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    <recommendedItem id="20100101_19_407"
                     title="ICU Catheter Infections Can Be Virtually Eliminated (CME/CE)"
                     score="0.01"
                     href="http://www.medpagetoday.com/CriticalCare/InfectionControl/tb/18308?impressionId=1265753580901"
                     
      Catheter-related infections aren&apos;t inevitable in the ICU, according to a quality initiative that maintained rates at nearly zero for three years in Michigan hospitals.&lt;br&gt;
&lt;br&gt;The maintenance phase, after initial implementation of low-tech measures such as handwashing and removal of unneeded catheters, saw no rebound in catheter-related infections, Peter J. Pronovost, MD, PhD, of Johns Hopkins, and colleagues reported online in &lt;em&gt;BMJ&lt;/em&gt;.&lt;br&gt;
&lt;br&gt;The first 18 months of their &lt;a href=&quot;http://www.medpagetoday.com/InfectiousDisease/GeneralInfectiousDisease/4771&quot; mce_href=&quot;http://www.medpagetoday.com/InfectiousDisease/GeneralInfectiousDisease/4771&quot; target=&quot;_blank&quot;&gt;Keystone ICU initiative&lt;/a&gt; dropped catheter-related interventions from a mean of 7.7 and median of 2.2 per 1,000 catheter days down to 1.3 and 0, respectively.&lt;br&gt;
&lt;br&gt;At the 36 month mark, infection rates remained almost nil, at a mean of 1.1 and median of 0 per 1,000 catheter days.&lt;p&gt;&lt;/p&gt;
&lt;p&gt;&quot;For the most part, hospitals view these infections as inevitable, as the cost of doing business, that patients are too sick, that these can&apos;t be prevented,&quot; Pronovost told &lt;em&gt;MedPage Today&lt;/em&gt;. &quot;That&apos;s just not true.&quot;&lt;/p&gt;
&lt;p&gt;Catheter-related infections are the number one cause of preventable death in hospitals and ICUs, ahead of even ventilator-related pneumonia, he noted.&lt;/p&gt;
&lt;p&gt;The changes seen at the 90 Michigan ICUs that stayed with the catheter-related infection initiative were impressive, representing one of the largest and longest improvements the field has seen.&lt;/p&gt;
&lt;p&gt;Often, quality initiatives fail on durability after the study funding and resources disappear, and hospitals are left on their own, Pronovost noted.&lt;/p&gt;
&lt;p&gt;&quot;If you push you might get some effect, but then you stop pushing  --  in other words the external control goes away  --  and the performance goes right back down,&quot; he said in an interview. &quot;It can&apos;t just be the stick that drives it.&quot;&lt;/p&gt;
&lt;p&gt;The intervention started with 103 ICUs that implemented strategies to reduce rates of catheter-related bloodstream infections rates over 18 months, with measurement and feedback of infection rates.&lt;/p&gt;
&lt;p&gt;The strategies aimed at improving execution of five evidence-based recommendations, as follows: &lt;ul&gt; &lt;li&gt;Hand washing before insertion of the catheter&lt;/li&gt; &lt;li&gt;Using gowns and full barrier precautions at catheter insertion&lt;/li&gt; &lt;li&gt;Cleaning the skin with chlorhexidine before catheter insertion&lt;/li&gt; &lt;li&gt;Avoiding the femoral site when possible&lt;/li&gt; &lt;li&gt;Removing unnecessary catheters&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Then, over the subsequent 18-month maintenance period, ICU teams were instructed to integrate this intervention into staff orientation, to collect monthly data from hospital infection control staff, and to report infection rates to physicians and others.&lt;/p&gt;
&lt;p&gt;Along with the sustained reduction in overall catheter-related infections, the researchers found a prolonged reduction in bloodstream infections that was significant during all study periods, compared to baseline.&lt;/p&gt;
&lt;p&gt;Rates decreased from a mean of 7.7 and median 2.7 of per 1,000 catheter days at baseline to 1.3 and 0, respectively, at 16 to 18 months after implementation. They remained at 1.1 and 0 at months 34 to 36 (-1% versus 18 months, 95% CI -9% to +7%).&lt;/p&gt;
