Author Interviews, JAMA, Ophthalmology, Pediatrics / 16.08.2017

MedicalResearch.com Interview with: Mary Elizabeth Hartnett, MD, FACS, FARVO Professor of Ophthalmology, Vitreoretinal Service and Surgery Principal Investigator Retinal Angiogenesis Laboratory Director of Pediatric Retina, Adjunct Professor of Pediatrics John A. Moran Eye Center Salt Lake City UT 84132 On behalf of the co-authors: Julia Shulman, Cindy Weng, Jacob Wilkes, Tom Greene, M. Elizabeth Hartnett MedicalResearch.com: What is the background for this study? Response: Maternal preeclampsia causes morbidity to mothers and infants worldwide. Retinopathy of prematurity (ROP) is a leading cause of childhood blindness worldwide. This study was done to gain insight into the effects of preeclampsia on ROP in a clinical population. The literature is mixed with some reports that preeclampsia increases risk of Retinopathy of prematurity, whereas others suggest preeclampsia is protective or has no effect. The presence of circulating anti-angiogenic factors in preeclamptic mothers that can enter the fetal circulation lends biologic plausibility to the notion that maternal preeclampsia might interfere with developing vascular beds in the fetus, such as the retina, and potentially lead to severe ROP. However, a report using an experimental model provided evidence that uteroplacental insufficiency, a characteristic of preeclampsia, led to protective mechanisms in the offspring that reduced oxygen-induced retinopathy and promoted overall growth. (more…)
Author Interviews, Exercise - Fitness, Geriatrics, JAMA / 15.08.2017

MedicalResearch.com Interview with: Jennifer Brach, Ph.D., P.T. Associate professor, Department of physical therapy School of Health and Rehabilitation Sciences University of Pittsburgh MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study compared two different group exercise programs to improve mobility in community-dwelling older adults. The first program, a seated program focused on strength, endurance and flexibility, was based on usual care. The second program, called On the Move, was conducted primarily in standing position and focused on the timing and coordination of movements important for walking. Both programs met two times per week for 12 weeks. It was found that the On the Move program was more effective at improving mobility than the usual seated program. (more…)
Author Interviews, Gastrointestinal Disease, JAMA / 15.08.2017

MedicalResearch.com Interview with: Maureen Leonard, MD MMSc Clinical Director, Center for Celiac Research and Treatment Instructor in Pediatrics Associate Investigator, Nutrition Obesity Research Center Harvard Medical School Pediatric Gastroenterology & Nutrition MassGeneral Hospital for Children   MedicalResearch.com: What is the background for this study? What are the main findings? Response: In this systematic review, we discuss the clinical approach to celiac disease and nonceliac gluten sensitivity, highlighting how to distinguish between these two conditions and their management. These disorders cannot be distinguished based on symptoms. A single elevated serology test is not diagnostic for celiac disease, and patients with abnormal serologic testing must be referred to a gastroenterologist for further testing and remain on a gluten-containing diet until their diagnostic evaluation is completed. While the treatment for both conditions is a gluten-free diet, the possibility of long-term complications differs. (more…)
Author Interviews, Cancer Research, Cost of Health Care, Duke, JAMA / 11.08.2017

MedicalResearch.com Interview with: Dr. Fumiko Chino, MD Duke Radiation Oncology Duke School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: The financial burden of cancer treatment is a growing concern. Out-of-pocket expenses are higher for patients with cancer than for those who have other chronic illnesses. Fifty percent of elderly cancer patients spend at least 10% of their income on treatment-related out-of-pocket expenses. Additionally, high financial burden is associated with both increased risk of poor psychological well-being and worse health-related quality of life. A cancer diagnosis has been shown to be an independent risk factor for declaring personal bankruptcy, and cancer patients who declare personal bankruptcy are at greater risk for mortality. These potentially harmful outcomes resulting from financial burden have been recognized as the financial toxicity of cancer therapy, analogous to the more commonly considered physical toxicity. We conducted an IRB approved study of financial distress and cost expectations among patients with cancer presenting for anti-cancer therapy. In this cross-sectional, survey based study of 300 patients, over one third of patients reported higher than expected financial burden. Cancer patients with highest financial distress are underinsured, paying nearly 1/3 of income in cancer-related costs. In adjusted analysis, experiencing higher than expected financial burden was associated with high/overwhelming financial distress (OR 4.78; 95% CI 2.02-11.32; p<0.01) and with decreased willingness to pay for cancer care (OR 0.48, 95% CI 0.25-0.95, p=0.03). Sambla, a Scandinavian lender, has been working with many patients to prevent any financial distress resulting from unexpected medical bills. As a result of customer feedback, it has modified the terms of all loans it issues to allow for jumbo loan sizes and reduced interest rates, combined with longer repayment times to help its borrowers. (more…)
Author Interviews, Heart Disease, JAMA, Outcomes & Safety, Race/Ethnic Diversity / 09.08.2017

