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Friday, November 21, 2014

BY REBECCA HISCOTT

 

Terminal cancer patients who enroll in hospice have lower rates of hospitalization, intensive care unit (ICU) admission, and invasive procedures at the end of life, as well as significantly lower total costs compared with patients who do not enroll in hospice, according to a new analysis published in the Nov. 17 issue of the Journal of the American Medical Association (JAMA).

 

Although the study focused on outcomes for terminal cancer patients specifically, the findings have ramifications for neurologists who advise their patients on end-of-life care and treatment options as well.  Moreover, as policymakers in the United States consider the evidence for reforming and streamlining end-of-life care, the research could be brought to bear on that debate, experts told Neurology Today.

 

“Because these [end-of-life] conversations are really hard to have, a lot of people don’t think ahead to what kind of care they want to receive,” Ziad Obermeyer, MD, an emergency medicine physician at Brigham and Women’s Hospital in Boston and one of the authors of the JAMA study, told Neurology Today. “So they end up getting sucked into this very aggressive mode of care as a kind of default option.”

 

The study provides more evidence that policymakers should reduce the systemic barriers that prevent some terminal patients from accessing hospice, Dr. Obermeyer said.

 

hospicepatient

 

Currently, Medicare regulations limit the number of patients who are eligible for, or even informed about, hospice programs, Dr. Obermeyer said. For example, Medicare penalizes hospices with inappropriately long patient stays, and does not reimburse physicians for having advance care planning discussions with patients — a shortcoming that was also highlighted in an Institute of Medicine (IOM) report on end-of-life care released earlier this year.

 

“There is this sense in the policy establishment that we need to restrict the demand for hospice, largely because people are worried that [more hospice utilization] is going to drive up costs,” he said. With the current study, Dr. Obermeyer and colleagues hoped to dispute these claims.

 

The study looked at Medicare fee-for-service beneficiaries diagnosed with poor-prognosis cancers such as brain, lung, and pancreatic cancers, as well as metastatic, ill-defined, or hematologic malignancies. Using Medicare claims data, they identified a group of 86,851 patients who died in 2011 after a full year of Medicare coverage and were eligible for the Medicare Hospice Benefit, which requires a diagnosis of terminal illness and expected survival of less than six months.

 

Dr. Obermeyer and colleagues then created two matched patient groups that differed in their utilization of hospice care. They matched 18,165 terminal cancer patients who had enrolled in hospice with 18,165 patients who did not; the patients were matched on age, sex, geographic region, time from poor-prognosis diagnosis to death, baseline care utilization, and exposure period the amount of time spent in hospice, in the case of hospice beneficiaries, versus the equivalent amount of time not spent in hospice, in the case of nonhospice beneficiaries.

 

“The people who chose hospice lived just as long as the ones who didn’t. But the hospice patients did so with many fewer hospitalizations, ICU stays, invasive procedures, and, ultimately, the people who chose hospice were about five times less likely to die in a hospital or nursing home,” Dr. Obermeyer said.

 

Among patients who did not enroll in hospice, 65 percent were hospitalized at some point during the last year of life, 36 percent were admitted to an ICU, and 51 percent underwent invasive procedures. These aggressive modes of care were largely tied to acute conditions such as infections and organ failure, as well as exacerbations of medical comorbidities, the researchers noted.

 

“Such care is unlikely to fit with the preferences of most patients,” they wrote.

 

Among hospice beneficiaries, 42 percent were hospitalized in the last year of life, 15 percent were admitted to an ICU, and 27 percent underwent invasive procedures. And while 74 percent of nonhospice patients died in hospitals or in skilled nursing facilities, only 14 percent of hospice patients did the same.

 

            Overall costs during the last year of life were also found to be lower for patients enrolled in hospice: $62,819 for hospice beneficiaries compared with $71,517 for nonhospice beneficiaries. The difference in cost for shorter hospice stays of between one and two weeks was smaller, but still statistically significant, the authors noted. However, the 2 percent of hospice beneficiaries who remained in hospice for more than one year had higher total costs.

 

Looking at the cost-effectiveness of hospice was necessary, Dr. Obermeyer said, because “it’s intrinsically important to people who do the numbers at the policy level.” But an emphasis on cost should not be the driving force behind health care, he added. “The first priority is getting people the care that they want, and then if it happens to cost less, that’s great.”

 

Look for the full story in the Dec. 4 issue of Neurology Today. For more coverage of end-of-life care, browse our archives here.


