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    <recommendedItem id="20100101_19_400"
                     title="Fractured Evidence: Spine Repair Debate Heats Up"
                     score="0.011"
                     href="http://www.medpagetoday.com/Surgery/Orthopedics/tb/18303?impressionId=1265777680172"
                     
      &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_424"
                     title="AAPM: Facet Graft Quells Refractory Back Pain (CME/CE)"
                     score="0.01"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAPM/tb/18343?impressionId=1265777680172"
                     
      &lt;p&gt;SAN ANTONIO  --  Minimally invasive facet arthrodesis significantly reduced pain and improved physical function for one&lt;strong&gt; &lt;/strong&gt;year in patients with medically refractory facet arthropathy, according to data from a prospective clinical series.&lt;/p&gt;
&lt;p&gt;Most patients discontinued narcotic pain relievers, researchers reported here, and only one of 28 patients in the series had no appreciable change in pain after the noninstrumented spinal surgery.&lt;/p&gt;
&lt;p&gt;&quot;The procedure does not disrupt stabilizing ligaments or muscular structures of the posterior spine, allowing unimpeded physiotherapy for low back muscular strengthening after 16 weeks,&quot; Daniel Bennett, MD, of Integrative Treatment Centers in Denver, told attendees at the American Academy of Pain Medicine meeting.&lt;/p&gt;
&lt;p&gt;&quot;If fusion occurs, symptoms should not return, as with traditional treatment modalities, such as thermal radiofrequency neurolysis.&quot;&lt;/p&gt;
&lt;p&gt;The results have provided the foundation for a prospective, multicenter, randomized clinical trial to compare radiofrequency neurolysis and minimally invasive spine facet arthrodesis, he added.&lt;/p&gt;
&lt;p&gt;Medical management of low back pain related to facet degeneration often provides minimal pain relief and can interfere with functioning. Direct injection of anesthesia into an affected joint also leads to negligible long-term benefits, said Bennett. Radiofrequency neurolysis provides only temporary pain relief and must be repeated because of nerve regeneration.&lt;/p&gt;
&lt;p&gt;All the patients had a return of pain after previous radiofrequency neurolysis and were eligible for repeat neurolytic procedures. Affected areas were confirmed by anesthetic injection, followed by a provocatory examination.&lt;/p&gt;
&lt;p&gt;The patients underwent a standardized procedure that included a small incision at the affected area, insertion of surgical pins to stabilize the joint, use of a surgical drill to achieve joint separation, and insertion of 5-mm or 7-mm Morse tapered cortical allografts.&lt;/p&gt;
&lt;p&gt;After surgery, patients wore a rigid brace for 16 weeks, at which point they began physical therapy to strengthen back muscles.&lt;/p&gt;
&lt;p&gt;The patients received a total of 102 grafts at 51 levels, and four dislodgements (3.9%) occurred. None of the patients had a return of pain after dislodgement.&lt;/p&gt;
&lt;p&gt;&quot;Among patients who retained grafts, all showed callus formation of the posterior joint and incorporation of the cortical allograft,&quot; said Bennett.&lt;/p&gt;
&lt;p&gt;At the 52-week follow-up, the average score on a 100-point visual analog pain scale was 23, down from an average of 79 prior to the intervention. Patients&apos; scores on the Oswestry Disability Index averaged 8.32, compared with 33.46 at baseline.&lt;/p&gt;
&lt;p&gt;All but four patients discontinued narcotic medication, and the morphine dose required by those four decreased from a baseline range of 150 to 360 mg to a range of 10 to 30 mg at one year.&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 Prism Healthcare Foundation.&lt;/p&gt;&lt;p&gt;Bennett disclosed relationships with Alphatec Spine, miniSURG, Boston Scientific, Cephalon, Nevro, and Paylon.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_402"
                     title="Minimally Invasive Surgery Takes Toll on MDs, Poll Shows (CME/CE)"
                     score="0.009"
                     href="http://www.medpagetoday.com/Surgery/GeneralSurgery/tb/18306?impressionId=1265777680172"
                     
      &lt;p&gt;Four out of five surgeons agree: Laparoscopic procedures cause substantial discomfort and pain for the surgeons who perform them.&lt;/p&gt;
&lt;p&gt;More than 80% of surgeons completing an online questionnaire reported pain or stiffness in the hands, neck, back, or legs after performing minimally invasive surgeries, according to Adrian Park, MD, of the University of Maryland Medical Center in Baltimore, and colleagues.&lt;/p&gt;
