Cardiac Radiation Can Increase Mortality in Lung Cancer Patients

MedicalResearch.com Interview with:

Raymond H Mak, MD Assistant Professor of Radiation Oncology Harvard Medical School

Dr. Mak

 

Raymond H Mak, MD
Assistant Professor of Radiation Oncology
Harvard Medical School
Radiation Oncology
Brigham and Women’s Hospital

 

 

Dr-Katelyn M. Atkins

Dr. Atkins

 

Katelyn M. Atkins MD PhD
Harvard Radiation Oncology Program
Dana-Farber Cancer Institute
Brigham and Women’s Hospital
Boston, Massachusetts

 

 

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

  • Lung cancer remains the leading cause of cancer-related death worldwide and nearly half of patients will require radiation therapy as part of their care.
  • Cardiac toxicity following radiotherapy has been well-studied in breast cancer and lymphomas, however the impact of cardiac toxicity following lung cancer radiotherapy has historically been under-appreciated due to the high risk of lung cancer death.
  • Recent studies highlighting cardiac toxicity following lung cancer radiotherapy have been limited by small numbers of patients and, to our best knowledge, have not included validated cardiac event endpoints defined by the American Heart Association (AHA)/American College of Cardiology (ACC).

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Fat Distribution Linked to Advanced and Fatal Prostate Cancer

MedicalResearch.com Interview with:

Barbra Dickerman, PhD Research Fellow Department of Epidemiology Harvard T.H. Chan School of Public Health Boston, MA

Dr. Dickerman

Barbra Dickerman, PhD
Research Fellow
Department of Epidemiology
Harvard T.H. Chan School of Public Health
Boston, MA

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

Response: Obesity is associated with a higher risk of advanced prostate cancer and poorer prognosis after diagnosis. However, emerging evidence suggests that the specific distribution of body fat may be an important prognostic factor for prostate cancer outcomes. In this original investigation, we analyzed body fat distribution on computed tomography imaging and the risk of being diagnosed with, and dying from, prostate cancer. This study was conducted among 1,832 Icelandic men with over a decade of follow-up in the Age, Gene/Environment Susceptibility-Reykjavik Study.

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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

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

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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Addiction Risk: No One Opioid Safer Than Other After Surgery

MedicalResearch.com Interview with:

Marilyn M. Heng, MD, MPH, FRCSCOrthopaedic Trauma SurgeonAssistant Professor of Orthopaedic SurgeryHarvard Medical School

Dr. Heng

Marilyn M. Heng, MD, MPH, FRCSC
Orthopaedic Trauma Surgeon
Assistant Professor of Orthopaedic Surgery
Harvard Medical School 

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

Response: The ultimate background for this study does come from the larger context of the opioid epidemic that is seen worldwide but particularly in North America. Orthopaedic surgeons should take responsibility as being among the top prescribers of opioids.

The more specific background that led to this specific study was the observation that several colleagues would insist that a drug like hydromorphone was so dangerous that they would not prescribe it but seemed okay prescribing large amounts of oxycodone.  It seemed like an urban myth that the type of opioid was what made it dangerous, so that led us to do the study to see if there was evidence for that.  Continue reading

Roux-en-Y Gastric Bypass Linked to More Hip Fractures

MedicalResearch.com Interview with:

Elaine W. Yu, MD, MMSc Assistant Professor,  Harvard Medical School Director, Bone Density CenterEndocrine Unit, Massachusetts General Hospital 

Dr. Elaine Yu

Elaine W. Yu, MD, MMSc
Assistant Professor,  Harvard Medical School
Director, Bone Density Center
Endocrine Unit, Massachusetts General Hospital

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

Response: Roux-en-Y gastric bypass (RYGB) is a popular surgical weight loss procedure.  We have previously shown that gastric bypass leads to rapid high-turnover bone loss.

Bariatric procedures are being increasingly performed in older adults, and the clinical consequences of gastric bypass-associated skeletal changes in this vulnerable population have been unclear to date.  Thus, we used Medicare claims data to investigate fracture risk among older adults after gastric bypass, and in comparison to adults who received another bariatric procedure called adjustable gastric banding (AGB), which is thought to have fewer negative bone effects.

