Author Interviews, JAMA, Johns Hopkins, Surgical Research / 15.03.2016

MedicalResearch.com Interview with: Shaun C. Desai, MD Assistant Professor Facial Plastic and Reconstructive Surgery Department of Otolaryngology - Head & Neck Surgery Johns Hopkins University School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Desai: Estimates of the rate of revision septorhinoplasty and the risk factors associated with revision are unknown because the current published literature is limited to small, retrospective, single-surgeon studies with limited follow-up time. The purpose of this study is to determine the overall revision rates of patients undergoing a septorhinoplasty procedure (for functional or cosmetic reasons) and to determine risk factors for the revision. We found that the overall revision rate was 3.3% (5,775 patients of a total of 175,842 patients undergoing the procedure) with an average time to revision at 1 year. Risk factors for revision surgery included female gender, younger age, a history of anxiety or autoimmune disease, cosmetic indications, and more complicated initial surgery (i.e. cleft rhinoplasty). (more…)
Author Interviews, Hand Washing, Hospital Acquired, JAMA, University of Michigan / 15.03.2016

MedicalResearch.com Interview with: Lona Mody, MD, MS Veterans Affairs Healthcare System, Geriatric Research, Education, and Clinical Center Division of Geriatric and Palliative Medicine, University of Michigan Medical School, School of Public Health University of Michigan, Ann Arbor MedicalResearch.com: What is the background for this study? Dr. Mody: Hand hygiene is considered to be the most important strategy to prevent infections and spread of drug resistant organisms. Surprisingly, all strategies and efforts have predominantly involved healthcare workers and that too mainly in acute care hospitals.  We are now facing a tsunami of an aging population in our hospitals, post-acute care facilities and long-term care facilities.  Hand hygiene falls off when patients are hospitalized compared to when they are at home.  So, we were very interested, first, in hand colonization in older patients who have recently been transferred from the acute care hospital to a post-acute care (PAC) facility for rehabilitation or other medical care before fully returning home. We were also interested in evaluating whether these organisms persisted. MedicalResearch.com: What are the main findings? Dr. Mody: We recruited and followed 357 patients (54.9 percent female with an average age of 76 years). The dominant hands of patients were swabbed at baseline when they were first enrolled in a post-acute care facility, at day 14 and then monthly for up to 180 days or until discharge. The study found:
  • To our surprise, nearly one-quarter (86 of 357) of patients had at least one multi-drug resistant organism on their hands when they were transferred from the hospital to the post-acute care facility
  • During follow-up, 34.2 percent of patients’ hands (122 of 357) were colonized with a resistant organism and 10.1 percent of patients (36 of 357) newly acquired one or more resistant organisms.
  • Overall, 67.2 percent of colonized patients (82 of 122) remained colonized at discharge from PAC.
(more…)
Author Interviews, Blood Pressure - Hypertension, Heart Disease, JAMA, OBGYNE / 14.03.2016

MedicalResearch.com Interview with: Ida Behrens, MD and Heather Boyd PhD Department of Epidemiology Research Statens Serum Institut Copenhagen, Denmark MedicalResearch.com: What is the background for this study? Response: Over the past decade, we have begun to realize that a woman’s pregnancy experiences can be a predictor of her future health. Miscarriages, stillbirths and preterm deliveries have all been linked with an increased risk of later cardiovascular disease, as have hypertensive disorders of pregnancy (preeclampsia and gestational hypertension). Women with preeclampsia also have an increased risk of peripartum cardiomyopathy, a rare but serious condition that severely compromises heart function at the end of pregnancy or shortly after delivery. We were interested to find out whether women with preeclampsia or gestational hypertension during one or more pregnancies also had an increased risk of cardiomyopathy later in life. MedicalResearch.com: What are the main findings? Response: Using Danish national registers, we followed more than 1 million women with pregnancies between 1978 and 2011 – with an average follow-up of almost 18 years per woman – to see whether women with hypertensive disorders of pregnancy had increased rates of cardiomyopathy later in life, compared with women who only had normotensive pregnancies. We found that the women with hypertensive disorders of pregnancy had a two-fold increased risk of cardiomyopathy later in life. Interestingly, only half of this increase in risk could be linked to chronic hypertension, which is common among women who have previously had a hypertensive disorder of pregnancy. The remaining 50% was not associated with hypertension and could potentially be directly attributable to the woman’s pregnancy experience (or to an underlying cause common to both hypertensive disorders of pregnancy and cardiomyopathy).  (more…)
Author Interviews, JAMA, Ophthalmology / 14.03.2016