&lt;p&gt;For most symptoms, the strongest predictor was high case volume, the researchers reported online in the &lt;em&gt;Journal of the American College of Surgeons&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Park and colleagues warned of &quot;an impending epidemic&quot; of occupational injuries among clinicians specializing in minimally invasive surgeries, as such procedures become more common.&lt;/p&gt;
&lt;p&gt;&quot;Now, especially in the face of an impending shortage of general surgeons in the U.S., the last thing that we as a society can afford is surgical careers shortened by occupationally related symptoms and conditions,&quot; they asserted.&lt;/p&gt;
&lt;p&gt;The researchers recommended more research into the ergonomics of laparoscopic surgery, as well as better implementation of existing guidelines meant to reduce injuries associated with the awkward postures and long surgical times often required with these procedures.&lt;/p&gt;
&lt;p&gt;&quot;That research must more clearly and emphatically define the ergonomic impact of minimally invasive surgery on the practicing surgeon (then set about improving it) is now all too painfully clear,&quot; Park and colleagues concluded.&lt;/p&gt;
&lt;p&gt;The researchers invited some 2,000 board-certified members of the Society of American Gastrointestinal and Endoscopic Surgeons (of which Park is currently secretary) to complete the online survey.&lt;/p&gt;
&lt;p&gt;The response rate was 14.4%, with 317 surgeons identified as actively and regularly involved in laparoscopic practices participating.&lt;/p&gt;
&lt;p&gt;Of these, 272 reported experiencing physical symptoms or discomfort that they believed were the result of performing minimally invasive procedures.&lt;/p&gt;
&lt;p&gt;This rate of reported symptoms is markedly higher than that found in earlier studies and surveys, in which the prevalences were in the range of 15% to 60%, Park and colleagues noted.&lt;/p&gt;
&lt;p&gt;They speculated that the current survey, as the most recent, may better reflect the accumulation of injuries over time as surgeons&apos; careers doing minimally invasive surgery have grown longer.&lt;/p&gt;
&lt;p&gt;Fortunately, they found, symptoms were generally not persistent. Only 10.8% of respondents indicated that pain or discomfort continued beyond the immediate aftermath of surgery.&lt;/p&gt;
&lt;p&gt;The largest class of symptoms were those occurring during surgery, with 20.8% of surgeons saying they had symptoms only during procedures and 27.8% reporting symptoms both during and immediately after surgery.&lt;/p&gt;
&lt;p&gt;Another 22.4% indicated that symptoms occurred only immediately after surgery and not persistently.&lt;/p&gt;
&lt;p&gt;About 15% chose &quot;nothing bothers me&quot; in the questionnaire.&lt;/p&gt;
&lt;p&gt;Age appeared to be a factor in the incidence of some complaints, although the pattern was not what might be expected. In particular, hand pain was most common among surgeons younger than 40 and in those older than 60, whereas it was least frequent among surgeons in their 50s.&lt;/p&gt;
&lt;p&gt;Park and colleagues did not report specific hazard ratios or correlation coefficients for case volume as a predictor of symptoms, but they indicated that it was associated with complaints more strongly than other factors such as age, career duration, gender, and height.&lt;/p&gt;
&lt;p&gt;About three-quarters of respondents attributed symptoms to instrument design. Some 40% indicated that operating room table setup and the display monitor location were also contributing factors.&lt;/p&gt;
&lt;p&gt;On the other hand, more than 180 respondents said they had slight or no awareness of published recommendations on surgical ergonomics, such as guidelines published last year in the journal &lt;em&gt;Surgical Endoscopy&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Among those reporting any level of knowledge about the guidelines, only 60% indicated that they had applied it in their practices, Park and colleagues indicated. But more than 90% of surgeons who said they had high awareness of ergonomic guidelines reported putting it to use.&lt;/p&gt;
&lt;p&gt;The researchers said future studies should address other issues not covered adequately in the survey, such as the effects of different monitor positions and instrument designs, as well as whether surgeon discomfort during laparoscopic surgery leads to adverse patient outcomes.&lt;/p&gt;
&lt;p&gt;Park and colleagues also suggested that similar research be conducted on open surgery.&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;No external funding for the study was reported.&lt;/p&gt;&lt;p&gt;No potential conflicts of interest were reported.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_264"
                     title="AAP Releases Tips on Preventing Soccer Injuries (CME/CE)"
                     score="-0"
                     href="http://www.medpagetoday.com/Orthopedics/Orthopedics/tb/18098?impressionId=1265777680172"
                     
