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<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_438"
                     title="Rituximab Shows Promise in Scleroderma (CME/CE)"
                     score="0.014"
                     href="http://www.medpagetoday.com/Rheumatology/GeneralRheumatology/tb/18352?impressionId=1265790341706"
                     
      &lt;p&gt;Rituximab (Rituxan) improved lung function in patients with scleroderma, a small proof-of-principle study found.&lt;/p&gt;
&lt;p&gt;At one year, patients randomized to receive rituximab had a median 10.25% increase in forced vital capacity (FVC) compared with baseline, while those who received standard treatment had a deterioration of 5.04% (&lt;em&gt;P&lt;/em&gt;=0.002), according to Dimitrios Daoussis, MD, and colleagues from the University of Patras in Greece.&lt;/p&gt;
&lt;p&gt;There also was a significant 19.46% increase in diffusing capacity of carbon monoxide (DL&lt;sub&gt;co&lt;/sub&gt;) in the rituximab-treated patients, while the controls showed deterioration of 7.5% (&lt;em&gt;P&lt;/em&gt;=0.023), the researchers reported in the February issue of &lt;em&gt;Rheumatology&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Interstitial lung disease is a common manifestation of diffuse scleroderma and represents the disease component that dictates prognosis because it can be progressive and typically responds poorly to treatment. Animal and human studies have suggested a possible pathogenic role for B cells in the disease.&lt;/p&gt;
&lt;p&gt;There have been a few reports of clinical and histologic improvements in scleroderma and in graft-versus-host disease (which shares some features with scleroderma) after treatment with the B-cell depleting monoclonal antibody rituximab.&lt;/p&gt;
&lt;p&gt;These encouraging early findings led Daoussis and colleagues to undertake an open-label, controlled study that included 14 patients with diffuse disease.&lt;/p&gt;
&lt;p&gt;Median age was 55 and mean disease duration was seven years.&lt;/p&gt;
&lt;p&gt;All patients continued their standard medications, which included various agents such as prednisone, bosentan (Tracleer), mycophenolate mofetil (CellCept), and cyclophosphamide.&lt;/p&gt;
&lt;p&gt;Those randomized to rituximab treatment also underwent four weekly pulses of the drug (375 mg/m&lt;sup&gt;2&lt;/sup&gt;) at baseline and six months later.&lt;/p&gt;
&lt;p&gt;By one year, the mean FVC in the rituximab group had risen from 68.13% of normal predicted value based on age, sex, and height, to 75.63% (&lt;em&gt;P&lt;/em&gt;=0.0018), while FVC in the control group fell nonsignificantly from 86% of normal to 81.67%.&lt;/p&gt;
&lt;p&gt;In the rituximab group, DL&lt;sub&gt;co&lt;/sub&gt; increased from a mean of 52.25% of normal at baseline to 62% (&lt;em&gt;P&lt;/em&gt;=0.017) at one year, while the controls decreased nonsignificantly from 65.33% to 60.17%.&lt;/p&gt;
&lt;p&gt;None of the patients treated with rituximab experienced worsening of FVC or DL&lt;sub&gt;co&lt;/sub&gt;, whereas lung function deteriorated in five controls.&lt;/p&gt;
&lt;p&gt;&quot;We should note, however, that patients in the control group tended to have more early disease and better lung function parameters (although not statistically different from the [rituximab] group) making them more likely to deteriorate over the time of the study,&quot; the investigators commented.&lt;/p&gt;
&lt;p&gt;Skin manifestations of the disease also showed improvements in the rituximab group. Skin thickening, as measured by the Modified Rodnan Skin Score, improved by 39.25% in the rituximab group and by 20.80% in the control group, a difference that was not statistically significant.&lt;/p&gt;
&lt;p&gt;Skin fibrosis also improved by a median of 38.33%, while it worsened by 5.23% in controls.&lt;/p&gt;
&lt;p&gt;Histologic improvement was seen in four of the rituximab-treated patients, corresponding with clinical benefits. One patient in the active treatment group had a significant reduction of fibrosis in both the papillary and reticular dermis, accompanied by an almost complete resolution of skin lesions.&lt;/p&gt;
&lt;p&gt;Improvement in skin fibrosis was most common in patients who had evidence of B-cell depletion in the skin.&lt;/p&gt;
&lt;p&gt;Overall function, as evaluated by the Health Assessment Questionnaire, improved from a median baseline score of 0.687 to 0.312 at one year (&lt;em&gt;P&lt;/em&gt;=0.03), while no change was seen in controls.&lt;/p&gt;
