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    <recommendedItem id="20100101_19_309"
                     title="Increasing Copays: Penny-Wise but Pound-Foolish? (CME/CE)"
                     score="0.004"
                     href="http://www.medpagetoday.com/Geriatrics/GeneralGeriatrics/tb/18173?impressionId=1265781417270"
                     
      &lt;p&gt;Raising seniors&apos; copayments for ambulatory care to offset increasing healthcare costs may backfire on insurers, researchers asserted.&lt;/p&gt;
&lt;p&gt;Seniors enrolled in Medicare plans that increased copayments had significantly fewer outpatient visits but spent more time in the hospital than patients in plans that left copayments untouched, according to Amal Trivedi, MD, MPH, of Brown University in Providence, R.I., and colleagues.&lt;/p&gt;
&lt;p&gt;Assuming an average reimbursement of $60 for an outpatient visit, seven annual visits per enrollee, and an average copay increase of $8.50 per visit, a plan should save $7,150 for every 100 enrollees, they noted in the Jan. 28 &lt;em&gt;New England Journal of Medicine&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;But, assuming an average cost of $11,065 per hospitalization of a person 65 to 84, the researchers estimated that the costs for inpatient care would actually increase by $24,000 for every 100 enrollees in the year after copays are increased.&lt;/p&gt;
&lt;p&gt;Even using more conservative criteria, the increased costs for inpatient care would nearly double any savings from increasing copays, they argued.&lt;/p&gt;
&lt;p&gt;&quot;Cost-sharing has generally been thought to reduce total healthcare spending without harming health for the average person,&quot; the researchers wrote, but these results suggest increasing copays in Medicare beneficiaries &quot;may be a particularly ill-advised cost-containment strategy.&quot;&lt;/p&gt;
&lt;p&gt;Increasing copayments may be particularly harmful to older patients, they said, because they have lower incomes and are more likely to have poor health and greater out-of-pocket healthcare expenses than younger patients.&lt;/p&gt;
&lt;p&gt;To explore the issue in a Medicare population, Trivedi and colleagues compared the use of outpatient and inpatient care between enrollees in 18 plans that increased copays for ambulatory care and 18 that did not. The study included 899,060 patients.&lt;/p&gt;
&lt;p&gt;According to data from the Medicare Healthcare Effectiveness Data and Information Set from the Centers for Medicare and Medicaid Services, mean copays increased during the study period for both primary care ($7.38 to $14.38) and specialty care ($12.66 to $22.05) in the case plans.&lt;/p&gt;
&lt;p&gt;Mean copays remained stable at $8.33 and $11.38 for primary and specialty care, respectively, in the control plans.&lt;/p&gt;
&lt;p&gt;In both groups, there were increases in the number of ambulatory visits over time, but the increase was smaller in the plans that raised copays.&lt;/p&gt;
&lt;p&gt;There was also a rise in the number of hospitalizations, the proportion of patients who were hospitalized, and the length of time spent in the hospital in both groups, but there were larger increases in the plans that increased copays.&lt;/p&gt;
&lt;p&gt;Compared with the control plans, in the year after the increase in copays, case plans had: &lt;ul&gt; &lt;li&gt;19.8 fewer annual outpatient visits per 100 enrollees (95% CI 16.6 to 23.1)&lt;/li&gt; &lt;li&gt;2.2 additional annual hospital admissions per 100 enrollees (95% CI 1.8 to 2.6)&lt;/li&gt; &lt;li&gt;13.4 more annual inpatient days per 100 enrollees (95% CI 10.2 to 16.6)&lt;/li&gt; &lt;li&gt;A 0.7% increase in the proportion of enrollees who were hospitalized (95% CI 0.51% to 0.95%)&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;The findings were amplified among enrollees living in areas of lower income and education, black patients, and those who had hypertension, diabetes, or a history of myocardial infarction.&lt;/p&gt;
&lt;p&gt;Trivedi and colleagues noted some limitations of the analysis: it was not randomized, and unmeasured differences could have influenced the results.&lt;/p&gt;
&lt;p&gt;Also, the case and control plans could not be matched in a geographic area smaller than census region because of the small number of Medicare plans, and data were lacking on diagnoses, procedures, and costs associated with hospital admissions and outpatient visits.&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;Trivedi is the recipient of a Pfizer Health Policy Scholars Award and a career development award from the Veterans Affairs Health Services Research and Development Services.&lt;/p&gt;&lt;p&gt;The authors reported no relevant 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_304"
                     title="&apos;Virtual&apos; Colon Scans Effective in Seniors (CME/CE)"
