<?xml version="1.0" encoding="utf-8"?>
<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_467"
                     title="FDA Unveils New Safety Plan for Medical Imaging"
                     score="0.012"
                     href="http://www.medpagetoday.com/Radiology/DiagnosticRadiology/tb/18398?impressionId=1265787407497"
                     
      &lt;p&gt;WASHINGTON  --  The Food and Drug Administration (FDA) says it wants to issue new safety requirements for manufacturers of computed tomography (CT) and fluoroscopic devices to reduce unnecessary radiation from medical imaging.&lt;/p&gt;
&lt;p&gt;The FDA&apos;s plan focuses on three procedures with high radiation doses: CT, nuclear medicine studies, and fluoroscopy. These are the greatest contributors to total radiation exposure within the U.S. population, the FDA said. That&apos;s because they require much higher radiation doses than other radiographic procedures, such as standard X-rays, dental X-rays, and mammography.&lt;/p&gt;
&lt;p&gt;&quot;The amount of radiation Americans are exposed to from medical imaging has dramatically increased over the past 20 years,&quot; Jeffrey Shuren, MD, director of the FDA&apos;s Center for Devices and Radiological Health, said in a prepared statement. &quot;The goal of FDA&apos;s initiative is to support the benefits associated with medical imaging while minimizing the risks.&quot;&lt;/p&gt;
&lt;p&gt;While the three procedures have led to early diagnosis of disease, they expose patients to ionizing radiation that may increase lifetime cancer risk  --  although there is debate within the medical community about the extent of the danger.&lt;/p&gt;
&lt;p&gt;Radiologist Joseph Schoepf, MD, director of Cardiovascular Imaging at the Medical University of South Carolina, lauded the FDA&apos;s initiative and said it would restore the public&apos;s trust in imaging.&lt;/p&gt;
&lt;p&gt;&quot;It is important to note, however, that an increase in cancer mortality [from radiation] has not been observed,&quot; he added. &quot;On the contrary, cancer mortality has dramatically decreased over the past decades, in step with increased utilization of medical imaging.&quot;&lt;/p&gt;
&lt;p&gt;The &lt;em&gt;Archives of Internal Medicine &lt;/em&gt;recently published results from two studies indicating that &lt;a href=&quot;http://www.medpagetoday.com/Radiology/DiagnosticRadiology/17530&quot; mce_href=&quot;http://www.medpagetoday.com/Radiology/DiagnosticRadiology/17530&quot; target=&quot;_blank&quot; title=&quot;CT&amp;#8200;Scans&amp;#8200;May&amp;#8200;Deliver&amp;#8200;Higher-than-Expected&amp;#8200;Radiation&amp;#8200;Doses&quot;&gt;CT scans deliver much higher doses of radiation &lt;/a&gt;than previously thought. The FDA has noted that a patient would have to get 400 standard chest X-rays to be exposed to the same level of radiation as just one CT abdomen scan.&lt;/p&gt;
&lt;p&gt;In an accompanying editorial, the journal&apos;s editor, Rita Redberg, MD, wrote that the studies &quot;make us question if we have gotten carried away in our enthusiasm&quot; for CT.&lt;/p&gt;
&lt;p&gt;It&apos;s becoming clear, she said, that the large doses of radiation from CT scans will lead to additional cancers, which must be taken into account when physicians consider CT for their patients.&lt;/p&gt;
&lt;p&gt;By working with healthcare providers and other federal agencies, the FDA says it hopes to promote safer use of medical imaging and increase patient awareness of their radiation exposure. Part of that involves pushing providers to justify their radiation procedures and optimize the radiation dose in each one.&lt;/p&gt;
&lt;p&gt;&lt;span&gt;Schoepf, who serves on several American College of Radiology committees that discuss the proper used of various imaging procedures, approved of the FDA&apos;s goal but cautioned against restrictions that would hinder clinicians.&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&quot;There is indeed a need for enhanced transparency, better patient education, more dialogue between patients and their healthcare providers, and increased involvement of the patient in the decision process leading up to an imaging study,&quot; Schoepf said.&lt;/p&gt;
&lt;p&gt;&lt;span&gt;&quot;What is often forgotten in this discussion is that serious injury or death, resulting from missing a potentially life-threatening diagnosis if no imaging is performed, is a much greater, more imminent, and very real risk.&quot;&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;In its statement, the FDA said it wants to boost efforts to develop at least one national registry of radiation doses that will capture information from a variety of imaging studies that can be used to establish benchmarks for healthcare facilities to use with patients.&lt;/p&gt;


 &lt;p&gt;Donald Frush, MD, a radiologist at Duke Medical Center and expert in CT radiation doses in children, said that radiation doses for CT examination vary widely, depending on the size of the patient and the body area scanned, among other things.&lt;/p&gt;