&lt;p&gt;ICU teams interviewed attributed the continuously low rates to five factors: &lt;ul&gt; &lt;li&gt;Continued feedback on infection data&lt;/li&gt; &lt;li&gt;Improvements in safety culture as part of the project&lt;/li&gt; &lt;li&gt;An &quot;unremitting belief in the preventability of bloodstream infections&quot;&lt;/li&gt; &lt;li&gt;Involvement of senior leaders&lt;/li&gt; &lt;li&gt;A noncompetitive, shared goal to reduce infection rates throughout the state&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Of these, Pronovost called culture change in the ICUs the key factor to sustainability, although the researchers cautioned that which aspects contributed were not formally evaluated.&lt;/p&gt;
&lt;p&gt;They said they could not determine the impact incentive payments from Blue Cross Blue Shield of Michigan to hospitals that continued their participation  --  payments that were based on performance thresholds in subsequent years.&lt;/p&gt;
&lt;p&gt;Pronovost&apos;s team is now working to implement the quality initiative state-by-state nationwide, supported by the Agency for Healthcare Research and Technology.&lt;/p&gt;
&lt;p&gt;&quot;It seems absurd that this wouldn&apos;t be in every hospital in the country,&quot; he said in an interview. &quot;It&apos;s worked on a large scale, it&apos;s exceedingly cheap, there&apos;s no fancy technology.&quot;&lt;/p&gt;
&lt;p&gt;Success isn&apos;t only for community hospitals, Pronovost emphasized.&lt;/p&gt;
&lt;p&gt;Large, often academic, medical centers frequently express the conviction that their sicker, more complex ICU population wouldn&apos;t produce the same results, that their infections truly are inevitable, he said.&lt;/p&gt;
&lt;p&gt;&quot;To them I say, Not so,&quot; he told &lt;em&gt;MedPage Today&lt;/em&gt;. &quot;We have shown at Johns Hopkins, at the University of Michigan, at Pittsburgh, using a similar but different approach, at Tufts  --  many large academic medical centers have had dramatic reductions of these infections.&quot;&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The project was supported, for the period from October 2003 to September 2005, by the Agency for Healthcare Research and Quality and the Michigan Health &amp;amp; Hospital Association.&lt;/p&gt;&lt;p&gt;Pronovost and a co-author reported receiving received lecture fees from various healthcare organizations and grant support from the Agency for Healthcare Research and Quality, the Robert Wood Johnson Foundation, the National Patient Safety Agency, and the World Health Organization to study and improve quality of care, including catheter-related bloodstream infections.&lt;/p&gt;&lt;p&gt;Co-authors reported conflicts of interest with government agencies, Cubist, Astellas, Merck, Forrest, Cadence, the Robert Wood Johnson Foundation, Lilly, Edward Life Sciences, and Sage.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_386"
                     title="FDA Approves First Excess Finger Collagen Drug"
                     score="0.009"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/18277?impressionId=1265753580901"
                     
      &lt;p&gt;WASHINGTON  --  The FDA has approved the first drug for the progressive hand disease known as Dupuytren&apos;s contracture  --  the injectable collagenase clostridium histolyticum (Xiaflex).&lt;/p&gt;
&lt;p&gt;The biologic drug, manufactured by Auxilium Pharmaceuticals of Malvern, Pa., breaks down excess collagen that builds up in the hand, preventing preventing the fingers from relaxing and straightening normally.&lt;/p&gt;
&lt;p&gt;In announcing the approval, the FDA noted that until now the only effective treatment for the condition was surgery, which often entails a long recovery with physical therapy.&lt;/p&gt;
&lt;p&gt;Drug approval was based on data from two randomized, double-blind, placebo-controlled, multicenter trials of 374 adult patients who had not received surgical treatment on a selected primary joint within 90 days of the first injection, and who did not use anticoagulation medicine within seven days of the study.&lt;/p&gt;
