Most Deaths During Triathlons Occur During The Swim

MedicalResearch.com Interview with:

Kevin M. Harris, MD Director, Fellowship Training; Director, Echocardiography Allina Health, Minnesota

Dr. Harris

Kevin M. Harris, MD
Director, Fellowship Training; Director, Echocardiography
Allina Health, Minnesota

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Triathlon is a popular endurance sport which combines swimming, bicycling and running. We investigated the death rate in the triathlon since its inception in the United States in 1985 through 2016. Specifically we were able to look at the rate of death in USAT races from 2006 to 2016.

We identified 135 deaths/cardiac arrests over the time period. 85% of victims were male and victims averaged 47 years. Most deaths and cardiac arrests occurred in the swim. 15 of the deaths were traumatic occurring during the bike portion. The rate of death was 1.74 per 100,000 participants. The death rate was significantly higher for males than females and increased significantly for men > 40 years. On autopsy, nearly half of those victims were found to have significant cardiovascular disease.

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New Rapid Flu Tests Are Simple, Fast and Accurate

MedicalResearch.com Interview with:

Jesse Papenburg, MD MSc FRCPC FRQS Clinical Research Scholar Assistant Professor of Pediatrics, McGill University Div. of Pediatric Infectious Diseases, Dept. of Microbiology Montreal Children’s Hospital Montreal, QC

Dr. Papenburg

Jesse Papenburg, MD MSc FRCPC
FRQS Clinical Research Scholar
Assistant Professor of Pediatrics, McGill University
Div. of Pediatric Infectious Diseases, Dept. of Microbiology
Montreal Children’s Hospital
Montreal, QC 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Influenza viruses cause yearly epidemics of acute respiratory illness affecting 5 to 30 percent of the population. Diagnosing influenza on the basis of only clinical symptoms is difficult because its manifestations vary and are nonspecific. Reverse transcriptase polymerase chain reaction (RT-PCR) is the gold standard for flu diagnosis, but these tests must be sent to a laboratory and have turnaround times that extend beyond the clinical encounter. Rapid and accurate diagnosis of influenza has the potential to improve patient outcomes and decrease health care costs.

Since 2011, two novel classes of rapid influenza diagnostic assays i.e., with results available in <30 minutes, have been commercialized with claims of improved sensitivities based on technological improvements: 1) automated immunochromatographic antigen detection tests (digital immunoassays, DIAs) and 2) rapid nucleic acid amplification tests (NAATs).

Our systematic review and meta-analysis synthesized the available evidence and compared the diagnostic accuracy of commercially available rapid tests for the detection of influenza A and B infection:

  • Overall, the rapid tests displayed very high specificities (≥98%). Physicians can therefore diagnose influenza with confidence on the basis of a positive RIDT, DIA, or rapid NAAT result.
  • The pooled sensitivities for DIAs (80.0% for influenza A and 76.8% for influenza B) and rapid NAATs (91.6% for influenza A and 95.4% for influenza B) are markedly higher than those for RIDTs (54.4% for influenza A and 53.2% for influenza B).

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Cardiovascular Prediction Tool Underestimated Risk In Poor Socioeconomic Groups

MedicalResearch.com Interview with:

Jarrod Dalton PhD Department of Quantitative Health Sciences Cleveland Clinic , Cleveland 

Dr. Dalton

Jarrod Dalton PhD
Department of Quantitative Health Sciences
Cleveland Clinic , Cleveland

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Accurate risk assessment is critical for identifying patients who are at high risk of cardiovascular events such as heart attacks and strokes.

We evaluated the performance of a widely-used risk assessment tool against the socioeconomic position of patients’ neighborhoods of residence. This tool, called the Pooled Cohort Equations Risk Model, or PCERM, was developed in 2013 jointly by the American College of Cardiology and the American Heart Association (ACC/AHA).

We found that the PCERM model accurately characterized risk among patients from affluent communities, but performed more poorly among patients from disadvantaged communities. In particular, for these patients, major cardiovascular events occurred at rates that were as much as 2-3 times than predicted from the PCERM model.

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Almost 40% US Adults Used Prescription Opioids In Course of One Year

MedicalResearch.com Interview with:
Beth Han, MD, PhD, MPH

From Substance Abuse and Mental Health Services Administration, Rockville, Maryland
National Institute on Drug Abuse, Bethesda, Maryland and
Office of the Assistant Secretary for Planning and Evaluation
U.S. Department of Health and Human Services
Washington, DC. 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Using the 2015 National Survey on Drug Use and Health (NSDUH), this is the first study examining the prevalence of overall prescription opioid use in addition to misuse, use disorders, and motivations for misuse in the U.S. adult population. The 2015 NSDUH collected nationally representative data on prescription opioid use, misuse, use disorder, and motivations for misuse among the U.S. civilian, noninstitutionalized population aged 12 or older. In 2015, NSDUH started to collect data on overall prescription opioid use as well as data on motivations for prescription opioid misuse.

This study found that in 2015, 91.8 million (37.8%) U.S. civilian, non-institutionalized adults used prescription opioids, 11.5 million (4.7%) misused them, and 1.9 million (0.8%) had a prescription opioid use disorder. Among adults who used prescription opioids, 12.5% reported misuse and, of those reporting misuse, 16.7% reported a prescription opioid use disorder.

The most common reported misuse motivation was to relieve physical pain (63.4%). Misuse and use disorders were most commonly reported in adults who were uninsured, were unemployed, had low income, or had behavioral health problems. Among adults with misuse, 59.9% reported using opioids without a prescription, and 40.8% obtained prescription opioids free from friends or relatives for their most recent misuse.

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Hepatitis C Can Be Safely Treated By Primary Care Providers

MedicalResearch.com Interview with:

Sarah Kattakuzhy, MD Clinical and Administrative Director, DC PFAP Hepatitis Clinical Research Program Assistant Professor, Institute of Human Virology Division of Infectious Diseases University of Maryland 

Sarah Kattakuzhy, MD
Clinical and Administrative Director, DC PFAP Hepatitis Clinical Research Program
Assistant Professor, Institute of Human Virology
Division of Infectious Diseases
University of Maryland  

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The recent introduction of highly effective, well-tolerated direct-acting antiviral (DAA) therapy for hepatitis C virus infection has raised the possibility of rapid treatment expansion and widespread cure. However, the current specialist workforce is insufficient to meet the treatment demands of the 2.7 million Americans living with HCV infection. Several studies of partial task shifting—shared treatment between specialists and primary care providers—have demonstrated success in improving access to HCV care. Yet, information on the success of nonspecialists practicing independent of specialist supervision is limited.

The primary objective of ASCEND was to evaluate the efficacy of Hepatitis C treatment managed independently by 3 community-based provider types—nurse practitioners (NPs), PCPs, and specialists—after a succinct, guideline-driven educational intervention, set within a real-world, urban population.

In this investigation, 516 out of 600 patients achieved SVR, a response rate of 86% (95% CI, 83.0% to 88.7%), with no major safety signals. Rates of SVR were consistent across the 3 provider types—NPs: 89.3% (CI, 83.3% to 93.8%); PCPs: 86.9% (CI, 80.6% to 91.7%); and specialists: 83.8% (CI, 79.0% to 87.8%). Patient loss to follow-up was the major cause of non-SVR.

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Single Measurement May Underestimate HIV Viral Suppression

MedicalResearch.com Interview with:
Dr. Nicole Crepaz PhD
Behavioral Scientist
Division of HIV/AIDS Prevention
CDC

MedicalResearch.com: What is the background for this study?

Response: The most common measure of viral suppression in clinical and surveillance studies is the most recent viral load in past 12 months. This single-value measure does not capture the viral load dynamics over time. We examined durable viral suppression, never virally suppressed, and cumulative HIV burden (measured in the viremia copy-year) to help us better understand viral suppression and transmission risk potential.

