Do Decision Aids Make a Difference in Prostate Cancer Screening?

MedicalResearch.com Interview with:

Kari Tikkinen, MD, PhD, Adjunct Professor Departments of Urology and Public Health University of Helsinki and Helsinki University Hospital Helsinki, Finland

Dr. Tikkinen

Kari Tikkinen, MD, PhD, Adjunct Professor
Departments of Urology and Public Health
University of Helsinki and Helsinki University Hospital
Helsinki, Finland

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

Response: Men’s choice of whether to undergo screening is value and preference sensitive: fully informed men will make different choices depending on their experience and perspective. For such decisions, shared decision-making represents an ideal approach to decision making. In shared decision-making both the patient and health care provider contribute to the medical decision-making process. The health care provider explains alternatives to patients, informs them of the best evidence regarding the anticipated consequences of a decision for or against the intervention, and helps them choose the option that best aligns with their preferences. All major guidelines of prostate cancer screening acknowledge the importance of informing men about risks and benefits of PSA screening.

Shared decision-making is challenging because it requires time, knowledge, and specific skills. Prostate cancer screening decisions aids may, by summarizing the current best evidence and by supporting conversations that address what matters most to men, address these challenges. The impact of decision aids on the decision-making process is, however, uncertain. We therefore undertook a systematic review and meta-analysis of the randomized trials that have addressed the impact of decision aids in the context of prostate cancer screening.  Continue reading

Lowered Price of Repatha® (evolocumab) Translates to Cost Effectiveness for Range of Heart Conditions in Some High Risk Patients

MedicalResearch.com Interview with:

Gregg C. Fonarow, MD, FACC, FAHA Eliot Corday Professor of Cardiovascular Medicine and Science Director, Ahmanson-UCLA Cardiomyopathy Center Co-Chief of Clinical Cardiology, UCLA Division of Cardiology Co-Director, UCLA Preventative Cardiology Program David Geffen School of Medicine at UCLA Los Angeles, CA, 90095-1679

Dr. Gregg Fonarow

Gregg C. Fonarow, MD, FACC, FAHA
Eliot Corday Professor of Cardiovascular Medicine and Science
Director, Ahmanson-UCLA Cardiomyopathy Center
Co-Chief of Clinical Cardiology, UCLA Division of Cardiology
Co-Director, UCLA Preventative Cardiology Program
David Geffen School of Medicine at UCLA
Los Angeles, CA 

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

Response: Last year, Amgen made the PCSK-9 inhibitor evolocumab available at a reduced list price of $5,850 per year This 60% reduction was aimed at improving patient access by lowering patient copays, especially for Medicare beneficiaries.

Additionally, the treatment landscape for PCSK9 inhibitors was further defined in 2018 when the American College of Cardiology/American Heart Association Multisociety Clinical Guideline on the Management of Blood Cholesterol recommended PCSK9 inhibitors for, among other patient populations, patients with very high-risk (VHR) ASCVD whose low-density lipoprotein cholesterol levels remain at 70 mg/dL or more  despite a heart-healthy lifestyle and treatment with standard background therapy.

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Decrease in Obesity Among Young US Children Enrolled in Special Supplemental Nutrition Program 2010-2016

MedicalResearch.com Interview with:

Liping Pan, MD, MPH Epidemiologist Division of Nutrition, Physical Activity, and Obesity National Center for Chronic Disease Prevention and Health Promotion Centers for Disease Control and Prevention

Dr. Pan

Liping Pan, MD, MPH
Epidemiologist
Division of Nutrition, Physical Activity, and Obesity
National Center for Chronic Disease Prevention and Health Promotion
Centers for Disease Control and Prevention

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

Response: Children with severe obesity face significant health and social challenges. Children with obesity are at higher risk for having other chronic health conditions and diseases, such as asthma, sleep apnea, bone and joint problems, and type 2 diabetes. They also have more risk factors for heart disease such as high blood pressure, impaired glucose tolerance, and high cholesterol than their healthyweight peers. Children with obesity can be bullied and teased more than their healthyweight peers. They are also more likely to suffer from social isolation, depression, and lower self-esteem. Children with obesity are also more likely to have obesity as adults. This can lead to lifelong physical and mental health problems. Adult obesity is associated with a higher risk of type 2 diabetes, heart disease, and many types of cancers. 