MedicalResearch.com Interview with: Fanny Raguideau Evaluateur en pharmaco-épidémiologie Direction Scientifique et de la Stratégie Européenne Pôle Epidémiologie des produits de santé  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Retinal detachment (RD), including both exudative types often associated with systemic diseases that might be receiving antibiotics for related conditions as well as rhegmatogenous which require prompt surgical intervention to reduce the chance of irreversible severe vision loss, has an annual incidence rate of 1 per 10,000 in the general population. Rhegmatogenous is the most common type. Fluoroquinolones are one of the most commonly prescribed classes of antibiotics. Thanks to their broad-spectrum antibacterial coverage, they are effective in the treatment of a wide variety of community-acquired infections. MedicalResearch.com: What is the background for this study? What are the main findings? Response: Several studies have suggested that oral fluoroquinolone use increased the risk of Retinal detachment, however this association remains controversial. We conducted a nationwide self-matched design study to overcome limitations of previous studies. Our finding of a significant increased risk of  Retinal detachment, including both rhegmatogenous and exudative types, following use of oral fluoroquinolone strongly supports the existence of this association. (more…)
Author Interviews, Hospital Readmissions, JAMA, Orthopedics, Surgical Research / 11.03.2016

MedicalResearch.com Interview with: Ronald S. Chamberlain, MD, MPA, FACS Chairman and Surgeon-in-Chief Department of Surgery Saint Barnabas Medical Center Professor of Surgery New Jersey Medical School Rutgers University MedicalResearch.com: What is the background for this study? Dr. Chamberlain:  With the rapidly growing arthritic, aging, and obese population, total hip replacement (THR) has become the most commonly performed orthopedic procedure in the United States (US).  The Affordable Care Act signed by President Barack Obama imposed financial penalties for excess readmissions following certain procedures and diagnoses. While the initial program aimed to reduce readmissions for heart failure, pneumonia, and acute myocardial infarction (AMI), the program expanded to include THR in 2015. With current research estimating a 10%, 30-day readmission rate following a total or partial hip replacement, this study sought to identify factors associated with readmission and to create a scale which could reliably stratify preoperative readmission risk. (more…)
Author Interviews, Cancer Research, JAMA / 11.03.2016

MedicalResearch.com Interview with: Joseph Unger, PhD, MS SWOG Statistical Center Assistant Member, Public Health Sciences Division, Fred Hutchinson Cancer Research Center Affiliate Assistant Professor, Health Services Research, University of Washington Seattle, WA  98109-1024 MedicalResearch.com: What is the background for this study? Dr. Unger: The rate at which trials are positive has previously been examined, and the relationship between trial results and publication rates in the context of publication bias has also been studied. But the comparative scientific impact of positive vs negative clinical trials using citation data has not been investigated We used the phase III trial database of SWOG, a major national cooperative clinical trials group, in combination with its trial publication database and citation data from Google Scholar, to compare the scientific impact of positive vs negative phase III cancer clinical treatment trials. (more…)
Author Interviews, Diabetes, JAMA, Multiple Sclerosis / 10.03.2016

MedicalResearch.com Interview with: Jorge Correale MD Department of Neurology, Institute for Neurological Research Dr Raúl Carrea Buenos Aires, Argentina MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Correale: First it is now well known that in parallel to the specific treatment of Multiple Sclerosis, those comorbidities that worsen the course of the disease should be treated. For example, cardiovascular diseases. Moreover there are in vitro and in animal models evidence of an anti-inflammatory role of compounds investigated in this publication evidence. (more…)
Author Interviews, JAMA, Rheumatology, Vitamin D / 10.03.2016

MedicalResearch.com Interview with: Changhai Ding, MBBS, MMED, MD Australian Research Council Future Fellow Associate Director (International), Menzies Institute for Medical Research Professor,  University of Tasmania, Australia Honorary Professor, University of Sydney, Australia MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Ding: Vitamin D can reduce bone turnover and cartilage degradation, thus potentially preventing the development and progression of knee osteoarthritis. Observational studies suggest that vitamin D supplementation is associated with benefits for knee osteoarthritis, but current evidence from clinical trials is contradictory. We  conducted a randomised clinical trial in Hobart, Tasmania and Melbourne, Victoria in Australia. We randomly assigned 413 patients with symptomatic knee osteoarthritis and low 25-hydroxyvitamin D to receive monthly treatment with oral vitamin D3 (50,000 IU; n = 209) or an identical placebo (n = 204) for 2 years. Of 413 enrolled participants (average age, 63 years; 50 percent women), 340 (82 percent) completed the study. Vitamin D supplementation significantly increased blood 25-hydroxyvitamin D levels over 2 years compared with placebo treatment; however, vitamin D supplementation, compared with placebo, did not result in significant differences in change in MRI-measured tibial cartilage volume or a measure of knee pain over 2 years. There were also no significant differences in change of tibiofemoral cartilage defects or change in tibiofemoral bone marrow lesions. Post-hoc analyses indicated that vitamin D supplementation might improve knee physical function and reduce another measure of knee pain and increases in bone marrow lesion. (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Vitamin D / 08.03.2016

