Liquid Biopsies Sent To Different Labs May Yield Different Results

MedicalResearch.com Interview with:
Gonzalo Torga, MD
Urology Department
Johns Hopkins Hospital
Baltimore, MD 21287

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

Response: Liquid biopsy is a new and noninvasive alternative to tumor tissue sequencing, and it is intended to specifically detect and sequence tumor DNA circulating in patients’ blood. The results are used to help guide oncologists to tailor the best treatment for patients at each point of their disease. Our research was initially aimed at finding the best commercial lab to test samples from metastatic prostate cancer patients. We wanted to make the best choice for our patients, so we started submitting the samples to both places at the same time to compare results. However, we found significant disparities in the results from identical patient samples submitted to two different commercial liquid biopsy providers, and we believed it would be important to share them with the oncology community.

The two liquid biopsy panels compared were the Guardant360, from Guardant Health, Inc., which sequenced at least part of the coding sequences of 73 genes; and the PlasmaSELECT panel from Personal Genome Diagnostics, which sequenced coding segments of 64 genes.  Both laboratories were licensed by Clinical Laboratory Improvement Amendments (CLIA) and accredited by the College of American Pathologists (CAP), and report having high sensitivity (in this case, the ability to correctly identify mutations when they occur) and high specificity (the ability to correctly report as negative when those mutations are not present). The two companies differ in which genes, and regions within each gene, are covered. Just 25 of the 40 patients in the study had at least one genetic mutation reported within the overlapping genetic sequences covered by both companies.

Even when the companies were analyzing DNA from the same blood drawn, their results rarely matched each other. When comparing results within the overlapping genetic sequences, the results from both companies completely matched for all the mutations reported in only 7.5 percent (3 of 40 patients) of cases. In 15 percent of the patients (6 of 40), both companies’ results matched for at least one of the reported mutations. In 40 percent (16 of 40) of the patients, no mutations reported that were potentially covered by both panels were detected by both companies.

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Most Laboratory Testing For Cancer-Causing Gene Mutations Found Reliable

MedicalResearch.com Interview with:

Annette S. Kim, MD, PhD Associate Professor, Harvard Medical School Brigham & Women's Hospital Boston MA 02115

Dr. Kim

Annette S. Kim, MD, PhD
Associate Professor, Harvard Medical School
Brigham & Women’s Hospital
Boston MA 02115 

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

Response: The recent debate on laboratory developed tests (LDTs) and FDA-approved companion diagnostics (FDA-CDs) has centered upon both the regulatory and performance aspects of LDTs and we, at the College of American Pathologists (CAP), had the data through our proficiency testing (PT) programs to address the latter point, performance that we wanted to share with the community.  We analyzed almost 7000 PT responses on three molecular oncology tests, those for BRAF, EGFR, and KRAS mutations, and found that both LDTs and FDA-CDs demonstrated excellent performance, with both test types exceeding 97% accuracy overall.

The second key finding of the study was that more than 60% of all laboratories in our study that were using an FDA-CD kit report using it with modifications from the FDA-approved protocol.  These modifications in fact render these test LDTs.  These modifications appear to be driven by the exigencies of real day-to-day clinical practice that requires adapting the assays to meet the needs of a variety of clinical situations that may not be accommodated by the FDA-approved protocol.  These modifications include, for example, the testing of other tumor types that may carry targetable variants, different types of input specimen preparations available in pathology such as cytology smears or other fresh specimens rather than paraffin blocks, and availability of different methods of DNA quantification that those mandated by the FDA approval based upon pre-existing technologies in the laboratories.  In the clinical laboratory, we are always acutely aware that there is a patient awaiting this result.

Therefore, we validate our assays to ensure that we can provide reliable and accurate results from our laboratory under as many varied clinical situations as possible. These data support that practice.

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Adolescent Violent Offenders With Childhood Adversity Have Increased Risk of Suicide

MedicalResearch.com Interview with:
Emma Björkenstam PhD
Department of Public Health Sciences
Karolinska Institutet

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

Response: My research team and I have previously shown that childhood adversity is associated with an elevated suicide risk in young adults, and this increased risk may be explained by maladaptive trajectories during adolescence. We also know that adolescent violent offending is linked with suicide, but up until now, less was known about the role of violent offending in the association between childhood adversity and later suicide.

Our main finding in the current study, based on almost half a million Swedes, is that individuals with a history of childhood adversity who also engage in violent offending in late adolescence, have a substantial increased risk of suicide.

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Small Increased Risk of Cardiac Birth Defects With ADHD Drug During Pregnancy

MedicalResearch.com Interview with:

Krista F. Huybrechts, M.S., Ph.D. Assistant Professor of Medicine at Harvard Medical School Epidemiologist in the Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women’s Hospital. Boston, MA 02120

Dr. Krista Huybrechts

Krista F. Huybrechts, MS PhD
Assistant Professor of Medicine
Division of Pharmacoepidemiology and Pharmacoeconomics
Brigham and Women’s Hospital
Harvard Medical School
Boston, MA 02120  

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

Response: In recent years, use of stimulant medications in adults, including women of reproductive age, has increased substantially.

However, data regarding the safety of stimulant medications in early pregnancy are sparse and conflicting.  For example, two recent cohort studies failed to detect an association between use of methylphenidate in early pregnancy and overall or cardiac malformations, while another found an 81% increased risk of cardiac malformations, although the estimate was imprecise.

Given the rapidly increasing use of stimulant medications during pregnancy and among women of reproductive age who may become pregnant inadvertently, there is an urgent need to better understand their safety.

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Deep Learning System Can Screen For Diabetic Retinopathy, Glaucoma and Macular Degeneration

MedicalResearch.com Interview with:

Blausen.com staff (2014). "Medical gallery of Blausen Medical 2014". WikiJournal of Medicine 1 (2). DOI:10.15347/wjm/2014.010. ISSN 2002-4436. Illustration depicting diabetic retinopathy

Illustration depicting diabetic retinopathy

Dr. Tien Yin Wong MD PhD
Singapore Eye Research Institute, Singapore National Eye Center,
Duke-NUS Medical School, National University of Singapore
Singapore

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

Response: Currently, annual screening for diabetic retinopathy (DR) is a universally accepted practice and recommended by American Diabetes Association and the International Council of Ophthalmology (ICO) to prevent vision loss. However, implementation of diabetic retinopathy screening programs across the world require human assessors (ophthalmologists, optometrists or professional technicians trained to read retinal photographs). Such screening programs are thus challenged by issues related to a need for significant human resources and long-term financial sustainability.

To address these challenges, we developed an AI-based software using a deep learning, a new machine learning technology. This deep learning system (DLS) utilizes representation-learning methods to process large data and extract meaningful patterns. In our study, we developed and validated this using about 500,000 retinal images in a “real world screening program” and 10 external datasets from global populations. The results suggest excellent accuracy of the deep learning system with sensitivity of 90.5% and specificity of 91.6%, for detecting referable levels of DR and 100% sensitivity and 91.1% specificity for vision-threatening levels of DR (which require urgent referral and should not be missed). In addition, the performance of the deep learning system was also high for detecting referable glaucoma suspects and referable age-related macular degeneration (which also require referral if detected).

The deep learning system was tested in 10 external datasets comprising different ethnic groups: Caucasian whites, African-Americans, Hispanics, Chinese, Indians and Malaysians

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Menopausal Hormone Replacement Should Not Be Used For Disease Prevention

MedicalResearch.com Interview with:

Dr-Suzanne Fenske.jpg

Dr. Fenske

Dr. Suzanne Fenske, MD
Assistant Professor of Obstetrics, Gynecology and Reproductive Science
Icahn School of Medicine at Mount Sinai

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

Response: USPSTF recommendations are based off several studies, but is mainly based off of the Women’s Health Initiative.

