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    <recommendedItem id="20100101_19_467"
                     title="FDA Unveils New Safety Plan for Medical Imaging"
                     score="0.014"
                     href="http://www.medpagetoday.com/Radiology/DiagnosticRadiology/tb/18398?impressionId=1265767336016"
                     
      &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_400"
                     title="Fractured Evidence: Spine Repair Debate Heats Up"
                     score="0.01"
                     href="http://www.medpagetoday.com/Surgery/Orthopedics/tb/18303?impressionId=1265767336016"
                     
      &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>
    <recommendedItem id="20100101_19_423"
                     title="Week 31: Baucus Quotes Gandhi; Obama Wants $80 Billion HHS Boost"
                     score="0.009"
                     href="http://www.medpagetoday.com/Washington-Watch/Reform/tb/18337?impressionId=1265767336016"
                     
      &lt;p&gt;WASHINGTON  --  Sen. Max Baucus (D-Mont.), chairman of the Senate Finance Committee, likes to start hearings with a quote from a famous leader. This week, he quoted Mahatma Gandhi.&lt;/p&gt;
&lt;p&gt;&quot;Every worthwhile accomplishment . . . has its stages of drudgery and triumph; a beginning, a struggle, and a victory,&quot; said Baucus, who has been an integral part of the negotiations that stalled last month with Congress apparently just weeks away from passing a healthcare reform bill.&lt;/p&gt;
&lt;p&gt;The effort to enact healthcare reform &quot;has certainly seen its struggles,&quot; Baucus said. But he said he agrees with President Barack Obama, who urged Congress during his State of the Union address not to give up on passing comprehensive reform.&lt;/p&gt;
&lt;p&gt;&quot;We have gone well past this effort&apos;s beginning,&quot; Baucus said. &quot;We have endured our share of struggle. Now let us at last bring this bill to victory.&quot;&lt;/p&gt;
&lt;p&gt;Since the election to the U.S. Senate of Massachusetts Republican Scott Brown  --  a vocal opponent of healthcare reform  --  and the president&apos;s State of the Union message, which focused strongly on job creation and improving the economy, healthcare reform has been moved to a back burner.&lt;/p&gt;
&lt;p&gt;But &quot;I&apos;m very confident we&apos;re going to pass healthcare reform this year,&quot; Baucus said during Wednesday&apos;s hearing.&lt;/p&gt;
&lt;p&gt;Obama also urged Congress again not to give up on a bill when he spoke to Democrats at a question-and-answer session on Thursday.&lt;/p&gt;
&lt;p&gt;&quot;All that&apos;s changed in the last two weeks is that our party&apos;s gone from having the largest majority in a generation to having the second-largest majority in a generation,&quot; Obama said. &quot;We&apos;ve got to remember that.&quot;&lt;/p&gt;
&lt;p&gt;Although Baucus used most of his speaking time talking about healthcare reform, the purpose of this week&apos;s hearing was to question Department of Health and Human Services secretary Kathleen Sebelius about the $80 billion increase in funding for HHS requested in the &lt;a href=&quot;http://www.medpagetoday.com/Washington-Watch/Reform/18248&quot; mce_href=&quot;http://www.medpagetoday.com/Washington-Watch/Reform/18248&quot; target=&quot;_blank&quot; title=&quot;Obama&amp;#8200;Requests&amp;#8200;$80&amp;#8200;Billion&amp;#8200;Increase&amp;#8200;in&amp;#8200;Healthcare&amp;#8200;Funding&quot;&gt;president&apos;s 2011 budget&lt;/a&gt;.&lt;/p&gt;
&lt;p&gt;Under Obama&apos;s blueprint, HHS would receive $911 billion in 2011, most of which would be Medicare and Medicaid spending. But the National Institutes of Health (NIH) would also get a $1 billion boost for medical research, and there would be money for improving food, drug, and device safety, and to intensify efforts to help Americans quit smoking and get healthy.&lt;/p&gt;
&lt;p&gt;The President&apos;s budget doesn&apos;t make any provisions for healthcare reform should it be enacted.&lt;/p&gt;
&lt;p&gt;Healthcare spending now accounts for 17.3% of the nation&apos;s total spending, according to &lt;a href=&quot;http://www.medpagetoday.com/Washington-Watch/Washington-Watch/18302&quot; mce_href=&quot;http://www.medpagetoday.com/Washington-Watch/Washington-Watch/18302&quot; target=&quot;_blank&quot; title=&quot;In&amp;#8200;Bad&amp;#8200;Economy,&amp;#8200;Record&amp;#8200;Growth&amp;#8200;in&amp;#8200;Health&amp;#8200;Spending&quot;&gt;new data&lt;/a&gt; released by the Centers for Medicare and Medicaid Services.&lt;/p&gt;
&lt;p&gt;The recession of 2009, coupled with growing use of medical services, led to the fastest one-year growth in health spending since the 1960s, according to the CMS report.&lt;/p&gt;
&lt;p&gt;By 2019, national health spending is projected to reach $4.5 trillion and account for about 19% of gross domestic product (GDP), according to the report.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_422"
                     title="Nurses Often Silent About Workplace Violence (CME/CE)"
                     score="0.009"
                     href="http://www.medpagetoday.com/HospitalBasedMedicine/WorkForce/tb/18335?impressionId=1265767336016"
                     