MedicalResearch.com Interview with: Kassandra Munger, Sc.D. Harvard T.H. Chan School of Public Health MedicalResearch.com: What is the background for this study? Dr. Munger: Previous work has shown that adequate vitamin D nutrition is associated with a lower risk of multiple sclerosis (MS).  Results from studies examining whether adequate vitamin D exposure during early-life are also associated with a lower risk of MS have been mixed.  One study reported that daughters of mothers with high dietary vitamin D intake during their pregnancy had a reduced risk of multiple sclerosis, while two studies measuring 25-hydroxy vitamin D either in a blood sample from the pregnant mother or from a sample taken from the neonate, were not associated with future multiple sclerosis risk in the child. (more…)
Accidents & Violence, Author Interviews, JAMA, Pediatrics / 08.03.2016

MedicalResearch.com Interview with: Alison Culyba, MD MPH Adolescent Medicine Advanced Research Fellow Craig-Dalsimer Division of Adolescent Medicine Children’s Hospital of Philadelphia PhD Candidate, Epidemiology Department of Epidemiology and Biostatistics Perelman School of Medicine at the University of Pennsylvania  MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Culyba: Youth violence is a major public health problem. Homicide is the second leading cause of death among all adolescents in the U.S., and the number one cause of death among African American adolescents. Prom prior research, we know that where you live and where you spend time has a major impact on health, and that making changes to environments, such as greening vacant lots and remediating abandoned buildings, can significantly reduce crime. However, much less is known about the relationship between adolescent’s immediate surroundings and the risk of homicide. The goal of this study was to examine associations between neighborhood environmental features, such as streets, buildings, and natural surroundings and adolescent homicide. We conducted a population-based case control study of 143 adolescents, ages 13 to 20, who were victims of homicides in Philadelphia and 155 matched controls in the same range, who were outdoors in Philadelphia at the same time that the homicides occurred. To assess features in the immediate environments of homicide victims and control individuals, trained field staff stood on the street corner of each homicide and control location and took a series of photographs that we stitched together into 360-degree high resolution panoramas, which we assessed for environmental features. After accounting for many individual and neighborhood contextual factors, we found that the odds of homicide was significantly lower in locations with street lighting, pedestrian infrastructure, public transportation, parks, and maintained vacant lots. (more…)
Author Interviews, JAMA / 07.03.2016

MedicalResearch.com Interview with: Dr. Agnes Dechartres MD, PhD Centre de Recherche Epidémiologie et Statistique Paris, France MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Dechartres: In general, the availability of trial results is not optimal, with about half of the results from clinical trials, especially those with negative results, not being published in journals. To improve the availability of results, the FDA Amendment Act (FDAAA) requires results to be posted at ClinicalTrials.gov for all trials evaluating FDA-approved drugs, devices, or biologics within one year of trial completion. However, some previous methodological studies showed poor compliance with this law1-3. Rare diseases are defined by a prevalence of fewer than 200,000 people, but overall, they may affect up to 25 million people in North America. The limited number of patients affected by each rare disease makes this research particularly challenging, and the access to information on all trials conducted and their results is even more necessary. In this study, we aimed to describe the characteristics of completed phase 3 or 4 trials of rare diseases registered at ClinicalTrials.gov and assess whether their results were publicly available. We found a substantial proportion of single-group trials and trials not randomized. Many trials were also conducted in a single-center. Concerning the availability of results, 36 months after trial completion, results were posted at ClinicalTrials.gov for 35% of trials, published in journals for 47%, and publicly available (ie, posted at ClinicalTrials.gov or published in journals) for 63%. Among the trials likely subject to the FDAAA, 68% had results posted at ClinicalTrials.gov: 4% had results posted at 12 months and 57% at 36 months. We also found that 21% of studies not concerned by the FDAAA had results posted. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, Hand Washing, Health Care Systems, JAMA, UCSF / 07.03.2016