The Women’s Health Initiative was a 15 year prevention study with a focus on death, disability and impaired quality of life in postmenopausal women. This study was originally performed in 1991.

The USPSTF reevaluated the data along with several other studies to assess the role of hormone replacement therapy in prevention of chronic diseases such as heart disease, stroke, blood clot, gallbladder disease, dementia.  The USPSTF has found that hormone replacement therapy has some benefit in reducing the risk of fractures, and, potentially, diabetes.  The USPSTF has found that hormone replacement therapy can increase the risk of coronary artery disease, stroke, blood clot, gall bladder disease, urinary incontinence and dementia.

With these risks, the USPSTF states that hormone replacement therapy should not be used as a preventative medicine, but, rather, used for treatment of symptomatic menopause and not prevention of osteoporosis or heart disease.

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Deep Learning Algorithms Can Detect Spread of Breast Cancer To Lymph Nodes As Well or Better Than Pathologists

MedicalResearch.com Interview with:
Babak Ehteshami Bejnordi Department of Radiology and Nuclear Medicine Radboud University medical center, NijmegenBabak Ehteshami Bejnordi

Department of Radiology and Nuclear Medicine
Radboud University medical center, Nijmegen

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

Response: Artificial intelligence (AI) will play a crucial role in health care. Advances in a family of AI popularly known as deep learning have ignited a new wave of algorithms and tools that read medical images for diagnosis. Analysis of digital pathology images is an important application of deep learning but requires evaluation for diagnostic performance.

Accurate breast cancer staging is an essential task performed by the pathologists worldwide to inform clinical management. Assessing the extent of cancer spread by histopathological analysis of sentinel lymph nodes (SLN) is an important part of breast cancer staging. Traditionally, pathologists endure time and labor-intensive processes to assess tissues by reviewing thousands to millions of cells under a microscope. Using computer algorithms to analyze digital pathology images could potentially improve the accuracy and efficiency of pathologists.

In our study, we evaluated the performance of deep learning algorithms at detecting metastases in lymph nodes of patients with breast cancer and compared it to pathologist’s diagnoses in a diagnostic setting.

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Thyroid Treatment Did Not Improve IVF Miscarriage Rate in Women With Thyroid Antibodies But Normal Thyroid Function

MedicalResearch.com Interview with:
Professor Tianpei Hong, MD, PhD
Of behalf of Prof. Jie Qiao and all the coauthors,
Director, Department of Endocrinology & Metabolism
Director, Department of Laboratory Medicine
Peking University Third Hospital
Beijing, China

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

  • Ÿ           Women who test positive for thyroid autoantibodies have been reported to be at 2- to 3-fold higher risk of spontaneous miscarriage than those who test negative. However, the effect of levothyroxine on miscarriage among women with positive thyroid autoantibodies and normal thyroid function has been documented in limited studies with conflicting results.
  • Ÿ           Given the substantial difficulty achieving successful pregnancy among infertile women, identifying optimal treatment for infertile women who test positive for thyroid autoantibodies is particularly important. There are a few randomized clinical trials showing a beneficial effect of levothyroxine treatment on pregnancy outcomes among women undergoing in vitro fertilization and embryo transfer (IVF-ET). However, the sample size of those trials was rather small which may weaken the quality of the evidence.
  • Ÿ           Therefore, the Pregnancy Outcomes Study in euthyroid women with Thyroid Autoimmunity after Levothyroxine (POSTAL) study was conducted in Peking University Third Hospital to evaluate whether levothyroxine treatment initiated before IVF-ET could decrease the miscarriage rate and improve the live birth rate in infertile women who tested positive for antithyroperoxidase antibody but had normal thyroid function.

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Medicaid Work Requirements May Have Unintended Consequences on Costs and Enrollees

MedicalResearch.com Interview with:

Renuka Tipirneni, MD, MSc Clinical Lecturer in Internal Medicine University of Michigan Department of Internal Medicine, Division of General Medicine, and Institute for Healthcare Policy & Innovation Ann Arbor, MI

Dr. Tipirneni

Renuka Tipirneni, MD, MSc
Clinical Lecturer in Internal Medicine
University of Michigan Department of Internal Medicine, Division of General Medicine, and
Institute for Healthcare Policy & Innovation
Ann Arbor, MI

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

Response: Several states have submitted proposals to require Medicaid expansion enrollees to work, actively seek work or volunteer, or risk losing Medicaid coverage. The current federal administration has signaled a willingness to approve the waivers states need to enact such requirements.

In our survey of over 4000 Medicaid expansion enrollees in Michigan, we found that nearly half of enrollees have jobs, another 11 percent can’t work, likely due to serious physical or mental health conditions, and another 27% are out of work but also are much more likely to be in poor health.

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Family Members of Patients Prescribed Opioids More Likely To Fill Opioid Prescriptions Themselves

MedicalResearch.com Interview with:
“Pills” by Victor is licensed under CC BY 2.0Marissa J. Seamans, Ph.D

Postdoctoral Fellow
Department of Mental Health
Johns Hopkins School of Public Health
Baltimore, MD 21205 

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

Response: Many patients report sharing their prescriptions for opioids with family members. What we didn’t know is whether family members of opioid users are more likely to fill opioid prescriptions themselves than family members of non-opioid users. Our study found that the 1-year risk of prescription opioid initiation among family members of prescription opioid users was an absolute 0.71% higher than among family members of non-opioid users. The risks were particularly higher for initial prescriptions with refills or longer days supply.

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Hearing Loss Associated With Higher Risk of Cognitive Decline and Dementia

MedicalResearch.com Interview with:
“Hear” by Jaya Ramchandani is licensed under CC BY 2.0David G. Loughrey, BA(Hons)

NEIL (Neuro Enhancement for Independent Lives) Programme
Trinity College Institute of Neuroscience, School of Medicine
Trinity College Dublin, Dublin, Ireland

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

Response: Age-related hearing loss, a common chronic condition among older adults, has emerged in the literature as a potential modifiable risk factor for dementia. This is of interest as current pharmacological therapies for dementias such as Alzheimer’s disease only offer symptom-modifying effects. Treatment of risk factors such as hearing loss may help delay the onset of dementia and may provide an alternate therapeutic strategy. However, there is variance in the research on hearing loss and cognition with some studies reporting a small or non-significant association. In this meta-analysis, we investigated this association and we only included observational studies that used standard assessments of cognitive function and pure-tone audiometry (the clinical standard).

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Weight Loss After Bariatric Procedures Mostly Sustained Over Time

MedicalResearch.com Interview with:

Anita P. Courcoulas MD, MPH Professor of Surgery, Chief MIS Bariatric & General Surgery University of Pittsburgh Medical Center

Dr. Courcoulas

Anita P. Courcoulas MD, MPH
Professor of Surgery, Chief MIS Bariatric & General Surgery
University of Pittsburgh Medical Center

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

Response: This study is the main long term outcomes report from The Longitudinal Assessment of Bariatric Surgery (LABS) Study, an NIH-NIDDK ( National Institute of Diabetes and Digestive and Kidney Diseases) funded study at 10 hospitals in 6 clinical centers and a data coordinating center.  It was a multicenter, prospective three phase longitudinal cohort study that began recruitment of participants in 2006 when gastric bypass and laparoscopic adjustable banding were the two most common bariatric procedures performed in the U.S.

The goal of this particular study from LABS was to address the longer-term durability and variability of weight loss and the assess the longer-term impact of bariatric surgery on major health conditions including diabetes, dyslipidemia, and hypertension. Continue reading

Capsule Fecal Transplant As Effective as By Colonoscopy for C. Diff Infections

MedicalResearch.com Interview with:

Clostridium difficile CDC image

Clostridium difficile
CDC image

Dina Kao, MD, FRCPC
Division of Gastroenterology, Department of Medicine
University of Alberta
Edmonton, Alberta, Canada

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

Response: We wanted to see what would be the best way to deliver fecal microbiota transplantation (FMT.)