    &lt;p&gt;&quot;However, sometimes this variation is not necessary, and the dose may be excessive,&quot; Frush said.&lt;/p&gt;

&lt;p&gt;The ACR launched a similar registry about a year ago, according to spokesman Shawn Farley. The database is intended as a guide so a radiologist can quickly see how levels of radiation delivered in other practices and hospitals compare to what he or she is delivering.&lt;/p&gt;
&lt;p&gt;&quot;Now that the FDA has come out in favor of doing that, we&apos;re hoping that will put a little more weight behind the process and make more facilities want to take part in this,&quot; Farley told &lt;em&gt;MedPage Today. &lt;/em&gt;&lt;/p&gt;


 &lt;p&gt;Schoepf noted that European governments already require a permanent record of radiation exposure for each patient.&lt;/p&gt;
    &lt;p&gt;As a result, manufacturers of radiation equipment, most of whom sell their products in Europe, already have that capability, he said. So it shouldn&apos;t be difficult to implement the same standard in the U.S.&lt;/p&gt;
    &lt;p&gt;&quot;Radiation exposure should be no secret,&quot; Schoepf said.&lt;/p&gt;


&lt;p&gt;The FDA will hold a public meeting March 30 and 31 to hear comments on what types of safety requirements to establish for manufacturers of CT and fluoroscopic devices. Requirements might include: &lt;ul&gt; &lt;li&gt;That the radiation device display, record, and report equipment settings and radiation dose&lt;/li&gt; &lt;li&gt;Alerting users when the dose exceeds the optimal dose for most patients&lt;/li&gt; &lt;li&gt;Increased training for users&lt;/li&gt; &lt;li&gt;Ability to capture and transmit radiation dose information to a patient&apos;s electronic medical record in addition to national dose registries &lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;&lt;em&gt;This article was developed in collaboration with ABC News. &lt;/em&gt;&lt;img src=&quot;http://www.medpagetoday.com/upload/2009/10/1/14357_1.jpg&quot; mce_src=&quot;http://www.medpagetoday.com/upload/2009/10/1/14357_1.jpg&quot; alt=&quot;&quot;&gt;&lt;/p&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_409"
                     title="&apos;Artificial Pancreas&apos; Improves Glucose Control at Night (CME/CE)"
                     score="0.009"
                     href="http://www.medpagetoday.com/Endocrinology/Diabetes/tb/18315?impressionId=1265787407497"
                     
      &lt;p&gt;Closed-loop insulin delivery systems can improve overnight blood sugar control and reduce hypoglycemia risk in young patients with type 1 diabetes, researchers have found.&lt;/p&gt;
&lt;p&gt;More patients with this &quot;artificial pancreas&quot; maintained target blood glucose levels over the course of the night than those on standard insulin pumps (60% versus 40%), according to Roman Hovorka, MD, of Addenbrooke&apos;s Hospital in Cambridge, England, and colleagues.&lt;/p&gt;
&lt;p&gt;They also avoided significant hypoglycemia events, while those on standard therapy had nine, the researchers reported online in &lt;em&gt;The Lancet&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;&quot;Overnight closed-loop delivery is appealing because it addresses the issue of nocturnal hypoglycemia,&quot; they wrote.&lt;/p&gt;
&lt;p&gt;Two management strategies for type 1 diabetes  --  continuous glucose monitoring devices and insulin pumps  --  can be combined to form closed-loop systems. This enables delivery of insulin determined by an algorithm using real-time sensor glucose data, rather than preprogrammed rates.&lt;/p&gt;
&lt;p&gt;Unfortunately, few prototypes have been developed, the researchers wrote, because progress has been hindered by suboptimum accuracy and reliability of monitoring devices, slow absorption, and inadequate control algorithms.&lt;/p&gt;
&lt;p&gt;So, to test whether these devices were effective overnight, the researchers conducted three randomized crossover studies at the Wellcome Trust Clinical Research Facility at Addenbrooke&apos;s Hospital in Cambridge.&lt;/p&gt;
&lt;p&gt;They assessed 17 patients, ages 5 to 18, with type 1 diabetes. During 54 nights in the hospital (33 nights on closed-loop devices, and 21 on standard insulin pumps), they monitored three different crossover groups: standard versus closed-loop delivery, closed-loop delivery after rapidly or slowly absorbed meals, and standard versus closed-loop delivery after exercise.&lt;/p&gt;
&lt;p&gt;In the closed-loop scenario, glucose measurements were fed to a control algorithm every 15 minutes, and a nurse adjusted the insulin pump.&lt;/p&gt;
&lt;p&gt;In the first group, the researchers found no significant differences for time in the targeted glucose range or hypoglycemic events (&amp;lt;3.90 mmol/l) between closed-loop and standard delivery (52% versus 39% and 1% versus 2%, respectively).&lt;/p&gt;