MedicalResearch.com Interview with: Dr. Andrew Auerbach MD Professor of Medicine in Residence Director of Research Division of Hospital Medicine UCSF and Jeffrey L. Schnipper, MD, MPH Associate Physician, Brigham and Women's Hospital Associate Professor of Medicine, Harvard Medical School Department of Medicine Brigham and Women's Hospital     MedicalResearch.com: What is the background for this study? Response: The Affordable Care Act required the Department of Health and Human Services to establish a program to reduce what has been dubbed a “revolving door of re-hospitalizations.” Effective October 2012, 1 percent of every Medicare payment was deducted for a hospital that was determined to have excessive readmissions. This percentage has subsequently increased to up to 3 percent. Penalties apply to readmitted Medicare patients with some heart conditions, pneumonia, chronic lung disease, and hip and knee replacements. Unfortunately, few data exist to guide us in determining how many readmissions are preventable, and in those cases how they might have been prevented. MedicalResearch.com: What are the main findings? Response: Our main findings were that 27 percent of readmissions were preventable, and that the most common contributors to readmission were being discharged too soon, poor coordination between inpatient and outpatient care providers, particularly in the Emergency Departments and in arranging post acute care. (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Stroke / 04.03.2016

MedicalResearch.com Interview with: Hakan Ay MD, FAHA Associate Professor of Neurology and Radiology Stroke Service, Department of Neurology Director of Stroke Research, A.A. Martinos Center, Department of Radiology Massachusetts General Hospital Harvard Medical School Boston MA, USA Medical Research: What is the background for this study? What are the main findings? Dr. Ay: Recurrent stroke is an important public health problem. One quarter of all strokes are recurrent strokes. Approximately one out of every 10 patients with stroke develops a second stroke within the next 2 years. The most critical period for recurrence after stroke is the first 90 days; approximately half of recurrent strokes that occur within 2 years occur within the first 90 days. The RRE tool was developed at the Massachusetts General Hospital in 2010 to assess the 90-day risk of recurrent stroke. The RRE was subsequently tested in a separate cohort of patients with transient stroke symptoms (mini strokes) admitted to the Massachusetts General Hospital in 2011. The current study expands upon prior two studies by showing that the RRE tool provides reliable risk estimates when tested in cohorts of patients recruited from different academic centers in various parts of the world. The study reports that the RRE can stratify approximately one-half of patients with stroke either at high-risk or at low-risk with a reasonable accuracy. (more…)
Author Interviews, Global Health, Heart Disease, Infections, JAMA / 04.03.2016

MedicalResearch.com Interview with: Thomas Pilgrim, Prof. Dr. med. Oberarzt, Invasive Kardiologie Universitätsspital Bern Bern Switzerland MedicalResearch.com: What is the background for this study? Dr. Pilgrim: Three quarters of all children worldwide grow up in regions endemic for rheumatic heart disease. Clinically manifest rheumatic heart disease represents only the tip of the iceberg: only one in in 5 to 8 children with valvular lesions consistent with rheumatic heart disease have a heart murmur or clinical symptoms; the remaining children have clinically silent disease that goes undetected unless echocardiography is performed. An understanding of incidence, prevalence, and progression of disease is an important prerequisite to guide active surveillance and secondary prevention. We therefore performed a school-based cross-sectional study among more than 5000 children from 26 schools in Nepal. The objective of the study was to assess prevalence of clinically silent and manifest rheumatic heart disease as a function of age, gender and socioeconomic status and to estimate the age-specific incidence from available prevalence data. MedicalResearch.com: What are the main findings? Dr. Pilgrim: In our population-based observational cross-sectional study, the prevalence of borderline or definite rheumatic heart disease among schoolchildren in Eastern Nepal amounted to 10.2 (95% CI 7.5-13.0) per 1000 children between the ages of 5 and 15 years, and was more common in girls as compared to boys. The prevalence increased across age categories in a nearly linear fashion from 5.5 (95% CI 3.5-7.5) per 1000 in children 5 years of age to 16.0 (95% CI 14.9-17.0) in children 15 years of age, while the average incidence remained stable at 1.1 per 1000 children per year. The prevalence of clinically silent rheumatic heart disease was 5 times higher compared to manifest disease and the ratio of manifest to subclinical disease increased with increasing age. (more…)
Author Interviews, Depression, JAMA, Johns Hopkins / 04.03.2016