There were many controlled studies of FMT delivered by various methods, showing different success rates. Not only were the route of delivery different, but the amount of donor stools also varied greatly from study to study. It appeared that most of the studies delivered by the upper routes gave a smaller amount of donor stool compared to the studies delivering FMT by colonoscopy.

Our hypothesis was that given the same amount of donor stool, the effectiveness would be similar by capsules and by colonsocopy.

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Price Transparency Not Keeping Up With High-Deductible Health Care Plans

MedicalResearch.com Interview with:
“Health Insurance” by Pictures of Money is licensed under CC BY 2.0
Allison Kratka
MD Candidate 2018
Duke University School of Medicine

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

Response: As there are increasing numbers of high-deductible plans and those with high rates of co-insurance, patients are increasingly expected to help contain the cost of their health care by being savvy health care consumers. We set out to determine how easy or hard it is to find healthcare prices online.

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Amyloid Deposits In Persons Without Dementia May Be First Sign of Alzheimer’s Disease 

MedicalResearch.com Interview with:

Willemijn Jansen, PhD  Postdoctoral researcher Department of Psychiatry & Neuropsychology Maastricht University Medical Center School for Mental Health and Neuroscience Alzheimer Center Limburg 

Dr. Jansen

Willemijn Jansen, PhD
Postdoctoral researcher
Department of Psychiatry & Neuropsychology
Maastricht University Medical Center
School for Mental Health and Neuroscience
Alzheimer Center Limburg 

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

Response: Cerebral amyloid-β aggregation is an early pathological event in Alzheimer’s disease (AD), starting decades prior to dementia onset. About 25% of cognitively normal elderly and 50% of patients with mild cognitive impairment (MCI) have biomarker evidence of amyloid pathology. These persons are at increased risk for developing AD-type dementia, but the extent to which amyloid-β aggregation affects cognitive function in persons without dementia is unclear. This is important to know for a better understanding of the course of Alzheimer’s disease and for the design of AD prevention trials.

We here investigate the association between amyloid plaques and memory scores, using data from 53 international studies included in the Amyloid Biomarker study. Cognitively healthy elderly people with plaques have a low memory score twice as often as these persons without plaques. MCI patients with plaques had 20% more often low memory and low global cognition scores than MCI patients without plaques.

We further observed 10- to 15-year intervals between the onset of amyloid positivity and emergence of low memory scores in cognitively healthy persons.

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SVC As Marker of Respiratory Decline in Amyotrophic Lateral Sclerosis

MedicalResearch.com Interview with:

Jinsy Andrews, MD, MS Director of Neuromuscular Clinical Trials Columbia University The Neurological Institute New York, NY 10032 

Dr. Andrews

Jinsy Andrews, MD, MS
Director of Neuromuscular Clinical Trials
Columbia University
The Neurological Institute
New York, NY 10032 

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

Response: The importance of respiratory function in Amyotrophic Lateral Sclerosis (ALS) has long been recognized. Despite ALS being a clinical diagnosis with variable presentation and variable rates of disease progression, all patients experience respiratory symptoms and inevitably die typically from respiratory failure. At present there is no validated biomarker of disease progression or clinical staging system. Direct measure of respiratory function in ALS is important and can be measured using vital capacity. Although the forced maneuver (FVC) has been widely used in patients with ALS, it can underestimate the actual lung capacity by causing fatigue or inducing bronchospasm in patients with ALS. More recently, the slow maneuver (SVC) has been used since it can be obtained from patients with advancing disease which can potentially minimize missing data and may reduce any underestimation of actual lung capacity due to a forceful effort. However, the prognostic value of the decline in SVC is unclear in patients with ALS.

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Thinking Abilities May Decline After Treatment For Head and Neck Cancers

MedicalResearch.com Interview with:

Lori J Bernstein, PhD, CPsych Neuropsychologist, Dept. of Supportive Care Core Member, Cancer Rehabilitation & Survivorship Program ELLICSR Centre for Health Wellness and Cancer Survivorship Princess Margaret Cancer Centre, UHN Clinical Research Unit Member, Princess Margaret Research Institute Assistant Professor, Dept. of Psychiatry, Faculty of Medicine University of Toronto Adjunct Faculty, Graduate Program in Psychology, York University

Dr. Bernstein

Lori J Bernstein, PhD, CPsych
Neuropsychologist, Dept. of Supportive Care
Core Member, Cancer Rehabilitation & Survivorship Program
ELLICSR Centre for Health Wellness and Cancer Survivorship
Princess Margaret Cancer Centre, UHN
Clinical Research Unit Member,
Princess Margaret Research Institute
Assistant Professor, Dept. of Psychiatry, Faculty of Medicine
University of Toronto
 

MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Despite the increasing role of (chemo-)radiation treatment for head and neck cancer (HNC), and involvement of central nervous system structures in the radiation field, we don’t know a lot about whether there are short or long term consequences in thinking abilities in survivors. So our question was this: Do people treated for head and neck cancer with radiation or chemoradiation have short or long term neurocognitive deficits after treatment?

We assessed head and neck cancer patients and healthy non-cancer controls four times, first at baseline (after diagnosis but before treatment), and then again 6, 12, and 24 months later. We found that compared to the controls, patients decline over time in several different neurocognitive domains, including concentration, verbal memory, and executive function. We found that as many as 38% of patients suffered from impaired global neurocognitive functioning by two years after treatment compared to none of the controls.

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

Response: The findings indicate that some (but not all) head and neck cancer survivors are at risk of suffering from declines in thinking abilities such as attention and memory. These changes can be subtle and increase gradually. We didn’t follow people beyond 2 years after treatment, so we don’t know whether these deficits would improve, worsen, or stabilize after that.

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

Response: Longer longitudinal follow-up is needed to determine if symptoms change after 2 years. More investigation of the relationships between treatment variables such as radiation dosing and long term neurocognitive function is important. Further research is also needed to find ways to avoid, reduce and compensate for declines.

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

Response: We are extremely grateful to the people who participated in this study. We plan to reassess participants for several more years, so we hope to know more about even longer term cognitive function in people treated for head and neck cancer. In addition, I want to acknowledge that we could not have done this work without the support of the Princess Margaret Cancer Foundation and The Canadian Institutes of Health Research.

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

Citation:

Alona Zer, Gregory R. Pond, Albiruni R. Abdul Razak, Kattleya Tirona, Hui K. Gan, Eric X. Chen, Brian O’Sullivan, John Waldron, David P. Goldstein, Ilan Weinreb, Andrew J. Hope, John J. Kim, Kelvin K. W. Chan, Andrew K. Chan, Lillian L. Siu, Lori J. Bernstein. Association of Neurocognitive Deficits With Radiotherapy or Chemoradiotherapy for Patients With Head and Neck Cancer. JAMA Otolaryngol Head Neck Surg. Published online November 22, 2017. doi:10.1001/jamaoto.2017.2235

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

 

 

 

 

 

 

Majority of Cataract Surgeries Now Performed in Ambulatory Centers

MedicalResearch.com Interview with:

cataract-eye-wikipedia Cataract in Human Eye  author Rakesh Ahuja, MD

Cataract in Human Eye

Brian C. Stagg, MD
Department of Ophthalmology and Visual Sciences
University of Michigan Medical School
National Clinician Scholars Program
University of Michigan Institute for Healthcare Policy and Innovation

Joshua D. Stein, MD, MS
Associate Professor
University of Michigan
Department of Ophthalmology and Visual Sciences
Director, Center for Eye Policy and Innovation
Ann Arbor 

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

Response: Cataract surgery is one of the most common surgeries in the US. It is typically performed at either hospital outpatient departments (HOPDs) or ambulatory surgery centers (ASCs). ASCs are cheaper and more efficient, but some people believe that HOPDs may be safer for people with co-morbid medical conditions.