      The physical and verbal abuse nurses face on the job often goes unreported, according to an Australian survey.&lt;br&gt;
&lt;br&gt;Over the prior year, 52% of nurses in one community hospital said they had been physically assaulted and 69% reported being threatened with violence, according to Rose Chapman, PhD, of the University of Western Australia in Perth, and colleagues.&lt;br&gt;
&lt;br&gt;Verbal abuse was almost universal, being reported by 92% of respondents, the researchers wrote in the February issue of the &lt;em&gt;Journal of Clinical Nursing&lt;/em&gt;.&lt;br&gt;
&lt;br&gt;However, only half mentioned the incidents to senior staff or co-workers, and just 16% filed an official report.&lt;br&gt;
&lt;br&gt;&quot;The reasons for not reporting are many and may include lack of time and management support and the belief that being attacked is &apos;just part of the job,&apos;&quot; they wrote.&lt;br&gt;
&lt;br&gt;The same is true in the U.S., where assaults and under-reporting appear just as common as suggested in the Australian survey, commented Kathleen M. McPhaul, PhD, RN, MPH, of the University of Maryland School of Nursing in Baltimore, who has been involved in such research in the U.S.&lt;br&gt;
&lt;br&gt;A culture change would likely be needed to make a real difference for nurses, Chapman&apos;s group suggested.&lt;p&gt;&lt;/p&gt;
&lt;p&gt;Hospitals would have to ensure that nurses have necessary support, education, encouragement, and time to complete official reports. Nurses who report abuse should get positive feedback from all levels of nursing, they said.&lt;/p&gt;
&lt;p&gt;&quot;If administrators and governments are serious in their intention to reduce workplace violence and provide staff with safe work environments, they should be seen to act on all reported [incidents],&quot; which is rare today, Chapman&apos;s group wrote.&lt;/p&gt;
&lt;p&gt;However, currently there&apos;s no strong lever or incentive to address this kind of workplace abuse since hospitals focus mainly on patient safety as part of accreditation, and national and state workplace safety organizations have little mechanism for monitoring such incidents, McPhaul noted.&lt;/p&gt;
&lt;p&gt;The researchers&apos; survey was intended to reach all 332 nurses working at one nontertiary hospital across all departments  --  emergency, medical, surgical, maternity, pediatric, and mental health.&lt;/p&gt;
&lt;p&gt;The 113 nurses who responded were mainly women in their early 40s who worked part time.&lt;/p&gt;
&lt;p&gt;Among them, about three-quarters reported at least one incident of workplace violence over the preceding 12 months  --  25% said it occurred weekly, 27% said monthly, and for 25% it was rarer, at once every six months. &lt;ul&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Fully 30% of the nurses said they had been involved in an episode involving a weapon  --  often hospital equipment and more rarely a knife or gun.&lt;/p&gt;
&lt;p&gt;The number of total incidents was lowest among nurse midwives, with a mean of 1.67 per year.&lt;/p&gt;
&lt;p&gt;Not surprisingly, the rate was highest among emergency department and mental health staff, who reported an average of 46.43 and 40.39 episodes over 12 months.&lt;/p&gt;
&lt;p&gt;One reason behind the high risk in these two departments may be the &quot;shift to a community-based approach to mental health care and a reduction in mental health beds&quot; such that the same psychiatric patients that assault mental health department nurses are mainstreamed to the emergency department as their point of entry to the hospital, the researchers said.&lt;/p&gt;
&lt;p&gt;However, more years of experience or higher educational qualification didn&apos;t appear to protect nurses. Senior nurse unit managers and clinical nurse specialists actually reported more physical assaults than less senior nurses.&lt;/p&gt;
&lt;p&gt;Age and gender didn&apos;t predict occurrence or type of incident either.&lt;/p&gt;
&lt;p&gt;When nurses did report workplace violence or verbal abuse, it was most often to their immediate manager (29%), other senior nursing staff (14.5%), or to their friends and colleagues (6%).&lt;/p&gt;
&lt;p&gt;Overall, 30% of nurses who responded to the survey gave as their reason for not reporting that workplace violence happens all the time and is simply part of the job.&lt;/p&gt;
&lt;p&gt;Even among those who did make a report of some sort, half said they thought hospital management failed to act on it.&lt;/p&gt;
&lt;p&gt;In fact, when the researchers audited hospital records, they found that 42 official incident reports had been filed by nurses over the prior one year period, nearly always involving injuries.&lt;/p&gt;
&lt;p&gt;In 95% of the cases, the only action taken by the hospital was making staff in the area aware of the incident. No other actions had been documented.&lt;/p&gt;
&lt;p&gt;The researchers cautioned that the voluntary nature and limited scope of the study may have limited generalizability, although the occurrence of violence against nurses is likely similar across developed countries.&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 researchers provided no information on conflicts of interest.&lt;/p&gt;&lt;p&gt;McPhaul 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_421"
                     title="BLOG: Super Sound Bite Sunday"
                     score="0.009"
                     href="http://www.medpagetoday.com/Blogs/18323?impressionId=1265767336016"
                     