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Cross-Sex Hormone Therapy Associated With Medical Risks and Psychosocial Benefits in Transgender Patients

MedicalResearch.com Interview with:

Carl G Streed Jr. M.D. Pronouns: he, him, his, himself Fellow, Division General Internal Medicine & Primary Care Brigham & Women’s Hospital

Dr. Streed

Carl G Streed Jr. M.D.
Pronouns: he, him, his, himself
Fellow, Division General Internal Medicine & Primary Care
Brigham & Women’s Hospital 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Recent reports estimate that 0.6% of adults in the United States, or approximately 1.4 million persons, identify as transgender. Despite gains in rights and media attention, the reality is that transgender persons experience health disparities, and a dearth of research and evidence-based guidelines remains regarding their specific health needs. The lack of research to characterize cardiovascular disease (CVD) and CVD risk factors in transgender populations receiving cross-sex hormone therapy (CSHT) limits appropriate primary and specialty care. As with hormone therapy in cisgender persons (that is, those whose sex assigned at birth aligns with their gender identity), existing research in transgender populations suggests that CVD risk factors are altered by CSHT.

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Trying Statins Again After Adverse Effect Linked To Lower Risk of Heart Attack

MedicalResearch.com Interview with:

Alexander Turchin, MD,MS Director of Quality in Diabetes Associate Professor, Harvard Medical School Brigham and Women's Hospital Boston, MA

Dr. Turchin

Alexander TurchinMD,MS
Director of Quality in Diabetes
Associate Professor, Harvard Medical School
Brigham and Women’s Hospital
Boston, MA

MedicalResearch.com: What is the background for this study?

Response: Cardiovascular disease is the # 1 cause of death in the U.S. and worldwide. Statins are some of the most effective medications available for prevention of cardiovascular events.

However, many patients stop statins, frequently because of adverse reactions. In our study we aimed to assess the risk-benefit balance of trying a statin again after experiencing an adverse reaction.

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Moderate Coffee Drinking Linked To Lower Risk of Death

MedicalResearch.com Interview with:
Marc J. Gunter, PhD 

From International Agency for Research on Cancer
Lyon, France

MedicalResearch.com: What is the background for this study?

Response: U.S. and Japanese studies have previously found that drinking more coffee was related with a lower risk of death. However, in European populations, where coffee consumption and preparation methods are more varied, the relationship was less certain as relatively small studies had previously been conducted. Our analysis was undertaken in ~500,000 men and women from 10 European countries, the largest study to date investigating the coffee and mortality relationship.

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Yoga As Effective As Physical Therapy For Chronic Low Back Pain

MedicalResearch.com Interview with:

Robert B. Saper, MD, MPH Department of Family Medicine Boston Medical Center Boston, MA

Dr. Saper

Robert B. Saper, MD, MPH
Department of Family Medicine
Boston Medical Center
Boston, MA

MedicalResearch.com: What is the background for this study?

Response: There are a number of studies that show that yoga is effective for chronic low back pain (cLBP), but those studies included mostly white and middle-class individuals as research participants. cLBP disproportionately impacts those who are economically disadvantaged and minorities; they receive less referrals to specialists, less referrals to rehabilitation, and also less patient-education. Therefore, it was important to test whether yoga would be well- received by an underserved population, as well as be an effective form of treating chronic low back pain.

This study consisted of patients from diverse racial and economic backgrounds with multiple medical problems who were able to successfully participate and benefit from both yoga and physical therapy. This study used yoga classes that were specifically designed for people suffering from  chronic low back pain and compared the results of that treatment to those who did physical therapy.

MedicalResearch.com: What are the main findings?

Response: The results show that the yoga was as effective as physical therapy for reducing pain intensity and improving people’s physical function. Patients in the study who did yoga reported that their overall pain intensity went down, that they were able to be more physically active, and a number of patients were also able to reduce or even stop all of their pain medication. The study shows that when yoga is made available and affordable to a diverse population, people of both sexes, people who are disabled, and people of different races and economic backgrounds are both receptive to yoga and, more importantly, can benefit from it.

MedicalResearch.com: What should readers take away from your report?

Response: Doctors should know that a structured yoga program for cLBP is a reasonable, effective, and safe approach for patients with chronic  chronic low back pain. Patients with cLBP should talk with their doctors about different options for treatment of back pain, starting with non-drug approaches like yoga and physical therapy. Policy makers need to examine the potential benefits for patients and cost savings for covering non-pharmacological approaches to pain.

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

Response: The cost effectiveness of yoga and physical therapy for chronic low back pain still needs to be looked at carefully, as well as how the medical community can implement yoga classes for back pain widely.

While medication, imaging and invasive procedures absolutely have their place, research and clinical guidelines show that non-pharmacological procedures as first treatment options may be best.

MedicalResearch.com: Is there anything else you would like to add?

Response: Yoga is increasingly popular in the United States, and many yoga teachers are available in urban areas. However, yoga teachers and yoga classes are still relatively rare in communities of color and disadvantaged areas. Therefore, it’s important that we begin to train, build, and make yoga more available to diverse communities. Changing the common view of yoga from a fitness exercise for the healthy and wealthy, to a therapeutic approach for people with chronic pain and other conditions, is also an ongoing challenge.

Finding that yoga is non-inferior to physical therapy makes a strong case that yoga programs like the one in this study should be covered by insurance and offered by health care facilities. When a therapy like yoga is shown to be as effective as standard therapies, it should be made available to everyone regardless of ability to pay. For patients who attended more classes or physical therapy sessions, their cLBP improvement was even greater.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:

Saper RB, Lemaster C, Delitto A, Sherman KJ, Herman PM, Sadikova E, et al. Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial. Ann Intern Med. [Epub ahead of print 20 June 2017] doi: 10.7326/M16-2579

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

 

 

 

Risk of Interval Colorectal Cancer Higher in Blacks Than Whites

MedicalResearch.com Interview with:

Stacey Fedewa PhD Strategic Director, Risk Factors & Screening Surveillance American Cancer Society, Inc. Atlanta, GA 30303

Dr. Fedewa

Stacey Fedewa PhD
Strategic Director, Risk Factors & Screening Surveillance
American Cancer Society, Inc.
Atlanta, GA 30303

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Screening for colorectal cancer is effective in reducing incidence and mortality by detecting precancerous lesions or cancer at more curable stages. But colorectal cancers can still develop in screened populations, some are missed at the time of screening; others can develop between recommended screenings. Patterns of risk for interval colorectal cancer, defined as cancers that develop after a negative result on colonoscopy, by race/ethnicity are not well known.

The risk for blacks was of interest to us because colorectal incidence and mortality rates in blacks are the highest among any race or ethnicity in the United States. We were also interested to see if quality of colonoscopy, measured by physician’s polyp detection rate, could account for differences.

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Use of HEART Score in ER Can Help Evaluate Low Risk Chest Pain

MedicalResearch.com Interview with:

Judith Poldervaart MD, PhD Assistant professor Julius Center for Health Sciences and Primary Care University Medical Center  Utrecht

Dr.Poldervaart

Judith Poldervaart MD, PhD
Assistant professor
Julius Center for Health Sciences and Primary Care
University Medical Center
Utrecht

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Since its development in 2008, interest in the HEART score is increasing and several research groups around the world have been publishing on the HEART score. After validation of any risk score for cardiac events, there is a concern about the safety when used in daily practice.

We were able to show the HEART score is just as safe as the usual care currently used at EDs, which has not been shown yet in previous research. That we did not find a decrease in costs, is probably due to the hesitance of physicians to discharge low-risk patients from the ED without further testing. But extrapolation of the findings of a cost-effectiveness analysis (including nonadherence) suggests that HEART care could lead to annual savings of €40 million in the Netherlands. Hopefully, in time (and more publications of the HEART score now appearing almost weekly from all over the world) this effect on use of health care resources will become more apparent.

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Rapid Rule-Out of Acute Myocardial Infarction With a Single High-Sensitivity Cardiac Troponin T Measurement

MedicalResearch.com Interview with:
Martin P. Than, MBBS
Emergency Department, Christchurch Hospital and
Dr John W Pickering, PhD
Associate Professor Senior Research Fellow in Acute Care
Emergency Care Foundation, Canterbury Medical Research Foundation, Canterbury District Health Board | Christchurch Hospital
Research Associate Professor | Department of Medicine | University of Otago
Christchurch New Zealand

MedicalResearch.com: What is the background for this study?