We conducted this study to evaluate how the use of ambulatory surgery centers for cataract and other ocular surgeries has changed since 2001. We also wanted to see what factors influenced whether or not a patient had cataract surgery at an ASC (versus a HOPD), and to compare ASC use for cataract surgery with ASC use for other common eye surgeries (glaucoma, cornea, retina, strabismus).

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Racial Differences in Plasma Biomarker May Partially Explain Stroke Disparities

MedicalResearch.com Interview with:

Pankaj Arora MD, FAHA Assistant Professor, Cardiology Division University of Alabama at Birmingham Section Editor, Circulation: Cardiovascular Genetics American Heart Association

Dr. Arora

Pankaj Arora MD, FAHA
Assistant Professor, Cardiology Division
University of Alabama at Birmingham
Section Editor, Circulation: Cardiovascular Genetics
American Heart Association 

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

Response: Natriuretic peptides are hormones produced by the heart in response to increased wall stress in the atria and ventricles. It is well known that blacks have increased prevalence of cardiovascular disease which contributes to racial disparities in outcomes.

In the current work, we tested the hypothesis that black race is a natriuretic peptide deficiency state using a stratified random cohort of 4,415 participants selected from the REGARDS study (a national population-based cohort study evaluating racial and geographic disparities in stroke in US adults aged ≥45 years of age or older). Next, we looked for published results on the percentage difference in N-terminal proB-type NP (NTproBNP) levels by race in participants free of cardiovascular disease from other population cohorts. Lastly, we explored whether association of natriuretic peptides with all-cause mortality and CV mortality in apparently healthy individuals from REGARDS differs by race.

We found that in multivariable adjustment, NTproBNP levels were up to 27% lower in black individuals as compared with white individuals in the REGARDS study. We pooled our results and found that in meta-analysis of the 3 cohorts, NTproBNP levels were 35% lower in black individuals than white individuals (more than 13,000 individuals in total). Lastly, we found that the higher NTproBNP levels were associated with higher incidence of all-cause mortality, and cardiovascular mortality in healthy blacks and white individuals, and this association did not differ by race.

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Nonphysician Clinicians Provide Wide Variety of Dermatology Services To Medicare Patients

MedicalResearch.com Interview with:

Adewole Adamson, MD, MPP Department of Dermatology UNC – Chapel Hill North Carolina

Dr. Adamson

Adewole Adamson, MD, MPP
Department of Dermatology
UNC – Chapel Hill North Carolina 

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

Response: Nurses practitioners and physician assistants, collectively known as non-physician clinicians (NPCs), provide many dermatology services, some which are billed for independently. Little is known about the types of these services provided. Even less is known about where these independently billed services are provided. Given that there is a purported shortage of dermatologists in the United States (US),  NPCs have been suggested as way to fill in the gap.

In this study, we found that NPCs independently billed for many different types of dermatology associated procedures, including surgical treatment of skin cancer, flaps, grafts, and billing for pathology. Most of these NPCs worked with dermatologists. Much like dermatologists, NPCs were unevenly distributed across the US, concentrating mostly in non-rural areas.

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Rapid Increase in ER Visits For Young Girls With Self-Inflicted Injuries

MedicalResearch.com Interview with:

Dr. Melissa C. Mercado PhD, MSc, MA Behavioral scientist Division of Violence Prevention National Center for Injury Prevention and Control CDC

Dr. Mercado

Dr. Melissa C. Mercado PhD, MSc, MA
Behavioral scientist
Division of Violence Prevention
National Center for Injury Prevention and Control
CDC

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

Response: Suicide ranks as the 10th leading cause of death for all age groups combined and has been among the top 12 leading causes of death since 1975 in the U.S. In 2015, across all age groups, suicide was responsible for 44,193 deaths in the U.S., which is approximately one suicide every 12 minutes.

Suicide was the second leading cause of death among U.S. youth aged 10-24 years in 2015. Self-inflicted injury is one of the strongest risk factors for suicide.

This study examined trends in non-fatal self-inflicted injuries treated in hospital emergency departments (EDs) among youth aged 10 to 24 years in the United States from 2001-2015.  The overall weighted age-adjusted rate for this group increased by 5.7% annually during the 2008 to 2015 period.  Age-adjusted trends for males overall and across age groups remained stable throughout 2001-2015.  However, rates among females increased significantly, by 8.4% annually. The largest increase among females was observed among those aged 10-14 years, with an increase of 18.8% annually from 2009 to 2015.

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Diabetic Atherosclerosis Management Can Be Personalized Using Coronary Artery Calcium Score

MedicalResearch.com Interview with:
Dr. MalikDr. Shaista Malik MD PhD MPH
Director of Samueli Center For Integrative Medicine
Assistant Professor, School of Medicine
University of California, Irvine

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

Response: Having diabetes has been considered to be a risk equivalent to already had a myocardial infarction for predicting future cardiovascular events.  We were interested in testing whether further risk stratification in those with diabetes and metabolic syndrome, using coronary artery calcium (CAC), would result in improved prediction of cardiovascular events.

We found that CAC score was associated with incident coronary heart disease and cardiovascular disease more than a decade after the scoring was performed.  We also found that even after we controlled for the duration of diabetes (of 10 years or more), insulin use, or hemoglobin A1c level, coronary artery calcium remained a predictor of cardiovascular events.

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Micro RNAs in Saliva May Predict Severity of Concussion Injuries

MedicalResearch.com Interview with:

Dr. Steven D. Hicks,  M.D., Ph.D Penn State Health

Dr. Hicks

Dr. Steven D. Hicks,  M.D., Ph.D
Penn State Health

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

Response: Previous research has shown that small epigenetic molecules called microRNAs are altered in the blood after a traumatic brain injury. Our own pilot research showed that microRNAs were also changed in the saliva after brain injury and that some of these changes mirrored changes in cerebrospinal fluid. In this study we investigated whether salivary microRNA patterns after a concussion could be used to predict the duration and character of symptoms one month after injury.

We found that levels of five microRNAs predicted presence of symptoms one month later with greater accuracy (~85%) than standard surveys of symptom burden (~65%). Interestingly, one of the predictive salivary microRNAs (miR-320c) targets pathways involved in synaptic plasticity and was significantly correlated with attention difficulties one month after concussive injury.   Continue reading

Collaborative Effort Allows Oversight of Antipsychotic Medications in Medicaid Children

MedicalResearch.com Interview with:

Julie M. Zito, PhD Professor of Pharmacy and Psychiatry University of Maryland, Baltimore Pharmaceutical Health Services Department Baltimore, MD 21201

Dr. Zito

Julie M. Zito, PhD
Professor of Pharmacy and Psychiatry
University of Maryland, Baltimore
Pharmaceutical Health Services Department
Baltimore, MD 21201 

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

Response: The growth of antipsychotic use in children, mainly for the treatment of behavior, has been of increasing concern in recent years. Clinical safety issues (Burcu et al. 2017) and government reports on overuse in the treatment of poor and foster care children (GAO, 2017; 2012) motivated our assessment of peer review programs. These programs are a relatively new approach to Medicaid oversight intended to monitor and assure clinical appropriateness of second generation antipsychotics in children. Critically important is the fact that most antipsychotic use is for child behavioral problems which are off-label conditions, i.e. without sufficient evidence of effectiveness or safety.

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Database Analyses May Find Supplemental Uses For Established Drugs In Cost-Effective Manner

MedicalResearch.com Interview with:

Michael Fralick, MD FRCPC Research Fellow at the Division of Pharmacoepidemiology and Pharmacoeconomics Harvard University and General Internist at the University of Toronto

Dr. Fralick

Michael Fralick, MD FRCPC
Research Fellow at the Division of Pharmacoepidemiology and Pharmacoeconomics
Harvard University and
General Internist at the University of Toronto

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

Response: Manufacturers of Food and Drug Administration (FDA)-approved prescription drugs often apply for additional indications based on randomized trials. “Real-world” data based on a medication’s actual use and outcomes in routine settings of care might help to inform decision-making regarding such supplemental indications.

