Author Interviews, Gastrointestinal Disease, JAMA / 06.10.2015

Nynne Nyboe Andersen, MD Department of Epidemiology Research Statens Serum Institut Denmark MedicalResearch.com Interview with: Nynne Nyboe Andersen, MD Department of Epidemiology Research Statens Serum Institut Denmark Medical Research: What is the background for this study? Response: The use of TNF-α inhibitors, including infliximab, adalimumab and certolizumab pegol to treat people with inflammatory bowel disease is increasing worldwide and has improved the medical treatment modalities. However, in the post-marketing period, case-reports, data from retrospective cohort studies and spontaneous reporting systems have identified patients with inflammatory bowel disease treated with TNF-α inhibitors, developing a demyelinating event of the central nervous system. It remains unanswered whether this reflect a true association between TNF-α inhibitors and demyelinating diseases or whether these cases are a result of the well-established underlying association between demyelinating diseases and inflammatory bowel disease per se. The rarity of demyelinating diseases has stalled a thorough safety evaluation through analytical studies. Consequently, by use of the nationwide Danish registries, we conducted a large population-based cohort study, aiming to address the risk of demyelinating events of the central nervous system in patients with inflammatory bowel disease treated with TNF-α inhibitors compared to untreated patients. Medical Research: What are the main findings? Response: Using a matched study design, a 2-fold increased risk of demyelinating diseases was observed in patients with inflammatory bowel disease treated with TNF-α inhibitors compared to untreated. The absolute risk was low with less than four additional cases per 10000 person years in those treated compared to untreated. The rarity of demyelinating diseases limited the statistical power and capacity to adjust for or match on potential confounder variables, and therefore findings should be considered preliminary as they could be a result of chance or unmeasured confounding and need confirmation in other studies. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, JAMA, Pediatrics / 06.10.2015

Susan Gray MD Division of Adolescent Medicine Boston Children's Hospital Boston, MAMedicalResearch.com Interview with: Susan Gray MD Division of Adolescent Medicine Boston Children's Hospital Boston, MA Medical Research: What is the background for this study? What are the main findings? Dr. Gray: This is a study of the health care costs of 13,000 privately insured adolescents (13 to 21 years old) cared for in an association of pediatric primary care practices. We found that a tiny fraction (1%) of adolescents accounted almost a quarter of the expenses of the whole cohort. Mental health disorders were the most common diagnosis among these high cost adolescents. The characteristics most strongly associated with high cost were complex chronic medical conditions, behavioral health disorders, and obesity, but many high cost adolescents had no chronic conditions. Pharmacy costs, especially orphan drug costs, were a surprisingly large contributor to high costs for these privately insured adolescents. Primary care costs were very small in high cost patients. (more…)
Author Interviews, Cancer Research, Endocrinology, JAMA, Menopause / 05.10.2015

Rodrigo R. Munhoz, MD Hospital Sírio Libanês São Paulo, Brazil MedicalResearch.com Interview with: Rodrigo R. Munhoz, MD Hospital Sírio Libanês São Paulo, Brazil  Medical Research: What is the background for this study? What are the main findings? Dr. Munhoz:  Chemotherapy-induced early menopause and its impact on quality of life is clinically relevant issue that often arises during the treatment with curative intent of premenopausal patients with early breast cancer. The use of neo-/adjuvant chemotherapy is associated with risks of ovarian dysfunction, permanent or transient amenorrhea, infertility and symptoms of menopause with a premature onset. In addition to osteoporosis, loss of libido, increased cardiovascular risk and atrophic vaginitis, early ovarian dysfunction may adversely impact quality of life and result in significant psychosocial burden. Currently available guidelines addressing fertility preservation in young women undergoing treatment for early breast cancer recommend that patients at reproductive ages should be advised about the potential risks of fertility impairment and additional effects of adjuvant chemotherapy and that preservation techniques should be carefully considered. However, “evidence regarding the effectiveness of ovarian suppression” is quoted as “insufficient” and the use GnRH agonists as “experimental” . The current meta-analysis includes a large number of patients and also the results of recently presented clinical trials, and suggest that the use of GnRH agonists is associated a higher rate of recovery of regular menses in patients with breast cancer undergoing chemotherapy.These results summarize the findings of different clinical trials and has immediate clinical implications - this was not clear in the literature, since negative results had been reported across different clinical trials. (more…)
Author Interviews, Blood Pressure - Hypertension, Heart Disease, JAMA, Surgical Research / 05.10.2015

Mads Emil Jørgensen Copenhagen University Hospital..., MedicalResearch.com Interview with: Mads E. Jørgensen, MB Cardiovascular Research Center Gentofte Hospital University of Copenhagen, Denmark Medical Research: What is the background for this study? What are the main findings? Response: For many years there has been a wide use of beta blockers in the non-cardiac surgery setting with the intent to protect the heart. Within recent years, this field of research has opened up to new studies evaluating in detail which patient subgroups do benefit from this therapy and which may actually be at increased risk. The current study evaluated chronic beta blocker use and risks of perioperative complications in a rather low risk population of patients with hypertension, but without cardiac, kidney or liver disease. Among 55,000 patients receiving at least two antihypertensive drugs, we found that patients treated with a beta blocker were at increased risks of complications during surgery and 30-day after surgery, compared to patients treated with other antihypertensive drugs only. In various subgroup analyses (by age, gender, diabetes, surgery risk etc.) the findings were consistent although challenged in power. (more…)
Author Interviews, Flu - Influenza, JAMA, Vanderbilt / 05.10.2015