In our analysis, we found that patients undergoing Roux-en-Y gastric bypass were 73% more likely to fracture than those undergoing AGB. Importantly, we found that hip fracture risk increased nearly 180% after RYGB, and that fracture rates in patients aged 65 or older were similar to the overall group.  Continue reading

What Makes Academic Physicians Satisfied With Their Job?

MedicalResearch.com Interview with:

Arabella L. Simpkin,  MD, MMScAssociate Director, Center for Educational Innovation and Scholarship, MGHAssociate Program Director, Education and Curriculum, Internal Medicine Residency, MGHInstructor in Medicine, Harvard Medical SchoolBoston, MA 02114

Dr. Simpkin

Arabella L. Simpkin,  MD, MMSc
Associate Director, Center for Educational Innovation and Scholarship, MGH
Associate Program Director, Education and Curriculum, Internal Medicine Residency, MGH
Instructor in Medicine, Harvard Medical School
Boston, MA 02114

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

Response: The academic health care environment has changed in unprecedented ways over several decades, with mounting evidence that faculty are becoming increasingly more unhappy, dissatisfied, and burnt out in their work. Concern for faculty wellbeing is high, with much speculation about causes of burnout. Comprehending what affects satisfaction at work in academic health care centers is critically important to stem this epidemic of discontent. For physicians, satisfaction has been reported to be associated with quality of care delivered, particularly as measured by patient satisfaction; faculty retention and job satisfaction are intricately linked, with dissatisfied physicians more likely to leave the profession and to discourage others from entering.

Other industries that have suffered similar rises in employee discontent have found that demonstration of respect is the most important leadership behavior in improving employees satisfaction. To our knowledge this factor has not been looked at in healthcare professionals. To address this gap, we sought to determine key variables influencing satisfaction at work for faculty in a large academic medical center in the United States.

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Fetal and Early Infant Growth Linked to Persistent Body Fat Patterns

MedicalResearch.com Interview with:

Vincent W. V. Jaddoe, MD, PhDAdjunct Professor of EpidemiologyDepartment of Epidemiology

Dr. Jaddoe

Vincent W. V. Jaddoe, MD, PhD
Adjunct Professor of Epidemiology
Department of Epidemiology

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

Response: Childhood body fat may be affected by patterns of fetal and infant weight change. Children born small for gestational age (SGA) tend to have infant growth acceleration, whereas those born large for gestational age (LGA) tend to have infant growth deceleration. Little is known about fetal and infant growth patterns affecting visceral, liver, and pericardial fat, which are strongly associated with cardiometabolic disease in later life.

We assessed in a large population cohort study whether fetal and infant weight change was associated with not only general, but also organ fat at school age. We observed that fetal and infant weight change patterns were both associated with childhood body fat, but weight change patterns in infancy tended to have larger effects. Fetal growth restriction followed by infant growth acceleration was associated with increased visceral and liver fat.  Continue reading

It’s Not Just Avoiding Red Meat, It’s the Substitute Diet That Influences Heart Health

MedicalResearch.com Interview with:

Marta Guasch-Ferre, PhD Research Scientist, Dept of Nutrition, Harvard TH Chan School of Public Health Instructor of Medicine, Channing Division of Network Medicine, Harvard Medical School Boston, MA, 02115

Dr. Guasch-Ferré

Marta Guasch-Ferre, PhD
Research Scientist, Dept of Nutrition
Harvard TH Chan School of Public Health
Instructor of Medicine, Channing Division of Network Medicin
Harvard Medical School
Boston, MA, 02115
 

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

Response: Previous findings from randomized controlled trials evaluating the effects of red meat on cardiovascular disease risk factors have been inconsistent.

But our new study, which makes specific comparisons between diets high in red meat versus diets high in other types of foods, shows that substituting red meat with high-quality protein sources lead to more favorable changes in cardiovascular risk factors. That is, to properly understand the health effects of red meat, it’s important to pay attention to the comparison diet. People do not simply eat more or less meat – it will almost always be in substitution with other foods. 

