Author Interviews, Cost of Health Care, Emergency Care, Heart Disease, JAMA / 16.11.2017

MedicalResearch.com Interview with: David L. Brown, MD, FACC Professor of Medicine Cardiovascular Division Washington University School of Medicine St. Louis, MO 63110 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Approximately 10 million patients present to emergency rooms in the US annually for evaluation of acute chest pain. The goal of that evaluation is to rule out the diagnosis of an acute heart attack. Imaging with coronary CT angiography and stress testing are not part of the diagnostic algorithm for acute heart attack.  Nevertheless many chest pain patients undergo some form of noninvasive cardiac testing in the ER. We found that CCTA or stress testing adding nothing to the care of chest pain patients beyond what is achieved by a history, physical examination, ECG and troponin test. (more…)
Author Interviews, Cognitive Issues, Compliance, HIV, JAMA / 16.11.2017

MedicalResearch.com Interview with: Ryan Sanford, MEng Department of Neurology and Neurosurgery Montreal Neurological Institute McGill University, Montréal, Québec, Canada   MedicalResearch.com: What is the background for this study? What are the main findings? Response: With the introduction of combination antiretroviral therapy (cART) the outlook for HIV+ individuals has dramatically shifted from a fatal disease to a chronic manageable condition. However, HIV-associated neurocognitive disorders are still prevalent. The etiology of this dysfunction remains unknown. Previous work has reported progressive brain atrophy in HIV+ individuals with advanced disease and poor viral suppression, but it is unclear whether stable treatment and effective viral suppression can mitigate the progression of brain atrophy. To examine this issue, we followed well-treated HIV+ individuals with good viral suppression and well-matched controls, and assessed whether ongoing brain atrophy occurs over time. The main finding in this study was the HIV+ participants had reduced brain volumes and poorer cognitive performance compared to the control group, but the changes in brain volumes and cognitive performance were similar between the groups. (more…)
Author Interviews, Genetic Research, Heart Disease, JAMA, Lipids / 15.11.2017

MedicalResearch.com Interview with: Hao Yu Chen, MSc Department of Medicine McGill University Montreal, Quebec, Canada Senior author: George Thanassoulis, MD, MSc MedicalResearch.com: What is the background for this study? Response: Aortic stenosis, a narrowing of the main valve of the heart, is the most common type of valve disease in the US. Present in more than 2.5 million individuals in North America, aortic stenosis can lead to heart failure and death. However, there is little known about the causes of aortic stenosis and how it should be treated. Previously, we have demonstrated that variants of the gene LPA are associated with the development of aortic stenosis. A better understanding of how this region contributes to aortic stenosis could identify higher-risk individuals and inform the development of new medical therapies for aortic stenosis.  (more…)
Author Interviews, Blood Pressure - Hypertension, Heart Disease, JAMA / 15.11.2017

MedicalResearch.com Interview with: Dr. Mattias Brunström Department of Public Health and Clinical Medicine Umeå University,Sweden MedicalResearch.com: What is the background for this study? What are the main findings? Response: Current guidelines recommend a systolic blood pressure treatment target below 140 mm Hg for most people. Since the publication of SPRINT however, many have suggested guidelines should be changed, recommending further blood pressure lowering. We performed a systematic review and meta-analysis of randomized clinical trials comparing different blood pressure targets or antihypertensive treatment verus placebo. We separated primary preventive trials from secondary preventive trials, and stratified primary preventive trials by mean baseline systolic blood pressure. The analyses included 74 trials, with in total > 300 000 participants. Interestingly, we found that treatment effect was dependent on baseline systolic blood pressure in people without previous CVD. While primary preventive treatment reduced the risk of death and cardiovascular disease if systolic blood pressure was 140 mm Hg or higher, treatment effect was neutral if systolic blood pressure was below 140 mm Hg. (more…)
Author Interviews, Biomarkers, Heart Disease, JAMA / 14.11.2017

