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Health IT: Patients Ready, Docs Lagging

Patients are well ahead of providers in demanding online access to health information (IT) and communication tools, according to a new survey. Consumers are eager to use both the internet and mobile devices to connect with their healthcare data and their providers in much the same way they have come to conduct business with other professionals. In June 2012, the Optum Institute surveyed physicians, hospital executives, and adult consumers about health IT and aspects of patient-centered care. Researchers found that while physicians are rapidly adopting health IT, functions that would facilitate patient engagement are falling short. Other results from the study include: 75% of patients are willing to go online to view their medical records (76% are willing to view test results), but only 41% of physicians have EMR systems capable of giving patients timely access to this information. 62% of patients want to correspond online with their primary physician about their health, but only 46% of physicians have EMR systems capable of communicating patient-specific information to help patients make decisions about their health 65% of patients want appointment reminders via e-mail, but only 44% of physicians have EMR systems that provide guideline-based follow-up or screening reminders. The report also found that nearly two-thirds of consumers are interested or very interested in receiving appointment reminders by e-mail; 40% want text reminders. Only 28% want mailed appointment reminders, which are typically still the norm today. The report concludes that Meaningful Use Stage 2 requirements set the bar too low, requiring that at least 50% of patients have access to their health information and that only 5% use that information and...

FDA Approves First Subcutaneous Heart Defibrillator

The U.S. Food and Drug Administration today approved a heart defibrillator that helps to restore regular heart rhythms with leads that can be implanted just under the skin (subcutaneously) instead of connected directly into the heart. An implantable defibrillator is a small battery-powered device that constantly monitors a person’s heart rhythm and can deliver a therapeutic dose of electricity to restore the rhythm when it senses the heart is beating dangerously fast (tachycardia) or chaotically (sudden cardiac arrest). Other implantable defibrillators on the market require a physician to insert one or more electrical conductor wires, called “leads,” into a vein in the upper chest and guide them into the patient’s heart. X-ray fluoroscopy, a real-time imaging method, helps the physician to visualize the heart and blood vessels to guide the leads to the correct position. The Subcutaneous Implantable Defibrillator (S-ICD) System uses a lead that is implanted just under the skin along the bottom of the rib cage and breast bone. Because the lead is placed under the skin rather than through a vein into the heart, a physician can implant the device without accessing a patient’s blood vessels or heart and without the need for fluoroscopy. “The S-ICD System provides an alternative for treating patients with life-threatening heart arrhythmias for whom the routine ICD placement procedure is not ideal,” said Christy Foreman, director of the Office of Device Evaluation at FDA’s Center for Devices and Radiological Health. “Some patients with anatomy that makes it challenging to place one of the implantable defibrillators currently on the market may especially benefit from this device.” The S-ICD System is approved to...

FDA Approves Humira to Treat Ulcerative Colitis

The U.S. Food and Drug Administration today expanded the approved use of Humira (adalimumab) to include treatment of moderate-to-severe ulcerative colitis in adults. Humira is approved to control ulcerative colitis when immunosuppressant medicines like corticosteroids, azathioprine, and 6-mercaptopurine have not worked. The drug is an anti-tumor necrosis factor (TNF) that blocks proteins that play an important role in abnormal inflammatory and immune responses. Ulcerative colitis is a chronic disease that causes inflammation and ulcers in the inner lining of the large intestine. It is one of two main forms of chronic inflammatory bowel disease and affects about 620,000 Americans, according to the National Institutes of Health. “Each patient with ulcerative colitis experiences the disease differently, and treatment must be adjusted to meet each individual’s needs,” said Donna Griebel, M.D., director of the Division of Gastroenterology and Inborn Errors Products in FDA’s Center for Drug Evaluation and Research. “Today’s approval provides an important new treatment option for patients who have had an inadequate response to conventional therapy.” The FDA previously approved Humira to treat rheumatoid arthritis (2002), psoriatic arthritis (2005), ankylosing spondylitis (2006), Crohn’s disease (2007), plaque psoriasis (2008) and juvenile idiopathic arthritis (2008). Patients with ulcerative colitis are normally evaluated for stool frequency, rectal bleeding, endoscopic findings and a physician’s assessment, which combined provide a score ranging from 0 to 12 to help assess the activity of ulcerative colitis. This scoring system is commonly referred to as the Mayo score. Humira’s safety and effectiveness for ulcerative colitis were established in two clinical studies. A total of 908 patients who had never been treated with a TNF-blocker, or who lost...