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AI Poised to Revolutionize Radiation Therapy for Cancer

MedicalResearch.com Interview with:

Raymond H Mak, MDRadiation OncologyBrigham and Women's Hospital

Dr. Mak

Raymond H Mak, MD
Radiation Oncology
Brigham and Women’s Hospital

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

  • Lung cancer remains the most common cancer, and leading cause of cancer mortality, in the world and ~40-50% of lung cancer patients will need radiation therapy as part of their care
  • The accuracy and precision of lung tumor targeting by radiation oncologists can directly impact outcomes, since this key targeting task is critical for successful therapeutic radiation delivery.
  • An incorrectly delineated tumor may lead to inadequate dose at tumor margins during radiation therapy, which in turn decreases the likelihood of tumor control.
  • Multiple studies have shown significant inter-observer variation in tumor target design, even among expert radiation oncologists
  • Expertise in targeting lung tumors for radiation therapy may not be available to under-resourced health care settings
  • Some more information on the problem of lung cancer and the radiation therapy targeting task here:https://www.youtube.com/watch?v=An-YDBjFDV8&feature=youtu.be

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Very Low LDL Cholesterol Associated with Hemorrhagic Stroke in Women

MedicalResearch.com Interview with:

Pamela M. Rist, ScDAssistant Professor of Medicine, Harvard Medical SchoolBrigham and Women's Hospital, Division of Preventive MedicineBoston, MA 02215 

Dr. Rist

Pamela M. Rist, ScD
Assistant Professor of Medicine, Harvard Medical School
Brigham and Women’s Hospital, Division of Preventive Medicine
Boston, MA 02215 

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

Response: Although hypercholesterolemia is a risk factor for ischemic stroke, some prior studies have observed an inverse association between total and low-density lipoprotein (LDL) cholesterol and risk of hemorrhagic stroke.  However, many studies were not able to study this association specifically among women.

Our main result was very low levels of low-density lipoprotein (LDL) cholesterol or low levels of triglycerides were associated with an increased risk of hemorrhagic stroke among women. Continue reading

Home Responsibilities Encourage Physician Mothers in Procedural Specialties To Consider Career Change

MedicalResearch.com Interview with:

Nelya Melnitchouk, MD,MScDirector, Program in Peritoneal Surface Malignancy, HIPECDr. Melnitchouk is an associate surgeon at Brigham and Women’s Hospital (BWH) and Brigham and Women’s Faulkner Hospital (BWFH) and instructor of surgery at Harvard Medical Schoo

Dr. Melnitchouk

Nelya Melnitchouk, MD,MSc
Director, Program in Peritoneal Surface Malignancy, HIPEC
Dr. Melnitchouk is an associate surgeon at Brigham and Women’s Hospital (BWH) and Brigham and Women’s Faulkner Hospital (BWFH) and
instructor of surgery at Harvard Medical School.

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

Response: Current literature on women in surgery show that female physicians, particularly those in procedural specialties, face many challenges in balancing responsibilities between work and home. We hypothesized that these challenges may affect career satisfaction more negatively for physician mothers in procedural specialties than those in nonprocedural specialties.

In our study, we found that physician mothers in procedural specialties who had more domestic responsibilities were more likely to report a desire to change careers than those in nonprocedural specialties.  Continue reading

Opioid-Related Hospitalizations Among Cancer Patients are Rare

MedicalResearch.com Interview with:

Isaac Chua MDInstructor of Medicine at Harvard Medical SchoolBoston, Massachusetts

Dr. Chua

Isaac Chua MD
Instructor of Medicine at Harvard Medical School
Boston, Massachusetts 

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

Response: Opioids are routinely prescribed for cancer-related pain, but little is known about the prevalence of opioid-related hospitalizations for patients with cancer. Although opioid addiction among patients with cancer is estimated to be as high as 7.7%, our understanding of opioid misuse is based on small, preliminary studies.

In light of the wider opioid epidemic, oncologists and palliative care clinicians frequently balance providing patients with legitimate access to opioids while protecting them and the general public from the risks of prescribing these medications.