MedicalResearch.com Interview with: Dr. Lee Joseph, MD, MS Postdoctoral fellow at University of Iowa Division of Cardiovascular Diseases Department of Internal Medicine University of Iowa Carver College of Medicine Iowa City MedicalResearch.com: What is the background for this study? Response: In-hospital cardiac arrest (IHCA) is common and affects more than 200,000 patients every year. Although survival for in-hospital cardiac arrest has improved in recent years, marked racial differences in survival are present. A previous study showed that black patients with in-hospital cardiac arrest have 27% lower chance of surviving an in-hospital cardiac arrest due to a shockable rhythm compared to white patients. Moreover, lower survival in black patients was largely attributable to the fact that black patients were predominantly treated in lower quality hospitals compared to white patients.  In other words, racial disparities in survival are closely intertwined with hospital quality, and this has been borne out in multiple other studies as well In this study, we were interested in determining whether improvement in in-hospital cardiac arrest survival that has occurred in recent years benefited black and white patients equally or not? In other words, have racial differences in survival decreased as overall survival has improved. If so, what is the mechanism of that improvement? And finally, did hospitals that predominantly treat black patients make the greatest improvement in survival? To address these questions, we used data from the Get With The Guidelines-Resuscitation, a large national quality improvement registry of in-hospital cardiac arrest that was established by the American Heart Association in the year 2000. Participating hospitals submit rich clinical data on patients who experience in-hospital cardiac arrest. Over the last 17 years, the registry has grown markedly and currently includes information on >200,000 patients from > 500 hospitals. The primary purpose is quality improvement. But it has also become an important resource to conduct research into the epidemiology and outcomes associated with in-hospital cardiac arrest. Using data from the Get With the Guidelines-Resuscitation, we identified 112,139 patients at 289 hospitals between 2000-2014. Approximately 25% of the patients were of black race and the remainder were white patients. We constructed two-level hierarchical regression models to estimate yearly risk adjusted survival rates in black and white patients and examined how survival differences changed over time both on an absolute and a relative scale. (more…)
Author Interviews, Cost of Health Care, JAMA, Social Issues / 07.08.2017

MedicalResearch.com Interview with: Arlene S. Ash, PhD Department of Quantitative Health Sciences University of Massachusetts Medical School Worcester  MedicalResearch.com: What is the background for this study? What are the main findings? Response: State Medicaid programs (and other health care purchasers) often contract with several managed care organizations, each of which agrees to address all health care needs for some of their beneficiaries. Suppose a Medicaid program has $5000 to spend, on average, for each of its 1 million beneficiaries. How much should they pay health plan “A” for the particular 100,000 beneficiaries it enrolls? If some group, such as those who are homeless, is much more expensive to care for than the payment, plans that try to provide good care for many such people will go broke. We describe the model now used by MassHealth to ensure that plans get more money for enrolling patients with greater medical and social needs. In this medical-social model, about 10% of total dollars is allocated by factors other than the medical-morbidity risk score. (more…)
Author Interviews, Cost of Health Care, JAMA, Lipids, University of Pittsburgh / 07.08.2017