A New Guide for Revascularizing Patients With CAD

In the December 6, 2011 Journal of the American College of Cardiology, the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) published guidelines on the management of patients undergoing CABG, one of the most common operations performed in the United States. These guidelines were released at the same time that the ACCF and AHA published recommendations for PCI. According to L. David Hillis, MD, FACP, chair of the ACCF/AHA guidelines committee for CABG, the landscape regarding when surgeons should perform CABG or PCI has been continually changing, particularly in the past 5 to 10 years. “Several recent investigations have shown that PCI and CABG have comparable outcomes when used in patients with certain coronary arterial anatomic features,” he says. “The last guidelines were published in 2004, but clinical trials have continued to improve our understanding of how to optimize the management of patients with coronary artery disease (CAD).” A Collaborative Approach to Determine Revascularization Through a collaboration of two writing committees, the ACCF/AHA guideline update contains the most extensive examination of CABG and PCI use for coronary revascularization. “While one committee was re-writing the CABG guidelines, a separate committee was revising the PCI guidelines,” explains Dr. Hillis. “Our goal was then to develop a consensus between cardiologists and surgeons over patient selection for these two procedures. Busy practitioners have historically been challenged when deciding on which patients should undergo revascularization rather than being treated medically, and whether revascularization should be accomplished with CABG or PCI.” Dr. Hillis says a section of the guidelines has been established to address questions that clinicians may have when deciding...

FDA Approves New Treatment for Advanced Colorectal Cancer

Priority review completed one month ahead of goal date The U.S. Food and Drug Administration today approved Stivarga (regorafenib) to treat patients with colorectal cancer that has progressed after treatment and spread to other parts of the body (metastatic). Stivarga is a multi-kinase inhibitor that blocks several enzymes that promote cancer growth. The drug was reviewed under the FDA’s priority review program that provides an expedited six-month review for drugs that offer major advances in treatment or that provide treatment when no adequate therapy exists. Stivarga is being approved one month ahead of the product’s prescription drug user fee goal date of Oct. 27, 2012, the date the agency was scheduled to complete review of the drug application. “Stivarga is the latest colorectal cancer treatment to demonstrate an ability to extend patients’ lives and is the second drug approved for patients with colorectal cancer in the past two months,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. According to the Centers for Disease Control and Prevention, colorectal cancer is the third most common cancer in men and in women and the third leading cause of cancer death in men and in women in the United States. The National Institutes of Health estimates 143,460 Americans will be diagnosed with colorectal cancer, and 51,690 will die from the disease in 2012. The safety and effectiveness of Stivarga were evaluated in a single clinical study of 760 patients with previously treated metastatic colorectal cancer. Patients were randomly assigned to receive Stivarga or placebo in addition to best supportive care...

In the Political Healthcare Debate, the Patients Always Lose

The wannabe congressman appeared with his neat hair and pressed suit, a competent yet compassionate expression on his face. “The first thing I am going to do when I get to Congress is to work to repeal Obamacare,” he said, expression growing subtly angry. “I will do everything I can to give you back the care you need from those who think big government is the solution to every problem.” My wife grabbed my arm, restraining me from throwing the nearest object at the television. I cursed under my breath. No, it’s not my liberal ideology that made me react this way; I’ve had a similar reaction to ads by Democrats who demonize Republicans as uncaring religious zealots who want corporations to run society. I am a “flaming moderate,” which means that I get to sneer at the lunacy on both sides of the political aisle. I grew up surrounded by conservative ideas — and probably still lean a bit more in that direction than to the left — but my direction has moved to a comfortable place in the middle. It’s not the ideology that bugs me, it’s the use of the “us and them” approach to problem-solving. If only we could get rid of the bad people, we could make everything work. If only those people weren’t oppressing us. If only those people weren’t so lazy.  It’s the radical religious people who are the problem. It’s the liberal atheists. It’s the corporations. It’s the government. All of this makes the problem into something that isn’t the fault of the person making the accusation, conveniently taking the heat...