MedicalResearch.com: What are the main findings?

Response:  In this non-randomized study we were able to replicate the results of the randomized trial that established the supplemental indication for telmisartan using data from a US healthcare database (insurance claims data) available at the time the randomized trial was completed.

We were also able to confirm the known decreased risk of angioedema with telmisartan compared to ramipril.

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

Response: If done selectively and with principled methodologies, it might be feasible to use non-randomized real-world data to provide supportive evidence in establishing supplemental drug indications. To improve the validity of the studies, they should ideally be registered prior to them starting.

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

Response: We used real-world data to recreate both the benefits and the harms found in a randomized controlled trial. The randomized trial costed 10s of millions of dollars and took over 7 years to complete. By contrast, our study took a few months to complete and was a small fraction of the cost of the randomized trial.

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

Citation:

Michael Fralick, Aaron S. Kesselheim, Jerry Avorn, Sebastian Schneeweiss. Use of Health Care Databases to Support Supplemental Indications of Approved Medications. JAMA Intern Med. Published online November 20, 2017. doi:10.1001/jamainternmed.2017.3919

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

 

 

 

 

 

Advanced Directive Forms Rarely Completed by Patients Seen For Palliative Care Consult

MedicalResearch.com Interview with:

Kara Bischoff, MD Assistant Clinical Professor, Hospital Medicine & Palliative Care Director of Quality Improvement for the Palliative Care Service UCSF Department of Medicine

Dr. Bischoff

Kara Bischoff, MD
Assistant Clinical Professor, Hospital Medicine & Palliative Care
Director of Quality Improvement for the Palliative Care Service
UCSF Department of Medicine

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

Response: Care planning, which we define as including both advance care planning and goals of care discussions, are a common need in seriously ill patients and a key function of palliative care teams.

However, few studies have looked at how often and how care planning is being done by inpatient palliative care teams throughout the United States, and similarly few studies have examined the precise impact of these care planning activities. Therefore, using data from a large quality improvement registry in palliative care called the Palliative Care Quality Network, we examined:

1) the characteristics of hospitalized patients who are referred to inpatient palliative care consult services,

2) the activities that occurred during those inpatient palliative care consults, and

3) the outcomes that resulted.

In looking at data from 73,145 patients who referred for an inpatient palliative care consult, we found that care planning was the most common reason for inpatient palliative care consultation, requested for 71.9% of patients who were referred to palliative care. Further, care planning needs were found in more than half (58%) of palliative care patients even when the consult was requested for reasons other than care planning. Patients referred to palliative care for care planning were somewhat older than patients referred for other reasons, they were less likely to have cancer, and were more often full code at the time of referral. Through care planning conversations, palliative care clinicians frequently identified surrogates and clarified patients’ preferences for life-sustaining treatments (including code status). For instance, 31% more patients chose a code status of DNR/DNI after a conversation with the palliative care team.

However, we also found that legal forms such as advance directives and Physician Orders for Life-Sustaining Treatments (POLST) forms were completed for just 3.2% and 12.3% of the patients see by palliative care teams, respectively. This highlights an important quality gap in need of improvement.

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Obsessive-Compulsive Disorder Associated With Educational Underachievment

MedicalResearch.com Interview with:

Ana Pérez-Vigil MD Department of Clinical Neuroscience Child and Adolescent Psychiatry Research Center Karolinska Institutet

Dr. Perez-Vigil

Ana Pérez-Vigil MD
Department of Clinical Neuroscience
Child and Adolescent Psychiatry Research Center
Karolinska Institutet

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

Response: Everyone who regularly works with persons who have obsessive-compulsive disorder (OCD) has seen that their patients often struggle with school work. It is not uncommon for these individuals to have poor school attendance and severe patients can be out of the education system altogether. This applies to persons of all ages, from school children to young adults who may be at university.

On the other hand there is a group of patients who, against all odds, working 10 times as hard as everybody else, manage to stay in education and eventually get a degree. So we have long suspected that OCD has a detrimental impact on the person’s education, with all the consequences that this entails (worse chances to enter the labour market and have a high paid job). But we did not really know to what extent OCD impacts education. So we wanted to know what is the actual impact of OCD on educational attainment using objectively collected information from the unique Swedish national registers. Previous work had been primarily based on small clinical samples from specialist clinics, using either self or parent report and cross-sectional designs. Previous work also tended not to control for important confounders such as psychiatric comorbidity or familial factors (genetic and environmental factors that could explain both OCD and the outcomes of interest).

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Increased Risk of Pregnancy Complications With Both Above and Below Normal BMI

MedicalResearch.com Interview with:
 <a href="https://www.flickr.com/photos/kit4na/8570833723">“Pregnancy”</a> by <i> <a href="https://www.flickr.com/people/kit4na/">Tatiana Vdb</a> </i> is licensed under <a href="https://creativecommons.org/licenses/by/2.0"> CC BY 2.0</a>Sarka Lisonkova, MD, PhD

Assistant Professor
Department of Obstetrics and Gynaecology
University of British Columbia.
Children’s and Women’s Health Centre
Vancouver, BC Canada 

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

Response: We know that high BMI is associated with adverse birth outcomes for baby, including stillbirth, neonatal death, and others illnesses. However, less was known about the association with serious maternal morbidity.

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

Response: Maternal pre-pregnancy BMI is important not only for baby’s health, but also for maternal health. The risk of majority of severe maternal complications, for example acute cardiac or pulmonary problems, increases with BMI above normal values. On the other side, women with BMI below-normal values also have increased risk of some complications, for instance, excessive bleeding before or after delivery that requires transfusion. However, maternal death​ or life-threatening complications are very rare, so the chance of experiencing such event is very low even for women who are obese.

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

Response: Adopting a healthy lifestyle and reaching normal BMI before pregnancy is the best strategy for healthy pregnancy and optimal childbirth. For women who are underweight, overweight, or obese and already pregnant, it is important to strive for optimal weight-gain during pregnancy and good prenatal care. Modern obstetric care can prevent most severe maternal and infant morbidity by careful monitoring of maternal blood pressure and glucose level during pregnancy, and by timely obstetric interventions when maternal or baby conditions worsen. 

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

Response: The epidemic of obesity in the industrialized countries is alarming. US data show that about 50% of pregnant women are now overweight or obese. Even though maternal death and severe morbidity are very rare, we will see more of these serious adverse events in the future if the trend in obesity continues. This will also put more strain on obstetric services and increase the need for obstetric interventions. High-risk mothers need to be closely monitored during pregnancy and deliver in higher-level hospitals with appropriate resources,  including, for example, availability of maternal-fetal medicine specialist and an intensive care unit.

No disclosures

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

Citation:

Lisonkova S, Muraca GM, Potts J, Liauw J, Chan W, Skoll A, Lim KI. Association Between Prepregnancy Body Mass Index and Severe Maternal Morbidity. JAMA. 2017;318(18):1777–1786. doi:10.1001/jama.2017.16191

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

 

 

 

 

 

 

No Clear Guidelines To Manage Pain After Surgical Procedures

MedicalResearch.com Interview with:
“Surgery” by mrpbps is licensed under CC BY 2.0
Sagar Patel MD
Facial Plastic Surgeon
Board Certified Otolaryngology, Head and Neck Surgeon
Facial Plastic Surgery Associates, Houston, Texas

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

Response: While the majority of diverted opioids that are abused originate from pills prescribed for chronic conditions, with 214,000 rhinoplasties performed in the US in 2015, assessing opioid usage after rhinoplasty is an important view into prescription practices for acute pain after surgical procedures. Opioid use, pain control, and adverse effects were examined and opioid use was compared across patient demographic and surgical procedure characteristics, including rhinoplasty and septoplasty, open vs closed techniques, revision vs primary operations, reduction of turbinates, and use of osteotomies. Opioid use was self-reported as the number of prescribed tablets containing a combination of hydrocodone bitartrate (5 mg) and acetaminophen (325 mg) that were consumed. We them mathematically analyzed.