Childhood obesity is more common among children from lower-income families, as many lack access to healthy, affordable foods and beverages and opportunities for low-cost physical activity.

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Most Older Adults Have Eyes Examined, But Disparities Remain

MedicalResearch.com Interview with:

Joshua R. Ehrlich, MD, MPH Assistant Professor, Ophthalmology and Visual Sciences Kellogg Eye Center Department of Ophthalmology and Visual Sciences University of Michigan

Dr. Ehrlich

Joshua R. Ehrlich, MD, MPH
Assistant Professor, Ophthalmology and Visual Sciences
Kellogg Eye Center
Department of Ophthalmology and Visual Sciences
University of Michigan 

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

Response: This study came out of data collected as part of the National Poll on Healthy Aging (NPHA). The NPHA is funded by AARP and the Institute for Healthcare Policy and Innovation at the University of Michigan to inform the public, healthcare providers, and policymakers on a variety issues related to health. The vision survey, conducted in March 2018, was just one of many NPHA surveys.

Due to aging of the population, the number of older U.S. adults with blindness and vision impairment is expected to double over the next 30 years. Thus, this study was designed to provide crucial data  on contemporary data on patterns of eye care utilization in older adults.

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Chronic Pain in Cancer Patients Varies by Income and Insurance Status

MedicalResearch.com Interview with:

Changchuan (Charles) Jiang MD, MPH MSSLW Internal Medicine Residency Program, Class of 2020 Ichan School of Medicine at Mount Sinai

Dr. Jiang

Changchuan (Charles) Jiang MD, MPH
MSSLW Internal Medicine Residency Program
Class of 2020
Ichan School of Medicine at Mount Sinai

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

Response: Chronic pain is one of the common side effects of cancer treatments and it has been linked to low life quality, lower adherence to treatment, higher medical cost. As the population of cancer survivors grows rapidly, chronic pain will be a major public health issue in this population. We know from previous studies that chronic pain is common in certain cancers such as breast cancer. However, little was known about the epidemiology of chronic pain in the cancer survivors until our study.

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Cinematic Rendering of CT Scans Can Assist Surgeons in Preparation for Surgery

MedicalResearch.com Interview with:

Christian Krautz, MD Department of Surgery, Universitätsklinikum Erlangen Friedrich-Alexander-Universität Erlangen Nürnberg Erlangen, Germany

Dr. Krautz

Christian Krautz, MD
Department of Surgery, Universitätsklinikum Erlangen
Friedrich-Alexander-Universität Erlangen Nürnberg
Erlangen, Germany 

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

Response: In this preclinical study that included 720 case evaluations, visualization with Cinematic Rendering allowed a more correct and faster comprehension of the surgical anatomy compared to conventional CT imaging independent from the level of surgical experience. Therefore,Cinematic Rendering is a tool that may assist HPB surgeons with preoperative preparation and intraoperative guidance through an improved interpretation of computed tomography imaging data.

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Unprofessional Behavior by Surgeons Linked to Surgical Complications in Their Patients

MedicalResearch.com Interview with:

William Cooper, M.D., M.P.H. Cornelius Vanderbilt Professor Pediatrics and Health Policy Associate Dean for Faculty Affairs Director, Center for Patient and Professional Advocacy Vanderbilt University Medical Center

Dr. Cooper

William Cooper, M.D., M.P.H.
Cornelius Vanderbilt Professor
Pediatrics and Health Policy
Associate Dean for Faculty Affairs
Director, Center for Patient and Professional Advocacy
Vanderbilt University Medical Center

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

Response: For surgical teams, high reliability and optimal performance are dependent on effective communication, mutual respect, and continuous situational awareness. Surgeons who model unprofessional behaviors may contribute to undermining a culture of safety, threaten teamwork, and thereby increase risk for medical errors and surgical complications.

