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	<title>Ossis: Notícias</title>
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	<description>Especialista em Biomateriais</description>
	<lastBuildDate>Wed, 02 May 2012 11:55:52 +0000</lastBuildDate>
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		<title>Why mobile health devices need FDA oversight</title>
		<link>http://www.ossis.com.br/blog/?p=143</link>
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		<pubDate>Wed, 02 May 2012 11:55:52 +0000</pubDate>
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		<description><![CDATA[Everyone has heard of a recall of a consumer product such as a component of an automobile, child’s toy, or an over the counter medication.  A recall of those types of products often implies taking them off the market as &#8230; <a href="http://www.ossis.com.br/blog/?p=143">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
			<content:encoded><![CDATA[<p>Everyone has heard of a recall of a consumer product such as a component of an automobile, child’s toy, or an over the counter medication.  A recall of those types of products often implies taking them off the market as well as replacement or repair (in the case of device or car components).</p>
<p>During my 20 years as a practicing cardiac electrophysiologist, I witnessed firsthand the evolution of how implanted medical device ‘recalls’ are viewed and dealt with by industry, the FDA, lawyers, physicians, and patients.  Specifically, I experienced a few major ‘recalls’ of implantable cardioverter defibrillators (ICDs) and pacemakers.  The companies at that time left it up to physicians to inform patients.  Unfortunately, the public found out from mass media before physicians were even informed by the device manufacturers. Physicians received little in the way of guidelines from either companies or the FDA with regards to managing affected patients.</p>
<p>&nbsp;</p>
<p>Today, much is different.  There are both professional and FDA guidelines on how physicians approach many recalls.  We have learned both to create registries of affected patients and to use remote patient monitoring to more rapidly and completely identify the problem at hand. The word recall is not appropriate in most circumstances, and the term advisory is used.  This is because most advisories do not necessitate the removal of the device or component.  It unnecessarily makes the issue a black and white one, conjuring up a lone solution consisting of device replacement.  In fact, most advisories are today solved with device software reprogramming.  There is currently an ICD advisory which has evolved into a public relations battle being fought in the mass media. I believe that advisories, like the manufacturing of the device itself, should focus on the patients themselves. The sensationalism only decreases confidence in the entire industry and might result in fewer people choosing to avail themselves of lifesaving technology, creating potentially more harm than that done by the recalled product.</p>
<p>So how does this tie in to digital health technologies? Firstly, it must be said that advisories or recalls affect an extremely small segment of most devices. Device advisories and recalls will occur with mHealth technologies as well.  These devices are not 100% immune to defects.  Most defects when they do occur, affect components which are not critical. Some will affect direct to consumer types of devices, which would translate into a voucher for refund or replacement. Others, however, will be of a potentially more significant nature, possibly affecting the accuracy of remote patient monitoring data (though in over 12 years of remote patient monitoring of ICDs no significant defects have been seen regarding the monitoring capabilities itself) or technical glitches possibly resulting in wrong advice being given.</p>
<p>It is when we get into the more sci-fi types of technologies where defects may affect patients more.  Implantable monitors, drug or DNA transporters or monitors injected into the bloodstream, or artificial type skin with sensors, where an advisory or recall approaches new territory.  The FDA is moving to tighten post-market surveillance of implantable devices, in part with the institution of a <a href="http://blog.medicaldesign.com/perspectives/2012/03/15/bill-focuses-on-udi-system-to-ensure-patient-safety-improve-fda-oversight-of-devices/">unique device identifier (UDI)</a> system. I believe that mHealth products will be able to be tracked much easier than by UDIs by virtue of their own technologies’ tools.  Quality control of mHealth should not be any different from other medical devices, and should therefore fall under the <a href="http://davidleescher.com/2012/02/14/five-reasons-why-digital-health-technologies-need-fda-oversight/">auspices of the FDA</a>.</p>
<p><em>David Lee Scher is a former cardiologist and a consultant at DLS Healthcare Consulting, LLC.  He blogs at his self-titled site, </em><a href="http://davidleescher.com/">David Lee Scher, MD</a><em>.</em></p>
<p><strong><em>Source: <a href="http://www.kevinmd.com/blog/2012/04/mobile-health-devices-fda-oversight.html">http://www.kevinmd.com/blog/2012/04/mobile-health-devices-fda-oversight.html</a></em></strong></p>
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		<title>We need to systematically evaluate digital health technologies</title>
		<link>http://www.ossis.com.br/blog/?p=140</link>
		<comments>http://www.ossis.com.br/blog/?p=140#comments</comments>
		<pubDate>Wed, 02 May 2012 11:51:01 +0000</pubDate>
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		<description><![CDATA[An old colleague once told me: “When you assume it makes an ass out of u and me.” Many of us would consider being an ass a bad thing.  If so, why are we making so many assumptions about digital &#8230; <a href="http://www.ossis.com.br/blog/?p=140">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