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How Much Non-Invasive Testing Is Necessary In ER To Rule Out Heart Attack?

MedicalResearch.com Interview with:

David L. Brown, MD, FACC Professor of Medicine Cardiovascular Division Washington University School of Medicine St. Louis, MO 63110

Dr. Brown

David L. Brown, MD, FACC
Professor of Medicine
Cardiovascular Division
Washington University School of Medicine
St. Louis, MO 63110

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

Response: Approximately 10 million patients present to emergency rooms in the US annually for evaluation of acute chest pain.

The goal of that evaluation is to rule out the diagnosis of an acute heart attack. Imaging with coronary CT angiography and stress testing are not part of the diagnostic algorithm for acute heart attack.  Nevertheless many chest pain patients undergo some form of noninvasive cardiac testing in the ER. We found that CCTA or stress testing adding nothing to the care of chest pain patients beyond what is achieved by a history, physical examination, ECG and troponin test.

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Adherence to HIV Treatment May Protect Brain From Further Injury

MedicalResearch.com Interview with:

Ryan Sanford

Ryan Sanford

Ryan Sanford, MEng
Department of Neurology and Neurosurgery
Montreal Neurological Institute
McGill University, Montréal, Québec, Canada
 

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

Response: With the introduction of combination antiretroviral therapy (cART) the outlook for HIV+ individuals has dramatically shifted from a fatal disease to a chronic manageable condition. However, HIV-associated neurocognitive disorders are still prevalent. The etiology of this dysfunction remains unknown. Previous work has reported progressive brain atrophy in HIV+ individuals with advanced disease and poor viral suppression, but it is unclear whether stable treatment and effective viral suppression can mitigate the progression of brain atrophy. To examine this issue, we followed well-treated HIV+ individuals with good viral suppression and well-matched controls, and assessed whether ongoing brain atrophy occurs over time.

The main finding in this study was the HIV+ participants had reduced brain volumes and poorer cognitive performance compared to the control group, but the changes in brain volumes and cognitive performance were similar between the groups.

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LPA Gene Variant May Help Identify Increased Risk of Aortic Stenosis 

MedicalResearch.com Interview with:

Aortic Stenosis Blaus Image Wikipedia

Aortic Stenosis Blaus Image Wikipedia

Hao Yu Chen, MSc
Department of Medicine
McGill University
Montreal, Quebec, Canada
Senior author: George Thanassoulis, MD, MSc

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

Response: Aortic stenosis, a narrowing of the main valve of the heart, is the most common type of valve disease in the US. Present in more than 2.5 million individuals in North America, aortic stenosis can lead to heart failure and death. However, there is little known about the causes of aortic stenosis and how it should be treated.

Previously, we have demonstrated that variants of the gene LPA are associated with the development of aortic stenosis. A better understanding of how this region contributes to aortic stenosis could identify higher-risk individuals and inform the development of new medical therapies for aortic stenosis.  Continue reading

Benefits of Hypertension Treatment Depends Somewhat on Starting Blood Pressure Level

MedicalResearch.com Interview with:

Blood pressure monitor reading 120/80 copyright American Heart Association

Blood pressure monitor reading 120/80
copyright American Heart Association

Dr. Mattias Brunström
Department of Public Health and Clinical Medicine
Umeå University,Sweden

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

Response: Current guidelines recommend a systolic blood pressure treatment target below 140 mm Hg for most people. Since the publication of SPRINT however, many have suggested guidelines should be changed, recommending further blood pressure lowering.

We performed a systematic review and meta-analysis of randomized clinical trials comparing different blood pressure targets or antihypertensive treatment verus placebo. We separated primary preventive trials from secondary preventive trials, and stratified primary preventive trials by mean baseline systolic blood pressure. The analyses included 74 trials, with in total > 300 000 participants. Interestingly, we found that treatment effect was dependent on baseline systolic blood pressure in people without previous CVD.

While primary preventive treatment reduced the risk of death and cardiovascular disease if systolic blood pressure was 140 mm Hg or higher, treatment effect was neutral if systolic blood pressure was below 140 mm Hg.

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High-Sensitivity Cardiac Troponin I Can Identify Low Risk Chest Pain Patients

MedicalResearch.com Interview with:

Dr Andrew R. Chapman BHF Clinical Research Fellow University of Edinburgh Chancellors Building Edinburgh 

Dr. Chapman

Dr Andrew R. Chapman
BHF Clinical Research Fellow
University of Edinburgh
Chancellors Building
Edinburgh 

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

Response: High-sensitivity cardiac troponin tests allow accurate measurement of cardiac troponin in the bloodstream. Currently, guidelines recommend we evaluate patients with suspected myocardial infarction using these tests, by looking for levels which are above the upper reference limit (99th centile). These troponin measurements are taken on arrival, and often repeated after admission to hospital up to six hours later. When levels are below this limit, the diagnosis of myocardial infarction is ruled out. However, using such a high limit in patients on arrival to hospital may not be safe, as lower risk stratification thresholds has been shown to reduce missed events,  and in these patients admission to hospital for repeat testing may not be necessary. However, there is no consensus as to the optimal threshold for use in practice.

In a worldwide study of 23,000 patients from 9 countries, we have shown when high-sensitivity cardiac troponin I concentrations are below a risk stratification threshold of 5 ng/L at presentation, patients are at extremely low risk of myocardial infarction or cardiac death at 30 days, with fewer than 1 in 200 patients missed. Importantly, this threshold identifies almost 50% of all patients as low risk after a single blood test. As admission or observation of these patients is estimated to cost as much as $11 billion per year in the United States, this strategy has major potential to improve the efficiency of our practice.

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No Link Found Inhaled Steroids and Bone Fractures in Asthmatic Children

MedicalResearch.com Interview with:
“Asthma” by Michael Havens is licensed under CC BY 2.0Teresa To, PhD
Biostatistics, Design and Analysis
Scientific Director
The Hospital for Sick Children
Dalla Lana School of Public Health, University of Toronto
Institute for Clinical Evaluative Sciences
Toronto, Ontario, Canada

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

Response: We studied asthma prescription drug use in Ontario children aged 2 to 18 years with physician diagnosed asthma between 2003 and 2014.

We found that:

  1. Currently in Ontario, nearly 50% of children with asthma did not fill a prescription for an inhaled corticosteroid during the study period, despite these medications being considered the gold-standard for asthma management.
  2. Our findings did not show clinically important association between inhaled corticosteroids and fracture among children with asthma.
  3. However, systemic corticosteroids (oral or injection) are associated with higher fracture risk in children with asthma (17% higher risk).

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More Lab Tests Ordered At Teaching vs Non-Teaching Hospitals

MedicalResearch.com Interview with:

Victoria Valencia, MPH Assistant Director for Healthcare Value Dell Medical SchoolThe University of Texas at Austin

Victoria Valencia

Victoria Valencia, MPH
Assistant Director for Healthcare Value
Dell Medical SchoolThe University of Texas at Austin

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

Response: We were surprised to find that despite the common anecdote that resident physicians in teaching environments order more lab tests, there was a lack of empirical data to support the claim that more lab tests are ordered for patients at teaching hospitals than at non-teaching hospitals. Our study of 43,329 patients with pneumonia or cellulitis across 96 hospitals  in the state of Texas found that major teaching hospitals order significantly more lab tests than non-teaching hospitals.  We found this to be true no matter how we looked at the data, including when restricting to the least sick patients in our dataset. We also found that major teaching hospitals that ordered more labs for pneumonia tended to also more labs for cellulitis, indicating there is some effect from the environment of the teaching hospital that affects lab ordering overall.