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Most Patients with Cellulitis May Not Need IV Antibiotics

MedicalResearch.com Interview with:

Example of cellulitis erysipelas from DermnetNZ.org

Example of cellulitis erysipelas from DermnetNZ.org

Richard Brindle DM FRCP
Honorary Reader, University of Bristol, UK 

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

Response: This review is an update of the 2010 Cochrane Review of Interventions for cellulitis and erysipelas (DOI: 10.1002/14651858.CD004299) but focusing on antibiotics.  It provides a valuable resource for clinicians in summarizing current best evidence and highlighting gaps in the research. This review will inform the production of evidence-based guidelines covering antibiotic choice, route of administration, duration of treatment and the role of combinations of antibiotics. Continue reading

Older Women Need Screening For Hip Fracture Risk

MedicalResearch.com Interview with:

Kristine E. Ensrud MD MPH Professor of Medicine and Epidemiology and Community Health University of Minnesota Core Investigator, Center for Care Delivery and Outcomes Research Minneapolis VA Health Care System

Dr. Ensrud

Kristine E. Ensrud MD MPH
Professor of Medicine and Epidemiology and Community Health
University of Minnesota
Core Investigator, Center for Care Delivery and Outcomes Research
Minneapolis VA Health Care System 

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

Response: Women aged 80 years and older, a rapidly growing segment of the population, account for the majority of hip fractures in the United States. Hip fractures account for 72% of fracture-related health care expenditures and lead to significant morbidity and mortality. However, many late-life women at high risk of hip fracture are undiagnosed. Clinicians have difficulty identifying late-life women most likely to benefit from osteoporosis screening and interventions to prevent hip fracture in part due to concerns about comorbidity burden and prognosis in this patient population. Continue reading

Non-Invasive Echocardiograms Can Be Overused Leading To Increased Costs

MedicalResearch.com Interview with:

Quinn R Pack, MD Assistant Professor of Medicine at University of Massachusetts Medical School - Baystate Adjunct Assistant Professor of Medicine Tufts University School of Medicine

Dr. Pack

Quinn R Pack, MD
Assistant Professor of Medicine
University of Massachusetts Medical School –
Baystate Adjunct Assistant Professor of Medicine
Tufts University School of Medicine

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

Response: Because echocardiograms are non-invasive, very low risk, and nearly universally available, it is easy to over-use this technique.  In myocardial infarction, echo is also recommended in guidelines.

However, in our lab, we frequently find echocardiograms that are ordered purely out of routine, without any thought as to the likelihood of finding an abnormality.   Prior studies also suggested that as many as 70% of echocardiograms provide no additional diagnostic value. When spread across the approximate 600,000 patients in the United States each year, this low diagnostic yield represents an opportunity to reduce costs by reducing echocardiograms. 

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TAVR vs Surgical Aortic Valve Replacement Among Low-Risk Patients With Aortic Stenosis

MedicalResearch.com Interview with:

Fausto Biancari, Professor of Surgery, University of Turku, Finland Professor of Cardiothoracic Surgery, University of Oulu, Finland Heart Center, T-Hospital, Hämeentie Turku, Finland

Prof. Biancari

Fausto Biancari, MD, PhD
Professor
University of Turku and University
Oulu, Finland

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

Response: Current data is scarce regarding the short- and midterm benefit of transcatheter aortic valve replacement (TAVR) compared to surgical aortic valve replacement (SAVR) in low-risk patients with severe aortic valve stenosis.

MedicalResearch.com: What are the main findings?

Response: In this observational study on 2841 low-risk patients with aortic valve stenosis from the Finnish nationwide FinnValve registry, propensity score matching analysis showed similar 30-day and three-year survival after TAVR and SAVR.