&lt;p&gt;The pathogenesis of scleroderma is poorly understood, according to the authors, but this study adds support to a possible role for B cells.&lt;/p&gt;
&lt;p&gt;In addition, rituximab indirectly targets T cells, which also are thought to be implicated.&lt;/p&gt;
&lt;p&gt;The authors noted potential limitations, including the study&apos;s small size and the fact that most patients had longstanding disease, had been treated with multiple immunosuppressive agents in the past, and were receiving concurrent therapies during the study.&lt;/p&gt;
&lt;p&gt;&quot;This is a proof-of-principle study that was performed in order to obtain preliminary data regarding the effect of [rituximab] on a limited number of patients,&quot; the authors wrote.&lt;/p&gt;
&lt;p&gt;&quot;Our data could serve as a good starting point for the design of larger scale, multicenter studies with longer evaluation periods and especially in earlier stages of the disease,&quot; they concluded.&lt;/p&gt;
&lt;p&gt;In an accompanying editorial, Robert W. Simms, MD, and Robert Lafyatis, MD, of Boston University, echoed concerns about the small number of patients and the lack of blinding in the study.&lt;/p&gt;
&lt;p&gt;&quot;One cannot...on the basis of this study, recommend rituximab in the routine clinical care of patients with scleroderma,&quot; the editorialists wrote.&lt;/p&gt;
&lt;p&gt;The findings will need to be replicated in a multicenter randomized trial, but &quot;do provide some hope that B-cell depletion might enhance the currently restricted therapeutic armamentarium of this disease.&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 funded by the Hellenic Rheumatology Society.&lt;/p&gt;&lt;p&gt;Funding to pay Open Access publication charges was provided by Roche Hellas.&lt;/p&gt;&lt;p&gt;Authors and editorialists declared to 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_468"
                     title="DSM-V Draft Promises Big Changes in Some Psychiatric Diagnoses"
                     score="0.01"
                     href="http://www.medpagetoday.com/Psychiatry/GeneralPsychiatry/tb/18399?impressionId=1265790341706"
                     
      &lt;p&gt;Substantial changes are in the offing for the &quot;psychiatrist&apos;s bible,&quot; the Diagnostic and Statistical Manual of Mental Disorders, according to a draft of the forthcoming fifth edition.&lt;/p&gt;
&lt;p&gt;The American Psychiatric Association (APA) has posted the draft of DSM-V on a special Web site, &lt;a href=&quot;http://www.psych.org/dsmv.aspx&quot; mce_href=&quot;http://www.psych.org/dsmv.aspx&quot; target=&quot;_blank&quot;&gt;www.dsm5.org&lt;/a&gt;, to obtain comments from its members, other members of the mental health community, and the public.&lt;/p&gt;
&lt;p&gt;At a telephone press briefing before the draft&apos;s release, members of the APA team leading the DSM revision highlighted several substantial innovations they are proposing: &lt;ul&gt; &lt;li&gt;Recategorizing learning disorders, including creation of a single diagnostic category for autism and other socialization disorders, and replacing the controversial term &quot;mental retardation&quot; with &quot;intellectual disability&quot;&lt;/li&gt; &lt;li&gt;Eliminating &quot;substance abuse&quot; and &quot;substance dependence&quot; as disorders, to be replaced with a single &quot;addiction and related disorders&quot; category&lt;/li&gt; &lt;li&gt;Creating a &quot;behavioral addictions&quot; category that will include addictions to gambling but not to the Internet or sex&lt;/li&gt; &lt;li&gt;Offering a new assessment tool for suicide risk&lt;/li&gt; &lt;li&gt;Including a category of &quot;risk syndromes&quot; for psychosis and cognitive impairment, intended to capture mild versions of these conditions that do not always progress to full-blown psychotic disorders or dementia, but often do&lt;/li&gt; &lt;li&gt;Adding a new disorder in children, &quot;temper dysregulation with dysphoria,&quot; for persistent negative mood with bursts of rage&lt;/li&gt; &lt;li&gt;Revising criteria for some eating disorders, including creation of a separate &quot;binge eating disorder&quot; distinct from bulimia&lt;/li&gt; &lt;li&gt;Using &quot;dimensional assessments&quot; to account for severity of symptoms, especially those that appear in multiple diagnostic categories&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;The APA will accept comments through April 20. The work groups managing the revision will consider them and make further changes as needed to the draft, said David Kupfer, MD, of the University of Pittsburgh, chairman of the DSM-V task force.&lt;/p&gt;