MedicalResearch.com Interview with: Dr Andrew R. Chapman BHF Clinical Research Fellow University of Edinburgh Chancellors Building Edinburgh  MedicalResearch.com: What is the background for this study? What are the main findings? Response: High-sensitivity cardiac troponin tests allow accurate measurement of cardiac troponin in the bloodstream. Currently, guidelines recommend we evaluate patients with suspected myocardial infarction using these tests, by looking for levels which are above the upper reference limit (99th centile). These troponin measurements are taken on arrival, and often repeated after admission to hospital up to six hours later. When levels are below this limit, the diagnosis of myocardial infarction is ruled out. However, using such a high limit in patients on arrival to hospital may not be safe, as lower risk stratification thresholds has been shown to reduce missed events,  and in these patients admission to hospital for repeat testing may not be necessary. However, there is no consensus as to the optimal threshold for use in practice. In a worldwide study of 23,000 patients from 9 countries, we have shown when high-sensitivity cardiac troponin I concentrations are below a risk stratification threshold of 5 ng/L at presentation, patients are at extremely low risk of myocardial infarction or cardiac death at 30 days, with fewer than 1 in 200 patients missed. Importantly, this threshold identifies almost 50% of all patients as low risk after a single blood test. As admission or observation of these patients is estimated to cost as much as $11 billion per year in the United States, this strategy has major potential to improve the efficiency of our practice. (more…)
Asthma, Author Interviews, JAMA, Orthopedics, Pediatrics / 14.11.2017

MedicalResearch.com Interview with: “Asthma” by Michael Havens is licensed under CC BY 2.0Teresa To, PhD Biostatistics, Design and Analysis Scientific Director The Hospital for Sick Children Dalla Lana School of Public Health, University of Toronto Institute for Clinical Evaluative Sciences Toronto, Ontario, Canada MedicalResearch.com: What is the background for this study? What are the main findings? Response: We studied asthma prescription drug use in Ontario children aged 2 to 18 years with physician diagnosed asthma between 2003 and 2014. We found that:
  1. Currently in Ontario, nearly 50% of children with asthma did not fill a prescription for an inhaled corticosteroid during the study period, despite these medications being considered the gold-standard for asthma management.
  2. Our findings did not show clinically important association between inhaled corticosteroids and fracture among children with asthma.
  3. However, systemic corticosteroids (oral or injection) are associated with higher fracture risk in children with asthma (17% higher risk).
(more…)
Author Interviews, Cost of Health Care, Education, JAMA / 14.11.2017

MedicalResearch.com Interview with: Victoria Valencia, MPH Assistant Director for Healthcare Value Dell Medical SchoolThe University of Texas at Austin MedicalResearch.com: What is the background for this study? What are the main findings? Response: We were surprised to find that despite the common anecdote that resident physicians in teaching environments order more lab tests, there was a lack of empirical data to support the claim that more lab tests are ordered for patients at teaching hospitals than at non-teaching hospitals. Our study of 43,329 patients with pneumonia or cellulitis across 96 hospitals  in the state of Texas found that major teaching hospitals order significantly more lab tests than non-teaching hospitals.  We found this to be true no matter how we looked at the data, including when restricting to the least sick patients in our dataset. We also found that major teaching hospitals that ordered more labs for pneumonia tended to also more labs for cellulitis, indicating there is some effect from the environment of the teaching hospital that affects lab ordering overall. (more…)
Author Interviews, Brigham & Women's - Harvard, Heart Disease, JAMA / 13.11.2017

MedicalResearch.com Interview with: Ankur Gupta, MD, PhD Division of Cardiovascular Medicine Brigham and Women’s Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The Hospital Readmissions Reduction Program (HRRP), established under the Affordable Care Act, aimed to reduce readmissions from various medical conditions including heart failure - the leading cause of readmissions among Medicare beneficiaries. The program financially penalizes hospitals with high readmission rates. However, there have been concerns of unintended consequences especially on mortality due to this program. Using American Heart Association's Get With The Guidelines-Heart Failure (GWTG-HF) data linked to Medicare data, we found that the policy of reducing readmissions after heart failure hospitalizations was associated with reduction in 30-day and 1-year readmissions yet an increase in 30-day and 1-year mortality. (more…)
Author Interviews, JAMA, Lung Cancer, Medical Imaging, Surgical Research, Vanderbilt / 10.11.2017