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Past and Present Smoking Raises Risk of Dermatology Surgery Complications

MedicalResearch.com Interview with:

Ian A. Maher, MD Department of Dermatology St Louis University, St Louis, Missouri

Dr. Maher

Ian A. Maher, MD
Department of Dermatology
St Louis University, St Louis, Missouri 

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

Response: One of our wonderful trainees at Saint Louis University was interested in the role of smoking in flap failures.  Dogma has been that smoking was a major risk factor for flap failures.  Looking at our database as well as published data, flap failures are a rare event, so rare as to be difficult to definitively associate with anything.  We decided to look more broadly at complications both acute (infections failures) and chronic (mainly cosmetic scarring associated) in flaps and grafts. Continue reading

Use of AV Grafts Drops in Dialysis Patients, But Still Room For Improvement

MedicalResearch.com Interview with:

Caitlin W. Hicks, M.D., M.S. Assistant Professor of Surgery Recipient of the Department of Surgery Rothman Early Career Development Award for Surgical Research Johns Hopkins Medicine

Dr. Hicks

Caitlin W. Hicks, M.D., M.S.
Assistant Professor of Surgery
Recipient of the Department of Surgery
Rothman Early Career Development Award for Surgical Research
Johns Hopkins Medicine

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

Response: Arteriovenous fistula are associated with better long-term patency, lower rates of infection, and lower long-term costs compared to arteriovenous graft. As a result, the Fistula First Catheter Last Guidelines recommend placement of an arteriovenous fistula over an AVG whenever possible.

We looked at individual physician utilization of AVF vs AVG for first-time AV access in Medicare beneficiaries. We found that the median physician utilization rate for AVG was only 18%, but that 21% of physicians use AVG in more than 34% of cases, which is above currently recommended  practice guidelines. 

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PTSD: Comparative Effectiveness of Medications, Psychotherapeutic and Combination Treatments

MedicalResearch.com Interview with:

Dr. Heike Gerger | Senior Postdoc University of Basel | Faculty of Psychology | Clinical Psychology and Psychotherapy Basel | Switzerland

Dr. Gerger

Dr. Heike Gerger | Senior Postdoc
University of Basel | Faculty of Psychology | Clinical Psychology and Psychotherapy
Basel | Switzerland

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

Response: Posttraumatic stress disorder (PTSD) is one of the most prevalent mental disorders, with a high risk of chronicity, comorbidity, and functional impairment. PTSD is complicated to treat, and the debate on the most efficacious treatment approach is ongoing. Treatment guidelines for the treatment of PTSD typically recommend different types of trauma-focused psychotherapeutic treatments as first-line PTSD treatment. However, concerning pharmacological therapies recommendations are inconsistent.

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Turn Off the Smartphone and TV at Night To Reduce Risk of Weight Gain

MedicalResearch.com Interview with:

Lead author: Yong-Moon (“Mark”) Park, MD, PhD Postdoctoral fellow Epidemiology Branch National Institute of Environmental Health Sciences

Dr. Park

Lead author: Yong-Moon (“Mark”) Park, MD, PhD
Postdoctoral fellow
Epidemiology Branch
National Institute of Environmental Health Sciences

Senior author: Dale P. Sandler, PhD Chief, Epidemiology Branch, National Institute of Environmental Health Sciences National Institutes of Health

Dr. Sandler

 

Senior author: Dale P. Sandler, PhD
Chief, Epidemiology Branch, National Institute of Environmental Health Sciences
National Institutes of Health

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

Response: A few studies had suggested that exposure to artificial light while sleeping was associated with obesity. However, the previous studies were cross-sectional, so we really do not know which came first – exposure to artificial light while sleeping or obesity. Another problem was that previous studies did not fully account for other characteristics that could affect this association, such as sleep duration and quality, calorie intake and dietary patterns, and physical activity.

We studied nearly 44,000 women ages 35-74 from across the US who are enrolled in the Sister Study cohort. Women had body weight characteristics measured at baseline and provided self-reported information on weight at baseline and follow-up – on average 5.7 years later.