&lt;p&gt;The draft diagnostic criteria will then undergo two years of field testing. The final DSM-V is scheduled for release in May 2013, &lt;a href=&quot;http://www.medpagetoday.com/Psychiatry/GeneralPsychiatry/17482&quot; mce_href=&quot;http://www.medpagetoday.com/Psychiatry/GeneralPsychiatry/17482&quot; target=&quot;_blank&quot;&gt;a year later than originally planned&lt;/a&gt;.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;New Categories for Dyslexia, Autism&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;In the area of neurodevelopmental disorders, DSM-V will put dyslexia and dyscalculia  --  reflecting disabilities of reading and mathematics, respectively  --  into a new category of learning disabilities.&lt;/p&gt;
&lt;p&gt;Autism, Asperger&apos;s syndrome, childhood disintegrative disorder, and pervasive developmental disorder not otherwise specified will make up the new &quot;autism and related disorders&quot; category.&lt;/p&gt;
&lt;p&gt;The head of the APA&apos;s work group on substance-related disorders, Charles O&apos;Brien, MD, PhD, of the University of Pennsylvania, told reporters on the press call that substance dependence and abuse had no basis in the research on addictions.&lt;/p&gt;
&lt;p&gt;&quot;We unanimously agreed that . . . there really isn&apos;t evidence for an intermediate stage [short of addiction] that is now known as abuse,&quot; he said. Instead, there will be substance use disorders for each of the major types of drugs that cause problems, such as alcohol.&lt;/p&gt;
&lt;p&gt;He added that the term &quot;dependence&quot; was problematic as a psychiatric diagnosis because some types of physical dependence are &quot;completely normal&quot; for some medications, such as opioid painkillers.&lt;/p&gt;
&lt;p&gt;In fact, under the draft, DSM-V will include &quot;discontinuation syndromes&quot; to allow physicians to properly assess symptoms of withdrawal from psychoactive substances, including caffeine, O&apos;Brien said.&lt;/p&gt;
&lt;p&gt;He also said his work group had considered including sex and Internet addictions as disorders, but decided there was insufficient evidence to allow development of reliable diagnostic criteria for them.&lt;/p&gt;
&lt;p&gt;Consequently, gambling addiction is slated to be the only disorder formally listed in the behavioral addictions category.&lt;/p&gt;
&lt;p&gt;But O&apos;Brien added that, under current plans, sex and Internet addictions would be included in an appendix to DSM-V, intended to encourage additional research that could lead to their inclusion in future editions.&lt;/p&gt;
&lt;p&gt;Carole Lieberman, MD, a Beverly Hills, Calif., psychiatrist who appears frequently on television, regretted the omission of Internet addiction.&lt;/p&gt;
&lt;p&gt;Contacted for comment by &lt;em&gt;MedPage Today&lt;/em&gt; and ABC News, Lieberman said in an e-mail that behavioral addictions are a worthy category. &quot;But why would it not include &apos;Internet addiction,&apos;&quot; she wrote. &quot;Could it be that the psychiatrists involved do not want to acknowledge that their own Internet usage could meet the criteria for addiction?&quot;&lt;/p&gt;
&lt;p&gt;Lieberman added that compulsive shopping was another form of behavioral addiction that deserves recognition.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Dimensional and Risk Assessments&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;APA leaders also emphasized the two new suicide risk assessment scales planned for DSM-V, one for adolescents and one for adults.&lt;/p&gt;
&lt;p&gt;David Shaffer, MD, of Columbia University, told reporters on the press call that suicide nearly always occurs in the context of some psychiatric disorder, but not always depression.&lt;/p&gt;
&lt;p&gt;The new risk assessment tools focus on risk factors such as impulsive behavior, heavy drinking, and chronic severe pain and illness.&lt;/p&gt;
&lt;p&gt;In DSM-IV, suicidal ideation is treated as a symptom of major depression and certain other disorders.&lt;/p&gt;
&lt;p&gt;Shaffer also explained the genesis of the proposed new childhood disorder, temper dysregulation with dysphoria (TDD).&lt;/p&gt;
&lt;p&gt;&quot;About 40% to 60% of the cases [seen by child psychiatrists] will be children who are doing things that other people don&apos;t want them to do,&quot; he said. Many of these are children who are &quot;stubborn and resistant and disobedient and moody.&quot;&lt;/p&gt;