MedicalResearch.com Interview with: Katherine L. Musliner, PhD National Centre for Register-Based Research, Department of Economics and Business Economics, Aarhus University, Aarhus, Denmark The Lundbeck Foundation Initiative for Integrative Psychiatric Research Department of Mental Health The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland   MedicalResearch.com: What is the background for this study? What are the main findings? Response: There is great variation among patients with depression in terms of long-term illness course. This variation may be indicative of underlying differences in the cause of the illness, and from a practical perspective, it also has implications for treatment and allocation of public health resources. Our goal was to identify different trajectories of depression course by examining inpatient and outpatient contacts for depression at psychiatric treatment facilities in Denmark (where healthcare is free) during the 10-year period following patients’ initial depression diagnosis. We found that the majority of patients (77% in our sample) followed a trajectory characterized by a brief period of contact with the psychiatric treatment system and no contact for depression during the remainder of the 10-year follow up period. Patients with more prolonged contact either had a drawn out initial period of contact lasting as long as five years (13%), left depression treatment for several years only to return with a depression diagnosis years later (7%) or exhibited a chronic course (3%). (more…)
Author Interviews, Geriatrics, JAMA, Ophthalmology, Primary Care / 03.03.2016

MedicalResearch.com Interview with: Dr. Albert Siu M.D., M.S.P.H. Chair of the U.S. Preventive Services Task Force Chairman and professor of the Brookdale Department of Geriatrics and Palliative Medicine Icahn School of Medicine at Mount Sinai Director of the Geriatric Research, Education, and Clinical Center James J. Peters Veterans Affairs Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Siu: Impaired vision is a serious and common problem facing older adults and can affect their independence, ability to function, and quality of life. When the Task Force reviewed the research around screening older adults for vision impairment in a primary care setting, we concluded that the current evidence is insufficient to assess the balance of benefits and harms. As a result, we issued an I statement, which is consistent with the 2009 final and 2015 draft recommendations. MedicalResearch.com: What should clinicians and patients take away from your report? Dr. Siu: Older adults who are having problems seeing should talk to their primary care doctor or an eye specialist. Primary care doctors can explore the various causes of vision problems and do an eye exam to check for refractive error. An eye specialist can do a full eye exam to look for and treat refractive errors and other eye conditions that affect vision, such as cataracts and age-related macular degeneration (AMD). With regards to clinicians, in the absence of clear evidence, they should use their clinical judgment when deciding whether to screen patients who have not reported any concerns about their vision. (more…)
Author Interviews, Diabetes, JAMA, Pharmacology / 01.03.2016

MedicalResearch.com Interview with: Dr. John Buse MD Ph.D Professor, Medicine Director, Diabetes Care Center Chief, Division of Endocrinology Executive Associate Dean, Clinical Research University of North Carolina School of Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Buse: Degludec is an longer acting basal insulin analog recently approved in the US.  Liraglutide is a once-daily GLP-1 receptor agonist.  Both are among the most powerful glucose lowering drugs available in the setting of type 2 diabetes.  They have very different properties.  Degludec is best at lowering fasting glucose. Liraglutide has effects on postprandial glucose as well.  The major side effects of degludec are hypoglycemia and weight gain. Liraglutide on the other hand has not an inherent effect to cause hypoglycemia and does promote weight loss.  Liraglutide does cause nausea and in fewer patients vomiting in a dose dependent manner. In developing the fixed dose combination the idea was to amplify glucose lowering efficacy and minimize the adverse effects of both components.  Prior studies have basically shown that this has been accomplished.  In this study we looked at the very common clinical scenario of the patient with type 2 diabetes inadequately controlled on basal insulin glargine and asked the question of whether switching from glargine to IDegLira (the combination product) would do better than continued titration of glargine. (more…)
Author Interviews, Health Care Systems, JAMA, Outcomes & Safety / 29.02.2016

MedicalResearch.com Interview with: Dr. Alisa Khan, MD MPH Division of General Pediatrics Boston Children’s Hospital Department of Pediatrics, Harvard Medical School, Boston, Massachusetts Medical Research: What is the background for this study? What are the main findings? Dr. Khan: Medical errors, or mistakes in the process of caring for patients, occur frequently. While methods of detecting errors have improved, parents and families are not typically included in routine hospital safety monitoring systems. We found that nearly 1 in 11 parents reported their child had experienced a safety incident during hospitalization. Most of these reports were confirmed to be medical errors when reviewed by physicians, and many were not otherwise documented in the patient’s medical record. (more…)
Author Interviews, Emergency Care, Infections, JAMA, Pediatrics, Pulmonary Disease, Respiratory / 29.02.2016