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Going the Wrong Way: ACA’s Readmission Reduction Program Linked To Increased Heart Failure Deaths

MedicalResearch.com Interview with:

Ankur Gupta, MD, PhD Division of Cardiovascular Medicine Brigham and Women’s Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts

Dr. Ankur Gupta

Ankur Gupta, MD, PhD
Division of Cardiovascular Medicine
Brigham and Women’s Hospital Heart & Vascular Center and
Harvard Medical School,
Boston, Massachusetts 

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

Response: The Hospital Readmissions Reduction Program (HRRP), established under the Affordable Care Act, aimed to reduce readmissions from various medical conditions including heart failure – the leading cause of readmissions among Medicare beneficiaries. The program financially penalizes hospitals with high readmission rates. However, there have been concerns of unintended consequences especially on mortality due to this program.

Using American Heart Association’s Get With The Guidelines-Heart Failure (GWTG-HF) data linked to Medicare data, we found that the policy of reducing readmissions after heart failure hospitalizations was associated with reduction in 30-day and 1-year readmissions yet an increase in 30-day and 1-year mortality.

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FDG-PET Scans of Lung Nodules Should Be Interpreted With Caution

MedicalResearch.com Interview with:

PET Scan Vanderbilt Health

PET Scan Vanderbilt Health

Amelia W. Maiga, MD MPH
Vanderbilt General Surgery Resident
VA Quality Scholar, TVHS

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

Response: Positron emission tomography (PET) combined with fludeoxyglucose F18 (FDG) is currently recommended for the noninvasive diagnosis of lung nodules suspicious for lung cancer. Our investigation adds to growing evidence that FDG-PET scans should be interpreted with caution in the diagnosis of lung cancer. Misdiagnosis of lung lesions driven by FDG-PET avidity can lead to unnecessary tests and surgeries for patients, along with potentially additional complications and mortality.

To estimate FDG-PET diagnostic accuracy, we conducted a multi-center retrospective cohort study. The seven cohorts originating from Tennessee, Arizona, Massachusetts and Virginia together comprised 1188 nodules, 81 percent of which were malignant. Smaller nodules were missed by FDG-PET imaging. Surprisingly, negative PET scans were also not reliable indicators of the absence of disease, especially in patients with smaller nodules or who are known to have a high probability of lung cancer prior to the FDG-PET test.

Our study supports a previous meta-analyses that found FDG-PET to be less reliable in regions of the country where fungal lung diseases are endemic. The most common fungal lung diseases in the United States are histoplasmosis, coccidioidomycosis and blastomycosis. All three fungi reside in soils. Histoplasmosis and blastomycosis are common across much of the Mississippi, Ohio and Missouri river valleys and coccidioidomycosis is prevalent in the southwestern U.S. These infections generate inflamed nodules in the lungs (granulomas), which can be mistaken for cancerous lesions by imaging.

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Married Head/Neck Cancer Patients Less Likely To Smoke, More Likely To Live Longer

MedicalResearch.com Interview with:

Nosayaba Osazuwa-Peters, BDS, MPH, CHES Instructor, Department of Otolaryngology-Head and Neck Surgery Saint Louis University School of Medicine Member, Saint Louis University Cancer Center St Louis, Missouri

Nosayaba Osazuwa-Peters

Nosayaba Osazuwa-Peters, BDS, MPH, CHES
Instructor, Department of Otolaryngology-Head and Neck Surgery
Saint Louis University School of Medicine
Member, Saint Louis University Cancer Center
St Louis, Missouri 

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

Response: Several studies have shown that there is an adverse effect of smoking on head and neck cancer survival; however, there are studies that show no effect between smoking and head and neck cancer. We wanted to investigate this problem using a single institution’s cancer dataset. Additionally, we wanted to understand the role of marital status in the smoking behavior of head and neck cancer patients, and to understand if smoking played any role in head and neck cancer survival.

Our study confirmed that head and neck cancer patients who were smokers at the time of diagnosis had lower survival rates than nonsmokers. We also found that married head and neck cancer patients were less likely to be smokers and more likely to survive longer than those unmarried.

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Lifestyle Modifications Slow Progression To Diabetes As Effectively As Medications

MedicalResearch.com Interview with:
Dr. Karla Galaviz PhD
Hubert Department of Global Health
Rollins School of Public Health
Emory University
Sonya Haw, MD| Assistant Professor
Division of Endocrinology, Metabolism & Lipids
Emory University, School of Medicine
Grady Memorial Hospital
Atlanta, GA

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

  • Diabetes affects 1 in 11 adults worldwide and though there is evidence that lifestyle modification (eating healthier diets and exercising about 150 mins a week) and certain medications can prevent or delay diabetes onset, it is not clear which of these strategies offers long-term benefits.
  • To answer this question, we compiled all available randomized controlled trials of lifestyle programs and medications to prevent diabetes and analyzed the data to see if the diabetes prevention effects persisted in the long-term. We specifically compared studies where the lifestyle or drug interventions were discontinued to see if the effect was long lasting or diminished when the intervention was stopped.

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Anti-TNF Agents In Inflammatory Bowel Disease Linked to Small Increased Risk of Lymphoma

MedicalResearch.com Interview with:
ANSM
Rosemary Dray-Spira, MD, PhD
Department of Epidemiology
French National Agency for Medicines and Health Products Safety (ANSM)
Saint-Denis, France

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

Response: Anti-tumor necrosis factor (anti-TNF) agents are increasingly used for the management of inflammatory bowel diseases (IBD), either alone or in combination with thiopurines. Their clinical benefits have been largely assessed, however they may expose to potentially serious adverse effects. While an increased risk of lymphoma has been established with thiopurines, up to now such a risk of lymphoma remained uncertain with anti-TNF agents.

In this study based upon a large, nationwide cohort of 189,289 patients with IBD, the use of anti-TNF agents alone was found associated with a 2 to 3 fold increase in the risk of lymphoma, similarly to thiopurines alone. In addition, the combination of these two treatments was associated with a 6 fold increase in the risk of lymphoma, ie a higher risk than with each treatment used alone. Although these differences are statistically significant, the risk of lymphoma among patients exposed to anti-TNF agents is less than 1 case per 1000 person-years.

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Labels of Majority of Online Cannabidiol Extracts Contain Inaccuracies

MedicalResearch.com Interview with:

Dr. Italia V. Rolle, PhD and Dr. Tim McAfee, MD Office on Smoking and Health National Center for Chronic Disease Prevention and Health Promotion CDC

Marijuana plant (Cannabis sativa)

Marcel Bonn-Miller, PhD
Adjunct assistant professor
Department of Psychiatry
Leader of the Substance Abuse and Anxiety Program
U.S. Veterans Affairs Department 

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

Response: A 2015 study found that edible cannabis products (e.g., brownies, cookies, drinks) are often mislabeled.  The FDA has also sent warning letters to a handful of companies selling cannabidiol extracts because of inaccurate labeling of content. This led us to conduct a systematic evaluation of the label accuracy of all cannabidiol extracts sold online.  We tested 84 products from 31 different companies.

The primary take-home of this study is that nearly 70 percent of all cannabidiol extracts sold online had over 10% more or less cannabidiol than advertised; 26% of products were over-labeled (less cannabidiol than indicated) and 42% of products were under-labeled (more cannabidiol than indicated).