			<content:encoded><![CDATA[<p>An old colleague once told me: “When you assume it makes an ass out of u and me.”</p>
<p>Many of us would consider being an ass a bad thing.  If so, why are we making so many assumptions about digital health?  Belief in the power of digital technologies to solve a host of pressing problems in health has us poised to devote billions of dollars to their adoption and development.  But are these beliefs based on solid evidence or wishful thinking?  I’m afraid it’s the latter.</p>
<p>&nbsp;</p>
<p>Given the austerity trends currently shaping the health industry, it is somewhat surprising that digital has gotten a free ride.  Partly due to the Affordable Care Act (ACA), physicians, hospitals and pharmaceutical companies are being financially incentivized to deliver high-quality, evidence-based care, products and services.  No matter what happens to the ACA in the Supreme Court, physicians will continue to be under ever-increasing pressure to adjust to this new financial reality.</p>
<p>Clearly, there’s a big focus on measuring and favoring medical interventions with proven benefits.  Given this, whither evidence-based digital health?  For the most part, we don’t know.</p>
<p>Why this state of affairs?  One major reason is that digital health technologies are in their infancy.  The health industry has struggled to catch up with consumers who have embraced online, social and mobile technologies.  Another has been psychological.  Technology has improved our lives so we assume it will do the same in health.</p>
<p>The time to begin systematically evaluating digital health technologies is now.  The costs associated with obesity, smoking, depression cancer and other conditions are staggering.  Not knowing whether mobile, social media and other digital tools can help people prevent or better manage disease is a big problem.  These technologies could deliver tremendous economic benefits to the public and private sectors.  Yet, if we don’t measure we won’t reap the rewards.</p>
<p>Some have begun answering the call to build the foundation for evidence-based digital health.  For example, Johns Hopkins recently launched a project designed to determine which mobile applications actually improve <a href="http://www.baltimoresun.com/health/bs-hs-mobile-health-apps-20120314,0,2590424.story?page=1">health and wellness</a>.  The social network PatientsLikeMe has conducted research suggesting joining the site significantly increases <a href="http://www.marketwire.com/press-release/survey-reveals-patientslikemer-helps-people-with-epilepsy-improve-seizure-understanding-1501220.htm">medication adherence</a>.  We have contributed by <a href="http://community.pathoftheblueeye.com/Articles/framework-justifying-investments-digital-health-content">developing a framework</a> for measuring the economic benefits associated with social, mobile and online content that activates or sustains positive health behaviors.</p>
<p>However, in our quest to measure digital health, we must avoid the mistakes of the past.  One criticism of evidence-based medicine has been the slow pace of research and translation of study findings to clinical practice.  To prevent this we must develop and use measurement methodologies that are appropriate for digital and allow for the rapid collection and dissemination of data.</p>
<p>In the meantime, we must not allow the fact that many digital health technologies are unproven inhibit experimentation.  We should follow the mantra of “first innovate, then measure.”  Doing so will encourage the spread of new, but proven digital tools that improve health and well-being.</p>
<p>If we don’t measure its luminosity, we’ll never know how bright digital health’s future will be.</p>
<p><strong>Source: <a href="http://www.kevinmd.com/blog/2012/04/systematically-evaluate-digital-health-technologies.html">http://www.kevinmd.com/blog/2012/04/systematically-evaluate-digital-health-technologies.html</a></strong></p>
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		<title>Robotic surgery shouldn’t be universally dismissed</title>
		<link>http://www.ossis.com.br/blog/?p=132</link>
		<comments>http://www.ossis.com.br/blog/?p=132#comments</comments>
		<pubDate>Fri, 30 Mar 2012 14:28:35 +0000</pubDate>
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		<description><![CDATA[A response to Why isn’t everyone excited about robotic assisted surgery? by Kelly Wright. Yes, it’s cool.  The surgical robot is every gamer-cum-surgeon’s dream. However, I, too, was a skeptic regarding incorporating robotic surgery into my practice.  I have been &#8230; <a href="http://www.ossis.com.br/blog/?p=132">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
			<content:encoded><![CDATA[<p><em>A response to <a href="http://www.kevinmd.com/blog/2012/03/isnt-excited-robotic-assisted-surgery.html">Why isn’t everyone excited about robotic assisted surgery?</a> by Kelly Wright.</em></p>
<p>Yes, it’s cool.  The surgical robot is every gamer-cum-surgeon’s dream.</p>
<p>However, I, too, was a skeptic regarding incorporating robotic surgery into my practice.  I have been practicing minimally-invasive surgery for over 20 years, including residency.  I became convinced of the value of minimally invasive surgery after observing patients postoperatively.  I have laparoscopically repaired an obturator nerve transection, done a radical hysterectomy ,  and more than 100 laparoscopic sacrocolpopexies and urethropexies.  I have removed uteruses weighing over 2000g laparoscopically.  The robot did not impress me initially as something useful to add, particularly when I had the skills to perform these cases laparoscopically.</p>
<p>&nbsp;</p>