Response: Patients being investigated for possible acute coronary syndrome comprise one of the largest groups of patients presenting to emergency rooms. Troponin assays have developed such that they can now measure with greater accuracy much lower concentrations of troponin. A large retrospective registry based study and a couple of smaller prospective studies suggested that patients with a very low concentrations of troponin T (below the current limit of detection of 5 ng/L) measured with Roche Diagnostic’s high-sensitivity troponin T (hsTnT) assay on presentation to the emergency department (ie single blood draw) are very unlikely to be having a myocardial infarction (MI).

Our study gathers the current best evidence for using concentrations below the limit of detection in conjunction with no evidence of new ischaemia on ECG to safely risk stratify patients to a very low-risk group for MI and, therefore, potentially identify patients safe for early discharge.

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Cystic Fibrosis Patients Survive Ten Years Longer in Canada than in US

MedicalResearch.com Interview with:
Dr. Anne L. Stephenson, MD, PhD

St. Michael’s Hospital
Toronto Canada

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Both Canada and the US have maintained national registries on individuals with cystic fibrosis (CF) dating back to the 1970s. Previous reports suggested that survival differed between the two countries however direct comparisons of survival estimates between national registry reports were limited because of differences in methodologies used, data processing techniques and possible differences in the patients captured within each registry.

We aimed to compare survival in  cystic fibrosis between Canada and the US to determine if differences existed when we applied a systematic and standardized approach.

Our analysis showed that between 1990 and 2013, survival for individuals with CF increased in both countries, however, the rate of increase was faster in Canada compared to the USA. The survival gap widened at two distinct time points: 1995 and 2005.

In the contemporary period between 2009 and 2013, the median age of survival for individuals with cystic fibrosis in Canada was found to be 50.9 years compared to 40.6 years in the US. Overall, the risk of death was 34% lower for Canadians compared Americans with CF after adjusting for markers of disease severity. When US CF subjects were classified by insurance status, we found a 77% lower risk of death among Canadians with CF compared to Americans who indicated unknown or no insurance, a 44% lower risk compared to Americans receiving continuous Medicare/Medicaid, and a 36% lower risk in Canadians compared to Americans receiving intermittent Medicare/Medicaid. The risk of death for Americans with private insurance was not statistically different from that of Canadians with cystic fibrosis .

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Physicians, PAs and Nurse Practitioners Provide Similar Amount of Low Value Care

MedicalResearch.com Interview with:

John N. Mafi, MD, MPH Division of General Internal Medicine and Health Services Research Department of Medicine, Ronald Reagan UCLA Medical Center Los Angeles, CA

Dr. John N. Mafi

John N. Mafi, MD, MPH
Division of General Internal Medicine and Health Services Research
Department of Medicine, Ronald Reagan UCLA Medical Center
Los Angeles, CA

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Our country has a primary care physician shortage. Some have advocated that we expand the scope of practice for nurse practitioners and physician assistants to help alleviate this problem and improve access to primary care. But a 2013 study in the New England Journal of Medicine found that a large number of physicians believed that nurse practitioners provided lower value care when compared with physicians. We decided to put that belief to the test. We studied 29,000 U.S. patients who saw either a nurse practitioner, physician assistant, or physician in the primary care setting for common conditions, and we compared the rate of low-value or unnecessary services—for example, unnecessary antibiotics for the common cold, or MRI for low back pain, or a CT scan for headache. Things that don’t help patients and may harm.

We found no difference in the rates of low value services between nurse practitioners, physician assistants, and physicians. In other words, they did equivalent amounts of inappropriate or bad care.

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Tele-Rehabilitation Can Improve Physical Function In Chronic Knee Pain Patients

MedicalResearch.com Interview with:
Rachel Nelligan, BPhysio
Physiotherapist & Research Physiotherapist
Department of Physiotherapy | Centre for Health, Exercise and Sports Medicine
The University of Melbourne
Victoria Australia

MedicalResearch.com: What is the background for this study?

Response: This novel study investigated the efficacy of an internet delivered model of service delivery that combined online education, Skype delivered exercise physiotherapy and an Internet-based interactive pain coping skills training program for people with persistent knee pain.

Osteoarthritis, the leading cause of chronic knee pain and disability globally, has a significant individual, societal and economic burden. On an individual level knee osteoarthritis causes loss of function, reduced quality of life, and psychological distress. Clinical guidelines recommend adoption of a biopsychosocial approach to management which should include nondrug, nonsurgical treatments. Specifically exercise, education and psychological interventions (including pain coping skills training (PCST)) that foster self-management are recommended. Evidence identifies that many knee OA sufferers are not receiving adequate management due in part to challenges of accessing these effective treatments. There is an urgent need for new models of health service delivery to rectify this.

Tele-rehabilitation is growing in acceptance as an effective, time efficient and convenient means for people to access effective health interventions. In knee OA internet delivered interventions specifically remotely delivered physiotherapy exercise using specialised tele-rehabilitation equipment and an Internet-based interactive PCST program (PainCOACH), designed to translate key therapeutic elements of clinician-delivered face-to-face PCST, have shown improved patient outcomes. Prior to this study the combination of these two internet-based treatments has not been investigated.

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Smokers Who Switch Completely To E-Cigs Reduce Their Exposure to Toxins

MedicalResearch.com Interview with:
Dr Lion Shahab
MA (Oxon) MSc MSc PhD CPsychol AFBPsS PGCLTHE
Senior Lecturer in Health Psychology
Department of Behavioural Science and Health
University College London
London 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: To date most studies on e-cigs have either looked at the product itself, i.e. analysed vapour/aerosol or e-liquid, or investigated its effects on animal and cell models. Only very few studies have looked at actual body-level exposure in users of e-cigarettes to evaluate their safety, and this study is the first to explore this in long-term real-life users of e-cigs.

We find that compared with people who continue to smoke conventional cigarettes, those who switch over completely to using e-cigarettes long-term (1.5 years) dramatically reduce their exposure to cancer-causing chemicals to levels observed in users of nicotine replacement products like nicotine patch or gum (which are known to be safe when used long-term).

Our results also suggest that while e-cigarettes are not only safer, the amount of nicotine they provide is not noticeably different to conventional cigarettes. This can help people to stop smoking altogether by dealing with their cravings in a safer way.

MedicalResearch.com: What should readers take away from your report?

Response: The public has been receiving very mixed signals about the safety of e-cigarettes, with some reports claiming to show that they are as harmful as smoking. These reports have been based on studies that bear little relationship to exposure of e-cigarette users in the real world.

We report the first study that has actually measured the intake of potentially harmful chemicals in e-cigarette users, and compared this with people using licensed nicotine products (e.g. nicotine patches), and cigarettes. This study should reassure smokers who are thinking of switching to an e-cigarette that if they manage to cut out cigarettes altogether, they should see a large benefit in terms of their health.

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

Response: The next step would be would be to follow smokers over a longer period of time who switch over to using e-cigarettes and measure potential harm and risks not only in relation to cancer but also lung function and cardiovascular health.

MedicalResearch.com: Is there anything else you would like to add?

Response: None of the other authors have received funding from an e-cigarette company or any organisation acting for one.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:

Shahab L, Goniewicz ML, Blount BC, Brown J, McNeill A, Alwis KU, et al. Nicotine, Carcinogen, and Toxin Exposure in Long-Term E-Cigarette and Nicotine Replacement Therapy Users: A Cross-sectional Study. Ann Intern Med. [Epub ahead of print 7 February 2017] doi: 10.7326/M16-1107

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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Exposure to Violence, Psychological Distress, and Gun Carrying Among Male Adolescents

MedicalResearch.com Interview with:
Joan A. Reid, Ph.D., LMHC

Assistant Professor
Criminology Program DAV 266
University of South Florida St. Petersburg

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Firearm-associated homicide and suicide are leading causes of death among American youth (i.e., 10-24 years old), with disproportionately high rates observed among male youth of color. Notably, gun violence and psychological problems are often conflated in public discourse regarding gun violence and prevention. However, few studies have assessed the impact of exposure to violence, either as a witness or a victim, when exploring the association between gun-carrying behavior and psychological distress.

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Medical Residents Spend More Time Working on Electronic Medical Records than With Patients

MedicalResearch.com Interview with:
Dresse Nathalie Wenger

Cheffe de clinique
FMH médecine interne
Département de Médecine Interne
CHUV – Lausanne 

MedicalResearch.com: What is the background for this study?