MedicalResearch.com Interview with: Inmaculada Hernandez, PharmD, PhD Assistant Professor of Pharmacy and Therapeutics University of Pittsburgh School of Pharmacy Pittsburgh, PA 1526 MedicalResearch.com: What is the background for this study? Response: A few months ago, the results of the FOURIER trial were published. This trial was the first one to evaluate the efficacy of PCSK9 inhibitors in the prevention of cardiovascular events, since the approval of these agents was based on trials that evaluated their efficacy in reducing levels of LDL-C. The results of the FOURIER trial did not meet the expectations generated by prior studies that had simulated how much the risk of cardiovascular events should decrease based on the observed reduction in LDL-C levels. A few hours after the publication of the results of the FOURIER trial, Amgen (evolocumab´s manufacturer) announced that it would be willing to engage in contracts where the cost of evolocumab would be refunded for those patients who suffer a heart attack or a stroke while using the drug. (more…)
Author Interviews, JAMA, Schizophrenia / 02.08.2017

MedicalResearch.com Interview with: Peter Kochunov PhD Professor Maryland Psychiatric Research Center  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Schizophrenia is a debilitating disorder that strikes young people at the point of entering adulthood. In the past, we and others demonstrated that patients with schizophrenia are characterized by deficits in the white matter of the brain. White matter is the part of the brain that serves the backbone of cerebral networks transmitting information and interconnecting brain regions. In this report, we link the impaired white matter of the brain in schizophrenia patients with the disorder-related deficits in the processing speed. We also showed that mental processing speed is a fundamental cognitive construct that partially supports other functions like working memory in patients, where processing speed acting as the intermediate between white matter deficits and reduced working memory. This interesting relationship between processing speed, working memory, and white matter is most obvious in white matter regions most vulnerable to schizophrenia. That was the main finding of the study. (more…)
Author Interviews, Breast Cancer, JAMA, Surgical Research / 02.08.2017

MedicalResearch.com Interview with: Dr. Lisa K. Jacobs MD Johns Hopkins School of Medicine Baltimore, Maryland MedicalResearch.com: What is the background for this study? What are the main findings? Response: Breast preservation is the preferred treatment for many women diagnosed with breast cancer.  The most common question that a patient will ask after the surgery is, “Did you get it all?” In the ideal case, this is accomplished in a single outpatient surgery with very good cosmetic results.  In our study, Beyond the Margins-Economic Costs and Complications Associated with Repeated Breast-Conserving Surgeries we evaluated the detrimental effects of an unsuccessful initial surgery due to positive surgical margins. Using private insurance claims data, we found that 16% of patients planning breast preservation required a second breast-conserving surgery and an additional 7% converted to mastectomy.  Of those patients that required additional surgery there was a 56% ($16,072) increase in cost and a 48% increase in complications.  Those complications include infection, hematoma, seroma, and fat necrosis.  This study demonstrates that repeated surgery has not only cosmetic consequences, but also has financial implications and increased risk. (more…)
Author Interviews, Cancer Research, JAMA / 02.08.2017

MedicalResearch.com Interview with: Benjamin Weixler, MD Department of Surgery University Hospital Basel, Basel, Switzerland and Leiden University Medical Center, Leiden, the Netherlands  MedicalResearch.com: What is the background for this study? What are the main findings? Response: For most patients with lymph node negative colon cancer (stage I and II) surgery is regarded to be the curative treatment. Despite the curative attempt up to thirty percent of these patients will develop disease recurrence, most likely due to missed micro-metastatic disease at initial tumor staging. Pathological standard processing with hematoxylin and eosin (H&E) entails a considerable risk of missing micro-metastatic deposits in the lymph nodes. Mounting evidence indicates that micro-metastatic tumor deposits in the lymph nodes as well as in the bone marrow might be associated with an increased risk of disease recurrence and death in node negative patients. With our study we wanted to examine the correlation between the occurrence of micro-metastatic deposits in the lymph nodes and the bone marrow as well as their prognostic significance. As a main finding, the study provides compelling evidence that tumor cell dissemination to the lymph nodes and to the bone marrow are independent events in patients with colon cancer. Most importantly did the study demonstrate that micro-metastatic deposits in the lymph nodes as well as in the bone marrow are independent negative prognostic factors regarding  disease-free and overall survival. The combined occurrence is associated with significantly worse prognosis compared to either one of them. (more…)
Author Interviews, Biomarkers, Brain Injury, JAMA / 01.08.2017