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Hepatitis C Treatment: Study Finds No Liver, Kidney or Cardiovascular Adverse Effects

MedicalResearch.com Interview with:

Elizabeth A. McGlynn, PhD Vice President for Kaiser Permanente Research Executive Director Kaiser Permanente Center for Effectiveness and Safety 

Dr. McGlynn

Elizabeth A. McGlynn, PhD
Vice President for Kaiser Permanente Research
Executive Director
Kaiser Permanente Center for Effectiveness and Safety 

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

Response: A report from the Institute for Safe Medication Practices based on FDA data and observations from a Kaiser Permanente physician leader raised questions about whether direct acting antiviral medications for the treatment of Hepatitis C posed any significant safety risks for patients. Since the decision to take medications requires making tradeoffs between benefits (which had been clearly established in clinical trials) and risks (which are often harder to ascertain until drugs are in widespread use in the real world) we decided this was an important question to pursue.  We found no evidence of increased risks of significant side effects associated with taking these drugs.  In this cohort study of 33,808 patients in three large health systems we found lower adjusted odds of experiencing the following adverse events:  death, multiple organ failure, hepatic decompensation, acute-on-chronic liver event, and arrhythmia.  Continue reading

Medicaid Expansion Linked to Reduced Deaths from Heart Disease

MedicalResearch.com Interview with:

Sameed Khatana, MD, MPH Fellow, Cardiovascular Medicine, Perleman School of Medicine Associate Fellow, Leonard Davis Institute of Health Economics University of Pennsylvania

Dr. Khatana

Sameed Khatana, MD, MPH
Fellow, Cardiovascular Medicine, Perleman School of Medicine
Associate Fellow,
Leonard Davis Institute of Health Economics
University of Pennsylvania 

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

Response: The Affordable Care Act (ACA) led to the largest increase in Medicaid coverage since the beginning of the program. However, a number of states decided not to expand eligibility. Studies of prior smaller expansions in Medicaid, such as in individual states, have suggested evidence of improved outcomes associated with Medicaid expansion. Additionally, studies of Medicaid expansion under the ACA of certain health measures such as access to preventive care and medication adherence have suggested some improvements as well. However, there have been no large, population-level studies to examine whether Medicaid expansion under the ACA led to changes in mortality rates. Given, a high burden of cardiovascular risk factors in the uninsured, we examined whether states that had expanded Medicaid had a change in cardiovascular mortality rates after expansion, compared to states that have not expanded Medicaid.

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Eggs Should Be Eaten In Moderation – Higher Intake Linked to Increased Mortality

MedicalResearch.com Interview with:

Prof. Katherine Tucker PhD Director of the Center for Population Health Zuckerberg College of Health Sciences Lowell’s Biomedical and Nutritional Sciences UMass

Dr. Tucker

Prof. Katherine Tucker PhD
Director of the Center for Population Health
Zuckerberg College of Health Sciences
Lowell’s Biomedical and Nutritional Sciences
UMass

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

Response: Cholesterol was excluded from the recent dietary guidelines, but research remains unclear about eggs and cholesterol on health.

MedicalResearch.com: What are the main findings? Why is the advice about the benefits/harms regarding egg intake often so conflicting?

Response: Higher egg intake and cholesterol intake were related to increased risk of mortality. Individual observational studies can be confusing as the overall results depend on the baseline intake of the population and adjustment for confounders.  

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

Response: Balance and moderation is the key. Complete avoidance of eggs and egg yolks is not recommended because they have healthy nutrients as well. Extremely high intake of any single food may lead to imbalances. 3-4 eggs a week appears healthy but intakes of multiple eggs/day are probably not a good idea.  

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

Response: We need to clarify what exactly it is about too many eggs that is causing the risk. Healthy metabolism depends on a complex interaction of nutrients.

No disclosures 

Citation:

Zhong VW, Van Horn L, Cornelis MC, et al. Associations of Dietary Cholesterol or Egg Consumption With Incident Cardiovascular Disease and Mortality. JAMA. 2019;321(11):1081–1095. doi:10.1001/jama.2019.1572

https://jamanetwork.com/journals/jama/article-abstract/2728487 

Jun 6, 2019 @ 3:32 pm 

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Fewer Psychiatrists Willing To Accept Medicaid Patients

MedicalResearch.com Interview with:

Hefei Wen, PhDAssistant Professor, Department of Health Management & PolicyUniversity of Kentucky College of Public Health

Dr. Wen

Hefei Wen, PhD
Assistant Professor,
Department of Health Management & Policy
University of Kentucky College of Public Health 

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

Response: Medicaid is the principal payer of behavioral health services in the U.S. and expected to play an increasing role in financing behavioral health services following Medicaid expansions under the ACA.