MedicalResearch.com Interview with: Suzanne Schuh, MD, FRCP(C), ABPEM The Hospital for Sick Children affiliated with the University of Toronto Medical Research: What is the background for this study? Dr. Schuh: Routine measurement of oxygen saturation in bronchiolitis is sometimes used as a proxy for illness severity, despite poor correlation between these parameters. This focus on oximetry may in part relate to lack of evidence on the natural history of desaturations in bronchiolitis which are often transient, and frequently not accompanied by increased respiratory distress. Desaturations occurring in infants with mild bronchiolitis in an ED often result in hospitalizations or prolonged hospital stay. They occur in healthy infants and may also occur in infants with mild bronchiolitis at home. The main objective of this study of infants with acute bronchiolitis was to determine if there is a difference in the proportion of unscheduled medical visits within 72 hours of ED discharge in infants who desaturate during home oximetry monitoring versus those without desaturations. Our study shows that the majority of infants with mild bronchiolitis experience desaturations after discharge home. (more…)
Accidents & Violence, Author Interviews, JAMA / 29.02.2016

MedicalResearch.com Interview with: Anna-Karin Numé MD, PhD student Copenhagen University Gentofte Hospital Department of Cardiology Cardiovascular Research Hellerup Denmark  Medical Research: What is the background for this study? Dr. Numé: While it is obvious that a loss of consciousness while driving a car is very dangerous, what is not known is whether individuals who have had an episode of fainting (syncope) have a significantly higher risk of having car crashes in the future. Because about one third of patients with syncope are likely to have a recurrence, physicians face a difficult judgment about whether patients with syncope are fit to drive. Medical Research: What are the main findings? Dr. Numé: In this nationwide study of patients with syncope, having a history of syncope were associated with a 2-fold-higher risk of later motor vehicle crashes requiring medical attention at an emergency department or hospital compared with the general population – a risk that remained elevated throughout a follow-up of 5 years. This risk was small in absolute terms, yet raises important questions about policies towards driving. (more…)
Author Interviews, JAMA, Sexual Health / 29.02.2016

MedicalResearch.com Interview with: Loes Jaspers MD, PhD scientist Dept. of Epidemiology Erasmus University Medical Center Rotterdam, the Netherlands Medical Research: What is the background for this study? What are the main findings? Dr. Jaspers: In August 2015, the U.S. Food and Drug Administration approved flibanserin as a medical treatment for women with hypoactive sexual desire disorder (HSDD). The approval was accompanied by considerable attention in the media. Some people were positive about the approval, while others questioned whether benefits outweigh the risks. That is why we systematically reviewed eight clinical trials (five published and three unpublished) that included 5,914 women to examine the efficacy and safety of the medication for treatment of hypoactive sexual desire disorder. We found that women taking flibanserin experienced one-half additional satisfying sexual event per month, and that they experienced 2-4 times more side-effects, such as dizziness, sleepiness, nausea, and tiredness, compared to placebo. The overall improvement that women reported while taking the drug was low. It ranged from ‘minimal improvement’ to ‘no change’. The quality of the evidence was graded using established and transparent guidelines, the Grades of Recommendation, Assessment, Development and Evaluation approach (GRADE), which have been adopted by leading scientific organizations globally. Although the studies reviewed were randomized clinical trials, the quality of the evidence was very low, particularly because of limitations in design, the indirectness of evidence, and more favorable efficacy outcomes in published compared with unpublished studies. (more…)
Author Interviews, JAMA, Ophthalmology / 27.02.2016

MedicalResearch.com Interview with: Jason Hsu, MD Retina Service, Wills Eye Hospital Assistant Professor of Ophthalmology Thomas Jefferson University Mid Atlantic Retina Medical Research: What is the background for this study? What are the main findings? Dr. Hsu: There are some patients with the wet type of age-related macular degeneration (AMD) who have persistent swelling in the retina despite regular, repeated eye injections with the anti-vascular endothelial growth factor (anti-VEGF) medications (e.g., Avastin, Lucentis, and Eylea). I had postulated that if we could decrease the turnover of fluid inside the eye, it might allow the injected medicine to stay in the eye for a longer period of time. I chose dorzolamide-timolol (brand name: Cosopt), a commonly available prescription eye drop used for glaucoma, since it is a very potent aqueous suppressant. By slowing down the production of eye fluid, I theorized it might decrease the outflow of fluid and medicine from the eye. Our study was a small, nonrandomized, exploratory pilot study. We enrolled 10 patients with wet AMD who had persistent retinal swelling despite chronic, fixed interval anti-VEGF injections. We kept patients on the exact same anti-VEGF medication and continued to see them at the exact same interval that they had been on before study enrollment. Once enrolled, the only difference is that we had them start using dorzolamide-timolol eye drops twice a day for the course of the study. The results were fairly striking with the retinal thickness decreasing from around 420 microns to 334 microns at the final visit. This decrease in swelling was significant at the first study visit after starting the drops and remained significant throughout the course of the study. (more…)
Author Interviews, JAMA, Ophthalmology, Surgical Research, Toxin Research / 27.02.2016