Carlos G. Grijalva, MD MPH Associate Professor Department of Health Policy Vanderbilt University Medical Center Nashville, TN 37212MedicalResearch.com Interview with: Carlos G. Grijalva, MD MPH Associate Professor Department of Health Policy Vanderbilt University Medical Center Nashville, TN 37212  Medical Research: What is the background for this study? Dr. Grijalva: Influenza is an important cause of disease. Every year influenza causes more than 200,000 hospitalizations in the US. The most effective strategy to prevent influenza infections is vaccination. Several studies have shown that influenza vaccines can prevent fever or respiratory symptoms caused by influenza. However, whether influenza vaccines can prevent more serious complications of influenza such as pneumonia, remains unclear This was a multicenter collaboration between academic institutions and the centers for disease control and prevention. We used data from the Etiology of Pneumonia in the community or EPIC study, a large prospective study of hospitalizations for pneumonia conducted between 2010 and 2012. The EPIC study enrolled patients from Chicago, IL, Salt Lake City, UT, and Memphis and Nashville, TN. The main goal of the EPIC study was to determine the causes of pneumonia in children and adults hospitalized with pneumonia. Medical Research:? What are the main findings? Dr. Grijalva: We conducted a case-control study using data from EPIC. Our study included more than 2700 patients hospitalized for pneumonia, including both children and adults. Approximately 6% of these patients had influenza pneumonia and were identified as cases. Other patients hospitalized for pneumonia that was not caused by influenza were the controls. We compared the history of influenza vaccination between cases and controls. We found that influenza vaccination was associated with a reduced risk of influenza pneumonia that required hospitalization. The estimated vaccine effectiveness was 57%. This means that about 57% of hospitalizations due to influenza-associated pneumonia could be prevented through influenza vaccination. (more…)
Author Interviews, Depression, Genetic Research, JAMA / 03.10.2015

Dr. David Brent MD Department of Psychiatry Western Psychiatric Institute and Clinic University of Pittsburgh Medical Center Pittsburgh, PennsylvaniaMedicalResearch.com Interview with: Dr. David Brent MD Department of Psychiatry Western Psychiatric Institute and Clinic University of Pittsburgh Medical Center Pittsburgh, Pennsylvania Medical Research: What is the background for this study? Dr. Brent: Youth with a parent with a history of depression are at increased risk for having a depressive episode themselves. Medical Research: What are the main findings? Dr. Brent: Those who received a cognitive behavioral educational group program were less likely to have had a depressive episode, and were functioning better than those who did to receive the program 6 years later, especially if their parent was NOT depressed at the time that they received the program. If the parent was depressed then the program was no better than usual care. (more…)
Accidents & Violence, Author Interviews, JAMA, Surgical Research / 03.10.2015

Russ S. Kotwal, M.D., M.P.H. United States Army Institute of Surgical Research Joint Base San Antonio-Ft. Sam HoustonMedicalResearch.com Interview with: Russ S. Kotwal, M.D., M.P.H. United States Army Institute of Surgical Research Joint Base San Antonio-Ft. Sam Houston Medical Research: What is the background for this study? Dr. Kotwal: The term golden hour was coined to encourage urgency of trauma care. In 2009, Secretary of Defense Robert M. Gates mandated prehospital helicopter transport of critically injured combat casualties in 60 minutes or less. The objectives of the study were to compare morbidity and mortality outcomes for casualties before vs after the mandate and for those who underwent prehospital helicopter transport in 60 minutes or less vs more than 60 minutes. A retrospective descriptive analysis of battlefield data examined 21,089 US military casualties that occurred during the Afghanistan conflict from September 11, 2001, to March 31, 2014. Medical Research: What are the main findings? Dr. Kotwal: For the total casualty population, the percentage killed in action and the case fatality rate (CFR) were higher before vs after the mandate, while the percentage died of wounds remained unchanged. Decline in CFR after the mandate was associated with an increasing percentage of casualties transported in 60 minutes or less, with projected vs actual CFR equating to 359 lives saved. Among 4542 casualties with detailed data, there was a decrease in median transport time after the mandate and an increase in missions achieving prehospital helicopter transport in 60 minutes or less. When adjusted for injury severity score and time period, the percentage killed in action was lower for those critically injured who received a blood transfusion and were transported in 60 minutes or less, while the percentage died of wounds was lower among those critically injured initially treated by combat support hospitals. Acute morbidity was higher among those critically injured who were transported in 60 minutes or less, those severely and critically injured initially treated at combat support hospitals, and casualties who received a blood transfusion, emphasizing the need for timely advanced treatment. (more…)
Author Interviews, JAMA, Melanoma, Ophthalmology / 01.10.2015