Thursday, November 20, 2014

BY REBECCA HISCOTT

 

A specialized ambulance was found to increase the proportion of stroke patients who received thrombolytic therapy during the “golden hour” the 60-minute window after symptoms start in which doctors believe the treatment is most effective.

 

            The study, published in the Nov. 17 online issue of JAMA Neurology, builds on past research showing that a special “stroke ambulance” equipped with a computed tomographic (CT) scanner and staffed by a neurologist, a parademic, and a radiology technician could treat stroke patients more quickly and efficiently than could hospital care. The latest study found that treatment during the golden hour carried no higher risk for seven- or 90-day mortality, and that patients receiving swift treatment were less likely to have prolonged hospital or nursing home stays.

 

In ischemic stroke, thrombolysis with tissue plasminogen activator (tPA) can break down the blood clots that halt blood and oxygen flow to part of the brain, and the sooner treatment begins, the better, doctors believe. However, treating stroke patients within the golden hour is extremely difficult, the authors from Charité-Universitätsmedizin Berlin in Germany wrote. In fact, past studies have suggested that only around 10 percent of stroke patients receive treatment within the first 90 minutes after symptoms appear, and only 1.4 percent are treated within the first hour.

 

Image via Till Krech on Flickr.

 

            For the current study, the researchers looked at the treatment of 6,182 patients with suspected stroke in Berlin, both at times when the stroke ambulance (called the stroke emergency mobile unit, or STEMO) was available and at times when it was not. They determined how many patients during that period received thrombolytic treatment, either during the golden hour or later than 60 minutes after symptom onset.

 

They found that 200 of 614 patients with ischemic stroke (32.6 percent) received thrombolytic therapy when STEMO was in use, compared with 330 of 1,497 patients (22 percent) who were treated when STEMO was not available, deemed “conventional care.” In all cases of ischemic stroke, the rate of thrombolysis occurring during the golden hour increased from 16 out of 1,497 patients (1.1 percent) during conventional care to 62 of 614 (10.1 percent) when STEMO was in use.

 

In addition, among all patients who received thrombolysis, the proportion of people who were treated during the golden hour increased six-fold when STEMO was in use 62 of 200 patients (31 percent) in the STEMO group compared with 16 of 330 patients (4.9 percent) in the conventional care group. For thrombolysis occurring during the golden hour, the average time from symptom onset to treatment was 50 minutes, compared with 105 minutes for thrombolysis occurring after the first 60 minutes.

 

The researchers also found that patients who received treatment during the golden hour were no more likely to die after seven or 90 days than patients who received later care, and they were more likely to be discharged home from the hospital.

 

In an editorial published in the same issue of JAMA Neurology, Steven Warach, MD, PhD, a professor of neurology and neurotherapeutics at the University of Texas Southwestern Medical Center in Austin, who was not involved in the study, praised the findings. “Although evidence addressing the long-term benefits of STEMO is not yet available, [the researchers] present indirect early indicators of a benefit for the patients who receive golden hour thrombolysis,” he wrote. “They were more likely to be discharged to their homes and less likely to go to nursing homes, while not at increased risk of hemorrhagic complications or death.”

 

However, Dr. Warach warned, “many questions need to be answered in order to determine the appropriate niche where the benefit justifies the intensive use of resources that this approach requires.”

 

For example, since the mobile stroke unit is more expensive than traditional ambulances, further studies will need to weigh the financial costs against the benefits the stroke ambulance can provide. In addition, since it is likely that there will be a limited number of mobile stroke units in any ambulance fleet, future analyses should look at which regions, perhaps those with a high incidence of stroke, would be best served by a stroke ambulance. Lastly, there may be other conditions that could be treated in the specialized ambulance: “If blood products are stocked in this specialized ambulance, then prehospital treatment of anticoagulation-associated intracranial hemorrhage is an obvious example,” he wrote.

 

“It is the duty of the early adopters to resist the temptation to uncritically embrace this approach…and to address these issues through rigorous clinical investigations,” he concluded.

 

Look for the full article and discussion in an upcoming issue of Neurology Today. For more coverage of ambulatory stroke care, browse our archives here.


Wednesday, November 19, 2014

BY REBECCA HISCOTT

 

Family members often provide the bulk of care for loved ones in the early stages of dementia, and even, in some cases, as the disease becomes more severe. And although caregivers might think they should focus exclusively of the needs of the patient, providing truly good care means caring for yourself, too.

 

In the United States, more than 15 million people provide informal caregiving to loved ones with dementia, and studies have shown that up to 40 percent of family caregivers experience clinical depression or anxiety, which can result in what is called “caregiver burnout.” Caregiver burnout can also impact the quality of care a dementia patient receives.