      I love football.&lt;br&gt;
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I loved it when I was a kid shivering in the bleachers watching my brothers play high school ball for a team that could never quite seem to level the playing field. &lt;br&gt;
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I loved it when I was a teenager cheering a team from that same high school, a team that often defined a winning season as 3-6. &lt;br&gt;
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I loved watching college ball when I was in college (my college didn&apos;t have a team, but when you&apos;re in college you can always find a team to support). &lt;br&gt;
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I loved it when I lived in NY and was a &lt;a href=&quot;http://www.pro-football-reference.com/teams/nyg/1977.htm&quot; target=&quot;_blank&quot;&gt;Giants&apos;&lt;/a&gt; fan  (no joy there), in Washington as a &lt;a target=&quot;_blank&quot; href=&quot;http://www.pro-football-reference.com/teams/was/1980.htm&quot;&gt;Redskins&lt;/a&gt; fans (damn Cowboys), and finally in Cleveland where the &lt;a target=&quot;_blank&quot; href=&quot;http://en.wikipedia.org/wiki/The_Drive&quot;&gt;&amp;quot;Brownies&amp;quot;&lt;/a&gt; have broken my fan&apos;s heart over and over and over. &lt;br&gt;
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So it is not surprising that Super Bowl Sunday is a special day for me and for my family as well. When our kids were little we would all gather in our family room for an afternoon of super Sunday punditry followed by &amp;quot;the game&amp;quot;, &amp;quot;the half-time show&amp;quot;, and, finally, &amp;quot;the call from the White House.&amp;quot;&lt;br&gt;
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And, of course, the Super Sunday menu -- should it be crab legs and subs? chili and natchos? pizza and wings?&lt;br&gt;
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But over the years, aside from offering us an excellent opportunity to test our knowledge of Roman numerals -- XLIV (let&apos;s see the L = 50,  X = 10, but X to the left of L means 50-10, so that&apos;s 40, V is 5, and whereas VI is 6, IV is 4, so Super Bowl 44) -- the football played in many of these games has been a little short of memorable. &lt;br&gt;
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Not to worry. TV, like nature, hates a vacuum almost as much as it abhors low ratings. So Madison Avenue has been the &amp;quot;guarantee&amp;quot; if the football was boring, the commercials would supply the excitement. &lt;br&gt;
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And they have -- who can forget &lt;a href=&quot;http://en.wikipedia.org/wiki/Super_Bowl_advertising&quot; target=&quot;_blank&quot;&gt;Mean Joe Green or the Bud Bowl or &amp;quot;When I grow up&amp;quot;&lt;/a&gt;?&lt;br&gt;
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But then the commercials crossed the line into my world, the world of medical news -- actually you could say they stepped over the line -- when &lt;a href=&quot;http://www.time.com/time/magazine/article/0,9171,996064-1,00.html&quot; target=&quot;_blank&quot;&gt;Christopher Reeve walked across the stage in 2000.&lt;/a&gt;&lt;br&gt;
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Whoa. Not a good idea.&lt;br&gt;
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And this year it looks like we have another &apos;not a good idea&apos; scenario. &lt;br&gt;
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I&apos;m talking not only about about the &lt;a href=&quot;http://abcnews.go.com/WN/tim-tebow-super-bowl-ad-cbs-air-controversial/story?id=9667638&quot; target=&quot;_blank&quot;&gt;Tim Tebow ad sponsored by Focus on Family&lt;/a&gt;, a conservative group that opposes abortion but also the pre-emptive strike delivered by &lt;a href=&quot;http://www.youtube.com/watch?v=utcxpuHF7jg&amp;feature=player_embedded&quot; target=&quot;_blank&quot;&gt;Planned Parenthood&lt;/a&gt;.&lt;br&gt;
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Dueling commercials may be a great way to sell cell phones or beer or hamburgers or cars, but I don&apos;t think its a good way to address serious issues such as treatment of spinal injuries or women&apos;s reproductive choices. &lt;br&gt;
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These are not only serious issues but also explosive issues that deserve thoughtful, measured discussion. Not the &amp;quot;Hey, grab me a beer and pass the chips. Uh-oh, what&apos;s this? An ad about abortion.&amp;quot; &lt;br&gt;
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Bring back the &lt;a target=&quot;_blank&quot; href=&quot;http://www.digibarn.com/collections/movies/digibarn-tv/xerox-monks/index.html&quot;&gt;Xerox monks. &lt;/a&gt;&lt;br&gt;
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    </recommendedItem>
</recommendedContent>