&lt;p&gt;There is currently a recognized syndrome known as oppositional defiant disorder, but some children also display severe aggression and negative moods that go beyond mere stubbornness, according to Shaffer.&lt;/p&gt;
&lt;p&gt;Such children are often tagged as having juvenile bipolar disorder, but research has shown that the label is often inappropriate, since they usually do not qualify for a bipolar disorder diagnosis when they reach adulthood, although they remain dysfunctional. More often, these children are diagnosed as depressed when they become adults.&lt;/p&gt;
&lt;p&gt;He said the addition of TDD would better describe the severity and frequency of irritable behavior while also recognizing the mood disorder that goes with it.&lt;/p&gt;
&lt;p&gt;Another innovation in DSM-V will be the extensive use of so-called dimensional assessments. Whereas DSM-IV relied heavily on present-absent symptom checklists, the new edition will include severity scales for symptoms, such as anxiety or insomnia, that may appear to larger or smaller degrees in many different mental illnesses.&lt;/p&gt;
&lt;p&gt;Darrel Regier, MD, MPH, the APA&apos;s research director, said such checklists &quot;don&apos;t always fit the reality that someone with a mental disorder experiences.&quot; Often, a symptom like insomnia isn&apos;t on the checklist for a particular disorder, he said, &quot;but they can still affect patients&apos; lives and affect the treatment planning.&quot;&lt;/p&gt;
&lt;p&gt;Incorporating quantitative dimensional assessments should allow clinicians to develop treatment and response-monitoring plans better tailored to individual patients&apos; needs, Regier said.&lt;/p&gt;
&lt;p&gt;But Lieberman foresaw problems with the dimensional assessments. &quot;I don&apos;t think [they] will add anything but confusion,&quot; she said in an e-mail. &quot;As it is now, people don&apos;t really make use of the subcategories that there are to describe severity of symptoms. Instead, I see this as a tool that insurance companies could well co-opt to try to deny benefits.&quot;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Gender Identity Disorder Stays&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;A closely watched issue in the DSM-V revision has been whether to change or do away with gender identity disorder, now listed in DSM-IV. At this point, the draft retains the designation but with some changes, officials said.&lt;/p&gt;
&lt;p&gt;People who consider themselves &quot;transgendered&quot; have long criticized DSM-IV and previous editions for labeling them with a mental disease when their problems, they believe, are purely somatic  --  that is, they have the wrong genitalia and hormonal balance.&lt;/p&gt;
&lt;p&gt;At the APA&apos;s annual meeting last May, members of the transgender community &lt;a href=&quot;http://www.medpagetoday.com/MeetingCoverage/APA/14270&quot; mce_href=&quot;http://www.medpagetoday.com/MeetingCoverage/APA/14270&quot; target=&quot;_blank&quot;&gt;made a case&lt;/a&gt; for dropping gender identity disorder from DSM-V, but keeping some kind of &quot;gender variance&quot; diagnosis as a medical condition. Such an approach would eliminate the stigma of a psychiatric diagnosis while leaving a pathway for third-party payment for gender transition treatments, they said.&lt;/p&gt;
&lt;p&gt;William Narrow, MD, the APA&apos;s research director for DSM-V, told reporters that the draft does remove the term &quot;disorder&quot; from the condition when applied to children, renaming it as &quot;gender incongruence.&quot;&lt;/p&gt;
&lt;p&gt;For adults, gender identity disorder will remain in DSM-V but with substantially altered diagnostic criteria, Narrow said.&lt;/p&gt;
&lt;p&gt;But APA officials said the organization planned more discussions with members of the transgender community.&lt;/p&gt;
&lt;p&gt;Kupfer, the DSM-V task force chairman, stressed that further changes in many diagnostic categories are likely following the comment period and field trials.&lt;/p&gt;
&lt;p&gt;Final revisions will be submitted in 2012 for approval by the APA&apos;s two governing bodies, the Assembly and the board of trustees.&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_467"
                     title="FDA Unveils New Safety Plan for Medical Imaging"
                     score="0.01"
                     href="http://www.medpagetoday.com/Radiology/DiagnosticRadiology/tb/18398?impressionId=1265790341706"
                     
      &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_466"
