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Eeric Truumees, MD

AAOS Now

Published 7/1/2017
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Eeric Truumees, MD

The Arduous Trek to Follow the Evidence

For years, close margins at the time of breast cancer excision led to a return to the operating room to achieve a wider margin. Surgical oncologists were simply not sure of how wide a margin was "enough." Then, in 2014, a meta-analysis of available data showed that as long as the margin was clear, it did not need to be wide.

Recently, the impact of this guidance on surgical rates was reported. In just 2 years, a sizable, 16 percent reduction in "take-back" surgery was reported. The rate at which women chose breast-conserving lumpectomy surgery over mastectomy also increased. The authors were convinced that, with time, adherence to the guideline would improve, and revision surgery rates would fall further.

In contradistinction, in 2004, the U.S. Surgeon General issued a report on bone health, which identified osteoporosis as among the most important health issues facing Americans due to the downward spiral of physical and mental health decline and early mortality that follow fragility fractures. The report noted that "much of the burden of bone disease can potentially be avoided … if at-risk individuals are identified and appropriate interventions" are undertaken. At that time, several studies concluded that "appropriate evaluation and treatment of low-energy (fragility) fractures are generally the exception, not the rule."

The American Orthopaedic Association responded to the report with a call to action. Initiated in 2005, the Own the Bone program focuses on the prevention of secondary fractures after a low-energy break. Although the program has been successful, much remains to be done. A decade later, a worldwide survey found that fewer than 10 percent of orthopaedists would order densitometry and only 33 percent would prescribe calcium and vitamin D supplementation for their patients who had sustained a low-energy fracture.

Evidence in orthopaedic surgery
Concurrent with coverage of the changes in breast cancer surgery were reports on the role of arthroscopy in patients with osteoarthritis of the knee. According to the lay media, arthroplasty is a frequently performed, "unnecessary" surgery. As an orthopaedic surgeon who has had—but does not perform—knee arthroscopy, I recalled earlier media attention around a 2002 study. I wondered whether surgery for this indication was still common in the United States, and if so, why? Apparently, knee arthroscopy is still common, not only in the United States, but also in Canada, England, Australia, and elsewhere.

Of course, the lay media coverage paints with a broad brush. The headline is "Knee Arthroscopy Is Unnecessary." Less attention is paid to the "for degenerative arthritis" part. The most recent popular press coverage came after a consensus statement published in The BMJ. Its conclusions included "a strong recommendation against the use of arthroscopy in nearly all patients with degenerative knee disease, based on linked systematic reviews; further research is unlikely to alter this recommendation." Patients with meniscus tears were also specifically mentioned as not benefitting from knee arthroscopy (no better than exercise therapy).

Other controversies have surrounded clinical guidelines and orthopaedic care, including strong recommendations against viscosupplementation and vertebroplasty. Because almost every orthopaedic surgeon I know wants to "do the right thing" for his or her patients, I had to ask: If we know what the right thing is, why aren't we doing it?

Barriers to adoption
The barriers to adoption of treatment guidelines are numerous. Often, these obstacles work in concert to frustrate the shift to evidence-based medicine. Throughout medicine, provider acceptance of clinical guidelines is most frequently limited by the perception that these guidelines, regardless of how broadly written, cannot account for all variations in clinical presentation.

In response to The BMJ's consensus study, the Advisory Board's "Daily Briefing" interviewed two orthopaedic surgeons—Peter MacDonald, MD, president of the Canadian Orthopaedic Association, and David Johnson, MD, a physician with the MedStar Orthopaedic Institute. In disagreeing with the conclusions of the consensus recommendation, Dr. Johnson stated that he would continue to consider each individual patient's symptoms and findings.

Dr. MacDonald's response echoed other voices. Avoiding the surgery is difficult, he said, because "the patient comes into your office with a preconceived notion that he needs arthroscopy, and then you discover there is arthritis in the knee. Trying to talk that patient out of surgery is not as easy as it sounds. Patients often demand it ... because for them it's better than having a knee replacement or languishing in pain."

Typically, shared decision making is framed as "I've recommended a surgery, but the patient doesn't want it." All too often, the situation is reversed: "I don't think the requested surgery is the best choice, but the patient is adamant." The emotional aspects of this challenging discussion are well-described in this issue's "New Habits Can Better Serve Patients" on page 12. Orthopaedic surgeons are human. The desire to please or carry out the action expected of us is powerful.

The lay media's focus on breakthroughs and advances drives patients to seek the latest and greatest, even when supporting evidence is in short supply. The rapid growth of laser surgery and stem cell centers provides an excellent example of this phenomenon. In addition, too many practitioners see guidelines as promoting "cookbook medicine" or stifling innovation. Conflicts are most frequently encountered in areas with rapidly evolving treatment options, multiple-specialty involvement, or a very limited evidence base.

A perfect example lies in the multiple guidelines surrounding surgery for low back pain. Some of the earliest, such as the Milliman Care Guidelines, are proprietary and were privately created for use by payers. When researchers used the AGREE (Appraisal of Guidelines Research and Evaluation) tool to assess several of these guidelines, they concluded that three were of "poor quality." The presence of multiple guidelines, even if they are largely in agreement, serves to confuse readers or to diminish their potential impact. For example, in contrast to The BMJ's consensus guidelines, the AAOS guideline does not recommend arthroscopic lavage for symptomatic knee osteoarthritis, but specifically excludes patients with a "primary diagnosis of meniscal tear, loose body, or other mechanical derangement."