<p>However, there is another side to this issue possibly better addressed by a veteran rather than someone still in training.  There is something to be said for surgical experience, technical knowledge and expertise gained after performing hundreds of cases on different body types in different circumstances.  A surgeon’s longevity, even with strict attention to proper operative ergonomics, may be restricted due to problems with arthritis, herniated discs, or other physical ailments which to a non-surgeon might not be as debilitating.  I found one day that due to the positioning issues I had with a particular type of case, my lower back began to bother me.  For the record, I am in top physical condition, better than most people half my age.  But much to my chagrin, I discovered I am human and not indestructible.  It was my own physical limitations that led me to engage in training on the robot.</p>
<p>As noted by Dr. Wright, studies have not demonstrated superior outcome to standard technique for robotic prostatectomy, and equivalent outcome compared with laparoscopic sacrocolpopexy.  In the case of the latter, operating times tended to be longer on the robot, with higher costs due to operating times and capital costs of equipment. However, thoracic surgery may be different.  More data is certainly needed.  Moreover, outcomes tend to be better with surgeons who perform many operations per year and who have greater experience.  In adding robotic surgery to my skillset, I reasoned that by embracing a technology allowing me to properly position my body, obtain 3D magnified visual information on the surgical field, I might be able to improve my surgical longevity.</p>
<p>I know of other surgeons with various physical ailments who are able to operate more effectively through the use of robotic technology.  Although this is not an issue being discussed, I believe it is a valid one.  I am a better surgeon now than I was 20 years ago.  My hope is to be able to continue at the top of my game for a long time.  Robotic surgical innovation has just begun.  Innovation is what propels us.  I believe that the surgical robot will evolve with surgeons and medicine, and allow us to do things not possible or practical even with laparoscopy.  Currently, I only use the robot for a few procedures, and continue to embrace standard laparoscopy for the rest.</p>
<p>I applaud careful evaluation of new technologies, but caution against straightforward dismissal based solely upon equipment cost.</p>
<p><em>Linda A. Kiley is an obstetrician-gynecologist. </em></p>
<p>Source: http://www.kevinmd.com/blog/2012/03/robotic-surgery-universally-dismissed.html</p>
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		<title>Building on the success of coordinated care</title>
		<link>http://www.ossis.com.br/blog/?p=129</link>
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		<pubDate>Fri, 30 Mar 2012 14:24:55 +0000</pubDate>
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		<description><![CDATA[With all the debate about how to best implement coordinated care that benefits patients while being feasible for providers and economical for the government, it’s ironic that little attention has been given to a decades-old managed care model that does &#8230; <a href="http://www.ossis.com.br/blog/?p=129">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
			<content:encoded><![CDATA[<p>With all the debate about how to best implement coordinated care that benefits patients while being feasible for providers and economical for the government, it’s ironic that little attention has been given to a decades-old managed care model that does all this.</p>
<p>But as Medicaid reform progresses in New York and elsewhere, that may be about to change.</p>
<p>&nbsp;</p>
<p>The program is called PACE, or the Program of All-inclusive Care for the Elderly, and it covers patients 55 and older who are eligible for Medicaid or Medicaid and Medicare and have been certified as eligible to live in a nursing home, even if they currently do not. PACE deploys multi-disciplinary teams of doctors, nurses, therapists and social workers who put together a customized, virtually all-inclusive care program for each patient. The goal is to optimize healthcare and quality of life, and allow patients to live as long as possible in the community rather than a nursing home.</p>
<p>In essence, PACE allows physicians to do what they do best – care for patients.</p>
<p>Results from this coordinated care approach are illustrated by a study conducted by PACE programs around the country that showed hospital days are 50% lower for PACE members compared to a fee for service Medicaid nursing home eligible population. Other studies have shown reduced rates of nursing home occupancy for PACE members compared to similar members in fee-for-service Medicaid programs along with a significant cost of care reduction.</p>
<p>So if PACE works so well, why isn’t it better known? The reason is that scaling the program has been difficult because the program’s rules require members to be seen by PACE physicians. Many seniors would prefer to see their own doctors in the community and fee-for-service Medicaid programs have allowed them to do so.</p>
<p>Recently CMS issued a waiver of that rule to one PACE program in a move that could presage a nationwide loosening of the restriction. Under this waiver, community physicians will be allowed to participate in PACE and receive capitated fees for providing care to patients.</p>
<p>Community physician participation is expected to be high, and PACE enrollment to increase substantially, because:</p>
<ul>
<li>Physicians will be relieved of the burden of addressing the multiple non-medical needs of these seniors. Those will be taken care of by the non-physician members of the multi-disciplinary team working in conjunction with the community physician.</li>
<li>Physicians will be able to spend more time on each patient visit because the capitated rate will be high enough to allow them to do so. That capitated rate is made possible by the financial structure of the program, which funnels payments from both Medicare and Medicaid to the PACE provider that are significantly higher than individual fees from either provider.</li>
</ul>