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Ebola Fight Hampered by Misinformation and Mistrust

MedicalResearch.com Interview with:

Patrick Vinck, PhDResearch Director, Harvard Humanitarian InitiativeAssistant Professor, Global Health and Population T.H. Chan Harvard School of Public Health; Emergency MedicineHarvard Medical SchoolLead Investigator, Brigham & Women's Hospital 

Dr. Vinck

Patrick Vinck, PhD
Research Director, Harvard Humanitarian Initiative
Assistant Professor, Global Health and Population
T.H. Chan Harvard School of Public Health; Emergency Medicine
Harvard Medical School
Lead Investigator, Brigham & Women’s Hospital 

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

Response: The second worst epidemic of Ebola on record is currently unfolding in the eastern part of the Democratic Republic of the Congo. Whether or not safe practices are implemented to prevent the spread of the epidemic is influenced by the behavior of individuals at-risk of contracting the Ebola Virus Disease (EVD) –

Will they follow the recommendations of health professionals? Will they report suspected cases and deaths? Will they seek treatment from health professionals? Will they accept vaccines and adopt preventive behaviors?

We find that belief in misinformation about Ebola is widespread and trust in authorities is generally low, likely as a result of decades of violence and poor governance and, more recently, the politicization of the Ebola response.

Our analysis shows that trust and (mis-)information influence adherence to risk avoidance behavior and acceptance of vaccination.

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Psoriasis: No Difference Found in Cardiovascular Risk Between Ustekinumab vs TNF Inhibitor Therapy

MedicalResearch.com Interview with:

Seoyoung C. Kim, MD, ScD, MSCEDirector, Program in Rheumatologic, Immunologic, and Musculoskeletal PharmacoEpidemiology Associate Professor of MedicineDivision of Pharmacoepidemiology & PharmacoeconomicsDivision of Rheumatology, Immunology and Allergy Brigham and Women's Hospital, Harvard Medical School

Dr. Kim

Seoyoung C. Kim, MD, ScD, MSCE
Director, Program in Rheumatologic, Immunologic, and Musculoskeletal PharmacoEpidemiology
Associate Professor of Medicine
Division of Pharmacoepidemiology & Pharmacoeconomics
Division of Rheumatology, Immunology and Allergy
Brigham and Women’s Hospital
Harvard Medical School

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

Response: Given a high cardiovascular (CV) risk among patients with psoriasis and psoriatic arthritis, it is important to have more information with regard to potential effect of different treatment agents on CV risk.

As the number of treatment options for psoriasis and psoriatic arthritis has been rising over the few decades, it is even more crucial to have high-quality evidence on comparative safety of different treatment options so physicians and patients can choose an agent based on the benefit-risk profile of each drug they are considering.

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Flu Linked to Marked Increase in Heart Failure Admissions

MedicalResearch.com Interview with:

Sonja Kytomaa MAResearch AssociateBrigham and Women’s Hospital

Sonja Kytomaa

Sonja Kytomaa MA
Research Associate
Brigham and Women’s Hospital

Scott D. Solomon, MDThe Edward D. Frohlich Distinguished ChairProfessor of MedicineHarvard Medical SchoolSenior PhysicianBrigham and Women’s HospitalInternational Associate Editor, European Heart Journal

Dr. Scott Solomon

Scott D. Solomon, MD
The Edward D. Frohlich Distinguished Chair
Professor of Medicine
Harvard Medical School
Senior Physician
Brigham and Women’s Hospital
International Associate Editor, European Heart Journal

 

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

Response: Influenza is associated with an increased risk of cardiovascular events, yet few studies have explored the temporal association between influenza activity and hospitalizations, especially due to heart failure (HF).

Our aim with this study was to explore the temporal association between influenza activity and hospitalizations for HF and myocardial infarction (MI) in the general population. We related the number of MI and HF hospitalizations by month, which were sampled from 4 US communities and adjudicated in the surveillance component of the Atherosclerosis Risk in Communities (ARIC) study, to monthly influenza-like illness activity, as reported by the Centers for Disease Control and Prevention. We found that a 5% increase in influenza activity was associated with a 24% increase in HF hospitalizations rates, while overall influenza was not significantly associated with MI hospitalizations. Influenza activity in the months before hospitalization was not associated with either outcome.

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Some ‘Inactive’ Pill Ingredients Can Trigger Allergic Reactions

MedicalResearch.com Interview with:

Daniel Reker, PhDKoch Institute for Integrative Cancer ResearchMassachusetts Institute of Technology

Dr. Reker

Daniel Reker, PhD
Koch Institute for Integrative Cancer Research
Massachusetts Institute of Technology

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

Response: We started thinking more about this topic following a clinical experience five years ago that Dr. Traverso was involved in where a patient suffering form Celiac disease received a prescription of a drug which potentially had gluten. This experience really opened our eyes for how little we knew about the inactive ingredients and how clinical workflows do not currently accommodate for such scenarios.