MedicalResearch.com Interview with: Amelia W. Maiga, MD MPH Vanderbilt General Surgery Resident VA Quality Scholar, TVHS MedicalResearch.com: What is the background for this study? What are the main findings? Response: Positron emission tomography (PET) combined with fludeoxyglucose F18 (FDG) is currently recommended for the noninvasive diagnosis of lung nodules suspicious for lung cancer. Our investigation adds to growing evidence that FDG-PET scans should be interpreted with caution in the diagnosis of lung cancer. Misdiagnosis of lung lesions driven by FDG-PET avidity can lead to unnecessary tests and surgeries for patients, along with potentially additional complications and mortality. To estimate FDG-PET diagnostic accuracy, we conducted a multi-center retrospective cohort study. The seven cohorts originating from Tennessee, Arizona, Massachusetts and Virginia together comprised 1188 nodules, 81 percent of which were malignant. Smaller nodules were missed by FDG-PET imaging. Surprisingly, negative PET scans were also not reliable indicators of the absence of disease, especially in patients with smaller nodules or who are known to have a high probability of lung cancer prior to the FDG-PET test. Our study supports a previous meta-analyses that found FDG-PET to be less reliable in regions of the country where fungal lung diseases are endemic. The most common fungal lung diseases in the United States are histoplasmosis, coccidioidomycosis and blastomycosis. All three fungi reside in soils. Histoplasmosis and blastomycosis are common across much of the Mississippi, Ohio and Missouri river valleys and coccidioidomycosis is prevalent in the southwestern U.S. These infections generate inflamed nodules in the lungs (granulomas), which can be mistaken for cancerous lesions by imaging. (more…)
Abuse and Neglect, Author Interviews, Cancer Research, ENT, JAMA, Smoking, Social Issues / 10.11.2017

MedicalResearch.com Interview with: Nosayaba Osazuwa-Peters, BDS, MPH, CHES Instructor, Department of Otolaryngology-Head and Neck Surgery Saint Louis University School of Medicine Member, Saint Louis University Cancer Center St Louis, Missouri  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Several studies have shown that there is an adverse effect of smoking on head and neck cancer survival; however, there are studies that show no effect between smoking and head and neck cancer. We wanted to investigate this problem using a single institution’s cancer dataset. Additionally, we wanted to understand the role of marital status in the smoking behavior of head and neck cancer patients, and to understand if smoking played any role in head and neck cancer survival. Our study confirmed that head and neck cancer patients who were smokers at the time of diagnosis had lower survival rates than nonsmokers. We also found that married head and neck cancer patients were less likely to be smokers and more likely to survive longer than those unmarried. (more…)
Author Interviews, Diabetes, JAMA, Lifestyle & Health / 09.11.2017

MedicalResearch.com Interview with: Dr. Karla Galaviz PhD Hubert Department of Global Health Rollins School of Public Health Emory University Sonya Haw, MD| Assistant Professor Division of Endocrinology, Metabolism & Lipids Emory University, School of Medicine Grady Memorial Hospital Atlanta, GA MedicalResearch.com: What is the background for this study? What are the main findings?
  • Diabetes affects 1 in 11 adults worldwide and though there is evidence that lifestyle modification (eating healthier diets and exercising about 150 mins a week) and certain medications can prevent or delay diabetes onset, it is not clear which of these strategies offers long-term benefits.
  • To answer this question, we compiled all available randomized controlled trials of lifestyle programs and medications to prevent diabetes and analyzed the data to see if the diabetes prevention effects persisted in the long-term. We specifically compared studies where the lifestyle or drug interventions were discontinued to see if the effect was long lasting or diminished when the intervention was stopped.
(more…)
Author Interviews, Gastrointestinal Disease, JAMA, Lymphoma / 08.11.2017

