we also need to test the efficacy of prolotherapy with trial designed with injected and non -injected groups, or non intra-tendinous injected patients to attest to the superiority of these techniques on the natural evolution of the tendinopathy.

• Citation:• European League Against Rheumatism Congress 2014

Le Goux P, Montalvan B, Leparc JM et al. Treatment Of Epicondylitis By Ultrasound-Guided Local Injections Of Autologous Conditioned Plasma (Acp®): A Double-Blind Placebo-Controlled Randomized Clinical Trial With 1-Year Follow-Up. EULAR 2014; Paris: Abstract OP0013

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