We therefore set up a large scale analysis to better understand the complexity of the inactive ingredient portion in a medication as well as how frequently critical ingredients are included that could potential affect sensitive patients.

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Serious Illness Conversation Guide Can Help Clinicians Communicate with Critically Ill Patients

MedicalResearch.com Interview with:
Joanna Paladino, MD
Director of Implementation, Serious Illness Care Program | Ariadne Labs
Brigham and Women’s Hospital | Harvard T.H. Chan School of Public Health
Palliative Care | Dana-Farber Cancer Institute
Instructor | Harvard Medical School and

Dr. Rachelle Bernacki MD MS
Director of Quality Initiatives
Psychosocial Oncology and Palliative Care
Senior Physician, Assistant Professor of Medicine
Harvard Medical School

Dr. Paladino’s responses:

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

Dr. Paladino: People living with serious illness face many difficult decisions over the course of their medical care. These decisions, and the care patients receive, should be guided by what matters most to patients, including their personal values, priorities, and wishes. These conversations don’t often happen in clinical practice or do so very late in the course of illness, leaving patients exposed to getting care they don’t want.

Doctors and nurses want to have these important discussions, but there are real challenges, including insufficient training and uncertainties about when and how to start the conversation. We designed an intervention with clinical tools, clinician training, and systems-changes to address these challenges. When tested in a randomized clinical trial in oncology, we found that the intervention led to more, earlier, and better conversations between oncology clinicians and their patients with life-limiting cancer. These findings demonstrate that it is possible to ensure reliable, timely, and patient-centered serious illness conversations in an outpatient oncology practice.

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Number of Opioid Prescriptions for New Users Has Dropped More Than 50%

MedicalResearch.com Interview with:

Wenjia Zhu, PhD. Marshall J. Seidman FellowDepartment of Health Care PolicyHarvard Medical School

Dr. Zhu

Wenjia Zhu, PhD.
Marshall J. Seidman Fellow
Department of Health Care Policy
Harvard Medical School 

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

Response: The current opioid epidemic continues to cause deaths and tremendous suffering in the United States, driven in large part by overuse of prescription opioids. Of special concern are new opioid prescriptions, i.e. opioids given to patients who have not used opioids before, which research tells us are an important gateway to long-term opioid use, misuse, overdoes and death. Recently, in their efforts to curb over prescribing of opioids, the CDC issued guidelines (December 2015 in draft form; March 2016 in final version) to encourage opioid prescribers to limit the use, duration and dose of opioids, particularly opioids to first-time users. Despite these, little is known about the prescribing of opioids to first-time users on a national scale, particularly among commercially insured patients.

In this study, we examined national monthly trends in the rate at which opioid therapy was started among commercially insured patients. Using administrative claims from Blue Cross Blue Shield Association commercial insurers from 2012 to 2017, we analyzed more than 86 million commercially insured patients across the United States.

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Most Deaths From Sepsis Occur in Frail Older Adults and Are Not Preventable

MedicalResearch.com Interview with:

Chanu Rhee, MD,MPHAssistant Professor of Population MedicineHarvard Medical School / Harvard Pilgrim Health Care InstituteAssistant Hospital EpidemiologistBrigham and Women’s Hospital

Dr. Rhee

Chanu Rhee, MD,MPH
Assistant Professor of Population Medicine
Harvard Medical School / Harvard Pilgrim Health Care Institute
Assistant Hospital Epidemiologist
Brigham and Women’s Hospital 

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

Response: Sepsis is the body’s reaction to a serious infection that results a cascade of inflammation in the body and organ dysfunction, such as low blood pressure, confusion, or failure of the lungs, kidneys, or liver.   Sepsis is a major cause of death, disability, and cost in the U.S. and around the world.  Growing recognition of this problem has led to numerous sepsis performance improvement initiatives in hospitals around the country.  Some of these efforts have also been catalyzed by high-profile tragic cases of missed sepsis leading to death, which may have contributed to a perception that most sepsis deaths are preventable if doctors and hospitals were only better at recognizing it.