Response: The structure of a residents’ working day dramatically changed during the last decades (limitation of working hours per week, wide implementation of electronic medical records (EMR), and growing volume of clinical data and administrative tasks), especially in internal medicine with increasing complexity of patients. Electronic Medical Records (EMR) have some positive effects but negative effects have been also described ie more time writing notes, more administrative works, and less time for communication between physicians and patients.

Few time motion studies have been published about the resident’s working day in Internal Medicine: the impact of the computer, and what really do the residents do during their work, especially the time spent with the patient versus the computer, as now the EMRs are widely implemented. Previous studies have been mostly performed in the US, so we decided to conduct one observational and objective study in Europe.

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Breast and Prostate Cancer Screenings Have Similar Potential for OverDiagnosis

MedicalResearch.com Interview with:
Karsten Juhl Jørgensen, MD, Dr. MedSci
The Nordic Cochrane Centre
Rigshospitalet, Copenhagen 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Our systematic Cochrane review of the original randomised breast screening trials showed substantial conflict between their estimates of the benefit. Some trials showed a large benefit, others none or a small benefit. This difference was related to the design of the trials.

The most optimistic trials were those with suboptimal randomisation.

The main findings of our current study support those of the most rigorously performed randomised trials: breast screening does not fulfill its fundamental premise, which is to reduce the occurrence of late stage disease. This means a mortality reduction is unlikely and that use of less invasive surgery due to breast screening is also unlikely.

However, we did find very substantial increases in early stage breast cancer, which persisted over our 17 year observation period. This means that breast screening likely leads to substantial overdiagnosis of breast cancers that would otherwise not have caused health problems during a woman’s lifetime. We estimate that 1 in 3 breast cancers detected in a screened population is likely overdiagnosed.

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Little Evidence Pay-For-Performance Improves Patient Outcomes

MedicalResearch.com Interview with:

Devan Kansagara MD, MCR Associate Professor of Medicine, Oregon Health and Science University Director, Evidence-based Synthesis Program, Portland VA Medical Center Staff Physician, Portland VA Medical Center

Dr. Devan Kansagara

Devan Kansagara MD, MCR
Associate Professor of Medicine
Oregon Health and Science University
Director, Evidence-based Synthesis Program, Portland VA Medical Center
Staff Physician, Portland VA Medical Center

MedicalResearch.com: What is the background for this study?

Response: Historically, the US health care system has been dominated by a fee-for-service payment structure in which health care providers are paid for discrete procedures and visits regardless of care quality. Pay for performance programs are part of the move towards value-based care. They tie a portion of payments to individual health care providers, institutions, or health care systems to performance on a discrete set of measures of health care quality.

In theory, these programs are meant to encourage the right care at the right time and thereby improve the health of the patient population. Over the last decade, many studies in and outside the US have examined whether or not, in fact, these programs do result in improved care, reduced cost, and improved patient health. Our study is a systematic review of this literature.

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No Association Between Length of Red Blood Cell Storage and Mortality

MedicalResearch.com Interview with:
Märit Halmin, MD, PhD student

Department of Medical Epidemiology and Biostatistics, Karolinska Institutet,  Stockholm, Sweden

MedicalResearch.com: What is the background for this study?

Response: During recent years the possible negative effects among recipients of stored red blood cells have been investigated.  Despite a large number of studies, including four randomized trials, no consensus exists.

We therefore performed the hitherto largest register based cohort study of transfused patients, assessing the association between length of storage of red blood cells and mortality. Our design allowed for detection of small but still clinically significant effect, if such exists.

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How Strong is the Scientific Basis of Sugar Intake Guidelines?

MedicalResearch.com Interview with:

Bradley C. Johnston, PhD Prevention Lab, Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Peter Gilgan Centre for Research and Learning, 686 Bay Street, Room 11.9859 West, Toronto, Ontario

Dr. Bradley Johnston

Bradley C. Johnston, PhD
Prevention Lab, Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute
Peter Gilgan Centre for Research and Learning
Toronto, Ontario

MedicalResearch.com: What is the background for this study?

Response: I am scientist at The Hospital for Sick Children and a professor of clinical epidemiology at the University of Toronto and McMaster University in Canada. I have a particular interest in research methodology and preventive medicine. As a research methodologist I am interested in how researchers get to their conclusions. In particular I am interested in the “uncertainty” in estimated treatment or exposure effects.

Many guidelines have methodological issues but it was suspected that the nutritional guidelines were especially problematic. Our study in Annals of Internal Medicine set out to document the issues systematically with respect to sugar intake recommendations from authoritative guidelines.

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Access To Two Different Health Care Systems Can Lead To Dangerous Presciption Combinations

MedicalResearch.com Interview with:

Dr-Joshua-M-Thorpe.jpg

Dr. Joshua Thorpe

Joshua M. Thorpe, PhD, MPH
From the Center for Health Equity Research and Promotion
Veterans Affairs Pittsburgh Healthcare System
Pittsburgh Pennsylvania, and
Center for Health Services Research in Primary Care
Department of Pharmacy and Therapeutics
University of Pittsburgh School of Pharmacy

MedicalResearch.com: What is the background for this study?

Response: Care coordination for persons with dementia is challenging for health care systems under the best of circumstances. These coordination challenges are exacerbated in Medicare-eligible veterans who receive care through both Medicare and the Department of Veterans Affairs (VA). Recent Medicare and VA policy changes (e.g., Medicare Part D, Veteran’s Choice Act) expand veterans’ access to providers outside the VA. While access to care may be improved, seeking care across multiple health systems may disrupt care coordination and increase the risk of unsafe prescribing – particularly in veterans with dementia. To see how expanded access to care outside the VA might influence medication safety for veterans with dementia, we studied prescribing safety in Veterans who qualified for prescriptions through the VA as well as through the Medicare Part D drug benefit.

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Immunotherapy Tofacitinib Can Halt Alopecia Areata

MedicalResearch.com Interview with:
Dr. Morton Scheinberg, MD, PhD
From Hospital Israelita Albert Einstein and Hospital AACD,
São Paulo, and
Clinica Dermatosineida, Maringa, Parana, Brazil.

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: That universal hair loss associated with a localized autoimmune reaction on the cells involved with the hair follicles can be halted with tofacitinib.

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Study Supports Routine Colon Cancer Screening Through Age 75, With Individualized Decisions Afterwards

MedicalResearch.com Interview with:

Xabier Garcia-De-Albeniz MD PhD Research Associate Department of Epidemiology Mongan Institute for Health Policy, Massachusetts General Hospital. Board Member, GEMCAD. Member, Group for Cancer Prevention, SEOM

Dr. Xabier Garcia-De-Albeniz

Xabier Garcia-De-Albeniz MD PhD
Research Associate
Department of Epidemiology
Harvard T.H. Chan School of Public Health
Mongan Institute for Health Policy
Massachusetts General Hospital

MedicalResearch.com: What is the background for this study?

Response: Randomized controlled trials are considered the gold standard to inform health care delivery. Unfortunately, no randomized controlled trials of screening colonoscopy have been completed. Ongoing trials exclude persons aged 75 or older, and will not have mature results before 2025. However, healthy persons older than 75 may live long enough to benefit from colorectal cancer (CRC) screening. The Medicare program reimburses screening colonoscopy without an upper age limit since the year 2001. We used the extensive experience of Medicare beneficiaries to evaluate the effectiveness and safety of screening colonoscopy.

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Three Criteria To Identify Out-of-Hospital Cardiac Arrest Patients With No Chance of Survival

MedicalResearch.com Interview with:

Prof. Xavier Jouven Service de Cardiologie Hôpital Européen Georges Pompidou Paris

Prof. Xavier Jouven

Prof. Xavier Jouven
Service de Cardiologie
Hôpital Européen Georges Pompidou
Paris

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: There are many cardiac arrests (around 300 000 per year in United States). The possibility to collect organs from a certain proportion of those cardiac arrests represents an important opportunity to fill the gap of the organ shortage.

It is absolutely mandatory to identify patients with no chance of survival. This study showed 3 criteria which allow this early identification. Several thousands of patients die every year waiting for organ transplantation.