&lt;p&gt;Nor were there differences in maintaining the targeted range for closed-loop patients after they ate their meals rapidly or slowly (53% versus 55%).&lt;/p&gt;
&lt;p&gt;&quot;In our studies, postprandial glucose concentrations were increased after large evening meals, but overall glucose control was unaffected and risk of hypoglycemia was low, documenting effective, nonaggressive insulin delivery,&quot; the researchers wrote.&lt;/p&gt;
&lt;p&gt;Patients in the closed-loop delivery group who did early-evening exercises spent the greatest percentage of time in the target blood glucose range, but the improvement was not significant at the corrected level, the researchers said (78% versus 43%).&lt;/p&gt;
&lt;p&gt;&quot;Moderate-intensity, late-afternoon or early-evening exercise in young people is a frequent occurrence and increases glucose requirements in the early morning, exacerbating the risk of nocturnal hypoglycemia,&quot; they wrote. &quot;Our closed-loop algorithm ameliorated this risk and maintained good glucose control.&quot;&lt;/p&gt;
&lt;p&gt;A secondary analysis of pooled data showed increased time in the target range and reduced hypoglycemia episodes for patients with the &quot;artificial pancreas,&quot; compared with those on the regular insulin pump (60% versus 40%, &lt;em&gt;P&lt;/em&gt;=0.002, and 2.1% versus 4.1%, &lt;em&gt;P&lt;/em&gt;=0.03, respectively).&lt;/p&gt;
&lt;p&gt;The closed-loop device also completely prevented blood glucose levels from falling below 3.0 mmol/l, which represents &quot;significant hypoglycemia,&quot; the researchers wrote.&lt;/p&gt;
&lt;p&gt;There were nine such events in the control group.&lt;/p&gt;
&lt;p&gt;They acknowledged that adoption of closed-loop devices is &quot;likely to be gradual,&quot; but &quot;advancements in glucose-sensing technologies could further improve the performance of closed-loop systems.&quot;&lt;/p&gt;
&lt;p&gt;In the future, fully automated closed-loop insulin delivery will &quot;need wireless data transmission to replace manual control of the pump by nurses.&quot;&lt;/p&gt;
&lt;p&gt;In an accompanying editorial, Eric Renard, MD, of the Center Hospitalier Universitaire de Montpellier in France, called the findings a &quot;milestone in the quest for an artificial pancreatic beta-cell that started almost 50 years ago.&quot;&lt;/p&gt;
&lt;p&gt;But he cautioned that glucose control at mealtimes &quot;will now be the challenge for Hovorka and co-workers and other research groups who adopted model predictive control algorithms.&quot;&lt;/p&gt;
&lt;p&gt;&quot;Because of the more complex effects that need to be considered for meal coverage, including the cephalic phase of insulin secretion, incretin&apos;s effects, and the variability of gut glucose absorption from mixed meals, model predictive control algorithms could offer more flexibility than do proportional-integral-derivative algorithms.&quot;&lt;/p&gt;
&lt;p&gt;Meanwhile, Renard wrote, &quot;Overnight closed-loop insulin delivery will hopefully be implemented at home.&quot;&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The study was supported by the Juvenile Diabetes Research Foundation, Abbott Diabetes Care, the European Foundation for the Study of Diabetes, Medical Research Council Center for Obesity and Related Metabolic Diseases, and the National Institute for Health Research Cambridge Biomedical Research Center.&lt;/p&gt;&lt;p&gt;Hovorka reported relationships with Minimed Medtronic, Abbott Diabetes Care, Lifescan, Novo Nordisk, and BBraun.&lt;/p&gt;&lt;p&gt;A co-author reported relationships with Novo Nordisk and Medtronic International Trading Sarl.&lt;/p&gt;&lt;p&gt;Renard reported no conflicts of interest.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_408"
                     title="BLOG: New Hospital Policy Leaves Cancer Patient in Tears"
                     score="0.009"
                     href="http://www.medpagetoday.com/Blogs/18310?impressionId=1265787407497"
                     
      								
								&lt;p&gt;&lt;a href=&quot;http://getbetterhealth.com/wp-content/uploads/2010/02/cryingpatient.jpg&quot;&gt;&lt;img width=&quot;210&quot; height=&quot;210&quot; alt=&quot;cryingpatient&quot; src=&quot;http://getbetterhealth.com/wp-content/uploads/2010/02/cryingpatient.jpg&quot; title=&quot;cryingpatient&quot; style=&quot;margin-left: 10px; margin-right: 10px;&quot; class=&quot;alignleft size-full wp-image-15264&quot;&gt;&lt;/a&gt;A
dear friend of mine (let&apos;s call her Amanda) has metastatic breast
cancer. She&apos;s far outlived her life expectancy, thanks to advances in
targeted chemotherapy, but is beginning to need more medical care.
She&apos;s the divorced mom of two teens, with a loving extended family who
keeps a close eye on her.&lt;/p&gt;
&lt;p&gt;When Amanda was recently admitted to her local hospital with
abdominal pain, a new policy resulted in some unintended consequences.
