Another large study has confirmed that cancer survivors have better physical function and quality of life when they are physically active after their treatment ends, researchers found.

According to a meta-analysis of randomized controlled trials, which aimed to surpass the quality of previous reviews, former cancer patients who exercised saw improvements across a host of outcomes, including body mass index (BMI), weight, fatigue, depression, and overall quality of life, reported Judy Ho, MD, of Queen Mary Hospital in Hong Kong, and colleagues, in BMJ.

To update the most recent meta-analysis, published in 2011, Ho and colleagues assessed 34 trials, 22 of which focused on breast cancer patients. The majority (27) assessed aerobic exercise, but six also looked at resistance training. The median duration of physical activity was 13 weeks.

Overall, the studies showed that exercise improved physical function and quality of life in all cancer patients.

Four breast cancer studies assessed physiological markers, including insulin-like growth factor-1 (IGF-1), insulin, glucose, and homeostatic model assessment (HOMA).

Analyses showed that exercise significantly reduced IGF-1 — potentially reducing the risk of disease recurrence — but it wasn’t tied to any of the other markers.

Among studies that looked at body parameters, exercise was associated with reduced BMI and weight, the researchers found (P<0.01 and P<0.001, respectively).

It was also linked with significantly increased peak oxygen consumption (P<0.01), peak power output (P<0.01), distance walked in six minutes (P=0.03), and right handgrip strength (P=0.03).

And for breast cancer patients, physical activity improved bench and leg press weight, they found (P<0.01 for both).

Working out was also tied to reduced fatigue among breast cancer survivors (P=0.03), and with diminished depression (P<0.01), as well as improvements in social function and mental health in all cancer survivors (P=0.03 and P=0.01, respectively).

However, Ho and colleagues cautioned that the study was limited by substantial heterogeneity across all of the included studies, which varied greatly in quality, size, patient age, outcomes, and type and duration of physical activity.

Although the study shows that physical activity is associated with “clinically important positive effects on physical function and quality of life in patients who had completed their treatment for cancer,” the authors called for more research on physical activity in cancers other than breast.

In an accompanying editorial, Liam Bourke, MD, of the Queen Mary University of London, and colleagues pointed out that more study is also needed on longer-term outcomes for physical activity in cancer survivors.

“Despite evidence of improved functional and quality of life outcomes, the key question remains: does habitual exercise reduce cancer specific mortality?” they wrote.

Evidence does imply that exercise improves survival, they wrote, but it’s largely from observational studies, and questions remain regarding longer-term benefits, potential adverse events, and compliance rates.

From Medscape Medical News

By: Roxanne Nelson

February 7, 2012 ( UPDATED March 1, 2012 ) — A provisional clinical opinion from the American Society of Clinical Oncology (ASCO) extends early palliative care to all patients with metastatic cancer, although the evidence so far shows a survival benefit only in patients with metastatic nonsmall-cell lung cancer (NSCLC).

The new advice, published online February 6 in the Journal of Clinical Oncology, recommends that palliative care should be offered to patients with metastatic NSCLC at the time of initial diagnosis, alongside concurrent standard cancer therapy. This is based on strong evidence from a phase 3 clinical trial that demonstrated a survival benefit from integrating palliative care into cancer therapy early in the course of care (N Engl J Med. 2010;363:733-742).

The panel notes that even though a “survival benefit from early involvement of palliative care has not yet been demonstrated in other oncology settings, substantial evidence demonstrates that palliative care — when combined with standard cancer care or as the main focus of care — leads to better patient and caregiver outcomes.”

“Therefore, it is the panel’s expert consensus that combined standard oncology care and palliative care should be considered early on in the course of illness for any patient with metastatic cancer and/or a high symptom burden.”

Incorporating palliative care earlier on improves patients’ symptoms, quality of life, and satisfaction, and reduces the burden on caregivers, the panel notes. It also leads to more appropriate referral to and use of hospice, and decreases the use of futile intensive care.

“Palliative care is about maintaining quality of life throughout the cancer journey,” said Jamie Von Roenn, MD, coauthor of the guidelines and professor of medicine in the division of hematology/oncology at the Feinberg School of Medicine, Northwestern University, and the Robert H. Lurie Comprehensive Cancer Center in Chicago, Illinois.

