The recent focus on evidence based medicine throughout the medical field has prompted both challenges and opportunities in orthopedics. "I think there will be much more scrutiny in the future of the value of medical interventions," says Daniel Berry, MD, an orthopedic surgeon at Mayo Clinic in Rochester, Minn., and president of the American Academy of Orthopaedic Surgeons. "As orthopedic surgeons, we should welcome the opportunity to evaluate what we do and demonstrate it's effectiveness." Orthopedic surgeons from around the country discuss six important issues surrounding evidence-based medicine and how the focus will impact orthopedics in the future.
1. What evidence-based medicine could contribute. There are many potential benefits of focusing on evidence-based medicine. High-level studies can help orthopedic surgeons prove their treatments are effective and identify treatments or procedures that aren't. "Some studies will show that the treatments and surgeries are beneficial to the patients and good value for the money spent on them," says Robert Berghoff, MD, an orthopedic surgeon with Arizona Orthopaedic Associates in Phoenix. "There are also some treatments that might not be worth it and we'll have to change them. We'll stop doing the things that don't hold up to scrutiny."
These studies can also aid surgeons in indicating the appropriate treatment for patients depending on their comorbidities. "The data is a big help for recommending treatment protocols when the physician has to make an ambiguous call due to conflicting or multiple diagnoses," says Scott Trenhaile, MD, an orthopedic surgeon at Rockford (Ill.) Orthopedic. "Surgeons could also use that evidence to better explain to a patient that a treatment may not be completely effective because of their comorbidities. Now we can show them the objective data on patients with similar comorbidities and that helps the patient understand that other health conditions may be part of the problem and could affect the outcome of their treatment."
2. Impact on technology and device markets. Orthopedic surgeons are constantly looking for ways to improve technologies and procedures, but these innovations usually come at an increased cost. Many orthopedists are now employing minimally invasive surgical techniques, which often require expensive systems and instrumentation. Some of this innovation may not be cost-effective for the surgeon due to low reimbursement rates or to patients due to lack of evidence supporting the technology's value over other treatment methods or procedures. "It's important we monitor upgrades and improvements for patients to ensure there is meaningful justification for the cost," says Dr. Trenhaile. "We have a responsibility to make sure those dollars are well spent, yet continue to innovate."
Stricter regulations in the FDA approval process mean orthopedic and spine device companies need to conduct extensive studies to prove a new device is equally or more effective than products already on the market. "Just because a product is new doesn't mean its better," says Dr. Berry.
3. The trouble with requiring high level studies. Empirical evidence and experience might tell a surgeon that a procedure is effective, but the high level studies don't currently exist to back up some of those claims. High level evidence studies aren't common in orthopedics because they are expensive and difficult to conduct. "In the past, studies have been published without real strong peer review and analysis of the information," says Eric Berkman, MD, an orthopedic surgeon at Elite Orthopaedics & Spine in Houston. "Evidence-based medicine emphasizes level one studies, which have every bell and whistle to make sure they are done accurately with an emphasis on treatment for the patients. They are prospective, randomized, controlled, double-blinded studies and include objective testing analysis to make sure the study itself was done correctly."
One way these studies are funded is through orthopedic and spine device companies because these companies must conduct research to prove their device belongs on the market. When evaluating the literature, surgeons and other industry professionals also need to consider the study's source. "Even with a good study, you have to see what companies are sponsoring them," says Dr. Berkman. Surgeons should be critical of studies funded by device companies because they could lead to a bias among the surgeons participating in the study if the surgeon has a financial investment.
4. Insurance companies and evidence-based medicine. Insurance companies are using published studies to form their coverage guidelines for orthopedic and spine procedures. Many won't cover an MRI or treatment unless there is a level one or level two study proving it's necessary. Often, insurance companies will find studies supporting evidence that leads to a lower cost of care. "Insurance companies can find a study that says only six sessions of physical therapy after a shoulder strain is acceptable while another strong study might say you need 20 sessions," says Dr. Berkman. "It makes the waters a little muddied."