<p>As Medicaid programs increasingly move to managed care, as is being mandated in New York State beginning in April, PACE offers a model of how to improve care while creating physician satisfaction and controlling costs.</p>
<p>Source: http://www.kevinmd.com/blog/2012/03/building-success-coordinated-care.html</p>
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		<title>FDA Adds Diabetes Warning to Statin Label</title>
		<link>http://www.ossis.com.br/blog/?p=126</link>
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		<pubDate>Wed, 29 Feb 2012 12:26:58 +0000</pubDate>
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		<description><![CDATA[By Peggy Peck, Executive Editor, MedPage Today Published: February 28, 2012 &#160; &#160; &#160; WASHINGTON &#8212; The FDA said today that all statins must carry warnings about increased risks of elevated blood sugar and possible transient memory and cognition problems, but &#8230; <a href="http://www.ossis.com.br/blog/?p=126">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
			<content:encoded><![CDATA[<p>By Peggy Peck, Executive Editor, MedPage Today</p>
<p>Published: February 28, 2012</p>
<div></div>
<p>&nbsp;</p>
<aside>
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<p>&nbsp;</p>
<p>&nbsp;</p>
<p>WASHINGTON &#8212; The FDA said today that all statins must carry warnings about increased risks of elevated blood sugar and possible transient memory and cognition problems, but at the same time the agency removed a standing recommendation for routine liver function tests for patients taking the cholesterol-lowering drugs.</p>
<p>The FDA said the label changes apply to atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), lovastatin extended-release (Altoprev), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor).</p>
<p>Despite the additional warnings, the FDA said it &#8220;continues to believe that the cardiovascular benefits of statins outweigh these small increased risks.&#8221;</p>
<p>Rather than regular monitoring of liver function, the agency said that clinicians should now simply order a liver function test before starting a patient on a statin. Although the drugs do carry a risk of liver damage, the agency has judged the risk to be &#8220;rare and unpredictable in individual patients.&#8221;</p>
<p>The diabetes warning has been rumored as a possibility since the findings from <a href="http://www.medpagetoday.com/MeetingCoverage/AHA/11684" target="_blank">the JUPITER trial of rosuvastatin</a> revealed an unexpected 27% increase in new onset diabetes among patients randomized to the statin.</p>
<p>That finding was especially perplexing because JUPITER was a study of statins in patients who had no history of cardiovascular disease, the so-called healthy patient trial. Moreover, based on the JUPITER results, the FDA approved <a href="http://www.medpagetoday.com/Cardiology/Prevention/18380" target="_blank">rosuvastatin for primary prevention</a>.</p>
<p>The FDA said hyperglycemia was also observed among patients treated with 40-mg atorvastatin in a substudy of PROVE-IT TIMI 22, and a meta-analysis of data from 13 statin trials &#8220;reported that statin therapy was associated with a 9% increased risk for incident diabetes.&#8221;</p>
<p>The cognitive data are a bit sketchier and rely mainly on post-marketing adverse event reporting. The FDA said those reports &#8220;generally described individuals over the age of 50 years who experienced notable, but ill-defined memory loss or impairment that was reversible upon discontinuation of statin therapy.&#8221;</p>
<p>In addition to those broad label changes, the FDA added a number of restrictions to the lovastatin (Mevacor) label, including a list of 10 drugs or drug classes that are contraindicated with lovastatin.</p>
<p>Drugs contraindicated with lovastatin include:</p>
<ul>
<li>Itraconazole</li>
<li>Ketoconazole</li>
<li>Posaconazole</li>
<li>Erythromycin</li>
<li>Clarithromycin</li>
<li>Telithromycin</li>
<li>HIV protease inhibitors</li>
<li>Boceprevir</li>
<li>Telaprevir</li>
<li>Nefazodone.</li>
</ul>
<p>&nbsp;</p>
<p>Additionally, the new lovastatin label states that cyclosporine and gemfibrozil should be &#8220;avoided&#8221; when taking lovastatin, and lovastatin dosing should be limited to 20 mg for patients taking danazol, diltiazem, or verapamil. Finally, patients taking amiodarone should limit lovastatin to 40 mg daily.</p>
<p>In general, cardiologists contacted by <em>ABC News/MedPage Today</em>, applauded the FDA action &#8212; particularly the decision to remove the requirement for liver function testing. Harlan Krumholz, MD, of Yale University, said, &#8220;Good news on liver testing &#8212; provides no benefit and a lot of Americans are being monitored unnecessarily.&#8221;</p>
<p>But Krumholz and others worried about patients being scared off statins by the diabetes and memory warnings.</p>
<p>&#8220;All drugs have side effects and rarely some patients will have an odd reaction to statins &#8212; cognitive effects are among those &#8212; and are usually mild and resolve with stopping the medication. The blood sugar and diabetes issue has emerged over the last couple of years &#8212; this appears to be a side effect,&#8221; Krumholz wrote in an email.</p>
<p>Scott Grundy, MD, of the University of Texas Southwestern Medical Center in Dallas, was dubious about the level of evidence linking diabetes and cognition problems with statins. &#8220;I do not believe there is enough hard evidence to justify information and warnings about memory loss and confusion or increase in blood sugar.&#8221;</p>
<p>And Grundy, too, worried about the impact on patients, writing, &#8220;I also think that these warnings will cause some people who need statins to stop taking them. That would be unfortunate.&#8221;</p>