      &lt;p&gt;Coaches, parents, doctors and soccer officials can help prevent soccer-related injuries as the popularity of the sport grows, according to a report from the American Academy of Pediatrics.&lt;/p&gt;
&lt;p&gt;Although soccer is an effective way for children and teens to increase their physical activity, injury rates are higher than in many other contact sports, including field hockey, rugby, basketball, and football, according to Chris Koutures, MD, a pediatrician in Anaheim Hills, Calif., and Andrew Gregory, MD, of Vanderbilt University.&lt;/p&gt;
&lt;p&gt;Both are members of the AAP&apos;s Council on Sports Medicine and Fitness, which released the report in the February issue of &lt;em&gt;Pediatrics&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Risk of injury goes up when dirty play enters the game. In one study, 11.9% of girls&apos; soccer injuries and 11.4% of boys&apos; were attributed to illegal actions.&lt;/p&gt;
&lt;p&gt;&quot;There is consensus that proper rule enforcement and limitation of violent contact can reduce the risk of injury,&quot; Koutures and Gregory noted.&lt;/p&gt;
&lt;p&gt;&quot;Officials controlling the physicality of the game and emphasis on safe play with respect for one&apos;s opponents can both play significant roles in reducing contact injuries in soccer.&quot;&lt;/p&gt;
&lt;p&gt;The U.S. Consumer Product Safety Commission (CPSC) estimated that there were 186,544 soccer-related injuries in 2006, with 80% occurring in athletes younger than 24. About 44% occurred in children and teens younger than 15, who have a higher risk of injury than their older counterparts.&lt;/p&gt;
&lt;p&gt;Most injuries are to the lower extremities, with ankle injuries accounting for up to 29% and knee injuries accounting for up to 36% of the total.&lt;/p&gt;
&lt;p&gt;Girls have a greater risk of knee injury and rupture of the anterior cruciate ligament, mostly from hyperextension of the knee when landing, cutting, or turning.&lt;/p&gt;
&lt;p&gt;Certain exercise programs focused on neuromuscular training have been shown effective for preventing knee injuries among adolescent girls. (See &lt;a href=&quot;http://www.medpagetoday.com/Orthopedics/Orthopedics/17887&quot; mce_href=&quot;http://www.medpagetoday.com/Orthopedics/Orthopedics/17887&quot; target=&quot;_blank&quot;&gt;Program Cuts Knee Injuries in Soccer&lt;/a&gt;)&lt;/p&gt;
&lt;p&gt;&quot;Pediatricians are encouraged to familiarize themselves with these programs and inform their patients on the availability and potential benefits,&quot; Koutures and Gregory wrote.&lt;/p&gt;
&lt;p&gt;Upper extremity injuries are much less common, accounting for 3% to 12% of the total.&lt;/p&gt;
&lt;p&gt;Soccer-related fatalities are rare and usually involve impact with the goalposts. According to the CPSC, there have been 28 deaths resulting from falling goalposts since 1979.&lt;/p&gt;
&lt;p&gt;Koutures and Gregory noted that guidelines have been developed by manufacturers and the CPSC on properly securing goalposts.&lt;/p&gt;
&lt;p&gt;Concussions occur at a rate similar to that seen in ice hockey and football players. Only about 3% of the total injuries are concussions, but the authors said there might be some under-reporting.&lt;/p&gt;
&lt;p&gt;About half of concussions (47%) are caused by a collision with another player, with the rest coming from contact with the ball (24%), the ground or goalpost (17%), or a combination of objects (10%).&lt;/p&gt;
&lt;p&gt;Koutures and Gregory noted that evidence does not support any adverse short- or long-term neurological consequences from heading the ball on purpose.&lt;/p&gt;
&lt;p&gt;&quot;However,&quot; they wrote, &quot;the AAP encourages heading of the ball only be taught when the child is willing to learn proper technique and has developed coordinated use of his or her head, neck, and trunk to properly contract the neck muscles and contact the ball with the forehead.&quot;&lt;/p&gt;
&lt;p&gt;The risk of eye and other facial injuries is considered low to moderate, according to the authors.&lt;/p&gt;
&lt;p&gt;Nevertheless, they wrote, &quot;protective eyewear is recommended for all participants in soccer ... and should be mandatory for athletes with only one functional eye or those with a past history of major eye surgery or trauma.&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 authors did not make any financial disclosures.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20090101_19_1041"
                     title="Special Report: Few Gaps in Analgesic Practice After Reuben Retractions"
                     score="-0.005"
                     href="http://www.medpagetoday.com/Surgery/Anesthesiology/tb/13592?impressionId=1265777680172"
                     
      LITTLE FALLS, N.J., April 3 -- With some of their specialty&apos;s most prominent, cutting-edge studies now exposed as fakes, anesthesiologists and pain management specialists are asking themselves: what do we know for sure?