MedicalResearch.com Interview with: Dr. Adrian Harel, PhD Chief Executive Officer Medicortex Finland MedicalResearch.com: What is the background for this study? What are the main findings? Response: Every 15 seconds, someone in the United States suffers a new head injury. Of the 2.5M people treated in hospital emergency rooms each year, 80,000 become permanently disabled because of TBI. Currently, there are no reliable diagnostic tests to assess the presence or severity of an injury on-site, nor are there any pharmaceutical therapies that could stop the secondary injury from spreading. Accurate diagnostics would benefit especially mild cases of TBI (concussions), which, if occurring repeatedly, may cause neurodegenerative conditions such as Chronic Traumatic Encephalopathy (which is typical for athletes in NFL and Ice-hockey). We have performed extensive preclinical research comparing fluid biopsies from normal and injured lab animals. The results showed some unique biomarkers released as a biodegradation products after head injury. The data served as the basis and confirmation for our patent applications to protect the biomarker concept. Medicortex has completed a clinical proof-of-concept trial in collaboration with Turku University Hospital (Tyks). Samples from 12 TBI patients and 12 healthy volunteers were collected and analyzed for the presence and for the level of the biomarker in state-of-the-art laboratories. The study demonstrated the diagnostic potential of the new biomarker in humans and it confirmed the prior preclinical findings. This was a significant milestone for Medicortex. (more…)
Author Interviews, Diabetes, JAMA, Ophthalmology, UC Davis / 30.07.2017

MedicalResearch.com Interview with: Jeffrey R. Willis MD, PhD UC Davis Eye Center University of California, Davis Sacramento California MedicalResearch.com: What is the background for this study? What are the main findings? Response: Diabetic retinopathy is one of the leading causes of blindness in the United States.  Yet there is limited national level data on the impact of worsening DR on quality of life and visual function. Our study aimed to address this knowledge gap by evaluating the functional burden of DR across severity levels, utilizing data from the National Health and Nutrition Examination Survey (NHANES). We found that one-half of US adults with severe non-proliferative diabetic retinopathy (NPDR) or proliferative diabetic retinopathy (PDR) had difficulty with ≥ 1 visual function task, possibly impacting their daily work/activities.  These patients reported a significantly greater vision-related functional burden relative to those with less severe forms of DR. (more…)
Author Interviews, Hearing Loss, JAMA, Pediatrics / 30.07.2017

MedicalResearch.com Interview with: Dr. Carlijn M. P. le Clercq, MD Speech and Language Pathology, Pediatrics, Otolaryngology Erasmus MC , Rotterdam MedicalResearch.com: What is the background for this study? What are the main findings? Response: There has been increasing interest for acquired hearing loss among children, and concerns about its prevalence possibly rising over time. One of the questions that come up, is whether there is an association with the growing use of portable music players with headphones, including smartphones and tablets. There have been few longitudinal studies to explore this relation. In order to examine this relation, among other factors, we have conducted a formal hearing screening among more than 5000 9- to 11-year-old children from a population-based birth cohort in the Netherlands. Our study showed that nearly one in five children did not have normal hearing. Of the cohort, 7.8% of the children showed signs of permanent hearing loss. (more…)
Author Interviews, Blood Pressure - Hypertension, Brigham & Women's - Harvard, JAMA / 28.07.2017

MedicalResearch.com Interview with: Stephen P. Juraschek, MD, PhD Instructor of Medicine Beth Israel Deaconess Medical Center Harvard Medical School MedicalResearch.com: What is the background for this study? Response: Many adults experience dizziness and light-headedness when they stand up. This is more common in older adults and is related to risk of falling, fractures, fainting, car crashes, and early death. These symptoms are thought to be caused by a drop in blood pressure after standing also called orthostatic hypotension. However, if measured at the wrong time it is possible to miss this important clinical sign. For over 2 decades (since 1996), it has been recommended that orthostatic hypotension be identified by measuring blood pressure within 3 minutes of standing. Furthermore, it was also thought that measurements immediately after standing be avoided because they might be inaccurate (based on fluctuation in blood pressure immediately after standing). As a result, a lot of clinical protocols instructing healthcare staff on measuring orthostatic blood pressure encourage measurement at 3 minutes, but this has not been scientifically evaluated. (more…)
Author Interviews, Education, Heart Disease, JAMA, Lifestyle & Health, Primary Care, UCLA / 28.07.2017