However, the extent to which sepsis-related deaths might be preventable with better hospital-based care is unknown.  In my own experience as a critical care physician, a lot of sepsis patients we treat are extremely sick and even when they receive timely and optimal medical care, many do not survive.  This led myself and my colleagues to conduct this study to better understand what types of patients are dying from sepsis and how preventable these deaths might be.  Continue reading

Collaborative Chronic Care Model Improved Patient Outcomes in Complex Mental Health Patients

MedicalResearch.com Interview with:

Mark S. Bauer, M.D.Professor of Psychiatry, EmeritusHarvard Medical SchoolCenter for Healthcare Organization and Implementation Research (CHOIR)VA Boston Healthcare System-152MBoston, MA 02130

Dr. Bauer

Mark S. Bauer, M.D.
Professor of Psychiatry, Emeritus
Harvard Medical School
Center for Healthcare Organization and Implementation Research
VA Boston Healthcare System-152M
Boston, MA 02130

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

Response: Collaborative Chronic Care Models (CCMs) have extensive evidence for their effectiveness in a wide variety of mental health conditions.  CCMs are frameworks of care that include several or all of the following six elements:  work role redesign for anticipatory, continuous care; self-management support for individuals in treatment; provider decision support; information system support for population-based and measurement-guided care; linkage to community resources; and organization and leadership support.

However, evidence for Collaborative Chronic Care Model effectiveness comes almost exclusively from highly structured clinical trials.  Little is known about whether CCMs can be implemented in general clinical practice settings, and the implementation evidence that does exist derives primarily from studies of the CCM used in primary care settings to treat depression.

We conducted a randomized, stepped wedge implementation trial using implementation facilitation to establish CCMs in general mental health teams in nine US Department of Veterans Affairs medical centers.

We found that establishing Collaborative Chronic Care Models was associated with reduced mental health hospitalization rates and, for individuals with complex clinical presentations, improvements in mental health status.  Additionally, standardized assessment of team clinicians indicated that facilitation improved clinician role clarity and increased focus on team goals.

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Antibody–Drug Conjugate in Refractory Metastatic Triple-Negative Breast Cancer

MedicalResearch.com Interview with:

Aditya Bardia, MBBS, MPH Director, Precision Medicine, Center for Breast Cancer, Attending Physician, Massachusetts General Hospital Cancer Center Harvard Medical School, Boston, MA 02114

Dr. Bardia

Aditya Bardia, MBBS, MPH
Director, Precision Medicine, Center for Breast Cancer,
Attending Physician
Massachusetts General Hospital Cancer Center
Harvard Medical School
Boston, MA 02114

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

Response: Metastatic triple negative breast cancer is associated with aggressive tumor biology, and tends to affect younger patients and African Amerians. The response rate with standard chemotherapy regimens in patients with pre-treated metastatic TNBC ranges from 10-15%, and median progression-free survival ranges from 3-4 months. The median survival of metastatic TNBC is around 12 months and has not changed in the past 20 years. Thus, treatment of metastatic triple negative breast cancer represents an unmet clinical need.  

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Bariatric Surgery Could be a Cost-Effective Intervention in Patients with NASH Cirrhosis who are Overweight or Obese.

MedicalResearch.com Interview with:

Jagpreet Chhatwal PhDAssistant Professor, Harvard Medical SchoolSenior Scientist, Institute for Technology AssessmentMassachusetts General Hospital

Dr. Jagpreet Chhatwal

Jagpreet Chhatwal PhD
Assistant Professor, Harvard Medical School
Senior Scientist, Institute for Technology Assessment
Massachusetts General Hospital

Chin Hur, MDAssociate Professor of MedicineHarvard Medical School

Dr. Chin Hur

Chin Hur, MD
Associate Professor of Medicine
Harvard Medical School

 

 

 

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

Response: Nonalcoholic steatohepatitis (NASH), a severe form of nonalcoholic fatty liver disease, is one of the leading causes of liver transplantation. Because of increasing prevalence of obesity in the United States, NASH-related cirrhosis cases are expected to increase in the near future. Unfortunately, there are few pharmacological treatments for NASH, and none with proven long-term benefit. Weight loss can be effective in managing NASH but not many patients can lose the sufficient weight necessary to impact NASH and/or maintain long-term weight loss. In contrast, bariatric surgery can provide long-term weight loss and thus potentially reverse liver damage in cirrhosis. However, bariatric surgery is associated with mortality and morbidity associated with the procedure.