While she was still in the Emergency Department, a nurse came by to ask
if Amanda wanted to be an organ donor. The family members - keenly
aware of her grave prognosis - assumed that the nurse knew about the
cancer, and was asking this question because it had been determined
that Amanda was about to die.&lt;/p&gt;
&lt;p&gt;Tearful sobs ensued. Amanda&apos;s sister called me the next day to tell me the news. &lt;span id=&quot;more-15262&quot;&gt;&lt;/p&gt;
&lt;p&gt;Based on my knowledge of Amanda&apos;s condition - and that she would
almost certainly not qualify as an organ donor for any organ (being
that she has metastases in many of them, has been on chemo for 7 years,
and completed many rounds of radiation therapy), it suddenly dawned on
me that the nurse must have simply been checking off a box on a list. I
suspected that someone at the hospital had created a new policy where
every patient who came through the ER was asked about their organ
donation wishes. It was a new routine procedure&amp;hellip; and probably
well-meant.&lt;/p&gt;
&lt;p&gt;But the generalized application of the policy is where the damage
was done. Even though Amanda had been in and out of the same hospital
for years, the impersonal nature of being asked such an obviously
inappropriate question was emotionally devastating. At her most
vulnerable hour - she was made to feel as if the vultures were
gathering in plain view, wondering if they could have her organs.&lt;/p&gt;
&lt;p&gt;I reassured Amanda and her family that the organ donation question
was likely asked of all ER patients, and that I fully understood how it
must have seemed (out of context) like a reflection on Amanda&apos;s
prognosis. I tried to comfort them - imagining what it must have felt
like to be at the same academic hospital for the 100th time, without
any glimmer of recognition on the part of the staff, nor any
personalization of care.&lt;/p&gt;
&lt;p&gt;I wish there were a way to humanize the hospital admissions process
more effectively, but since hospitals are under extreme pressure to
adhere to checklists and code-based quality measures for financial
survival, personalized care is not the top priority. It is the rare
patient who has &lt;a href=&quot;http://getbetterhealth.com/goto/http://www.aafp.org/online/en/home/policy/policies/p/patientcenteredmedhome.html&quot; rel=&quot;nofollow&quot; target=&quot;_blank&quot;&gt;a medical home&lt;/a&gt;
to turn to in these times of need - with a primary care physician who
can advocate on their behalf and facilitate their safe and emotionally
sensitive care (which is what I try to do &lt;a href=&quot;http://getbetterhealth.com/goto/http://www.doctalker.com/page.php?id=7&amp;name=Medical%20Team&quot; rel=&quot;nofollow&quot; target=&quot;_blank&quot;&gt;in my practice&lt;/a&gt;).&lt;/p&gt;
&lt;p&gt;Sometimes I think that with all this talk of quality healthcare, it seems we&apos;ve lost the most important one&amp;hellip; the human quality.&lt;/p&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_407"
                     title="ICU Catheter Infections Can Be Virtually Eliminated (CME/CE)"
                     score="0.009"
                     href="http://www.medpagetoday.com/CriticalCare/InfectionControl/tb/18308?impressionId=1265787407497"
                     
      Catheter-related infections aren&apos;t inevitable in the ICU, according to a quality initiative that maintained rates at nearly zero for three years in Michigan hospitals.&lt;br&gt;
&lt;br&gt;The maintenance phase, after initial implementation of low-tech measures such as handwashing and removal of unneeded catheters, saw no rebound in catheter-related infections, Peter J. Pronovost, MD, PhD, of Johns Hopkins, and colleagues reported online in &lt;em&gt;BMJ&lt;/em&gt;.&lt;br&gt;
&lt;br&gt;The first 18 months of their &lt;a href=&quot;http://www.medpagetoday.com/InfectiousDisease/GeneralInfectiousDisease/4771&quot; mce_href=&quot;http://www.medpagetoday.com/InfectiousDisease/GeneralInfectiousDisease/4771&quot; target=&quot;_blank&quot;&gt;Keystone ICU initiative&lt;/a&gt; dropped catheter-related interventions from a mean of 7.7 and median of 2.2 per 1,000 catheter days down to 1.3 and 0, respectively.&lt;br&gt;
&lt;br&gt;At the 36 month mark, infection rates remained almost nil, at a mean of 1.1 and median of 0 per 1,000 catheter days.&lt;p&gt;&lt;/p&gt;
&lt;p&gt;&quot;For the most part, hospitals view these infections as inevitable, as the cost of doing business, that patients are too sick, that these can&apos;t be prevented,&quot; Pronovost told &lt;em&gt;MedPage Today&lt;/em&gt;. &quot;That&apos;s just not true.&quot;&lt;/p&gt;
&lt;p&gt;Catheter-related infections are the number one cause of preventable death in hospitals and ICUs, ahead of even ventilator-related pneumonia, he noted.&lt;/p&gt;
&lt;p&gt;The changes seen at the 90 Michigan ICUs that stayed with the catheter-related infection initiative were impressive, representing one of the largest and longest improvements the field has seen.&lt;/p&gt;
&lt;p&gt;Often, quality initiatives fail on durability after the study funding and resources disappear, and hospitals are left on their own, Pronovost noted.&lt;/p&gt;
&lt;p&gt;&quot;If you push you might get some effect, but then you stop pushing  --  in other words the external control goes away  --  and the performance goes right back down,&quot; he said in an interview. &quot;It can&apos;t just be the stick that drives it.&quot;&lt;/p&gt;
&lt;p&gt;The intervention started with 103 ICUs that implemented strategies to reduce rates of catheter-related bloodstream infections rates over 18 months, with measurement and feedback of infection rates.&lt;/p&gt;