Weekend Vs Weekday Admissions for AF

A review of more than 86,000 discharges with a primary diagnosis of atrial fibrillation (AF) sug­gests that patients admitted on weekends appear to be less likely to undergo a cardioversion procedure and more likely to die resulting from AF when compared with patients admitted on weekdays. Cardioversion procedures were performed in 7.6% of AF patients during weekend admissions, compared with 16.2% for those being admitted during weekdays. The in-hospital mortality odds ratio was 1.23 for AF patients admitted during weekends. Abstract: American Journal of Cardiology, July 15,...

Herbal Cannabis Use in Fibromyalgia

A study analyzing self-reports from patients with fibromyalgia who were referred to a ter­tiary care pain center indicate that 13% used cannabi­noids to manage their pain. Among these patients, 80% used marijuana, 24% used prescription cannabi­noids, and 3% used both. Users tended to be unem­ployed and receiving disability payments. Marijuana use was associated with: Unstable mental illness (36%). Male gender (26%). Opioid drug-seeking behavior (17%). Abstract: Arthritis Care & Research, June 21, 2012...

Comparing Weight Loss Approaches

American research suggests that use of a standard behavioral weight loss intervention (SBWI) appears to result in greater weight loss than use of a stepped-care weight loss interven­tion (STEP) in overweight and obese adults. After 18 months, weight decreased by 8.1% in the SBWI group, compared with a 6.9% rate for the STEP group. However, the cost per participant was $1,357 for the SBWI group, which was nearly twice as much as that of the STEP group ($785). Abstract: JAMA, June 27,...

Weight Management Drug Gains FDA Approval

The FDA has approved phentermine and topiramate extended-release tablets (Qsymia, Vivus Inc.) for chronic weight management when used in addition to a reduced-calorie diet and exercise. The drug is indicated for use in obese or overweight adults who have at least one weight-related condition (eg, hypertension, type 2 diabetes, or dyslipidemia). Source:...

A New MRSA Molecular Assay

An MRSA molecular test (BD Max MRSA, BD Diagnostics) has received marketing clearance from the FDA for use in identifying patients with the infection. The automated, bench-top assay is designed to perform a broad range of molecular testing. Source: BD...

Report: More U.S. Women Going Uninsured

From 2000 to 2010, the estimated number of uninsured women aged 19 to 64 in the United States increased from 12.8 million to 18.7 million, according to a report from the Commonwealth Fund. The report, available at www.commonwealthfund.org, compared the healthcare experiences of U.S. women to those of 10 industrialized nations with universal health insurance systems. Download report...

Walking Speed Predicts Blood Pressure Risks in the Elderly

Walking speed appears to be a simple measure for identifying elderly patients most at risk for adverse outcomes relating to high blood pressure (BP). In a study of patients aged 65 and older who were fast walkers, those with an elevated systolic BP had a greater mortality risk than those without. Abstract: Archives of Internal Medicine, July 2012 (online).[xyz_lbx_custom_shortcode...

In-Hospital Mortality Down for Cardiac Arrests

The rate for in-hospital mortality appears to have decreased by 11.8% between 2001 and 2009 for patients hospitalized with cardiac arrest, according to an analysis of data from a national hospital discharge database.  During the study period, the mortality rate declined across gender, age, race, and stratification by comorbidity. Abstract: Circulation, June 27, 2012...