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Live Nasal and Injectable Flu Vaccines Had Similar Effectiveness in Pediatric Study

MedicalResearch.com Interview with:

Dr. Mark Loeb BSc (McGill), MD (McGill), MSc (McMaster), FRCPC Professor, Department of Pathology and Molecular Medicine Joint Member, Dept of Clinical Epidemiology & Biostatistics Division Director, Infectious Diseases, McMaster University

Dr. Mark Loeb

Dr. Mark Loeb
BSc (McGill), MD (McGill), MSc (McMaster), FRCPC
Professor, Department of Pathology and Molecular Medicine
Joint Member, Dept of Clinical Epidemiology & Biostatistics
Division Director, Infectious Diseases, McMaster University

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The background for this study is that in the U.S, the Advisory Committee on Immunization Practices (ACIP), the committee that advises the CDC on vaccination policy, decided this June not to recommend LAIV (nasal live vaccine) for children. This is because of non-randomized studies conducted in the U.S suggesting that the vaccine was ineffective. This was an unprecedented decision in influenza vaccine policy making for children.

Our study, a randomized, blinded, controlled trial, which is the most rigorous type of study design, conducted over 3 years (2012-13, 2013-2014, 2014-2015 influenza seasons), showed in fact very similar protection for children and their communities for the live and inactivated vaccines. We conducted the study in the Hutterite community of Western Canada which allowed us to compare the effect of the vaccines in entire communities. That is, we were able to study the direct effect and the indirect effect of these vaccines.

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Breast Density Interpretation Varies Among Radiologists

MedicalResearch.com Interview with:

Dr-Brian-SpragueBrian L. Sprague, PhD
Assistant Professor
Department of Surgery
Assistant Professor
Department of Biochemistry
University of Vermont

MedicalResearch.com: What is the background for this study?

Response: Having dense breasts makes mammography more difficult to interpret and is also an independent risk factor for developing breast cancer. About half of all U.S. states require that information on the density of a woman’s breasts be made available to her after a mammogram, and in some states the report must also inform such women that there are additional tests, such as breast magnetic resonance imaging (MRI), that may detect breast cancer in women who have dense breasts and normal mammograms.

Such laws are controversial because of the large number of women affected (around 40% of women aged 40-74) and due to a lack of consensus in the medical community regarding the benefits and harms of supplemental screening strategies. An additional concern is the subjective nature of breast density assessment, which is based on the Breast Imaging Reporting and Data System (BI-RADS) that provides four possible categories for breast density.

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Risk of Staph Bacteremia Can Run in Families

MedicalResearch.com Interview with:
Louise Bruun Østergaard MD. Ph.D student
Faculty of Medicine and Faculty of Engineering and Science
Aalborg University
Department of Cardiology, Gentofte Hospital
Hellerup

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Staphylococcus aureus bacteremia strikes people of all ages resulting in devastating consequence even in young and healthy individuals. Animal studies have shown that the susceptibility to Staphylococcus aureus differs among different genetic strains in mice, suggesting that genetic differences could influence the susceptibility to Staphylococcus aureus in other spices. As a first step in determining whether genetics influence risk of Staphylococcus aureus infections we aimed to study whether a family history of Staphylococcus aureus bacteremia in first-degree relatives was associated with risk of the disease.

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Prehypertension in Pregnancy Linked to Postpartum Metabolic Syndrome

MedicalResearch.com Interview with:

Jian-Min Niu Department of Obstetrics Guangdong Women and Children Hospita Guangzhou , China

Dr. Jian Min Niu

Dr. Jian-Min Niu
Department of Obstetrics
Guangdong Women and Children Hospita
Guangzhou , China

MedicalResearch.com: What is the background for this study?

Response: Physiological alteration leads to the question of whether the criteria for the diagnosis of gestational hypertension are suitable because the current criteria (systolic BP [SBP] ≥140 mm Hg and diastolic BP [DBP] ≥90 mm Hg) are derived from the non-pregnant population. The optimal blood pressure levels in pregnant women remain an open question. Recent studies have demonstrated associations between prehypertension before pregnancy and hypertensive disorders during pregnancy and gestational diabetes mellitus. To our knowledge, the association between prehypertension during pregnancy and postpartum cardiovascular risk has not been addressed.

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Prescribing Naloxone To Patients on Chronic Opioids Reduces ER Visits for Opioid Concerns

MedicalResearch.com Interview with:

Phillip O. Coffin, MD, MIA Director of Substance Use Research San Francisco Department of Public Health Assistant Professor, Division of HIV, ID & Global Health University of California, San Francisco

Dr. Phillip Coffin

Phillip O. Coffin, MD, MIA
Director of Substance Use Research
San Francisco Department of Public Health
Assistant Professor, Division of HIV, ID & Global Health
University of California, San Francisco

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: San Francisco has a longstanding naloxone distribution program that primarily works out of syringe exchange programs and is temporally associated with a substantial decline in opioid overdose death due to heroin or involving injection drug use. Over 90% of opioid overdose deaths from 2010-2012 were due to prescription opioids in the absence of heroin, and most of those decedents were prescribed opioids in primary care settings. Based on these data, as well as anecdotal reports from sites such as U.S. Army Fort Bragg in North Carolina – where providing naloxone to pain patients appeared to be associated with a radical decline in opioid overdose admissions to the emergency department – we implemented a naloxone prescribing program in the safety net primary care clinics.

We recommended that providers offer naloxone to all patients who used opioids on a regular basis, or were otherwise at risk for experiencing or witnessing an opioid overdose, although we only measured outcomes related to patients who were prescribed opioids for chronic pain. We also recommended that providers avoid the term “overdose” as that term does not properly reflect the epidemiology of opioid poisoning and is interpreted by many to mean intentionally consuming a large amount of opioids; instead we recommended saying things like: “Opioids can cause bad reactions where you stop breathing or can’t be woken up.” Providers prescribed mostly the jerry-rigged nasal device, with the atomizer and a brochure dispensed at clinic and the naloxone picked up at the patients’ usual pharmacies, to approximate real-world medical practice.

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Pioglitazone Is Safe and Effective Option For Patients with Type 2 Diabetes and NASH

MedicalResearch.com Interview with:

Kenneth Cusi, M.D., F.A.C.P., F.A.C.E. Professor of Medicine VAMC staff Chief, Division of Endocrinology, Diabetes and Metabolism The University of Florida Gainesville, FL 32610-0226

Dr. Kenneth Cusi

Kenneth Cusi, M.D., F.A.C.P., F.A.C.E.
Professor of Medicine
VAMC staff
Chief, Division of Endocrinology, Diabetes and Metabolism
The University of Florida
Gainesville, FL 32610-0226

MedicalResearch.com: What is the background for this study?

Dr. Cusi: Many patients with prediabetes or Type 2 Diabetes Mellitus (T2DM) are not diagnosed with Nonalcoholic steatohepatitis (NASH), a disease that is the second cause of liver transplantation in the United States. It is also associated with worse cardiovascular disease and harder to control T2DM. We had done in this population a proof-of-concept study published in Nov 2006 in the NEJM. But we lacked a larger, long-term study for definitive proof. This is the largest SINGLE center study, and the longest ever (3 years).

NASH is an overlooked problem for perhaps as many as one-third of patients with Type 2 Diabetes Mellitus. There is now a safe and effective treatment option for patients with T2DM and NASH – pioglitazone will become for NASH what metformin is to the treatment of T2DM: a safe, effective, the “backbone therapy” to which other treatments will be added.

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Physician Extenders Utilize Similar Rates of Low Value Services as Primary Care Physicians

MedicalResearch.com Interview with:

John N. Mafi, MD, MPH Assistant Professor of Medicine Division of General Internal Medicine and Health Services Research UCLA David Geffen School of Medicine Los Angeles, CA 90024 Affiliated Adjunct in Health Policy RAND Corporation Santa Monica, CA 90401

Dr. John Mafi

John N. Mafi, MD, MPH
Assistant Professor of Medicine
Division of General Internal Medicine and Health Services Research
UCLA David Geffen School of Medicine
Los Angeles, CA 90024
Affiliated Adjunct in Health Policy
RAND Corporation
Santa Monica, CA 90401

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Mafi: The U.S. healthcare system faces a looming shortage of primary care physicians, with some estimates as high as 20,000 physicians by the year 2020. In addition, fewer and fewer trainees enter primary care careers because of the harder work and lower salaries. Combine this with the passage of the Affordable Care Act and the millions of newly insured patients looking for a primary care provider, and you have created a perfect storm where timely access to primary care becomes essentially unachievable.