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Nearly Half of Adolescents Had At Least One Sunburn In Past Year

MedicalResearch.com Interview with:
“Dymchurch Beach - May 2012 - Sunburn with Matching Bikini” by Gareth Williams is licensed under CC BY 2.0
Dawn M. Holman, MPH
Behavioral Scientist
Division of Cancer Prevention and Control
Centers for Disease Control and Prevention

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

Response: Scientific evidence clearly shows that even one sunburn during adolescence can increase a person’s chances of developing skin cancer as an adult. Surprisingly, little research has been done to understand the factors associated with sunburn during this phase of life. The CDC wanted to examine beliefs, behaviors, and demographic characteristics that might be associated with adolescent sunburns in hopes that the findings could inform future intervention efforts. We used data from the 2015 YouthStyles survey (adolescents aged 12 to 17 years) to explore this research question

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Exercise, Vision Testing and Osteoporosis Evaluation Are Keys To Fall Prevention

MedicalResearch.com Interview with:

Andrea C. Tricco PhD, MSc Scientist and Lead of the Knowledge Synthesis Team Associate Professor Dalla Lana School of Public Health, University of Toronto Associate Editor Journal of Clinical Epidemiology, BMC Medical Research Methodology, Systematic Reviews

Dr. Tricco

Andrea C. Tricco PhD, MSc
Scientist and Lead of the Knowledge Synthesis Team
Associate Professor Dalla Lana School of Public Health, University of Toronto
Associate Editor Journal of Clinical Epidemiology, BMC Medical Research Methodology, Systematic Reviews

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

Response: Falls are the leading cause of injury among older adults and account for $2 billion in direct health-care costs annually ($31 billion in costs to Medicare in the United States in 2012). We aimed to determine which types of fall-prevention programs may be effective for reducing falls in older people.

MedicalResearch.com: What are the main findings?

Response: Exercise, along with vision assessment and treatment, as well as an assessment and possible modification of a person’s living environment, reduced the risk of injurious falls by 23% compared to usual care.

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Chronic Valvular Heart Disease Linked To White Matter Brain Changes

MedicalResearch.com Interview with:
Dr. Keun-Hwa Jung MD PhD

Program in Neuroscience, Neuroscience Research Institute of SNUMRC
College of Medicine
Seoul National University
First author: Dr. Woo-Jin Lee MD
Department of Neurology
Seoul National University Hospital
Seoul, South Korea 

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

Response: Cerebral white matter hyperintensity is a prevalent consequence of brain aging process and associated with various complications. One of the main mechanisms underlying the progression of white matter hyperintensity is chronic dysfunction of the glymphatic system which maintains metabolic homeostasis in brain. Glymphatic system is the route where the cerebrospinal fluid enters into the brain parenchyma and is cleared out with soluble wastes to the perivascular space of the cerebral small veins, peri-meningeal lymphatic vessels, deep cervical lymph nodes, and finally to the right atrium.

Although the integrity of the glymphatic system is dependent on the adequate drainage of cerebral veins and lymphatics to the downstream chamber, the right atrium, the impact of hemodynamic changes in right-sided cardiac chambers on the development of white matter hyperintensity have not been elucidated.

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Trained Volunteers Can Deliver Effective Brief Smoking Cessation Advice

MedicalResearch.com Interview with:
“Stop smoking!” by Emil_95 is licensed under CC BY 2.0
Dr. Man Ping Wang, PhD
School of Nursing
University of Hong Kong
Hong Kong

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

Response: Smoking cessation (SC) services can effectively increase the chance of abstinence, but few smokers proactively seek help from these services worldwide. Smoking cessation guidelines recommend referring smokers to SC services, but such referrals were usually conducted in a passive way (e.g. providing contacts of these services and asking smokers to use them). Actively referring smokers may increase use of smoking cessation services and abstinence rates.

Previous studies were mostly conducted in clinical settings. We investigated the efficacy of using trained volunteers to actively refer smokers recruited in the community to smoking cessation services in this cluster randomized control trial. We found that smokers who received a brief cessation advice and active referral had significantly higher abstinence rate and smoking cessation service use rate at 6-month follow-up, compared with smokers who received a minimal advice and a self-help booklet.

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Most Adolescents Not Receiving Important Health Care Preventive Services

MedicalResearch.com Interview with:

Sally H. Adams, PhD, RN Specialist, Division of Adolescent and Young Adult  Medicine Adolescent and Young Adult Health National Resource Center University of California, San Francisco Benioff Children’s Hospital San Francisco, CA 94118

Dr. Adams

Sally H. Adams, PhD, RN
Specialist, Division of Adolescent and Young Adult  Medicine
Adolescent and Young Adult Health National Resource Center
University of California, San Francisco
Benioff Children’s Hospital
San Francisco, CA 94118

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

Response: Major causes of adolescent illness and mortality are preventable. To address this, in the 1990s, professional medical organizations developed healthcare provider guidelines for the delivery of adolescent preventive healthcare. These include the receipt of anticipatory guidance and risk screening services in the effort to promote healthy behaviors and avoid risky behaviors that are intended to be covered within a preventive care visit, but could be addressed in other healthcare visits.

The adolescent developmental period is an important time for adolescents to be engaged with the healthcare system. Transitioning from childhood to adulthood, adolescents are becoming increasingly independent – having more responsibility and freedom for decision making in many areas, including healthy choices in behaviors and activities. While families and community settings (schools, churches) play strong roles in this process, the healthcare system also plays an important role.

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Anticoagulant Warfarin May Lower Cancer Risk

MedicalResearch.com Interview with:
Gry Haaland, MD

James Lorens PhD, Professor
The Department of Biomedicine
University of Bergen

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

Response: Antitumor activity of the common blood thinner warfarin has been reported in several experimental cancer model systems. We therefore considered whether warfarin is cancer protective.

Using the comprehensive national health registries in Norway, we examined cancer incidence among a large number of people taking warfarin (92,942) and compared to those not taking warfarin (more than 1.1 million).

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Physician Extenders Can Modestly Reduce Wait Times For a Dermatology Appointment

MedicalResearch.com Interview with:

Eliot N. Mostow, MD, MPH Professor & Chair, Dermatology Section Department of Internal Mediciine Northeast Ohio Medical University

Dr. Mostow

Eliot N. Mostow, MD, MPH
Professor & Chair, Dermatology Section
Department of Internal Mediciine
Northeast Ohio Medical University 

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

Response: The background for the study is my continued interest in what is sometimes called health services research. That is, how do we improve our ability to deliver optimal medical care from a healthcare system perspective? Simply put, one of the most frequent criticisms about getting a dermatologist to see if patient is that there are delays in scheduling (wait times are too high). I’m not sure this is really justified, as it seems to take a long time to get into psychiatrists, gynecologists, and other specialists in our community as well.

That being said, since I’m in the dermatology community and our community has been utilizing physician assistants and nurse practitioners more frequently for many years now, we thought it was worthwhile to explore whether this was having an impact on wait times to get a visit in a dermatologist’s office.

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Pesticide Residues On Fruits & Vegetables Associated With Increased Risk of Pregnancy Loss

MedicalResearch.com Interview with:

“Pesticide spraying” by jetsandzeppelins is licensed under CC BY 2.0

“Pesticide spraying” by jetsandzeppelins

Yu-Han Chiu, M.D., M.P.H., Sc.D
Department of Nutrition
Harvard T.H. Chan School of Public Health

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

Response:  Animal experiments suggest that ingestion of pesticide mixtures at environmentally relevant concentrations decreases the number of live-born pups. However, it is unclear whether intake of pesticide residues has any adverse effects in humans, especially for susceptible populations such as pregnant women and their fetuses. Therefore, in this study we examined the association of preconception intake of pesticide residues in fruits and vegetables with pregnancy outcomes among 325 women undergoing assisted reproduction.

We found that intake of high pesticide residue fruits and vegetables were associated with higher risks of pregnancy loss, while low pesticide residue fruit and vegetable intake was associated with lower risks of early pregnancy loss. These data suggest dietary pesticide exposure within the range of typical human exposure may be associated with adverse reproductive consequences

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