                     title="Surgery Trumps Lifestyle Change for Teen Weight Loss (CME/CE)"
                     score="0.01"
                     href="http://www.medpagetoday.com/Pediatrics/Obesity/tb/18397?impressionId=1265790341706"
                     
      &lt;p&gt;Gastric banding resulted in significantly greater weight loss in obese teens than an intensive lifestyle modification program, a randomized trial showed.&lt;/p&gt;
&lt;p&gt;In the two-year study, 84% of patients in the surgery group lost at least half of their excess weight, compared with 12% who underwent the lifestyle intervention (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.001), according to Paul O&apos;Brien, MD, of Monash University in Melbourne, Australia, and colleagues.&lt;/p&gt;
&lt;p&gt;None of the teens who had surgery had metabolic syndrome at the end of follow-up, compared with 22% in the control group (&lt;em&gt;P&lt;/em&gt;=0.025), the researchers reported in the Feb. 10 issue of the &lt;em&gt;Journal of the American Medical Association&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Although the improvements were substantial, O&apos;Brien and his colleagues stressed that &quot;the gastric banding approach to weight loss is not a quick fix.&quot;&lt;/p&gt;
&lt;p&gt;&quot;For optimal effectiveness,&quot; they wrote, &quot;it requires long-term supportive follow-up by trained health professionals.&quot;&lt;/p&gt;
&lt;p&gt;They also noted that the study demonstrates that lifestyle interventions can be effective for some teens and should remain the first option.&lt;/p&gt;
&lt;p&gt;Surgeons contacted for comment on the study unanimously touted the results as evidence that bariatric surgery can be a safe and effective means of weight loss for obese adolescents, a topic that remains controversial.&lt;/p&gt;
&lt;p&gt;J. Christopher Eagon, MD, a bariatric surgeon at Washington University in St. Louis, noted in an e-mail that the significance of the study lies in the fact that participants were randomized between surgery and medical management of weight.&lt;/p&gt;
&lt;p&gt;&quot;This helps to eliminate biases that may have been present in other studies of the effectiveness of bariatric surgery and should make the case for the benefits of surgery more compelling,&quot; Eagon wrote.&lt;/p&gt;
&lt;p&gt;There are more than five million obese adolescents in the U.S., according to O&apos;Brien and his colleagues, and obesity-related complications, once rare in pediatric populations, are becoming more common.&lt;/p&gt;
&lt;p&gt;Because of the generally disappointing results of lifestyle programs aimed at improving diet, increasing exercise, and modifying unhealthy behaviors, bariatric surgery, widely used in adults, has been explored as a strategy for reducing weight in these patients.&lt;/p&gt;
&lt;p&gt;But no randomized trials of bariatric surgery had been conducted in adolescents.&lt;/p&gt;
&lt;p&gt;So O&apos;Brien&apos;s group randomized 50 obese teens ages 14 to 18 (mean 16.5) to laparoscopic adjustable gastric banding or an intensive, supervised lifestyle modification program.&lt;/p&gt;
&lt;p&gt;The participants all had a body mass index of at least 35 kg/m&lt;sup&gt;2&lt;/sup&gt; and had obesity-related complications, such as hypertension, metabolic syndrome, asthma, back pain, physical limitations, and psychosocial difficulties.&lt;/p&gt;
&lt;p&gt;All had previously failed to lose weight through lifestyle changes.&lt;/p&gt;
&lt;p&gt;Before the study began, prospective participants attended a two-month program teaching them about healthy eating and the importance of physical activity.&lt;/p&gt;
&lt;p&gt;Those randomized to the lifestyle intervention were on a diet of 800 to 2,000 calories a day, and were instructed to increase activity and decrease sedentary behavior at regular visits with a physician, dietitian, exercise coordinator, nurse, and sports medicine physician. The program included six weeks with a personal trainer.&lt;/p&gt;
&lt;p&gt;Teens in the surgery group were given instructions on correct eating and exercising at regular visits.&lt;/p&gt;
&lt;p&gt;Through two years, all but one of the teens in the surgery group completed the study; 18 of 25 in the lifestyle group completed.&lt;/p&gt;
&lt;p&gt;The mean weight loss was significantly greater in the surgery group (76.3 pounds versus 6.6), which equated to a significantly greater percentage of excess weight lost (78.8% versus 13.2%).&lt;/p&gt;