Many advocate for expanding the role of nurse practitioners and physician assistants to mitigate the physician shortage. But this is controversial as most doctors believe nurse practitioners provide inferior care to doctors and many feel that expanding their role would worsen the value and efficiency of the U.S. healthcare system.

While studies suggest they provide similar quality of care to physicians, few have actually evaluated whether they provide greater amounts of inefficient or low value care. Low value care is important because it can harm patients (antibiotics for colds don’t help patients and have harmful side effects) and they can raise healthcare costs. In this context, we used a large national database on ambulatory visits to compare the quality and efficiency of care among nurse practitioners, physician assistants, and physicians in the U.S. primary care setting.

In our 15 year analysis of nearly 29,000 patients who saw either a nurse practitioner, physician assistant, or a physician, we found similar rates of inappropriate antibiotic use for colds, unnecessary imaging (such as x-rays, CT scans, and MRI scans) for back pain and headache, and potentially necessary referrals to specialists for these same three conditions.

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Single-Step Testing Can Improve Access To Hepatitis C Testing

MedicalResearch.com Interview with:

J. Morgan Freiman, MD Infectious disease research fellow Boston Medical Center

Dr. Morgan Freiman

J. Morgan Freiman, MD
Infectious disease research fellow
Boston Medical Center

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Freiman:  There are 130-150 million persons infected with chronic HCV with 75% of all cases occurring in low- and middle- income countries (LMICs). Diagnosis is a 2-step process that starts with screening for exposure with an assay that detects antibodies to HCV (anti-HCV), followed by nucleic acid testing (NAT) for persons with reactive anti-HCV to measure HCV ribonucleic acid (RNA) and confirm active viremia.

In LMICs diagnostic capacity is low, and fewer than 1% of patients are aware of their infection. Additionally, a significant proportion of patients who test positive for anti-HCV are lost to follow-up before nucleic acid testing. The 2-step diagnostic process is thus a major bottleneck to the HCV cascade of care. Testing for hepatitis C virus core antigen (HCVcAg) is a potential replacement for NAT.

Our systematic review evaluated the accuracy of diagnosis of active HCV infection among adults and children for 5 commercially available HCVcAg tests compared with NAT. We found that HCVcAg assays with signal amplification have high sensitivity, high specificity, and have the potential to replace NAT in settings with high HCV prevalence.

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ClinicalTrials.gov and Drugs@fda.gov Report Complementary Information

MedicalResearch.com Interview with:

Steven Woloshin, MD Professor of The Dartmouth Institute Professor of Medicine Professor of Community and Family Medicine

Dr. Steven Woloshin

Steven Woloshin, MD
Professor of The Dartmouth Institute
Professor of Medicine
Professor of Community and Family Medicine
New Hamphsire

MedicalResearch.com: What is the background for this study?

Dr. Woloshin: Drug companies are required by law to post results of trials used to support drug applications to the FDA on the clinicaltrials.gov website – but it is not clear whether posted results are complete and accurate. Recent studies attempting to validate posted results by comparing them to corresponding peer reviewed medical journal publications suggest that discrepancies are relatively common. But it is which source is more likely to be correct. We tried to validate posted results against an arguably better gold standard, the drug approval packages from the FDA (ie, the medical and statistical reviews posted on the drugs@fda.gov website). FDA reviews have an advantage over peer reviewed publications: unlike medical journal editors and peer reviewers, FDA has access to the individual participant data from the trials. This means FDA can see all the trials and all the outcomes (avoiding sleective publication) and it means FDA can independently reanalyze according to what they believe to be the best statistical practices (data can be analyzed in many ways – and different decisions, for example, how to account for missing data, can yield very different results).

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Cardiovascular Risks More Common With Newer TKI Chemotherapeutics for CML

MedicalResearch.com Interview with:
Torsten Dahlén MD
Centre for Hematology
Karolinska University Hospital Solna
Stockholm Sweden

MedicalResearch.com: What is the background for this study? 

Dr. Dahlén: Patients diagnosed with CML have had a dramatic increase in life-expectancy since the widespread introduction of tyrosine kinase inhibitors (TKI) in 2001. However, treatment is today regarded as life-long. We thus need to observe for late-effects of continuous TKI exposure. Recent reports have demonstrated a linkage between TKI treatment, especially more potent 2nd and 3rd generation drugs, and to the occurrence of peripheral arterial occlusive disease (PAOD). This study aimed to use real-world data utilizing Swedish population based registries together with the dedicated Swedish CML registry which contains data and follow-up on more than 98% of all CML patients diagnosed in Sweden since 2002.

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Suicide Rates Much Higher In Army Than Other Service Lines

MedicalResearch.com Interview with:

Andrew Anglemyer, PhD MPH Operations Research Department U.S. Naval Postgraduate School Monterey, CA 93943

Dr. Andrew Anglemyer

Andrew Anglemyer, PhD MPH
Operations Research Department
U.S. Naval Postgraduate School
Monterey, CA 93943

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Anglemyer: Suicide prevention programs in the military are ubiquitous. We aimed to identify the trends in suicide for each service specifically and explore any nonclinical factors that may be associated with the chosen methods of suicide. The trends in suicide are similar to what others have found.

The differences in those rates between services are striking, though. Not only are most suicides in the active duty military among the Army personnel, but the suicide rate among Army personnel is the highest and has been every year since 2006. Additionally, among Army personnel and Marines who committed suicide, those with an infantry or special operations job classification were significantly more likely to use a firearm to commit suicide than those without those job classifications.

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Nurses Financial Relationships With Industry May Not Be Transparent

Quinn Grundy,

Dr. Quinn Grundy

MedicalResearch.com Interview with:
Quinn Grundy, PhD, RN
Postdoctoral Research Associate
Charles Perkins Centre
Faculty of Pharmacy
The University of Sydney

MedicalResearch.com: What is the background for this study?

Dr. Grundy: In 2010, United States (US) lawmakers passed the Physician Payments Sunshine Act as part of the Affordable Care Act. The goal of this legislation was to make publicly transparent the financial relationships between physicians and pharmaceutical and medical device companies. These relationships are associated with increased prescribing of high cost, brand name medications with limited track records for safety. Policymakers hoped that increased transparency would help to deter relationships between physicians and industry that could bias treatment decision-making in this way.

What caught our attention was that nurses, though they represent the largest proportion of health professionals, are omitted from the US Sunshine legislation. We questioned whether policymakers believed that nurses did not have the same kinds of relationships with industry as their physician counterparts, or, whether they did not believe that the consequences of nurse-industry interactions would warrant regulation.

Rather than assuming that nurses interacted with industry in the same way that physicians do, we conducted an exploratory, in-depth qualitative study of nurses’ interactions with industry representatives in day-to-day clinical practice. At 4 hospitals in the western US, we interviewed 72 nurses, hospital administrators, supply chain professionals and industry representatives. Over a period of 2 years, we also directly observed nurses’ interactions with what we call “medically-related” industry, including pharmaceutical, medical equipment and device, infant formula, and health technology companies.

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PCSK9 Antibody May Revolutionize Treatment of Atherosclerosis and Acute Coronary Syndrome

MedicalResearch.com Interview with:

Paul A. Gurbel, M.D. Director, Inova Center for Thrombosis Research and Drug Development Director, Cardiovascular Medicine Research Director, Interventional Cardiology Inova Heart and Vascular Institute Falls Church, VA Professor of Medicine, Johns Hopkins University School of Medicine Adjunct Professor of Medicine, Duke University School of Medicine

Dr. Paul Gurbel

Paul A. Gurbel, M.D.
Director, Inova Center for Thrombosis Research and Drug Development
Director, Cardiovascular Medicine Research
Director, Interventional Cardiology
Inova Heart and Vascular Institute
Falls Church, VA
Professor of Medicine,
Johns Hopkins University School of Medicine
Adjunct Professor of Medicine,
Duke University School of Medicine 

MedicalResearch.com: What is the background for this review? What are the main findings?