&lt;p&gt;The primary endpoint in both studies was a reduction of joint contracture by five degrees after up to three injections. Patients in the collagenase group outperformed placebo, with 64% meeting endpoint in all joints versus 7% in placebo group in Study 1, and 44% versus 5% in Study 2.&lt;/p&gt;
&lt;p&gt;Serious side effects of the collagenase drug include tendon rupture and ligament damage that can prevent a finger from fully bending and may require surgery to correct.&lt;/p&gt;
&lt;p&gt;Other side effects include swelling, bruising, bleeding, and injection site pain.&lt;/p&gt;
&lt;p&gt;Patients using anticoagulants other than low-dose aspirin should avoid using collagenase clostridium histolyticum, according to the prescribing information.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_344"
                     title="FDA Revises HIV Drug Label for Liver Complication"
                     score="0.007"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/18229?impressionId=1265753580901"
                     
      &lt;p&gt;WASHINGTON  --  The FDA has updated labels of the HIV drug didanosine (Videx and Videx EC) to include warnings for potentially serious liver damage.&lt;/p&gt;
&lt;p&gt;Although these cases are rare, the drug may cause noncirrhotic hypertension in patients, a potentially fatal complication which the FDA discovered through 42 postmarket, adverse event reports.&lt;/p&gt;
&lt;p&gt;Of those patients, three required liver transplant and four died. Two deaths were caused by esophageal hemorrhage, while two more were caused by progressive liver failure.&lt;/p&gt;
&lt;p&gt;One patient suffered multiorgan failure, cerebral hemorrhage, sepsis, and lactic acidosis.&lt;/p&gt;
&lt;p&gt;The FDA said in a statement that it chose not to recall the drug because it believes its benefits outweigh potential risks, but advised that treatment decisions be made on an individual basis between healthcare professionals and patients.&lt;/p&gt;
&lt;p&gt;The agency added that causal association is difficult to determine in postmarket reports, but that alternative causes of the hypertension were ruled out in well-documented cases.&lt;/p&gt;
&lt;p&gt;Healthcare professionals who determine didanosine is effective in treating a patient should monitor that patient for the development of portal hypertension and esophageal varices, the agency said.&lt;/p&gt;
&lt;p&gt;Didanosine is used in combination with other HIV medications to help maintain CD4 cells in patients.&lt;/p&gt;
&lt;p&gt;The drug already has a black box warning for lactic acidosis and hepatomegaly with steatosis.&lt;/p&gt;
&lt;p&gt;Like the antiretroviral agents hydroxyurea and ribavirin, didanosine has been associated with the development of liver toxicity.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_343"
                     title="U.S. Marshals Seize Unapproved Ozone Generators"
                     score="0.007"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/EnvironmentalHealth/tb/18228?impressionId=1265753580901"
                     
      &lt;p&gt;WASHINGTON  --  U.S. Marshals have seized 77 unapproved ozone generators, valued at almost $76,000 from a California device manufacturer, the FDA announced.&lt;/p&gt;
&lt;p&gt;The devices were advertised as treatments for various conditions, including cancer, AIDS, hepatitis, herpes, and other diseases, but lacked approval or efficacy data to support the claims made on their behalf, an FDA release said.&lt;/p&gt;
&lt;p&gt;The raid came after the company, Applied Ozone Systems (AOS) of Auburn, Calif., failed to respond to a voluntary recall request last December, the agency said.&lt;/p&gt;
&lt;p&gt;The FDA raised concerns that patients using AOS-IM and AOS-IMD devices will consider it an appropriate treatment for an affliction and delay or stop FDA-approved and proven medical treatments. Patients using the devices may risk infection from contamination of the applicator or catheter, the release said.&lt;/p&gt;
&lt;p&gt;The FDA recommended that healthcare professionals and consumers cease use of the devices.&lt;/p&gt;