Ann-Cathrine Larsen MD, PhD-student University of Copenhagen Faculty of Health Sciences Department of Neuroscience and Pharmacology, Eye Pathology Section CopenhagenMedicalResearch.com Interview with: Ann-Cathrine Larsen MD, PhD-student University of Copenhagen Faculty of Health Sciences Department of Neuroscience and Pharmacology, Eye Pathology Section Copenhagen Medical Research: What is the background for this study? Dr. Larsen: Conjunctival melanoma is an uncommon malignancy with a high mortality. Population-based studies evaluating prognostic features and treatment are rare. The clinicopathological and prognostic features associated with BRAF-mutations in conjunctival melanoma are unclear. Medical Research: What are the main findings? Dr. Larsen: Extrabulbar tumor location and invasion of adjacent tissue structures were poor prognostic features. Incisional biopsy and excision without adjuvant therapy were associated with metastatic disease. Younger age at diagnosis, bulbar or caruncular tumor location, T1 stage tumor, lack of clinical melanosis and mixed or non-pigmented tumor color were features associated with BRAF-mutated conjunctival melanoma. Furthermore, Patients with BRAF mutated tumors seem to have an increased risk of distant metastatic disease. (more…)
Author Interviews, Cancer Research, JAMA, Lung Cancer / 28.09.2015

MedicalResearch.com Interview with: Dr. Rebecca Prince MBBS Clinical Research Fellow and first author and Monika K. Krzyzanowska, MD MPH FRCPC Medical Oncologist, Princess Margaret Cancer Centre, Associate Professor, Dept of Medicine and Institute of Health Policy, Management & Evaluation, University of Toronto Senior Adjunct Scientist, Institute for Clinical Evaluative Sciences Clinical Lead, Quality Care & Access, Systemic Treatment Program, Cancer Care Ontario Toronto, ON  Medical Research: What is the background for this study? What are the main findings? Response: This study was inspired by our previous work using administrative data in which we found that a large proportion of patients receiving chemotherapy in routine practice were visiting the emergency department and being admitted to hospital. Our perception was that the frequency of these events was higher than expected but when we went to look what was expected, ie. how often were people ending up in hospital during treatment in clinic trials, this data was not readily available. This led us to perform a systematic review of the literature including a comparison of hospitalization rates between patients treated in clinical trials and patients in similar clinical scenarios treated in routine practice. We ended up focusing on metastatic lung cancer as that was one of the clinical scenarios where we were able to identify published data from both clinical trials and routine practice. The main finding of our study is that hospitalizations are very common during chemotherapy. We compared patients with metastatic lung cancer being treated in routine practice and clinical trials and found that that approximately half (51%) of patients treated in routine practice were hospitalized during chemotherapy, compared to 16% of trial patients. We also found that very few clinical trials reported this information which is routinely collected during the trial. (more…)
Author Interviews, Depression, Heart Disease, JAMA / 28.09.2015

MedicalResearch.com Interview with:Dr-Ken-Freedland Kenneth E. Freedland, PhD Professor of Psychiatry and Psychology Washington University School of Medicine St. Louis, Missouri Medical Research: What is the background for this study? What are the main findings? Dr. Freedland: Major depression is a common problem in patients with heart failure, and it makes heart failure self-care tasks such as daily weight checks and compliance with dietary restrictions more difficult for these them.  Unfortunately, recent clinical trials have shown that both depression and inadequate self-care can be hard to treat in patients with heart failure. Cognitive behavior therapy (CBT) is often used to treat depression in otherwise healthy individuals, but it hasn’t been tested in patients with heart failure. We added a self-care component to the standard CBT treatment protocol and conducted a clinical trial to determine whether it is effective both for depression and for self-care.  We randomized 158 heart failure patients to  cognitive behavior therapy or to usual care, and both groups received heart failure education.  About 1/3 of the patients in both groups were also taking antidepressant medications. The intervention was effective for depression, with remission rates of 51% in the cognitive behavior therapy group compared to only 20% in the usual care group.  However, it was not effective for heart failure self-care. (more…)
Author Interviews, Brigham & Women's - Harvard, Heart Disease, JAMA, Prostate Cancer, Testosterone / 27.09.2015

Anthony V. D'Amico, MD, PhD Chief, Division of Genitourinary Radiation Oncology Professor of Radiation Oncology, Harvard Medical SchoolMedicalResearch.com Interview with: Anthony V. D'Amico, MD, PhD Chief, Division of Genitourinary Radiation Oncology Professor of Radiation Oncology, Harvard Medical School Medical Research: What is the background for this study? What are the main findings? Dr. D'Amico: Controversy exists as to whether androgen deprivation therapy (ADT) used to treat prostate cancer can cause fatal cardiac events. We found that in men with moderate to severe comorbidity based most often on a history of a heart attack that the use of 6 months of androgen deprivation therapy to treat non metastatic but clinically significant prostate cancer was associated with both an increased risk of a fatal heart attack and shortened survival. (more…)
Author Interviews, Geriatrics, Hearing Loss, JAMA / 25.09.2015

Kevin J. Contrera, MPH MD Candidate Johns Hopkins School of MedicineMedicalResearch.com Interview with: Kevin J. Contrera, MPH MD Candidate Johns Hopkins School of Medicine Medical Research: What is the background for this study? What are the main findings? Response: Hearing impairment is common in older adults. The prevalence of clinically significant hearing loss doubles with every decade of life, affecting two-thirds of adults 70 years of age or older. Hearing loss has been shown to be associated with various negative cognitive, mental, and physical health outcomes. In a nationally representative sample of 1,666 adults aged 70 years or older, moderate or greater hearing impairment was associated with a 54% increased risk of mortality. This was after we statistically took into account factors that could influence this association. Essentially, the worse the patient's hearing loss, the greater the risk of death. (more…)
Author Interviews, Cancer Research, CT Scanning, JAMA, Melanoma, Radiology, University of Michigan / 25.09.2015