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Traumatic Injuries Cost Medicare More Than Heart Failure, Pneumonia, Stroke or Heart Attacks

MedicalResearch.com Interview with:

Dr. Mark R. Hemmila MD Associate Professor of Surgery Division of Acute Care Surgery University of Michigan

Dr. Hemmila

Dr. Mark R. Hemmila MD
Associate Professor of Surgery
Division of Acute Care Surgery
University of Michigan 

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

Response: Traumatic injury has a tendency to be thought of as a disease that preferentially impacts younger people.  We wanted to explore the prevalence and impact of traumatic injury within the population of patients for whom Medicare is the third party payer.  Continue reading

Home Based Physical Therapy Can Help Prevent Falls in the Elderly

MedicalResearch.com Interview with:

Teresa Liu-Ambrose, PT, PhDCanada Research Chair (Tier II), Physical Activity, Mobility, and Cognitive NeuroscienceDirector, Aging, Mobility, and Cognitive Neuroscience LaboratoryUniversity of British Columbia

Dr. Liu-Ambrose

Teresa Liu-Ambrose, PT, PhD
Canada Research Chair (Tier II), Physical Activity, Mobility, and Cognitive Neuroscience
Director, Aging, Mobility, and Cognitive Neuroscience Laboratory
University of British Columbia

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

Response:  Falls in older adults are the third-leading cause of chronic disability and the leading cause of hospitalization for adults over age 65. Older adults who experience multiple falls are at increased risk for disability, loss of independence, and even death. How to best prevent falls in this high risk group is not well established. 

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Many Teens Do Not Fill Their Prescriptions for STDs

MedicalResearch.com Interview with:

Monika K. Goyal, M.D., MSCE Assistant chief of Children’s Division Emergency Medicine and Trauma Services

Dr. Goyal

Monika K. Goyal, M.D., MSCE
Assistant chief of Children’s Division
Emergency Medicine and Trauma Services 

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

Response: Adolescents are disproportionately affected by sexually transmitted infections (STIs) and often present to the emergency department for care. I have devoted almost 15 years of my career trying to improve the sexual health of teens through advocacy and the development of novel interventions in the emergency department to increase access to sexual health services for youths.

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Canadian ERs Use Less Pediatric Diagnostic Imaging Than US

MedicalResearch.com Interview with:

Eyal Cohen, MD, M.Sc, FRCP(C)Professor, PediatricsUniversity of TorontoCo-Founder, Complex Care ProgramThe Hospital for Sick Children

Dr. Cohen

Eyal Cohen, MD, M.Sc, FRCP(C)
Professor, Pediatrics
University of Toronto
Co-Founder, Complex Care Program
The Hospital for Sick Children
 

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

Response: Minimizing care that provides little benefit to patients has become an important focus to decrease health care costs and improve the quality of care delivery.  Diagnostic imaging in children is a common focus for campaigns designed to reduce overuse both in Canada and the US. There are some suggestions that there may be more overuse of care in the United States than Canada, but there has been little study in children.

We compared the use of low-value diagnostic imaging rates from four pediatric emergency departments in Ontario to 26 in the United States from 2006 to 2016.  We defined low-value imaging as situations where children are discharged from an emergency department with a diagnosis for which routine use of diagnostic imaging may not be necessary, like asthma or constipation.  Continue reading

Atrial Fibrillation Common After TAVR and Aortic Valve Replacement

MedicalResearch.com Interview with:
Rajat Kalra, MBCh
Cardiovascular Division
University of Minnesota, Minneapolis

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

Response: New-onset atrial fibrillation after aortic valve procedures is thought to occur frequently after aortic valve procedures, such as transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (AVR). However, the incidence estimates and implications of this new-onset atrial fibrillation in the contemporary era are unclear.