&lt;p&gt;The agency said it obtained an inspection warrant for the company&apos;s manufacturing facilities after the owner refused to admit FDA inspectors. It said the inspection revealed several breaches of the FDA&apos;s good manufacturing practice requirements for medical devices, which had never been approved in the first place.&lt;/p&gt;
&lt;p&gt;Ozone is an unstable allotrope of oxygen with three atoms, instead of the normal two. Ozone generators produce ozone from oxygen and have consumer and industrial applications, but ozone itself is harmful to the respiratory system, even at relatively low concentrations.&lt;/p&gt;
&lt;p&gt;Instructions with the Applied Ozone Systems devices suggest blowing ozoned air into the rectal and vaginal areas.&lt;/p&gt;
&lt;p&gt;Friday&apos;s seizure was part of a joint effort of the FDA and the California Department of Public Health to remove or prevent unapproved or unsafe medical devices from entering the market.&lt;/p&gt;
&lt;p&gt;A statement on the company&apos;s Web site said the two ozone generator models, which sold for $750 and $1,200 respectively, were no longer available by order of the FDA and California authorities.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_329"
                     title="Nixing Routine ICU Sedation Improves Outcomes (CME/CE)"
                     score="0.004"
                     href="http://www.medpagetoday.com/CriticalCare/Intensivists/tb/18199?impressionId=1265753580901"
                     
      A protocol of no sedation in the ICU may get patients off the ventilator and back home sooner, Danish researchers found.&lt;br&gt;
&lt;br&gt;Unsedated patients spent 4.2 fewer days on mechanical ventilators than those treated under a more conventional protocol for daily interruption of sedation (mean 13.8 versus 9.6 days without ventilation, &lt;em&gt;P&lt;/em&gt;=0.0191) in a randomized trial led by Thomas Str&amp;#248;m, MD, of Odense University Hospital.&lt;br&gt;
&lt;br&gt;Length of stay in the ICU and in the hospital were significantly shorter as well, the researchers reported in the Feb. 6 issue of &lt;em&gt;The Lancet&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;The strategy appeared safe, with no increase in accidental extubation or other complications, Str&amp;#248;m&apos;s group said.&lt;/p&gt;
&lt;p&gt;Although simpler than daily interruption of sedation, a no-sedation protocol could mean extra work for ICU staff, according to an accompanying editorial.&lt;/p&gt;
&lt;p&gt;Laurent Brochard, MD, of the Centre Hospitalier Albert Chenevier&amp;#8211;Henri Mondor in Cr&amp;#233;teil, France, wrote that the protocol would call for &quot;more frequent individual assessment of the patient&apos;s pain, fear, anxiety, agitation, or confusion, and adaption to the ventilator.&quot;&lt;/p&gt;
&lt;p&gt;It would also likely impose an increased workload in reassurance and patient mobilization, he said. Still, he called the results &quot;impressive and promising.&quot;&lt;/p&gt;
&lt;p&gt;Sedation is often overused in the ICU, particularly since drugs can accumulate in critically ill patients, Brochard asserted, and daily interruption of sedation was a major breakthrough in patient care because it was shown to &lt;a href=&quot;http://www.medpagetoday.com/MeetingCoverage/ATS/5713&quot; mce_href=&quot;http://www.medpagetoday.com/MeetingCoverage/ATS/5713&quot; target=&quot;_blank&quot;&gt;reduce duration of ventilation&lt;/a&gt;.&lt;/p&gt;
&lt;p&gt;Other benefits of the current study included reductions in &lt;a href=&quot;http://www.medpagetoday.com/MeetingCoverage/SCCM/8240&quot; mce_href=&quot;http://www.medpagetoday.com/MeetingCoverage/SCCM/8240&quot; target=&quot;_blank&quot;&gt;post-traumatic stress disorder&lt;/a&gt; and &lt;a href=&quot;http://www.medpagetoday.com/EmergencyMedicine/EmergencyMedicine/7931&quot; mce_href=&quot;http://www.medpagetoday.com/EmergencyMedicine/EmergencyMedicine/7931&quot; target=&quot;_blank&quot;&gt;complications&lt;/a&gt; such as ventilator-associated pneumonia, Str&amp;#248;m and colleagues added.&lt;/p&gt;
&lt;p&gt;In an effort to further reduce the negative effects of ICU sedation, their hospital adopted a routine protocol of no sedation for intubated medical and surgical ICU patients receiving mechanical ventilation.&lt;/p&gt;