MedicalResearch.com Interview with: Yu-Chih Hou, MD Department of Ophthalmology National Taiwan University Hospital Taipei, Taiwan MedicalResearch: What is the background for this study? Dr. Yu-Chih Hou: We have encountered 3 patients with right eye pain and corneal edema after left orofacial surgery under general anesthesia since December 6. 2010. The first patient underwent a left tongue tumor excision by an ENT doctor. Postoperative day one, corneal epithelial defect and edema with mild anterior chamber reaction were noted in the right eye. Because his presentation was different from corneal abrasion which was the most common eye injury after general anesthesia, we suspected this ocular complication could be due to toxic reaction to antiseptic. Although corneal edema decreased, corneal endothelial cell density decreased and cataract developed later in the first patient. Two months later, the second patient had a similar toxic keratopathy but with severe corneal edema in his right eye after wide tumor excision of left lower gingival cancer by dentist surgeons. We found the antiseptic they used contained alcohol. We recommended not to use alcohol-containing antiseptics in oral surgery. Unfortunately, more severe toxic keratopathy occurred in the third patient after a left nasal tumor excision by other ENT doctor one year later. Because these severe ocular complications may occur again, it raised us to do detail study and we found all antiseptics they used contained alcohol. We hope to prevent occurrence of this toxic keratopathy in nonocular surgery by reporting our findings to other clinicians. (more…)
Author Interviews, Breast Cancer, Genetic Research, JAMA / 25.02.2016

MedicalResearch.com Interview with: Dr. Shoshana Rosenberg ScD, MPH Department of Medical Oncology Dana-Farber Cancer Institute Boston, Massachusetts Medical Research: Why would BRCA testing rates have increased among younger women with cancer?   Dr. Rosenberg: There has been increasing awareness surrounding genetic testing for breast cancer in more recent years, likely contributing to the trend that we saw over time  in our cohort. This has included more media attention, most notably Angelina Jolie’s sharing her story in 2013. Medical Research: Is this increase in testing a good thing? Dr. Rosenberg: Young women who are diagnosed with breast cancer should be getting tested so the fact that an increasing proportion of women have been undergoing BRCA testing in recent years indicates patients (and the physicians who treat them) are following recommendations. (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, Infections, JAMA / 24.02.2016

MedicalResearch.com Interview with: Dr. Manu Shankar-Hari MB BS MD FRCA EDIC FFICM MSc[Epi] Consultant, Intensive Care Medicine; Guy’s and St Thomas’ NHS Foundation Trust Clinical Research Associate, Intensive Care National Audit and Research Centre Honorary Senior Lecturer in Intensive Care Medicine Division of Asthma Allergy and Lung Biology King’s College London, UK  Medical Research: What is the background for this study? What are the main findings? Dr. Shankar-Hari: Septic shock is a complex illness.  The previous Consensus Definitions (1991 and 2001) place emphasis on the circulatory abnormalities as the core concept and neither definitions provide data driven clinical criteria. In addition, last ten years of basic science research has established the concept that septic shock is associated with plethora of cellular and metabolic abnormalities (often referred to as cellular stress), alongside circulatory dysfunction. In this background, the paper published in JAMA provides an updated illness concept (definitions) and data driven clinical criteria for diagnosing septic shock at the bedside.

The updated illness concept: 'Septic shock is defined as a subset of sepsis in which underlying circulatory, cellular, and metabolic abnormalities are associated with a greater risk of mortality than sepsis alone.’

The clinical criteria: 'Adult patients with septic shock can be identified using the clinical criteria of hypotension requiring vasopressor therapy to maintain mean arterial blood pressure 65 mm Hg or greater and having a serum lactate level greater than 2 mmol/L after adequate fluid resuscitation.' (more…)
Author Interviews, Heart Disease, JAMA, Kidney Disease, Pharmacology / 24.02.2016

MedicalResearch.com Interview with: Frederic T. Billings IV, MD, MSc Assistant Professor of Anesthesiology and Medicine Additional Specialty: Cardiothoracic Anesthesiology Vanderbilt University Medical Research: What is the background for this study? What are the main findings? Dr. Billings: Acute kidney injury (AKI) affects up to 30% of patients following cardiac surgery and is associated with long-term kidney function decline as well as a 5-fold increase in death during hospitalization following surgery. Statins affect several mechanisms of AKI following cardiac surgery including improvement of endothelial function and attenuation of oxidative stress, so we performed a clinical trial to test the hypothesis that high-dose atorvastatin (brand name Lipitor) use prior to and following surgery reduces AKI following cardiac surgery. In 615 patients who completed the study high-dose atorvastatin treatment, compared to placebo administration, did not reduce the risk of AKI overall, among patients naïve to statins, or patients already using a statin. In fact, among patients naïve to statins with baseline chronic kidney disease we found some evidence that atorvastatin may increase risk for kidney injury, although the number of patients was small in this subgroup. (more…)
Anesthesiology, Author Interviews, Critical Care - Intensive Care - ICUs, JAMA, Pulmonary Disease / 22.02.2016