However, he says, surgeons who practice evidence-based medicine stand to save millions of dollars in healthcare spending by performing proven surgeries and treatments on appropriately indicated patients. This is especially true in spine surgery, where more than $80 billion is spent annually treating back pain and all of the related modalities. Some insurance companies are scrutinizing requests for spine surgery coverage more closely after the number of surgeries performed over the last few years rose dramatically. "I've seen some surgeons who have very loose indications for spine surgery," says Michael Finn, MD, a neurosurgeon in the department of neurosurgery at the University of Colorado. "There's a lot more money to be made from fusions than discectomies. There might be some surgeons that are pushing the level of fusions and that's going to backfire. The payors are questioning everyone's motivation because of a few bad apples."
Insurance companies' approval guidelines run the risk of becoming too restricting and hindering the patient's access to care, especially if the guidelines are created without physician input. "Surgeons, as experts, really need to be the ones in charge of finding the evidence and making the guidelines," says Dr. Berghoff. "I don't think insurance companies should figure that out for us."
Even when the insurance companies collaborate with physicians for approval criteria, the approving physician may not be an orthopedic or spine surgeon. Sometimes, the surgeon must speak with a physician from the insurance company to receive approval. "We are finding these physicians aren't experienced spine surgeon or orthopedic surgeons, but another type of physician," says Sumeer Sathi, MD, a neurosurgeon with Long Island Neurosciences. "They are following protocol and policy to see if the criteria fit for the patients to have surgery. I don't have a problem with speaking with another physician for approval, but it would be helpful if it were someone who is an experienced spine surgeon who understands the conditions and can render helpful decisions."
5. Procedural guidelines' impact on professional practice. Guidelines set forth by professional organizations examine literature surrounding a specific procedure, such as rotator cuff repair, and devise recommendations for treatment based on the strength of the previously conducted studies, says Dr. Berghoff. Many of the guidelines focus on conducting non-surgical treatment first and using surgery as a last resort in patients without the need for immediate surgical intervention. "Sometimes, the guidelines from one society conflict with what another group has come up with," he says. "Going forward, analysis of the evidence that is out there is going to be very helpful to justify the treatment of what we are doing."
However, in some cases, the focus on non-surgical treatment could drain resources when it's obvious in the patient's individual case that surgery is necessary. "It can really slow down the process because it doesn't allow patients to get surgery in a timely manner if it's appropriate," says Dr. Berkman. "If a patient has suffered a bad rotator cuff tear, they can't work or function normally. The costs are sometimes higher if the patient goes through six weeks of physical therapy and injections and then goes onto surgery when it was evident they would need surgery in the first place."
6. What the future holds. As the industry intensifies its demands for evidence-based medicine, orthopedic and spine surgeons will most likely be driven to conduct research in areas that are lacking evidence. "We're going to have to come up with a little better evidence and a little better rationale if we want to keep getting paid for what we do," says Dr. Finn. Electronic medical record implementation and the creation of a total joint replacement registry in the Untied States will make a large amount of data available for surgeons and researchers to evaluate patient outcomes. "I think orthopedics will be one of the more effective places to put resources," says Dr. Berry. "We're able to keep people active and healthy enough to continue to work and lead productive lives independently."
However, some surgeons have patients who fall outside of the guidelines or evidence-based research and they may worry about malpractice suits because of the patient's situation, says Dr. Berghoff. This level of worry already happens in some fields, such as pulmonary embolism, where conflicting studies and guidelines exist. "As knowledge improves and we learn more about the field, these types of conflicts will likely go away," he says.
The assessment of a successful treatment could also change, as the evidence-based research is more focused on the patient's perception of their outcome. Instead of examining MRIs or the surgeon's assessment, the research will focus on the patient's quality of life and their ability to manage daily activities, says Dr. Berghoff.