Dr. Gurbel: In current practice, treatment with statins and antiplatelet agents is the primary strategy to reduce death and ischemic cardiovascular events following ACS (acute coronary syndrome)/PCI. Immediately following ACS, many patients are incompletely responsive to potent current therapy and remain at high risk for recurrent thrombotic events. Treatment with monoclonal antibodies that target proprotein convertase subtilisin/kexin type 9 (PCSK9) is a new potent lipid lowering therapy. Recent studies have shown that PCSK9 antibodies combined with statins provided marked additional benefits in reducing atherogenic lipid fractions. In a recent meta-analysis, PCSK9 antibody therapy was also associated with a reduction in mortality and no increase in serious adverse events. In the current Narrative Review, we focused on novel pathways affected by PCSK9 antibodies that may make them appropriate for immediate treatment in patients with acute coronary syndrome.

MedicalResearch.com: What are the main findings?

Dr. Gurbel: PCSK9 antibodies, in addition to markedly reducing LDL levels, may also reduce pro-inflammatory oxidized LDL levels and platelet function. The latter properties, in addition to plaque stabilization, may provide antithrombotic properties favorably influencing clinical outcomes following acute administration at the time of  acute coronary syndrome.

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

Dr. Gurbel: In addition to a potent lipid lowering effect, PCSK9 antibody therapy when administered immediately at the time of acute coronary syndrome in addition to standard statin and antiplatelet therapy may provide additional antithrombotic effects. The latter novel properties of PCSK9 antibodies may be associated with improved patient outcomes. However, at this time there is no direct evidence for recommending PCSK9 antibody therapy in patients at the time of presentation with acute coronary syndrome .

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

Dr. Gurbel: A large scale randomized study assessing the clinical effects of PCSK9 antibody therapy on top of current statin and antiplatelet therapy is needed. In addition, mechanistic studies to further delineate anti-inflammatory and antithrombotic effects of PCSK9 antibody therapy are also needed.

MedicalResearch.com: Is there anything else you would like to add?

Dr. Gurbel: PCSK9 antibody therapy provides marked lowering of LDL. The latter property may revolutionize the treatment of patients with atherosclerosis. The potential antithrombotic effects of PCSK9 antibody therapy, in turn, may revolutionize acute therapy of ACS. 

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:

Navarese EP, Kołodziejczak M, Kereiakes DJ, Tantry US, O’Connor C, Gurbel PA. Proprotein Convertase Subtilisin/Kexin Type 9 Monoclonal Antibodies for Acute Coronary Syndrome: A Narrative Review. Ann Intern Med. [Epub ahead of print 22 March 2016] doi:10.7326/M15-2994

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

More Medical Research Interviews on MedicalResearch.com

Dr. Paul Gurbel (2016). PCSK9 Antibody May Revolutionize Treatment of Atherosclerosis and Acute Coronary Syndrome MedicalResearch.com

Pathologists Often Disagree On Atypia or DCIS in Breast Biopsies

MedicalResearch.com Interview with:

Joann G. Elmore M.D., M.P.H. Professor of Medicine, Adjunct Professor of Epidemiology, University of Washington School of Medicine Harborview Medical Center Seattle, WA 98104-2499

Dr. Joann Elmore

Joann G. Elmore M.D., M.P.H.
Professor of Medicine,
Adjunct Professor of Epidemiology,
University of Washington School of Medicine
Harborview Medical Center
Seattle, WA 98104-2499

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Elmore: Our team began studying diagnostic agreement among pathologists while interpreting breast biopsies in 2009. Early findings from the Breast Pathology Study (B-Path) were published in March 2015 in the Journal of the American Medical Association and indicated strong agreement among pathologists when diagnosing invasive breast cancer or benign breast tissue. Agreement, however, was much lower for ductal carcinoma in situ (DCIS) and atypia. Results from this study raised concerns that a high percentage of breast biopsies may be inaccurately diagnosed. These concerns were amplified in the media with statements like “as many as one-in-four biopsies are incorrectly diagnosed.” Statements like this inaccurately depicted the results of our study, which included a test set weighted heavily with DCIS and atypia cases. It is important to consider the percentage that each outcome category contributes to the overall number of biopsies in the U.S. population as we found that the agreement rate of pathologists varies drastically across these diagnostic categories.

Atypia in Breast Tissue Elmore Image

In the new work published in Annals of Internal Medicine, we have analyzed the B-Path results to reflect variation among diagnoses of women using U.S. population-adjusted estimates,

In an effort to help physicians and patients better understand what the B-Path results mean for women, we have analyzed the B-Path results to reflect variation among diagnoses of women using U.S. population-adjusted estimates. When adjusted using population-based predictive value estimates, the B-Path results indicate that pathologists’ overall interpretations of breast biopsies would be confirmed by an expert panel 92 out of 100 biopsies, with more of the initial diagnoses over-interpreted rather than under-interpreted.

Of concern, our results noted that among 100 breast biopsies given an initial diagnosis of atypia, less than half of these cases would be given a diagnosis of atypia after review by a panel of three experienced breast pathologists. Over half of the biopsies would be downgraded from atypia to a diagnosis of benign without atypia after review.

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Hospital Stays Provide Opportunity to Vaccinate High Risk Patients

MedicalResearch.com Interview with:

Sara Y. Tartof, PhD, MPH Kaiser Permanente Southern California Department of Research & Evaluation

Dr. Sarah Tartoff

Sara Y. Tartof, PhD, MPH
Kaiser Permanente Southern California Department of Research & Evaluation

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Tartof: The flu is a highly contagious respiratory infection that can cause serious complications, hospitalizations and, in some cases, even death. Some people, such as older adults, young children and people with certain health conditions, are at high risk for serious complications. In addition to recommending annual flu vaccination for people 6 months of age and older, the Centers for Disease Control and Prevention recommends that hospitalized patients who are eligible receive the flu vaccine before discharge.

Historically, inpatient rates of vaccination have been low. There has been concern among surgeons that vaccinating patients while they are in the hospital can contribute to increased risk of vaccine-related fever or muscle pain, which might be incorrectly attributed to surgical complications. However, there have been no data to support that concern. The objective of this study was to provide clinical evidence that would either substantiate or refute concerns about the safety of perioperative vaccination.

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Quitting Smoking Cold Turkey Leads To More Success

MedicalResearch.com Interview with:

Dr Nicola Lindson-Hawley PhD Cochrane Tobacco Addiction Group (TAG) Managing Editor

Dr. Lindson-Hawley

Dr Nicola Lindson-Hawley PhD
Cochrane Tobacco Addiction Group (TAG) Managing Editor

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Lindson-Hawley: For many people, the obvious way to quit smoking is to cut down gradually until they stop.  After all, that’s how we accomplish most other goals that are hard.  With addictions other than smoking, we aim to get people to cut down gradually rather than stop abruptly.  But with smoking, the norm is to advise people to stop all at once.  Around the world, physicians and others who support smoking cessation help people to quit abruptly and not to cut down first.  However, if physicians are not providing support to people who want to quit by reduction, then they will have less chance of success as we know that people who receive support to quit are more likely to succeed.  On the other hand, if cutting down is a bad way to quit, then we need to persuade people to abandon their common sense idea and quit abruptly instead. Therefore, this study investigated this by comparing a group of smokers advised to quit gradually by cutting down with a group who quit all at once. What we found was that cutting down first, was a less successful way to quit than smoking as normal and then stopping. Smokers who quit abruptly were 25% more likely to have quit after 4 weeks than those who quit gradually.

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Steroids An Option to NSAIDS for Treatment of Acute Gout

MedicalResearch.com Interview with:

Professor Timothy H Rainer MD MBBCh Director, Accident & Emergency Medicine Academic Unit The Chinese University of Hong Kong

Prof. Timothy Rainer

Professor Timothy H Rainer  MD MBBCh
Director, Accident & Emergency Medicine Academic Unit
The Chinese University of Hong Kong 

Medical Research: What is the background for this study? What are the main findings?

Prof. Rainer: Gout is a type of arthritis characterised by periodic attacks of acute joint swelling and severe pain, and  often treated with colchicine or nonsteroidal anti-inflammatory drugs (NSAIDs).  Two recent randomized, controlled trials showed that oral prednisolone, a corticosteroid, was as effective as NSAIDs in the treatment of acute gout, but these studies involved small numbers of patients.  The researchers investigatedwhether oral prednisolone was as effective and safe as indomethacin (a NSAID) in a larger sample of patients who had acute gout symptoms and who were seen in the emergency department (ED) setting. Patients in both the prednisolone and indomethacin groups had clinically meaningful decreases in their pain levels during the 2 hours they were observed in the ED as well as during the 14-day follow-up period. Both groups had a similar decrease in pain levels. No major adverse events were reported in either group although there were more minor adverse events in the indomethacin group.