<p>The Cleveland Clinic&#8217;s Steven Nissen, MD, often a critic of the FDA, told ABC News/<em>MedPage Today</em>, &#8220;these are reasonable and prudent recommendations. I am pleased that FDA did not overstate the diabetes and cognitive function risks. Both problems are uncommon and don&#8217;t diminish the importance of statins in cardiovascular protection. For the vast majority of patients, the benefits far outweigh the risks.&#8221;</p>
<p>Moreover, Nissen said, the FDA&#8217;s decision on liver monitoring could boost statin use because it &#8220;will help to allay public apprehension about the liver safety of statins.&#8221;</p>
<p><em>This article was developed in collaboration with ABC News. </em><img src="http://www.medpagetoday.com/upload/2009/10/1/14357_1.jpg" alt="" /></p>
<p>Source: <a href="http://www.medpagetoday.com/Cardiology/Dyslipidemia/31408">http://www.medpagetoday.com/Cardiology/Dyslipidemia/31408</a></p>
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		<title>Chronic pain has a price</title>
		<link>http://www.ossis.com.br/blog/?p=123</link>
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		<pubDate>Wed, 29 Feb 2012 12:23:22 +0000</pubDate>
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		<description><![CDATA[Everyone who knows a person with chronic pain is aware that it comes with a huge price on quality of life, but indeed chronic pain also have a heavy economic price for the society in general. A price we might &#8230; <a href="http://www.ossis.com.br/blog/?p=123">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
			<content:encoded><![CDATA[<p>Everyone who knows a person with chronic pain is aware that it comes with a huge price on quality of life, but indeed chronic pain also have a heavy economic price for the society in general. A price we might be able to reduce by awareness and intervention for those who need it and especially for those who need it most.</p>
<p>The size of the economic burden is of cause different from country to country, based on differences in health economy and in the organisation and extent of health care and social care. But all presented figures from different countries are high and in it self calls for action.</p>
<p>&nbsp;</p>
<p>Recently a Swedish study was published looking at “Diagnosis Related To Pain” (DRTP), that is not for chronic pain alone but total costs for persons with diagnosis connected with chronic pain conditions. The total cost for society was a huge 20% of Swedish tax burden. Indirect costs associated with lost production because the patient is absent from work constituted the largest proportion of the cost estimate (about 60%).</p>
<p>If we hold this in mind when looking at another recent published study looking at the economic burden associated with chronic pain, there is important information to get. In this study from Ireland the researches found, that a small proportion of patients account for the bulk of costs—the top 5% most expensive patients accounted for 26% of costs, the 10% most expensive patients were responsible for 43% of all costs, and the top 20% of patients accounted for 64% of all costs.</p>
<p>Now who are those patients with the highest costs? Well, the Irish researchers found two important determinants of costs one is the intensity of experienced pain, high levels of experienced pain was four times higher than for the group with low level of pain. The other factor was patients with depression, as the authors pointed out, this is unsurprising, but highlights the importance of intervention also from an economic perspective.</p>
<p>You would probably also guess, that higher pain scores are connected to higher economic costs, but these two papers make it clear and provide the evidence as well as documents the surprisingly high costs and their distribution among the patients.</p>
<p>While we often are still looking for the biomedical solution for the pain, encouraged by the patient experiencing that “something <em>must</em> be wrong”, there is a great risk of missing the co-existing depression, and miss the opportunity to reduce the risk of developing chronic pain, by early sufficient pain treatment – and that is more than pharmaceuticals.</p>
<p>We must screen for depression and pay attention to the experienced pain intensity, because we <em>need</em>to reduce both the human and the economical cost of chronic pain, one of the major health and health care problems of our time.</p>
<p><em>Kim Kristiansen is a family physician in Denmark who blogs at </em><a href="http://blog.dolotest.com/">Picture of Pain</a><em>.</em></p>
<p>Source: <a href="http://www.kevinmd.com/blog/2012/02/chronic-pain-price.html">http://www.kevinmd.com/blog/2012/02/chronic-pain-price.html</a></p>
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		<title>Nota à Sociedade</title>
		<link>http://www.ossis.com.br/blog/?p=120</link>
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		<pubDate>Tue, 17 Jan 2012 13:51:02 +0000</pubDate>
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		<description><![CDATA[11 de janeiro de 2012 O Ministério da Saúde e a Agência Nacional de Vigilância Sanitária em conjunto com as Sociedades Médicas de Especialistas: Sociedade Brasileira de Mastologia, Sociedade Brasileira de Cirurgia Plástica, Conselho Federal de Medicina, bem como o &#8230; <a href="http://www.ossis.com.br/blog/?p=120">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
			<content:encoded><![CDATA[<p><em>11 de janeiro de 2012</em></p>
<p><img src="http://portal.anvisa.gov.br/wps/wcm/connect/59c41d0049c251c59f88bf6dcbd9c63c/13.jpg?MOD=AJPERES&amp;CACHEID=59c41d0049c251c59f88bf6dcbd9c63c" alt="" /></p>
<p>O Ministério da Saúde e a Agência Nacional de Vigilância Sanitária em conjunto com as Sociedades Médicas de Especialistas: Sociedade Brasileira de Mastologia, Sociedade Brasileira de Cirurgia Plástica, Conselho Federal de Medicina, bem como o Departamento de Proteção e Defesa do Consumidor/Ministério da Justiça, a partir das ações sanitárias realizadas pela Anvisa, dentre elas a suspensão da importação, comercialização e posteriormente o cancelamento do registro das próteses mamárias das marcas PIP e Rofil, e da necessidade de avaliação e acompanhamento das pessoas que receberam este tipo de implante, passam a informar:</p>