MedicalResearch.com Interview with: John G. Laffey MD Chief, Department of Anesthesia; Co-Director, Critical illness and Injury Research Centre; Scientist, Keenan Research Centre for Biomedical Science ‑ St. Michael's Hospital Professor, Anesthesia, Critical Care, and Physiology ‑ University of Toronto Medical Research: What is the background for this study? Dr. Laffey: Acute respiratory distress syndrome is the commonest cause of severe acute respiratory failure in the critically ill. ARDS is a major cause of death and disability in the critically ill worldwide. Second, there is no treatment for ARDS, and our present management approaches are limited to supporting organ function while treating the underlying causes We performed the LUNG SAFE study to address several clinically important questions regarding ARDS. First, the current incidence in a large international cohort was not known. Large regional differences had been suggested: for example, the incidence of ARDS in the US was reported to be ten times greater of that in Europe_ENREF_4. Second, we wanted to understand how we manage patients with  Acute respiratory distress syndrome in the ‘real world’ situation. Specifically, it was not clear to what extent newer approaches to artificial ventilation, such as reducing the size of the breaths (lower tidal volumes) and keeping the lung pressure positive at all times to minimize collapse (PEEP) were used. The impact of studies showing promise for other measures to improve gas exchange such as turning patients prone during mechanical ventilation, or using neuromuscular blockade, on routine clinical practice in the broader international context was not known. Third, there were some concerns over the extent of clinician recognition of ARDS. This was an important issue because implementation of the effective therapies may be limited by lack of recognition of ARDS by clinicians. A better understanding the factors associated with ARDS recognition and how this recognition influenced patient management could lead to effective interventions to improve care. Lastly we wanted to determine the outcome from  Acute respiratory distress syndrome in a global cohort of patients. Medical Research: What are the main findings? Dr. Laffey: We found that ARDS continues to represent an important public health problem globally, with 10% of ICU patients meeting clinical criteria for ARDS. While there appeared to be some geographic variation, this did not seem as great as previously thought. An important finding was the under-recognition of  Acute respiratory distress syndrome by clinicians, with 40% of all cases not being recognized. In addition, over one third of patients did not receive protective lung ventilation strategies. The use of other measures to aid gas exchange during artificial ventilation, such as turning the patient into the prone position, or the use of neuromuscular blockade was also quite low. Of most concern, ARDS continues to have a very high mortality of approximately 40% of patients dying in hospital. (more…)
Author Interviews, Autism, JAMA, Pediatrics / 18.02.2016

MedicalResearch.com Interview with: Dr. David Grossman MD MPH Vice chair of the U.S. Preventive Services Task Force Professor at the University of Washington Schools of Public Health and Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Grossman: The Task Force cares deeply about the challenges that children affected by autism and their families face in getting the care and support they need. This was the first time that we assessed the evidence around screening young children for autism, and our recommendation was informed by a review of the most up-to-date science, which included randomized trials, observational studies, and research from a number of Federal health agencies. We concluded that the current evidence is insufficient to assess the balance of benefits and harms of screening for autism spectrum disorder in children for whom no concerns of autism have been raised by their parents or a clinician. This is an I statement, which is not a recommendation against screening, but a call for more research on screening and treatment in young children who don’t have obvious symptoms. It is important to note that this recommendation will not affect insurance coverage for autism screening, which is currently covered under the Affordable Care Act as a result of the American Academy of Pediatrics’ Bright Futures Guidelines. (more…)
Author Interviews, Breast Cancer, JAMA, Outcomes & Safety, Surgical Research / 17.02.2016

MedicalResearch.com Interview with: Dr. Art Sedrakyan MD PhD ScD Professor of Healthcare Policy and Research in Cardiothoracic Surgery Department of Public Health Weill Cornell Medical College  Medical Research: What is the background for this study? What are the main findings? Dr. Sedrakyan: In the most recent years available to us for research(2011-2013) one in four women underwent repeat surgery within 90 days after breast conserving approach to cancer removal. Patients operated by higher volume physicians had lower chance of undergoing repeat surgery.Uniform guidelines and increased surgical training are needed to standardize the breast conserving surgery to reduce the high rate of repeat surgery. (more…)