In other cases, multiple provider specialties may be variably involved in the delivery of non–evidence-based care. For example, the AAOS guideline offers strong evidence that it cannot recommend viscosupplementation. When news of 41 knee infections after such injections was recently reported, the practice focus of the three named physicians—Mariam Rubbani, MD; Carol Skipper, MD; and clinic owner John Rush, MD—was not included. Not one is an orthopaedic surgeon, but rather a physical medicine and rehabilitation specialist, a family practitioner, and an internist, respectively. At times, different groups or societies may come to different conclusions based on the same evidence.
(A recent example is the routine use of prostate-specific antigen screening.) These conflicting guidelines increase confusion and decrease overall adherence.

The initiation and maintenance of bone-building therapies in osteoporotic patients offer another example of the multidisciplinary cooperation required to comply with clinical guidelines. Orthopaedic surgeons, when surveyed, accept recommendations that bone loss must be addressed in patients who sustain a fragility fracture. However, they often do not feel adequately trained in the assessment and management of osteoporosis and prefer to defer this care to primary and other caregivers. But patients, primary caregivers, and others may not see the value in following evidence-based recommendations.

One recent study suggested that, despite its much higher cost, zoledronic acid infusion offered increased value over oral alendronate because of improved drug adherence. Another recent study documented high discontinuation rates with a wide array of anti-osteoporotic therapies: "At 12 months, discontinuation was highest among patients using ibandronate (69.1 percent), followed by teriparatide (67.1 percent), zoledronic acid (59.2 percent), and denosumab (48.8 percent). By 24 months, discontinuation was higher for each treatment: 87.5 percent for ibandronate, 87.9 percent for teriparatide, 79.8 percent for zoledronic acid, and 64.3 percent for denosumab."

A 2015 study reported an "ecological analysis" of oral bisphosphonate use relative to lay media reports of adverse effects of these drugs and the rate of hip fractures. Media reports about effects such as osteonecrosis of the jaw between 2006 and 2010 were associated with spikes in Internet searches about bisphosphonates. Then, between 2008 and 2012, oral bisphosphonate use dropped more than 50 percent.

Because popular media are unconstrained by peer review and operate on a daily or weekly cycle, they are much more influential than scientific publications that publish on a monthly or yearly cycle. In addition, lay media reports mentioned—but offered incomplete information about—study groups' and experts' financial ties with the pharmaceutical industry. Moreover, those reports rarely offered a balanced analysis of the risks and benefits of these therapies. Interestingly, funding for many of the involved television programs came from companies that produced alternative anti-osteoporotic therapies.

The impact of economic factors cannot be minimized. Although few orthopaedic surgeons purposefully do the wrong thing, a strong conflict of interest may bias their interpretation of the literature and their anecdotal recollection of patients' experiences with the intervention under consideration. More commonly, though, economic access to evidence-based care is an obstacle. Whether in the management of major depression or in anticipation of complex psychosocial needs in a spine surgery patient, orthopaedic surgeons are good at giving the drug and performing the surgery, but evidence-based recommendations for cognitive-behavioral therapy are often ignored simply because the care is not available or affordable to the patient. Even proper pharmaceutical and surgical therapy may become difficult to obtain due to increasing deductibles and other affordability issues.

Moving forward
Today, most medical and legal authorities have concluded that "guidelines do not always establish a presumption of adequate care. Principally for this reason, proposed clinical practice guidelines (CPGs) are not equated with per se legal liability in negligence cases." Typically, the physician's deviation from these guidelines is best supported by "reasoned medical analysis." Perhaps, over time, increasingly sophisticated guidelines and various software tools to incorporate them into electronic medical records, prescribing, and hospital order entry systems will change this perception.

Guidelines adherence is higher in the more controlled hospital setting. In a 2013 study, compliance with the American College of Chest Physician's venous thromboembolism prophylaxis guidelines was 85.7 percent for inpatients, but only 63.4 percent for outpatients. Perhaps in this area, bundling of care will improve compliance. Alternatively, the loss of immediate oversight when the patient is released from the hospital may leave the surgeon and hospital responsible for quality markers over which they have little control. Certainly, increased incorporation of guidelines-based treatment and testing recommendations into quality metrics (and thus physician reimbursement) will affect adoption.

The sidebar to the "New Habits Can Better Serve Patients" story offers another, potentially powerful tool to address this problem: the narrative. In engaging orthopaedic surgeons, our partner physicians, or the patients themselves, a good story goes a long way. Just as scary stories about bisphosphonates in the lay media had a marked, negative impact on patient compliance, a few powerful anecdotes about the importance of bone building therapies may increase interest and resolve.

AAOS Now will continue to report on new CPGs that affect orthopaedic surgeons, along with the impact of any new quality metrics. In addition, the AAOS Committee on Evidence-Based Quality and Value recently began an initiative to highlight the most "impactful" recommendations of each AAOS CPG. Their work will be presented in future issues.

Eeric Truumees, MD, is editor-in-chief of AAOS Now.

References:

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