MedicalResearch.com Interview with: Carol M. Mangione, MD, MSPH, FACP Barbara A. Levey, MD, and Gerald S. Levey, MD Endowed chair in medicine David Geffen School of Medicine University of California, Los Angeles Professor of public health at the UCLA Fielding School of Public Health MedicalResearch.com: What is the background for this study? Response: Americans can experience several health benefits from consuming healthy foods and engaging in physical activity. The Task Force recommends that primary care professionals work together with their patients when making the decision to offer or refer adults who are not obese and do not have hypertension, high cholesterol, high blood sugar, or diabetes to behavior counseling to promote healthful diet and physical activity. Our focus was on the impact of a healthful diet and physical activity on cardiovascular risk because this condition is the leading cause of premature morbidity and mortality. The Task Force evaluates what the science tells us surrounding the potential benefits and harms of a particular preventive service. In this case, the Task Force found high quality evidence focusing on the impact a healthful diet and physical activity can have on a patient’s risk of cardiovascular disease. Relying on this evidence, the Task Force was able to conclude that there is a positive but small benefit of behavioral counseling to prevent cardiovascular disease. (more…)
Author Interviews, JAMA, Pediatrics, Sleep Disorders / 26.07.2017

MedicalResearch.com Interview with: Rachel Y. Moon, M.D. Division Head, General Pediatrics Professor of Pediatrics University of Virginia School of Medicine Charlottesville, VA 22908 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Approximately 3500 babies die suddenly and unexpectedly during sleep in the US every year. Even though there are safe sleep recommendations, many parents do not follow them because of misinformation or misconceptions. Therefore we tested 2 complementary interventions to promote infant safe sleep practices. The first was a nursing quality improvement intervention aimed at ensuring that mothers would hear key messages and that there was appropriate role modeling of safe sleep practices by hospital personnel. The second was a mobile health intervention, in which mothers received videos and text messages or emails with safe sleep information during the baby's first two months of life. We randomized mothers to receive either the safe sleep interventions or breast-feeding interventions (the control interventions). Mothers who received the mobile health intervention reported statistically significantly higher rates of placing their babies on their back, room sharing without bed sharing, no soft bedding use, and pacifier use, compared with mothers who received a control intervention. Although the nursing quality improvement intervention did not influence infant safe sleep practices, there was an interaction such that mothers who received both the safe sleep nursing quality improvement intervention and the safe sleep mobile health intervention had the highest rates of placing their babies on the back. (more…)
Author Interviews, Cognitive Issues, General Medicine, JAMA / 26.07.2017

MedicalResearch.com Interview with: Jochen René Thyrian, PhD German Center for Neurodegenerative Diseases (DZNE) Greifswald, Germany MedicalResearch.com: What is the background for this study? What are the main findings? Response: Dementia presents a challenge to the health care systems worldwide. People with dementia (PWD) need comprehensive medical, nursing, psychological and social support to delay the progression of disease and sustain autonomy and social inclusion. Evidence-based interventions alleviate the burden of disease for PwD and their caregivers, as no curative treatment is currently available. Involving caregivers is important because they provide the largest proportion of care for PwD. General physicians in residency have been identified as the first point of contact for PwD and is thus a promising setting for identification, comprehensive needs assessment and initiating dementia-specific treatment and care. In this study we tested the effectiveness and safety of a model of collaborative care, Dementia Care Management (DCM) on patient-oriented outcomes in n=634 people screened positive for dementia in primary care. DCM is provided by specifically trained nurses, supported by a computerized intervention management system, in close cooperation with the treating physician at the people´s homes. Recommendations for improving treatment and care were based on a comprehensive needs assessment, discussed interprofessionally and their implementation monitored/ adjusted over the course of 6-12 months (more…)
ADHD, Author Interviews, JAMA, Pharmacology / 26.07.2017