MedicalResearch.com Interview with: Benjamin Y. Scheier, MD Division of Hematology/Oncology Department of Internal Medicine University of Michigan, Ann Arbor Medical Research: What is the background for this study? What are the main findings? Dr. Scheier: Existing data suggests that PET/CT has use in the detection of metastases from multiple primary tumor types. However, PET/CT lacks data supporting its use in staging asymptomatic patients with early-stage melanoma, may inconsistently impact treatment decisions, and carries a false-positive finding risk that may detract from its use. To evaluate an evolving practice, this study aims to assess the use of PET/CT in detecting occult metastases in SLN-positive melanoma prior to resection. In this retrospective evaluation of patients with melanoma and clinically silent regional lymph nodes treated at the University of Michigan, only 7% had PET/CT findings that ultimately identified metastatic melanoma and precluded LND. Of the 46 patients who underwent a preoperative PET/CT, 15 (33%) had intense uptake distant from the primary tumor and local lymph node basin. Nine of those 15 patients (60%) had abnormalities biopsied prior to LND. Three of the 9 biopsies yielded metastatic melanoma, a false-positive rate of 67% for PET/CT in identifying distant metastases in asymptomatic patients. (more…)
JAMA, Vanderbilt / 24.09.2015

Michael A. Vella, M.D. Veterans Affairs Medical Center Vanderbilt University, NashvilleMedicalResearch.com Interview with: Michael A. Vella, M.D. Veterans Affairs Medical Center Vanderbilt University, Nashville Medical Research: What is the background for this study? What are the main findings? Dr. Vella: We are fortunate to take care of Veterans from all over Middle TN at the Tennnessee Valley Healthcare System Nashville Campus.  A significant number of Veterans travel long distances and invest time and money in order to visit with us.  We noticed that many patients undergoing "low complexity" operations like removal of gallbladders and repair of groin hernia spend a significant amount of time, energy, and, in some cases, money to travel to our facility for post operative visits relative to the amount of time they spend in their evaluations.  We wanted to look at the quality of and Veteran preference for telehealth visits (phone and video) with the idea that, if feasible, we could implement a telehealth program at our facility. In our small pilot study, 23 Veterans underwent sequential phone, video, and in-person visits.  The Veterans were evaluated on four domains at each visit type: general recovery, follow-up needs, wound care needs, and complications.  We then determined the agreement among the three visit types.  There was 100% agreement across the three visit types in the domains of general recovery and follow-up needs.  Percent agreement for wound needs and complications was 96%, reflecting a possible infection on a phone encounter that was not present on clinic or video assessment.  One Veteran in the sample had a wound infection that was detected by both phone and video and confirmed during the in-person visit.  Importantly, there were no instances in which we failed to detect a wound issue or postoperative complication by phone or video.  We also found an association between preference for telehealth visits and distance traveled, although the majority of Veterans in our study preferred telehealth visitation over traditional face-to-face encounters. We found that over the phone and video visits were not only high quality, but were preferred by our Veterans, especially those living far from our facility.  We have implemented a telehealth program for general surgery post operative follow up at our institution and currently evaluate 3-5 patients a week using telehealth modalities with plans to continue to expand. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, JAMA / 24.09.2015

Aaron L. Schwartz, PhD Department of Health Care Policy Harvard Medical School Boston, Massachusetts MedicalResearch.com Interview with: Aaron L. Schwartz, PhD Department of Health Care Policy Harvard Medical School Boston, Massachusetts   Medical Research: What is the background for this study? What are the main findings? Dr. Schwartz: It is widely believed that much health care spending is devoted to services that provide little or no health benefit to patients. In previous work, we demonstrated that low-value services were commonly delivered to the Medicare population. In this study, we examined whether a new form of paying physicians and hospitals was effective in discouraging the use of low-value services. The payment reform we studied was the Medicare Pioneer Accountable Care Organization (ACO)  Program, a feature of the Affordable Care Act. This program financially rewards health care provider groups who keep spending under a specified budget and achieve high performance on measures of quality of care. This voluntary program employs a similar ACO payment model that some private insurers have adopted.  The hope is that such models can encourage providers to be more efficient by allowing them to share in the savings generated by lower health care spending. In previous work, we demonstrated that the Pioneer ACO Program was associated with lower overall health care spending and steady or improved performance on health care quality measures. However, it was unclear whether providers were focusing on low-value services in their attempts to reduce spending. We examined  2009-2012 Medicare claims data and measured the use of, and spending on, 31 services often provided to patients that are known to provide minimal clinical benefit. We found that patients cared for in the ACO model experienced a greater reduction in the use of low-value services when compared to patients who were not served by ACOs. We attributed a 4.5 percent reduction in low-value service spending to the ACO program. Interestingly, this was a greater reduction than the 1.2 percent reduction in overall spending attributed to the program, which suggests that providers were targeting low-value services in their efforts to reduce spending. In addition, we found that providers with the greatest rate of low-value services prior to the ACO program showed the greatest reduction in these services. We also found similar reductions in service use between services that are more likely to be requested by patients (i.e. early imaging for lower-back pain) and other services. (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, JAMA, Pulmonary Disease, University of Michigan / 23.09.2015