Read other analysis on orthopedic and spine surgery:
- The Year Ahead: 9 Biggest Issues for Orthopedic Surgeons in 2011
- AAOS President Dr. Daniel Berry: 4 Thoughts on the Future
- Spinal Fusion's Place in the Future: 9 Points on Fusion Efficacy and Coverage
1. What evidence-based medicine could contribute. There are many potential benefits of focusing on evidence-based medicine. High-level studies can help orthopedic surgeons prove their treatments are effective and identify treatments or procedures that aren't. "Some studies will show that the treatments and surgeries are beneficial to the patients and good value for the money spent on them," says Robert Berghoff, MD, an orthopedic surgeon with Arizona Orthopaedic Associates in Phoenix. "There are also some treatments that might not be worth it and we'll have to change them. We'll stop doing the things that don't hold up to scrutiny."
These studies can also aid surgeons in indicating the appropriate treatment for patients depending on their comorbidities. "The data is a big help for recommending treatment protocols when the physician has to make an ambiguous call due to conflicting or multiple diagnoses," says Scott Trenhaile, MD, an orthopedic surgeon at Rockford (Ill.) Orthopedic. "Surgeons could also use that evidence to better explain to a patient that a treatment may not be completely effective because of their comorbidities. Now we can show them the objective data on patients with similar comorbidities and that helps the patient understand that other health conditions may be part of the problem and could affect the outcome of their treatment."
2. Impact on technology and device markets. Orthopedic surgeons are constantly looking for ways to improve technologies and procedures, but these innovations usually come at an increased cost. Many orthopedists are now employing minimally invasive surgical techniques, which often require expensive systems and instrumentation. Some of this innovation may not be cost-effective for the surgeon due to low reimbursement rates or to patients due to lack of evidence supporting the technology's value over other treatment methods or procedures. "It's important we monitor upgrades and improvements for patients to ensure there is meaningful justification for the cost," says Dr. Trenhaile. "We have a responsibility to make sure those dollars are well spent, yet continue to innovate."
Stricter regulations in the FDA approval process mean orthopedic and spine device companies need to conduct extensive studies to prove a new device is equally or more effective than products already on the market. "Just because a product is new doesn't mean its better," says Dr. Berry.
3. The trouble with requiring high level studies. Empirical evidence and experience might tell a surgeon that a procedure is effective, but the high level studies don't currently exist to back up some of those claims. High level evidence studies aren't common in orthopedics because they are expensive and difficult to conduct. "In the past, studies have been published without real strong peer review and analysis of the information," says Eric Berkman, MD, an orthopedic surgeon at Elite Orthopaedics & Spine in Houston. "Evidence-based medicine emphasizes level one studies, which have every bell and whistle to make sure they are done accurately with an emphasis on treatment for the patients. They are prospective, randomized, controlled, double-blinded studies and include objective testing analysis to make sure the study itself was done correctly."
One way these studies are funded is through orthopedic and spine device companies because these companies must conduct research to prove their device belongs on the market. When evaluating the literature, surgeons and other industry professionals also need to consider the study's source. "Even with a good study, you have to see what companies are sponsoring them," says Dr. Berkman. Surgeons should be critical of studies funded by device companies because they could lead to a bias among the surgeons participating in the study if the surgeon has a financial investment.
4. Insurance companies and evidence-based medicine. Insurance companies are using published studies to form their coverage guidelines for orthopedic and spine procedures. Many won't cover an MRI or treatment unless there is a level one or level two study proving it's necessary. Often, insurance companies will find studies supporting evidence that leads to a lower cost of care. "Insurance companies can find a study that says only six sessions of physical therapy after a shoulder strain is acceptable while another strong study might say you need 20 sessions," says Dr. Berkman. "It makes the waters a little muddied."