&lt;p&gt;The strategies aimed at improving execution of five evidence-based recommendations, as follows: &lt;ul&gt; &lt;li&gt;Hand washing before insertion of the catheter&lt;/li&gt; &lt;li&gt;Using gowns and full barrier precautions at catheter insertion&lt;/li&gt; &lt;li&gt;Cleaning the skin with chlorhexidine before catheter insertion&lt;/li&gt; &lt;li&gt;Avoiding the femoral site when possible&lt;/li&gt; &lt;li&gt;Removing unnecessary catheters&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Then, over the subsequent 18-month maintenance period, ICU teams were instructed to integrate this intervention into staff orientation, to collect monthly data from hospital infection control staff, and to report infection rates to physicians and others.&lt;/p&gt;
&lt;p&gt;Along with the sustained reduction in overall catheter-related infections, the researchers found a prolonged reduction in bloodstream infections that was significant during all study periods, compared to baseline.&lt;/p&gt;
&lt;p&gt;Rates decreased from a mean of 7.7 and median 2.7 of per 1,000 catheter days at baseline to 1.3 and 0, respectively, at 16 to 18 months after implementation. They remained at 1.1 and 0 at months 34 to 36 (-1% versus 18 months, 95% CI -9% to +7%).&lt;/p&gt;
&lt;p&gt;ICU teams interviewed attributed the continuously low rates to five factors: &lt;ul&gt; &lt;li&gt;Continued feedback on infection data&lt;/li&gt; &lt;li&gt;Improvements in safety culture as part of the project&lt;/li&gt; &lt;li&gt;An &quot;unremitting belief in the preventability of bloodstream infections&quot;&lt;/li&gt; &lt;li&gt;Involvement of senior leaders&lt;/li&gt; &lt;li&gt;A noncompetitive, shared goal to reduce infection rates throughout the state&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Of these, Pronovost called culture change in the ICUs the key factor to sustainability, although the researchers cautioned that which aspects contributed were not formally evaluated.&lt;/p&gt;
&lt;p&gt;They said they could not determine the impact incentive payments from Blue Cross Blue Shield of Michigan to hospitals that continued their participation  --  payments that were based on performance thresholds in subsequent years.&lt;/p&gt;
&lt;p&gt;Pronovost&apos;s team is now working to implement the quality initiative state-by-state nationwide, supported by the Agency for Healthcare Research and Technology.&lt;/p&gt;
&lt;p&gt;&quot;It seems absurd that this wouldn&apos;t be in every hospital in the country,&quot; he said in an interview. &quot;It&apos;s worked on a large scale, it&apos;s exceedingly cheap, there&apos;s no fancy technology.&quot;&lt;/p&gt;
&lt;p&gt;Success isn&apos;t only for community hospitals, Pronovost emphasized.&lt;/p&gt;
&lt;p&gt;Large, often academic, medical centers frequently express the conviction that their sicker, more complex ICU population wouldn&apos;t produce the same results, that their infections truly are inevitable, he said.&lt;/p&gt;
&lt;p&gt;&quot;To them I say, Not so,&quot; he told &lt;em&gt;MedPage Today&lt;/em&gt;. &quot;We have shown at Johns Hopkins, at the University of Michigan, at Pittsburgh, using a similar but different approach, at Tufts  --  many large academic medical centers have had dramatic reductions of these infections.&quot;&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The project was supported, for the period from October 2003 to September 2005, by the Agency for Healthcare Research and Quality and the Michigan Health &amp;amp; Hospital Association.&lt;/p&gt;&lt;p&gt;Pronovost and a co-author reported receiving received lecture fees from various healthcare organizations and grant support from the Agency for Healthcare Research and Quality, the Robert Wood Johnson Foundation, the National Patient Safety Agency, and the World Health Organization to study and improve quality of care, including catheter-related bloodstream infections.&lt;/p&gt;&lt;p&gt;Co-authors reported conflicts of interest with government agencies, Cubist, Astellas, Merck, Forrest, Cadence, the Robert Wood Johnson Foundation, Lilly, Edward Life Sciences, and Sage.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_400"
                     title="Fractured Evidence: Spine Repair Debate Heats Up"
                     score="0.009"
                     href="http://www.medpagetoday.com/Surgery/Orthopedics/tb/18303?impressionId=1265787407497"
                     
      &lt;p&gt;Hundreds of thousands have benefited from vertebroplasty, advocates insist. They say the minimally-invasive procedure has freed them from hospital beds and dependence on intravenous narcotics.&lt;/p&gt;
&lt;p&gt;Spine physicians swear that inserting a large-gauge needle into fractured vertebrae and injecting a cement compound to stabilize the bone hastens healing and helps relieve the often-crippling pain of compression fractures brought on by osteoporosis or metastatic disease.&lt;/p&gt;
&lt;p&gt;But two recently-published, randomized controlled trials  --  the gold standard of evidence-based medicine  --  say otherwise. As far as disability and pain relief were concerned, they found that vertebroplasty for osteoporotic vertebral compression fractures was no better than a sham procedure.&lt;/p&gt;
&lt;p&gt;Publication of the results triggered an outraged backlash from radiologists, for whom vertebroplasty is a bread-and-butter operation. The entire specialist community lambasted the studies  --  statistically and methodologically.&lt;/p&gt;
&lt;p&gt;But experts in evidence-based medicine argue that when profits are on the line, it&apos;s easy to be persuaded that studies are flawed.&lt;/p&gt;