<p>1. Os portadores de próteses (PIP e Rofil) desde 2004, serão chamados para avaliação clínica nos serviços de saúde;</p>
<p>2. Serão elaboradas diretrizes de avaliação, diagnóstico, conduta e acompanhamento em conjunto com as sociedades médicas e Ministério da Saúde, divulgadas oportunamente;</p>
<p>3. O tratamento cirúrgico de substituição das próteses identificado mediante as diretrizes supracitadas será considerado reparador;</p>
<p>4. Até o momento, não há evidências que justifiquem a remoção e substituição preventiva das próteses em questão;</p>
<p>5. A qualquer tempo que sejam diagnosticadas alterações clínicas ou ruptura da prótese, o tratamento cirúrgico será de caráter reparador;</p>
<p>6. Os eventos adversos devem ser notificados à Anvisa, através do site<a href="http://www.anvisa.gov.br/">www.anvisa.gov.br</a>;</p>
<p>7. Serão realizadas reuniões periódicas deste fórum, para o acompanhamento das ações definidas nesta reunião, o que possibilitará a revisão das decisões e novas orientações.<br />
Ministério da Saúde</p>
<p>Agência Nacional de Vigilância Sanitária</p>
<p>Departamento de Proteção e Defesa do Consumidor – MJ</p>
<p>Conselho Federal de Medicina</p>
<p>Sociedade Brasileira de Mastologia</p>
<p>Sociedade Brasileira de Cirurgia Plástica</p>
<p>Brasília, 11 de janeiro de 2012</p>
<p>Fonte: www.anvisa.gov.br</p>
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		<title>Are doctors given more responsibility than they can handle?</title>
		<link>http://www.ossis.com.br/blog/?p=117</link>
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		<pubDate>Tue, 17 Jan 2012 13:47:07 +0000</pubDate>
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		<description><![CDATA[Doctors inevitably come into spotlight, being at the front end of health care delivery. Sometimes seen as guardian angels restoring health and life, other times, greedy minds sucking resources while they carelessly harm and kill patients to fill their wallets. &#8230; <a href="http://www.ossis.com.br/blog/?p=117">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
			<content:encoded><![CDATA[<p>Doctors inevitably come into spotlight, being at the front end of health care delivery. Sometimes seen as guardian angels restoring health and life, other times, greedy minds sucking resources while they carelessly harm and kill patients to fill their wallets. After experiencing, observing, and hearing from others like me, I wonder if doctors are given more responsibility than they can handle, often attributed more aura than they deserve and frequently accused of more corruption than they are liable for.</p>
<p>This is my attempt to redeem them from their “divineness” and their “evil” and make expectations, speculations and skepticisms a bit more realistic. When I say doctors, I mean, a typical one in the community, having a clinical job or practice, who doesn’t do research, but reads them, member of medical societies, attends CME conferences regularly. In short, a doctor who is a consumer within the healthcare industry, which form the majority.</p>
<p>&nbsp;</p>
<p>Doctors are trained for their skills and are not magicians. Medicine is artfully delivered science. Patients get better not because of anyone’s angelic touch or some celestial mediation, but because of treatments and interventions that are tested, tried and known to work. However, the art of delivering leaves a long lasting impression in patients’ minds. These minor details are the major differences between top and mediocre hospitals. This ends my argument about the supernatural powers that doctors are supposed or expected to have.</p>
<p>It is an inescapable fact that healthcare industry is more similar to other non-medical fields than it is different. However doctors are expected to play a superior role while everything else in the industry isn’t necessarily so. Healthcare is a business where workers have to be paid, professional relationships have to be maintained, the patients have to be satisfied, the corporation should run successfully. There are lots of limitations that doctors work under, making it extremely difficult if not impossible to meet all of the expectations. Held responsible for the fallacies of the healthcare system, doctors see themselves more as victims of it. There are lot of judgmental attitudes and actions that occur based on isolated events. They feel this tug and pull as they try to strike a balance between cost- cutting, defensive medicine, patient satisfaction while remaining in control of their practice and avoid an unsustainable situation personally and professionally. One patient’s angel may be another’s devil. An awesome doctor for a patient may be a colleagues nightmare and with time, it can all be reversed within no time. It just takes one bad moment to damage the reputation that has been built over years. For a doctor it is devastating, even if the factual consequences for everyone else are hardly so.</p>
<p>Doctors get overworked (sometimes voluntarily when they have independent practices), become victims of abuse and overuse by hospitals, employers and administrators (when employed). As a result they too become irritable, annoyed, annoying, depressed. They walk on the proverbial tight rope on each side of which are the hot oil of litigation and the fire of cost cutting that is flaring up, with the heat almost singeing their hairs. Professional competition, conflicts of interest shake and wiggle the rope, while the balancing stick has to be held on to tightly. The stick consists of professional ethics, competence, compassion and empathy to patients without getting attached to them, business and communication etiquette, time management, family, personal growth. It is indeed challenging to become a doctor who is loved by everyone around including patients, colleagues, staff, community and family especially all through their career. But if they do make it to the other end of the rope, there is a well deserved applause waiting. Mostly from self as no one else would be watching.</p>