FDA Clears Relay Thoracic Stent-Graft for Thoracic Aortic Aneurysms and Penetrating Ulcers

Bolton Medical announced today that they have received approval from the U.S. Food and Drug Administration for the Relay Thoracic Stent-Graft with Plus Delivery System. Specifically designed for the thoracic aorta, the Relay device is offered in a wide range of sizes to help to expand the use of this minimally-invasive treatment for thoracic aortic aneurysms and penetrating atherosclerotic ulcers. Bolton Medical stent-grafts have been widely used in Europe and other international markets since 2005 and, to date, more than 7,000 Relay and Relay NBS Thoracic Stent-Grafts have been implanted worldwide. The U.S. pivotal study included 120 endovascular patients at 30 hospitals across the country. National Principal Investigator, Dr. Mark Farber, Director, UNC Aortic Center; Vascular Surgery Program Director; Associate Professor of Surgery and Radiology stated, “The Relay Thoracic Stent-Graft allows for precision and conformability, especially in patients with more challenging anatomies. As a physician, I find that the Relay device makes it easier for me to offer this life-saving treatment to a broader population of patients suffering from thoracic aortic aneurysm.” The Relay system offers the following features: Distinct performance zones provide varying levels of radial support and apposition. Four-step dual sheath delivery system. Wide range of sizes to meet patient needs: lengths of 100mm-250mm, diameters of 22-46mm, straight and tapered. “With worldwide experience of the Relay family of devices, we are pleased that the FDA has now approved the use of this device in the United States. We believe that U.S. physicians will benefit tremendously from access to the latest medical technology of the Relay Thoracic Stent-Graft with Plus Delivery System,” said Oscar Rospigliosi, CEO, Bolton Medical,...

Predicting Preadmission Medication Understanding

In the hospital setting, it is vitally important that patients understand their medication regimen. Patients are often the primary source of information when physicians take a medication history for medication reconciliation. If patients don’t understand their preadmission medication regimen, their risk for errors in inpatient and post-discharge medication orders increases. “Lower health literacy, impaired cognition, and a higher number of medications can affect the accuracy of patient-reported medication regimens.” Few studies have examined how well patients understand their preadmission medication regimen and the factors that affect understanding. Low health literacy, advanced age, and impaired cognitive function all have the potential to adversely affect understanding of medication instructions. To address gaps in research, my colleagues and I conducted a study that was published in the November 2011 Journal of Hospital Medicine in which we examined how certain patient factors affected understanding of preadmission medication regimens. Predictors of Medication Understanding In our analysis, 790 patients from Vanderbilt University Hospital and Brigham & Women’s Hospital were eligible for the investigation. We found that 21% of participants had marginal or inadequate health literacy. Also, the median number of medications that they were taking was eight. The following were each independently associated with less understanding of the purpose, dose, and/or frequency of their preadmission medication regimen: Lower health literacy. Lower cognitive function. Higher number of medications. Furthermore, we found that for each increase by one medication, there was a significant decrease in medication understanding. Patients on six medications were about half as likely to understand their medication regimen as patients on only one medication. For patients on 11 medications, the odds of medication understanding...

A Look at Near-Miss Mortality and Morbidity in Pregnancy

Previous research suggests that timely delivery of appropriate healthcare services may prevent almost half of all pregnancy-related deaths in the United States. Although maternal deaths are increasingly attributed to preexisting condi­tions, the relative effect of these conditions and the extent to which maternal morbidity and mortality are concentrated in high-risk patients have not been well defined. Focusing on Near-Miss Pregnancy Events Jill M. Mhyre, MD, and colleagues had a study published in the November 2011 issue of Anesthesiology that sought to iden­tify which preexisting conditions predicted maternal morbidity, mortality, and “near- miss” events. A near miss occurs when preg­nant women or recently postpartum women survive a life-threatening event, either because of high-quality medical care or by chance alone. “In our study, we investigated women who died as well as those who sur­vived an event in the hopes of uncovering important lessons with regard to predicting outcomes and preventing progression from near misses to death,” says Dr. Mhyre. A near miss was defined as end-organ injury that impacted hospital discharge. The highest rates of near-miss morbidity or mortality events were found among women with pulmonary hypertension (PH), malig­nancy, and systemic lupus erythematosus (Table). Advancing maternal age and non-white race also increased risk for near-miss morbidity or mortality. “While the effect sizes we observed for age and race were relatively modest when compared with certain medical conditions, these effects remained statistically significant even after controlling for all other medical and obstet­ric conditions,” Dr. Mhyre says. “The abso­lute rate per thousand deliveries increased three-fold when age older than 40 was com­pared with ages 20 to 34, but the adjusted odds ratio was...