&lt;p&gt;Given the lack of randomized data on the benefits of this strategy, the researchers randomized 140 critically ill adults expected to need more than 24 hours of ventilation to unblinded treatment without sedation or with an infusion of propofol (Diprivan) for 48 hours, then an infusion of midazolam (Versed) as needed for sedation with daily interruption until awake.&lt;/p&gt;
&lt;p&gt;Both groups got bolus doses of morphine (2.5 or 5 mg) as needed and daily mobilization to a chair if possible.&lt;/p&gt;
&lt;p&gt;Along with the reduction in ventilated days, the researchers found that patients on the no-sedation protocol left the ICU 9.7 days sooner on average and were discharged from the hospital 24 days earlier than those routinely sedated.&lt;/p&gt;
&lt;p&gt;After adjustment for baseline variables, sedation remained significantly associated with increased ICU stay (HR 1.86, 95% CI 1.05 to 3.23).&lt;/p&gt;
&lt;p&gt;The effect on hospital stay duration, though, was limited to the first 30 days (HR 3.57 for sedation, 95% CI 1.52 to 9.09).&lt;/p&gt;
&lt;p&gt;For days 31 to 90, sedation protocol had no impact (&lt;em&gt;P&lt;/em&gt;=0.54), likely because other factors, such as comorbidities, were more important when patients couldn&apos;t be weaned from ventilation, the researchers said.&lt;/p&gt;
&lt;p&gt;Complications were similar between no-sedation and sedation protocol groups as follows: &lt;ul&gt; &lt;li&gt;Accidental removal of endotracheal tube (seven versus six cases, &lt;em&gt;P&lt;/em&gt;=0.69)&lt;/li&gt; &lt;li&gt;Need for CT or MRI brain scans (five versus eight cases, &lt;em&gt;P&lt;/em&gt;=0.43)&lt;/li&gt; &lt;li&gt;Ventilator-associated pneumonia (six versus seven cases, &lt;em&gt;P&lt;/em&gt;=0.85)&lt;/li&gt; &lt;li&gt;Need for reintubation within 24 hours (seven versus 11 cases, &lt;em&gt;P&lt;/em&gt;=0.37)&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Mortality in the ICU tended to be higher with sedation (38% versus 22%, P=0.06), but there was no significant difference in overall inhospital mortality between the groups (47% with sedation versus 36% without, &lt;em&gt;P&lt;/em&gt;=0.27).&lt;/p&gt;
&lt;p&gt;Overall, 18% of patients in the no-sedation group couldn&apos;t tolerate it and had to receive continuous sedation on more than two occasions, typically to permit sufficient oxygenation in severe acute respiratory distress syndrome.&lt;/p&gt;
&lt;p&gt;The one negative impact of the no-sedation strategy appeared to be an increase in agitated delirium (20% versus 7%, &lt;em&gt;P&lt;/em&gt;=0.04) resulting in more frequent use of haloperidol (Haldol, &lt;em&gt;P&lt;/em&gt;=0.0100).&lt;/p&gt;
&lt;p&gt;Morphine, which does have a sedative effect, was used at a low level in both groups without a significant difference.&lt;/p&gt;
&lt;p&gt;But it&apos;s likely that delirium went undetected in some sedation group patients, given the difficulty of assessing the condition even when patients are awakened routinely, Str&amp;#248;m&apos;s group said. Assessing confusion rather than hyperactive delirium might be a better strategy, they suggested.&lt;/p&gt;
&lt;p&gt;They said they plan to follow patients at one year to assess long-term psychological effects.&lt;/p&gt;
&lt;p&gt;The researchers and editorialist agreed that further confirmation of these results are needed in multicenter research to determine whether the strategy is generalizable.&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 Danish Society of Anesthesiology and Intensive Care Medicine, the Fund of Danielsen, the Fund of Kirsten Jensa la Cour, and the Fund of Holger og Ruth Hess.&lt;/p&gt;&lt;p&gt;The researchers reported no conflicts of interest.&lt;/p&gt;&lt;p&gt;Brochard reported that his research laboratory has received research grants from several ventilator companies (Maquet, Dr&amp;#228;ger, Philips Respironics, General Electric) but no personal relationship to disclose for the use of sedation in intensive care.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
</recommendedContent>