Thomas Valley, MD Fellow, Division of Pulmonary and Critical Care University of Michigan Ann Arbor, MIMedicalResearch.com Interview with: Thomas Valley, MD Fellow, Division of Pulmonary and Critical Care University of Michigan Ann Arbor, MI Medical Research: What is the background for this study? What are the main findings? Dr. Valley: There has been dramatic growth in intensive care unit (ICU) use over the past 30 years. As the reasons for this growth are not entirely clear, some have suggested that the ICU is a meaningful source of low-value care. The value of the ICU, however, depends on the net benefit that ICUs provide patients. Prior observational studies assessing the effectiveness of the ICU were limited because patients admitted to the ICU are inherently sicker and more likely to die than patients admitted to the general ward. Given the substantial number of patients with pneumonia who are admitted to an ICU, it is vital to understand whether admission to the ICU is beneficial. In our study of 1.1 million Medicare beneficiaries with pneumonia between 2010 and 2012, we used an instrumental variable, a statistical technique to pseudo-randomize patients based on their proximity to a hospital that uses the ICU frequently for pneumonia, in order to determine whether ICU admission saved lives and at what financial cost. An estimated 13 percent of patients were admitted to the ICU solely because they lived closest to a hospital that used the ICU frequently for pneumonia. Among these patients, ICU admission was associated with a nearly six percent reduction in 30-day mortality compared to general ward admission. In addition, there were no significant differences in hospital costs or Medicare reimbursement between patients admitted to the ICU and to the general ward. (more…)
Alzheimer's - Dementia, Author Interviews, Cleveland Clinic, JAMA / 22.09.2015

Jeffrey L. Cummings, M.D., Sc.D. Director, Lou Ruvo Center for Brain Health Camille and Larry Ruvo Chair for Brain Health Cleveland Clinic Las Vegas, NV 89106MedicalResearch.com Interview with: Jeffrey L. Cummings, M.D., Sc.D. Director, Lou Ruvo Center for Brain Health Camille and Larry Ruvo Chair for Brain Health Cleveland Clinic  Las Vegas, NV 89106  Medical Research: What is the background for this study? What are the main findings? Dr. Cummings: Agitation is a common problem in Alzheimer’s disease (AD); approximately 70% of patients with AD will experience periods of agitation.  This difficult behavior challenges patients and caregivers, adversely affects quality of life, and may precipitate institutionalization.  There are not drugs approved for treatment of agitation in Alzheimer’s disease. The study reported in JAMA showed that a drug based on a combination of dextromethorphan and quinidine (DM/Q) produced statistically significant and clinically meaningful reduction in agitation in Alzheimer’s disease patients.  The study met its primary outcome (decline in the Neuropsychiatric Inventory agitation scale in drug compared to placebo) and many of its secondary outcomes (e.g, decreases in caregiver stress).  The agent was safe and well tolerated. (more…)
Author Interviews, End of Life Care, Heart Disease, JAMA / 22.09.2015

MedicalResearch.com Interview with: Dr. Timothy J. FendlerMedicalResearch.com Interview with: Dr. Timothy J. Fendler MD MS Department of Cardiology, Saint Luke’s Mid America Heart Institute Kansas City, Missouri Medical Research: What is the background for this study? What are the main findings? Dr. Fendler: In-hospital cardiac arrest occurs commonly in the United States and is associated with low rates of meaningful survival. This poor prognosis should prompt patient-clinician discussions about goals of care and preferences for future resuscitative efforts. Little is known about how prognosis is aligned with code status decisions among survivors of in-hospital cardiac arrest (in other words, as prognosis worsens, are patients more likely to adopt Do-Not-Resuscitate orders, a sign of less aggressive treatment preferences, should recurrent cardiac arrest occur). We found that, among patients who survive an in-hospital cardiac arrest, there is generally good alignment between prognosis and code status decisions. That is, as prognosis worsens among survivors of in-hospital cardiac arrest, the rate of DNR status adoption increases, on average. However, among patients with very low levels of neurologic functioning and very poor prognosis, nearly two-thirds did not adopt DNR status, despite the fact that only about 4% of these patients with poor prognosis experienced actual favorable neurological survival. These results imply that there could be better alignment between prognosis and goals of care decisions that places the patient's wishes, safety, and quality of life at the forefront of decision-making and decreases the likelihood of undue suffering when the outcome may not be improved by it. Second, survival rates were much lower in patients with DNR orders, compared to those who did not adopt DNR status, after survival from in-hospital cardiac arrest. This was observed regardless of prognosis, implying that patients who adopt DNR status, and thus only request they be treated differently in the setting of recurrent cardiac arrest, may be receiving less aggressive treatment than they prefer, in areas of their care outside of resuscitation from cardiac arrest. (more…)
Author Interviews, FDA, JAMA, University of Pittsburgh / 21.09.2015