In advanced cancer, “the data are increasingly showing us that palliative care can be incredibly valuable for patients and their caregivers from the time they are diagnosed, not just at the end of life,” she said in a statement.

Improves Survival, Quality of Life

The optimal delivery of palliative care needed to improve patient outcomes has not yet been clarified; the evidence continues to evolve. However, according to the expert panel, no trials to date have demonstrated any harm to patients or caregivers or excessive costs associated with this regimen.

Nearly half of all patients with metastatic cancer cannot be cured with currently available treatments, but they can survive for years after diagnosis. The focus of palliative management emphasizes medically appropriate goal setting, honest and open communication with patients and families, and meticulous symptom assessment and control, the panel writes.

Unfortunately, the current medical-care model in the United States is unable to meet the needs of many patients dealing with advanced illness. Both the quality and associated costs of healthcare, particularly for those with advanced disease, have become central in the healthcare reform debate.

The expert panel points out that 7 randomized controlled trials have shown that concurrent palliative care in patients with advanced cancer maintains or improves survival and quality of life. In addition, most studies demonstrate that these improved outcomes are achieved at a lower cost than standard oncologic care alone.

“Preserving quality of life is of utmost importance for all patients,” said coauthor Tom Smith, MD, professor of oncology and director of palliative care at Johns Hopkins Medicine in Baltimore, Maryland. “We now have strong evidence in metastatic cancer that combining palliative care with standard cancer treatment improves our patients’ lives in many ways and, in some cases, can help extend their lives.”

“Patients deserve to have access to palliative care services and specialists throughout the course of their care,” said Dr. Smith in a release.

More Studies Needed

Strategies to optimize concurrent palliative and standard oncology care and to evaluate its impact on patient and caregiver outcomes and on society should be an area of intense research, the authors conclude.

Areas that need to be evaluated in future studies include the optimal timing and venue for palliative care, such as inpatient and outpatient/community settings; evidence-based reimbursement models to support the use of palliative care; the components of palliative care that are effective; such a regimen in diseases other than advanced lung cancer; and the way palliative care affects the continuum of care, particularly during the delivery of antitumor therapy.

(The authors have disclosed no relevant financial relationships.

J Clin Oncol. Published online February 6, 2012.)

From Medscape Medical News

BY: Fran Lowry

January 5, 2012 — Spinal manipulation therapy (SMT) and exercises that patients can learn to do at home are more effective than medication for relieving neck pain, both in the short and long term, according to results from a new study published in the January 3, 2012, issue of the Annals of Internal Medicine.

However, the results of this trial are not going to be applicable to all patients, lead author Gert Bronfort, DC, PhD, from the Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University, Bloomington, Minnesota, told Medscape Medical News.

“You have to individualize the treatment,” he said. “It has a lot to do with where the patients are in their history of neck pain, what they’ve experienced in the past, and what their preferences are, but at least these treatments represent some viable options that can be offered to patients.”

Dr. Bronfort said that he and his team believed that spinal manipulation would be better than medication for improving neck pain, at least in the short term, based on their past experience. However, they were surprised to find that the home exercise program turned out to be just as successful, he admitted.

“The home program involved a couple hours of instruction in self-care and specific neck exercises, where patients were taught how to avoid certain postures, such as sleeping and working postures, that would aggravate their neck pain,” he explained.

Nonspecific Neck Pain

In the study, 272 patients aged 18 to 65 years who had nonspecific neck pain for 2 to 12 weeks were randomly assigned to receive 12 weeks of spinal manipulation therapy, medication, or home exercise with advice. The spinal manipulation therapy was given by 5 chiropractors who were well trained and experienced in the procedure, Dr. Bronfort said.

Medication was provided by licensed medical physicians, with a focus on prescription drugs. First-line therapy was nonsteroidal anti-inflammatory drugs, acetaminophen, or both, the authors note. Those patients who did not respond or could not tolerate the first-line therapy received narcotic medications. Muscle relaxants were also used, and advice to stay active or modify activity was given as needed. “The choice of medications and number of visits was made by the physician on the basis of the participant’s history and response to treatment,” the authors write.

Pain, as reported by the study participants, was measured at 2, 4, 8, 12, 26, and 52 weeks.

Results showed that spinal manipulation had a statistically significant advantage over medication after 8, 12, 26, and 52 weeks (P < .010), and that home exercise was superior to medication at 26 weeks (P = .02). No important differences in pain were found between spinal manipulation therapy and home exercises at any time.