              &lt;p&gt; 
              &lt;p&gt;The answer from academics, journal editors, and practicing physicians is: we still know a whole lot. But there are some hypotheses that will certainly need to be retested.
              &lt;p&gt; 
              &lt;p&gt;At the top of the list, the effects of NSAIDs and COX-2 inhibitors on bone fusion will have to be re-evaluated, along with the role of multimodal analgesic regimens in preventing chronic pain.
              &lt;p&gt; 
              &lt;p&gt;The impetus for this reworking is an internal audit by Baystate Medical Center in Springfield, Mass., into the work of Scott Reuben, M.D., until recently one the nation&apos;s most respected authorities on anesthesia and pain medicine.
              &lt;p&gt; 
              &lt;p&gt;In March, Dr. Reuben was accused of fabricating data in 21 studies over the last 15 years. 
              &lt;p&gt; 
              &lt;p&gt;Now, some researchers say additional retractions may be in the cards. In fact, a PubMed search yielded more than 70 studies by Dr. Reuben, who is on indefinite leave from his position at Baystate and no longer holds a professorship at Tufts University in Medford, Mass. 
              &lt;p&gt; 
              &lt;p&gt;Despite the need for some new, incontrovertible data, there isn&apos;t much in current clinical practice based solely on Dr. Reuben&apos;s work on multimodal anesthesia and other cutting-edge projects, researchers say. 
              &lt;p&gt; 
              &lt;p&gt;&quot;The big ramification isn&apos;t &apos;What pieces of information are we suddenly missing?&apos; because I don&apos;t think there are huge gaps,&quot; said James P. Rathmell, M.D., of director of the Center for Pain Medicine at Massachusetts General Hospital. &quot;Multimodal anesthesia works. It&apos;s not a panacea, but even [Dr. Reuben&apos;s] data didn&apos;t show it to be one.&quot; 
              &lt;p&gt; 
              &lt;p&gt;&lt;strong&gt;What Works&lt;/strong&gt;
              &lt;p&gt;The multimodal approach to analgesia involves using more than just opioids to control pain. NSAIDs and COX-2 inhibitors have been common, effective additions to analgesic regimens in the perioperative period of orthopedic and spinal surgeries. There were others besides Dr. Reuben who demonstrated the effectiveness of these combinations.
              &lt;p&gt; 
              &lt;p&gt;&quot;We know that if you try multiple approaches to pain control rather than just one approach, you&apos;re more likely to have good pain control and reduce overall side effects,&quot; said Steven Shafer, M.D., of Columbia University and editor of &lt;em&gt;Anesthesia &amp; Analgesia&lt;/em&gt;, a journal that published some of Dr. Reuben&apos;s work. &quot;That&apos;s not really in doubt.&quot;
              &lt;p&gt; 
              &lt;p&gt;James C. Eisenach, M.D., of Wake Forest University and editor of &lt;em&gt;Anesthesiology&lt;/em&gt;, which also published some of the retracted studies, noted that Dr. Reuben also investigated whether antiepileptic and antidepressant agents could be used in multimodal approaches. 
              &lt;p&gt; 
              &lt;p&gt;Dr. Reuben&apos;s positive findings were corroborated by other work, so Dr. Eisenach said he doubts that the practice of using these agents such as pregabalin (Lyrica) and gabapentin (Neurontin), &quot;is going to change as a result of retracting those articles.&quot;
              &lt;p&gt; 
              &lt;p&gt;However, Dr. Eisenach said the role of COX-2 inhibitors, specifically in the postoperative period of orthopedic surgery, &quot;remains controversial with Scott&apos;s studies taken out.&quot;
              &lt;p&gt; 
              &lt;p&gt;&lt;strong&gt;Invalidated Hypotheses&lt;/strong&gt;
              &lt;p&gt; 
              &lt;p&gt;One major question that has arisen with the wake of the scandal is whether COX-2 inhibitors slow bone healing. 
              &lt;p&gt; 
              &lt;p&gt;One of Dr. Reuben&apos;s studies found that COX-2 inhibitors &quot;had no apparent effect on the rate of nonunion at the time of the one-year follow-up.&quot;  
              &lt;p&gt; 
              &lt;p&gt;Many animal studies, however, have found the opposite effect, so Dr. Rathmell said most orthopedic surgeons were already skeptical about using COX-2 and other anti-inflammatories, particularly in spinal surgeries.