&lt;p&gt;The mean decrease in BMI was 12.7 kg/m&lt;sup&gt;2&lt;/sup&gt; in the surgery group and 1.3 kg/m&lt;sup&gt;2&lt;/sup&gt; in the lifestyle modification group.&lt;/p&gt;
&lt;p&gt;All differences were significant at &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001.&lt;/p&gt;
&lt;p&gt;Insulin sensitivity improved in both groups, but to a larger extent in the surgery group (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.001).&lt;/p&gt;
&lt;p&gt;Quality of life was also improved in the surgery group.&lt;/p&gt;
&lt;p&gt;Overall, adverse events occurred at similar rates in the surgery (48%) and lifestyle modification (44%) groups.&lt;/p&gt;
&lt;p&gt;There were no perioperative adverse events in the surgery group, but seven patients required revisional procedures during follow-up, for proximal pouch dilatation or tubing injury.&lt;/p&gt;
&lt;p&gt;The researchers said eating small meals slowly is an important way to avoid these problems.&lt;/p&gt;
&lt;p&gt;In an accompanying editorial, Edward Livingston, MD, a surgeon at the University of Texas Southwestern Medical Center in Dallas, said the high rate of revisional procedures is significant because the study authors &quot;are among the most experienced group in the world with these operations, suggesting that these complication rates will probably be higher in actual community practice.&quot;&lt;/p&gt;
&lt;p&gt;Added Jonathan Schoen, MD, a bariatric surgeon at the University of Colorado Hospital in Denver, in an e-mail: &quot;One thing to keep in mind is that the results they get in Australia with the band are the best in the world and are not uniformly reproducible.&quot;&lt;/p&gt;
&lt;p&gt;In addition to the uncertain generalizability to other settings, the researchers said the study may be limited by its length, which may not be long enough to assess outcomes from the surgery over time.&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 funded by a grant from the National Health and Medical Research Council. The laparoscopic adjustable gastric bands used in the study were provided by the manufacturer, Allergan. The Center for Obesity Research and Education receives an unrestricted research support grant from Allergan.&lt;/p&gt;&lt;p&gt;O&apos;Brien did not make any financial disclosures. One of his co-authors reported having relationships with Allergan, Bariatric Advantage, Scientific Intake, SP Health Co., Optifast, Abbott Australasia, Eli Lilly Australia, Merck Sharp &amp;amp; Dohme Australia, Nestle Australia, and Roche Products Australia.&lt;/p&gt;&lt;p&gt;Livingston did not make any financial disclosures.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&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_465"
                     title="Genetic Pathways Play Role in NSCLC Survival (CME/CE)"
                     score="0.01"
                     href="http://www.medpagetoday.com/HematologyOncology/LungCancer/tb/18396?impressionId=1265790341706"
                     
      Researchers say they&apos;ve found genetic characteristics associated with age and sex differences observed in recurrence-free survival among non-small cell lung cancer patients.&lt;br&gt;
&lt;br&gt;Older patients at higher risk for recurrence had increased activation of wound-healing and invasiveness pathways, while high-risk women had increased activation of invasiveness and &lt;em&gt;STAT3&lt;/em&gt; pathways, Anil Potti, MD, of Duke University, and colleagues reported in the Feb. 10 issue of the &lt;em&gt;Journal of the American Medical Association&lt;/em&gt;.&lt;br&gt;
&lt;br&gt;High-risk men had increased activation of the &lt;em&gt;STAT3&lt;/em&gt;, tumor necrosis factor, &lt;em&gt;EGFR&lt;/em&gt;, and wound-healing pathways, Potti the researchers found.&lt;br&gt;
&lt;br&gt;&quot;This analysis represents one of the first large-scale attempts to comprehensively characterize the biology of early-stage [non-small cell lung cancer] at a molecular pathway level and demonstrates a clear distinction in gene expression profiles within relevant age and sex categories,&quot; they wrote.&lt;p&gt;&lt;/p&gt;
&lt;p&gt;There&apos;s lots of evidence that clinical and pathologic factors are clinically relevant, the researchers noted, but little is known about the underlying biological differences in lung tumor gene expression among patients with different characteristics, including age and gender.&lt;/p&gt;
&lt;p&gt;So Potti and colleagues conducted a retrospective analysis of 787 patients with predominantly early stage non-small cell lung cancer at Duke University from July 2008 to June 2009.&lt;/p&gt;