MedicalResearch.com Interview with: ANSMRosemary Dray-Spira, MD, PhD Department of Epidemiology French National Agency for Medicines and Health Products Safety (ANSM) Saint-Denis, France MedicalResearch.com: What is the background for this study? What are the main findings? Response: Anti-tumor necrosis factor (anti-TNF) agents are increasingly used for the management of inflammatory bowel diseases (IBD), either alone or in combination with thiopurines. Their clinical benefits have been largely assessed, however they may expose to potentially serious adverse effects. While an increased risk of lymphoma has been established with thiopurines, up to now such a risk of lymphoma remained uncertain with anti-TNF agents. In this study based upon a large, nationwide cohort of 189,289 patients with IBD, the use of anti-TNF agents alone was found associated with a 2 to 3 fold increase in the risk of lymphoma, similarly to thiopurines alone. In addition, the combination of these two treatments was associated with a 6 fold increase in the risk of lymphoma, ie a higher risk than with each treatment used alone. Although these differences are statistically significant, the risk of lymphoma among patients exposed to anti-TNF agents is less than 1 case per 1000 person-years. (more…)
Author Interviews, Cannabis, JAMA / 08.11.2017

MedicalResearch.com Interview with: Marcel Bonn-Miller, PhD Adjunct assistant professor Department of Psychiatry Leader of the Substance Abuse and Anxiety Program U.S. Veterans Affairs Department  MedicalResearch.com: What is the background for this study? What are the main findings? Response: A 2015 study found that edible cannabis products (e.g., brownies, cookies, drinks) are often mislabeled.  The FDA has also sent warning letters to a handful of companies selling cannabidiol extracts because of inaccurate labeling of content. This led us to conduct a systematic evaluation of the label accuracy of all cannabidiol extracts sold online.  We tested 84 products from 31 different companies. The primary take-home of this study is that nearly 70 percent of all cannabidiol extracts sold online had over 10% more or less cannabidiol than advertised; 26% of products were over-labeled (less cannabidiol than indicated) and 42% of products were under-labeled (more cannabidiol than indicated). (more…)
Author Interviews, CDC, Dermatology, Environmental Risks, JAMA, Pediatrics / 08.11.2017

MedicalResearch.com Interview with: “Dymchurch Beach - May 2012 - Sunburn with Matching Bikini” by Gareth Williams is licensed under CC BY 2.0Dawn M. Holman, MPH Behavioral Scientist Division of Cancer Prevention and Control Centers for Disease Control and Prevention MedicalResearch.com: What is the background for this study? Response: Scientific evidence clearly shows that even one sunburn during adolescence can increase a person’s chances of developing skin cancer as an adult. Surprisingly, little research has been done to understand the factors associated with sunburn during this phase of life. The CDC wanted to examine beliefs, behaviors, and demographic characteristics that might be associated with adolescent sunburns in hopes that the findings could inform future intervention efforts. We used data from the 2015 YouthStyles survey (adolescents aged 12 to 17 years) to explore this research question (more…)
Accidents & Violence, Author Interviews, Exercise - Fitness, Frailty, Geriatrics, JAMA, Osteoporosis / 07.11.2017

MedicalResearch.com Interview with: Andrea C. Tricco PhD, MSc Scientist and Lead of the Knowledge Synthesis Team Associate Professor Dalla Lana School of Public Health, University of Toronto Associate Editor Journal of Clinical Epidemiology, BMC Medical Research Methodology, Systematic Reviews MedicalResearch.com: What is the background for this study? Response: Falls are the leading cause of injury among older adults and account for $2 billion in direct health-care costs annually ($31 billion in costs to Medicare in the United States in 2012). We aimed to determine which types of fall-prevention programs may be effective for reducing falls in older people. MedicalResearch.com: What are the main findings? Response: Exercise, along with vision assessment and treatment, as well as an assessment and possible modification of a person’s living environment, reduced the risk of injurious falls by 23% compared to usual care. (more…)
Author Interviews, Heart Disease, JAMA, Mental Health Research / 07.11.2017