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Partial Meniscectomy Doesn’t Reduce Mechanical Knee Symptoms Any Better Than Sham Procedure

MedicalResearch.com Interview with:

Teppo L N Järvinen MD PhD Sports Medicine, Orthopedic Surgery, Clinical Trials University of Helsinki, Helsinki

Dr. Teppo Järvinen

Teppo L N Järvinen MD PhD
Sports Medicine, Orthopedic Surgery, Clinical Trials
University of Helsinki, Helsinki

MedicalResearch: What is the background for this study? What are the main findings?

Dr. Järvinen: When the primary analysis of the FIDELITY trial was published in the New England Journal of Medicine (http://www.nejm.org/doi/full/10.1056/NEJMoa1305189), showing that arthroscopic partial meniscectomy (APM) is no better than sham/placebo surgery in relieving knee pain and improving knee function in patients with a degenerative meniscus tear and no knee OA, the study was met with unprecedented criticism, even hostility. The advocates of APM (which was at the time and probably still is the most common orthopedic procedure in the US and most other “western” countries) argued – despite the fact that our study only confirmed what several other high-quality RCTs had suggested – that  arthroscopic partial meniscectomy is a highly beneficial procedure in the “right” patients. Among the subgroups of patients allegedly having a favourable response to APM, those experiencing “mechanical symptoms” — sensations of knee catching or locking — represented the most obvious group who would benefit from  arthroscopic partial meniscectomy surgery. This assertion is plausible because knee catching or locking is believed to result from a mechanical blocking mechanism in the knee – a piece of the joint structure lodging between the articular surfaces. Because degenerative meniscal tears are very common pathologic alterations found by arthroscopy in the knee joints of patients with degenerative knee disease, trimming the torn meniscus should, in theory at least, improve the apparent mechanical derangement.

Against this background, it is somewhat unusual that no study has yet specifically tested whether  arthroscopic partial meniscectomy is effective in alleviating these symptoms. Mechanical symptoms are usually thought to be a solid indication for arthroscopic knee surgery. This is what we set out to examine in our secondary analysis of our sham-surgery controlled FIDELITY trial.

Our key finding: arthroscopic partial meniscectomy (partial resection of a torn meniscus) does not reduce or alleviate mechanical symptoms any better than a sham surgical procedure.

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Metabolically Healthy Obese Still At Increased Risk of Chronic Kidney Disease

MedicalResearch.com Interview with:
Yoosoo Chang MD PhD

Kangbuk Samsung Hospital
Sungkyunkwan University School of Medicine
Seoul, Korea

Medical Research: What is the background for this study? What are the main findings?

Response: There is substantial controversy and a lot of interest on the health implications of metabolically healthy obesity, that is, subjects who are obese but do not have metabolic abnormalities in spite of their high body mass index. The risk for chronic kidney disease (CKD) among obese patients without metabolic abnormalities is unknown.

In this cohort study of South Korean men and women, metabolically healthy overweight and obese participants had increased incidence of Chronic Kidney Disease (CKD) compared with normal-weight participants.
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Stool Test May Get More People To Be Screened For Colon Cancer

Douglas A. Corley, MD, PhD Gastroenterologist and Research Scientist III Division of Research Kaiser Permanente Oakland, CA

Dr. Douglas Corley

MedicalResearch.com Interview with:
Douglas A. Corley, MD, PhD

Gastroenterologist and Research Scientist III
Division of Research
Kaiser Permanente
Oakland, CA 

Medical Research: What is the background for this study? What are the main findings?

Dr. Corley: Colorectal cancer is a leading cause of cancer death in the United States, so understanding how cancer screening tests for this cancer are used and if they are effective is extremely important.

There are two commonly used tests for colorectal cancer screening in the United States: colonoscopy and fecal immunochemical tests (also known as “FIT”). Colonoscopy requires a bowel preparation to clean you out and is invasive but, if normal, it is done infrequently (every ten years).

FIT is simple to do at home but, to be most effective, needs to be done every year. This has the advantage of potentially picking up cancers that grow between tests. There are few studies that have looked at how well FIT picks up cancers when used year after year. If a test picks up most cancers, it is said to be very “sensitive” for picking up cancer. Most studies only looked at 1 or 2 years of use for how well FITdetected cancers. It is possible that the first year of use may “clear out” most of the easily detectable cancers and that FIT might not work as well in subsequent years.

This very large study over several years at Kaisier Permanente, where we use both colonoscopy and FIT for colorectal cancer screening, looked at whether FIT worked as well at detecting cancer in years 3 and 4 as it did the first time someone used it.

We found that the sensitivity was highest in the first year, likely from clearing out cancers that were there for a while and easily detected, but that in subsequent years the sensitivity, though 5-10% lower, remained high. Also, most people who started with FIT continued doing it, suggesting that it is both feasible and effective for colorectal cancer screening.

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Acupuncture No Better Than Placebo For Hot Flashes

Acupuncture-Wikipedia-Image

Acupuncture Presure

MedicalResearch.com Interview with:
Carolyn Ee
MBBS
Department of General Practice
University of Melbourne
Carlton, Victoria, Australia

Medical Research: What is the background for this study? What are the main findings?

Response: Hot flushes affect up to 90% of women during the menopause and beyond, and women are turning to complementary therapies. Our randomised sham-controlled trial found no difference between real and sham acupuncture (given with a blunt needle) for hot flushes, with both groups improving by around 40% at the end of treatment.

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New Breast Cancer Screening Recommendations Carry Risks Of Later Diagnosis

Susan K. Boolbol, MD, FACS Chief, Division of Breast Surgery Chief, Appel-Venet Comprehensive Breast Service Co-Director, Breast Surgery Fellowship Mount Sinai Beth Israel Associate Professor of Surgery Icahn School of Medicine at Mount Sinai New York, NY 10003

Dr. Boolbol

MedicalResearch.com Interview with:
Susan K. Boolbol, MD, FACS
Chief, Division of Breast Surgery
Chief, Appel-Venet Comprehensive Breast Service
Co-Director, Breast Surgery Fellowship
Mount Sinai Beth Israel
Associate Professor of Surgery
Icahn School of Medicine at Mount Sinai
New York, NY 10003


Medical Research: What is the background for these new recommendations?

Dr. Boolbol: To make this final recommendation, the Task Force conducted a comprehensive review of the science since its 2009 recommendation and considered the public comments it received on its 2015 draft recommendation statement. Based on all of this, the task force issued their recommendations.

Medical Research: What are the main changes from current guidelines?

Dr. Boolbol: Presently, there are several different guidelines and recommendations regarding screening mammography. Depending on the group issuing the guidelines, the recommendations vary from annual mammography beginning at 40 years old to biennial mammograms from 50 to 74 years old. The Task Force continues to find that the benefit of mammography increases with age, and recommends biennial screening in women ages 50 to 74.

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Most Patients Receive Another Opioid Prescription After Overdose

Dr. Marc LaRochelle MD MPH

Dr. LaRochelle

MedicalResearch.com Interview with:
Marc R. Larochelle, MD, MPH
Assistant Professor of Medicine
Boston Medical Center
Boston, MA 

Medical Research: What is the background for this study? What are the main findings?

Dr. Larochelle: More than 16 thousand people in the United States die from prescription opioid overdose each year. However, morbidity extends well beyond fatal overdose – nearly half a million emergency department visits each year are related to prescription opioid-related harms. Emergency department visits for misuse of opioids represent an opportunity to identify and intervene on opioid use disorders, particularly for patients who receive prescriptions for opioids to treat pain. We examined a cohort of nearly 3000 commercially insured individuals prescribed opioids for chronic pain who were treated for a nonfatal opioid overdose in an emergency department or inpatient setting. We were interested in examining rates of continued prescribing after the overdose and the association of that prescribing with risk of repeated overdose. We found that 91% of individuals received another prescription for opioids after the overdose. Those continuing to receive opioids at high dosages were twice as likely as those whose opioids were discontinued to experience repeated overdose.

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