ROCHESTER, Minn. — A new study led by Mayo Clinic researchers has found that relief of pain from vertebral compression fractures, as well as improvement in pain-related dysfunction, were similar in patients treated with vertebroplasty and those treated with simulated vertebroplasty without cement injections. The article, “A Randomized Controlled Trial of Vertebroplasty for Osteoporotic Spine Fractures,” was released today in the New England Journal of Medicine.
Vertebroplasty is a widely applied procedure in which medical cement is injected into the spine to relieve pain and improve function in patients who have osteoporotic fractures. This study, funded by the National Institutes of Health, was the first of its kind, using a double-blinded research model to examine the impact of vertebroplasty.
“Though the medical community has been using vertebroplasty for many years, there were no research results to prove whether the efficacy of the treatment relates to the cement injections, patient expectations, or other factors,” says the study’s leader, David Kallmes, M.D., a Mayo Clinic physician who specializes in radiology and neurosurgery. “The cement is a permanent medical implant, and there is some concern that it places patients at future risk for additional spinal fractures.”
Researchers from eight medical centers in the United States, United Kingdom and Australia enrolled a total of 131 patients in the trial. The baseline characteristics of pain and function were similar in the vertebroplasty group containing 68 patients and the control group containing 63 patients. Within days of treatment, both groups showed similar improvements in function and pain. Researchers continue to follow study participants, and one year results will be released at a later date.
“We aren’t saying the vertebroplasty doesn’t work, because it somehow does,” says Dr. Kallmes. “But both sets of patients experienced significant improvements in pain and function a month following the procedure, whether they received cement injections or not. Improvements may be the result of local anesthesia, sedation, patient expectations, or other factors.”
“Patients should seek medical advice from their care provider before making a decision about treatment options,” Dr. Kallmes advises.
Other centers involved in the research included the University of Washington, Seattle; Nuffield Orthopaedic Centre NHS Trust, Oxford, UK; St. George Hospital, University of New South Wales, Sydney, Australia; Gartnavel General Hospital, Glasgow, UK; Department of Social Medicine, Bristol, UK; Nottingham University Hospital NHS Trust, UK; and Western General Hospital, University of Edinburgh, UK. University of Washington researcher Jerry Jarvik, M.D., coordinated the data gathering and analysis for the project.
Dr. Kallmes says that several related research projects are in progress at Mayo Clinic, including a study of kyphoplasty, which uses a balloon to make space for cement injections, as well as an unblinded trial to measure the impact of local anesthesia on pain.
About Mayo Clinic
Mayo Clinic is the first and largest integrated, not-for-profit group practice in the world. Doctors from every medical specialty work together to care for patients, joined by common systems and a philosophy of “the needs of the patient come first.” More than 3,300 physicians, scientists and researchers and 46,000 allied health staff work at Mayo Clinic, which has sites in Rochester, Minn., Jacksonville, Fla., and Scottsdale/Phoenix, Ariz. Collectively, the three locations treat more than half a million people each year. To obtain the latest news releases from Mayo Clinic, go to www.mayoclinic.org/news. For information about research and education visit www.mayo.edu. MayoClinic.com (www.mayoclinic.com) is available as a resource for your health stories.
The problem with “pay for performance” measures is that they are a nice sound bite that make people think that the additional regulation and bureaucracy will improve outcomes and access to care. I’ve already seen some of these actions taken with regard to pneumonia and antibiotic time. In our busy ER our reimbursement is linked to providing antibiotics to all pneumonia patients in under 4 hours with idea that this improves their outcome. However, this then means every patient with a fever and cough must be pushed aggressively through our waiting room at which average wait times exceeding 7 hours for non-life threatening chief complaints in order to avoid missing our time targets. Consequently we prioritize low-risk patients with colds over someone with potentially more serious complaints. Ultimately, studies support that this race to antibiotic times does not improve patient outcomes. I fear that “pay for performance” measures will simply increase the morass of regulation that makes the difficult practice of medicine even more aggravating than it already is, with little actual benefit to patients.
Complex medical decision making is hard to quantify and ultimately get reduced to its simplest base elements such as “how long did the patient have to wait?” and “did the patient get a warm blanket when they asked for it?” which may have no bearing on the medical outcome.
Evidence based medicine studies such as the recent New
England Journal publication that vertebroplasty outcomes did not differ from sham operation may be a better example of finding ways to eliminate expensive therapies with little clinical value.
The ‘innovative’ idea of a ‘pay for value / outcome’ pack came after the CBO had previously pointed out this health care reform wouldn’t work without ‘fundamental’ change in the out of date system. It is said that as much as 30 percent of all health-care spending in the U.S. -some $700 billion a year- may be wasted on tests and treatments that do not improve the health of the recipients, and this 700 billion dollars a year can cover a lot of uninsured people.
The expected Benefits of this ‘innovative idea’ are as follows ;
1. Meet the objective of revenue-neutral.
Supporters of the agreement say it could save the Medicare System more than $100 billion a year and ‘improve’
care, that means more than $1trillian over next decade, and virtually needs no other resources including tax on the
wealthiest. Supposedly even the ‘conservative’ number of such savings might be able to meet the objective of
revenue-neutral.
2. Quality and affordability.
If you are a physician, and your pay is dependant upon your patient’s outcome, you will most likely strive to
prescribe the best medicine earlier in the process, let alone skipping the wasteful, unnecessary treatments.
3. No intervention in decision-making.
The innovative idea of ‘a pay for outcome’ will more likely prompt team approach and decision, as at Myo clinic.
Under the ‘pay for outcome’ pack, for good reason, best practices as ‘recommendations’ would simply help them
make a better decision, and the government won’t still have to meddle in the final, actual decision-making
process as a non-expert.
4. Speed up the introduction of IT SYSTEM.
The pay for ‘Outcome’ pack is most likely to expedite the introduction of Health Care IT SYSTEM.
The synergy effect of the combined Health Care IT & a pay for ‘outcome’ system may allow the clinicians to
‘correctly’ diagnose and effectively treat a patient earlier in the process so that it can measurably scale back the
crushing lawsuits and deter the excuse for unnecessary cares to make fortunes.
5. Accelerate the progress in medical science, in return, it saves more cash.
6. Settle the regional disparity.
7. Reduce the emergency room visits & save immense costs.
Public health insurance plans such as Medicare and Medicaid paid for more than 40 percent of U.S. emergency
room visits in 2006, according to government figures released recently. Many experts say reducing these hospital
visits would be an important way to lower the enormous, and growing, expense of U.S. health care.
I share the opinion that unlike the insurer-friendly senate plan by ‘some’ members, only a strong public option will be capable of getting the premium inflation under control and saving the U.S in turbulence.
To my knowledge, a dual system tends to deliver better results than a pure single payer system. Supposedly, to be or not to be might be up to the innovations like a pay for value program, otherwise, the forthcoming start-ups may fill the void with competitive deals. The competition based on ‘fair’ market value would be a beauty of true capitalism, not monopoly, an objective for anti-trust.
Thank You !