MedicalResearch.com Interview with: Dr. Keun-Hwa Jung MD PhD Program in Neuroscience, Neuroscience Research Institute of SNUMRC College of Medicine Seoul National University First author: Dr. Woo-Jin Lee MD Department of Neurology Seoul National University Hospital Seoul, South Korea  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Cerebral white matter hyperintensity is a prevalent consequence of brain aging process and associated with various complications. One of the main mechanisms underlying the progression of white matter hyperintensity is chronic dysfunction of the glymphatic system which maintains metabolic homeostasis in brain. Glymphatic system is the route where the cerebrospinal fluid enters into the brain parenchyma and is cleared out with soluble wastes to the perivascular space of the cerebral small veins, peri-meningeal lymphatic vessels, deep cervical lymph nodes, and finally to the right atrium. Although the integrity of the glymphatic system is dependent on the adequate drainage of cerebral veins and lymphatics to the downstream chamber, the right atrium, the impact of hemodynamic changes in right-sided cardiac chambers on the development of white matter hyperintensity have not been elucidated. (more…)
Author Interviews, JAMA, Smoking, Tobacco Research / 07.11.2017

MedicalResearch.com Interview with: “Stop smoking!” by Emil_95 is licensed under CC BY 2.0Dr. Man Ping Wang, PhD School of Nursing University of Hong Kong Hong Kong MedicalResearch.com: What is the background for this study? What are the main findings? Response: Smoking cessation (SC) services can effectively increase the chance of abstinence, but few smokers proactively seek help from these services worldwide. Smoking cessation guidelines recommend referring smokers to SC services, but such referrals were usually conducted in a passive way (e.g. providing contacts of these services and asking smokers to use them). Actively referring smokers may increase use of smoking cessation services and abstinence rates. Previous studies were mostly conducted in clinical settings. We investigated the efficacy of using trained volunteers to actively refer smokers recruited in the community to smoking cessation services in this cluster randomized control trial. We found that smokers who received a brief cessation advice and active referral had significantly higher abstinence rate and smoking cessation service use rate at 6-month follow-up, compared with smokers who received a minimal advice and a self-help booklet. (more…)
Author Interviews, JAMA, Pediatrics / 06.11.2017

MedicalResearch.com Interview with: Sally H. Adams, PhD, RN Specialist, Division of Adolescent and Young Adult  Medicine Adolescent and Young Adult Health National Resource Center University of California, San Francisco Benioff Children’s Hospital San Francisco, CA 94118 MedicalResearch.com: What is the background for this study? Response: Major causes of adolescent illness and mortality are preventable. To address this, in the 1990s, professional medical organizations developed healthcare provider guidelines for the delivery of adolescent preventive healthcare. These include the receipt of anticipatory guidance and risk screening services in the effort to promote healthy behaviors and avoid risky behaviors that are intended to be covered within a preventive care visit, but could be addressed in other healthcare visits. The adolescent developmental period is an important time for adolescents to be engaged with the healthcare system. Transitioning from childhood to adulthood, adolescents are becoming increasingly independent - having more responsibility and freedom for decision making in many areas, including healthy choices in behaviors and activities. While families and community settings (schools, churches) play strong roles in this process, the healthcare system also plays an important role. (more…)
Author Interviews, Cancer Research, JAMA / 06.11.2017

MedicalResearch.com Interview with: Gry Haaland, MD James Lorens PhD, Professor The Department of Biomedicine University of Bergen  MedicalResearch.com: What is the background for this study? Response: Antitumor activity of the common blood thinner warfarin has been reported in several experimental cancer model systems. We therefore considered whether warfarin is cancer protective. Using the comprehensive national health registries in Norway, we examined cancer incidence among a large number of people taking warfarin (92,942) and compared to those not taking warfarin (more than 1.1 million). (more…)
Author Interviews, Dermatology, JAMA / 01.11.2017