&lt;p&gt;They stratified their results by risk of recurrence, age, and gender.&lt;/p&gt;
&lt;p&gt;They found that high-risk patients under 70 had greater activation of the &lt;em&gt;Src&lt;/em&gt; and tumor necrosis factor pathways than low-risk patients (25% versus 6%, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001; and 76% versus 42%, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001, respectively).&lt;/p&gt;
&lt;p&gt;In patients 70 and older, those at high risk for recurrence had greater activation of the wound-healing and invasiveness pathways than low-risk patients (40% versus 24%, &lt;em&gt;P&lt;/em&gt;=0.02; and 64% versus 20%, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001, respectively).&lt;/p&gt;
&lt;p&gt;&quot;Although this is a novel finding, biologically this is not entirely unexpected,&quot; the researchers wrote in reference to the data in older patients. &quot;The invasiveness and wound-healing gene signatures likely identify tumors at high risk of metastasis, along with the wound-healing signature identifying activation of angiogenesis pathways.&quot;&lt;/p&gt;
&lt;p&gt;Their findings also corroborated previous evidence that biology and clinical course of the disease are sex-specific, as the analysis found that women had significantly better progression-free survival than men (&lt;em&gt;P&lt;/em&gt;=0.008).&lt;/p&gt;
&lt;p&gt;In general, men had a higher probability of activation of these pathways than women:&lt;ul&gt;&lt;li&gt;Chromosomal instability (&lt;em&gt;P&lt;/em&gt;=0.001)&lt;/li&gt;&lt;li&gt;Epigenetic stem cell (&lt;em&gt;P&lt;/em&gt;=0.03)&lt;/li&gt;&lt;li&gt;Invasiveness (&lt;em&gt;P&lt;/em&gt;=0.005)&lt;/li&gt;&lt;li&gt;&lt;em&gt;Myc&lt;/em&gt; (&lt;em&gt;P&lt;/em&gt;=0.02)&lt;/li&gt;&lt;li&gt;Wound-healing (&lt;em&gt;P&lt;/em&gt;=0.004)&lt;/li&gt;&lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Women, meanwhile, had a higher probability of activation of the &lt;em&gt;E2F1&lt;/em&gt; pathway (&lt;em&gt;P&lt;/em&gt;=0.04).&lt;/p&gt;
&lt;p&gt;When stratified by risk, high-risk women had increased activation of the invasiveness and &lt;em&gt;STAT3&lt;/em&gt; pathways compared with low-risk women (99% versus 2%, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001; and 72% versus 35%, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001, respectively).&lt;/p&gt;
&lt;p&gt;Compared with low-risk men, those with high risk had increased activation of the following pathways:&lt;ul&gt;&lt;li&gt;&lt;em&gt;STAT3&lt;/em&gt; (87% versus 18%, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001)&lt;/li&gt;&lt;li&gt;Tumor necrosis factor (90% versus 46%, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001) &lt;/li&gt;&lt;li&gt;&lt;em&gt;EGFR&lt;/em&gt; (13% versus 2%, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001)&lt;/li&gt;&lt;li&gt;Wound-healing pathways (50% versus 22%, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001)&lt;/li&gt;&lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Multivariate analyses confirmed pathway-based subphenotypes in women (HR 2.02, 95% CI 1.34 to 3.03, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001) and in patients under 70 (HR 1.83, 95% CI 1.24 to 2.71, &lt;em&gt;P&lt;/em&gt;=0.003).&lt;/p&gt;
&lt;p&gt;&quot;While differences in clinical outcomes and the biology of [non-small cell lung cancer] based on age and sex have been previously noted, we were able to describe the molecular networks contributing to these differences,&quot; the researchers wrote.&lt;/p&gt;
&lt;p&gt;They said the findings are &quot;apt for therapeutic interventions when planning clinical trials with drugs that target specific pathway-related abnormalities or tumor biology.&quot;&lt;/p&gt;
&lt;p&gt;&quot;With genomic assays now being increasingly practical and clinically applicable, with turnaround times of five to seven days,&quot; they concluded, &quot;we believe our findings, while hypothesis generating and needing further validation, represent a step forward in defining pathway-driven cohorts of [non-small cell lung cancer] that likely explain the age-and sex-specific differences.&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 grants from the Emilene Brown Cancer Research Fund, the Harold and Linda Chapman Lung Cancer Fund, the Jimmy V Foundation, the American Cancer Society, and the National Cancer Institute.&lt;/p&gt;&lt;p&gt;The researchers reported no conflicts of interest.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
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