Physician-Authored Book Addresses Transparency in Healthcare

PRESS RELEASE: In Unaccountable, Dr. Makary argues that patients blindly walk into a marketplace they can’t study or evaluate. Readers will learn the shocking truth about the Wild West of modern medicine, including its hazards and its heroes. Why are medical errors now the fifth leading cause of death in America? Why do some prestigious hospitals have complication rates five times higher than others? Why are 20-30% of all medications and procedures unnecessary, according to a new study? How do you find the best medical care? Today, more than ever, doctors and nurses describe a “corporatization” of healthcare by executives increasingly removed from the front lines of patient care – a detachment parallel to that of large bank executives before the financial collapse. The only difference is that, instead of a onetime taxpayer bailout for the banks, healthcare is being bailed out every day. The personal advice and broader reforms Dr. Makary lays out are neither impractical nor partisan. They are common sense. With thousands of lives at stake every year, and a broken system that is burdening families, businesses and our national debt, we need the fresh new ideas this book provides. Now available for pre-order, wherever books are sold. Source: www.unaccountablebook.com.  ...

Masimo Oximeters and Neonatal Sensors Receive FDA 510(k) Clearance for Use in Newborn Screening for Critical Congenital Heart Disease

Masimo announced today that it has received U.S. FDA 510(k) clearance for Masimo Signal Extraction Technology (SET) pulse oximeters, rainbow SET Pulse CO-Oximeters, and neonatal sensors with labeling for screening newborns for critical congenital heart disease (CCHD). Masimo SET pulse oximeters and sensors have previously been cleared to measure oxygen saturation and pulse rate during motion and low perfusion conditions in newborns, but this marks the first time the FDA has cleared specific labeling indicating the use of pulse oximeters, in conjunction with a physical exam, to screen newborns for CCHD. In conjunction with the FDA clearance, Masimo also announced the HEART Program (Help Ensure Access to the Right Technology) for CCHD screening enabling hospitals in countries where Masimo has a presence that want to perform CCHD screening with a Masimo SET pulse oximeter, but do not have one and do not have funds to purchase one, to receive a free Masimo SET pulse oximeter. More details are available at www.masimo.com/heartprogram. CCHD causes up to 3% of all infant deaths in the first year of life.1 According to the U.S. Department of Health and Human Services (HHS), these types of heart defects affect about 7 to 9 of every 1,000 live births, one quarter of which could be detected and potentially treated by measuring blood oxygen saturation. FDA clearance comes as California recently became the latest state to mandate CCHD pulse oximetry screening (www.aroundthecapitol.com/Bills/AB_1731/20112012/), following HHS’s September 2011 action to add pulse oximetry CCHD screening for newborns as part of the Recommended Uniform Screening Panel. HHS took this action based on the published findings of the CCHD Workgroup,2 which...

How to Lower 30-Day Hospital Readmission Rates

As new Medicare rules kick in, some 2,200 hospitals nationwide are facing financial penalties for 30-day readmission rates for myocardial infarction, congestive heart failure and pneumonia. Medicare payments will be lowered by as much as 1%. Investigators at the Skeptical Scalpel Institute for Evidence-Based Outcomes and Advanced Research (SSIEBOAR, catchy acronym, don’t you think?) have come up with a plan that is certain to lower readmission rates across the board. Some have said the idea should be patented, but the institute is not-for-profit and thus is willing to share. The solution is quite simple — let the patients die. Yes, death reduces readmission rates for all diseases, not just MI, CHF and pneumonia. Oh, there may be some resistance and relatives of the patients may complain, but at least Medicare will be satisfied and after all, isn’t that why we became doctors? Another outcome measure, hospital length of stay, is also positively impacted by death. For example, if the average length of stay for a patient with a heart attack is 4 days, a patient who dies on hospital day #2 would lower the hospital’s average. Death also results in fewer resources being utilized, which saves the hospital money for patients whose reimbursement is based on the DRG. I confess. I’m not serious, and the idea is not original. There are many issues. In most cases, as length of stay is ratcheted down, readmission rates will rise. One way to reduce readmissions is to keep patients in the hospital longer. And what about the things the hospitals and doctors can’t control? A recent study found that only 63% of...
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