MedicalResearch.com Interview with: Eliot N. Mostow, MD, MPH Professor & Chair, Dermatology Section Department of Internal Mediciine Northeast Ohio Medical University  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The background for the study is my continued interest in what is sometimes called health services research. That is, how do we improve our ability to deliver optimal medical care from a healthcare system perspective? Simply put, one of the most frequent criticisms about getting a dermatologist to see if patient is that there are delays in scheduling (wait times are too high). I’m not sure this is really justified, as it seems to take a long time to get into psychiatrists, gynecologists, and other specialists in our community as well. That being said, since I’m in the dermatology community and our community has been utilizing physician assistants and nurse practitioners more frequently for many years now, we thought it was worthwhile to explore whether this was having an impact on wait times to get a visit in a dermatologist’s office. (more…)
Author Interviews, Brigham & Women's - Harvard, Environmental Risks, JAMA, OBGYNE / 01.11.2017

MedicalResearch.com Interview with: Yu-Han Chiu, M.D., M.P.H., Sc.D Department of Nutrition Harvard T.H. Chan School of Public Health MedicalResearch.com: What is the background for this study? What are the main findings? Response: Animal experiments suggest that ingestion of pesticide mixtures at environmentally relevant concentrations decreases the number of live-born pups. However, it is unclear whether intake of pesticide residues has any adverse effects in humans, especially for susceptible populations such as pregnant women and their fetuses. Therefore, in this study we examined the association of preconception intake of pesticide residues in fruits and vegetables with pregnancy outcomes among 325 women undergoing assisted reproduction. A pesticide is far cheaper than pest control services, like termite control los angeles, so it makes sense why most farmers choose to use pesticide for their farmhouse and crops. However, this isn't necessarily the best procedure for human health, or consumption! We found that intake of high pesticide residue fruits and vegetables were associated with higher risks of pregnancy loss, while low pesticide residue fruit and vegetable intake was associated with lower risks of early pregnancy loss. These data suggest dietary pesticide exposure within the range of typical human exposure may be associated with adverse reproductive consequences (more…)
Author Interviews, JAMA, Menopause, Ophthalmology, UCLA / 31.10.2017

MedicalResearch.com Interview with: Anne L. Coleman, MD, PhD Center for Community Outreach and Policy, Stein Eye Institute David Geffen School of Medicine Director, UCLA Mobile Eye Clinic Department of Epidemiology, Fielding School of Public Health UCLA MedicalResearch.com: What is the background for this study? Response: Cataracts are a leading cause of vision loss worldwide, and cataract surgery is an intervention that is known to be extremely effective to address the vision loss related to cataract. However, it is unclear if there are benefits of cataract surgery beyond vision improvement in people with cataracts. Previous studies have suggested that in addition to improving vision, cataract surgery may decrease the risk of fractures and accidents, improve mental health, and improve overall quality of life. The purpose of the present study was to further investigate the potential benefits of cataract surgery and to determine if cataract surgery was associated with increased survival in people with cataracts. (more…)
Author Interviews, Heart Disease, JAMA, Pulmonary Disease, Vanderbilt / 27.10.2017

MedicalResearch.com Interview with: Dr. Evan L. Brittain, MD Assistant Professor of Medicine Vanderbilt University School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: The purpose of this study was to determine whether pulmonary pressure values below the diagnostic threshold for pulmonary hypertension (25mmHg) are associated with an increased risk of mortality. We studied over 4,000 consecutive individuals referred for right heart catheterization, the “gold-standard” procedure for measuring pulmonary pressure. We found that borderline levels of mean pulmonary pressure (19-24mmHg) were common, representing 18% of all patients referred for this procedure. Borderline mean pulmonary pressure values were also associated with 31% increase in mortality after accounting for many other clinical factors. Finally, we found that most of the patients with borderline pulmonary hypertension who underwent repeat catheterization often progressed to overt pulmonary hypertension. This study suggests that patients with borderline pulmonary hypertension should be considered an at-risk group. (more…)
Author Interviews, Heart Disease, JAMA / 27.10.2017