Dr. Tamar Krishnamurti PhD Department of Engineering & Public Policy Carnegie Mellon University Pittsburgh, PA 15213MedicalResearch.com Interview with: Dr. Tamar Krishnamurti PhD Department of Engineering & Public Policy Carnegie Mellon University Pittsburgh, PA 15213  Medical Research: What is the background for this study? What are the main findings? Dr. Krishnamurti: In 2012, the Food and Drug Administration Safety and Innovation Act became law. As part of this law, FDA can assign drugs the “breakthrough” designation. Breakthrough drugs are drugs that are intended to treat a serious or life threatening condition and have shown preliminary evidence of a substantial improvement over existing therapies on at least one one clinically significant endpoint. These clinical endpoints can be surrogate outcomes and don't have to be a direct outcome of the disease. All FDA press releases announcing approval of breakthrough-designated drugs use the term “breakthrough” and about half use the term “promising” when describing the drugs. Our study randomly assigned participants to read 1 of 5 short descriptions of a recently approved drug. These vignettes differed by the term assigned to the drug (e.g. "breakthrough" or "promising") or by whether the basis for the designation was clearly and succinctly explained in the description. We found that using the terms "breakthrough" and "promising" to describe these drugs resulted in people having unwarranted confidence about the effectiveness of breakthrough drugs, which could prevent them from making a fully informed decision about whether to take the drug or not. The influence of these terms on peoples' judgments was mitigated by explaining the regulatory meaning of the drug's approval (which is required in the drug's professional label, but not in public discourse about the drug). (more…)
Accidents & Violence, Author Interviews, JAMA, Pediatrics / 21.09.2015

Dr. Ziming Xuan ScD, SM, MA Assistant Professor, Community Health Sciences School of Public Health Boston University MedicalResearch.com Interview with: Dr. Ziming Xuan ScD, SM, MA Assistant Professor, Community Health Sciences School of Public Health Boston University  Medical Research: What is the background for this study? Dr. Xuan: With respect to background, among the 15000 some teenagers died annually in the US, the 3 leading causes of death were unintentional injuries, homicide, and suicide. Among these fatal youth injuries, 83% homicides were gun-related, and about half of suicides involved a gun (45%). So, The purpose of the study was to investigate the association between state gun law environment and youth gun carrying in the United States, and whether this association is mediated by adult gun ownership. Medical Research: What are the main findings? Dr. Xuan:
  • Among 38 states in our study, 5.7%of high school students living in the 19 states with stricter gun laws carried a gun in past 30 days while 7.3% of students living in states with the weaker gun laws carried a gun.
  • A 10-point increase in the strictness of the state gun law score was associated with a 9% decrease in the odds of youth gun carrying.
  • Across states, restrictive gun laws may reduce youth gun carrying by limiting adult gun ownership.
(more…)
Author Interviews, Endocrinology, JAMA, Prostate Cancer / 18.09.2015

MedicalResearch.com Interview with: Sindy Magnan, MD, MSc, FRCPC Division of Radiation Oncology, Department of Medicine CHU de Québe Université Laval Québec City, Québec, Canada Medical Research: What is the background for this study? What are the main findings? Dr. Magnan : Androgen deprivation is the standard therapy for patients with advanced or recurrent prostate cancer. Intermittent administration of this treatment could offer several advantages over the standard continuous administration by delaying the development of castration-resistant disease and by reducing the drugs’ adverse effects. However, this mode of administration remains controversial. We thus conducted a systematic review with meta-analysis of randomized controlled trials to compare the effectiveness and tolerability of intermittent versus continuous androgen deprivation. Intermittent therapy was non-inferior to continuous therapy with respect to overall survival. No major difference in global quality of life was observed between the two interventions, but some quality-of-life criteria, mainly in relation with physical and sexual functioning, seemed improved with intermittent therapy. (more…)
Author Interviews, Brigham & Women's - Harvard, Hospital Readmissions, JAMA / 17.09.2015

J. Michael McWilliams MD, PhD Associate Professor andMedicalResearch.com Interview with: J. Michael McWilliams MD, PhD Associate Professor and Dr. Michael Barnett MD Researcher and General Medicine Fellow Dept. of Health Care Policy Harvard Medical School Boston MADr. Michael Barnett MD Researcher and General Medicine Fellow Dept. of Health Care Policy Harvard Medical School Boston MA Medical Research: What is the background for this study? Response: The financial impact of Medicare’s Hospital Readmissions Reduction Program on hospitals is growing.  In this year’s round of penalties, nearly 2,600 hospitals were collectively fined $420 million for excess readmissions. There has been concern that the risk-adjustment methods used by Medicare to calculate a hospital’s expected readmission rate is inadequate, meaning that hospitals disproportionately serving sicker and more disadvantaged patients are being penalized because of the populations they serve rather than their quality of care.  Specifically, Medicare accounts only for some diagnoses, age and sex but no other clinical or social characteristics of patients admitted to the hospital. No study to date has examined the impact adjusting for a comprehensive set of clinical and social factors on differences in readmission rates between hospitals. We did this by using detailed survey data from the Health and Retirement Study linked to information on admissions and readmissions in survey participants’ Medicare claims data.  We then compared differences in readmission rates between patients admitted to hospitals in the highest vs. lowest quintile of publicly reported readmission rates, before vs. after adjusting for a rich set of patient characteristics.  These included self-reported health, functional status, cognition, depressive symptoms, household income and assets, race and ethnicity, educational attainment, and social supports. Medical Research: What are the main findings? Response: Our two most important findings were: 1) Patients admitted to hospitals with higher readmission rates are sicker and more socially disadvantaged in a variety of ways than patients admitted to hospitals with lower readmission rates. 2) After adjusting for all measurable patient factors that are not accounted for in standard Medicare adjustments, the difference in readmission rates between hospitals with high vs. low readmission rates fell by nearly 50%. (more…)
Author Interviews, Cleveland Clinic, Cost of Health Care, Heart Disease, JAMA, Radiology / 16.09.2015