MedicalResearch.com Interview with: Professor Ian Chi Kei Wong and Kenneth KC Man, Senior Research Assistant Department of Social Work and Social Administration, Faculty of Social Science Department of Pharmacology and Pharmacy, LKS Faculty of Medicine The University of Hong Kong MedicalResearch.com: What is the background for this study? What are the main findings? Response: Patients with attention-deficit/hyperactivity disorder (ADHD) are at higher risk of various mental health problems. Previous studies suggested that individuals with ADHD are having a higher chance of both attempted and completed suicide. Methylphenidate is a psychostimulant that is recommended for the treatment of ADHD. With the increasing usage of methylphenidate over the past decade, there are concerns about the safety of the medication, in particular, psychiatric adverse effects such as suicide attempt. The current study looked into over 25,000 patients aged 6 to 25 years in Hong Kong who were receiving methylphenidate in 2001 to 2015. Using the self-controlled case series design, in which the patients act as their own control, we found that the risk of suicide attempt was 6.5 fold higher during a 90-day period before methylphenidate was initiated, remained elevated 4-fold during the first 90 days of treatment, and returned to the normal level during ongoing treatment. (more…)
Author Interviews, JAMA, Mental Health Research / 26.07.2017

MedicalResearch.com Interview with: Robert J. Ursano, M.D. Professor of Psychiatry and Neuroscience Director, Center for the Study of Traumatic Stress Dept of Psychiatry Uniformed Services University of the Health Sciences Bethesda, MD  MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study is part of the STARRS study- a study to identify risk and protective factors for suicide in US Army. Originally funded by NIMH it is not funded by DoD. It has been called the "Framingham study" for suicide and has been highly productive. In this study we report that units with one suicide attempt are at increased risk of a second- indicating clustering of suicide attempts. (more…)
Author Interviews, Cognitive Issues, JAMA, Schizophrenia / 26.07.2017

MedicalResearch.com Interview with: Olav B. Smeland MD PhD Postdoctoral researcher SFF NORMENT, KG Jepsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital & Institute of Clinical Medicine University of Oslo Oslo, Norway MedicalResearch.com: What is the background for this study? What are the main findings? Response: Schizophrenia is a severe mental disorder associated with widespread cognitive impairments. The cognitive deficits are associated with disabilities in social, economic and occupational functioning and lower quality of life among individuals with schizophrenia. Despite this, current treatment strategies largely fail to ameliorate these cognitive impairments. To develop more efficient treatment strategies in schizophrenia, a better understanding of the disease mechanisms underlying cognitive deficits is needed. For a long time we have known that schizophrenia is heritable, and in recent years many schizophrenia risk genes have been identified. Moreover, several studies have indicated that genetic risk of schizophrenia may contribute to cognitive dysfunction. In this study, we aimed to identify schizophrenia risk genes that also influence cognitive function. In a large international collaboration of researchers, we combined genome-wide association studies on schizophrenia and the cognitive traits of verbal-numerical reasoning, reaction time and general cognitive function. In total, we analyzed genetic data from more than 250.000 participants. We were able to identify 21 genetic variants shared between schizophrenia and cognitive traits. For 18 of these genetic variants, schizophrenia risk was associated with poorer cognitive performance. (more…)
Author Interviews, Brain Injury, Exercise - Fitness, JAMA / 25.07.2017

MedicalResearch.com Interview with: Daniel H. Daneshvar, M.D., Ph.D. Chronic Traumatic Encephalopathy Center Team Up Against Concussions | Founder Boston University  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Chronic traumatic encephalopathy (CTE) is a neurodegenerative disease associated with repetitive head impacts. CTE was first described in JAMA in 1928. In the 99 years since, just over 100 cases of CTE have been described in the world’s literature. This study nearly doubles the number of reported cases of CTE, with 177 cases of CTE in football players. Of note, 110 of the 111 athletes who played in the NFL had CTE. This study represents the largest and the most methodologically rigorous description of a series of patients with CTE ever published. Such a richness of data regarding the clinical and pathological features of CTE has never been previously compiled. As such, this study represents an important advance to the medical literature and an enormous scientific advance in our understanding of  chronic traumatic encephalopathy. (more…)
Author Interviews, JAMA, Stem Cells / 25.07.2017