 

            Now, a new study from researchers in the United Kingdom has found that one-on-one therapy sessions designed to provide caregivers with skills for coping with the demands of caregiving can reduce feelings of depression and anxiety and result in a higher sense of wellbeing among family caregivers, without adding an extra financial burden.

 

 

The study, published in the Nov. 18 online issue of the journal The Lancet Psychiatry, tested a mental health program called START (Strategies for Relatives) in 260 people who cared for family members with dementia. Of those, 173 caregivers began an eight-session START therapy program, while 87 received “treatment as usual,” which consisted of medical, psychological, and social services for the dementia patient, but not for the caregiver.

 

In the START program, psychology graduate students worked with the caregivers in one-on-one sessions to identify the emotional challenges and stressors associated with their caregiving duties. The sessions focused on common issues like managing stress, accessing emotional support, identifying and changing unhelpful thoughts, and practicing relaxation techniques. In the final session, the psychology students worked with the caregivers to develop a long-term “maintenance plan” with useful coping strategies.

 

At multiple points during the two-year study, the researchers asked the family caregivers to complete questionnaires indicating their overall levels of stress, anxiety, and depression, including the Hospital Anxiety and Depression Scale (HADS), which assigns a score of 0 to 42 points, with a higher score meaning higher levels of depression and anxiety. The researchers also evaluated the cost-effectiveness of the intervention, based on whether the therapy sessions added substantially to the caregiver or patient’s total health care costs.

 

            The caregivers who did not participate in the START therapy sessions were seven times more likely to develop clinical depression by the end of the study than those who received the therapy, the researchers found. Caregivers in the START group also scored an average of 2.58 points lower on the Hospital Anxiety and Depression Scale by the end of the study, meaning they experienced a small but significant decrease in feelings of depression and anxiety. These benefits were observed eight months into the study and persisted to two years.

 

            The therapy sessions were not associated with any substantial increase in financial burden to the caregivers, the study authors added.

 

            “Worldwide, there are an estimated 44 million people with dementia, and this figure is likely to double every 20 years,” Gill Livingston, MD, a professor of psychiatry at University College London, said in a news release. “Too often people forget the substantial effect dementia has on family members caring for relatives with dementia...This new cost-neutral program is an effective way to support [caregivers] and improve their mental health and quality of life and should be made widely available.”

 

For more articles about caregiving, browse our new For the Caregiver department and our complete digital archive here.


Monday, November 17, 2014

BY REBECCA HISCOTT

 

The U.S. Food and Drug Administration (FDA) has awarded marketing approval to alemtuzumab (Lemtrada) for treating relapsing-remitting multiple sclerosis (RRMS), drug manufacturer Genzyme announced Friday. The drug has already been approved for use in MS in Canada, Europe, and Australia.

 

The announcement marks a tempered reversal of the FDA’s position on the drug. In December 2013, the agency stated that Lemtrada was not ready for approval, arguing that “Genzyme has not submitted evidence from adequate and well-controlled studies that demonstrate the benefits of Lemtrada outweigh its serious adverse effects."

 

At press time, the FDA had not yet issued a statement of its own regarding the drug’s approval.

 

The drug should still be considered a third-line treatment for RRMS, Genzyme’s parent company, Sanofi, noted in its announcement. “Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS,” the company said.

 

In MS, alemtuzumab, which is also sold under the brand name Campath as a leukemia treatment, is administered by intravenous infusion in two treatment courses of five consecutive days and three consecutive days 12 months later. The drug works to temporarily disable T and B cells, which leads to prolonged changes in the immune system. When these cells repopulate, the body’s autoimmune attack on myelin — a fatty white substance in the nervous system that coats the thread-like fibers known as axons that carry signals between brain cells — is halted or at least slowed considerably. Inflammation caused by the body’s attack on myelin is believed to cause the debilitating symptoms of MS.

 

Initiating IV fluid infusion.

 

In clinical trials of alemtuzumab, most RRMS patients showed significant declines in annual relapse rates that persisted beyond the final annual infusion. The drug was found to be more effective than interferon beta-1a at reducing relapse rates.

 

However, the FDA raised questions about the safety profile of the drug. Since alemtuzumab targets the immune system, it can increase a patient’s risk of developing other diseases and infections. A small but significant minority of patients in the clinical trials developed new, sometimes fatal autoimmune conditions such as thyroid disease, as well as malignancies such as thyroid cancer and melanoma. In addition, the FDA took issue with the open label design of the trials.