Patients who received spinal manipulation therapy or home exercises also reported similar improvements in self-reported disability, medication use, general health status, and adverse events. However, patients said they were more satisfied with spinal manipulation than with home exercise.

With regard to adverse effects, 40% of the spinal manipulation group and 46% of the home exercise group reported adverse events. The most common was musculoskeletal pain, and less frequently they experienced paresthesia, stiffness, headache, and crepitus.

Among patients randomly assigned to the medication group, 60% reported adverse effects. The most common were gastrointestinal symptoms and drowsiness, followed by dry mouth, cognitive disturbances, rash, congestion, and disturbed sleep.

Dr. Bronfort pointed out that patients could not be blinded in this study, and that this was an important limitation. He also suggested that participants who received spinal manipulation may have been more likely to experience improvement in their neck pain and be more satisfied with their care because they had more frequent interactions with their care providers.

“When we started the study there was really not very much scientific evidence to support any treatment, really,” he said. “You would think that neck pain would disappear by itself, and it does in a number of patients, but about half will go on to have chronic or sporadic neck pain, even a year later. What we don’t know is to what extent spinal manipulation or home exercise can prevent more chronic conditions, and this is something that we need to find out.”

Pragmatic Trials

In an accompanying editorial, Bruce F. Walker, DC, MPH, DrPH, from Murdoch University, Perth, and Simon D. French, PhD, from the University of Melbourne, both in Australia, point out that the 3 therapies in this study were not compared with a placebo or sham therapy. Such comparisons would have provided more convincing evidence of effectiveness, they write.

A cost analysis would also have been useful, they add, and they point out that neck manipulation has the potential for a rare, but potentially catastrophic, risk for vertebral artery stroke, and warn that patients should be advised of this possibility.

“Pragmatic trials, such as the one by Bronfort and colleagues, have their place in answering important questions about current treatment approaches, but we need innovative studies that explore which treatments benefit which of the many people who experience disabling neck pain,” the editorialists conclude.

This study was funded by the National Center for Complementary and Alternative Medicine, National Institutes of Health. Dr. Bronfort, Dr. Walker, and Dr. French have disclosed no relevant financial relationships.

Ann Intern Med. 2012;156:1-10, 52-53. Article abstract, Editorial extract

From Medscape Medical News

By: Robert Lowes

January 5, 2012 — Physicians who wonder whether they received a hardship exemption from Medicare’s 1% penalty in 2012 for failing to e-prescribe in 2011 will have to find out by reading the fine print on their payment remittance statements.

The Centers for Medicare and Medicaid Services (CMS) had intended to inform physicians and other prescribers whether they would be subject to the penalty through a feedback report that they could access online. However, on December 29, the agency announced that “due to the high volume of significant hardship exemption requests, it is no longer technically feasible for CMS to provide a…feedback report.”

Instead, CMS encouraged prescribers to check their remittance statements for claims submitted for services rendered since January 1, 2012. If they were hit with the 1% penalty (a “payment adjustment” in CMS parlance), they would see the letters “LE” on the statement and 2 different codes. The first is Claim Adjustment Reason Code (CARC[I1]) 237, indicating a “legislated/regulatory penalty.” The second is Remittance Advice Remark Code (RARC) N545, which explains that the provider was an “unsuccessful e-prescriber” in 2010 as defined by Medicare’s e-prescribing incentive program.

If CMS penalizes a prescriber in error, it will reprocess the claims in question and return the 1% that was originally subtracted. One example of such an error that the agency cited is a penalized prescriber who requested a hardship exemption that is “ultimately approved.” That statement suggests that as of December 29, CMS might not have ruled on all the exemption requests submitted before the deadline of November 1, 2011. As of press time, Medscape Medical News had not received an answer from CMS as to how many exemption requests it has received and when it expects to finish processing them.

First Carrots, Then Sticks

The 1% penalty is part of a carrot-and-stick approach taken by the government to persuade physicians to electronically transmit scripts from their computer to a pharmacy’s computer. A 2008 law called the Medicare Improvements for Patients and Providers Act (MIPPA) authorized bonus payments for physicians who use approved e-prescribing software in the course of treating Medicare patients. The bonus in 2012 is 1% of fee-for-service (FFS) charges. It decreases to 0.5% in 2013 and vanishes in 2014.