MedicalResearch.com Interview with: Dr. Paul J. Hauptman, MD Professor of Internal Medicine Division of Cardiology Assistant Dean, Clinical and Translational  Research Saint Louis University School of Medicine St. Louis MO 63110-0250  MedicalResearch.com: What is the background for this study? What are the main findings? Response: A publication in 2016 by Leigh Turner from the University of Minnesota in 2016 shed light on the proliferation of stem cell centers or "businesses" that offer non FDA approved treatments, described as "stem cell therapy" for a variety of conditions. We opted to evaluate sites that claimed to treat heart failure. We collected data on type of infusion, need for a medical evaluation, board certification status of the center physician, cost and other factors. Self reported patient volumes were very variable. Most centers/businesses claimed to use autologous stem cells; a number offered ancillary treatment (i.e. vitamin infusions and hyperbaric oxygen); only one appeared to have a board-certified cardiologist involved. The costs were high for single infusions (mean price of $7694, SD 2737 for autologous cells; slightly less for allogeneic cells). Efficacy claims made during telephone calls with the centers were highly positive. (more…)
Author Interviews, FDA, JAMA, Race/Ethnic Diversity / 25.07.2017

MedicalResearch.com Interview with: Sanket Dhruva, MD, MHS, FACC Cardiology, VA Connecticut Healthcare System Robert Wood Johnson Foundation Clinical Scholar Yale University MedicalResearch.com: What is the background for this study? What are the main findings? Response: In 2012, Congress passed the Food & Drug Administration (FDA) Safety and Innovation Act, with the goal of increasing enrollment and availability of data in important patient groups such as the elderly, women, and racial and ethnic minorities. In 2014, as mandated by the legislation, the FDA released an Action Plan to address these issues. This Action Plan included the goal of increasing the transparency by posting demographic information of pivotal (or key) clinical trials used to support approval decisions. We examined how often these data were available in 2015 for all studies used to support approval of all original high-risk medical devices approved in the calendar year following the FDA Action Plan. Examples of these medical devices include stents, bone grafts, heart valves, and spinal cord stimulators. We wanted to understand if age, sex, and race and ethnicity data were available and if the results of clinical studies supporting these medical devices were analyzed to assess if there were differences in safety and effectiveness by these important demographic factors. Our main findings are that FDA Summaries publicly reported age for 65% of study populations, sex for 66%, and race and/or ethnicity for 51%. Analyses to assess if demographic factors may have impacted device safety and effectiveness were only conducted by age for 9%, by sex for 17%, and by race for 4% of clinical studies. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, JAMA, Mental Health Research / 20.07.2017

MedicalResearch.com Interview with: Bastian Ravesteijn PhD Department of Health Care Policy Harvard Medical School  MedicalResearch.com: What is the background for this study? What are the main findings? Response: We find that higher out-of-pocket costs for mental health care could have the unintended consequence of increasing the use of acute and involuntary mental health care among those suffering from the most debilitating disorders. (more…)
Author Interviews, Brigham & Women's - Harvard, Heart Disease, JAMA, Pediatrics / 19.07.2017

MedicalResearch.com Interview with: Holly Gooding, MD, MSc Assistant Professor of Medicine and Pediatrics Harvard Medical School Division of Adolescent/Young Adult Medicine Boston Children's Hospital Division of General Internal Medicine Brigham and Women's Hospital Boston, MA MedicalResearch.com: What is the background for this study? What are the main findings? Response: Dr Stephanie Chiuve and colleagues at the Harvard TH Chan School of Public Health developed the Healthy Heart Score to predict the risk of heart disease in older adults based on lifestyle factors measured in middle age. We have known for some time that the precursor to heart disease – known as atherosclerosis – actually starts in childhood and adolescence. We calculated the Healthy Heart Score for young adults ages 18-30 years old and found it works in this age group as well. (more…)
Aging, Author Interviews, Brigham & Women's - Harvard, JAMA, Weight Research / 19.07.2017