<p>When it comes to business of health care, doctors are again stuck between a rock and hard place.</p>
<p>An integral part of the health care industry, in patients’ eyes, doctors also represent it. They are seen as accountable for any flaws in the health care system, including but not limited by the flaws in pharmaceutical industries, medico-legal system and the health insurance system. Doctors find themselves being measured with a different scale while the rest of the components that ideally have to function in parallel and in sync with doctors, go by the general rule of the industry. The medical profession requires us to empathize but not get attached to patients. It requires us to treat equally, while the insurance companies are allowed to be discriminatory in their payment. In other words, the system rewards you differently for the same treatment delivered. Doctors do not fix the price for their services, the system does. The cost of physician services vary by specialty and by procedures. Physicians cannot sell themselves to drug companies, but the companies have a strong grip on the whole health care system be it through funding research or sponsoring activities of medical societies.</p>
<p>In a typical private practice, overhead costs are prohibitively high (includes space, computers, electronic medical records, staffing, housekeeping, power and water supply), 70% in one place I interviewed! Moreover, the insurance companies &amp; medicare decide the reimbursement. Again doctors are not as powerful as they appear.</p>
<p>Taking care of people who are suffering and making them feel better is an extremely rewarding job by itself. But there is just not enough time to do that rewarding job. If you are scheduled to see 30-40 patients in a clinic, how is it humanly possible to listen to every patient’s complete story? When our job is to care, where and when does it end?</p>
<p><strong>Source: <a href="http://www.kevinmd.com/blog/2011/12/doctors-responsibility-handle.html">http://www.kevinmd.com/blog/2011/12/doctors-responsibility-handle.html</a></strong></p>
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		<title>How much guidance do patients want with their medical decisions?</title>
		<link>http://www.ossis.com.br/blog/?p=114</link>
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		<pubDate>Tue, 17 Jan 2012 13:38:23 +0000</pubDate>
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		<description><![CDATA[The following column was published on November 10, 2011  inMedical Economics. I recently saw two patients in my primary care clinic, each with new-onset hypertension. The first, a middle-aged executive, brought printouts from the Internet and already had researched the &#8230; <a href="http://www.ossis.com.br/blog/?p=114">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
			<content:encoded><![CDATA[<p><em>The following column was published on November 10, 2011  in</em>Medical Economics<em>.</em></p>
<p>I recently saw two patients in my primary care clinic, each with new-onset hypertension.</p>
<p>The first, a middle-aged executive, brought printouts from the Internet and already had researched the various treatment options for high blood pressure. During the visit, we discussed this information, and I gave my thoughts on what to do next. He considered and appreciated my input but made it clear that the ultimate decision was his.</p>
<p>The second was an elderly gentleman in his 70s. Again, I discussed the various management approaches and then gave my opinion on what we should do. In contrast to the other patient, he said, “I want to do whatever you suggest. After all, you’re the doctor.”</p>
<p>&nbsp;</p>
<p>As a publisher of a social media health Web site, I’ve observed closely the growth of the patient empowerment movement, facilitated by the Web making health information more accessible. According to the Pew Internet and American Life Project, 80% of Internet users <a href="http://pewinternet.org/Reports/2011/Social-Life-of-Health-Info.aspx">go online to research their health</a>, and this effort gives patients a greater voice in their care. Paternalistic decision making that traditionally drove the doctor-patient relationship slowly is being replaced by shared decisions. But not all patients embrace their new decision-making role.</p>
<p>In a recent study from the <em>Journal of Medical Ethics</em>, researchers interviewed more than 8,000 patients. Almost all wanted doctors to offer choices and help consider their options, but two-thirds preferred that the <a href="http://well.blogs.nytimes.com/2011/08/11/letting-doctors-make-the-tough-decisions/?partner=rss&amp;emc=rss|~http://well.blogs.nytimes.com/2011/08/11/letting-doctors-make-the-tough-decisions/?partner=rss&amp;emc=rss%0A">final medical decision to be left to the physician</a>.</p>
<p>According to Farr A. Curlin, MD, an associate professor of medicine at the University of Chicago and one of the authors of the study, “the data [say] decisively that most patients don’t want to make these decisions on their own.”</p>
<p>There is a spectrum of how much physician involvement patients want. Some may want physicians only to suggest and inform but leave the ultimate decision to them. Others prefer doctors to have the final say.</p>
<p>The only way to know a patient’s preference is through a continuous relationship where that comfort level can be developed over time. After several encounters, a clinician should have a sense of how much, or how little, direction a patient needs.</p>