We sought to examine the incidence of atrial fibrillation after aortic valve procedures, compare the incidence between TAVI and AVR, and evaluate the associated morbidity and mortality implications using a ‘big data’ approach. This big data approach employed the National Inpatient Sample and was validated in the New York State Inpatient Database. Both are publicly available datasets that are developed as part of the Healthcare Cost and Utilization Project, a federal-state-industry partnership that is sponsored by the Agency for Healthcare Research and Quality.  Continue reading

Mortality: Number of Steps Matter, Up To a Point

MedicalResearch.com Interview with:

I-Min Lee, MD, ScDProfessor of Medicine, Harvard Medical SchoolProfessor of EpidemiologyHarvard T.H. Chan School of Public Health

Prof. I-Min Lee

I-Min Lee, MD, ScD
Professor of Medicine, Harvard Medical School
Professor of Epidemiology
Harvard T.H. Chan School of Public Health 

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

Response: While we have many studies showing that physical activity is beneficial for health, there are few data on steps and health, particularly long-term health outcomes.  An expert committee – the 2018 Physical Activity Guidelines Advisory Committee, which reviewed the scientific evidence to support the recently released Physical Activity Guidelines for Americans, 2nd edition – noted this (i.e., the relation between steps and health outcomes) to be a critical gap in knowledge, since many individuals are using wearables and monitoring their step counts.

We often hear the number 10,000 steps cited as a daily goal, but the basis for this number is unclear. It likely originated as a marketing tool: in 1965, the Yamasa Clock and Instrument Company, Japan sold a pedometer called “Manpo-kei” – “ten thousand steps meter” in Japanese.

For many older people, 10,000 steps/day can be a very daunting goal; thus, we wanted to investigate whether this was necessary for lower mortality rates in older women.  Additionally, steps taken can be fast or slow, and there are no published studies on step intensity and long-term health outcomes.  Note that walking pace and step intensity are not the same concept: walking pace gauges intensity when walking purposefully (e.g., for exercise or transportation), while step intensity assesses an overall best natural effort in our daily life. Continue reading

Vitiligo: Off Label Topical Calcineurin Inhibitors Help Some Patients

MedicalResearch.com Interview with:

Dr-Jung Min Bae

Dr. Jung Min Bae

Jung Min Bae, MD, PhD
Associate Professor, Department of Dermatology
St. Vincent’s Hospital
College of Medicine, The Catholic University of Korea 

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

Response: Vitiligo is a common chronic skin disease affecting 1% of the population, and it causes low self-esteem and social stigma. To date, there are no approved drugs for the treatment of vitiligo, even though growing evidence indicates favorable therapeutic responses of topical calcineurin inhibitors (TCIs) including tacrolimus and pimecrolimus.

In this study, we conducted a systematic review and meta-analysis of all relevant prospective studies (n = 46) and identified remarkable therapeutic responses of TCI monotherapy and TCI plus phototherapy for vitiligo. Continue reading

Does Genetic Information Encourage Doctors to Switch Anticoagulation Medications?

MedicalResearch.com Interview with:

Thomas J. Povsic, MD, PhDInterventional CardiologistDuke Clinical Research InstituteDuke University School of MedicineDurham, North Carolina 

Dr. Povsic

Thomas J. Povsic, MD, PhD
Interventional Cardiologist
Duke Clinical Research Institute
Duke University School of Medicine
Durham, North Carolina 

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

Response: The background for this study is that it is unknown how mandatory reporting of CYP2C19 metabolizer status affects how doctors treat patients or to what degree provision of this information would affect choice of a P2Y12 inhibitor within a clinical trial.

As part of the GEMINI-ACS trial, all patients underwent CYP2C19 metabolizer testing.  This trial enrolled patients with a recent acute coronary syndrome and randomized them to aspirin or a low dose of rivaroxaban.  All patients were also to be treated with ticagrelor or clopidogrel, which was at the discretion of the investigator.  Investigators were given information regarding the CYP2C19 metabolizer status about a week after randomization.  Importantly prior to randomization, all investigators were asked how they expected to use this information, and then we followed what they actually did.