              &lt;p&gt; 
              &lt;p&gt;&quot;Scott had a small amount of data and it wasn&apos;t very convincing,&quot; Dr. Rathmell said. &quot;It wasn&apos;t prospective randomized studies. The first work was done retrospectively and the latter work prospectively but without randomization. So we were worried about it anyway.&quot;
              &lt;p&gt; 
              &lt;p&gt;The role of COX-2 inhibitors in chronic pain years after surgery is also called into question.
              &lt;p&gt; 
              &lt;p&gt;&quot;Scott suggested that Celebrex, given around the time of surgery for a few days helped reduce the incidence of chronic pain a year later, but that work was retracted,&quot; Dr. Eisenach said. &quot;So we&apos;ll have to repeat the research to know if that&apos;s true or not.&quot;
              &lt;p&gt; 
              &lt;p&gt;He noted that since the work only entailed a study, he doubts &quot;most clinicians in regular practice picked up on that and started using it.&quot; 
              &lt;p&gt; 
              &lt;p&gt;Another area that needs to be re-evaluated is the &quot;preemptive&quot; effect of NSAIDs and COX-2 inhibitors, according to Paul F. White, M.D., Ph.D., of University of Texas Southwestern Medical Center.
              &lt;p&gt; 
              &lt;p&gt;In an editorial to be published online in &lt;em&gt;Anesthesia &amp; Analgesia&lt;/em&gt;, Dr. White noted that Dr. Reuben and his colleagues consistently reported that NSAIDs produce a preemptive effect when given before surgical incision, rather than afterwards. 
              &lt;p&gt; 
              &lt;p&gt;Those effects include a longer duration of analgesia during surgery, less need for the use of opioids, and lower pain scores. 
              &lt;p&gt; 
              &lt;p&gt;However, several reviews have disagreed with those findings, said Dr. White, who believes that more retractions will occur in the future. 
              &lt;p&gt; 
              &lt;p&gt;Overall, few anesthesiologists are worried that practice will change dramatically.
              &lt;p&gt; 
              &lt;p&gt;&quot;I really don&apos;t think [the retractions] will change what doctors do normally,&quot; Dr. Eisenach said. &quot;That&apos;s not to say the work was inconsequential, but others have validated [much of the data].&quot;
              &lt;p&gt; 
              &lt;p&gt;&quot;I think it is a tragedy, and there will be some holes,&quot; Dr. Rathmell said, &quot;but they&apos;re not enormous holes and it really isn&apos;t going to change what we do every day.&quot;
              &lt;p&gt; 
              &lt;p&gt;&lt;strong&gt;Getting Back on Track&lt;/strong&gt;
              &lt;p&gt;Journal editors have already taken action to fill the vacuum left by Dr. Reuben&apos;s retracted work. &lt;em&gt;Anesthesiology&apos;s&lt;/em&gt; Dr. Eisenach published an editorial with a call for &quot;submission of studies reexamining the questions that seemed to be answered by Reuben.&quot;
              &lt;p&gt; 
              &lt;p&gt;&lt;em&gt;Anesthesia &amp; Analgesia&lt;/em&gt; will publish Dr. White&apos;s editorial in May, and Dr. Shafer anticipates that the journals will end up working together to determine how best to handle the potential scope of the fraud.
              &lt;p&gt; 
              &lt;p&gt;&quot;For fraud this massive, we have to consider the possibility that everything has been falsified,&quot; Dr. Shafer said. &quot;I&apos;m hoping to work with other journals to identify those papers for which nobody can vouch for the data. If nobody can vouch for their integrity, then I think we have to consider additional retractions.&quot;
              &lt;p&gt; 
              &lt;p&gt;Dr. Shafer said there would be no reason to retract studies that cite Dr. Reuben&apos;s work, and he also added that he believes the co-authors on the retracted studies are also victims in the scandal. 
              &lt;p&gt; 
              &lt;p&gt;Dr. Rathmell says the biggest victims may be participants in clinical trials.
              &lt;p&gt; 
              &lt;p&gt;&quot;As researchers, we&apos;re just worried that our own patients we&apos;re enrolling in trials will have some kind of suspicion about the way we do things,&quot; he said. &quot;The most important ramification [of the entire situation] is its effects on the public in terms of their confidence in what we do -- that&apos;s the real catastrophe here.&quot; 
            
    </recommendedItem>
</recommendedContent>