                     score="0.004"
                     href="http://www.medpagetoday.com/HematologyOncology/ColonCancer/tb/18164?impressionId=1265781417270"
                     
      Patients 65 and older are as suitable as younger individuals for CT colonography, said researchers conducting a large retrospective study.&lt;br&gt;
&lt;br&gt;Advanced neoplasias were detected with CT colonography  --  often called &quot;virtual colonoscopy&quot;  --  in older patients at more than double the rate in the general screening population, reported David H. Kim, MD, of the University of Wisconsin in Madison, Wis., and colleagues in the February issue of &lt;em&gt;Radiology&lt;/em&gt;.&lt;br&gt;
&lt;br&gt;They found that 7.6% of older patients had advanced neoplasias, compared with 3.2% of all patients screened in the university&apos;s clinic (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.001).&lt;/p&gt;
&lt;p&gt;On the basis of this and other findings in 577 individuals 65 and older versus the entire group of 3,120 patients undergoing the procedure, Kim and colleagues concluded that &quot;CT colonography performance is maintained in an older cohort.&quot;&lt;/p&gt;
&lt;p&gt;&quot;Overall, the observations from this clinical experience confirm that CT colonography may be a valuable screening modality in the older population,&quot; they wrote.&lt;/p&gt;
&lt;p&gt;On the other hand, the study did not address several objections raised by the Centers for Medicare and Medicaid Services (CMS) in its decision last year to deny Medicare coverage for the procedure. (See &lt;a href=&quot;http://www.medpagetoday.com/PublicHealthPolicy/Medicare/14186&quot; mce_href=&quot;http://www.medpagetoday.com/PublicHealthPolicy/Medicare/14186&quot; target=&quot;_blank&quot;&gt;Medicare Finalizes Denial of Virtual Colonoscopy Coverage&lt;/a&gt;)&lt;/p&gt;
&lt;p&gt;CMS had pointed to relatively low sensitivity of CT colonography compared with optical colonoscopy in prospective trials, especially for small lesions.&lt;/p&gt;
&lt;p&gt;The agency also determined that CT colonography increased the costs of positive findings, since abnormalities in the CT scans must be confirmed with optical colonoscopy. In addition, CMS said there was no evidence to support claims that the less invasive imaging procedure would be more acceptable to patients and therefore would raise screening rates.&lt;/p&gt;
&lt;p&gt;The data analyzed by Kim and colleagues did not allow for calculations of false-negative rates or predictive values of positive or negative findings. Nor did the researchers report cost information.&lt;/p&gt;
&lt;p&gt;Mean age of their older cohort was 69.2 (SD 3.8). The oldest was 79.&lt;/p&gt;
&lt;p&gt;The researchers reported that 15.3% of the older patients were referred for optical colonoscopy on the basis of the CT results, compared with 7.9% of the overall screening group.&lt;/p&gt;
&lt;p&gt;Less than 4% of positive findings were determined to be false with the optical procedure (3.6% for polyps 6 to 10 mm in diameter, 2.1% for larger lesions).&lt;/p&gt;
&lt;p&gt;Of the 59 advanced neoplasias identified in the older patients, all but three were at least 10 mm in size.&lt;/p&gt;
&lt;p&gt;The scans also suggested abnormalities outside the colon in 89 (15.4%) patients. Of these, 45 received a full workup, which revealed substantial and previously unsuspected diagnoses in 21 cases  -- 18 were vascular aneurysms. The other three included one lung tumor, a femoral hernia, and a malrotation.&lt;/p&gt;
&lt;p&gt;Kim and colleagues reported that no &quot;substantial complications&quot; such as perforations or major hemorrhage occurred in the older patients, either with the CT scan or follow-up colonoscopy.&lt;/p&gt;
&lt;p&gt;They also indicated that the ratio of large to small neoplasias was similar in the older patients compared with their CT screening group as a whole. Histologic and morphologic findings were similar as well.&lt;/p&gt;
&lt;p&gt;The researchers cited the observational nature of the study, in which negative findings were not corroborated with optical colonoscopy, and its restriction to a single center as its main limitations.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;No external funding for the study was reported.&lt;/p&gt;&lt;p&gt;Kim and one co-author reported relationships with Viatronix and Medicsight and are co-founders of a company called VirtuoCTC, which produces educational materials on CT colonography.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_200"
                     title="Debate Surges on Composite Endpoints"
                     score="-0.004"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/ClinicalTrials/tb/18046?impressionId=1265781417270"
                     