Wael A. Jaber, MD FACC, FAHA Professor of Medicine Cleveland Clinic Lerner College of Medicine Fuad Jubran Endowed Chair in Cardiovascular Medicine Heart and Vascular Institute Cleveland Clinic Cleveland, OH MedicalResearch.com Interview with: Wael A. Jaber, MD FACC, FAHA Professor of Medicine Cleveland Clinic Lerner College of Medicine Fuad Jubran Endowed Chair in Cardiovascular Medicine Heart and Vascular Institute Cleveland Clinic  Cleveland, OH Medical Research: What is the background for this study? What are the main findings? Prof. Jaber: Risk stratification of patients presenting with atrial fibrillation often includes a non-invasive evaluation for coronary artery disease. However, the yield of such testing in patients without angina or anginal-equivalent symptoms is uncertain. That is, how often do we find silent myocardial ischemia? In our cohort of 1700 consecutive patients with atrial fibrillation, less than 5% had ischemia on nuclear stress testing, even though comorbidities were prevalent. Moreover, in patients with ischemia that had invasive coronary angiography, less than half had obstructive coronary artery disease. (more…)
Author Interviews, Cognitive Issues, JAMA, Vitamin D / 15.09.2015

Joshua W. Miller, PhD Professor and Chair Dept. of Nutritional Sciences Rutgers The State University of New Jersey New Brunswick, NJ 08901 MedicalResearch.com Interview with: Joshua W. Miller, PhD Professor and Chair Dept. of Nutritional Sciences Rutgers The State University of New Jersey New Brunswick, NJ 08901  Medical Research: What is the background for this study? What are the main findings? Response: In recent years, there has been a growing scientific literature on the associations between low vitamin D status in older adults and risk of Alzheimer's disease/dementia, cognitive impairment and decline, and brain atrophy.  The vast majority of these studies have been conducted in predominantly white populations.  The relatively unique aspect of our study was that over half of the cohort consisted of African Americans and Hispanics.  What we found in our cohort (mean age ~75y, n=382 at baseline) was that participants with vitamin D deficiency (serum 25-hydroxyvitamin D <12 ng/ml) or vitamin D insufficiency (serum 25-hydroxyvitamin D between 12 ng/ml and <20 ng/ml) on average experienced faster rates of cognitive decline in episodic memory and executive function than participants with adequate vitamin D status.  Importantly, the association between vitamin D status and the rate of decline in cognitive function was independent of race/ethnicity.  However, the prevalence of low vitamin D status in the study participants was significantly higher in the African American and Hispanic participants compared with the White participants.  This is most likely due to the fact that darker skin pigmentation reduces the ability of sunlight to induce vitamin D synthesis in the skin.  It may also reflect differences in dietary intake of vitamin D and supplement use between the different race/ethnicity groups, though we did not assess this in our study.  Thus, though the rate of cognitive decline in African Americans and Hispanics does not seem to be more or less affected by low vitamin D status than in Whites, because African Americans and Hispanics have a higher prevalence of low vitamin D status, as subpopulations they may be more prone to rapid cognitive decline in old age.  Further studies addressing this possibility are needed. (more…)
Author Interviews, JAMA, Pain Research, Pediatrics, Race/Ethnic Diversity, Surgical Research / 14.09.2015

Monika Goyal, MD Pediatric emergency medicine Children’s National Hospital Washington, DC MedicalResearch.com Interview with: Monika Goyal, MD Pediatric emergency medicine Children’s National Hospital Washington, DC Medical Research: What is the background for this study? What are the main findings? Dr. Goyal: Appendicitis is a painful surgical condition and adequate analgesia, particularly with opioids, are considered one of the mainstays of management. We found that almost half of all children diagnosed with appendicitis did not receive any analgesia. Furthermore, among the patients that did receive analgesia, there were marked racial differences with black children having lower rates of opioid medication receipt than white children, even after we took pain scores or acuity level into account. (more…)
Author Interviews, Breast Cancer, JAMA, Mediterranean Diet / 14.09.2015

MedicalResearch.com Interview with: Miguel Ángel Martínez González MD Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y Nutrición, Instituto de Salud Carlos III, Madrid IdiSNA, Navarra Institute for Health Research, Pamplona, Navarra, Spain Medical Research: What is the background for this study? Response: Several observational studies and mechanistic experiments in animal models and cell lines suggested that the Mediterranean diet and minor components of extra-virgin olive oil may reduce the risk of developing breast cancer. The PREDIMED study was a randomized primary prevention trial for cardiovascular disease among high risk patients initially free of cardiovascular disease. The participants were 7,447 men and women (60-80 years old). We have used the data from women in this trial to assess the effect of the randomized diets on the occurrence of new cases of breast cancer. Medical Research: What are the main findings? Response: Among 4,152 women randomized to 3 different diets (1.- Mediterranean diet with free provision of extra-virgin​ olive oil; 2.- Mediterranean diet with free provision of tree nuts; and 3.- Advice to follow a low-fat diet, i.e. control group) We confirmed 35 new cases of invasive breast cancer during 4.8 of follow-up. A statistically significant 68% relative reduction in the risk of breast cancer in the Mediterranean diet with free provision of extra-virgin​ olive oil versus the control group was found. There was a significant trend of risk reduction associated with progressive increments in the intake of extra-virgin olive oil during the trial (with repeated yearly measurements of diet) when the 3 groups were assessed together. (more…)
Accidents & Violence, Author Interviews, JAMA / 12.09.2015

