BMP Issue Not Going Away…Registries on the Rise…Poorer Patient, Better Outcomes? and More…
BMP Issue Not Going Away
A certain spine surgeon has been thinking a lot lately about the BMP controversy. He tells OTW, “It’s a real mess…the average orthopedic surgeon is at a loss as to whom to believe and whether or not BMP is safe. The surgeons who have been the principal investigators in the BMP studies—and who reported that even higher levels were safe—had significant conflicts of interest. True, there is no concrete evidence that the lower dose of BMP (4mg)—which is FDA approved—is associated with cancer. But when the dose was ramped up to 40 mg there did appear to be some association between BMP and cancer. A big issue is that the data was there but the original investigators who reported the results failed to include the data related to the cancer association. I still think that BMP is reasonably safe at a lower dose; but I would be very cautious about using it on a patient with a history of cancer. If someone has had a lump removed from a breast and the spine surgeon wants to use BMP…not a good idea.”
“The worst is that now we are stuck because you may get a better fusion with the higher dose. But then it’s like taking 20 aspirins instead of 3. Medtronic has contracted a new group of independent researchers from Yale to review and reanalyze the cancer data. I don’t think they will find anything dramatically different, but they might say that they don’t have enough data. And the question is, ‘Who will fund the study that would yield more answers?’”
Lower Income, Higher Satisfaction Rate?
A recent study by researchers from Mayo Clinic and the University of Alabama has found that patients earning $35, 000 a year or less report better outcomes after knee replacement surgery than people who earn more. Study co-author Jasvinder Singh, M.D. of the University of Alabama at Birmingham told OTW, “These patients were also less likely to report moderate to severe pain, which was quite surprising. In other health care settings, lower-income individuals are disadvantaged for health outcomes. There are several possible reasons, although we did not test them in the current study. We believe that a better outcome in patients with lower income may be due to expectations about a more positive outcome and not much gap between expectations and actual outcome of total knee arthroplasty, which have both been shown to impact total knee arthroplasty outcomes. Total knee arthroplasty is a surgery done mostly for an aging population, with many being Medicare eligible. Another reason may be that the negative effect of socioeconomic disparity on health care access and health outcomes leads to a lesser impact once patients are Medicare-eligible and have uniform health care access (which accounts for >2/3rd of all patients undergoing arthroplasty). This study highlights that total knee arthroplasty has good results regardless of income status.”
As for how they will proceed with future research, Dr. Singh told OTW, “Future research needs to assess the reasons why outcomes were better in those in low-income group. Studies should assess whether this is related to differences in patient expectations, patient goals and/or medical and psychological comorbidity.”
AAOS Wins CLIO Award…Again!
For the fourth time, the American Academy of Orthopaedic Surgeons (AAOS) has been honored with a CLIO Healthcare Award. The Academy accepted the Bronze CLIO along with its co-recipient, the Pediatric Orthopaedic Society of North America, for their television public service advertisement “Sedentary.” “Sedentary” is a TV spot that uses humor to address childhood obesity; the creators of the advertisement depicted things children could do without physically moving. The CLIO was accepted at a recent award ceremony in New York City by the renowned Sandy Gordon, director of Public Relations for AAOS, and representatives from advertising agency August, Lang, & Husak.
Training Orthopedists, Saving Nations
Andrew Pollak, M.D. is chief of the Division of Orthopaedic Traumatology and associate director of Trauma at the R Adams Cowley Shock Trauma Center. He tells OTW about novel research that could vastly alter the future of many nations. “My colleagues and I have done a cost effectiveness analysis of surgical trauma care as it applies to developing nations. We built our concept based on the population being treated in Haitian emergency rooms and clinics. Fundamentally, it is an assessment of value as compared to other medical interventions that are frequently put in place in the developing world—such as immunizations. We have shown that despite the major cost associated with the startup of a surgical education program, the long-term costs are in fact less than that of other common interventions, including an antiretroviral therapy program.”