MedicalResearch.com Interview with: Yan Zheng Research Fellow, Department of Nutrition Harvard T.H. Chan School of Public HealthYan Zheng Research Fellow, Department of Nutrition Harvard T.H. Chan School of Public Health MedicalResearch.com: What is the background for this study? What are the main findings? Response: Most people gain weight cumulatively during young and middle adulthood. Because the amount of weight gain per year may be relatively small, it may go unnoticed by individuals and their doctors—but the cumulative weight gain during adulthood may eventually lead to obesity over time. Compared to studies of attained body weight or BMI, the investigation of weight change may better capture the effect of excess body fat because it factors in individual differences in frame size and lean mass. (more…)
Author Interviews, Boehringer Ingelheim, Heart Disease, JAMA / 18.07.2017

MedicalResearch.com Interview with: Javed Butler, MD, PhD Chief of the Cardiology Division Dr. Vincent Yang, Simons Chair in Internal Medicine Stony Brook University  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Persistent congestion is associated with worse outcomes in acute heart failure (AHF). Mineralocorticoid receptor antagonists at high doses may relieve congestion, overcome diuretic resistance, and mitigate the effects of adverse neurohormonal activation in AHF. We therefore studies high dose spironolactone in patients with AHF. Unfortunately all of our primary and secondary endpoints were not different between spironolactone and placebo arms. (more…)
Author Interviews, Infections, JAMA, Pediatrics, Respiratory, Vitamin D / 18.07.2017

MedicalResearch.com Interview with: Jonathon Maguire MD MSc FRCPC Scientist, Li Ka Shing Knowledge Institute Staff Pediatrician, Department of Pediatrics, St. Michael’s Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Response: Vitamin D has been hypothesized as being protective of seasonal viral upper respiratory tract infections.  In this randomized clinical trial, high dose wintertime vitamin D supplementation (2000 IU/day) was compared with standard-dose vitamin D supplementation (400 IU/day) among 703 children.  The number of laboratory confirmed viral upper respiratory tract infections was not statistically different between groups. (more…)
Author Interviews, Blood Pressure - Hypertension, Geriatrics, JAMA / 17.07.2017

MedicalResearch.com Interview with: Donal J. Sexton, BSc, MD The Irish Longitudinal Study on Ageing Trinity College Dublin Health Research Board Clinical Research Facility Galway National University of Ireland Galway, Galway, Ireland Trinity Health Kidney Centre, Tallaght Hospital Department of Nephrology, Beaumont Hospital, Royal College of Surgeons of Ireland Dublin, Ireland MedicalResearch.com: What is the background for this study? What are the main findings? Response: In this study we used the inclusion criteria for SPRINT to identify those community dwelling elders who would meet criteria for the trial in clinical practice. Our data are based on a prospective cohort study composed of participants chosen by a national stratified random sampling mechanism. If SPRINT participants were truly representative of the population, then the participants in the standard care arm of the trial should resemble the population to some extent. If this were true then the injurious falls rate might be similar between the two samples also. (more…)
Author Interviews, JAMA, Opiods, Pain Research, Primary Care / 17.07.2017

MedicalResearch.com Interview with: Jane M. Liebschutz, MD, MPH Associate Professor of Medicine Section of General Internal Medicine Boston University School of Medicine Boston, Massachusetts MedicalResearch.com: What is the background for this study? Response: The number of patients receiving opioids for chronic pain has risen over the past 2 decades in the US, in parallel with an increase in opioid use disorder. The CDC and professional medical societies have created clinical guidelines to improve the safety of opioid prescribing, yet individual prescribers can find them onerous to implement. We developed an intervention to change clinical practice to support primary care physicians who prescribe the majority of opioids for chronic pain. The intervention included 4 elements- a nurse care manager to help assess, educate and monitor patients, an electronic registry to keep track of patient data and produce physician level reports, an individualized educational session for the physician by an opioid prescribing expert based on the physician-specific practice information and online resources to help with decision-making for opioid prescribing (www.mytopcare.org). We tested whether the intervention would improve adherence to guidelines, decrease opioid doses and decrease early refills, as a marker of potential prescription opioid misuse among 985 patients of 53 primary care clinicians in four primary care practices. (more…)