Commentary

Join the effort to create truly valuable clinical practice guidelines

More than 10 years ago, the American Academy of Orthopaedic Surgeons established multiple initiatives to better define quality care. Among the efforts was the development of evidence-based clinical practice guidelines. To date, more than 16 clinical practice guidelines have been developed by work groups organized through the AAOS Department of Research and Scientific Affairs and the Committee on Evidence-Based Quality and Value, with more guidelines in progress.

The clinical practice guidelines (CPGs) are intended to help musculoskeletal care providers make evidence-based decisions about specific conditions. A valuable CPG inherently has two goals: a systematic review of the evidence-based research on a clinically relevant question, and subsequently, the development of recommendations on how patients who have the defined clinical problem should be managed.

Anthony A. Romeo, MD
Anthony A. Romeo

Value of CPGs

A valuable CPG is not only constructed with effective guidelines as established by the Institute of Medicine (IOM), but serves as a tool to use in clinical and surgical environments. A CPG developed with strict adherence to the ideal methodology, but with conclusions and language not applicable to current clinical care has little value other than as a research tool to identify areas where evidence is limited and study is warranted. Unfortunately, that is the case with some of the key CPGs developed by the AAOS.

Using the strictest criteria for methodology, even beyond IOM standards, the AAOS receives high marks for the methodological quality used in the development of its CPGs. Factors, such as scope and purpose, stakeholder involvement and editorial independence, are high. Unfortunately, the applicability and use of the recommendations in clinical practice remains low. In the face of poor applicability with substantial costs in terms of time of staff and work group members, value to AAOS membership can be regarded as questionable.

As concerns about the ability to apply CPG recommendations to clinical practice have grown, orthopedic surgeons are anxious when they read the conclusions of specific domains and questions in the CPG labeled as “inconclusive” or “limited evidence.” Researchers interpret this as weak or absent evidence with further study necessary. To a third-party payer, this may be interpreted as reasonable grounds for denying care and could interfere with the physician-patient relationship.

Constructive criticism of the process and its conclusions comes from various sources. A consistent criticism has been that evidence-based medicine allows for five levels of evidence to be involved in the conclusion, yet the work groups were discouraged to consider level 4 (case control) and level 5 (expert opinion) studies in their rulings on treatment and often level 1 and level 2 studies were unavailable. Some expressed concern that numerous level 4 studies would be outweighed by a single level 1 or level 2 study, even if the methodology of higher level studies was inconsistent with typical clinical practice. If higher level evidence was lacking, but level 4 and level 5 evidence was present, the official opinion of the work group regarding the treatment domain could still be labeled as “inconclusive,” implying limited or no value and therefore no support to incorporate into the treatment plan, as well as no support for a third-party payer to provide approval and payment for care.

The work group recently introduced the concept of a minimally clinically important difference to analyze results of a clinical trial, which led to a change from an earlier recommendation of inconclusive to “strongly recommending against” for therapeutic treatments that have numerous studies to support their clinical use. With this new stricter standard, the bar was raised higher to suggest that even with statistically significant positive results, the results needed to have a higher level of clinical relevance. Unfortunately, this takes into consideration many factors, such as the documentation of baseline symptoms with strong subjective components. This affects patient care and reimbursement by removing the treatment from a subset of the population who benefit from the intervention.

Valuable opportunities ahead

The AAOS leadership and AAOS Committee on Evidence-Based Quality and Value have heard the criticisms and representatives have authored responses. They remain steadfast in suggesting that CPGs “are statements that include recommendations intended to optimize patient care.” Fortunately, in 2014, the Committee on Evidence-Based Quality and Value adopted changes to improve clinical usefulness and clarity. The changes included: clarification of the roles of experts with potential conflicts of interests; allowing input on question development from all stakeholders; listing all relevant studies, including studies with lower levels of evidence; being alert to articles that qualify as an upgrade in quality; addition of a benefits and harm component; and elimination of the “inconclusive” rating. Furthermore, when supporting evidence is lacking, specialty societies are invited to develop companion consensus statements. This is taking place for periprosthetic joint infection. The recent changes in the CPG process provide a new and more valuable opportunity to engage all stakeholders, especially subspecialty societies, to achieve the goals of systematic research review on clinically relevant questions and the development of recommendations for clinical care.

The AAOS should be commended for its effort to respond to the constructive criticism and provide improved transparency by the AAOS Committee on Evidence-Based Quality and Value and the work groups, as well as efforts for improved participation from stakeholders, and a better focus on the development of clinically relevant recommendations for practicing orthopedic surgeons. The best and brightest evidence-based practitioners and clinical experts in areas where evidence lacks should be encouraged to create truly valuable CPGs for all who care for musculoskeletal problems.

Disclosure: Romeo reports he receives royalties, is on the speakers 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.