&lt;p&gt;So the debate rages, with radiologists citing case after case of success, arguing that patients with the worst fractures will have no treatment alternatives if the nation&apos;s third-party payers  --  Medicare and the insurance companies&lt;strong&gt; -&lt;/strong&gt;- refuse to pay for the procedure anymore.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;The Studies&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;Both randomized, controlled studies were published last August in the &lt;em&gt;New England Journal of Medicine&lt;/em&gt;. They involved a combined total of about 200 patients. Each found that vertebroplasty did not yield significantly better results in terms of disability or short-term pain relief than sham procedures for patients with this type of vertebral fracture.&lt;/p&gt;
&lt;p&gt;In an e-mail to &lt;em&gt;MedPage Today&lt;/em&gt;, the author of one study, Rachelle Buchbinder, PhD, of Monash University in Australia, suggested that the research showed the procedure was ineffective.&lt;/p&gt;
&lt;p&gt;&quot;Based upon the results of both trials I don&apos;t think that this treatment should be offered in routine care,&quot; she declared.&lt;/p&gt;
&lt;p&gt;But the leader of the other trial, David Kallmes, MD, of the Mayo Clinic in Rochester, Minn., offered a different interpretation. He said the studies have been largely misunderstood by the trials&apos; critics&lt;strong&gt;.&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;&quot;I&apos;ve been practicing for 15 years and had strong confidence that the procedure was effective, and that&apos;s exactly what we showed,&quot; he said in a telephone interview.&lt;/p&gt;
&lt;p&gt;Mean baseline pain intensity on a 10-point scale was 6.9 in the vertebroplasty group and 7.2 in the sham-operated group in his trial, which had 131 patients. One month later, these scores had declined to 3.9 and 4.6, respectively.&lt;/p&gt;
&lt;p&gt;Kallmes said this degree of pain reduction with vertebroplasty &quot;exactly reproduces our prior experience.&quot; He vehemently denied that the findings were &quot;discordant&quot; with prior experience, as two statements from the Society of Interventional Radiology (SIR) put it.&lt;/p&gt;
&lt;p&gt;&quot;I don&apos;t know what they&apos;re talking about,&quot; Kallmes said. &quot;It is concordant.&quot;&lt;/p&gt;
&lt;p&gt;He said the real surprise was the effectiveness of the sham procedure, which should be the focus of follow-up investigations.&lt;/p&gt;
&lt;p&gt;It involved inserting needles into the spinal column and injecting short-acting painkillers such as lidocaine, as was also done with vertebroplasty prior to inserting needles into the fractured vertebrae and injecting the cement.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;The Flaws&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;Critics of the two studies cite a laundry list of complaints: too few patients, failure to meet enrollment, inclusion of patients with milder degrees of pain and disability than those usually treated.&lt;/p&gt;
&lt;p&gt;In a November commentary from SIR, issued in conjunction with &lt;em&gt;NEJM&apos;s &lt;/em&gt;publication of letters critical of the studies, J. Kevin McGraw, MD, of Riverside Radiology and Interventional Associates in Columbus, Ohio, highlighted the fact that Kallmes&apos; study originally called for 250 patients.&lt;/p&gt;
&lt;p&gt;Only 131 enrolled, and the vast majority  --  1,682 of 1,813 screened  --  were excluded, &quot;introducing significant selection bias into the study,&quot; he complained.&lt;/p&gt;
&lt;p&gt;McGraw also pointed out that Kallmes&apos; group didn&apos;t use screening MRI to ensure that a fracture was the cause of the patient&apos;s pain.&lt;/p&gt;
&lt;p&gt;In addition, he did some additional statistical noodling and found that if one additional patient had reported a favorable response in the vertebroplasty group, the &lt;em&gt;P&lt;/em&gt;-value would be 0.04, rather than a nonsignificant 0.06. Likewise, if one more patient had an unfavorable response in control group, the association&apos;s&lt;em&gt; P&lt;/em&gt;-value would become significant.&lt;/p&gt;
&lt;p&gt;Finally, in the crossover part of the trial, McGraw highlighted that 12% of patients in the vertebroplasty arm elected the sham procedure, while 43% of those who got the sham went for the real thing.&lt;/p&gt;
&lt;p&gt;&quot;The tremendous crossover rate speaks for some obvious benefit of vertebroplasty over sham and is worthy of a future adequately powered analysis to evaluate,&quot; McGraw wrote.&lt;/p&gt;
&lt;p&gt;As for the Buchbinder trial, McGraw said it was convoluted by selection bias, since two-thirds of patients came from a single center and their procedures were performed by a single radiologist. The commentary also criticizes the volume of cement injected into vertebrae as lower than normal.&lt;/p&gt;
&lt;p&gt;Similarly, the North American Spine Society issued a critique of patient selection criteria and outcome measures, and questioned whether the sham treatment was actually an active therapy. The statement suggested that dry needling might be a more appropriate control.&lt;/p&gt;
&lt;p&gt;One of the letters published in &lt;em&gt;NEJM&lt;/em&gt; also criticized the protocol requirement that patients undergo four weeks of medical therapy prior to enrollment in the trial. During that time, some fractures would have already healed, &quot;resulting in a study on healed fractures,&quot; a group of Australian physicians wrote.&lt;/p&gt;
&lt;p&gt;SIR president Brian F. Stainken, MD, took issue with the fact that patients with the most pain  --  typically older, osteoporotic women  --  weren&apos;t represented.&lt;/p&gt;
&lt;p&gt;McGraw said these patients would be the least likely to agree to be in a randomized trial with a 50% chance of receiving the sham treatment.&lt;/p&gt;
&lt;p&gt;&quot;Most people in severe pain won&apos;t enroll,&quot; Stainken said. &quot;At some level, research design has to take reality into consideration.&quot;&lt;/p&gt;