MIPPA penalties for paper-bound prescribers, meanwhile, debuted in 2012 at 1% of FFS charges. The penalty increases to 1.5% in 2013 and 2% in 2014.

Physicians are automatically spared the penalty in 2012 — and the need for a hardship exemption — if they:

• Reported at least 10 e-prescriptions via claims in the first half of 2011;
• Reported that they lacked prescribing privileges on at least 1 eligible Medicare claim before June 30, 2011;
• Were not a licensed physician, nurse practitioner, or physician assistant as of June 30, 2011;
• Did not have at least 100 claims for patient visits involving 1 of the 56 required billing codes for the first 6 months of 2011; or
• Did not generate at least 10% of their total allowed Medicare charges in the first half of 2011 through services associated with the 56 billing codes.

All other physicians had until November 1, 2011, to apply for 1 of 6 hardship exemptions, which included practicing in a rural area that lacks high-speed Internet access and having registered to participate in the government’s program to reward “meaningful use” of electronic health records.

More information on the government’s e-prescribing incentive program is available on the CMS Web site.

By: Joe Barber Jr, PhD

January 18, 2012 — Roux-en-Y gastric bypass (RYGBP) provides superior, more rapid weight loss than gastric banding (GB) and results in lower long-term complication and comorbidity rates, although it is associated with a higher early morbidity rate, according to the findings of a case-matched study.

Sébastien Romy, MD, from Centre Hospitalier Universitaire Vaudois, in Lausanne, Switzerland, and colleagues published their findings online January 16 in the Archives of Surgery.

The authors note that bariatric procedures remain an issue of contention. “Controversy about bariatric procedures has been ongoing,” the authors write. “For patients with body mass index (BMI) less than 50 (calculated as the weight in kilograms divided by the height in meters squared), it lies mostly between purely restrictive procedures (GB and vertical banded gastroplasty) and restrictive/malabsorptive procedures (RYGBP) also acting by hormone-mediated mechanisms influencing hunger and satiety.”

The investigators enrolled patients with a BMI of more than 40 kg/m², or more than 35 kg/m² with at least 1 severe comorbidity, all of whom had failed conservative therapy and undergone a complete evaluation by a multidisciplinary team. The authors compared outcomes for 221 patients who had undergone GB with an equal number of patients who had undergone RYGBP. Patients were matched according to age, sex, and initial BMI.

Among eligible patients, maximal weight loss was achieved a mean of 18 months after RYGBP compared with 36 months after GB (P < .01). The maximal percentage of excess weight loss was significantly higher after RYGBP (78.5%) than after GB (64.8%; P < .001).

A significantly greater percentage of patients in the GB group had a BMI of more than 35 kg/m² after 3 (22.3% vs 6.9%, P < .001) and 6 (33.5% vs 12.3%; P < .001) years.

There were higher rates of early complication (17.2% vs 5.4%; P < .001) after RYGBP than after GB and a non-significant trend toward higher major morbidity (3.6% vs 2.2%; P = .54). However, the rates of long-term complication (41.6% vs 19%; P < .001) and failure (defined as a percentage of excess weight loss < 25%) or need for reversal/conversion (18.2% vs 0%; P < .001) were significantly higher in the GB group.

The authors conclude that RYGBP appears superior to GB based on their findings but that further studies are needed to confirm the results. “These results should ideally be confirmed by a large randomized study with long follow-up,” the authors write. “Ethical considerations might prevent potential investigators, however, from setting up a study where one treatment arm seems to be clearly inferior to the other and where the lack of equipoise makes patient information and accrual difficult if not impossible.”

In an invited critique, Jacques Himpens, MD, from St. Pierre University Hospital in Brussels, Belgium, agrees that RYGBP is superior to GB, but cautions that some issues remain to be settled. “A growing number of patients have problems linked with glucose metabolism like neuroglycopenia and diabetes recurrence late after RYGBP,” Dr. Himpens writes. “The exact origin of this evolution appearing several years after RYGBP remains unclear, but it is a source of increasing concern.”

Dr. Himpens is a consultant with Ethicon Endosurgery and Covidien and organizes workshops for Gore. The authors have disclosed no relevant financial relationships.

Arch Surg. Published online January 16, 2012. Abstract, Editorial