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Whole Grains and Fiber Linked to Lower Risk of Liver Cancer

MedicalResearch.com Interview with:

Xuehong Zhang, MD, ScD Assistant Professor in Medicine | Harvard Medical School Associate Epidemiologist | Brigham and Women's Hospital Boston, MA

Dr. Xuehong Zhang

Xuehong Zhang, MD, ScD
Assistant Professor in Medicine
Harvard Medical School
Associate Epidemiologist
Brigham and Women’s Hospital
Boston, MA

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

Response: In the United States., liver cancer incidence is rapidly increasing and over 42,200 new cases were projected to be diagnosed in 2018. The majority of individuals with liver cancer are diagnosed at a late stage, are not eligible for curative therapy, and die within 1 year of diagnosis. Established risk factors for liver cancer are limited to hepatitis B and C virus (HBV/HCV) infections, metabolic disorders, and smoking. Clearly, identification of novel risk factors, particularly those that are modifiable, is urgently needed.

Dietary factors have been suspected as important, but only excessive alcohol use and aflatoxin-contaminated foods are considered to be established dietary risk factors for hepatocellular carcinoma (HCC). Consumption of whole grains and dietary fiber, especially cereal fiber, have been associated with lower risk of obesity, type 2 diabetes, and nonalcoholic fatty liver disease, which are known predisposing factors for HCC. We thus hypothesized that long-term intake of whole grains and dietary fiber may lower the risk of developing hepatocellular carcinoma (HCC) and tested this hypothesis using data from two large prospective cohort studies, the Nurses’ Health Study (NHS) and the Health Professionals Follow-up Study (HPFS).

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Sleep is Good For Your Health, Including Your Heart!

MedicalResearch.com Interview with:

Cameron S. McAlpine, Ph.D. Banting Postdoctoral Fellow Center for Systems Biology Massachusetts General Hospital Harvard Medical School Boston, MA, 02114

Dr. McAlpine

Cameron S. McAlpine, Ph.D.
Banting Postdoctoral Fellow
Center for Systems Biology
Massachusetts General Hospital
Harvard Medical School
Boston, MA, 02114

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

Response: Cardiovascular disease is caused by the build up of white blood cells and fat in arteries. We have known for a long time that poor sleep is associated with an increased risk of developing cardiovascular disease. A number of human observational studies have found this correlation. However, the reasons for this correlation have been largely unknown.

Our study, performed in mice, provides one possible explanation. We found that when we disturbed the sleep of mice they produced more inflammatory white blood cells. These cells caused larger lesions in their arteries and more advanced cardiovascular disease.

We found that his phenomenon is controlled by a hormone produced in the brain that normally suppresses the production of white blood cells. When mice have their sleep disturbed this pathway breakdown causing the increased production of white blood cells.

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How Functional Are Frail Adults After Aortic Valve Replacement?

MedicalResearch.com Interview with:

Dae Hyun Kim, MD, MPH, ScD Assistant Professor of Medicine, Harvard Medical School Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital Division of Gerontology, Department of Medicine, Beth Israel Deaconess Medical Center

Dr. Dae Hyun Kim

Dae Hyun Kim, MD, MPH, ScD
Assistant Professor of Medicine, Harvard Medical School
Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital
Division of Gerontology, Department of Medicine,
Beth Israel Deaconess Medical Center

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

Response: The number of older adults undergoing aortic valve replacement is increasing.  Since these patients are at high risk for complications and functional decline due to preexisting multimorbidity and frailty, the latest guideline (Otto et al. J Am Coll Cardiol 2017;69:1313–46) emphasizes shared decision-making based on patient-centered outcomes.  Despite this recommendation, we witness many decision-making processes are cardio-centric—mainly informed by expected benefit in terms of cardiac-specific measures.  Many patients are not adequately informed about what their daily life would be like after the procedure.