&lt;p&gt;&quot;The population with low-grade pain, that&apos;s the population these papers focused on,&quot; he continued. &quot;It&apos;s not clear what the right solution is for this group. But I think the contribution of these [two &lt;em&gt;NEJM&lt;/em&gt; studies] may be toward that.&quot;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;On the Defense&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;Kallmes, however, responded that there was no difference in baseline pain scores between patients entering the study and those considered eligible but refusing to participate.&lt;/p&gt;
&lt;p&gt;He also told &lt;em&gt;MedPage Today&lt;/em&gt; that he and colleagues &quot;enrolled patients that are very similar to those treated around the world.&quot;&lt;/p&gt;
&lt;p&gt;&quot;These studies were by far, by far, the best studies ever done,&quot; Kallmes declared.&lt;/p&gt;
&lt;p&gt;&quot;I have full confidence that if we had shown something different, that is, if we had found the procedure was more effective than placebo, people would have embraced it and said they were great studies,&quot; he continued.&lt;/p&gt;
&lt;p&gt;&quot;They would have said, &apos;Look at it, they were prospective, randomized, blinded, near 100% follow-up.&apos; They would have been held up as the paragon for how to do studies in the future  --  if we had reinforced people&apos;s preconceived notions.&quot;&lt;/p&gt;
&lt;p&gt;Richard Deyo, MD, MPH, professor of evidence-based medicine at Oregon Health &amp;amp; Science University in Portland and deputy editor of &lt;em&gt;Spine,&lt;/em&gt; told &lt;em&gt;MedPage Today&lt;/em&gt; that the studies are the best evidence to date regarding the effectiveness of vertebroplasty in these patients.&lt;/p&gt;
&lt;p&gt;&quot;No study is perfect, and these are not perfect, but I do think they&apos;re the best we have,&quot; Deyo said.&lt;/p&gt;
&lt;p&gt;Deyo said there was some validity to complaints that the studies enrolled too few patients, although both trials were adequately powered to detect a difference in pain reduction.&lt;/p&gt;
&lt;p&gt;&quot;If the benefit of this treatment were as enormous as many of the advocates argue,&quot; he said, &quot;then it would take a much smaller study to demonstrate a huge benefit.&quot;&lt;/p&gt;
&lt;p&gt;On the other hand, the studies were too small to evaluate the effects among various patient subgroups.&lt;/p&gt;
&lt;p&gt;Kallmes also criticized the societies&apos; press releases, charging they were written by some &quot;who haven&apos;t read the studies carefully.&quot;&lt;/p&gt;
&lt;p&gt;&quot;The societies are in a great position,&quot; he said. &quot;They have thought leaders that they can partner with to move the science forward. Moving the science forward is not done by sending out press releases.&quot;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Radiologists&apos; Concerns&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;SIR&apos;s reaction may not be surprising, given that radiologists are so vested in vertebroplasty. Medicare will pay physicians from $522 to $554 for a procedure on one vertebra performed in a hospital or outpatient surgery clinic  --  or more than $2,000 if it&apos;s conducted in the physician&apos;s office.&lt;/p&gt;
&lt;p&gt;The number of annual procedures varies from office to office, and radiologists provide varying estimates. McGraw said he performs about 150 vertebroplasties annually, and Stainken said the procedure accounts for about 20% of radiologists&apos; procedures, although that estimate &quot;may be a little high.&quot;&lt;/p&gt;

&lt;p&gt;One of the radiologists&apos; main concerns is that insurance companies will use the trials to justify ending coverage of vertebroplasty for osteoporotic spinal fractures.&lt;/p&gt;
&lt;p&gt;But insurers started playing that card long before the &lt;em&gt;NEJM&lt;/em&gt; trials were published.&lt;/p&gt;
&lt;p&gt;In a 2008 report, the Technology Evaluation Center of the Blue Cross and Blue Shield Association (BCBSA) concluded that neither vertebroplasty nor the related kyphoplasty  --  which restores compression-fractured vertebrae to their normal size with a balloon before the cement injection  --  had been demonstrated to be any better at improving net health outcomes than medical treatments.&lt;/p&gt;
&lt;p&gt;That same year, Wellpoint, the insurance giant with 35 million members, announced plans to classify both procedures &quot;investigational.&quot; That prompted a letter from SIR imploring the company to reconsider.&lt;/p&gt;
&lt;p&gt;Another spine physician, Christopher Bono, MD, of Brigham &amp;amp; Women&apos;s Hospital in Boston, told &lt;em&gt;MedPage Today &lt;/em&gt;that Aetna was also reconsidering coverage for vertebroplasty following the &lt;em&gt;NEJM&lt;/em&gt; publications.&lt;/p&gt;

&lt;p&gt;He said that he believed the firms would not end coverage entirely, but policies would be more restrictive.&lt;/p&gt;
&lt;p&gt;&quot;My gut sense is that payers are going to be much more selective in who they will pay for [regarding vertebroplasty],&quot; Bono said. &quot;They will ask for certain documentation and many more criteria than they did in the past.&quot;&lt;/p&gt;
&lt;p&gt;McGraw worries that seniors will be &quot;denied coverage when they are in the twilight of their lives and could possibly have long-standing suffering&quot; that &quot;could lead to their demise.&quot;&lt;/p&gt;
&lt;p&gt;Stainken said there&apos;s &quot;clear, unambiguous data that prolonged bed rest is the beginning of the cycle of decline for these patients. The key is to be able to do everything we can to ... keep these patients ambulatory and avoid that whole scenario.&quot;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Change is Hard&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;Deyo said money may partly explain the reluctance of physicians who perform vertebroplasties to scale back their use of the procedure.&lt;/p&gt;