      &lt;p&gt;Composite endpoints can obscure the real findings of clinical trials, two researchers charged in a &lt;em&gt;JAMA&lt;/em&gt; commentary this week, but others who had led trials using such outcomes defended the practice.&lt;/p&gt;
&lt;p&gt;Composite endpoints  --  where a study&apos;s main outcome is a combination of two or more different types of events, such as death and nonfatal myocardial infarction  --  can serve useful purposes, George Tomlinson, PhD, and Allan S. Detsky, MD, PhD, both of the University of Toronto, wrote in the Jan. 20 &lt;em&gt;Journal of the American Medical Association&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;But the benefits of composite endpoints come with a price, they argued  --  confusion to physicians and patients.&lt;/p&gt;
&lt;p&gt;&quot;Clinicians want to know if all events in the composite outcome are affected equally by the intervention,&quot; Tomlinson and Detsky wrote.&lt;/p&gt;
&lt;p&gt;Physicians can usually find results for the endpoint&apos;s individual components, they acknowledged, but it may &quot;result in some confusion, because the component relative risks may have broad confidence intervals and differ widely, at times even extending in opposite directions.&quot;&lt;/p&gt;
&lt;p&gt;Moreover, the Toronto researchers argued, if readers must examine results of the individual components of the composite endpoint to grasp the study&apos;s clinical implications, it defeats the composite endpoint&apos;s original purpose.&lt;/p&gt;
&lt;p&gt;&quot;While [readers] were enticed by a trial performed according to rigorous principles and based on the primary composite outcome, once the results have been reported they find that their interest has been redirected to individual outcomes of questionable importance,&quot; Tomlinson and Detsky wrote.&lt;/p&gt;
&lt;p&gt;They acknowledged that composites may sometimes make clinical sense, or are necessary because no single outcome is a natural primary endpoint by itself. Another practical rationale is to reduce the number of patients necessary in a study to detect a significant treatment effect.&lt;/p&gt;
&lt;p&gt;For example, if an outcome is expected to occur at a 5% annual rate and the trial is planned to last five years, more than 2,500 patients are needed to establish a hazard ratio of 0.75 with &lt;em&gt;P&lt;/em&gt;&amp;lt;0.05, Tomlinson and Detsky noted.&lt;/p&gt;
&lt;p&gt;But if several outcomes can be combined into a composite endpoint that has an annual rate of 20%, fewer than 800 patients will provide adequate power.&lt;/p&gt;
&lt;p&gt;That&apos;s generally fine when the individual component events occur at approximately equal rates, are of similar seriousness, and change in the same way with treatment, but that is frequently not the case, Tomlinson and Detsky contended.&lt;/p&gt;
&lt;p&gt;Steven Nissen, MD, a Cleveland Clinic cardiologist, agreed in a phone interview with &lt;em&gt;MedPage Today&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Noting that composites of death, heart attack, and stroke are common in cardiovascular therapy trials, &quot;one would argue that all three of those outcomes are fairly grave [and] involve death or permanent injury,&quot; he said, and thus can be appropriate to combine into a single outcome.&lt;/p&gt;
&lt;p&gt;But, he added, &quot;what if the combination of endpoints is illogical, where you&apos;re combining grave endpoints with endpoints that are much less serious.&quot; In that case, the composite is much more difficult to interpret and may actually mislead readers about the study&apos;s true findings, Nissen suggested.&lt;/p&gt;
&lt;p&gt;&quot;Composite endpoints are a necessary evil, but they have to be thought through very carefully,&quot; he said.&lt;/p&gt;
&lt;p&gt;One trial with composites of serious and not-so-serious outcomes was reported last month at the American Society of Hematology meeting.&lt;/p&gt;
&lt;p&gt;Presented by Jeffrey Carson, MD, of the University of Medicine and Dentistry of New Jersey in New Brunswick, N.J., it tested different postoperative blood transfusion volumes. (See &lt;a href=&quot;http://www.medpagetoday.com/MeetingCoverage/ASHHematology/17418&quot; mce_href=&quot;http://www.medpagetoday.com/MeetingCoverage/ASHHematology/17418&quot; target=&quot;_blank&quot;&gt;ASH: Lower Threshold for Post-op Transfusion Proves Safe&lt;/a&gt;)&lt;/p&gt;
&lt;p&gt;Its primary outcome was a combination of death and walking ability, and a secondary endpoint was a composite of death, myocardial infarction, infection, congestive heart failure, stroke, and venous thromboembolism.&lt;/p&gt;
&lt;p&gt;In a recent phone interview with &lt;em&gt;MedPage Today&lt;/em&gt;, Carson said composites are frequently chosen to reduce the necessary sample size, but in his study the rationale was more about finding an outcome that best reflected the clinical issue.&lt;/p&gt;