 

The FDA approval of alemtuzumab comes with a requirement for a black box warning about the potential for a host of severe side effects, most notably autoimmune disorders, infusion reactions, and malignant cancers, but also rash, headache, nausea, vomiting urinary tract infection, upper respiratory tract infection, fatigue, insomnia, fungal infection, back pain, diarrhea, dizziness, abdominal pain, and more.

 

In addition, the drug can only be prescribed, administered, and used by physicians, pharmacies, and patients who have obtained the proper certification. This is done in order to “educate healthcare providers and patients on the serious risks associated with Lemtrada and the appropriate periodic monitoring required to support the detection of these risks for 48 months after the last infusion,” Genzyme said.

 

The drug’s long-lasting effects “may profoundly influence the course of relapsing MS, but will require careful and sustained monitoring for side effects,” Bruce A. Cohen, MD, a professor of neurology and clinical neurosciences at Northwestern University and chair of the National MS Society’s National Medical Advisory Committee, said in a news release. “Individuals with MS who are considering treatment with this medicine should thoroughly educate themselves on its potential benefits and risks.”

 

For more information about alemtuzumab, see Neurology Today’s past coverage here.


Thursday, November 13, 2014

BY REBECCA HISCOTT

 

Most athletes who experience a sports-related concussion can expect their symptoms to clear up within four weeks. But around 10 percent of sports concussion patients will have longer-lasting symptoms, and little is known about which athletes will take longer to recover.

 

Now, a new study suggests that the severity of a patient’s initial symptoms can help predict whether they experience a prolonged recovery. The study also found that neurocognitive testing, which uses a computerized tool to test athletes’ memory, attention, processing speed, and reaction time, is not helpful in predicting recovery from sports-related concussion.

 

Example of how a concussion occurs.

 

            The study, published in the Nov. 7 online issue of Neurology, sought to identify a set of variables that could predict which patients would experience concussion symptoms for longer than 28 days. Researchers from Boston Children’s Hospital looked at 531 patients, aged seven to 26, who had visited the hospital’s Sports Concussion Clinic between October 2009 and July 2011. On average, these patients visited the clinic 12 days after experiencing a concussion.

 

All patients completed the Post-Concussion Symptom Scale (PCSS), a questionnaire that asks them to rate the severity of 22 symptoms that commonly result from concussion, such as headache, loss of consciousness, confusion, amnesia, dizziness, and nausea. The scale has a maximum score of 132 points, indicating extremely severe symptoms. In addition, 129 patients in the study (or 24 percent) received neurocognitive testing.

 

            The authors looked at variables such as age, sex, PCSS and neurocognitive test scores, and a history of past concussions, headaches, or migraines, to see whether any of these data could help predict which patients would experience prolonged recovery.

 

            Ultimately, they found that only the patients’ cumulative score on the PCSS could help predict how long their symptoms would persist. Eighty-six percent of patients who scored less than 13 on the PCSS recovered completely within 28 days, while only 35 percent of those who scored higher than 13 did the same. Neither neurocognitive testing nor any of the other variables were effective in predicting which patients would take longer to recover.

 

            “We hoped that by using multiple variables we could develop a clinical model for predicting which athletes who sustain sport-related concussions are at highest risk for prolonged symptoms beyond 28 days,” the researchers wrote. “Our study suggests, however, that the best predictor of prolonged symptoms after sport-related concussion is simply total symptom burden at the time of presentation.”

 

Physicians whose patients score higher than 13 on the PCSS should therefore consider warning these athletes that their recovery might take longer, and begin treatment earlier, they suggested.

 

            The results are consistent with past studies of symptom burden in concussion, Jack W. Taso, MD, PhD, FAAN, Briana N. Perry, BA, Carrie H. Kennedy, PhD, and Richard Beresford, MD, JD, wrote in an accompanying Neurology editorial. The finding that neurocognitive testing did not help predict patient outcomes was significant because it shows that such testing “may not be necessary, thereby conserving resources,” they said.

 

            However, they noted that the study would have benefitted from long-term tracking of patients whose symptoms persisted past 28 days, in order to see when the symptoms cleared up, “as this would help clinicians manage patient expectations in the setting of prolonged symptoms.

 

            “Based on the findings of this study,” they added, “patients and their medical providers should feel reassured that complete recoveries are likely within a month if initial symptom burden is lower.”

 

For more coverage of the latest concussion research, browse our archives here: http://bit.ly/1tInDrR.