“When you look at the lifelong surgical skills that this type of a program will transmit to individuals, you find that the long-term value of such intervention is astounding. We do require that surgeons-in-training commit to the two-year program, and we teach these physicians approaches that apply specifically to the needs of the local population. This means that fracture care is the major component, not arthroscopy or total hips. This also cuts down on the possibility of ‘brain drain.’ We believe these individuals will be highly likely to remain in their respective countries and help strengthen them.”
“We are now working with the U.S. government to further this effort. The issue is that it’s not in the portfolio of the U.S. Agency for International Development or of the Centers for Disease Control and Prevention [CDC]. However, we have designed a program using similar principles…an educational program that matches the priorities that the CDC has already defined for Haiti, namely, emergency maternal obstetric care (EMOC). We essentially said, ‘We will show you that we can teach EMOC effectively in a developing world environment.’ Once we do that we will go back and point to our effectiveness…and say, ‘OK, now we want to do the same thing for trauma and orthopedics.’ Stay tuned.”
Registries on the Rise
Alexander Vaccaro, M.D., Ph.D. is a spine surgeon with the Rothman Institute in Philadelphia. He is also vice chairman of the Department of Orthopaedics at Thomas Jefferson University. As if he’s not busy enough, Dr. Vaccaro is facilitating the coordination of the existing American spine registries. He tells OTW, “At present, there are several popular spine registries in the U.S. The North American Spine Society (NASS) has recently formulated one, the neurosurgeons have one, and then the one that supports the Association for Collaborative Spine Research (ACSR), PhDx. I have the responsibility, along with the Board of ACSR, of coordinating the efforts of our registry with those of others, and finding a coherent way to make the registries ‘crosstalk’ to one another so that we capture useful data.”
“What a lot of people don’t understand is that having a registry isn’t just saying, ‘OK, let’s put all our data in a computer.’ For a registry to be effective, it must be well thought out beforehand. There are different categories of questions: Does the treatment that we render have any positive effect on outcomes? What are the complications of our interventions? What about the effectiveness of X and Y implants? The first thing to consider is the design of the data fields. We must determine what basic information is important to capture so that we obtain basic demographics. Here’s the tricky part: it must be universally accepted—including by insurers and the government.”
“The typical orthopedist and neurosurgeon are normally too busy to sit and type in a lot of information about their daily patients outside of routine clinic responsibilities, so for this to work what we record has to be very simple. We’ve determined that the most efficient way is to examine electronic medical records (EMR) and ensure that the data fields we establish for the registry emulate these somewhat to make future data transfer efficient (i.e., sex, age, treatment rendered, etc.). Then you must ask, ‘What outcome measures should be used?’ Keep in mind that if you ask too many questions the average doctor is not going to use it. We are striving to make data fields similar to what is normally captured in office hours, focusing on basic questions useful for future research. We may use the Oswestry Disability Index, Visual Analog Scale, and abbreviated versions of the SF-36 form; imaging data is also important for more advanced registries and hopefully these will be able to be efficiently imported from the EMR. When the individual becomes an established patient, they may be sent an email with questions, then after treatment they are sent ‘ticklers’ via email to motivate them to respond as far as how they are faring. If the person does not respond an administrative person takes note of that and will follow up.”
“Someone has to pay for all of this. Although the ACSR has a three-year grant for our registry, I’m pushing to obtain federal assistance…imagine, for example, if you got a tax break for participating in this? We will need some type of outside funding because for a practice with around 12 physicians you’re looking at possibly $10, 000 to 15, 000 a year for basic support services. At the recent NASS meeting I argued that we see so many nonsensical treatments in spine—and that the government is pushing for comparative effectiveness research—so having a coordinated registry effort should make complete sense.”
“If we can get grants then we can demonstrate to the government that XYZ modality is or is not effective. For example, there are two recent studies—one from our group—showing that if you got an epidural injection you tended not to do as well if you eventually have surgery for spinal stenosis. That is the kind of information that can be gleaned from a registry so that insurers or the government can look into that further and design studies to ask specific questions raised by registry data. We should pay attention to such things…especially because a considerable amount of money is spent in this country on nonoperative and surgical care…and determining what has value should be a priority to all.”