<p>Sadly, two factors in healthcare today work against such a sustained doctor-patient relationship. One is the fragmentation of medical care. More patients are seeing not only a primary care physician (PCP) in a clinic, but also a hospitalist when admitted to a hospital, along with an array of specialists both in the hospital and the clinic. According to a <em>New England Journal of Medicine</em> study, Medicare beneficiaries saw an average of <a href="http://www.nejm.org/doi/full/10.1056/NEJMsa063979">two primary care physicians and five specialists working in four different practices</a>. Without knowing the patient well, each provider may differ with his or her input in the medical decision process, which can frustrate patients who may have their own ideas of how much their doctors should be involved.</p>
<p>Next, consider the decay of primary care itself. There is a profound shortage of PCPs, with the American College of Physicians noting that “primary care, the backbone of the nation’s healthcare system, is at grave risk of collapse.” Patients who cannot schedule timely primary care appointments go to the emergency department, where they encounter clinicians they’ve never met before. The shortage is compounded by what is shown in the results of an <em>Annals of Internal Medicine</em> survey, which revealed that <a href="http://www.annals.org/content/151/1/28.abstract">30% of PCPs were likely to leave the field</a>, citing burnout from time pressures, a chaotic work pace, and little control over their work. Both the shortage and attrition of primary care providers worsen the odds of forming long-term relationships with patients.</p>
<p>Having known my two patients with hypertension for years, I anticipated how much physician involvement they would need to make a treatment decision and was able to tailor my approach to meet their individual expectations. During this turbulent period of healthcare reform, we cannot lose sight of the importance of a continuous relationship between doctors and patients. Otherwise, our fragmented health system and deterioration of primary care will make it challenging to provide the proper amount of guidance for patient medical decisions.</p>
<p>Source: <a href="http://www.kevinmd.com/blog/2011/12/guidance-patients-medical-decisions.html">http://www.kevinmd.com/blog/2011/12/guidance-patients-medical-decisions.html</a></p>
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		<title>Considering cancer and heart disease in opposing ways</title>
		<link>http://www.ossis.com.br/blog/?p=112</link>
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		<pubDate>Wed, 30 Nov 2011 13:31:02 +0000</pubDate>
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		<description><![CDATA[The American public seems to consider cancer and cardiovascular disease in diametrically opposing ways. Cancer evokes the threat of relentless, painful suffering and whatever medical science can do to delay the judgement day is appreciated. Therapeutic regimens may involve disfiguring &#8230; <a href="http://www.ossis.com.br/blog/?p=112">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
			<content:encoded><![CDATA[<p>The American public seems to consider cancer and cardiovascular disease in diametrically opposing ways. Cancer evokes the threat of relentless, painful suffering and whatever medical science can do to delay the judgement day is appreciated. Therapeutic regimens may involve disfiguring operations, prolonged toxic irradiation and chemotherapeutic agents that may be beneficial if they do not kill you first.</p>
<p>&nbsp;</p>
<p>Response to treatment of limited incidence and duration are accepted and deemed beneficial. Recurrence after therapy is often attributed to innate tumor aggressiveness. The cancerous process is beyond a patient’s control. Chromosomal aberrations and environmental toxins trigger carcinogenesis in undeserving people. Even tobacco abuse is blamed on unscrupulous tobacco companies, passive smoke exposure or faulty building insulation. There are few data bases comparing survival and complications for specific treatments between individual hospitals or practitioners.</p>
<p>Compare this regard for the vagaries of cancer incidence and treatment with the strict scrutiny of the cardiac surgeon. Despite decades of self abuse, patients expect surgical treatment of coronary artery disease to be painless, not deforming, mostly risk-free and curative. Untoward events are implicitly due to incompetence and subject to litigation. Patients not taking responsibility for modifying their lifestyle to retard disease progression is accepted as human frailty. No medical practice is subjected to the public scrutiny as cardiac surgery. Hospitals and surgeons have their reputations besmirched or praised in newspapers or magazines for supposed poor results with little consideration as to whether different patient populations are in fact comparable. In summary, the public has little tolerance for an imperfect result following open heart surgery.</p>
<p>Why do cardiac surgeons have to answer to a more demanding grading system? Maybe they have themselves to blame. Holding another person’s heart in your hand confers an aura of omnipotence. This high profile is accentuated by the facts that the practice is technologically intense, requires a cadre of skilled personnel and it is relatively new with rapid improvements in technique and results. All of which have occurred within the memory span of their patient population.</p>
<p>With this background, previously richly compensated people may have reinforced the unrealistic expectations of the public and are now facing the consequences. The current trend of decreasing surgical volume, lower reimbursement and more stringent operative criteria have chastened cardiac surgeons. Hopefully, their patients’ tolerance and expectations will be appropriately modified, not too expect inferior care, just more realistic outcomes and also understand the importance of taking control of their own risk factors.</p>
<p>Source: <a href="http://www.kevinmd.com/blog/2011/11/cancer-heart-disease-opposing-ways.html">http://www.kevinmd.com/blog/2011/11/cancer-heart-disease-opposing-ways.html</a></p>
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