More than 10 years ago, the American Academy of Orthopaedic Surgeons established multiple initiatives to better define quality care. Among the efforts was the development of evidence-based clinical practice guidelines. To date, more than 16 clinical practice guidelines have been developed by work groups organized through the AAOS Department of Research and Scientific Affairs and the Committee on Evidence-Based Quality and Value, with more guidelines in progress.

The clinical practice guidelines (CPGs) are intended to help musculoskeletal care providers make evidence-based decisions about specific conditions. A valuable CPG inherently has two goals: a systematic review of the evidence-based research on a clinically relevant question, and subsequently, the development of recommendations on how patients who have the defined clinical problem should be managed.

Anthony A. Romeo, MD
Anthony A. Romeo

Value of CPGs

A valuable CPG is not only constructed with effective guidelines as established by the Institute of Medicine (IOM), but serves as a tool to use in clinical and surgical environments. A CPG developed with strict adherence to the ideal methodology, but with conclusions and language not applicable to current clinical care has little value other than as a research tool to identify areas where evidence is limited and study is warranted. Unfortunately, that is the case with some of the key CPGs developed by the AAOS.

Using the strictest criteria for methodology, even beyond IOM standards, the AAOS receives high marks for the methodological quality used in the development of its CPGs. Factors, such as scope and purpose, stakeholder involvement and editorial independence, are high. Unfortunately, the applicability and use of the recommendations in clinical practice remains low. In the face of poor applicability with substantial costs in terms of time of staff and work group members, value to AAOS membership can be regarded as questionable.

As concerns about the ability to apply CPG recommendations to clinical practice have grown, orthopedic surgeons are anxious when they read the conclusions of specific domains and questions in the CPG labeled as “inconclusive” or “limited evidence.” Researchers interpret this as weak or absent evidence with further study necessary. To a third-party payer, this may be interpreted as reasonable grounds for denying care and could interfere with the physician-patient relationship.

PAGE BREAK

Constructive criticism of the process and its conclusions comes from various sources. A consistent criticism has been that evidence-based medicine allows for five levels of evidence to be involved in the conclusion, yet the work groups were discouraged to consider level 4 (case control) and level 5 (expert opinion) studies in their rulings on treatment and often level 1 and level 2 studies were unavailable. Some expressed concern that numerous level 4 studies would be outweighed by a single level 1 or level 2 study, even if the methodology of higher level studies was inconsistent with typical clinical practice. If higher level evidence was lacking, but level 4 and level 5 evidence was present, the official opinion of the work group regarding the treatment domain could still be labeled as “inconclusive,” implying limited or no value and therefore no support to incorporate into the treatment plan, as well as no support for a third-party payer to provide approval and payment for care.

The work group recently introduced the concept of a minimally clinically important difference to analyze results of a clinical trial, which led to a change from an earlier recommendation of inconclusive to “strongly recommending against” for therapeutic treatments that have numerous studies to support their clinical use. With this new stricter standard, the bar was raised higher to suggest that even with statistically significant positive results, the results needed to have a higher level of clinical relevance. Unfortunately, this takes into consideration many factors, such as the documentation of baseline symptoms with strong subjective components. This affects patient care and reimbursement by removing the treatment from a subset of the population who benefit from the intervention.

Valuable opportunities ahead

The AAOS leadership and AAOS Committee on Evidence-Based Quality and Value have heard the criticisms and representatives have authored responses. They remain steadfast in suggesting that CPGs “are statements that include recommendations intended to optimize patient care.” Fortunately, in 2014, the Committee on Evidence-Based Quality and Value adopted changes to improve clinical usefulness and clarity. The changes included: clarification of the roles of experts with potential conflicts of interests; allowing input on question development from all stakeholders; listing all relevant studies, including studies with lower levels of evidence; being alert to articles that qualify as an upgrade in quality; addition of a benefits and harm component; and elimination of the “inconclusive” rating. Furthermore, when supporting evidence is lacking, specialty societies are invited to develop companion consensus statements. This is taking place for periprosthetic joint infection. The recent changes in the CPG process provide a new and more valuable opportunity to engage all stakeholders, especially subspecialty societies, to achieve the goals of systematic research review on clinically relevant questions and the development of recommendations for clinical care.

PAGE BREAK

The AAOS should be commended for its effort to respond to the constructive criticism and provide improved transparency by the AAOS Committee on Evidence-Based Quality and Value and the work groups, as well as efforts for improved participation from stakeholders, and a better focus on the development of clinically relevant recommendations for practicing orthopedic surgeons. The best and brightest evidence-based practitioners and clinical experts in areas where evidence lacks should be encouraged to create truly valuable CPGs for all who care for musculoskeletal problems.

Disclosure: Romeo reports he receives royalties, is on the speakers 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.