&lt;p&gt;Including death alongside less serious outcomes such as inability to walk or infections was intended to capture the possibility that a transfusion regime might improve the lesser outcome but increase mortality.&lt;/p&gt;
&lt;p&gt;&quot;You wouldn&apos;t want to declare that, well, it improves your chances of walking and not consider its impact on death,&quot; Carson explained.&lt;/p&gt;
&lt;p&gt;Another study with a composite endpoint was a 2006 study of rosiglitazone (Avandia) called DREAM. Its primary endpoint combined death with incidence of new-onset diabetes. (See &lt;a href=&quot;http://www.medpagetoday.com/Endocrinology/Diabetes/4115&quot; mce_href=&quot;http://www.medpagetoday.com/Endocrinology/Diabetes/4115&quot; target=&quot;_blank&quot;&gt;EASD: Avandia Prevents Progression to Diabetes in High-Risk Patients&lt;/a&gt;)&lt;/p&gt;
&lt;p&gt;Tomlinson and Detsky held up DREAM in the very first paragraph of their &lt;em&gt;JAMA&lt;/em&gt; commentary as an example of a questionable composite endpoint.&lt;/p&gt;
&lt;p&gt;&quot;Death and diabetes are quite far apart in the spectrum of severity,&quot; they wrote, suggesting that clinicians would find the outcome  --  a 60% reduction in the two events  --  hard to interpret.&lt;/p&gt;
&lt;p&gt;&quot;Two questions arise,&quot; they wrote. &quot;Was there a 60% reduction in both death and diabetes? Are the two outcomes just as likely to occur?&quot;&lt;/p&gt;
&lt;p&gt;Nissen agreed that DREAM well illustrated the problems that can arise from composite endpoints.&lt;/p&gt;
&lt;p&gt;&quot;I do not like the situation where endpoints that have a great deal of difference in gravity and seriousness are combined,&quot; he told &lt;em&gt;MedPage Today&lt;/em&gt;. &quot;This was a great example.&quot;&lt;/p&gt;
&lt;p&gt;But the lead investigator on DREAM defended the composite outcome in a phone interview with &lt;em&gt;MedPage Today&lt;/em&gt;, insisting that sample size or other cost-based rationales never entered into the decision to use it.&lt;/p&gt;
&lt;p&gt;&quot;I&apos;ll quote from the paper,&quot; said Hertzel Gerstein, MD, of McMaster University in Hamilton, Ontario. &quot;It was to account for the possibility that diabetes might develop at a different rate in individuals who died than in individuals who survived. . . . It had nothing to do with any suggestion that the drug might prevent death. In fact, what we did in the DREAM trial, it was explicitly designed to [enroll] people at low risk of having serious outcomes including death.&quot;&lt;/p&gt;
&lt;p&gt;Gerstein continued, &quot;It was designed that way in order to be careful that we did not overestimate the benefit of the drug and provide the most conservative estimate of the benefit of the drug on diabetes prevention.&quot;&lt;/p&gt;
&lt;p&gt;Nissen, however, argued that composites chosen for legitimate scientific reasons are subject to misinterpretation when the results are published or submitted to regulators.&lt;/p&gt;
&lt;p&gt;Consider the composite of death, myocardial infarction, stroke, or hospitalization for unstable angina or revascularization, a common endpoint in registration trials for cardiovascular drugs, he said. Very often it&apos;s the hospitalizations that dominate the composite outcome, as they are far more common than the more serious events.&lt;/p&gt;
&lt;p&gt;&quot;When these companies go to the FDA, they often ask for a label related to the composite outcome. &apos;This drug is approved to reduce the risk of death, heart attack, stroke, and hospitalization for revascularization.&apos; Is that a good regulatory decision or a bad regulatory decision?&quot; Nissen asked.&lt;/p&gt;
&lt;p&gt;Jeffrey Carson said such composites are frequently criticized, but they can be reported in such a way as to minimize the chance of misinterpretation.&lt;/p&gt;
&lt;p&gt;&quot;It&apos;s likely that readmission to the hospital is the predominant reason for an event [in the composite] in studies of that sort,&quot; he said. &quot;You shouldn&apos;t say that it affects mortality, and you shouldn&apos;t say it affects myocardial infarction. What you should say is that it looks like the predominant effect here is on readmissions.&quot;&lt;/p&gt;
&lt;p&gt;Tomlinson and Detsky suggested that one way around this problem would be for authors and readers to assign weights to the various components of a composite outcome to reflect their clinical importance, &quot;similar to the way quality of life is measured.&quot;&lt;/p&gt;
&lt;p&gt;Alternatively, they wrote, when a composite outcome is driven by effects on the most numerous but least severe component, it should be understood to have shown an &quot;effect on surrogate outcomes and not definitive ones.&quot;&lt;/p&gt;

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                     title="Relatives Claim Surrogate Role for Alzheimer?��s Informed Consent"
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