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Only 1 in 5 Cancer Drugs Receiving FDA Accelerated Approval Have Proven Benefits in Confirmatory Trials

MedicalResearch.com Interview with:

Bishal Gyawali  MD PhD Med Onc. Asst. Professor 

Dr. Gyawali

Bishal Gyawali  MD PhD

  • Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
  • Department of Oncology, Department of Public Health Sciences, and Division of Cancer Care and Epidemiology, Queen’s University, Kingston, Ontario, Canada

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

Response: Accelerated approval pathway from the FDA allows cancer drugs to come to market sooner by showing improvement in surrogate measures such as change in tumor size. Surrogate measures do not reflect clinical benefit in terms of living longer or feeling better. So, when a drug receives accelerated approval, the drug is required to undergo a confirmatory trial to confirm that true clinical benefit from the drug actually exists.

Last year, a paper from the FDA argued that accelerated approval pathway is working effectively because 55% of such drugs confirmed clinical benefit. However, we saw that most of those drugs were actually improving only a surrogate measure even in confirmatory trials. So the confirmatory trials were not confirming clinical benefit but actually confirming benefit in a surrogate endpoint. We investigate that issue in our study using updated results from the confirmatory trials that were ongoing at the time of FDA review.

Our main finding is that only one-fifth of cancer drugs that received accelerated approval actually improved overall survival later in confirmatory trials. For, 20% of other drugs, the confirmatory trials tested the same surrogate endpoint as did the preapproval trial. For another 21%, the confirmatory trial showed benefit in a surrogate endpoint different from the one used in preapproval trial. Furthermore, when drugs fail to confirm clinical benefits in confirmatory trials, they still continue to remain on market.  Continue reading

Team Sports Benefits Teens With a Troubled Childhood

MedicalResearch.com Interview with:
Molly C. Easterlin, MD

Fellow, UCLA National Clinician Scholars Program
Clinical Instructor, Pediatrics, Cedars-Sinai Medical Center 

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

Response: Adverse childhood experiences or ACEs (including physical or emotional neglect or abuse, sexual abuse, domestic abuse, exposure to household substance misuse or mental illness, parental separation or divorce, and parental incarceration) are common with about half of children experiencing 1 and one-quarter of children experiencing 2 or more.

Children exposed to adverse childhood experiences have worse mental health throughout life, including higher rates of depression and anxiety. However, little is known about what factors improve long-term mental health in those exposed to ACEs. Additionally, as far as we are aware, no studies have looked at team sports participation as a potential factor that may be associated with improved mental health among those with adverse childhood experiences.

Continue reading

Study Finds You Don’t Have To Fast Before Getting Your Lipids Measured

MedicalResearch.com Interview with:

Samia Mora, MD, MHSAssociate Physician, Brigham and Women's HospitalAssociate Professor of Medicine, Harvard Medical SchoolBrigham and Women's HospitalDepartment of MedicinePreventive MedicineBoston, MA 02115 

Dr. Mora

Samia Mora, MD, MHS
Associate Physician, Brigham and Women’s Hospital
Associate Professor of Medicine, Harvard Medical School
Brigham and Women’s Hospital
Department of Medicine
Preventive Medicine
Boston, MA 02115 

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

Response: Lipid testing plays a major role in cardiovascular disease (CVD) risk screening, prediction, and treatment. In the past decade, several pivotal studies (including the Women’s Health Study, the Copenhagen City Heart Study, and the Copenhagen General Population Study) compared populations of individuals who had fasting lipid testing with populations of individuals who had nonfasting lipid testing, and found that non-fasting lipids were at least as good as fasting lipids in cardiovascular risk screening and predicting CVD risk.

To date, however, no study has examined the cardiovascular predictive value of lipids measured on the same individuals who had both fasting and nonfasting lipid testing. This is important because individual-level variability in fasting versus nonfasting lipids may not be captured when looking at population-level risk associations, and evidence from randomized studies is lacking. Furthermore, it is unclear whether substituting nonfasting lipids would misclassify cardiovascular risk for individuals who may be eligible for statin therapy.

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