In this single-center prospective cohort study, we examined functional status trajectories via assessments of global functional status at 1, 3, 6, 9, and 12 months in 246 patients who underwent transcatheter and surgical aortic valve replacement.  We identified 5 clinically meaningful functional trajectories, ranging from high baseline function-early complete recovery to low baseline function-large and persistent decline.  We were able to predict most likely trajectory as well as best possible and worse possible trajectories using the preoperative frailty index.  Delirium and postoperative complications were also strongly associated with undesirable functional trajectories.  Continue reading

NUEDEXTA® (Dextromethorphan and Quinidine) Studied for ALS and MS but Primarily Use in Dementia

MedicalResearch.com Interview with:

Michael Fralick, MD, FRCPC, SM, PhD (Cand) Clinical Associate, General Internal Medicine, St Michael’s Hospital Phillipson Scholar, Clinician Scientist Program, University of Toronto  PhD Candidate, IHPME, University of Toronto Affiliated Faculty, Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women’s Hospital, Harvard University

Dr. Fralick

Michael Fralick, MD, FRCPC, SM, PhD (Cand)
Clinical Associate, General Internal Medicine
St Michael’s Hospital
Phillipson Scholar, Clinician Scientist Program, University of Toronto
PhD Candidate, IHPME, University of Toronto
Affiliated Faculty, Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics
Brigham and Women’s Hospital, Harvard University

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

Response: This medication is a pill that combines two ingredients: dextromethorphan (the active ingredient in cough syrup) and quinidine (used to increase the concentration of dextromethorphan). The medication was primarily studied and evaluated in patients with amyotrophic lateral sclerosis (ALS)   or (multiple sclerosis) MS, but anecdotal evidence suggested it was being prescribed to patients with dementia. We used data from two nationwide healthcare databases to understand how the medication was being used in routine care.

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Does Zofran (ondansetron) for Nausea & Vomiting Cause Birth Defects?

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
Associate Professor of Medicine
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: Pregnant women often experience nausea and vomiting, particularly during the first trimester.  Early treatment is recommended to relieve symptoms and prevent progression to hyperemesis gravidarum.  Although not formally approved for this indication, ondansetron is the most frequently prescribed treatment for nausea and vomiting in pregnancy in the US: 22% of pregnant women reportedly used ondansetron in the US in 2014. Despite this common use, the available evidence on the fetal safety of ondansetron is limited and conflicting, and the possibility of a doubling in risk of cleft palate and cardiac malformations has been raised.

We therefore evaluated the association between ondansetron exposure during the first trimester of pregnancy, the period of organogenesis, and the risk of congenital malformations in a cohort of 1,816,414,publicly insured pregnancies using the nationwide Medicaid Analytic eXtract data for 2000-2013.  A total of 88,467 women (4.9%) were exposed to ondansetron during the first trimester.  After adjusting for a broad range of potential confounding variables, we found no association with cardiac malformations (RR = 0.99; 95% CI, 0.93 – 1.06)  and congenital malformations overall (RR = 1.01; 95% CI, 0.98 – 1.05). For oral clefts, we found a 24% increase in risk (RR=1.24; 95% CI, 1.03 – 1.48), which corresponds to an absolute risk of 2.7 per 10,000 births (95% CI, 0.2 – 5.2 per 10,000 births).  These findings were consistent across sensitivity analyses, conducted to address potential misclassification and confounding bias. 

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When Asked, Teens Frequently Report Hallucinations, Paranoia or Anxiety with Marijuana Use

MedicalResearch.com Interview with:

Sharon Levy, MD, MPH Director, Adolescent Substance Use and Addiction Program Boston Children's Hospital Associate Professor of Pediatrics Harvard Medical School

Dr. Levy

Sharon Levy, MD, MPH
Director, Adolescent Substance Use and Addiction Program
Boston Children’s Hospital
Associate Professor of Pediatrics
Harvard Medical School 

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

Response: ​For this study we analyzed data that were collected as part of a larger survey study that recruited a sample of adolescents who were coming to the doctor’s office for routine medical care.  We asked them a lot of questions about their health, school, extracurricular activities, plans for the future, substance use patterns and problems associated with use among other things.

The main finding was that among the participants who reported marijuana use in the past year, many of them, more than 40%, said that they had experienced either an hallucination, or paranoia/anxiety related to their use.

Kids who used more frequently and those who met criteria for a substance use disorder were more likely to experience these symptoms, as were those who had symptoms of depression Continue reading