&lt;p&gt;&quot;There are people who are making a living doing this, and you don&apos;t easily change what you do for a living,&quot; Deyo said.&lt;/p&gt;
&lt;p&gt;The man credited with coining the term &quot;evidence-based medicine&quot; agreed.&lt;/p&gt;
&lt;p&gt;&quot;If you are making money from a procedure, it is very easy to persuade yourself that new evidence that the procedure is ineffective is in some way flawed or limited to allow you to continue to make money on the procedure,&quot; Gordon Guyatt, MD, of McMaster University in Hamilton, Ontario, told &lt;em&gt;MedPage Today.&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;&quot;When we have opinions and beliefs, we are very resistant to new evidence.&quot;&lt;/p&gt;
&lt;p&gt;Kallmes, too, said there are psychological reasons for not accepting the results: &quot;People just don&apos;t want to be convinced. They don&apos;t want to change their preconceived notions.&quot;&lt;/p&gt;
&lt;p&gt;&quot;They have this anecdotal experience,&quot; he added, &quot;but I can tell them anecdotes of miraculous results with the placebo. So if they do this same study themselves, they may find the same thing I found.&quot;&lt;/p&gt;
&lt;p&gt;Still, McGraw and Bono insisted the studies were too flawed to serve as the evidence base for clinical practice.&lt;/p&gt;
&lt;p&gt;&quot;Before we make these two studies the Holy Grail of evidentiary medicine with regard to vertebroplasty, we need to have larger trials,&quot; McGraw said.&lt;/p&gt;
&lt;p&gt;Bono said evidence-based medicine, properly implemented, has three components: reviewing and applying the best data, &quot;but also incorporating surgeon experience and patient preference.&quot;&lt;/p&gt;
&lt;p&gt;&quot;If you are just using the first, and I&apos;m a strong advocate for using data and literature and references, I think you&apos;re doing a disservice,&quot; he said. &quot;And then if you are misinterpreting the data or twisting the data or slanting the data, and eliminating the other two, you are really abusing the word evidence-based medicine.&quot;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Outcomes&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;So, will vertebroplasty go the way of other procedures that seemed to work clinically, but bombed in trials, such as knee arthroscopy for osteoarthritis?&lt;/p&gt;
&lt;p&gt;SIR is awaiting the results of VERTOS II, a 200-patient Dutch trial comparing vertebroplasty with conservative therapy in patients with painful, osteoporotic vertebral compression fractures. And Stainken called for large trials that will address several of the methodology issues raised with the &lt;em&gt;NEJM &lt;/em&gt;reports.&lt;/p&gt;
&lt;p&gt;With regard to the potential placebo effect, Kallmes said he has nearly completed a 20-patient, open-label study of a procedure like that used as the sham in the randomized trial  --  a spinal injection of short-acting painkillers.&lt;/p&gt;
&lt;p&gt;Also in the works is a comparative trial of vertebroplasty and balloon kyphoplasty, he said.&lt;/p&gt;
&lt;p&gt;Stainken said he has heard from colleagues who said they had slowed down or stopped doing the procedures after the studies were published, &quot;which is not unreasonable  --  to think it through and understand the situation.&quot;&lt;/p&gt;
&lt;p&gt;However, most have resumed performing the procedure, and demand for it continues, he added.&lt;/p&gt;
&lt;p&gt;Aman Patel, MD, an associate professor of radiology and neurosurgery at Mount Sinai School of Medicine in New York City, said he and his colleagues have not changed their practice since learning of the studies&apos; findings.&lt;/p&gt;
&lt;p&gt;However, he has started telling patients about the findings from the &lt;em&gt;NEJM&lt;/em&gt; studies so they can be fully informed of the existing evidence about the risks and benefits of vertebroplasty.&lt;/p&gt;
&lt;p&gt;&quot;I firmly believe this procedure benefits some, if not many, patients,&quot; Patel said.&lt;/p&gt;
&lt;p&gt;McGraw said he tells patients about the trials, but he also tells patients who he thinks would benefit from vertebroplasty that he doesn&apos;t believe the findings apply to them.&lt;/p&gt;
&lt;p&gt;He said one patient had initially declined the procedure after talking it over. &quot;That patient called me up a week later to proceed with vertebroplasty,&quot; he said.&lt;/p&gt;
&lt;p&gt;Even if the findings don&apos;t change the way spine doctors use vertebroplasty in the short term, Deyo suspects the results will lead to fewer procedures in the long run.&lt;/p&gt;
&lt;p&gt;Guyatt and Deyo predicted that eventually, a critical mass of evidence would be assembled  --  assuming future randomized studies replicate these results  --  that would convince even the most steadfast adherents.&lt;/p&gt;
&lt;p&gt;Also, the &lt;em&gt;NEJM&lt;/em&gt; studies could have an immediate effect in promoting more research by increasing the level of doubt about the procedure, Deyo said: &quot;I don&apos;t think we have the final word here.&quot;&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;Deyo, Guyatt, Patel, and Stainken reported having no relevant conflicts of interest.&lt;/p&gt;&lt;p&gt;Bono reported financial relationships other than research funding with Life Spine, Depuy, Medtronic, and Stryker, and research funding from Archus Orthopedics and Synthes Spine. He was lead author of the North American Spine Society&apos;s critique of the two randomized trials published in the &lt;em&gt;New England Journal of Medicine&lt;/em&gt;.&lt;/p&gt;&lt;p&gt;McGraw has had relationships with Cardinal Spine, Arthrocare Spine, and Hatch Medical.&lt;/p&gt;&lt;p&gt;Kallmes reported relationships with ArthroCare, Stryker, Cardinal, and Cook.&lt;/p&gt;&lt;p&gt;Buchbinder reported receiving research funding from Cook.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
</recommendedContent>