MedicalResearch.com Interview with: Dr. Tahereh Orouji Jokar, MD International research fellow and Dr Joseph Bellal Joseph, MD Division of Trauma, Emergency Surgery, Critical Care, and Burns Department of Surgery University of Arizona, Tucson Medical Research: What is the background for this study? Response: Domestic violence is a social evil and bears significant social, financial, medical, and personal implications. Frequently victims of domestic violence, present in a trauma center due to injuries from domestic violence. However, despite bearing such grievous significance, there is no standardized practice to screen for domestic violence. In this study we sought out to identify the incidence and trends of domestic violence to highlight the burden of the disease. Medical Research: What are the main findings? Response: In our study we reported an overall incidence of domestic violence to be 569.564/100,000 trauma admissions. Over the study period the rate of domestic violence increased from 490/100,000 (2007) to 680/100,000 (2012) trauma admissions. We observed an increasing trend of domestic violence in children, adults, and elderly. On sub-analysis of adults, we observed an increasing trend of violence in both male and female victims. (more…)
Author Interviews, JAMA, Pediatrics, Tobacco Research, University of Pittsburgh / 12.09.2015

Brian A. Primack, MD, PhD Associate Professor of Medicine, Pediatrics, and Clinical and Translational Science Director, Center for Research on Media, Technology, and Health Assistant Vice Chancellor for Research on Health and Society University of Pittsburgh School of Medicine Pittsburgh, PA 15213MedicalResearch.com Interview with: Brian A. Primack, MD, PhD Associate Professor of Medicine, Pediatrics, and Clinical and Translational Science Director, Center for Research on Media, Technology, and Health Assistant Vice Chancellor for Research on Health and Society University of Pittsburgh School of Medicine Pittsburgh, PA 15213 Medical Research: What is the background for this study? Dr. Primack: Adolescents and young adults who have never smoked traditional cigarettes are now using e-cigarettes. It is unclear whether these people are at risk for progression to traditional cigarette smoking. Therefore, we followed 694 non-smokers ages 16-26 who did not intend on taking up smoking for 1 year. Medical Research: What are the main findings? Dr. Primack: At baseline, only 16 of the 694 participants had used e-cigarettes. However, those individuals were significantly more likely to start smoking traditional cigarettes by the 1-year follow-up. In fully adjusted models, baseline e-cigarette use was independently associated with both progression to smoking (AOR = 8.3, 95% CI  = 1.2-58.6) and to susceptibility (AOR = 8.5, 95% CI = 1.3-57.2). (more…)
Accidents & Violence, Author Interviews, JAMA / 10.09.2015

Antti Latvala PhD Post-doctoral researcher Department of Public Health, University of Helsinki Helsinki, Finland MedicalResearch.com Interview with: Antti Latvala PhD Post-doctoral researcher Department of Public Health, University of Helsinki Helsinki, Finland   Medical Research: What is the background for this study? Dr. Latvala: Motivation for the study came from the fact that antisocial and aggressive behavior has been associated with lower resting heart rate in children and adolescents. Heart rate, being regulated by the autonomic nervous system, has been viewed as an indicator of stress responding or autonomic arousal, and the association has been hypothesized to indicate low levels of stress or a chronically low level of autonomic arousal in antisocial individuals. However, empirical evidence for such an association in adulthood has been very limited. Medical Research: What are the main findings? Dr. Latvala: We found that men with lower resting heart rate had an increased risk of violent and nonviolent criminality. Specifically, men in the lowest fifth of the heart rate distribution had an estimated 39% increased risk for violent criminality and a 25% increased risk for nonviolent crimes compared with men in the highest fifth. These are estimates after adjusting for physical, cardiovascular, cognitive and socioeconomic covariates. When we further adjusted for cardiorespiratory fitness, which was available in a subsample, the associations were even stronger. In addition to the crime outcomes, we found that low resting heart rate predicted exposure to assaults and accidents, such as traffic crashes, falls and poisonings, in a very similar fashion. (more…)
Author Interviews, JAMA, Surgical Research, Urology / 10.09.2015

MedicalResearch.com Interview with: Blayne Welk MD Assistant Professor in the Division of Urology The University of Western OntarioBlayne Welk MD Assistant Professor in the Division of Urology The University of Western Ontario Medical Research: What is the background for this study? What are the main findings? Dr. Welk: Stress incontinence is a common problem among women. The most frequently used surgical treatment is a mesh-based midurethral sling. This procedure is commonly called a transvaginal sling, and is usually an outpatient procedure that takes about an hour in the operating room. However, there has been significant concern about some of the complications of this procedure, which include chronic pain, and mesh erosions into the urinary tract. This prompted the FDA and Health Canada to issue warnings regarding the use of transvaginal mesh, and numerous lawsuits have been launched against manufactures of transvaginal mesh products. This study by Dr Welk and colleagues identifies the long term rate of surgical treated complications among a group of almost 60,000 women who had mesh based incontinence procedures between 2002-2012. The rate of surgically treated complications at 1 year is 1.2%, however this increased to 3.3% after 10 years of followup. The FDA and Health Canada recommend that surgeons obtain training and experience in their chosen type of midurethral sling, and we demonstrated that patients of high volume surgeons (who frequently performed mesh based incontinence procedures) were 27% less likely to have one of these complications. (more…)