MedicalResearch.com Interview with: Elad Asher, M.D, M.H.A Interventional Cardiologist, Director Intensive Cardiac Care Unit Deputy Director Heart Institute Assuta Ashdod Medical Center MedicalResearch.com: What is the background for this study? Response: Dual antiplatelet therapy represents the standard care for treating ST elevation myocardial infarction (STEMI) patients. Given the higher risk of peri-procedural thrombotic events in patients undergoing primary percutaneous coronary intervention (PPCI), there is a need to achieve inhibition of platelet aggregation (IPA) more promptly. Although chewing ticagrelor has been shown to be more efficient for IPA in stable coronary disease and in patients with acute coronary syndrome (ACS)/non-ST elevation myocardial infarction (NSETMI), there are no studies that have specifically assessed the efficacy and safety of chewing ticagrelor in STEMI patients. Therefore, the aim of our study was to investigate whether chewing ticagrelor (180mg) loading dose is associated with more favorable platelet inhibitory effects compared with the conventional way of swallowing whole tablets loading dose in STEMI patients undergoing PPCI. (more…)
Author Interviews, Heart Disease, JAMA / 25.10.2017

MedicalResearch.com Interview with: Hawkins C. Gay, MD, MPH Resident Physician, Internal Medicine Feinberg School of Medicine Northwestern University MedicalResearch.com: What is the background for this study? What are the main findings? Response: The National Academy of Medicine and other leading institutions have highlighted clinical trial data sharing as an important initiative for enhancing trust in the clinical research enterprise. More recently, the International Committee of Medical Journal Editors stipulated that manuscripts published in their journals must clearly state plans for data sharing in the trial’s registration, and the National Institutes of Health now requires a data sharing plan as part of new grant applications. Many clinical trialists rightly debate the costs and time required to curate their data into a format that is usable by third part data analysts. Similarly, there has been debate about the most efficient platforms from which to distribute this data, and different models exist, including governmental (NIH BioLINCC), commercial (ClinicalStudyDataRequest.com), and academic (Yale Open Access Data Project [YODA]) platforms. Our study sought to explore these questions by conducting a reproduction analysis of the Thermocool Smarttouch Catheter for Treatment of Symptomatic Paroxysmal Atrial Fibrillation (SMART-AF) trial (NCT01385202), which is the only cardiovascular clinical trial available through the YODA platform. Reproduction analyses represent a fundamental approach for and outcome from data sharing but are uncommonly performed even though results change more than one-quarter of the time in reproduction analyses. SMART-AF was a multicenter, single-arm trial evaluating the effectiveness and safety of an irrigated, contact force-sensing catheter for ablation of drug refractory, symptomatic paroxysmal atrial fibrillation in 172 participants recruited from 21 sites between June 2011 and December 2011. The time from our initial proposal submission to YODA and the final analysis completion was 11 months. Freedom from atrial arrhythmias at 12 months post-procedure was similar compared with the primary study report (74.0%; 95% CI, 66.0-82.0 vs 76.4%; 95% CI, 68.7-84.1). The reproduction analysis success rate was higher than the primary study report (65.8%; 95% CI 56.5-74.2 vs 75.6%; 95% CI, 67.2-82.5). Adverse events were minimal and similar between the two analyses. We could not reproduce all analyses that were conducted in the primary study report; specifically, the analyses relating to contact force range and regression models. The primary reason for non-reproducibility was missing or un-locatable data in the analyzable dataset. (more…)
Author Interviews, JAMA, Kidney Disease, Surgical Research / 25.10.2017

MedicalResearch.com Interview with: In Gab Jeong, MD Associate Professor Department of Urology, Asan Medical Center University of Ulsan College of Medicine Seoul, Korea MedicalResearch.com: What is the background for this study? What are the main findings? Response: Use of robotic surgery has increased in urological practice over the last decade especially for the surgery that was difficult to perform with laparoscopic techniques such as radical prostatectomy for prostate cancer or partial resection of kidney cancer. However, the use, outcomes, and costs of robotic nephrectomy are unknown. We examined the trend in use of robotic-assisted operations for radical nephrectomy in the United States and compared the perioperative outcomes and costs with laparoscopic radical nephrectomy. The proportion of radical nephrectomies using robotic-assisted operations increased from 1.5% in 2003 to 27.0% in 2015. Although there was no significant difference between robotic-assisted vs laparoscopic radical nephrectomy in major postoperative complications, robotic-assisted procedures were associated with longer operating time and higher direct hospital costs. The rate of prolonged operating time (>4 hours) for patients undergoing the robotic-assisted procedure was higher than for patients receiving the laparoscopic procedure (46.3% vs 25.8%; risk difference, 20.5%; 95% CI, 14.2% to 26.8%). Robotic-assisted radical nephrectomy was associated with higher mean 90-day direct hospital costs ($19530 vs $16851; difference, $2678; 95% CI, $838 to $4519). (more…)
Accidents & Violence, Author Interviews, JAMA / 20.10.2017