However, he says, surgeons who practice evidence-based medicine stand to save millions of dollars in healthcare spending by performing proven surgeries and treatments on appropriately indicated patients. This is especially true in spine surgery, where more than $80 billion is spent annually treating back pain and all of the related modalities. Some insurance companies are scrutinizing requests for spine surgery coverage more closely after the number of surgeries performed over the last few years rose dramatically. "I've seen some surgeons who have very loose indications for spine surgery," says Michael Finn, MD, a neurosurgeon in the department of neurosurgery at the University of Colorado. "There's a lot more money to be made from fusions than discectomies. There might be some surgeons that are pushing the level of fusions and that's going to backfire. The payors are questioning everyone's motivation because of a few bad apples."
Insurance companies' approval guidelines run the risk of becoming too restricting and hindering the patient's access to care, especially if the guidelines are created without physician input. "Surgeons, as experts, really need to be the ones in charge of finding the evidence and making the guidelines," says Dr. Berghoff. "I don't think insurance companies should figure that out for us."
Even when the insurance companies collaborate with physicians for approval criteria, the approving physician may not be an orthopedic or spine surgeon. Sometimes, the surgeon must speak with a physician from the insurance company to receive approval. "We are finding these physicians aren't experienced spine surgeon or orthopedic surgeons, but another type of physician," says Sumeer Sathi, MD, a neurosurgeon with Long Island Neurosciences. "They are following protocol and policy to see if the criteria fit for the patients to have surgery. I don't have a problem with speaking with another physician for approval, but it would be helpful if it were someone who is an experienced spine surgeon who understands the conditions and can render helpful decisions."
5. Procedural guidelines' impact on professional practice. Guidelines set forth by professional organizations examine literature surrounding a specific procedure, such as rotator cuff repair, and devise recommendations for treatment based on the strength of the previously conducted studies, says Dr. Berghoff. Many of the guidelines focus on conducting non-surgical treatment first and using surgery as a last resort in patients without the need for immediate surgical intervention. "Sometimes, the guidelines from one society conflict with what another group has come up with," he says. "Going forward, analysis of the evidence that is out there is going to be very helpful to justify the treatment of what we are doing."
However, in some cases, the focus on non-surgical treatment could drain resources when it's obvious in the patient's individual case that surgery is necessary. "It can really slow down the process because it doesn't allow patients to get surgery in a timely manner if it's appropriate," says Dr. Berkman. "If a patient has suffered a bad rotator cuff tear, they can't work or function normally. The costs are sometimes higher if the patient goes through six weeks of physical therapy and injections and then goes onto surgery when it was evident they would need surgery in the first place."
6. What the future holds. As the industry intensifies its demands for evidence-based medicine, orthopedic and spine surgeons will most likely be driven to conduct research in areas that are lacking evidence. "We're going to have to come up with a little better evidence and a little better rationale if we want to keep getting paid for what we do," says Dr. Finn. Electronic medical record implementation and the creation of a total joint replacement registry in the Untied States will make a large amount of data available for surgeons and researchers to evaluate patient outcomes. "I think orthopedics will be one of the more effective places to put resources," says Dr. Berry. "We're able to keep people active and healthy enough to continue to work and lead productive lives independently."
However, some surgeons have patients who fall outside of the guidelines or evidence-based research and they may worry about malpractice suits because of the patient's situation, says Dr. Berghoff. This level of worry already happens in some fields, such as pulmonary embolism, where conflicting studies and guidelines exist. "As knowledge improves and we learn more about the field, these types of conflicts will likely go away," he says.
The assessment of a successful treatment could also change, as the evidence-based research is more focused on the patient's perception of their outcome. Instead of examining MRIs or the surgeon's assessment, the research will focus on the patient's quality of life and their ability to manage daily activities, says Dr. Berghoff.
Read other analysis on orthopedic and spine surgery:
- The Year Ahead: 9 Biggest Issues for Orthopedic Surgeons in 2011
- AAOS President Dr. Daniel Berry: 4 Thoughts on the Future
- Spinal Fusion's Place in the Future: 9 Points on Fusion Efficacy and Coverage