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During this presidential election year, we have been challenged to understand the platforms and goals of the candidates. Negative rhetoric has distracted voters from focusing on key issues. Likewise, the general public rightfully questions whether elected officials represent their interests or just provide opportunities for financial supporters to continue to prosper at unprecedented levels.
At the core of participation in any political process is appreciation for the different models of leadership. Two primary models include the trustee model and delegate model. In the trustee model, voters believe the representative is selected for their overall belief structure and campaign goals. However, once in office, they should be allowed to use their best judgment to make decisions and vote on legislation. The hope is the representative will consider the various views of his or her constituency and understand the legislation’s consequences, then vote based on his or her own best decision, even it if does not match the majority of the constituency. This is the model most commonly assumed in American politics and professional organizations, such as the American Academy of Orthopaedic Surgeons (AAOS).
The delegate model requires more consistent interaction between representatives and constituency. The elected official is not expected to make key decisions based on a personal bias and judgment, but rather vote and support the view of the majority of the constituents.
Anthony A. Romeo
In reality, both models are in action. The higher the level of involvement of the constituents means the greater the likelihood that representatives will vote according to the sentiments of the majority of supporters.
‘Quality’ programs
In our professional lives, we recognize the AAOS as our key representative for all issues related to orthopedic surgery. The AAOS services more than 39,000 members worldwide, especially the more than 28,000 members from the United States, according to the 2014 AAOS Orthopaedic Surgeon Census. The census allows the AAOS and its elected officials to better understand its constituency. With participation from a majority of orthopedists, the information can be used for more of a delegate model of leadership, providing data that reflects its constituency without extensive estimations.
The AAOS has made a strong effort to provide education regarding musculoskeletal conditions since its beginning in 1933, including more recently an entire team dedicated to the topic of “quality.” The AAOS quality programs include clinical practice guidelines (CPGs), appropriate use criteria (AUC), performance measures and patient safety. In many cases, the development of these programs is initiated by the leadership and then accomplished by committee. For CPGs, there is a further vetting process, with invited public comments finally resulting in a CPG that is published and supported by the AAOS. Positions statements are developed and accepted without concern.
The effort in the creation of CPGs and AUCs is a valuable service for AAOS constituents, as ideally we prefer our peers and leaders to be involved in the process instead of a third party where cost concerns can bias the final results. However, acceptance without criticism has not been the case with some of the CPGs and AUC, including those on rotator cuff problems and osteoarthritis (OA) of the knee. What has been surprising for some orthopedic surgeons is the effort to eliminate valuable evidence from the analysis and discussion because it does not meet the strictest criteria or the latest statistical manipulation of the data. When the process restricts the available data to only the highest level of evidence, realizing day-to-day practice and patient care are full of decisions based on level 4 or level 5 evidence, then a unique academic bias has been imparted on the process. This raises the threshold for supporting practice patterns widely accepted as beneficial to most patients. Furthermore, when the AAOS, committees and leadership then impart a more stringent mathematical analysis, such as minimal clinically important difference (MCID), the leadership is aware these statistical metrics can result in significant changes even in the value of the highest evidence-based medicine available.
Role of evidence-based medicine
For rotator cuff problems, the CPG includes statements, such as there is limited evidence for the treatment of chronic, symptomatic full thickness rotator cuff tears with surgical repair; and there is limited evidence to support early surgical repair after an acute injury that results in a rotator cuff tear. Furthermore, the committee concluded the evidence was inconclusive regarding factors, such as smoking, prior shoulder infection and diabetes and the potential for adverse events on the outcome.
One of the most contentious issues in this area is viscosupplementation and its role in the management of knee OA. Multiple studies with variable levels of evidence have demonstrated a positive clinical effect with the use of certain types of viscosupplementation for knee OA. The selected level of evidence-based medicine was based on the committee and its leadership bias. A systematic review of most of the published literature considered more than 80 articles, while the CPGs were based on only 14 studies. Evidence-based medicine includes expert opinion and case series, although their values are weighted less than higher levels of evidence, but this evidence was excluded from the process by the AAOS committee. In addition, the committee applied the statistical metric MCID, which adversely affected the conclusions on clinical outcomes even with the higher levels of evidence-based medicine. Based on this process, from 2008 to 2013, the AAOS committee changed its recommendation from inconclusive to strongly recommending against the use of viscosupplementation.
Consequences were immediately felt by thousands of orthopedic surgeons. Insurance companies began denying coverage, patients had to pay for the treatment on their own and orthopedic surgeons had one less clinical method to try to delay knee arthroplasty. This has been frustrating for surgeons and patients who have experienced good results with viscosupplementation. Fortunately, numerous contemporary studies have shown positive clinical effects, which may affect future CPGs.
Stay engaged
The role of politics and the influence of constituents can seem hidden in these examples of how leadership has attempted to apply science to clinical practice. However, they do show the scientific process of evidence-based medicine, analysis of the process and development of CPGs are flawed. When contributing to the published literature, personal biases, experiences and concerns play a role in the final product. Peer review helps to minimize bias and disclosure of conflicts of interest also provide insight. However, there may be hidden conflicts of interest, with perhaps the greatest one being the ego of the people who conduct the research. After a tremendous commitment of time and effort, the need to hold fast to the conclusions despite flawed evidence is a product of human nature.
We are all constituents of some political process by way of either the election of public officials or participation in the AAOS. If we do not make the effort to stay engaged with our representatives, they will act from the trustee model, making decisions they feel are best for the constituency even without consensus.
If we are engaged in the process, we will move toward the delegate model where representatives feel a greater level of responsibility to reflect the majority of the constituency. Be involved with those who represent us. Although the entire process is human-based and, thus, flawed at some level, it represents the best opportunity to influence change.
- Reference:
- AAOS Department of Research and Scientific Affairs. Orthopaedic practice in the U.S. 2014. Available online at www.aaos.org/2014OPUS/?ssopc=1.
- For more information:
- Anthony A. Romeo, MD, is the Chief Medical Editor of Orthopedics Today. He can be reached at Orthopedics Today, 6900 Grove Rd., Thorofare, NJ 08086; email: orthopedics@healio.com.
Disclosures: Romeo reports he receives royalties, is on the speaker’s bureau and a consultant for Arthrex; does contracted research for Arthrex and DJO Surgical; receives institutional grants from AANA and MLB; and receives institutional research support from Arthrex, Ossur, Smith & Nephew, ConMed Linvatec, Athletico and Miomed.