MedicalResearch.com Interview with: Michael Siegel, MD, MPH Professor, Department of Community Health Sciences Boston University School of Public Health Boston, MA 02118 MedicalResearch.com: What is the background for this study? Response: A central question in the debate about public policies to reduce firearm violence is whether easier access to concealed handguns increases or decreases the rate of firearm-related homicides. Previous studies on the impact of concealed carry permitting laws have yielded inconsistent results. Most of these studies were conducted more than a decade ago. This study provided a reexamination of this research question with more recent data, up to and including the year 2015. While all states allow certain persons to carry concealed handguns, there are 3 major variations in permitting policy. In 9 states, law enforcement officials have wide discretion over whether to issue concealed carry permits; these are referred to as “may issue” states because police chiefs can deny a permit if they deem the applicant to be at risk of committing violence, even if there is not a criminal history. In 29 states, there is little or no discretion; these are referred to as “shall-issue” states because permits must be issued if requisite criteria are met. In an additional 12 states, no permit is necessary to carry a concealed handgun. (more…)
Author Interviews, Cancer Research, Cost of Health Care, JAMA / 20.10.2017

MedicalResearch.com Interview with: Aparna Soni, MA Department of Business Economics and Public Policy Kelley School of Business Indiana University, Bloomington MedicalResearch.com: What is the background for this study? What are the main findings? Response: Cancer is the leading cause of death among the non-elderly population in the United States. Unfortunately, uninsured people are less likely to get screened for cancer, and treatment is often unaffordable for those who are uninsured. One of the key objectives of the Affordable Care Act (ACA) was to improve outcomes for cancer patients. Our objective in this study was therefore to assess changes under the ACA in insurance coverage among patients newly diagnosed with cancer. Our main finding is that uninsurance among patients with newly diagnosed cancer fell by one-third in 2014. (more…)
Author Interviews, C. difficile, Critical Care - Intensive Care - ICUs, Infections, JAMA, Outcomes & Safety / 18.10.2017

MedicalResearch.com Interview with: Dr. Robert Hiensch MD Assistant Professor, Medicine, Pulmonary, Critical Care and Sleep Medicine Icahn School of Medicine at Mount Sinai. MedicalResearch.com: What is the background for this study? What are the main findings? Response: New sepsis guidelines that recommend screening and early treatment for sepsis cases appear to have significant positive impacts on patient outcomes. Less research has been published on what potential side effects may result from these guidelines. Antibiotics are a cornerstone of sepsis treatment and early antibiotic administration is strongly recommended.  We examined whether the introduction of an electronic based sepsis initiative changed antibiotic prescribing patterns at our hospital. Antibiotics, even when appropriate, contribute to hospital onset Clostridium difficile infections (HO CDIs).  While the authors do not dispute the importance of antibiotic administration in sepsis, it is valuable to know whether the sepsis initiative coincided with both increased antibiotic administration and HO CDIs. (more…)
Author Interviews, Diabetes, JAMA, Pediatrics / 18.10.2017

MedicalResearch.com Interview with: Prof. Dr. med. Reinhard Holl Division of Endocrinology and Diabetes, Medical Faculty Aachen University, Aachen, Institute of Epidemiology and Medical Biometry University of Ulm, Ulm Germany  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Today there are two accepted strategies to treat type-1 diabetes: pump or multiple daily injections. In a large group of patients we compared both strategies, and our results indicate advantages for pump therapy with fewer severe hypos, fewer events of diabetic ketoacidosis, and better metabolic control. (more…)